Centura Health-Penrose St Francis Health Services

“PATIENT RIGHTS CFR(s): 482.13 A hospital must protect and promote each patient’s rights. This Condition is not met as evidenced by: 50313 Based on the manner and degree of the standard level deficiencies referenced to the Condition, it was determined the Condition of Participation §482.13 Patient’s Rights, was out of compliance. A-0168 The use of restraint or seclusion must be in accordance with the order of a physician or other licensed practitioner who is responsible for the care of the patient and authorized to order restraint or seclusion by hospital policy in accordance with State law. Based on interviews and documents reviewed, the facility failed to ensure staff notified a patient’s provider and obtained a provider’s order after physical restraints were applied in one of two records reviewed for patients who were physically restrained in the emergency department (ED). Additionally, the facility failed to ensure patients were released from physical restraints in the timeframe specified by the providers’ orders. This failure was identified in two of two records reviewed for patients who were physically restrained in the ED. A-0178 When restraint or seclusion is used for the management of violent or self-destructive behavior that jeopardizes the immediate physical safety of the patient, a staff member, or others, the patient must be seen face-to-face within 1-hour after the initiation of the intervention (i) By a (A) Physician or other licensed practitioner; or (B) Registered nurse who has been trained in accordance with the requirements specified in paragraph (f) of this section. Based on interviews and documents reviewed, the facility failed to ensure patients were evaluated face-to-face by a physician or other licensed practitioner within one hour of restraint initiation according to facility policy. This failure was identified in two of two records reviewed for patients who were physically restrained in the ED.”

“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: 52761 Based on the manner and degree of the standard level deficiency referenced to the Condition, it was determined the Condition of Participation §482.23, was out of compliance. A-0395 A registered nurse must supervise and evaluate the nursing care for each patient. Based on interviews and document reviews, the facility failed to ensure nursing staff supervised and evaluated the nursing care for each patient. Specifically, the facility failed to ensure a patient was reassessed in a timely manner following the identification of abnormal vital signs. Additionally, the facility failed to ensure a patient’s pain was reassessed following the administration of pain medication according to facility policy. These failures were identified in one of four patients who presented to the emergency department (ED) for care. (Patient #11)”

“PATIENT RIGHTS: RESTRAINT OR SECLUSION CFR(s): 482.13(e)(5) §§482.13(e)(5) - The use of restraint or seclusion must be in accordance with the order of a physician or other licensed practitioner who is responsible for the care of the patient and authorized to order restraint or seclusion by hospital policy in accordance with State law. This Standard is not met as evidenced by: 50313 Based on interviews and documents reviewed, the facility failed to ensure staff notified a patient’s provider and obtained a provider’s order after physical restraints were applied in one of two records reviewed for patients who were physically restrained in the emergency department (ED). Additionally, the facility failed to ensure patients were released from physical restraints in the timeframe specified by the providers’ orders. This failure was identified in two of two records reviewed for patients who were physically restrained in the ED. Findings include: Facility policies: The Restraints policy read, use of restraint is limited to situations in which it is necessary to ensure the immediate physical safety of the patient, staff members, or others. Restraints are used only with appropriate and adequate clinical justification when less restrictive interventions are ineffective and the least restrictive means of restraint to ensure safety is applied. It is not used as a means of coercion, discipline, convenience, or staff retaliation. Discontinuation of restraint occurs as soon as possible, based on an individualized patient assessment and reevaluation, regardless of the scheduled expiration of the order. Ordering restraint is the responsibility of a physician, a clinical psychologist, or another licensed practitioner primarily responsible for the patient’s ongoing care orders and authorized to order restraints. Any application of restraint, for any amount of time, requires an order. In an emergency, if a physician/advanced practice provider (APP) is not available, a trained registered nurse (RN) may apply restraints. The physician/APP shall be notified as soon as possible after application of emergency restraints, as soon as the emergency situation has been resolved and documentation of actions taken is being initiated. Orders may be renewed according to the time limits below for a maximum of 24 consecutive hours: Four hours if ages 18 years of age and older; and two hours for ages 9-17 years of age. Restraint must be discontinued at earliest time possible, regardless of the length of time identified in the order. The Patient Bill of Rights policy read, patients have the right to be free from restraints or seclusion imposed as a means of coercion, discipline, convenience or retaliation by staff. 1. The facility failed to ensure staff notified a patient’s provider and obtained a provider’s order for physical restraint application according to facility policy. A. Document Review i. A review of Patient #5’s medical record revealed Patient #5 presented to the ED on 10/8/25 at 3:59 p.m. for a psychiatric evaluation. A nursing note from 10/10/25 at 9:28 p.m. revealed Patient #5 was being uncooperative, leaving their room, and attacking security. Staff placed Patient #5 in physical restraints on 10/10/25 at 9:28 p.m. There was no evidence staff notified Patient #5’s provider or obtained a provider’s order for the physical restraint application. This was in contrast with the Restraints policy which read, ordering restraint was the responsibility of a physician, a clinical psychologist, or another licensed practitioner primarily responsible for the patient’s ongoing care orders and authorized to order restraints. Any application of restraint, for any amount of time, required an order. The physician/APP should have been notified as soon as possible after application of emergency restraints. This was also in contrast with the Patient Bill of Rights policy which read, patients had the right to be free from restraints or seclusion imposed as a means of coercion, discipline, convenience or retaliation by staff. B. Interviews i. An interview was conducted on 1/14/26 at 9:53 a.m. with RN #4. RN #4 stated all patients who were placed in restraints should have had a provider’s order for restraints. RN #4 stated it was important not to restrain a patient’s freedom unless necessary and when ordered by the patient’s provider. RN #4 stated there was a risk to patient safety if staff physically restrained patients and did not notify their provider. ii. An interview was conducted on 1/14/26 at 11:07 a.m. with ED provider (Provider) #5. Provider #5 stated there should have been specific restraint orders from a provider in order to restrain a patient. Provider #5 stated provider orders included the type of restraint to be used and the timeframe for restraint application. Provider #5 stated it was concerning if staff had restrained a patient and not notified their provider or obtained a provider’s order for the restraint application, as restraining patients was an extreme measure with risks involved. These interviews were in contrast with the medical record review, which revealed staff placed Patient #5 in physical restraints and did not notify the provider or obtain a provider’s order for the restraint application. 2. The facility failed to ensure patients were released from physical restraints in the timeframe specified by the providers’ orders. a. A review of Patient #5’s medical record revealed Patient #5, a 17 year old, presented to the ED on 10/8/25 at 3:59 p.m. for a psychiatric evaluation. On 10/13/25 at 2:35 p.m., the ED care timeline revealed Patient #5 was placed in violent/self-destructive physical restraints for uncontrolled behaviors, which included banging on walls and doors, threatening to harm others, and threatening to harm themselves. At 3:06 p.m., a provider ordered violent/self-destructive physical restraints to be applied for a duration of two hours. Patient #5 was released from restraints at 5:29 p.m., 54 minutes after the two hour duration specified in the provider’s order. b. A review of Patient #6’s medical record revealed Patient #6, a 30 year old, presented the ED on 12/1/25 at 11:09 a.m. with a chief complaint of increased aggression. On 12/1/25 at 5:58 p.m., Patient #6 was placed in violent/self-destructive restraints for uncontrolled behaviors, which included screaming, attempting to escape, assaulting staff, and being dangerously impulsive. At 6:02 p.m., a provider ordered violent/self-destructive restraints for a duration of four hours. Patient #6 was released from restraints at 10:30 p.m., 32 minutes after the four hour duration specified in the provider’s order. These medical record reviews were in contrast with the Restraints policy which read, any application of restraint, for any amount of time, required an order. Orders should have been renewed according to the following time limits for a maximum of 24 consecutive hours: Four hours if ages 18 years of age and older; and two hours for ages 9-17 years of age. c. An interview was conducted on 1/14/26 at 9:53 a.m. with RN #4. RN #4 stated it was important to obtain and follow a provider’s order for restraint application when a patient’s freedom was being restrained. RN #4 stated if a patient were younger than 18 years old, the timeframe for restraint order duration was different than an order for an adult. RN #4 stated if a patient was not safe to release from restraints at the conclusion of the restraint order duration, an additional order from the provider was necessary. RN #4 stated staff were expected to discontinue the restraints or obtain a new order if the patient was not safe to release from restraints at the conclusion of the restraint order’s duration. This was in contrast with the medical record reviews for Patient #5 and Patient #6, which revealed they were in physical restraints past the duration specified in the provider’s order, without a new order being obtained.”

“PATIENT RIGHTS: RESTRAINT OR SECLUSION CFR(s): 482.13(e)(12) When restraint or seclusion is used for the management of violent or self-destructive behavior that jeopardizes the immediate physical safety of the patient, a staff member, or others, the patient must be seen face-to-face within 1-hour after the initiation of the intervention -- o By a-- - Physician or other licensed practitioner; or - Registered nurse who has been trained in accordance with the requirements specified in paragraph (f) of this section. This Standard is not met as evidenced by: 50313 Based on interviews and documents reviewed, the facility failed to ensure patients were evaluated face-to-face by a physician or other licensed practitioner within one hour of restraint initiation according to facility policy. This failure was identified in two of two records reviewed for patients who were physically restrained in the emergency department (ED). Findings include: Facility policy: The Restraints policy read, use of restraint is limited to situations in which it is necessary to ensure the immediate physical safety of the patient, staff members, or others. Restraints are used only with appropriate and adequate clinical justification when less restrictive interventions are ineffective and the least restrictive means of restraint to ensure safety is applied. Face to face evaluation and documentation by the physician/advanced practice provider (APP) is required within one hour of restraint initiation. Evaluation includes an evaluation of the patient’s immediate situation, the patient’s reaction to the intervention, the patient’s medical and behavioral condition, and the need to continue or terminate the restraint. 1. The facility failed to ensure physically restrained patients were evaluated face-to-face by a physician or other licensed practitioner within one hour of restraint initiation according to facility policy. a. A review of Patient #5’s medical record revealed Patient #5 presented to the ED on 10/8/25 at 3:59 p.m. for a psychiatric evaluation. On 10/10/25, a nursing note revealed staff placed Patient #5 in physical restraints at 9:28 p.m. There was no evidence a physician or APP conducted a face-to-face evaluation of Patient #5 within one hour of restraint initiation. On 10/11/25 at 10:40 a.m., the ED care timeline revealed staff placed Patient #5 in violent/self destructive physical restraints. There was no evidence a physician or APP conducted a face-to-face evaluation of Patient #5 within one hour of restraint initiation. On 10/13/25, the ED care timeline revealed staff placed Patient #5 in violent/self-destructive physical restraints at 2:35 p.m. There was no evidence a physician or APP conducted a face-to-face evaluation of Patient #5 within one hour of restraint initiation. b. A review of Patient #6’s medical record revealed Patient #6 presented the ED on 12/1/25 at 11:09 a.m. with a chief complaint of increased aggression. On 12/1/25 at 5:58 p.m., staff placed Patient #6 in violent/self-destructive physical restraints. There was no evidence a physician or APP conducted a face-to-face evaluation of Patient #6 within one hour of restraint initiation. These medical record reviews were in contrast with the Restraints policy which read, face to face evaluation and documentation by the physician or APP was required within one hour of restraint initiation. Evaluation should have included an evaluation of the patient’s immediate situation, the patient’s reaction to the intervention, the patient’s medical and behavioral condition, and the need to continue or terminate the restraint. c. An interview was conducted on 1/14/26 at 11:07 a.m. with ED provider (Provider) #5. Provider #5 stated a face-to-face evaluation by a provider was required each time staff initiated restraints for a patient. Provider #5 stated the face-to-face evaluation should have included the decision to restrain the patient and an assessment of the patient’s condition. Provider #5 stated it was important for a provider to conduct the face-to-face evaluation within an hour of restraint initiation to determine what caused the escalation leading to the need for restraint. Provider #5 stated a patient requiring restraints might have been experiencing a change in condition. Provider #5 stated it was important to determine if intoxication, or a psychiatric or medical condition, was causing the patient’s agitation.”

