Memorial Medical Center

“GOVERNING BODY CFR(s): 482.12 There must be an effective governing body that is legally responsible for the conduct of the hospital. If a hospital does not have an organized governing body, the persons legally responsible for the conduct of the hospital must carry out the functions specified in this part that pertain to the governing body ... This Condition is not met as evidenced by: 49884 Based on interview and record review, the hospital failed to have an effective governing body that is legally responsible for the conduct of the hospital and failed to ensure that medical staff appointments requirements were met when: 1. The GB did not have a system in place to oversee the privileges and reappointments of physicians and ensured GB Bylaws were followed. Medical Doctor (MD) 1 requested reappointment and was granted cardiac surgery privileges without MD 1 meeting the requirements set forth by department and Medical Staff Bylaws. (Refer to A-0340 -1) 2. The GB did not have a system in place to oversee the privileges and credentialing of physicians. MD 2’s credential file included Intensive Care Unit (ICU - specialized area within a hospital or healthcare facility dedicated to providing intensive medical care to patients with serious, life-threatening conditions) procedural privileges and the credential file did not include MD 2 to have approved privilege to manage patients in ICU or privileges for EKG interpretations. (Refer to A-0340 -2) 3. The GB did not have a system in place to oversee the privileges and reappointments of physicians and ensured GB Bylaws were followed. MD 3 and MD 4 at the end of their provisional appointment did not have evaluation in accordance with Medical Staff Bylaws. MD 3 and MD 4 did not have required proctoring completed and their appointment was not extended following the process as listed in Medical Staff Bylaws (Refer to A-0340 -3) The cumulative effect of these systemic problems resulted in the hospital’s inability to provide care in a safe and quality manner.”

“PATIENT RIGHTS CFR(s): 482.13 A hospital must protect and promote each patient’s rights. This Condition is not met as evidenced by: 49884 Based on observation, interview and record review, the hospital failed to protect and promote each patient’s rights when: 1. One of seven patients (Pt 9) whose preferred language was not English, and a signed consent was not obtained in a language Pt 9 could understand, according to the hospital Policy and Procedure (P&P) titled, “Language Assistance Services Policy” and “Consent, Informed,”. (Refer to A-131 Finding 1) 2. One of 12 patients (Pt 15) whose preferred language was not English, the Conditions of Admissions [COA-documents the patient’s consent to the general terms and condition for receiving care from the hospital] documents were not provided in the preferred language, in accordance with the hospital P&P titled, “Language Assistance Services Policy” and “Conditions of Admissions and/or Registration Form”. (Refer to A-131 Finding 2) 3. Staff stored non-compatible products in the warmer located in emergency department (ED) of the hospital and not in accordance with the operating instructions of the warmer. (Refer to A-144 Finding 1) 4. One of one patient (Patient [Pt]5), Lead Nuclear Medical Technologist (LNMT-Lead staff working in Nuclear Medicine Department) 1 failed to verify patient identity prior to the administration of a radiopharmaceutical (drug containing radioactive material). LNMT 1 injected 3 milliliters (ML- a unit of volume measurement) of another patient’s (Pt 6’s) radioisotope tagged white blood cells (-a small amount of radioactive material attached to the white blood cell [WBC-part of blood], in a special pharmacy) into Pt 5’s vein. LNMT 1 failed to follow the hospital P&Ps titled, “Nuclear Medicine: Radiopharmaceutical Preparation, Labeling, and Administration”, and “Identification: Patient Armband/Patient Verification” and did not follow standards of practice for medication administration. (Refer to A-144 Finding 2) 5. Respiratory Therapist (RT) 2 removed sutures from the tracheostomy (a surgical procedure that creates an opening in the windpipe to allow air to enter the lungs) site for Pt 4 without being trained to competently perform this task. (Refer to A-144 Finding 3) 6. Staff were aware of Pt 7’s obstructive sleep apnea (OSA-a sleep disorder that causes breathing to repeatedly stop and start during sleep) and did not assess Pt 7’s ability to safely use personal continuous positive airway pressure (CPAP-a machine that uses mild air pressure to keep breathing airways open while you sleep) from home prior to use in the hospital. (Refer to A-144 Finding 4) 7. Staff were aware of Pt 2’s chronic obstructive pulmonary disease (COPD-a common lung disease causing restricted airflow and breathing problems) and congestive heart failure (CHF-a condition where the heart is unable to pump blood effectively) and administered CPAP without first obtaining a physician order. Pt 2 was changed from CPAP to bilevel positive airway pressure (BiPAP a non-invasive breathing machine that helps people breathe when they are having trouble) without first obtaining a physician order to establish the setting parameters for the BiPAP. (Refer to A-144 Finding 5) The cumulative effect of these systemic problems resulted in the hospital’s inability to provide care in a safe setting.”

“PATIENT RIGHTS CFR(s): 482.13 A hospital must protect and promote each patient’s rights. This Condition is not met as evidenced by: 49884 Based on observation, interview and record review, the hospital failed to protect and promote each patient’s rights when: 1. One of seven patients (Pt 9) whose preferred language was not English, and a signed consent was not obtained in a language Pt 9 could understand, according to the hospital Policy and Procedure (P&P) titled, “Language Assistance Services Policy” and “Consent, Informed,”. (Refer to A-131 Finding 1) 2. One of 12 patients (Pt 15) whose preferred language was not English, the Conditions of Admissions [COA-documents the patient’s consent to the general terms and condition for receiving care from the hospital] documents were not provided in the preferred language, in accordance with the hospital P&P titled, “Language Assistance Services Policy” and Conditions of Admissions and/or Registration Form”. (Refer to A-131 Finding 2) 3. Staff stored non-compatible products in the warmer located in emergency department (ED) of the hospital and not in accordance with the operating instructions of the warmer. (Refer to A-144 Finding 1) 4. One of one patient (Patient [Pt]5), Lead Nuclear Medical Technologist (LNMT-Lead staff working in Nuclear Medicine Department) 1 failed to verify patient identity prior to the administration of a radiopharmaceutical (drug containing radioactive material). LNMT 1 injected 3 milliliters (ML- a unit of volume measurement) of another patient’s (Pt 6’s) radioisotope tagged white blood cells (-a small amount of radioactive material attached to the white blood cell [WBC-part of blood], in a special pharmacy) into Pt 5’s vein. LNMT 1 failed to follow the hospital P&Ps titled, “Nuclear Medicine: Radiopharmaceutical Preparation, Labeling, and Administration”, and “Identification: Patient Armband/Patient Verification” and did not follow standards of practice for medication administration. (Refer to A-144 Finding 2) 5. Respiratory Therapist (RT) 2 removed sutures from the tracheostomy (a surgical procedure that creates an opening in the windpipe to allow air to enter the lungs) site for Pt 4 without being trained to competently perform this task. (Refer to A-144 Finding 3) 6. Staff were aware of Pt 7’s obstructive sleep apnea (OSA-a sleep disorder that causes breathing to repeatedly stop and start during sleep) and did not assess Pt 7’s ability to safely use personal continuous positive airway pressure (CPAP-a machine that uses mild air pressure to keep breathing airways open while you sleep) from home prior to use in the hospital. (Refer to A-144 Finding 4) 7. Staff were aware of Pt 2’s chronic obstructive pulmonary disease (COPD-a common lung disease causing restricted airflow and breathing problems) and congestive heart failure (CHF-a condition where the heart is unable to pump blood effectively) and administered CPAP without first obtaining a physician order. Pt 2 was changed from CPAP to bilevel positive airway pressure (BiPAP a non-invasive breathing machine that helps people breathe when they are having trouble) without first obtaining a physician order to establish the setting parameters for the BiPAP. (Refer to A-144 Finding 5) The cumulative effect of these systemic problems resulted in the hospital’s inability to provide care in a safe setting.”

“MEDICAL STAFF CFR(s): 482.22 The hospital must have an organized medical staff that operates under bylaws approved by the governing body, and which is responsible for the quality of medical care provided to patients by the hospital. This Condition is not met as evidenced by: 49884 Based on the interview and record review hospital failed to ensure that medical staff operated under Bylaws approved by governing board, followed medical staff rules and regulations for privileging, followed policies for periodic evaluation of medical staff and provided quality of medical care to the patients when: 1. Medical Doctor (MD) 1 at reappointment requested and was granted cardiac surgery privileges without MD 1 meeting the requirements set forth by department and Medical Staff ByLaws. MD 1 was reappointed by Medical Executive Committee (MEC) and hospital board with cardiac surgery privileges without documented board certification in cardiac surgery; MD 1 did not complete the proctoring requirement and without MD 1 having the expected volume of cases listed for the procedures in which he was granted privileges. MD 1’s specialty specific Ongoing Professional Practice Evaluation (OPPE -A process that identifies and evaluates professional practice trends of practitioners with privileges that impact quality of care and patient safety on an ongoing basis and focus on the individual practitioner’s performance and competence related to privileges ) data was not available for at minimum every 12-month interval as indicated in Medical staff policy (Refer to A-0340 -1) 2. MD 2’s credential file included Intensive Care Unit (ICU - specialized area within a hospital or healthcare facility dedicated to providing intensive medical care to patients with serious, life-threatening conditions) p procedural privileges and the credential file did not include MD 2 to have approved privilege to manage patients in ICU or privileges for EKG interpretations. MD 2 was actively working in ICU, managing patients that require EKG interpretation. MD 2 specialty specific OPPE data was not available for at minimum every 12-month interval as indicated in Medical staff policy (Refer to A-0340 -2) 3. MD 3 and MD 4 at the end of their provisional appointment did not have evaluation in accordance with Med Staff ByLaws. MD 3 and MD 4 did not have required proctoring completed and their appointment was not extended following the process as listed in Medical Staff ByLaws ((Refer to A-0340 -3) 4. Physicians failed to document a progress note for one out of 10 sampled patients Patient (Pt) 25, on a daily basis, during her hospital admission (Refer to A-0347) The cumulative effects of these systemic problems resulted in the hospital’s inability to ensure the provision of quality health care to patients in a safe environment.”

“MEDICAL STAFF CFR(s): 482.22 The hospital must have an organized medical staff that operates under bylaws approved by the governing body, and which is responsible for the quality of medical care provided to patients by the hospital. This Condition is not met as evidenced by: 49884 Based on the interview and record review hospital failed to ensure that medical staff operated under Bylaws approved by governing board, followed medical staff rules and regulations for privileging, followed policies for periodic evaluation of medical staff and provided quality of medical care to the patients when: 1. Medical Doctor (MD) 1 at reappointment requested and was granted cardiac surgery privileges without MD 1 meeting the requirements set forth by department and Medical Staff ByLaws. MD 1 was reappointed by Medical Executive Committee (MEC) and hospital board with cardiac surgery privileges without documented board certification in cardiac surgery; MD 1 did not complete the proctoring requirement and without MD 1 having the expected volume of cases listed for the procedures in which he was granted privileges. MD 1’s specialty specific Ongoing Professional Practice Evaluation (OPPE -A process that identifies and evaluates professional practice trends of practitioners with privileges that impact quality of care and patient safety on an ongoing basis and focus on the individual practitioner’s performance and competence related to privileges ) data was not available for at minimum every 12-month interval as indicated in Medical staff policy (Refer to A-0340 -1) 2. MD 2’s credential file included Intensive Care Unit (ICU - specialized area within a hospital or healthcare facility dedicated to providing intensive medical care to patients with serious, life-threatening conditions) p procedural privileges and the credential file did not include MD 2 to have approved privilege to manage patients in ICU or privileges for EKG interpretations. MD 2 was actively working in ICU, managing patients that require EKG interpretation. MD 2 specialty specific OPPE data was not available for at minimum every 12-month interval as indicated in Medical staff policy (Refer to A-0340 -2) 3. MD 3 and MD 4 at the end of their provisional appointment did not have evaluation in accordance with Med Staff ByLaws. MD 3 and MD 4 did not have required proctoring completed and their appointment was not extended following the process as listed in Medical Staff ByLaws ((Refer to A-0340 -3) 4. Physicians failed to document a progress note for one out of 10 sampled patients Patient (Pt) 25, on a daily basis, during her hospital admission (Refer to A-0347) The cumulative effects of these systemic problems resulted in the hospital’s inability to ensure the provision of quality health care to patients in a safe environment.”

“NURSING SERVICES CFR(s): 482.23 The hospital must have an organized nursing service that provides 24-hour nursing services. The nursing services must be furnished or supervised by a registered nurse. This Condition is not met as evidenced by: 49884 Based on observation, interview and record review, the facility failed to have a well-organized and effective nursing service when: 1. Registered Nurses (RNs) failed to create an individualized care plan for Pt 5’s severe protein and calorie malnutrition (body not getting enough calories or nutrients) according to the hospital policy and procedure (P&P), titled “Patient Plan of Care” and the hospital “Registered Nurse Job Description”. (Refer to A-396 Finding 1) 2. RNs did not develop an individualized care plan for Pt 13’s hypertension (high blood pressure). (Refer to A-396 Finding 2) 3. RN 3 received a critical result (a laboratory result falling outside normal range and requiring immediate attention) from the blood bank for one of one patient (Pt 3) and the RN did not notify the surgeon, or Pt 3’s primary physician within the 30-minute time frame according to the hospital P&P titled “Laboratory Critical and or Call Values”, and did not document a notification to the primary physician per the hospital’s P&P titled “Documentation (Charting) for the Patient Health Record”. (Refer to A-398 Finding 1) 4. Emergency Department (ED) RNs did not administer pain medications or escalate to a physician when one of 3 patients (Pt 26) reported a pain score of 8 out of 10 in the ED, according to hospital P&P titled, “Pain Management”. Pt 26 reported a pain score of 8/10 on three separate occasions and was discharged from the ED with a reported pain score of 8/10, without having her pain addressed by RNs or physicians. (Refer to A-398 Finding 2) 5. One of 10 patients (Pt 5) had an active medical problem of severe protein and calorie malnutrition (body not getting enough nutrients), and RNs and Certified Nursing Assistants (CNA)s failed to document nutritional intake, according to hospital P&P titled, “(Medical) Nutrition Therapy: Meal/Snack Delivery, Pick Up and Intake Recording”. (Refer to A-398 Finding 3) 6. RNs did not assess and document a temperature for one of three patients (Pt 25) in the Labor and Delivery (L&D- a specialized unit where babies are born and pregnant patients are treated) Unit every two hours after rupture of membranes (ROM- when the bag of water that surrounds the unborn baby breaks), according to the hospital’s P&P titled “Admission of Labor Patient”. (Refer to A-398 Finding 4) 7. ED nurses failed to assess Pt 4’s skin and implement pressure relieving interventions upon arrival to ED in accordance with hospital policy. Pt 4 stayed in gurney in ED over nine hours and was not turned, or repositioned. Pt 4 upon arrival to Intensive Care Unit (ICU-specialized unit providing advanced care for critically ill or injured patients) had redness and purple discoloration to back/coccyx area. (Refer to A-398 Finding 5) 8. Nursing staff failed to change Pt 4’s colostomy bag and do a complete assessment of skin around stoma every three to five days in accordance with facility standards or receive a physician order to leave bag in place. Pt 4’s colostomy bag was not changed for 16 days and skin around stoma site was note assess appropriately. (Refer to A-398 Finding 6) 9. One of two patients (Pt 9) did not have an Aldrete assessment (a tool used to assess a patient’s readiness for discharge from the Post-Anesthesia Care Unit (PACU-a specialized area in hospitals where patients recover from anesthesia and surgery) after surgery) completed before discharging from the PACU according to the hospital’s P&P titled, “Transfer From PACU.” (Refer to A-398 Finding 7) 10. One of two patients (Pt 9) did not have a temperature assessed before discharging from the PACU according to the hospital’s P&P titled, “Transfer From PACU. (Refer to A-398 Finding 8) 11. One of three patients (Pt 9) did not have an assessment completed when transferred from one unit of the hospital to another. (Refer to A-398 Finding 9) 12. Two of eight patients (Pt 9 and Pt 13) did not have physician notifications for elevated systolic blood pressure (SBP-the pressure in the arteries when the heart contracts) according to the physician order. (Refer to A-398 Finding 10) 13. Two of two patients (Pt 7 and Pt 10) did not have an incision assessment each shift according to the hospital’s standard of practice. (Refer to A-398 Finding11) 14. One of one patient (Pt 2) who had a community acquired pressure injury (pressure injuries that develop outside of hospital) was not turned every two hours according to the hospital’s P&P titled, “Skin Care: Pressure Related Injury Management.” (Refer to A-398 Finding 12) 15. One of two patients (Pt 2) did not have pain assessments completed according to the physician’s order. (Refer to A-398 Finding 13) 16. One of two patients (Pt 1) did not have triage vital signs completed when arriving to the emergency department (ED) according to the hospital’s P&P titled “Triage Policy.” (Refer to A-398 Finding 14) 17. RN 8 did not clamp the normal saline (NS-a mixture of sodium chloride and water) tubing during a blood administration observation according to nursing standards of practice. (Refer to A-398 Finding 15) The cumulative effect of these system problems resulted in the hospital’s inability to provide quality nursing care in a safe setting.”

“NUCLEAR MEDICINE SERVICES CFR(s): 482.53 If the hospital provides nuclear medicine services, those services must meet the needs of the patients in accordance with acceptable standards of practice. This Condition is not met as evidenced by: 49884 Based on observation, interview and record review, the hospital failed to provide nuclear medicine services in accordance with acceptable standards of practice when: Lead Nuclear Medicine Technologist (LMNT) 1 transported radioactive material meant for Patient (Pt) 6 to the wrong floor and wrong room in the hospital and administered the radioactive material to Pt 5 without first verifying the correct patient. LMNT 1 administered via injection 3 milliliters of radioisotope tagged white blood cells belonging to Pt 6 into Pt 5’s vein and did not follow hospital P&Ps titled, “Nuclear Medicine: Radiopharmaceutical Preparation, Labeling, and Administration”, and “Identification: Patient Armband/Patient Verification” and standards of practice for medication administration. (Refer to A-1035) The cumulative effect of this systemic problem resulted in the hospital’s inability to provide quality patient care in a safe environment.”

“NUCLEAR MEDICINE SERVICES CFR(s): 482.53 If the hospital provides nuclear medicine services, those services must meet the needs of the patients in accordance with acceptable standards of practice. This Condition is not met as evidenced by: 49884 Based on observation, interview and record review, the hospital failed to provide nuclear medicine services in accordance with acceptable standards of practice when: Lead Nuclear Medicine Technologist (LMNT) 1 transported radioactive material meant for Patient (Pt) 6 to the wrong floor and wrong room in the hospital and administered the radioactive material to Pt 5 without first verifying the correct patient. LMNT 1 administered via injection 3 milliliters of radioisotope tagged white blood cells belonging to Pt 6 into Pt 5’s vein and did not follow hospital P&Ps titled, “Nuclear Medicine: Radiopharmaceutical Preparation, Labeling, and Administration”, and “Identification: Patient Armband/Patient Verification” and standards of practice for medication administration. (Refer to A-1035) The cumulative effect of this systemic problem resulted in the hospital’s inability to provide quality patient care in a safe environment.”

“LICENSURE OF PERSONNEL CFR(s): 482.11(c) The hospital must assure that personnel are licensed or meet other applicable standards that are required by State or local laws. This Standard is not met as evidenced by: 49884 Based on interview and record review, the hospital failed to ensure, one out of 13 employees sampled, (Clinical Laboratory Scientist (CLS) 2) completed the required annual abuse training, according to the standard of practice and by state law for California healthcare workers. CLS 2 had not completed the annual training titled, “Reporting Abuse and Neglect”, since 3/28/2021. This failure had the potential to result in CLS 2 failing to understand hospital and State reporting requirements of abuse and neglect for healthcare providers, thereby placing patients of abuse and/or neglect at risk of going unreported by CLS 2. Findings: During a concurrent interview and record review on 4/4/25 at 2:40 p.m. with the Director of Human Resources (DHR), Registered Nurse (RN) 7, and Nurse Educator (NE) 7, CLS 2’s competency and training documentation, dated 2012 to 2025, was reviewed. The competency and training documentation, indicated, the “Reporting Abuse and Neglect,” education module was not completed by CLS 2 for the 2023-2024 year. NE 7 stated the abuse training was an online computer education module and was an annual requirement for CLS 2. NE 7 stated, the last date CLS 2 completed the “Reporting Abuse and Neglect,” education module was 3/28/2021. NE 7 stated, CLS 2 should have completed the education module in 2024. NE 7 stated the education module was important because all healthcare workers needed to know how to report abuse and neglect. During an interview on 4/4/25 at 4: 15 p.m. with the Manager of Accreditation and Licensure (MAL) the MAL stated, the hospital changed the online computer education system to a new provider and the “Reporting Abuse and Neglect,” required education module did not flow over for all departments. The MAL stated CLS 2 should have received the annual abuse education. During a review of a hospital document titled, “List of Job Profiles [LJP],” undated, the “LJP” indicated, 158 hospital employees across 60 departments did not receive the “Reporting Abuse and Neglect,” annual education module for the 2023-2024 year. During a review of a professional reference titled, “Meeting California Training Requirements for Healthcare,” undated, the professional reference indicated “ ...California is known for its progressive politics with a strong emphasis on social justice, environmental issues, and diverse representation. These unique characteristics influence required California training for healthcare professionals. For example, California requires all employers of five or more employees to provide training to supervisory (two hours of training) and nonsupervisory employees (one hours of training) on sexual harassment and abusive conduct prevention. California also requires all individuals who are considered mandated reporters under California law to receive training. Domestic violence training is required based on licensing ....”. During a review of a professional reference titled, “Mandatory Reporting of Child Abuse and Neglect - California,” 5/23, the professional reference indicated, “ ... Mandated reporters include the following: ...An adult person whose duties require direct contact with and supervision of minors in the performance of the minors’ duties in the workplace is a mandated reporter of sexual abuse, as defined in § 11165.1. ...This training shall include training in child abuse and neglect identification and training in child abuse and neglect reporting. The training requirement may be met by completing the general online training for mandated reporters ...”. During a review of a professional reference titled, “California’s New Workplace Violence Prevention Law: The Path to Compliance,” dated 1/10/24, the professional reference indicated, “ ...California has enacted a new workplace violence prevention law, SB 553/California Labor Code Section 6401.9, requiring nearly all California employers to develop and implement a written workplace violence prevention plan, provide annual training on the plan to employees, and maintain a log of incidents of workplace violence ...”.”

“LICENSURE OF PERSONNEL CFR(s): 482.11(c) The hospital must assure that personnel are licensed or meet other applicable standards that are required by State or local laws. This Standard is not met as evidenced by: 49884 Based on interview and record review, the hospital failed to ensure, one out of 13 employees sampled, (Clinical Laboratory Scientist (CLS) 2) completed the required annual abuse training, according to the standard of practice and by state law for California healthcare workers. CLS 2 had not completed the annual training titled, “Reporting Abuse and Neglect”, since 3/28/2021. This failure had the potential to result in CLS 2 failing to understand hospital and State reporting requirements of abuse and neglect for healthcare providers, thereby placing patients of abuse and/or neglect at risk of going unreported by CLS 2. Findings: During a concurrent interview and record review on 4/4/25 at 2:40 p.m. with the Director of Human Resources (DHR), Registered Nurse (RN) 7, and Nurse Educator (NE) 7, CLS 2’s competency and training documentation, dated 2012 to 2025, was reviewed. The competency and training documentation, indicated, the “Reporting Abuse and Neglect,” education module was not completed by CLS 2 for the 2023-2024 year. NE 7 stated the abuse training was an online computer education module and was an annual requirement for CLS 2. NE 7 stated, the last date CLS 2 completed the “Reporting Abuse and Neglect,” education module was 3/28/2021. NE 7 stated, CLS 2 should have completed the education module in 2024. NE 7 stated the education module was important because all healthcare workers needed to know how to report abuse and neglect. During an interview on 4/4/25 at 4: 15 p.m. with the Manager of Accreditation and Licensure (MAL) the MAL stated, the hospital changed the online computer education system to a new provider and the “Reporting Abuse and Neglect,” required education module did not flow over for all departments. The MAL stated CLS 2 should have received the annual abuse education. During a review of a hospital document titled, “List of Job Profiles [LJP],” undated, the “LJP” indicated, 158 hospital employees across 60 departments did not receive the “Reporting Abuse and Neglect,” annual education module for the 2023-2024 year. During a review of a professional reference titled, “Meeting California Training Requirements for Healthcare,” undated, the professional reference indicated “ ...California is known for its progressive politics with a strong emphasis on social justice, environmental issues, and diverse representation. These unique characteristics influence required California training for healthcare professionals. For example, California requires all employers of five or more employees to provide training to supervisory (two hours of training) and nonsupervisory employees (one hours of training) on sexual harassment and abusive conduct prevention. California also requires all individuals who are considered mandated reporters under California law to receive training. Domestic violence training is required based on licensing ....”. During a review of a professional reference titled, “Mandatory Reporting of Child Abuse and Neglect - California,” 5/23, the professional reference indicated, “ ... Mandated reporters include the following: ...An adult person whose duties require direct contact with and supervision of minors in the performance of the minors’ duties in the workplace is a mandated reporter of sexual abuse, as defined in § 11165.1. ...This training shall include training in child abuse and neglect identification and training in child abuse and neglect reporting. The training requirement may be met by completing the general online training for mandated reporters ...”. During a review of a professional reference titled, “California’s New Workplace Violence Prevention Law: The Path to Compliance,” dated 1/10/24, the professional reference indicated, “ ...California has enacted a new workplace violence prevention law, SB 553/California Labor Code Section 6401.9, requiring nearly all California employers to develop and implement a written workplace violence prevention plan, provide annual training on the plan to employees, and maintain a log of incidents of workplace violence ...”.”

“PATIENT RIGHTS: INFORMED CONSENT CFR(s): 482.13(b)(2) The patient or his or her representative (as allowed under State law) has the right to make informed decisions regarding his or her care. The patient’s rights include being informed of his or her health status, being involved in care planning and treatment, and being able to request or refuse treatment. This right must not be construed as a mechanism to demand the provision of treatment or services deemed medically unnecessary or inappropriate. This Standard is not met as evidenced by: 49884 Based on interview and record review, the hospital failed to consider the rights of two out of 12 sampled patients to receive communication in their preferred language when: 1. One of seven patients (Pt 9) whose preferred language was not English, and a signed consent was not obtained in a language Pt 9 could understand, according to the hospital Policy and Procedure (P&P) titled, “Language Assistance Services Policy” and “Consent, Informed.” This failure denied Pt 9 of her right to make informed consent about her care. 2. One of 12 patients (Pt 15) whose preferred language was not English, the Conditions of Admissions [COA-documents the patient’s consent to the general terms and condition for receiving care from the hospital] documents were not provided in the preferred language, in accordance with the hospital P&P titled, “Language Assistance Services Policy” and “Conditions of Admissions and/or Registration Form.” This failure had the potential for Pt 15 to have ineffective communication, misunderstandings, and possible patient harm. Findings: 1. During a review of Pt 9’s “History and Physical (H&P- a complete patient assessment by the physician),” dated 3/18/25, the H&P indicated Pt 9 was recently diagnosed with colon cancer (a type of cancer that develops in the large intestine (colon) and rectum) and was admitted to the hospital for a robotic low anterior resection of rectosigmoid colon (a minimally invasive surgical procedure, using a robotic system, to remove a cancerous portion of the rectum and reconnect the remaining colon) and a loop ileostomy (where a loop of small intestine is pulled out through a cut (incision) in the abdomen, before being opened up and stitched to the skin to form a stoma). Pt 9 had a past medical history of hypertension (HTN-high blood pressure), diabetes mellitus (DM-a disorder characterized by difficulty in blood sugar control and poor wound healing), and coronary artery disease (a common type of heart disease). During a concurrent interview and record review on 3/27/25 at 1:55 p.m. with Nurse Manager (NM) 4, Pt 9’s “Electronic Medical Record (EMR-a digital version of a patient’s medical chart), undated, “Verification of Informed Consent to Surgery or Special Procedure (Informed Consent),” dated 3/21/25 and “Interpreter Services Flowsheet (ISF),” dated 3/21/25 were reviewed. The “EMR” indicated Pt 9’s primary and preferred language was Farsi. The “Informed Consent” indicated the patient signed the consent form on 3/21/25 at 6:35 a.m. and an interpreter was not used as evidenced by the blank lines under the interpreter’s statement. NM 4 stated there was no interpreter information written on the “Informed Consent.” NM 4 stated there was no documentation in the “ISF” that an interpreter was used when Pt 9 signed the “Informed Consent.” NM 4 stated an interpreter was important to ensure the patient understood in her preferred language what the plan for the procedure was. During an interview on 4/4/25 at 9:45 a.m. with the Director of Peri-Operative (DPO), the DPO stated he expected nurses to use an interpreter when the patient requires interpreting services. During an interview on 4/4/25 at 5:10 p.m. with the Chief Nurse Executive (CNE), the CNE stated nurses are expected to make every effort to provide interpretive services and to document when an interpreter is used. During a review of the hospital’s policy and procedure (P&P) titled, “Language Assistance Services Policy,” dated 2/19/25, the P&P indicated, “ ... DEFINITIONS: ... LEP - Limited English Proficiency: Individuals who are “Limited English Proficient” cannot speak, read, write or understand the English language at a level that permits them to effectively communicate with health care professionals ... PROCEDURES: ... Identifying LEP persons and their language ... The patient’s preferred communication language will be documented in the medical record when the patient is registered ... Obtaining a Qualified Interpreter ... The interpreter’s responsibilities will include translating the information regarding the recommended medical treatment that the patient or the patient’s legal representative needs to receive before deciding whether to give consent, as well as instructions regarding medical care ... Documentation ... Any subsequent use of any interpreter services will be documented in the medical record, using EHR Interpreter Flowsheet: a. Reason for service (i.e., consent for surgery, etc.) b. Agency used ... c. Name and/or ID number of the interpreter...” During a review of the hospital’s P&P titled, “Consent, Informed,” dated 2/1/23, the P&P indicated, “ ... PURPOSE: A. To give guidance and direction in obtaining informed consent for surgery, therapeutic, or special diagnostic procedures, including blood transfusions ... PROCEDURE: ... After the patient has voiced that he/she understands the medical treatment, and has no further questions, obtain the patient’s/patient designee’s signature on the “Verification of Informed Consent” form. Document the date, time, witness when applicable, and translator if involved ...” 2. During a concurrent interview and record review on 3/26/25 at 3:48 p.m. with Registered Nurse (RN) 5, Pt 5’s “H&P”, “Admission Preferred Language (APL)”, and “COA,” dated 3/25/25 were reviewed. The “H&P” indicated Pt 5 was 39 weeks and one day pregnant who presented to the Labor and Delivery (L&D -Special unit were babies are delivered, and pregnant women are cared for) Unit on 3/25/25 for labor admission due to onset of frequent painful contractions (tightening of muscles in the womb) every two to four minutes. The “H&P” indicated; Pt 5 was admitted to the L&D department for active labor (baby would be delivered soon). The “APL” indicated, Pt 5’s preferred language was Spanish. RN 5 stated, the “APL” indicated, an interpreter was needed for communication. RN 5 validated the “COA” document was in English. The “COA” was signed by Pt 5 on 3/25/25 at 11:53 a.m. and an interpreter name and identification number was entered on the form. RN 5 stated, nursing staff were not responsible for the “COA” forms completion, so did not know if the Spanish form was downloaded into the “Electronic Medical Record”. During a concurrent interview and record review on 4/3/25 at 3:10 p.m. with the Manager of Patient Access (MAP) and The Supervisor of Patient Access (SPA), Pt 5’s “COA,” dated 3/25/25 was reviewed. The SPA stated, when patients were Spanish speaking, a Spanish speaking staff member could interpret and sign the “COA” form, in the interpreter area. The SPA stated the “COA” forms were available in Spanish, and Pt 5 should have received the “COA” in Spanish. The MAP validated Pt 5’s “COA” was in English. During a review of the hospital’s P&P titled “Conditions of Admissions and/or Registration Form,” dated 3/27/24, indicated, “ ...If a patient is identified as having Limited English proficiency (LEP), language assistance will be provided through use of language identification cards, proficient bilingual staff, telephone language interpretation vendor services, and/or other arrangements. A patient, after being informed of the availability of the interpreter service, may choose to use a family member/friend instead ...” During a review of the hospital’s P&P titled, “Language Assistance Services Policy,” 2/19/25, indicated, “ ...The patient’s preferred communication language will be documented in the medical record when the patient is registered. ...Providing Written Translations 1. Vital documents, including consent forms, presented by hospital staff to a patient will be written in a language that the patient can understand or translated into such a language. 2. Certain documents are also available in frequently encountered languages within the EHR [Electronic Health Record] ...””

“PATIENT RIGHTS: INFORMED CONSENT CFR(s): 482.13(b)(2) The patient or his or her representative (as allowed under State law) has the right to make informed decisions regarding his or her care. The patient’s rights include being informed of his or her health status, being involved in care planning and treatment, and being able to request or refuse treatment. This right must not be construed as a mechanism to demand the provision of treatment or services deemed medically unnecessary or inappropriate. This Standard is not met as evidenced by: 49884 Based on interview and record review, the hospital failed to consider the rights of two out of 12 sampled patients to receive communication in their preferred language when: 1. One of seven patients (Pt 9) whose preferred language was not English, and a signed consent was not obtained in a language Pt 9 could understand, according to the hospital Policy and Procedure (P&P) titled, “Language Assistance Services Policy” and “Consent, Informed.” This failure denied Pt 9 of her right to make informed consent about her care. 2. One of 12 patients (Pt 15) whose preferred language was not English, the Conditions of Admissions [COA-documents the patient’s consent to the general terms and condition for receiving care from the hospital] documents were not provided in the preferred language, in accordance with the hospital P&P titled, “Language Assistance Services Policy” and “Conditions of Admissions and/or Registration Form.” This failure had the potential for Pt 15 to have ineffective communication, misunderstandings, and possible patient harm. Findings: 1. During a review of Pt 9’s “History and Physical (H&P- a complete patient assessment by the physician),” dated 3/18/25, the H&P indicated Pt 9 was recently diagnosed with colon cancer (a type of cancer that develops in the large intestine (colon) and rectum) and was admitted to the hospital for a robotic low anterior resection of rectosigmoid colon (a minimally invasive surgical procedure, using a robotic system, to remove a cancerous portion of the rectum and reconnect the remaining colon) and a loop ileostomy (where a loop of small intestine is pulled out through a cut (incision) in the abdomen, before being opened up and stitched to the skin to form a stoma). Pt 9 had a past medical history of hypertension (HTN-high blood pressure), diabetes mellitus (DM-a disorder characterized by difficulty in blood sugar control and poor wound healing), and coronary artery disease (a common type of heart disease). During a concurrent interview and record review on 3/27/25 at 1:55 p.m. with Nurse Manager (NM) 4, Pt 9’s “Electronic Medical Record (EMR-a digital version of a patient’s medical chart), undated, “Verification of Informed Consent to Surgery or Special Procedure (Informed Consent),” dated 3/21/25 and “Interpreter Services Flowsheet (ISF),” dated 3/21/25 were reviewed. The “EMR” indicated Pt 9’s primary and preferred language was Farsi. The “Informed Consent” indicated the patient signed the consent form on 3/21/25 at 6:35 a.m. and an interpreter was not used as evidenced by the blank lines under the interpreter’s statement. NM 4 stated there was no interpreter information written on the “Informed Consent.” NM 4 stated there was no documentation in the “ISF” that an interpreter was used when Pt 9 signed the “Informed Consent.” NM 4 stated an interpreter was important to ensure the patient understood in her preferred language what the plan for the procedure was. During an interview on 4/4/25 at 9:45 a.m. with the Director of Peri-Operative (DPO), the DPO stated he expected nurses to use an interpreter when the patient requires interpreting services. During an interview on 4/4/25 at 5:10 p.m. with the Chief Nurse Executive (CNE), the CNE stated nurses are expected to make every effort to provide interpretive services and to document when an interpreter is used. During a review of the hospital’s policy and procedure (P&P) titled, “Language Assistance Services Policy,” dated 2/19/25, the P&P indicated, “ ... DEFINITIONS: ... LEP - Limited English Proficiency: Individuals who are “Limited English Proficient” cannot speak, read, write or understand the English language at a level that permits them to effectively communicate with health care professionals ... PROCEDURES: ... Identifying LEP persons and their language ... The patient’s preferred communication language will be documented in the medical record when the patient is registered ... Obtaining a Qualified Interpreter ... The interpreter’s responsibilities will include translating the information regarding the recommended medical treatment that the patient or the patient’s legal representative needs to receive before deciding whether to give consent, as well as instructions regarding medical care ... Documentation ... Any subsequent use of any interpreter services will be documented in the medical record, using EHR Interpreter Flowsheet: a. Reason for service (i.e., consent for surgery, etc.) b. Agency used ... c. Name and/or ID number of the interpreter...” During a review of the hospital’s P&P titled, “Consent, Informed,” dated 2/1/23, the P&P indicated, “ ... PURPOSE: A. To give guidance and direction in obtaining informed consent for surgery, therapeutic, or special diagnostic procedures, including blood transfusions ... PROCEDURE: ... After the patient has voiced that he/she understands the medical treatment, and has no further questions, obtain the patient’s/patient designee’s signature on the “Verification of Informed Consent” form. Document the date, time, witness when applicable, and translator if involved ...” 2. During a concurrent interview and record review on 3/26/25 at 3:48 p.m. with Registered Nurse (RN) 5, Pt 5’s “H&P”, “Admission Preferred Language (APL)”, and “COA,” dated 3/25/25 were reviewed. The “H&P” indicated Pt 5 was 39 weeks and one day pregnant who presented to the Labor and Delivery (L&D -Special unit were babies are delivered, and pregnant women are cared for) Unit on 3/25/25 for labor admission due to onset of frequent painful contractions (tightening of muscles in the womb) every two to four minutes. The “H&P” indicated; Pt 5 was admitted to the L&D department for active labor (baby would be delivered soon). The “APL” indicated, Pt 5’s preferred language was Spanish. RN 5 stated, the “APL” indicated, an interpreter was needed for communication. RN 5 validated the “COA” document was in English. The “COA” was signed by Pt 5 on 3/25/25 at 11:53 a.m. and an interpreter name and identification number was entered on the form. RN 5 stated, nursing staff were not responsible for the “COA” forms completion, so did not know if the Spanish form was downloaded into the “Electronic Medical Record”. During a concurrent interview and record review on 4/3/25 at 3:10 p.m. with the Manager of Patient Access (MAP) and The Supervisor of Patient Access (SPA), Pt 5’s “COA,” dated 3/25/25 was reviewed. The SPA stated, when patients were Spanish speaking, a Spanish speaking staff member could interpret and sign the “COA” form, in the interpreter area. The SPA stated the “COA” forms were available in Spanish, and Pt 5 should have received the “COA” in Spanish. The MAP validated Pt 5’s “COA” was in English. During a review of the hospital’s P&P titled “Conditions of Admissions and/or Registration Form,” dated 3/27/24, indicated, “ ...If a patient is identified as having Limited English proficiency (LEP), language assistance will be provided through use of language identification cards, proficient bilingual staff, telephone language interpretation vendor services, and/or other arrangements. A patient, after being informed of the availability of the interpreter service, may choose to use a family member/friend instead ...” During a review of the hospital’s P&P titled, “Language Assistance Services Policy,” 2/19/25, indicated, “ ...The patient’s preferred communication language will be documented in the medical record when the patient is registered. ...Providing Written Translations 1. Vital documents, including consent forms, presented by hospital staff to a patient will be written in a language that the patient can understand or translated into such a language. 2. Certain documents are also available in frequently encountered languages within the EHR [Electronic Health Record] ...””

“PATIENT RIGHTS: CARE IN SAFE SETTING CFR(s): 482.13(c)(2) The patient has the right to receive care in a safe setting. This Standard is not met as evidenced by: 49884 Based on observation, interview, and record review, the hospital failed to ensure the rights of patients to receive care in a safe environment when: 1. Staff stored non-compatible products in the warmer located in emergency department (ED) of the hospital and not in accordance with the operating instructions of the warmer. This failure had the potential for fire or other hazards and did not ensure the right to care in a safe environment. 2. One of one patient (Patient [Pt]5) Lead Nuclear Medical Technologist (LNMT-Lead staff working in Nuclear Medicine Department) 1 failed to verify patient identity prior to the administration of a radiopharmaceutical (drug containing radioactive material). LNMT 1 injected 3 milliliters (mL- a unit of volume measurement) of another patient’s (Pt 6’s) radioisotope tagged white blood cells (-a small amount of radioactive material attached to the white blood cell [WBC-part of blood], in a special pharmacy) into Pt 5’s vein. LNMT 1 failed to follow the hospital P&Ps titled, “Nuclear Medicine: Radiopharmaceutical Preparation, Labeling, and Administration”, and “Identification: Patient Armband/Patient Verification” and did not follow standards of practice for medication administration. This failure had the potential to infect Pt 5 with a bloodborne pathogen (disease causing germs found in human blood) from Pt 6’s blood, causing illness because, Pt 6 was diagnosed with osteomyelitis (bone infection caused by bacteria) at the time of the incident and had an increased risk for Pt 5 to have a reaction to the blood product injected, leading to fever, chills, hives (raised itchy bumps on the skin), difficulty breathing, requiring a longer hospital stay. 3. Respiratory Therapist (RT) 2 removed sutures from the tracheostomy (a surgical procedure that creates an opening in the windpipe to allow air to enter the lungs) site for Pt 4 without being trained to competently perform this task. This failure resulted in RT 2 possibly performing tasks outside of RT’s scope of practice and had the potential for negative outcome for Pt 4, such as bleeding and surgical site infection. 4. Staff were aware of Pt 7’s obstructive sleep apnea (OSA-a sleep disorder that causes breathing to repeatedly stop and start during sleep) and did not assess Pt 7’s ability to safely use personal continuous positive airway pressure (CPAP-a machine that uses mild air pressure to keep breathing airways open while you sleep) from home prior to use in the hospital. This failure had the potential for Pt 7 to experience respiratory distress and be placed on unsafe equipment. 5. Staff were aware of Pt 2’s chronic obstructive pulmonary disease (COPD-a common lung disease causing restricted airflow and breathing problems) and congestive heart failure (CHF-a condition where the heart is unable to pump blood effectively) and administered CPAP without first obtaining a physician order. Pt 2 was changed from CPAP to bilevel positive airway pressure (BiPAP a non-invasive breathing machine that helps people breathe when they are having trouble) without first obtaining a physician order to establish the setting parameters for the BiPAP. This failure had the potential for Pt 2 to be placed on noninvasive (not required instruments into the body) support with wrong settings, ineffective gas exchange and could further complicate her respiratory condition. Findings: 1. During a concurrent observation and interview on 3/25/25 at 3:16 p.m. in the “Emergency Department (ED) Pod” with the ED Manager (NM 3) and Assistant Nurse Manager (ANM 1) observed [Brand name 1] warmer stocked with rinse free shampoo caps of [Brand name 2] along with [Brand name 1] pre moistened wipes. ANM 1 stated she was not aware of any concerns with stocking [Brand 2] rinse free shampoo caps in the [Brand 1] warmer. ANM 1 stated it was not their normal practice to use [Brand name 1] warmer for both [Brand name 1] & [Brand name 2] products. ANM 1 stated as far as she knows both brand products were compatible with the [Brand name 1] warmer. NM 3 stated she would have to review manufactures instructions for use and was not aware of the compatibility with using the [Brand 2] products in [Brand 1] warmer. NM 3 stated it was not the normal practice at the hospital to stock [Brand 2] products in [Brand 1] warmer. During an interview on 3/27/25 at 1:52 p.m. with the NM 3, NM 3 stated she had reviewed the [Brand name 1] warmer’s operating instructions. NM 3 stated the instructions clearly states that [Brand name 1] warmer was exclusively to be used with same brand [Brand name 1] products. NM 3 stated the hospital was not using the [Brand name 1] warmer in accordance with instructions for use. NM 3 stated she understood the fire risk and risk for other hazards with the use of [Brand name 2] products in the [Brand name 1] warmer. NM 3 stated the practice had been immediately stopped , and all [Brand 2] products were removed from the warmer and going forward, the hospital team will only use [Brand name 1] wipes and products with the [Brand name 1] warmer. During an interview on 4/4/25 at 5:35 p.m. with the Chief Nurse Executive (CNE), the CNE stated she expected staff to follow the manufacturer’s instructions for use and agreed that [Brand 2] products should not be used in [Brand 1] warmer. The CNE stated instructions clearly state using any other brand’s product in [Brand 1] warmer could lead to fire and safety hazard. During a review of [Brand name 1] “Warmer Operating Instructions”, undated, the “Warmer Operating Instructions” indicated, “ ...Please read and understand these instructions completely prior to operating the warmers ...IMPORTANT SAFETY INSTRUCTIONS This product is to be used SOLELY for warming premoistened cloth and hair care products manufactured by [Brand name 1] LLC. The warmer has been designed and safety tested to be used exclusively with these products. ANY other use of the warmer by the facility including, but not limited to, use with other bathing products, can result in overheating, fire or other hazardous conditions and is expressly forbidden ...” 2. During an observation and interview on 3/26/25 at 10:46 a.m. in the Nuclear Medicine (Nuc Med) Department, with Nuclear Medicine Technologist (NMT) 1, the metal boxes used to carry the radioisotope tagged WBCs to the patient’s bedside were observed in the Hot Lab (special room to deliver, store and prepare radioactive materials). NMT 1 stated the metal boxes were made of lead and were called “pigs”. NMT 1 stated, the process for preparing a patient for a Nuclear Medicine scan (uses small amounts of radioactive material, called radiotracers, to create images of the inside of the body) with tagged WBCs, began when a Nuclear Medicine Technologist (NMT) received the order from a physician. NMT 1 stated, a NMT would draw a sample of the patient’s blood and apply a Nuc Med Department wrist band. NMT 1 stated, the band had numbers on it matching the blood sample labels. NMT 1 stated, the blood was then sent to the Radiopharmacy (pharmacy for radioactive materials) in another town, where the isotopes were added. NMT 1 stated, the dose was brought back within a few hours. NMT 1 stated, the same NMT who drew the blood would administer the dose. NMT 1 stated, the NMT took the “pig” containing the syringe “kit” (dose of tagged WBCs), and the physician order to the patient’s bedside. NMT 1 stated, the NMTs were supposed to verify patient identity by checking the wrist band placed earlier, and by verifying name, date of birth (DOB). NMT 1 stated, the patient’s “kit” numbers were verified against the wrist band. NMT 1 stated, now the patient’s nurse had to sign off to ensure the correct patient was about to receive the dose. NMT 1 stated, the nurse’s completing the double check started a few months ago. NMT 1 stated, the double check was important to prevent errors, and ensure the correct patient received the dose. NMT 1 stated, an error injecting the wrong patient could harm the patient not due to the isotopes but due to the blood. NMT 1 stated, patients could go into anaphylactic shock (a severe, life-threatening allergic reaction that could cause a rapid decline in blood pressure and difficulty breathing) due to receiving a blood product not the same type as their own. During an interview on 3/26/25 at 11:34 a.m. with the Radiology Safety Officer (RSO), the RSO stated, his role as safety officer was to oversee the radioactive material at the hospital and, to ensure patient and employee safety. The RSO stated, he was a practicing Radioactive Oncology Physician. The RSO stated, he remembered the incident regarding LNMT 1 injecting Pt 5 with Pt 6’s radioisotope tagged WBCs on 12/9/24. The RSO stated, he was involved with the hospital internal investigation. The RSO stated the incident involved two patients, Pt 5 and Pt 6. The RSO stated, Pt 6 had a physician order for an injection of blood with radioactive isotopes for a nuclear radiologic procedure (scan), and Pt 5 did not have an order for a nuclear radiologic procedure. The RSO stated, Pt 5 was injected with Pt 6’s blood by LNMT 1. The RSO stated, when a physician ordered a nuclear scan, a report went to the Nuc Med Department through the Electronic Medical Record (EMR- a digital version of a patient’s medical history, including diagnoses, medications, tests, allergies, immunizations, and treatment plans), and the type of scan the physician ordered required a radioisotope be attached to white blood cells. The RSO stated, LNMT 1 went to Pt 6’s hospital room and drew a vial of blood. The RSO stated, the vial of blood was sent to an offsite Radiopharmacy in a town one- and one-half hours away by the nuclear pharmacy courier (transporter). The RSO stated, the WBCs were tagged at the nuclear pharmacy then returned to the hospital for injection. RSO stated, LNMT 1 took the blood product to the patient’s hospital room and “just didn’t identify patient”, injecting the radioisotope tagged WBCs into Pt 5 instead of Pt 6. The RSO stated, LNMT 1 got off on the wrong floor and went into the same room number. The RSO, stated LNMT 1 identified his error, “right after the administration”. The RSO stated, LNMT 1 reported the error to the nurse, and leadership immediately. The RSO stated, Pt 5’s physician was notified as well as the patient and the family. The RSO stated, LNMT 1 “missed the double check”, and “just didn’t identify patient [did not verify Pt 5’s name and date of birth, against the armband]” The RSO stated, Pt 5 could have been harmed by any infections that were present in the blood infected into her. The RSO stated, the radiation was not an issue, it was given to the wrong patient, but it had a short half-life (the time it takes for one of the atoms in the sample to decay [lose energy] one that decays quickly). During a concurrent interview and record review on 3/28/25 at 9:33 a.m. with Nurse Educator (NE)1, Pt 6’s “History & Physical [H&P- an assessment from physician including medical history and exam],” dated 1/1/25 was reviewed. The “H&P” indicated, Pt 6 was a Portuguese speaking 86-year-old with past medical history (PMH) of Type 2 Diabetes Mellitus (disorder characterized by difficulty in blood sugar control and poor wound healing), and hypertension (high blood pressure), presenting to the emergency department (ED) on 12/29/24 for right foot redness, swelling and pain, as well as generalized weakness. The “H&P” indicated, Pt 6 was admitted to the hospital as an inpatient on 12/31/24 for a diabetic ulcer (open sores on the feet, a serious complication of diabetes), and acute osteomyelitis (a bone infection that develops rapidly). During a concurrent interview and record review on 3/28/25 at 9:40 a.m. with NE 1, Pt 6’s “Provider Progress Note [PPN],” dated 1/2/25 to 1/8/25, “Physician Orders [PO]”, “Medication Physician Orders [MPO], dated 12/30/24 to 1/3/25, and “Medication Administration Record [MAR],” dated 12/31/24 to 1/3/25, were reviewed. The “PO” indicated, on 12/30/24 at 4:50 p.m. an order for a Nuc Med scan was entered. NE 1 stated, the “PO” indicated the scan was performed on 1/3/25 at 11:38 a.m. and read by the physician on 1/4/25. The “MPO” indicated, on 1/2/25 at 11:05 a.m. an order for “...Radioisotope 12millicuire [a unit of radioactivity]” ...Electronically signed by: [LNMT 1] on 1/2/25 at 1105 [11:05 a.m.] ...” The “MAR” indicated, the radioisotope 12 millicurie was ordered by LNMT 1 on 1/2/25 at 11:05 a.m. but was administered by NMT 1 intravenously on 1/3/25 at 11:38 a.m. The “MAR” had no indication the radioisotope was scanned before administration. During a review of Pt 5’s “H&P,” dated 12/31/24, The H&P indicated Pt 5 was a Spanish speaking 96 year-old patient brought into the ED on 12/31/25 at 12:45 p.m. by family, with complaints of right upper quadrant pain (the area of the stomach located on the right side above the belly button) for two weeks. The “H&P” indicated Pt 5 was admitted as an inpatient on 12/31/24 at 8:50 p.m. for a renal abscess (a pocket of pus that forms within the kidney tissue) and moved to the Medical Surgical (MS) Unit at 11:56 p.m. During a concurrent interview and record review on 3/28/25 at 9:55 a.m. with NE 1 Pt 5’s “Provider Progress Note [PPN],” and “Labs”, dated 1/2/25 to 1/8/25, “Physician Orders [PO]”, “Medication Physician Orders [MPO], dated 12/31/24 to 1/3/25, and “Medication Administration Record [MAR],” dated 12/31/24 to 1/3/25, were reviewed. NE 1 stated, Pt 5’s “PO” and “MPO” had no orders indicating a Nuc Med scan, or any radiopharmaceuticals were ordered for Pt 5. NE 1 stated, Pt 5s “MAR” had no documentation indicating Pt 5 was administered isotope tagged WBCs. NE 1 stated, Pt 5’s “MAR” would not have documentation, because there were no orders for the patient to have radiopharmaceuticals. The “PPN” dated 1/2/25 indicated, “ ...I was informed (01/02/2025) that patient [Pt 5] was (accidentally and erroneously [incorrectly]) injected (by nuclear medicine technologist) another patient’s blood product [Pt 6]. This was communicated to the patient’s sons ... Active Problems: ...Accidental injection of blood products from another patient - This was reported to the patient’s both sons and risks/plans were explained. - Discussed with infection control; source patient [Pt 6] has strep [type of germ] bacteremia [serious infection enters the bloodstream] and Pseudomonas (common bacterial disease-causing organisms) wound infection. -Source patient is being tested for [bloodborne pathogens] ...per Infectious control request. ...Will repeat blood cultures with a.m. labs and follow up ...”. NM 1 stated, multiple labs were drawn, and results were negative for bloodborne pathogens. During an interview on 4/1/25 at 11:42 a.m. with the Director of Imaging (DI), the DI stated, she was a part of the hospital internal investigation of Pt 5 being injected with Pt 6’s radioisotope tagged WBCs. The DI stated LNMT 1 failed to use two patient identifiers prior to injecting the radioisotope tagged WBCs for Pt 6 into Pt 5. The DI stated, her expectation was for LNMT 1 to report the error immediately, which he did. The DI stated, the discovery during the investigation was, LNMT1 got off the elevator on the incorrect floor and entered what would be the same room number if he was on the correct floor. The DI stated, Pt 6 and Pt 5 were located on different floors but were in the same room number, and in the same bed location. The DI stated, LNMT 1did draw the correct patient’s blood (Pt 6), in the morning around 6 a.m. The DI stated, LNMT 1claimed he only “glanced” at Pt 5’s armband, and both patients had similar first names, and both patients were similar in appearance. The DI stated, LNMT 1 did not notice Pt 5 did not have the Nuc Med Department armband applied, and he did not verify the “kit” numbers against the armband, or the patient’s name against the physician’s order. The DI stated, as soon as LNMT 1realized he injected the wrong patient he called the manager, the house supervisor and both patient’s physicians. LNMT 1 stated, Pt 6 needed to be tested for bloodborne pathogens, and be redrawn for the nuclear isotope tagging and rescheduled for the scan, and Pt 5 needed to be monitored for reactions and tested for infections. The DI stated, the incident was reported to the RSO the same day as the event, and there was no concern for harm to Pt 5 due to the radiation dose. The DI stated, Pt 5 receiving Pt 6’s blood was concerning but both patients were tested, and the results were negative for any bloodborne pathogens. The DI stated, the Nuc Med Department had label tracking (to scan) into the Nuclear Medicine Information System (NMIS-software designed to manage patient, department, including inventory, dosing and billing), but there was no barcode scanning to scan the “kit” into the main hospital EMR system. The DI stated the NMT’s document in the patient’s MAR when completing the administration. During a review of hospital document titled, “Labeling Tracking Record [LTR],” dated 1/2/25, the “LTR” indicated, Pt 5 had blood drawn for WBC tagging by LNMT 1 on 1/2/25 at 6:25 a.m. The “LTR” had a checkmark indicating the “Patient name on all labeling stickers”, “Specimen syringe sticker attached to blood specimen container” and “Bracelet attached to patient”. The “LTR” indicated, Pt 5’s blood was received at the Radiopharmacy on 1/2/25 at 8:30 a.m. The “LTR” indicated, a dual verification of the dose was verified, loaded and sealed in the transporting case. The “LTR” indicated, five separate steps for verification of patient name to ensure correct patient prior to sending the dose to the hospital. The “LTR” indicated, the radioisotope tagged WBCs were delivered to the hospital on 1/2/25 at 11:11 a.m. During an interview on 4/1/25 at 2:50 p.m. with the Manager of Accreditation and Licensure (MAL), the MAL stated LNMT 1 was as not available to be interviewed because LNMT 1 no longer worked for the hospital. During an interview on 4/2/25 at 1:19 p.m. with the Healthcare Risk Officer (HRO) the HRO stated, the reason the Nuclear Medicine incident was initially not thought to be reported, and an RCA was not completed was because it did not meet the criteria. The HRO stated, the hospital completed an Intensive analysis, considered one step above a regular investigation but did not rise to the level of a root cause analysis. During an interview on 4/3/25 at 1:57 p.m. with the DI, the DI stated, the NTs scan the radiopharmaceutical product for the NIMS system at patient’s bedside. The DI stated, during the incident with Pt 5 LNMT 1 had trouble logging into the computer workstation at Pt 5’s bedside so he attempted to use identifiers, then scanned the label when returning to the Nuc Med department. The DI stated, when he scanned the label, he discovered his error. During an interview on 4/4/25 at 5:25 p.m. with the Chief Nursing Executive (CNE), the CNE stated, LNMT 1 should have gone to the patient’s room and verified the patient’s identity, ensuring right patient, right drug, right dose, right route, and right time. The CNE stated the five rights of medication administration should have been followed for this patient to avoid the error. During a review of the hospital’s P&P titled, “Nuclear Medicine: Radiopharmaceutical Preparation, Labeling, and Administration,” dated 6/8/23, indicated, “ ... PURPOSE A. To ensure patient and staff safety during the preparation and administration of radiopharmaceuticals. ...Patient identity shall be verified by comparing patient name and date of birth on identification band with same identifiers on applicable health information documents prior to initiating this policy/procedure ... Maintain adequate shielding throughout the department. Reaction vials are to remain in covered leaded carriers (“pigs”), when not in use. Dose syringes must be in syringe shield or “pig” except when in the dose calibrator. ... Double check vial and syringe labels before injecting. ...Administration ...Establish patient identity before prepping or injecting. Ask patient to state full name (rather than to confirm name) and the date of birth. For inpatients, confirm identification in same manner against identification armband. Nuclear Medicine Technologist will cross-reference patient identification with that printed on NMIS labels and/or registration record. ...Labeling of Blood Products a. On studies that involve invitro tagging of blood cells ... the patient should be carefully identified as above and given a wristband with specific identifiers for the return of the tagged blood cells. b. The same Nuclear Medicine technologist should draw the blood that re- injects the tagged cells. ...Documentation: ...Order radiopharmaceutical in the exam navigator under “orders”, with correct information as to drug, route, and time. ...One eMAR [electronic Medication Administration Record] and NMIS computer system, document patient name, date of birth, and medical record number with radiopharmaceutical, manufacturer and lot number, dose, date and time of administration, date and time of expiration and Nuclear Medicine technologist administering ...” During a review of the hospital’s P&P titled, “Identification: Patient Armbands/Patient Verification,” dated 2/8/22, indicated, “ ...PURPOSE A. To assure accurate identification of all patients at [name of hospital] B. To assure the two approved patient identifiers are used to match service or treatment to that individual in a manner that prevents wrong patient identity. ...Verification of patient identity by comparing patient name and date of birth on identification band with same identifiers on applicable health information documents will occur prior to initiating this procedure ...Applicable patients will have an identification band on at all times. ... Accurate patient identification will occur whenever administering medications or blood products, taking blood samples and other specimens for clinical testing, or providing any other care, treatments or procedures. 1. Accurate identification MUST occur at the “point of care” any time care/treatment is to be provided. 2. Containers used for blood and other specimens are to be labeled in the presence of the patient. ... Whenever patient care is being managed through Order Entry (OE) or other computerized methods, accurate patient identification will occur by comparing patient’s full name and date of birth on document being entered (physician’s order for example) to patient pulled up in computer application. 1. Using medical record number and/or patient account number can be used to further verify correct patient IN ADDITION to, but not as replacements for, using patient’s full name and date of birth. ... Patients who are hospitalized who are unable to participate in verification at time of admission will have identity verified through reliable family member or friend as soon as possible. The name of the family member or friend verifying identity will be entered into admission history to provide reference that identity was initially verified through this reliable source. This is intended to provide reference to subsequent caregivers that identity has been validated. ... VERIFYING PATIENT IDENTITY: POINT OF CARE VERIFICATION AND INFORMATION DOCUMENT COMPARISON 1. Upon first interaction or at beginning of shift with a conscious patient, verify patient identity by asking the patient to state their full name and date of birth. Compare this to same information on patient’s identification band and same in health information documents (eMAR, physician orders). 2. Upon all subsequent interactions while assigned to patient within same day, verify identity by checking full name and date of birth on identification band and comparing to same information on applicable health information documents (eMAR, physicians orders, lab results or other documents triggering nursing intervention). ...Non-English speaking: Obtain interpreter and follow same guidelines ...” During a review of a professional reference titled, “Safe Medication Administration: So Many Considerations,” dated July-August 2023, the professional reference indicated, “ ... For decades, the five rights for administering medications have been a recognized safety standard (Martyn et al., 2019). The framework of the seminal five rights (i.e., right patient, drug, dose, time, route) has evolved, and other rights considered as additional influences on medication administration processes have been identified in changing healthcare environments ...” 3. During a review of Pt 4’s “Emergency Department (ED) Note”, dated 2/6/25, the “ED Note” indicated, “ ... [Pt 4] is a 43 year old female with [past medical history] significant for fibroids [noncancerous growths that develop in the uterus, often without causing symptoms], prior alcohol abuse, adenocarcinoma [type of cancer that starts in the glands that line organs] of the rectosigmoid colon [lower part of the large intestine] metastatic [cancer that has spread from its original location to other parts of the body] to the liver seen by [hospital name] oncology, diverting colostomy [surgical procedure where a portion of the colon is brought out through an opening in the abdominal wall, creating a stoma, which allows waste to be eliminated into a bag attached to the skin], cirrhotic liver [condition where healthy liver tissue is replaced by scar tissue, leading to impaired liver function], who presents to the ED for evaluation of [altered mental status (AMS)]. Per friend, Per friend, patient did not eat yesterday or take medications. She has been sleeping all day today and was briefly unresponsive for family ... stage IV colorectal rectal cancer [indicates that the cancer has spread from the colon or rectum to other parts of the body] metastatic to liver and bones not a candidate for chemoradiation therapy [cancer treatment] ... discussed with the intensivist [medical doctor who possesses special training and experience in treating critically ill patients] for admission to [Intensive Care Unit (ICU - is a specialized hospital unit providing advanced care for critically ill or injured patients who require constant monitoring, life support, and specialized medical treatments)] ... FINAL DIAGNOSIS ... Septic shock ...Metastatic colon cancer to liver ... Acute kidney injury [sudden decline in kidney function, often reversible, where the kidneys can’t filter waste products from the blood] ... Influenza [Flu, an infection of the nose, throat and lungs] ...” During a concurrent interview and record review on 4/3/25 at 9:07 a.m. with Respiratory Therapist (RT) 3, PT 4’s Electronic Medical Record (EMR) was reviewed for the hospital encounter date of 2/6/25. The review of document titled “POST - OP NOTE” dated 2/27/25 at 4:56 p.m. indicated, “ ... PROCEDURE: Tracheostomy placement ... We placed a 7.5 ID [internal diameter] cuffed [Brand name] tracheostomy tube [a curved, hollow tube inserted into the trachea (windpipe) to help a person breathe] ... Adequate position confirmed ... the trach was secured with Prolene suture [brand of non-absorbable, synthetic suture made from polypropylene (type of plastic) ] and trach tie ...”. The review of flow sheet note filed on 3/8/25 at 11:26 a.m. by RT 2 indicated, “ ... Trach sutures removed from each corner at this time. Patient tolerated well without adverse event ...” RT 3 stated RTs do not remove sutures on tracheostomy tubes at the facility and the hospital did not provide any competencies, training or skills validation for respiratory staff to remove sutures. RT 3 stated she was not aware that RTs can remove suture and, in her experience, it was usually physician, nurse practitioner (NP) or physician assistant (PA) that remove sutures on new trach. RT 3 stated she was not aware of any policy or guidelines at the facility for RTs to remove sutures from tracheostomy tube. RT 3 stated she was not sure whether it was in the scope of RTs to remove sutures at this facility and would have to defer to her manager or director for answer. During an interview on 4/3/25 at 9:46 a.m. with the Manager of Respiratory Therapy (MRT), the MRT stated “We do not have any policies, training or competencies for RCPs to remove trach suture, RT 2 should not have done it”. MRT stated RT 2 had no competency or training to remove Pt 4 tracheostomy tube sutures. MRT stated removing sutures from new tracheostomy tube was not part of the scope of RTs at the hospital. MRT stated without training, competencies or skills validation it could potentially cause harm to the patient. During an interview on 2/4/25 at 9:15 with the Director of Critical Care and Respiratory (DCC), the DCC stated he had reviewed the chart and spoken with the physician in Intensive Care Unit (ICU). The DCC stated RT 2 was working outsider of her scope and should not have removed sutures. The DCC validated that RT 2 had no training, no competency and no skills validations completed for tracheostomy suture removal. The DCC stated hospital did not have a policy, training or competencies for RTs to remove suture. The DCC stated he expects all RTs to follow hospital policy and not perform tasks that are outside their scope of practice. The DCC stated working outside the scope puts patient at harm for adverse outcomes. 4. During a review of Pt 7’s “H&P,” dated 3/17/25, the “H&P” indicated Pt 13 was admitted to the hospital for an abdominal hysterectomy (a surgical procedure where the uterus is removed through an incision in the abdomen) due to abdominal pressure. The “H&P” indicated Pt 7 had a past medical history of chronic kidney disease (a gradual loss of kidney function over time), hyperlipidemia (an excess of fats in your blood), gastroesophageal reflux disease (GERD-a condition in which stomach acid repeatedly flows back up into the tube connecting the mouth and stomach, called the esophagus) and OSA on CPAP. During a concurrent interview and record review on 3/26/25 at 2:47 p.m. with Nurse Educator (NE) 1, Pt’s 7’s “Physician Orders,” dated 3/17/25 to 3/26/25 were reviewed. The “Physician Orders” indicated there were no orders for CPAP use. NE 1 validated she was unable to find any active order for CPAP use for Pt 7 and Pt 7 should have been evaluated to determine if a CPAP was needed while hospitalized. NE 1 stated Pt 7 should have had an assessment completed to determine her breathing while sleeping. During a concurrent observation and interview on 3/27/25 at 9:56 a.m. with Pt 7, in Pt 7’s room, a CPAP machine was observed on Pt 7’s nightstand. Pt 7 stated she brought her CPAP from home to use at night. Pt 7 stated she did not sign any forms to use her CPAP from home during her stay in the hospital and stated she did not recall anyone assessing her ability to use her home CPAP for safety while used in the hospital. Pt 7 stated no one evaluated or asked her questions about her use of the CPAP. During an interview on 3/27/25 at 10 a.m. with the Director of Medical Surgical Services (DMS) and Nurse Manager (NM) 5, NM 5 stated respiratory therapy should have come to evaluate the Pt 7’s home CPAP and identify any issues. NM 5 stated a physician order should have been entered to evaluate Pt 7 for CPAP use when Pt 7 was admitted. The DMS stated the home CPAP would be on a fixed setting and respiratory therapy needed to come to check the setting before patient use. During a concurrent interview and record review on 3/27/25 at 10:45 a.m. with NM 4, the hospital’s P&P titled, “Obtaining and Using Patient Owned Respiratory Medical Devices,” dated 2/16/22, and Pt 7’s “Electronic Medical Record (EMR-an electronic version of a patient’s medical history),” dated 3/17/25 to 3/27/25 were reviewed. The P&P indicated, “ ... POLICY: ... The use of patient-owned medical devices is discouraged. However, due to medical necessity, patient-owned medical devices can be used if: A. A physician order allowing the patient to use their own device has been entered into the EHR ... C. A Release of Liability has been completed and scanned into the EHR. D. For CPAP and BiPAP devices, the licensed staff needs to verify that the patient can use their own device independently. For example, the patient can turn on and off the device and apply and remove the masks interface independently ...” The “EMR” indicated “ ... CPAP NIV [non-invasive ventilation-use of breathing support administered through a face mask, nasal mask, or a helmet] - ADULT - OSA ... Patient can use own equipment: Yes ... Order Information ... Order Date 3/27/25 ... Order Time [10:34 a.m.] ...” NM 4 stated the order should have been placed before the patient used the CPAP in the hospital. NM 4 stated an order was important to ensure the physician was directing the care of the patient. The “EMR” indicated the Liability Release for Use of Patient-Owned Medical Equipment was signed by Pt 7’s husband on 3/27/25 at 10:37 a.m. and an evaluation of Pt 7’s ability to use the device was assessed by a respiratory therapist. NM 4 stated the Liability Release form was signed today and should have been signed upon admission. NM 4 stated the Liability Release form was important for the patient to understand the home equipment has not gone through the hospital’s normal process of inspection and the patient was taking the responsibility of her own equipment and safety. During an interview on 4/4/25 at 11:10 a.m. with the DMS, the DMS stated nurses were expected to get a physician order to use equipment from home when a patient brought in their own equipment to use in the hospital. The DMS stated staff should ensure the equipment was safe to use by contacting respiratory therapy to ensure the settings were correct. The DMS stated the Liability Release form should be completed before the patient used their own equipment from home. During an interview on 4/4/25 at 5:10 p.m. with the Chief Nurse Executive (CNE), the CNE stated the nurse was responsible to obtain a physician order for patient to use home equipment. The CNE stated she expected the Liability Release form to be completed before the patient used home equipment. The CNE stated she expected respiratory therapy to come to assess the patient’s ability to use home equipment and ensure patient safety at all times. 5. During a review of Pt 2’s “H&P,” dated 1/27/25, the “H&P” indicated, “ ... [Pt 2] is a 78 year old female with [past medical history] significant for developmental delay, CVA [cerebrovascular accident-stroke] with residual aphasia [language difficulties that some individuals continue to experience], COPD [chronic obstructive pulmonary disease-a common lung disease causing restricted airflow and breathing problems], CHF [congestive heart failure-a condition where the heart is unable to pump blood effectively], DM [diabetes mellitus-a disorder characterized by difficulty in blood sugar control and poor wound healing], CKD [chronic kidney disease], chronically bed bound, presenting from home by ambulance with chief complaint of worsening SOB [shortness of breath-difficulty breathing]. Patients’ family reporting several day [history] of URI [upper respiratory infection] like symptoms with worsening dyspnea [a sensation of running out of the air and of not being able to breathe fast enough or deeply enough] ... In [emergency department], initial [vital signs] notable for tachypnea [a breathing rate that is higher than normal]. VBG [Venous blood gas-a medical test that measures the acidity and alkalinity of blood, along with levels of oxygen and carbon dioxide, taken from a vein] reveals acute on chronic hypercapnic respiratory failure [when a patient with long-standing respiratory insufficiency (chronic) experiences a sudden deterioration in their respiratory function, resulting in high levels of carbon dioxide in the blood (hypercapnia)]. CXR [chest x-ray] showing [left lower lobe] infiltrate ...” During a concurrent interview and record review on 4/3/25 at 4:27 p.m. with the Respiratory Educator (RE) and Assistant Nurse Manager (ANM) 4, the hospital’s P&P titled, “Noninvasive Ventilation (NIV) [breathing support method that delivers oxygen and positive pressure to the lungs without requiring a tube inserted into the trachea ] Protocol - Emergent,” dated 12/6/24, Pt 2’s “Physician Orders,” dated 1/26/25, “Ventilation Flowsheet (VF),” dated 1/29/25 were reviewed. The P&P indicated, “ ... PURPOSE: This procedure provides instructions for initiating, maintaining and monitoring non-invasive positive pressure ventilation (NIV) ... PROTOCOL: Respiratory Care Practitioners will provide the initial setup, subsequent operation, and monitoring of non-invasive positive pressure ventilation (NIV) upon a written physician order ... Select NIV mode desired ....CPAP/BIPAP [mode on machine that offer two different pressure levels: one for inhalation (IPAP) and another for exhalation (EPAP)]/ PC-BIPAP [mode of breathing where pressure is control on inspiration]/ CPAP-PS [mode of breathing that supports spontaneous breathing with specific pressures] ... IPAP 8-25 [Centimeter of Water (cm H2O - unit of measurement for pressure)] targeting a tidal volume [the amount of air inhaled and exhaled during normal, restful breathing] 6-8 [milliliter /kilogram (ml/kg) - Unit of measurement] ... EPAP 4-10 cm H2O ....[Respiratory rate (RR)] - 8 and adjust for ABG [Arterial Blood Gas] .... FiO2 [concentration of oxygen] to target SpO2 [measures the percentage of oxygen in your blood] 92% or greater ...” The “Physician Order” on 1/26/25 at 5:36 p.m. indicated, “ ... CPAP NIV - ADULT - OSA ... Patient Mask: Full Face Mask ...” The RE validated and stated there were no specified pressures or oxygen concentration settings ordered by the physician for CPAP order. The RE stated the physician order for CPAP did not indicate to initiate CPAP per respiratory protocol. The RE stated respiratory therapists (RTs) need a physician order or order for the protocol for the settings to initiate CPAP. The “VF” on 1/29/25 at 8:54 a.m. indicated Pt 2 was on a CPAP, placed on a [Brand name] CPAP machine with high flow nasal cannula (HFNC- an oxygen supply system capable of delivering up to 100% humidified and heated oxygen), and CPAP pressure of 14. The RE stated the CPAP order was indicated for OSA, not respiratory failure. The RE had no explanation as to why Pt 2 was started on a pressure of 14 without any order from the physician. The RE stated he was unable to explain why the documentation reflects both HFNC and CPAP, and he was unable to explain which modality patient was on. The RE stated documentation by RT was not clear and Pt 2 was either on CPAP or HFNC. The RE stated without the physician order or machine that auto titrates pressures he was unable to confirm that CPAP of 14 was correct and safe settings for Pt 2. The “Physician Orders” on 1/26/25 at 8:39 p.m. indicated, “ ... BIPAP NIV PROTOCOL - ADULT - RESP FAILURE ...” The “VF” on 1/29/25 at 1 p.m. indicated Pt 2 was changed from CPAP to BIPAP mode with settings IPAP of 12, EPAP 6, RR 16, Oxygen 30%. The RE reviewed the settings and was unable to answer why the IPAP of 12 was selected. The RE stated the protocol does not specify to use ideal body weight instead of Pt 2’s actual weight, however, the RT used the ideal body weight to set up IPAP to deliver tidal volume of 6 -8 ml/kg which was lower based on the current protocol. The RE stated the protocol needs to be corrected to indicate “use of ideal body weight instead of patient actual weight”. The RE stated the protocol does not specify how to titrate EPAP and only states “EPAP 4-10” with no criteria/parameters on when to go up or down on EPAP, where to start and increments use for adjustments. The RE stated it was up to RT’s judgement and their clinical ability to place patient on appropriate settings. The RE agreed this could potentially lead to an error, variance in practice among RT and potentially could harm the patient. The RE reviewed the RR set at 16 and stated the protocol only states start “rate at 8 and titrate for ABG.” The RE stated protocol does not provide maximum rate, when to go up or down on the rate, increments to go up or down and what value or values to monitor on ABG and what range to keep those ABG values. The RE was unable to comment on how hospital RTs were using this protocol and titrating settings on BIPAP without these parameters. The RE stated the protocol needs to be revised. The RE stated RTs were using their “critical thinking” and did not have a physician order and protocol did not reflect the criteria to make adjustments to BIPAP settings. The RE agreed this has the potential to cause harm to the patient and potential for ineffective gas exchange (inability to adequately exchange oxygen and carbon dioxide between the lungs and the bloodstream) in Pt 2. During an interview on 4/4/25 at 4:54 p.m. with the Director of Critical Care and Respiratory (DCC), the DCC stated he was in charge of Respiratory Therapy. The DCC stated he had spoken to RE and agreed the protocol was not safe and needed to be revised. The DCC stated RCPs need physician order or protocol that clearly outlines parameters and criteria for settings that include when to change, how to change, what to monitor and other relevant information. The DCC stated the titration of settings for Pt 2 were conducted by RT based on their judgement and experience, not based on physician order or protocol that outlines the evidence-based criteria. During a review of Medical Staff ByLaws, dated January 2024, the Medical Staff ByLaws indicated, “ ... Care provided by allied health professionals, residents, fellow and/or medical students shall be under the appropriate degree of supervision by a licensed practitioner with clinical privilege ...””

