Pam Specialty Hospital of Denver

“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: 46674 Based on interviews and documents reviewed, the facility failed to ensure a patient received care in a safe setting. Specifically, the facility failed to ensure a patient representative’s decision regarding resuscitative services was implemented in one of one patients reviewed with resuscitative status changes. (Patient #1) Findings include: Facility policy: According to the Code Status policy, the purpose is to describe the hospital’s classification for resuscitation in the event of a cardiopulmonary arrest (when the heart stops beating and the patient stops breathing) and the procedure for communicating code status during the hospital stay. In a full code, the patient will receive those items designated per Advanced Cardiovascular Life Support (ACLS) protocol (a set of lifesaving protocols to guide healthcare providers in managing severe cardiovascular (heart and blood vessels) emergencies) in the event of a cardiac or respiratory arrest (when breathing stops). In a do not resuscitate (DNR), also known as a “no code”, no cardiopulmonary resuscitation (CPR - an emergency lifesaving procedure performed when the heart stops beating) will be administered in the event of cardiac or pulmonary arrest. The patient or legal representative who issues the “no code” directive may rescind the directive issued by the representative. This will be documented in the patient’s chart noting the time and date revocation was received. The physician will be notified. If a “no code” form is already in the chart, a note will be written on this form documenting the date, time, and who revoked the DNR, and the patient or legal representative will sign, date, and time this revocation. Reference: The Patient Rights and Responsibilities read, all patients’ rights apply to the person who has legal responsibility to make decisions regarding medical care on your behalf. You or your legal representative have the right to make decisions regarding medical care and receive care in a safe setting. 1. The facility failed to ensure a patient representative’s decision to revoke a DNR order was implemented in accordance with facility policy. a. Medical record review revealed Patient #1 was admitted on 12/19/25 with acute respiratory failure with hypoxia (when the lungs cannot get enough oxygen into the bloodstream to support the body’s organs). A provider’s order was placed at 8:13 p.m. for Patient #1’s status to be full resuscitation (full code). Review of a Medical Orders for Scope of Treatment (MOST) form signed on 1/15/26 by Patient #1’s provider revealed Patient #1 was not to receive CPR if they did not have a pulse and stopped breathing. Review of a provider’s order placed on 1/16/26 at 9:28 a.m. revealed Patient #1’s status was changed to DNR and do not intubate (DNI - an order to not insert a breathing tube into the patient’s airway if they stopped breathing). Case management documentation entered on 1/21/26 at 1:51 p.m. read, Patient #1’s medical power of attorney (MPOA) and sister had called the case manager (CM) to change the patient’s code status. The code status was recently changed to a DNR and they both believed Patient #1 was getting better and wanted to change the code status back. The CM informed the provider and the house supervisor to follow through with the order. CM documentation entered on 1/27/26 at 11:59 a.m. revealed Patient #1’s family had changed the code status back to a full code. There was no evidence in the medical record of provider’s order or a MOST form indicating Patient #1’s code status had been changed from a DNR to a full code. This was in contrast to the Code Status policy which read, the legal representative who issued the “no code” directive could rescind the directive. If a “no code” form was already in the chart, a note would be written on the form with the date, time, and who revoked the DNR, and the patient or legal representative would sign, date, and time this revocation. This was also in contrast to the Patient Rights and Responsibilities which read, all patients’ rights applied to the person who had legal responsibility to make decisions regarding medical care on the patient’s behalf. The patient or their legal representative had the right to make decisions regarding medical care and receive care in a safe setting. b. On 4/8/26 at 3:00 p.m., a live medical record review was conducted with house supervisor (Supervisor) #1. Supervisor #1 confirmed Patient #1’s status had not been changed from a DNR to a full code after Patient #1’s MPOA made their decision known to the CM. c. On 4/8/26 at 1:02 p.m., an interview was conducted with CM #2. CM #2 stated it was important for a patient’s code status to be updated in the medical record. CM #2 stated staff needed to know what the patient’s correct code status was to ensure the patient’s wishes were followed if they experienced a cardiac arrest. This was in contrast to the medical record review for Patient #1, which revealed Patient #1’s code status was not changed from a DNR to a full code after Patient #1’s MPOA made their decision known to the CM.”

“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: 44751 Based on the manner and degree of the standard level deficiencies referenced to the Condition, it was determined the Condition of Participation §482.23 NURSING SERVICES, was out of compliance. A-0405 (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. Based on observations, interviews, and document review, the facility failed to ensure medications were administered in accordance with provider orders, facility policy, and national guidelines. This failure was identified in one of one observations of medication administration.”

“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: 44751 Based on observations, interviews, and document review, the facility failed to ensure medications were administered in accordance with provider orders, facility policy, and national guidelines. This failure was identified in one of one observations of medication administration. Findings include: Facility policies: The Medication Administration Record and Medication Administration policy read, prior to administering medication, the nurse will verify against the Medication Administration Record (MAR) the patient’s name and date of birth, the name of the drug, the dose strength on the package or unit dose package, the route of administration, and the time of administration. The Medication Orders policy read, medications will be prepared and administered in accordance with the orders of a licensed independent practitioner responsible for the patient’s care, and in accordance with law and regulation. The Pain Management policy read, all patients have the right to appropriate assessment and management of pain. Pain will be assessed on admission, on a routine basis, and as needed (PRN). Pain reassessment will occur within four hours of administration and be documented in the medical record. Pain scale utilization will be tailored to the patient’s needs, to include a numerical rating scale, visual analog scales, and a verbal rating scale. Reference: According to the Wolter Kluwer Nursing 2025-2026 Drug Handbook, “How to Use the Nursing 2025-2026 Drug Handbook”, the handbook contains medication summaries and the most pertinent clinical information nurses must know to administer medications safely. The “Contraindications and Cautions” section contains any diseases or conditions in which the use of the drug is undesirable or should be given with caution. The “Nursing Considerations” section provides guidance on patient monitoring and nursing practices for preventing and managing adverse reactions. The “Adverse Reactions” section contains adverse reactions and life-threatening adverse reactions that are known to occur. The Contraindications and Cautions section for oxycodone hydrochloride (Oxy IR- pain medication) read, patients with the following medical conditions are at an increased risk for oversedation and respiratory depression and require close monitoring: sleep apnea and preexisting pulmonary or cardiac disease. The Nursing Considerations section read, may cause life-threatening or fatal respiratory depression at any time during therapy. Carefully monitor vital signs, pain level, respiratory status, and sedation level. Reassess the patient’s level of pain at least 15 minutes and 30 minutes after administration. The Contraindications and Cautions section for hydrocodone bitartrate-acetaminophen read, patients with the following medical conditions are at an increased risk for oversedation and respiratory depression and require close monitoring: sleep apnea and preexisting pulmonary or cardiac disease. The Nursing Considerations section read, may cause life-threatening or fatal respiratory depression at any time during therapy. Carefully monitor vital signs, pain level, respiratory status, and sedation level. Regularly monitor blood pressure and pulse. Chapter 3, Safe Drug Administration, Medication Administration Process section, the eight rights of medication administration read, verify the route by which the drug is to be given, verify the drug prescribed is appropriate to the patient’s condition, and completely and accurately document in the patient’s medical record the drug administered. 1. Nursing staff failed to administer medications in accordance with provider orders, facility policy, and national guidelines. a. Medical record review revealed Patient #2 was admitted on 8/14/25 after a left middle cerebral artery ischemic stroke (a blood clot blocked blood flow in the brain). Patient #2 had a history of obstructive sleep apnea (OSA, when breathing stops during sleep because of a windpipe blockage), hypertension (high blood pressure), congestive heart failure (CHF, a condition where the heart muscle cannot pump blood effectively), chronic hypercapnic respiratory failure (inability to remove carbon dioxide from the blood), and pulmonary hypertension (elevated blood pressure in the pulmonary arteries that increases cardiac workload and causes difficulty breathing). Additionally, Patient #2 had aphasia (inability to speak and understand words, read, and write). b. On 8/19/25, from 4:26 p.m. to 5:36 p.m., an observation was conducted in Patient #2’s room. During the observation, licensed practical nurse (LPN) #1 entered Patient #2’s room and informed the patient and their caregiver they would need to collect a urine sample. Before leaving to gather the supplies, Patient #2’s caregiver requested pain medication for the patient. LPN #1 asked Patient #2 to rate their pain on a scale of 0 to 10, with 0 indicating no pain and 10 indicating the worst possible pain. Patient #2 attempted to respond. However, their response was unintelligible. LPN #1 asked the patient’s caregiver to provide a pain score for the patient. Patient #2’s caregiver told LPN #1 they did not know the patient’s current pain level. Patient #2’s caregiver further told LPN #1 the patient suffered from chronic pain and took prescription pain medication. LPN #1 then stated they felt a pain score of 7 would accurately reflect the patient’s current level of pain. This observation contrasted with the facility’s Pain Management policy, which required staff to use numerical, visual, or verbal pain scales based on patient needs. The facility provided Patient #2’s medication orders and medication administration records during the observation. Review of the medication administration record revealed Patient #2 was prescribed 5 mg immediate-release oxycodone by mouth three times daily as needed for a pain score between 4-10. Further review of the medication administration record revealed, at 4:41 p.m., LPN #1 administered 5 mg of immediate-release oxycodone to the patient and documented a pain score of 7. LPN #1 administered the oxycodone to Patient #2 without using a pain scale tailored to their inability to communicate pain verbally. Upon request, the facility was unable to provide evidence Patient #2’s vital signs, respiratory status, or sedation level had been assessed, and a pain reassessment had been completed after the oxycodone had been administered. This contrasted with the Wolters Kluwer Nursing 2025-2026 Drug Handbook, which was provided by the facility. According to the handbook, patients with sleep apnea and preexisting pulmonary or cardiac disease required continuous monitoring of vital signs, pain level, respiratory status, and sedation level, as the medication could cause life-threatening or fatal respiratory depression. The handbook further stated the patient’s pain level should be reassessed at least 15 and 30 minutes after administration. At 4:50 p.m., LPN #1 was observed applying Voltaren gel 1 percent (%) (topical medication used to reduce pain, stiffness, and inflammation) to both of Patient #2’s knees. Furthermore, during the observation, LPN #1 asked Patient #2’s caregiver where on Patient #2’s body the Voltaren gel should be applied. The observation contrasted with the provider’s order for the Voltaren gel. Review of the Voltaren gel order revealed the medication was to be applied topically to Patient #2’s left hand four times daily for pain. Additionally, the observation was in contrast to the facility’s Medication Administration Record and Medication Administration policy which stated, nurses verified the medication name, dose, route, and time of administration against the provider’s order and the patient’s MAR before administering medication. This observation also contrasted with the Wolters Kluwer Nursing 2025-2026 Drug Handbook. According to the Safe Drug Administration, Medication Administration Process section, nursing staff were to confirm the medication order, verify the route of administration, and accurately document how the medication was administered in the patient’s record. Additionally, LPN #1 failed to document the actual site where the medication was applied in Patient #2’s medical record. At 4:52 p.m., observations revealed Patient #2 brought their right hand to their chest and struck the area repeatedly. In response, LPN #1 retrieved a portable vital signs machine and conducted an assessment which showed Patient #2’s oxygen saturation was 78%. Based on this finding, LPN #1 increased the flow rate of supplemental oxygen from 1 L to 3 L and then rechecked Patient #2’s oxygen saturation level, which fluctuated between 88% and 91%. At 5:03 p.m., respiratory therapist (RT) #3 entered Patient #2’s room. RT #3 assessed Patient #2’s breathing and placed the patient on continuous oxygen monitoring. At 5:21 p.m., RT #3 administered a hand-held nebulizer treatment (HHN-inhaled medication that opens the airway and lungs) to Patient #2. After the HHN treatment, RT #3 decreased the patients supplemental oxygen to 2.5 L, and Patient #2 had an oxygen saturation of 95%. Medical record review for Patient #2 revealed on 8/14/25 at 8:03 a.m., nurse practitioner (NP) #6 documented the patient was on 3 L supplemental oxygen through nasal cannula (medical device used to deliver supplemental oxygen into the nose). Additionally, the patient’s need for supplemental oxygen was documented in Patient #2’s plan of care. However, from 8/14/25 to 8/20/25 (a total of six days) supplemental oxygen had not been ordered by a provider for Patient #2. When requested, the facility was unable to provide evidence supporting the administration of oxygen without a provider order or verification of the required amount. This observation and medical record review contrasted with the Medication Orders policy, which stated, medications were to be administered in accordance with provider orders. c. Review of the facility’s Pain Management policy required nurses to perform a pain reassessment within four hours of administering pain medication. This contrasted with the Wolters Kluwer Nursing 2025-2026 Drug Handbook which stated, the patient’s pain level should be reassessed at least 15 and 30 minutes after medication administration. Upon request, the facility was unable to provide evidence of how the Pain Management policy aligned with national guidelines. d. On 8/21/25 at 4:23 p.m., an interview was conducted with LPN #2. LPN #2 stated at shift change, nurses performed handoff reports. LPN #2 stated the outgoing nurse reviewed the patient’s oxygen use, medications, and physician orders with the oncoming nurse. However, LPN #2 further stated in addition to the handoff report, nurses were still expected to verify the patient’s orders in the patient’s electronic medical record. LPN #2 stated patient orders were reviewed to ensure the medications administered, and the care interventions implemented, matched the provider’s orders and treatment plan for the patient. LPN #2 stated the nurse was required to administer medication and care interventions according to the provider’s orders and treatment plan. LPN #2 stated when a patient’s pain score was fabricated, a complete and accurate pain assessment had not been performed. LPN #2 stated accurate pain scores helped to understand the severity of the patient’s condition and guided the pain management treatment and interventions. LPN #2 stated administering pain medication using an inaccurate pain score placed patients at risk of overdosing from an excessive dose or experiencing uncontrolled pain from an inadequate dose. e. On 8/19/25 at 5:45 p.m. an interview was conducted with chief nursing officer (CNO) #4. CNO #4 stated during the observation conducted in Patient #2’s room, they had reviewed Patient #2’s medication orders and noted concerns with the manner in which LPN #1 administered the medications. CNO #4 stated nurses were required to review medication and physician orders for each patient under their care. CNO #4 stated before administering medication, nurses were to confirm the medication, its indication, and the method of administration to ensure what was being administered was in accordance with the provider’s order. Additionally, CNO #4 stated a provider’s order was required for patients on supplemental oxygen. CNO #4 stated oxygen orders included the oxygen flow rate, the delivery method, the target oxygen level, how often the oxygen should be given, and the reason oxygen was needed. CNO #4 further stated Patient #2 did not have an order for oxygen, despite having received continuous supplemental oxygen.”

“PATIENT RIGHTS CFR(s): 482.13 A hospital must protect and promote each patient’s rights. This Condition is not met as evidenced by: 49541 Based on the manner and degree of the standard level deficiency referenced to the Condition, it was determined the Condition of Participation §482.13 PATIENT RIGHTS was out of compliance. A-0144 CARE IN SAFE SETTING The patient has the right to receive care in a safe setting. Based on observations, document reviews, and interviews, the facility failed to ensure patients received care in a safe setting. Specifically, the facility failed to ensure telemetry monitoring (monitoring a patient’s heart rhythm) and continuous pulse oximetry (a medical device used to measure the saturation of oxygen carried in red blood cells) were provided in accordance with the providers’ orders, facility policies, and facility-adopted educational references. This failure was identified in two of ten observations of patients on pulse oximetry and in one of five telemetry patients’ medical records reviewed.”

“QAPI CFR(s): 482.21 The hospital must develop, implement and maintain an effective, ongoing, hospital-wide, data-driven quality assessment and performance improvement program. The hospital’s governing body must ensure that the program reflects the complexity of the hospital’s organization and services; involves all hospital departments and services (including those services furnished under contract or arrangement); and focuses on indicators related to improved health outcomes and the prevention and reduction of medical errors. The hospital must maintain and demonstrate evidence of its QAPI program for review by CMS. This Condition is not met as evidenced by: 47959 Based on the manner and degree of the standard level deficiency referenced to the Condition, it was determined the Condition of Participation §482.21 QUALITY ASSESSMENT AND PERFORMANCE IMPROVEMENT PROGRAM was out of compliance. A-286 Program Scope. (1) The program must include, but not be limited to, an ongoing program that shows measurable improvement in indicators for which there is evidence that it will ...identify and reduce medical errors. (2) The hospital must measure, analyze, and track ...adverse patient events ....§482.21(c) Standard: Program Activities ...(2) Performance improvement activities must track medical errors and adverse patient events, analyze their causes, and implement preventive actions and mechanisms that include feedback and learning throughout the hospital. §482.21(e) Standard: Executive Responsibilities. The hospital’s governing body (or organized group or individual who assumes full legal authority and responsibility for operations of the hospital), medical staff, and administrative officials are responsible and accountable for ensuring the following: ...(3) That clear expectations for safety are established. Based on interviews, and record review, the facility failed to ensure the quality assurance and performance improvement (QAPI) committee implemented a quality control process which addressed failures in patient care related to patient monitoring in two of two events reviewed.”

“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: 47959 Based on the manner and degree of the standard level deficiency referenced to the Condition, it was determined the Condition of Participation §482.42 INFECTION PREVENTION AND CONTROL AND ANTIBIOTIC STEWARDSHIP PROGRAMS was out of compliance. A-749 - 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. Based on observations, interviews, and record review, the facility failed to ensure staff followed infection control practices and policies in two of two observations of patients on ventilators, in two of two observations of patients with tube feedings, and in three of three observations of patients in contact isolation.”

