Pagosa Springs Medical Center

“COMPLIANCE WITH 489.24 CFR(s): 489.20(l) [The provider agrees,] in the case of a hospital as defined in §489.24(b), to comply with §489.24. This Standard is not met as evidenced by: 47962 Based on interviews and document review, the facility failed to comply with the Medicare provider agreement as defined in §489.20 and §489.24 related to Emergency Medical Treatment and Labor Act (EMTALA) requirements. FINDINGS 1. The facility failed to meet the following requirements under the EMTALA regulations: Tag 2406 - Applicability of Provisions of this Section (1) In the case of a hospital that has an emergency department, if an individual (whether or not eligible for Medicare benefits and regardless of ability to pay) “comes to the emergency department”, as defined in paragraph (b) of this section, the hospital must- (i) Provide an appropriate medical screening examination within the capability of the hospital’s emergency department, including ancillary services routinely available to the emergency department, to determine whether or not an emergency medical condition exists. The examination must be conducted by an individual(s) who is determined qualified by hospital bylaws or rules and regulations and who meets the requirements of §482.55 of this chapter concerning emergency services personnel and direction. Based on interviews and document review, the facility failed to ensure patients received a medical screening exam (MSE) according to facility policy. Specifically, the facility failed to ensure patients presenting to the facility with a potential emergency medical condition (EMC) were medically screened according to facility policy. Tag 2407 - Necessary Stabilizing Treatment for Emergency Medical Conditions (1) General. Subject to the provisions of paragraph (d)(2) of this section, if any individual (whether or not eligible for Medicare benefits) comes to a hospital and the hospital determines that the individual has an emergency medical condition, the hospital must provide either-- (i) Within the capabilities of the staff and facilities available at the hospital, for further medical examination and treatment as required to stabilize the medical condition. Based on interviews and document review, the facility failed to ensure patients presenting to the emergency department (ED) with an emergency medical condition (EMC) received stabilizing treatment according to facility policy. This failure impacted five of 22 patients’ medical records reviewed.”

“MEDICAL SCREENING EXAM CFR(s): 489.24(a) and 489.24(c) (a) Applicability of provisions of this section. (1) In the case of a hospital that has an emergency department, if an individual (whether or not eligible for Medicare benefits and regardless of ability to pay) “comes to the emergency department”, as defined in paragraph (b) of this section, the hospital must- (i) Provide an appropriate medical screening examination within the capability of the hospital’s emergency department, including ancillary services routinely available to the emergency department, to determine whether or not an emergency medical condition exists. The examination must be conducted by an individual(s) who is determined qualified by hospital bylaws or rules and regulations and who meets the requirements of §482.55 of this chapter concerning emergency services personnel and direction; and (ii) If an emergency medical condition is determined to exist, provide any necessary stabilizing treatment, as defined in paragraph (d) of this section, or an appropriate transfer as defined in paragraph (e) of this section. If the hospital admits the individual as an inpatient for further treatment, the hospital’s obligation under this section ends, as specified in paragraph (d)(2) of this section. (2)(i) When a waiver has been issued in accordance with section 1135 of the Act that includes a waiver under section 1135(b)(3) of the Act, sanctions under this section for an inappropriate transfer or for the direction or relocation of an individual to receive medical screening at an alternate location do not apply to a hospital with a dedicated emergency department if the following conditions are met: (A) The transfer is necessitated by the circumstances of the declared emergency in the emergency area during the emergency period. (B) The direction or relocation of an individual to receive medical screening at an alternate location is pursuant to an appropriate State emergency preparedness plan or, in the case of a public health emergency that involves a pandemic infectious disease, pursuant to a State pandemic preparedness plan. (C) The hospital does not discriminate on the basis of an individual’s source of payment or ability to pay. (D) The hospital is located in an emergency area during an emergency period, as those terms are defined in section 1135(g)(1) of the Act. (E) There has been a determination that a waiver of sanctions is necessary. (ii) A waiver of these sanctions is limited to a 72-hour period beginning upon the implementation of a hospital disaster protocol, except that, if a public health emergency involves a pandemic infectious disease (such as pandemic influenza), the waiver will continue in effect until the termination of the applicable declaration of a public health emergency, as provided under section 1135(e)(1)(B) of the Act. (c) Use of dedicated emergency department for nonemergency services. If an individual comes to a hospital’s dedicated emergency department and a request is made on his or her behalf for examination or treatment for a medical condition, but the nature of the request makes it clear that the medical condition is not of an emergency nature, the hospital is required only to perform such screening as would be appropriate for any individual