“PATIENT RIGHTS: CARE IN SAFE SETTING CFR(s): 482.13(c)(2) The patient has the right to receive care in a safe setting. This Standard is not met as evidenced by: 49884 Based on observation, interview, and record review, the hospital failed to ensure the rights of patients to receive care in a safe environment when: 1. Staff stored non-compatible products in the warmer located in emergency department (ED) of the hospital and not in accordance with the operating instructions of the warmer. This failure had the potential for fire or other hazards and did not ensure the right to care in a safe environment. 2. One of one patient (Patient [Pt]5) Lead Nuclear Medical Technologist (LNMT-Lead staff working in Nuclear Medicine Department) 1 failed to verify patient identity prior to the administration of a radiopharmaceutical (drug containing radioactive material). LNMT 1 injected 3 milliliters (mL- a unit of volume measurement) of another patient’s (Pt 6’s) radioisotope tagged white blood cells (-a small amount of radioactive material attached to the white blood cell [WBC-part of blood], in a special pharmacy) into Pt 5’s vein. LNMT 1 failed to follow the hospital P&Ps titled, “Nuclear Medicine: Radiopharmaceutical Preparation, Labeling, and Administration”, and “Identification: Patient Armband/Patient Verification” and did not follow standards of practice for medication administration. This failure had the potential to infect Pt 5 with a bloodborne pathogen (disease causing germs found in human blood) from Pt 6’s blood, causing illness because, Pt 6 was diagnosed with osteomyelitis (bone infection caused by bacteria) at the time of the incident and had an increased risk for Pt 5 to have a reaction to the blood product injected, leading to fever, chills, hives (raised itchy bumps on the skin), difficulty breathing, requiring a longer hospital stay. 3. Respiratory Therapist (RT) 2 removed sutures from the tracheostomy (a surgical procedure that creates an opening in the windpipe to allow air to enter the lungs) site for Pt 4 without being trained to competently perform this task. This failure resulted in RT 2 possibly performing tasks outside of RT’s scope of practice and had the potential for negative outcome for Pt 4, such as bleeding and surgical site infection. 4. Staff were aware of Pt 7’s obstructive sleep apnea (OSA-a sleep disorder that causes breathing to repeatedly stop and start during sleep) and did not assess Pt 7’s ability to safely use personal continuous positive airway pressure (CPAP-a machine that uses mild air pressure to keep breathing airways open while you sleep) from home prior to use in the hospital. This failure had the potential for Pt 7 to experience respiratory distress and be placed on unsafe equipment. 5. Staff were aware of Pt 2’s chronic obstructive pulmonary disease (COPD-a common lung disease causing restricted airflow and breathing problems) and congestive heart failure (CHF-a condition where the heart is unable to pump blood effectively) and administered CPAP without first obtaining a physician order. Pt 2 was changed from CPAP to bilevel positive airway pressure (BiPAP a non-invasive breathing machine that helps people breathe when they are having trouble) without first obtaining a physician order to establish the setting parameters for the BiPAP. This failure had the potential for Pt 2 to be placed on noninvasive (not required instruments into the body) support with wrong settings, ineffective gas exchange and could further complicate her respiratory condition. Findings: 1. During a concurrent observation and interview on 3/25/25 at 3:16 p.m. in the “Emergency Department (ED) Pod” with the ED Manager (NM 3) and Assistant Nurse Manager (ANM 1) observed [Brand name 1] warmer stocked with rinse free shampoo caps of [Brand name 2] along with [Brand name 1] pre moistened wipes. ANM 1 stated she was not aware of any concerns with stocking [Brand 2] rinse free shampoo caps in the [Brand 1] warmer. ANM 1 stated it was not their normal practice to use [Brand name 1] warmer for both [Brand name 1] & [Brand name 2] products. ANM 1 stated as far as she knows both brand products were compatible with the [Brand name 1] warmer. NM 3 stated she would have to review manufactures instructions for use and was not aware of the compatibility with using the [Brand 2] products in [Brand 1] warmer. NM 3 stated it was not the normal practice at the hospital to stock [Brand 2] products in [Brand 1] warmer. During an interview on 3/27/25 at 1:52 p.m. with the NM 3, NM 3 stated she had reviewed the [Brand name 1] warmer’s operating instructions. NM 3 stated the instructions clearly states that [Brand name 1] warmer was exclusively to be used with same brand [Brand name 1] products. NM 3 stated the hospital was not using the [Brand name 1] warmer in accordance with instructions for use. NM 3 stated she understood the fire risk and risk for other hazards with the use of [Brand name 2] products in the [Brand name 1] warmer. NM 3 stated the practice had been immediately stopped , and all [Brand 2] products were removed from the warmer and going forward, the hospital team will only use [Brand name 1] wipes and products with the [Brand name 1] warmer. During an interview on 4/4/25 at 5:35 p.m. with the Chief Nurse Executive (CNE), the CNE stated she expected staff to follow the manufacturer’s instructions for use and agreed that [Brand 2] products should not be used in [Brand 1] warmer. The CNE stated instructions clearly state using any other brand’s product in [Brand 1] warmer could lead to fire and safety hazard. During a review of [Brand name 1] “Warmer Operating Instructions”, undated, the “Warmer Operating Instructions” indicated, “ ...Please read and understand these instructions completely prior to operating the warmers ...IMPORTANT SAFETY INSTRUCTIONS This product is to be used SOLELY for warming premoistened cloth and hair care products manufactured by [Brand name 1] LLC. The warmer has been designed and safety tested to be used exclusively with these products. ANY other use of the warmer by the facility including, but not limited to, use with other bathing products, can result in overheating, fire or other hazardous conditions and is expressly forbidden ...” 2. During an observation and interview on 3/26/25 at 10:46 a.m. in the Nuclear Medicine (Nuc Med) Department, with Nuclear Medicine Technologist (NMT) 1, the metal boxes used to carry the radioisotope tagged WBCs to the patient’s bedside were observed in the Hot Lab (special room to deliver, store and prepare radioactive materials). NMT 1 stated the metal boxes were made of lead and were called “pigs”. NMT 1 stated, the process for preparing a patient for a Nuclear Medicine scan (uses small amounts of radioactive material, called radiotracers, to create images of the inside of the body) with tagged WBCs, began when a Nuclear Medicine Technologist (NMT) received the order from a physician. NMT 1 stated, a NMT would draw a sample of the patient’s blood and apply a Nuc Med Department wrist band. NMT 1 stated, the band had numbers on it matching the blood sample labels. NMT 1 stated, the blood was then sent to the Radiopharmacy (pharmacy for radioactive materials) in another town, where the isotopes were added. NMT 1 stated, the dose was brought back within a few hours. NMT 1 stated, the same NMT who drew the blood would administer the dose. NMT 1 stated, the NMT took the “pig” containing the syringe “kit” (dose of tagged WBCs), and the physician order to the patient’s bedside. NMT 1 stated, the NMTs were supposed to verify patient identity by checking the wrist band placed earlier, and by verifying name, date of birth (DOB). NMT 1 stated, the patient’s “kit” numbers were verified against the wrist band. NMT 1 stated, now the patient’s nurse had to sign off to ensure the correct patient was about to receive the dose. NMT 1 stated, the nurse’s completing the double check started a few months ago. NMT 1 stated, the double check was important to prevent errors, and ensure the correct patient received the dose. NMT 1 stated, an error injecting the wrong patient could harm the patient not due to the isotopes but due to the blood. NMT 1 stated, patients could go into anaphylactic shock (a severe, life-threatening allergic reaction that could cause a rapid decline in blood pressure and difficulty breathing) due to receiving a blood product not the same type as their own. During an interview on 3/26/25 at 11:34 a.m. with the Radiology Safety Officer (RSO), the RSO stated, his role as safety officer was to oversee the radioactive material at the hospital and, to ensure patient and employee safety. The RSO stated, he was a practicing Radioactive Oncology Physician. The RSO stated, he remembered the incident regarding LNMT 1 injecting Pt 5 with Pt 6’s radioisotope tagged WBCs on 12/9/24. The RSO stated, he was involved with the hospital internal investigation. The RSO stated the incident involved two patients, Pt 5 and Pt 6. The RSO stated, Pt 6 had a physician order for an injection of blood with radioactive isotopes for a nuclear radiologic procedure (scan), and Pt 5 did not have an order for a nuclear radiologic procedure. The RSO stated, Pt 5 was injected with Pt 6’s blood by LNMT 1. The RSO stated, when a physician ordered a nuclear scan, a report went to the Nuc Med Department through the Electronic Medical Record (EMR- a digital version of a patient’s medical history, including diagnoses, medications, tests, allergies, immunizations, and treatment plans), and the type of scan the physician ordered required a radioisotope be attached to white blood cells. The RSO stated, LNMT 1 went to Pt 6’s hospital room and drew a vial of blood. The RSO stated, the vial of blood was sent to an offsite Radiopharmacy in a town one- and one-half hours away by the nuclear pharmacy courier (transporter). The RSO stated, the WBCs were tagged at the nuclear pharmacy then returned to the hospital for injection. RSO stated, LNMT 1 took the blood product to the patient’s hospital room and “just didn’t identify patient”, injecting the radioisotope tagged WBCs into Pt 5 instead of Pt 6. The RSO stated, LNMT 1 got off on the wrong floor and went into the same room number. The RSO, stated LNMT 1 identified his error, “right after the administration”. The RSO stated, LNMT 1 reported the error to the nurse, and leadership immediately. The RSO stated, Pt 5’s physician was notified as well as the patient and the family. The RSO stated, LNMT 1 “missed the double check”, and “just didn’t identify patient [did not verify Pt 5’s name and date of birth, against the armband]” The RSO stated, Pt 5 could have been harmed by any infections that were present in the blood infected into her. The RSO stated, the radiation was not an issue, it was given to the wrong patient, but it had a short half-life (the time it takes for one of the atoms in the sample to decay [lose energy] one that decays quickly). During a concurrent interview and record review on 3/28/25 at 9:33 a.m. with Nurse Educator (NE)1, Pt 6’s “History & Physical [H&P- an assessment from physician including medical history and exam],” dated 1/1/25 was reviewed. The “H&P” indicated, Pt 6 was a Portuguese speaking 86-year-old with past medical history (PMH) of Type 2 Diabetes Mellitus (disorder characterized by difficulty in blood sugar control and poor wound healing), and hypertension (high blood pressure), presenting to the emergency department (ED) on 12/29/24 for right foot redness, swelling and pain, as well as generalized weakness. The “H&P” indicated, Pt 6 was admitted to the hospital as an inpatient on 12/31/24 for a diabetic ulcer (open sores on the feet, a serious complication of diabetes), and acute osteomyelitis (a bone infection that develops rapidly). During a concurrent interview and record review on 3/28/25 at 9:40 a.m. with NE 1, Pt 6’s “Provider Progress Note [PPN],” dated 1/2/25 to 1/8/25, “Physician Orders [PO]”, “Medication Physician Orders [MPO], dated 12/30/24 to 1/3/25, and “Medication Administration Record [MAR],” dated 12/31/24 to 1/3/25, were reviewed. The “PO” indicated, on 12/30/24 at 4:50 p.m. an order for a Nuc Med scan was entered. NE 1 stated, the “PO” indicated the scan was performed on 1/3/25 at 11:38 a.m. and read by the physician on 1/4/25. The “MPO” indicated, on 1/2/25 at 11:05 a.m. an order for “...Radioisotope 12millicuire [a unit of radioactivity]” ...Electronically signed by: [LNMT 1] on 1/2/25 at 1105 [11:05 a.m.] ...” The “MAR” indicated, the radioisotope 12 millicurie was ordered by LNMT 1 on 1/2/25 at 11:05 a.m. but was administered by NMT 1 intravenously on 1/3/25 at 11:38 a.m. The “MAR” had no indication the radioisotope was scanned before administration. During a review of Pt 5’s “H&P,” dated 12/31/24, The H&P indicated Pt 5 was a Spanish speaking 96 year-old patient brought into the ED on 12/31/25 at 12:45 p.m. by family, with complaints of right upper quadrant pain (the area of the stomach located on the right side above the belly button) for two weeks. The “H&P” indicated Pt 5 was admitted as an inpatient on 12/31/24 at 8:50 p.m. for a renal abscess (a pocket of pus that forms within the kidney tissue) and moved to the Medical Surgical (MS) Unit at 11:56 p.m. During a concurrent interview and record review on 3/28/25 at 9:55 a.m. with NE 1 Pt 5’s “Provider Progress Note [PPN],” and “Labs”, dated 1/2/25 to 1/8/25, “Physician Orders [PO]”, “Medication Physician Orders [MPO], dated 12/31/24 to 1/3/25, and “Medication Administration Record [MAR],” dated 12/31/24 to 1/3/25, were reviewed. NE 1 stated, Pt 5’s “PO” and “MPO” had no orders indicating a Nuc Med scan, or any radiopharmaceuticals were ordered for Pt 5. NE 1 stated, Pt 5s “MAR” had no documentation indicating Pt 5 was administered isotope tagged WBCs. NE 1 stated, Pt 5’s “MAR” would not have documentation, because there were no orders for the patient to have radiopharmaceuticals. The “PPN” dated 1/2/25 indicated, “ ...I was informed (01/02/2025) that patient [Pt 5] was (accidentally and erroneously [incorrectly]) injected (by nuclear medicine technologist) another patient’s blood product [Pt 6]. This was communicated to the patient’s sons ... Active Problems: ...Accidental injection of blood products from another patient - This was reported to the patient’s both sons and risks/plans were explained. - Discussed with infection control; source patient [Pt 6] has strep [type of germ] bacteremia [serious infection enters the bloodstream] and Pseudomonas (common bacterial disease-causing organisms) wound infection. -Source patient is being tested for [bloodborne pathogens] ...per Infectious control request. ...Will repeat blood cultures with a.m. labs and follow up ...”. NM 1 stated, multiple labs were drawn, and results were negative for bloodborne pathogens. During an interview on 4/1/25 at 11:42 a.m. with the Director of Imaging (DI), the DI stated, she was a part of the hospital internal investigation of Pt 5 being injected with Pt 6’s radioisotope tagged WBCs. The DI stated LNMT 1 failed to use two patient identifiers prior to injecting the radioisotope tagged WBCs for Pt 6 into Pt 5. The DI stated, her expectation was for LNMT 1 to report the error immediately, which he did. The DI stated, the discovery during the investigation was, LNMT1 got off the elevator on the incorrect floor and entered what would be the same room number if he was on the correct floor. The DI stated, Pt 6 and Pt 5 were located on different floors but were in the same room number, and in the same bed location. The DI stated, LNMT 1did draw the correct patient’s blood (Pt 6), in the morning around 6 a.m. The DI stated, LNMT 1claimed he only “glanced” at Pt 5’s armband, and both patients had similar first names, and both patients were similar in appearance. The DI stated, LNMT 1 did not notice Pt 5 did not have the Nuc Med Department armband applied, and he did not verify the “kit” numbers against the armband, or the patient’s name against the physician’s order. The DI stated, as soon as LNMT 1realized he injected the wrong patient he called the manager, the house supervisor and both patient’s physicians. LNMT 1 stated, Pt 6 needed to be tested for bloodborne pathogens, and be redrawn for the nuclear isotope tagging and rescheduled for the scan, and Pt 5 needed to be monitored for reactions and tested for infections. The DI stated, the incident was reported to the RSO the same day as the event, and there was no concern for harm to Pt 5 due to the radiation dose. The DI stated, Pt 5 receiving Pt 6’s blood was concerning but both patients were tested, and the results were negative for any bloodborne pathogens. The DI stated, the Nuc Med Department had label tracking (to scan) into the Nuclear Medicine Information System (NMIS-software designed to manage patient, department, including inventory, dosing and billing), but there was no barcode scanning to scan the “kit” into the main hospital EMR system. The DI stated the NMT’s document in the patient’s MAR when completing the administration. During a review of hospital document titled, “Labeling Tracking Record [LTR],” dated 1/2/25, the “LTR” indicated, Pt 5 had blood drawn for WBC tagging by LNMT 1 on 1/2/25 at 6:25 a.m. The “LTR” had a checkmark indicating the “Patient name on all labeling stickers”, “Specimen syringe sticker attached to blood specimen container” and “Bracelet attached to patient”. The “LTR” indicated, Pt 5’s blood was received at the Radiopharmacy on 1/2/25 at 8:30 a.m. The “LTR” indicated, a dual verification of the dose was verified, loaded and sealed in the transporting case. The “LTR” indicated, five separate steps for verification of patient name to ensure correct patient prior to sending the dose to the hospital. The “LTR” indicated, the radioisotope tagged WBCs were delivered to the hospital on 1/2/25 at 11:11 a.m. During an interview on 4/1/25 at 2:50 p.m. with the Manager of Accreditation and Licensure (MAL), the MAL stated LNMT 1 was as not available to be interviewed because LNMT 1 no longer worked for the hospital. During an interview on 4/2/25 at 1:19 p.m. with the Healthcare Risk Officer (HRO) the HRO stated, the reason the Nuclear Medicine incident was initially not thought to be reported, and an RCA was not completed was because it did not meet the criteria. The HRO stated, the hospital completed an Intensive analysis, considered one step above a regular investigation but did not rise to the level of a root cause analysis. During an interview on 4/3/25 at 1:57 p.m. with the DI, the DI stated, the NTs scan the radiopharmaceutical product for the NIMS system at patient’s bedside. The DI stated, during the incident with Pt 5 LNMT 1 had trouble logging into the computer workstation at Pt 5’s bedside so he attempted to use identifiers, then scanned the label when returning to the Nuc Med department. The DI stated, when he scanned the label, he discovered his error. During an interview on 4/4/25 at 5:25 p.m. with the Chief Nursing Executive (CNE), the CNE stated, LNMT 1 should have gone to the patient’s room and verified the patient’s identity, ensuring right patient, right drug, right dose, right route, and right time. The CNE stated the five rights of medication administration should have been followed for this patient to avoid the error. During a review of the hospital’s P&P titled, “Nuclear Medicine: Radiopharmaceutical Preparation, Labeling, and Administration,” dated 6/8/23, indicated, “ ... PURPOSE A. To ensure patient and staff safety during the preparation and administration of radiopharmaceuticals. ...Patient identity shall be verified by comparing patient name and date of birth on identification band with same identifiers on applicable health information documents prior to initiating this policy/procedure ... Maintain adequate shielding throughout the department. Reaction vials are to remain in covered leaded carriers (“pigs”), when not in use. Dose syringes must be in syringe shield or “pig” except when in the dose calibrator. ... Double check vial and syringe labels before injecting. ...Administration ...Establish patient identity before prepping or injecting. Ask patient to state full name (rather than to confirm name) and the date of birth. For inpatients, confirm identification in same manner against identification armband. Nuclear Medicine Technologist will cross-reference patient identification with that printed on NMIS labels and/or registration record. ...Labeling of Blood Products a. On studies that involve invitro tagging of blood cells ... the patient should be carefully identified as above and given a wristband with specific identifiers for the return of the tagged blood cells. b. The same Nuclear Medicine technologist should draw the blood that re- injects the tagged cells. ...Documentation: ...Order radiopharmaceutical in the exam navigator under “orders”, with correct information as to drug, route, and time. ...One eMAR [electronic Medication Administration Record] and NMIS computer system, document patient name, date of birth, and medical record number with radiopharmaceutical, manufacturer and lot number, dose, date and time of administration, date and time of expiration and Nuclear Medicine technologist administering ...” During a review of the hospital’s P&P titled, “Identification: Patient Armbands/Patient Verification,” dated 2/8/22, indicated, “ ...PURPOSE A. To assure accurate identification of all patients at [name of hospital] B. To assure the two approved patient identifiers are used to match service or treatment to that individual in a manner that prevents wrong patient identity. ...Verification of patient identity by comparing patient name and date of birth on identification band with same identifiers on applicable health information documents will occur prior to initiating this procedure ...Applicable patients will have an identification band on at all times. ... Accurate patient identification will occur whenever administering medications or blood products, taking blood samples and other specimens for clinical testing, or providing any other care, treatments or procedures. 1. Accurate identification MUST occur at the “point of care” any time care/treatment is to be provided. 2. Containers used for blood and other specimens are to be labeled in the presence of the patient. ... Whenever patient care is being managed through Order Entry (OE) or other computerized methods, accurate patient identification will occur by comparing patient’s full name and date of birth on document being entered (physician’s order for example) to patient pulled up in computer application. 1. Using medical record number and/or patient account number can be used to further verify correct patient IN ADDITION to, but not as replacements for, using patient’s full name and date of birth. ... Patients who are hospitalized who are unable to participate in verification at time of admission will have identity verified through reliable family member or friend as soon as possible. The name of the family member or friend verifying identity will be entered into admission history to provide reference that identity was initially verified through this reliable source. This is intended to provide reference to subsequent caregivers that identity has been validated. ... VERIFYING PATIENT IDENTITY: POINT OF CARE VERIFICATION AND INFORMATION DOCUMENT COMPARISON 1. Upon first interaction or at beginning of shift with a conscious patient, verify patient identity by asking the patient to state their full name and date of birth. Compare this to same information on patient’s identification band and same in health information documents (eMAR, physician orders). 2. Upon all subsequent interactions while assigned to patient within same day, verify identity by checking full name and date of birth on identification band and comparing to same information on applicable health information documents (eMAR, physicians orders, lab results or other documents triggering nursing intervention). ...Non-English speaking: Obtain interpreter and follow same guidelines ...” During a review of a professional reference titled, “Safe Medication Administration: So Many Considerations,” dated July-August 2023, the professional reference indicated, “ ... For decades, the five rights for administering medications have been a recognized safety standard (Martyn et al., 2019). The framework of the seminal five rights (i.e., right patient, drug, dose, time, route) has evolved, and other rights considered as additional influences on medication administration processes have been identified in changing healthcare environments ...” 3. During a review of Pt 4’s “Emergency Department (ED) Note”, dated 2/6/25, the “ED Note” indicated, “ ... [Pt 4] is a 43 year old female with [past medical history] significant for fibroids [noncancerous growths that develop in the uterus, often without causing symptoms], prior alcohol abuse, adenocarcinoma [type of cancer that starts in the glands that line organs] of the rectosigmoid colon [lower part of the large intestine] metastatic [cancer that has spread from its original location to other parts of the body] to the liver seen by [hospital name] oncology, diverting colostomy [surgical procedure where a portion of the colon is brought out through an opening in the abdominal wall, creating a stoma, which allows waste to be eliminated into a bag attached to the skin], cirrhotic liver [condition where healthy liver tissue is replaced by scar tissue, leading to impaired liver function], who presents to the ED for evaluation of [altered mental status (AMS)]. Per friend, Per friend, patient did not eat yesterday or take medications. She has been sleeping all day today and was briefly unresponsive for family ... stage IV colorectal rectal cancer [indicates that the cancer has spread from the colon or rectum to other parts of the body] metastatic to liver and bones not a candidate for chemoradiation therapy [cancer treatment] ... discussed with the intensivist [medical doctor who possesses special training and experience in treating critically ill patients] for admission to [Intensive Care Unit (ICU - is a specialized hospital unit providing advanced care for critically ill or injured patients who require constant monitoring, life support, and specialized medical treatments)] ... FINAL DIAGNOSIS ... Septic shock ...Metastatic colon cancer to liver ... Acute kidney injury [sudden decline in kidney function, often reversible, where the kidneys can’t filter waste products from the blood] ... Influenza [Flu, an infection of the nose, throat and lungs] ...” During a concurrent interview and record review on 4/3/25 at 9:07 a.m. with Respiratory Therapist (RT) 3, PT 4’s Electronic Medical Record (EMR) was reviewed for the hospital encounter date of 2/6/25. The review of document titled “POST - OP NOTE” dated 2/27/25 at 4:56 p.m. indicated, “ ... PROCEDURE: Tracheostomy placement ... We placed a 7.5 ID [internal diameter] cuffed [Brand name] tracheostomy tube [a curved, hollow tube inserted into the trachea (windpipe) to help a person breathe] ... Adequate position confirmed ... the trach was secured with Prolene suture [brand of non-absorbable, synthetic suture made from polypropylene (type of plastic) ] and trach tie ...”. The review of flow sheet note filed on 3/8/25 at 11:26 a.m. by RT 2 indicated, “ ... Trach sutures removed from each corner at this time. Patient tolerated well without adverse event ...” RT 3 stated RTs do not remove sutures on tracheostomy tubes at the facility and the hospital did not provide any competencies, training or skills validation for respiratory staff to remove sutures. RT 3 stated she was not aware that RTs can remove suture and, in her experience, it was usually physician, nurse practitioner (NP) or physician assistant (PA) that remove sutures on new trach. RT 3 stated she was not aware of any policy or guidelines at the facility for RTs to remove sutures from tracheostomy tube. RT 3 stated she was not sure whether it was in the scope of RTs to remove sutures at this facility and would have to defer to her manager or director for answer. During an interview on 4/3/25 at 9:46 a.m. with the Manager of Respiratory Therapy (MRT), the MRT stated “We do not have any policies, training or competencies for RCPs to remove trach suture, RT 2 should not have done it”. MRT stated RT 2 had no competency or training to remove Pt 4 tracheostomy tube sutures. MRT stated removing sutures from new tracheostomy tube was not part of the scope of RTs at the hospital. MRT stated without training, competencies or skills validation it could potentially cause harm to the patient. During an interview on 2/4/25 at 9:15 with the Director of Critical Care and Respiratory (DCC), the DCC stated he had reviewed the chart and spoken with the physician in Intensive Care Unit (ICU). The DCC stated RT 2 was working outsider of her scope and should not have removed sutures. The DCC validated that RT 2 had no training, no competency and no skills validations completed for tracheostomy suture removal. The DCC stated hospital did not have a policy, training or competencies for RTs to remove suture. The DCC stated he expects all RTs to follow hospital policy and not perform tasks that are outside their scope of practice. The DCC stated working outside the scope puts patient at harm for adverse outcomes. 4. During a review of Pt 7’s “H&P,” dated 3/17/25, the “H&P” indicated Pt 13 was admitted to the hospital for an abdominal hysterectomy (a surgical procedure where the uterus is removed through an incision in the abdomen) due to abdominal pressure. The “H&P” indicated Pt 7 had a past medical history of chronic kidney disease (a gradual loss of kidney function over time), hyperlipidemia (an excess of fats in your blood), gastroesophageal reflux disease (GERD-a condition in which stomach acid repeatedly flows back up into the tube connecting the mouth and stomach, called the esophagus) and OSA on CPAP. During a concurrent interview and record review on 3/26/25 at 2:47 p.m. with Nurse Educator (NE) 1, Pt’s 7’s “Physician Orders,” dated 3/17/25 to 3/26/25 were reviewed. The “Physician Orders” indicated there were no orders for CPAP use. NE 1 validated she was unable to find any active order for CPAP use for Pt 7 and Pt 7 should have been evaluated to determine if a CPAP was needed while hospitalized. NE 1 stated Pt 7 should have had an assessment completed to determine her breathing while sleeping. During a concurrent observation and interview on 3/27/25 at 9:56 a.m. with Pt 7, in Pt 7’s room, a CPAP machine was observed on Pt 7’s nightstand. Pt 7 stated she brought her CPAP from home to use at night. Pt 7 stated she did not sign any forms to use her CPAP from home during her stay in the hospital and stated she did not recall anyone assessing her ability to use her home CPAP for safety while used in the hospital. Pt 7 stated no one evaluated or asked her questions about her use of the CPAP. During an interview on 3/27/25 at 10 a.m. with the Director of Medical Surgical Services (DMS) and Nurse Manager (NM) 5, NM 5 stated respiratory therapy should have come to evaluate the Pt 7’s home CPAP and identify any issues. NM 5 stated a physician order should have been entered to evaluate Pt 7 for CPAP use when Pt 7 was admitted. The DMS stated the home CPAP would be on a fixed setting and respiratory therapy needed to come to check the setting before patient use. During a concurrent interview and record review on 3/27/25 at 10:45 a.m. with NM 4, the hospital’s P&P titled, “Obtaining and Using Patient Owned Respiratory Medical Devices,” dated 2/16/22, and Pt 7’s “Electronic Medical Record (EMR-an electronic version of a patient’s medical history),” dated 3/17/25 to 3/27/25 were reviewed. The P&P indicated, “ ... POLICY: ... The use of patient-owned medical devices is discouraged. However, due to medical necessity, patient-owned medical devices can be used if: A. A physician order allowing the patient to use their own device has been entered into the EHR ... C. A Release of Liability has been completed and scanned into the EHR. D. For CPAP and BiPAP devices, the licensed staff needs to verify that the patient can use their own device independently. For example, the patient can turn on and off the device and apply and remove the masks interface independently ...” The “EMR” indicated “ ... CPAP NIV [non-invasive ventilation-use of breathing support administered through a face mask, nasal mask, or a helmet] - ADULT - OSA ... Patient can use own equipment: Yes ... Order Information ... Order Date 3/27/25 ... Order Time [10:34 a.m.] ...” NM 4 stated the order should have been placed before the patient used the CPAP in the hospital. NM 4 stated an order was important to ensure the physician was directing the care of the patient. The “EMR” indicated the Liability Release for Use of Patient-Owned Medical Equipment was signed by Pt 7’s husband on 3/27/25 at 10:37 a.m. and an evaluation of Pt 7’s ability to use the device was assessed by a respiratory therapist. NM 4 stated the Liability Release form was signed today and should have been signed upon admission. NM 4 stated the Liability Release form was important for the patient to understand the home equipment has not gone through the hospital’s normal process of inspection and the patient was taking the responsibility of her own equipment and safety. During an interview on 4/4/25 at 11:10 a.m. with the DMS, the DMS stated nurses were expected to get a physician order to use equipment from home when a patient brought in their own equipment to use in the hospital. The DMS stated staff should ensure the equipment was safe to use by contacting respiratory therapy to ensure the settings were correct. The DMS stated the Liability Release form should be completed before the patient used their own equipment from home. During an interview on 4/4/25 at 5:10 p.m. with the Chief Nurse Executive (CNE), the CNE stated the nurse was responsible to obtain a physician order for patient to use home equipment. The CNE stated she expected the Liability Release form to be completed before the patient used home equipment. The CNE stated she expected respiratory therapy to come to assess the patient’s ability to use home equipment and ensure patient safety at all times. 5. During a review of Pt 2’s “H&P,” dated 1/27/25, the “H&P” indicated, “ ... [Pt 2] is a 78 year old female with [past medical history] significant for developmental delay, CVA [cerebrovascular accident-stroke] with residual aphasia [language difficulties that some individuals continue to experience], COPD [chronic obstructive pulmonary disease-a common lung disease causing restricted airflow and breathing problems], CHF [congestive heart failure-a condition where the heart is unable to pump blood effectively], DM [diabetes mellitus-a disorder characterized by difficulty in blood sugar control and poor wound healing], CKD [chronic kidney disease], chronically bed bound, presenting from home by ambulance with chief complaint of worsening SOB [shortness of breath-difficulty breathing]. Patients’ family reporting several day [history] of URI [upper respiratory infection] like symptoms with worsening dyspnea [a sensation of running out of the air and of not being able to breathe fast enough or deeply enough] ... In [emergency department], initial [vital signs] notable for tachypnea [a breathing rate that is higher than normal]. VBG [Venous blood gas-a medical test that measures the acidity and alkalinity of blood, along with levels of oxygen and carbon dioxide, taken from a vein] reveals acute on chronic hypercapnic respiratory failure [when a patient with long-standing respiratory insufficiency (chronic) experiences a sudden deterioration in their respiratory function, resulting in high levels of carbon dioxide in the blood (hypercapnia)]. CXR [chest x-ray] showing [left lower lobe] infiltrate ...” During a concurrent interview and record review on 4/3/25 at 4:27 p.m. with the Respiratory Educator (RE) and Assistant Nurse Manager (ANM) 4, the hospital’s P&P titled, “Noninvasive Ventilation (NIV) [breathing support method that delivers oxygen and positive pressure to the lungs without requiring a tube inserted into the trachea ] Protocol - Emergent,” dated 12/6/24, Pt 2’s “Physician Orders,” dated 1/26/25, “Ventilation Flowsheet (VF),” dated 1/29/25 were reviewed. The P&P indicated, “ ... PURPOSE: This procedure provides instructions for initiating, maintaining and monitoring non-invasive positive pressure ventilation (NIV) ... PROTOCOL: Respiratory Care Practitioners will provide the initial setup, subsequent operation, and monitoring of non-invasive positive pressure ventilation (NIV) upon a written physician order ... Select NIV mode desired ....CPAP/BIPAP [mode on machine that offer two different pressure levels: one for inhalation (IPAP) and another for exhalation (EPAP)]/ PC-BIPAP [mode of breathing where pressure is control on inspiration]/ CPAP-PS [mode of breathing that supports spontaneous breathing with specific pressures] ... IPAP 8-25 [Centimeter of Water (cm H2O - unit of measurement for pressure)] targeting a tidal volume [the amount of air inhaled and exhaled during normal, restful breathing] 6-8 [milliliter /kilogram (ml/kg) - Unit of measurement] ... EPAP 4-10 cm H2O ....[Respiratory rate (RR)] - 8 and adjust for ABG [Arterial Blood Gas] .... FiO2 [concentration of oxygen] to target SpO2 [measures the percentage of oxygen in your blood] 92% or greater ...” The “Physician Order” on 1/26/25 at 5:36 p.m. indicated, “ ... CPAP NIV - ADULT - OSA ... Patient Mask: Full Face Mask ...” The RE validated and stated there were no specified pressures or oxygen concentration settings ordered by the physician for CPAP order. The RE stated the physician order for CPAP did not indicate to initiate CPAP per respiratory protocol. The RE stated respiratory therapists (RTs) need a physician order or order for the protocol for the settings to initiate CPAP. The “VF” on 1/29/25 at 8:54 a.m. indicated Pt 2 was on a CPAP, placed on a [Brand name] CPAP machine with high flow nasal cannula (HFNC- an oxygen supply system capable of delivering up to 100% humidified and heated oxygen), and CPAP pressure of 14. The RE stated the CPAP order was indicated for OSA, not respiratory failure. The RE had no explanation as to why Pt 2 was started on a pressure of 14 without any order from the physician. The RE stated he was unable to explain why the documentation reflects both HFNC and CPAP, and he was unable to explain which modality patient was on. The RE stated documentation by RT was not clear and Pt 2 was either on CPAP or HFNC. The RE stated without the physician order or machine that auto titrates pressures he was unable to confirm that CPAP of 14 was correct and safe settings for Pt 2. The “Physician Orders” on 1/26/25 at 8:39 p.m. indicated, “ ... BIPAP NIV PROTOCOL - ADULT - RESP FAILURE ...” The “VF” on 1/29/25 at 1 p.m. indicated Pt 2 was changed from CPAP to BIPAP mode with settings IPAP of 12, EPAP 6, RR 16, Oxygen 30%. The RE reviewed the settings and was unable to answer why the IPAP of 12 was selected. The RE stated the protocol does not specify to use ideal body weight instead of Pt 2’s actual weight, however, the RT used the ideal body weight to set up IPAP to deliver tidal volume of 6 -8 ml/kg which was lower based on the current protocol. The RE stated the protocol needs to be corrected to indicate “use of ideal body weight instead of patient actual weight”. The RE stated the protocol does not specify how to titrate EPAP and only states “EPAP 4-10” with no criteria/parameters on when to go up or down on EPAP, where to start and increments use for adjustments. The RE stated it was up to RT’s judgement and their clinical ability to place patient on appropriate settings. The RE agreed this could potentially lead to an error, variance in practice among RT and potentially could harm the patient. The RE reviewed the RR set at 16 and stated the protocol only states start “rate at 8 and titrate for ABG.” The RE stated protocol does not provide maximum rate, when to go up or down on the rate, increments to go up or down and what value or values to monitor on ABG and what range to keep those ABG values. The RE was unable to comment on how hospital RTs were using this protocol and titrating settings on BIPAP without these parameters. The RE stated the protocol needs to be revised. The RE stated RTs were using their “critical thinking” and did not have a physician order and protocol did not reflect the criteria to make adjustments to BIPAP settings. The RE agreed this has the potential to cause harm to the patient and potential for ineffective gas exchange (inability to adequately exchange oxygen and carbon dioxide between the lungs and the bloodstream) in Pt 2. During an interview on 4/4/25 at 4:54 p.m. with the Director of Critical Care and Respiratory (DCC), the DCC stated he was in charge of Respiratory Therapy. The DCC stated he had spoken to RE and agreed the protocol was not safe and needed to be revised. The DCC stated RCPs need physician order or protocol that clearly outlines parameters and criteria for settings that include when to change, how to change, what to monitor and other relevant information. The DCC stated the titration of settings for Pt 2 were conducted by RT based on their judgement and experience, not based on physician order or protocol that outlines the evidence-based criteria. During a review of Medical Staff ByLaws, dated January 2024, the Medical Staff ByLaws indicated, “ ... Care provided by allied health professionals, residents, fellow and/or medical students shall be under the appropriate degree of supervision by a licensed practitioner with clinical privilege ...””

“MEDICAL STAFF PERIODIC APPRAISALS CFR(s): 482.22(a)(1) The medical staff must periodically conduct appraisals of its members. This Standard is not met as evidenced by: 49884 Based on the interview and record review, the hospital failed to ensure Medical staff conducted appraisals to grant privileges and conducted evaluation of service line specific performance metrics of its members in accordance with Medical Staff ByLaws and Medical staff policy when: 1. Medical Doctor (MD) 1 at reappointment requested and was granted cardiac surgery privileges without MD 1 meeting the requirements set forth by department and Medical Staff ByLaws. MD 1 was reappointed by Medical Executive Committee (MEC) and hospital board with cardiac surgery privileges without documented board certification in cardiac surgery; MD 1 did not complete the proctoring requirement and without MD 1 having the expected volume of cases listed for the procedures in which he was granted privileges. MD 1’s specialty specific Ongoing Professional Practice Evaluation (OPPE -A process that identifies and evaluates professional practice trends of practitioners with privileges that impact quality of care and patient safety on an ongoing basis and focus on the individual practitioner’s performance and competence related to privileges ) data was not available for at minimum every 12-month interval as indicated in Medical staff policy. 2. MD 2’s credential file included Intensive Care Unit (ICU - specialized area within a hospital or healthcare facility dedicated to providing intensive medical care to patients with serious, life-threatening conditions) p rocedural privileges and the credential file did not include MD 2 to have approved privilege to manage patients in ICU or privileges for EKG interpretations. MD 2 was actively working in ICU, managing patients that require EKG interpretation. MD 2 specialty specific OPPE data was not available for at minimum every 12-month interval as indicated in Medical staff policy. 3. MD 3 and MD 4 at the end of their provisional appointment did not have evaluation in accordance with Med Staff ByLaws. MD 3 and MD 4 did not have required proctoring completed and their appointment was not extended following the process as listed in Medical Staff ByLaws. These failures had the potential to result in appointing and granting privileges to Medical staff without first determining qualifications and could affect the quality of care provided to patients. Findings: 1. During a concurrent interview and record review on 4/4/25 at 10:35 a.m. with Senior System Quality Director (SDQ), Medical Staff Manager (MSM), Medical Staff Coordinator (MSC) 1 and MSC 2, MD 1’s credential file was reviewed. MD 1’s credential file indicated MD 1 was board certified in General Surgery. MD 1’s original appointment was on 9/1/21 and was reappointed on 12/1/24. MD 1 reappointment application for two-year term was approved by Department Chair on 9/19/24. MD 1’s credential file indicated Medical Executive Committee (MEC - a decision-making sub-committee of the medical staff composed of physicians and other key medical staff members, that makes decisions related to patient care, clinical policies, and physician performance) approved the reappointment on 10/22/24 and board of directors approved it on 11/7/24. The review of MD 1 reappointment application indicated MD 1 requested and was granted privileges [specific services and procedures a healthcare provider is deemed qualified to provide or perform] for cardiac surgery. The review of criteria for granting privileges under cardiac surgery on reapplication indicated “CRITERIA: Prior to being granted privileges to perform cardiac surgery, the following criteria shall be met: The physician shall be Board Certified in Cardiothoracic Surgery; OR The physician shall have successfully completed a recognized and approved Residency training program within Cardiothoracic Surgery. He/she shall be expected to take the board certification. examination at the earliest possible opportunity and will be allowed two (2) attempts to pass. The physician shall scrub [becoming a member of the sterile surgical team] with Board Certified Cardiothoracic Surgeon for ten (10) cases, as well as being proctored [refers to an experienced surgeon observing and mentoring a colleague during a procedure, often to evaluate competency or provide guidance for new techniques]; AND Obtain letters of reference from the training program addressing independence and competence; AND Submit a copy of the operative report and, in so much as possible, a copy of the history and physical, consultations and discharge note from the most recent fifty (50) pump cases [procedures using cardiopulmonary bypass (CPB), where a heart-lung machine temporarily takes over the heart and lungs’ functions] in which the applicant was the primary surgeon; AND Special attention will be directed not only to documentation of technical surgical competence, but also, thorough analysis of cases and on the basis of personal reference, to a demonstration of commitment to careful and precise pre-operative evaluation and work-up and to evidence of commitment to personal post-operative care and management; AND - At the discretion of the Department Chairman [upon recommendation from the reviewing practitioner (s)], these basic materials may be reviewed by an outside source (e.g., Cardiovascular-Thoracic Surgeon and/are Invasive Cardiologist). PROCTORING: Shall be performed by a Board-Certified Cardiothoracic Surgeon, consisting of the first five (5) scheduled adult coronary artery bypass graft cases and the first five (5) scheduled valve replacement cases. An outside physician may be assigned as proctor, at the chairperson’s discretion.” MSC 1 stated MD 1 was not board certified in cardiothoracic surgery and she was unable to find any documentation regarding proctoring, or number of cases completed as listed in the criteria for granting privileges. MSC 1 stated she was unable to comment on what criteria MEC used to grant these cardiac surgery privileges. MSC 1 validated MD 1’s credential file and reapplication does not include any information that indicates MD 1 met the criteria listed for granting cardiac surgery privileges. MSC 1 stated she was also not able to find Focused Professional Practice Evaluation (FPPE- A process whereby the medical staff evaluates the privilege-specific competence of a practitioner who requests a new privilege, or when a practitioner’s competence to perform a privilege is questioned) in the physician credential file. MSC 1 stated it was the hospital policy to have FPPE completed when granting new privileges to the provider. MSM and SDQ both validated that MD 1’s credential file did not reflect the Medical staff rules and ByLaws were followed in granting privileges and FPPE process for MD 1. During a concurrent interview and record review on 4/4/25 at 3:20 p.m. with the System Quality and Patient Safety Analyst (QSA), SDQ & MSC 1, MD 1’s Ongoing Professional Practice Evaluation ( OPPE - A process that identifies and evaluates professional practice trends of practitioners with privileges that impact quality of care and patient safety on an ongoing basis and focus on the individual practitioner’s performance and competence related to privileges. ) data dash board was reviewed. The QSA was not able to explain the data listed under “PEER” column and stated would have to research and provide update. The QSA stated she was unable to comment on data for “OR on time” listed as “0”. The QSA stated it appears that the system may have a glitch and data pulling in to dashboard was not accurate. The QSA stated she was unable to comment who reviews this OPPE data and how often it gets reviewed. MSC 1 stated the medical staff only looks at the OPPE data at the time of reappointment which was every two years. The QSA was also unable to provide specific service line data for MD 1. The SDQ provided a list of metrics being tracked for each specialty and stated unable to provide any data for MD 1 for surgery specific metrics. The SDQ stated nurses that track and monitor data for OPPE were not available to discuss the data at this time. The SDQ stated the hospital have identified gaps in how they are tracking OPPE and FPPE data and it should be monitored on an ongoing basis and kept updated in physician credential file. The SDQ stated that MD 1’s credential file does not reflect FPPE and OPPE was completed in accordance with the hospital policy and Medical Staff ByLaws. During a review of the hospital Medial Staff Bylaws dated January 2024, the Medical staff Bylaws indicated, “ ...After receipt of the application, the department chair or appropriate designee of each department to which the application is submitted, shall review the application and supporting documentation, and may conduct a personal interview with the applicant at the department chair or designee’s discretion. The chair or appropriate designee shall evaluate all matters deemed relevant to a recommendation, including but not limited to, information concerning the applicant’s judgment, the applicant’s provision of services within the scope of privileges granted, including the individual’s clinical and/or technical skills indicated in part by the results of quality assessment and improvement activities, as reflected on the physician’s reappointment profile ... The Credentials Committee, or designee on behalf of the Credentials Committee, shall review the application, evaluate, and verify the supporting documentation, including clinical privileges, the department chair’s recommendations, and other relevant information ... The Medical Executive Committee shall forward to the Board of Directors, a written report and recommendation as to Medical Staff appointment and, if appointment is recommended, as to membership category, department affiliation, and any special conditions to be attached to the appointment ... the Board of Directors concurs in that recommendation; the decision of the Board shall be deemed final action ... Exercise of Privileges Except as otherwise provided in these Bylaws, a member providing clinical services at this Hospital shall be entitled to exercise only those clinical privileges specifically granted. Said privileges and services must be hospital specific, within the scope of any license, certificate, or other legal credential authorizing practice in this State and consistent with any restrictions thereon and shall be subject to the rules and regulations of the clinical department and the authority of the department chair and the Medical Executive Committee. Only an appropriately licensed practitioner with clinical privileges shall be directly responsible for a patient’s diagnosis and treatment within the area of his/her privileges ... Criteria for General Competencies ... The Medical Staff shall, in addition to criteria for privileges, also develop areas of “general competencies” by which all hospital practitioners shall be measured for current proficiency. Each department shall define how to measure these general competencies as applicable to that department and use them to monitor and assess each practitioner’s current proficiencies on an ongoing basis ... Basis for Privileges Determination ... Requests for clinical privileges shall be evaluated on the basis of the member’s education, training, experience, demonstrated current professional competence and judgment. Privilege determinations may also be based on pertinent information concerning clinical performance obtained from other sources, especially other institutions, and health care settings where a member exercises clinical privileges. The decision to grant or deny a privilege and/or to renew an existing privilege shall also be based on peer recommendations addressing the applicant’s .... Medical/clinical knowledge ... Technical and clinical skills ... Clinical judgment ... Interpersonal skills ... Communication skills ... Professionalism ... Health status ... Information regarding each practitioner’s scope of privileges shall be updated as changes in clinical privileges for each practitioner are made ... Performance Monitoring Generally ... Except as otherwise determined by the Medical Executive Committee and Board of Directors, the Medical Staff shall regularly monitor all members’ privileges in accordance with standards and procedures set forth in these Bylaws ... Performance monitoring activities and reports shall be integrated into other quality improvement activities. Any monitoring performed on a practitioner shall be considered in the review of that practitioner associated with granting, renewing, revising, or revoking any of their privilege(s) at hospital ... Ongoing Professional Performance Evaluation ... Each practitioner exercising privilege(s) at hospital shall be monitored and evaluated on a regular basis to identify professional performance trends that impact on quality of care and patient safety. The Medical Staff shall be responsible for establishing the frequency of these regular, ongoing professional performance evaluations ... Ongoing performance reviews shall be factored into the decision to maintain, revise, or revoke existing privilege(s) at the time of renewal. The Medical Staff shall take additional actions as necessary, in accordance with these Bylaws, based on the results of such evaluations. Each department shall recommend, and the Medical Executive Committee shall ultimately approve, the criteria used in the ongoing professional performance evaluations ... Focused Professional Practice Evaluation ... The Medical Staff is responsible for developing a focused professional practice evaluation process that will be used in predetermined situations to evaluate, for a time limited period, a practitioner’s competency in performing a specific privilege(s) at hospital. The Medical Staff shall clearly define when such a focused evaluation will occur, what criteria and methods should be used for conducting the focused evaluation, the duration of the evaluation period and requirements for extending the evaluation period, and how the information gathered during the evaluation process will be analyzed and communicated ... A focused professional practice evaluation shall be used in at least the following situations ... When questions arise regarding a practitioner’s competency in performing a specific privilege(s) at the hospital ... All initially requested privileges ... As a condition of renewal of privileges, as necessary (for example, when a member requests renewal of a privilege that has been performed so infrequently that it is difficult to assess the member’s current competence in that area) ... Proctoring ... General Provisions ... All initial appointees to the Medical Staff, Medical Staff members who have insufficient activity from which to assess current competence, as determined by the Medical Staff, and all members granted new clinical privileges shall be subject to a period of proctoring. Proctoring may also be implemented whenever the Medical Executive Committee determines that additional information is needed to assess a practitioner’s performance ... Each appointee or recipient of new clinical privileges shall be assigned to the appropriate department, where performance of an appropriate number of cases as established by the Medical Executive Committee or department, shall be observed by the Department Chair(s) or his or her designee, during the period of proctoring specified in the departments privilege list to determine suitability to continue to exercise the clinical privileges granted ... Departments are responsible for developing and approving the proctoring criteria for their departments based on their applicants’ qualifications, requested privileges, and established current competency ... The proctor shall complete the required proctoring paperwork and submit to the Medical Staff Office ...The member shall remain subject to such proctoring until the Medical Executive Committee has been furnished with a recommendation from the department chair(s) to discontinue proctoring. A recommendation to discontinue proctoring must include the following statements: that the applicant appears to meet all of the qualifications for unsupervised practice in the hospital, that the applicant has discharged all of the responsibilities of Medical Staff membership, and that the applicant has not exceeded or abused the prerogatives of the category to which the appointment was made ... When a practitioner is subject to proctoring as a result of a focused professional practice evaluation plan, the department shall set the terms of proctoring in a manner consistent with the Medical Staff Bylaws, Rules and Regulations, and policies and procedures that address focused professional practice evaluation ... Failure to Successfully Complete Proctoring ... Any initial appointee who fails within the time of Provisional membership to complete the proctoring required, or any member exercising new clinical privileges or undergoing proctoring for infrequently performed procedures who fails to complete the required proctoring within the time allowed by the Medical Executive Committee, shall be deemed to have voluntarily relinquished the membership or privileges involved, and he or she shall not be afforded the procedural rights provided in article VIII, unless otherwise required by law. However, the Medical Executive Committee in its sole discretion may extend the time for completing proctoring requirements. The inability to obtain such an extension shall not give rise to procedural rights described in article VIII. Any practitioner whose membership or privileges are relinquished pursuant to this section may not reapply for the privileges involved or, in the case of initial appointees, for membership for one (1) year, unless the Medical Executive Committee makes an exception in its sole discretion for good cause ...” During a review of the hospital policy and procedure (P&P) titled, “ Focused Professional Practice Evaluation (FPPE) and Ongoing Professional Performance Evaluation (OPPE) Policy”, with an approval date of, 11/8/23, the “P&P” indicated, “The purpose of this policy is to define Focus Professional Practice Evaluation and Ongoing Professional Performance Evaluation. (FPPE) and (OPPE) are designed to evaluate a practitioner’s performance to continuously improve the quality safety and effectiveness of care rendered by the practitioners privileged at [Hospital name) ... A. Focused Professional Practice Evaluation (“FPPE”) - A process whereby the medical staff evaluates the privilege-specific competence of a practitioner who requests a new privilege, or when a practitioner’s competence to perform a privilege is questioned. FPPE entails the following four components ... Measures used to evaluate whether an FPPE is needed when issues are identified ... Method for establishing the monitoring plan specific to the privilege or expected behavior ... Method to determine the duration of the performance monitoring; and, ... Triggers or issues (single incidents or a trend) to trigger an FPPE ... Ongoing Professional Practice Evaluation (“OPPE”) - A process that identifies professional practice trends of practitioners with privileges that impact quality of care and patient safety on an ongoing basis and focuses on the individual practitioner’s performance and competence related to privileges. The process evaluates the quality, adequacy and competency of an individual practitioner’s performance utilizing specialty-specific performance indicators ... initial FPPE ... Departments will determine the parameters of the review period (type of review, number of cases, and duration of review) based on education, training, experience, and current competence ... Review must continue until competency has been determined for privileges granted ... Upon completion, the Department Chair or designee reviews the activity and evaluations ... The FPPE report is kept in the Credentials file ... FPPE Conclusion ... At the end of the FPPE, a report is created which includes findings and conclusions ... If all or any portion of the review is deemed satisfactory, all or that portion of FPPE are considered concluded ... If all or any portion of the review is deemed unsatisfactory ... The current FPPE may be extended, or A new FPPE may be initiated for any area requiring improvement, or ... Recommend to MEC for corrective action ... The practitioner is notified in writing with the results of the FPPE ... OPPE ... Selection of Practitioner Performance Measures for OPPE ... Practitioner performance measures are selected utilizing the framework of the six areas of “General Competencies” (Patient Care / Medical Knowledge / Practice - Based Learning and Improvement / Interpersonal and Communication Skills / Professionalism / Systems-Based Practice) developed by the Accreditation Council for Graduate Medical Education (ACGME) and the American Board of Medical Specialties (ABMS) joint initiatives ... Practitioner performance measures shall be applicable to the practitioner’s specialty ... Practitioner performance measures shall reflect practitioner performance as an individual or part of a related practice group when relevant ... Each department shall recommend practice specific indicators and the MEC shall approve the criteria used in OPPE ... Qualitative and quantitative data may be utilized to gather information for OPPE ... 2. OPPE Report and Practitioner Performance Feedback ... OPPE is intended to look at data on the performance of all practitioners with privileges on an ongoing basis rather than at the reappointment cycle to take steps to improve performance on a timely basis ... After initial granting of privileges, the review of the professional practice data of each practitioner cannot exceed every 12 months. The Quality & Safety Department notifies the Department Chair or designee when the OPPE profiles are available for review. Practitioners do not sign off on their own OPPE ...c. The OPPE Report shall be reviewed by the appropriate Medical Staff Department Chair or designee ... Conclusion codes ... No opportunity for improvement ... Minor opportunity for improvement ... Significant opportunity for improvement ... Rule Indicator ... The OPPE report is retained per policy ... Use of OPPE and FPPE at Reappointment ... At reappointment, the Department Chair or designee will review the OPPE and FPPE data from last re-appointment cycle and document the interpretation and any improvement activities for each indicator that required follow-up ... If no activity is provided, FPPE may be initiated. During the OPPE and FPPE processes, the practitioner is NOT considered to be “under investigation” for purposes of reporting requirements under the Health Care Quality Improvement Act”. 2. During a concurrent interview and record review on 4/4/25 at 10:50 a.m. with Senior System Quality Director (SDQ), Medical Staff Manager (MSM), Medical Staff Coordinator (MSC) 1 and MSC 2, MD 2’s credential file was reviewed. MD 2’s credential file indicated MD 2 was a board certified in Critical Care and Pulmonary Medicine. MD 2’s original appointment was on 8/6/15 and was reappointed on 7/31/23. MD 2’s reappointment application for two-year term was approved by Department chair on 6/7/23. MD 2’s credential file indicated MEC approved the reappointment on 6/20/23 and board of directors approved it on 7/6/23. The review of MD 2 reapplication indicated MD 2 requested and was granted privileges under Critical Care for “ ... Intubation [a medical procedure where a tube, usually an endotracheal tube, is inserted through the mouth or nose into the trachea (windpipe) to secure the airway and facilitate breathing], Sedation [using medication to induce a state of calmness, relaxation, or sleepiness, often used to reduce anxiety and discomfort during medical or surgical procedures]/analgesia [ loss of sensation of pain achieved by medication ]for the non-anesthesiologist (moderate), Central venous access [inserting catheter to provide access to the bloodstream for administering fluids, medications, or blood products], Swan Ganz placement [a thin, flexible tube inserted into a vein and threaded through the heart into the pulmonary artery to monitor heart function, blood flow, and pressures, particularly in critically ill patients], Thoracentesis [procedure used to obtain a sample of fluid from the space around the lungs, called the pleural space], Abdominal paracentesis [a procedure to drain fluid from the peritoneal cavity (the space within the abdomen) using a needle or catheter], Lumbar puncture, Joint Aspiration, ICU Bronchoscopy ...”. The request for privileges reapplication of MD 2 indicated “ ...Other ...Care of patients in ICU/CCU (can only manage patients in area of specialty and/or subspeciality) ...” and EKG interpretation was not requested and was not granted. MSC 1 stated MD 2 has been actively working in ICU and manages patients. MSC 1 stated she was unable to comment and was not certain why this section was not selected under other and EKG [a test to record the electrical signals in the heart] interpretation. MSC 1 stated MD 2 was reappointed and had volume to maintain privileges, but she was unable to comment on department specific metrics for OPPE for MD 2. MSC 1 stated MD 2 was granted privileges under ICU section but the [software name] portal does not reflect section “CRITICAL CARE MEDICINE” was selected. The SDQ stated “the privilege request form for MD 2 was not very clear.” The SDQ validated and agreed that reapplication and [software name] portal does not reflect whether MD 2 was granted privileges to take care of patients in ICU or EKG interpretation which were essential for managing patient in ICU. The SDQ stated the [software name] portal was what staff at the hospital uses to validate privileges. The SDQ stated the staff would not be able to validate MD 2’s privileges to manage patient in ICU by looking at the [software name] portal. The SDQ stated although MD 2 was board certified in critical care, was granted privileges for ICU procedures, the privilege to manage patients along with EKG should have been selected and granted as well but were not. The SDQ validated with the hospital leadership and stated MD 2 have been managing patients actively in ICU and does not have any reported adverse outcomes related to MD 2’s practice. The SDQ stated the privilege request form needs to be reviewed and updated to make it clear whether the privilege to manage patient in ICU were included/bundled with rest of privileges with ICU. During a phone interview on 4/4/25 at 3:52 p.m. with the Chief of Medical Staff (CMS), the CMS stated the hospital have a process in place for OPPE. The CMS stated every six months report cards for physicians get shared and the chair for each department was responsible for ensuring and reviewing service line indicators. The CMS stated the expectation for every service line is to have their own indicators for OPPE for providers in their service line. The CMS stated he was unable to comment on credentialing for MD 2 or any particular provider, but the process was that credentialing committee reviews the application and final decision was with board of directors. The CMS stated the department chair were expected to review and approve the application for appointments and privilege request to ensure it meets the requirements prior to routing it for MEC or board of director approval. The CMS stated he expected Medical staff office and department chairs to follow the facility Medical Staff ByLaws when approving or granting privileges. During a review of the hospital Medial Staff ByLaws dated January 2024, the Medical Staff ByLaws indicated, “ ...After receipt of the application, the department chair or appropriate designee of each department to which the application is submitted, shall review the application and supporting documentation, and may conduct a personal interview with the applicant at the department chair or designee’s discretion. The chair or appropriate designee shall evaluate all matters deemed relevant to a recommendation, including but not limited to, information concerning the applicant’s judgment, the applicant’s provision of services within the scope of privileges granted, including the individual’s clinical and/or technical skills indicated in part by the results of quality assessment and improvement activities, as reflected on the physician’s reappointment profile ... The Credentials Committee, or designee on behalf of the Credentials Committee, shall review the application, evaluate, and verify the supporting documentation, including clinical privileges, the department chair’s recommendations, and other relevant information ... The Medical Executive Committee shall forward to the Board of Directors, a written report and recommendation as to Medical Staff appointment and, if appointment is recommended, as to membership category, department affiliation, and any special conditions to be attached to the appointment ... the Board of Directors concurs in that recommendation; the decision of the Board shall be deemed final action ... Exercise of Privileges Except as otherwise provided in these Bylaws, a member providing clinical services at this Hospital shall be entitled to exercise only those clinical privileges specifically granted. Said privileges and services must be hospital specific, within the scope of any license, certificate, or other legal credential authorizing practice in this State and consistent with any restrictions thereon and shall be subject to the rules and regulations of the clinical department and the authority of the department chair and the Medical Executive Committee. Only an appropriately licensed practitioner with clinical privileges shall be directly responsible for a patient’s diagnosis and treatment within the area of his/her privileges ... Criteria for General Competencies ... The Medical Staff shall, in addition to criteria for privileges, also develop areas of “general competencies” by which all hospital practitioners shall be measured for current proficiency. Each department shall define how to measure these general competencies as applicable to that department and use them to monitor and assess each practitioner’s current proficiencies on an ongoing basis ... Basis for Privileges Determination ... Requests for clinical privileges shall be evaluated on the basis of the member’s education, training, experience, demonstrated current professional competence and judgment. Privilege determinations may also be based on pertinent information concerning clinical performance obtained from other sources, especially other institutions, and health care settings where a member exercises clinical privileges. The decision to grant or deny a privilege and/or to renew an existing privilege shall also be based on peer recommendations addressing the applicant’s ... Medical/clinical knowledge ... Technical and clinical skills ... Clinical judgment ... Interpersonal skills ... Communication skills ... Professionalism ... Health status ... Information regarding each practitioner’s scope of privileges shall be updated as changes in clinical privileges for each practitioner are made ... Performance Monitoring Generally ... Except as otherwise determined by the Medical Executive Committee and Board of Directors, the Medical Staff shall regularly monitor all members’ privileges in accordance with standards and procedures set forth in these Bylaws ... Performance monitoring activities and reports shall be integrated into other quality improvement activities. Any monitoring performed on a practitioner shall be considered in the review of that practitioner associated with granting, renewing, revising, or revoking any of their privilege(s) at hospital ... Ongoing Professional Performance Evaluation ... Each practitioner exercising privilege(s) at hospital shall be monitored and evaluated on a regular basis to identify professional performance trends that impact on quality of care and patient safety. The Medical Staff shall be responsible for establishing the frequency of these regular, ongoing professional performance evaluations ... Ongoing performance reviews shall be factored into the decision to maintain, revise, or revoke existing privilege(s) at the time of renewal. The Medical Staff shall take additional actions as necessary, in accordance with these Bylaws, based on the results of such evaluations. Each department shall recommend, and the Medical Executive Committee shall ultimately approve, the criteria used in the ongoing professional performance evaluations ... Focused Professional Practice Evaluation ... The Medical Staff is responsible for developing a focused professional practice evaluation process that will be used in predetermined situations to evaluate, for a time limited period, a practitioner’s competency in performing a specific privilege(s) at hospital. The Medical Staff shall clearly define when such a focused evaluation will occur, what criteria and methods should be used for conducting the focused evaluation, the duration of the evaluation period and requirements for extending the evaluation period, and how the information gathered during the evaluation process will be analyzed and communicated ... A focused professional practice evaluation shall be used in at least the following situations ... When questions arise regarding a practitioner’s competency in performing a specific privilege(s) at the hospital ... All initially requested privileges ... As a condition of renewal of privileges, as necessary (for example, when a member requests renewal of a privilege that has been performed so infrequently that it is difficult to assess the member’s current competence in that area) ... Proctoring ... General Provisions ... All initial appointees to the Medical Staff, Medical Staff members who have insufficient activity from which to assess current competence, as determined by the Medical Staff, and all members granted new clinical privileges shall be subject to a period of proctoring. Proctoring may also be implemented whenever the Medical Executive Committee determines that additional information is needed to assess a practitioner’s performance ... Each appointee or recipient of new clinical privileges shall be assigned to the appropriate department, where performance of an appropriate number of cases as established by the Medical Executive Committee or department, shall be observed by the Department Chair(s) or his or her designee, during the period of proctoring specified in the departments privilege list to determine suitability to continue to exercise the clinical privileges granted ... Departments are responsible for developing and approving the proctoring criteria for their departments based on their applicants’ qualifications, requested privileges, and established current competency ... The proctor shall complete the required proctoring paperwork and submit to the Medical Staff Office ...The member shall remain subject to such proctoring until the Medical Executive Committee has been furnished with a recommendation from the department chair(s) to discontinue proctoring. A recommendation to discontinue proctoring must include the following statements: that the applicant appears to meet all of the qualifications for unsupervised practice in the hospital, that the applicant has discharged all of the responsibilities of Medical Staff membership, and that the applicant has not exceeded or abused the prerogatives of the category to which the appointment was made ... When a practitioner is subject to proctoring as a result of a focused professional practice evaluation plan, the department shall set the terms of proctoring in a manner consistent with the Medical Staff Bylaws, Rules and Regulations, and policies and procedures that address focused professional practice evaluation ... Failure to Successfully Complete Proctoring ... Any initial appointee who fails within the time of Provisional membership to complete the proctoring required, or any member exercising new clinical privileges or undergoing proctoring for infrequently performed procedures who fails to complete the required proctoring within the time allowed by the Medical Executive Committee, shall be deemed to have voluntarily relinquished the membership or privileges involved, and he or she shall not be afforded the procedural rights provided in article VIII, unless otherwise required by law. However, the Medical Executive Committee in its sole discretion may extend the time for completing proctoring requirements. The inability to obtain such an extension shall not give rise to procedural rights described in article VIII. Any practitioner whose membership or privileges are relinquished pursuant to this section may not reapply for the privileges involved or, in the case of initial appointees, for membership for one (1) year, unless the Medical Executive Committee makes an exception in its sole discretion for good cause ...” 3. During a concurrent interview and record review on 4/4/25 at 11:05 a.m. with Senior System Quality Director (SDQ), Medical Staff Manager (MSM), Medical Staff Coordinator (MSC) 1 and MSC 2, MD 3’s credential file was reviewed. MD 3’s credential file indicated MD 3 was board certified in critical care medicine and his initial appointment was on 6/1/23. MD 3 application was approved by ME C on 5/30/23 and final approval was on 6/1/23. The review of application indicated MD 3 requested and was granted privileges for “ ...ICU Bronchoscopy [a procedure to look directly at the airways in the lungs using a thin, lighted tube] Flexible bronchoscopy, diagnostic and therapeutic, performed on patients who are intubated in the ICU ...Proctoring Requirements/Chair Recommendation ...First five (5) cases proctored or reviewed retrospectively ... Tube Thoracostomy [a flexible tube inserted through the chest wall into the pleural space (the area between the lung and the chest wall)] ... First three (3) cases proctored or reviewed retrospectively ...Stress electrocardiogram [measures the heart’s electrical activity during physical exertion] ... First two (2) cases to be reviewed retrospectively with report and tracing available for review by proctored ...”. MSC 1 stated she was unable to find whether proctoring was completed or not. MSC 1 stated the MD 3’s appointment was still provisional. MSC 1 stated the process at the hospital was to grant provisional status upon appointment and the providers have one year to complete the required proctoring and at the end of one year either the status gets changed to active or the provisional period get extended if the provider was not able to complete proctoring. MSC 1 stated she was unable to find any documentation in the credential file in regard to evaluation of FPPE, proctoring completion or extension of provisional appointment. MSC 1 stated the medical staff leader that use to work at the hospital was in charge of this and she was unable to comment on why the process was not followed or the file was incomplete. MSC 1 also stated similar to MD 2, MD 3 did not have ability to manage patient in ICU selected under other privileges. During a concurrent interview and record review on 4/4/25 at 11:10 a.m. with Senior System Quality Director (SDQ), Medical Staff Manager (MSM), Medical Staff Coordinator (MSC) 1 & MSC 2, the Medical Staff ByLaws dated January 2024 were reviewed. The Medical Staff ByLaws indicated “... Provisional Staff ... Qualifications ... The Provisional Staff shall consist of members who ... meet the general qualifications for membership set forth in Section 2.2 and ... immediately prior to their application and appointment were not members (or were no longer members) in good standing of this Medical Staff ... Observation of Provisional Staff Member Each Provisional Staff member shall undergo a period of observation by designated monitors as described in section 5.3 ... The observation shall be to evaluate the member’s (1) proficiency in the exercise of clinical privileges initially granted and (2) overall eligibility for continued staff membership and advancement within staff categories. Observation of Provisional Staff members shall follow whatever frequency and format each department deems appropriate in order to adequately evaluate the Provisional Staff member including, but not limited to, concurrent or retrospective chart review, mandatory consultation, and/or direct observation. Appropriate records shall be maintained. The results of the observation shall be communicated by the department chair to the Credentials Committee ... Term of Provisional Staff Status A member shall remain on the Provisional Staff for a period of one (1) year, unless that status is extended by the Medical Executive Committee, upon recommendation by the department chair or designee, for an additional period up to one (1) year upon a determination of good cause, which determination shall not be subject to review pursuant to Articles VI or VII ... Action at Conclusion of Provisional Staff Status ... If the Provisional Staff member has satisfactorily demonstrated his or her ability to exercise the clinical privileges initially granted and otherwise appears qualified for continued Medical Staff Membership, the member shall be eligible for placement in the Active, Courtesy or Consulting Staff as appropriate, upon recommendation of the Medical Executive Committee and ... In all other cases, the appropriate department shall advise the Credentials Committee which shall make its report to the Medical Executive Committee which, in turn, shall make its recommendation to the Board of Directors regarding a modification or termination of clinical privileges or termination of Medical Staff membership ... Failure to Complete Provisional Staff Requirements and to Obtain Provisional Staff Status Extension ... If the Provisional Staff member fails to complete a sufficient number of proctoring cases and fails to obtain an extension of the term of Provisional Staff status pursuant to article 3.5-4 above, the member will not be afforded hearing rights, and such failure to complete proctoring will result in automatic termination of Medical Staff membership effective at the expiration of the twelve (12) month provisional period ...” The SDQ stated MD 3’s credential file does not reflect that the provisional period evaluation was completed in accordance with the medical staff bylaws. The SDQ stated at the end of one year mark of provisional appointment if the providers was not able to finish the requirement, provider’s appointment should have been extended through MEC and board of directors in accordance with the medical staff bylaws and documentation should have been kept in provider’s credential file. The SDQ stated Bylaws clearly reflects that if the provider failed to complete proctoring or fails to obtain an extension it will result in automatic termination. The SDQ stated the Medical staff manager position recently opened up and the person covering previously was responsible for ensuring the process was followed and credential files were completed. The SDQ stated she was unable to comment on where the gap occurred in assuring files were complete. The SDQ stated facility need to evaluate and update the privilege request form to ensure critical privileges clearly outlines what was bundled with in the core privilege. The SDQ stated the quality nurses were in charge of monitoring physician specific PEER review and FPPE data for providers and were not available at this time to talk about the FPPE data associated with the provisional appointment. During an interview on 4/4/25 at 11:20 a.m. with the SDQ, the SDQ stated similar to MD 3, MD 4 provisional appointment to Obstetrics (care during pregnancy, childbirth, and postpartum) and Gynecology (women’s reproductive health) was on 9/7/23 and the credentialing file does not reflect that provisional evaluation was completed and appointment was extended in accordance with the Medical Staff ByLaws. The SDQ validated with both MSC 1 & MSM and stated that MD 4’s file only have record that shows MD 4 was proctored for two C-section surgeries (surgical procedure where a baby is delivered through incisions in the mother’s abdomen and uterus), and hysteroscopy (a test to look inside a woman’s womb, using a thin tube with a small camera inside it). The SDQ stated she was unable to comment on why the provision evaluation was not completed and MD 4 appointment was not reviewed in MEC for extension or termination. The SDQ stated that MD 4’s file have other special privileges listed that have proctoring requirement and MD 4’s credential file does not reflect that requirement was met or evaluated for extension or termination of appointment in accordance with Med Staff ByLaws. During an interview on 4/4/25 at 12:15 p.m. with the Manger of Accreditation and Licensing (MAL), the MAL stated the hospital have identified opportunity for improvement with the process of handling provisional appointment. The MAL stated she was made aware of the opportunities identified with MD 3 and MD 4. The MAL stated hospital have several other provisional appointments that are currently passed the provisional period and were not evaluated for extension, termination or conversion to active or other status as mentioned in Medical Staff ByLaws. The MAL stated the quality nurses in charge of peer review process and OPPE were not available to share the data for providers and it was not available with the Medical Staff team. The MAL stated QSA was the best person to go over OPPE dashboard but service line and special privileges data for each provider as listed in the Medical Staff ByLaws was not available at this time. The MAL stated provider specific performance data specific to each specialty as specified in Medical Staff Bylaws was something the hospital should have readily available or in credential file of providers at all times. During a review of the hospital Medial Staff Bylaws dated January 2024, the Medical staff Bylaws indicated, “... Proctoring ... General Provisions ... All initial appointees to the Medical Staff, Medical Staff members who have insufficient activity from which to assess current competence, as determined by the Medical Staff, and all members granted new clinical privileges shall be subject to a period of proctoring. Proctoring may also be implemented whenever the Medical Executive Committee determines that additional information is needed to assess a practitioner’s performance ... Each appointee or recipient of new clinical privileges shall be assigned to the appropriate department, where performance of an appropriate number of cases as established by the Medical Executive Committee or department, shall be observed by the Department Chair(s) or his or her designee, during the period of proctoring specified in the departments privilege list to determine suitability to continue to exercise the clinical privileges granted ... Departments are responsible for developing and approving the proctoring criteria for their departments based on their applicants’ qualifications, requested privileges, and established current competency ... The proctor shall complete the required proctoring paperwork and submit to the Medical Staff Office ...The member shall remain subject to such proctoring until the Medical Executive Committee has been furnished with a recommendation from the department chair(s) to discontinue proctoring. A recommendation to discontinue proctoring must include the following statements: that the applicant appears to meet all of the qualifications for unsupervised practice in the hospital, that the applicant has discharged all of the responsibilities of Medical Staff membership, and that the applicant has not exceeded or abused the prerogatives of the category to which the appointment was made ... When a practitioner is subject to proctoring as a result of a focused professional practice evaluation plan, the department shall set the terms of proctoring in a manner consistent with the Medical Staff Bylaws, Rules and Regulations, and policies and procedures that address focused professional practice evaluation ... Failure to Successfully Complete Proctoring ... Any initial appointee who fails within the time of Provisional membership to complete the proctoring required, or any member exercising new clinical privileges or undergoing proctoring for infrequently performed procedures who fails to complete the required proctoring within the time allowed by the Medical Executive Committee, shall be deemed to have voluntarily relinquished the membership or privileges involved, and he or she shall not be afforded the procedural rights provided in article VIII, unless otherwise required by law. However, the Medical Executive Committee in its sole discretion may extend the time for completing proctoring requirements. The inability to obtain such an extension shall not give rise to procedural rights described in article VIII. Any practitioner whose membership or privileges are relinquished pursuant to this section may not reapply for the privileges involved or, in the case of initial appointees, for membership for one (1) year, unless the Medical Executive Committee makes an exception in its sole discretion for good cause ...Effect of Failure to Complete Proctoring ... Failure to Complete Necessary Volume: any member who fails to complete the required number of proctored cases within the time frame established for the applicable privileges shall be deemed to have voluntarily withdrawn his or her request for such privileges and he or she shall not be afforded the procedural rights provided in article VIII. The inability to obtain such an extension shall not give rise to procedural rights described in article VIII ... Failure to Satisfactorily Complete Proctoring: if a member completes the necessary volume of proctored cases but fails to perform satisfactorily during proctoring, the relevant privileges may be revoked, and he or she shall be afforded the procedural rights as provided in article VIII. In the event procedural rights are invoked, the practitioner who has not successfully completed proctoring shall be deemed an “applicant” for purposes of article 8.4-7 ...” During a review of the hospital policy and procedure (P&P) titled, “ Focused Professional Practice Evaluation (FPPE) and Ongoing Professional Performance Evaluation (OPPE) Policy”, with an approval date of, 11/8/23, the “P&P” indicated, “The purpose of this policy is to define Focus Professional Practice Evaluation and Ongoing Professional Performance Evaluation. (FPPE) and (OPPE) are designed to evaluate a practitioner’s performance to continuously improve the quality safety and effectiveness of care rendered by the practitioners privileged at [Hospital name) ... A. Focused Professional Practice Evaluation (“FPPE”) - A process whereby the medical staff evaluates the privilege-specific competence of a practitioner who requests a new privilege, or when a practitioner’s competence to perform a privilege is questioned. FPPE entails the following four components ... Measures used to evaluate whether an FPPE is needed when issues are identified ... Method for establishing the monitoring plan specific to the privilege or expected behavior ... Method to determine the duration of the performance monitoring; and, ... Triggers or issues (single incidents or a trend) to trigger an FPPE ... Ongoing Professional Practice Evaluation (“OPPE”) - A process that identifies professional practice trends of practitioners with privileges that impact quality of care and patient safety on an ongoing basis and focuses on the individual practitioner’s performance and competence related to privileges. The process evaluates the quality, adequacy and competency of an individual practitioner’s performance utilizing specialty-specific performance indicators ... initial FPPE ... Departments will determine the parameters of the review period (type of review, number of cases, and duration of review) based on education, training, experience, and current competence ... Review must continue until competency has been determined for privileges granted ... Upon completion, the Department Chair or designee reviews the activity and evaluations ... The FPPE report is kept in the Credentials file ... FPPE Conclusion ... At the end of the FPPE, a report is created which includes findings and conclusions ... If all or any portion of the review is deemed satisfactory, all or that portion of FPPE are considered concluded ... If all or any portion of the review is deemed unsatisfactory ... The current FPPE may be extended, or A new FPPE may be initiated for any area requiring improvement, or ... Recommend to MEC for corrective action ... The practitioner is notified in writing with the results of the FPPE ... OPPE ... Selection of Practitioner Performance Measures for OPPE ... Practitioner performance measures are selected utilizing the framework of the six areas of “General Competencies” (Patient Care / Medical Knowledge / Practice - Based Learning and Improvement / Interpersonal and Communication Skills / Professionalism / Systems-Based Practice) developed by the Accreditation Council for Graduate Medical Education (ACGME) and the American Board of Medical Specialties (ABMS) joint initiatives ... Practitioner performance measures shall be applicable to the practitioner’s specialty ... Practitioner performance measures shall reflect practitioner performance as an individual or part of a related practice group when relevant ... Each department shall recommend practice specific indicators and the MEC shall approve the criteria used in OPPE ... Qualitative and quantitative data may be utilized to gather information for OPPE ... 2. OPPE Report and Practitioner Performance Feedback ... OPPE is intended to look at data on the performance of all practitioners with privileges on an ongoing basis rather than at the reappointment cycle to take steps to improve performance on a timely basis ... After initial granting of privileges, the review of the professional practice data of each practitioner cannot exceed every 12 months. The Quality & Safety Department notifies the Department Chair or designee when the OPPE profiles are available for review. Practitioners do not sign off on their own OPPE ...c. The OPPE Report shall be reviewed by the appropriate Medical Staff Department Chair or designee ... Conclusion codes ... No opportunity for improvement ... Minor opportunity for improvement ... Significant opportunity for improvement ... Rule Indicator ... The OPPE report is retained per policy ... Use of OPPE and FPPE at Reappointment ... At reappointment, the Department Chair or designee will review the OPPE and FPPE data from last re-appointment cycle and document the interpretation and any improvement activities for each indicator that required follow-up ... If no activity is provided, FPPE may be initiated. During the OPPE and FPPE processes, the practitioner is NOT considered to be “under investigation” for purposes of reporting requirements under the Health Care Quality Improvement Act””