“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: 49541 Based on observations, document reviews, and interviews, the facility failed to ensure patients received care in a safe setting. Specifically, the facility failed to ensure telemetry monitoring (monitoring a patient’s heart rhythm) and continuous pulse oximetry (a medical device used to measure the saturation of oxygen carried in red blood cells) were provided in accordance with the providers’ orders, facility policies, and facility-adopted educational references. This failure was identified in two of ten observations of patients on pulse oximetry and in one of five telemetry patients’ medical records reviewed. (Patient #1). Findings include: Facility policies: The Digital Diagnostics Remote Telemetry policy read, telemetry is monitored 24 hours a day, 7 days a week with an external telemetry monitoring company. In the event of a significant cardiac rhythm disturbance, the external telemetry monitoring company will call the primary number provided at go-live to inform the staff of the change. In case of no answer, the external telemetry monitoring company will contact all subsequent numbers provided in the facility’s escalation tree. The external telemetry monitoring company will fax or email a rhythm strip to the nurse’s station. The Telemetry Monitoring policy read, alarms may not be silenced or turned off at any time, during monitoring. Every shift, or per order, review the monitor strips, trends, and alarms. Ongoing care: reassess the patient for signs of hemodynamic compromise with any significant changes in cardiac rate or rhythm (i.e. BP, oxygen saturation, respiratory rate, signs of myocardial ischemia, etc.). The cardiac rhythm will be interpreted and documented in the patient chart at the initiation of cardiac monitoring, every shift, or per MD order, and with any rhythm change. The Patient Safety Hand Off Communication policy read, the primary objective of a “hand-off” of information between staff is to provide accurate information about a patient’s care, treatment, services, current condition, and any recent and anticipated changes. The information communicated during a handoff must be accurate to meet patient safety goals. Information handoffs regarding patients should occur if temporary responsibility for staff leaving the unit for a short time. Handoffs require verification of the received information, including repeat back or read back as appropriate to the information being communicated. Reference: The Lippincott Mechanical ventilation, humidification, and respiratory therapy procedure, revised on 12/10/23 and provided by the facility, read, the Joint Commission issued a sentinel event alert concerning medical device alarm safety because alarm-related events have been associated with permanent loss of function or death. Among the major contributing factors were improper alarm settings, alarm settings turned off inappropriately, and alarm signals that were inaudible to staff. Make sure alarm limits are set appropriately and that alarms are turned on, functioning properly, and audible to staff. 1. The facility failed to ensure adequate telemetry monitoring and continuous pulse oximetry as ordered in order to detect any changes in condition for patients including a patient who experienced cardiac arrest and was subsequently diagnosed with an anoxic brain injury (a complete lack of oxygen to the brain which results in the death of brain cells). A. Observations i. On 9/9/24 at 1:07 p.m., observations were conducted in the intensive care unit (ICU). The observations revealed a telemetry monitoring log with multiple blank entries. Registered Nurse (RN) #1 stated that the telemetry monitoring log had been put in place to audit the external telemetry monitoring company. RN #1 also stated that the facility had experienced issues with the monitoring company calling the facility regarding changes in vital signs and cardiac rhythms. Further observations revealed an entry at 8:35 a.m. for the patient in room 208, indicating a rhythm of sinus tachycardia (a cardiac rhythm where the heart beats faster than normal). The telemetry call log also revealed the external telemetry monitoring company did not call the facility. RN #1 stated that the external telemetry monitoring company should have contacted the facility and informed them of the rhythm change. Further observations revealed an entry at 8:47 a.m. for the patient in room 313, indicating the patient was off of telemetry monitoring. The telemetry call log also revealed that the external telemetry monitoring company did not call the facility. RN #1 stated that the external telemetry monitoring company should have contacted the facility and informed them the patient was off of telemetry monitoring. ii. On 9/10/24 at 9:53 a.m., observations were conducted in the ICU. The observations revealed a telemetry monitoring log with multiple blank entries. Further observations revealed an entry at 7:35 a.m. for the patient in room ICU #1, indicating a pulse oximetry of 84%. The telemetry call log also revealed that the external telemetry monitoring company did not call the facility. RN #1 stated that the external telemetry monitoring company should have contacted the facility of the patients low pulse oximetry. This observation was in contrast to the external telemetry monitoring company contract which read, the external monitoring company’s role was limited to remote surveillance of telemetry monitors and providing immediate notification to providers in cases of cardiac rhythm changes, patients going offline, or battery depletion. There was no evidence in the contract listing monitoring pulse oximetry as a responsibility of the contracted services provided. B. Document Review i. A live medical record review for Patient #1 was completed on 9/11/24 with chief nursing officer (CNO) #5. The medical record revealed Patient #1 was admitted to the ICU on 7/25/24 for acute respiratory failure with hypoxia (when the air sacs of the lungs cannot release enough oxygen into the blood). Further review of the medical record revealed, on 7/29/24 at 5:26 p.m., the restraint management documentation reported Patient #1 could not understand or follow directions to avoid activities that might have caused self-harm. Impulsive behaviors were noted, such as disconnecting or removing medical devices, which disrupted treatment. On 7/29/24 at 6:58 p.m., Patient #1’s ICU nursing assessment reported the patient was alert and disorientated times four (person, place, time, and situation). Further review of the nursing assessment revealed Patient #1’s restraints were removed. Medical record review revealed, on 7/30/24 at 8:10 a.m., RT #11 changed Patient #1’s ventilator setting to PSV wean (a procedure that helped patients transition from mechanical ventilation to spontaneous breathing). Further review of the medical record revealed RT #11 removed the Patient #1 from the ventilator and placed the patient on a tracheostomy collar (a medical device used to deliver oxygen to patients with a tracheostomy by providing oxygen directly to the tracheostomy tube). Further review of the medical record revealed at 9:05 a.m., RT #11 stated they walked by Patient #1’s room and saw the tracheostomy pulled out and pressed against the wall of the trachea (tube in the neck and chest that carries air to and from the lungs) and occluded the airway. RT #11 stated they heard the alarms and saw the patient was in an asystolic cardiac rhythm (a condition where the heart’s electrical and mechanical activity stops). RT #11 stated they pushed the code blue button, placed the trach back into the patient’s airway, inflated the cuff, and started ventilations with a bag valve mask. ii. A review of Patient #1’s medical record revealed a late entry nursing note on 7/30/24 at 2:39 p.m., five hours and 33 minutes after the incident. RN #12’s nursing note reported at 9:06 a.m., they were passing medications to another patient when RT #11 alerted them that Patient #1 had an asystolic cardiac rhythm. RN #12 stated the staff immediately called a code (an overhead page to alert staff of a medical emergency), started cardiopulmonary resuscitation (CPR), and initiated advanced cardiac life support (ACLS) protocol. RN #12 also stated that the external monitoring company called the facility at 9:09 a.m., three minutes after the code was called. Further review of the medical record revealed the patient was transferred to a local level one trauma center for further evaluation and treatment. iii. Review of the external monitoring company’s call log revealed the only calls placed to the facility during the events that led up to Patient #1’s emergency code on 7/30/24 were at 8:26 a.m. and 9:47 a.m. This was in contrast to the Digital Diagnostics Remote Telemetry policy which read, telemetry was monitored 24/7 by an external company. In the event of a significant cardiac rhythm disturbance, the company would call the primary number provided and, if unanswered, proceed through the facility’s escalation contacts. iv. Review of Patient #1’s resuscitation record showed an asystolic cardiac rhythm, with CPR and the code starting at 9:10 a.m. Further review of the resuscitation record revealed the patient was already intubated at that time. This was in contrast to RT #11’s note, which stated that at 9:05 a.m., Patient #1 was found in asystole with their tracheostomy pulled out and pressed against the tracheostomy wall, occluding the airway. This was in contrast to RN #12’s note, which stated that CPR began at 9:06 a.m., and the external monitoring company called the facility at 9:09 a.m., three minutes after the code was initiated. v. Review of an external level one trauma center medical record, provided by the facility, revealed Patient #1 was transferred to an acute care hospital, presented to the ED, and admitted to the ICU with a diagnosis of hypoxic brain injury secondary to hypoxic cardiac arrest. Further review of the external medical record revealed a provider note from ICU resident (Provider) #7. Provider #7 documented the patient had an unwitnessed arrest for approximately seven minutes prior to the initiation of CPR. Further review of the external medical record revealed an electroencephalogram (EEG) was done on 7/30/24. The EEG (a test that measured the electrical activity of the brain) showed moderate to severe cerebral dysfunction (impairment of the brain’s normal functioning) related to an anoxic injury. C. Interviews i. On 9/10/24 at 2:38 p.m., an interview was conducted with RT #11. RT #11 stated they changed Patient #1’s ventilator setting to PSV wean, which the patient tolerated well without distress. RT #11 then removed the patient from the ventilator and placed them on a tracheostomy collar. After five minutes, they left the room, informed RN #12 at 9:00 a.m. that they were leaving the floor and noted the patient was not restrained. RT #11 returned to the ICU at 9:05 a.m., heard alarms, and found the patient in asystolic cardiac rhythm, with gray skin and blue lips. RT #11 pushed the code blue button, reinserted the trach, inflated the cuff, and began bag valve mask ventilations. RT #11 stated the external telemetry company called during the code and after the patient went into cardiac arrest. RT #11 stated before Patient #1’s event, the facility monitored telemetry patients in-house. RT #11 stated they believed that if in-house monitoring had been in place, the alarms would have been recognized, preventing the code. ii. On 9/12/24 at 11:33 a.m., an interview was conducted with CNO #5. CNO #5 stated the survey triggered the facility to complete a second root cause analysis (RCA) regarding Patient #1’s event. CNO #5 stated the findings of the second RCA revealed RT #11 removed the Patient #1 from the ventilator, applied the trach collar, and remained at the bedside for approximately five minutes before leaving. CNO #5 stated a staff member was expected to be at the bedside for 30 minutes during the trach trial. However, upon request, the facility was unable to provide a policy or national guidance showing the expectation of staff to be at the bedside for 30 minutes. CNO #5 stated RT #11 notified RN #12 that they needed to leave the floor and would not be at the patient’s bedside. CNO #5 stated RN #12 did not report to the patient’s bedside for one-on-one monitoring as expected. CNO #5 stated RN #12 did not pause their medication pass to observe the patient during the trach trial. CNO #5 stated the second RCA revealed Patient #1’s alarm for oxygen saturation sounded, and hospital staff failed to respond for approximately 10-12 minutes. CNO #5 stated at the time of Patient #1’s event, staff and administration believed the external telemetry monitoring company was responsible for monitoring the patient’s vital signs, including oxygen saturation. CNO #5 stated they were unaware that the company was not responsible for monitoring oxygen saturation, which contributed to failures leading up to Patient #1’s event. The interview with CNO #5 was in contrast to the Patient Safety Hand Off Communication policy which read, the primary objective of a “hand-off” of information between staff was to provide accurate information about a patient’s care, treatment, services, current condition, and any recent or anticipated changes. The information communicated during a handoff had to be accurate to meet patient safety goals. Information handoffs regarding patients were required if temporary responsibility for staff leaving the unit for a short time. The interview with CNO #5 was in contrast to the Lippincott Mechanical ventilation, humidification, respiratory therapy procedure read which read, The Joint Commission (TJC) had issued a sentinel event alert concerning medical device alarm safety due to alarm-related events being associated with permanent loss of function or death. iii. On 9/11/24 at 12:34 p.m., an interview was conducted with medical director (Director) #14. Director #14 stated the facility’s first RCA revealed staff were present when the patient went into asystole, the code started immediately, the airway was reestablished without issue, two rounds of ACLS were administered, including administration of one milligram of epinephrine and the patient regained a pulse. Director #14 stated the original RCA for Patient #1 did not match the patient’s current clinical presentation and diagnosis of anoxic brain. Director #14 stated after further review it was determined the patient was in a pulseless electrical activity (PEA) rhythm (electrical activity present in the heart with an absence of a pulse), and the patient was found after the patient went into cardiac arrest. Director #14 stated they did not know how long the patient was in cardiac arrest before staff started CPR. Director #14 stated there were gaps in documentation and the timeline that the facility could not answer for. Director #14 stated they were concerned when the facility took away in-house telemetry monitoring. Director #14 stated staff shared concerns with the external telemetry monitoring company’s ability to safely monitor patients. 2. The facility failed to provide adequate continuous pulse oximetry as ordered to monitor for changes in condition. A. Observations i. On 9/10/24 at 9:22 a.m., observations were conducted in the medical surgical unit on the second floor. Observations revealed Patient #3 was on continuous pulse oximetry with the door closed. Further observations revealed the continuous pulse oximetry monitor was not hardwired or centrally monitored. B. Document Review i. A live medical record review for Patient #3 was completed on 9/11/24 with licensed practical nurse (LPN) #15. Medical record revealed Patient #3 had an active order for continuous pulse oximetry placed on 9/10/24. C. Interviews i. On 9/10/24 at 9:30 a.m., an interview was conducted with LPN #15. LPN #15 stated the continuous pulse oximetry monitors were not centrally monitored and were only monitored by the staff on the floor. LPN #15 stated patients on continuous pulse oximetry should not have closed doors, as staff would not hear the alarms. LPN #15 stated if the alarms were not heard, patients could have gone into respiratory distress and potentially die without treatment. ii. On 9/10/24 at 9:38 a.m., an interview was conducted with RT #11. RT #11 stated patients who were on continuous pulse oximetry should have their doors open at all times for patient safety. RT #11 stated if the patient’s door was closed staff would not be able to hear the alarms. RT #11 stated that if staff did not hear and respond to continuous pulse oximetry alarms, the patient could go into respiratory distress, leading to respiratory arrest and possible death. iii. On 9/10/24 at 9:45 a.m., an interview was conducted with CNO #5. CNO #5 stated for safety, patients on continuous pulse oximetry should have their doors open, as closed doors prevented staff from hearing alarms. CNO #5 stated the facility did not have a policy addressing door status or proximity to the nursing station for alarm monitoring. However, CNO #5 stated they were updating their policy to centrally monitor pulse oximetry for high-risk patients. CNO #5 stated missed alarms could have resulted in significant events, like decannulation (the process of removing a breathing tube), which, if untreated, could have been fatal.”