presenting in that manner, to determine that the individual does not have an emergency medical condition. This Standard is not met as evidenced by: 47962 Based on interviews and document review, the facility failed to ensure patients received a medical screening exam (MSE) according to facility policy. Specifically, the facility failed to ensure patients presenting to the facility with a potential emergency medical condition (EMC) were medically screened according to facility policy. This failure impacted eight of 20 patients’ medical records reviewed. (Patients #1-4, #7, #16, #17, and #19) (Cross-reference C-2407) Findings include: Facility policies: According to the Emergency Medical Treatment and Labor Act (EMTALA) policy, any patient who comes to the hospital requesting emergency services will receive an MSE to determine whether an emergency medical condition (EMC) exists. Services provided under this policy shall be provided regardless of the patient ’ s diagnosis and shall be the same for all individuals who present with the same signs and symptoms. The MSE is the process to determine whether or not an EMC exists. Such screening must be done within the facility’s capabilities and the capabilities of available personnel and may range from a simple process involving only a brief history and physical examination to a complex process that involves performing ancillary studies and procedures. The MSE includes both a generalized assessment and a focused assessment based on the patient ’ s chief complaint. An MSE is not an isolated event but is an ongoing process which involves continued monitoring according to the patient ’ s needs until the patient is stabilized. The ED physician on duty shall be responsible for the general care of all patients presenting themselves to the ED. According to the Standards of Practice of Care policy, assessments reflect changes in patients’ condition and are appropriately charted and communicated. Patients’ response to treatment and interventions is reflected in the electronic medical record (EMR). The nursing process is used to reflect the patients’ current conditions and treatment plans, which includes evaluation of patient response to interventions and outcomes. The patients will be continually assessed for changes and progress toward meeting outcome goals and discharge objectives. Fundamental ED nursing interventions for class I patients include vital signs taken every 15 minutes two times then every 30 minutes and for class II patients, vital signs taken every 30 minutes two times then every two hours. For class III patients, vital signs are taken on admission, post-intervention, and/or discharge. Vital signs will be repeated if not within normal limits. Vital signs will be repeated after administration of medications with potential side effects. Patient response to medical and nursing interventions is evaluated and documented. Reference: According to the Colorado Code of Regulations (CCR) for Emergency Medical Services (EMS) Scope of Practice, medical supervision of the EMS provider in a clinical setting must be provided by a medical supervisor who is a Colorado licensed physician or registered nurse licensed in good standing, trained and experienced in the acts and skills for which supervision is being provided, knowledgeable about the maximum skills, acts, or medications that an emergency medical technician (EMT) or paramedic are authorized to perform, and immediately available and physically present at the clinical setting where the care is being delivered to provide oversight or guidance to the EMS provider during the performance of medical acts. 1. The facility failed to ensure patients presenting to the facility for an EMC received an MSE per facility policies. A. Medical record review i. A review was conducted of Patient #16’s medical record which revealed Patient #16 had presented to the ED on 7/29/24 after a suicide attempt from overdosing on alcohol and acetaminophen. On 7/29/24 at 9:50 a.m., the RN documented the first assessment, an ED Triage and Assessment. Although Patient #16 was at the facility until 7/30/24 at 9:15 a.m. (23 hours and 35 minutes later), the medical record failed to reveal another RN assessment of the patient. This gap in patient assessment was in contrast to an interview conducted on 8/13/24 at 5:09 p.m. with chief nursing officer (CNO) #3 during which they stated reassessments were performed at least once every shift and at shift change to ensure nurses observed and responded to changes in patient condition. On 7/29/24, the RN notes documented vital signs at 11:10 a.m., 1:57 p.m. (two hours and 47 minutes later), 3:30 p.m. (one hour and 33 minutes later), and 5:00 p.m. (one hour and 30 minutes later). The 3:30 p.m. and 5:00 p.m. vitals failed to reveal an assessment of Patient #16’s BP. The next assessment of Patient #16’s vital signs was on 7/30/24 at 3:45 a.m., 10 hours and 45 minutes after the last set of vital signs were assessed, and 13 hours and 48 minutes after the BP was last assessed. On 7/30/24 at 9:15 a.m., Patient #16 was discharged. The medical record failed to reveal an assessment of the vital signs between 7:00 a.m. and 9:15 a.m. which was in contrast to an interview conducted on 8/12/24 at 4:57 p.m., during which RN and ED Manager (Manager) #2 stated RNs obtained discharge vitals no less than an hour before discharge to ensure the patients’ conditions had not changed. This lack of assessment, including RN reassessments and vital signs, in a patient with behavioral health and medical concerns, revealed an inappropriate MSE which was in contrast to the EMTALA policy which read, patients presenting to the ED received an MSE to determine whether an EMC existed. An MSE was not an isolated event but an ongoing process which involved