“MEDICAL STAFF PERIODIC APPRAISALS CFR(s): 482.22(a)(1) The medical staff must periodically conduct appraisals of its members. This Standard is not met as evidenced by: 49884 Based on the interview and record review, the hospital failed to ensure Medical staff conducted appraisals to grant privileges and conducted evaluation of service line specific performance metrics of its members in accordance with Medical Staff ByLaws and Medical staff policy when: 1. Medical Doctor (MD) 1 at reappointment requested and was granted cardiac surgery privileges without MD 1 meeting the requirements set forth by department and Medical Staff ByLaws. MD 1 was reappointed by Medical Executive Committee (MEC) and hospital board with cardiac surgery privileges without documented board certification in cardiac surgery; MD 1 did not complete the proctoring requirement and without MD 1 having the expected volume of cases listed for the procedures in which he was granted privileges. MD 1’s specialty specific Ongoing Professional Practice Evaluation (OPPE -A process that identifies and evaluates professional practice trends of practitioners with privileges that impact quality of care and patient safety on an ongoing basis and focus on the individual practitioner’s performance and competence related to privileges ) data was not available for at minimum every 12-month interval as indicated in Medical staff policy. 2. MD 2’s credential file included Intensive Care Unit (ICU - specialized area within a hospital or healthcare facility dedicated to providing intensive medical care to patients with serious, life-threatening conditions) p rocedural privileges and the credential file did not include MD 2 to have approved privilege to manage patients in ICU or privileges for EKG interpretations. MD 2 was actively working in ICU, managing patients that require EKG interpretation. MD 2 specialty specific OPPE data was not available for at minimum every 12-month interval as indicated in Medical staff policy. 3. MD 3 and MD 4 at the end of their provisional appointment did not have evaluation in accordance with Med Staff ByLaws. MD 3 and MD 4 did not have required proctoring completed and their appointment was not extended following the process as listed in Medical Staff ByLaws. These failures had the potential to result in appointing and granting privileges to Medical staff without first determining qualifications and could affect the quality of care provided to patients. Findings: 1. During a concurrent interview and record review on 4/4/25 at 10:35 a.m. with Senior System Quality Director (SDQ), Medical Staff Manager (MSM), Medical Staff Coordinator (MSC) 1 and MSC 2, MD 1’s credential file was reviewed. MD 1’s credential file indicated MD 1 was board certified in General Surgery. MD 1’s original appointment was on 9/1/21 and was reappointed on 12/1/24. MD 1 reappointment application for two-year term was approved by Department Chair on 9/19/24. MD 1’s credential file indicated Medical Executive Committee (MEC - a decision-making sub-committee of the medical staff composed of physicians and other key medical staff members, that makes decisions related to patient care, clinical policies, and physician performance) approved the reappointment on 10/22/24 and board of directors approved it on 11/7/24. The review of MD 1 reappointment application indicated MD 1 requested and was granted privileges [specific services and procedures a healthcare provider is deemed qualified to provide or perform] for cardiac surgery. The review of criteria for granting privileges under cardiac surgery on reapplication indicated “CRITERIA: Prior to being granted privileges to perform cardiac surgery, the following criteria shall be met: The physician shall be Board Certified in Cardiothoracic Surgery; OR The physician shall have successfully completed a recognized and approved Residency training program within Cardiothoracic Surgery. He/she shall be expected to take the board certification. examination at the earliest possible opportunity and will be allowed two (2) attempts to pass. The physician shall scrub [becoming a member of the sterile surgical team] with Board Certified Cardiothoracic Surgeon for ten (10) cases, as well as being proctored [refers to an experienced surgeon observing and mentoring a colleague during a procedure, often to evaluate competency or provide guidance for new techniques]; AND Obtain letters of reference from the training program addressing independence and competence; AND Submit a copy of the operative report and, in so much as possible, a copy of the history and physical, consultations and discharge note from the most recent fifty (50) pump cases [procedures using cardiopulmonary bypass (CPB), where a heart-lung machine temporarily takes over the heart and lungs’ functions] in which the applicant was the primary surgeon; AND Special attention will be directed not only to documentation of technical surgical competence, but also, thorough analysis of cases and on the basis of personal reference, to a demonstration of commitment to careful and precise pre-operative evaluation and work-up and to evidence of commitment to personal post-operative care and management; AND - At the discretion of the Department Chairman [upon recommendation from the reviewing practitioner (s)], these basic materials may be reviewed by an outside source (e.g., Cardiovascular-Thoracic Surgeon and/are Invasive Cardiologist). PROCTORING: Shall be performed by a Board-Certified Cardiothoracic Surgeon, consisting of the first five (5) scheduled adult coronary artery bypass graft cases and the first five (5) scheduled valve replacement cases. An outside physician may be assigned as proctor, at the chairperson’s discretion.” MSC 1 stated MD 1 was not board certified in cardiothoracic surgery and she was unable to find any documentation regarding proctoring, or number of cases completed as listed in the criteria for granting privileges. MSC 1 stated she was unable to comment on what criteria MEC used to grant these cardiac surgery privileges. MSC 1 validated MD 1’s credential file and reapplication does not include any information that indicates MD 1 met the criteria listed for granting cardiac surgery privileges. MSC 1 stated she was also not able to find Focused Professional Practice Evaluation (FPPE- A process whereby the medical staff evaluates the privilege-specific competence of a practitioner who requests a new privilege, or when a practitioner’s competence to perform a privilege is questioned) in the physician credential file. MSC 1 stated it was the hospital policy to have FPPE completed when granting new privileges to the provider. MSM and SDQ both validated that MD 1’s credential file did not reflect the Medical staff rules and ByLaws were followed in granting privileges and FPPE process for MD 1. During a concurrent interview and record review on 4/4/25 at 3:20 p.m. with the System Quality and Patient Safety Analyst (QSA), SDQ & MSC 1, MD 1’s Ongoing Professional Practice Evaluation ( OPPE - A process that identifies and evaluates professional practice trends of practitioners with privileges that impact quality of care and patient safety on an ongoing basis and focus on the individual practitioner’s performance and competence related to privileges. ) data dash board was reviewed. The QSA was not able to explain the data listed under “PEER” column and stated would have to research and provide update. The QSA stated she was unable to comment on data for “OR on time” listed as “0”. The QSA stated it appears that the system may have a glitch and data pulling in to dashboard was not accurate. The QSA stated she was unable to comment who reviews this OPPE data and how often it gets reviewed. MSC 1 stated the medical staff only looks at the OPPE data at the time of reappointment which was every two years. The QSA was also unable to provide specific service line data for MD 1. The SDQ provided a list of metrics being tracked for each specialty and stated unable to provide any data for MD 1 for surgery specific metrics. The SDQ stated nurses that track and monitor data for OPPE were not available to discuss the data at this time. The SDQ stated the hospital have identified gaps in how they are tracking OPPE and FPPE data and it should be monitored on an ongoing basis and kept updated in physician credential file. The SDQ stated that MD 1’s credential file does not reflect FPPE and OPPE was completed in accordance with the hospital policy and Medical Staff ByLaws. During a review of the hospital Medial Staff Bylaws dated January 2024, the Medical staff Bylaws indicated, “ ...After receipt of the application, the department chair or appropriate designee of each department to which the application is submitted, shall review the application and supporting documentation, and may conduct a personal interview with the applicant at the department chair or designee’s discretion. The chair or appropriate designee shall evaluate all matters deemed relevant to a recommendation, including but not limited to, information concerning the applicant’s judgment, the applicant’s provision of services within the scope of privileges granted, including the individual’s clinical and/or technical skills indicated in part by the results of quality assessment and improvement activities, as reflected on the physician’s reappointment profile ... The Credentials Committee, or designee on behalf of the Credentials Committee, shall review the application, evaluate, and verify the supporting documentation, including clinical privileges, the department chair’s recommendations, and other relevant information ... The Medical Executive Committee shall forward to the Board of Directors, a written report and recommendation as to Medical Staff appointment and, if appointment is recommended, as to membership category, department affiliation, and any special conditions to be attached to the appointment ... the Board of Directors concurs in that recommendation; the decision of the Board shall be deemed final action ... Exercise of Privileges Except as otherwise provided in these Bylaws, a member providing clinical services at this Hospital shall be entitled to exercise only those clinical privileges specifically granted. Said privileges and services must be hospital specific, within the scope of any license, certificate, or other legal credential authorizing practice in this State and consistent with any restrictions thereon and shall be subject to the rules and regulations of the clinical department and the authority of the department chair and the Medical Executive Committee. Only an appropriately licensed practitioner with clinical privileges shall be directly responsible for a patient’s diagnosis and treatment within the area of his/her privileges ... Criteria for General Competencies ... The Medical Staff shall, in addition to criteria for privileges, also develop areas of “general competencies” by which all hospital practitioners shall be measured for current proficiency. Each department shall define how to measure these general competencies as applicable to that department and use them to monitor and assess each practitioner’s current proficiencies on an ongoing basis ... Basis for Privileges Determination ... Requests for clinical privileges shall be evaluated on the basis of the member’s education, training, experience, demonstrated current professional competence and judgment. Privilege determinations may also be based on pertinent information concerning clinical performance obtained from other sources, especially other institutions, and health care settings where a member exercises clinical privileges. The decision to grant or deny a privilege and/or to renew an existing privilege shall also be based on peer recommendations addressing the applicant’s .... Medical/clinical knowledge ... Technical and clinical skills ... Clinical judgment ... Interpersonal skills ... Communication skills ... Professionalism ... Health status ... Information regarding each practitioner’s scope of privileges shall be updated as changes in clinical privileges for each practitioner are made ... Performance Monitoring Generally ... Except as otherwise determined by the Medical Executive Committee and Board of Directors, the Medical Staff shall regularly monitor all members’ privileges in accordance with standards and procedures set forth in these Bylaws ... Performance monitoring activities and reports shall be integrated into other quality improvement activities. Any monitoring performed on a practitioner shall be considered in the review of that practitioner associated with granting, renewing, revising, or revoking any of their privilege(s) at hospital ... Ongoing Professional Performance Evaluation ... Each practitioner exercising privilege(s) at hospital shall be monitored and evaluated on a regular basis to identify professional performance trends that impact on quality of care and patient safety. The Medical Staff shall be responsible for establishing the frequency of these regular, ongoing professional performance evaluations ... Ongoing performance reviews shall be factored into the decision to maintain, revise, or revoke existing privilege(s) at the time of renewal. The Medical Staff shall take additional actions as necessary, in accordance with these Bylaws, based on the results of such evaluations. Each department shall recommend, and the Medical Executive Committee shall ultimately approve, the criteria used in the ongoing professional performance evaluations ... Focused Professional Practice Evaluation ... The Medical Staff is responsible for developing a focused professional practice evaluation process that will be used in predetermined situations to evaluate, for a time limited period, a practitioner’s competency in performing a specific privilege(s) at hospital. The Medical Staff shall clearly define when such a focused evaluation will occur, what criteria and methods should be used for conducting the focused evaluation, the duration of the evaluation period and requirements for extending the evaluation period, and how the information gathered during the evaluation process will be analyzed and communicated ... A focused professional practice evaluation shall be used in at least the following situations ... When questions arise regarding a practitioner’s competency in performing a specific privilege(s) at the hospital ... All initially requested privileges ... As a condition of renewal of privileges, as necessary (for example, when a member requests renewal of a privilege that has been performed so infrequently that it is difficult to assess the member’s current competence in that area) ... Proctoring ... General Provisions ... All initial appointees to the Medical Staff, Medical Staff members who have insufficient activity from which to assess current competence, as determined by the Medical Staff, and all members granted new clinical privileges shall be subject to a period of proctoring. Proctoring may also be implemented whenever the Medical Executive Committee determines that additional information is needed to assess a practitioner’s performance ... Each appointee or recipient of new clinical privileges shall be assigned to the appropriate department, where performance of an appropriate number of cases as established by the Medical Executive Committee or department, shall be observed by the Department Chair(s) or his or her designee, during the period of proctoring specified in the departments privilege list to determine suitability to continue to exercise the clinical privileges granted ... Departments are responsible for developing and approving the proctoring criteria for their departments based on their applicants’ qualifications, requested privileges, and established current competency ... The proctor shall complete the required proctoring paperwork and submit to the Medical Staff Office ...The member shall remain subject to such proctoring until the Medical Executive Committee has been furnished with a recommendation from the department chair(s) to discontinue proctoring. A recommendation to discontinue proctoring must include the following statements: that the applicant appears to meet all of the qualifications for unsupervised practice in the hospital, that the applicant has discharged all of the responsibilities of Medical Staff membership, and that the applicant has not exceeded or abused the prerogatives of the category to which the appointment was made ... When a practitioner is subject to proctoring as a result of a focused professional practice evaluation plan, the department shall set the terms of proctoring in a manner consistent with the Medical Staff Bylaws, Rules and Regulations, and policies and procedures that address focused professional practice evaluation ... Failure to Successfully Complete Proctoring ... Any initial appointee who fails within the time of Provisional membership to complete the proctoring required, or any member exercising new clinical privileges or undergoing proctoring for infrequently performed procedures who fails to complete the required proctoring within the time allowed by the Medical Executive Committee, shall be deemed to have voluntarily relinquished the membership or privileges involved, and he or she shall not be afforded the procedural rights provided in article VIII, unless otherwise required by law. However, the Medical Executive Committee in its sole discretion may extend the time for completing proctoring requirements. The inability to obtain such an extension shall not give rise to procedural rights described in article VIII. Any practitioner whose membership or privileges are relinquished pursuant to this section may not reapply for the privileges involved or, in the case of initial appointees, for membership for one (1) year, unless the Medical Executive Committee makes an exception in its sole discretion for good cause ...” During a review of the hospital policy and procedure (P&P) titled, “ Focused Professional Practice Evaluation (FPPE) and Ongoing Professional Performance Evaluation (OPPE) Policy”, with an approval date of, 11/8/23, the “P&P” indicated, “The purpose of this policy is to define Focus Professional Practice Evaluation and Ongoing Professional Performance Evaluation. (FPPE) and (OPPE) are designed to evaluate a practitioner’s performance to continuously improve the quality safety and effectiveness of care rendered by the practitioners privileged at [Hospital name) ... A. Focused Professional Practice Evaluation (“FPPE”) - A process whereby the medical staff evaluates the privilege-specific competence of a practitioner who requests a new privilege, or when a practitioner’s competence to perform a privilege is questioned. FPPE entails the following four components ... Measures used to evaluate whether an FPPE is needed when issues are identified ... Method for establishing the monitoring plan specific to the privilege or expected behavior ... Method to determine the duration of the performance monitoring; and, ... Triggers or issues (single incidents or a trend) to trigger an FPPE ... Ongoing Professional Practice Evaluation (“OPPE”) - A process that identifies professional practice trends of practitioners with privileges that impact quality of care and patient safety on an ongoing basis and focuses on the individual practitioner’s performance and competence related to privileges. The process evaluates the quality, adequacy and competency of an individual practitioner’s performance utilizing specialty-specific performance indicators ... initial FPPE ... Departments will determine the parameters of the review period (type of review, number of cases, and duration of review) based on education, training, experience, and current competence ... Review must continue until competency has been determined for privileges granted ... Upon completion, the Department Chair or designee reviews the activity and evaluations ... The FPPE report is kept in the Credentials file ... FPPE Conclusion ... At the end of the FPPE, a report is created which includes findings and conclusions ... If all or any portion of the review is deemed satisfactory, all or that portion of FPPE are considered concluded ... If all or any portion of the review is deemed unsatisfactory ... The current FPPE may be extended, or A new FPPE may be initiated for any area requiring improvement, or ... Recommend to MEC for corrective action ... The practitioner is notified in writing with the results of the FPPE ... OPPE ... Selection of Practitioner Performance Measures for OPPE ... Practitioner performance measures are selected utilizing the framework of the six areas of “General Competencies” (Patient Care / Medical Knowledge / Practice - Based Learning and Improvement / Interpersonal and Communication Skills / Professionalism / Systems-Based Practice) developed by the Accreditation Council for Graduate Medical Education (ACGME) and the American Board of Medical Specialties (ABMS) joint initiatives ... Practitioner performance measures shall be applicable to the practitioner’s specialty ... Practitioner performance measures shall reflect practitioner performance as an individual or part of a related practice group when relevant ... Each department shall recommend practice specific indicators and the MEC shall approve the criteria used in OPPE ... Qualitative and quantitative data may be utilized to gather information for OPPE ... 2. OPPE Report and Practitioner Performance Feedback ... OPPE is intended to look at data on the performance of all practitioners with privileges on an ongoing basis rather than at the reappointment cycle to take steps to improve performance on a timely basis ... After initial granting of privileges, the review of the professional practice data of each practitioner cannot exceed every 12 months. The Quality & Safety Department notifies the Department Chair or designee when the OPPE profiles are available for review. Practitioners do not sign off on their own OPPE ...c. The OPPE Report shall be reviewed by the appropriate Medical Staff Department Chair or designee ... Conclusion codes ... No opportunity for improvement ... Minor opportunity for improvement ... Significant opportunity for improvement ... Rule Indicator ... The OPPE report is retained per policy ... Use of OPPE and FPPE at Reappointment ... At reappointment, the Department Chair or designee will review the OPPE and FPPE data from last re-appointment cycle and document the interpretation and any improvement activities for each indicator that required follow-up ... If no activity is provided, FPPE may be initiated. During the OPPE and FPPE processes, the practitioner is NOT considered to be “under investigation” for purposes of reporting requirements under the Health Care Quality Improvement Act”. 2. During a concurrent interview and record review on 4/4/25 at 10:50 a.m. with Senior System Quality Director (SDQ), Medical Staff Manager (MSM), Medical Staff Coordinator (MSC) 1 and MSC 2, MD 2’s credential file was reviewed. MD 2’s credential file indicated MD 2 was a board certified in Critical Care and Pulmonary Medicine. MD 2’s original appointment was on 8/6/15 and was reappointed on 7/31/23. MD 2’s reappointment application for two-year term was approved by Department chair on 6/7/23. MD 2’s credential file indicated MEC approved the reappointment on 6/20/23 and board of directors approved it on 7/6/23. The review of MD 2 reapplication indicated MD 2 requested and was granted privileges under Critical Care for “ ... Intubation [a medical procedure where a tube, usually an endotracheal tube, is inserted through the mouth or nose into the trachea (windpipe) to secure the airway and facilitate breathing], Sedation [using medication to induce a state of calmness, relaxation, or sleepiness, often used to reduce anxiety and discomfort during medical or surgical procedures]/analgesia [ loss of sensation of pain achieved by medication ]for the non-anesthesiologist (moderate), Central venous access [inserting catheter to provide access to the bloodstream for administering fluids, medications, or blood products], Swan Ganz placement [a thin, flexible tube inserted into a vein and threaded through the heart into the pulmonary artery to monitor heart function, blood flow, and pressures, particularly in critically ill patients], Thoracentesis [procedure used to obtain a sample of fluid from the space around the lungs, called the pleural space], Abdominal paracentesis [a procedure to drain fluid from the peritoneal cavity (the space within the abdomen) using a needle or catheter], Lumbar puncture, Joint Aspiration, ICU Bronchoscopy ...”. The request for privileges reapplication of MD 2 indicated “ ...Other ...Care of patients in ICU/CCU (can only manage patients in area of specialty and/or subspeciality) ...” and EKG interpretation was not requested and was not granted. MSC 1 stated MD 2 has been actively working in ICU and manages patients. MSC 1 stated she was unable to comment and was not certain why this section was not selected under other and EKG [a test to record the electrical signals in the heart] interpretation. MSC 1 stated MD 2 was reappointed and had volume to maintain privileges, but she was unable to comment on department specific metrics for OPPE for MD 2. MSC 1 stated MD 2 was granted privileges under ICU section but the [software name] portal does not reflect section “CRITICAL CARE MEDICINE” was selected. The SDQ stated “the privilege request form for MD 2 was not very clear.” The SDQ validated and agreed that reapplication and [software name] portal does not reflect whether MD 2 was granted privileges to take care of patients in ICU or EKG interpretation which were essential for managing patient in ICU. The SDQ stated the [software name] portal was what staff at the hospital uses to validate privileges. The SDQ stated the staff would not be able to validate MD 2’s privileges to manage patient in ICU by looking at the [software name] portal. The SDQ stated although MD 2 was board certified in critical care, was granted privileges for ICU procedures, the privilege to manage patients along with EKG should have been selected and granted as well but were not. The SDQ validated with the hospital leadership and stated MD 2 have been managing patients actively in ICU and does not have any reported adverse outcomes related to MD 2’s practice. The SDQ stated the privilege request form needs to be reviewed and updated to make it clear whether the privilege to manage patient in ICU were included/bundled with rest of privileges with ICU. During a phone interview on 4/4/25 at 3:52 p.m. with the Chief of Medical Staff (CMS), the CMS stated the hospital have a process in place for OPPE. The CMS stated every six months report cards for physicians get shared and the chair for each department was responsible for ensuring and reviewing service line indicators. The CMS stated the expectation for every service line is to have their own indicators for OPPE for providers in their service line. The CMS stated he was unable to comment on credentialing for MD 2 or any particular provider, but the process was that credentialing committee reviews the application and final decision was with board of directors. The CMS stated the department chair were expected to review and approve the application for appointments and privilege request to ensure it meets the requirements prior to routing it for MEC or board of director approval. The CMS stated he expected Medical staff office and department chairs to follow the facility Medical Staff ByLaws when approving or granting privileges. During a review of the hospital Medial Staff ByLaws dated January 2024, the Medical Staff ByLaws indicated, “ ...After receipt of the application, the department chair or appropriate designee of each department to which the application is submitted, shall review the application and supporting documentation, and may conduct a personal interview with the applicant at the department chair or designee’s discretion. The chair or appropriate designee shall evaluate all matters deemed relevant to a recommendation, including but not limited to, information concerning the applicant’s judgment, the applicant’s provision of services within the scope of privileges granted, including the individual’s clinical and/or technical skills indicated in part by the results of quality assessment and improvement activities, as reflected on the physician’s reappointment profile ... The Credentials Committee, or designee on behalf of the Credentials Committee, shall review the application, evaluate, and verify the supporting documentation, including clinical privileges, the department chair’s recommendations, and other relevant information ... The Medical Executive Committee shall forward to the Board of Directors, a written report and recommendation as to Medical Staff appointment and, if appointment is recommended, as to membership category, department affiliation, and any special conditions to be attached to the appointment ... the Board of Directors concurs in that recommendation; the decision of the Board shall be deemed final action ... Exercise of Privileges Except as otherwise provided in these Bylaws, a member providing clinical services at this Hospital shall be entitled to exercise only those clinical privileges specifically granted. Said privileges and services must be hospital specific, within the scope of any license, certificate, or other legal credential authorizing practice in this State and consistent with any restrictions thereon and shall be subject to the rules and regulations of the clinical department and the authority of the department chair and the Medical Executive Committee. Only an appropriately licensed practitioner with clinical privileges shall be directly responsible for a patient’s diagnosis and treatment within the area of his/her privileges ... Criteria for General Competencies ... The Medical Staff shall, in addition to criteria for privileges, also develop areas of “general competencies” by which all hospital practitioners shall be measured for current proficiency. Each department shall define how to measure these general competencies as applicable to that department and use them to monitor and assess each practitioner’s current proficiencies on an ongoing basis ... Basis for Privileges Determination ... Requests for clinical privileges shall be evaluated on the basis of the member’s education, training, experience, demonstrated current professional competence and judgment. Privilege determinations may also be based on pertinent information concerning clinical performance obtained from other sources, especially other institutions, and health care settings where a member exercises clinical privileges. The decision to grant or deny a privilege and/or to renew an existing privilege shall also be based on peer recommendations addressing the applicant’s ... Medical/clinical knowledge ... Technical and clinical skills ... Clinical judgment ... Interpersonal skills ... Communication skills ... Professionalism ... Health status ... Information regarding each practitioner’s scope of privileges shall be updated as changes in clinical privileges for each practitioner are made ... Performance Monitoring Generally ... Except as otherwise determined by the Medical Executive Committee and Board of Directors, the Medical Staff shall regularly monitor all members’ privileges in accordance with standards and procedures set forth in these Bylaws ... Performance monitoring activities and reports shall be integrated into other quality improvement activities. Any monitoring performed on a practitioner shall be considered in the review of that practitioner associated with granting, renewing, revising, or revoking any of their privilege(s) at hospital ... Ongoing Professional Performance Evaluation ... Each practitioner exercising privilege(s) at hospital shall be monitored and evaluated on a regular basis to identify professional performance trends that impact on quality of care and patient safety. The Medical Staff shall be responsible for establishing the frequency of these regular, ongoing professional performance evaluations ... Ongoing performance reviews shall be factored into the decision to maintain, revise, or revoke existing privilege(s) at the time of renewal. The Medical Staff shall take additional actions as necessary, in accordance with these Bylaws, based on the results of such evaluations. Each department shall recommend, and the Medical Executive Committee shall ultimately approve, the criteria used in the ongoing professional performance evaluations ... Focused Professional Practice Evaluation ... The Medical Staff is responsible for developing a focused professional practice evaluation process that will be used in predetermined situations to evaluate, for a time limited period, a practitioner’s competency in performing a specific privilege(s) at hospital. The Medical Staff shall clearly define when such a focused evaluation will occur, what criteria and methods should be used for conducting the focused evaluation, the duration of the evaluation period and requirements for extending the evaluation period, and how the information gathered during the evaluation process will be analyzed and communicated ... A focused professional practice evaluation shall be used in at least the following situations ... When questions arise regarding a practitioner’s competency in performing a specific privilege(s) at the hospital ... All initially requested privileges ... As a condition of renewal of privileges, as necessary (for example, when a member requests renewal of a privilege that has been performed so infrequently that it is difficult to assess the member’s current competence in that area) ... Proctoring ... General Provisions ... All initial appointees to the Medical Staff, Medical Staff members who have insufficient activity from which to assess current competence, as determined by the Medical Staff, and all members granted new clinical privileges shall be subject to a period of proctoring. Proctoring may also be implemented whenever the Medical Executive Committee determines that additional information is needed to assess a practitioner’s performance ... Each appointee or recipient of new clinical privileges shall be assigned to the appropriate department, where performance of an appropriate number of cases as established by the Medical Executive Committee or department, shall be observed by the Department Chair(s) or his or her designee, during the period of proctoring specified in the departments privilege list to determine suitability to continue to exercise the clinical privileges granted ... Departments are responsible for developing and approving the proctoring criteria for their departments based on their applicants’ qualifications, requested privileges, and established current competency ... The proctor shall complete the required proctoring paperwork and submit to the Medical Staff Office ...The member shall remain subject to such proctoring until the Medical Executive Committee has been furnished with a recommendation from the department chair(s) to discontinue proctoring. A recommendation to discontinue proctoring must include the following statements: that the applicant appears to meet all of the qualifications for unsupervised practice in the hospital, that the applicant has discharged all of the responsibilities of Medical Staff membership, and that the applicant has not exceeded or abused the prerogatives of the category to which the appointment was made ... When a practitioner is subject to proctoring as a result of a focused professional practice evaluation plan, the department shall set the terms of proctoring in a manner consistent with the Medical Staff Bylaws, Rules and Regulations, and policies and procedures that address focused professional practice evaluation ... Failure to Successfully Complete Proctoring ... Any initial appointee who fails within the time of Provisional membership to complete the proctoring required, or any member exercising new clinical privileges or undergoing proctoring for infrequently performed procedures who fails to complete the required proctoring within the time allowed by the Medical Executive Committee, shall be deemed to have voluntarily relinquished the membership or privileges involved, and he or she shall not be afforded the procedural rights provided in article VIII, unless otherwise required by law. However, the Medical Executive Committee in its sole discretion may extend the time for completing proctoring requirements. The inability to obtain such an extension shall not give rise to procedural rights described in article VIII. Any practitioner whose membership or privileges are relinquished pursuant to this section may not reapply for the privileges involved or, in the case of initial appointees, for membership for one (1) year, unless the Medical Executive Committee makes an exception in its sole discretion for good cause ...” 3. During a concurrent interview and record review on 4/4/25 at 11:05 a.m. with Senior System Quality Director (SDQ), Medical Staff Manager (MSM), Medical Staff Coordinator (MSC) 1 and MSC 2, MD 3’s credential file was reviewed. MD 3’s credential file indicated MD 3 was board certified in critical care medicine and his initial appointment was on 6/1/23. MD 3 application was approved by ME C on 5/30/23 and final approval was on 6/1/23. The review of application indicated MD 3 requested and was granted privileges for “ ...ICU Bronchoscopy [a procedure to look directly at the airways in the lungs using a thin, lighted tube] Flexible bronchoscopy, diagnostic and therapeutic, performed on patients who are intubated in the ICU ...Proctoring Requirements/Chair Recommendation ...First five (5) cases proctored or reviewed retrospectively ... Tube Thoracostomy [a flexible tube inserted through the chest wall into the pleural space (the area between the lung and the chest wall)] ... First three (3) cases proctored or reviewed retrospectively ...Stress electrocardiogram [measures the heart’s electrical activity during physical exertion] ... First two (2) cases to be reviewed retrospectively with report and tracing available for review by proctored ...”. MSC 1 stated she was unable to find whether proctoring was completed or not. MSC 1 stated the MD 3’s appointment was still provisional. MSC 1 stated the process at the hospital was to grant provisional status upon appointment and the providers have one year to complete the required proctoring and at the end of one year either the status gets changed to active or the provisional period get extended if the provider was not able to complete proctoring. MSC 1 stated she was unable to find any documentation in the credential file in regard to evaluation of FPPE, proctoring completion or extension of provisional appointment. MSC 1 stated the medical staff leader that use to work at the hospital was in charge of this and she was unable to comment on why the process was not followed or the file was incomplete. MSC 1 also stated similar to MD 2, MD 3 did not have ability to manage patient in ICU selected under other privileges. During a concurrent interview and record review on 4/4/25 at 11:10 a.m. with Senior System Quality Director (SDQ), Medical Staff Manager (MSM), Medical Staff Coordinator (MSC) 1 & MSC 2, the Medical Staff ByLaws dated January 2024 were reviewed. The Medical Staff ByLaws indicated “... Provisional Staff ... Qualifications ... The Provisional Staff shall consist of members who ... meet the general qualifications for membership set forth in Section 2.2 and ... immediately prior to their application and appointment were not members (or were no longer members) in good standing of this Medical Staff ... Observation of Provisional Staff Member Each Provisional Staff member shall undergo a period of observation by designated monitors as described in section 5.3 ... The observation shall be to evaluate the member’s (1) proficiency in the exercise of clinical privileges initially granted and (2) overall eligibility for continued staff membership and advancement within staff categories. Observation of Provisional Staff members shall follow whatever frequency and format each department deems appropriate in order to adequately evaluate the Provisional Staff member including, but not limited to, concurrent or retrospective chart review, mandatory consultation, and/or direct observation. Appropriate records shall be maintained. The results of the observation shall be communicated by the department chair to the Credentials Committee ... Term of Provisional Staff Status A member shall remain on the Provisional Staff for a period of one (1) year, unless that status is extended by the Medical Executive Committee, upon recommendation by the department chair or designee, for an additional period up to one (1) year upon a determination of good cause, which determination shall not be subject to review pursuant to Articles VI or VII ... Action at Conclusion of Provisional Staff Status ... If the Provisional Staff member has satisfactorily demonstrated his or her ability to exercise the clinical privileges initially granted and otherwise appears qualified for continued Medical Staff Membership, the member shall be eligible for placement in the Active, Courtesy or Consulting Staff as appropriate, upon recommendation of the Medical Executive Committee and ... In all other cases, the appropriate department shall advise the Credentials Committee which shall make its report to the Medical Executive Committee which, in turn, shall make its recommendation to the Board of Directors regarding a modification or termination of clinical privileges or termination of Medical Staff membership ... Failure to Complete Provisional Staff Requirements and to Obtain Provisional Staff Status Extension ... If the Provisional Staff member fails to complete a sufficient number of proctoring cases and fails to obtain an extension of the term of Provisional Staff status pursuant to article 3.5-4 above, the member will not be afforded hearing rights, and such failure to complete proctoring will result in automatic termination of Medical Staff membership effective at the expiration of the twelve (12) month provisional period ...” The SDQ stated MD 3’s credential file does not reflect that the provisional period evaluation was completed in accordance with the medical staff bylaws. The SDQ stated at the end of one year mark of provisional appointment if the providers was not able to finish the requirement, provider’s appointment should have been extended through MEC and board of directors in accordance with the medical staff bylaws and documentation should have been kept in provider’s credential file. The SDQ stated Bylaws clearly reflects that if the provider failed to complete proctoring or fails to obtain an extension it will result in automatic termination. The SDQ stated the Medical staff manager position recently opened up and the person covering previously was responsible for ensuring the process was followed and credential files were completed. The SDQ stated she was unable to comment on where the gap occurred in assuring files were complete. The SDQ stated facility need to evaluate and update the privilege request form to ensure critical privileges clearly outlines what was bundled with in the core privilege. The SDQ stated the quality nurses were in charge of monitoring physician specific PEER review and FPPE data for providers and were not available at this time to talk about the FPPE data associated with the provisional appointment. During an interview on 4/4/25 at 11:20 a.m. with the SDQ, the SDQ stated similar to MD 3, MD 4 provisional appointment to Obstetrics (care during pregnancy, childbirth, and postpartum) and Gynecology (women’s reproductive health) was on 9/7/23 and the credentialing file does not reflect that provisional evaluation was completed and appointment was extended in accordance with the Medical Staff ByLaws. The SDQ validated with both MSC 1 & MSM and stated that MD 4’s file only have record that shows MD 4 was proctored for two C-section surgeries (surgical procedure where a baby is delivered through incisions in the mother’s abdomen and uterus), and hysteroscopy (a test to look inside a woman’s womb, using a thin tube with a small camera inside it). The SDQ stated she was unable to comment on why the provision evaluation was not completed and MD 4 appointment was not reviewed in MEC for extension or termination. The SDQ stated that MD 4’s file have other special privileges listed that have proctoring requirement and MD 4’s credential file does not reflect that requirement was met or evaluated for extension or termination of appointment in accordance with Med Staff ByLaws. During an interview on 4/4/25 at 12:15 p.m. with the Manger of Accreditation and Licensing (MAL), the MAL stated the hospital have identified opportunity for improvement with the process of handling provisional appointment. The MAL stated she was made aware of the opportunities identified with MD 3 and MD 4. The MAL stated hospital have several other provisional appointments that are currently passed the provisional period and were not evaluated for extension, termination or conversion to active or other status as mentioned in Medical Staff ByLaws. The MAL stated the quality nurses in charge of peer review process and OPPE were not available to share the data for providers and it was not available with the Medical Staff team. The MAL stated QSA was the best person to go over OPPE dashboard but service line and special privileges data for each provider as listed in the Medical Staff ByLaws was not available at this time. The MAL stated provider specific performance data specific to each specialty as specified in Medical Staff Bylaws was something the hospital should have readily available or in credential file of providers at all times. During a review of the hospital Medial Staff Bylaws dated January 2024, the Medical staff Bylaws indicated, “... Proctoring ... General Provisions ... All initial appointees to the Medical Staff, Medical Staff members who have insufficient activity from which to assess current competence, as determined by the Medical Staff, and all members granted new clinical privileges shall be subject to a period of proctoring. Proctoring may also be implemented whenever the Medical Executive Committee determines that additional information is needed to assess a practitioner’s performance ... Each appointee or recipient of new clinical privileges shall be assigned to the appropriate department, where performance of an appropriate number of cases as established by the Medical Executive Committee or department, shall be observed by the Department Chair(s) or his or her designee, during the period of proctoring specified in the departments privilege list to determine suitability to continue to exercise the clinical privileges granted ... Departments are responsible for developing and approving the proctoring criteria for their departments based on their applicants’ qualifications, requested privileges, and established current competency ... The proctor shall complete the required proctoring paperwork and submit to the Medical Staff Office ...The member shall remain subject to such proctoring until the Medical Executive Committee has been furnished with a recommendation from the department chair(s) to discontinue proctoring. A recommendation to discontinue proctoring must include the following statements: that the applicant appears to meet all of the qualifications for unsupervised practice in the hospital, that the applicant has discharged all of the responsibilities of Medical Staff membership, and that the applicant has not exceeded or abused the prerogatives of the category to which the appointment was made ... When a practitioner is subject to proctoring as a result of a focused professional practice evaluation plan, the department shall set the terms of proctoring in a manner consistent with the Medical Staff Bylaws, Rules and Regulations, and policies and procedures that address focused professional practice evaluation ... Failure to Successfully Complete Proctoring ... Any initial appointee who fails within the time of Provisional membership to complete the proctoring required, or any member exercising new clinical privileges or undergoing proctoring for infrequently performed procedures who fails to complete the required proctoring within the time allowed by the Medical Executive Committee, shall be deemed to have voluntarily relinquished the membership or privileges involved, and he or she shall not be afforded the procedural rights provided in article VIII, unless otherwise required by law. However, the Medical Executive Committee in its sole discretion may extend the time for completing proctoring requirements. The inability to obtain such an extension shall not give rise to procedural rights described in article VIII. Any practitioner whose membership or privileges are relinquished pursuant to this section may not reapply for the privileges involved or, in the case of initial appointees, for membership for one (1) year, unless the Medical Executive Committee makes an exception in its sole discretion for good cause ...Effect of Failure to Complete Proctoring ... Failure to Complete Necessary Volume: any member who fails to complete the required number of proctored cases within the time frame established for the applicable privileges shall be deemed to have voluntarily withdrawn his or her request for such privileges and he or she shall not be afforded the procedural rights provided in article VIII. The inability to obtain such an extension shall not give rise to procedural rights described in article VIII ... Failure to Satisfactorily Complete Proctoring: if a member completes the necessary volume of proctored cases but fails to perform satisfactorily during proctoring, the relevant privileges may be revoked, and he or she shall be afforded the procedural rights as provided in article VIII. In the event procedural rights are invoked, the practitioner who has not successfully completed proctoring shall be deemed an “applicant” for purposes of article 8.4-7 ...” During a review of the hospital policy and procedure (P&P) titled, “ Focused Professional Practice Evaluation (FPPE) and Ongoing Professional Performance Evaluation (OPPE) Policy”, with an approval date of, 11/8/23, the “P&P” indicated, “The purpose of this policy is to define Focus Professional Practice Evaluation and Ongoing Professional Performance Evaluation. (FPPE) and (OPPE) are designed to evaluate a practitioner’s performance to continuously improve the quality safety and effectiveness of care rendered by the practitioners privileged at [Hospital name) ... A. Focused Professional Practice Evaluation (“FPPE”) - A process whereby the medical staff evaluates the privilege-specific competence of a practitioner who requests a new privilege, or when a practitioner’s competence to perform a privilege is questioned. FPPE entails the following four components ... Measures used to evaluate whether an FPPE is needed when issues are identified ... Method for establishing the monitoring plan specific to the privilege or expected behavior ... Method to determine the duration of the performance monitoring; and, ... Triggers or issues (single incidents or a trend) to trigger an FPPE ... Ongoing Professional Practice Evaluation (“OPPE”) - A process that identifies professional practice trends of practitioners with privileges that impact quality of care and patient safety on an ongoing basis and focuses on the individual practitioner’s performance and competence related to privileges. The process evaluates the quality, adequacy and competency of an individual practitioner’s performance utilizing specialty-specific performance indicators ... initial FPPE ... Departments will determine the parameters of the review period (type of review, number of cases, and duration of review) based on education, training, experience, and current competence ... Review must continue until competency has been determined for privileges granted ... Upon completion, the Department Chair or designee reviews the activity and evaluations ... The FPPE report is kept in the Credentials file ... FPPE Conclusion ... At the end of the FPPE, a report is created which includes findings and conclusions ... If all or any portion of the review is deemed satisfactory, all or that portion of FPPE are considered concluded ... If all or any portion of the review is deemed unsatisfactory ... The current FPPE may be extended, or A new FPPE may be initiated for any area requiring improvement, or ... Recommend to MEC for corrective action ... The practitioner is notified in writing with the results of the FPPE ... OPPE ... Selection of Practitioner Performance Measures for OPPE ... Practitioner performance measures are selected utilizing the framework of the six areas of “General Competencies” (Patient Care / Medical Knowledge / Practice - Based Learning and Improvement / Interpersonal and Communication Skills / Professionalism / Systems-Based Practice) developed by the Accreditation Council for Graduate Medical Education (ACGME) and the American Board of Medical Specialties (ABMS) joint initiatives ... Practitioner performance measures shall be applicable to the practitioner’s specialty ... Practitioner performance measures shall reflect practitioner performance as an individual or part of a related practice group when relevant ... Each department shall recommend practice specific indicators and the MEC shall approve the criteria used in OPPE ... Qualitative and quantitative data may be utilized to gather information for OPPE ... 2. OPPE Report and Practitioner Performance Feedback ... OPPE is intended to look at data on the performance of all practitioners with privileges on an ongoing basis rather than at the reappointment cycle to take steps to improve performance on a timely basis ... After initial granting of privileges, the review of the professional practice data of each practitioner cannot exceed every 12 months. The Quality & Safety Department notifies the Department Chair or designee when the OPPE profiles are available for review. Practitioners do not sign off on their own OPPE ...c. The OPPE Report shall be reviewed by the appropriate Medical Staff Department Chair or designee ... Conclusion codes ... No opportunity for improvement ... Minor opportunity for improvement ... Significant opportunity for improvement ... Rule Indicator ... The OPPE report is retained per policy ... Use of OPPE and FPPE at Reappointment ... At reappointment, the Department Chair or designee will review the OPPE and FPPE data from last re-appointment cycle and document the interpretation and any improvement activities for each indicator that required follow-up ... If no activity is provided, FPPE may be initiated. During the OPPE and FPPE processes, the practitioner is NOT considered to be “under investigation” for purposes of reporting requirements under the Health Care Quality Improvement Act””

“MEDICAL STAFF ORGANIZATION & ACCOUNTABILITY CFR(s): 482.22(b)(1), (2), (3) The medical staff must be well organized and accountable to the governing body for the quality of the medical care provided to the patients. (1) The medical staff must be organized in a manner approved by the governing body. (2) If the medical staff has an executive committee, a majority of the members of the committee must be doctors of medicine or osteopathy. (3) The responsibility for organization and conduct of the medical staff must be assigned only to one of the following: (i) An individual doctor of medicine or osteopathy. (ii) A doctor of dental surgery or dental medicine, when permitted by State law of the State in which the hospital is located. (iii) A doctor of podiatric medicine, when permitted by State law of the State in which the hospital is located. This Standard is not met as evidenced by: 49884 Based on interview and record review, the hospital failed to ensure that Medical Staff was accountable for the quality of the medical care provided to the patients and followed the “Medical Staff Rules and Regulations” when Physicians failed to document a progress note for one out of 10 sampled patients Patient (Pt) 25, on a daily basis, during her hospital admission. This failure had the potential for Pt 25’s diagnostic and therapeutic needs to go unmet, and for her physician directed questions to go unanswered, which could lead to psychosocial harm, including anger, fear, and anxiety, due to Pt 25’s vulnerable state. Findings: During a concurrent interview and record review on 3/27/25 at 2:33 p.m. with Registered Nurse (RN) 6, Pt 25’s “History and Physical [H&P- complete patient assessment by physician],” dated 3/23/25, and “Physician Progress Notes [PPN],” dated 3/23/25 to 3/25/25 were reviewed. The “H&P” indicated Pt 25 was admitted on 3/23/25 at 7:37 a.m. for an elective induction of labor (the use of medications or other methods to start labor). RN 6 stated Pt 25 was 40 weeks and 5 days pregnant (upon admission to the Labor and Delivery (L&D) Unit. The “PPN” from 3/23/25 indicated, at 10 a.m. a physician performed an exam on Pt 25. RN 6 stated no progress notes were in Pt 25’s electronic medical record (EMR) for 3/24/25 indicating a physician assessment was completed on Pt 25, or any indication Pt 25’s labor progression was discussed with her by the physician. The “PPN” from 3/25/25 indicated, at 6:07 a.m. Pt 25’s physician was at bedside discussing protracted labor course abnormally slow dilation [opening of womb] or fetal descent [baby head coming out]) and risk for hemorrhage (excessive bleeding after birth). The physician discussed recommending proceeding with cesarean section (CS a surgical procedure used to deliver a baby through a cut in the mother’s stomach and womb) due to labor dystocia (slow or abnormal progress of labor) The “PPN” indicated, at 6:24 a.m. an additional to the 6:07 a.m. note, “ ...Patient was seen at bedside. She is agreeable to proceed with CS ...” RN 6 stated, physicians should see the patient every day. RN 6 stated, she did not know why there was no progress note documentation in Pt 25’s in EMR on 3/24 by a physician, RN 6 stated there should be. During an interview on 4/2/25 at 10:20 a.m. with the Director of the Family Birth Center (DFBC) the DFBC stated, her expectation was that the physicians, see the patient’s and document the progress notes every day. During a review of the hospital’s document titled, “Medical Staff Rules and Regulations,” dated, 2/1/24, the hospital document indicated, “ ...Patients admitted to the Acute Care units of the hospital will be seen on a daily basis, either by the attending physician or his/her designee ...”.”

“MEDICAL STAFF ORGANIZATION & ACCOUNTABILITY CFR(s): 482.22(b)(1), (2), (3) The medical staff must be well organized and accountable to the governing body for the quality of the medical care provided to the patients. (1) The medical staff must be organized in a manner approved by the governing body. (2) If the medical staff has an executive committee, a majority of the members of the committee must be doctors of medicine or osteopathy. (3) The responsibility for organization and conduct of the medical staff must be assigned only to one of the following: (i) An individual doctor of medicine or osteopathy. (ii) A doctor of dental surgery or dental medicine, when permitted by State law of the State in which the hospital is located. (iii) A doctor of podiatric medicine, when permitted by State law of the State in which the hospital is located. This Standard is not met as evidenced by: 49884 Based on interview and record review, the hospital failed to ensure that Medical Staff was accountable for the quality of the medical care provided to the patients and followed the “Medical Staff Rules and Regulations” when Physicians failed to document a progress note for one out of 10 sampled patients Patient (Pt) 25, on a daily basis, during her hospital admission. This failure had the potential for Pt 25’s diagnostic and therapeutic needs to go unmet, and for her physician directed questions to go unanswered, which could lead to psychosocial harm, including anger, fear, and anxiety, due to Pt 25’s vulnerable state. Findings: During a concurrent interview and record review on 3/27/25 at 2:33 p.m. with Registered Nurse (RN) 6, Pt 25’s “History and Physical [H&P- complete patient assessment by physician],” dated 3/23/25, and “Physician Progress Notes [PPN],” dated 3/23/25 to 3/25/25 were reviewed. The “H&P” indicated Pt 25 was admitted on 3/23/25 at 7:37 a.m. for an elective induction of labor (the use of medications or other methods to start labor). RN 6 stated Pt 25 was 40 weeks and 5 days pregnant (upon admission to the Labor and Delivery (L&D) Unit. The “PPN” from 3/23/25 indicated, at 10 a.m. a physician performed an exam on Pt 25. RN 6 stated no progress notes were in Pt 25’s electronic medical record (EMR) for 3/24/25 indicating a physician assessment was completed on Pt 25, or any indication Pt 25’s labor progression was discussed with her by the physician. The “PPN” from 3/25/25 indicated, at 6:07 a.m. Pt 25’s physician was at bedside discussing protracted labor course abnormally slow dilation [opening of womb] or fetal descent [baby head coming out]) and risk for hemorrhage (excessive bleeding after birth). The physician discussed recommending proceeding with cesarean section (CS a surgical procedure used to deliver a baby through a cut in the mother’s stomach and womb) due to labor dystocia (slow or abnormal progress of labor) The “PPN” indicated, at 6:24 a.m. an additional to the 6:07 a.m. note, “ ...Patient was seen at bedside. She is agreeable to proceed with CS ...” RN 6 stated, physicians should see the patient every day. RN 6 stated, she did not know why there was no progress note documentation in Pt 25’s in EMR on 3/24 by a physician, RN 6 stated there should be. During an interview on 4/2/25 at 10:20 a.m. with the Director of the Family Birth Center (DFBC) the DFBC stated, her expectation was that the physicians, see the patient’s and document the progress notes every day. During a review of the hospital’s document titled, “Medical Staff Rules and Regulations,” dated, 2/1/24, the hospital document indicated, “ ...Patients admitted to the Acute Care units of the hospital will be seen on a daily basis, either by the attending physician or his/her designee ...”.”

“NURSING CARE PLAN CFR(s): 482.23(b)(4) The hospital must ensure that the nursing staff develops, and keeps current, a nursing care plan for each patient that reflects the patient’s goals and the nursing care to be provided to meet the patient’s needs. The nursing care plan may be part of an interdisciplinary care plan. This Standard is not met as evidenced by: 49884 Based on interview and record review, the hospital failed to ensure staff developed and updated a nursing care plan (a comprehensive, interdisciplinary [group of healthcare providers from different fields who work together] approach to patient care from entry into the hospital until discharge) for two of 34 sampled patients (Patient [Pt] 5 and Pt 13), when the staff did not identify patient care needs and did not develop a care plan with interventions or goals to address the identified needs when: 1. Registered Nurses (RNs) failed to create an individualized care plan for Pt 5’s severe protein and calorie malnutrition (body not getting enough calories or nutrients) according to the hospital policy and procedure (P&P), titled “Patient Plan of Care” and the hospital “Registered Nurse Job Description”. This failure had the potential to cause weight loss in Pt 5 which placed Pt 5 at an increased risk for skin breakdown, slower wound healing to the open wound on the coccyx (tailbone), and in the gluteal cleft (groove between the buttocks), and a longer hospital admission. 2. RNs did not develop an individualized care plan for Pt 13’s hypertension (high blood pressure). This failure had the potential to cause inconsistent delivery of care, which could result in the decline or lack of improvement for Pt 13’s health conditions. Findings: 1. During a concurrent interview and record review on 3/28/25 at 9:48 a.m. with Nurse Educator (NE) 1, Pt 5’s “History & Physical (H&P- a complete patient assessment by the physician),” dated 12/31/24, was reviewed, the H&P indicated Pt 5 was brought into the Emergency Department (ED) on 12/31/25 at 12:45 p.m. by family with complaints of right upper quadrant pain (the area of the stomach located on the right side above the belly button) for two weeks. The H&P indicated, Pt 5 was admitted as an inpatient on 12/31/24 at 8:50 p.m. for a renal abscess (a pocket of pus that forms within the kidney tissue) and moved to the Medical Surgical (MS) Unit at 11:56 p.m. During a concurrent interview and record review on 3/28/25 at 9:55 a.m. with NE 1, Pt 5’s “Hospitalist Progress Note (HPN),” dated 1/2/25, “Care Plan Accordion (CPA)”, dated 1/2/25 to 1/8/25 and the “Intake and Output Flowsheet (IOF)”, dated 1/2/25 to 1/8/25 was reviewed. The HPN indicated, Pt 5 had an active medical problem identified by the physician of “severe protein and calorie malnutrition”. The CPA” indicated; no care plans were entered by LNs for Nutrition Deficiency. NE 1 stated, Pt 5 possibly should have had a care plan for nutritional deficit. The IOF indicated, on 1/2/25 no lunch intake was documented. The IOF indicated, on 1/3/25, 1/4/25, and 1/5/25 no breakfast or lunch documentation were in the medical record. NE 1 stated the Electronic Medical Record (EMR) did not have a cell to document intake for dinner, prior to the system update in February 2025. NE 1 stated, nursing staff (CNAs, RNs) should have documented intake on the IOF when collecting the meal tray. NE 1 stated nursing staff were trained to document intake. NE 1 stated CNAs should have informed the RN when patients were refusing meals or not eating at least 75% of their meals. NE 1 stated nursing staff were supposed to document on the IOF when patients refused meals. NE 1 stated RNs could then notify the Pt’s physician. NE 1 stated, the physician could, enter a Registered Dietitian Consult, enter an order for nutrition supplements, or prescribe medications to increase the patient’s appetite. NE 1 stated, RNs should also speak to the Pt and the Pt’s family because the Pt may have specific foods they prefer from home. NE 1 stated, ensuring Pt 5 was receiving enough nutrition was important for body healing and to improve wound healing. During a review of Pt 5’s “Medical Nutrition Therapy Nutrition (MNTN) Consult,” dated 1/2/25, the “MNTN Consult” indicated Pt 5 was four feet eight inches tall and 74 pounds (lbs.- a unit of weight measurement) and 8.3 ounces (oz- a unit of weight measurement). The MNTN Consult indicated, Pt 5 was underweight. The MNTN Consult indicated, Monitoring/Evaluation/Goals, Monitor weight, and tolerance to diet. Pt 5 did not have any additional weights assessed after her admission weight of on 12/31/25. During a concurrent interview and record review on 4/2/25 at 2:46 p.m. with the Registered Dietitian Supervisor (RDS), Pt 5’s “IOF,” dated 1/2/25 through 1/8/25, “and “MNTN Consult” dated 1/2/25 were reviewed. The RDS stated, he reviewed Pt 5’s medical record prior to the interview. The RDS stated, when Registered Dietitian’s (RDs) assess patients for a nutrition consult the RD would look at the weight history as well as, admitting diagnosis, medical history, recent active problems or new diagnosis, diet, intake and output, nausea and vomiting, medications, and labs, to see if there was anything that may be significant. The RDS stated it was important for nutrition intake to be documented accurately, and Pt 5 was missing nutrition documentation. The RDS stated it was important to document accurately, to see progression (was the patient increasing or decreasing intake), and to get an estimate of calorie intake, also to see if the patient needed modification to nutrition (supplements, etcetera). During an interview on 4/4/2025 at 5:17p.m, with the Chief Nursing Executive (CNE), the CNE stated her expectation was for LNs to customize the care plans to the patient as a part of their care. During a review of the hospital’s P&P titled, “Patient Plan of Care,” dated 10/19/20, the P&P indicated, “...Each patient will have a plan of care that is appropriate to his/her specific assessed needs. Care planning begins on admission and is individualized within 24 hours. ...The plan is individualized/revised based on ongoing assessment findings, the patient’s response to treatment/interventions and evaluation of progress toward outcomes. Care planning ends at discharge/ transition of care to another facility ... The registered nurse (RN) is accountable for the initiation and coordination of the Patient Plan of Care in collaboration with the inter-professional team members and for its ongoing additions and revision based on identified needs, per professional scope of practice ...”. During a review of the hospital’s document titled, “Job Description Registered Nurse II, [Job Description]” dated 3/28/25, the “Job Description” indicated, “ ... Accountable for the assessment, coordination delivery and evaluation of nursing care, including direct patient care, patient/family education and transitions of care in an acute patient setting. Delivers holistic and individualized care to all patients in an assigned area. Develops, implements, and coordinates a plan of care that incorporates psychological, sociocultural, spiritual, economic, and life-style factors. Fosters and maintains collaborative relationships between patients, their family/support group, physicians, and other healthcare providers through timely and effective communications. Adheres to hospital polices, industry standards, best practices, and applicable laws and regulations to promote an optimal patient experience ...”. During a review of a professional reference titled, “Nutritional Assessment,” dated 4/10/23, (retrieved from https://www.ncbi.nlm.nih.gov/books/NBK580496/) indicated, “ ... Evaluation of nutritional status is critical, either to identify if an individual has nutritional imbalance due to an underlying condition or to assess if an individual is likely to develop a pathological [condition related to disease or illness] condition due to nutritional imbalance. ...Nutritional assessment and intervention together break the vicious cycle between malnutrition and various diseases or conditions, in which malnutrition aggravates a disease/condition, and the disease/condition, in turn, precipitates malnutrition. Breaking this cycle helps in improving clinical outcomes. Nutritional and clinical management based on comprehensive nutritional assessment results in positive healthcare outcomes by reducing the recovery period, hospital length of stay, risk of complications, susceptibility to infections, and mortality (a term also used for death rate, or the number of deaths in a certain group of people in a certain period of time) associated with clinical and surgical illnesses. The use of standardized, systematic nutrition risk screening and assessment in the clinical setting also helps in reducing overall healthcare costs ...Nurses also help with early nutritional screening to identify nutrition risk factors and monitor the patient’s condition to maintain timely documentation records of clinical status...”. 2. During a review of Pt 13’s “History and Physical (H&P- a complete patient assessment by the physician),” dated 3/23/25, the H&P indicated, Pt 13 was admitted to the hospital for a left femur (thigh bone) fracture (a break or crack in a bone). The H&P indicated, Pt 13 had a past medical history of diabetes mellitus (a disorder characterized by difficulty in blood sugar control and poor wound healing) and hypertension. During a concurrent interview and record review on 3/28/25 at 9:30 a.m. with Nurse Manager (NM) 4, Pt 13’s “Care Plan Event Log (CPEL),” dated 3/23/25 to 3/26/25 was reviewed. The “CPEL” indicated, Pt 13 had a care plan to address issues for discharge planning, skin and tissue integrity, fall safety, pain, musculoskeletal (the human body’s system of muscles and bones), respiratory (responsible for taking in oxygen and expelling carbon dioxide, essentially enabling us to breathe), genitourinary (the organs related to both reproduction and urination), and metabolic (all the chemical reactions happening in your body to keep you alive), fluid and electrolytes (minerals in your blood and other body fluids). NM 4 stated Pt 13’s hypertension was not addressed in the care plan. NM 4 stated there should have been a nursing care plan to address Pt 13’s hypertension. NM 4 stated care plans helped to guide nurses to ensure there was a plan of care including interventions to support the patient’s care. During an interview on 4/4/25 at 11:10 a.m. with the Director of Medical Surgical Services (DMS), the DMS stated she expected nurses to individualize care plans to each patient. During an interview on 4/4/25 at 5:10 p.m. with the Chief Nurse Executive (CNE), the CNE stated she expected nurses to identify the proper body system and customize the care plan to the patient. The CNE stated a care plan should be individualized to meet the patient’s needs. During a review of the hospital’s policy and procedure (P&P) titled, “Patient Plan of Care,” dated 10/19/20, the P&P indicated, “ ... POLICY: A. Each patient will have a plan of care that is appropriate to his his/her specific assessed needs ... The plan is individualized/revised based on ongoing assessment findings, the patient’s response to treatment/interventions and evaluation of progress toward outcomes ... Patient Plan of Care: Patient-centric documented plan for care, treatment and services that reflects his/ her specific needs and preferences. It may include individualized goals and services required to meet those goals in the designated setting of care. It is maintained/revised based on the patient’s condition, preferences, response to interventions. It is the patient’s plan - the centralized plan that drives the priorities and professional processes of care for the inter-professional team to prevent/manage/minimize potential problems and outcomes ... PROCEDURE: ... Planning care starts with learning the patient’s history, medical diagnosis and assessment of findings to determine his/her individualized needs and identify the appropriate Clinical Practice Guidelines to initiate on the plan of care ... Reviewing and updating the plan of care occurs on an ongoing basis throughout the patient’s hospitalization. Each shift the registered nurse is responsible for reviewing and updating the plan of care after assessing the patient. Additionally, other members of the inter-professional care team will review and update the plan of care as necessary ...”.”