“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: 52761 Based on interviews and document reviews, the facility failed to ensure nursing staff supervised and evaluated the nursing care for each patient. Specifically, the facility failed to ensure a patient was reassessed in a timely manner following the identification of abnormal vital signs. Additionally, the facility failed to ensure a patient’s pain was reassessed following the administration of pain medication according to facility policy. These failures were identified in one of four patients who presented to the emergency department (ED) for care. (Patient #11) Findings include: Facility policies: The Assessment, Reassessment, Vital Signs, and Documentation of Patient Care policy read, the purpose is to outline the standards of care for assessment, reassessment, vital signs and procedures to document and maintain an accurate record of patients’ assessments, progress, treatments, medications, and condition within the electronic health record (EHR). Reassessment of the hospitalized patient is a continuous, ongoing process based on department specific assessment parameters, and in response to changes in diagnosis, treatments, procedures, and the plan of care. Patients with an Emergency Severity Index (ESI) (algorithm used to assess patient acuity) of 3 (urgent) shall have vital sign assessments performed at least every two hours, and one hour prior to transfer from the unit. Patient condition and ongoing changes in status warrant more frequent reassessment and documentation of specific system changes. The Emergency Department Nursing Standards of Practice read, the emergency registered nurse (RN) performs and/or oversees the collection of pertinent data and information relative to the patient’s health. Data shall be obtained by observation, physical exam and review of the patient record. Priority of data collection is determined by the patient’s immediate health care needs. The ED RN analyzes assessment data to determine actual or potential diagnosis, problems and issues in a manner that facilitates the development of the expected outcomes and collaborative plan. All patients in the ED shall be reassessed as warranted by ESI and presentation. Reassessment includes a complete set of vital signs and pain assessment. Vital sign assessments shall include temperature, blood pressure, heart rate, respiratory rate, and oxygen saturation. Provision of pain control includes an initial assessment of the patient’s pain level and reassessment of pain control following intervention. The ED RN shall document pain relief interventions, assessments, and responses to treatment. Pain reassessment shall be performed within two hours after medication interventions and as needed. References: According to Elsevier, Skills: Pain Assessment and Management, 2025, the nursing process offers a systematic method of pain management that results in improved pain relief for most patients. Pain shall be assessed before and after intervention. A focused assessment is a detailed nursing assessment relating to the presenting problem or current concerns of the patient. A focused assessment shall take place if the patient’s physiologic status warrants a change in level of care. The information from the focused assessment gives baseline data to confirm maintenance of hemodynamic stability (the body maintains adequate blood pressure and blood flow to tissues) or changes in the patient’s status. Abnormal findings merit further nursing assessment and intervention, and the focus of the clinical assessment may be modified based on findings. Additionally, abnormal findings shall be reported to the physician in a timely manner. 1. The facility failed to ensure a patient was reassessed in a timely manner following the identification of abnormal vital signs. A. Document Review i. Review of Patient #11’s medical record revealed Patient #11 presented to the facility on 1/2/26 for left-sided pain with concern for kidney stones. During the triage assessment at 4:24 p.m., Patient #11 reported their pain as 7/10 (severe) and was assigned an ESI of 3 (urgent). At 4:30 p.m., Patient #11’s blood pressure (BP) was 179/103 (normal 120/80), heart rate (HR) was 100 (normal 60-100), and blood oxygen saturation (measures the percentage of oxygen in blood) (SpO2) was 96% (normal greater than 90%). Subsequently, Patient #11’s BP was 197/98 at 5:00 p.m., 231/135 at 5:19 p.m, and 231/135 at 6:00 p.m. The medical record failed to reveal a reassessment of Patient #11’s vital signs until 7:00 p.m., at which point their BP was 228/129 and their HR was 190. A note from the ED charge RN revealed Patient #11’s SpO2 was less than 70% at that time. Patient #11’s vital signs were reassessed at 7:50 p.m., at which time their BP was 215/179, and then at 8:00 p.m., at which time their BP was 227/138. The medical record failed to reveal reassessment of Patient #11’s vital signs until 10:30 p.m., two hours and 30 minutes later, at which time their BP was 196/104. This was in contrast to the Assessment, Reassessment, Vital Signs, and Documentation of Patient Care policy, which revealed reassessment of the hospitalized patient was a continuous, ongoing process. Vital signs were assessed at least every two hours for patients with an ESI of 3, however changes in patient condition warranted more frequent reassessment. This was also in contrast to the Emergency Department Nursing Standards of Practice, which revealed the ED RN performed the collection of pertinent data and information relative to the patient’s health. Priority of data collection was determined by the patient’s immediate health care needs. Additionally, this was in contrast to Elsevier, Skills: Assessment: Focused, which revealed a focused assessment took place if the patient’s physiologic status warranted a change in level of care. Abnormal findings merited further nursing assessment and intervention, and the focus of the clinical assessment was modified based on findings. Patient #11 was admitted to an inpatient unit at 10:29 p.m. The medical record failed to reveal a reassessment of Patient #11’s vital signs prior to transfer. This was in contrast to the Assessment, Reassessment, Vital Signs, and Documentation of Patient Care policy, which revealed vital signs were assessed within one hour prior to transfer from ED. Patient #11 received 0.2 mg of clonidine (medication used to treat high blood pressure) at 11:27 p.m., approximately seven hours after they had presented to the ED with an elevated BP. ii. Review of a patient safety event, filed on 1/5/26, revealed Patient #11’s abnormal vital signs were discovered during a bed board meeting (meeting between charge nurses, clinical leadership, and staffing coordinators to discuss patient flow and determine appropriate bed placement for patients who have admission or transfer orders) on 1/2/26 at 7:40 p.m. During this meeting, a charge RN from a different unit notified the ED charge RN of Patient #11’s abnormal vital signs (BP 228/129 and HR 190 at 7:00 p.m.). Review of a note by the ED charge RN at 7:40 p.m. revealed Patient #11’s SpO2 had maintained less than 70% for a prolonged period of time, however, review of Patient #11’s medical record failed to reveal evidence of SpO2 assessment from 5:19 p.m. until 7:00 p.m., and from 7:00 p.m. until 7:40 p.m. Additionally, the medical record failed to reveal evidence the primary RN identified concerns with Patient #11’s assessment findings prior to notification from the charge RN. This was in contrast to the Emergency Department Nursing Standards of Practice, which revealed the ED RN analyzed assessment data to determine actual or potential diagnosis, problems, and issues in a manner that facilitated the development of the expected outcomes and collaborative plan. All patients in the ED were reassessed as warranted by presentation. Reassessment included a complete set of vital signs. Vital sign assessments included temperature, blood pressure, heart rate, respiratory rate, and oxygen saturation. The medical record revealed the physician was notified of Patient #11’s abnormal vital signs at 7:40 p.m., 40 minutes after assessment. The medical record failed to reveal evidence the physician was notified of Patient #11’s abnormal vital signs following assessments conducted at 4:30 p.m., 5:00 p.m., 5:19 p.m., and 6:00 p.m. This was in contrast to Elsevier, Skills: Assessment: Focused, which revealed abnormal findings should have been reported to the physician in a timely manner. B. Interviews i. Between 1/12/26 and 1/14/26, interviews were conducted with facility staff. a. In an interview conducted with charge RN #1, RN #1 stated a systolic BP (the first number in a BP reading; represents force of blood being pushed against artery walls when the heart beats) greater than 200 would be considered abnormal. Additionally, RN #1 stated vital signs were assessed at least every 15 minutes for patients with abnormal vital signs. This was in contrast to review of Patient #11’s medical record, which revealed a 40 minute gap between vital sign assessments following a BP of 231/135 at 5:19 p.m., a one hour gap following a BP of 231/135 at 6:00 p.m., a 40 minute gap following a BP of 228/129 at 7:00 p.m., and a two hour and 30 minute gap following a BP of 227/138 at 8:00 p.m. Furthermore, RN #1 explained it was important to frequently reassess abnormal vital signs to determine whether interventions were required to stabilize the patient. RN #1 stated risks of not treating hypertension (high BP) included stroke and death. b. In an interview conducted with RN #2, RN #2 stated a BP of 179/103 would be considered abnormal. Additionally, RN #2 stated abnormal vital signs should have been reported to the physician immediately to ensure the timely delivery of care. This was in contrast to review of Patient #11’s medical record, which failed to reveal provider notification of Patient #11’s abnormal vital signs at 4:30 p.m. until 7:40 p.m., three hours and 16 minutes later. Furthermore, RN #2 explained it was important for the physician to be made aware of abnormal BPs in a timely manner in case medications were required to stabilize the patient and prevent stroke and cardiac events (sudden problems with the heart’s function or blood flow, such as heart attacks, heart failure, or death). c. In an interview conducted with Physician #3, Physician #3 stated changes in patient condition should have been reported to the physician in a timely manner because additional diagnostic testing could be required to rule out emergency medical conditions (serious health issues requiring immediate care). Furthermore, Physician #3 explained a BP of 231/135 needed prompt evaluation because it could indicate the presence of life-threatening emergencies, such as stroke or aortic dissection (condition in which there is a tear in the wall of the major artery carrying blood out of the heart). This was in contrast to review of Patient #11’s medical record, which revealed Patient #11’s BP was 231/135 at 6:00 p.m., however failed to reveal provider notification of this alteration until 7:40 p.m., one hour and 40 minutes later. 2. The facility failed to ensure a patient’s pain was reassessed following the administration of pain medication according to facility policy. a. Review of Patient #11’s medical record revealed Patient #11 presented to the facility on 1/2/26 for left-sided pain with concern for kidney stones. During the nursing triage assessment at 4:24 p.m., Patient #11 reported their pain as 7/10 (severe). Patient #11 received 4 mg of morphine (narcotic pain medication) at 5:16 p.m., and 0.5 mg of dilaudid (narcotic pain medication) at 8:08 p.m. The medical record failed to reveal reassessment of Patient #11’s pain following the administration of morphine, before the administration of dilaudid, and following the administration of dilaudid. This was in contrast to the Emergency Department Nursing Standards of Practice, which revealed provision of pain control included an initial assessment of the patient’s pain level and reassessment of pain control following intervention. The ED RN documented pain relief interventions, assessments, and responses to treatment. Pain reassessment was performed within two hours after medication interventions and as needed. This was also in contrast to Elsevier, Skills: Pain Assessment and Management, which revealed the nursing process offered a systematic method of pain management that resulted in improved pain relief. Pain was to be assessed before and after intervention. b. Between 1/12/26 and 1/14/26, an interview was conducted with charge RN #1. RN #1 stated pain was to be assessed before and after the administration of narcotic pain medication in order to determine whether the patient’s pain was appropriately treated. This was in contrast to review of Patient #11’s medical record, which failed to reveal reassessment of Patient #11’s pain following the administration of morphine, before the administration of dilaudid, and following the administration of dilaudid.”

“Condition of Participation: Pharmaceutical Se CFR(s): 482.25 §482.25 Condition of Participation: Pharmaceutical Services. The hospital must have pharmaceutical services that meet the needs of the patients. The institution must have a pharmacy directed by a registered pharmacist or a drug storage area under competent supervision. The medical staff is responsible for developing policies and procedures that minimize drug errors. This function may be delegated to the hospital’s organized pharmaceutical service. This Condition is not met as evidenced by: 49541 Based on the manner and degree of the standard level deficiency referenced to the Condition, it was determined the Condition of Participation §482.25 Pharmaceutical Services, was out of compliance. A-0502 All drugs and biologicals must be kept in a secure area, and locked when appropriate. Based on observations, interviews, and document reviews, the facility failed to ensure medications in the emergency department (ED) were securely stored to prevent unauthorized access in one of one observation of the ED.”

“SECURE STORAGE CFR(s): 482.25(b)(2)(i) §482.25(b)(2)(i) - All drugs and biologicals must be kept in a secure area, and locked when appropriate. This Standard is not met as evidenced by: 49541 Based on observations, interviews, and document reviews, the facility failed to ensure medications in the emergency department (ED) were securely stored to prevent unauthorized access in one of one observation of the ED. Findings include: Facility policies: The Controlled Substances: Administration, Waste, Inventory, and Storage policy read, the purpose is to ensure strict accounting and appropriate record-keeping of all controlled drugs by hospital staff and providers in order to prevent theft and/or diversion, and compliance with all state and federal laws and regulations. All controlled medications will be secured and accounted for properly. Each department, along with pharmacy, is responsible for the security and accountability of all controlled drugs. Handling and accounting of controlled substances will be in compliance with the rules and regulations of the State of Colorado and the Drug Enforcement Administration (DEA). The Medication Security and Storage policy read, medications are stored in a manner consistent with applicable laws or regulations. All drugs throughout the hospital must be stored under proper conditions of sanitation, temperature, light, moisture, ventilation, segregation, and security, according to manufacturer specifications to ensure stability of the medication. All medications should be safely and securely stored between receipt and administration, return, or wasting. Actions must be taken to prevent unauthorized individuals from obtaining medications. References: The Fentanyl Citrate Injection Hikma Pharmaceuticals instructions for use (IFU) read, fentanyl citrate injection contains fentanyl, a schedule II controlled drug substance. Fentanyl citrate injection exposes users to risks of addiction, abuse, and misuse, which can lead to overdose and death. Fentanyl citrate injection, like other opioids, can be diverted for nonmedical use into illicit channels of distribution. Opioids are sought for nonmedical use and are subject to diversion from legitimate prescribed use. Consider these risks when handling fentanyl citrate injection. Strategies to reduce these risks include proper product storage and control practices for a schedule (C)-II drug. Serious, life-threatening, or fatal respiratory depression has been reported with the use of opioids, even when used as recommended. Misuse and abuse of fentanyl citrate injection increases risk of overdose, which may lead to central nervous system and respiratory depression, hypotension, seizures, and death. 1. The facility failed to ensure medications in the ED were securely stored to prevent unauthorized access. A. Observations i. On 11/17/25 at 1:22 p.m., observations were conducted throughout the ED. Observations revealed an unlocked supply cart located in the hall outside of room #3. Further observations revealed the unlocked cart contained needles, syringes, and intravenous (IV) fluids. Further observations throughout the ED revealed an additional six unsecured supply carts in patient care areas which contained medications. ii. On 11/17/25 at 1:39 p.m., observations were conducted in ED trauma bay #20. Observations revealed an unsecured fentanyl citrate 2,500 mcg per 50 mL glass infusion bottle hung from an IV pole. Further observations revealed visitors were in the room, and staff were not present at the bedside during the observation. iii. On 11/20/25 at 9:37 a.m., observations were conducted in the intensive care unit (ICU). Observations in room 2009 revealed a clear plastic locked box securely mounted to an IV pole which contained a fentanyl citrate 2,500 mcg per 50 mL glass infusion bottle. During the observation, registered nurse (RN) #1 stated fentanyl was a controlled substance and needed to be secured at all times. RN #1 stated it was the facility’s policy to keep all continuous IV controlled substances in a locked box at the bedside to prevent diversion. RN #1 stated if a controlled medication was diverted and administered without proper monitoring, it could have caused respiratory depression and possibly cardiac arrest. This was in contrast to the observations in the ED, which revealed an unsecured fentanyl citrate 2,500 mcg per 50 mL glass infusion bottle hung from an IV pole. Observations on 11/17/25 were in contrast to the Controlled Substances: Administration, Waste, Inventory, and Storage policy which read, all controlled medications should have been secured and accounted for properly. Each department, along with pharmacy, was responsible for the security and accountability of all controlled drugs. Observations on 11/17/25 were also in contrast to the Medication Security and Storage policy which read, all drugs throughout the hospital must be stored under proper conditions of sanitation, temperature, light, moisture, ventilation, segregation, and security, according to manufacturer specifications, to ensure stability of the medication. All medications should have been safely and securely stored between receipt and administration, return, or wasting. Actions should have been taken to prevent unauthorized individuals from obtaining medications. Additionally, observations on 11/17/25 were in contrast to the fentanyl citrate IFU which read, fentanyl citrate injection contained fentanyl, a schedule II controlled drug substance and could be diverted for nonmedical use into illicit channels of distribution. Opioids were sought for nonmedical use and were subject to diversion from legitimate prescribed use. The facility should have considered these risks when handling fentanyl citrate injection and identified strategies to reduce these risks, which included the proper product storage and control practices for a C-II drug. B. Interviews i. On 11/20/25 at 10:21 a.m., an interview was conducted with RN #2. RN #2 stated supply carts in the ED should have been locked at all times for the safety of the patients and visitors. RN #2 stated the supply carts contained needles, syringes, IV fluids, and other medical supplies. RN #2 stated it was not common practice to secure continuous IV controlled medications at the bedside. This was in contrast to the Controlled Substances: Administration, Waste, Inventory, and Storage policy which read, all controlled medications should be secured and accounted for properly. Each department, along with pharmacy, was responsible for the security and accountability of all controlled drugs. This was also in contrast to the Medication Security and Storage policy which read, all medications should have been safely and securely stored between receipt and administration, return, or wasting. Actions should have been taken to prevent unauthorized individuals from obtaining medications. RN #2 stated when a patient was on continuous IV controlled medication, the staff should have been at the bedside or kept the medication within sight. RN #2 stated leaving controlled medications unattended or unsecured created a diversion risk and could have resulted in a patient, visitor, or staff member taking the drug and overdosing, potentially causing death. ii. On 11/20/25 at 11:39 a.m., an interview was conducted with nursing manager (Manager) #4. Manager #4 stated nursing staff were expected to maintain the chain of custody of narcotic medications. Manager #4 stated the nurse should not have left a controlled substance at the bedside unattended. Manager #4 stated the facility treated many patients with substance abuse, and this issue was common within the facility’s patient population. Manager #6 stated all medications had to be secured, and if patients had access to medications, they were at risk of taking the medications, potentially resulting in an adverse reaction, which could result in overdose or death. iii. On 11/20/25 at 10:59 a.m., an interview was conducted with clinical pharmacist (Pharmacist) #3. Pharmacist #3 stated controlled substances required secure storage at all times and linked safety concerns to the high concentration of fentanyl, noting lockboxes and portless tubing mitigated diversion risk. Pharmacist #3 explained staff were required to maintain control of medications across storage, dispensing, and administration. Pharmacist #3 stated unsecured fentanyl drips with ported tubing (injection ports) failed to meet the “controlled at all times” standard. Pharmacist #3 stated pharmacy oversight focused on Pyxis (automated medication dispensing system) and the narcotic vault and once medications reached the bedside, security became the responsibility of the clinical unit. Pharmacist #3 stated diversion detection after Pyxis removal relied on discrepancies such as mismatched counts, and diversion from unsecured vials and tubing with ports was difficult to track. Pharmacist #3 stated breaks in custody when controlled drugs remained unsecured at the bedside increased diversion risk. Pharmacist #3 stated there was a risk of diversion, as patients could sell or take narcotic medications, which could result in overdose and death. The interviews on 11/20/25 were in contrast to the observations on 11/17/25, which revealed unsecured medications throughout the ED.”

