Memorial Medical Center

“RN SUPERVISION OF NURSING CARE CFR(s): 482.23(b)(3) A registered nurse must supervise and evaluate the nursing care for each patient. This Standard is not met as evidenced by: 50645 Based on document review and interview, it was determined that 1 of 11 (Pt #1) patient records reviewed, the Hospital failed to ensure nursing staff reassessed patients following administration of pain medication for effectiveness or adverse events per the hospital policy. Findings include: 1. Pt #1’s record was reviewed on 7/6/26 at approximately 11:30 AM. Pt #1’s record included an order for Norco (opiod/narcotic pain medication) 10/325mg 1 tab PO Q 4 hours PRN. Medication Administration Record is as follows: -1/27/26 at 9:41 PM Norco given by RN E #14. Pain score was 8 (pain score 1-10, with 1 being the least pain and 10 being the most severe pain). No follow-up pain reassessment was completed. -1/28/26 12:01 AM Norco given by RN E #15. Pain score was 8. Follow-up pain reassessment was completed an hour after pain medication administration. -1/28/26 at 4:04 AM Norco given by RN E #15. Pain score was 8. No follow-up pain reassessment was completed. -1/28/26 at 10:05 AM Norco given by RN E #13. Pain score was 10. No follow-up pain reassessment was completed. -1/28/26 at 2:33 PM Norco given by RN E #13. Pain score was 8. No follow-up pain reassessment was completed. -1/28/26 at 5:45 PM Norco given by RN E #13. Pain score was 8. No follow-up pain reassessment was completed. -1/29/26 at 7:22 AM Dilaudid (opioid/narcotic pain medication) 0.2 mg IV Q 6 hours PRN given by RN E # 16. Pain score was 8. No follow-up pain reassessment was completed. Pt #1’s record lacked documentation of pain reassessments after pain medications were administered as required per policy. 2. The policy titled “MH Pain Management and Practice Standards” (Revised 7/2025) was reviewed on 7/7/26 at approximately 1:30 PM. The policy stated, “ .... Reassessment of pain is to be done within 60 minutes of each intervention.” 3. An interview was conducted on 7/7/26 at approximately 11:00 AM with the Manager of Patient Safety and Accreditation (E #3). While discussing the missed pain reassessments, E #3 stated, “I already have that being addressed.” E #3 verbally agreed that pain assessments were not being completed by policy.”

“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: 50645 Based on document review and staff interview, for 1 of 11 patient records reviewed (Pt #1), the Hospital failed to ensure that medications were administered in accordance with the practitioner’s orders. Findings include: 1. Pt #1’s record was reviewed on 7/6/26 at approximately 1:30 PM. Pt #1’s record included a physician order for Norco 10/325 mg 1 tablet every 4 hours as needed. The Medication Administration Record shows that on 1/28/26, Norco 10/325 mg was administered at 9:41 PM on 1/27/26 and then again at 12:01 AM (2 hours and 20 minutes later) on 1/28/26 by RN (E #15). Pt #1’s record did not include any additional orders for Norco. 2. The policy titled “Administration of Medication” (revised 3/2026) was reviewed on 7/7/26 at approximately 2:30 PM. The policy stated, “ .... PRN medications - Verify appropriate time since administration of prior dose.” 3. An interview was conducted with the Manager of Patient Safety and Accreditation (E #3) on 7/7/26 at approximately 11:30 am, E #3 verbally confirmed that medication was given too soon and there were no additional Norco orders.”