“PATIENT SAFETY CFR(s): 482.21(a), (c)(2), (e)(3) (a) Standard: Program Scope (1) The program must include, but not be limited to, an ongoing program that shows measurable improvement in indicators for which there is evidence that it will ... identify and reduce medical errors. (2) The hospital must measure, analyze, and track ...adverse patient events ... (c) Program Activities ..... (2) Performance improvement activities must track medical errors and adverse patient events, analyze their causes, and implement preventive actions and mechanisms that include feedback and learning throughout the hospital. (e) Executive Responsibilities, The hospital’s governing body (or organized group or individual who assumes full legal authority and responsibility for operations of the hospital), medical staff, and administrative officials are responsible and accountable for ensuring the following: ... (3) That clear expectations for safety are established. This Standard is not met as evidenced by: 47959 Based on interviews, and record review, the facility failed to ensure the quality assurance and performance improvement (QAPI) committee implemented a quality control process which addressed failures in patient care related to patient monitoring in two of two events reviewed (Patients #1 and #4) (Cross-reference A-0144). Findings include: Facility policy: The Sentinel Event and Root Cause Analysis policy read, a sentinel event is a patient safety event that reached a patient and resulted in a death, permanent harm, or severe temporary harm. The policy of the facility was to identify sentinel events and conduct investigations of such events in accordance with accrediting body standards. The purpose was to focus the attention of the sentinel event on understanding factors which contributed to the event, and to change the culture, system, and processes to reduce the probability of future events. To be thorough and credible, a root cause analysis included an analysis that determined where redesign might reduce risks, inquiry in all areas related to the event, and a determination of potential improvements that led to a decrease in the likelihood of future events. Once improvement plans were developed and actions implemented, the effectiveness of the changes was evaluated. Reference: The Quality Assurance and Performance Improvement (QAPI) Plan read, the plan monitored every aspect of patient care as it related to the treatment of disease and disability, in order to identify and resolve any breakdowns that could result in suboptimal patient care and safety. The overall objectives improved performance on an ongoing basis. The function of the QAPI committee acted expeditiously to remove barriers when improvement suggestions were identified and ensured the monitoring and follow-up of corrective action plans. 1. The facility failed to ensure the QAPI committee implemented a process that addressed failures in patient monitoring. A. Medical record review i. A live medical record review for Patient #1 was completed on 9/11/24 with chief nursing officer (CNO) #5. The medical record revealed Patient #1 was admitted to the ICU on 7/25/24 for acute respiratory failure with hypoxia (when the air sacs of the lungs cannot release enough oxygen into the blood). Further review of the medical record revealed, on 7/29/24 at 5:26 p.m., the restraint management documentation reported Patient #1 could not understand or follow directions to avoid activities that might have caused self-harm. Impulsive behaviors were noted, such as disconnecting or removing medical devices, which disrupted treatment. On 7/29/24 at 6:58 p.m., Patient #1’s ICU nursing assessment reported the patient was alert and disorientated times four (person, place, time, and situation). Further review of the nursing assessment revealed Patient #1’s restraints were removed. Medical record review revealed, on 7/30/24 at 8:10 a.m., RT #11 changed Patient #1’s ventilator setting to PSV wean (a procedure that helped patients transition from mechanical ventilation to spontaneous breathing). Further review of the medical record revealed RT #11 removed the Patient #1 from the ventilator and placed the patient on a tracheostomy collar (a medical device used to deliver oxygen to patients with a tracheostomy by providing oxygen directly to the tracheostomy tube). Further review of the medical record revealed at 9:05 a.m., RT #11 stated they walked by Patient #1’s room and saw the tracheostomy pulled out and pressed against the wall of the trachea (tube in the neck and chest that carries air to and from the lungs) and occluded the airway. RT #11 stated they heard the alarms and saw the patient was in an asystolic cardiac rhythm (a condition where the heart’s electrical and mechanical activity stops). RT #11 stated they pushed the code blue button, placed the trach back into the patient’s airway, inflated the cuff, and started ventilations with a bag valve mask. ii. Medical record review revealed Patient #4 was admitted to room 414 on 7/11/24 for post acute physical, occupational, and speech therapy after an acute hospitalization for acute myeloblastic leukemia (a type of blood cancer), and myocarditis (an inflammation of the heart muscle). Patient #4 developed intermittent episodes of chest heaviness and shortness of breath during their hospitalization. The medical team performed diagnostic tests on Patient #4 which ruled out cardiac complications. Medical record review revealed Patient #4 desired full cardiopulmonary resuscitation if their heart stopped for any reason. Medical record review of the resuscitation log revealed on 7/19/24 at 4:36 p.m., staff called a rapid response (a team which responded to a patient’s deteriorated condition) because staff found Patient #4 unresponsive with agonal breathing (an abnormal breathing pattern which indicated a severe medical emergency). Medical record review of a provider note, written on 7/20/24 at 6:02 p.m. read, the patient became unconscious while talking to the RN. This was in contrast to the resuscitation log which read staff found Patient #4 unresponsive. Medical record review revealed a late entry nurse’s note entered on 7/26/24 (seven days after the event) at 5:31 p.m. which read, Patient #4’s telemetry box (a heart rhythm monitor) read ventricular tachycardia (a condition where the lower chambers of the heart beat too fast and cause a lack of oxygenated blood to the rest of the body) and the leads needed replacement. The nurse notified Patient #4’s primary nurse who replaced one lead and stated they planned to replace all the leads. Staff called a rapid response approximately two minutes later for the unresponsive patient. B. Document review i. A document review of the QAPI committee meeting minutes was completed. The review revealed the meeting minutes for 5/13/24 and 8/19/24 were identical for the nursing services discussion for staffing for patient safety, new monitors for patients, rapid response, codes, and effectiveness of resuscitation. When asked, chief executive officer (CEO) #8 stated Director #7 did not complete meeting minutes for all meetings and frequently cut and pasted materials for quality meetings from month to month without updates. ii. A document review of the RCA done on 8/5/24 for Patient #1’s code blue event was completed. The review revealed four pages on handwritten notes taken on notebook paper and one page of a portion of an RCA formatted guide. The RCA notes included limited information about the patient admission condition and a few events which led up to and occurred during the code blue. The document lacked the elements outlined in the sentinel event and root cause analysis policy including analysis, inquiry, explanation, identification of risks and actions plans which decreased the likelihood of future events. C. Interviews i. An interview was conducted on 9/12/24 at 11:33 a.m. with director of quality management (Director) #7, chief nursing officer (CNO) #5, and corporate quality director (Director) #10. Director #10 stated the facility had concerns that the root cause analysis (RCA) completed on 8/5/24 for a code blue event (an event that required cardiopulmonary resuscitation for a stopped heart beat) on Patient #1 had missed some elements, so they reviewed and re-assessed the RCA on 9/11/24. Director #10 stated the re-evaluation revealed gaps in the original RCA which showed the failure to evaluate facility staff and monitor alarms. Director #10 stated the original RCA did not include a deeper investigation of the event and the reassessment revealed additional opportunities for improvements in the process for patient monitoring. Director #7 stated the original RCA revealed inconsistencies between the services offered by the contracted company hired to remotely monitor patients and what staff believed the contracted services provided to monitor patients. Director #7 stated the contracted services monitored only heart rhythms, but staff believed the contracted services also monitored patients’ blood pressure, respirations, heart rates, and oxygen saturation (SPO2). Director #7 stated the facility completed RCAs when there were difficulties with situations and not all code blue events had RCAs. Director #7 stated there was a code blue event with Patient #4 which resulted in the patient being transferred to a higher level of care but the decision was made to forego the RCA due to unidentified concerns with monitoring. Director #7 stated they later reviewed the circumstances around the code blue event and discovered Patient #4 had an episode of approximately 20 minutes in which staff did not have a consistent connection of their heart monitoring leads. Director #7 stated in retrospect, the facility should have completed an RCA because they later identified issues with patient monitoring. Director #7 stated they did not confirm if Patient #4 coded while they did not have the monitor leads attached to their chest. CNO #5 stated no one made them aware of the current inconsistencies of patient monitoring between staff and contracted services. CNO #5 stated staff logged phone calls made to the unit by contracted services and handed off to CNO #5 for review. CNO #5 stated they reviewed the logs, but made no changes to practice as a result of the data collected. CNO #5 stated the internal process for quality and process improvement contained flaws and no processes changed as a result of the phone logs collected which showed the inconsistencies of patient monitoring. ii. An interview was conducted on 9/19/24 at 11:55 a.m. with registered nurse (RN) #9. RN #9 stated the facility’s RCA process lacked a nurse driven approach which allowed for a deeper investigation into issues. RN #9 stated education provided to staff lacked information from the quality department that encouraged understanding and compliance with a new process. RN #9 stated the RCA for Patient #1 completed on 8/5/24 was not a formalized process which identified all barriers to safe patient care. iii. On 9/19/24 at 7:07 a.m., an interview was conducted with CNO #5. CNO #5 stated they learned the contracted services did not monitor patients completely during the RCA on 8/5/24. CNO #5 stated they changed the process for staff to monitor patients in addition to the contracted services, however, the facility did not use a formal auditing tool to ensure staff compliance with patient monitoring. CNO #5 stated staff monitored the monitors and alarms in the rooms of medical surgical patients on the unit and not monitored by contract services. CNO #5 stated staff did not hear the monitors alarm when patients chose to shut their doors. CNO #5 stated there was no protocol in place to ensure staff heard and responded to monitor alarms. CNO #5 stated a quality plan, which included process improvement, looked at the risks and trends and made improvements for increased patient safety. CNO #5 stated a lack of follow-up for process improvement projects resulted in patient harm and adverse outcomes for patients. Interviews and document review were in contrast to the sentinel event and root cause analysis policy which read, RCAs focused on factors which contributed to events, and to change culture, system, and processes to reduce the probability of future events. Once the team developed improvement plans and implemented action plans, the team then evaluated the effectiveness of the changes. Furthermore, interviews and document review were in contrast to the QAPI plan which read, the plan monitored every aspect of patient care to identify and resolve breakdowns that resulted in suboptimal patient care and safety and improved performance on an ongoing basis. The function of the QAPI committee was to remove barriers of identified improvement suggestions and ensure staff monitored and followed up on corrective action plans.”