“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: 47959 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. A0392 - 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. Based on observations, interviews, and document review, the facility Based on observations, interviews, and document review, the facility failed to ensure minimum staffing requirements were maintained to allow adequate numbers of licensed registered nurses to provide nursing care to all patients as needed, in accordance with the facility’s nurse staffing plan and in accordance with Code of Colorado Regulations (CCR) 1011-1 Chapter Four regulations. A0395 - A registered nurse must supervise and evaluate the nursing care for each patient. Based on observations, interviews, and document review the facility Based on observations, interviews, and document review, the facility failed to ensure patients were continuously monitored in accordance with facility policy in order to meet physician ordered pulse oximetry (pulse ox, a medical device used to measure the saturation of oxygen carried in red blood cells) ranges ordered to identify a change in a patient’s condition in one of two patient care units observed.”

“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: 47959 Based on observations, interviews, and document review, the facility failed to ensure minimum staffing requirements were maintained to allow adequate numbers of licensed registered nurses to provide nursing care to all patients as needed, in accordance with the facility’s nurse staffing plan and in accordance with Code of Colorado Regulations (CCR) 1011-1 Chapter Four regulations. Additionally, the facility failed to have an established process to reduce nurse-to-patient assignments to align with patient acuity demands in accordance with Code of Colorado Regulations (CCR) 1011-1 Chapter Four regulations. Findings include: Facility policies: The Staffing Guideline policy read, variations to the staffing plan may be needed for emergent circumstances or may be appropriate based on the actual acuity on the unit at any given time. The charge nurse should use the staffing plan for guidance and adjust based on clinical judgment of acuity. The nurse in charge should consider patient acuity, staff experience, staff competency, and individualized patient needs when making patient assignments. Whenever the nursing clinical staff are made aware of emergent staffing concerns and complaints, they have the ability to escalate these complaints and concerns up through leadership. The Surge and Capacity Management policy read, the emergency department (ED) will evaluate and stabilize all patients presenting to the ED. Subsequent transfer will be arranged if unable to provide appropriate services. If the required hospital resources are not readily available, the patient will be transferred to an appropriate trauma center, specialty care center, or other appropriate facility. References: According to the Standards for Hospitals and Health Facilities Chapter 4 - General Hospitals 6 CCR 1011-1 Chapter 4, Part 14.7 Nurse Staffing Plans, (A) Master Nurse Staffing Plan, (1) The nurse staffing committee shall annually develop and oversee a master nurse staffing plan for the hospital that: (c) Includes minimum staffing requirements for each inpatient unit and emergency department that are aligned with nationally recognized standards and guidelines; (e) Includes guidance and a process for reducing nurse-to-patient assignments to align with the demand based on patient acuity; (f) Is voted on and recommended by at least sixty (60) percent of the nurse staffing committee (B)(5) The nurse staffing committee shall: (6) Make the hospital’s complaint and feedback process available to all providers, including clinical staff nurses, nurse aides, and EMS providers, and include information on the Department’s complaint reporting process. The Master Staffing Plan read, the staffing plans are built for specific patient types and average unit acuity with unit type with consideration of patient flow, patient turnover, and acuity. The facility has detailed unit staffing plans that guide appropriate staffing for each census level. The unit staffing plan provides clear guidance to the number of caregivers needed at each patient census level. The staffing plans, which were identified by staff as the facility’s staffing grids, were provided by Facility A (separately licensed facility certified under Facility B) and Facility B. The staffing plans listed the name of each unit at the facility, specified the variable patient census range for each unit, and the specified number of registered nurses (RN) and certified nursing assistants (CNA) expected to be staffed and present on each unit according to the current patient census. The staffing plans specified the nurse-to-patient ratios according to the patient census and amount of nurses required. The staffing plans read, the unit charge nurse would make adjustments as needed based on clinical judgment of acuity. 1. The facility failed to ensure minimum staffing requirements were maintained in accordance with the facility’s staffing plan to allow adequate numbers of licensed registered nurses (RNs) to provide nursing care to all patients as needed. A. Observations i. Observations were conducted in the intensive care unit (ICU) of Facility A on 3/3/25. Observations revealed the ICU unit had a census of 13 patients. Staffing for the unit included the unit manager with no patient assignment and five staff nurses. Observations revealed one RN’s assignment included four patients who had a downgraded status (not ICU level patients), three RNs had two ICU level patients, and one RN had three ICU level patients (a triple assignment). ii. Observations were conducted in the ICU of Facility B (a separately licensed facility certified under Facility A) on 3/4/25. Observations revealed the ICU had a census of 32 patients. Staffing for the unit included one charge nurse without a patient assignment, one resource nurse (a nurse without a patient assignment and used as extra help on the unit), one CNA, and 13 RNs. Observations revealed seven RNs had triple assignments. Additionally, the ICU had three additional patient admissions expected for the day shift (a post-operative open heart surgery patient, a stroke patient transfer from an internal system hospital, and an intubated [a tube inserted into the windpipe to keep the airway open and assist with breathing] ED patient). iii. Observations were conducted in the ICU of Facility A on 3/5/25. Observations revealed the ICU had a census of 10 patients. Staffing for the unit included one charge nurse without a patient assignment, two RNs with two ICU level patients, and two RNs with triple assignments. These observations were in contrast to the unit staffing grids for the ICU which indicated the nurse-to-patient ratio for the ICU was 1:2 (one RN to two patients). Additionally, these observations were in contrast to the staffing plans which specified the nurse-to-patient ratios according to the patient census and amount of nurses required. The staffing plans read, the unit charge nurse would make adjustments as needed based on clinical judgement of acuity. B. Document review i. A document review of Facility A’s daily staffing assignments for the ICU unit from 1/1/25 through 3/4/25 was conducted. The staffing assignments revealed the day shift RNs had triple assignments on 1/4/25, 1/5/25, 1/9/25, 2/10/25, 2/14/25, 2/15/25, 2/16/25, 2/17/25, 2/18/25, 2/22/25, 2/24/25, 2/25/25, and 3/3/25. Additionally, document review revealed the nightshift RNs had triple assignments on 1/4/25, 1/5/25, 1/7/25, 1/12/25,1/19/25, 1/23/25, 1/25/25, 1/29/25, 2/5/25, 2/6/25, 2/8/25, 2/9/25, 2/14/25, 2/15/25, 2/17/25, 2/18/25, 2/23/25, 2/24/25, 3/1/25, and 3/3/25. All shifts listed above had at least one triple assignment and as many as four triple assignments for the shift. ii. A document review of Facility B’s daily staffing assignments for the ICU unit from 1/1/25 through 3/4/25 was conducted. The staffing assignments revealed the day shift RNs had triple assignments on 1/8/25, 1/9/25, 1/10/25, 1/27/25, 2/6/25, 2/7/25, 2/9/25, 2/15/25, 2/20/25, 2/21/25, 2/22/25. 2/26/25, and 3/4/25. Additionally, document review revealed the nightshift RNs had triple assignments on 1/5/25, 1/6/25, 1/9/25, 1/11/25, 1/13/25, 1/14/25, 1/17/25, 1/18/25, 1/19/25, 1/25/25, 1/26/25, 1/27/25, 2/2/25, 2/3/25, 2/5/25, 2/6/25, 2/11/25, 2/12/25, 2/15/25, 2/19/25, 2/20/25,2/23/25, 2/24/25, 2/25/25, 2/28/25, 3/1/25, 3/3/25, and 3/4/25. All shifts listed above had at least one triple assignment and as many as seven triple assignments for the shift. iii. A document review of the Divert and Pause Logs for both Facility A and B revealed the facility inconsistently utilized the divert (when a hospital ED is temporarily closed to ambulance traffic) or admission pause protocol for surge and capacity management and instead, while RNs cared for triples in the ICU, the units also admitted additional patients for care. Additionally, document review of the daily assignment sheets revealed staff inconsistently escalated their staffing concerns. When nursing staff escalated their concerns for staffing shortages, the charge nurses documented no resolution or leadership denied divert for the staffing concerns. Furthermore, the document review of the daily assignment sheets revealed the units continued to admit patients to the units, despite the number of intubated patients (patients who required breathing tubes) and patients on vasopressors (medication used to treat critically low blood pressures), even when admissions caused a triple assignment. This was in contrast to the Surge and Capacity Management policy which read, ED staff should have evaluated and stabilized patients in the ED and transferred to an appropriate facility when the facility did not have the required resources to care for the patients. Additionally, this was in contrast to the staffing guidelines policy which read, whenever staff made the clinical nursing staff aware of emergent staffing concerns and complaints, they escalated the complaints and concerns up through leadership. iv. A review of the facility’s previous deficiencies cited for failure to ensure minimum staffing requirements revealed the facility was cited on 1/11/24 and again on 3/20/24. C. Interviews i. Interviews were conducted with staff over the course of the survey between 3/3/25 and 3/12/25. RN #1 stated triple assignments in the ICU happened regularly and had increased in frequency over the past few months. RN #1 stated they did not feel safe with some of the assignments because they could not complete all tasks and had a difficult time managing all patient care necessary for an ICU level patient. RN #1 stated when they felt unsafe, they escalated concerns to the charge nurse, however, the assignments did not change due to lack of staffing. RN #1 stated short staffing affected patient outcomes such as when patients self-extubated (pulled out their breathing tube) or when RNs had medication errors during the care of their patients. ii. An interview was conducted with RN #2. RN #2 stated they had concerns with the frequency of triple assignments in the ICU and the lack of interventions by leadership. RN #2 stated they had access to the unit staffing grid, however, leadership focused on accepting patients in order to stay off of divert. RN #2 stated when leadership placed the ICU on divert, it did not always help because divert only applied to patients who needed intubation or vasopressors. RN #2 stated they still admitted patients with other diagnoses who needed ICU level care and these admissions resulted in triple assignments. RN #2 stated triple assignments put patients at risk for harm. RN #2 stated ICU patients’ conditions changed rapidly and adverse events, such as a deteriorated condition or self-extubation, could occur if the patients were not monitored closely. iii. An interview was conducted with RN #3. RN #3 stated they had triple assignments several times while they worked as a new graduate nurse. RN #3 stated their assignment included three ICU level patients and one of those patients needed to be intubated due to a deteriorated condition. RN #3 stated they were also assigned a new admission on another shift, but received no support because the other nurses had triple assignments as well. RN #3 stated they were not able to complete tasks for patients when they had a triple assignment, such as wound care, bathing, or skin care. iv. An interview was conducted with RN #4. RN #4 stated they had concerns about the lack of support new graduate nurses had when they had a triple assignment. RN #4 stated when RNs had triple assignments, the new graduate nurses missed things, such as a tourniquet left on a patient’s arm or that the RN did not fully know the patient’s condition. RN #4 stated they knew about the escalation process, however, the escalations did not result in a resolution for staffing concerns. v. An interview was conducted with RN #5. RN #5 stated charge nurses followed the unit matrix (staffing grid) when they made assignments. RN #5 stated the ICU matrix called for a 1:2 ratio and frequently, staff were assigned more than two patients because they did not have adequate numbers of staff. RN #5 stated the charge nurses would inform the house supervisor, staffing office, and unit manager to request more nurses. RN #5 stated frequently they did not get additional staff to prevent triple assignments. Additionally, RN #5 stated unsafe triple assignments resulted when the facility could not provide nurses that met the staffing matrix requirements. vi. On 3/11/25 at 12:42 p.m., an interview was conducted with ICU manager (Manager) #6. Manager #6 stated the ICU staffing goal was a 1:2 ratio of ICU level patients. Manager #6 stated the charge nurses considered the acuity of the patients in the RN assignments. Manager #6 stated they were hiring new staff that would accommodate the increased census and turnover on the unit, but in the meantime, they used staff from the float pool, the acuity tool, patient downgrades from ICU level status, and divert to keep the triple assignments to a minimum and to keep patients safe. Manager #6 stated they consulted with the chief nursing officer (CNO) when the staff had valid concerns and could not move patients to a lower level of care. Manager #6 stated they would go on divert if staff had valid concerns and patients could not relocate to another unit. Manager #6 stated the facility took divert very seriously and the decision to go on divert was made on a case-by-case basis. vii. An interview was conducted on 3/10/25 at 4:21 p.m. with CNO #7 and CNO #8. CNO #7 stated they did not consider the triple assignments in ICU to be true triples when the RN had one ICU level patient and two downgraded level patients. CNO #7 stated there was no policy or matrix adjustments that supported this practice. CNO #7 stated the staff escalated their concerns up the chain of command and leadership made the decision to pause admissions or to initiate intubation-vasopressor divert for ICU. CNO #8 stated it was not the decision of the facility to put the ED on divert to prevent triple assignments in the ICU. CNO #8 stated the local emergency medical services (EMS) made the decision to bring patients to the facility if the patient needed to be stabilized. CNO #8 further stated once at the facility, the patients were admitted to the ICU, and at times, this caused triple assignments. CNO #8 stated providers determined the level of acuity, such as ICU or downgraded level, and the facility used acuity levels in the master staffing plan to guide the charge nurses when they made assignments. These interviews were in contrast to the surge and capacity management policy which read, patients were evaluated and stabilized in the ED and transferred to an appropriate facility when the facility did not have the required resources to care for the patients. Additionally, the interviews were in contrast to the CCR 1011-1 Chapter Four, Part 14.7 Nurse Staffing Plans regulations which read, a master nurse staffing plan included guidance and a process to reduce nurse-to-patient assignments to align with the demand based on patient acuity. Additionally, the interviews were in contrast to the master staffing plan which read, the facility had detailed unit staffing plans that guided appropriate staffing for each census level. The unit staffing plan provided clear guidance to the number of caregivers needed at each patient census level.”