“PATIENT RIGHTS: RESTRAINT OR SECLUSION CFR(s): 482.13(e)(1)(i)(A) Definitions. (i) A restraint is- (A) Any manual method, physical or mechanical device, material, or equipment that immobilizes or reduces the ability of a patient to move his or her arms, legs, body, or head freely; or This Standard is not met as evidenced by: 50771 Based on record review, document review, and interview, it was determined for 1 of 10 (Pt. #1) clinical records reviewed on the Cardiac Unit, the hospital failed to ensure the policy for restraint usage was followed. As evidenced by: 1. A review of the Restraint Documentation through discharge was completed and notes as follows: - 3/27/2026 at 6:00 PM soft wrist restraint applied, proper documentation is completed. Food offered. - 3/27/2026 at 10:00 PM Restraint removed. Fluids offered. - 3/28/2026 at 8:00AM soft wrist restraint applied with proper documentation completed. Food and fluids offered. - 3/28/2026 10:00 AM Every 2-hour assessment completed per policy. Food and fluids offered. - 3/28/2026 12:00 PM Every 2-hour assessment completed per policy. Food and fluids offered. - 3/28/2026 2:00 PM Every 2-hour assessment completed per policy. Food and fluids offered. - 3/28/2026 4:00 PM Every 2-hour assessment completed per policy. Food and fluids offered. - 3/28/2026 6:00 PM Every 2-hour check not conducted per policy. Food and fluids offered. - 3/28/2026 7:00 PM restraint removed. No assessment documented. - 3/28/2026 9:00 PM vest restraint applied with proper documentation completed. Food and fluids offered. - 3/28/2026 11:00 PM Every 2-hour check not conducted per policy. Food and fluids offered. - 3/29/2026 1:00 AM Every 2-hour check not conducted per policy. Food and fluids offered. - 3/29/2026 3:00 AM Every 2-hour check not conducted per policy. Food and fluids offered. - 3/29/2026 4:00 AM soft limb ankle restraint applied with proper documentation completed. - 3/29/2026 5:00 AM Every 2-hour check not conducted per policy. Food and fluids offered. - 3/29/2026 7:00 AM soft wrist restraint applied, proper documentation is completed. Food and fluids offered. - 3/29/2026 8:00 AM Every 2-hour check not conducted per policy. Pt is NPO. - 3/29/2026 10:00 AM Every 2-hour check not conducted per policy. Pt is NPO. - 3/29/2026 12:00 PM Every 2-hour check not conducted per policy. Pt is NPO. There is no further documentation of assessment or removal of restraints from Pt#1. 2. The policy titled “MH Restraints for Non-Violent Behaviors (revised 7/2024)” was reviewed and indicated, “Policy: ....3. Safe use of restraints will be achieved by: ...D. The following will be evaluated and documented every 2 hours or more often based upon the individual needs of the patient: i. Restraint intact ii. Need continues iii. Restraint removed & reapplied iv. Circulation, sensation, motion check v. Skin integrity intact vi. Food/fluids vii. Toileted viii. Range of motion ix. Turned / repositioned x. Comfort & Privacy measures 3. An interview was conducted with the Nurse Manager of 6E Cardiac Unit (E#7) on 5/20/2026 at 12:15 PM. E#7 was asked about the documentation regarding non-violent restraints and checks not being completed every 2 hours per policy and not documented being removed and verbally agreed that they were not completed per policy and should have been.”

“PATIENT RIGHTS CFR(s): 482.13 A hospital must protect and promote each patient’s rights. This Condition is not met as evidenced by: 50645 Based on document review and interview it was determined that the hospital failed to comply with the Condition of Participation 42 CFR 482.13, Patient Rights. Findings include: 1. The hospital failed to ensure patients met criteria for an admission to a locked psychiatric unit. (See A-145A) 2. The Hospital failed to ensure the patient had the required consents necessary for continued treatment during hospitalization, which should have included: consents for inpatient psychiatric unit admission, consents for forced medication administration, and consent/petition for emergent ECT (electroconvulsant therapy). 3. The Hospital failed to ensure that medications used as a restriction to manage the patient’s behavior were not administered unnecessarily, and were given with appropriate clinical justification, to ensure the safety of the patient.”

“PATIENT RIGHTS: FREE FROM ABUSE/HARASSMENT CFR(s): 482.13(c)(3) The patient has the right to be free from all forms of abuse or harassment. This Standard is not met as evidenced by: 50645 A. Based on document review and interview, it was determined that 2 of 12 (Pt #1 and Pt #12) clinical records reviewed, the hospital failed to ensure patients met criteria for an admission to a locked psychiatric unit. Findings include: 1. The policy titled “Scope of Service and Admitting Guidelines” (revised 12/2023) was reviewed and indicated, “ ...Admitting Criteria: i. Patients must be diagnosed with a primary psychiatric disorder and be at least 18 years of age. ii. Patients must be able to participate in the social aspects of the milieu or, at a minimum, not demonstrate behaviors that disrupt the milieu experience for the remaining patients...B. The unit does not have appropriate programmatic and/or medical services to meet the following patient needs ...iii. Patients who have behavioral issues primarily related to their development/intellectual disabilities/diagnoses, or those who have limited cognitive functioning that restricts them from engaging in psychotherapeutic treatment ...iv. Interdisciplinary treatment plans are developed and reviewed/revised at regularly scheduled team meetings, or as necessitated by changing patient needs ... B. Treatment modalities include medication management, psychiatric nursing care, psychotherapy (individual, group, and family), psychoeducation, activity therapy, and/or ECT (electroconvulsive therapy) ...” 