“SUPERVISION OF CONTRACT STAFF CFR(s): 482.23(b)(6) All licensed nurses who provide services in the hospital must adhere to the policies and procedures of the hospital. The director of nursing service must provide for the adequate supervision and evaluation of all nursing personnel which occur within the responsibility of the nursing service, regardless of the mechanism through which those personnel are providing services (that is, hospital employee, contract, lease, other agreement, or volunteer). This Standard is not met as evidenced by: 49884 Based on observation, interview, and record review, the hospital failed to ensure all Licensed nurses (LNs) adhered to the hospital’s policies and procedures (P&P) and nursing standards of practice, when: 1. Registered Nurse (RN) 3 received a critical lab result from the blood bank for one of one patient (Pt 3) and the RN did not notify the surgeon, or Pt 3’s primary physician within the 30-minute time frame according to the hospital P&P titled “Laboratory Critical and or Call Values”, and did not document a notification to the primary physician per the hospital’s P&P titled “Documentation (Charting) for the Patient Health Record”. These failures delayed care for Pt 3 by delaying the physician’s order to the blood bank for crossmatched (a crucial test performed to ensure donor blood is compatible with recipients’ blood to prevent a reaction) blood, by one hour and 40 minutes. The crossmatched blood needed to be ordered from an outside blood bank vendor, and Pt 3 could not go into surgery until the blood was at the hospital and ready for transfusion. 2. Emergency Department (ED) RNs did not administer pain medications or develop a pain management plan when one of 3 patients (Pt 26) reported a pain score of 8 out of 10 in the ED, according to hospital P&P titled, “Pain Management”. Pt 26 reported a pain score of 8/10 on three separate occasions and was discharged from the ED with a reported pain score of 8/10, without having her pain addressed by RNs or physicians. These failures had the potential to affect the physical, emotional, and psychosocial (the influence of both physical and social factors on an individual) well-being of Pt 26, by failing to address her pain. 3. One of 10 patients (Pt 5) had an active medical problem of severe protein and calorie malnutrition (body not getting enough nutrients), and RNs and Certified Nursing Assistants (CNA)s failed to document nutritional intake, according to hospital P&P titled, “(Medical) Nutrition Therapy: Meal/Snack Delivery, Pick Up and Intake Recording”. This failure had the potential to cause weight loss in Pt 5 which placed Pt 5 at an increased risk for skin breakdown, slower wound healing to the open wound on the coccyx (tailbone), and in the gluteal cleft (groove between the buttocks), and a longer hospital admission. 4. RNs did not assess and document a temperature for one of three patients (Pt 25) in the Labor and Delivery (L&D- a specialized unit where babies are born and pregnant patients are treated) Unit every two hours after rupture of membranes (ROM- when the bag of water that surrounds the unborn baby breaks), according to the hospital’s P&P titled “Admission of Labor Patient”. This failure placed Pt 25 at risk for infection, to have delayed treatment, and could pose risks to the fetus (unborn baby). Risks include, infection being passed to the fetus, hyperthermia (high level of temperature), fetal distress (low oxygen levels), and brain damage. 5. ED nurses failed to assess Pt 4’s skin and implement pressure relieving interventions upon arrival to ED in accordance with hospital P&P titled “Skin Care: Prevention of Hospital-Acquired Pressure Injury- Adults & Pediatrics”. Pt 4 stayed on a gurney in the ED over nine hours and was not turned, or repositioned. Pt 4 upon arrival to the Intensive Care Unit (ICU-specialized unit providing advanced care for critically ill or injured patients) had redness and purple discoloration to the back/coccyx area. This failure led to Pt 4 developing deep tissue injury resulting in a full thickness wound to the coccyx area with bone exposed. 6. Nursing staff failed to change Pt 4’s colostomy bag (a waterproof pouch that collects stool from the surgical opening in large intestine through stomach) and do a complete assessment of skin around the stoma (a surgically created opening in the stomach allowing waste to exit the body) every three to five days in accordance with standards of practice or receive a physician order to leave the bag in place. Pt 4’s colostomy bag was not changed for 16 days and skin around the stoma site was not assessed appropriately. This failure had the potential for Pt 4’s skin around the stoma site to get irritated, have tears and get infected. 7. One of two patients (Pt 9) did not have an Aldrete assessment (a tool used to assess a patient’s readiness for discharge from the Post-Anesthesia Care Unit (PACU-a specialized area in hospitals where patients recover from anesthesia and surgery) completed before discharging from the PACU according to the hospital’s P&P titled, “Transfer From PACU.” This failure had the potential for Pt 9 to be discharged from the PACU before meeting discharge criteria and leading to potential complications. 8. One of two patients (Pt 9) did not have a temperature assessed before discharging from the PACU according to the hospital’s P&P titled, “Transfer From PACU”. This failure had the potential for Pt 9 to develop complications such as hypothermia (a dangerously low body temperature) or fever which could negatively impact recovery. 9. One of three patients (Pt 9) did not have an assessment completed when transferred from one unit of the hospital to another , according to the hospital P&P titled “Assessment: Admission and Reassessment.” This failure had the potential for nurses to not identify health problems and delay appropriate treatment based on Pt 9’s individualized needs. 10. Two of eight patients (Pt 9 and Pt 13) did not have physician notifications for elevated systolic blood pressure (SBP-the pressure in the arteries when the heart contracts) according to the physician order. This failure had the potential for Pt 9 and Pt 13’s elevated SBP to go unresolved and delay treatment resulting in complications such as stroke (when blood flow to part of the brain is disrupted, leading to brain damage) or heart failure (when the heart muscle doesn’t pump blood as well as it should). 11. Two of two patients (Pt 7 and Pt 10) did not have an incision assessment each shift according to standard of practice. This failure had the potential for Pt 7 and Pt 10’s incision to have delayed healing, infection, or wound dehiscence. 12. One of one patient (Pt 2) who had a community acquired pressure injury (pressure injuries that develop outside of hospital) was not turned every two hours according to the hospital’s P&P titled, “Skin Care: Pressure Related Injury Management.” This failure had the potential for Pt 2’s pressure injury to worsen, delayed wound healing, infection, and pain. 13. One of two patients (Pt 2) did not have pain assessments completed according to the physician’s order. This failure had the potential to affect Pt 2’s physical, emotional, and psychosocial well-being. 14. One of two patients (Pt 1) did not have triage (process of sorting patients according to urgency) vital signs completed when arriving to the ED according to the hospital’s P&P titled “Triage Policy.” This failure had the potential to delay a quick assessment of Pt 1’s condition and determine the need for immediate attention. 15. Registered Nurse (RN) 8 did not clamp the normal saline (NS-a mixture of sodium chloride and water) tubing during a blood administration observation according to nursing standards of practice. This failure had the potential for Pt 28 to receive diluted blood and to not complete the blood transfusion within four hours. Findings: 1. During a telephone interview on 3/28/25 at 12:49 p.m. with Complainant (CO) 2, CO 2 stated she was Pt 3’s daughter and was at the hospital with her father on 12/9/24. CO 2 stated Pt 3 was scheduled for an abdominal surgery because he had a small bowel obstruction (SBO- a blockage in the small intestine can cause inability to pass stool), and he was deteriorating (getting sicker). CO 2 stated the family was notified Pt 3 had antibodies (antibody-proteins in blood to fight germs, need specific blood or immune system will attack the donor blood) in his blood on 12/9/24 in the morning, and that the blood bank had to order blood from an out-of-town blood bank, prior to surgery. CO 2 stated the blood not being at the hospital delayed the surgery, and two other people went to the operating room (OR) ahead of Pt 3. CO 2 stated Pt 3’s nurse was asked several times what was taking so long to get the blood and get to surgery. CO 2 stated around 5 p.m., RN 3 called the lab to inquire and reported to the family the blood was on the way to the hospital. CO 2 stated by 8 p.m. the blood had arrived and the “ball started rolling”. CO 2 stated not long after the blood arrived her father was taken to surgery, but by then he was having long runs of Supraventricular Tachycardia (SVT- heart rhythm where heart beats rapidly and originates in the upper chambers of the heart). CO 2 stated, she believed Pt 3’s bowl ruptured while he was waiting for surgery. CO 2 stated Pt 3 coded (heart stopped beating) in surgery, the OR team achieved return of spontaneous circulation (ROSC-heart pumped blood effectively and had a pulse) and was rushed to the Intensive Care Unit (ICU), but after Pt 3 was transferred to the ICU, he coded again and died. CO 2 stated she believed if Pt 3’s blood would have been available sooner there may have been a different outcome. During a concurrent interview and record review on 3/28/25 at 1:56 p.m. with Nurse Manager (NM) 4, Pt 3’s “Emergency Department Physician Note EDPN”, dated 12/5/24, and “History and Physical [H&P- complete patient assessment by physician],” dated 12/6/24, was reviewed. The “EDPN”” indicated, Pt 3 was brought in by ambulance to the ED on 12/5/24 for abdominal pain and a cough for two weeks. The “H&P” indicated, Pt 3 was admitted to the hospital as an inpatient on 12/6/24 for septic shock (a life-threatening condition that occurs when a severe infection leads to dangerously low blood pressure, potentially causing organ damage and failure) and a small bowel obstruction (SBO- a blockage in the small intestine can cause inability to pass stool). The “H&P” indicated, Pt 3 was moved to the Intensive Care Unit, (ICU - a specialized hospital unit that provides advanced medical care to critically ill patients) on 12/6/24 at 7:30 a.m. During a concurrent interview and record review on 4/1/25 at 1:30 p.m. with NM 1 Pt 3’s “Progress Notes (PN)”, “Care Team Notes (CTN)”, “Lab Transfusion Services (LTS)”, and “Provider Orders (PO),” dated 12/9/24 to 12/10/24 were reviewed. The “LTS” indicated, on 12/9/25 at 9:18 a.m. staff from the blood bank called RN 3 to report Pt 3 had a critical lab result of a positive antibody screen (a test). NM 1 stated no documentation was entered by RN 3, Pt 3’s primary nurse about receipt of a critical lab result from the blood bank, or about contacting the physician for an order for crossmatched blood from the blood bank. The “CTN” from 12/9/25 entered by RN 2, a surgical nurse indicated, “ ...0900 [9 a.m.] ...report from inpatient RN [RN 3] for preop [preparation for surgery]. 1055 [10:55 a.m.]- Received call from inpatient RN [RN 3] that patient has antibodies, in blood. Spoke with [Surgeon] and type and crossmatch ordered. 1610 [4:10 p.m.]- called blood bank and blood in process of being sent from [Town Name]. Informed [Surgeon] and OR [Operating Room] crew. Will wait for blood to arrive to send for patient ...”. NM 1 stated, Pt 3’s medical record on 12/9/24 had no documentation from RN 3 about speaking to Pt 3’s primary physician, the surgeon, RN 2, the blood bank, Pt 3 or Pt 3’s family regarding Pt 3’s blood having antibodies, Pt 3’s surgery being delayed, or any updates about the blood in transit. NM 1 stated the RN was made aware by the blood bank that something else needed to be done. NM 1 stated, nurses were aware, when they receive a call about critical lab information, the information needed to be passed to the ordering physician. During a concurrent interview and record review on 4/1/25 at 3:07 p.m. with RN 3, Pt 3’s “CTN”, “LTS”, and “PO”, dated 12/9/24, were reviewed. RN 3 stated, she was Pt 3’s primary nurse on 12/9/24 during the day shift. RN 3 stated, she vaguely remembered Pt 3 but had reviewed the patient’s Electronic Medical Record [EMR]. RN 3 stated, Pt 3 was supposed to go to surgery in the morning on 12/9/24. RN 3 stated, the blood bank notes from 12/9/24 indicating the blood bank called with a critical lab result of a positive antibody screen at 9:18 a.m. were accurate. RN 3 stated, she called and gave report to the RN in the surgical area (RN 2) when the blood bank called about Pt 3’s positive antibody screen. RN 3 stated she did not document in Pt 3’s EMR receiving the critical lab value information or reporting the information to RN 2. RN 3 stated, antibodies in the blood were considered a critical lab value and she passed on the information to RN 2 who ordered the crossmatched blood from the blood bank. RN 3 stated critical lab results should be given to the physician as soon as possible. RN 3 stated the information was time sensitive because the blood was coming from another city 1.5 hours away. RN 3 stated she communicated with Pt 3 and Pt 3’s family to keep them updated about where the blood was in the process, but she did not document the conversations. RN 3 stated she reported the critical lab antibody information to Pt 3’s primary physician but did not document the information. RN 3 stated she should have documented reporting to the physician, and RN 2, as well as updating the family, because “If you didn’t document it, you didn’t do it”. During a concurrent interview and record review on 4/2/25 at 11:04 a.m. with the Transfusion Supervisor (TS) and Clinical Laboratory Scientist (CLS) 1, Pt 3’s “Transfusion Records (TR)”, dated 12/9/24 and 12/10/24 were reviewed. The TS stated the process for transfusions was, the blood bank would receive an order in the EMR, and the order also translates into the lab system, the blood bank staff would then identify if a pt had a history in the hospital system to determine if the blood type and if there were special requirements or antibodies. The TS stated the type and cross was completed on the blood bank analyzer equipment (automated system to perform tests on blood samples, primarily for blood typing, antibody screening, and compatibility testing) the staff verified the current blood sample with the history to ensure a match. The TS stated the initial type and screen process took approximately 45 minutes for one sample. The TS stated if the pt had a history of antibodies, or the current screen was positive, the system would give a pop up critical. The TS stated, the CLS would call the patient’s nurse to report there may be a possible delay with the blood for transfusion. The TS stated during the initial screening which antibody was not known, or how long the delay would be to get the blood. The TS stated for certain single antibodies the blood may be available in house, and for multiple antibodies the blood could take a while. The TS stated Pt 3 had one antibody, and a possible second antibody, so the blood was not available at the hospital and needed to be ordered from the blood bank supplier in another town 1.5 hours away. The TS stated Pt 3’s timeline of events were a type and screen was drawn at 7:33 a.m., resulted at 9:18 a.m., and the CLS called RN 3 and reported a positive antibody screen. The TS stated at 10:29 a.m. the antibody was identified, and at 11 a.m. an order for two units of blood came through the computer system. The TS stated the blood was ordered through the computer to the offsite supplier and the supplier had to find the blood, all orders were patient specific. The TS stated the blood was ordered STAT (immediately). The TS stated the process had about a four to six hour turn around, then the hospital blood bank must confirm the product through testing to ensure Pt 3 would not have a transfusion reaction when the blood was transfused. The TS stated Pt 3’s donor blood was received by the hospital at 6:52 p.m. and confirmation (testing) of the blood product was completed at 7:50 p.m. and was available for allocation (distribution) at 8:13 p.m. The TS stated she acknowledged a delay but there was nothing the blood bank could do since Pt 3 had specific antibodies in the blood, and the blood was not in house. During an interview on 4/2/25 at 2:20 p.m. with RN 2, RN 2 stated, she was the surgical nurse on 12/9/24 who received the call from RN 3 regarding Pt 3 having a positive antibody screen. RN 2 stated she entered the order for Pt 3’s blood crossmatch. RN 2 stated, RN 3 called her in the morning around 9 a.m. and gave report about Pt 3 because he was a case (surgery) for an abdominal surgery. RN 2 stated RN 3 called her again around 11 a.m. and asked what she (RN 3) should do, because Pt 3 had a positive antibody screen. RN 2 stated she grabbed a surgeon walking by and got a verbal order for a crossmatch for Pt 3 and entered it. RN 2 stated, she (RN 2) contacted the blood bank one time for an update and reported the information to the surgeon and OR team. RN 2 stated nurses should document in the medical record when speaking to other nurses, receiving critical lab results or when reporting information to the physician, because it helped to track why and how things happened. During an interview on 4/4/25 at 5:17 p.m. with the Chief Nursing Executive (CNE), the CNE stated her expectation was for RNs to follow timeliness, and documentation standards. During a review of the hospital’s P&P titled, “Laboratory Critical or Call Values,” dated 3/14/24, indicated, “ ... Purpose: ...To outline laboratory values which have a potentially adverse or life-threatening effects. ...To ensure accurate and timely notification of critical results to the appropriate care provider or physician. ...within 30 minutes from the time the critical result is identified. The Clinical Laboratory Scientist (CLS) will notify any primary care nurse of the unit when the following values are identified ... the CLS must contact the primary care nurse or charge nurse within 30 minutes from the time the critical result is identified. ...The receiver of the critical test results or critical value results will immediately notify the attending physician of the results. ...Transfusion Service: ...Positive Antibody Screen ...”. During a review of the hospital’s P&P titled, “Documentation (Charting) for the Patient Health Record”, dated 7/12/24, indicated, “ ...Policy: A. It is policy that information related to patient assessments, interventions, evaluations, and outcomes is documented tin the electronic health record for all patients admitted or accepted for treatment at [hospital Name]. ...Documentation should be factual, accurate, complete, and timely. ...Documentation should be ... Complete- Document all actions/interventions, including but not limited to, changes in patient condition, patient responses, education, and communication with care team ...Documentation Requirements a. Will include but not limited to: ... Education provided to patient, family, or significant other ...Critical Results i. Will be documented in the EHR [Electronic Health Record] critical value reporting flow sheet and will include type of test and critical result, date/time, full name of person you receive result from, date and time and name of licensed provider the result was reported to. ...Significant events ... Notation of communication with the patient and/or family shall be made in the medical record by the individual communicating the event”. 2. During a concurrent interview and record review on 4/2/25 at 10:22 a.m. with the Nurse Informaticist (NI), Pt 26’s “Emergency Department Timeline (EDT)” was reviewed. The EDT indicated, Pt 26 arrived in the ED on 1/25/25 at 12:59 p.m. The EDT indicated, on 1/25/25 at 1:32 p.m. Pt 26 had a Medical Screening Exam completed by a Licensed Nurse (LN), and Pt 26 reported a chief complaint of onset of vaginal bleeding in pregnancy less than 20 weeks Estimated Gestation Age (EGA-number of weeks that have elapsed between the first day of the last normal menstrual period and the date of delivery) beginning two hours before. The NI stated Pt 26 indicated she had changed two large pads in the last hour. The “EDT” indicated; Pt 26 also had a chief complaint of abdominal pain in pregnancy less than 20 weeks EGA. The NI state at 1:34 p.m. LNs assigned Pt 26 a patient Emergency Severity Index (ESI-System used in ED to prioritize patient care by severity of illness or injury 5 being lowest and 1 being highest urgency) number of 3 (urgent but stable), and Pt 26’s pain score was eight out of 10 (8/10). The NI stated, no pain medications were administered. The “EDT” indicated, an ED Note from 3:54 p.m. where Pt 26 reported an unwitnessed syncopal (fainting) episode in the restroom, and Pt 26’s ESI number was updated to a 2 (high-risk requiring immediate nursing assessment, but not necessarily immediate life-saving intervention). The “EDT” indicated, at 5:21 p.m. Pt 26 reported a pain score of 8/10. The NI stated, no pain medications were administered. The “EDT” indicated, at 6:08 p.m. Pt 26 reported a pain score of 8/10. The NI stated no medications were administered. The “EDT” indicated at 6:14 the physician was at bedside. The “EDT” indicated, on 1/25/25 at 6:26 p.m. Pt 26 was provided discharge instructions, and discharged from the ED. The NI stated Pt 26’s “EDT” documentation did not have any documentation of LNs requesting medication for pain from the physician. During a telephone interview on 4/2/25 at 1:31 p.m. with Pt 26, Pt 26 stated, she went to the ED in January because she was around 11 weeks pregnant and began bleeding heavily and having very bad abdominal pain. Pt 26 stated, when she was assessed by the nurse, she reported heavy bleeding and pain, the nurse told her she would try to get her a bed as soon as possible. Pt 26 stated she told the nursing staff multiple times she was having very bad pain and asked for something for pain. Pt 26 stated the nurses told her she would have to wait until she was seen by the physician. Pt 26 stated she waited five hours in the waiting room bleeding heavily and at one point when she went to the bathroom she stood up and fainted, hitting her head on the bathroom stall. Pt 26 stated when she came out of the bathroom the security guard near the bathroom saw her and assisted her to a stool, then got a nurse to help her. Pt 26 stated, a nurse put her in a wheelchair and took her vital signs, then “parked her to the side”, where she waited about two more hours to be seen by a physician. Pt 26 stated she reported again to nurses about having pain, still in her abdomen and then also in her head. Pt 26 stated no one addressed the pain to her head and the physician told her pain and bleeding were normal during a miscarriage (an unexpected loss of pregnancy before the 20th week of pregnancy). Pt 26 stated she was discharged home with instructions to follow up with her primary physician. Pt 26 stated she was not administered any pain medication or given any prescriptions for pain medications. Pt 26 stated she felt the nurses and the physician should have addressed her pain during her ED visit. Pt 26 stated she followed up with her primary physician and received orders for imaging testing for her head and neck pain. During a concurrent interview and record review on 4/4/25 at 10:42 a.m. with Nurse Manager (NM) 3, Pt 26’s “EDT”, dated 1/25/25, ED Provider Note (EDPN), dated 1/25/25 were reviewed. NM 3 stated, according to the documentation on the “EDT” Pt 26 did not report hitting her head to ED nurses or the physician when she had a syncopal episode. The EDPN indicated, the problems addressed during the visit were, vaginal bleeding in the first trimester (a division of pregnancy into three equal periods of approximately 13 weeks each) NM 3 stated Pt 26’s pain was not addressed during the visit on 1/25/25. NM 3 stated Pt 26’s pain “possibly could have been addressed.” The EDPN indicated, given the testing results the most likely diagnosis was miscarriage (The spontaneous loss of a woman’s pregnancy before the 20th week that can be both physically and emotionally painful). The EDPN indicated, no discharge prescriptions were written for Pt 26. During an interview on 4/4/25 at 5:20 p.m. with the Chief Nursing Executive (CNE), the CNE stated her expectation was for LNs to assess pain and escalate (to refer an issue or problem to a higher authority) to a physician to address Pt 26’s pain. During a review of the hospital’s P&P titled, “Pain Management,” dated 2/24/25, indicted, “ ... Initial Pain Assessment 1. Upon admission to a patient care setting, including Emergency Department visits, patients will be assessed for pain using an appropriate scale. ... Patients experiencing pain will have a comprehensive assessment of pain completed by a Registered Nurse (RN) or Licensed Independent Practitioner (LIP). ...This assessment may include pain score, type, location, stated pain goal, and pain interventions. ... The patient experiencing pain will have a pain management plan developed in collaboration with the patient ... The pain management plan may include ... non-pharmacologic (non- pain medications) pain treatment strategies Pharmacological (pain medications) pain treatment strategies ...The pain management plan may be documented in the care plan and/or interdisciplinary notes. ...Discharge Education for Pain Management Plan: ... The patient/family/caregiver is educated regarding the discharge pain management plan ...Strategies to manage pain at home ....”. During a review of the professional reference titled, “Acute Pain Assessment Inadequacy in the Emergency Department: Patients’ Perspective,” dated 1/9/24, the professional reference indicated, “ ...For many patients, acute pain is a common cause to seek treatment in an Emergency Department (ED). An inadequate assessment could cause inappropriate pain management. ... Patients’ perceptions of pain assessment and management have become an important criterion and relevant outcome measure for healthcare institution. Patient’ self-assessment is the most reliable and accurate evidence of the existence of pain and should be used whenever possible. ... However, pain management in the ED is challenging, and one of the main aims is to achieve patient satisfaction by reducing discomfort. Crowding EDs, and nurses’ lack of knowledge may prevent nurses from performing adequate pain assessment and correct pain management. An inadequate assessment could cause underestimation of the patient’s pain, leading to inappropriate pain management. According to governing organizations on pain, and guidelines, patients have the right to be involved in all aspects of their pain management. Previous studies have shown that the accurate assessment of pain is a crucial step in providing effective pain management. Discrepancies between a patient’s and nurse’s assessments are identified as the most powerful predictor of poor pain management. Previous studies have shown that acute pain management has been concentrated on the components of the pain management process, including the assessment of pain, provision of interventions. ... Acute pain management should include appropriate assessment together with the patient, and usually, resulting in a direct impact on patient pain management satisfaction ...”. 3. During a concurrent interview and record review on 3/28/25 at 9:48 a.m. with Nurse Educator (NE) 1, Pt 5’s “History & Physical (H&P- a complete patient assessment by the physician),” dated 12/31/24, was reviewed, the H&P indicated Pt 5 was brought into the Emergency Department (ED) on 12/31/25 at 12:45 p.m. by family with complaints of right upper quadrant pain (the area of the stomach located on the right side above the belly button) for two weeks. The H&P indicated, Pt 5 was admitted as an inpatient on 12/31/24 at 8:50 p.m. for a renal abscess (a pocket of pus that forms within the kidney tissue) and moved to the Medical Surgical (MS) Unit at 11:56 p.m. During a concurrent interview and record review on 3/28/25 at 9:55 a.m. with NE 1, Pt 5’s “Hospitalist Progress Note (HPN),” dated 1/2/25, “Care Plan Accordion (CPA)”, dated 1/2/25 to 1/8/25 and the “Intake and Output Flowsheet (IOF)”, dated 1/2/25 to 1/8/25 was reviewed. The HPN indicated, Pt 5 had an active medical problem identified by the physician of “severe protein and calorie malnutrition”. The CPA” indicated; no care plans were entered by LNs for Nutrition Deficiency. NE 1 stated, Pt 5 possibly should have had a care plan for nutritional deficit. The IOF indicated, on 1/2/25 no lunch intake was documented. The IOF indicated, on 1/3/25, 1/4/25, and 1/5/25 no breakfast or lunch documentation were in the medical record. NE 1 stated the Electronic Medical Record (EMR) did not have a cell to document intake for dinner, prior to the system update in February 2025. NE 1 stated, nursing staff (CNAs, RNs) should have documented intake on the IOF when collecting the meal tray. NE 1 stated nursing staff were trained to document intake. NE 1 stated CNAs should have informed the RN when patients were refusing meals or not eating at least 75% of their meals. NE 1 stated nursing staff were supposed to document on the IOF when patients refused meals. NE 1 stated RNs could then notify the Pt’s physician. NE 1 stated, the physician could, enter a Registered Dietitian Consult, enter an order for nutrition supplements, or prescribe medications to increase the patient’s appetite. NE 1 stated, RNs should also speak to the Pt and the Pt’s family because the Pt may have specific foods they prefer from home. NE 1 stated, ensuring Pt 5 was receiving enough nutrition was important for body healing and to improve wound healing. During a review of Pt 5’s “Medical Nutrition Therapy Nutrition (MNTN) Consult,” dated 1/2/25, the “MNTN Consult” indicated Pt 5 was four feet eight inches tall and 74 pounds (lbs.- a unit of weight measurement) 8.3 ounces (oz- a unit of weight measurement). The “MNTN Consult” indicated; Pt 5 was underweight. The “MNTN Consult” indicated, Monitoring/Evaluation/Goals”, Monitor weight, and tolerance to diet. Pt 5 did not have any additional weights assessed after her admission weight of on 12/31/25. During a concurrent interview and record review on 4/2/25 at 2:46 p.m. with the Registered Dietitian Supervisor (RDS), Pt 5’s “IOF,” dated 1/2/25 through 1/8/25, “and “MNTN Consult” dated 1/2/25 were reviewed. The RDS stated, he reviewed Pt 5’s medical record prior to the interview. The RDS stated, when Registered Dietitian’s (RDs) assess patients for a nutrition consult the RD would look at the weight history as well as, admitting diagnosis, medical history, recent active problems or new diagnosis, diet, intake and output, nausea and vomiting, medications, and labs, to see if there was anything that may be significant. The RDS stated it was important for nutrition intake to be documented accurately, and Pt 5 was missing nutrition documentation. The RDS stated it was important to document accurately, to see progression (was the patient increasing or decreasing intake), and to get an estimate of calorie intake, also to see if the patient needed modification to nutrition (supplements, etcetera). During an interview on 4/4/2025 at 5:17 with the Chief Nursing Executive (CNE), the CNE stated her expectation was for nursing staff to document nutrition with every meal per policy. During a review of the hospital’s P&P titled, “(Medical) Nutrition Therapy: Meal/Snack Delivery, Pick Up and Intake Recording,” dated 8/22/21, indicated, “ ...Purpose: ...To ensure timely and safe delivery, pickup and recording of patient intake ...Nursing are responsible for accurately and thoroughly documenting patients’ meal, snack and fluid intake upon removal of meal trays or empty food/beverage containers. ...The person picking up will: ...Accurately and appropriately document the intake of the meal/snack using the percentage method and volume of fluids in milliliters. ...Nursing Staff will either transfer the written percent and volume intake to the EHR [Electronic Health Record] or document intake directly into the EHR”. During a review of a professional reference titled, “Nutritional Assessment,” dated 4/10/23, (retrieved from https://www.ncbi.nlm.nih.gov/books/NBK580496/) indicated, “ ... Evaluation of nutritional status is critical, either to identify if an individual has nutritional imbalance due to an underlying condition or to assess if an individual is likely to develop a pathological [condition related to disease or illness] condition due to nutritional imbalance. ...Nutritional assessment and intervention together break the vicious cycle between malnutrition and various diseases or conditions, in which malnutrition aggravates a disease/condition, and the disease/condition, in turn, precipitates malnutrition. Breaking this cycle helps in improving clinical outcomes. Nutritional and clinical management based on comprehensive nutritional assessment results in positive healthcare outcomes by reducing the recovery period, hospital length of stay, risk of complications, susceptibility to infections, and mortality (a term also used for death rate, or the number of deaths in a certain group “. 4. During a concurrent interview and record review on 3/27/25 at 2:33 p.m. with Registered Nurse (RN) 6, Pt 25’s “History and Physical [H&P- complete patient assessment by physician],” dated 3/23/25 was reviewed. The H&P indicated Pt 25 was admitted on 3/23/25 at 7:37 a.m. for an elective induction of labor (the use of medications or other methods to start labor). RN 6 stated Pt 25 was 40 weeks and 5 days pregnant upon admission to the Labor and Delivery (L&D-provides care during labor, childbirth, and immediately after birth) Unit. During a concurrent interview and record review on 3/27/25 at 2:37 p.m. with RN 6, Pt 25’s “Membrane [thin flexible layer that forms the outer boundary makes up bag of water around fetus] Status Flowsheet (MSF),” dated 3/23/25 to 3/24/25, “Physician Order (PO),” dated 3/23/25 and “Vital Sign Flowsheet (VSF),” dated 3/24/25 to 3/25/25 were reviewed. The MSF indicated on 3/24/25 at 1:15 a.m. Pt 25 had a spontaneous rupture of membranes (when the amniotic sac that surrounds and protects a fetus break on its own). The PO indicated, 3/23/25 at 10:30 a.m. “ ...Vital Signs AS SPECIFIED ... Ruptured Membranes ... temp [Temperature] Q2 hrs [every 2 hours] once membranes have ruptured ...” The VSF indicated Pt 25 had temperature assessed on 3/24/24 at 11 a.m., 2 p.m., 4 p.m., and at 7:15 p.m. RN 6 stated Pt 25 should have had her temperature assessed every two hours after a ROM, to ensure Pt 25 was not “spiking a temp [getting a fever]”. RN 6 stated, an elevated maternal temperature, or an elevated fetal heart rate could be signs of chorioamnionitis (a serious infection of the placenta and amniotic fluid that can occur during pregnancy). RN 6 stated, when patients have prolonged rupture of membranes there could be risks to the mother and unborn baby including sepsis (a serious infection), the baby and mother would need antibiotics after delivery. During an interview on 4/2/25 at 10:10 a.m. with the Director of the Family Birth Center (DFBC) the DFBC stated, her expectation was for LNs to assess patient’s temperature every two hours after a ROM, and if patient became febrile to monitor every one hour per hospital policy. The DFBC stated LNs were expected to monitor patient temperature and to assess patients for infection after a ROM. During an interview on 4/4/25 at 5:12 p.m. with the Chief Nursing Executive (CNE) the CNE stated, the expectation was for LNs to assess and document patient temperature every two hours after ROM per hospital policy. During a review of the hospital’s P&P titled, “Admission of Labor Patient,” revised 6/23/21, the P&P indicated, “ ...Procedure ... Vital signs are to be recorded as follows: ... Maternal temperature ...a minimum of four hours. If ROM, then temperature, pulse, and respirations (TPR) every 2 hours. If clinical signs or symptoms of infection are present (uterine tenderness, fever, fetal tachycardia [fast heart rate]), perform TPR every 1 hour ...”. During a review of a professional reference titled “Suspected clinical chorioamnionitis with peak intrapartum [onset of labor through delivery of placenta] temperature <38°C: the prevalence of confirmed chorioamnionitis [CA] and short term neonatal outcome,” dated 2022, the professional reference indicated, “ ... Intraamniotic infection (IAI) or Chorioamnionitis (CA) refers to the infection of the amniotic fluid, membranes, placenta (temporary organ that forms in the womb during pregnancy) ... At term, CA complicates approximately 1 to 4 percent of deliveries overall. CA is a well-recognized risk factor for early-onset neonatal sepsis (EOS).Adverse fetal/neonatal outcomes of CA include perinatal death (fetal death from 22 completed weeks of development in the womb to seven days after birth), asphyxia (not enough oxygen), early-onset neonatal sepsis, septic shock, ...and long-term disability ...The acute (sudden onset) symptomatic (showing symptoms) condition which often presents with fever, uterine tenderness, genital discharge, tachycardia, and evidence of fetal infection, is termed clinical chorioamnionitis ...”. 5. During a review of Pt 4’s “Emergency Department (ED) Note”, dated 2/6/25, the “ED Note” indicated, “ ... [Pt 4] is a 43 year old female with [past medical history] significant for fibroids [noncancerous growths that develop in the uterus, often without causing symptoms], prior alcohol abuse, adenocarcinoma [type of cancer that starts in the glands that line organs] of the rectosigmoid colon [lower part of the large intestine] metastatic [cancer that has spread from its original location to other parts of the body] to the liver seen by [hospital name] oncology, diverting colostomy [surgical procedure where a portion of the colon is brought out through an opening in the abdominal wall, creating a stoma, which allows waste to be eliminated into a bag attached to the skin], cirrhotic liver [condition where healthy liver tissue is replaced by scar tissue, leading to impaired liver function], who presents to the ED for evaluation of [altered mental status (AMS)]. Per friend, per friend, patient did not eat yesterday or take medications. She has been sleeping all day today and was briefly unresponsive for family ... stage IV colorectal rectal cancer [indicates that the cancer has spread from the colon or rectum to other parts of the body] metastatic to liver and bones not a candidate for chemoradiation therapy [cancer treatment] ... discussed with the intensivist [medical doctor who possesses special training and experience in treating critically ill patients] for admission to [Intensive Care Unit (ICU - is a specialized hospital unit providing advanced care for critically ill or injured patients who require constant monitoring, life support, and specialized medical treatments)] ... FINAL DIAGNOSIS ... Septic shock ...Metastatic colon cancer to liver ... Acute kidney injury [sudden decline in kidney function, often reversible, where the kidneys can’t filter waste products from the blood] ... Influenza [Flu, an infection of the nose, throat and lungs] ...”. During a concurrent interview and record review on 4/1/25 at 1:43 p.m. with the ICU Assistant Nurse Manager (ANM 3), Pt 4’s Electronic Medical Record (EMR) was reviewed for the entire hospital stay of hospital encounter on 2/6/25. The review of wound nurse note on 2/7/25 at 11:42 a.m. indicated, “ ... Assessed photos in media and chart reviewed: Assessed the photo of the bilateral gluteal [buttock or posterior region of the pelvis], coccyx [tailbone - a small, triangular bone at the very bottom of spine area], sacral spine [at the bottom of the spine area], gluteal cleft [the space or crease between rear ends, the part of your body people sit on] there is purple, red discoloration with the appearance of a traumatic wound ...” ANM 3 stated the review of wound nurse documentation on 3/28/25 at 11:45 a.m. indicated, “ Open Wound 02/07/25 Bilateral gluteal; coccyx; sacral spine; gluteal cleft traumatic; Pressure Ulcer - Suspected Deep Tissue Injury [DTI- type of pressure injury where the underlying soft tissue, rather than the skin surface, is damaged by prolonged pressure or shear]; moisture associated skin damage ... Date First Assessed: 02/07/25 Wound present on admission?: yes Side: Bilateral Location: gluteal; coccyx; sacral spine; gluteal cleft Wound Type: (c) traumatic; Pressure Ulcer - Suspected Deep Tissue Injury; moisture associated skin damage Additional Wound Description not intact; full thickness Dressing Appearance moist drainage; intact ... Dressing Changed ... Base: moist; pink; red; yellow; gray; slough [presence of string or fibrous tissue in the wound bed] ... Exposed Structures Bone (bone palpable under tissue) ... Edges open ... Wound Length ... 6 [Centimeter (cm - unit of measurement)] ... Wound Width ... 10 cm ... Wound Depth ... 0.8 cm ....” ANM 3 stated Pt 4 had skin assessment completed upon arrival to ICU on 2/7/25 at 1:15 a.m. ANM 3 stated ICU nurses documented redness on back, coccyx area, and pictures were taken. The wound nurse saw Pt 4 ten hours later reviewed the pictures, assessed Pt 4 and documented potentially DTI. ANM 3 stated DTI got progressively worse, opened up and on assessment on 3/28/25 at 11:45 by wound nurse indicates full thickness wound with bone exposed. ANM 3 reviewed Pt 4 EMR and stated Pt 4 was turned appropriately, had appropriate care plan and had all interventions in palace to prevent DTI or pressure injury during entire stay in ICU. ANM 3 Pt 4 was very sick, had multiple factors, poor skin integrity, nutrition status and despite preventative measures, her skin was at risk of worsening DTI. ANM 3 stated record does not reflect Pt arrived to hospital ED with DTI, however, Pt 4 arrived in ICU from ED with DTI. ANM 3 stated she was not familiar with ED documentation and would have to defer to ED leadership for record review to validate whether Pt 4’s skin was assessed upon arrival to ED and appropriate interventions were in place to avoid pressure injuries while the patient was in ED gurney for nine hours. During a concurrent interview and record review on 4/1/25 at 4:13 p.m. with the ANM 3 & Wound Nurse (WN ) 2, Pt 4’s Electronic Medical Record (EMR) for the entire hospital encounter dated 2/6/25 was reviewed. WN 2 stated she was familiar with Pt 4 and worked with her on several occasion. WN 2 stated wounds nurses rarely see patient in ED. WN 2 stated she had reviewed the first wound nurse consult for the hospital encounter on 2/6/25 that was dated 2/7/25. WN 2 stated that it appears that patient had traumatic injury prior to hospital arrival, and it got progressively worse due to patient’s medical condition. WN 2 stated Pt 4 had history of falls, however, no documentation that reflects that she had injury to coccyx area. WN 2 agreed that without the documentation any wound nurse would not be able to confirm if the DTI was present on admission. WN 2 stated without turning and pressure relieving interventions, Patients with fragile skin similar to Pt 4 could potentially get DTI from sitting in gurney for nine hours During a concurrent interview and record review on 4/2/25 at 3:11 p.m. with the ED Manager (NM 3) Pt 4’s Electronic Medical Record (EMR) was reviewed. NM 3 stated EMR indicated Pt 4 arrived in ED on 2/6/25 at 3:46 p.m. and was in ED until 1:04 a.m. on 2/7/25. Pt 4 was transferred to ICU from ED. NM 3 stated Pt 4 was in suite “D” in ED in a gurney for the entire duration in ED (nine hour and eighteen minutes). NM 3 stated she was unable to find any documented skin assessment during the entire stay in ED that reflects Pt 4 had any pressure injuries [areas of damaged skin and underlying tissue caused by sustained pressure, often over bony prominences] or deep tissue injury [DTI- type of pressure injury where the underlying soft tissue, rather than the skin surface, is damaged by prolonged pressure or shear] on back or coccyx [tailbone - a small, triangular bone at the very bottom of spine area] upon arrival or in ED. NM 6 stated ED nursing documentation indicated on 2/6/25 at 4:11 p.m. “Skin - Cool, dry, WDL [with in define limits], except characteristics. NM 3 she was not able to find any documentation that indicated patient had any pressure injuries or DTI on back on arrival to ED. NM 3 stated no pictures were taken in the ED upon arrival or during entire duration of Pt 4’s ED stay. NM 3 stated Pt 4 was not on any pressure relieving devices in the gurney in ED. NM 3 stated it was not a typical process at the hospital’s ED to have pressure relieving devices for patients in gurney. NM 3 stated if the patient was in the ED department for extended time and was getting admitted then she would expect the staff to move them in a hospital bed. NM 3 stated she was unable to find any documentation in the ED that indicates patient was turned during their entire stay in ED. NM 3 stated ED staff reposition patient frequently, however they only chart by exception. NM 3 reviewed the skin assessment at 2/7/25 at 1:15 a.m. and pictures taken by ICU team upon admission. The skin assessment sheet completed on 2/7/25 at 1:15 a.m. indicated “ ...Mark drawing with the appropriate letter: ... RD -Red ...”. The skin assessment had picture with “RD” written on back/coccyx area. NM 3 stated RD indicated redness on the back and coccyx area. NM 3 stated she would have expected to have skin sheet completed similar to one completed in ICU done in ED along with pictures and documentation. NM 3 stated admission to ICU order was written on 2/6/25 at 10:15 p.m. and pt stayed until 2/7/25 at 1:04 a.m. (two hours and forty-eight minutes) in the gurney. NM 3 stated she was unable to comment whether any pressure relieving interventions were considered for Pt 4 based on the documentation alone and would have to ask nurses providing care to the Pt 4. NM 3 stated she was also unable to find the Braden score [used to assess a patient’s risk for developing pressure injuries] documentation completed in ED and would have expected to have it done. NM 3 stated Pt 4 was at high risk for pressure injuries due to past medical history. NM 3 stated she was unable to comment if Pt 4 could develop redness or DTI for being in a gurney in ED for over nine hours with no pressure relieving interventions and would have to defer to wound nurse or wound coordinator. During a concurrent interview and record review on 4/2/25 at 3:24 p.m. with NM 3, the hospital’s policy and procedure (P&P) titled , “ Skin Care: Prevention of Hospital-Acquired Pressure Injury- Adults & Pediatrics”, with an effective date of 4/15/21 was reviewed. The “P&P” indicated, “... It is policy that every patient is assessed for Pressure Injury and risk for Pressure Injury on admission, then provided risk mitigation strategies, as needed during the hospital stay ... The Risk Assessment for Pressure Injury formation is the responsibility of licensed nursing staff ... Repositioning (by staff, or by patient self-turning) should be undertaken, regardless of support surface, to reduce the duration and magnitude of pressure over vulnerable areas of the body that include high pressure over bony prominences ... For patients in the Emergency Department (ED), Pressure Injury prevention begins with a thorough skin assessment for existing Pressure Injury. It also includes identifying factors that may increase the risk of Pressure Injury development such as decreased activity and/or mobility and implementing risk prevention strategies as needed. An initial risk screening for patients will be completed and documented for the following conditions ... non-ambulatory patients ... Restricted/limited mobility ... Altered level of consciousness (ALOC) ... Skin breakdown/discoloration (i.e., red, purple, black) ... If ED patient is at risk for Pressure Injury, consider placing patient on a pressure redistribution surface (overlay support surface or hospital bed) ... An initial risk assessment is performed upon admission that includes the following ... Braden Risk Assessment for all adult patients ... A skin assessment is performed and documented on admission and daily. Special attention should be given to assessing pressure points such as sacrum, coccyx and heels and skin beneath removable medical devices. Assessment may include integrity, color, temperature, turgor, and moisture ... The patient/family will be notified if Pressure Injury is present on admission ... The provider is notified of the following ... Any skin breakdown or discoloration (i.e., red, purple, black) ...”. NM 3 stated documentation does not reflect that Pt 4’s skin was assessed and interventions were implemented to relieve pressure in accordance with hospital policy. NM 3 stated EMR also does not reflect that ED Physician, or family was notified of any discoloration of skin in back or coccyx area and without that she was not able to comment if the injury was present on admission to ED. 6. During a concurrent interview and record review on 4/1/25 at 1:58 p.m. with the ICU Assistant Nurse Manager (ANM 3), Pt 4’s Electronic Medical Record (EMR) was reviewed for the entire hospital stay of hospital encounter on 2/6/25. Pt 4’s colostomy site care documentation was reviewed. ANM 3 stated she was unable to find any documentation that colostomy bag was changed between 2/8/25 to 2/25/25 (16 days). ANM 3 stated it was standard of care to change ostomy bag every three to five days at the facility. ANM 3 stated without removing the bag it would not be possible to assess the skin around stoma site for any excoriation or irritation. ANM 3 stated although the documentation reflect stoma site was assessed each shift, but the nurses would not be able to assess completely without removing the ostomy appliances as the bag gets attached to a second piece that gets attached around stoma on skin around it. ANM 3 stated without optimal care and assessment it could potentially lead to pain, skin excoriation and tears. ANM 3 reviewed the order and stated the wound order to change bag every three to five days was not placed until 2/25/25, however, wound nurses note on 2/7/25 clearly states plan of care to change bag every three to five days. ANM 3 stated it appears that it was missed by nurses. ANM 3 stated she would expect the nurses to follow standard of care or expects them to discuss with patient’s physician and receive an order to do something that was beneficial for patient condition but may go against the standards of care. During a concurrent interview and record review on 4/1/25 at 4:18 p.m. with the ANM 3 & Wound Nurse (WN ) 2, Pt 4’s Electronic Medical Record (EMR) for the entire hospital encounter dated 2/6/25 was reviewed. The review of wound nurse note on 2/7/25 at 11:42 a.m. indicated “Recommended nursing staff to change the pouch every 3-5 days “. WN 2 stated the hospital standard of care was to change colostomy bag every 3-5 days for all patients with colostomy bags in place. WN 2 stated “ you can see stoma but cannot see peristomal [area around stoma] skin without removing the colostomy bag”. WN 2 stated on certain patients that have fragile skin wound nurses may leave that colostomy bag in place for extended time. WN 2 stated Pt 4’s skin was very fragile and was going to tear therefore it was not changed, however, the documentation was missing. WN 2 stated nurses should have documented the plan, discussed it the physician and received an order to leave the bag in place without changing for extended period of time against the standard of care. WN stated failure to assess skin around stoma site can lead to deterioration, infection, pain and other issues for the patients. WN stated that policy does not specify time frame for changing colostomy bag but it was hospital standard of care to change it every three to five days. During a review of professional reference titled, “ Colostomy Care”, retrieived from https://www.ncbi.nlm.nih.gov/books/NBK560503/, dated May 28, 2023, the professional reference indicated “ ...Colostomy care, as the name suggests, is an all-encompassing term referring to colostomy management, from its creation to peristomal skin management, to colostomy appliance application and mental health management while dealing with a colostomy. The purpose of colostomy care is for skin protection and care for patient acceptance and to prevent stoma related complications ... Moderately severe complaints include pain and skin excoriation around the stomal site ... The colostomy appliance should be changed every 5-7 days, depending on the appliance. Patients generally do this themselves or with the help of the primary caregiver, or parent in case of children. Any case of skin breakdown or skin irritation or difference in stomal appearance should be seen by a health worker ...” 7. During a review of Pt 9’s “History and Physical (H&P- a complete patient assessment by the physician),” dated 3/18/25, the H&P indicated Pt 9 was recently diagnosed with colon cancer (a type of cancer that develops in the large intestine (colon) and rectum) and was admitted to the hospital for a robotic low anterior resection of rectosigmoid colon (a minimally invasive surgical procedure, using a robotic system, to remove a cancerous portion of the rectum and reconnect the remaining colon) and a loop ileostomy (where a loop of small intestine is pulled out through a cut (incision) in your abdomen, before being opened up and stitched to the skin to form a stoma). Pt 9 had a past medical history of hypertension (high blood pressure), diabetes mellitus (a disorder characterized by difficulty in blood sugar control and poor wound healing), and coronary artery disease (a common type of heart disease). During a concurrent interview and record review on 3/28/25 at 1:55 p.m. with Assistant Manager (ANM) 2, Pt 9’s “Aldrete Flowsheet (AS),” dated 3/21/25 was reviewed. The “AS” indicated Pt 9 had an Aldrete assessment completed at 1:50 p.m. with a score of 8 and no other Aldrete assessment was completed. ANM 2 stated, “I only see the one [Aldrete score documentation].” ANM 2 stated the Aldrete assessment was discontinued when the Aldrete score was 10. ANM 2 stated an Aldrete assessment was important to show the progression of the patient’s status as she recovered from anesthesia. ANM 2 stated missed Aldrete assessments could miss a delay in the patient’s recovery. During an interview on 4/4/25 at 9:45 a.m. with the Director of Peri-Operative (DPO), the DPO stated he expected nurses to complete an Aldrete assessment upon arrival to the PACU, prior to discharge when the patient meets criteria for discharge, and when there is a change in between. The DPO stated he expected nurses to follow the policy because it was there to keep the patient safe. During an interview on 4/4/25 at 5:10 p.m. with the Chief Nurse Executive (CNE), the CNE stated she expected nurses to follow the policy. During a review of the hospital’s P&P titled, “Transfer From PACU,” dated 1/16/25, the P&P indicated, “ ... PURPOSE: A. To provide directions in determining a patient’s readiness to be transferred from Phase I [the initial recovery period after surgery, where patients are closely monitored and supported as they emerge from anesthesia (the use of medicines to prevent pain during surgery and other procedures)] PACU to another patient care unit after the administration of a general anesthesia [brings on a sleep-like state with the use of a combination of medicines], regional anesthesia [numbs a specific part of the body] or monitored anesthesia [a type of light anesthesia used for minor procedures]. B. To define the physiological criteria that must be met for safe transfer from PACU Phase I. Transfer criteria, inclusive of a post anesthesia recovery score system (Aldrete) will be used by the Post Anesthesia Care RN [registered nurse] to assess patient’s readiness for transfer from PACU ... DEFINITIONS: ... Aldrete Post - Anesthesia Recovery Score (with O2 saturation [The percentage of hemoglobin in your blood that is carrying oxygen, and a normal reading is typically between 95% and 100%): a medical scoring system for the measurement of recovery after anesthesia (post anesthesia) which includes activity, respiration, circulation, consciousness, and O2 saturation ... PROCEDURE: ... TRANSFER REQUIREMENTS: 1. Aldrete Post-Anesthesia Recovery Scoring System (PAS) will be used by the PACU RN to assess patient readiness for transfer from Phase I ... Aldrete assessment scores will be documented on the PACU record upon admission, and when there is a change in the score, and upon discharge ... Patient’s temperature is taken upon arrival in the PACU and upon transfer ...” 8. During a review of Pt 9’s “H&P,” dated 3/18/25, the H&P indicated Pt 9 was recently diagnosed with colon cancer and was admitted to the hospital for a robotic low anterior resection of rectosigmoid colon and a loop ileostomy. Pt 9 had a past medical history of hypertension, diabetes mellitus, and coronary artery disease. During a concurrent interview and record review on 3/28/25 at 1:55 p.m. with Assistant Manager (ANM) 2, Pt 9’s “Vital Signs Flowsheet (VSF),” dated 3/21/25 was reviewed. The VSF indicated Pt 9 had a temperature of 97.5 degrees Fahrenheit (F-measure of temperature; normal range of 97 degrees F to 99 degrees F) at 1:50 p.m. and no other temperature was checked while Pt 9 was in the PACU. AMN 2 stated, a temperature should be checked when the patient entered PACU and rechecked before the patient was transferred to an inpatient unit. During an interview on 4/4/25 at 9:45 a.m. with the DPO, the DPO stated a temperature was assessed when the patient arrived in the PACU to assess for hypothermia. The DPO stated he expected nurses to follow the policy. During an interview on 4/4/25 at 5:10 p.m. with the CNE, the CNE stated she expected nurses to assess and document a temperature prior to discharge from the PACU. The CNE stated she expected nurses to follow the policy. During a review of the hospital’s P&P titled, “Transfer From PACU,” dated 1/16/25, the P&P indicated, “ ... PURPOSE: A. To provide directions in determining a patient’s readiness to be transferred from Phase I [the initial recovery period after surgery, where patients are closely monitored and supported as they emerge from anesthesia (the use of medicines to prevent pain during surgery and other procedures)] PACU to another patient care unit after the administration of a general anesthesia [brings on a sleep-like state with the use of a combination of medicines], regional anesthesia [numbs a specific part of the body] or monitored anesthesia [a type of light anesthesia used for minor procedures]. B. To define the physiological criteria that must be met for safe transfer from PACU Phase I. Transfer criteria, inclusive of a post anesthesia recovery score system (Aldrete) will be used by the Post Anesthesia Care RN [registered nurse] to assess patient’s readiness for transfer from PACU ... PROCEDURE: ... TRANSFER REQUIREMENTS: ... Patient’s temperature is taken upon arrival in the PACU and upon transfer ...” 9. During a review of Pt 9’s “H&P,” dated 3/18/25, the H&P indicated Pt 9 was recently diagnosed with colon cancer and was admitted to the hospital for a robotic low anterior resection of rectosigmoid colon and a loop ileostomy. Pt 9 had a past medical history of hypertension, diabetes mellitus, and coronary artery disease. During a concurrent interview and record review on 3/27/25 at 1:55 p.m. with Nurse Manager (NM) 4, Pt 9’s “ADT Events,” dated 2/31/25, and “Basic Assessment Flowsheet (BAF),” dated 3/21/25 were reviewed. The “ADT Events” indicated Pt 9 was transferred from the PACU to an inpatient room at 5:02 p.m. The “BAF” indicated Pt 9 had a full head to toe assessment completed at 1:50 p.m. and 7:45 p.m. NM 4 stated Pt 9 had a full head to toe assessment completed after a shift change. During an interview on 4/3/25 at 11:07 a.m. with NE 1, NE 1 stated a complete head to toe assessment should be completed when the patient is admitted to the unit to assess for any changes in condition from previous assessment. During a concurrent interview and record review on 4/4/25 at 11:10 a.m. with the Director of Medical Surgical Services (DMS), the hospital’s P&P titled “Assessment: Admission and Reassessment,” dated 1/10/19, the P&P indicated, “ ... PURPOSE: A. To give guidance and direction to patient care providers with patient assessment, reassessment and plan of care development. POLICY: ... INITIAL ASSESSMENT: 1. Pertinent systems assessments are completed upon admission and according to unit standards thereafter ... Review of pertinent systems, including skin assessment ... REASSESSMENTS: 1. Patients will be reassessed at least every shift and when there is a change in diagnosis, a change in condition or behavior, or to determine the patient’s response to treatment, and when the patient is transferred from on unit to another ... Reassessment will be utilized to determine a patient’s response to care ... DELEGATION OF ASSESSMENT COMPONENTS ... It is the responsibility of the admitting RN to complete the Physiological Assessment and to review the patient’s history. The Admission screening and assessment is to be completed within 8 hours for all general nursing units, four hours for Telemetry patients ...” The DMS stated the policy was contradicting on when a complete head to toe should be completed. The DMS stated she expected nurses to complete and document an initial assessment when the patient arrived in the unit. During an interview on 4/4/25 at 5:10 p.m. with the CNE, the CNE stated there was an opportunity to clarify the policy on head-to-toe assessment. The CNE stated the policy did indicate it should be completed when the patient is transferred to another unit and a time frame based on the area of service. 10. During a review of Pt 9’s “H&P,” dated 3/18/25, the H&P indicated Pt 9 was recently diagnosed with colon cancer and was admitted to the hospital for a robotic low anterior resection of rectosigmoid colon and a loop ileostomy. Pt 9 had a past medical history of hypertension, diabetes mellitus, and coronary artery disease. During a concurrent interview and record review on 3/27/25 at 1:55 p.m. with Nurse Manager (NM) 4, Pt 9’s “Orders,” dated 3/21/25, “Vital Signs Flowsheet (VSF),” dated 3/23/25 to 3/24/25, “Communication Flowsheet (CF),” dated 3/23/25 to 3/24/25, and “Notes,” dated 3/23/25 to 3/24/25 were reviewed. The “Orders” indicated, “ ... NOTIFY PROVIDER FOR VITAL SIGN PARAMETERS ... Systolic blood pressure greater than: 160 ...” The “VSF” on 3/23/25 at 3:32 a.m. indicated Pt 9 had a blood pressure of 169/81 (BP-the force of your blood pushing against your artery walls, measured as two numbers: systolic (when your heart beats) and diastolic (when your heart rests); normal reading 120/80). NM 4 reviewed Pt 9’s “CF” dated 3/23/25 and stated there was no physician notification of Pt 9’s SBP above 160. NM 4 reviewed the nursing notes dated 3/23/25 and stated there were no physician notifications of Pt 9’s SBP above 160. The “VSF” on 3/24/25 at 7 a.m. indicated Pt 9 had a BP of 173/81. NM 4 reviewed Pt 9’s “CF” dated 3/24/25 and stated there was no physician notification of Pt 9’s SBP above 160. NM 4 reviewed the nursing notes dated 3/24/25 and stated there were no physician notifications of Pt 9’s SBP above 160. NM 4 stated nurses should reassess the BP to make sure it was resolved, especially if it was related to pain. NM 4 stated nurses should notify the physician to get the physician’s input on the care of plan and to see if additional treatment was warranted. NM 4 stated the physician should be notified if the patient was not meeting the vital sign parameters. During a review of Pt 13’s “H&P,” dated 3/23/25, the “H&P” indicated, Pt 13 was admitted to the hospital for a left femur (thigh bone) fracture (a break or crack in a bone). The “H&P” indicated Pt 13 had a past medical history of diabetes mellitus and hypertension. During a concurrent interview and record review on 3/28/25 at 9:30 a.m. with NM 4, Pt 13’s “Orders,” dated 3/23/25, “VSF,” dated 3/23/25 to 3/26/25, “CF,” dated 3/23/25 to 3/26/25, and “Notes,” dated 3/23/25 to 3/26/25 were reviewed. The “Orders” indicated, “ ... NOTIFY PROVIDER FOR VITAL SIGN PARAMETERS ... Systolic blood pressure greater than: 160 ...” The “VSF” on 3/23/25 indicated Pt 13 had a BP of 176/80 at 7:36 p.m. and a BP of 165/72 at 10:21 p.m. The “VSF” on 3/24/25 indicated Pt 13 had a BP of 163/73 at 8:07 a.m. The “VSF” on 3/25/25 indicated Pt 13 had a BP of 170/74 at 7:17 a.m., 165/88 at 8 a.m., 178/80 at 9 a.m., 166/63 at 11:06 a.m., and 169/69 at 7 p.m. The “VSF” on 3/26/25 indicated Pt 13 had a BP of 165/74 at 7:12 a.m. and 162/71 at 10:47 a.m. NM 4 reviewed Pt 9’s “CF” dated 3/23/25 to 3/26/25 and stated there were no physician notification of Pt 13’s SBP above 160. NM 4 reviewed the nursing notes dated 3/23/25 to 3/26/25 and stated there were no physician notifications of Pt 13’s elevated SBP above 160. NM 4 stated Pt 13 received medications for the hypertension. NM 4 stated the physician should have been notified if the treatment was not effective in lowering Pt 13’s BP. During an interview on 4/4/25 at 11:10 a.m. with the DMS, the DMS stated nurses are expected to follow the physician order. The DMS stated the physician should have been notified for elevated blood pressures and document the notification to the physician. During an interview on 4/4/25 at 5:10 p.m. with the CNE, the CNE stated she expected nurses to follow the physician order. During a review of the hospital’s document of Registered Nurse job description, dated 3/27/25, the document indicated, “ ... Job Profile Name: Registered Nurse II ... Job Profile Summary ... Fosters and maintains collaborative relationships between patients, their family/support group, physicians, and other healthcare providers through timely and effective communications ... Job Description ... ASSESSMENT AND PLANNING OF PATIENT CARE: ... Collaborates and communicates with physicians and other members of the healthcare team to interpret, adjust, and coordinate daily patient care plan to ensure a plan of care that is patient centric with continuity of care ...” 11. During a review of Pt 7’s “H&P,” dated 3/17/25, the “H&P” indicated Pt 13 was admitted to the hospital for an abdominal hysterectomy due to abdominal pressure. The “H&P” indicated Pt 7 had a past medical history of chronic kidney disease (a gradual loss of kidney function over time), hyperlipidemia (an excess of lipids or fats in your blood), gastroesophageal reflux disease (GERD-a condition in which stomach acid repeatedly flows back up into the tube connecting the mouth and stomach, called the esophagus) and obstructive sleep apnea (intermittent airflow blockage during sleep). During a concurrent interview and record review on 3/26/25 at 2:47 p.m. with Nurse Educator (NE) 1, Pt 7’s “WALDO” flowsheet, dated 3/24/25 to 3/25/25, and “Integumentary Flowsheet (IF),” dated 3/24/25 to 3/25/25 were reviewed. The “WALDO” indicated Pt 13’s closed incision to the abdomen was assessed on 3/24/25 at 7:54 p.m. and 3/25/25 at 8 p.m. NE 1 stated Pt 13’s closed incision to the abdomen was not assessed during the day shift on 3/25/25. The “IF” dated 3/25/25 at 7:45 a.m. indicated there was no assessment completed for Pt 13’s closed incision to the abdomen. NE 1 it was important to assess and document the incision site to determine what it looked like and if there was any drainage. NE 1 stated an incision assessment was important to make sure the site was not infected and a change in the site’s condition could be missed if not assessed. During a review of Pt 10’s “H&P,” dated 1/28/25, the “H&P” indicated Pt 10 was admitted to the hospital for suspected pituitary macroadenoma (a large pituitary (secretes hormones which carry messages around the body via the bloodstream) tumor) and scheduled for a transnasal transsphenoidal pituitary resection (a surgical procedure used to remove tumors from the pituitary gland). The “H&P” indicated Pt 10 had a past medical history of hypertension, hyperlipidemia, and GERD. During a concurrent interview and record review on 3/27/25 at 3:05 p.m. with NM 4, Pt 10’s “WALDO” flowsheet, dated 3/20/25 to 3/24/25, and “IF,” dated 3/20/25 to 3/24/25 were reviewed. The “WALDO” indicated Pt 13’s closed incision to the right lower abdomen was assessed on 3/20/25 at 8 a.m. and 11 a.m., 3/21/25 at 12 p.m., 3/22/25 at 8:23 a.m., 3/23/25 at 7:11 a.m. and 5 p.m., and 3/24/25 at 7 a.m. NM 4 stated there were no night shift assessments completed on 3/20/25 to 3/23/35. NM 4 reviewed Pt 13’s “IF” from 3/20/25 to 3/23/25 and stated the incision was not assessed and documented on the “IF.” During an interview on 4/3/25 at 11:07 a.m. with NE 1, NE 1 stated nurses are expected to assess a patient’s incision at least once a shift and document the assessment. NE 1 stated an incision was part of a skin assessment. NE 1 stated it was important to assess a patient’s incision to make sure it was healing and there were no infections. During an interview on 4/4/25 at 11:10 a.m. with the DMS, the DMS stated she expected nurses to assess a patient’s incision since it was part of the skin assessment. The DMS stated if the skin assessment was not “within normal limits,” it should be documented on the WALDO flowsheet. During an interview on 4/4/25 at 5:10 p.m. with the CNE, the CNE stated she expected nurses to assess and document a patient’s incision as part of their daily shift assessment. During a review of the hospital’s document, untitled, undated, the document indicated, “ ... Wound assessment provides the baseline for planning and evaluating the wound care plan. It is central to good wound management and should be an integral part of wound care practice ... Evaluating the wound’s status provides an ongoing assessment of wound healing and aids in determining wound treatments ... Routine ...wound assessment helps to determine whether any signs of infection are present that may require further intervention ... Comparing the current ...wound assessment to previous assessments helps determine the patient’s progress toward healing. 12. During a review of Pt 2’s “H&P,” dated 1/27/25, the “H&P” indicated, “ ... [Pt 2] is a 78 year old female with [past medical history] significant for developmental delay, CVA [cerebrovascular accident-stroke] with residual aphasia [language difficulties that some individuals continue to experience], COPD [chronic obstructive pulmonary disease-a common lung disease causing restricted airflow and breathing problems], CHF [congestive heart failure-a condition where the heart is unable to pump blood effectively], DM [diabetes mellitus-a disorder characterized by difficulty in blood sugar control and poor wound healing], CKD [chronic kidney disease], chronically bed bound, presenting from home by ambulance with chief complaint of worsening SOB [shortness of breath-difficulty breathing]. Patients’ family reporting several day [history] of URI [upper respiratory infection] like symptoms with worsening dyspnea [a sensation of running out of the air and of not being able to breathe fast enough or deeply enough] ... In [emergency department], initial [vital signs] notable for tachypnea [a breathing rate that is higher than normal]. VBG [Venous blood gas-a medical test that measures the acidity and alkalinity of blood, along with levels of oxygen and carbon dioxide, taken from a vein] reveals acute on chronic hypercapnic respiratory failure [when a patient with long-standing respiratory insufficiency (chronic) experiences a sudden deterioration in their respiratory function, resulting in high levels of carbon dioxide in the blood (hypercapnia)]. CXR [chest x-ray] showing [left lower lobe] infiltrate ...” During a concurrent interview and record review on 4/1/25 at 1:25 p.m. with Assistant Manager (ANM) 4, Pt 2’s “Skin History Assessment (SHA),” dated 1/27/25 and “Positioning Flowsheet (RF),” dated 1/28/25 were reviewed. The “SHA” indicated Pt 2 had a wound to the lower back. ANM 4 stated Pt 2 had a wound to her coccyx. The “PF” indicated Pt 2 was not turned on 1/28/25 from 8 a.m. to 8 p.m. ANM 2 stated Pt 2 should have been turned every two hours to prevent her skin from getting worse. ANM 2 stated it was the nurse’s responsibility to ensure the patient was turned and it was documented. ANM 2 stated she expected nurses to turn patients every two hours. During an interview on 4/2/25 at 1:45 p.m. with the Director of Critical Care (DCC), the DCC stated he expected nurses to turn patients every two hours. During a review of the hospital’s P&P titled, “Skin Care: Pressure Related Injury Management,” dated 2/10/24, the P&P indicated, “ ... PURPOSE: A. To provide evidence-based recommendations for the prevention and treatment of Pressure injuries ... PROCEDURE: Apply waffle mattress for pressure prevention, off load heels and turn every 2 hour schedule ...” 13. During a review of Pt 2’s “H&P,” dated 1/27/25, the “H&P” indicated, “ ... [Pt 2] is a 78 year old female with [past medical history] significant for developmental delay, CVA [cerebrovascular accident-stroke] with residual aphasia [language difficulties that some individuals continue to experience], COPD [chronic obstructive pulmonary disease-a common lung disease causing restricted airflow and breathing problems], CHF [congestive heart failure-a condition where the heart is unable to pump blood effectively], DM [diabetes mellitus-a disorder characterized by difficulty in blood sugar control and poor wound healing], CKD [chronic kidney disease], chronically bed bound, presenting from home by ambulance with chief complaint of worsening SOB [shortness of breath-difficulty breathing]. Patients family reporting several day [history] of URI [upper respiratory infection] like symptoms with worsening dyspnea [a sensation of running out of the air and of not being able to breathe fast enough or deeply enough] ... In [emergency department], initial [vital signs] notable for tachypnea [a breathing rate that is higher than normal]. VBG [Venous blood gas-a medical test that measures the acidity and alkalinity of blood, along with levels of oxygen and carbon dioxide, taken from a vein] reveals acute on chronic hypercapnic respiratory failure [when a patient with long-standing respiratory insufficiency (chronic) experiences a sudden deterioration in their respiratory function, resulting in high levels of carbon dioxide in the blood (hypercapnia)]. CXR [chest x-ray] showing [left lower lobe] infiltrate ...”. During a concurrent interview and record review on 4/2/25 at 9:27 a.m. with Nurse Informaticist (NI) 1, Pt 2’s “Emergency Department Patient Care Timeline (EDPCT),” dated 1/26/25 and “Orders,” dated 1/26/25 were reviewed. The “EDPCT” at 6:11 p.m. indicated Pt 2 had admit orders for the Intensive Care Unit (ICU-a specialized hospital department or section that provides intensive medical care and monitoring to patients with life-threatening illnesses or injuries). The “Orders,” at 6:11 pm. indicated “ ... NURSING COMMUNICATION ... What is the nursing communication order: Assess for pain ... Comments: Assess for pain every 4 hours ...” The “EDPCT” indicated Pt 2 had a pain assessment completed at 2:59 p.m. NI 1 stated Pt 2 had one pain assessment completed in the ED at 2:59 p.m. NI 1 stated Pt 2’s pain was not assessed according to the physician order. NI 1 stated it was important for nurses to assess Pt 2’s pain because there was an order and to make sure Pt 2 was comfortable. During an interview on 4/4/25 at 1:32 p.m. with NM 3, NM 3 stated she expected nurses to follow the physician order for pain assessment. During an interview on 4/4/25 at 5:10 p.m. with the CNE, the CNE stated she expected nurses to follow the physician order for pain assessment. 14. During a review of Pt 1’s “Emergency Department Provider Note (EDPN),” dated 12/20/24, the “EDPN” indicated Pt 1 was a 38-year-old female, gravida (the number of times a woman has been pregnant) 2 para (the number of times a woman has given birth) 0, estimated gestational age (how far along the pregnancy is) of 26 weeks. The “EDPN” indicated Pt 1 had a past medical history of HTN, GERD, small bowel obstruction (SBO-occurs when the small intestine is blocked, preventing the normal passage of digestive contents) with a past roux-en-y gastric bypass (a bariatric surgery procedure that reduces stomach size and reroutes the small intestine to help with weight loss and improve related health conditions). The “EDPN” indicated Pt 1 came into the hospital for abdominal pain and vomiting. During a concurrent interview and record review on 4/2/25 at 10:30 a.m. with NI 1, Pt 1’s “EDPCT,” dated 12/20/25 was reviewed. The “EDPCT” indicated Pt 1 arrived in the ED at 1:52 a.m. and was triaged at 2:04 a.m. The “EDPCT” indicated Pt 1 did not have a set of vital signs completed during triage. NI 1 stated Pt 1 did not have a set of vital signs completed during triage and should have had a set of vital signs completed. NI 1 stated it was important to have a complete set of vital signs at triage to assess the patient’s acuity (the severity or complexity of a patient’s medical condition) and if any abnormal vital signs were present. During an interview on 4/4/25 at 1:32 p.m. with NM 3, NM 3 stated she expected nurses to complete a set of vital signs when the patient was triaged. During an interview on 4/4/25 at 5:10 p.m. with the CNE, the CNE stated she expected nurses to complete a set of vital signs when the patient was triaged. During a review of the hospital’s P&P titled, “Triage Policy,” dated 7/16/24, the P&P indicated, “ ... PURPOSE: To ensure proper triage of patients presenting via the lobby to the Emergency Department (ED) ... PROCEDURE: ... Triage Policies and Assessment of Acuity levels: A. Walk in patients who present to the ED will be triaged by the ED Triage Nurse to prioritize their need for medical care. B. Triage consists of a brief assessment called Phase I triage that helps to determine the level of acuity. This will include a history of the present illness/injury, allergies, complete set of vital signs including pain scale ...”. 15. During a concurrent observation and interview with on 3/26/25 at 1:33 p.m. with RN 8, in Pt 28’s room, RN 8 was initiating a blood transfusion for Pt 28. RN 8 primed the NS bag through the blood IV tubing set (a Y-tubing used to administer blood products which contains a filter and allows for saline flushing) then connected the tubing set to Pt 28’s peripheral intravenous line (PIV- a small, short plastic catheter that is placed through the skin into a vein). After performing a double check on the blood unit with another nurse, RN 8 spiked the blood bag and started the blood infusion without clamping the NS tubing. Blood was observed to be backflowing into the NS tubing. RN 8 stated blood should not be backflowing into the NS tubing. RN 8 stated the NS tubing should have been clamped after spiking the blood bag to prevent blood from backflowing. RN 8 stated the blood could become diluted when the NS tubing was not clamped. During an interview on 4/3/25 at 9:27 a.m. with NE 1, NE 1 stated the NS tubing should be clamped to prevent the backflow of blood into the NS bag. NE 1 stated the hospital’s practice was to clamp the NS bag. NE 1 stated when the NS bag was not clamped, it would be difficult to determine which fluid was going into the patient and the blood should be given within a four-hour timeframe. During an interview on 4/4/25 at 11:10 a.m. with the DMS, the DMS stated she expected nurses to clamp the NS tubing before blood administration was started. The DMS stated, “It’s nursing 101.” The DMS stated the NS tubing should be clamped so blood does not flow back up into the NS bag. During an interview on 4/4/25 at 5:10 p.m. with the CNE, the CNE stated she expected nurses to clamp the NS tubing, so the blood infused straight to the patient and not back flow into the NS tubing. During a review of the hospital’s document, untitled, undated, the document indicated, “ ... The content in Clinical Skills is evidence based and intended to be a guide to clinical practice ... PROCEDURE ... Use blood tubing with a 170- to 260-micron filter [a type of filter that removes particles from a liquid or gas based on their size, measured in microns] designed to retain blood clots and particles. Close the roller clamp on the tubing ... Prime the blood tubing ... Y-tubing: Prime the tubing and micron filter by spiking a bag of 0.9% sodium chloride solution with one tail of the Y-tubing. Spike the blood bag with the second tail of the Y-tubing. Ensure that the drip chamber is half full and that the filter is covered with 0.9% sodium chloride solution ... Connect the primed blood tubing to the IV catheter ... Open the roller clamp on the blood tubing and gently squeeze the filter to help start the flow ...”.”