“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: 47959 Based on observations, interviews, and document review, the facility failed to ensure patients were continuously monitored in accordance with facility policy in order to meet physician ordered pulse oximetry (pulse ox) (a medical device used to measure the saturation of oxygen carried in red blood cells) ranges ordered to identify a change in a patient’s condition in one of two patient care units observed. Findings include: Facility policies: The Cardiac and Pulse Oximetry Monitoring policy read, communication from telemetry technician to nursing associates on the unit included changes in pulse oximetry outside of set parameters. Communication chain of command response to the alarm was the assigned certified nursing assistant (CNA), registered nurse (RN), house supervisor, or hospital specific rapid response team (a team that responds to a patient’s deteriorated condition) or code blue process (a team who provides advanced life care support in the event the patient’s heart stops beating). Appendix A to the Cardiac and Pulse Oximetry Monitoring policy read, a CNA could respond to a non-urgent alarm such as low battery, partial leads off, or poor quality pulse oximeter waveform. An RN responded to an urgent alarm, such as a pulse oximeter reading (SPO2) of less than 85%, a pause greater than three seconds, a ventricular tachycardia (a dangerous heart rhythm) of less than five seconds, a heart rate greater than 140 beats per minute or less than 40 beats per minute, or a change in the heart rhythm. An RN responded to an emergent alarm of a pulse oximeter reading of less than or equal to 80%, an SPO2 probe off or not reading, a lethal arrhythmia, a dead battery, or all leads off. The algorithm read for the technician to call the RN or charge nurse for emergent alarms. If the RN could check on the patient, the RN was to stay on the phone with the technician until the RN had direct eye contact with the patient. If the RN or charge nurse was unable to check the patient, the algorithm directed the technician to call a rapid response or code blue. The Assessment, Reassessment, Vital Signs, and Documentation of Patient Care policy read, reassessment of the hospitalized patient is a continuous, ongoing process based upon department specific assessment parameters as well as in response to changes in diagnosis, treatments, procedures, and the plan of care. Patient condition and ongoing changes in status warrant more frequent reassessment and documentation of specific system changes. Notes should be used to document any actions/observations that do not have an appropriate or corresponding documentation section. 1. The facility failed to ensure patients were continuously monitored in accordance with facility policy in order to meet physician ordered pulse oximetry ranges. A. Observations i. On 3/6/25 at 9:55 a.m., observations were conducted in the IMC unit. Observations revealed IMC manager (Manager) #9 and charge nurse (RN) #10 talking at the nursing station while a continuous alarm sounded for Patient #6. Further observation revealed RN #11 walked behind the nurses’ station, looked at the monitors, and briskly walked down the hall to room 701, Patient #6’s room. At 9:57 a.m., observations were conducted in room 701. Observations revealed Patient #6 was slouched in the bed, gray in color, and showed visible signs of respiratory distress. Patient #6 was noted to have labored breathing and was unable to speak in full sentences. Further observations revealed the patient had pulled their oxygen off, and their pulse oximetry was 83%. According to the document review of the pulse ox machine strips for this timeframe, Patient #6 had low oxygenation saturations from 9:49 a.m. through 9:58 a.m. This was in contrast to the Telemetry Monitoring Alarm Notification and Escalation Process policy, which instructed the telemetry technician to immediately notify the patient’s nurse or charge nurse if the patient’s pulse oximetry was less than 85%. The nurse was to stay on the phone with the telemetry tech until entering the patient ’ s room to confirm eyes on the patient. If the telemetry technician could not reach the nurse or charge nurse, the telemetry technician was then expected to call a rapid response or a code blue. B. Document review i. Medical record review for Patient #6 was conducted on 3/6/25. The medical record review revealed Patient #6 was an 85 year old who presented to the emergency department (ED) on 2/27/25 with abnormal lab values. Medical record review revealed Patient #6 had acute pneumonia (a lung infection) and respiratory failure and was admitted to the intermediate care (IMC) unit on 2/28/25. Medical record review revealed a provider order on 2/27/25 to titrate oxygen to keep saturation above 90%, which was changed on 3/1/25 to titrate oxygen to keep saturation above 86%. Review of Patient #6’s oxygenation documentation on 3/7/25 revealed at 9:01 a.m., the monitor alarms showed the pulse ox was off and the telemetry monitoring technician (Tech) notified the RN. The medical record showed no indication that the staff responded to the alarm. At 9:28 a.m., the medical record revealed Patient #6’s oxygen saturation was low at 85% and the Tech notified the RN. The medical record showed no indication that the staff responded to the alarm. At 9:55 a.m., the medical record revealed Patient #6’s oxygen saturation was low at 84% and the Tech notified the RN. The medical record showed no indication staff responded to the alarm, however, the documentation time corresponded to the observation of Patient #6 in room 701. This was in contrast to the Assessment, Reassessment, Vital Signs, and Documentation of Patient Care policy which read, staff should have continuously reassessed the patient in an ongoing process based on department specific assessment parameters, as well as in response to change in treatments and procedures. The policy instructed staff to use notes to document any actions/observations that did not have a corresponding documentation section. ii. A review of the pulse ox machine strips for Patient #6 revealed at 8:50 a.m., the pulse ox probe was off. At 8:51 a.m., Patient #6’s pulse ox was 83%. At 8:52 a.m., Patient #6’s pulse ox was 82%. The record review revealed no indication the Tech had notified any staff on the unit per facility policy, or that staff had responded to the low oxygen saturation levels. The review of the pulse ox machine strips also revealed at 8:55 a.m., Patient #6’s probe was off and remained off in documented one-minute increments until 9:11 a.m., for a total of 16 minutes. Patient #6’s medical record review revealed the Tech had notified the RN at 9:01 a.m. Further review of the pulse ox machine strips revealed Patient #6’s oxygen saturation dropped again at 9:41 a.m. to 84% and stayed below 87% until 9:47 a.m. with no indication the telemetry monitoring technician notified any staff on the unit per facility policy or that staff had responded to the low oxygen saturation levels. Additionally, the review revealed Patient #6’s oxygen saturation was 85% at 9:49 a.m. and remained low (81%-85%) until 10:02 a.m., 13 minutes later. The medical record review revealed the Tech notified staff at 9:55 a.m. and RN #11 documented Patient #6’s vital signs at 10:00 a.m. This was in contrast to the provider order placed on 3/1/25, which instructed staff to keep Patient #6’s oxygen saturation above 86%. This was also in contrast to the Telemetry Monitoring Alarm Notification and Escalation Process policy, which instructed the telemetry technician to immediately notify the patient’s nurse or charge nurse if the patient’s pulse oximetry was less than 85%. The nurse was to stay on the phone with the telemetry tech until entering the patient ’ s room to confirm eyes on the patient. If the telemetry technician could not reach the nurse or charge nurse, the telemetry technician was then expected to call a rapid response or a code blue. Additionally, this was in contrast to the Assessment, Reassessment, Vital Signs, and Documentation of Patient Care policy which read, staff should have continuously reassessed the patient in an ongoing process based on department specific assessment parameters, as well as in response to change in treatments and procedures. The policy instructed staff to use notes to document any actions/observations that did not have a corresponding documentation section. C. Interviews i. On 3/6/25 at 3:28 p.m., an interview was conducted with telemetry monitoring technician (RN) #13. RN #13 stated they documented the times staff were notified of low oxygen saturation levels in Patient #6’s medical record. RN #13 stated they had called RN #11 several times during the shift, but did not ask RN #11 to stay on the phone until they had eyes on the patient after the pulse ox probe came off as required by facility policy. RN #13 stated as long as the RN acknowledged the need to check the patient, the telemetry monitoring technicians did not remain on the phone. RN #13 stated they had an abundance of alarms that required calls to the staff, so they only ensured staff were notified. RN #13 stated staff should have checked on the patient when the pulse ox probe came off to ensure the patient had not deteriorated. ii. On 3/10/25 at 3:26 p.m., an interview was conducted with Manager #9. Manager #9 stated the telemetry monitoring unit monitored Patient #6 remotely and the pulse oximeter machine also showed on the monitor at the unit’s nurses’ station. Manager #9 stated once the RN received a call from the telemetry monitoring technician, the primary nurse was expected to check on the patient; if the primary nurse could not check the patient, then the charge nurse was expected to check on the patient. Manager #9 stated CNAs could check on patients when pulse ox probes came off. The CNAs escalated issues they did not know how to handle and escalated issues of patient distress to the RN. Manager #9 stated they reviewed Patient #6’s incident of desaturation and stated the CNA had checked on the patient because RN #11 and RN #10 could not check on the patient at the time the probe was off of Patient #6. iii. On 3/1/25 at 1:27 p.m., an interview was conducted with the cardiovascular and telemetry units manager (Manager) #14. Manager #14 stated the telemetry monitoring technicians called CNAs with green alarms such as a low battery, or if the patient had one telemetry lead off but had a visible heart rhythm. Manager #14 stated the telemetry monitoring technicians called RNs for yellow alarms such as vital signs which were outside of parameters. They called the unit charge nurse when RNs could not respond. Manager #14 stated the telemetry monitoring technician called RNs for red alarms, such as when pulse oximetry probes were off of the patient. They called rapid responses or code blues for lethal arrhythmias (a life-threatening irregular heartbeat) or when the RN did not respond or check on the patient. Manager #14 stated the telemetry monitoring technicians were expected to follow the escalation process. This was in contrast to the medical record review and review of the pulse ox machine strips which revealed the patient had a 16 minute episode in which the probe was off six minutes before the RN was notified and remained off an additional 10 minutes while the CNA changed the probe. Additionally, Manager #14 stated telemetry monitoring technicians did not stay on the phone with the staff when oxygen probes came off the patients. Manager #14 stated they would continue to the next call because they had constant alarms in the monitoring room. This was in contrast to the Telemetry Monitoring Alarm Notification and Escalation Process policy, which instructed the nurse to stay on the phone with the telemetry tech until entering the patient ’ s room to confirm eyes on the patient. If the telemetry technician could not reach the nurse or charge nurse, the telemetry technician was then expected to call a rapid response or a code blue. iv. On 3/10/25 at 4:21 p.m., an interview was conducted with CNO #8. CNO #8 stated they performed a full investigation of the Patient #6 incident of desaturation and learned CNA #12 went into Patient #6’s room after RN #11 called them to check on the patient. CNO #8 stated CNA #12 saw Patient #6 did not show signs of distress, so obtained a new pulse ox probe. CNO #8 stated this happened from 9:11 a.m. to 9:28 a.m., a total of 17 minutes.”