2. Census log for psychiatric unit 5A and 5G were reviewed. Pt #12 was admitted to the inpatient psychiatric unit on 09/12/25. The log indicated Pt #12’s primary diagnosis was “Major Small and Large Bowel Procedures.” Pt #12’s record lacked documentation of a primary psychiatric diagnosis. 3. The clinical record of Pt #1 was reviewed on 9/22/25 at approximately 1:30 PM. Pt #1’s clinical record dated 9/5/25, written by an Internal Medicine physician, stated, “Impression/Plan: 27-year-old with history of remote TB (tuberculosis) status post treatment... who presented to hospital ED on 6/18 following a MVA (motor vehicle accident) without acute injuries but was found to have AMS (altered mental status) and episodes of unresponsiveness/staring spells alternating with agitation. Hospital course complicated by incidental right frontal lobe calcified mass with associated encephalomalacia and right mesial temporal sclerosis on neuroimaging, right frontotemporal epileptogenicity (recurring seizure activity) on EEG 7/18, suspected hypokinetic catatonia requiring ECT (started 7/7, completed on 8/8). Severe protein-calorie malnutrition (due to refusal to eat), and Klebsiella aerogenes (bacteria) UTI (urinary tract infection) completed cefepime (antibiotics) x 5 days 7/5/25). (Pt #1) has made multiple attempts to elope throughout hospital stay.... Dx (diagnoses) Hypokinetic catatonia, Right frontal lobe calcified mass with encephalomalacia, unclear etiology, Right mesial temporal sclerosis, Right frontotemporal seizures, and unreactive right pupil 5mm, sluggish left pupil 4mm (stable) ... (Pt #1) transferred to 5A due to elopement risk. IM (Internal Medicine) will remain primary ....” Pt #1’s record lacked documentation of a primary psychiatric diagnosis. Pt #1’s does not contain any documentation of participation of the milieu. 4. An interview was conducted on 9/24/25 at 3:30 PM with the Psych RN manager (E #17). E #17 stated, “(Pt #1) was admitted to the unit for elopement precautions. (Pt #1) is a medical patient rather that a psychiatric patient. Three or four people expressed concerns about (Pt #1) being placed on a psychiatric unit as a medical patient. Given the unusual nature of the situation, administration has been actively consulting with legal to navigate the situation. These discussions are still in progress.” B. Based on document review and interview, it was determined that for 1 of 4 (Pt #1) inpatient psychiatric unit patients, the Hospital failed to ensure the patient had the required consents necessary for continued treatment during hospitalization, which should have included: consents for inpatient psychiatric unit admission, consents for forced medication administration, and consent/petition for emergent ECT. 1. On 09/24/25 the policy titled, “Admission Procedure 5A/G (Revised April 2024, Reviewed April 2025)” was reviewed. The scope of the policy was identified as “Department of Psychiatry” and indicated, “1. Admission to 5A/G. A. Priority of Admission: iv. Transfers from medical units that have been general status for a minimum of 24 hours. B. ...The charge nurse will determine if the referral meets the criteria for admission to 5AG. If the referral meets admission criteria to the unit, the psychiatrist will then determine if the individual requires admission. If they require admission, the psychiatrist will order the type of admission designated as administrative. D ...No patient may be admitted or brought to the unit without the necessary and properly completed mental health forms ... 1. Admission Process .... E. Staff will read patient his/her rights according to the Mental Health Code, provide him/her with a copy of the rights and a copy of his/her petition, if involuntary.” 2. On 9/24/2025, the Hospital’s policy titled “Administration of Psychotropic Medication and Electroconvulsive Therapy (ECT) (Reviewed September 2023)” was reviewed. The scope of the policy was identified as “Department of Psychiatry” and required “2. Informed Consent. Except as otherwise allowed under this policy and the Illinois Mental Health and Developmental Disabilities Code, psychotropic medications and/or ECT may only be administered to patients who voluntarily sign a consent form after an explanation of the treatment has been provided by the physician ... 3. Right to Refusal. The patient, or, if applicable, a patient’s guardian or substitute decision maker, must be informed of and given the right to refuse generally accepted mental health or developmental disability services, including, but not limited to, psychotropic medication or ECT. If such services are refused, they shall not be given unless: A. Such services are necessary to prevent the patient from causing serious and imminent physical harm to the patient or others, and, B. No less restrictive alternative is available... 