“INFECTION CONTROL SURVEILLANCE, PREVENTION CFR(s): The infection prevention and control program includes surveillance, prevention, and control of HAIs, including maintaining a clean and sanitary environment to avoid sources and transmission of infection, and addresses any infection control issues identified by public health authorities; and This Standard is not met as evidenced by: 49884 Based on observations, interviews and record review, the hospital failed to maintain a clean and sanitary environment in accordance with hospital policy and procedures, CDC, and clinical standards of practice for infection control when: 1.The Respiratory supply room in the Emergency Department had a box of corrugated tubing used for airway devices stored with corrugated tubing hanging out and was touching the supply room floor. The Third-Floor Operating Room Department’s clean and sterile supply room had one package of sutures (surgical needle attached to a thread) on the floor. The Gastrointestinal (GI) Department’s hallway clean supply room had two surgical filters on the floor, contrary to infection control standards of practice. 2.Expired [Brand name] nasal cannula were stored throughout the hospital with the intent to use on patients needing nasal cannula support in the hospital. 3.Emergency Department staff failed to ensure humidity and temperature was monitored daily in the sterile supplies’ storage area when the log in the emergency room for sterile supplies storage area was not completed with temperature and humidity reading on 3/1/25 and 3/23/25. 4.Two of two sharps containers (containers used for the safe disposal of needles and other sharp medical instruments) in the Nuclear Medicine (radioactive substances for medical imaging) Department’s Hot Lab (special room where radioactive materials, are prepared, stored, and delivered), were overfilled past the fill line marked on the side of the container, or out of the top of the container, contrary to the hospital’s policy and procedure (P&P) titled, “Sharps”, and “Nuclear Medicine: Radioactive Decay and Disposal of Radioactive Waste”. 5.One opened and used 10 milliliter (mL a measurement of volume) vial (container) of 0.9 % Normal Saline (0.9%NS-common hydration and electrolyte replacement), and one used 12 mL 0.9% NS intravenous (IV-into the vein) flush (push liquid) syringe (a tube with a nozzle and a piston for pushing liquid) with 6 mL of fluid remaining in the syringe, was observed on the counter of the Nuclear Medicine Unit’s Hot Lab, contrary to the Center for Disease Control (CDC). As a result of these failures, all patients and staff were at risk for transmission of infections (an infectious agent is transferred from a reservoir to a susceptible host) and cross contamination (the process by which bacteria or other microorganisms are unintentionally transferred from one substance or object to another, with harmful effect) and increased the potential for hospital acquired infections. Findings: 1. During a concurrent observations and interview on 3/25/25 at 2:52 p.m. with the director of critical care & respiratory care (DCC) and Respiratory Therapist (RT) 1 in the clean Respiratory Supply room across from “D- Pod” in the emergency department (ED) noticed box of corrugated tubing with tubing hanging out and touching the floor. The DCC stated the corrugated tubing was used by the RTs for trach (a tube-like structure that connects the larynx (voice box) to the lungs) devices, and airway masks. The DCC stated the corrugated tubing should not be touching the floor. The DCC stated this was not acceptable practice to store the tubing on the floor and would lead to infection issues. The DCC stated tubing would now be considered contaminated (the state of containing unwanted or dangerous substances) and he would ensure that team disposes the contaminated tubing. The DCC stated he expected staff to ensure that supplies were not touching the floor in the clean supply rooms. RT 1 also stated he was not able to comment on why the tubing was on the floor. RT 1 stated it was important to keep the tubing off the floor. RT 1 stated contaminated tubing could lead to infection issues as these corrugated tubing gets used with airway devices. During an interview on 3/25/25 at 2:43 p.m. with Registered Nurse (RN) 1 in the third-floor Operating Room (OR) Department’s clean and sterile patient supply room, one package of sutures were observed on the floor. RN 1 stated, the package of sutures should not be on the floor because the floor was contaminated, and the package was also a sharp. RN 1 stated, the contents of the package should be discarded in the sharps container. RN 1discarded the package. During an observation on 3/25/25 at 3:23 p.m. with Nurse Manager (NM) 1 in the Gastrointestinal (GI) Department Hallway supply room, two filters used during patient surgery were observed on the floor. NM 1 stated, the surgical filters should not be on the floor, because the floor was considered dirty. NM 1 stated, the filters should be thrown away. NM 1 discarded the filters. During an interview on 4/4/25 at 5:12 p.m. with the Chief Nursing Executive (CNE), the CNE stated, her expectation was for no clean or sterile patient supplies to be on the floors of the hospital. The CNE stated, by ensuring patient supplies were not on the floor, the hospital could eliminate a potential risk for infection. During an interview on with the Chief Nurse Executive (CNE) on 4/4/25 at 5:45 p.m., the CNE stated she was made aware of the supplies touching the floor in the RT supply room in ED. The CNE stated the supplies touching the floor was not acceptable as it had the potential for cross contamination (the unintentional transfer of harmful bacteria or other contaminants from one surface, or object to another) and impact patient safety. The CNE stated she expected staff to ensure all patient care supplies are stored off the floor at all times. During a review of the professional reference titled, “The role of the surface environment in healthcare-associated infections”, dated August 2013, the professional reference indicated, “ ...Hospital surfaces are frequently contaminated with important healthcare-associated pathogens (bacteria). Contact with the contaminated environment by healthcare personnel is equally as likely as direct contact with a patient to lead to contamination of the healthcare provider’s hands or gloves that may result in patient-to-patient transmission of nosocomial (originating from the hospital) pathogens ...” During a review of the professional reference titled, “Good Storage and Distribution Practices for Medical Products”, (retrieved from https://www.who.int/publications/m/item/trs-1025-annex-7) dated 6/17/20, the professional reference indicated, “ ...Storage and distribution are important activities in the supply chain management of medical products ... Storage areas should be of sufficient capacity to allow orderly storage of the various categories of medical products ... Storage areas should be appropriately designed, constructed, maintained or adapted. They should be kept clean and there should be sufficient space and lighting ... Materials and medical products should be stored off the floor, away from walls and ceilings, protected from direct sunlight and suitably spaced, to permit ventilation, cleaning and inspection ... Materials and medical products should be handled and stored in such a manner as to prevent contamination, mix-ups and cross-contamination ...” During a review of the professional reference titled, “Keeping it Sterile: Fundamentals of Sterile Storage,” (retrieved from https://www.ormanager.com/keeping-it-sterile-fundamentals-of-sterile-storage/) dated 7/20/23, the professional reference indicated, “ ... Using sterile items in surgery is a fundamental practice, not a rudimentary one that can or should be taken for granted. Put simply, using unsterile items can result in a patient infection. If sterile storage conditions are not appropriate, the items can become contaminated. Such contamination may go undetected, rendering items unsafe and unusable. Therefore, healthcare facilities must take action to create an environment that properly protects sterile packages. This includes securing a proper sterile storage environment and developing policies and procedures to help ensure sterile packages are safely stored and handled ... Sterile packages should be handled with care and positioned so they are not crushed, bent, compressed, or punctured. Sterile items should never be stored on floors ...” 2. During a concurrent observation and interview on 3/26/25 at 9:59 a.m. with the DCC, and assistant nurse manager (ANM) 3 in the Intensive Care Unit (ICU - specialized hospital unit that provides advanced medical care to patients with life-threatening illnesses or injuries, requiring constant monitoring and specialized treatment) found supply closet stocked with three [brand name] nasal cannulas with manufacture date of 6/18/20 and two [Brand name] nasal cannulas with manufacture date of 6/28/20. The DCC was unable to locate the expiry date on the individual pack of [Brand name] nasal cannulas. The DCC stated he would have to check with vendor or stock room staff for expiry dates. The DCC stated he was not aware how long these [Brand name] cannulas were ok to use after manufacturer date. During an interview on 3/27/25 at 8:50 a.m. with the Manager Accreditation and Licensure (MAL), the MAL stated she had reviewed the manufacturer’s instructions for [Brand name] nasal cannula and the instructions indicated that [Brand name] cannula was good for three years from the manufacturer date listed on the cannula. The MAL stated all five [Brand name] cannulas stocked in ICU were expired. The MAL stated these cannulas should had been removed from the ICU and should not be used on patients. The MAL stated the hospital supply chain team was working on removing the expired [Brand name] nasal cannulas from rest of the hospital. The MAL stated the hospital staff was not aware that [Brand name] cannulas were good for three years from the manufacturer date and the hospital have the expired cannulas stocked in other parts of the hospital as well. During an interview on 3/28/25 at 11:30 a.m. with the DCC, the DCC stated that he had reviewed the instructions for use for [Brand name] nasal cannulas. The DCC stated the hospital was using the [Brand name] cannula past three years from the manufacturer date and were not aware of the manufacture recommendations. The DCC stated all expired cannulas now have been pulled from all different floors. The DCC stated ICU had eight cannulas that were expired with manufacturer date of year 2020 and would have been used for the next patient needing [Brand name] nasal cannula. The DCC stated the stock room team have been working on creating a list of expired [Brand name] cannulas as they are being pulled from clean supply storage and ready to be used in different parts of the hospital. The DCC stated expired supplies should never be used on patient. The DCC stated the expired items might be unsafe, deteriorate over time and it could possess a risk for infection and patient health issues. During a review of letter by “Food and Drug Administration (FDA - government agency responsible for protecting public health by ensuring the safety, efficacy, and security of human and veterinary drugs, biological products and medical devices), titled to “Company Name”, dated “3/19/20”, indicated “ ... [Brand Name] Nasal Cannula is intended to be used in a hospital/institutional environment .... intended Use /Indications for Use ... the [Brand name] nasal cannula is a 14-day single use nasal cannula interface for use with specified respiratory gas humidifiers to deliver Nasal High Flow (NHF) [a non-invasive respiratory support method that delivers heated and humidified gas with a controlled oxygen concentration through a nasal cannula] therapy to spontaneously breathing adult patients ... Shelf life ... 3 years ...” 3. During a concurrent observation and interview on 3/25/25 at 2:20 p.m. in the ED with the ED Manager (NM 3) and Assistant Nurse Manager (ANM 1) observed more than 10 surgical trays (to hold surgical instruments), containing instruments and supplies, packaged in peel packs (pouches use to keep instruments and tray inside the pouch free from bacteria or other living microorganisms) stored in the trauma room (room primarily used for trauma patients). NM 3 stated the trays were used by the ED physicians or surgeons to do urgent or emergent procedure at bedside. NM 3 stated the storage of surgical trays have been in place for a long time (unable to comment on the exact time) and have been approved by infection prevention team. NM 3 stated the ED staff monitors temperature and humidity of the room with sterile [free from germs and microorganisms] trays storage daily to ensure that it meets the requirements for sterile supplies. During a concurrent interview and record review on 3/25/25 at 2:23 p.m. in the ED with NM 3, the ED “temperature and humidity log” for ED trauma room, for the month of March 2025 was reviewed. The “temperature and humidity log” for the trauma room for the month of March 2025 indicated that log was not filled out for Temperature and Humidity reading for 3/1/25 and 3/23/25. NM 3 stated it was not acceptable and should have been filled out daily. NM 3 stated without appropriate temperate and humidity monitoring the integrity of the sterile trays could not be maintained and the trays should not be kept in the trauma room. NM 3 stated temperature or humidity out of range could potentially lead to infection and may cause harm to the patients. During a concurrent interview and record review on 3/27/25 at 10:45 a.m. with the Sterile Processing Department Manager (SPDM), ED “Temperature and Humidity log” for trauma room was reviewed. The SPDM validated log was missing readings for both temperature and humidity for 3/1/25 and 3/23/25. The SPDM stated she has been working as SPDM for three years. The SPDM stated her team was responsible for cleaning, disinfecting, and sterilizing reusable medical instruments and equipment. The SPDM stated surgical trays with instruments stored in ER were good to use until the package is open, however, it requires temperature and humidity monitoring on daily basis to ensure sterility. The SPDM stated her team does not check on the surgical trays stored in the ED trauma room and the trays were managed by the ED staff. The SPDM stated, temperature and humidity should be monitored in the storage areas for surgical trays on daily basis to ensure sterility of the trays. The SPDM stated she expected the log to be filled out daily with temperature and humidity readings in all storage areas with sterile trays. During a review of professional article, “Curless, M. S., Bow, L., Lentz, T., Trexler, P., & Maragakis, L. L. (2021). Management and Mitigation of Temperature and Humidity Events in the Perioperative Setting. AORN Journal, 114(6), 563-571. https://doi-org.castatelib.idm.oclc.org/10.1002/aorn.13563”, dated, 2021, the article indicated “ ... Temperature or relative humidity variations that fall outside the recommended parameters for the perioperative environment can have serious implications for patient safety and satisfaction as well as business continuity. Some pathogenic microbes can thrive in prolonged elevated humidity. Supplies and equipment in perioperative environments exposed to variations in temperature and humidity may become sources of infection or undergo alterations in function, putting patients at increased risk of harm ...” During a review of professional reference retrieved from https://www.jointcommission.org/standards/standard-faqs/ambulatory/environment-of-care-ec/000001275/, titled “Do we need to monitor the temperature and humidity of the rooms where sterile supplies are stored?”, with the last review date of October 19, 2021, the reference indicate, “ ... ASHRAE Standard 170- 2008 Table 7.1 ventilation requirements for sterile storage in CENTRAL MEDICAL AND SURGICAL SUPPLY areas includes the following ... Positive air pressure relationship to adjacent areas ... Maximum relative humidity 60% ... Temperature range 72 to 78 F or 22 to 26 C ...” During a review of professional reference retrieved from https://www.jointcommission.org/standards/standard-faqs/ambulatory/environment-of-care-ec/000001275/, titled “Temperature and Humidity - Monitoring Requirements”, dated 4/11/16, the reference indicated, “ ... Rooms that are considered critical, like those where invasive procedures are performed or where sterile items are stored, are to be in constant compliance when being used for their intended purpose. Therefore, some reliable strategy is to be implemented to ensure continuous compliance, such as daily readings, real-time indicating devices in the space, alarming through a building automation system, etc. ... Daily monitoring would be acceptable as long as the organization has assessed there to be a reasonable assurance that the snap-shot-in-time selected represents compliant humidity and temperature levels throughout the operational day. Non-continuous, periodically checked conditions are to be logged. All non-compliant conditions are to be documented with corrective actions described. If the room is not in-use and is placed in a non-compliant mode, like for energy conservation, then the room must be validated to be in compliance before a procedure begins; an energy conservation mode must maintain proper relative humidity levels ...” 4. During an observation and interview on 3/26/25 at 10:59 a.m. with the Director of Imaging (DI) and the NMT, the Nuclear Medicine Unit Hot Room counter had one used 10 mL vial of 0.9 % NS, and one used 12 mL NS IV flush on the counter. The 10 mL vial had ¾ of the fluid remaining and the 12 mL NS flush had 6 mL of fluid remaining. The NMT stated, the fluid in the vial was used to prepare “kits-(define)” for the scans (process for taking images of the interior of a body) preformed in the department. The NMT stated, the vials were a onetime use vial and should have been thrown away after preparation of the “kit” for the scan. The NMT stated, if the vial were counter and used for another patient the staff would not know if there were germs on the stopper (plug top) of the vial. The NMT stated, a NS flush was a one-time use, because the flush was used directly on the patient, to push fluids into the IV line (soft flexible tube inserted into a vein, to deliver fluids, medications, or blood products). The DI stated, the vial and the flush should have been discarded after use. During an interview on 4/2/25 at 12 p.m. with the Infection Prevention Manager (IPM) the IPM stated, the vial used for reconstituting medication and/or scan contrast (define) should be discarded after medication reconstitution. The IPM stated, if the NS flush was used for a previous case (scan or procedure), it should not have been left behind. The IPM stated, the NS flush should have been discarded after use. The IPM stated, the risk for infection by not discarding the NS flush could be, using on the same flush on another patient, or contaminating another surface. The IPM stated, by not discarding the vial of NS, there was a risk of reusing the single-use vial on another patient. During a review of a professional reference titled, “Preventing Unsafe Injection Practices,” dated 3/24/24 (retrieved from https://www.cdc.gov/injection-safety/hcp/clinical-safety/index.html), the professional reference indicated, “ ... Safe injection practices are every provider’s responsibility. A safe injection does not harm the person, expose the provider to risks or result in hazardous waste for the community. Improper use and disposal of syringes, needles, and medications imposes risks on patients and healthcare providers. ...Unsafe injection practices may result in serious consequences like: ...Transmission of bloodborne pathogens ...Outbreaks of bacterial or fungal infections. ...Safe injection practices include one-time use of needles and syringes and limiting the sharing of medication vials. ... Recommendations ...The following safe injection practices are critical for patient safety: ...Use a new sterile syringe and needle for each patient. Once used, the syringe and needle are both contaminated and must be discarded. ...Do not administer medications from the same syringe to more than one patient ...Never use medications intended for single use for more than one patient. This includes single-dose vials. ...A single-dose vial of liquid medication intended for injection or infusion is only approved for use in a single patient for a single case, procedure or injection. ...”. 5. During a concurrent observation and interview on 3/26/25 at 11:10 a.m. with the Director of Imaging (DI) and the NMT in the Nuclear Medicine Department’s Hot Lab, two of two sharps’ containers were observed on a counter through a window behind a metal shield, overfilled past the fill line. The sharps container on the left side of the counter had sharps filled to approximately one inch (in- a unit of length measurement) below the entry hole in the top. The sharps container on the right side was inside a metal box with a hole cut in the top, there were three used syringes visible coming out of the entry hole to the box. The NMT stated the large metal shield was called an L Block and was made of lead to protect against radioactive material, when preparing the “kit” (a sterile, non-radioactive mixture of substances to add to radioactive) doses. The NMT stated, the sharps container on the right was inside a lead box because the sharps inside were considered “hot [something with high levels of radioactivity]”, due to the previous contact with radioactive material. The NMT stated, the containers should be emptied when they got “full” then close the lid. The NMT stated, the sharps from the department were held in the Hot Lab in a lead cabinet due to radiation. The DI stated, the sharps container should not be more than ¾ full, and the NMT should contact the manager whenever the sharps got to the fill line for a new container. The NMT stated, the sharps container should not be full because the staff could get poked. During an interview on 11:55 a.m. with the IPM, the IPM stated sharps should not exceed the fill line. The IPM stated, overfilled sharps container increases the risk for a sharps injury. The IPM stated, “Hot” sharps should be all the way through the hole on the top under the lead shield. During a review of the hospital’s P&P titled, “Sharps,” dated 7/20/22, indicated, “ ...To establish a standard for the safe handling, transport and disposal of needles, syringes and other medical sharps. To reduce/sand or eliminate accidental punctures from these devices. ...Sharps containers are to be closed and removed when ¾ full ...If there is some condition which presents a sharps hazard through the container has not yet reached the designated level, the container should be closed and removed. ...You should visually confirm it has dropped completely into the container and do not insert finger near the opening ...”. During a review of the hospital’s P&P titled, “Nuclear Medicine: Radioactive Decay and Disposal of Radioactive Waste,” dated 8/22/23, indicated, “ ...To ensure safe storage and disposal of radioactive materials/supplies received/utilized in the Nuclear Medicine Department. ...Liquid and solid wastes greater than the background will be held for decay until radiation levels, as measures with a low-level survey meter and with all shielding removed, has reached levels not statistically significant as compared with background levels. ...decaying radioactive wastes are stored in the Radiopharmacy Hot Lab, in shielded containers/cabinets ...”. During a review of professional reference titled, “Sharps Safety Guidelines,” dated 12/26/22, (found at https://www.infectioncontroltoday.com/view/sharps-safety-guidelines) the professional reference indicated, “ ... Punctures and cuts can introduce bloodborne pathogens into the body, such as hepatitis B virus (HPV), hepatitis C virus (HCV), and human immunodeficiency virus (HIV) ... Most sharps-related injuries can be prevented and occur during or immediately after use it is important to understand safe sharps waste disposal ...Containers should also be marked with a line to indicate when the container is three-fourths full. Once the container reaches that point, do not place any more sharps in the container-this line is to prevent injuries. One of the leading causes of sharps injuries is overfilled containers. Never force items into the sharps container...”.”

“RADIOACTIVE MATERIALS STORAGE & DISPOSAL CFR(s): 482.53(b), (b)(2) Radioactive materials must be prepared, labeled, used, transported, stored, and disposed of in accordance with acceptable standards of practice. §482.53(b)(2) There is proper storage and disposal of radioactive material. This Standard is not met as evidenced by: 49884 Based on observation, interview and record review, the hospital failed to transport and use radioactive materials in accordance with professional standards of practice and hospital policy and procedure when Lead Nuclear Medicine Technologist (LMNT) 1 transported radioactive material meant for Patient (Pt) 6 to the wrong floor and wrong room in the hospital and administered the radioactive material to Pt 5 without first verifying the correct patient. LMNT 1 administered via injection 3 milliliters of radioisotope tagged white blood cells belonging to Pt 6 into Pt 5’s vein and did not follow hospital P&Ps titled, “Nuclear Medicine: Radiopharmaceutical Preparation, Labeling, and Administration”, and “Identification: Patient Armband/Patient Verification” and standards of practice for medication administration. These failures had the potential to infect Pt 5 with a bloodborne pathogen (disease causing germs found in human blood) from Pt 6’s blood, causing illness because Pt 6 was diagnosed with osteomyelitis (bone infection caused by bacteria) at the time of the incident. This failure also had the potential for Pt 5 to have a reaction to the blood product injected, leading to fever, chills, hives (raised itchy bumps on the skin), difficulty breathing, requiring a longer hospital stay. Findings: During an observation and interview on 3/26/25 at 10:46 a.m. in the Nuclear Medicine (Nuc Med) Department, with Nuclear Medicine Technologist (NMT) 1, the metal boxes used to carry the radioisotope tagged WBCs to the patient’s bedside were observed in the Hot Lab (special room to deliver, store and prepare radioactive materials). NMT 1 stated the metal boxes were made of lead and were called “pigs”. NMT 1 stated, the process for preparing a patient for a Nuclear Medicine scan (uses small amounts of radioactive material, called radiotracers, to create images of the inside of the body) with tagged WBCs, began when a Nuclear Medicine Technologist (NMT) received the order from a physician. NMT 1 stated, a NMT would draw a sample of the patient’s blood and apply a Nuc Med Department wrist band. NMT 1 stated, the band had numbers on it matching the blood sample labels. NMT 1 stated, the blood was then sent to the Radiopharmacy (pharmacy for radioactive materials) in another town, where the isotopes were added. NMT 1 stated, the dose was brought back within a few hours. NMT 1 stated, the same NMT who drew the blood would administer the dose. NMT 1 stated, the NMT took the “pig” containing the syringe “kit” (dose of tagged WBCs), and the physician order to the patient’s bedside. NMT 1 stated, the NMTs were supposed to verify patient identity by checking the wrist band placed earlier, and by verifying name, date of birth (DOB). NMT 1 stated, the patient’s “kit” numbers were verified against the wrist band. NMT 1 stated, now the patient’s nurse had to sign off to ensure the correct patient was about to receive the dose. NMT 1 stated, the nurse’s completing the double check started a few months ago. NMT 1 stated, the double check was important to prevent errors, and ensure the correct patient received the dose. NMT 1 stated, an error injecting the wrong patient could harm the patient not due to the isotopes but due to the blood. NMT 1 stated, patients could go into anaphylactic shock (a severe, life-threatening allergic reaction that could cause a rapid decline in blood pressure and difficulty breathing) due to receiving a blood product not the same type as their own. During an interview on 3/26/25 at 11:34 a.m. with the Radiology Safety Officer (RSO), the RSO stated, his role as safety officer was to oversee the radioactive material at the hospital and, to ensure patient and employee safety. The RSO stated, he was a practicing Radioactive Oncology Physician. The RSO stated, he remembered the incident regarding LNMT 1 injecting Pt 5 with Pt 6’s radioisotope tagged WBCs on 12/9/24. The RSO stated, he was involved with the hospital internal investigation. The RSO stated the incident involved two patients, Pt 5 and Pt 6. The RSO stated, Pt 6 had a physician order for an injection of blood with radioactive isotopes for a nuclear radiologic procedure (scan), and Pt 5 did not have an order for a nuclear radiologic procedure. The RSO stated, Pt 5 was injected with Pt 6’s blood by LNMT 1. The RSO stated, when a physician ordered a nuclear scan, a report went to the Nuc Med Department through the Electronic Medical Record (EMR- a digital version of a patient’s medical history, including diagnoses, medications, tests, allergies, immunizations, and treatment plans), and the type of scan the physician ordered required a radioisotope be attached to white blood cells. The RSO stated, LNMT 1 went to Pt 6’s hospital room and drew a vial of blood. The RSO stated, the vial of blood was sent to an offsite Radiopharmacy in a town one- and one-half hours away by the nuclear pharmacy courier (transporter). The RSO stated, the WBCs were tagged at the nuclear pharmacy then returned to the hospital for injection. RSO stated, LNMT 1 took the blood product to the patient’s hospital room and “just didn’t identify patient”, injecting the radioisotope tagged WBCs into Pt 5 instead of Pt 6. The RSO stated, LNMT 1 got off on the wrong floor and went into the same room number. The RSO, stated LNMT 1 identified his error, “right after the administration”. The RSO stated, LNMT 1 reported the error to the nurse, and leadership immediately. The RSO stated, Pt 5’s physician was notified as well as the patient and the family. The RSO stated, LNMT 1 “missed the double check”, and “just didn’t identify patient [did not verify Pt 5’s name and date of birth, against the armband]” The RSO stated, Pt 5 could have been harmed by any infections that were present in the blood infected into her. The RSO stated, the radiation was not an issue, it was given to the wrong patient, but it had a short half-life (the time it takes for one of the atoms in the sample to decay [lose energy] one that decays quickly). During a concurrent interview and record review on 3/28/25 at 9:33 a.m. with Nurse Educator (NE)1, Pt 6’s “History & Physical [H&P- an assessment from physician including medical history and exam],” dated 1/1/25 was reviewed. The “H&P” indicated, Pt 6 was a Portuguese speaking 86-year-old with past medical history (PMH) of Type 2 Diabetes Mellitus (disorder characterized by difficulty in blood sugar control and poor wound healing), and hypertension (high blood pressure), presenting to the emergency department (ED) on 12/29/24 for right foot redness, swelling and pain, as well as generalized weakness. The “H&P” indicated, Pt 6 was admitted to the hospital as an inpatient on 12/31/24 for a diabetic ulcer (open sores on the feet, a serious complication of diabetes), and acute osteomyelitis (a bone infection that develops rapidly). During a concurrent interview and record review on 3/28/25 at 9:40 a.m. with NE 1, Pt 6’s “Provider Progress Note [PPN],” dated 1/2/25 to 1/8/25, “Physician Orders [PO]”, “Medication Physician Orders [MPO], dated 12/30/24 to 1/3/25, and “Medication Administration Record [MAR],” dated 12/31/24 to 1/3/25, were reviewed. The “PO” indicated, on 12/30/24 at 4:50 p.m. an order for a Nuc Med scan was entered. NE 1 stated, the “PO” indicated the scan was performed on 1/3/25 at 11:38 a.m. and read by the physician on 1/4/25. The “MPO” indicated, on 1/2/25 at 11:05 a.m. an order for ... “radioisotope 12millicuire [a unit of radioactivity]” ...Electronically signed by: [LNMT 1] on 1/2/25 at 1105 [11:05 a.m.] ...”. The “MAR” indicated, the radioisotope 12 millicurie was ordered by LNMT 1 on 1/2/25 at 11:05 a.m. but was administered by NMT 1 intravenously on 1/3/25 at 11:38 a.m. The “MAR” had no indication the radioisotope was scanned before administration. During a concurrent interview and record review on 3/28/25 at 9:48 a.m. with Nurse Educator (NE) 1, Pt 5’s “H&P,” dated 12/31/24, was reviewed, The H&P indicated Pt 5 was a Spanish speaking 96 year-old patient brought into the ED on 12/31/25 at 12:45 p.m. by family with complaints of right upper quadrant pain (the area of the stomach located on the right side above the belly button) for two weeks. The “H&P” indicated Pt 5 was admitted as an inpatient on 12/31/24 at 8:50 p.m. for a renal abscess (a pocket of pus that forms within the kidney tissue) and moved to the Medical Surgical (MS) Unit at 11:56 p.m. During a concurrent interview and record review on 3/28/25 at 9:55 a.m. with NE 1 Pt 5’s “Provider Progress Note [PPN],” and “Labs”, dated 1/2/25 to 1/8/25, “Physician Orders [PO]”, “Medication Physician Orders [MPO], dated 12/31/24 to 1/3/25, and “Medication Administration Record [MAR],” dated 12/31/24 to 1/3/25, were reviewed. NE 1 stated, Pt 5’s “PO” and “MPO” had no orders indicating a Nuc Med scan, or any radiopharmaceuticals were ordered for Pt 5. NE 1 stated, Pt 5s “MAR” had no documentation indicating Pt 5 was administered isotope tagged WBCs. NE 1 stated, Pt 5’s “MAR” would not have documentation, because there were no orders for the patient to have radiopharmaceuticals. The “PPN” dated 1/2/25 indicated, “ ...I was informed (01/02/2025) that patient [Pt 5] was (accidentally and erroneously [incorrectly]) injected (by nuclear medicine technologist) another patient’s blood product [Pt 6]. This was communicated to the patient’s sons ... Active Problems: ...Accidental injection of blood products from another patient - This was reported to the patient’s both sons and risks/plans were explained. - Discussed with infection control; source patient [Pt 6] has strep [type of germ] bacteremia [serious infection enters the bloodstream] and Pseudomonas (common bacterial disease-causing organisms) wound infection. -Source patient is being tested for [bloodborne pathogens] ...per Infectious control request. ...Will repeat blood cultures with a.m. labs and follow up ...”. NM 1 stated, multiple labs were drawn, and results were negative for bloodborne pathogens. During an interview on 4/1/25 at 11:42 a.m. with the Director of Imaging (DI), the DI stated, she was a part of the hospital internal investigation of Pt 5 being injected with Pt 6’s radioisotope tagged WBCs. The DI stated LNMT 1 failed to use two patient identifiers prior to injecting the radioisotope tagged WBCs for Pt 6 into Pt 5. The DI stated, her expectation was for LNMT 1 to report the error immediately, which he did. The DI stated, the discovery during the investigation was, LNMT1 got off the elevator on the incorrect floor and entered what would be the same room number if he was on the correct floor. The DI stated, Pt 6 and Pt 5 were located on different floors but were in the same room number, and in the same bed location. The DI stated, LNMT 1did draw the correct patient’s blood (Pt 6), in the morning around 6 a.m. The DI stated, LNMT 1claimed he only “glanced” at Pt 5’s armband, and both patients had similar first names, and both patients were similar in appearance. The DI stated, LNMT 1 did not notice Pt 5 did not have the Nuc Med Department armband applied, and he did not verify the “kit” numbers against the armband, or the patient’s name against the physician’s order. The DI stated, as soon as LNMT 1realized he injected the wrong patient he called the manager, the house supervisor and both patient’s physicians. LNMT 1 stated, Pt 6 needed to be tested for bloodborne pathogens, and be redrawn for the nuclear isotope tagging and rescheduled for the scan, and Pt 5 needed to be monitored for reactions and tested for infections. The DI stated, the incident was reported to the RSO the same day as the event, and there was no concern for harm to Pt 5 due to the radiation dose. The DI stated, Pt 5 receiving Pt 6’s blood was concerning but both patients were tested, and the results were negative for any bloodborne pathogens. The DI stated, the Nuc Med Department had label tracking (to scan) into the Nuclear Medicine Information System (NMIS-software designed to manage patient, department, including inventory, dosing and billing), but there was no barcode scanning to scan the “kit” into the main hospital EMR system. The DI stated the NMT’s document in the patient’s MAR when completing the administration. During a review of hospital document titled, “Labeling Tracking Record [LTR],” dated 1/2/25, the “LTR” indicated, Pt 5 had blood drawn for WBC tagging by LNMT 1 on 1/2/25 at 6:25 a.m. The “LTR” had a checkmark indicating the “Patient name on all labeling stickers”, “Specimen syringe sticker attached to blood specimen container” and “Bracelet attached to patient”. The “LTR” indicated, Pt 5’s blood was received at the Radiopharmacy on 1/2/25 at 8:30 a.m. The “LTR” indicated, a dual verification of the dose was verified, loaded and sealed in the transporting case. The “LTR” indicated, five separate steps for verification of patient name to ensure correct patient prior to sending the dose to the hospital. The “LTR” indicated, the radioisotope tagged WBCs were delivered to the hospital on 1/2/25 at 11:11 a.m. During an interview on 4/1/25 at 2:50 p.m. with the Manager of Accreditation and Licensure (MAL), the MAL stated LNMT 1 was as not available to be interviewed because LNMT 1no longer worked for the hospital. During an interview on 4/2/25 at 1:19 p.m. with the Healthcare Risk Officer (HRO) the HRO stated, Reason the Rad incident was not thought to be reported, and an RCA was not completed was because it didn’t meet criteria. The HRO stated, the hospital completed an Intensive analysis, considered one step above a regular investigation but did not rise to the level of a root cause analysis. During an interview on 4/3/25 at 1:57 p.m. with the DI, the DI stated, the NTs scan the radiopharmaceutical product for the NIMS system at patient’s bedside. The DI stated, during the incident with Pt 5 LNMT 1 had trouble logging into the computer workstation at Pt 5’s bedside so he attempted to use identifiers, then scanned the label when returning to the Nuc Med department. The DI stated, when he scanned the label, he discovered his error. During an interview on 4/4/25 at 5:25 p.m. with the Chief Nursing Executive (CNE), the CNE stated, LNMT 1 should have gone to the patient’s room and verified the patient’s identity, ensuring right patient, right drug, right dose, right route, and right time. The CNE stated the five rights of medication administration should have been followed for this patient to avoid the error. During a review of the hospital’s P&P titled, “Nuclear Medicine: Radiopharmaceutical Preparation, Labeling, and Administration,” dated 6/8/23, indicated, “ ... PURPOSE A. To ensure patient and staff safety during the preparation and administration of radiopharmaceuticals. ...Patient identity shall be verified by comparing patient name and date of birth on identification band with same identifiers on applicable health information documents prior to initiating this policy/procedure ... Maintain adequate shielding throughout the department. Reaction vials are to remain in covered leaded carriers (“pigs”), when not in use. Dose syringes must be in syringe shield or “pig” except when in the dose calibrator. ... Double check vial and syringe labels before injecting. ...Administration ...Establish patient identity before prepping or injecting. Ask patient to state full name (rather than to confirm name) and the date of birth. For inpatients, confirm identification in same manner against identification armband. Nuclear Medicine Technologist will cross-reference patient identification with that printed on NMIS labels and/or registration record. ...Labeling of Blood Products a. On studies that involve invitro tagging of blood cells ... the patient should be carefully identified as above and given a wristband with specific identifiers for the return of the tagged blood cells. b. The same Nuclear Medicine technologist should draw the blood that re- injects the tagged cells. ...Documentation: ...Order radiopharmaceutical in the exam navigator under “orders”, with correct information as to drug, route, and time. ...One eMAR [electronic Medication Administration Record] and NMIS computer system, document patient name, date of birth, and medical record number with radiopharmaceutical, manufacturer and lot number, dose, date and time of administration, date and time of expiration and Nuclear Medicine technologist administering ...”. During a review of the hospital’s P&P titled, “Identification: Patient Armbands/Patient Verification,” dated 2/8/22, indicated, “ ...PURPOSE A. To assure accurate identification of all patients at [name of hospital] B. To assure the two approved patient identifiers are used to match service or treatment to that individual in a manner that prevents wrong patient identity. ...Verification of patient identity by comparing patient name and date of birth on identification band with same identifiers on applicable health information documents will occur prior to initiating this procedure ...Applicable patients will have an identification band on at all times. ... Accurate patient identification will occur whenever administering medications or blood products, taking blood samples and other specimens for clinical testing, or providing any other care, treatments or procedures. 1. Accurate identification MUST occur at the “point of care” any time care/treatment is to be provided. 2. Containers used for blood and other specimens are to be labeled in the presence of the patient. ... Whenever patient care is being managed through Order Entry (OE) or other computerized methods, accurate patient identification will occur by comparing patient’s full name and date of birth on document being entered (physician’s order for example) to patient pulled up in computer application. 1. Using medical record number and/or patient account number can be used to further verify correct patient IN ADDITION to, but not as replacements for, using patient’s full name and date of birth. ... Patients who are hospitalized who are unable to participate in verification at time of admission will have identity verified through reliable family member or friend as soon as possible. The name of the family member or friend verifying identity will be entered into admission history to provide reference that identity was initially verified through this reliable source. This is intended to provide reference to subsequent caregivers that identity has been validated. ... VERIFYING PATIENT IDENTITY: POINT OF CARE VERIFICATION AND INFORMATION DOCUMENT COMPARISON 1. Upon first interaction or at beginning of shift with a conscious patient, verify patient identity by asking the patient to state their full name and date of birth. Compare this to same information on patient’s identification band and same in health information documents (eMAR, physician orders). 2. Upon all subsequent interactions while assigned to patient within same day, verify identity by checking full name and date of birth on identification band and comparing to same information on applicable health information documents (eMAR, physicians orders, lab results or other documents triggering nursing intervention). ...Non-English speaking: Obtain interpreter and follow same guidelines ...”. During a review of a professional reference titled, “Safe Medication Administration: So Many Considerations,” dated July-August 2023, the professional reference indicated, “ ... For decades, the five rights for administering medications have been a recognized safety standard (Martyn et al., 2019). The framework of the seminal five rights (i.e., right patient, drug, dose, time, route) has evolved, and other rights considered as additional influences on medication administration processes have been identified in changing healthcare environments ...”.”

“RADIOACTIVE MATERIALS STORAGE & DISPOSAL CFR(s): 482.53(b), (b)(2) Radioactive materials must be prepared, labeled, used, transported, stored, and disposed of in accordance with acceptable standards of practice. §482.53(b)(2) There is proper storage and disposal of radioactive material. This Standard is not met as evidenced by: 49884 Based on observation, interview and record review, the hospital failed to transport and use radioactive materials in accordance with professional standards of practice and hospital policy and procedure when Lead Nuclear Medicine Technologist (LMNT) 1 transported radioactive material meant for Patient (Pt) 6 to the wrong floor and wrong room in the hospital and administered the radioactive material to Pt 5 without first verifying the correct patient. LMNT 1 administered via injection 3 milliliters of radioisotope tagged white blood cells belonging to Pt 6 into Pt 5’s vein and did not follow hospital P&Ps titled, “Nuclear Medicine: Radiopharmaceutical Preparation, Labeling, and Administration”, and “Identification: Patient Armband/Patient Verification” and standards of practice for medication administration. These failures had the potential to infect Pt 5 with a bloodborne pathogen (disease causing germs found in human blood) from Pt 6’s blood, causing illness because Pt 6 was diagnosed with osteomyelitis (bone infection caused by bacteria) at the time of the incident. This failure also had the potential for Pt 5 to have a reaction to the blood product injected, leading to fever, chills, hives (raised itchy bumps on the skin), difficulty breathing, requiring a longer hospital stay. Findings: During an observation and interview on 3/26/25 at 10:46 a.m. in the Nuclear Medicine (Nuc Med) Department, with Nuclear Medicine Technologist (NMT) 1, the metal boxes used to carry the radioisotope tagged WBCs to the patient’s bedside were observed in the Hot Lab (special room to deliver, store and prepare radioactive materials). NMT 1 stated the metal boxes were made of lead and were called “pigs”. NMT 1 stated, the process for preparing a patient for a Nuclear Medicine scan (uses small amounts of radioactive material, called radiotracers, to create images of the inside of the body) with tagged WBCs, began when a Nuclear Medicine Technologist (NMT) received the order from a physician. NMT 1 stated, a NMT would draw a sample of the patient’s blood and apply a Nuc Med Department wrist band. NMT 1 stated, the band had numbers on it matching the blood sample labels. NMT 1 stated, the blood was then sent to the Radiopharmacy (pharmacy for radioactive materials) in another town, where the isotopes were added. NMT 1 stated, the dose was brought back within a few hours. NMT 1 stated, the same NMT who drew the blood would administer the dose. NMT 1 stated, the NMT took the “pig” containing the syringe “kit” (dose of tagged WBCs), and the physician order to the patient’s bedside. NMT 1 stated, the NMTs were supposed to verify patient identity by checking the wrist band placed earlier, and by verifying name, date of birth (DOB). NMT 1 stated, the patient’s “kit” numbers were verified against the wrist band. NMT 1 stated, now the patient’s nurse had to sign off to ensure the correct patient was about to receive the dose. NMT 1 stated, the nurse’s completing the double check started a few months ago. NMT 1 stated, the double check was important to prevent errors, and ensure the correct patient received the dose. NMT 1 stated, an error injecting the wrong patient could harm the patient not due to the isotopes but due to the blood. NMT 1 stated, patients could go into anaphylactic shock (a severe, life-threatening allergic reaction that could cause a rapid decline in blood pressure and difficulty breathing) due to receiving a blood product not the same type as their own. During an interview on 3/26/25 at 11:34 a.m. with the Radiology Safety Officer (RSO), the RSO stated, his role as safety officer was to oversee the radioactive material at the hospital and, to ensure patient and employee safety. The RSO stated, he was a practicing Radioactive Oncology Physician. The RSO stated, he remembered the incident regarding LNMT 1 injecting Pt 5 with Pt 6’s radioisotope tagged WBCs on 12/9/24. The RSO stated, he was involved with the hospital internal investigation. The RSO stated the incident involved two patients, Pt 5 and Pt 6. The RSO stated, Pt 6 had a physician order for an injection of blood with radioactive isotopes for a nuclear radiologic procedure (scan), and Pt 5 did not have an order for a nuclear radiologic procedure. The RSO stated, Pt 5 was injected with Pt 6’s blood by LNMT 1. The RSO stated, when a physician ordered a nuclear scan, a report went to the Nuc Med Department through the Electronic Medical Record (EMR- a digital version of a patient’s medical history, including diagnoses, medications, tests, allergies, immunizations, and treatment plans), and the type of scan the physician ordered required a radioisotope be attached to white blood cells. The RSO stated, LNMT 1 went to Pt 6’s hospital room and drew a vial of blood. The RSO stated, the vial of blood was sent to an offsite Radiopharmacy in a town one- and one-half hours away by the nuclear pharmacy courier (transporter). The RSO stated, the WBCs were tagged at the nuclear pharmacy then returned to the hospital for injection. RSO stated, LNMT 1 took the blood product to the patient’s hospital room and “just didn’t identify patient”, injecting the radioisotope tagged WBCs into Pt 5 instead of Pt 6. The RSO stated, LNMT 1 got off on the wrong floor and went into the same room number. The RSO, stated LNMT 1 identified his error, “right after the administration”. The RSO stated, LNMT 1 reported the error to the nurse, and leadership immediately. The RSO stated, Pt 5’s physician was notified as well as the patient and the family. The RSO stated, LNMT 1 “missed the double check”, and “just didn’t identify patient [did not verify Pt 5’s name and date of birth, against the armband]” The RSO stated, Pt 5 could have been harmed by any infections that were present in the blood infected into her. The RSO stated, the radiation was not an issue, it was given to the wrong patient, but it had a short half-life (the time it takes for one of the atoms in the sample to decay [lose energy] one that decays quickly). During a concurrent interview and record review on 3/28/25 at 9:33 a.m. with Nurse Educator (NE)1, Pt 6’s “History & Physical [H&P- an assessment from physician including medical history and exam],” dated 1/1/25 was reviewed. The “H&P” indicated, Pt 6 was a Portuguese speaking 86-year-old with past medical history (PMH) of Type 2 Diabetes Mellitus (disorder characterized by difficulty in blood sugar control and poor wound healing), and hypertension (high blood pressure), presenting to the emergency department (ED) on 12/29/24 for right foot redness, swelling and pain, as well as generalized weakness. The “H&P” indicated, Pt 6 was admitted to the hospital as an inpatient on 12/31/24 for a diabetic ulcer (open sores on the feet, a serious complication of diabetes), and acute osteomyelitis (a bone infection that develops rapidly). During a concurrent interview and record review on 3/28/25 at 9:40 a.m. with NE 1, Pt 6’s “Provider Progress Note [PPN],” dated 1/2/25 to 1/8/25, “Physician Orders [PO]”, “Medication Physician Orders [MPO], dated 12/30/24 to 1/3/25, and “Medication Administration Record [MAR],” dated 12/31/24 to 1/3/25, were reviewed. The “PO” indicated, on 12/30/24 at 4:50 p.m. an order for a Nuc Med scan was entered. NE 1 stated, the “PO” indicated the scan was performed on 1/3/25 at 11:38 a.m. and read by the physician on 1/4/25. The “MPO” indicated, on 1/2/25 at 11:05 a.m. an order for ... “radioisotope 12millicuire [a unit of radioactivity]” ...Electronically signed by: [LNMT 1] on 1/2/25 at 1105 [11:05 a.m.] ...”. The “MAR” indicated, the radioisotope 12 millicurie was ordered by LNMT 1 on 1/2/25 at 11:05 a.m. but was administered by NMT 1 intravenously on 1/3/25 at 11:38 a.m. The “MAR” had no indication the radioisotope was scanned before administration. During a concurrent interview and record review on 3/28/25 at 9:48 a.m. with Nurse Educator (NE) 1, Pt 5’s “H&P,” dated 12/31/24, was reviewed, The H&P indicated Pt 5 was a Spanish speaking 96 year-old patient brought into the ED on 12/31/25 at 12:45 p.m. by family with complaints of right upper quadrant pain (the area of the stomach located on the right side above the belly button) for two weeks. The “H&P” indicated Pt 5 was admitted as an inpatient on 12/31/24 at 8:50 p.m. for a renal abscess (a pocket of pus that forms within the kidney tissue) and moved to the Medical Surgical (MS) Unit at 11:56 p.m. During a concurrent interview and record review on 3/28/25 at 9:55 a.m. with NE 1 Pt 5’s “Provider Progress Note [PPN],” and “Labs”, dated 1/2/25 to 1/8/25, “Physician Orders [PO]”, “Medication Physician Orders [MPO], dated 12/31/24 to 1/3/25, and “Medication Administration Record [MAR],” dated 12/31/24 to 1/3/25, were reviewed. NE 1 stated, Pt 5’s “PO” and “MPO” had no orders indicating a Nuc Med scan, or any radiopharmaceuticals were ordered for Pt 5. NE 1 stated, Pt 5s “MAR” had no documentation indicating Pt 5 was administered isotope tagged WBCs. NE 1 stated, Pt 5’s “MAR” would not have documentation, because there were no orders for the patient to have radiopharmaceuticals. The “PPN” dated 1/2/25 indicated, “ ...I was informed (01/02/2025) that patient [Pt 5] was (accidentally and erroneously [incorrectly]) injected (by nuclear medicine technologist) another patient’s blood product [Pt 6]. This was communicated to the patient’s sons ... Active Problems: ...Accidental injection of blood products from another patient - This was reported to the patient’s both sons and risks/plans were explained. - Discussed with infection control; source patient [Pt 6] has strep [type of germ] bacteremia [serious infection enters the bloodstream] and Pseudomonas (common bacterial disease-causing organisms) wound infection. -Source patient is being tested for [bloodborne pathogens] ...per Infectious control request. ...Will repeat blood cultures with a.m. labs and follow up ...”. NM 1 stated, multiple labs were drawn, and results were negative for bloodborne pathogens. During an interview on 4/1/25 at 11:42 a.m. with the Director of Imaging (DI), the DI stated, she was a part of the hospital internal investigation of Pt 5 being injected with Pt 6’s radioisotope tagged WBCs. The DI stated LNMT 1 failed to use two patient identifiers prior to injecting the radioisotope tagged WBCs for Pt 6 into Pt 5. The DI stated, her expectation was for LNMT 1 to report the error immediately, which he did. The DI stated, the discovery during the investigation was, LNMT1 got off the elevator on the incorrect floor and entered what would be the same room number if he was on the correct floor. The DI stated, Pt 6 and Pt 5 were located on different floors but were in the same room number, and in the same bed location. The DI stated, LNMT 1did draw the correct patient’s blood (Pt 6), in the morning around 6 a.m. The DI stated, LNMT 1claimed he only “glanced” at Pt 5’s armband, and both patients had similar first names, and both patients were similar in appearance. The DI stated, LNMT 1 did not notice Pt 5 did not have the Nuc Med Department armband applied, and he did not verify the “kit” numbers against the armband, or the patient’s name against the physician’s order. The DI stated, as soon as LNMT 1realized he injected the wrong patient he called the manager, the house supervisor and both patient’s physicians. LNMT 1 stated, Pt 6 needed to be tested for bloodborne pathogens, and be redrawn for the nuclear isotope tagging and rescheduled for the scan, and Pt 5 needed to be monitored for reactions and tested for infections. The DI stated, the incident was reported to the RSO the same day as the event, and there was no concern for harm to Pt 5 due to the radiation dose. The DI stated, Pt 5 receiving Pt 6’s blood was concerning but both patients were tested, and the results were negative for any bloodborne pathogens. The DI stated, the Nuc Med Department had label tracking (to scan) into the Nuclear Medicine Information System (NMIS-software designed to manage patient, department, including inventory, dosing and billing), but there was no barcode scanning to scan the “kit” into the main hospital EMR system. The DI stated the NMT’s document in the patient’s MAR when completing the administration. During a review of hospital document titled, “Labeling Tracking Record [LTR],” dated 1/2/25, the “LTR” indicated, Pt 5 had blood drawn for WBC tagging by LNMT 1 on 1/2/25 at 6:25 a.m. The “LTR” had a checkmark indicating the “Patient name on all labeling stickers”, “Specimen syringe sticker attached to blood specimen container” and “Bracelet attached to patient”. The “LTR” indicated, Pt 5’s blood was received at the Radiopharmacy on 1/2/25 at 8:30 a.m. The “LTR” indicated, a dual verification of the dose was verified, loaded and sealed in the transporting case. The “LTR” indicated, five separate steps for verification of patient name to ensure correct patient prior to sending the dose to the hospital. The “LTR” indicated, the radioisotope tagged WBCs were delivered to the hospital on 1/2/25 at 11:11 a.m. During an interview on 4/1/25 at 2:50 p.m. with the Manager of Accreditation and Licensure (MAL), the MAL stated LNMT 1 was as not available to be interviewed because LNMT 1no longer worked for the hospital. During an interview on 4/2/25 at 1:19 p.m. with the Healthcare Risk Officer (HRO) the HRO stated, Reason the Rad incident was not thought to be reported, and an RCA was not completed was because it didn’t meet criteria. The HRO stated, the hospital completed an Intensive analysis, considered one step above a regular investigation but did not rise to the level of a root cause analysis. During an interview on 4/3/25 at 1:57 p.m. with the DI, the DI stated, the NTs scan the radiopharmaceutical product for the NIMS system at patient’s bedside. The DI stated, during the incident with Pt 5 LNMT 1 had trouble logging into the computer workstation at Pt 5’s bedside so he attempted to use identifiers, then scanned the label when returning to the Nuc Med department. The DI stated, when he scanned the label, he discovered his error. During an interview on 4/4/25 at 5:25 p.m. with the Chief Nursing Executive (CNE), the CNE stated, LNMT 1 should have gone to the patient’s room and verified the patient’s identity, ensuring right patient, right drug, right dose, right route, and right time. The CNE stated the five rights of medication administration should have been followed for this patient to avoid the error. During a review of the hospital’s P&P titled, “Nuclear Medicine: Radiopharmaceutical Preparation, Labeling, and Administration,” dated 6/8/23, indicated, “ ... PURPOSE A. To ensure patient and staff safety during the preparation and administration of radiopharmaceuticals. ...Patient identity shall be verified by comparing patient name and date of birth on identification band with same identifiers on applicable health information documents prior to initiating this policy/procedure ... Maintain adequate shielding throughout the department. Reaction vials are to remain in covered leaded carriers (“pigs”), when not in use. Dose syringes must be in syringe shield or “pig” except when in the dose calibrator. ... Double check vial and syringe labels before injecting. ...Administration ...Establish patient identity before prepping or injecting. Ask patient to state full name (rather than to confirm name) and the date of birth. For inpatients, confirm identification in same manner against identification armband. Nuclear Medicine Technologist will cross-reference patient identification with that printed on NMIS labels and/or registration record. ...Labeling of Blood Products a. On studies that involve invitro tagging of blood cells ... the patient should be carefully identified as above and given a wristband with specific identifiers for the return of the tagged blood cells. b. The same Nuclear Medicine technologist should draw the blood that re- injects the tagged cells. ...Documentation: ...Order radiopharmaceutical in the exam navigator under “orders”, with correct information as to drug, route, and time. ...One eMAR [electronic Medication Administration Record] and NMIS computer system, document patient name, date of birth, and medical record number with radiopharmaceutical, manufacturer and lot number, dose, date and time of administration, date and time of expiration and Nuclear Medicine technologist administering ...”. During a review of the hospital’s P&P titled, “Identification: Patient Armbands/Patient Verification,” dated 2/8/22, indicated, “ ...PURPOSE A. To assure accurate identification of all patients at [name of hospital] B. To assure the two approved patient identifiers are used to match service or treatment to that individual in a manner that prevents wrong patient identity. ...Verification of patient identity by comparing patient name and date of birth on identification band with same identifiers on applicable health information documents will occur prior to initiating this procedure ...Applicable patients will have an identification band on at all times. ... Accurate patient identification will occur whenever administering medications or blood products, taking blood samples and other specimens for clinical testing, or providing any other care, treatments or procedures. 1. Accurate identification MUST occur at the “point of care” any time care/treatment is to be provided. 2. Containers used for blood and other specimens are to be labeled in the presence of the patient. ... Whenever patient care is being managed through Order Entry (OE) or other computerized methods, accurate patient identification will occur by comparing patient’s full name and date of birth on document being entered (physician’s order for example) to patient pulled up in computer application. 1. Using medical record number and/or patient account number can be used to further verify correct patient IN ADDITION to, but not as replacements for, using patient’s full name and date of birth. ... Patients who are hospitalized who are unable to participate in verification at time of admission will have identity verified through reliable family member or friend as soon as possible. The name of the family member or friend verifying identity will be entered into admission history to provide reference that identity was initially verified through this reliable source. This is intended to provide reference to subsequent caregivers that identity has been validated. ... VERIFYING PATIENT IDENTITY: POINT OF CARE VERIFICATION AND INFORMATION DOCUMENT COMPARISON 1. Upon first interaction or at beginning of shift with a conscious patient, verify patient identity by asking the patient to state their full name and date of birth. Compare this to same information on patient’s identification band and same in health information documents (eMAR, physician orders). 2. Upon all subsequent interactions while assigned to patient within same day, verify identity by checking full name and date of birth on identification band and comparing to same information on applicable health information documents (eMAR, physicians orders, lab results or other documents triggering nursing intervention). ...Non-English speaking: Obtain interpreter and follow same guidelines ...”. During a review of a professional reference titled, “Safe Medication Administration: So Many Considerations,” dated July-August 2023, the professional reference indicated, “ ... For decades, the five rights for administering medications have been a recognized safety standard (Martyn et al., 2019). The framework of the seminal five rights (i.e., right patient, drug, dose, time, route) has evolved, and other rights considered as additional influences on medication administration processes have been identified in changing healthcare environments ...”.”

“COMPLIANCE WITH 489.24 CFR(s): 489.20(l) [The provider agrees,] in the case of a hospital as defined in §489.24(b), to comply with §489.24. This Standard is not met as evidenced by: 37529 Based on observation, interview and record review, the hospital failed to comply with the regulatory requirements for EMTALA for two of 20 sampled patients, Patients (Pt) 1, and Pt 2, when: 1. Pt 2, a three day old infant was brought to the ED by his parents on 9/20/24 at 8:21 p.m. with a chief complaint of abnormal lab results, a high bilirubin (a substance produced by the breakdown of red blood cells) level and not eating well. Pt 2 was triaged and assigned an Emergency Severity Index level 2 (ESI- a 5-level acuity scale used by triage nurses to indicate the seriousness of the patient’s condition, and the resources needed in order to prioritize care; ESI 1 is the most serious). The MSE (Medical Screening Examination) was initiated by a physician assistant (PA) after triage, a bilirubin test was ordered and Pt 2 was sent with his parents to wait in the lobby for three and a half hours and then in an ED room for another three and a half hours during which time Pt 2’s vital signs were not reassessed, a bottle of formula or a private place for Pt 2’s mother to breastfeed or pump was not provided resulting in Pt 2 not eating for almost eight hours. After seven hours without the MSE being completed, Pt 2 was carried out by parents at 3:21 a.m. on 9/21/24. These failures resulted in Pt 2 not receiving an appropriate MSE to rule out an EMC and had the potential to cause harm due to increased risk for complications of hyperbilirubinemia (a condition in which there is a build up of bilirubin in the blood) in the late preterm infant (LPI- infants born between 34 0/7 weeks’ gestation and 36 6/7 weeks’ gestational age). (Refer to A 2406) 2. Pt 1 arrived via personal car to Hospital A’s emergency department (ED) on 12/15/24 at 11:37 p.m. with a chief complaint of pregnancy at 37 weeks, 2 days and rupture of membranes (ROM- rupture [breaking open] of the amniotic sac [membranes inside the uterus that contains the fetus and the amniotic fluid that cushions the fetus]) and Pt 1 was taken to the L&D unit for evaluation and had an episode of moderate vaginal bleeding with clots. Continuous electronic fetal monitoring (EFM) was initiated at 11:55 p.m. and indicated Pt 1 was having irregular uterine contractions and constituted an EMC. Medical Doctor (MD) 1 examined Pt 1 at 12:04 a.m. on 12/16/24 (approximately 25 minutes after arrival to the L&D) and determined Pt 1 was in “early labor and possible ROM” and proceeded to discharge patient. MD 1 did not consider obtaining information from Pt 1 about any pregnancy complications, medical history, assessment of fetal presentation, assessment of amount and color of vaginal bleeding, or presence of odor of fluid from vagina. MD 1 did not consider a course of action or other means to validate ROM. MD 1 did not provide or document a rationale for discharge. Pt 1 was not provided safe transport to Hospital B. These failures resulted in not stabilizing Pt 1’s labor with ruptured membranes and bleeding, and not providing labor and delivery services for which Hospital A had capacity and capability. The inappropriate discharge placed Pt 1 and her unborn baby at risk for harm due to potential for infection, risk of prolapsed cord, bleeding and death. (Refer to A 2407) The cumulative effect of these systemic problems resulted in the hospital’s inability to ensure the provision of quality healthcare in a safe and responsible manner.”