“GOVERNING BODY CFR(s): 482.12 There must be an effective governing body that is legally responsible for the conduct of the hospital. If a hospital does not have an organized governing body, the persons legally responsible for the conduct of the hospital must carry out the functions specified in this part that pertain to the governing body ... This Condition is not met as evidenced by: 42693 Based on the manner and degree of the standard level deficiency referenced to the Condition, it was determined the Condition of Participation §482.12 Governing Body, was out of compliance. A-0043: There must be an effective governing body that is legally responsible for the conduct of the hospital. If a hospital does not have an organized governing body, the persons legally responsible for the conduct of the hospital must carry out the functions specified in this part that pertain to the governing body. Based on observations, interviews, and document review, the governing body failed to ensure patient care services were provided in a safe manner and in accordance with professional standards of practice. Specifically, the governing body failed to provide oversight in the following areas: patient rights and nursing services. Findings include: Facility policy: The Staffing Guideline policy, originated on 4/24/14, read, the staffing coordinator will work collaboratively with nurse in charge prior to shift start and clinical manager/assistant nurse manager (ANM) to ensure unit/department is staffed to specific unit staffing plan. Under usual patient type and patient acuity, a -1/+1 to staffing plan is within acceptable staffing guidelines. The charge nurse should use the staffing plan for guidance and adjust based on clinical judgment of acuity. The policy was approved by the vice president of enterprise nursing excellence and the enterprise clinical policy coordinator on 1/23/23; however, there was no evidence showing the policy was approved by the facility’s nurse staffing committee. References: The facility’s Scope of Services read, Governance and Leadership: Leadership will be responsible for providing a framework for planning health care services provided by the organization based on the hospital’s mission statement and for developing and implementing an effective planning process that allows for defining timely and clear goals. The planning process includes a collaborative assessment of our customers and community health needs, defining a strategic plan, developing operational plans, establishing and operating budgets, and monitoring compliance. Establishing resource allocation and policies, and ongoing evaluation of the implementation and success of the plans. Leadership is responsible for establishing standards of care that all patients can expect, and which can be monitored through the hospital performance improvement and patient safety plan. The performance improvement and patient safety plan is approved by hospital leadership and the Board of Trustees and is designed to be able to prioritize areas for improvement and to adjust and re-prioritize in response to unexpected events. Additional responsibilities include: ensuring staffing and resources are available to appropriately meet the needs of the patients served and delivering care in a safe manner. The Board of Trustees has the responsibility for activities related to performance improvement, patient care and safety, credentialing of the medical staff, financial oversight, and all other activities related to the delivery of safe and effective care. The Chief Executive Officer (CEO) is responsible for operating the hospital according to the authority provided by the Board of Trustees (The Board). The CEO is responsible and accountable for the planning, organization, direction, coordination, and evaluation of the delivery of services at the facility. According to the Standards for Hospitals and Health Facilities Chapter 4 - General Hospitals 6 CCR 1011-1 Chapter 4, Part 14.7 Nurse Staffing Plans, (A) Master Nurse Staffing Plan, (1) The nurse staffing committee shall annually develop and oversee a master nurse staffing plan for the hospital that: (c) Includes minimum staffing requirements for each inpatient unit and emergency department that are aligned with nationally recognized standards and guidelines; (e) Includes guidance and a process for reducing nurse-to-patient assignments to align with the demand based on patient acuity; (f) Is voted on and recommended by at least sixty (60) percent of the nurse staffing committee. The staffing plans, which were identified by staff as the facility’s staffing grids, were provided by the facility. The staffing plans listed the name of each unit at the facility, specified the variable patient census range for each unit and the specified number of registered nurses (RN) and certified nursing assistants (CNA) expected to be staffed and present on each unit according to the current patient census. The staffing plans specified the nurse-to-patient ratios according to the patient census and amount of nurses required. The staffing plans read, the unit charge nurse would make adjustments as needed based on clinical judgment of acuity. 1. The Governing Body failed to ensure patients were provided care in a safe environment. A. A review of medical records from Facility A (separately licensed facility certified under Facility B) revealed a lack of monitoring of patients and notifying providers of changes in condition, resulting in an adverse patient outcome. (Cross-reference A-0286) For example: i. Medical record review revealed, on 12/14/23 at 11:42 a.m., Patient #2 was admitted to 6W (medical-surgical unit) with a diagnosis of sepsis (life-threatening response to an infection) and acute hypoxic respiratory failure (inadequate oxygen to the body). At 12:51 p.m., Patient #2’s provider placed an order which read, keep oxygen saturation (o2 sat) above 90 percent (%), and notify the provider if the patient experienced a change in oxygen flow rate of 4 liters per minute (lpm) or more in 6 hours, required high flow mask to maintain o2 sat level, and or the patient’s o2 sat was less than 90% on 6 lpm. According to the history and physical (H&P) notes entered by Physician #1 at 1:45 p.m., Physician #1 documented Patient #2 did not normally require oxygen supplementation, however, upon admission Patient #2 required 4 liters (L) of supplemental oxygen to be delivered by nasal cannula to maintain an o2 sat of 91%. i. A review of the Full Disclosure (the cardiac and pulse oximetry record) for Patient #2 revealed on 12/14/23 at 11:32 p.m. Patient #2’s o2 sat level was 64%. Five minutes later at 11:37 p.m., Patient #2’s o2 sat level was 38% and at 11:49 p.m. Patient #2’s o2 sat was 39%. There was no evidence RN #2 was notified Patient #2’s o2 sat had dropped below 90% between 11:37 p.m. to 11:49 p.m. Further review of the Full Disclosure revealed RN #2 was not notified Patient #2’s pulse ox probe was off and no o2 sat readings were recorded for one hour and 31 minutes, from 12:00 a.m. to 1:31 a.m. Upon review of the discharge summary note signed by Provider #1 on 12/15/23 at 7:50 a.m., a code blue (a code used to indicate a patient requiring resuscitation) was initiated for Patient #2 on 12/15/23 at approximately 1:35 a.m. According to the discharge summary note, the code blue was initiated after RN #2 had received a call from telemetry, entered Patient #2’s room, and identified Patient #2 was unresponsive, pulseless, and not breathing. Provider #1 documented life-saving interventions had been attempted however Patient #2 remained pulseless during the entire course of the code blue. The discharge summary note revealed Patient #2’s time of death was 1:54 a.m. on 12/15/23. There was no evidence of telemetry tech communications in Patient #2’s medical record from 12/14/23 at 10:18 p.m. through 12/15/23 at 1:30 a.m. and there was no evidence the telemetry tech had attempted to notify RN #2 or had escalated communication to the Charge RN regarding Patient #2’s o2 sat being below 90% and or Patient #2’s pulse ox probe had been off. This was in contrast to the Cardiac and Pulse Oximetry Monitoring Appendix A and the High-Risk Clinical Alarm Safety policy (see above) which stated telemetry techs would notify the primary RN or the inpatient unit Charge RN when the patient’s pulse ox levels were less than or equal to 80% and when pulse ox probes were off or not reading. In addition, alarm systems were intended to alert healthcare providers of potential problems and if not properly addressed and managed, could compromise the patient’s safety. B. Observations and document review revealed similar failures of a lack of continuous monitoring as identified in the review of Patient #2’s medical record. i. On 12/28/23 between 5:50 a.m. and 6:52 a.m., observations were conducted in the telemetry monitoring room. Observations revealed Patient #5’s o2 sat was not monitored as required per provider orders. During the observation, telemetry staff called the primary RN for Patient #5 at 6:10 a.m. and 6:18 a.m. and informed the primary RN that Patient #5’s o2 sat was not visible on the telemetry monitor screen and was not being monitored. At 6:21 a.m. Patient #5’s o2 sat level returned on the telemetry monitor screen. a. Review of Patient #5’s Full Disclosure revealed on 12/28/23 from 5:51 a.m. to 6:21 a.m. (30 minutes), Patient #5’s o2 sat level was not detected and monitored. The Telemetry Tech had not identified Patient #5’s o2 sat level was not visible on the monitor for 19 minutes before calling the patient’s nurse. C. Interviews revealed staff were aware of the continuing concerns regarding the monitoring of patients, however, additional measures had not been implemented to mitigate the concern. i. On 12/28/23 at 6:30 a.m., an interview was conducted with Telemetry Tech #5. Telemetry Tech #5 stated Telemetry techs were required to perform multiple activities while also continuously monitoring patients. Telemetry Tech #5 stated lapses in continuous monitoring could occur when telemetry techs were required to continuously monitor up to 60 patients. Telemetry tech #5 stated irregular heart rhythms, disconnection of the pulse ox cord, declining o2 sats, and even death could occur when telemetry techs were unable to continuously monitor patients. Telemetry Tech #5 stated on 12/27/23 they had monitored 54 patients at the same time. Telemetry Tech #5 also stated the number of patients monitored by the tech increased when they monitored their stations and another telemetry station during breaks and meals. ii. On 1/11/24 at 1:46 p.m., an interview was conducted with chief medical officer (CMO) #35. CMO #35 stated they were responsible for overseeing quality at both Facility A and B as well as oversight of the medical staff and care provided. CMO #35 further explained they had only been at the facility for a few weeks so could not speak to how the facility had been operating prior to his arrival. CMO #35 stated they would take any concerns to the Board to ensure they were aware of the concerns and what was being done to correct the concern. iii. On 1/11/24 at 1:04 p.m., an interview was conducted with chief executive officer (CEO) #30. CEO #30 stated they oversaw the operations at Facility A. CEO #30 stated the Board had responsibility for the quality of care provided at the facility. CEO #30 explained the Board was made aware of concerns at the facility and ensured staff had the resources they needed to provide care to patients. This was in contrast to a review of staffing schedules for Facility A which revealed the facility was consistently understaffed according to their nurse staffing plan. iv. On 1/11/24 at 11:42 a.m., an interview was conducted with CEO #31. CEO #31 stated they oversaw the operations at Facility B. CEO #31 explained if there was a safety concern, the CMO would notify them. They further explained the quality committee would also provide a report to the Board on serious safety events. Interviews were in contrast to the review of Board meeting for Facility A and Facility B on 11/2/23 which revealed the Board was aware of the lack of continuous monitoring concern when initially identified, however, there was no evidence of the Board’s action while the concerns continued to occur. 2. The Governing Body failed to ensure nursing services were provided according to facility policies and procedures and failed to ensure there was an adequate amount of nursing staff to provide safe patient care. A. A review of medical records and corresponding staff assignment sheets for Facility A revealed inadequate staffing based on the facility’s staffing plan. i. On 12/14/23 at 11:42 a.m., Patient #2 was admitted to 6W (medical-surgical unit) with a diagnosis of sepsis (life-threatening response to an infection) and acute hypoxic respiratory failure (inadequate oxygen to the body). At 12:51 p.m., Patient #2’s provider placed an order which read, keep oxygen saturation (o2 sat) above 90 percent (%), and notify the provider if the patient experienced a change in oxygen flow rate of 4 liters per minute (lpm) or more in 6 hours, required high flow mask to maintain o2 sat level, and or the patient’s o2 sat was less than 90% on 6 lpm. A review of the Full Disclosure (the cardiac and pulse oximetry record) for Patient #2 revealed on 12/14/23 at 11:32 p.m. Patient #2’s o2 sat level was 64%. Five minutes later at 11:37 p.m., Patient #2’s o2 sat level was 38% and at 11:49 p.m. Patient #2’s o2 sat was 39%. There was no evidence RN #2 was notified Patient #2’s o2 sat had dropped below 90% between 11:37 p.m. to 11:49 p.m. Further review of the Full Disclosure revealed RN #2 was not notified Patient #2’s pulse ox probe was off and no o2 sat readings were recorded for one hour and 31 minutes, from 12:00 a.m. to 1:31 a.m. Upon review of the discharge summary note signed by Provider #1 on 12/15/23 at 7:50 a.m., a code blue (a code used to indicate a patient requiring resuscitation) was initiated for Patient #2 on 12/15/23 at approximately 1:35 a.m. According to the discharge summary note, the code blue was initiated after RN #2 had received a call from telemetry, entered Patient #2’s room, and identified Patient #2 was unresponsive, pulseless, and not breathing. Provider #1 documented life-saving interventions had been attempted however Patient #2 remained pulseless during the entire course of the code blue. The discharge summary note revealed Patient #2’s time of death was 1:54 a.m. on 12/15/23. a. A review of 6W (medical-surgical unit) staffing assignments revealed, on 12/14/23, the 6W staffing did not meet the 6W staffing plan. The Plan read the ratio of nurse to patients based on the census at that time was to be 1 nurse for 4 patients. Further review revealed Registered nurse (RN) #2 who provided care to Patient #2, was assigned five patients at this time. ii. A review of four additional medical records and corresponding staff assignment sheets revealed similar findings for patients on 6W and other units throughout the facility (Patient #1, #9, #10, and #12). B. Interviews with staff from Facility A revealed the leadership and the governing board had not implemented actions to ensure the approved staffing plan was met in order to provide safe patient care. i. On 1/8/24 at 1:43 p.m., an interview was conducted with staffing committee RN #12. RN #12 stated -1/+1 referred to the ability to adjust nursing staff based on acuity. RN #12 stated when the units had high acuity, nurses could ask for extra personnel. RN #12 also stated when acuity changed during the shift, units did not receive extra nurses. ii. On 1/8/24 at 4:28 p.m., an interview was conducted with house supervisor (Supervisor) #9. Supervisor #9 stated they were not aware of the -1/+1 to staffing plan referenced in the Staffing Guideline policy. Supervisor #9 stated the staffing guidelines were created by staff in finance and were based on productivity. Supervisor #9 also stated the RN ratios were never met if the charge nurse did not take patients. Supervisor #9 stated it was expected for nurses on 6W to have six patients each and it was never a four-patient ratio on the night shift. Additionally, Supervisor #9 stated patients did not receive the attention and care they required when nurses had five or six patients each. Supervisor #9 stated nurses did not have time to fully assess their patients or to review the patients’ records which could result in changes being missed. iii. On 1/11/24 at 10:06 a.m., an interview was conducted with vice president of nursing operations (VP) #11. VP #11 stated the allotted number of nursing staff hours for each shift was determined by finance staff and depended on the patient demographic for the unit. VP #11 stated the unit staffing plans were based on the facility’s budget. VP #11 also stated the auditing process for the staffing plan effectiveness was based on how many times the units had enough nurses based on the units’ staffing plans and how often the units utilized the -1/+1 addition or subtraction referenced in the Staffing Guideline policy. iv. On 1/11/24 at 1:04 p.m., an interview was conducted with CEO #30. CEO #30 stated they oversaw the operations at Facility A. CEO #30 explained the Board was made aware of concerns at the facility and ensured staff had the resources they needed to provide care to patients. CEO #30 stated they looked at daily staffing reports to see the amount of staff that worked in comparison to the amount of patients that were on each unit. C. A review of staff assignment sheets for Facility B revealed inadequate staffing based on the facility’s staffing plan. i. A review of the Critical Care Unit’s (CCU)staff assignment sheets revealed numerous instances where CCU RNs were routinely assigned three patients. For example: a. On 11/19/23 seven nurses were assigned three patients each. b. On 11/26/23 twelve nurses were assigned three patients each. c. Additional shifts reviewed throughout the months of December and January revealed similar findings of nurses being assigned three patients each. These examples were in contrast to the CCU FY23 Staffing Plan which read, CCU nurses should be assigned to provide nursing care for one to two patients. ii. A review of the Renal/Diabetic Unit (5W) staff assignment sheets revealed RNs were assigned to care for patients on the 5W unit in addition to patients on other units who needed to receive continuous ambulatory peritoneal dialysis (CAPD). D. Interviews with staff from Facility B revealed the leadership and the governing board had not implemented actions to ensure the approved staffing plan was met in order to provide safe patient care. i. On 1/11/24 at 11:42 a.m., an interview was conducted with CEO #31. CEO #31 stated they oversaw the operations at Facility B. CEO #31 stated the facility tried to avoid ICU nurses having more than two patients assigned to care for, however, this could not always be avoided. Interviews with leadership and review of staff assignment sheets were in contrast to the Standards for Hospitals and Health Facilities Chapter 4 - General Hospitals 6 CCR 1011-1 Chapter 4, Part 14.7 Nurse Staffing Plans, (A) Master Nurse Staffing Plan, which read, the plan included guidance and a process for reducing nurse-to-patient assignments to align with the demand based on patient acuity. The facility failed to provide evidence the master staffing plan considered individual patient acuity as in accordance with Code of Colorado Regulations (CCR) 1011-1 Chapter Four regulations.”