4. Administration of Psychotropic Medication and/or ECT Due to Serious and Imminent Harm. A. If the administration of psychotropic medication and/or ECT are necessary to prevent the patient from causing serious and imminent physical harm to the patient or others, and no less restrictive alternative is available, psychotropic medication or ECT may be administered for up to twenty-four (24) hours on a ‘PRN’ basis. The circumstances leading up to the need for emergency treatment must be set forth in writing in the patient’s electronic health record. 5. Administration of Psychotropic Medication and ECT upon Application to a Court. Psychotropic Medication and ECT may be administered to a patient without the informed consent of the patient under the following standards: A. Any person 18 years of age or older, including any guardian, may petition the court for an order authorizing the administration of psychotropic medication and ECT to a patient.” 3. The clinical record for Pt #1 was reviewed throughout the survey. Pt. #1 was admitted to the Intermediate Care Unit on 6/19/2025, transferred to the general Medical floor on 6/26/2025, and transferred to the Inpatient Psychiatric unit on 9/5/2025, with diagnoses of: hypercatatonia (catatonia is a state of altered behaviors and consciousness); secondary to medical diagnosis (condition resulting from another medical condition); Right frontal lobe calcified mass with encephalomalacia (softening and degeneration of brain tissue) of unclear etiology (cause or origin of a condition); Right mesial temporal sclerosis (scarring in the deep part of the temporal lobe of the brain, affecting memory and emotions); Right frontotemporal seizures (focal seizures that start in the frontal lobes of the brain, an area responsible for voluntary movement, speech, and personality); and Anisocoria (Uneven pupil sizes, which can indicate an underlying life-threatening condition). - A Psychiatric MD Note dated 7/6/25 written at 10:54 AM stated, “... Psych Plan: Involuntary psychiatric admission ... May be difficult to place due to still requiring IV Ativan and Lacosamide despite being medically cleared. Medically cleared for ECT and inpatient admission, will proceed with emergent ECT. Petition for forced ECT to be filed ...” - Pt #1’s record included an order for ECT, and the Electroconvulsive Therapy Record from 7/7/25, written at 9:43 AM, indicated, “Catatonia with failure to thrive ...Minimal eye contact. Poverty speech. Flat affect. ... (Pt #1) has not been eating with failure to thrive resulting in today’s emergency ECT...” Pt #1 received the first electroconvulsive therapy (ECT) treatment on 7/7/2025. Following the initial session, additional ECT treatments were ordered and administered on 7/11, 7/16, 7/18, 7/23, 7/25, 7/28, 7/30, 8/1, 8/4, and 8/6. For each ECT treatment administered to Pt #1, a treatment order is placed on the same day the procedure occurs. - A Psychiatry MD Progress Note dated 9/10/25 written at 4:52 PM stated, “...Was weighed on 8/2 and was 67.3kg, and today, 9/10 (Pt #1) is 65.2 kg. Note admit weight was 78.5 kilograms. Labs showing hypernatremia (high sodium level) and elevated CPK (muscle enzymes), showing catatonia is causing electrolyte derangements, and placing him at risk for rhabdomyolysis (breakdown of muscle tissue) ... given the severe malnutrition, electrolyte derangements, minimal improvement on IV Benzodiazepines, minimal dietary intake, (Pt #1) is at risk for further deterioration from a medical perspective...Catatonia is a life-threatening condition. Emergent ECT is indicated... Plan: State guardianship of (Pt #1) is pending as family cannot be reached. Emergency ECT to start Friday. Continue lorazepam 2 milligrams IV(intravenously) QID (four times a day). (Pt #1) cannot refuse it as it is medically indicated for catatonia, and (Pt #1) is not decisional. PRNs for non-directable agitation. Haldol 10 milligrams IM Q 8 hours and Benadryl 50 milligrams IM Q 6 hours...” ECT Treatments were completed on 9/12, 9/15, 9/17, 9/19, and 9/22. Pt #1’s record lacked Involuntary Psychiatric Admission documents (Certificate and/or petition) and did not include a petition for forced ECT. Pt #1’s chart also lacked restriction of rights, and consent/court order for forced medications or ECT consent. 4. On 9/24/2025 an interview was conducted with Psychiatry Unit Nurse Supervisor (E #8) and Psychiatry Unit Nurse Manager (E #17) E #17, stated, “medications are not considered chemical restraints, as they are used to treat the diagnoses.” E #8 stated, “This Hospital doesn’t use chemical restraints.” 5. On 9/26/2025 at approximately 1:50 PM, an interview was conducted with the Patient Safety Manager (E # 7). E #7 noted there was no psychotropic medication policy for the general inpatient medical population. Additionally, E #7 stated “there is no policy on Restriction of Rights, other than what’s in the Mental Health Code.” 6. On 9/26/2025 at approximately 2:16 PM, an interview was conducted with Psychiatric Unit Nursing Supervisor (E #8) and System Director of Quality (E #18) E #8 stated, “We would provide them with the Rights of Individuals Receiving Mental Health Treatment, and Notice Requiring Restriction of Rights of the Individual.” E #18 reviewed Pt #1’s record and stated, “They would not have been completed, because he wasn’t a psychiatric patient.””