“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: 47959 Based on observations, interviews, and record review, the facility failed to ensure staff followed infection control practices and policies in two of two observations of patients on ventilators, in two of two observations of patients with tube feedings, and in three of three observations of patients in contact isolation. Findings include: Facility policies: The Standard Precautions policy read, all staff would practice standard precautions. Precautions included hand hygiene and the use of personal protective equipment (PPE) depending on the anticipated exposure. The Transmission Based Precautions policy read, the facility’s policy was to prevent the transmission of infectious agents among patients and healthcare personnel in all settings. Contact precautions (actions taken by staff and visitors to prevent the spread of germs) were intended to prevent transmission of infectious agents by direct or indirect contact with the patient or the patient’s environment. Healthcare personnel who cared for patients on contact precautions wore a gown and gloves for all interactions that involved contact with the patient or contaminated areas. Staff donned PPE upon room entry and discarded before they exited the patient’s room to contain and prevent the spread of germs. The Donning and Removal of Personal Protective Equipment policy read, PPE was to be used to provide a protective barrier and reduce the risk of transmission of organisms. References: The Infection Prevention and Control Plan read, the infection prevention and control program was to ensure the facility had a functioning coordinated process in place to minimize the risks of hospital associated infection (HAI) in patients and health care workers. The program was aimed at reducing the risk of nosocomial infections and designed to reduce the risk of transmission of the infections among patients, employees, and visitors. Policies and procedures of the plan included hand hygiene, personal protective equipment, exposure, and isolation precautions. The Tube Feeding protocol, approved by the Medical Executive Committee on 2/26/24, read, to prevent tube feeding contamination, staff were to label and date the formula and tubing and were to be changed every 24 hours. The Breathing Circuit Ventilator manufacturer’s instructions for use (IFU) read, ensure that all unused ports are capped. 1. The facility failed to ensure equipment used for patients on ventilators were used in a way to prevent infection. A. Observations i. Observations were conducted on the intensive care unit (ICU) on 9/11/24. At 9:42 a.m. in ICU room #3, the observation revealed the ventilation circuit was left uncapped, open to air, and hung on the oxygen regulator. ii. Observations were conducted on the intensive care unit (ICU) on 9/11/24. At 9:55 a.m. in ICU room #6, the observation revealed the ventilation circuit was left uncapped, open to air, and hung on the oxygen regulator. This was in contrast to the breathing circuit ventilator IFU which instructed to cap all unused ports to the ventilator. B. Interviews i. On 9/11/24 at 10:04 a.m., an interview was conducted with respiratory therapist (RT) #4. RT #4 stated the ventilator circuit should not have been left open to air and should have been capped when not in use. RT #4 stated a ventilator circuit left open to air allowed bacteria or viruses into the ventilator circuit and could have caused patient respiratory infections. ii. On 9/11/24 at 9:42 a.m., an interview was conducted with chief nursing officer (CNO) #5. CNO #5 stated ventilator circuits should not have been left open to air and should have been capped when not in use. CNO #5 stated a ventilator circuit left open to air allowed bacteria to get into the tubing and had the potential to cause infections. 2. The facility failed to ensure tube feedings were labeled in order to ensure they were not expired. A. Observations i. Observations were conducted on the ICU on 9/11/24. At 9:42 a.m. in ICU room #10, observations revealed a feeding bottle of formula was hung, running, and not dated. Additionally, staff in the room stated they did not date the tube feeding tubing. ii. Observations were conducted on the medical-surgical unit on 9/12/24 at 9:22 a.m. In room #320, observations revealed a tube feeding bottle was hung, running, and not dated. Additionally, staff in the room stated they did not date the tube feeding tubing. B. Interviews i. On 9/11/24 at 10:15 a.m., an interview was conducted with licensed practical nurse (LPN) #6. LPN #6 stated tube feeding containers needed an open date label. LPN #6 stated tube feeding bottles expired after 24 hours and the tube feeding tubes expired after 48 hours. LPN #6 stated bacteria grew in the bottle and tubing after the expiration date and a patient could experience nausea, vomiting, or an infection if exposed to an expired product. ii. On 9/11/24 at 9:42 a.m., an interview was conducted with CNO #5. CNO #5 stated nurses were responsible to date the tube feeding bottles and tubing prior to patient administration. CNO #5 stated nurses changed the tube feedings every 24 hours and patients could have experienced gastrointestinal (stomach and colon) upset if staff used expired formula to tube feed patients. This was in contrast to the tube feeding protocol which instructed staff to label and date formula and tubing to prevent tube feeding contamination. 3. The facility failed to ensure staff wore the appropriate PPE in accordance with facility policy when caring for patients in contact isolation. A. Observations i. Observations were conducted on 9/11/24 at 10:15 a.m. in ICU room #1. Observations revealed a contact isolation sign on the door of room #1. Registered nurse (RN) #1 entered room #1 to hang an intravenous medication and wore only a simple face mask. Additionally, RN #1 did not perform hand hygiene upon exit of the room. ii. Observations were conducted on 9/11/24 at 10:47 a.m. in medical surgical room #412. Observations revealed a contact isolation sign on the door of room #412. Observations revealed RN #2 entered the room to silence an IV medication pump alarm with no personal protective equipment (PPE). iii. Observations were conducted on 9/11/24 at 10:53 a.m. in medical surgical room #412. Observations revealed a contact isolation sign on the door of room #412. Observations revealed RT #3 entered room #412 to care for the patient without PPE. This was in contrast to the standard precautions policy which read, all staff practiced standard precautions which included hand hygiene and PPE. Additionally, it was in contrast to the donning and removal of personal protective equipment policy which read PPE was used to provide a protective barrier and reduce the risk of transmission of organisms. Furthermore, this was in contrast to the transmission based precautions policy which read staff who cared for patients in contact precautions wore a gown and gloves for all interactions that involved contact with the patient or contaminated area and was put on upon room entry and discarded before they exited the patient room to contain and prevent the spread of germs. B. Interviews i. On 9/11/24 at 10:15 a.m., an interview was conducted with RN #1. RN #1 stated the patient in room #1 was in contact isolation for extended-spectrum beta-lactamase (ESBL), a bacteria resistant to certain antibiotics. RN #1 stated they had to administer an IV medication and did not have time to put PPE on. RN #1 stated it was important to wear PPE to prevent the spread of infection. RN #1 stated when they did not wear PPE, an infection could have spread to other patients. ii. On 9/11/24 at 10:47 a.m., an interview was conducted with RN #2. RN #2 stated they forgot to put on PPE before they entered contact isolation ICU room #1 to silence the IV pump alarm. RN #2 stated PPE was important because it prevented the spread of infection. RN #2 stated there was a risk of infection to staff and other patients when they did not wear PPE. iii. On 9/11/24 at 10:53 a.m., an interview was conducted with RT #3. RT #3 stated they did not see the contact isolation sign on the door of room #412. RT #3 stated PPE was important and prevented the spread of infection. RT #3 stated there was a risk of infection to staff and other patients when they did not wear PPE. iv. On 9/11/24 at 10:23 a.m. an interview was conducted with CNO #5. CNO #5 stated staff received infection control and PPE education multiple times in the last six months. CNO #5 stated they expected and required staff to wear PPE in isolation rooms. CNO #5 stated when staff did not wear PPE, they increased patients’ and staffs’ risk of infection. C. Document review i. The 2024 infection control committee meeting minutes were reviewed and revealed the benchmark for PPE compliance was 95%. The review revealed the facility had a PPE compliance rate of 82% for January, 2024 with 112 observations and 95.9% for July, 2024 with 73 observations. This was in contrast to the observations on 9/11/24 which revealed three staff members entered into three patient rooms without PPE or infection control compliance. ii. The infection prevention and control plan was reviewed and read, the facility had a functioning coordinated process in place to minimize the risks of hospital associated infection (HAI) in patients and health care workers. This was in contrast to observations on 9/11/24 and 9/12/24 which revealed staff did not follow IFUs, protocols, or policies for ventilators, tube feedings, or PPE for isolation.”