“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: 42693 Based on the manner and degree of the standard level deficiency referenced to the Condition, it was determined the Condition of Participation §482.21 QAPI was out of compliance. A-0286: PATIENT SAFETY (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. Based on interviews and document reviews, the facility failed to ensure adverse patient safety events were reported, investigated, and analyzed to identify contributing factors and implement preventive actions to prevent recurrence. A-0315: (e)(4) PROVIDING ADEQUATE RESOURCES [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:] (4) That adequate resources are allocated for measuring, assessing, improving, and sustaining the hospital’s performance and reducing risk to patients. Based on interviews and document review, the facility failed to ensure adequate resources were allocated to operate a quality assurance and performance improvement (QAPI) program which analyzed underlying causes of adverse patient events and developed performance improvement plans to reduce risk to patients.”

“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: 44751 Based on interviews and document reviews, the facility failed to ensure adverse patient safety events were reported, investigated, and analyzed to identify contributing factors and implement preventive actions to prevent recurrence. (Cross-reference A-0043) Findings include: Facility policy: The Adverse Clinical Event Reporting, Analysis, Disclosure and Non-Payment policy requires a rapid response team for event investigations, initiated within 72 hours of event awareness and completed within 45 days. Reference: The Clinical Quality Assurance, Patient Safety, and Process Improvement Plan FY2024 (QAPI) mandates oversight responsibilities for ensuring quality care. 1. The facility failed to adhere to patient safety protocols, policy and practice, and ensure leadership’s oversight, to prevent further occurrences of patient safety events. A. Review of reporting and investigating adverse events revealed: i. Patient #13 Incident (9/27/23): Patient #13 was admitted at 2:17 a.m. for alcohol withdrawal. Provider #16 ordered continuous telemetry monitoring at 3:54 a.m. for 48 hours. RN #17 noted the absence of available telemetry boxes. At 11:28 a.m., the patient was found unresponsive and pulseless, leading to a code blue at 12:10 p.m. and subsequent death. The RCA, conducted on 11/30/23, failed to address the non-notification of Provider #16 regarding the unavailability of telemetry monitoring. ii. Patient #9 Incident (9/30/23): Admitted at 1:00 p.m. with pneumonia and other complications. Provider orders specified notification for specific oxygen saturation levels. Records from 10/5/23 showed Patient #9’s oxygen saturation dropped below the required threshold with no provider notification. Patient #9’s condition worsened, resulting in death on 10/6/23. No safety event report was filed. iii. Patient #1 Incident (11/28/23): Admitted at 1:59 p.m. with congestive heart failure. On 11/29/23, telemetry indicated ventricular tachycardia. The nurse failed to notify the provider of this critical change, leading to the patient’s cardiac arrest and subsequent death. iv. Patient #6 Incident (11/29/23): Admitted at 6:19 p.m. with general weakness and encephalopathy. An IV morphine order was placed, to be administered only if oral medication was not an option. RN #21 administered IV morphine without verifying the patient’s ability to take oral medication. The patient’s condition deteriorated, leading to cardiac arrest and death. B. Leadership interviews revealed a lack of compliance with facility policy and preventative action implementation: i. Interview with Interim Quality Director (1/10/24): The director admitted to not being involved in the review or investigation of adverse patient safety events since their appointment in September 2023. This lack of oversight contributed to the continued pattern of non-compliance. ii. Interview with Patient Safety Program Manager (1/10/24): The manager confirmed the absence of event reporting for Patients #1 and #9. They acknowledged that no interventions were implemented following the investigation into Patient #6’s event. They expressed concern that more thorough investigations could have prevented subsequent incidents, such as that of Patient #2 on 12/14/23. (Cross-reference A-0043)”

“PROVIDING ADEQUATE RESOURCES CFR(s): 482.21(e)(4) [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:] (4) That adequate resources are allocated for measuring, assessing, improving, and sustaining the hospital’s performance and reducing risk to patients. This Standard is not met as evidenced by: 42693 Based on interviews and document review, the facility failed to ensure adequate resources were allocated to operate a quality assurance and performance improvement (QAPI) program which analyzed underlying causes of adverse patient events and developed performance improvement plans to reduce risk to patients. (Cross-reference A-0043 and A-0286). Findings include: Facility references: The facility’s Community Board Bylaws read, the Board holds the facility’s CEO and leadership accountable for quality safety and patient experience scores. Additionally, the Board is to be aware of risks and hold leadership accountable for taking all reasonable steps to avoid patient harm. The Board will review the facility’s quality indicators and safety metrics and develop a plan to promote and report quality of patient care. The Clinical Quality Assurance, Patient Safety and Process Improvement Plan read, the services Community Board maintains the following QAPI oversight responsibilities: assuring adequate resources to support the plan; approving key indicators for measuring clinical quality, patient experience and patient safety; and reviewing and making recommendations on any other matter pertaining to the quality of care and patient safety. The facility’s Scope of Services read, Governance and Leadership: Leadership will be responsible for providing a framework for planning health care services provided by the organization based on the hospital’s mission statement and for developing and implementing an effective planning process that allows for defining timely and clear goals. The planning process includes a collaborative assessment of our customers and community health needs, defining a strategic plan, developing operational plans, establishing and operating budgets, and monitoring compliance. Establishing resource allocation and policies, and ongoing evaluation of the implementation and success of the plans. Leadership is responsible for establishing standards of care that all patients can expect, and which can be monitored through the hospital performance improvement and patient safety plan. The performance improvement and patient safety plan is approved by hospital leadership and the Board of Trustees and is designed to be able to prioritize areas for improvement and to adjust and re-prioritize in response to unexpected events. Additional responsibilities include: ensuring staffing and resources are available to appropriately meet the needs of the patients served and delivering care in a safe manner. The Board of Trustees has the responsibility for activities related to performance improvement, patient care, and safety, credentialing of the medical staff, financial oversight, and all other activities related to the delivery of safe and effective care. The chief executive officer (CEO) is responsible for operating the hospital according to the authority provided by the board of trustees (The Board). The CEO is responsible and accountable for the planning, organization, direction, coordination, and evaluation of the delivery of services at the facility. 1. The facility’s governing body failed to ensure the QAPI program had adequate resources to conduct its duties. a. Patient incidents/safety events were reviewed (Cross-reference A-0286). There was insufficient evidence to show that incidents/safety events were investigated to determine contributing factors and to prevent recurrent incidents/safety events. For example: i. Medical record review revealed on 9/27/23 at 2:17 a.m., Patient #13 was directly admitted to inpatient unit 6W (medical-surgical unit) for alcohol withdrawal. Patient #13’s medical record revealed at 11:28 a.m., approximately seven hours and three minutes after Patient #13 had been admitted to the facility, the patient was unresponsive and pulseless. The Discharge Summary signed by Provider #16 on 10/1/23 at 7:51 a.m. revealed a code blue (a code used to indicate a patient requiring resuscitation) was initiated on 9/27/23 at 12:10 p.m., and the patient subsequently died. On 11/30/23, over two months after the patient’s event occurred, the facility completed a root cause analysis (RCA) in response to Patient #13’s adverse safety event. However, the RCA revealed no evidence the facility addressed the lack of provider notification for changes in patient condition and provider orders not being followed as written. b. During a survey conducted from 12/26/23 to 1/11/24, continued non-compliance of patients not being continuously monitored and providers not being notified of changes in condition resulting in negative patient outcomes were identified between the date of Patient #13’s adverse event on 9/27/23 and when the RCA was completed on 11/30/23. (Cross-reference A-0043 and A-0263) c. Interviews with staff revealed there were not adequate resources and staff to complete incident investigations, analyze underlying causes, and develop corrective action plans or performance improvement activities. i. On 1/10/24 at 8:36 a.m., an interview was conducted with Patient Safety Program Manager (Manager) #22. Manager #22 stated another patient safety manager assisted in training her on how to investigate patient safety events. Manager #22 explained the facility did not have a succinct process to track and trend incident reports. They further explained a tracking sheet had been developed but was not implemented at the time of the interview. Manager #22 stated they felt they did not have adequate resources to investigate events and implement preventative measures. Manager #22 stated staff who investigated incident reports were not able to meet the expectations of the facility to investigate all patient events. Manager #22 explained the patient safety program requested additional resources from leadership to assist with investigating patient events, however, they were only provided additional education on the investigation process. Manager #22 stated there was a potential for a patient event to continue happening if uninvestigated, causing a potential risk of harm to patients. This was in contrast to the Clinical Quality Assurance, Patient Safety and Process Improvement Plan which read, the Board was responsible for assuring adequate resources to support the plan and reviewing and making recommendations on any other matter pertaining to the quality of care and patient safety.”

“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’S RIGHTS was out of compliance. A-0144 - 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 was provided in accordance with the provider’s orders, facility policies, and facility-adopted educational references in five of six telemetry patients’ medical records reviewed. (Patient #1, #3, #4, #5, and #6)”

“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: 42693 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-395 - A registered nurse must supervise and evaluate the nursing care for each patient. Based on interviews and document review, the facility failed to provide nursing services in accordance with facility protocol, policy, and national guidelines. Specifically, the facility failed to ensure registered nurses (RN) assessed detox patients on Clinical Institute Withdrawal Assessment (CIWA) protocols (clinical assessment used to diagnose the severity of alcohol withdrawal) in four of eight medical records reviewed (Patients #1, #11, #13, and #15). Additionally, nursing staff failed to assess patients after the administration of as needed (PRN) medications and scheduled medications in three of eight medical records reviewed (Patient #1, #11, and #15).”

“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: 46674 Based on the manner and degree of the standard level deficiency referenced to the Condition, it was determined the Condition of Participation: §485.640 Infection Prevention and Control and Antibiotic Stewardship Programs, was out of compliance. A-0750- The infection prevention and control program includes surveillance, prevention, and control of HAIs, including maintaining a clean and sanitary environment to avoid sources and transmission of infection, and addresses any infection control issues identified by public health authorities. Based on document reviews and interviews, the facility failed to ensure the infection prevention and control program investigated and implemented preventative measures to avoid sources and transmission of surgical site infections (SSI).”