“MEDICAL SCREENING EXAM CFR(s): 489.24(a) & 489.24(c) (a) Applicability of provisions of this section. (1) In the case of a hospital that has an emergency department, if an individual (whether or not eligible for Medicare benefits and regardless of ability to pay) “comes to the emergency department”, as defined in paragraph (b) of this section, the hospital must- (i) Provide an appropriate medical screening examination within the capability of the hospital’s emergency department, including ancillary services routinely available to the emergency department, to determine whether or not an emergency medical condition exists. The examination must be conducted by an individual(s) who is determined qualified by hospital bylaws or rules and regulations and who meets the requirements of §482.55 of this chapter concerning emergency services personnel and direction; and (ii) If an emergency medical condition is determined to exist, provide any necessary stabilizing treatment, as defined in paragraph (d) of this section, or an appropriate transfer as defined in paragraph (e) of this section. If the hospital admits the individual as an inpatient for further treatment, the hospital’s obligation under this section ends, as specified in paragraph (d)(2) of this section. (2)(i) When a waiver has been issued in accordance with section 1135 of the Act that includes a waiver under section 1135(b)(3) of the Act, sanctions under this section for an inappropriate transfer or for the direction or relocation of an individual to receive medical screening at an alternate location do not apply to a hospital with a dedicated emergency department if the following conditions are met: (A) The transfer is necessitated by the circumstances of the declared emergency in the emergency area during the emergency period. (B) The direction or relocation of an individual to receive medical screening at an alternate location is pursuant to an appropriate State emergency preparedness plan or, in the case of a public health emergency that involves a pandemic infectious disease, pursuant to a State pandemic preparedness plan. (C) The hospital does not discriminate on the basis of an individual’s source of payment or ability to pay. (D) The hospital is located in an emergency area during an emergency period, as those terms are defined in section 1135(g)(1) of the Act. (E) There has been a determination that a waiver of sanctions is necessary. (ii) A waiver of these sanctions is limited to a 72-hour period beginning upon the implementation of a hospital disaster protocol, except that, if a public health emergency involves a pandemic infectious disease (such as pandemic influenza), the waiver will continue in effect until the termination of the applicable declaration of a public health emergency, as provided under section 1135(e)(1)(B) of the Act. (c) Use of dedicated emergency department for nonemergency services. If an individual comes to a hospital’s dedicated emergency department and a request is made on his or her behalf for examination or treatment for a medical condition, but the nature of the request makes it clear that the medical condition is not of an emergency nature, the hospital is required only to perform such screening as would be appropriate for any individual presenting in that manner, to determine that the individual does not have an emergency medical condition. This Standard is not met as evidenced by: 37529 Based on observation, interview, and record review, the hospital failed to provide an appropriate medical screening examination (MSE-assessment performed by Qualified Medical Personnel [QMP] for the purpose of determining whether an emergency medical condition [EMC] exists) within the capability of the hospital’s emergency department (ED) for one of 20 sampled patients, Patient (Pt) 2, when: 1. Pt 2, a three day old infant was brought to the ED by his parents on 9/20/24 at 8:21 p.m. with a chief complaint of abnormal lab results, a high bilirubin (a substance produced by the breakdown of red blood cells) level and not eating well. Pt 2 was triaged and assigned an Emergency Severity Index level 2 (ESI- a 5-level acuity scale used by triage nurses to indicate the seriousness of the patient’s condition, and the resources needed in order to prioritize care; ESI 1 is the most serious). The MSE was initiated by a physician assistant (PA) after triage, a bilirubin test was ordered and Pt 2 was sent with his parents to wait in the lobby for three and a half hours and then in an ED room for another three and a half hours during which time Pt 2’s vital signs were not reassessed, a bottle of formula or a private place for Pt 2’s mother to breastfeed or pump was not provided resulting in Pt 2 not eating for almost eight hours. After seven hours without the MSE being completed, Pt 2 was carried out by parents at 3:21 a.m. on 9/21/24. These failures resulted in Pt 2 not receiving an appropriate MSE to rule out an EMC and had the potential to cause harm due to increased risk for complications of hyperbilirubinemia (a condition in which there is a build up of bilirubin in the blood) in the late preterm infant (LPI- infants born between 34 0/7 weeks’ gestation and 36 6/7 weeks’ gestational age). Findings: 1. During a review of Pt 2’s Electronic Medical Record (EMR-digital version of a patient’s medical record) dated 9/20/24 at 8:21 p.m., the record indicated Pt 2 was a three day old infant brought into the ED by his mother on 9/20/24 at 8:21 p.m. with a chief complaint of “abnormal lab results.” The EMR indicated Pt 2 was born by cesarean section on 9/17/24 at 36 weeks 6 days gestation. Pt 2’s vital signs were obtained at 8:24 p.m. and indicated, temperature 99 degrees Fahrenheit (F), heart rate 156 beats per minute (bpm), respirations 58 per minute, oxygen saturation 97% on room air, and no blood pressure was obtained. Triage was completed at 8:34 p.m. and an ESI level 2 was assigned. The Physician Assistant (PA 1) initiated the MSE at 8:54 p.m. Review of PA 1’s rapid medical exam (RME) note dated 9/20/24 at 8:54 p.m. indicated “ ... Patient presents with abnormal lab result. Pt with high bilirubin 15.3 [milligrams per deciliter (mg/dL, range 0 - 12.0 mg/dL)] at primary care provider [PCP] ...and not eating/lethargic for a few hours not wanting to eat. 36 weeks and 6 days 1st pregnancy, c section. Pumping/ formula feeding. Last ate 1 hour ago 1/2 ounce formula ...Brief Exam- General: In no distress. Respiratory: No increased work of breathing. Neuro: Normal for age. No signs of immediate life threatening emergency at this time. Plan: Patient awaiting further evaluation by a medical provider ...” Review of the orders for Pt 2, indicated PA 1 ordered a blood test for bilirubin level which was collected at 9:38 p.m. The results were back at 10:30 p.m. and indicated total bilirubin 14.2 mg/dL, direct 0.3 mg/dL (range 0.0-0.3), however the record did not indicate if or when the results were review by a physician or nurse. The EMR indicated Pt 2 was moved from the waiting room to an ED room at 11:49 p.m. and Pt 2 respirations were recorded by RN 4 on 9/21/24 at 12:05 a.m. The record indicated no other contact with Pt 2 until 2:55 a.m. when Pt 2 was fed pumped breast milk by his mother. At 3:18 a.m. the nurses notes indicated the parents of Pt 2 were frustrated after waiting for hours without being seen by a doctor and left with Pt 2 at 3:20 a.m.. The EMR indicated that MD 1 was assigned to Pt 2 at 2:39 a.m. and the MD note at 3:27 a.m. indicated, “...Patient was assigned to me, and I reviewed the chart, however when went to find the patient, the family had eloped prior to my evaluation...” During an interview on 1/2/25 at 2:38 p.m. with Pt 2’s mother (PM), PM stated she brought her son who was three days old to the ED because the previous day when they were at the pediatrician’s office his bilirubin level was high and the pediatrician told her (PM) that if the bilirubin continued to be high she would need to take her baby back to the hospital. PM stated her baby started not eating well so she brought him into the ED. PM stated they were taken back within thirty minutes but then were sent back out to the waiting area where they waited for hours. PM stated it had been hours since the baby had eaten, and she was not offered a bottle for the baby or a private place for her to pump to feed her baby breast milk. PM stated finally they were taken back to a room which was shared with a male patient and no privacy was provided. PM stated they waited in the ED room for hours and still they were not seen by a doctor. PM stated the other patient in the room was moved out around thirty minutes before they left, and then she (PM) was able to pump and finally give her baby a bottle. PM stated after hours of waiting without being seen by a doctor she could not wait any longer and left with her baby at 3:20 a.m. PM stated she was not told the results of the bilirubin test before they left the hospital. PM stated they received a bill for the lab test and for being seen by a doctor which was not true. PM stated it felt like “it was chaotic that night and I just feel like we were forgotten about.” During a concurrent interview and record review on 1/16/24 at 3 p.m. with RN 4 and the Emergency Department Manager (EDM), Pt 2’s EMR, dated 9/20/24-9/21/24, was reviewed. RN 4 stated he did not remember Pt 2 but had reviewed the record. The record indicated Pt 2 had been in the waiting room (the lobby) until being moved to ED bed 6 at 11:49 p.m. on 9/20/24 where RN 4 assumed care. RN 4 stated the record indicated he recorded Pt 2’s respiratory rate (52 respirations per minute) at 12:05 a.m. on 9/21/24 but no other vital signs. RN 4 stated he did not know why he did not obtain Pt 2’s vital signs and stated he was going off shift at 12:15 a.m. and would have handed off Pt 2 to another RN before he (RN 4) left. RN 4 stated he was aware of Pt 2’s ESI of 2 and stated vital signs should have been reassessed every two hours and the record does not reflect that. Review of the record indicated vital signs were obtained (except for a blood pressure) at 8:24 p.m. on 9/20/24 in triage and were not assessed again during Pt 2’s seven hour ED visit. RN 4 stated the patients in the ED waiting room did have a nurse assigned to them. The EDM stated vital signs for patients in the lobby are reassessed by whoever was available including the ED techs, the lobby nurse if one is scheduled, the triage nurse, or the greet nurse. The EDM stated it was policy to have vital signs reassessed according to the ESI to make sure patients conditions don’t change. The EDM stated the policy was not followed for Pt 2. Review of the record indicated after RN 4’s note at 12:05 a.m., there was no documentation of contact with Pt 2 until 2:55 a.m., and the parents left with Pt 2 at 3:20 a.m. Review of the record indicated PA 1 initiated the MSE 8:54 p.m. on 9/20/24 and ordered a blood test for bilirubin. RN 4 stated he did not know if Pt 2’s mother was given the bilirubin lab results; it was the responsibility of the provider to inform patients of test results. The EDM stated PA 1 saw Pt 2 briefly to initiate the MSE, but would not have been assigned to Pt 2 after that. The EDM stated the physicians assign themselves to the patients and when they did, it was noted in the EMR. Review of the record indicated an ED physician assigned herself to Pt 2 at 2:39 a.m. but did not see Pt 2. RN 4 stated if a physician was needed for orders or to assess a patient and no physician had picked up the patient yet, the nurse would go to whichever physician is available. During a concurrent interview and record review on 1/17/25 at 10 a.m. with RN 5 and the EDM, Pt 2’s EMR, dated 9/20/24 was reviewed. RN 5 stated she did not remember Pt 2 because the ED visit was four months ago, but according to the medical record she (RN 5) triaged Pt 2. RN 5 was asked what criteria she used to determine the ESI level 2, and RN 5 stated, “Just to be on the safe side, I guess.”. The EDM stated they wanted to keep a close eye on a three day old baby with jaundice and decreased appetite. RN 5 stated vital signs for a patient assigned an ESI 2 are supposed to be checked every two hours and according to the record they were not. During a concurrent interview and record review on 1/22/25 at 2 p.m. with the Physician Assistant (PA 1), Pt 2’s EMR dated 9/20/24 was reviewed. PA 1 stated he remembered Pt 2 because the baby’s skin was jaundiced (yellowing of the skin, eyes, and mucous membranes caused by an excess of bilirubin [a substance produced by the breakdown of red blood cells] in the blood), which was not something PA 1 saw very often. PA 1 stated he realized now that he did not document that Pt 2’s skin was jaundiced, and he should have. The PA stated he saw Pt 2 briefly in the Rapid Medical Evaluation/Examination (RME- a brief evaluation, the initiation of the MSE) area and he put an order in for a blood test to assess Pt 2’s bilirubin level and then communicated that Pt 2 was to go to a “bed in back,” meaning one of the ED rooms. PA 1 stated after that he was not involved in Pt 2’s care and did not see Pt 2 again or review his chart. PA 1 stated his expectation was that a physician would “pick up” (continue care) Pt 2. PA 1 stated he did not know whether or not Pt 2’s mother was given the results of he bilirubin test. During a review of the professional reference “American Academy of Pediatrics Updates on an At-Risk Population: Late-Preterm and Early-Term Infants,” dated 11/2019, the reference indicated,” ... Late-preterm (LPT) infants (born between 34 0/7 weeks’ gestation and 36 6/7 weeks’ gestation are at increased risk for a number of adverse events, including respiratory distress, hypoglycemia, feeding difficulties, hypothermia, hyperbilirubinemia, apnea, seizures, and a higher rate of readmission after initial discharge. Evidence revealed by strong population health research demonstrated that LPT or early-term (ET) births (between 37 0/7 weeks’ gestation and 38 6/7 weeks’ gestation pose a significant risk to an infant’s survival, growth, and development because of increased morbidities and mortality in these at-risk groups ...” Review of the article from the International Journal of Pediatrics and Adolescent Medicine, titled, “Late preterm infants- Changing trends and continuing challenges,” dated March 2020, the article indicated, “ ...Late preterm infants (LPI), defined as newborns born between 34 0/7-36 6/7 weeks of gestational age, constitute a unique group among all premature neonates. Often overlooked because of their size when compared to very premature infants, this population is still vulnerable because of physiological and structural immaturity. Comprising nearly 75% of babies born less than 37 weeks of gestation, late preterm infants are at increased risk for morbidities involving nearly every organ system as well as higher risk of mortality when compared to term neonates ... Hyperbilirubinemia is the most common reason for readmissions in preterm infants following discharge. LPIs are also at increased risk for developing Bilirubin Induced Neurologic Damage (BIND) ...Feeding difficulties- Careful attention and vigilance to oral intake, weight gain and milk supply is clearly needed in this population to prevent added morbidity and/or rehospitalization ...” During a review of the professional reference titled, “EMERGENCY SEVERITY INDEX HANDBOOK FIFTH EDITION,” dated 2023, the reference indicated, “ ...ESI level 2 patients remain a high priority, and placement and treatment should be initiated rapidly. ESI level 2 patients have the potential to be very ill and at high risk for decompensation. Usually, rather than move to the next patient, the triage nurse determines that the charge nurse or staff in the patient care area should be immediately alerted that they have an ESI level 2 patient ...””

“STABILIZING TREATMENT CFR(s): 489.24(d)(1-3) (1) General. Subject to the provisions of paragraph (d)(2) of this section, if any individual (whether or not eligible for Medicare benefits) comes to a hospital and the hospital determines that the individual has an emergency medical condition, the hospital must provide either- (i) within the capabilities of the staff and facilities available at the hospital, for further medical examination and treatment as required to stabilize the medical condition. (ii) For for transfer of the individual to another medical facility in accordance with paragraph (e) of this section. (2) Exception: Application to inpatients. (i) If a hospital has screened an individual under paragraph (a) of this section and found the individual to have an emergency medical condition, and admits that individual as an inpatient in good faith in order to stabilize the emergency medical condition, the hospital has satisfied its special responsibilities under this section with respect to that individual (ii) This section is not applicable to an inpatient who was admitted for elective (nonemergency) diagnosis or treatment. (iii) A hospital is required by the conditions of participation for hospitals under Part 482 of this chapter to provide care to its inpatients in accordance with those conditions of participation. (3) Refusal to consent to treatment. A hospital meets the requirements of paragraph (d)(1)(i) of this section with respect to an individual if the hospital offers the individual the further medical examination and treatment described in that paragraph and informs the individual (or a person acting on the individual’s behalf) of the risks and benefits to the individual of the examination and treatment, but the individual (or a person acting on the individual’s behalf) does not consent to the examination or treatment. The medical record must contain a description of the examination, treatment, or both if applicable, that was refused by or on behalf of the individual. The hospital must take all reasonable steps to secure the individual’s written informed refusal (or that of the person acting on his or her behalf). The written document should indicate that the person has been informed of the risks and benefits of the examination or treatment, or both. This Standard is not met as evidenced by: 37529 Based on interview and record review, the hospital failed to provide stabilizing measures for an identified emergency medical condition (EMC) within the capability and capacity of the hospital for one of 20 sampled patients, Patient (Pt)1 when: Pt 1 arrived via personal car to Hospital A’s emergency department (ED) on 12/15/24 at 11:37 p.m. with a chief complaint of pregnancy at 37 weeks, 2 days and rupture of membranes (ROM- rupture [breaking open] of the amniotic sac [membranes inside the uterus that contains the fetus and the amniotic fluid that cushions the fetus]) and Pt 1 was taken to the L&D unit for evaluation and had an episode of moderate vaginal bleeding with clots. Continuous electronic fetal monitoring (EFM) was initiated at 11:55 p.m. and indicated Pt 1 was having irregular uterine contractions and constituted an EMC. Medical Doctor (MD) 1 examined Pt 1 at 12:04 a.m. on 12/16/24 (approximately 25 minutes after arrival to the L&D) and determined Pt 1 was in “early labor and possible ROM” and proceeded to discharge patient. MD 1 did not consider obtaining information from Pt 1 about any pregnancy complications, medical history, assessment of fetal presentation, assessment of amount and color of vaginal bleeding, or presence of odor of fluid from vagina. MD 1 did not consider a course of action or other means to validate ROM. MD 1 did not provide or document a rationale for discharge other than “ ...Pt is going to present to [Hospital B] to be assessed by her OB Dr. [Name of physician] ...” Pt 1 was not provided safe transport to Hospital B. These failures resulted in not stabilizing Pt 1’s labor with ruptured membranes and bleeding, and not providing labor and delivery services for which Hospital A had capacity and capability. The inappropriate discharge placed Pt 1 and her unborn baby at risk for harm due to potential for infection, risk of prolapsed cord, bleeding and death. Findings: During a review of Pt 1’s medical record dated 12/15/24 at 11:37 p.m. to 12/16/24 at 12:27 a.m., the record indicated on 12/15/24 at 11:37 p.m., Pt 1 came to Hospital A complaining of ruptured membranes. Pt 1 was 39 years old, 37 weeks and 2 days pregnant with her first baby and was taken to the Labor and Delivery unit (L&D). Review of the nurses notes dated 12/15/24 at 11:45 p.m. indicated, while Pt 1 was in the bathroom providing a urine sample she had vaginal bleeding and called the registered nurse (RN 1). The note indicated RN 1 “assessed blood amount ...bleeding did not seem like a significant amount.” The note indicated at 11:52 p.m. RN 1 pulled the sheet back to perform rupture of membranes test and a “puddle of dark red blood about the size of two grapefruits had formed underneath patient ...” The note indicated RN 1 called another nurse (RN 2) to the room to assess Pt 1’s bleeding, and then at midnight RN 2 notified the obstetrician (a doctor who specializes in caring for women during pregnancy and childbirth) on duty in L&D (MD 1) of the bleeding and requested he come to Pt 1’s room to assess her. The note indicated at 12:04 a.m. on 12/16/24, “ ... [MD 1] at bedside at this time to assess bleeding. Upon evaluation, MD then proceeded to conduct SVE (sterile vaginal examination) with patient’s consent. MD educated patient that her cervix felt like she was going into labor soon, but unfortunately, we would not be able to complete rupture of membranes test d/t pt’s bleeding status. MD then proceeded to inform patient that he recommended discharge at this time, and that he recommended she drive to Hospital B for further evaluation ...MD requested pt be discontinued from all monitors and be discharged from unit ...” Review of Pt 1’s assessment flowsheet dated 12/15/24 at 11:55 p.m. indicated continuous electronic fetal monitoring (EFM- device that records the fetal heart rate and uterine contractions) was started at 11:55 p.m., and on 12/16/24 at 12:15 a.m. the baseline fetal heart rate (FHR) was 125 beats per minute (bpm 120-160) with moderate variability (normal) and uterine contractions every 1.5 to 3 minutes. The flowsheet indicated at 12:20 a.m., “Vaginal Bleeding in Labor: Present; Characteristics: with clots, painless, intermittent; Color: dark red; Qualitative Assessment: Moderate amount.” The baseline FHR was 130 bpm, moderate variability, uterine contractions every two minutes, and the monitor was discontinued. Pt 1 was discharged from Hospital A on 12/16/24 at 12:27 a.m. During a review of Pt 1’s “Physician OB Triage Note” dated 12/16/24 at 12:20 a.m., indicated, “ ... [Pt 1] is a 39 year old Gravida 1 [first pregnancy] Para 0 [G 1P 0] at 37 weeks 2 days who presents to OB triage for vaginal bleeding. Pt noted UCs [uterine contractions] and passage of fluid with bleeding. Limited prenatal records available for review ...Vaginal exam: cervix fingertip [FT]; Effacement: 90%; Station: 0; Membranes: Bleeding. Assessment and Plan: [Pt 1] is a 39 year old year old G1P0 who is evaluated in OBED for: Vaginal bleeding, Early labor, Possible spontaneous rupture of membranes (SROM) but unable to determine. FHR 145 Category 1. DC [discharge] Home. Pt is going to go to present to [Hospital B] to be assessed by her OB Dr. [Name of physician] ...” During a review of Pt 1’s medical record from Hospital B dated 12/16/24 at 12:44 a.m., the record indicated Pt 1 came to the ED at Hospital B on 12/16/24 at 12:44 a.m. (17 minutes after being discharged from Hospital A) with a chief complaint of “leaking [amniotic fluid] and [vaginal] bleeding,” and was admitted to L&D. The record indicated, “...Leaking noted at 11 p.m. on 12/15 prompting pt visit to [Hospital A], then referred to [Hospital B] and found to have rupture of membranes...” The record indicated on 12/16/24 at 1 a.m., a vaginal exam noted Pt 1’s cervix was dilated to 1 centimeter (cm), 60% effaced, and -3 station, with a moderate amount of bloody fluid from vagina. FHR 140 bpm, moderate variability. The record indicated Pt 1’s Group B streptococcus (GBS- a bacteria that can be transmitted from a pregnant woman to her newborn during labor or after rupture of membranes. The leading cause of newborn infection.) was unknown, so Pt 1 was started on intravenous antibiotics every four hours. At 2:30 a.m. the variability was minimal with late and variable decelerations treated with intravenous fluids, oxygen and position changes. Labor was induced and Pt 1 had a vacuum-assisted vaginal delivery on 12/16/24 at 6:35 p.m., Apgars 8 and 9 at one and five minutes respectively. Nuchal cord (umbilical cord wrapped around baby’s neck) was reduced at delivery. During an interview on 1/2/25 at 5 p.m. with a registered nurse from Hospital B (RNB), RNB stated when Pt 1 arrived at Hospital B on 12/16/24 she was grossly ruptured. RNB stated Pt 1 had been discharged from Hospital A and had apparently been told to go to Hospital B. RNB stated Pt 1 indicated Hospital A did not do any tests to rule out ruptured membranes and to determine Pt 1 was stable before discharging her. RNB stated “you worry that there may be a prolapsed cord [when the umbilical cord exits the cervical opening before the fetal presenting part].” RNB stated Pt 1 had expressed that she was “made to feel unwelcome, they [Hospital A] did not address her issues and just sent her out and did not answer her questions.” RNB stated Pt 1 indicated she lived right around the corner from Hospital A and felt she should go to the nearest hospital because she was concerned about being ruptured and bleeding. During an interview on 1/7/25 at 11:03 a.m. with Pt 1, Pt 1 stated she was only at Hospital A for a short time before she was discharged. Pt 1 stated the doctor (MD 1) told her she should have gone to Hospital B instead because her doctor was there. Pt 1 stated MD 1 told her he could not tell if she was ruptured, and he was not going to do anything so she should go home. Pt 1 stated she was still worried about the amount she was bleeding, and went to Hospital B. During an interview on 1/16/25 at 7 p.m. with the Labor and Delivery (L&D) charge nurse (LDCN), the LDCN stated she was working on 12/15/24, the night Pt 1 came to L&D. The LDCN stated Pt 1 came into L&D triage at 11:37 p.m. with a chief complaint of pregnancy with rupture of membranes at 37 weeks, two days. The LDCN stated RN 1 was taking care of Pt 1 and RN 1 notified her (LDCN) that Pt 1 had vaginal bleeding and that MD 1 checked Pt 1 and said he could not confirm rupture of membranes and planned to discharge her. The LDCN stated she and RN 1 did not think Pt 1 should be discharged so soon because Pt 1 was bleeding, possibly ruptured, had contractions, and had not been on the monitor long enough to ensure everything was ok. The LDCN stated they had an ultrasound machine in L&D and she asked MD 1 if he would order an ultrasound for Pt 1 but MD 1 declined and said “I am not doing anything for her.” The LDCN stated RN 1 asked MD 1 for an order for lab tests for preeclampsia (a complication of pregnancy characterized by persistent high blood pressure, along with protein in the urine and organ damage) and MD 1 said no. The LDCN stated MD 1 was insistent that Pt 1 was to be discharged and said “she [Pt 1] doesn’t need to be here,” and printed the discharge instructions himself and walked the patient out. The LDCN stated the printed discharge instructions given to Pt 1 were the routine instructions given to all patients who come in for a labor check. The LDCN stated MD 1 emphasized that Pt 1 should go to Hospital B after she was discharged from Hospital A. The LDCN stated MD 1 was not Pt 1’s physician, but worked as a laborist and saw the patients who did not have a physician on staff at Hospital A. The LDCN stated MD 1 verbalized on several occasions that patients with certain types of insurance do not belong at Hospital A, and should go to Hospital B. The LDCN stated if a situation like this occurred in the future where the nurse felt it was not safe to discharge a patient she (the LDCN) would escalate the situation to the house supervisor and the director. During an interview on 1/17/25 at 1:45 p.m. with the L&D Assistant Manager (LDAM), the LDAM stated she had been informed by the charge nurse that Pt 1 had been discharged and told to go to Hospital B, and that the nurse and charge nurse did not think it was safe to discharge Pt 1 due to the bleeding and short time that Pt 1 was monitored. The LDAM stated she was not surprised someone reported it [to CMS]. The LDAM stated when the survey started this week she informed MD 1 and he asked her if the survey was about his case (Pt 1) and she confirmed that it was. The LDAM stated MD 1 responded that it was better for Pt 1 to go to Hospital B because “she [Pt 1] was in a lesbian relationship and had in vitro fertilization (IVF-a process where eggs from a woman’s ovaries and fertilized with sperm in a lab and then the embryo is transferred into the uterus), so she had too many social problems for us [Hospital A] to handle.” The LDAM stated she did not know what problems MD 1 thought Hospital A was unable to handle. During an interview on 1/21/25 at 12 p.m. with an L&D nurse (RN 1), RN 1 stated she was Pt 1’s nurse on 12/15/24. RN 1 stated Pt 1 came into triage with complaints of rupture of membranes accompanied by her partner. RN 1 stated when Pt 1 went to the bathroom to provide a urine sample she had some vaginal bleeding. RN 1 stated initially she was not alarmed by the amount of bleeding and reassured Pt 1 who appeared scared. RN 1 stated as Pt 1 got settled in bed she left the room to get the test to check for ruptured membranes and when she returned to the room to perform the test she noted a pool of dark red blood had formed under Pt 1. RN 1 stated she was concerned about the bleeding and called another RN in L&D to come to the room to look at the amount of blood. RN 1 stated she did not do the test for ruptured membranes because of the bleeding. RN 1 stated her co-worker agreed the amount of blood was concerning and called MD 1. RN 1 stated she spoke to MD 1 who asked her what kind of insurance Pt 1 had and after being told, MD 1 asked why Pt 1 did not go to [Hospital B]. RN 1 stated MD 1 then went into Pt 1’s room, did a vaginal exam and told Pt 1 her cervix felt like she was going into labor soon, and told Pt 1 they could not do a test to check for ruptured membranes because she was bleeding. MD 1 looked at the fetal monitor strip and told Pt 1 he was discharging her and that she could go home or to Hospital B where they took Pt 1’s insurance. RN 1 stated she asked MD 1 if he would order a PIH panel (blood tests to assess for preeclampsia), because Pt 1’s blood pressure was elevated, and MD 1 said no after Pt 1 indicated she did not have any symptoms of preeclampsia. RN 1 stated MD 1 did not want to get an ultrasound and requested that the fetal monitor be discontinued. RN 1 stated she did not feel Pt 1 should have been discharged because of the bleeding, possible ruptured membranes, and because Pt 1 had only been on the fetal monitor for around twenty minutes and had contractions. RN 1 stated it seemed like MD 1 had already made up his mind he was going to discharge Pt 1 before he went into Pt 1’s room. RN 1 stated Pt 1 and her partner were uncomfortable with being discharged and were unsure what to do. RN 1 stated she advised Pt 1 that although MD 1 said Pt 1 could go home or go to Hospital B after being discharged, she (RN 1) encouraged Pt 1 to go to Hospital B. RN 1 stated as Pt 1 was being discharged MD 1 restated the importance of Pt 1 driving to Hospital B after leaving Hospital A. During an interview on 1/21/25 at 7 p.m. with RN 2, RN 2 stated when she was working the night of 12/15/24, RN 1 asked her to assess Pt 1’s bleeding. RN 2 stated she felt that the amount of bleeding warranted notification to the physician and assessment of Pt 1 by the physician, so she called MD 1 and requested he come to Pt 1’s bedside. RN 2 stated when MD 1 came into Pt 1’s room, she stepped out and did not have any other involvement with Pt 1’s care. RN 2 stated she was surprised when Pt 1 was discharged so soon. During an interview on 1/22/25 at 12 p.m. with MD 1, MD 1 stated he worked as a laborist and was responsible for patients who came into L&D but did not have a physician on staff at Hospital A. MD 1 stated he was on duty the night of 12/15/24 when Pt 1 came in complaining of possible ruptured membranes with some contractions and bleeding. MD 1 stated he did a [vaginal] exam, and Pt 1 had bleeding but that was common in early labor. MD 1 stated because Pt 1 was bleeding, the test to determine if she was ruptured could not be done because there could be a false positive result. MD 1 stated nursing staff did not ask him about getting an ultrasound or to monitor Pt 1 for a longer period of time. MD 1 stated he never asked what kind of insurance Pt 1 had, but did tell her that her doctor did not come to Hospital A, he was on staff at Hospital B. MD 1 stated he told Pt 1 he was not able to determine if she was ruptured because she was bleeding, and she would be discharged. MD 1 stated he did mention she could go to Hospital B since that is where her doctor was. MD 1 stated he was willing to keep Pt 1, but “we could not prove she was ruptured, so she did not meet criteria for admission. They [Hospital B] were able to see that she was ruptured.” MD 1 stated the nursing staff had no concerns about the discharge and neither did Pt 1. MD 1 stated it was probably better for Pt 1 to go to [Hospital B] anyway because there were psychosocial issues due to Pt 1 being in a same sex marriage. During a review of the policy and procedure titled, “Compliance with Emergency Medical Treatment (EMTALA),” dated 3/10/21, the P&P indicated, “ ...Medical Screening Examination (MSE): The process required to reach, within reasonable clinical confidence, the point at which it can be determined whether an emergency medical condition does or does not exist. The hands-on, patient clinical assessment is required of every EMTALA encounter to identify or rule out the existence of an EMC. A MSE can involve a wide spectrum of actions ranging from a brief history and physical examination to a complex process that also involves performing ancillary studies and procedures. The medical record must reflect continued monitoring according to the individual’s needs until it is determined whether or not the individual has an EMC and, if he/she does, until he/she is stabilized, admitted or appropriately transferred ...For a woman experiencing contractions, the MSE include a determination of whether the woman is in true or false labor. Labor: The process of childbirth beginning with the latent or early phase of labor and continuing through the delivery of the placenta. A woman experiencing contractions is in true labor unless a physician, certified nurse midwife or other qualified medical person acting within his or her scope certifies that after a reasonable time of observation, the woman is in false labor ...” During a review of the Medscape article titled, “Premature Rupture of Membranes,” dated 2/24/23, the article indicated, “ ... Premature rupture of membranes (PROM) at term is rupture of membranes prior to the onset of labor at or beyond 37 weeks’ gestation. PROM occurs in approximately 10% of pregnancies. Patients with PROM present with leakage of fluid, vaginal discharge, vaginal bleeding, and pelvic pressure ...ROM is diagnosed by speculum vaginal examination of the cervix and vaginal cavity. Pooling of fluid in the vagina is by far the most accurate for diagnosis of ROM. If all fluid has leaked out as in early PROM, an ultrasonographic examination may then show absence of or very low amounts of amniotic fluid in the uterine cavity. Accurate diagnosis is required for appropriate counseling and management of PROM ...Digital vaginal examinations should be avoided until labor is initiated; however, fetal presentation should be documented to avoid discovering malpresentation of the fetus long after admission for ROM ...All patients with ROM should be asked to come to the hospital to ensure fetal well-being. At term, infection remains the most serious complication associated with PROM for the mother and the neonate ... PROM at term should be managed by delivery unless reasons exist to consider waiting for spontaneous labor ...””

“NURSING SERVICES CFR(s): 482.23 The hospital must have an organized nursing service that provides 24-hour nursing services. The nursing services must be furnished or supervised by a registered nurse. This Condition is not met as evidenced by: 42321 Based on observations, interviews, and record review, that facility failed to have a well-organized and effective nursing service when: 1. Licensed Nurses (LN) did not follow the hospital’s P&Ps for “Pain Management”, Licensed Provider Orders: Receiving, Transcribing, Reviewing” and “Medication Administration” for eight of 14 Pts (Pts 1, 3, 7, 8, 12, 15, 19, 21). For six of 14 Pts (Pts 1, 3, 12, 15, 19, 21), LNs did not complete a pain assessment. For three of 14 Pts (Pts 1, 15, 19), LNs did not reassess pain after administration of pain medication within the expected timeframe. LNs did not administer adequate pain medications to address 10/10 pain experienced by Pt 3 and instead inappropriately administered Acetaminophen. LNs did not follow the Pt 7’s physician’s order to titrate (slowly increasing the dose of a medicine by very small amounts to find the right dose that is effective) the pain medication. (Refer to A-0398 Finding 1) 2. Licensed Nurses (LNs) did not monitor the patient while administering a high-risk/high-alert medications (Medications that have a heightened risk of causing significant patient harm when they are used in error) in accordance with their policies for “Medication Administration” and “High Risk/High Alert Medications” for one of one sampled patient (Pt 10). (Refer to A-0398 Finding 2) 3. Licensed nurses (LNs) did not clarify an order of “ventilator compliance” for a medication used for sedation in accordance with their policy for “Medication Administration” for one of one sampled patient (Pt 5). (Refer to A-0398 Finding 3) 4. LNs did not follow the physician order (PO) for two of three patients (Pt 1 and Pt 20), when the ordered neurological assessment (a physical exam that helps identify disorders of the brain, spinal cords, and nerves) was completed by LNs without the pupil measurement, according to hospital policy and procedure (P&P) “Neurological Assessment and Flow Sheet”. (Refer to A-0398 Finding 4) 5. LNs did not document a change of condition assessment for one of 17 patients (Pt 1) after Pt 1 had an unexplained injury, in accordance with the hospital P&P titled, “Assessment: Admission and Reassessment.” (Refer to A-0398 Finding 5) 6. LNs failed to document discharge instructions were to two of 36 patients (Pt 1 and Pt 20) according to hospital P&P titled “Discharge Planning Services”. (Refer to A-0398 Finding 6) 7. LNs failed to review one of four sampled patients (Pt 5) discharge medications with the patient and family prior to discharge on 11/22/24, which resulted in Pt 5 being prescribed the wrong dose of Coreg (medication used to treat high blood pressure and heart failure (chronic condition in which the heart does not pump blood as well as it should)) causing Pt 5 to be readmitted on 11/26/24 with low blood pressure (hypotension) and low heart rate (bradycardia- below 60 heart rate). (Refer to A-0398 Finding 7) 8. LNs did not develop and keep current nursing care plans for two of 14 patients (Pt 4 and Pt 20). (Refer to A-0396) 9. The hospital failed to monitor and keep current one of two Monitor Technician (MT- staff member who monitors heart rhythms and reports to nurse if there are irregular rhythms)/ Nursing Assistant (NA) required annual and biannual skills validation training (process of assessing, verifying, and documenting an individual’s competencies in a specific area) for Basic Life Support (BLS - a course designed to equip healthcare providers with basic skills and knowledge needed to respond effectively to breathing and cardiac emergencies in adults, children and infants) and Monitor Technician Electrocardiograph (EKG- test that measures the heart’s electrical activity) Exam. (Refer to A-0397) The cumulative effect of these system problems resulted in the hospital’s inability to provide quality nursing care in a safe setting.”

“Condition of Participation: Pharmaceutical Se CFR(s): 482.25 §482.25 Condition of Participation: Pharmaceutical Services. The hospital must have pharmaceutical services that meet the needs of the patients. The institution must have a pharmacy directed by a registered pharmacist or a drug storage area under competent supervision. The medical staff is responsible for developing policies and procedures that minimize drug errors. This function may be delegated to the hospital’s organized pharmaceutical service. This Condition is not met as evidenced by: 41166 Based on observation, interview and record review, the hospital failed to ensure pharmaceutical services met the needs of patients when: 1. The appropriateness of Patient 5’s medication regimen prior to discharge was not reconciled. Patient 5’s carvedilol (medication to lower blood pressure and strengthens heart to pump blood) dose was inappropriately increased prior to discharge. This failure resulted in Patient 5’s return to the hospital’s emergency department four days after discharge with hypotension (low blood pressure) and bradycardia (slow heart rate) and potential beta blocker (medication like carvedilol that lowers prssure) overdose. (Refer to A500) 2. An effective system to monitor high controlled substance (CS, medications with high probability of addiction and are controlled by the federal government) usages was not implemented and accurately reconcile controlled drugs losses for three of four sampled patients (Patients 57, 58, 59). These failures increased the potential to result in unaccounted controlled drug loss and for hospital staff to divert controlled drugs, which could place patients at risk for potential adverse outcomes including inadequate pain relief, as well as the potential for hospital staff to abuse controlled drugs. (Refer to A494) 3. Controlled substance (CS medications with high probability of addiction and are controlled by the federal government) medications were not stored according to hospital policy and procedures (P&P) for three of three sampled patients (Patients 56, 54, 55). These failures had the potential for CS medication diversion (illegal use of prescription medication or use for purposes not intended by the prescriber) and unauthorized access to medications. (Refer to A503) 4. The hospital failed to follow its policy titled, “Labeling of Medications” when three of 10 medications were observed to be unlabeled and left in a patient’s (Pt 8) drawer in a medication cart on the Oncology (a branch of medicine that specializes in the diagnosis and treatment of cancer) unit and were available for patient use. (Refer to 505) The cumulative effect of these systemic problems resulted in the hospital’s inability to ensure quality patient care in a safe setting.”

“PATIENT RIGHTS: NOTICE OF RIGHTS CFR(s): 482.13(a)(1) A hospital must inform each patient, or when appropriate, the patient’s representative (as allowed under State law), of the patient’s rights, in advance of furnishing or discontinuing patient care whenever possible. This Standard is not met as evidenced by: 49884 Based on interview and record review, the hospital failed to consider the right of patients to receive communication in preferred language for four of sixteen patients (Pt 6, Pt 16, Pt 17 and 21) whose preferred language was not English, patient care and services were not communicated in the preferred language, and interpreter services (help people communicate with each other when they speak different languages) were not used, in accordance with the hospital policies and procedures (P&P) titled, “Language Assistance Services Policy” and “Conditions of Admission and/or Registration Form”. These failures had the potential for ineffective communication, misunderstandings, and possible patient harm. Findings: During a concurrent interview and record review on 12/3/24 at 3:40 p.m. with Registered Nurse (RN) 2, Pt 21’s “Electronic Medical Record [EMR]” was reviewed. RN 2 stated she was Pt 21’s primary nurse for the day shift on 12/3/24. RN 2 stated Pt 21 understood some English. RN 2 stated, Pt 21’s “Admission Navigator Admit Information [ANAA],” dated 12/1/24 indicated Pt 21’s preferred language was Pashto, and an interpreter was needed for communication. RN 2 stated Pt 21’s brother had been at bedside during her beginning of shift assessment, and he interpreted for Pt 21. RN 2 reviewed Pt 21’s “Interpreter Services Flowsheet [ISF],” dated 12/3/24 and no interpreter information was documented. RN 2 stated she had not documented in the interpreter flowsheet for the morning assessment yet. RN 2 stated she should document on the “ISF” when Pt 21’s brother interprets. RN 2 stated Pt 21 should have signed a consent form indicating his brother could interpret for him, but none was scanned into the “EMR”. RN 2 stated the interpreter line should have used for Pt 21 when family was not at bedside for any new information and to ensure Pt 21 understood his plan of care, so “nothing gets lost in translation.” During an observation and interview on 12/3/24 at 3:48 p.m. with Pt 21 in his hospital room, Pt 21 was observed lying in bed with his eyes open. Pt 21 had no family at bedside. Pt 21 had bruising to right eye, with bandages to the cheekbone by right eye. Pt 21 stated he understood a little English, but he preferred Pashto was spoken to him. Pt 21 stated his brother was there sometimes and interpreted. During an interview on 12/3/24 at 3:53 p.m. with Director (DIR) 3, DIR 3 stated, common practice was to use an interpreter for non-English speaking patients for medical treatment. DIR 3 stated patients could designate family to interpret for them, and the hospital designated family interpreter form was signed by the patient and scanned into the medical record. DIR 3 stated LNs must document who interpreted in the medical record. DIR 3 stated the expectation was for LNs to follow the hospital’s interpreter policy and procedure. During a concurrent interview and record review on 12/5/24 at 1:30 p.m. with Nurse Educator (NE) 1 Pt 21’s “ISF,” dated 12/1/24 was reviewed. NE 1 stated on 12/1/24 no LN documentation was entered on the “ISF”. NE 1 stated LNs should have used an interpreter when communicating Pt 21’s plan of care, for any consents, and any new medications. NE 1 stated an interpreter should have been used and the information documented on the “ISF”. During an interview on 12/11/24 at 2:50 p.m. with the Chief Nursing Officer (CNO) the CNO stated, LNs should follow the hospital’s policy and procedure for interpreters. During a review of Pt 17’s “H&P” dated 11/23/24, the “H&P” indicated, Pt 17 was brought into the Emergency Department (ED) on 11/9/24 with Altered Mental Status (AMS - change in a person’s mental function, including their level of consciousness, awareness, cognition, or behavior) after being found in a parked car. Pt 17 was admitted to the hospital as an inpatient on 11/9/24 for acute respiratory failure (lungs cannot get enough oxygen for the body to survive) and Fournier’s gangrene (a type of flesh-eating disease that effects the genital area) and was moved to the ICU. The H&P indicated Pt 17 was in the Intensive Care Unit (ICU) from 11/9/24 to 11/22/24 and Pt 17 was moved to the Cardiac Telemetry (patient’s heart rhythm and rate, respiratory rate and oxygen are continuously monitored) Unit on 11/23/24 for intensive medical and surgical management due to the complexity and severity of his health issues. During an observation on 12/4/24 at 10:04 a.m. in Pt 17’s hospital room, Pt 17 was observed lying in bed at a 30-degree angle watching television with a sitter and Licensed Nurse (LN) at bedside. Pt 17 was heard speaking Spanish to his LN, and safety sitter. During an interview on 12/4/24 at 10:25 a.m. with Registered Nurse (RN) 10, RN 10 stated she was Pt 17’s primary nurse. RN 10 stated Pt 17 was a Spanish speaking patient who could be “belligerent [hostile and aggressive]” and “combative [ready to fight]” with the LNs and Certified Nursing Assistants (CNAs) when receiving care. RN 10 stated she used interpreter services for Pt 17 when communicating new medical information, and any consents. During a concurrent interview and record review on 12/5/24 at 9:35 a.m. with NE 2 Pt 17’s, “Interpreter Tab” documents dated 11/23/24 to 11/25/24 were reviewed. The “ADA [American with Disabilities Act] Accommodations Provided [ADAP]” under the “Interpreter Tab,” indicated, Pt 17’s, preferred language was Spanish and language assistance was needed. The “ISF” documentation was blank on 11/23/24, 11/24/24, and the a.m. shift of 11/25/24 indicating an interpreter was not used to communicate with Pt 17. NE 2 stated on 11/23/24 at 1:30 p.m. and 11/25/24 at 9:10 a.m. LNs documented in the “ADAP” Pt 17 needed language assistance in Spanish, but the “ISF” was blank. NE 2 stated on 11/24/24 no documentation was in the medical record for Interpreter Services. NE 2 stated LNs should have used an interpreter to communicate with Pt 17. NE 2 stated using an interpreter was important when communicating things such as, education, medications, and plans of care, so that Pt 17 could understand what was being done to him and for him. NE 2 stated LNs should be providing “patient centered care”. During an interview on 12/11/24 at 2:50 p.m. with the Chief Nursing Officer (CNO) the CNO stated, LNs should follow the hospital’s policy and procedure for interpreters. During a concurrent interview and record review on 12/5/24 at 1:40 p.m. with Nurse Educator (NE) 2, Pt 16’s “H&P,” dated 12/1/24, “Conditions of Admission [COA-consent to the general terms and condition for receiving care from hospital. Authorizes general medical and nursing to be provided and financial responsibility for payment of hospital charges for services rendered],” dated 12/1/24 at 2:50 p.m. and “ISF” dated 12/1/24 p.m. was reviewed. The “H&P” indicated Pt 16 was “Cambodian Speaking”. NE 2 stated Pt 16’s “COA” was in English, Pt 16 signed the form, and two staff members witnessed the form but the area on the form indicating an interpreter was used was left blank. NE 2 stated Patient Access Staff completed the “COA” form with patients upon admission to the hospital. NE 2 stated Pt 16’s “ISF” had no documentation an interpreter was used for the “COA”. NE 2 stated hospital staff were supposed to document in the “ISF” when an interpreter was used. During an interview on 12/9/24 at 8:40 a.m. with the Manager of Patient Access (MPA) and the Patient Access Lead (PAL), the PAL stated Pt 16’s preferred language (Cambodian) was not available (in written form) in the facility’s “COA” so Patient Access Staff should have used an interpreter. The PAL stated when an interpreter was used, registration staff were supposed to document the interpreter’s name, ID number, and if interpreter was by phone, video, or in person. The PAL stated Patient Access Staff could also document in the “ISF” when an interpreter was used. The PAL stated using an interpreter for non-English speaking patients was important to ensure understanding of the document before signing. During a concurrent interview and record review on 12/6/24 at 10:25 a.m. with Registered Nurse (RN) 6, Pt 6’s “Electronic Medical Record [EMR] was reviewed. Pt 6’s “Admission Navigator Admit Information [ANAA],” dated 12/2/24 indicated Pt 6’s preferred language was Spanish, and an interpreter was needed for communication. Pt 6’s “COA,” dated 12/2/24 at 7:28 a.m. was in English, signed by Pt 6 and Patient Access Staff, and the interpreter field was blank. RN 6 stated the “COA” should have been given to the patient in Spanish or the interpreter field should have been completed if an interpreter was used to translate the form. RN 6 stated PT 6’s “ISF” had no documentation from Patient Access Staff. During a concurrent interview and record review on 12/9/24 at 8:45 a.m. with the MPA and the PAL, Pt 6’s, “ANAA” and “ISF,” dated 12/2/24, and the “COA,” dated 12/2/24 at 7:28 a.m. were reviewed. The PAL verified on the “ANAA” Pt 6 indicated her preferred language was Spanish, and she requested an interpreter. The PAL verified Pt 6’s “COA” was written in English and no interpreter information was documented on the “COA” or on the “ISF”. The PAL stated the “COA” should have been written in Pt 6’s preferred language and/or an interpreter should have been used to interpret the form. During a review of the hospital’s P&P titled, “Language Assistance Services Policy,” dated 1/8/24, indicated, “ ... To ensure that Limited English Proficient (LEP) persons and persons with hearing or visual impairments have equal access as well as awareness as to possible options for all services offered by [hospital] ... [hospital] will promptly identify the language and communication needs of the LEP person ... The interpreter’s responsibilities will include translating the information regarding the recommended medical treatment that the patient or the patient’s legal representative needs to receive before deciding whether to give consent, as well as instructions regarding medical care ... The patient has the right to appoint someone to interpret for themselves. In these cases, the patient MUST sign the [hospital] “Patient Appointed Language and Sign Language Consent” Form ... Use of family members or companions as interpreters is discouraged, except for the most extraordinary circumstances, such as medical emergencies ... Staff will be utilized only for simple interpretations such as those dealing with Activities of Daily Living (ADLs) and simple patient care related issues ... Staff will not translate for conversations dealing with medical issues, i.e. [such as] diagnosis and/or treatment, risks and benefits, informed consents, etc. ... Vital documents, including consent forms, presented by hospital staff to a patient will be written in a language that the patient can understand or translated into such a language ... [hospital] will conduct a nursing admission assessment of the communication needs of each patient served and record the patient’s needs in the medical record ... The assessment will include: ... Preferred language ... Need for interpreter services (e.g., LEP, hearing impairment, sight impairment) Any subsequent use of any interpreter services will be documented in the medical record ... Reason for service ... Agency Used ... Name/and or ID number of the interpreter ...” During a review of the hospital’s P&P titled, “Conditions of Admission and/or Registration Form,” dated 3/27/24, indicated, “ ... A Conditions of Admission (COA) and/or Conditions of Registration (COR) Consent Form must be signed by each patient or patient’s representative upon admission to [hospital name] or as soon thereafter as possible. It is the responsibility of the representative to clearly define each aspect of the conditions of admission to the patient/patient representative ... If a patient is identified as having Limited English proficiency (LEP), language assistance will be provided through use of language identification cards, proficient bilingual staff, telephone language interpretation vendor services, and/or other arrangements. A patient, after being informed of the availability of the interpreter service, may choose to use a family member/friend instead ...” During a review of professional reference titled, “Clinicians’ Obligations to Use Qualified Medical Interpreters When Caring for Patients with Limited English Proficiency,” dated 3/2017, (retrieved from https://journalofethics.ama assn.org/article/clinicians obligations use qualified medical interpreters when caring patients limited English/2017 03) indicated, “ ... Access to language services is a required and foundational component of care for patients with limited English proficiency (LEP) ... In the United States, patients with LEP have a legal right to access health care in their preferred language ...””

“NURSING CARE PLAN CFR(s): 482.23(b)(4) The hospital must ensure that the nursing staff develops, and keeps current, a nursing care plan for each patient that reflects the patient’s goals and the nursing care to be provided to meet the patient’s needs. The nursing care plan may be part of an interdisciplinary care plan. This Standard is not met as evidenced by: 49884 Based on observation, interview and record review, the hospital failed to ensure nursing staff developed and kept current a nursing care plan when: 1. Licensed Nurses (LNs) did not assess and develop a care plan for Pt 20’s primary admitting diagnosis of seizures (a temporary episode of abnormal electrical activity in the brain that causes sudden change of behavior, movement, or consciousness) and alcohol withdrawal in accordance with hospital policy and procedure (P&P) titled, “Patient Plan of Care” and the hospital “Registered Nurse Job Description”. This failure had the potential to result in Pt 20’s seizure and alcohol withdrawal care needs going unmet and could possibly lead to a decline in health status. 2. LNs did not assess and revise an individualized care plan for one of two sampled patients (Pt 4) for safety and smoking cessation in accordance with their policy and procedure titled “Patient Plan of Care”. This failure had the potential to result in Pt 4’s care needs going unmet and could possibly lead to a decline in health status. Findings: 1. During a concurrent interview and record review on 12/5/24, at 2:40 p.m. with Nurse Educator (NE) 1, Pt 20’s “History and Physical [H&P - the formal document that physicians produce through interview with the patient, physical exam, and the summary of testing either obtained or pending]”, dated 12/2/24, was reviewed. The “H&P” indicated, Pt 20 had a past medical history of hypertension (high blood pressure), seizure disorder (a chronic brain condition that causes recurring temporary episodes of abnormal electrical activity in the brain that cause sudden change of behavior, movement, or consciousness), and alcohol abuse, who presented to the ED (Emergency Department) after three unwitnessed seizures the day before. NE 1 stated Pt 20 was admitted to the hospital as an inpatient on 12/2/24 for alcohol withdrawal seizures. NE 1 stated Pt 20 was moved to the Medical Surgical (MS) unit on 12/2/24 at 5:51 a.m. During a concurrent interview and record review on 12/5/24, at 2:48 p.m. with NE 1, Pt 20’s “Care Plan Event Log [CPEL]”, dated 12/2/24 to 12/4/24 was reviewed. Pt 20’s “CPEL” addressed issues for impaired skin integrity, and falls. NE 1 stated Pt 20’s alcohol withdrawal and history of seizures were not addressed in the care plan. NE 1 stated there should have been a nursing care plan to address Pt 20’s seizures and alcohol withdrawal. NE 1 stated LNs were expected to develop care plans that matched and guided the care needs of the patient and ensured individualized care was provided. During an interview on 12/6/24 at 9:03 a.m. with Nurse Manager (NM) 3, NM 3 stated, nurses were expected to initiate and revise care plans for patient’s care needs. During a concurrent interview and record review with the Chief Nursing Officer (CNO), on 12/11/24, at 2:40 p.m., Pt 20’s primary diagnosis and past medical history were reviewed. The CNO stated Pt 20’s primary diagnosis and any chronic diseases should have been addressed by LNs in the care plan. The CNO stated, LNs were expected to follow hospital policy and procedure to develop, document and update the care plan to meet the patients’ care needs. During a review of the facility P&P titled, “Patient Plan of Care”, dated 10/19/23, the P&P indicated, “ ... The plan is individualized/revised based on ongoing assessment findings, the patient’s response to treatment/interventions and evaluation of progress toward outcomes. Care planning ends at discharge/ transition of care ... Patient Plan of Care: Patient-centric documented plan for care, treatment and services that reflects his/ her specific needs and preferences. It may include individualized goals and services required to meet those goals in the designated setting of care. It is maintained/revised based on the patient’s condition, preferences, response to interventions. It is the patient’s plan - the centralized plan that drives the priorities and professional processes of care for the inter-professional team to prevent/manage/minimize potential problems and outcomes ...Reviewing and updating the plan of care occurs on an ongoing basis throughout the patient’s hospitalization. Each shift the registered nurse is responsible for reviewing and updating the plan of care after assessing the patient. Additionally, other members of the inter-professional care team will review and update the plan of care as necessary ...” During a review of the hospital’s document titled, “ Registered Nurse Job Description” dated 12/3/24, indicated, “ ... Delivers holistic and individualized care to all patients in an assigned area. Develops, implements, and coordinates a plan of care that incorporates psychological, sociocultural, spiritual, economic, and life-style factors ... Collaborates and communicates with physicians and other members of the healthcare team to interpret, adjust, and coordinate daily patient care plan to ensure a plan of care that is patient centric [centered] with continuity of care [consistent and seamless provision of ongoing healthcare management to a patient over time] ...”. The “Lippincott Manual of Nursing Practice 10th Edition,” dated 2014, page 16-17 indicated, “ ...Standards of practice General Principles... 1. The practice of professional nursing has standards of practice setting minimum levels of acceptable performance for which its practitioners are accountable ...b. These standards provide patients with a means of measuring the quality of care they receive ...5. A deviation from the protocol should be documented in the patient’s chart with clear, concise statements of the nurse’s decisions, actions, and reasons for the care provided, including any apparent deviation ... Legal claims most commonly made against professional nurses include the following departures from appropriate care: failure to assess the patient properly or in a timely fashion, follow physician orders, follow appropriate nursing measures, communicate information about the patient, adhere to facility policy or procedure, document appropriate information in the medical record ... Failure to formulate or follow the nursing care plan ...” 2. During a concurrent interview, on 12/6/24, at 8:15 a.m., with Director of Accreditation (DA) and Director, Quality and Patient Safety (DQPS), dated 12/3/2024, was reviewed. DQPS stated, Pt 4 had come to the hospital for chest pain, cough, and shortness of breath. DQPS stated, Pt 4 had been smoking in his room and was found with burn to chin and bedding. DQPS stated, Pt 4 has been treated and no other patients have been harmed. DA stated, Pt 4 was still in the hospital. During a concurrent observation and interview on 12/6/24, at 8:45 a.m., with Pt 4, Pt 4 was observed sitting in bed and watching television. Pt 4 observed with uneven beard and white cream substance in strands of his beard. Pt 4 stated he had some pain but very minimal as he rubbed his chin. Pt 4 stated, he did not remember how fire started in his room or what happened. Pt 4 denied being a smoker and stated he did not know anything about the fire. Pt 4 stated he was in bed and fire was there and did not remember how big the fire was. During a concurrent interviews and record review on 12/6/24, at 8:55 a.m. and 9:20 a.m., with Registered Nurse (RN) 9, Pt 4’s electronic health record (EHR- digital collection of medical information) and Pt 4’s “H&P”, dated 12/4/2024 at 2:16 a.m. were reviewed. Pt 4’s H&P indicated Pt 4 was brought to the hospital with shortness of breath and a productive cough. Pt 4 was admitted with a diagnosis of pneumonia (infection of the lungs) and was prescribed intravenous (by the vein) antibiotics (medications to treat infections). Pt 4 denied smoking tobacco in the H&P. RN 9 stated, Pt 4 had attempted to smoke in his room on 12/4/2024 at 10:07 a.m. and burned his chin from the oxygen tubing that caught on fire. RN 9 stated, patient had denied smoking and illicit drug use, although a lighter was found in his belongings. During an interview on 12/6/24 at 9:03 a.m. with Nurse Manager (NM) 3, NM 3 stated, nurses were expected to initiate and revise care plans for patient’s care needs. NM 3 stated, nurses should have updated the care plan for Pt 4 to include safety with oxygen and smoking cessation. During a concurrent interviews and record review on 12/6/24, at 9:20 a.m., with Registered Nurse (RN) 9, Pt 4’s EHR and “Document in Plan [Nursing Care Plan]”, dated 12/4/2024, were reviewed. RN 9 stated, had Pt 4’s “Nursing Care Plan” indicated, “ ... Diabetes (disorder characterized by difficulty in blood sugar control and poor wound healing), ... Respiratory Insufficiency (a medical condition that makes it difficult to breathe) ... Pain (Acute-sudden) ... Pressure Ulcer (localized area of skin damage caused by constant pressure on the skin) Risk ... Violence, Risk/Actual ... Fall Risk ... Patient Care Overview ... as the focused care problems for nursing interventions ....” RN 4 stated, the care plan did not address the issue of smoking cessation or safety. RN 4 stated, after the incident, she was unable to find any documentation from the nurses, educating Pt 4 about not smoking or safety in regard to use of oxygen. RN 4 stated, the care plan should be updated to include educating the patient about not smoking and safety with oxygen use. RN 4 stated, care plans were used to guide the care of the patient and ensured the continuity of the care of the patient. During an interview on 12/11/2024 at 2:40 p.m., with the CNO, the CNO stated, the nursing care plan should have been revised to addressed Pt 4’s primary needs for safety and smoking cessation. The CNO stated, nurses were expected to follow the policy to develop, document and update the care plan to meet the patient’s care needs. During a review of the facility P&P titled, “Patient Plan of Care”, dated 10/19/2023, the P&P indicated, “ ... The plan is individualized/revised based on ongoing assessment findings, the patient’s response to treatment/interventions and evaluation of progress toward outcomes. Care planning ends at discharge/ transition of care ... Patient Plan of Care: Patient-centric documented plan for care, treatment and services that reflects his/ her specific needs and preferences. It may include individualized goals and services required to meet those goals in the designated setting of care. It is maintained/revised based on the patient’s condition, preferences, response to interventions. It is the patient’s plan - the centralized plan that drives the priorities and professional processes of care for the inter-professional team to prevent/manage/minimize potential problems and outcomes ...Reviewing and updating the plan of care occurs on an ongoing basis throughout the patient’s hospitalization. Each shift the registered nurse is responsible for reviewing and updating the plan of care after assessing the patient. Additionally, other members of the inter-professional care team will review and update the plan of care as necessary ...”. During a review of the hospital’s document titled, “ Registered Nurse Job Description” dated 12/3/24, indicated, “ ... Delivers holistic and individualized care to all patients in an assigned area. Develops, implements, and coordinates a plan of care that incorporates psychological, sociocultural, spiritual, economic, and life-style factors ... Collaborates and communicates with physicians and other members of the healthcare team to interpret, adjust, and coordinate daily patient care plan to ensure a plan of care that is patient centric [centered] with continuity of care [consistent and seamless provision of ongoing healthcare management to a patient over time] ...” The “Lippincott Manual of Nursing Practice 10th Edition,” dated 2014, page 16-17 indicated, “ ...Standards of practice General Principles... 1. The practice of professional nursing has standards of practice setting minimum levels of acceptable performance for which its practitioners are accountable ...b. These standards provide patients with a means of measuring the quality of care they receive ...5. A deviation from the protocol should be documented in the patient’s chart with clear, concise statements of the nurse’s decisions, actions, and reasons for the care provided, including any apparent deviation ... Legal claims most commonly made against professional nurses include the following departures from appropriate care: failure to assess the patient properly or in a timely fashion, follow physician orders, follow appropriate nursing measures, communicate information about the patient, adhere to facility policy or procedure, document appropriate information in the medical record ... Failure to formulate or follow the nursing care plan ...””

“PATIENT CARE ASSIGNMENTS CFR(s): 482.23(b)(5) A registered nurse must assign the nursing care of each patient to other nursing personnel in accordance with the patient’s needs and the specialized qualifications and competence of the nursing staff available. This Standard is not met as evidenced by: 49769 Based on interview and record review, the hospital failed to ensure staff received appropriate education and training to provide care for each patient in accordance with the individual needs of each patient according to job description, titled “Monitor Technician & Nurse Assistant” when one of two sampled Monitor Technician [MT] did not complete the required annual and biannual skills validation training (process of assessing, verifying, and documenting an individual’s competencies in a specific area) for Basic Life Support (BLS - a course designed to equip healthcare providers with basic skills and knowledge needed to respond effectively to breathing and cardiac emergencies in adults, children and infants) and Monitor Technician Electrocardiograph (EKG- test that measures the heart’s electrical activity) Exam. These failures resulted in MT to be not trained to handle emergency situations and had the potential to result in patients’ harm due to lack of staff training in the management of patients with medical emergencies. Findings: During a concurrent interview and record review on 12/6/2024 at12:30 p.m. with Director of Critical Care Services (DIR), MT’s personnel file was reviewed. MT was hired June 2014 and had been oriented to his current position on July 2015. A document titled, “Basic Life Support”, undated, indicated, MT’s BLS certification was expired as of January 2024 and was not current. DIR 1 stated, MT had worked earlier in the week as a MT. DIR stated MT should have completed BLS training per hospital policy. A document titled, “Student and Group Transcript Report”, undated, indicated, MT’s annual competency for EKG was completed 4/17/2017 indicating it expired on 4/17/2018. There was no updated EKG competency completed since 4/17/2017. DIR 1 stated the MT Should have completed the annual competency per MT’s job description. DIR stated, MT had been suspended until he had updated all trainings. During an interview on 12/11/24 at 2:30 p.m. with the Chief Nursing Officer (CNO), the CNO stated MT was not in compliance with up-to-date EKG competencies or BLS Certification. The CNO stated MT not being in complianc was unacceptable. CNO stated MT should not have had expired EKG and BLS certification. The CNO stated the expectation was for all staff to be compliant with all training. During a review of MT’s personnel file, a document titled, “Monitor Technician and Nurse Assistant- Job Description”, undated, indicated, “... COMPLIANCE ... Retains and completes mandated continuing education requirements to meet departmental and facility requirements ... CERTIFICATION AND LICENSURE: BLS-Basic Life Support Healthcare Provider EKG-Technician within 30 days ...””