“COMPLIANCE WITH LAWS CFR(s): 482.11 Compliance with Federal, State and Local Laws This Condition is not met as evidenced by: 46926 Based on the manner and degree of the standard level deficiency referenced to the Condition, it was determined the Condition of Participation §482.11 Compliance with Federal, State and Local Laws was out of compliance. A-0020 Based on document reviews and interviews, the facility failed to follow state laws. Specifically, the facility failed to ensure bedside nurses annually developed and oversaw a master nurse staffing plan for the facility in one of one staffing committee meeting minutes reviewed. Findings include: Facility policy: The Staffing Plan read, committee establishment date: 12/8/22. The committee will receive input from staff nurses regarding the development, ongoing monitoring, and evaluation of the staffing plan. The nurse staffing advisory committee meets every quarter or more often if a need or staffing concern is identified. At least 60% of the members of the nurse staffing advisory committee are RNs who are involved in direct patient care at least 50% of their work time. The chief nursing officer and nurse manager are voting members of the committee. References: The Code of Colorado Regulations, 6 CCR 1011-1 Chapter 4 14.6(B)(2) and (3) read, the nurse staffing committee shall annually develop and oversee a master nurse staffing plan for the facility. The nurse staffing committee shall have at least 60% or greater participation by clinical staff nurses who routinely provide direct care to patients, in addition to auxiliary personnel and nurse management. 1. The facility failed to ensure bedside nurses annually developed and oversaw a master nurse staffing plan. a. The Staffing Plan read that the facility established a nurse staffing committee on 12/8/22. A review of the facility’s nursing staff committee meeting minutes revealed only one agenda dedicated to a nurse staffing committee; This document, titled Nurse Council Meeting Minutes, was dated October 2023. Further review of the agenda did not reveal evidence the staffing committee developed or had oversight of the master nurse staffing plan. The Nurse Council Meeting Minutes identified 13 members as either registered nurses (RNs) or licensed practical nurses (LPNs). Two of the RNs were house supervisors, making it unclear if they provided direct patient care at least 50% of the time. The agenda and the Staffing Plan identified 26 members of the committee, which included the nurse manager and the facility’s chief nursing officer (CNO). With the house supervisors included as bedside nurses and the nurse manager and CNO as members of the committee, 54% of the committee were bedside nurses. The lack of evidence the bedside nurses had input into the development of the master staffing plan was in contrast to the Staffing Plan, which instructed the committee to receive input from staff nurses regarding the development, ongoing monitoring, and evaluation of the plan. Additionally, the Staffing Plan instructed the staffing committee to meet every quarter or more often if a staffing concern was identified. The Staffing Plan also instructed at least 60% of the members of the nurse staffing advisory committee to have been nurses who were involved in direct patient care at least 50% of their work time. Additionally, evidence showing bedside nurses had not had input into the facility’s master staffing plan and less than 60% of committee membership was comprised of bedside nurses was in contrast to Code of Colorado Regulations, 6 CCR 1011-1 Chapter 4 14.6(B)(2) and (3). The regulation instructed the nurse staffing committee to annually develop and oversee a master nurse staffing plan for the hospital. The regulation instructed the nurse staffing committee to have at least 60% or greater participation by clinical staff nurses who routinely provided direct care to patients, in addition to auxiliary personnel and nurse management. b. A review of the facility’s nursing assignment sheets revealed the facility failed to provide an adequate number of certified nursing assistant (CNA) staff according to the staffing matrices provided by the facility. For example, on the day shift of 5/23/23, the facility census included 48 medical/surgical patients. The staffing matrix called for ten nursing and five CNA personnel to staff the medical/surgical floors. The nursing assignment sheet indicated only four CNAs worked that day. An additional example occurred on the night shift of 11/7/23. The facility census indicated 48 medical/surgical patients. The staffing matrix called for ten nursing and five CNA personnel to staff the medical/surgical floors. The nursing assignment sheet indicated only four CNAs worked that night. i. On 11/29/23 at 10:27 a.m., an interview was conducted with registered nurse (RN) #6. RN #6 explained two of the medical/surgical floors in the facility had 20 patient beds. RN #6 said if four nurses assigned to these floors each had five patients, the workload was manageable; however, if leadership assigned more patients, nurses did not have enough time to complete all necessary tasks. RN #6 stated the facility did not employ enough CNA staff to provide activities of daily living (essential and routine tasks that most healthy individuals can provide for themselves, such as bathing and toothbrushing). She said if nurses did not have enough CNAs to support patient’s activities of daily living (ADLs), the nursing staff did not have enough time to give medications and perform other nursing duties. RN #6 said if the facility scheduled too few CNAs, nursing staff provided total patient care by acting as a CNA and a nurse. c. On 11/30/2023 at 10:58 a.m., an interview was conducted with RN #1. RN #1 said he was a member of the staffing committee. He explained the first staffing committee meeting occurred in late October 2023. RN #1 stated during the meeting members discussed a generalized overview of committee responsibilities and held discussions regarding bedside staff concerns. RN #1 was unable to explain why a staffing committee meeting had not occurred before the October 2023 meeting. He stated other meetings before October 2023 were town hall meetings for all staff and not staffing committee meetings. RN #1 said during the October 2023 nurse staffing committee leadership presented a staffing plan previously developed by the facility’s corporate owner, but the matrix was not open for suggestions. RN #1 explained the bedside nurses discussed workflow on the floors and how to optimize nursing time for the patients, but this conversation was not taken into account when allocating nursing and associated personnel hours to patient care. RN #1 stated bedside nurses provided the work of actual patient care and therefore had insight into workflow not available to a corporate owner. RN #1 also stated bedside nurses needed appropriately allocated time to assess patients, provide interventions, and give medications. RN #1 expressed concern that if staffing levels were not developed by bedside nurses, patients would not receive equitable amounts of nursing time and not get all needed interventions. d. On 11/30/2023 at 3:25 p.m., an interview was conducted with RN #8. RN #8 said she was a member of the nurse staffing committee. She said during the October 2023 meeting leadership presented a staffing plan and matrix but did not allow bedside nurses to have input or make decisions concerning either document. RN #8 said the corporate owner developed the staffing matrix and that nurses felt prior staffing plans had been better suited to the nurses and their patients. RN #8 also said the corporate owner and local leadership had not set the nurse staffing committee up for success. RN #8 explained the facility’s corporate owner experienced culture shock after they had purchased the facilities in Colorado and explained the owner did not understand how nurses provided care in the state. She further explained the current corporate matrix worked well at high census numbers, but for lower census days nurses were assigned too many patients to provide all necessary care. RN #8 said this exhausted the bedside staff, and in turn, patients felt they had not received quality care. RN #8 stated the facility had a nursing council under previous corporate owners, but these meetings stopped occurring due to frequent leadership changes. RN #8 said the meetings before October 2023 were open town hall, all-staff meetings and did not meet the Colorado requirements for a nurse staffing committee. e. On 11/30/2023 at 1:49 p.m., an interview was conducted with CNO #5. CNO #5 said facility leadership had written the staffing plan, and that the corporate owner had developed the matrix. CNO #5 also said bedside nurses should have been given a voice in the staffing plan and the staffing matrix.”

“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: 46926 Based on the manner and degree of the standard level deficiency referenced to the Condition, it was determined the Condition of Participation §482.23 Nursing Services was out of compliance. A-0392 Based on document reviews, observations, and interviews, the facility failed to provide adequate numbers of licensed registered nurses, licensed practical nurses, and other personnel to provide nursing care to all patients as needed. Specifically, the facility failed to ensure staff provided bathing, assistance with activities of daily living (essential and routine tasks that most healthy individuals can provide for themselves), and assistance with turning in bed every two hours to meet patients’ needs and in accordance with facility policy and national standards in four of four medical records reviewed (Patients #1, 2, 3, and 4). A-0405 Based on document reviews and interviews, the facility failed to administer medications in accordance with the orders of the practitioner and acceptable standards of practice. Specifically, the facility failed to ensure staff administered patients’ medications within the timeframe specified by facility policy and national guidelines in four of four medical records reviewed (Patients #1, 2, 3, and 4). Additionally, the facility failed to follow national guidelines by developing a policy regarding the administration of time-critical medications.”