“PATIENT RIGHTS: RESTRAINT OR SECLUSION CFR(s): 482.13(e)(1)(i)(B) [A restraint is-] (B) A drug or medication when it is used as a restriction to manage the patient’s behavior or restrict the patient’s freedom of movement and is not a standard treatment or dosage for the patient’s condition. This Standard is not met as evidenced by: 50645 Based on document review and interview, it was determined that for 1 of 4 (Pt #1) clinical records reviewed for chemical restraints, the Hospital failed to ensure that medications used as a restriction to manage the patient’s behavior were not administered unnecessarily, and were given with appropriate clinical justification, to ensure the safety of the patient. Findings include: 1.The Hospital’s policy titled, “Restraint and/or Seclusion for Violent Behaviors” (revised 3/2025), stated, “ ...Definitions: Restraints ...2. A drug or medication, when used as a restriction to manage the patient’s behavior or restrict the patient’s freedom of movement and is not a standard treatment or dosage for the patient’s condition. 3. The use of force to medicate a violent patient is considered a restraint for violent behavior. If the patient requests to be held still for an injection or procedure, it is not considered a restraint.” 2.The clinical record for Pt #1 was reviewed on 9/23/25. Pt #1 was admitted to a Behavioral Health Unit on 9/5/25 with a primary medical diagnosis of “Hypokinetic catatonia, right frontal lobe calcified mass with encephalomalacia, unclear etiology, right mesial temporal sclerosis, and right frontotemporal seizures.” Pt #1’s medication orders included “PRN” (as needed) orders for haloperidol (Haldol - anti-psychotic medication affecting mental processes and behaviors). “Haldol IM (intramuscular) injection, 10 mg (milligrams) every 8 hours, PRN for agitation,” with a start date of 6/19/2025, 1:55 PM, with no stop date indicated. “Haldol IM injection, 10 mg ONE TIME, STAT,” dated 7/9/2025 at 10:37 AM, with no indication for administration provided. “Haldol IM injection, 5 mg ONE TIME,” dated 9/9/2025 at 2:00 PM, with no indication for administration provided. “Diphenhydramine (Benadryl) 50 mg, IM, every 6 hours, PRN for agitation” was also ordered on 7/9/2025 at 10:18 AM with no stop date indicated. This medication is given due to its sedative properties with calming effect on the central nervous system, as well as in conjunction with Haldol to help control extrapyramidal system symptoms, including muscle spasms, rigidity, tremors, and jerky, involuntary movements. - Pt #1’s eMAR (Electronic Medication Administration Record) was reviewed and included: Haldol 5 mg IM given on 7/3/2025 at 12:37 AM and Haldol 10 mg IM given with Benadryl 50 mg IM was given on: - 7/9/2025 at 10:42 AM - 8/2/2025 at 2:32 AM - 8/3/2025 at 7:43 AM - 8/20/2025 at 11:26 AM - 8/22/2025 at 5:46 PM - 9/8/2025 at 9:38 AM - 9/11/2025 at 1:00 PM - 9/12/2025 at 9:47 AM - Pt #1’s chart lacked consent for forced medication and Pt #1’s. The clinical record lacked documentation of behaviors exhibited or less-restrictive measures attempted before administration of the IM Haldol injections. 3. On 9/24/2025 an interview was conducted with Psychiatry Unit Nurse Supervisor (E #8) and Psychiatry Unit Nurse Manager (E #17). E #17, stated, “medications are not considered chemical restraints, as they are used to treat the diagnoses.” E #8 stated, “This Hospital doesn’t use chemical restraints.””

“NURSING CARE PLAN CFR(s): 482.23(b)(4) The hospital must ensure that the nursing staff develops, and keeps current, a nursing care plan for each patient that reflects the patient’s goals and the nursing care to be provided to meet the patient’s needs. The nursing care plan may be part of an interdisciplinary care plan. This Standard is not met as evidenced by: 50771 Based on document review and interview, it was determined for 1 of 10 (Pt#1) patients, the Hospital failed to ensure post operative assessments/vital signs were conducted per policy. Findings include: 1. Pt #1’s medical record was reviewed throughout the survey. Pt #1 is a 45-year-old who presented to hospital on 4/17/25 at 11:26 AM for a planned prophylactic bilateral mastectomy with DIEP (Deep Inferior Epigastric Perforator) flap reconstruction, scheduled for a staged surgery on 4/17/25 and 4/18/25. Pt #1 is positive for BRCA2+ (breast cancer gene 2) indicating high risk for breast cancer. Pt #1 has a history of morbid obesity, obstructive sleep apnea, and acid reflux, bariatric surgery, and a hysterectomy. Vital sign order dated 4/17/25 at 5:31 PM written by the Plastic Surgery Resident stated, “ ...Vital signs every 4 hours for 24 hours, then twice daily.” Pt #1’s recordin included a “Vital Sign Flowsheet” dated 4/17/25 which indicated the following BP’s: -9:00 PM shows a low BP of 85/54 (normal BP range is 120/80) Pt #1’s record lacks assessment, communication, or intervention related to low BP. -10:00 PM - BP of 84/60. -11:00 PM - BP of 90/59. -12:00 AM - BP of 93/62. The next recorded vital signs were taken at 5:55 AM (5 hours and 55 minutes after the last recorded vital signs) and indicated a BP of 92/61. Pt #1’s record lacks assessment, communication, or intervention related to the low BPs. 2. The policy titled “Nursing Documentation” (dated July 2024) was reviewed on 7/9/2025. The policy noted “...5. Ongoing Assessments a. Ongoing assessments may be completed by the RN (Registered Nurse) or delegated to the LPN (Licensed Practical Nurse)...b. Patients will be assessed at least once per shift (minimum of twice in 24 hours)...f. Reassessments occur in a problem-focused manner, as the patient’s condition warrants, according to the plan of care, with a significant change in diagnosis...or response to previous care.” 3. A review of an update titled “Nursing Practice Update” dated January 26, 2022 to February 4, 2022 was reviewed on 7/8/2025. It stated “...Post-op/post- procedure general status patients (vital signs) are now Q1Hx4 (every 1 hour for 4 hours), Q4Hx20 hrs (every 4 hours for 20 hours), then BID (twice daily)...If VS (vital signs) frequency changes, how will it be communicated? VS frequency will always be based on provider orders and will be clearly stated in Powerchart (Electronic Medical Record)...” 4. During an interview on 7/9/2025 at approximately 3:30 PM, the Patient Safety Coordinator (E #5) reviewed Pt#1’s record and verbally agreed the record lacked the required assessments and vital signs per order and policy.”