“SUPERVISION OF CONTRACT STAFF CFR(s): 482.23(b)(6) All licensed nurses who provide services in the hospital must adhere to the policies and procedures of the hospital. The director of nursing service must provide for the adequate supervision and evaluation of all nursing personnel which occur within the responsibility of the nursing service, regardless of the mechanism through which those personnel are providing services (that is, hospital employee, contract, lease, other agreement, or volunteer). This Standard is not met as evidenced by: 42321 Based on observation, interview, and record review, the hospital failed to follow their policies and procedures (P&P) for 11 of 36 sampled patients (Pt), Pt 1, Pt 3, Pt 5, Pt 7, Pt 8, Pt 10, Pt 12, Pt 15, Pt 19, Pt 20, Pt 21) when: 1.Licensed Nurses (LN) did not follow the hospital’s P&Ps for “Pain Management”, Licensed Provider Orders: Receiving, Transcribing, Reviewing” and “Medication Administration” for eight of 14 Pts (Pts 1, 3, 7, 8, 12, 15, 19, 21). For six of 14 Pts (Pts 1, 3, 12, 15, 19, 21), LNs did not complete a pain assessment. For three of 14 Pts (Pts 1, 15, 19), LNs did not reassess pain after administration of pain medication within the expected timeframe. LNs did not administer adequate pain medications to address 10/10 pain experienced by Pt 3 and instead inappropriately administered Acetaminophen. LNs did not follow the Pt 7’s physician’s order to titrate (slowly increasing the dose of a medicine by very small amounts to find the right dose that is effective) the pain medication. These failures had the potential for patients to receive inadequate pain management and had the potential for LNs to miss a change in condition. 2. LNs did not monitor the patient while administering a high-risk/high-alert medications (Medications that have a heightened risk of causing significant patient harm when they are used in error) in accordance with their policies for “Medication Administration” and “High Risk/High Alert Medications” for one of one sampled patient (Pt 10). This failure placed Pt 10 at risk for not receiving the desired patient therapeutic medication goals (meaningful outcome for patients). 3. LNs did not clarify an order of “ventilator [a machine for used to assist with breathing] compliance” for a medication used for sedation (administering of a medication that causes a state of calm or sleep) in accordance with their policy for “Medication Administration” for one of one sampled patient (Pt 5). This failure had the potential to leave patients with under (to little sedation can cause a patient to be in pain or increase the patient’s anxiety) or oversedation (causing excessive drowsiness, loss of response to verbal command, inappropriate movement, hearing and vision disturbances, etc.). 4. LNs did not follow the physician order (PO) for two of three patients (Pt 1 and Pt 20), when the ordered neurological assessment (a physical exam that helps identify disorders of the brain, spinal cords, and nerves) was completed by LNs without the required pupil measurement, according to hospital policy and procedure (P&P) “Neurological Assessment and Flow Sheet”. This failure had the potential to result in missing a change in condition in patients and a possible delay in implementing interventions to address the clinical needs of patients. 5. LNs did not document a change of condition assessment for one of 17 patients (Pt 1) after Pt 1 had an unexplained injury, in accordance with the hospital P&P titled, “Assessment: Admission and Reassessment.” This failure resulted in conflicting documentation about Pt 1’s injury site and had the potential to result in a possible delay of needed treatment and services for Pt 1. 6. LNs failed to document discharge instructions for two of 36 patients (Pt 1 and Pt 20) according to hospital P&P titled “Discharge Planning Services”. These failures had the potential for Pt 1 and Pt 20 to be discharged without fully understanding discharge information, including any follow up appointments and new or changed medications which could lead to patient harm. 7. LNs did not follow the hospital policy “Medication Reconciliation” for one of four patients, Pt 5 upon discharge on 11/22/24. This failure resulted in Pt 5 being discharged on 11/22/24 on the wrong dose of Coreg (medication used to treat high blood pressure and heart failure) and being readmitted on 11/26/24 with low blood pressure and low heart rate. Findings: 1. During a review of Pt 1’s “History and Physical [H&P - an assessment from physician including medical history and exam],” dated 9/23/24, the “H&P” indicated, Pt 1was brought in by ambulance to the Emergency Department (ED) after a motor vehicle accident (MVA). Pt 1 was admitted as an inpatient to the hospital on 9/23/24 at 9:37 a.m. for a scalp laceration (cut on the head), a closed dislocation of phalanx (finger bone) of right hand, a dislocation (joint if forced out of normal position) of tarsometatarsal (joints connecting mid-foot bones to hindfoot bones) joint of right foot, a right metatarsal (tubular bones in the middle of foot connecting ankle to toes) fracture, and a Subarachnoid hemorrhage (Bleeding in the space between the brain and the tissue covering the brain). During a concurrent interview and record review on 12/4/24 at 1:30 p.m. with Nurse Educator (NE)2 Pt 1’s “Physician Medication Order [PMO],” dated 9/23/24 at 7:01 a.m. was reviewed. The “PMO” indicated, “ ...fentanyl [strong pain medication] ... Inj [injection] 50 mcg [micrograms - a unit of measurement] ... intravenous (into the vein) ... EVERY 30 MINUTES PRN [as needed] ... IV push [pushed into the intravenous line with a syringe] over 1 to 2 min [minutes]. During a concurrent interview and record review on 12/4/24 at 1:35 p.m. with NE 2 Pt 1’s “PMO,” dated 9/23/24 at 9:41 a.m. was reviewed. The “PMO” indicated, “ ... acetaminophen [mild pain medication] ... 1000 mg [milligram - a unit of measurement] ...intravenous ... Q8HR [every 8 hours] ...”. During a concurrent interview and record review on 12/4/24 at 2 p.m. with NE 2, Pt 1’s “Pain Assessment Flowsheet [PAF], and “Medication Administration Record [MAR]” dated 9/23/24 were reviewed. The “PAF” and “MAR” indicated complete pain assessments were not documented with medication administration per P&P. The “PAF” indicated at 7:38 a.m. a pain score of 10 out of 10 “worst possible” and the “MAR” indicated administration of 50 mcg Fentanyl. The “PAF” had no additional pain assessment indicators documented. NE 2 stated LNs should have documented a complete pain assessment prior to administering pain medications, including the location of the pain, if pain was radiating (pain that travels from one body part to another) and a description of the type of pain. The “PAF” indicated at 3:14 p.m. a pain score of 9 and the “MAR” indicated administration of 1,000 mg acetaminophen. NE 2 stated no additional pain assessment indicators were documented. NE 2 stated her expectation was for the entire pain assessment flowsheet to be completed when LNs assessed pain. NE 2 stated controlling patient’s pain promoted better healing. During an interview on 12/9/24 at 10:05 a.m. with Registered Nurse (RN) 5, RN 5 stated he was an ED Trauma Nurse. RN 5 was Pt 1’s primary nurse in the ED on 9/23/24. RN 5 stated when he assessed for pain, he talked with the patient about where the pain was located, the quality of the pain, what made it worse, and where the injury site was. RN 5 stated he did not always document the entire pain assessment on the “PAF”, but he assessed pain fully. RN 5 stated he should document the entire pain assessment. RN 5 stated completing a full pain assessment was important because a pain score number did not “paint a full picture [give enough information]” of a patient’s pain. During an interview on 12/9/24 at 10:05 a.m. with Nurse Manager (NM) 6, NM 6 stated pain should be assessed completely and documented. During an interview on 12/9/24 at 10:37 a.m. with Pt 1, Pt 1 stated, he had a lot of pain when he was first admitted to the hospital. Pt 1 stated he did not feel his pain was controlled very well the first day of admission. Pt 1 stated he felt LNs were always “behind the pain”, so his pain was not controlled. Pt 1 stated medications were not administered until his pain was a nine or 10. Pt 1 stated he felt if LNs administered pain medications sooner his pain would have been more controlled. During an interview on 12/11/24 at 2:36 p.m. with the Chief Nursing Officer (CNO), the CNO stated her expectation was for LNs to do a full pain assessment according to hospital P&P. The CNO stated LNs should complete a full pain assessment during the initial and shift assessment, when patient’s had pain, and when pain medications were administered. During a review of Pt 15’s “H&P,” dated 12/1/24, the “H&P” indicated, Pt 15 presented to the ED with a chief complaint of right hip pain. The “H&P” indicated Pt 15 had a past medical history (PMH) of type 2 diabetes (disorder characterized by difficulty in blood sugar control and poor wound healing) with peripheral neuropathy (disease or dysfunction of one or more nerves, typically causing numbness or weakness in the hands and feet). The “H&P” indicated Pt 15 was admitted to the hospital on 12/1/24 at 2:14 p.m. for closed fracture of the neck of right femur (top of the thigh bone breaks just below the hip joint). During a concurrent interview and record review on 12/5/24 at 3:10 p.m. with NE 2 Pt 15’s “PMO,” dated 12/1/24 at 1:02 p.m. was reviewed. The “PMO” indicated, “ ... acetaminophen [mild pain medication] ... 1000 mg [milligram - a unit of measurement] ...Oral ... Now ...”. During a concurrent interview and record review on 12/5/24 at 3:14 p.m. with NE 2 Pt 15’s “PMO,” dated 12/1/24 at 2:08 p.m. was reviewed. The “PMO” indicated, “ ...fentanyl [strong pain medication] ... Inj ... 25 mcg ... intravenous ... NOW ... IV push [pushed into the intravenous line with a syringe] over 1 to 2 min [minutes]. During a concurrent interview and record review on 12/5/24 at 3:18 p.m. with NE 2 Pt 15’s “PMO,” dated 12/1/24 at 2:08 p.m. was reviewed. The “PMO” indicated, “ ... tramadol (medication for moderate to moderately severe pain) ... tab [tablet] 50 mg ... Oral ... Q6H [every 6 hours] for moderate pain (4-6) ...”. During a concurrent interview and record review on 12/5/24 at 3:22 p.m. with NE 2, Pt 15’s “PAF”, and “MAR” dated 12/1/24 were reviewed. The “PAF” and “MAR” indicated complete pain assessments were not documented with medication administration and reassessments were not completed within two hours after medication administration. The “PAF” indicated at 1:02 p.m. a pain score of five out of 10 “moderate pain” with no additional pain assessment information documented, and the “MAR” indicated administration of 1000 mg acetaminophen. NE 2 stated LNs should have documented a complete pain assessment prior to administering pain medications, including the location of the pain, if pain was radiating and a description of the type of pain. The “PAF” indicated at 3:18 p.m. a pain score of five with no additional pain assessment information documented, and the “MAR” indicated administration of 25 mcg of fentanyl. The “PAF” indicated at 6:05 p.m. a pain score of 5. NE 2 stated a pain reassessment should have been documented at 5:18 p.m. NE 2 stated LNs should have reassessed Pt 15’s pain within two hours of medication administration to ensure effectiveness. During an interview on 12/11/24 at 2:36 p.m. with the Chief Nursing Officer (CNO), the CNO stated her expectation was for LNs to do a full pain assessment, and reassess pain according to hospital P&P. During a review of Pt 19’s “H&P,” dated 11/18/24, the “H&P” indicated, Pt 19 was transferred from another hospital for bariatric (making changes to digestive system to lose weight) and gastroenterologist (GI -physician who specializes in digestive system) evaluation. The “H&P” indicated Pt 19 had a Previous Medical History (PMH) of Roux-en-Y (weight loss surgery that involves creating a small stomach pouch connected directly to the small intestine) surgery, who presented to the hospital with abdominal pain. The “H&P” indicated Pt 19 was a direct admit to the hospital on 11/18/24 at 8:32 a.m. for cholecystitis (inflammation of the gallbladder) with gangrene (body tissue dies due to a lack of blood supply) of gallbladder after bariatric surgery. During a concurrent observation and interview on 12/4/24 at 10:19 a.m. with Pt 19 in Pt 19’s hospital room, Pt 19 was lying in his hospital bed on his back with his eyes open at a 45-degree angle. Patient had several red and swollen areas on his abdomen. Pt 19’s wounds were initially covered with a dressing (applied to wounds to protect from infection) and a surgical drain coming out of one of the wounds draining fluid to a collection bag attached to the railing of his hospital bed. Pt 19’s LNs were performing a dressing change to his abdominal wound. Pt 19 stated he had an infection in his abdomen requiring surgical cleaning of the wound. Pt 19 stated he required twice a day dressing changes with packing (a method of filling a wound with dressing material to help healing) into the wound. Pt 19 stated his abdominal pain was “really bad” when he was first admitted to the hospital. During a concurrent interview and record review on 12/5/24 at 3:52 p.m. with NE 2, Pt 19’s “PMO,” dated 11/18/24 at 9:23 a.m. were reviewed. The PMO indicated, “ ... morphine lnj 2 mg ... Intravenous ... Q2H [every 2 hours] PRN [as needed] for Moderate Pain (4-6), Severe Pain (7-10) ...”. During a concurrent interview and record review on 12/5/24 at 3:57 p.m. with NE 2, Pt 19’s “PAF”, and “MAR” dated 11/18/24 were reviewed. The “PAF” and “MAR” indicated complete pain assessments were not documented with medication administration and reassessments were not completed within two hours after medication administration. The “PAF” indicated at 9:40 a.m. a pain score of eight (severe pain) out of 10 with no additional pain assessment information documented, and the “MAR” indicated administration of 2 mg morphine. NE 2 stated LNs should have documented a complete pain assessment prior to administering pain medications, including the location of the pain, if pain was radiating and a description of the type of pain. NE 2 stated Pt 19’s “PAF” indicated at 1 p.m. a pain score of seven (severe) with no additional pain assessment information documented. NE 2 stated Pt 19’s pain should have been reassessed at 11:40 a.m. within two hours of medication administration to ensure effectiveness. During a review of Pt 21’s “H&P,” dated 11/30/24, the “H&P” indicated, Pt 21 was brought in by ambulance to the ED after an MVA. Pt 21 was admitted as an inpatient to the hospital on 11/30/24 at 10:45 p.m. for a compression fracture of T12 vertebra (a broken bone in the spine of the middle back), closed fracture (broken bone where skin remains intact) of right sided and left sided mandibular body (lower jaw), and closed fracture of maxilla (bone that forms the upper jaw). During a concurrent observation and Interview with on 12/3/24 at 3:48 p.m. in Pt 21’s hospital room, Pt 21 was observed lying in bed at a 45-degree angle with his eyes open. Pt 21 had bruising to his face around his right eye, with scrapes along his cheekbone near his eye. Pt 21 had no family with him at bedside. Pt 21 had a non-English preferred language but stated he understood some English. When Pt 21 was asked if he had pain from his injuries, Pt 21 stated sometimes his injuries hurt “a lot”. During a concurrent interview and record review on 12/5/24 at 1:38 p.m. with NE 1, Pt 21’s “PMO,” dated 11/30/24 at 11:42 p.m. was reviewed. The “PMO” indicated, “ ... HYDROcodone/acetaminophen [medication for moderate to severe pain]5mg/325mg [5 mg hydrocodone with 325 mg acetaminophen] ... 1 tab [tablet] ... Oral ... Q4H PRN for Severe Pain (7-10) ...”. During a concurrent interview and record review on 12/5/24 at 1:43 p.m. with NE 1 Pt 21’s “PAF” and “MAR,” dated 12/4/24 was reviewed. The “PAF” and “MAR” indicated Pt 21 was administered pain medication and was discharged from the hospital without a pain reassessment. The “PAF” indicated on 12/4/24 at 2:15 a.m. a pain assessment score of eight out of 10 and the “MAR” indicated administration of one tablet hydrocodone/acetaminophen. NE 1 stated the “PAF” had no documentation of a pain reassessment for Pt 21. NE 1 stated Pt 21 was discharged from the hospital on 12/4/24 at 2:32 a.m. NE 1 stated Pt 21 was discharged with a documented pain score of eight. NE 1 stated LNs should have reassessed Pt 21 prior to discharge to ensure he had relief from pain. During an interview on 12/11/24 at 2:36 p.m. with the CNO, the CNO stated Pt 21’s pain should have been reassessed prior to discharge. The CNO stated her expectation was for LNs to follow hospital P&P and reassess for pain after pain medications were administered. During a concurrent interview and record review on 12/5/24, at 3:34 p.m., with the NE 6, Pt 12’s “Face sheet” (provides demographics of the patient, name, date of birth, admission date, chief complaint), “PMF”, and “electronic health records” (EHR), were reviewed for Pt 12’s admission dated 11/23/2024. NE 6 stated Pt 12 had an order for Hydrocodone/acetaminophen 5mg /325 mg one tablet ordered every 4 hours for pain. The PMF indicated, Pt 12 received 1 table of Hydrocodone/acetaminophen 5mg /325 mg on 12/4/24 at 11:06 a.m., for a pain level of 7 but no reassessment was documented. NE 6 validated the missing reassessment and interventions for the elevated pain assessment after the medication was given. NE 6 stated the pain medication should be reassessed up to 2 hours after medications administration per policy. NE 6 stated she expected nurses to treat patients’ pain and try to control the patients’ level of pain to what is acceptable to the patient. NE 6 stated nurses were expected to monitor patients for adverse affects to pain medications. During a review of Pt 12’s,”HOSPITALISTS H&P,” dated 11/23/24, the “H&P” indicated, Pt 12 was admitted on 11/23/24 for “ ...Chief Complaint: dark stool ... with PMH significant for esrd [end stage renal disease] HD [hemodialysis - a machine used to filter blood when kidneys no longer function] since 11/01/24, urine retention, chronic foley [a catheter in the bladder to drain urine], ... HFpEF [Heart Failure with Preserved Ejection Fraction - a type of heart failure where the heart does not pump the blood efficiently], RLE DVTs [Right Lower Extremity Deep Vein Thrombosis - blood clots in the leg] on coumadin [a medication to prolong the clotting time of blood and prevent clots], who presents for evaluation of dark stool. ... the patient developed blood in her stool, however she is unsure which color ... She unchanged back pain which has been occurring for the past 2 weeks, she has multiple black lesions in skin abd [abdomen] ...” During an interview on 12/11/24, at 2:35 p.m. with the Chief Nursing Officer (CNO), the CNO stated, a complete assessment should be completed at least once a shift. The CNO stated, pain reassessments should have been done as per the policy. The CNO stated, nurses were expected to assess patient pain levels to help determine the effectiveness of the pain medications no longer than two hours or based on the intervention as per policy. During a review of Pt 3’s H&P dated 8/15/24 at 7:03 p.m., the H&P indicated Pt 3 was a 65 year old male with a chief complaint of left (Lt) lower extremity (LE) weakness, with a past history of hypertension (HTN- high blood pressure), Type 2 Diabetes (DM- a chronic disease that occurs when the body doesn’t produce enough insulin or doesn’t use insulin properly) with neuropathy (Weakness, numbness, and pain from nerve damage, usually in the hands and feet), sciatica (pain affecting the back, hip, and outer side of the leg, caused by compression of a spinal nerve root in the lower back), chronic back pain, history of chronic opioid (class of drug that is addictive) dependence, tobacco abuse and atrial fibrillation (Afib- irregular heart rhythm). Pt 3 presented with numbness and weakness in his left lower extremity (interior medial thigh) that started around 2 p.m. this afternoon. During a concurrent interview and record review on 12/4/24 at 1:40 p.m., with Register Nurse Manager (NM) 5, Pt 3’s Electronic Health Record (EHR- medical records in electronic form) for his admission from 8/15/24 - 8/30/24 were reviewed. Pt 3’s PAF indicated on 8/30/24 at 12:14 p.m. Pt 3’s pain score was 10 out of 10 described as right abdominal aching pain, intervention was medication given; at 12:59 p.m. Pt 3’s pain score was still a 10 out of 10 with no description of the pain and no pain interventions documented at this time. During a review of Pt 3’s Medication Administration Record (MAR) dated 8/15/24-8/30/24 indicated, Pt 3 had the following as needed (PRN) medications: Oxycodone (strong pain medication) 10 mg (milligram- unit of measurement) oral every 6 hours (Q6H) for Severe Pain (7-10) order start dated 8/24/24 at 2:03 p.m. and ended 8/30/24 at 7:24 p.m. Last given: Oxycodone 10 mg on 8/30/24 at 12:14 p.m.; Oxycodone 5 mg oral Q6H for Moderate Pain (4-6); Acetaminophen (Tylenol- medication used for fever and pain) 650 mg oral Q6H PRN fever greater than 37.5 degrees Celsius (C) order start dated 8/15/24 at 6:57 p.m. and ended 8/30/24 at 7:23 p.m. Last given: Acetaminophen 650 mg given on 8/30/24 12:59 p.m. During a concurrent interview and record review on 12/4/24, at 5:10 p.m., with RN 8, Pt 3’s Progress Note dated 8/30/24 at 1:47 p.m. written by RN 8 was reviewed. RN 8 stated she remembered caring for Pt 3 and discharging him on 8/30/24. Pt 3’s Progress Note indicated, “End of Day Shift Summary Mentation: Alert and oriented x 4 [alert to person, place, time, and event] Pain: has complaint(s) of abd [abdomen] pain ... Significant events: Report called to nurse [name] at [name of skilled nursing facility] at 13:56 [1:56 p.m.]. All questions answered ... Pt medicated with PRN pain medication Tylenol 650 mg po [by mouth] x1, oxycodone 10mg PO x 1. Discharge information explained to patient with no questions. Pt received milk of mag [medication used to help with constipation] 60 ml with large BM [bowel movement] resulted. Transport arrived at 1600 [4 p.m.]. Pt leaving via gurney to [name of skilled nursing facility] at 1618 [4:18 p.m.] ...” RN 8 reviewed Pt 3’s Pain flowsheet for 8/30/24 and stated that Pt 3 had pain score of 10 out of 10 and she gave oxycodone and reassessed Pt 3’s pain less than an hour later and Pt 3’s was still reporting a pain score of 10 out of 10. RN 8 stated there was no other documentation and she stated, “I would not have discharged him with a 10 out of 10 pains ... I probably gave something [to Pt 3] and just didn’t document a reassessment”. During a concurrent interview and record review on 12/6/24 at 8:40 a.m. with NM 1, Pt 3’s EHR for his admission 8/15/24-8/30/24 were reviewed. NM 1 stated, “No” the acetaminophen order was not for pain it was indicated for fever. NM 1 stated the RN 8 should not have given the acetaminophen for Pt 3’s pain since it was indicated for fever. NM 1 stated she would have expected “[name of RN 8] to document a reassessment of the patient’s [referring to Pt 3] pain level after it was given and if it was not helping, I would have expected the nurse to escalate to the physician if medications ordered were not effective”. During an interview on 12/11/24, at 2:40 p.m. with the CNO, the CNO stated, “We [referring to hospital staff] need to adhere to what the order is, and we need to follow the policy.” The CNO stated a complete assessment of the patient’s pain should be done every four hours, and the reassessment can just be the number the patient states for their pain level. The CNO stated after pain medication is given per the policy a reassessment should be done within two hours. The CNO stated if acetaminophen was written for fever, it should not be given for pain and the nurse should not have given a pain medication less affective if the pain was still a 10 out of 10. The CNO stated, “We should have notified the doctor and attempted to improve the patient’s pain before considering discharging the patient and hold or delay the discharge if needed.” During a record review on 12/4/24 at 1:48pm with NE 4, Pt 8’s EMR was reviewed. The H&P dated 11/27/24 at 12:59 p.m., indicated, Pt 8 had a history of kidney and pancreatic transplants (a surgical procedure where both a kidney and a pancreas from a deceased donor are transplanted into a living patient), pancreatic cancer which spread and on chemotherapy (a cancer treatment that uses drugs to kill or stop the growth of cancer cells). Pt 8 chief complaint was blood in stool. Pt 8’s MAR, dated 3/25/24-12/4/24, indicated, “ ...Morphine [opioid medicine for severe pain] 2 mg [milligrams, unit of measure] Injection. Dose: 2mg. Frequency: Q4H [every 4 hours] PRN, Route: IV [Into the vein] PRN Reason: pain ...”. The EMR indicated morphine was administered on 12/3/24 at 10:26 p.m., 12/4/24 at 5:53 a.m., and 12/4/24 at 3:18 p.m. The EMR PFS did not have documentation of pain reassessment 30 minutes after medication was administered. NE 4 stated there should be pain reassessment documentation 30 minutes after each medication was administered. During an interview on 12/10/24 at 7:45 a.m. with NM 7, NM 7 stated pain reassessment should be done within 30 minutes after administration. Peak effectiveness of morphine is 15 minutes therefore 30 minutes is enough time to determine if medication worked or not. During a record review on 12/4/24 at 1:42 p.m. with Nurse Educator (NE) 4, NE 4 opened the Electronic Medical Record (EMR) for Pt 7. The document titled, “History and Physical [H&P],” dated 11/24/24 at 4:43 p.m., the “H&P” indicated, Pt 7 tripped over his dog yesterday, went to urgent care and found to be with left ninth rib fracture. Pain worsened over time and not relieved with medication or ice. Patient then presented to Emergency Department and found to be hypotensive (the pressure of blood circulating around the body is lower than normal or lower than expected) and diagnosed with “hemothorax [a serious condition that occurs when blood accumulates in the space between the chest wall and the lung making hard to breathe] and Traumatic Hemorrhagic Shock [a life-threatening condition when severe blood loss from trauma impairs the body’s ability to deliver oxygen to the organs of the body] ...Plan and Recommendations: Admit to ICU, NEURO: PO [by mouth]/IV pain medication ...”. Pt 7’s “Medication Administration Record” (MAR), dated 12/1/24-12-3/24, indicated, “ ...Morphine [opioid medicine for severe pain or well-controlled and regularly titrated can help ease respiratory distress] 1mg [milligrams, unit of measure]/ml [milliter- unit of measure] IV Bolus from drip 1-8 mg, Dose: 1-8mg, Freq: Every 15 minutes PRN [Latin phrase pro re nata, which means “as the need arises”], Route: IV ... Give initial dose of 1mg. After each 15-minute interval, reassess pain for a total of 4 additional assessments. For pain scale 0-3, give no bolus. For pain scaled 4-6, give same as previous dose administer. For pain scale 7-10, increase previous dose administer by 2mg ...”. Pt 7’s EMR indicated boluses of morphine were administered on 12/2/24 at 7:53 p.m., 12/2/24 at 8:52 p.m., 12/3/24 at 12:16 a.m., 12/3/24 at 2:00 a.m., 12/3/24 at 3:53 a.m., and 12/3/24 at 5:01 a.m. Pt 7’s EMR “Pain Flowsheet” (PFS) did not have documentation of pain reassessment 15 minutes after boluses were administered or the additional assessments. NE 4 stated there should be pain reassessment documentation 15 minutes after each bolus was administered and a total of 4 pain assessments. NE 4 stated pain assessments were not done according to the orders written. During a concurrent interview and record review on 12/10/24 at 7:30 a.m. with Registered Nurse (RN) 7, Pt 7’s EMR was reviewed. RN 7 stated nurses are expected to follow all Physician orders and document accordingly. RN 7 verified orders for Pt 7 and read aloud order for Pt 7 Morphine bolus order. RN 7 was asked to show documentation of pain assessment after each bolus with a total of 4 pain assessments. RN 7 stated she forgot to document after each bolus and did not document any additional pain assessments regarding boluses. RN 7 stated she did not follow Physician orders. During an interview on 12/10/24 at 7:45 a.m. with Nurse Manager (NM) 7, NM 7 stated all staff including nurses are expected to follow all physician orders without deviation. NM 7 stated the hospital policy is to follow physician orders. NM 7 stated RN 7 did not follow physician orders regarding Pt 7’s morphine bolus order. During an interview on 12/11/24 at 2:30 p.m. with the Chief Nursing Officer (CNO), the CNO stated the hospital policy is to follow physician order. All staff should always follow physician orders and policies and protocol are in place to protect patients. The CNO stated RN 7 did not follow hospital policy regarding following physician orders. In a professional article retrieved from https://www.ncbi.nlm.nih.gov/books/NBK2658/#:~:text=Assessment%20of%20effect%20should%20be,45%E2%80%9360%20minutes%20after%20administration. on 12/17/24 titled, “Patient Safety and Quality: An Evidence-Based Handbook for Nurses,” indicates, “ ...Based upon evidence and clinical practice, there are several principles of analgesic management to meet the objective of preventing moderate to severe pain: ... Assessment of effect should be based upon the onset of action of the drug administered; for example, IV opioids are reassessed in 15-30 minutes, whereas oral opioids and nonopioids are reassessed 45-60 minutes after administration ...” During a review of the hospital’s P&P titled, “Pain Management,” dated 4/9/24, indicated, “ ... Initial Pain Assessment ... Upon admission to a patient care setting, including Emergency Department visits, patients will be assessed for pain using an appropriate scale ... Patients experiencing pain will have a comprehensive assessment of pain completed by a Registered Nurse (RN) or Licensed Independent Practitioner (LIP) ... This assessment may include pain score, type, location, stated pain goal, and pain interventions ... Pain should be assessed using an appropriate pain scale ... The use of a pain scale involving self-reporting of pain is preferred, when possible ... The patient is assessed for pain/presence of pain: at least once each shift ... Upon new reports of pain ... Prior to and/or during procedures or activities that are anticipated to cause pain ... Reassessment following pain intervention ... Occurs within a time frame sufficient for the intervention to reach effectiveness ... Should not exceed 2 hours following the intervention ... Reassessment of pain is demonstrated through evaluation and documentation of responses to pain intervention(s) ...” During a professional reference review titled, “Acute Pain Management Pearls: A Focused Review for the Hospital Clinician [health care professional],” dated 12/22/22, (found at https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9818465/) indicated, “ ... Uncontrolled pain worsens patient outcomes ... Uncontrolled acute pain triggers a complex neurohormonal cascade [a series of coordinated responses where hormones produced by neurons [make up brain and nervous system] that are released in succession to body responses] that is toxic to nearly every organ system, as evidenced by increased rates of renal [kidney] and gastrointestinal [stomach and intestine] dysfunction, infection, cardiopulmonary [heart and lungs] and thrombotic [blood clot] complications, impaired wound healing, adverse psychological effects, and poorer functional recovery and quality of life ... Acute pain management in hospitalized patients should therefore be a clinician and institutional [facility] priority as a key driver of patient outcomes ...” During a review of the hospital’s P&P titled, “Licensed Provider Orders: Receiving, Transcribing, Reviewing,” dated 10/11/2023, the P&P indicated, “ ...3. Communication orders may include, but are not limited to: ... h. On-going patient assessments ...F. The Nurse will acknowledge ALL medication and standard communication orders and document care provided. G. Every Shift Order Review: 1. The assigned nurse is responsible to review entered/active orders for each patient assigned each shift. 2. The nurse will confirm that the orders are being carried out as entered. 3. The nurse will confirm appropriateness of orders bases on scope of service for that unit, and policy and procedure, as appropriate. A. This will include use of the MAR (Medication Administration Record) and any other EHR (Electronic Health Record) areas to confirm information. 4. Once the review is completed, the RN will incorporate in the end of shift care plan note a statement that the orders where completed. 5. The Licensed Practitioner (LP) will be notified as need to clarify any orders or to make changes ...” During a review of the hospital’s P&P titled, “Medication Administration” dated 1/18/23, the P&P indicated, “PURPOSE: A. To define the role of the health care professional in the administration of medication to the patient. B. To identify some general safety precautions that the health care professional observes in the preparation and administration of medication ... G. PRN medications for pain management will be administered according to the following guidelines: 1. Every attempt will be made for all patients to have pain safely managed at a level perceived to be effective. All patients will be involved in the decision-making process regarding the effective management of their pain level. 2 ... A second pain medication may be given for that intensified level of pain no sooner than 60 minutes after PO/IM pain medication administration or 30 minutes after IV administration. 3. When pain management continues to be ineffective, notify physician ... J. Documentation (eMAR): 1. Medications are administered utilizing EHR functionality with bar code scanning of the patient’s identification armband, the medication to be administered, and comparing with the eMAR, completing the “6 rights” (right patient, right medication, right does, right route, right time, right documentation) and also noting the “7th right” for the right reason for the medication ...” 2. During a concurrent interview and record review, on 12/5/24, at 1:37 p.m. with the Assistant Nurse Manager (ASM) 1, Pt 10’s electronic health record (EHR- digital collection of medical information) was reviewed. Pt 15’s H&P, dated 11/29/24, “Medication administration record”, 11/30/24 and “Flowsheet”, 11/30/24, were reviewed. ASM 1 stated, Pt 10 had ordered norepinephrine (a medication used to treat low blood pressure) intravenously titrated to maintain a mean arterial blood pressure (MAP) of 65 mmHg (millimeters of Mercury). Pt 10’s “Flowsheet” indicated, Pt 10’s vital signs (essential body functions, including heartbeat, breathing rate, temperature, and blood pressure) were not monitored from 11/30/2024 5:30 a.m. to 6:45 a.m. No nursing progress notes were present to address the lack of monitoring. ASM 1 stated, while on the medication norepinephrine, Pt 10 should have vital signs taken frequently, at least every 15 minutes. ASM 1 stated, it appeared the nurse did not document the vital signs during the 1.25 hour gap while the patient was being administered norepinephrine at 7 mcg/min (micrograms/min). ASM 1 stated, the nurse should have documented the vital signs during the time Pt 10 was on the medication. During a review of Pt 10s,”CRITICAL CARE NOTE” dated 11/29/24, the note indicated, Pt 10 was admitted on 11/29/24, “ ... with multiple PMHx [Previous medical history] as per below, significant for alcoholic liver cirrhosis [liver failure] with ascites [symptom of liver failure with fluid in the abdomen] and active alcohol use, who was brought in by the neighbor for altered mentation [consciousness], found to have hypotension [low blood pressure] and low hemoglobin [blood count] ... On further work-up, patient was also found to have small subdural hematoma [bleed on the outside of the brain] on CT [computed tomograph - a scan that produces detailed images of inside the body] imaging and acute renal [kidney] failure in the setting of CKD [chronic kidney disease]. ... She later became hypotensive, [low blood pressure] hence, was referred to the ICU for admission ...” During a review of Pt 10’s “Order Sheet (OS)”, dated 11/30/24, the OS indicated, “ ... norepinephrine [LEVOPHED] ... IV DRIP [intravenous], ... Routine TITRATE ... Starting does: 5 mcg/min, Incremental dose 1 mcg/min, Titration interval: every minute, Goal: MAP greater than 65 mmHg ... “ During an interview on 12/11/24 at 2:35 p.m. with the Chief Nursing Officer (CNO), the CNO stated nurses should monitor patients closely on vasoactive (something that causes the blood vessels to get narrower or wider) medications in order to adjust the medications according to any changes. The CNO stated, the nurses should follow the parameters and guidelines for medications as outlined in the policies. During a review of the facility’s policy and procedure (P&P) titled, “Medication Administration”, dated 1/18/23, was reviewed. The P&P indicated, “ ... To identify some general safety precautions that the health care professional observes in the preparation and administration of medication. ...H. Titration of continuous infusions/wean orders: Follow Physician order for titration parameters ... 5. Monitor vital signs at a minimum of every 15 minutes x4 after initiation and each rate change. a. Titration of continuous infusions require frequent monitoring to assess patient response and safety. ... “ During a review of the facility’s policy and procedure (P&P) titled, “High Risk [High Alert] Medications”, dated 6/10/2024 was reviewed. The P&P indicated, “ ... Policies and Procedures related to medication ordering, preparing, administration and evaluation of outcomes will be based on current and valid research/best practice guidelines. ... Use of certain medications is restricted to specific hospital areas. Refer to reference tools (i.e. Lexicomp Online) for specific precautions, and to the policy “IV Medication - Master Guidelines for IV Medication Administration” for location-specific restrictions. 1. Vasoactive medications (e.g., dobutamine, dopamine, EPINEPHrine, norepinephrine, phenylephrine, vasopressin) ...”. Review of Federal Drug Administration label for Norepinephrine, dated 6/20, (found at https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/007513s038lbl.pdf/) indicated, “ ... Dosage ... After an initial dosage of 8 to 12 mcg per minute via intravenous infusion, assess patient response and adjust dosage to maintain desired hemodynamic effect. ... Monitor blood pressure every two minutes until the desired hemodynamic effect is achieved, and then monitor blood pressure every five minutes for the duration of the infusion ...” 3. During a concurrent interview and record review on 12/4/24, at 1:30 p.m., with the Assistant Nurse Manager (ANM 2), Pt 5’s “Face sheet” (provides demographics of the patient, name, date of birth, admission date, chief complaint), “Hemodynamics Monitoring Flowsheet [HMF]”, “Medication Administration Record”, 11/27/2024 and “electronic health records” (EHR), were reviewed for Pt 5’s admission dated 11/26/2024. The ANM 2 stated, Pt 12 had an order at 11/27/24 at 8:58 a.m. for propofol (medication used for sedation) intravenous drip, 0 to 50 mcg/kg/min (micrograms/kilogram/minute) to titrate for a RASS (Richmond Agitation -Sedation Scale -a 10-point scale to assess a patient’s level of sedation) score of 0 to -1. ANM 2 stated, the indication parameter for the medication was changed on 11/27/24 at 8:00 a.m. to “Per [Doctor], titrate for Ventilator Compliance.” ANM 2 stated, there is no policy or protocol to define “Ventilator Compliance.” ANM 2 stated, the nurse took the order and should have asked a specific parameter to use to titrate the medication. ANM 2 stated, the order is not clear for every nurse or clinician working with the patient. ANM 2 stated, “range orders” (orders in which the dose varies over a prescribed range, depending on the patient’s status) should not be used in caring for patients. During a concurrent interview and record review on 12/5/24, at 1:25 p.m., with the Assistant Nurse Manager (ANM 1), Pt 5’s “Face sheet”, “Hemodynamics Monitoring Flowsheet [HMF]”, “Medication Administration Record”, 11/27/24 and “electronic health records” (EHR), were reviewed for Pt 5’s admission dated 11/26/24. The ANM 1 stated, the order on indication “Ventilator Compliance” is a vague term and could be interpreted by nurses in different ways. ANM 1 stated, the nurse should have called the provider and clarified the order with specific parameters. During a review of Pt 5’s,”HOSPITALISTS H&P [HISTORY AND PHYSICAL],” dated 11/26/24, the “H&P” indicated, Pt 5 was admitted on 11/26/24 for “ ...with PMHx [previous medical history] significant for methamphetamine use, HTN [Hypertension - high blood pressure], ..., CHF [Congestive Heart Failure -when the heart does not pump blood efficiently], ... obesity hypoventilation syndrome (breathing disorder in obese individuals where the body does not remove enough cardon dioxide) on 4L [liters] home O2 [oxygen], pulmonary hypertension [blood pressure in the lungs is higher than normal] , ... CKD [Chronic Kidney Disease - where the kidney do not filter the blood efficiently), DM (diabetes mellitus - a disorder where the body does not control the amount of glucose in the blood), with recent hospitalization 11/17-11/22/2024 for ... respiratory failure from pulmonary edema (fluid in the lungs) and fluid overload (heart failure). days. ...” Pt 5 was admitted to the Intensive Care Unit and was intubated (a tube in the mouth to the lungs for breathing) and put on a ventilator. During an interview on 12/11/24, at 2:35 p.m. with the Chief Nursing Officer (CNO), the CNO stated, the nurse should have clarified the sedation medication order and ask the doctor what they meant by “ventilator compliance”. The CNO stated, the orders should follow the policy on medication administration so that all the nurses and providers are doing the same thing. During a review of the facility’s policy and procedure (P&P) titled, “Medication Administration”, dated 1/18/23, was reviewed. The P&P indicated, “ ... To identify some general safety precautions that the health care professional observes in the preparation and administration of medication. ...F. Range order ... 1. Range orders will not be accepted ... H. Titration of continuous infusions/wean orders: Follow Physician order for titration parameters ... The physician must be contacted if the goal parameter, a starting dose, and titration parameters are not included in the order. ... 6. If the maximum infusion rate (per EHR parameters) has been achieved and patient has not reached goal parameter, the provider must be called for further orders ...” 4. During a review of Pt 1’s “History and Physical [H&P],” dated 9/23/24, the “H&P” indicated, Pt 1was brought in by ambulance to the Emergency Department (ED) after a motor vehicle accident (MVA). Pt 1 was admitted to the hospital on 9/23/24 at 9:37 a.m. for a scalp laceration (cut on the head), and a Subarachnoid hemorrhage (Bleeding in the space between the brain and the tissue covering the brain). During an interview on 11/27/24 at 12:10 p.m. with Family Member (FM) 1 stated, stated her father began texting her when he was admitted to the hospital and reported having some “memory issues”. FM 1 stated Pt 1 did not recall her coming to visit the day he was admitted. FM 1 stated she did not believe staff were doing neurological checks accurately because her father was becoming “more confused”, and staff “did not change the plan of care”. FM 1 stated she believed, because her father had a brain hemorrhage staff should have been monitoring him for behavior changes. FM 1 stated she believed staff should have noticed her father was becoming more confused and having difficulty remembering things. During a concurrent interview and record review on 12/4/24 at 1:40 p.m. with Nurse Educator (NE) 2, Pt 1’s “Physician Order [PO],” dated 9/23/24 was reviewed. The “PO” indicated, “ ... Neurological Check ... Routine Q [every] shift ... Neuro Check Assessments include: - Pupil [size/reaction] ...” During a concurrent interview and record review on 12/4/24 at 2 p.m. with NE 2, Pt 1’s “Adult Care Summary Flowsheet [ACSF],” dated 9/24/24 and 9/25/24, were reviewed. The “ACSF” under the “Pupils” heading indicated, Pt 1’s pupil size was not documented on 9/24/24 and 9/25/24 at 8:15 a.m. per physician order. NE 2 stated Pt 1’s pupil size should have been documented when LNs completed the neurological assessment. NE 2 stated monitoring pupil size was important because a change in pupil size or irregular sizing could indicate expansion of Pt 1’s brain hemorrhage. During a concurrent interview and record review on 12/5/24 at 11:10 a.m. with Registered Nurse (RN) 4, Pt 1’s “ACSF,” dated 9/25/24 was reviewed. RN 4 stated she was Pt 1’s primary nurse on 9/25/24 during the a.m. shift. RN 4 verified her documentation for Pt 1 from 9/25/24 at 8:15 a.m. on the “ACSF”. RN 4 stated during a neurologic exam she should have assessed and documented pupil size and reaction to light. RN 4 verified she did not document Pt 1’s pupil size in the “ACSF”. RN 4 stated Pt 1’s pupil size was important to assess to ensure the pupils were reacting to light and were not fixed or dilated. RN 4 stated if the pupils were fixed or dilated Pt 1’s brain hemorrhage could be worsening, and the physician would need to be immediately notified. During an interview on 12/5/24 at 12:35 with Nurse Manager (NM) 5, NM 5 stated, LNs should have documented pupil size for Pt 1 during the neurologic assessment. NM 5 stated her expectation was for LNs to follow physician orders. NM 5 stated LNs could contact physicians if clarification was needed about specific orders. During a review of Pt 20’s “H&P,” dated 12/2/24, the “H&P” indicated, Pt 20 had a PMH of hypertension, seizure disorder, chronic back pain, alcohol abuse, and anemia (a condition characterized by a lower-than-normal number of red blood cells (erythrocytes) or hemoglobin levels in the blood), who presented to the ED after three unwitnessed seizures (a temporary episode of abnormal electrical activity in the brain that causes sudden change of behavior, movement, or consciousness) the day before. Pt 20 was admitted to the hospital as an inpatient on 12/2/24 for alcohol withdrawal seizures. During a concurrent interview and record review on 12/5/24 at 2:28 p.m. with NE 2, Pt 20’s “PO,” dated 12/2/24 was reviewed. The “PO” indicated, “ ... Neurological Check ... Neuro Check Assessments include: - Pupil [size/reaction] ...”. During a concurrent interview and record review on 12/5/24 at 2:30 p.m. with NE 1, Pt 20’s “ACSF,” dated 12/2/24 and 12/3/24, were reviewed. The “ACSF” under the “pupils” header dated 12/2/24 at 7:30 p.m. indicated, Pt 20’s pupil size and reaction were not documented. NE 1 stated Pt 20’s pupils could show a brain herniation (when something inside the skull produces pressure that moves brain tissues) or reactions to different medication. NE 1 stated LNs must follow physician orders and if clarification was needed LNs should call the physician to clarify. During an interview on 12/11/24 at 2:52 p.m. with the Chief Nursing Officer (CNO), the CNO stated her expectation was for LNs to follow all elements of the physician order for neuro exams. The CNO stated all elements of the neuro exam were important to monitor neurological changes. The CNO stated neurological changes could mean a worsening of condition. During a review of the hospital’s P&P titled, “Neurological Assessment and Flow Sheet,” dated 10/22/21, indicated, “ ... Pupils must be compared to each other .... Examine pupils for shape, size, and equality. The normal diameter is 2-6mm ... Accommodation: pupils constrict as object approaches them ... Direct light reflex: shine light directly into one pupil and note constriction and dilation of pupil. Test each eye individually ... Brisk response: Very rapid constriction with the introduction of light ... Sluggish: constriction occurs more slowly than expected ... No reaction/Fixed: No constriction or dilation noted ...”. 5. During a review of Pt 1’s “History and Physical [H&P],” dated 9/23/24, the “H&P” indicated, Pt 1was brought in by ambulance to the Emergency Department (ED) after a motor vehicle accident (MVA). Pt 1 was admitted as an inpatient to the hospital on 9/23/24 at 9:37 a.m. for a closed dislocation (joint moves out of place but does not break the skin) of phalanx (finger bone) of right hand, multiple dislocations of tarsometatarsal (joints connecting mid-foot bones to hindfoot bones) joints of right foot, multiple right foot comminuted (bone that has shattered into more than two pieces) metatarsal (tubular bones in the middle of foot connecting ankle to toes) fractures, and a subarachnoid hemorrhage (Bleeding in the space between the brain and the tissue covering the brain). During an interview on 11/27/24 at 12:10 p.m. with Family Member (FM) 1, FM 1 stated, Pt 1 sent her a text message a few days into his hospital admission reporting he had “a fall” when he was walking into the bathroom. FM 1 stated Pt 1 was admitted to the hospital on 9/23/24 after a MVA and had “shattered metatarsals” and a brain hemorrhage. FM 1 stated Pt 1 was a high fall risk because he was only able to bear weight on one foot (his left), was on a lot of pain medications and had a head injury. FM 1 stated Pt 1 needed staff help to go to the bathroom FM 1 stated hospital staff were storing “a lot of medical equipment” in the bathroom. FM 1 stated Pt 1 would have to try to balance himself and walk around the equipment. FM 1 stated on one side of the toilet a grab bar was attached to the wall near the toilet paper and did not move, and on the other side of the toilet the grab bar was movable to be folded up against the wall then hinged down 90-degree angle to hold onto. FM 1 stated when he tried to sit on the toilet the grab bar that was movable was not in the down position for him to hold onto. FM 1 stated Pt 1 tried to steady himself to sit and did not realize staff had not put down the grab bar, he fell to the right side stopping himself on his non-weight baring injured foot. FM 1 stated Pt 1 reported to her he re-injured his right foot but LNs ordered an X-ray (a photographic or digital image of the internal composition of a body part) of his ankle. During an observation and interview on 12/3/24 at 3:24 p.m. on the Orthopedic Trauma Unit with Nurse Manager (NM) 7, the bathroom in room 5420 was observed. Pt 1 was on the Orthopedic Trauma Unit during his hospital admission. The right side of the toilet had a non-movable grab bar attached to the wall, and on the left side was a hinging grab bar. The movable grab bar was in the down position. A commode was stored in the bathroom against the far-right wall but was not in the path of the toilet. The bathroom was wide enough for a walker or a wheelchair, and additional staff (to help a patient) to maneuver around the toilet without difficulty. NM 7 stated Certified Nursing Assistants (CNAs), or Registered Nurses may help high fall risk patients to the bathroom. NM 7 stated a pathway to the toilet without obstacles was important to avoid falls. NM 7 stated when patients were on “certain” meds patients could be higher fall risks. During a concurrent interview and record review on 12/5/24 at 2:15 p.m. with NE 2, Pt 1’s “Care Team Note [CTN]” from 9/25/24 at 11:06 a.m. was reviewed. NE 2 stated the “CTN” was documented by Registered Nurse (RN 4). The “CTN” indicated, “ ... Phone ... NP [nurse practitioner] patient stated he rotated his foot in the opposite direction and now it is hurting and throbbing ... NP will order new x-ray.” NE 2 stated the “CTN” did not indicate which foot Pt 1 injured. NE 2 stated the physician who ordered the imaging did not enter any additional notes into the medical record. During a concurrent interview and record review on 12/4/24 at 2:25 p.m. with NE 2 Pt 1’s “Adult Care Summary [ACS],” dated 9/25/24 was reviewed. The “ACS” indicated, on 9/25/24 at 8:15 a.m. RN 4 documented Pt 1’s head-to toe (comprehensive physical exam, checking all major body systems) assessment. NE 2 stated Pt 1’s “ACS” had no other physical assessments until 9:36 p.m. on the night shift. NE 2 stated RN 4 should have documented a physical assessment on the “ACS” prior to contacting Pt 1’s physician for an X-ray at 11:06 a.m. NE 2 stated completing a physical assessment after Pt 1 was injured was important to ensure his safety, and the information must be reported to Pt 1’s physician. NE 2 stated LNs must assess patients when patients had a change of condition. During a concurrent interview and record review on 12/4/24 at 2:30 p.m. with NE 2, Pt 1’s “Imaging Report,” dated 9/25/24 at 11:07 a.m. was reviewed. The “Imaging Report” indicated, Pt 1’s physician ordered an X- ray to his right ankle at 11:07 a.m. The “Imaging Report” indicated the imaging was performed on 9/25/24 at 12:35 p.m. and the results were read by the Radiologist (physician specializing in diagnosing using medical imaging) at 2:42 p.m. NE 2 stated Pt 1’s physician listed “fracture” as the indication for the imaging study. The “Imaging Report” results indicated, “ ...Impression ...Overlying cast material obscures fine bony detail. Metatarsal fracture-dislocations are demonstrated to better advantage on prior foot radiographs. No acute (sudden) osseous injury (a bone-related abnormality) involving the ankle ...” During a concurrent interview and record review on 12/4/24 at 2:35 p.m. with NE 2, Pt 1’s “End of Shift Summary [ESS],” dated 9/25/24 at 4 p.m. was reviewed. The “ESS” indicated on 9/25/24 Pt 1 had “Significant Events” documented by a student nurse and co-signed by RN 4 (primary nurse). The “ESS” indicated “ ... Patient walked to bathroom using FWW [Front Wheeled Walker] but was unsteady while trying to sit on the toilet and used LLE [Left Lower Extremity] for support. Patient reported increased pain and swelling after, X-Ray of the LLE taken awaiting results. Plan is possible outpatient surgery of the LLE. Hourly rounding completed and patient safety maintained per hospital policy ...”. NE 2 stated Pt 1’s primary nurse was responsible to ensure all student nurse documentation was accurate before cosigning. NE 2 sated Pt 1’s X-ray was to his right lower extremity, not the left lower extremity. NE 2 stated since there was no physical assessment after Pt 1’s injury, the documentation in the medical record was unclear which lower extremity was injured. During a concurrent interview and record review on 12/4/24 at 2:35 p.m. with NE 2 Pt 1’s “Daily Care Flowsheet [DCF],” dated 9/25/24 was reviewed. The “DCF” indicated, nursing staff did not document assisting Pt 1 to the bathroom on 9/25/24. NE 2 stated the “DCF” was used for nursing staff to document any daily care activities performed on or with Pt 1. NE 2 stated daily care activities of daily living (ADL) such as bathing, toileting, walking and changing. NE 2 stated Pt 1’s “DCF” had no documentation to indicate he was assisted to the bathroom, by staff. NE 2 stated CNA 1 documented on 9/25/24 at 9:50 a.m. “minimally assisting” Pt 1 with an activity, but the “DCF” did not specify what activity. NE 2 stated CNA 1 should have documented what activity Pt 1 was helped with. NE 2 stated her expectation was for nursing staff to document on the “DCF” every time Pt was helped with an activity and what the activity was, what assistive device the patient used and how far the patient walked. NE 2 stated documenting on the “DCF” was important to keep a record of activities patients were completing to ensure their plan of care was working. During a concurrent interview and record review on 12/5/24 at 11:15 a.m. with RN 4, Pt 1’s “Electronic Medical Record [EMR]”, was reviewed. The documents reviewed by RN 4 in Pt 1’s “EMR” were the, “CTN”, “ACF”, “Imaging Report”, “ESS” and “DCF,” dated 9/25/24. RN 4 sated she was Pt 1’s primary nurse on 9/25/24 during the day shift from 7 a.m. to 7:30 p.m. RN 4 stated she did not remember the patient or the incident in question. RN 4 verified her documentation and agreed she cosigned the documentation from the student nurse during the dayshift on 9/25/24. Pt 1’s “ACF” was reviewed and RN 4 stated, she did not document a physical assessment after the 8:15 a.m. beginning of shift assessment. RN 4 stated according to her “CTN” she called the physician for an order for an ankle X-ray, RN 4 stated her “CTN” did not indicate if the right or left ankle required the X-ray. RN 4 sated her documentation did not indicate she performed an assessment of the injured area prior to or after the phone call to the physician. RN 4 stated the “ESS” documentation indicated Pt 1 injured his LLE, but the “Imaging Report” indicated the physician ordered a right ankle X-ray. RN 4 stated the “ESS” was written by the student nurse she oversaw. RN 4 stated double checking student nurse documentation before cosigning the information was her responsibility. RN 4 stated she should have assessed Pt 1 and documented the assessment after he had a complaint of injury. RN 4 stated assessing patients after a change in condition was important to give a full report to the physician. During an interview on 12/5/24 at 12:35 p.m. with Nurse Manager (NM) 5, NM 5 stated her expectation was for LNs to assess patients if they had a fall or were reporting pain in a different area. NM 5 stated a change in condition required an assessment by a LN, and a report of the change to the patient’s physician. During an interview on 12/9/24 at 10:38 a.m. with Pt 1, Pt 1 stated he remembered the incident when he was injured. Pt 1 stated the “fall” occurred when he was going to the bathroom and a “trainee nurse” and another nurse were taking him. Pt 1 stated one nurse left the bathroom and left him with the “trainee nurse” Pt 1 stated he had not seen the “trainee nurse” before. Pt 1 stated he told the nurse, “If I fall you ain’t gonna be able to catch me”, because he felt the nurse would not be strong enough. Pt 1 stated staff used the bathroom in his room for storage. Pt 1 stated when he and the nurse got near the toilet, he realized the grab bar was not down, so he reached out to steady himself with what he thought was the wall. Pt 1 stated he then realized it was a shower curtain. Pt 1 stated he then lost his balance, and his right ankle was all twisted up and hurt badly. Pt 1 stated the nursing staff in the bathroom with him told the staff outside the room he did not fall but he sat down too fast on the toilet and twisted his ankle. Pt 1 did not recall LNs looking at his left foot and ankle after the incident. Pt 1 stated he had an X-ray of the ankle after the incident. During an interview on 12/11/24 at 2:55 with the Chief Nursing Officer (CNO), the CNO stated her expectation was for LNs to complete an assessment of the patient when a patient reported an unexplained injury or had a change in condition. The CNO stated LNs should check on the patient to ensure they were “ok” (physically, mentally) and assess for any injuries. During a review of the hospital’s P&P titled, “Assessment: Admission and Reassessment,” dated 1/10/19, indicated, “ ... Patients will be reassessed ... when there is a change in diagnosis, a change in condition or behavior, or to determine the patient’s response to treatment ... Student Nurses ... May complete those portions of the assessment that they have successfully completed in their training program ... The supervision RN must review, validate, and electronically sign the assessment form ...”. 6. During a review of Pt 1’s “History and Physical [H&P],” dated 9/23/24, the “H&P” indicated, Pt 1was brought in by ambulance to the Emergency Department (ED) after a motor vehicle accident (MVA). Pt 1 was admitted as an inpatient to the hospital on 9/23/24 at 9:37 a.m. for a closed dislocation (joint moves out of place but does not break the skin) of phalanx (finger bone) of right hand, multiple dislocations of tarsometatarsal (joints connecting mid-foot bones to hindfoot bones) joints of right foot, multiple right foot comminuted (bone that has shattered into more than two pieces) metatarsal (tubular bones in the middle of foot connecting ankle to toes) fractures, and a subarachnoid hemorrhage (Bleeding in the space between the brain and the tissue covering the brain). During a concurrent interview and record review on 12/5/24 at 8:36 a.m. with Nurse Educator (NE) 2, Pt 1’s “Electronic Medical Record” was reviewed. The “Discharge” tab had no documentation indicating Pt 1 was given any discharge information, or education materials. NE 2 stated Pt 1 was discharged from the hospital and transferred to a Skilled Nursing Facility on 9/30/24 at 4:20 p.m. NE 2 stated the “Discharge and After Visit Summary Review [DAR]” form was not completed for Pt 1. NE 2 stated the “DAR” was where LNs should document giving patient’s exit care instructions, materials given to patients or their families, reviewing discharge medications and last doses of medications, and if the patient’s caregiver was contacted prior to discharge. NE 2 stated no LN care team notes were in the medical record to indicate Pt 1 was given discharge instructions verbally. NE 2 stated LNs should educate all patients about discharge information, including any follow up appointments, new or changed medications, and ways to prevent future illness or injury. NE 2 stated educating patients about discharge information was important so patients understood any new or different health information that may have occurred due to hospital stay. During an interview on 12/9/24 at 10:40 a.m. with Pt 1, Pt 1 stated he did not recall any discharge education or discharge instructions being discussed or given to him. During a review of Pt 20’s “H&P,” dated 12/2/24, the “H&P” indicated, Pt 20 had a past medical history of hypertension, seizure disorder, chronic back pain, alcohol abuse, and anemia, who presented to the ED after three unwitnessed seizures (a temporary episode of abnormal electrical activity in the brain that causes sudden change of behavior, movement, or consciousness) the day before. During a concurrent interview and record review on 12/5/24 at 2:40 p.m. NE 2, Pt 20’s “Electronic Medical Record” was reviewed. The “Discharge” tab indicated Pt 20 was not given any discharge information, or education materials. NE 2 stated Pt 20 was discharged on 12/4/24 at 11:52 a.m. NE 2 stated the “DAR” form was not completed for Pt 20. NE 2 stated no LN care team notes were in the medical record to indicate Pt 1 was given discharge instructions verbally. NE 2 stated LNs should document discharge in the “DAR” or in a Care Team Note. NE 2 stated LNs should educate all patients about discharge information, including any follow up appointments, new or changed medications, and ways to prevent future illness or injury. NE 2 stated educating patients about discharge information was important so patients understood any new or different health information that may have occurred due to hospital stay. During an interview on 12/11/24 at 2:55 p.m. with the Chief Nursing Officer (CNO), the CNO stated her expectation was a discharge summary was to be reviewed with and a copy given to each patient or their caregiver. The discharge information should have been reviewed with both Pt 1 and Pt 20. The CNO stated discharge information should include what the patient was in the hospital for and any new or changed health information. During a review of the hospital’s P&P titled, “Discharge Planning Services,” dated 4/21/23, indicated, “ ...The discharge planning process must include informing the family caregiver of the patient’s continuing health care needs after discharge and providing the caregiver an opportunity to engage in and ask questions during the discharge planning process. This should include providing information and instruction on a patient’s post hospital care needs, and when applicable, include education and counseling about the patient’s medications, including proper dosing and proper use of medication delivery devices, Additionally, information and education must be provided in a culturally competent manner and in a language that is comprehensible to the patient and caregiver. (AFL 15-25) ...” 7. During a concurrent interview and record review on 12/5/24, at 1:10 p.m. with Healthcare Risk Specialist (HRS) and Director of Critical Care Services (Dir 1), Pt 5’s Electronic Health Records for his admission 11/17/24 and his readmission on 11/26/24, were reviewed. The HRS stated the hospital reported an unusual occurrence on 12/4/24 involving Pt 5 being discharged on the wrong dose of Coreg. Dir 1 stated he was informed of the incident on 12/2/24, Pt 5 was discharged from here on 11/22/24, during Pt 5’s stay he was put on Coreg 3.125 mg (milligrams- unit of measurement) po (oral) BID (twice a day) and then increased to 6.25 mg po BID and was then discharged home a day later on Coreg 50 mg po BID. Dir 1 stated he spoke with Pt 5’s spouse and disclosed that the hospital believes Pt 5 was discharged on the wrong dosage of Coreg. Dir 1 stated he interviewed his staff to the discharge process of Pt 5 and found Pt 5 was on a new program started for all heart failure (HF) patients where each HF patient is assigned a Transitional Care (TOC) pharmacist from start of their admission to discharge. Dir 1 explained that the TOC pharmacist deals with the medications that the HF patients are on and during his investigation he found that the TOC pharmacist was the one who reviewed Pt 5’s discharge medication with him and his spouse before discharge. Dir 1 stated he interviewed his nursing staff and discovered nurse (RN 11) discharged Pt 5 on 11/22/24 she stated she did not go over the home medication list with Pt 5 because she felt the experts referring to the TOC pharmacist had already reviewed the home medications with the patient and his spouse. Dir 1 stated he did further interviews with his nursing staff and found there was some opportunity in how nursing reviewed the discharge medications with the patients. During a review of Pt 5’s After Visit Summary (AVS- document printed for each patient on discharge that explains follow up appointments, discharge medications and any changes made and when to take your next dose, education on reason patient was in the hospital, etc.) dated 11/22/24, the AVS indicated, “Patient Instructions You have been scheduled for a cardiology follow up appointment: ... Your medications have changed ... CHANGE how you take carvedilol (COREG) ... TAKE these medications ... carvedilol 25 mg Tab Dose: 50 mg Take two tabs by mouth twice daily What changed how much to take Commonly known as COREG Signed by [Medical Doctor- MD 1] Notes to patient: Lowers blood pressure and heart rate Strengthens the heart to pump blood Hold medication and call doctor’s office if SBP [systolic blood pressure- the pressure in the arteries when the heart contracts and pumps blood throughout the body] < [less than] = [equal] 90 and / or HR [heart rate]<= 60 ...” During a review of Pt 5’s,”H&P,” dated 11/26/24, the “H&P” indicated, Pt 5 was admitted on 11/26/24 for “ ... Plan: -Hypotension and bradycardia likely secondary to high dose Coreg causing beta blocker toxicity - Intubated [a tube in the mouth to the lungs for breathing] for hypoxemia [low levels of oxygen in the blood] - Started on vasopressors [class of medications used to raise blood pressure] to help with bradycardia and hypotension - Central line [a thin, flexible tube that’s inserted into a large vein near the heart] placed emergently for IV [intravenous in the vein] access ... 56 year old male with PMHx [past medical history] significant for methamphetamine use, HTN [Hypertension - high blood pressure], ..., CHF [Congestive Heart Failure -when the heart does not pump blood efficiently], ... obesity hypoventilation syndrome [breathing disorder in obese individuals where the body does not remove enough cardon dioxide] on 4L [liters] home O2 [oxygen], pulmonary hypertension [blood pressure in the lungs is higher than normal] , ... CKD [Chronic Kidney Disease - where the kidney do not filter the blood efficiently], DM [diabetes mellitus - a disorder where the body does not control the amount of glucose in the blood], with recent hospitalization 11/17-11/22/2024 for ... respiratory failure from pulmonary edema [fluid in the lungs] and fluid overload [heart failure] days. ...” During an observation on 12/9/24 at 3 pm while in the intensive care unit Pt 5 was seen with his head of bed elevated, intubated (tube in mouth to help patient breath), eyes closed and on multiple intravenous (IV) medications running into Pt 3’s central IV line. During a review of Pt 5’s Progress Note by pharmacist on 11/22/24 at 2 p.m., the progress note indicated, “All medication(s) were reviewed with the patient and/or family member(s). Patient/family medication related questions and concerns were addressed. Counseled patient on newly prescribed medications in regard to indication, administration, and common side effects. Emphasized guideline directed medication(s) and effectiveness. Emphasized changed and/or discontinued medications. Discharge prescriptions were delivered to the patient by Medications In Hand pharmacy service. The following interventions were made at the time of discharge that may or may not be included in the provider’s discharge documentation: 1. In discussion with the provider, Jardiance [medication used to improve glucose control] 10 mg daily was added to optimize HF GDMT [Guideline-Directed Medical Therapy- set of evidence-based treatments recommended for patients with heart failure]. 2. In discussion with the provider, Coreg 25 mg bid was escalated to Coreg 25mg 2 tablets po bid to achieve a HF target dose. 3. In discussion with the provider, [name of inhaler] was added for COPD maintenance therapy. 4. Since our out-patient pharmacy did not have Glipizide [medication used to help lower blood sugar and restore the way you use food to make energy] in stock, it was re-routed to patient’s home pharmacy.” The HRS stated this pharmacist is on a leave of absence and not available for interview. During a concurrent interview and record review on 12/9/24, at 4 pm with Medical Doctor (MD 1), Pt 5’s Discharge Summary dated 11/28/24 at 12 p.m. was reviewed, the discharge summary indicated, “ ...Discharge meds review: On 11/22: I discharged patient on his home doses medications of Coreg 25 mg twice a day: after review of his BP [Blood Pressure] and HR [heart rate]. It was changed to 50 mg bid by pharmacist and sent to pharmacy electronically by pharmacist: this was done without discussion with me. I had no discussion regarding changing Coreg dosing: to 50 mg bid. Note from pharmacist on 11/22 “ 2. In discussion with the provider, Coreg 25 mg bid was escalated to Coreg 25mg 2 tablets po bid to achieve a HF target dose”: is incorrect. I did not prescribe this dose myself, but it was ordered under my name by pharmacist and it was done without my approval and without a discussion with me about changing my order ...” MD 1 stated she remembered the pharmacist asking her to give them a call and when she did the “pharmacist wanted to know if Pt 5 met criteria for an inhaler but at no point did we discuss the Coreg dosage”. MD 1 stated she did not know why the pharmacist changed the dosage. MD 1 stated she discharged Pt 5 on Coreg 25 mg po BID. MD 1 stated she did sign off the order for Coreg 25 mg 2 tablets po BID but did not realize the pharmacist had increased the dosage. During an interview on 12/6/24, at 10:49 a.m., with Registered Nurse (RN) 11, RN 11 stated she remembers Pt 5 came in for congestive heart failure (CHF-) exacerbation. RN 11 stated she printed and reviewed the After Visit Summary (AVS) that included the discharge instructions for Pt 5, it included the patients name, date of birth, next primary care appointment and if the patient is not part of the HF program “meds in hand [the TOC pharmacist brings the patient their medications and reviews them with the patient]” then she would review the medications the patient is taking that day. RN 11 stated because Pt 5 was part of the “meds in hand” the TOC pharmacist had reviewed the discharge medications with him, and she did not. RN 11 stated if she had seen the order for the Coreg 25 mg 2 tabs po BID she would have questioned it and called the physician. During a review of the hospital policy titled, “Medication Reconciliation” approved date 4/15/22, indicated, “PURPOSE: To define an interdisciplinary process designed to avoid medication omissions, and decrease actual or potential adverse drug events. POLICY: Medication Reconciliation will occur for patients on admission to the hospital, a change in the level of care, and at discharge ... Medication history shall be obtained by nursing upon admission. - Pharmacy department shall obtain medication history for patients deemed “high risk” (Appendix A) ? Under pharmacist supervision, pharmacy technicians and interns may obtain patients’ medication history. ? Pharmacy technician and interns obtaining patients’ medication history will receive training and pass a competency exam. - Licensed Provider will perform medication reconciliation at admission, transfer, and discharge ... 4. Discharge a. The Licensed Provider shall review the PTA med list and current inpatient medications and reconcile medications for discharge. b. The nurse will then provide the patient and/or family/caregiver with an After Visit Summary (AVS), which includes the discharge medication that the patient should follow once discharged from the hospital. c. The patient and/or family/caregiver will receive a verbal explanation of the AVS in regard to managing their medication regimen. d. Pharmacist will review the discharge medication list per consult and contact the licensed provider for any discrepancies ... ATTACHMENTS Medication History High Risk Criteria 1. Patients admitted for Systolic Heart Failure exacerbation 2. EHR Medication History Score of 100 or higher ...” During a review of the hospitals Job Description for “Registered Nurse II” last updated 12/3/24, the job description indicated the following, “[Registered Nurse] Accountable for the assessment, coordination delivery and evaluation of nursing care, including direct patient care, patient/family education and transitions of care in an acute patient setting. Delivers holistic and individualized care to all patients in an assigned area. Develops, implements, and coordinates a plan of care that incorporates psychological, sociocultural, spiritual, economic, and life-style factors. Fosters and maintains collaborative relationships between patients, their family/support group, physicians, and other healthcare providers through timely and effective communications. Adheres to hospital polices, industry standards, best practices, and applicable laws and regulations to promote an optimal patient experience ... Partners with peers, management, and other healthcare providers to effectively streamline patient workflow, improve patient outcomes, and provide the highest care quality ... Partners with peers, management, and other healthcare providers to effectively streamline patient workflow, improve patient outcomes, and provide the highest care quality ...” During a review of a professional reference titled, “Discharging A Patient - Here’s What You Need to Know and Do” dated 7/29/19, retrieved from Lippincott Nursing Center: https://www.nursingcenter.com/ncblog/july-2019/discharging-a-patient this reference indicated, “You’re preparing to discharge a patient to home. It’s a busy day as usual, but you want to make sure you explain everything to the patient so they don’t experience any complications which could lead to hospital readmission. Here are some tips to keep in mind. 1. Explain the Paperwork Thoroughly. Make sure you read through the discharge paperwork with the patient and their family members to ensure they understand everything completely. Discharge instructions should be written in a patient-friendly language and should include educational materials to help successfully transition the patient from the hospital. In 2013, researchers reported that in adults age 65 years and older, 40% could not accurately describe the reason for their hospitalization and 54% didn’t accurately remember follow-up appointment instructions (Horwitz et al, 2013). Remember that after reviewing the discharge instructions, the patient should be able to “repeat back.” This includes telling you why they were in the hospital, how they will manage at home, what medications they are on and why, and follow-up plans ... 2. Review medications. Medication errors are a top reason for hospital readmissions. Medication reconciliation should be completed with the patient when they are first admitted. At discharge, thoroughly review the current medication list with the patient and family members, as medications may have changed during the hospitalization. Be sure to discuss: -Any new medications that have been added. -Any changes to medications they were taking prior to the hospitalization. -Plans for obtaining medications from the pharmacy ... 3. Never make assumptions. As healthcare professionals, we often assume that the patient knows certain things about their disease process or medications. It’s important to review everything with the patient. A good way to make sure your patient and their family members understand what you have discussed is to ask, “What questions do you have?” Asking open-ended questions puts the patient at ease and allows them the freedom to share their thoughts and concerns ...””

“PHARMACY DRUG RECORDS CFR(s): 482.25(a)(3) Current and accurate records must be kept of the receipt and distribution of all scheduled drugs. This Standard is not met as evidenced by: 41166 Based on interview and record review, the hospital failed to ensure an effective system to monitor high controlled substance (CS, medications with high probability of addiction and are controlled by the federal government) usages for providers and accurately reconcile controlled drugs losses for three of four sampled patients (Patients 57, 58, 59). This failure increased the potential to result in unaccounted controlled drug loss and for hospital staff to divert controlled drugs, which could place patients at risk for potential adverse outcomes including inadequate pain relief, as well as the potential for hospital staff to abuse controlled drugs. Findings: During a concurrent interview and record review on 12/11/24 at 9:24 a.m., with Medication Safety Pharmacist (MSP), an electronic hospital document titled, “Unreconciled Incidents Closed October November Anesthesia [loss of feeling or awareness caused by a drug] (UIC)” was reviewed. The UIC document indicated patients including Patients 57, 58, 59 had CS medication transaction incidents that had been documented as resolved by pharmacy staff. MSP stated that for Patient 57, an anesthesia provider dispensed a hydromorphone (a CS medication for pain) 2 milligrams (mg- unit of measure) per milliliter (ml- unit of measure) vial from an automated dispensing unit (ADU- machine that stores medication and uses passcode for access) on 11/12/24 at 10:52 a.m. MSP stated a notification for a partially missing 1.25 mg hydromorphone dose was received, with Patient 57’s medication administration record (MAR) indicating 0.75 mg hydromorphone was administered. MSP stated pharmacy staff was unable to find documentation for administration or wastage of hydromorphone 1.25 mg. The UIC document indicated an email was sent to the anesthesia provider, and on 11/21/24, the anesthesia provider stated the documentation had been fixed. MSP stated the fixing process was for anesthesia providers to back chart by going back in the patient’s record as documenting the missing doses as administered. MSP stated that for Patient 58, an anesthesia provider dispensed a fentanyl (a CS medication for pain) 100mcg (microgram- unit of measure) per 2 ml vial from an ADU on 11/12/24 at 11:53 a.m. MSP stated a notification for a partially missing 50 mcg fentanyl dose was received, with Patient 58’s MAR indicating 50 mcg fentanyl was administered. MSP stated pharmacy was unable to find documentation for administration or wastage of fentanyl 50 mcg. The UIC document indicated, “[anesthesia provider] updated patient MAR to reflect a total of 100 mcg of fentanyl given. Back charted on 11/25/24 at 1036”. MSP stated that for patient 59, an anesthesia provider dispensed a midazolam (a CS medication for anxiety) 5 mg per ml vial from an ADU on 11/14/24 at 3:27 p.m. MSP stated a notification for a missing 5 mg midazolam was received. MSP stated pharmacy staff was unable to find documentation for administration or wastage of midazolam 5 mg. The UIC document indicated an email was sent to the anesthesia provider, and on 12/2/24, the anesthesia provider indicated the charting has been completed. During an interview on 12/11/24 at 3:31 p.m. with MSP, MSP acknowledged the use of back charting for reconciling CS medication could be a potential for diversion. MSP stated the diversion prevention committee had a list, but it was not specific to back charting and only reported numbers and did not have a process in place for tracking and trending providers who back charted for potential diversion. During an interview on 12/11/24 at 3:38 p.m. with Pharmacy Manager (PM), PM acknowledged the use of back charting for reconciling CS medication could be a potential for diversion. During an interview on 12/11/24 at 3:45 p.m. with Director of Pharmacy (DIR 5), DIR 5 stated there was no effective system to reconcile controlled drugs related to back charting, as pharmacy did not track and trend back charting alone. DIR 5 stated back charting was potentially bad because somebody could falsely document that a CS medication was administered. During a review of the hospital’s Policy and Procedure (P&P) titled, “Controlled Drug Management and Diversion Prevention”, dated 4/15/22, the P&P indicated, “Anesthesia Providers Administration of controlled substances removed from a Pyxis machine will be documented in the EHR [electronic health record]. Waste will be documented in the Pyxis [automated dispensing machine storing medications] with a co-signer/witness ... Waste will be documented in the Pyxis with a cosigner/witness. Controlled substances discrepancies will be resolved as soon as possible (ASAP) or by the shift end by the Anesthesiologist.””

“DELIVERY OF DRUGS CFR(s): 482.25(b) §482.25(b) Standard: Delivery of Services In order to provide patient safety, drugs and biologicals must be controlled and distributed in accordance with applicable standards of practice, consistent with Federal and State law. This Standard is not met as evidenced by: 41166 Based on interview and record review, the hospital failed to ensure dose appropriateness of a patient’s medication regimen prior to discharge when Patient 5’s carvedilol (medication to lower blood pressure and strengthens heart to pump blood) dose was inappropriately increased prior to discharge. This failure resulted in Patient 5 presenting to the Emergency Department 4 days after discharge with hypotension (low blood pressure) and bradycardia (slow heartbeat) and potential beta blocker (medication like carvedilol that lowers blood pressure) overdose. Findings: During a concurrent interview and record review on 12/9/24 at 11:09 a.m. with Transition of Care Pharmacist (TCP) 1, Patient 5’s medical record was reviewed. TCP 1 stated TCPs were involved in discharge medication reconciliation and bedside education for high-risk patients including heart failure patients. TCP 1 stated once a patient was discharged by a provider, a TCP would review the discharge orders for completeness, accuracy, check for discrepancies, verify correct pharmacy for medication to be dispensed, and provide bedside education to the patient. A review of Patient 5’s Discharge Summary dated 12/5/24, indicated Patient 5 had diagnoses including hypertension (high blood pressure) and heart failure (condition where the heart is unable to pump enough blood and oxygen to the heart and organs), was admitted to the hospital on 11/17/24 for shortness of breath and discharged on 11/22/24. Patient 5’s Medication Administration Record (MAR), dated 12/9/24, indicated Patient 5 was administered carvedilol 3.125 milligrams (mg- unit of measure) twice daily ( 11/ 18/24 at 10:15 a.m., 6:53 p.m.;11/19/24 at 8:42 a.m., 7:25 p.m.;11/20/24 at 8:08 a.m., 5:15 p.m.; 11/21/24 at 7:45 a.m.), and carvedilol 6.25 mg twice daily (11/21/24 5:36 p.m.; 11/22/24 9:04 a.m.) while admitted. A review of TCP 2’s “Discharge Progress Notes (DPN)” for Patient 5, dated 11/22/24 at 2 p.m., the DPN indicated, “In discussion with the provider [Physician 2], Coreg [carvedilol] 25 mg bid [twice daily] was escalated to Coreg 25 mg 2 tablets po [by mouth] bid to achieve a HF [heart failure] target dose.” TCP 1 stated Patient 5’s discharge medication list was reviewed and changed by TCP 2 on 11/22/24. During a telephone interview on 12/9/24 at 2:35 p.m., with Physician (PHY) 1, Patient 5’s admitting physician, PHY 1 stated Patient 5 had worsening symptoms of heart failure upon admission on 11/17/24. PHY 1 stated although Patient 5’s home medication list showed carvedilol 25 mg twice daily, Patient 5 was not compliant with taking medications, so she initiated Patient 5 on a low carvedilol dose at 3.125 mg twice daily. PHY 1 stated with heart failure, it was important to start patient at low dose and titrate slowly, and not have patient on too many antihypertensive medications. During a telephone interview on 12/9/24 at 3:10 p.m., with Patient 5’s wife (FM 2), FM 2 stated Patient 5 was discharged on 11/22/24 with a bottle of carvedilol 25 mg tablets after the pharmacist went over the directions. FM 2 stated Patient 5 was home for 4 days and had to call the ambulance to take him to the hospital, because he was weak, and his heart rate was in the forties. FM 2 stated she had followed the directions on the medication bottle and had administered approximately 2 carvedilol 25 mg tablets twice daily to Patient 5 for a total of approximately 16 tabs. During an interview with Outpatient Pharmacy Manager (OPM) on 12/9/24 at 3:58 p.m., OPM acknowledged an order for carvedilol 25 mg, 2 tablets twice daily was processed and dispensed for Patient 5 on 11/22/24. OPM stated once Patient 5’s carvedilol medication was processed, it was taken to a TCP. A review of Patient 5’s carvedilol order printed 12/9/24 indicated, a telephone order for carvedilol 25 mg, 2 tablets twice daily for quantity 120 tabs was created by TCP 2 on 11/22/24 at 10:36 a.m., electronically confirmed by the hospital’s outpatient pharmacy on 1/22/24 at 10:37 a.m., and signed by PHY 2 on 11/22/24 at 11:42 a.m. During a telephone interview on 12/9/24 at 4:18 p.m., with PHY 2, PHY 2 stated she received a call from TCP 2 on 11/22/24 regarding two other medications but not regarding carvedilol. PHY 2 stated her concern was that she ordered carvedilol 25 mg twice daily and did not know why TCP 2 changed the carvedilol dose. PHY 2 stated she ordered carvedilol 25 mg twice daily for Patient 5 because Patient 5 had been taking the dosage prior to hospitalization. PHY 2 acknowledged she signed TCP 2’s order for carvedilol 25 mg, 2 tablets twice daily and did not recognize the order as a high dose or odd dose. A review of Patient 5’s carvedilol 25 mg tablet order printed 12/9/24, indicated carvedilol 50 mg twice daily, written date 11/22/24 by TCP 2. The order indicated, “Filtered Medication Warnings ...drug-disease ... stabilize patients on heart failure regimen prior to initiation or titration of beta-blocker. Beta-blocker therapy should be initiated at very low doses with gradual and careful titration. Worsening heart failure or fluid retention may occur during upward titration; dose reduction and/or slower titration may be necessary.” During a review of Patient 5’s “Hospital Critical Care Notes (HCCN)” dated 11/26/24, the HCCN indicated, “ ... recent hospitalization 11/17-11/22/2024 for hypoxic respiratory failure [not enough oxygen in blood] from pulmonary edema [too much fluid in lungs, making it difficult to breathe] and fluid overload who presents to [hospital] 11/26/2024 for evaluation of weakness x [for] 5 days and shortness of breath for 10 days ... The patient reports he has been compliant with his medications, noting that he was recently prescribed 80mg Lasix [medication that helps lower blood pressure and remove excess water from the body] BID and 50mg carvedilol BID ... The patient was given glucagon for possible beta blocker overdose .... Admitted to ICU [intensive care unit] for further management ... assessment/plan ... bradycardia; beta blocker overdose ...” During an interview on 12/11/24 at 2:54 p.m. with TCP 1, TCP 1 acknowledged it was not standard of practice to increase carvedilol from 6.25 mg twice daily to 50 mg twice daily. TCP 1 stated if patient’s heart rate was elevated and dose increase was warranted, a recommendation would be to increase to 12.5 mg twice daily and titrate up as tolerated. During an interview on 12/11/24 at 3:57 p.m. with Director of Pharmacy (DIR 5), DIR 5 stated he would not go from carvedilol 6.25 mg twice daily to 50 mg twice daily due to possibility for low heart rate, low blood pressure and heart block in extreme cases. During a review of DailyMed, a nationally recognized database, the manufacturer for carvedilol indicated, “DOSAGE MUST BE INDIVIDUALIZED AND CLOSELY MONITORED BY A PHYSICIAN DURING UP-TITRATION. Prior to initiation of COREG [carvedilol], it is recommended that fluid retention be minimized. The recommended starting dose of COREG is 3.125 mg twice daily for 2 weeks. If tolerated, patients may have their dose increased to 6.25, 12.5, and 25 mg twice daily over successive intervals of at least 2 weeks. Patients should be maintained on lower doses if higher doses are not tolerated. A maximum dose of 50 mg twice daily has been administered to patients with mild-to-moderate heart failure weighing over 85 kg (187 lbs.) ... Overdosage may cause severe hypotension, bradycardia, cardiac insufficiency [heart cannot pump enough blood], cardiogenic shock [ life-threatening condition that occurs when the heart is unable to pump enough blood and oxygen to the body’s organs], and cardiac arrest [medical emergency that occurs when the heart suddenly stop beating]. Respiratory problems, bronchospasms [difficulty breathing], vomiting, lapses of consciousness, and generalized seizures may also occur ... To support cardiovascular function: Glucagon, 5 to 10 mg IV rapidly over 30 seconds, followed by a continuous infusion of 5 mg per hour; sympathomimetics [drugs to help increase heart rate and breathing] (dobutamine, isoprenaline, adrenaline) at doses according to body weight and effect.”