“STAFFING AND DELIVERY OF CARE CFR(s): 482.23(b) The nursing service must have adequate numbers of licensed registered nurses, licensed practical (vocational) nurses, and other personnel to provide nursing care to all patients as needed. There must be supervisory and staff personnel for each department or nursing unit to ensure, when needed, the immediate availability of a registered nurse for care of any patient. This Standard is not met as evidenced by: 46926 Based on document reviews, observations, and interviews, the facility failed to ensure nurses supervised and evaluated the nursing care for each patient. Specifically, the facility failed to ensure staff provided bathing, assistance with activities of daily living (essential and routine tasks that most healthy individuals can provide for themselves), and assistance with turning in bed every two hours to meet patients’ needs and per facility policy and national standards in four of four medical records reviewed (Patients #1, 2, 3, and 4). Findings include: Facility policy: The Guidelines for Nursing Care policy read, activity and mobility: The bedfast patient will be turned and documented every two hours and as needed. The patient’s hair is combed or shaved every day and as needed. Oral care will be provided daily and as needed. If no contraindications, a bath or shower will be provided three times a week and as needed. Reference: The Lippincott Manual of Nursing Practice 11th Edition (2018), provided by the facility read, turning: Changing positions from back to side-lying (and vice-versa) stimulates circulation, encourages deeper breathing, and relieves pressure areas. 1. Help the patient to move onto his or her side if assistance is needed. 2. Place the uppermost leg in a more flexed position than that of the lower leg, and place a pillow comfortably between the legs. 3. Make sure that the patient is turned from one side to the back and onto the other side every 2 hours. Bathe the patient regularly. 1. The facility failed to ensure staff provided bathing, assistance with activities of daily living (ADLs) such as toothbrushing and assistance with turning in bed every two hours. a. A review of Patient #1’s medical record revealed the facility admitted her on 10/11/23 for treatment of a through-the-knee amputation of her right leg due to wound infections and lymphedema (body swelling caused by poor circulation in the immune system). An occupational (a type of therapy that encouraged rehabilitation through the performance of ADLs) therapist documented that Patient #1 required substantial or maximum assistance with toileting hygiene. Patient #1’s medical record defined toileting hygiene as the ability to maintain perineal hygiene (washing the genital or rectal areas of the body) and adjusting clothes before and after voiding or having a bowel movement. The occupational therapist also documented that Patient #1 required partial or moderate assistance to bathe. A review of the Shift ADL flowsheet for Patient #1 revealed multiple examples of days when she did not receive perineal care or a bath. For example, staff did not provide a bath for five days starting on 11/3/23 and ending on 11/7/23. During that time staff provided perineal hygiene for Patient #1 only once, on 11/5/23. Another example occurred on the three days starting on 11/23/23 and ending on 11/25/23, when staff did not provide either perineal care or bathing assistance to Patient #1. This was in contrast to the Guidelines for Nursing Care policy, which instructed to provide a bath or shower three times a week and as needed. i. On 11/27/23 at 9:59 a.m., an interview was conducted with Patient #1. Patient #1 said she needed help with toileting hygiene. Patient #1 stated when staff did not respond to the call light she activated for assistance with toileting, she had to sit in her urine or feces for up to 40 minutes. Patient #1 further explained staff rushed during certain busy times, which led to mistakes or missed care. Patient #1 stated due to lymphedema increasing her skin’s fragility she feared staff would have left her on a bedpan too long. Patient #1 explained the sharp edges of the pan could have easily cut her skin and caused wounds and further infections. She also stated the wounds from her amputation were close to the area affected by incontinence, which increased her fear of infection. Patient #1 said her concerns about lack of assistance with ADLs led her to experience poor sleep, anxiety, and stress because she had a prior experience with sepsis (blood infection) and could not live through the experience again. ii. In an interview on 11/30/23 at 10:58 a.m., registered nurse (RN) #1 explained patients should have to wait less than five minutes for staff to respond to a call light. He said staff performed and documented perineal hygiene on the Shift ADL flowsheet each time they assisted a patient with incontinence care. RN #1 also said perineal hygiene was different from a bath. He stated a bath cleaned the entire body and perineal hygiene cleaned the perineum (rectum and genitals). RN #1 said both perineal hygiene and baths reduced the risk of patient infections. iii. Upon request to the director of quality (Director) #9, the facility was unable to provide call bell response times for Patient #1. In an interview on 11/29/23 at 9:06 a.m., Director #9 stated the call bell system did not record the times when the patient activated the call bell and when staff turned it off after responding to it. b. A review of Patient #2’s medical record revealed the facility admitted her on 6/29/23 after she suffered two cerebral vascular accidents (strokes that occurred due to the loss of blood flow to the brain) which left her severely disabled on her right side. At the time of her admission, an occupational therapist documented that Patient #2 required maximal assistance for toileting and bathing, she communicated by gesturing with her left hand, and the patient’s son provided most of the assistance with ADLs. i. A review of the ADL flowsheet for Patient #2 revealed multiple days when she did not receive oral care or a bath. For example, there was no evidence that staff provided oral care between 7/25/23 and 7/30/23 or that Patient #2 received a bath between 9/30/23 and 10/6/23. Additionally, on a Patient Rounding flowsheet which recorded recording every two-hour turns, multiple staff members documented the patient independently repositioned herself. For example, throughout the night shift on 11/26/23, staff documented Patient #2 repositioned herself. On the same flowsheet, staff documented they turned the patient multiple times throughout a shift. However, each turn throughout the shift was entered in the medical record at the same date and time, indicating staff documented the turns before they occurred (forward documentation). For example, on 11/20/23, staff documented turning Patient #2 was turned every two hours throughout the night shift (from 7:00 p.m. until 7:00 a.m.), but all of the turns for the shift were documented at 1:55 a.m. ii. On 11/30/23 at 12:57 p.m., observations were conducted of Patient #2 in her room in the presence of her son. Patient #2 appropriately answered yes or no questions by gesturing with her left hand. Upon request, Patient #2 was unable to independently turn herself from side to side. Patient #2 also required repeated cues to pay attention to questions and could not speak. Also on 11/30/23 at 12:57 p.m., an interview was conducted with Patient #2 and her son. Patient #2 indicated she could not turn herself onto her right side when asked to do so. Patient #2’s son explained she was mobile in bed but due to her strokes, could mainly only move up and down in the bed on her back. He also stated staff “breathed a sigh of relief” when he was present at the facility because they would not have to provide ADLs, baths, or turn her as he provided those services for his mother. He further stated he felt obligated to provide hygiene care and turns for his mother, as it would not otherwise have occurred. Patient #2’s son stated he was afraid to leave her alone at the facility because she was non-verbal, the staff felt rushed as they provided care, and he was concerned the lack of hygiene and turns could have led to long-term consequences such as depression, infection, or pressure injuries. iii. On 11/27/23 at 9:05 a.m., an interview was conducted with certified nursing assistant (CNA) #2. CNA #2 stated the nursing assistant staff provided most of the assistance with ADLs if patients required support. She explained this included setting up the toothpaste and a toothbrush if a patient could brush for themselves, or brushing their teeth if they could not. CNA #2 said CNA and RN staff took turns rounding on (checking) patients every other hour and during these rounds, staff turned patients every two hours if they were unable to turn themselves. She stated staff provided bathing assistance for patients who required it every other day. CNA #2 explained staff documented these activities on the ADL flowsheet, and if care was provided by a family member this should have been documented in the same place. She further explained if patients did not have their teeth brushed they could have developed sores in their mouths which could have led to infections. CNA #2 said if staff failed to turn or bathe patients who required assistance, patients could have developed pressure injuries (damage to the skin or underlying tissue), longer hospitalizations, and delayed discharges. iv. In an interview on 11/30/23 at 10:58 a.m., RN #1 explained forward documentation was not acceptable because it documented something that had not yet happened. He stated this decreased the reliability of the medical record, recorded an action the staff member had not yet performed or could have been completely inaccurate if the patient experienced a change of condition. c. A review of Patient #3’s medical record revealed the facility admitted him on 12/30/22 for osteomyelitis (bone infection) in his left foot which led to a below-the-knee amputation. The occupational therapist documented Patient #3 required moderate assistance with ADLs, such as preparing the toothbrush and toothpaste, and assistance in the shower or set-up assistance for a bed bath. A review of Patient #3’s ADL and Shift flowsheets revealed multiple days when Patient #3 had not received assistance to perform oral care or bathing. For example, staff did not assist Patient #3 with either oral care or bathing between 5/23/23 and 5/25/23. d. A review of Patient #4’s medical record revealed the facility admitted him on 6/13/23 due to quadriplegia (paralysis that affected all four limbs, starting at the neck) suffered after a fall. A review of Patient #3’s ADL and Shift flowsheets revealed multiple days Patient #4 had not received oral care or a bath. For example, the staff did not provide oral care between 8/17/23 and 8/19/23 or bathe him between 6/26/23 and 7/12/23. i. A review of Patient #4’s Patient Rounding flowsheet revealed staff documented Patient #4 turned himself. The Patient Rounding flowsheet also included evidence of forward documentation for his every two-hour turns. Throughout the flowsheet, there were multiple days when staff documented the same date and time for each turn. For example, on 11/21/23 staff documented Patient #4 repositioned himself throughout the day shift. On 10/1/23, staff documented Patient #4 refused turns throughout the shift but each refusal was timed at 12:56 a.m. ii. On 11/27/23 at 9:40 a.m., observations were conducted of Patient #4 in his room. Patient #4 was able to move his head in a limited range from side to side and up and down but was otherwise immobile. Patient #4 could not reposition himself in bed when requested to do so. Also on 11/27/23 at 9:40 a.m., an interview was conducted with Patinet #4. Patient #4 said he was dependent on others for all care, including assistance with ADLs, bathing, and turning in bed. He further said he was concerned staff did not brush his teeth frequently, as he had caps and feared the lack of care would lead to an oral infection. Patient #4 explained he received ADL assistance, turns, and bathing depending on which staff member cared for him during the shift. He stated if the facility hired agency (temporary) staff he would not receive assistance with ADLs or a bath. The findings in the medical records of Patients #1, 2, 3, and 4 were in contrast to the Guidelines for Nursing Care policy which instructed to turn and document bedfast patients every two hours and as needed. The policy also instructed to provide oral care daily and as needed. Additionally, the policy instructed to provide a bath or shower three times a week and as needed. The findings were also in contrast to the Lippincott Manual of Nursing Practice which read changing positions from back to side-lying (and vice-versa) stimulated circulation, encouraged deeper breathing, and relieved pressure areas. The guideline instructed to help the patient to move onto his or her side if assistance was needed and to make sure that the patient turned from one side to the back and onto the other side every two hours. The guideline also instructed to bathe patients regularly. e. On 11/27/23 at 10:45 a.m., an interview was conducted with RN #3. RN #3 stated staff bathed patients who required assistance every other day. RN #3 explained incontinent patients required more frequent bathing and perineal hygiene. She said she was not familiar with the Guidelines for Nursing Care policy but understood the expectations from the facility’s leadership. RN #3 also said nursing care extended beyond providing medications and all nursing staff should have provided hands-on care. RN #3 explained failure to provide hygiene could have caused infections. She also explained if a patient refused ADLs staff should have documented the refusal in the medical record. RN #3 said if an action was not documented in the medical record, it was not done. f. On 11/29/23 at 7:47 a.m., an interview was conducted with RN #4. RN #4 explained she was a certified wound care nurse and had practiced wound care at the facility for the past four years. RN #4 said if patients were not turned every two hours they developed pressure injuries. She further said if this occurred the patients became less interactive with staff and their hospitalizations became harder. RN #4 said failure to provide oral care and bathing impacted patients because moisture caused skin breakdown. She also explained many patients remained hospitalized in the facility for months at a time, and staff assisting patients with ADLs and providing baths gave isolated patients a chance to receive human interactions. RN #4 stated hands-on care allowed nursing staff to see their patients’ skin and identify pressure injuries as soon as they developed. g. On 11/30/23 at 1:49 a.m., an interview was conducted with chief nursing officer (CNO) #5. CNO #5 reviewed the Patient Rounding flowsheets used to document every two-hour turns and agreed it was not possible to determine if and when staff had turned patients. CNO #5 stated forward documentation should not have occurred as it caused the medical record to be inaccurate.”