“LABORATORY SERVICES CFR(s): 482.27 The hospital must maintain, or have available, adequate laboratory services to meet the needs of its patients. The hospital must ensure that all laboratory services provided to its patients are performed in a facility certified in accordance with Part 493 of this chapter. This Condition is not met as evidenced by: 45565 Based on document review and interview, it was determined that the Hospital failed to maintain adequate laboratory services to meet the needs of its patients. As a result, the Condition of Participation, 42 CFR 482.27 Laboratory Services was not in compliance. Findings include: 1. The Hospital failed to provide laboratory services in accordance with hospital policy, including appropriate labeling of specimens. Subsequently, resulting in Pt #1’s death. (A-582)”

“ADEQUACY OF LABORATORY SERVICES CFR(s): 482.27(a) The hospital must have laboratory services available, either directly or through a contractual agreement with a certified laboratory that meets the requirements of part 493 of this chapter. This Standard is not met as evidenced by: 45565 Based on document review and interview, it was determined for 1 of 1 (Pt # 1) laboratory sentinel event patient records and 4 of 20 (Pt # 11 -Pt #14) adverse events which could cause significant harm, the Hospital failed to provide laboratory services in accordance with hospital policy, including appropriate labeling of specimens. Subsequently, resulting in Pt #1’s death. Findings include: 1. The policy titled, “Specimen Collection Guidelines for Urine, Blood (Line Draw), and Blood Cultures” (revised August 2024) was reviewed. The policy noted, “Objective: To obtain specimen(s) using proper identification, collection, and labeling process that will ensure that patient care requirements are met. Policy: ... 2. Specimen labels are to be generated at the time a specimen is collected and labeling is to occur at the bedside .... 8. All specimens being submitted to the laboratory via the pneumatic tube system must be labeled properly, packaged in a clear biohazard bag, and protected by foam padding placed inside the pneumatic tube system carrier ....” 2. The Laboratory Adverse Event and the Laboratory Sentinel Event Logs were reviewed 3/1/2024 through 12/11/24. The logs included an event for Pt #1 on 3/21/2024 which stated, “Labeling issue.” The Sentinel Event Log indicated, “Final Harm: Unexpected Clinical Outcome.” 3. Pt #1’s record was reviewed throughout the survey Pt #1 arrived to the Emergency Department (ED) on 3/19/24 at 10:10 PM with a chief complaint of “sent here by oncologist for neutropenic fever temp at home 104.” The ED Physician noted, “History of Present Illness: 49-year-old with history of AML (Acute Myeloid Leukemia - cancer) on chemotherapy, PE (Pulmonary Embolism - blood clot in the lung) not on chemotherapy secondary to pancytopenia (low counts of all blood cells) and thrombocytopenia (low platelet count), diabetes 2, severe morbid obesity, here with fever, malaise and shortness of breath. Patient was discharged yesterday from the hospital after being admitted for neutropenic (low white blood cell count - white blood cells help to fight off infection) ... (Pt #1) came in today because (Pt #1) had a fever at home of 100.5, (Pt #1) felt very chilled and malaise. (Pt #1) is on antibiotics currently. (Pt #1) has not been able to take anticoagulation (blood thinners to reduce the risk of blood clot) due to severe thrombocytopenia but has a known pulmonary embolism which had initially improved on Eliquis (blood thinner) ...Lab results: ... Hemoglobin - 8.6 (normal count is 10-12), Hematocrit - 23% (36% -48%), Platelets - 27 (flagged as Critical - normal range 150-450) ... Reexamination/Reevaluation: Time: 3/20/24 2:12 AM - Assessment: Patient resting, still tachycardic (fast heart rate - greater than 100 beats per minute) after a Liter of fluids, CTA (Computed Tomography Angiography - test that checks for blood clot, bleeding, and tumors) showing evidence of possible pneumonia on the right side. Given (Pt #1) tachycardia, symptoms of dyspnea (difficulty breathing), current antibiotic regimen, will broaden coverage with cefepime (antibiotic) and vancomycin (antibiotic). Will admit the patient for clinical observation ... Plan: Condition: Stable ....” - The CTA completed on 3/20/24 at 12:56 AM indicated, “ ... Impression: 1. No evidence of pulmonary embolism... 