“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 was provided in accordance with the provider’s orders, facility policies, and facility-adopted educational references in five of six telemetry patients’ medical records reviewed. (Patient #1, #3, #4, #5, and #6) Findings include: Facility policies: The Cardiac and Pulse Oximetry Monitoring read, purpose: to outline safe practices for adult patients requiring continuous cardiac (heart) monitoring, promote the safety of patients, and recommend the efficient utilization of resources. The procedure of initiation of cardiac monitoring: obtain an order for continuous cardiac monitoring from the licensed independent practitioner (LIP) and ensure that the order is in the electronic health record (EHR): ensure the availability of monitoring equipment prior to receiving the patient on the unit. Communication chain of command response to alarm: assigned nurse’s aide, RN, charge RN, house supervisor or hospital-specific Rapid Response Team or Code Blue process The Telemetry Monitoring Alarm Notification and Escalation Process policy read, in an emergent situation (e.g. pulse ox less than or equal to 80%, SPO2 probe off or not reading, lethal arrhythmias, telemetry box with a dead battery, or all of the telemetry leads off) the telemetry technician must immediately notify the patient’s nurse or charge nurse. The RN must immediately put eyes on the patient while on the phone with the telemetry technician. If the telemetry technician can not reach the nurse or charge nurse, the telemetry technician will follow the hospital-specific Response Team or Code Blue notification process. Reference: The Elsevier Procedures - Cardiac Monitor Setup and Lead Placement guideline provided by the facility read, continuous cardiac electrophysiologic monitoring is performed routinely for most acute and critically ill patients. A key component of such monitoring is the electrocardiogram (ECG), which provides a continuous graphic picture of electrical activity generated by the depolarization and repolarization of cardiac tissue. These images may be used for diagnostic, documentation, and treatment purposes. The basic goals of ECG monitoring are to monitor patients for rate or rhythm changes, myocardial ischemia (cardiac tissue death) and injury, and to monitor the QT or QTC interval (measurement of the electrical activity in the heart) in patients at risk of torsades de pointes (a lethal heart rhythm). Alterations in electrode position may distort the appearance of the waveform significantly, leading to misdiagnosis or mistreatment. 1. The facility failed to ensure an adequate number of telemetry monitor equipment to ensure continuous cardiac monitoring occurred as ordered in a patient who experienced an unexpected death. Additionally, the facility failed to provide continuous cardiac monitoring for patients, including continuous observation of a patient’s heart rate and rhythm, as ordered by their physicians, to detect any changes in condition. A. Observations i. On 10/30/23 at 12:16 p.m., observations were conducted in the intensive care unit (ICU). Observations revealed a continuous alarm sounding from Patient #3’s room. Further observation revealed the cardiac monitor leads were hanging at the bedside, and the patient’s bed was empty without staff present. During the observation, the charge nurse stated the nursing staff walked patients around the unit on a portable monitor. At 12:19 p.m., the patient was located with the nurse on the intermediate care (IMC) unit without receiving continuous cardiac monitoring. ii. On 10/30/23 at 12:38 p.m., observations conducted in the 6W surgical and trauma unit revealed three of the 17 patients with telemetry orders were off of telemetry monitoring according to the display screen at the nurse’s station. (Patient #4, #5, and #6) At 12:54 p.m., observations conducted in the 6W surgical and trauma unit revealed Patient #4 was off of telemetry monitoring in her room without nursing staff present. Patient #4’s nurse and charge nurse stated they were unaware Patient #4 was off of cardiac monitoring and that they did not receive a notification from the telemetry technician informing them that the patient’s leads were off. This was in contrast to the Telemetry Monitoring Alarm Notification and Escalation Process policy, which instructed the telemetry technician to immediately notify the patient’s nurse or charge nurse that the patient’s leads were off. If the telemetry technician could not reach the nurse or charge nurse, the telemetry technician was then expected to follow the hospital-specific Response Team or Code Blue notification process. B. Review of Medical Records and Telemetry Records i. Review of Patient #1’s medical record revealed on 9/27/23 at 2:17 a.m., the patient was directly admitted from an outside facility to 6W for alcohol withdrawal. At 3:54 a.m., Provider #6 ordered continuous telemetry monitoring for 48 hours. Further review of the medical record revealed that RN #4 documented the patient had a telemetry order for continuous cardiac monitoring, however, the equipment was unavailable, and she would place the cardiac monitor on the patient when a telemetry box was found. The medical record showed at 11:25 a.m., approximately seven and a half hours after the patient arrived at the facility, the CNA notified RN #12 that the patient did not look well. Provider #6’s note indicated the patient was found unresponsive and without a pulse at 11:28 a.m., a code blue (a code used to indicate a patient requiring resuscitation) was called, and CPR (cardiopulmonary resuscitation) was initiated. Provider #6 terminated CPR at 12:10 p.m., and the patient subsequently died. There was no evidence in the medical record of Patient #1 on continuous telemetry monitoring throughout the patient’s stay. ii. Review of Patient #5’s medical record revealed on 10/29/23 at 7:07 p.m., the patient presented to the emergency department (ED) with shortness of breath. Patient #5’s medical record indicated the patient was admitted to the facility with a diagnosis of pneumonia (an infection in the lungs) and placed on 6W. On 10/29/23 at 10:03 p.m., Provider #7 ordered continuous telemetry monitoring for 48 hours. Patient #5’s telemetry record revealed on 10/30/23 at 2:05 a.m., the telemetry flowsheet documentation showed the patient’s cardiac rhythm was sinus tachycardia (a regular cardiac rhythm in which the heart beat faster than normal). At 5:59 a.m., the patient was noted to be off telemetry monitoring per the Full Disclosure documentation. Further review of the telemetry record revealed Patient #5’s nurse was not notified that the patient’s cardiac leads were off until 10:55 a.m. (four hours and 56 minutes after the patient was noted to be off of telemetry monitoring) and again at 12:41 p.m. The telemetry record showed the notification was escalated to the charge nurse at 12:41 p.m. At 12:56 p.m., six hours and 57 minutes after the patient was noted to be off continuous telemetry monitoring, the Full Disclosure documentation revealed the patient was placed back on cardiac monitoring. iii. Review of Patient #4’s medical record revealed on 10/29/23 at 1:49 p.m., the patient presented to the ED with severe abdominal pain. On 10/29/23 at 1:57 p.m., Provider #8 ordered an EKG (a test where a snapshot recording of the electrical signals in the heart) that showed the patient had a left bundle branch block (a condition in which there was a delay or blockage along the pathway that electrical impulses traveled to make the heart beat) cardiac rhythm. On 10/29/23 at 5:31 p.m., Provider #7 ordered continuous telemetry monitoring for 48 hours. Patient #5’s medical record indicated the patient was admitted to the hospital with a diagnosis of a splenic infarct (occurred when blood flow to the spleen was compromised, causing tissue damage) and placed on 6W. Review of Patient #4’s telemetry record revealed on 10/30/23 at 3:50 a.m., the telemetry flowsheet documentation showed the patient’s cardiac rhythm was atrial fibrillation with a rapid ventricular rate (an irregular and very rapid heart rhythm). At 6:05 a.m., the telemetry flowsheet documentation showed the patient’s cardiac rhythm was atrial fibrillation (irregular heartbeat) with a heart block (when the electrical signal that controls the heartbeat was partially or completely blocked). At 9:20 a.m., the patient was noted to be off telemetry monitoring per the Full Disclosure documentation. Further review of the telemetry record revealed Patient #4’s nurse was notified that the patient’s cardiac leads were off at 10:55 a.m. (one hour and 35 minutes after the patient was noted to be off of telemetry monitoring) and again at 12:41 p.m. At 12:44 p.m., three hours and 24 minutes after the patient was noted to be off of continuous telemetry monitoring the Full Disclosure documentation revealed the patient was placed back on cardiac monitoring. At 2:12 p.m., the telemetry flowsheet documentation shows a four-beat run of ventricular tachycardia (a potentially lethal fast heart rhythm). iv. Review of Patient #6’s medical record revealed on 10/29/23 at 2:05 a.m., the patient presented to the ED with weakness and confusion. At 6:15 a.m., Provider #9 ordered an EKG test that showed the patient’s cardiac rhythm was sinus tachycardia. At 6:15 a.m., Provider #10 ordered continuous telemetry monitoring for 48 hours. Patient #6’s medical record indicated the patient was admitted to the hospital with a diagnosis of sepsis (a serious condition in which the body responds improperly to an infection) and placed on 6W. Review of Patient #6’s telemetry record revealed on 10/30/23 at 7:08 a.m., the telemetry flowsheet documentation showed the patient’s cardiac rhythm was normal sinus (a normal heart rhythm). At 9:49 a.m., the patient was noted to be off telemetry monitoring per the Full Disclosure documentation. Further review of the telemetry record revealed Patient #6’s nurse was notified that the patient’s cardiac leads were off at 12:41 p.m. (two hours and 52 minutes after the patient was noted to be off of telemetry monitoring). At 12:47 p.m., two hours and 58 minutes after the patient was noted to be off continuous telemetry monitoring, the Full Disclosure documentation revealed the patient was placed back on cardiac monitoring. v. Review of Patient #3’s medical record revealed on 10/24/23 at 8:54 p.m., the patient presented to the ED with alcohol intoxication and stated he had a seizure before coming to the hospital. Further review of Patient #3’s medical record revealed he was admitted to 6W on 10/25/23 at 2:59 a.m. for altered mental status and tachycardia. The medical record indicated Patient #3 was transferred to the ICU on 10/27/23 at 6:57 a.m. for alcohol withdrawal. The medical record review further revealed on 10/28/23, Provider #11 wrote that the patient should be on continuous cardiac monitoring due to hypokalemia (low potassium level in the blood). This was in contrast with the observation conducted on 10/30/23 at 12:16 p.m., which showed Patient #3 was observed in the ICU without being on continuous cardiac monitoring. C. Interviews i. On 10/30/23 at 1:40 p.m., an interview was conducted with telemetry technician (Tech) #1. Tech #1 stated telemetry monitoring allowed staff to monitor a patient’s cardiac rhythm and alert the nurse of any changes. Tech #1 stated she was responsible for monitoring up to 48 patients at any given time. Upon review of Patient #4, who was observed on 6W at 12:54 p.m. without telemetry monitoring, Tech #1 said she notified Patient #4’s nurse that the cardiac leads were off at 10:55 a.m and 12:41 p.m. Tech #1 said that when a patient’s cardiac leads were off, it was considered an urgent matter and required the telemetry technician to call the nurse immediately and if the nurse or charge nurse did not answer she would call the Rapid Response to check on the patient. Tech #1 stated that she missed that Patient #4 was off of the telemetry monitor because she was analyzing cardiac rhythms for other patients. Tech #1 stated if a patient was not on continuous cardiac monitoring, the staff could miss a cardiac event, and the patient could go into a lethal rhythm and die. This was in contrast to the Telemetry Monitoring Alarm Notification and Escalation Process which read, in an emergent situation (e.g., pulse ox less than or equal to 80%, SPO2 probe off or not reading, lethal arrhythmias, telemetry box with a dead battery, or all of the telemetry leads off) the telemetry technician should have notified the patient’s nurse or charge nurse and the nurse should have immediately put eyes on the patient while on the phone with the telemetry technician. ii. On 10/30/23 at 12:20 p.m., an interview was conducted with RN #2. RN #2 stated when a patient was admitted to the ICU, the patient would be placed on a cardiac monitor. RN #2 stated all patients admitted to the ICU would be placed on continuous cardiac monitoring unless they had discharge orders to the general floor without telemetry orders and were waiting for a bed. RN #2 stated that if the patient was off cardiac monitoring, the nursing staff could miss a change in the patient’s condition, and the patient could code. This interview was in contrast with the observation conducted on 10/30/23 at 12:16 p.m., which showed Patient #3 was observed in the ICU without being on continuous cardiac monitoring. iii. On 10/30/23 at 12:20 p.m., an interview was conducted with RN #4, who provided care to Patient #1. RN #4 stated Patient #1 was transferred from an outside facility’s Emergency Room to 6W as a direct admit for severe alcohol withdrawal. RN #4 said an order for a telemetry monitor for continuous cardiac monitoring was placed; however, the floor lacked telemetry leads. RN #4 stated she notified the charge nurse of the lack of telemetry equipment and documented the concern in the patient’s chart. RN #4 stated Patient #1 did not receive a telemetry monitor due to the lack of telemetry supplies. RN #4 stated nursing staff would triage those who needed telemetry monitoring and write orders under a provider’s name to discontinue telemetry monitoring from patients they felt were stable enough not to be monitored. RN #4 said providers were not notified of the discontinuation of telemetry orders as there was only one provider on nights, and they were busy with attending codes, rapid responses, and admitting patients. This was in contrast to the Cardiac and Pulse Oximetry Monitoring, which read the procedure of initiation of cardiac monitoring was to ensure the availability of monitoring equipment prior to receiving the patient on the unit. iv. On 11/08/23 at 8:01 a.m., an interview was conducted with the clinical nurse manager (Manager) #5. Manager #5 stated staff from 6W would sometimes borrow telemetry equipment from another department if needed. Manager #5 said the nurse would notify the charge nurse of the equipment shortage, and the charge nurse would then escalate the need to the house supervisor. Manager #5 stated if staff was unable to locate equipment, such as telemetry boxes, the nurse would notify the provider to triage the patients and determine which patients could be removed from continuous cardiac monitoring. Manager #5 stated Patient #1 was a direct admit to 6W with telemetry orders; however, the patient was not placed on continuous cardiac monitoring due to lack of equipment. Manager #5 said at the time of Patient #1’s admission, staff was not able to pull telemetry boxes from other floors as staff was not trained on how to assign the telemetry boxes to their floor in the computer system, and the telemetry box would not read appropriately. v. On 11/08/23 at 1:13 p.m., an interview was conducted with Provider #6. Provider #6 stated continuous telemetry monitoring was defined as the ability of nursing staff to view and monitor a patient’s heart rhythm. Provider #6 stated it was the expectation that after the provider placed the telemetry monitor order, the patient would be placed on continuous cardiac monitoring. Provider #6 stated the provider was expected to be notified of any pulse oximetry or cardiac rhythm changes. Provider #6 said that a lack of cardiac monitoring could have resulted in missing significant cardiac changes, and the patient could die.”