“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: 46926 Based on document reviews and interviews, the facility failed to administer medications in accordance with the orders of the practitioner and standards of practice. Specifically, the facility failed to ensure staff administered patients’ medications within the timeframe specified by facility policy and national guidelines in four of four medical records reviewed (Patients #1, 2, 3, and 4). Additionally, the facility failed to follow national guidelines by developing a policy regarding the administration of time-critical medications. Findings include: Facility policies: The Medication Administration Record and Medication Administration policy read, all medication will be administered within one hour before or after the scheduled time. Recording of medication administration will occur immediately after the medication is given and prior to proceeding to the next patient. Prior to administering the medication, the nurse will verify against the medication administration record (MAR) the time of administration. If the medication is given at a time greater than one hour before or one hour after the scheduled time, document in the medication administration record why the medication was not given at the scheduled time. The Medication Administration - Pharmacy policy read, time-critical scheduled medications are those where early or delayed administration of maintenance doses of greater than 30 minutes before or after the scheduled dose may cause harm or result in substantial sub-optimal therapy or pharmacological effect. Medications shall be administered by or under the supervision of appropriately licensed personnel designated by the medical staff in its approved rules and regulations. References: The Lippincott Procedure - Safe Medication Administration Practices, General guideline provided by the facility read, for medications that require administration more frequently than daily but less frequently than every for hours (for example, twice daily, three times per day), administration should occur no more than one hour before or after the scheduled time. Identify a time-critical list of common scheduled medications specific to the patient population of the unit. 1. The facility failed to ensure staff administered patients’ medications within the timeframe specified by facility policy and national guidelines. a. The facility’s Medication Administration Record (MAR) and Medication Administration policy instructed to administer all medication within one hour before or after the scheduled time. The policy also instructed to record medication administration immediately after the medication was given and before proceeding to the next patient. i. A review of Patient #1’s medical record revealed the facility admitted her on 10/11/23 for treatment of a through-the-knee amputation of her right leg due to wound infections. A review of Patient #1’s MAR revealed multiple instances of late medication administration. For example, physicians had ordered the nurses to administer methocarbamol (a muscle relaxer) and gabapentin (an anti-seizure medication also used for nerve pain) four times a day. On 10/12/23 these medications were due at noon. The nurse administered the medications to Patient #1 at 1:24 p.m., 24 minutes past the time frame specified in the facility’s policy. Another example of late administration in Patient #1’s medical administration record occurred on 11/26/23. The medications given once a day included venlafaxine (an antidepressant also used for pain) and rivaroxaban (a blood thinner, used to prevent blood clots) were due at 9:00 a.m. Patient #1 did not receive her daily medications until 10:19 a.m., 19 minutes outside of the expected time frame. ii. A review of Patient #2’s medical record revealed the facility admitted her on 6/29/23 after she suffered two cerebral vascular accidents (strokes that occurred due to the loss of blood flow to the brain) which left her severely disabled on her right side. A review of Patient #2’s MAR revealed multiple instances of late medication administration. For example, physicians ordered ondansetron (to treat nausea and vomiting) four times a day. On 10/17/23 a dose was due at 4:00 p.m. Nurses did not give Patient #2 the medication until 6:24 p.m., 1 hour and 24 minutes outside of the expected time frame. Another example of late medication administration occurred on 11/11/23. Patient #2’s daily medications, which included oxcarbazepine (an anti-seizure medication), were due at 9:00 a.m. Patient #2 received her medication at 10:24 a.m., 24 minutes outside of the expected time frame. A review of the medical records of Patients #3 and 4 revealed similar findings. The medical records did not include documentation of why the medications were not administered at the scheduled time. The late medication administrations in the medical records of patients #1, 2, 3, and 4 were in contrast to the Medication Administration Record and Medication Administration policy which instructed nurses to verify against the MAR the time of administration before the medication was administered. If the medication was given at a time greater than one hour before or one hour after the scheduled time, the policy instructed to document in the MAR why the medication was not given at the scheduled time. b. On 11/29/23 at 10:27 a.m., an interview was conducted with registered nurse (RN) #6. RN #6 stated nursing staff had one hour before and one hour after a medication’s scheduled time to administer it. She explained nurses administered medication late if a patient needed to be cleaned or have linen changed, required transportation for medical imaging in the middle of medication administration times, or too many nurses were waiting for access to the Pyxis (an automated medication dispensing system) to retrieve the medications. RN #6 stated nursing staff also administered medications late due to the assigned number of patients. She explained two of the medical/surgical floors in the facility had 20 patient beds. RN #6 said if four nurses assigned to these floors each had five patients, the workload was manageable. However, if leadership assigned more than five patients, nurses did not have enough time to complete all necessary tasks. RN #6 stated the facility did not employ enough certified nurse assistants (CNAs). RN #6 explained CNAs primarily assisted patients with activities of daily living (essential and routine tasks that most healthy individuals can provide for themselves) and baths. She further explained if nurses provided this care due to a lack of CNA staff, the nursing staff was unable to give medications on time. c. On 11/30/23 at 10:58 a.m., an interview was conducted with RN #1. RN #1 stated if physicians scheduled medications several times a day and one of these was given late, it affected the patient’s blood levels of the medication. He said physicians scheduled many daily medications at 9:00 a.m., which was a time when many patients required assistance with ADLs. RN #1 explained if the patients needed assistance with ADLS, the medication for the fourth and fifth patients were late because he was behind the schedule. d. On 11/30/23 at 10:22 a.m., an interview was conducted with pharmacy manager (Pharmacist) #7. Pharmacist #7 said the facility gave the hour before and hour after the medication’s due time for the medication to be administered because it allowed nurses flexibility in their schedules. She explained it took nurses 15 to 20 minutes to retrieve medications for one patient, and that nurses completed medication administration before returning to the Pyxis to retrieve the next patient’s medication. Pharmacist #7 stated the timing of administration for scheduled medications used to decrease spasticity or pain, such as baclofen and gabapentin, was important because patients were less likely to participate in therapy if they experienced increased pain or muscle tightness. Pharmacist #7 explained nurses should have administered antidepressant medication, such as venlafaxine, at the same time daily because it took weeks for antidepressant blood levels to increase to the point where patients experienced relief from depression or pain symptoms. 2. Based on national guidelines, the facility failed to identify a time-critical list of common scheduled medications. a. The facility failed to identify a list of time-critical medications specific to their patient population. i. A review of the facility policy Medication Administration Record and Medication Administration failed to reveal evidence the facility identified a list of time-critical medications. The Medication Administration - Pharmacy policy defined time-critical scheduled medications as those where early or delayed administration of maintenance doses of greater than 30 minutes before or after the scheduled dose caused harm or resulted in substantial sub-optimal therapy or pharmacological effect. ii. On 11/29/23 at 10:27 a.m., an interview was conducted with RN #6. RN #6 stated she was not familiar with time-critical medications. She was unable to give examples of time-critical medications. RN #6 was unable to identify why nurses should have administered time-critical medications within 30 minutes of the scheduled time. This interview was in contrast to the Lippincott Procedure - Safe Medication Administration Practices, General guideline that instructed to identify a time-critical list of common scheduled medications specific to the patient population of the unit. iii. On 11/30/23 at 10:22 a.m., an interview was conducted with Pharmacist #7. Pharmacist #7 explained certain classes of medications, such as scheduled pain medications, antibiotics, and anti-seizure medications were time-critical. Pharmacist #7 said without time-critical administration patients experienced increased pain, a decrease in the antibiotic’s ability to fight infection, lab work timing would have been wrong which led to over- or underdosing of antibiotics such as Vancomycin, or a patient seizure as blood levels of the medication decreased. Further, Pharmacist #6 said the pharmacy kept a list of time-critical medications that nurses should have administered within a 30-minute window before or after the scheduled due time. Upon request to CNO #5, the facility was unable to provide this list. iv. During an interview on 11/30/23 at 1:49 p.m., chief nursing officer (CNO) #5 reviewed the Medication Administration Record and Medication Administration policy used by nurses to guide medication administration. CNO #5 was unable to identify any time-critical guidelines within the policy or in any other policies or procedures used by the facility. He stated antibiotics that required lab testing to guide dosing such as Vancomycin and anti-seizure medications were time-critical, due to the harm that could have come to patients via suboptimal antibiotic blood levels or the increased possibility of seizures. CNO #5 was unable to identify other, specific time-critical medications and stated he deferred the question to the pharmacy. The interviews with RN #6 and CNO #5 were in contrast to the Lippincott Procedure - Safe Medication Administration Practices, General guideline that instructed to identify a time-critical list of common, scheduled medications specific to the patient population of the unit.”