3. Nodular structure in the right middle lobe. This could be infectious or inflammatory at this is new since 2/24/24. A follow-up exam in 3 months is recommended. - Pt #1 was admitted to the Hospital on 3/20/24 at 11:04 AM. -Pt #1’s History and Physical on 3/20/24 at 4:49 AM indicated, “Impression: SIRS (Systemic Inflammatory Response Syndrome), HAP (Hospital Acquired Pneumonia), Pancytopenia secondary to AML, AML on chemo ...” - Hospitalist MD progress note dated 3/20/24 at 6:07 AM noted, “ ... Plan: ... Platelet count has improved and is in the 20s now (referencing previous admission lab results). Transfuse as needed for platelet count less than 20 or symptoms. She was last transfused on 3/18/2024 ... - Infectious Disease Consult Note on 3/20/24 at 2:50 PM noted, “Reason for consult: Antimicrobial management ... Assessment: fever in an immunosuppressed host, this patient has hematological malignancy in the form of AML, and (Pt #1) is on chemotherapy. (Pt #1) was previously pancytopenic and on G-CSF (granulocyte-colony stimulating factor - growth factor that increases WBCs), is not currently neutropenic, thrombocytopenic, diabetes with hyperglycemia, new pulmonary nodule, not present on CT (computed tomography) imaging from 2/24... Plan: ... In light of new lung nodule seen on CT chest, would recommend biopsy for diagnostic purposes ... however (Pt #1) also has refractory thrombocytopenia which complicates any possible diagnostic biopsy ...” -Complete Blood Count (includes hemoglobin, hematocrit, and platelet counts) was drawn on 3/21/24 at 5:49 AM. The platelet count results indicated Pt #1’s count was 173 (within normal ranges - no treatment had been provided to increase the platelets from the critical level of 27). - MD progress note 3/21/24 6:13 AM noted, “ ... Plan: ... ID (Infectious Disease) consulted. Discussed (ID MD) yesterday and again today ... Will get a biopsy / aspirate of (Pt #1’s) new right middle lobe lung nodule as (Pt #1’s) platelet counts have now normalized .... Platelet count has improved and is now 170s. (Pt #1) was last transfused on 3/18/24 .... Addendum: Saw (Pt #1’s) for recurrent episodes of hypotension (low blood pressure) after lung bx (biopsy). CT showed new hemothorax (blood in lung cavity) but no active extravasation (leaking of blood from vessels) per my discussion with IR (Interventional Radiology). Consulted ICU (Intensive Care Unit). Patient evaluated with (IR), (ICU intensivist), and RR (Rapid Response) team ...” - A CT guided lung biopsy was completed in IR on 3/21/24 at 1:12 PM. The procedure noted included, “The patient complained of chest discomfort immediately after the procedure. The patient also experienced a brief change in mental status with lightheadedness and diaphoresis (sweating). Immediate postprocedural imaging demonstrates no intracranial (inside the head/brain) findings. CT chest demonstrates a new moderate right hemothorax without evidence for active bleeding .... Patient’s vital signs remained stable with a return to baseline at the status. The patient is an inpatient and has been returned to the floor. ... Impression: CT guided right middle lobe lung nodule complicated by moderate right hemothorax ...” - Rapid Response Team was called at 3:26 PM to the CT Scanner due to an “acute change in LOC (Level of consciousness).” Pt #1 was then transferred to IMC (Immediate Care Unit). -Rapid Response Team was again called at 3:39 PM due to “Patient exhibiting another unresponsive episode when transferring from bed to bed. BP (blood pressure) dropped to 83/55 with HR (heart rate) 85 ... ICU consulted and accepted... Disposition: Transfer to ICU ...” - “SIU ICU Code Note” at 9:41 PM noted, “(Pt #1) was recently diagnosed with AML s/p (status post) induction chemotherapy. (Pt #1) was admitted on 3/20/24 due to concerns for sepsis, after recently being discharged on the 18th for neutropenic fever of unknown etiology. A new lung nodule was noted, therefore underwent CT guided Bx (biopsy) today. This was followed by symptoms of chest pain, hypotension, in addition to a 3 g (gram) Hb (hemoglobin) drop. Repeat CT showed right sided hemothorax, upgraded to the ICU for closer monitoring. At 7:42 PM, Code was called due to PEA (pulseless electrical activity) arrest. It seems that the patient developed bradycardia, apneic episodes prior to the code ... After a few rounds of CPR(cardiopulmanary resuscitation), eventually achieving ROSC (return of spontaneous circulation) at 7:58 PM, sinus tach (tachycardia) on the monitor. At 8:01 PM another code was called for asystole (no heart activity)/PEA following multiple rounds of CPR with similar rhythms without achieving ROSC, eventually expiring at around 8:55 PM after discussing poor prognosis with family. Labs showed declining Hb despite multiple PRBC (packed red blood cells) .... Potential etiologies of the PEA arrest including hemorrhagic shock ....” - “Report of Postmortem Examination” dated 3/26/24 noted, “ ... Opinion: the proximal cause of death is attributed to the right hemothorax with resulting mass effect on the right lung and mediastinum, originating from the recent biopsy site of the lung. Contributing to (Pt #1’s) death is acute myeloid leukemia.” 4. The “Summary of Root Causes and Recommended Improvement Plan” for Pt #1’s event was reviewed. It included, “Root Cause: Mislabeled Specimen. Corrective Actions: Remediation with individual and huddles with all phlebotomy staff to review process. QI (Quarter 1) review of Bridge Specimen Collection Process (identification of additional process gaps) and create check list for phlebotomy. Root Cause - Platelet Delta Flag (computerized alert for abnormal labs - whether high, low, or a significant change from the last results) - Not acknowledged/addressed by lab technologist. Corrective Action: Remediation with individual technologist involved. Reviewed procedure with all lab technicians. 