“CONTROLLED DRUGS KEPT LOCKED CFR(s): 482.25(b)(2)(ii) Drugs listed in Schedules II, III, IV, and V of the Comprehensive Drug Abuse Prevention and Control Act of 1970 must be kept locked within a secure area. This Standard is not met as evidenced by: 41166 Based on observation, interview and record review, the hospital failed to ensure controlled substance (CS medications with high probability of addiction and are controlled by the federal government) medications were stored according to hospital policy and procedures (P&P) for three of three sampled patients (Patients 56, 54, 55). These failures had the potential for CS medication diversion (illegal use of prescription medication or use for purposes not intended by the prescriber) and unauthorized access to medications. Findings: During a tour of the hospital’s pharmacy on 12/9/24 at 9:45 a.m., with the Pharmacy Supervisor (PS) and Pharmacy Manager (PM), an inspection of clear bags containing patient own medications hanging on a pole against the pharmacy wall, was conducted. During the inspection, Patient 56’s medication brought from home were identified as 29 tramadol (CS medication used for pain) 50 milligrams (mg- unit of measure) tablets inside a clear bag, Patient 54’s medication brought from home were identified as oxycodone-acetaminophen (CS medication used for pain) tablets inside a clear bag, and Patient 55’s medication brought from home were identified as hydrocodone-acetaminophen 10 (CS medication used for pain) tablets inside a clear bag hanging against the pharmacy wall near the entrance of the pharmacy, unsecured. During a concurrent interview and document review on 12/9/24 at 9:50 a.m. with PM and PS, Patients 56, 54 and 55 patient own medication (POM) bags were reviewed. Patients 54 and 55’s POM bags did not indicate the strength or quantity of the CS medications. PM stated POM were brought to the pharmacy by nursing staff with a completed form, and pharmacy staff filed the forms and placed the POM in clear bags and stored them against the wall in the pharmacy. PM acknowledged nursing staff did not accurately document the strength or quantity of Patients 54 and 55’s medications brought from home. PM acknowledged pharmacy staff would not be able to accurately reconcile the CS medications if the CS medications were destroyed and the quantity and strength of each patient own CS medications brought to the pharmacy were not accurately identified. PS acknowledged the POM CS medications were stored with non-controlled POM on the wall. PS stated it was important to track storage and destruction of all CS medications because not accurately tracking storage and destruction could lead to an opportunity for diversion. During an interview on 12/11/24 at 3:43 p.m., with Director of Pharmacy (DIR 5), DIR 5 acknowledged POM CS medications were not stored securely in the pharmacy and stated all CS medications received by pharmacy should be stored in the CS safe (secured storage system accessible only by passcode). During a review of the hospital’s P&P titled, “Medication Procurement, Storage, and Inspection”, dated 6/16/21, the P&P indicated, “Controlled Substances ... Medications are stored in a secure manner to prevent diversion, in accordance with law and regulation ... Controlled substances will be kept secured at all times in automated dispensing machines [machine used to stored medications accessible only by passcode] (e.g., Pyxis) throughout the facility. “”

“UNUSABLE DRUGS NOT USED CFR(s): 482.25(b)(3) §482.25(b)(3) - Outdated, mislabeled, or otherwise unusable drugs and biologicals must not be available for patient use This Standard is not met as evidenced by: 49769 Based on observation, interview, and record review, the hospital failed to follow its policy titled, “Labeling of Medications” when three of 10 medications were observed to be unlabeled and left in a patient’s (Pt 8) drawer in a medication cart on the Oncology (a branch of medicine that specializes in the diagnosis and treatment of cancer) unit and were available for patient use . This failure had the potential for the patient to receive the wrong medication and cause harm or even death. Findings: During a concurrent observation and interview on 12/3/24 at 2:00 p.m. with Nurse Educator (NE) 5 and Nurse Manager (NM) 9 on the Oncology Unit in the Medication Room, two pills (Sevelamer-medication for high blood levels of phosphorus in people with chronic kidney disease) and one transdermal (Lidocaine-to relieve nerve pain, it attaches to skin and contains medication) patch in manufacturer packaging were observed loose in Pt 8’s drawer in a medication cart in the medication room with no patient identifiers. NE 5 stated all medications in the medication cart should have patient identifiers and be stored in a bag. NE 5 stated if a medication was not labeled properly, it might be given to wrong patient causing harm. NM 9 stated all medications should be labeled completely and properly. NM 9 stated nurses should discard medications that were not properly labeled. During an interview on 12/9/24 at 8:00 a.m. with the Pharmacy Supervisor (PS), the PS stated all medications should be properly labeled which included but not limited to patient name, time of administration, dosage, and route. PS stated if medication did not have proper labeling, it should be returned to pharmacy. PS stated if wrong medication was given, it could harm patient to the point of death. During an interview on 12/9/24 at 8:15 a.m. with Director of Pharmacy (DIR) 5, DIR 5 stated all medications without exception should be properly and completely labeled. DIR 5 stated medications in a medication cart should be stored in a bag and not loose. DIR 5 stated if medication is not labeled correctly and given to the wrong patient, the medication can cause harm or death for that patient. DIR 5 stated medication that did not have proper labeling should be returned to pharmacy. During an interview on 12/11/24 at 2:30 p.m. with the Chief Nursing Officer (CNO), the CNO stated medications for all patients should be labeled correctly and placed together, not separated or loose in a container. The CNO stated if medications are not properly labeled, they have the potential to cause harm to the patient. During a review of the facility’s policy and procedure (P&P) titled, “Labeling of Medications,” dated 10/15/2020, the P&P indicated, “PURPOSE: A. To provide guidelines for the correct labeling of medications dispensed ... D. Labels shall be printed by computer and firmly affixed to the prescription container or dose.” During a review of the facility’s policy and procedure (P&P) titled, “Medication Procurement, Storage, and Inspection” dated 6/16/21, the P&P indicated, “PURPOSE: A. To establish guidelines and processes for medication procurement, storage, and inspection ... F. Storage 3. Drugs are stored under condition of sanitation, temperature, light, moisture, ventilation, segregation, and security ... 9. Drugs and antiseptics designated for external use shall be stored separately from internal and injectable medications ...””

“INFECTION CONTROL SURVEILLANCE, PREVENTION CFR(s): The infection prevention and control program includes surveillance, prevention, and control of HAIs, including maintaining a clean and sanitary environment to avoid sources and transmission of infection, and addresses any infection control issues identified by public health authorities; and This Standard is not met as evidenced by: 45977 Based on observation, interview, and record review, the facility failed to maintain a clean and sanitary environment to avoid sources transmission of infection according to hospital’s policy and procedures, and the Center’s for Disease Control and Prevention’s (CDC) standards of practice for infection when: 1. One of three sampled rooms (Clean storage rooms), clean patient care supplies were found on shelves on the bottom shelf 2 inches from the contaminated floor. 2. One of one sampled clean vital sign machines (measures the basic medical indicators of health - temperature, pulse, breathing, and blood pressure), was found in a clean equipment room connected to a contaminated disposable pulse oximeter (a medical device that measures the oxygen levels in the blood). 3. Registered Nurse (RN) 1 failed to follow hospital policy and procedure (P&P) for one of one sampled patient (Pt 23) when RN 1 was observed in the Neonatal Intensive Care Unit (NICU-a hospital area that provides specialized care for newborn babies who are sick or premature) not performing hand hygiene (practice of cleaning hands to remove germs, dirt, or other harmful substances) and donning (putting on) new non-sterile gloves before and after touching Pt 23. 4. Six of six bottles of expired baby formula and one container of expired blood capillary collection tubes (very thin blood collection tubes) were found in the NICU supply room. These failures placed all patients and staff at risk for transmission of infections (an infectious agent is transferred from a reservoir to a susceptible host) and cross contamination (the process by which bacteria or other microorganisms are unintentionally transferred from one substance or object to another, with harmful effect) and increased the potential for hospital acquired infections and illnesses. Findings: 1. During a concurrent observation and interview, on 12/3/24, at 3:25 p.m., with the Director of Critical Care Services (Dir 1), in intensive care unit, clean storage room, the bottom shelf of a shelving unit for clean medical supplies was observed to be less than two inches from the floor. The Dir 1 stated, a mop could not fit under the shelving unit to clean underneath. The Dir 1 stated, the floors should be swept and mopped daily and as needed, including under the shelving units. The Dir 1 stated, supplies could become contaminated from the debris on the floor and possible infections could result. During an interview, on 12/10/24, at 11:00 a.m., with the Infection Prevention Manager (IPM), the IPM stated, items should be stored 6 inches from the floor and 18 inches from the ceiling. IPM stated, this was important because staff needed to be able to clean and mop under the shelves, or otherwise, dust and debris will accumulate, and the environment would not be clean and safe for the supplies. During a review of the facility’s policy and procedure (P&P) titled, “Storage Requirements”, dated 5/2022, the P&P indicated, “... To insure that all supplies and durable medical equipment are stored in a safe and uniform manner. ... 4. All sterile and non-sterile supplies, durable medical equipment, and materials will be stored 8-10 inches from the floor and 18-20 inches from the ceiling. ...” During a professional reference review retrieved from https://www.cdc.gov/infectioncontrol/pdf/guidelines/environmental-guidelines-P.pdf titled, “Guidelines for Environmental Infection Control in Health-Care Facilities,” dated 7/2019, the professional reference indicated, “ ... Infection-control strategies and engineering controls, when consistently implemented, are effective in preventing opportunistic, environmentally-related infections in immunocompromised populations...” 2. During a concurrent observation and interview, on 12/3/24, at 4:15 p.m., with the Dir 1, on the third floor of the intensive care unit, in the clean equipment room, a vital sign machine was observed to be marked, “clean for use”; however, a disposable pulse oximeter with used foam tape was attached to the machine. The Dir 1 stated, the pulse oximeter should not be attached to the machine as it appeared to be used and was not reusable between patients. The Dir 1 stated, only clean equipment should be stored in the room to be ready for use with patients. The Dir 1 stated, it was important to use clean equipment with patients to prevent the spread of infections and ensure safe patient care. During an interview, on 12/10/24, at 11:00 a.m., with the IPM, the IPM stated, disposable pulse oximetry units should not be reused and was for one patient only. IPM stated, disposable pulse oximetry units should be disposed of after used and not use with multiple patients. The IPM stated, reusing a disposable pulse oximetry unit multiple patients could cause transmission of organisms and a risk of infection. During a review of the pulse oximetry manual titled, “[NAME BRAND] Single-Patient-Use Cloth and Foam SpO2 [oxygen saturation - amount of oxygen in the blood] Sensors”, not dated, the manual indicated, “... sensors are for single-patient-use ... Dispose of sensor after use. Do not use the same sensor on another patient. ... “ During a review of the document titled, “CDC’s Core Infection Prevention and Control Practices for Safe Healthcare Delivery in All Settings” retrieved from, https://www.cdc.gov/infection-control/hcp/core-practices/index.html dated 4/12/24, “ ...standard precautions (basic level of infection control that is used in patient care) include: ...hand hygiene ...environmental cleaning and disinfection .. Reprocessing of reusable medical equipment between each patient or when soiled...” 3. During an observation and interview on 12/3/23 at 2:25 p.m. with Registered Nurse (RN) 1 in the NICU, RN 1 was observed providing care to Pt 23 with contaminated gloves. Pt 23 was lying in the radiant warmer (baby bed used in hospitals to provide heat to the body) quietly, on her back. RN 1 was observed listening to Pt 23’s chest with a stethoscope (a medical device to listen to sounds inside the body). RN 1 set the stethoscope down on the radiant warmer’s rail, touching multiple areas of the radiant warmer, turned to the side counter picking up her pen and writing on a clipboard. RN 1 then picked up a thermometer (device used to measure temperature) and took Pt 23’s axillary (under arm) temperature. RN 1 set down the thermometer and proceeded to change Pt 23’s diaper after which, she again picked up her pen and wrote on the same clipboard. RN 1 completed all tasks without removing contaminated gloves or performing hand hygiene. RN 1 stated she should have changed gloves between tasks and performed hand hygiene. RN 1 stated by not changing gloves, and cleaning her hands after touching the environment, pathogens (a disease-causing organisms) could transfer from her hands to the baby. During an interview on 12/3/24 at 2:41 p.m. with Director (DIR) 3, DIR 3 stated her expectation was that LNs followed the hospital’s hand hygiene policy and procedure exactly. During a review of the hospital’s policy and procedure (P&P) titled, “Hand Hygiene,” dated 5/20/22, indicated, “ ... Hand hygiene is performed by all healthcare workers (HCW) and hospital staff/employees. Hand hygiene is performed: ... immediately before touching a patient ... Before performing an aseptic task [free from contamination] ... or handling invasive [enters the body] medical devices ... Before moving from work on a soiled body site to a clan body site on the same patient ... after touching a patient or the patient’s immediate environment ... after contact with blood, body fluids, or contaminated surface3s ... Before donning [putting on] gloves, after glove removal, and in between, glove changes ...” During a review of professional reference from the CDC titled, “Clinical Safety: Hand Hygiene for Healthcare Workers, dated 2/27/24, the professional reference indicated, “ ... Hand hygiene protects both healthcare personnel and patients. Hand hygiene means cleaning your hands with Handwashing with water and soap (e.g., plain soap or with an antiseptic). Antiseptic hand rub (alcohol-based foam or gel hand sanitizer) ... Cleaning your hands reduces: The potential spread of deadly germs to patients. The spread of germs, including those resistant to antibiotics ... Know when to clean your hands ... Immediately before touching a patient ... Before performing an aseptic task such as placing an indwelling device or handling invasive medical devices ... Before moving from work on a soiled body site to a clean body site on the same patient ... After touching a patient or patient’s surroundings ... After contact with blood, body fluids, or contaminated surfaces ... Immediately after glove removal ...” 4. During a concurrent observation and interview on 12/3/24 at 2:38 p.m. with DIR 3 in the NICU clean storage area, six 2-ounce (oz-a unit of fluid measurement) bottles of [brand name] infant formula with the expiration date of 12/1/24 and one container of expired blood capillary collection tubes (a thin tube used to collect and analyze small amounts of blood) with the expiration date of 10/31/24. DIR 3 stated the six bottles of infant formula were expired and expired formula should not be used to feed babies. DIR 3 stated the potential for harm would be exposing pathogens to the baby and, “the baby is already immunocompromised [lower defenses against infections and diseases]”. DIR 3 stated the blood capillary collection tubes were also expired and LNs should not use expired medical products because the product may no longer work as designed. DIR 3 stated Central Supply stocked supplies and checked the expiration dates on the supplies, but LNs should also check expiration dates and not use expired products. DIR 3 stated LNs should remove expired product from circulation and contact Central Supply for new unexpired products. During an interview on 12/10/24 at 10:55 a.m. with the IPM, the IPM stated expired products should not be used on any patients. The IPM stated using expired products could cause infections and allergic reactions. During an interview on 12/11/24 at 2:55 p.m. with the Chief Nursing Officer (CNO), the CNO stated, the hospital should not have any expired supplies in the supply rooms, especially expired baby formula. The CNO stated LNs should know to check expiration dates and take the products out of circulation. The CNO stated using expired formula had the potential for food poisoning to the baby. During a review of the hospital’s P&P titled, “Outdated, Expired, Defective and Event Related Sterile or Non-Sterile Manufactured Supplies,” dated 5/31/22, indicated, “ ... All Central Supply Distribution personnel shall insure that all sterile supplies are monitored for out dates, expiration dates, and defects. No outdated, expired, or defective medical supply (sterile or non-sterile) shall be maintained in the main inventory, or unit supply areas. Event- Related supplies should be monitored for packaging integrity and serviceability. Appropriate measures shall be taken to [ensure] that these supplies are removed from all supply areas, hospital-wide ... If sterile or non-sterile supplies are found to be outdated, expired, defective or damaged upon receipt into the Main Central Supply Inventory the department supervisors or lead should be notified so that a product failure may be reported ...” During a review of the professional reference titled, “Handling Infant Formula Safely ...”, dated April 2024, the professional reference indicated, “ ... “Use By” Date-Don’t use a package or container of infant formula after this date. The manufacturer guarantees the nutrient content and quality of the formula only up to the “use by” date. FDA [Food and Drug Administration] rules require a “use by” date on every container of infant formula ...” During a professional reference review retrieved from https://www.cdc.gov/infectioncontrol/pdf/guidelines/environmental-guidelines-P.pdf titled, “Guidelines for Environmental Infection Control in Health-Care Facilities,” dated 7/2019, the professional reference indicated, “ ... Infection-control strategies and engineering controls [physical changes to a work area or process that reduce or eliminate the risk of workers coming into contact with hazards], when consistently implemented, are effective in preventing opportunistic [exploiting chances offered by immediate circumstances], environmentally related infections in immunocompromised populations...””

“MAINTENANCE OF PHYSICAL PLANT CFR(s): 482.41(a) The condition of the physical plant and the overall hospital environment must be developed and maintained in such a manner that the safety and well-being of patients are assured. This Standard is not met as evidenced by: 40644 Based on observation, interview and record review, the hospital failed to maintain a safe and clean environment when the floors and walls were damaged. These failures placed all patients, staff, and visitors in the Emergency Department (ED) at risk of injury and infection. Findings: During an observation and interview on 9/30/24 at 11:30 a.m. with the Director of the Emergency Department (Dir 3) and the Manager of the Emergency Department (Mgr 1), the hospital walls, floors, and furniture were observed. The baseboards were pulled away from the corner of the wall outside Pod D (different areas of the ED are designated as “Pods”) creating a hole in the wall, and the corner moulding outside Pod D was pulled away from the corner, exposing the wall behind it. In Pod C, the wall had a hole approximately four inches by three inches, approximately two feet above the ground. Dir 3 stated the holes in the wall and the molding pulling away are a problem in the ED because equipment crashes into the walls and causes damage. Dir 3 stated this could be a patient safety and infection control risk, because the damaged walls can’t be disinfected properly. During an observation and interview on 10/1/24 at 9:30 a.m. with the Dir 3 and the Manager of Infection Prevention (MIP) in the ED, the MIP observed the baseboards, holes in walls, and where the moulding was pulling away from the corner. The MIP stated could be a source for the spread of infections. During an interview on 10/2/24 at 10:50 a.m. with the Facilities Director (FD), the FD stated he does environmental rounds in the ED twice a year. The FD stated large holes in walls can be a life safety issue (someone could get hurt) because an arm could get stuck in a hole or a patient could be injured, and small holes are also a concern because they can be the source for spread of infection since they can’t be cleaned. The FD stated he has observed children sitting on the floor in the ED playing with the cracks in the walls and the moulding where is had come separated from the wall. The FD stated the ED is on a list to have improvements made to the walls, baseboards, and moulding. According to an article in Health Facilities Management, dated August 16, 2019, titled, “The Role of Maintenance in Infection Prevention,” retrieved from https://www.hfmmagazine.com/articles/3728-how-maintenance-can-help-or-hurt-infection-prevention, the article indicated, “ ... Because of their random nature, miscellaneous HAI (Hospital Acquired Infection) concerns can sometimes be the hardest to spot. Some things to look for include: Peeling paint or damaged wall surface. A wall surface that is not smooth is not cleanable and also is an infection prevention concern ...Damaged plastic laminate, upholstery, doors, and similar items. Plastic laminate casework (cabinets, moulding, etc) is frequently damaged, resulting in a surface that cannot be cleaned properly. The same applies to damaged upholstery, mattresses, and other surfaces. Damaged materials must be repaired or replaced to provide a cleanable surface ...””

“NURSING SERVICES CFR(s): 482.23 The hospital must have an organized nursing service that provides 24-hour nursing services. The nursing services must be furnished or supervised by a registered nurse. This Condition is not met as evidenced by: 42321 Based on observation, interview and record review, the hospital failed to have a well-organized and effective nursing service when the hospital failed to ensure three medications were administered in accordance with the physician orders, facility policies and accepted standards of practice for three of 8 sampled patients when: 1. Patient 1 was administered 25 times the prescribed dose of nitroglycerin (a medication to relax the blood vessels and increase the supply of blood and oxygen to the heart for the management of chest pain). (Refer to A 405 Finding 1) 2. The dose of Patient 2’s propofol (a medication used for the induction and maintenance of anesthesia or sedation) was not adjusted as prescribed according to Patient 2’s Richmond Agitation-Sedation Scale (RASS, a medical scale used to measure the agitation or sedation level). (Refer to A 405 Finding 2) 3. Patient 3’s medications were crushed and administered together through a feeding tube without properly flushing the tube. (Refer to A 405 Finding 3) 4. The facility failed to follow two of their policy and procedures titled “Medication Reconciliation,” when two of seven patients sampled (Patient (Pt) 80 and 81) in the emergency department (ED), medication reconciliation (a process of comparing the licensed provider’s admission, transfer, and/or discharge orders to current and home medications) process was not completed. (Refer to A 398) The cumulative effect of these systemic problems resulted in the hospital’s inability to ensure the provision of quality patient care in a safe environment.”

“INFECTION PREVENTION CONTROL ABX STEWARDSHIP CFR(s): 482.42 The hospital must have active hospital-wide programs for the surveillance, prevention, and control of HAIs and other infectious diseases, and for the optimization of antibiotic use through stewardship. The programs must demonstrate adherence to nationally recognized infection prevention and control guidelines, as well as to best practices for improving antibiotic use where applicable, and for reducing the development and transmission of HAIs and antibiotic resistant organisms. Infection prevention and control problems and antibiotic use issues identified in the programs must be addressed in collaboration with the hospital-wide quality assessment and performance improvement (QAPI) program. This Condition is not met as evidenced by: 42321 Based on observation, interview, and record review, the hospital failed to have an active Infection Prevention and Control program which adhered to nationally recognized infection prevention and control guidelines for the surveillance, prevention, and control of HAIs (hospital acquired infections) and other infectious diseases, when: 1. Seventy-five of 75 patients had a rectal probe (device used to insert something into ones bottom) used on them without high level disinfection (HLD- complete elimination of all microorganisms in or on an instrument) being done on the probe before each use. The facility did not follow the Manufacture Guidelines for Use (MFU) for this rectal probe. (Refer to A 749) 2. The facility did not maintain audits for the inspection of sterilized surgical instruments; did not have a policy and procedure for inspecting surgical instruments; did not have a predetermined standard of compliance with which to measure the audits; did not report steam sterilization performance data to the facility’s Quality Assurance and Performance Improvement (QAPI) Program; audits were incomplete; and an audit failed to identify damaged instruments. (Refer to A 772) 3. One of one laminate countertop around the hand sink used to feed water to the dialysis machines in South Tower Telemetry/Dialysis 5, room 5-006, had become rough and bubbled. The countertop had over ten half inch circles where the laminate was missing, and the bare wood was exposed. (Refer to A 750 finding 1) 4. Two surgical instruments called a needle holder, had etching and scratching that could be felt on the instrument were in use and passed an audit inspection for damage to instruments. (Refer to A 750 finding 2) The cumulative effects of these systemic problems resulted in the hospital’s inability to ensure the provision of quality patient care in a safe and sanitary environment.”

“SUPERVISION OF CONTRACT STAFF CFR(s): 482.23(b)(6) All licensed nurses who provide services in the hospital must adhere to the policies and procedures of the hospital. The director of nursing service must provide for the adequate supervision and evaluation of all nursing personnel which occur within the responsibility of the nursing service, regardless of the mechanism through which those personnel are providing services (that is, hospital employee, contract, lease, other agreement, or volunteer). This Standard is not met as evidenced by: 42321 Based on observations, interviews and record review, the facility failed to follow two of their policy and procedures titled “Medication Reconciliation,” when two of seven patients sampled (Patient (Pt) 80 and 81) in the emergency department (ED), medication reconciliation (a process of comparing the licensed provider’s admission, transfer, and/or discharge orders to current and home medications) process was not completed. This failure placed Pt 80 and 81 at risk of having duplicate medication orders and had the potential to place these patients at risk of the wrong dosages. Findings: During a concurrent interview and record review on 2/28/24, at 9:30 a.m. with the ED Manager (EDM), Patient 81’s electronic health records (EHR) for his ED visit on 6/26/23 was reviewed. The EHR indicated Pt 81 was a 37-year-old male who walked into the ED with chief complaint of bilateral leg swelling and redness and admitting diagnosis of septic shock (a life-threatening condition that happens when your blood pressure drops to a dangerously low level after an infection). The EDM reviewed Pt 81’s EHR and stated the patients home medication list and medication reconciliation was not completed for this visit and it should have been completed in phase 2 (Triage nurse completes phase 1 (includes chief complaint, vital signs, pain, allergies and etc.) and the phase 2 triage (includes home medication list and etc.) and screenings will be completed by primary nurse in patient care areas)(what’s phase 2) in the ED. During a concurrent interview and record review on 2/28/24, at 1:50 p.m., with the EDM, Pt 80’s EHR for her ED visit on 1/21/24 was reviewed. The EHR indicated, “Pt was walking in our parking lot while going to get the car to pick up her husband when she tripped and fell striking her head and right knee. Pt takes thinners for a-fib (irregular heart rhythm- places patient at higher risk of stroke). No loc (loss of consciousness). GCS (Glasgow Coma Scale/Score (GCS) estimates coma severity based on Eye (4), Verbal (5), and Motor (6) criteria) 15. Sustained laceration to forehead bleeding controlled”. The EDM reviewed Pt 80’s EHR and stated the patients home medication list and medication reconciliation was not completed for this visit and it should have been completed in phase 2 in the ED. During a review of the facility’s P&P titled, “Medication Reconciliation,” effective date 4/15/2022, it indicated, “PURPOSE: A. To define an interdisciplinary process designed to avoid medication omissions and decrease actual or potential drug events. POLICY: Medication Reconciliation will occur for patients on admission to the hospital, a change in the level of care and at discharge a list of medications that the patient is taking prior to admission should be documented as soon as possible, within 24 hours of admission as best possible... A. Medication Reconciliation: A process of comparing the licensed provider’s admission, transfer, and/or discharge orders to current and home medications. B. Medication History: A process of obtaining a complete and accurate list of prior two admission medications (including drug name, dosage, route and frequency...””

“ADMINISTRATION OF DRUGS CFR(s): 482.23(c)(1), (c)(1)(i) & (c)(2) (1) Drugs and biologicals must be prepared and administered in accordance with Federal and State laws, the orders of the practitioner or practitioners responsible for the patient’s care as specified under §482.12(c), and accepted standards of practice. (i) Drugs and biologicals may be prepared and administered on the orders of other practitioners not specified under §482.12(c) only if such practitioners are acting in accordance with State law, including scope of practice laws, hospital policies, and medical staff bylaws, rules, and regulations. (2) All drugs and biologicals must be administered by, or under supervision of, nursing or other personnel in accordance with Federal and State laws and regulations, including applicable licensing requirements, and in accordance with the approved medical staff policies and procedures. This Standard is not met as evidenced by: 41600 Based on observation, interview, and record review, the hospital failed to ensure medications were administered in accordance with the physician orders, facility policies and accepted standards of practice when: 1. Patient 1 was administered 25 times the prescribed dose of nitroglycerin (a medication to relax the blood vessels and increase the supply of blood and oxygen to the heart for the management of chest pain). This failure resulted in Patient 1 suffering symptoms of nitroglycerin overdose including low blood pressure, dizziness, and visual changes. Patient 1 required medical intervention including the administration of activated charcoal (a product for the management of poisoning) and intravenous norepinephrine (a medication for the management of severe low blood pressure) to regain stable condition. 2. The dose of Patient 2’s propofol (a medication used for the induction and maintenance of anesthesia or sedation) was not adjusted as prescribed according to Patient 2’s Richmond Agitation-Sedation Scale (RASS, a medical scale used to measure the agitation or sedation level). This failure resulted in Patient 2 to experience excessive agitation or sedation. 3. Patient 3’s medications were crushed and administered together through a feeding tube without properly flushing the tube. This failure had the potential for Patient 3 to have compatibility issues between the administered medications which could result in tube occlusion. Findings: 1. A review of Patient 1’s clinical record showed that Patient 1 was a 75-year-old patient admitted to the facility for chest pain and shortness of breath at approximately 5:34 p.m. on 1/11/24. Patient 1 underwent coronary angiogram (a procedure to evaluate the heart muscles, valves, and blood vessels that carry blood and oxygen to the heart) and was admitted to the Intensive Care Unit (ICU) for chest pain and close monitoring after the procedure at approximately 4:12 p.m. on 1/12/24. A review of Patient 1’s Physician Orders dated 1/11/24 indicated an order for nitroglycerin as follow: Nitroglycerin (NITROSTAT) SL (sublingual, under the tongue) Tab (tablet) 0.4 mg (milligram, unit of measure) Ordered Dose: 0.4 mg Admin (administration) Dose: 0.4 mg Route: Sublingual Frequency: Every 5 minutes PRN (as needed) for chest pain Admin Instructions: Max 3 doses in 15 minutes. Call physician if patient still has chest pain. A review of Patient 1’s Medication Administration Report (MAR) showed that nitroglycerin 0.4 mg was given to Patient 1 at approximately 11:15 p.m. on 1/12/24 by Registered Nurse (RN) 2. A review of Patient 1’s clinical record showed that the Patient 1’s blood pressure dropped from 137/76 mmHg (millimeters of mercury, unit of measure) at 11:15 p.m. to 74/37 mmHg at 11:30 p.m. on 1/12/24, fifteen minutes after the administration of nitroglycerin. During an interview with Nursing Unit Manager (NUM) 1 at 11:20 a.m. on 2/28/24, NUM 1 reported that there was an incident involving Patient 1 receiving 25 tablets of nitroglycerin sublingual tablets instead of the prescribed dose of one tablet on 1/12/24. NUM 1 stated that poison control center was contacted, and Patient 1 was administered activated charcoal and norepinephrine to manage overdose symptoms and to bring up the patient’s blood pressure. During an electronic record review with ICU informatics (ICU-I) at approximately 3:05 p.m. on 2/28/24, ICU-I confirmed that Patient 1 was administered 25 tablets of nitroglycerin 0.4mg at 11:15 p.m. on 1/12/24 by RN 2. ICU-I stated that according to Patient 1’s flowsheets, a nasogastric tube (a thin, flexible plastic tube that’s used for temporary medical purposes) was inserted at 12 a.m. for the administration of activated charcoal and the physician was notified of patient’s drop in blood pressure. During an interview with RN 2 at 7:40 a.m. on 2/29/24, RN 2 stated that she read 0.4 mg on the bottle, not 0.4 mg per tablet and poured all the 25 tablets in a plastic cup and told Patient 1 to put them under the tongue. RN 2 acknowledged that it was a mistake and further stated that Patient 1 complained of vision changes, nausea, and dizziness shortly after receiving nitroglycerin. An inspection of the nitroglycerin bottle with NUM 1 on 2/28/24 at 12 p.m. showed that the container was labeled with the following in the center of the label: Nitroglycerin Sublingual Tablets 0.4mg/tablet On the bottom of the label, it was printed: 25 Sublingual Tablets NUM 1 confirmed the bottle used for nitroglycerin administration on 1/12/24 was made by the same manufacturer. A review of Patient 1’s provider communication dated 1/13/24 at 12:23 a.m., Physician 1 dictated, “I was informed that patient was given accidental dose of NTG [nitroglycerin] sublingually. I responded to the call.” According to the manufacturer’s product labeling, nitroglycerin sublingual tablet is in a class of medication called vasodilators. It works by relaxing the blood vessels to relieve chest pain caused by heart muscle not getting enough oxygen-rich blood. Nitroglycerin 0.4mg tablets should be taken sublingually at the first sign of an acute anginal attack (chest pain). One additional tablet may be taken every 5 minutes until relief is obtained but no more than three tablets are recommended within a 15-minute period. Nitroglycerin overdosage may result in dizziness, visual changes, severe low blood pressure, heart block (when the electrical impulses that control the beating of the heart muscle are disrupted), increased intracranial (within the skull) pressure with cerebral (brain) symptoms of confusion and moderate fever, paralysis and coma followed by clonic convulsions (seizure activities characterized by jerking or twitching), and possibly death due to circulatory collapse (interruption of blood circulation). According to an online publication on low blood pressure by the Mayo Clinic, Mayo Foundation for Medical Education and Research (a nonprofit American academic medical center focused on integrated health care, education, and research), severely low blood pressure can reduce the body’s oxygen levels, which can lead to heart and brain damage, and a sudden fall in blood pressure can be dangerous. A change of just 20 mmHg - a drop from 110 mmHg systolic to 90 mmHg systolic can cause dizziness and fainting, and significant drops in blood pressure can be life-threatening. A review of the facility’s policy and procedure titled Medication Administration, last revised 1/2023, indicated healthcare professional should verify that the medication selected for administration is the correct one based on the medication order and the product label before administration. Healthcare professional should also verify that the medication is being administered at the proper time, in the prescribed dose. 2. A review of Patient 2’s clinical notes showed that Patient 2 was a 65-year-old patient who presented to the ED with altered mental status and respiratory distress and was intubated (had a breathing tube placed through the mouth and down the throat into the lungs to help with breathing) on 1/31/24. A review of Patient 2’s Physician Orders dated 1/31/24, indicated an order for propofol intravenous (IV) drip with starting dose of 20 mcg/kg/min (microgram per kilogram per minute, unit of measure) to adjust by 5 mcg/kg/min every 5 minutes to maintain a RASS score of -1 to -2 (The RASS is a 10-point scale ranging from -5 to +4. Levels -1 to -5 denote 5 levels of sedation, starting with “awakens to voice” and ending with “unarousable.” Levels +1 to +4 describe increasing levels of agitation. The lowest level of agitation starts with apprehension and anxiety, and peaks at combative and violent. RASS level 0 is “alert and calm). During a concurrent interview and clinical record review with ICU-I at 10:30 a.m. on 2/29/24, ICU-I stated that Patient 2’s propofol was started at 12:55 a.m. on 1/31/24, but RASS score was not documented every hour when there was no RASS documentation from 1:03 p.m. to 5:24 p.m. on 1/31/24. ICU-I stated that the propofol dose should have been reduced when Patient 2’s RASS was documented at 1:51 a.m. (-4, deep sedation) on 2/1/24. ICU-I also stated that the propofol dose should have been increased when Patient 2’s RASS were documented at 2 p.m. (+1, restless), 3 p.m. (+1, restless), and 4 p.m. (+1, restless) on 2/1/24. During an interview with ICU-I at 11:09 a.m. on 2/29/24, ICU-I acknowledged that nurses did not document RASS hourly, and nurses did not follow the propofol titration order to the goal to prevent excessive sedation or agitation. During a review of the facility’s P&P titled, “Sedation and continuous Neuromuscular Blockade in the Critical Care Unit,” last revised 12/2022, the P&P indicated, “General Ventilator Management Order set for guidance and direction regarding care ...nursing care: assess and document RASS hourly and with every titration while on sedation. Goal is per physician order.” 3. During an observation of medication administration at 9:42 a.m. on 2/28/24, RN 1 was observed to crush and administer Patient 3’s medications together through a feeding tube which included one sildenafil tablet (a medication used to treat high blood pressure that affects arteries in the lungs and in the heart) 20 mg, one apixaban tablet (a medication used to treat and prevent blood clots) 5 mg, and one-half tablet of metoprolol tartrate (medication used to treat high blood pressure) 25 mg. All crushed medications were mixed in 120 ml (milliliters, unit of measure) of water and administered with a 60 ml syringe in two parts. Each 60 ml part was pushed into the feeding tube over 3 seconds without flushing the feeding line before, in between, or after medication administration. During an interview with RN 1 at 10:05 a.m. on 2/28/24, RN 1 stated that the line was not flushed prior, throughout, or after medication administration. During a review and reconciliation of the medication administration observation with Patient 3’s electronic orders, two Physician Orders (dated 2/11/24) indicated sildenafil 20 mg via PEG Tube (a feeding tube is passed into a patient’s stomach through the abdominal wall) three times daily and apixaban 5 mg via PEG tube twice daily, and a Physician Order (dated 2/22/24) indicated metoprolol tartrate 12.5 mg via PEG tube twice daily. During an interview with RPh 1 at 10:55 a.m. on 2/28/24, RPh 1 acknowledged the three medications should have been administered separately following the proper steps to flush the tube. During an interview with Nursing Unit Manager (NUM) 1 at 12:25 p.m. on 2/28/24, NUM 1 stated that post flush should have been done at least since medications would still be in the line and not in the stomach. During an interview with the facility’s Clinical Coordinator (CC) at 12:30 p.m. on 2/28/24, the CC stated that the medications should be crushed and given separately to prevent clogging. The line should be flushed with 30 ml of water after checking placement, 10 to 15 ml of water per medication in between, and 30 ml of water to flush the line after the last medication. During a review of Journal of Parenteral and Enteral Nutrition “ASPEN Safe Practices for Enteral Nutrition Therapy” dated 1/2017, “ the journal indicated, “Provide appropriate tube irrigation around the timing of drug administration: a. Prior to administering medication, stop the feeding and flush the tube with at least 15 ml water. b. Administer the medication using a clean enteral syringe. c. Flush the tube again with at least 15 ml water. d. Repeat with the next medication. e. Flush the tube one final time with at least 15 ml water.” During a review of the facility’s policy and procedure (P&P) titled, “Tube Feeding: Enteral Nutrition,” revised 2/2022, the P&P indicated, “Medication administration: refer to Clinical Key for Nursing: How To Give Medicine Through a Feeding Tube...do not mix medicines in 1 syringe ...if giving more than 1 medicine, give each medicine separately. Flush the tube between each medicine and after the last dose of medicine. Use a clean syringe for each medicine.” During a review of the facility’s P&P titled, “Medication Administration,” last revised 1/2023, the P&P indicated, “Crush each medication separately ...crushed medication should be administered separately to ensure complete administration.””

“PHARMACY PERSONNEL CFR(s): 482.25(a)(2) The pharmaceutical service must have an adequate number of personnel to ensure quality pharmaceutical services, including emergency services. This Standard is not met as evidenced by: 27000 Based on interview and document review, the hospital pharmacy failed to ensure it had complete skills and competency records for two out of three pharmacists (RPh 5 and RPh 6). The failure had the potential for the pharmacists not having the demonstrated skills and competencies to perform the duties and responsibilities required of their position. Findings: 1. During an interview and document review with the Director of Pharmacy on 3/1/24 at 10:05 a.m., he stated the pharmacists were required to conduct an annual skill competency, including the clinical monitoring, related to their field of practice. The training and competency records for three pharmacists were randomly selected and requested for review. On 3/1/24 at 11:11 a.m., a review of the training and competency records for RPh 5 was conducted with the Pharmacy Clinical Supervisor (RPh 2). RPh 5 was hired in August 2023. His duties included being the floor-based pharmacist (a clinical pharmacist who, besides reviewing and verifying medication orders, also acts as direct drug therapy consultant to bedside practitioners). She stated newly hired pharmacists are given the competency checklist so they could make sure they check them off; however, she did not keep records of the checklist for each new hire. A review of the said checklist with RPh 2 indicated it included a list of therapeutic monitoring such as anticoagulation (medications to prevent blood clots that require close monitoring by the pharmacists) monitoring. When asked for evidence of completion, RPh 2 reviewed the training tracking record and stated RPh 5 had received training and been assessed for competency in therapeutic monitoring including anticoagulation monitoring; however, she did not have written evidence RPh 5 completed this training/competency. A review of the pharmacy practice guidelines of the 2013 “ASHP Guidelines: Minimum Standard for Pharmacies in Hospitals” by the American Society of Health System Pharmacists (ASHP, a national organization advocating and supporting the professional practice of pharmacists in hospitals, health systems, and other settings spanning the full spectrum of medication use), indicated the following under Orientation of Personnel: “There shall be an established, structured procedure for orienting new personnel to the pharmacy, the hospital, and their respective positions. Evaluation of the effectiveness of orientation programs should be done in conjunction with the competency assessment required before a new hire can assume full responsibility for the new position.” 2. On 3/1/24 at 11:40 a.m., an interview and document review of RPh 6’s training and competency records with RPh 2 indicated RPh 6 was hired on 6/11/2022. She stated RPh 6 works as an infusion pharmacist (one who works with patients receiving infusions, such intravenous infusion; and is responsible for accurately preparing the medication and monitoring the patient throughout the treatment). She stated RPh 6’s primary role is chemotherapeutic therapy (cancer drug treatment). RPh 2 stated the electronic tracking software indicated RPh had the chemotherapy training on 8/26/22; however, there was none conducted in 2023. During an interview with the Pharmacy Operations Supervisor (RPh 1) on 3/1/24 at 11:56 a.m., he stated the infusion pharmacists should have competency training, such as dosing and monitoring of chemotherapeutic agents, annually. He stated if it was not in the training tracking record, then he did not know where else to look. During a follow-up interview on 3/1/24 at 1:35 p.m., RPh 1 stated RPh 6 was overdue for the annual chemotherapy training. He confirmed none was done in 2023. A review of the hospital’s policy and procedure titled “Orientation and Ongoing Education, Training and Competency Assessment of Pharmacy Personnel,” effective 9/3/2021, indicated: “The initial orientation checklist will be provided to each new employee during his/her orientation period. The Pharmacy Management or designee will be responsible for ensuring that the new employee has reviewed and successfully completed the information on the checklist... Periodic skills assessment and competency testing will take place for staff employees. It will occur as often as is required to perform the duties outlined in the job description but at least yearly. Issues such as clinical knowledge and skills... will be included in the competency assessments. Pharmacy management or designee will act as the validator and will determine satisfactory performance based on... demonstrated performance skills.””

“ACCESS TO LOCKED AREAS CFR(s): 482.25(b)(2)(iii) Only authorized personnel may have access to locked areas. This Standard is not met as evidenced by: 45977 Based on observation, interview, and record review, the facility failed to ensure three of 3 medication carts and one of 14 anesthesia medication carts were locked and medications were securely stored and when: 1. A medication cart on South Tower Medical/Telemetry 3 was left unlocked and unattended. 2. A medication cart on South Tower Telemetry/Dialysis 5 was left unlocked and unattended. 3. Registered Nurse (RN) 5 left a medication cart unlocked and unattended in the infusion clinic. 4. One of 14 Anesthesia carts in the facility Operating rooms (ORs- where surgery is performed) was left open and had IV medication left out on top and in a lock box that was not locked. These failures resulted in the availability of medications to be diverted by unauthorized patients, staff and visitors. Findings: 1. During an observation and interview on 2/27/24, 3:10 p.m., on Unit South Tower Medical/Telemetry 3, next to room 3765, there was an unlocked medication cart. A nurse walked by the medication cart and went into Room 3761 but did not attend to the medication cart. Room 3765’s door was closed. For ten minutes, the cart was left unattended and unlocked with medication drawer visibly open. Medication cart locked automatically but draw was still open. Charge Nurse (CN) 1 stated, medication carts should be locked when nurses are not using them. CN 1 stated, the nurse should not have left her medication cart unattended and should have locked her medication cart. During interview on 2/27/24, at 3:10 p.m., with Nurse Manager (NM) 2, NM 2 stated, should be kept locked when the nurse is not using the medication cart. NM 2 stated, visitors or unauthorized individuals could get into the medication cart and take medications. NM 2 stated, it is a safety issue. 2. During an observation and interview on 2/28/24, 9:55 a.m., on Unit South Tower Telemetry/Dialysis 5, next to room 5751, there was an unlocked medication cart. For ten minutes, the cart was left unattended and unlocked. Eventually, medication cart locked automatically. CN 2 stated, nurses can not leave unlocked medication carts unattended and unlocked as it is a safety issue. During interview on 2/28/24, at 9:55 a.m., with NM 3, NM 3 stated, nurses should make sure carts are locked and medications are secure. NM 3 stated, someone could have taken medications. 3. During an observation and interview on 2/28/24, 2:10 p.m., in the Outpatient Infusion Clinic, in bay 4, there was an unlocked medication cart with no nurse using the cart. For five minutes, the cart was left unattended and unlocked. RN 5 had been using the cart. RN 5 stated, the medication cart should have been locked when she is not using it. RN 5 stated, people who are not authorized could take medications. During an interview on 2/28/24, at 2:10 p.m., with NM 4, NM 4 stated, medication carts should be locked when not being used and it is a safety issue. NM 4 stated, we have visitors and public in this area and they could have taken medications that are needed for patients. During a review facility’s policy and procedure (P&P) titled, “Medication Procurement, Storage, and Inspection,” dated 6/16/2021. The P&P indicated “... B. Medications shall be stored securely ... G. Floor Stock ... 1. All floor stock shall be secured in tamper-evident kits/boxes/carts, locked cabinets, or locked medication rooms ... 2. Only authorized personnel will have access to medications ... “ 4. During a concurrent observation and interview on 2/28/24, at 3:13 p.m., while in OR 2 with the Director of Surgical Services (DSS) and the Manager of Surgical Services (MSS) , the Anesthesia cart was seen open with a full 5 ml (milliter- unit of measurement) syringe sitting on top labeled Rocuronium (Paralytic it can relax muscles during surgery and medical procedures), in the top drawer was 10 ml normal saline flush and 50 ml bag of normal saline, and in the open lock box on the side of the cart was a full vial of Succinylcholine (Paralytic it can relax the muscles during surgery or other medical procedures) 200 mg (milligrams- unit of measurement) per 10 ml with “WARNING: Paralyzing Agent” written in red on the vial. The DSS and the MSS stated it is the responsibility of the anesthesiologist to secure and waste the medications that they use. The DSS and MSS stated they have anesthesia technicians (AT) that are responsible to clean all anesthesia equipment including the cart, stock the cart and lock it so it is ready for the Anesthesiologist for the next procedure, normally the AT would have seen the medication and contacted the charge nurse to let her know so she could contact the Anesthesiologist and the secure the medication. The MSS stated no medications should be left out, they should be locked up immediately after surgery to protect them from being diverted. During a review of the facility’s P&P titled, “Medication Procurement, Storage, and Inspection” date 6/16/21, the policy indicated, “PURPOSE: A. To establish guidelines and processes for medication procurement, storage, and inspection ... POLICY: ... B. Medications shall be stored securely and under proper conditions as stated by the medication’s manufacturer to ensure stability of that medication ... PROCEDURE: E. Controlled Substances ... 3. Medications are stored in a secure manner to prevent diversion, in accordance with law and regulation (TJC MM 03.01.01, EP-3). A. Controlled substances will be kept secured at all times in automated dispensing machines (e.g., Pyxis) throughout the facility ... F. Storage ... 3. Drugs are stored under the proper conditions of sanitation, temperature, light, moisture, ventilation, segregation, and security as directed by state/federal regulations and by the drugs manufacturer to assure stability of that drug or in the absence of such recommendations, according to a pharmacist’s instructions ... G. Floor Stock 1. All floor stock shall be secured in tamper-evident kits/boxes/carts, locked cabinets, or locked medication rooms. 2. Only authorized personnel will have access to medications ...””

“UNUSABLE DRUGS NOT USED CFR(s): 482.25(b)(3) §482.25(b)(3) - Outdated, mislabeled, or otherwise unusable drugs and biologicals must not be available for patient use This Standard is not met as evidenced by: 41600 Based on observation, interview, and document review, the facility failed to ensure expired pharmaceutical products were removed and not accessible to use according to the facility’s policies and procedures, as evidenced by: Four 1 L (Litter, unit of measure) bags of cardioplegic solution (a solution used to induce arrest of the heart during heart surgery) were found expired in the operating room (OR). This failure had the potential to compromise the potency and effectiveness of the cardioplegic solution used in heart surgeries. Findings: During an inspection of a medication storage area on the second floor (North) OR on 2/27/24 at approximately 3:45 p.m., four 1 L bags of cardioplegic solution were found in the medication refrigerator with expiration dates of 2/19/24 (bag #1), 2/19/24 (bag #2), 2/21/24 (bag #3), and 2/22/24 (bag #4). The label of the identified products indicated they contained the following: Potassium chloride (KCl) (a type of electrolyte supplement) 80 mEq (milliequivalent, unit of measure)/ 8.4% (percent, unit of measure) bicarbonate solution (a buffering solution) 10 mEq. During an interview with Registered Pharmacist 1 (RPh1) on 2/27/24 at approximately 3:48 p.m., RPh 1 acknowledged that the four 1 L cardioplegic solution bags were expired. RPh 1 stated that all expired cardioplegic bags should have been disposed of. A review of the cardioplegic solution manufacturer’s label indicated, “Store solution containing bicarbonate under refrigeration. Do not store longer than 24 hours.” A review of the facility’s policy and procedure (P&P) titled, “Medication Procurement, Storage and Inspection,” dated 6/2021, the P&P indicated, “expired, damaged and/or contaminated medications are removed from drug storage areas ...outdated drugs and related supplies shall not be dispensed.””

“INFECTION CONTROL PROGRAM CFR(s): 482.42(a)(1) The hospital infection prevention and control program, as documented in its policies and procedures, employs methods for preventing and controlling the transmission of infections within the hospital and between the hospital and other institutions and settings; This Standard is not met as evidenced by: 42321 Based on interview and record review the facility failed to properly monitor, inspect, and perform high level disinfection (complete elimination of all microorganisms in or on an instrument) to the 8848 [name of company] transducer (rectal probe- used to examine the prostate (small, walnut-shaped organ, it is below your bladder and in front of your rectum) or rectum (last several inches of the large intestine closest to the anus) thoroughly) that was used in Radiation/Oncology department on 75 of 75 patients (Patients 5-79). This failure resulted in placing the 75 patients at risk for transmission of infections and diseases. Findings: During an interview on 2/27/24, at 2:08 p.m., with the Manager of Radiation Oncology (MRO), the MRO stated the rectal probe was brought in by an outside vendor [name] who had a contract with this facility and the last time the rectal probe was used was on 11/2/23. The MRO stated the vendor handled the cleaning of the probe and informed them that he does not perform high level disinfection on the probe after each use on a patient but does clean the probe prior to use and puts on a clean sleeve and then cleans the probe after the sleeve was removed. The MRO stated the procedures that use these rectal probes were being done once a month in the Radiation Oncology department. During an interview on 2/29/24, at 3:45 p.m., with the Accreditation and Licensure Manager (ALM) and the Director of Quality (DQ) stated on 11/3/23 the facility was notified by their System [name of system] infection preventionist (IP) that there was the possibility that the rectal probes brought in by the vendor [name] were not being disinfected appropriately between patients. The ALM and DQ stated their IPs created a timeline and on 11/3/23 this Facility’s IP reached out to the Radiation Oncology department leadership to confirm the use of this vendor and on 11/6/23 this was confirmed. On 11/9/23 the facility’s IPs confirmed the cleaning process of the rectal probes by this vendor and the facility decided to stop using this vendor and these rectal probes until they could ensure high level disinfection (HLD) can be done prior to use on a patient. On 11/10/23 the Radiation Oncology department began the process of purchasing the ultrasound equipment with the rectal probes. The DQ stated when the facility spoke with the vendor and asked if they could do HLD on the rectal probes the vendor refused indicating that it took too much time, so the facility has stopped using this vendor. The ALM and DQ provided a list of 75 patients the rectal probe had been used on the earliest dated 3/4/2021 and last on 11/2/2023. During an interview on 3/4/24, at 11:06 a.m., with the Infection Preventionist (IP) 1, the IP 1 stated she is one of three IPs that work for this facility. IP 1 stated she had reviewed the timeline put together for the rectal probes and confirmed it was accurate and she had been the IP to reach out to the Radiation Oncology department. IP 1 stated the importance of HLD is “to eliminate the organisms from the device to not transmit infections to the patient for patient safety”. IP 1 stated as an infection preventionist she does environmental rounds in the radiation oncology department quarterly but will more than likely be doing them monthly or even weekly once the new probes get put into place. IP 1 stated, “Honestly, we didn’t know they had a probe” in this department and if they had known they would have asked about the cleaning, storing, transporting and education on its use, like we do for the vaginal probes in the ultrasound department. The IP 1 stated the manager of the department knows what devices come into their departments and the steps to maintain the safety of the device and we are here to consult if they need us. During an interview on 3/4/24, at 12:53 p.m., with the Radiation Officer for Radiation Oncology (RAD), the RAD stated he has been the RAD since 2012. The RAD stated he started using this rectal probe a couple of years ago, he stated it was used to place biodegradable gel between the rectum and the prostate, to provide protection from the radiation done to the prostate for prostate cancer. The RAD stated he was informed about the rectal probes not being HLD in November of 2023. The RAD stated he never saw the vendor doing the cleaning or HLD of the rectal probes, that as the doctor he would do the procedure and leave while the vendor did the rest (cleaning and prep of rectal probe for next procedure). The RAD stated he was very surprised when he was informed that the HLD was not being done in between use on patients. During a review of the facilities Policy and Procedure (P&P) titled, “Loaned and Borrowed Instruments, Implants, Equipment, and Supplies” dated 9/14/22, the policy indicated, “PURPOSE: A. To give guidance for tracking loaned/borrowed instruments and implants to/from another medical facility. B. To assure instruments, implants, equipment, and supplies are available and sterile for scheduled cases ... POLICY: A. All incoming (borrowed) or outgoing (loaned) instruments, implants, equipment, or supplies will be documented on hospital approved LOAN/BORROW FORM ... D. Borrowed instruments will be cleaned, inspected, disinfected, and sterilized by the [name of the hospital] SPD (sterile processing department) prior to use ... SCOPE: ... B. For all instruments, implants, equipment, or supplies that are loaned or borrowed from a physician, another facility, or a sales representative ... PROCEDURE: B. Instrument trays brought in by vendors for scheduled cases will follow the protocol for sterilization of loaned instruments ... E. VENDOR TRAYS: 1. The vendor representative will bring the instruments or implant trays at least 24 hours prior to the scheduled procedure. 2. The vendor must provide an inventory sheet of instrument provided and the manufacturers’ written instructions for the care, cleaning, assembly, and sterilization of the instruments ... F. RETURN OF VENDOR TRAYS: 1. Upon arrival to the decontamination area of the workroom the trays/instruments will be washed in the washer or decontaminated as per policy ... 4. The vendor representative will reassemble the instrument trays and arrange for transportation to their final destination ... 3. Physicians electing to supply their own instrumentation or implants are expected to comply with this policy. They must arrange the delivery of their instruments to the sterile processing department following the timeline mandated by this policy ...” Review of [name of company] Care and Cleaning Information User Guide English BB1564-BF Issues 2023-06 For healthcare professional users only (Manufacturer for Use Instructions - MFU). The MFU indicated, “ ... Warnings Infection control-follow established procedures WARNING Reproc-w2 Users of this equipment have an obligation responsibility to provide the highest possible degree of infection control to patients, co-workers and themselves. The instructions in this book are meant as a guide. To avoid cross- contamination, follow all infection control policies (including for reprocessing, packing and storage) for personnel and equipment that have been established from your office, department or hospital ... Chapter 2: ...Transducers ... Chapter 3: Introduction & Safety this user guide contains information about carrying form reprocessing [name of company] equipment. It includes important information about what you must do to ensure the safe and proper performance of the system, transducers and accessories. This includes information about cleaning, disinfecting and sterilization ... storing devices when not in use... Always reprocess the transducer prior to use.... General storage conditions... devices must be stored in a way that maintains the reprocessing level (e.g. Sterile, high-level disinfected), or else it must be reprocessed again prior to use for the local and national guidelines ... Chapter 4: Reprocessing Information and Methods ... levels of reprocessing the level reprocessing required depends on the type of equipment and its use the CDC in (Centers for Disease control and prevention) the US... Classify medical devices according to their use. For each classification they specify the level of disinfection sterilization processing that is required before use table 4 summarizes the information... semi critical devices contacts mucous membranes in parentheses table and the applications level of reprocessing required immediate cleaning and disinfection (in the USA, high-level disinfection or sterilization) ... STERRAD systems use low moisture and low temperature hydrogen peroxide gas plasma technology to process heat dash and moisture dash sensitive medical devices the systems are intended for terminal sterilization of properly cleaned, rinse, and thoroughly dried reusable medical devices ... Appendix: Reprocessing Information and Tables ... Endocavity ... 8848 ... Sterilization ... Sterrad 200 short cycle ...””

“INFECTION CONTROL SURVEILLANCE, PREVENTION CFR(s): The infection prevention and control program includes surveillance, prevention, and control of HAIs, including maintaining a clean and sanitary environment to avoid sources and transmission of infection, and addresses any infection control issues identified by public health authorities; and This Standard is not met as evidenced by: 45977 Based on observation, interview, and record review the facility failed to maintain a clean and sanitary environment to prevent the transmission of infection when: 1. One of one laminate countertop around the hand sink used to feed water to the dialysis machines in South Tower Telemetry/Dialysis 5, room 5-006, had become rough and bubbled. The countertop had over ten half inch circles where the laminate was missing, and the bare wood was exposed. 2. Two surgical instruments called a needle holder, had etching and scratching that could be felt on the instrument were in use and passed an audit inspection for damage to instruments. These failures placed patients and staff in an unsafe and unsanitary environment which could potentially lead to negative outcomes such avoidable patient infection and staff injury. Findings: 1. 2. During a concurrent observation and interview on 2/28/24, at 10:34 a.m., with NM 3, in South Tower Telemetry/Dialysis 5, room 5-006, the laminated surface around the hand sink, used to hook up water for the dialysis machine, was observed to be rough and “bubbled”. The countertop was observed to have over ten half inch circles where the laminate was missing, and the bare wood was exposed. NM 3 stated the chemicals from the dialysis might be causing the bubbles on the countertops. NM 3 stated, the countertops cannot be properly cleaned, and bacteria can grow in the countertop. NM 3 stated, it is an infection control risk to the patients. During a concurrent observation and interview on 2/29/22, at 1:10 p.m., with IP 1, in South Tower Telemetry/Dialysis 5, room 5-006, IP 1 stated, the countertops are unacceptable and need to be replaced. IP 1 stated, the countertops cannot be cleaned sufficiently to eliminate bacteria and it could cause infection. During a review of the hospital’s policy and procedure (P&P) titled, “Infection Control Plan”, unknown date, the P&P indicated “... Purpose of Infection Prevention and Control ... As a resource within [ HOSPITAL] and the community, the Infection Preventionist educates other professionals as well as the public about risk of infection and measures to minimize and/or eliminate the risks, and to enhance patient safety and quality. ... Authority and Responsibilities ... All healthcare workers have responsibility for adherence to infection prevention and control processes/strategies. ... Surveillance Methodology ... When surveillance data identifies an area of concern, a specific problem or an opportunity for improvement, the Infection Control team will initiate actions appropriate to the issue. ...” 2. During a concurrent observation and interview on 2/28/24 at 9:35 a.m. with the Director of Surgical Services (DSS) and SPM, the SPM completed an audit of a processed and sterile surgical instrument tray was opened and the instruments inspected for cleanliness, functionality, and integrity. The tray contained 91 separate instruments. Two titanium needle holders were noted to have an etching and/or scratches that could be felt with the bare hand. SPM did not identify the etching and scratched and passed all 91 pieces as ready for use. The SPM stated the instruments should not have passed the audit as the etching/scratches created a space for a potential bioburden (bacteria living on a surface). The DSS requested a ST to remove the instruments from use. The SPM stated the facility follows the Association for the Advancement of Medical Instruments (AAMI) standards. During a review of “AAMI Standards (AAMI)”, dated 2021, indicated, “ ...Damaged instruments should be removed from service ... Damaged instruments ... increase risk of patient harm ...”. During a review of a professional reference titled, “Surgical Instrument Inspection: Mission for zero patient harm (SI)”, dated 2024, the “SI” indicated, “ ... The condition of the instrument has a significant effect on how adequately it can be cleaned. Instruments subjected to rough handling will develop scratches and roughened surfaces over time, which will trap and hold dirt. Damaged surfaces not only allow dirt and bacteria to collect but can also be potentially dangerous for both medical staff and patients ...”.”

“IC PROFESSIONAL RESPONSIBILITIES POLICIES CFR(s): Standard: Leadership responsibilities (2) The infection preventionist(s)/infection control professional(s) is responsible for: (i) The development and implementation of hospital-wide infection surveillance, prevention, and control policies and procedures that adhere to nationally recognized guidelines. This Standard is not met as evidenced by: 45929 Based on observations, interviews, and record review, the Infection Preventionist (IP) failed to adhere to the national standards of the Association for the Advancement of Medical Instrumentation (AAMI) when audits for the inspection of sterilized surgical instruments were not developed and implemented; did not have a policy and procedure for inspecting surgical instrument prior to being sterilized and processed; did not have a predetermined standard of compliance with which to measure the audits; did not report steam sterilization performance data to the facility’s Quality Assurance and Performance Improvement (QAPI) Program; audits were incomplete; and an audit failed to identify damaged instruments on 2/28/24 and white debris was found on the outside window of an instrument washer on 2/28/24. These failures resulted in the potential for increased patient harm related to instrument malfunction and/or contamination of microorganisms. Findings: During a concurrent observation and interview on 2/28/24 at 9:20 a.m. with the Sterile Processing Manager (SPM), the Sterile Processing Department (SPD, an area where reusable surgical instruments and devices are cleaned, disinfected, and sterilized [made void of bacteria]) was toured. The SPM stated she audited (randomly inspected) sterile surgical trays (set of surgical instruments for a particular procedure) and the audit included a check for functionality, organization, and sterilization confirmation) monthly. The SPM stated she is the only person who performs tray audits and has no audit form (a list of items to be inspected when reviewing cleanliness and functionality of instruments) for the tray audits. The SPM stated the number of trays audited every month varies and the results of the audits are not recorded. The SPM stated they do not report the tray audit results to the Quality Assurance & Performance Improvement (QAPI) Committee, Infection Prevention nor other entities. During a concurrent observation and interview on 2/28/24 at 9:25 a.m. with the SPM, the SPM was asked to perform a tray audit on sampled tray and to explain what she was doing along the way. The SPM opened the tray and checked the steam sterilization indicators (a small strip on the inside of the sealed tray that indicates steam sterilization took place), checked tray integrity, opened clamps and checked for debris or damaged, and alignment and function of the forceps (handheld instruments for grasping and holding objects). The SPM stopped her audit while approximately half of the clamps were still in the tray and on the stabilization bar (a bar running the length of the tray on which the clamp handles are threaded) of the tray. The SPM did not remove the clamps and open them until asked if the audit was completed. During a concurrent observation and interview on 2/28/24 at 9:35 a.m. with the Director of Surgical Services (DSS) and SPM, the SPM completed an audit of a sterile surgical instrument tray consisting of 91 pieces for inspection of cleanliness, functionality, and integrity of the instruments suitable for surgery. SPM passed all 91 pieces. After the audit, it was brought to the SPM and DSS’s attention that two titanium (type of metal) needle holders had etching and/or scratches on the side of the instrument that could be felt with the bare hand. The SPM stated the instrument should not have passed the audit as the etching/scratches created a space for a potential bioburden (bacteria living on a surface). The DSS requested a Sterile Processing Technician (ST) to remove the instruments from use. When asked what the acceptable passing rate for audits (for example 89 of 91 instruments passing, the rate would be 98%) is standard, the SPM stated there was not a set passing rate. The SPM stated a tray instrument not passing is an educational issue 1:1 (one on one, individualized education or remediation regarding mistakes) with the employee who put the tray together and the remediation was not documented. During a concurrent observation and interview on 2/28/24 at 9:55 a.m. with the SPM in SPD Decontamination Room, dried white debris lined the windowsill of one of three washers. The SPM stated it was calcium deposits from the city’s “ ... hard water ...”. During an interview on 2/28/24 at 11:50 a.m. the SPM stated the facility followed the Association for the Advancement of Medical Instruments (AAMI) standards. During an interview on 2/29/24 at 11:45 a.m. the Quality Director (QD) and the Accreditation Program Manager (APM) stated there was no policy or procedure for inspection of surgical instruments. During an interview on 3/4/24 at 11:06 a.m. IP 1 stated she performed rounded (act of visiting an area) in SPD quarterly per year and was last there in January of 2024. IP 1 stated during rounding she looks for proper protective equipment, cleanliness of machines, floors, ceilings, expirations on devices and materials, and how staff are cleaning instruments. IP 1 stated AAMI standards required a standard pass rate for tray audits, but one could not get process improvement measure when there was no data. IP 1 stated remediation with staff 1:1 regarding tray issues should be documented to know how often and with whom tray audits fail. IP 1 stated there is a difference in doing the work (referred to audits) and improvement. IP 1 stated according to the facility’s Infection Control and Prevention Plan and AAMI standards SPD tray audits should have been part of the QAPI Program and were not. During a concurrent interview and record review on 3/4/24 at 1:55 p.m. with the SPM and DSS reviewed the instruction for use for the SPD washers titled, “Operating Instructions Decomat (OP)” (undated), the “OP” indicated, “ ... Maintenance ... exterior ... The front and side walls can be cleaned and disinfected with an alcohol-based detergent, surgical spirit, or normal detergent ...”. The SPM and DSS stated the calcium deposits should not have been on the window and should have been cleaned to maintain a clean environment. During a review of the a professional reference titled, “AAMI Standards (AAMI)”, dated 2021, “AAMI” indicated, “ ... 8.2 Inspection of instruments ... Damaged instruments should be removed from service; damage is addressed according to organizational policy and procedure (e.g. evaluation, repair) ... 7.2 Policies and procedures ...The health care organization should establish policies and procedures for all methods of cleaning and decontamination of reusable items ... Process audits to monitor compliance with various policies and procedures should be performed on a scheduled basis, with appropriate follow-up to address problems ... Audits of the process can help identify gaps so methods can be identified to improve the process ... 8.1 General considerations ...In preparation for sterilization, devices should be ... inspected for cleanliness, flaws, and damage ... 14 Quality process improvement ... For steam sterilization CQI [continuous quality improvement] program encompasses the entire process of decontamination, preparation, and packaging, sterilization, quality control, sterile storage, ad product distribution ... The quality process should be developed in conjunction with appropriate departments and integrated into the overall quality process in the health facility ... A risk analysis should be completed for all aspects of the steam sterilization to identify any risk that could occur to personnel or patients ... There should be a planned, systematic, and ongoing process for verifying compliance with procedures. Quality processes can be enhanced by audits that are conducted on a regular basis. The information from these activities should be summarized and made available to appropriate individuals or groups/teams ... Measurements of process performance allow the steam sterilization process to be monitored against a predetermined level of quality ... Ongoing auditing provides data essential to assess the effectiveness of the process and make improvements in performance ... 14.2.3 ... Risk analysis ... Risk management should include determining which of the potential sterilization failures identified in the risk assessment process require management and selecting and implementing plans and corrective action ...Risk ...should include an interactive dialogue between SPD, user areas, and infection prevention ...”.”

“HISTORY AND PHYSICAL CFR(s): 482.51(b)(1) Prior to surgery or a procedure requiring anesthesia services and except in the case of emergencies: (i) A medical history and physical examination must be completed and documented no more than 30 days before or 24 hours after admission or registration, and except as provided under paragraph (b)(1)(iii) of this section. This Standard is not met as evidenced by: 45977 Based on interview and record review the facility failed to obtain a History and Physical (H&P) (a term used to describe a doctor’s examination of the patient) update within 24 hours of a surgery for one of six patients (Patient 90). This failure had the potential for the surgical team not having the most up to date information prior to surgery. Findings: During a concurrent interview and record review, on 2/29/2024 at 10:30 a.m., with RN 6, Patient 90’s medical record was reviewed. Patient 90 had surgery on 2/27/2024 for a coronary artery bypass grafting (a surgical procedure to improve blood flow to the heart). Patient 90 had a medical H&P completed on 2/24/2024. An update to the H&P was missing on 2/26/24 and 2/27/24 in the medical record. During an interview on 2/29/24, at 11:00 a.m., with the QD, the QD stated, per the medical bylaws, an update to the H&P should be done 24 hours prior to the surgery. QD stated, it appears it was not done and it was missed for this patient. During a review facility’s policy and procedure (P&P) titled, “Medical Staff Rules and Regulations”, not dated. The P&P indicated “... L. History and Physical Examinations ... A history and physical examination shall, in all cases, be recorded within 24 hours of admission of the patient by the attending, admitting practitioner, or his/her designee. ... 2. If a history and physical examination has been done within thirty (30) days prior to admission, a durable, legible copy of this report may be used in the patient’s hospital medical record. An updated medical record entry documenting an examination for any change in the patient’s condition must be included in the patient’s medical record. This updated examination must be completed and documented within twenty-four (24) hours after admission ...””