“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: 42693 Based on interviews and document review, the facility failed to provide nursing services in accordance with facility protocol, policy, and national guidelines. Specifically, the facility failed to ensure registered nurses (RNs) assessed detox patients on Clinical Institute Withdrawal Assessment (CIWA) protocols (clinical assessment used to diagnose the severity of alcohol withdrawal) in four of eight medical records reviewed (Patients #1, #11, #13, and #15). Additionally, nursing staff failed to assess patients after the administration of as needed (PRN) medications and scheduled medications in three of eight medical records reviewed (Patient #1, #11, and #15). Findings include: Facility order set: The Provider Order Set: Alcohol Withdrawal CIWA Less Than 19 read, vital signs are to be completed routinely until discontinued. Vital signs should be completed at the following time period based on the patient’s CIWA Score. If the CIWA is greater than 19, vital signs should be completed every 30 minutes. For CIWA between 8-19, vital signs should be completed every 2 hours times 2 then every 4 hours. Patients must be awakened for vital signs when CIWA score is 8 or above. CIWA nursing assessments should be completed as follows: For CIWA greater than 19, every 30 minutes times 2, then every 2 hours. For CIWA between 8-19, every 2 hours times 2 then every 4 hours. For CIWA less than 8, every 4 hours. Always check CIWA within 1 hour after medications. Notify the provider if CIWA does not decrease by at least 3 points after medication administration. The provider should be notified if the CIWA score is greater than 19, if there is any seizure activity, and/or if there is new onset delirium and/or hallucinations. Reference: The Elsevier Clinical Skills - Alcohol Withdrawal reference provided by the facility read, delirium tremens (DTs) is a potentially fatal condition occurring 24 to 72 hours after cessation or reduction of prolonged and heavy alcohol use. Reassess signs and symptoms of alcohol withdrawal symptoms (AWS) including assessing for DTs using standardized assessment tools such as CIWA. Assess the patient’s response to medications and other treatments or interventions. Monitor the patient’s vital signs, orientation, sleep, and emotional status, including suicidal thoughts. Monitor a patient receiving pharmacotherapy for signs of oversedation and respiratory depression. Continue to reassess the patient’s condition until an assessment is no longer clinically indicated per the organization’s practice regarding alcohol withdrawal. 1. The facility failed to ensure patients who were detoxing from alcohol were assessed per facility protocol, policy, and national guidelines. A. Record Review i. A review of Patient #1’s medical record revealed on 9/27/23 at 2:17 a.m., the patient was directly admitted to 6W for alcohol withdrawal. Further review of the record revealed the provider ordered CIWA monitoring and vital sign assessments. a. A review of Patient #1’s flowsheets revealed at 3:04 a.m., Patient #1’s CIWA score was 7. Patient #1’s vital signs assessments revealed a blood pressure of 138/79, heart rate of 134, and respirations of 20. At 7:56 a.m., the patient’s vital signs assessments revealed a blood pressure of 144/89, heart rate of 109, and respirations of 20 breaths per minute, however, there was no indication of a CIWA at this time. Patient #1’s next CIWA was assessed at 9:00 a.m. at which time Patient #1’s score was 9. The CIWA assessment performed at 9:00 a.m. was five hours and 56 minutes after the initial CIWA had been assessed for Patient #1. This was in contrast to the CIWA order set which read, patients with a CIWA score of less than 8 should have been assessed every four hours. b. The next CIWA assessment for Patient #1 was due at 11:00 a.m. according to the facility order set (protocol), however, there were no further CIWA assessments documented in the medical record. At 11:25 a.m., the CNA notified RN #12 that the patient did not look well. Provider #6’s note indicated the patient was found unresponsive and without a pulse at 11:28 a.m. A code blue (a code used to indicate a patient requiring resuscitation) was called and CPR (cardiopulmonary resuscitation) was initiated. CPR was terminated at 12:10 p.m., and the patient subsequently died. ii. A review of Patient #11’s medical record revealed on 9/27/23 at 6:45 a.m. Patient #11 arrived at the emergency department (ED). According to Patient #11’s medical record, Patient #11 had abdominal pain, alcohol problems, and a blood alcohol level (BAL) of 297. At 7:59 a.m., Patient #11’s physician ordered CIWAs to be conducted for Patient #11. a. A review of the CIWAs performed for Patient #11 revealed at 9:30 a.m., Patient #11’s CIWA score was 8. Further record review revealed another CIWA was initiated at 12:57 p.m., however, the CIWA was not completed and as a result, the CIWA score was not calculated for Patient #11 at that time. At 3:46 p.m., six hours and 16 minutes after Patient #11’s CIWA score was 8, Patient #11 was discharged home. The facility was unable to provide evidence a second CIWA had been completed for Patient #11 prior to being discharged home. This was in contrast to the CIWA order set which read, CIWAs should have been performed every two hours for patients whose CIWA score was between 8 and 19. iii. A review of Patient #13’s medical record revealed Patient #13 arrived at the ED on 10/28/23 at 1:15 a.m. due to a fall. a. A review of Patient #13’s orders revealed on 10/28/23 at 7:35 a.m., an order was placed for CIWAs. A review of Patient #13’s medical record revealed her first CIWA was conducted at 8:22 a.m. with a score of 1. The next assessment was performed at 11:24 a.m. with a score of 0. A third assessment with a score of 1 was completed at 8:00 p.m., eight hours and 36 minutes later. The next CIWA was assessed on 10/29/23 at 11:33 a.m., Patient #13’s CIWA score was 3. The next CIWA was not performed until 8:33 p.m., eight hours later. This was in contrast to the CIWA order set which read, for a CIWA score less than 8, the patient should be assessed every four hours. B. Interviews i. On 11/2/23 at 2:48 p.m., an interview was conducted with the 6 West charge RN (RN) #16. RN #16 stated for a patient with CIWA orders, the assessment should have been done every four hours or more often based on the CIWA score. RN #16 stated if a CIWA patient was not assessed or treated with medication, there was a risk for the patient would have a seizure or possible death. ii. On 11/8/23 at 1:13 p.m., an interview was conducted with Provider #6. Provider #6 stated the CIWA assessment was used to identify the severity of a patient’s alcohol withdrawal symptoms. Provider #6 stated patients with CIWA scores of 8 or more were actively experiencing alcohol withdrawal. Provider #6 stated CIWA assessments were performed to prevent the patient from worsening and to decrease the body’s physical reaction to alcohol withdrawal. Provider #6 stated the physical symptoms of alcohol withdrawal were vomiting and aspirating, life-threatening seizures, and even death of the patient. 2. The facility failed to ensure patients were assessed after medication was administered. A. Medical Record Reviews i. A review of Patient #1’s record revealed Librium (a medication used to treat alcohol withdrawal symptoms) was ordered to be administered four times a day. Review of Patient #1’s Medication Administration Record (MAR) revealed Librium was administered to the patient on 9/27/23 at 4:08 a.m. There was no indication the patient was reassessed after medication administration to ensure efficacy. Librium was administered again at 9:06 a.m., however, there was no evidence the patient was reassessed after medication administration. This was in contrast to the CIWA order set which read, always check CIWA within one hour after medication administration. Notify the provider if the CIWA score does not decrease by three points. ii. A review of Patient #11’s medical record revealed Phenobarbital (a medication used to prevent seizures and for alcohol withdrawal treatment) was ordered at 1:40 p.m. on 9/27/23. Review of Patient #11’s MAR revealed Phenobarbital was administered at 2:52 p.m. There was no evidence the patient was reassessed after medication administration to ensure effectiveness. iii. A review of Patient #15’s medical record revealed the patient arrived at the facility on 10/28/23 at 3:56 p.m. for alcohol problems and suicidal ideation (SI). At 4:06 p.m., an order was placed for CIWA assessments. At 9:58 p.m., an order was placed for Patient #15 to be administered 2 milligrams (mg) of Lorazepam (a medication often used to treat alcohol withdrawal) for CIWA scores between 8 and 14. According to the MAR for Patient #15, at 10:48 p.m. Patient #15 was administered 2 mg of Lorazepam. The patient’s next CIWA assessment was conducted at 12:56 a.m. on 10/29/23. This was over two hours after the medication was administered. B. Interviews i. On 11/7/23 at 2:25 p.m., an interview was conducted with RN #13. RN #13 stated it was important to follow CIWA protocol to prevent seizures and possible death. RN #13 stated it was important to reassess patients after medication administration to ensure the medication was working to treat the patient’s symptoms. She further stated if the medication was not effective, she would notify the provider. ii. On 11/2/23 at 2:48 p.m., an interview was conducted with the 6 West charge RN (RN) #16. RN #16 stated Lorazepam was often used to treat withdrawal symptoms. She further stated the patient needed to be assessed one hour after medication administration. RN #16 stated if a CIWA patient was not assessed or treated with medication, there was a risk that the patient would have a seizure or possible death. iii. On 11/8/23 at 1:13 p.m., an interview was conducted with Provider #6. Provider #6 stated it was important to reassess a patient after medication administration to ensure the medication was working and to ensure the patient was not going through withdrawal. Provider #6 stated he would expect to be notified if a patient’s CIWA score increased despite medication being administered.”

“INFECTION CONTROL SURVEILLANCE, PREVENTION CFR(s): The infection prevention and control program includes surveillance, prevention, and control of HAIs, including maintaining a clean and sanitary environment to avoid sources and transmission of infection, and addresses any infection control issues identified by public health authorities; and This Standard is not met as evidenced by: 46674 Based on document reviews and interviews, the facility failed to ensure the infection prevention and control program investigated and implemented preventative measures to avoid sources and transmission of surgical site infections (SSI). Findings include: Facility policies: The Infection Prevention and Control Plan policy read, the Infection Prevention and Control program and its surveillance activities are part of a plan of action designed to reduce the risk of acquisition and transmission of infections among patients. The goals and objectives for the Infection Prevention and Control (IPCC) program is to identify and minimize or eliminate the risk of acquiring or transmitting infections that pose the most threat to any person within our facilities. The surveillance data will be collected, reviewed and analyzed to: Improve outcomes, obtain “baseline” data, identify problems/trends, investigate perceived problems, evaluate control interventions, and monitor quality of care (current practices). The infection prevention program manager oversees and investigates outbreaks, unusual clusters of infections, risk management issues or patient safety concerns, and institutes appropriate corrective actions. The Adverse Clinical Event Reporting, Analysis, Disclosure, and Non-Payment policy read, the facility Patient Safety and Quality Department will assemble an internal multidisciplinary team with representatives from Quality, Patient Safety, Administration, and the department involved in the incident as soon as possible to stabilize the situation, determine next steps including the need for a Root Cause Analysis (RCA) or Critical Event Analysis (CEA), and assign an executive sponsor and team leader. Events requiring a RCA or CEA will utilize a standardized event analysis process. The cause analysis process should begin within 72 hours of awareness of the event and be completed no later than 45 days post-event, dependent on event severity and outcome. Reference: The How SSIs Are Identified document read, when a SSI is identified, infection prevention will enter it into Midas (safety event system) and identify any potential deviation in care. If unable to identify an obvious deviation, infection prevention will ask the operating room (OR) director to investigate the case for any potential deviation in care. If no deviation in care is identified, infection prevention will enter results into Midas for Patient Safety to score as appropriate for a SSE (Serious Safety Event). If an obvious deviation in care is identified, infection prevention will set up a CEA with the OR Director and send to Patient Safety to Score as an SSE as appropriate. 1. The facility failed to ensure the infection prevention and control program investigated and implemented preventative measures to avoid sources and transmission of surgical site infections related to cesarean sections (surgery to deliver a baby through a cut in the mother’s abdomen). A. Document Review i. Review of the SSI log revealed Patient A had a cesarean section on 6/12/23. Patient A’s SSI was identified on 6/23/23. A CEA for Patient A was completed on 7/27/23. Upon request, the facility was unable to provide evidence of any preventative measures implemented to prevent the recurrence of SSIs related to cesarean sections. ii. Review of the SSI log revealed Patient B had a cesarean section on 6/30/23. Patient B’s SSI was identified on 7/28/23. Review of safety event documentation provided by the facility revealed on 8/8/23, a CEA was to be scheduled within two weeks (8/22/23). A CEA for Patient B was completed on 10/6/23, 70 days after the SSI was identified. Upon request, the facility was unable to provide evidence of any preventative measures implemented to prevent the recurrence of SSIs related to cesarean sections. iii. Review of the SSI log revealed Patient C had a cesarean section on 8/8/23. Patient C’s SSI was identified on 8/17/23. Review of safety event documentation provided by the facility revealed on 9/1/23, a CEA was to be scheduled within 2 weeks (9/15/23). The CEA for Patient C had not been completed prior to the start of the survey on 10/30/23, 74 days after the SSI was identified. Upon request, the facility was unable to provide evidence of any preventative measures implemented to prevent the recurrence of SSIs related to cesarean sections. iv. Review of the SSI log revealed Patient D had a cesarean section on 8/13/23. Patient D’s SSI was identified on 8/24/23. Safety event documentation in Midas (the facility’s safety event documentation system) and a CEA had not been completed for Patient D prior to the start of the survey on 10/30/23, 67 days after the SSI was identified. Upon request, the facility was unable to provide evidence of any preventative measures implemented to prevent the recurrence of SSI related to cesarean sections. This was in contrast to the How SSI Are Identified documentation provided by the facility which read, when a SSI was identified, infection prevention would enter it into Midas and identify any potential deviation in care. v. Review of the SSI log revealed Patient E had a cesarean section on 8/15/23. Patient E’s SSI was identified on 8/30/23. Review of safety event documentation provided by the facility revealed a CEA was to be scheduled with infection prevention by 9/14/23. A CEA for Patient E was completed on 10/6/23. Upon request, the facility was unable to provide evidence of any preventative measures implemented to prevent the recurrence of SSIs related to cesarean sections. vi. Review of the SSI log revealed Patient F had a cesarean section on 8/29/23. Patient F’s SSI was identified on 9/12/23. Review of safety event documentation provided by the facility revealed a CEA was scheduled for 10/27/23 with infection prevention. A CEA for Patient F had not been completed prior to the start of the survey on 10/30/23, 48 days after the SSI was identified. Upon request, the facility was unable to provide evidence of any preventative measures implemented to prevent the recurrence of SSI related to cesarean sections. Patients B-D & F were in contrast to the Adverse Clinical Event Reporting, Analysis, Disclosure, and Non-Payment policy which read, the cause analysis process should have begun within 72 hours of awareness of the event and be completed no later than 45 days post-event, dependent on event severity and outcome. Patients A-F were also in contrast to the Infection Prevention and Control Plan policy which read, the surveillance data would be collected, reviewed and analyzed to: Improve outcomes, obtain “baseline” data, identify problems/trends, investigate perceived problems, evaluate control interventions, and monitor quality of care (current practices). The infection prevention program manager oversaw and investigated outbreaks, unusual clusters of infections, risk management issues or patient safety concerns, and instituted appropriate corrective actions. B. Interviews i. On 11/7/23 at 11:19 a.m., an interview was conducted with the operating room director (Director) #14. Director #14 stated she investigated SSIs. Director #14 stated she spoke with staff who were involved in patients’ surgical procedures, performed medical record reviews, filled out gap analysis templates (used to identify gaps in infection prevention), and reviewed safety events to determine if issues were identified with contaminated surgical instruments when she conducted SSI investigations. Director #14 also stated SSIs were investigated to determine if any deviations or gaps were identified to see how the facility could improve. Director #14 stated in June and August, there were SSIs with cesarean sections and the action plan identified for improvement was to have patients complete nose-to-toes disinfection (used to reduce bacteria on the skin before surgery). Director #14 stated she was unable to speak with the obstetrics and gynecology department providers about the proposed process change because she had missed the last two month’s meetings. Additionally, Director #14 stated no one had gone to the labor and delivery department to observe cesarean sections and there had been no further discussions related to process changes. Furthermore, Director #14 stated SSIs could ruin patients’ lives and cause the need for additional procedures. ii. On 11/7/23 at 3:23 p.m. and 11/8/23 at 9:48 a.m., interviews were conducted with infection preventionist (IP) #15. IP #15 stated her role as IP was to facilitate and oversee the investigation of SSIs. IP #15 stated the managers and directors were the experts in their field and she relied on the experts to recognize gaps in care. IP #15 stated IPs needed to be able to observe the units to determine if there were deviations in care. IP #15 also stated observations had not been conducted in labor and delivery in response to the cesarean section SSIs. Additionally, IP #15 stated the root cause of the cesarean section SSIs had not been identified. IP #15 stated she was concerned due to a recognized trend of three cesarean section SSIs with the same provider who performed patients’ surgical skin preps (cleaning and disinfecting the skin). Additionally, IP #15 stated Director #14 had not yet talked with the provider or observed his prepping technique.”