5. An interview was conducted with the Director of Clinical Laboratory (E #2) on 12/11/24 at 10:45 AM. While reviewing Pt #1’s adverse event, E #2 stated, “This patient I remember very well. This labeling issue was a mislabel. This actually was mislabeled by one of our phlebotomists (E #6). An investigation of this event was done, and it was found that basically the phlebotomist went into this patient’s room and went through the process of scanning the patient’s arm band, printing out the labels, went to go attempt to draw. It was an oncology patient, so patient ended up being a line draw and the phlebotomist didn’t end up drawing the patient. (E #6) finished out and left that room, left the two labels that she printed on the zebra printer (portable lab label printer that phlebotomist carry to each room). The two labels were sticking up on the printer, (E #6) went to the next patient’s room which was next door and basically scanned that patient’s arm band and printed those labels, did draw that person’s blood but utilized those two labels that were first on the printer to label those specimens and basically then (Pt #1)’s labels were then put on that other patient’s blood. Those tubes were sent down for testing. The specimens came down went through processing and results then were filed. There was a platelet count issue on this patient where it was an oncology patient whose platelet count was very low. I don’t remember the exact number, but it was very low, and the platelet counts that got reported off that blood the phlebotomist drew was 174, so it was total opposite extreme of what that initial platelet was in the hematology department. Approximately about an hour later the nurse went in and drew samples and so then we got those.” While discussing the process of data entry related to the Pt #1, E #2 stated, “So there were two issues, there was the mislabel and then in the hematology department. We have deltas (computerized alert for abnormal labs) set up in our computer system on some of our analytes to detect things like abnormal platelets. A delta will flag if there’s a percent difference in the results. The machine does look at previous results. If there’s a difference in those previous results then based on our criteria that we have preset, then it will flag that delta. It did in this scenario because that patient’s platelet count was really low, I want to say in the critical range. It did delta the technologist and it reported out those results. The technologist missed that delta and reported out that result. When the Provider saw the result, they ended up determining the Pt’s labs had improved and ended up taking the patient to do a lung biopsy. The patient didn’t do well and had some issues going on and then ultimately ended up dying.” While discussing the investigation regarding Pt # 1, E #2 stated, “We did a root cause analysis on this. I started investigating. Once I got the information then I went back and saw that there were extra tubes that had been drawn by the nurse and went and reran those tubes the next day to see if those results matched that of (Pt #1) and to make sure they were truly (Pt #1’s) and they matched exactly of what the patient’s previous results were originally. Those results then got error corrected. An error correction process is where we go in and basically take out those results and put “see footnote” and then there’s an option for us to put a blurb in about what the situation was. I think I did those corrections.” 6. A review of Laboratory Labeling Issue adverse event report was reviewed. The log included 20 events from 3/25/24 through 11/1/24. The log included 5 “Near Miss,” 11 “No Harm” and 4 “Unsafe Condition.” The “Unsafe Condition” events included: -7/17/24 - Blood specimen from 7B (Maternity) that was mislabeled. -8/17/24 - Urine specimen labeled with the wrong patient label -10/4/24 - Blood was sent from room C205 (Surgical ICU) with the wrong label 3 times. The label that was used was a label left over from the previous patient that was in the same room. -10/13/24 - a bag of urine and a swab that were not labeled. 7. An interview with the Manager of Patient Safety and Accreditation (E #4) on 12/12/24 at 11:30 AM. E #4 reviewed the Laboratory Adverse Event log for “Labeling Issues.” E #4 stated, “The Harm level indicated ‘Unsafe Condition’ means that the harm didn’t reach the patient but has the potential for serious harm.” E #4 reviewed four events (7/17/24, 8/17/24, 104/24 and 10/13/24) that were noted as “Unsafe Conditions.” E #4 stated Manager of patient safety and accreditation states, “The unit manager is responsible for the investigation and determines what level of discipline is required. We do not investigate too deeply once it’s determined PSO (Patient Safety Organization).””