continued monitoring according to the patient ’ s needs until the patient was stabilized. ii. A review was conducted of Patient #17’s medical record which revealed Patient #17 had presented to the ED for suicidal and homicidal ideations (thoughts) on 6/10/24. On 6/10/24 at 3:17 a.m., the RN Triage Assessment documented Patient #17’s ED intake. Although Patient #17 was at the facility until 6/11/24 at 9:45 a.m. (30 hours and 28 minutes later), the medical record failed to reveal another RN assessment of the patient. This gap in patient assessment was in contrast to an interview conducted on 8/13/24 at 5:09 p.m. with chief nursing officer (CNO) #3 during which they stated reassessments were performed at least once every shift and at shift change to ensure nurses observed and responded to changes in patient condition. On 6/10/24 at 9:42 p.m., the RN Rounding Comments documented Patient #17 was agitated, in pain, and had requested pain medication. On 6/11/24 at 12:23 a.m., the physician notes documented Patient #17 complained of general diffuse pain and requested olanzapine (helps regulate mood, behavior, and thoughts) and gabapentin (relieves nerve pain), however, there was a concern for additive effects (a combined unintended effect that occurs when two or more medications are administered together) with the gabapentin so Patient #17 would be given olanzapine and was then to be reassessed. The Medication Administration Record (MAR) documented olanzapine was administered to Patient #17 on 6/10/24 at 9:42 p.m. On 6/11/24 at 6:27 a.m., the RN Rounding Comments documented Patient #17 slept after the administration of medication. The record failed to reveal a follow-up assessment of Patient #17 in accordance with the physician’s note. On 6/11/24 at 9:22 a.m., the physician note documented Patient #17 had baseline postsurgical ankle pain and had been given ibuprofen (a non-steroidal anti-inflammatory medication). The MAR documented ibuprofen was given on 6/11/24 at 9:21 a.m. The record failed to reveal a thorough assessment or follow-up assessment of Patient #17’s pain. This lack of assessment, including RN reassessments and a thorough assessment of pain, in a patient with behavioral health and medical concerns, revealed an inappropriate MSE which was in contrast to the EMTALA policy which read, patients presenting to the ED received an MSE to determine whether an EMC existed. An MSE was not an isolated event but an ongoing process which involved continued monitoring according to the patient ’ s needs until the patient was stabilized. iii. A review was conducted of Patient #2’s medical record which revealed Patient #2 had presented to the ED for lateral tibial plateau fracture (a break of the larger leg bone below the knee that breaks into the knee joint itself) on 7/3/24. At 11:17 a.m., the RN note documented Patient #2’s blood pressure (BP) was 172/113 (normal is 120/80) and pain was 5/10. At 12:25 p.m. (one hour and eight minutes later), the RN administered an intramuscular (IM) injection of ketorolac (NSAID) for pain. At 12:30 p.m. (five minutes after the pain medication was administered), Patient #2 was discharged. The medical record failed to reveal an assessment of Patient #2’s pain after the administration of the pain medication or before discharge. The medical record also failed to reveal a reassessment of Patient #2’s vital signs, including BP, before they were discharged. The lack of ongoing assessment, including for pain and vital signs, revealed an inappropriate MSE which was in contrast to the EMTALA policy which read, patients presenting to the ED received an MSE to determine whether an EMC existed. An MSE was not an isolated event but an ongoing process which involved continued monitoring according to the patient ’ s needs until the patient was stabilized. iv. A review was conducted of Patient #1’s medical record which revealed Patient #1 had presented to the ED for wrist fracture (broken bone) after a motor vehicle accident (MVA) on 7/23/24. At 1:41 p.m., the RN triage assessment documented Patient #1 rated their pain as four out of 10, with 10 being the worst possible pain. At 2:50 p.m. (one hour and nine minutes after triage), the RN administered ibuprofen (a nonsteroidal anti-inflammatory (NSAID)) to Patient #1. At 5:03 p.m. (two hours and 13 minutes after the pain medication was administered), Patient #1 was discharged. The medical record failed to reveal an assessment of Patient #1’s pain after the administration of pain medication or before discharge. The lack of ongoing assessment for pain revealed an inappropriate MSE which was in contrast to the EMTALA policy which read, patients presenting to the ED received an MSE to determine whether an EMC existed. An MSE was not an isolated event but an ongoing process which involved continued monitoring according to the patient ’ s needs until the patient was stabilized. v. A review was conducted of Patient #3’s medical record which revealed Patient #3 had presented to the ED for lateral tibial plateau fracture on 7/30/24. At 10:54 a.m., the RN note documented Patient #3 rated their pain 6/10. At 12:32 p.m. (an hour and 38 minutes later), the RN documented only Patient #3’s pulse rate, respiratory rate, and oxygen saturation and the patient was discharged at 12:34 p.m. The medical record failed to reveal a reassessment of Patient #3’s pain or BP before they were discharged. The lack of ongoing assessment, including for pain and blood pressure, revealed an inappropriate MSE which was in contrast to the EMTALA policy which read, patients presenting to the ED received an MSE to determine whether an EMC existed. An MSE was not an isolated event but an ongoing process which involved continued monitoring according to the patient ’ s needs until the patient was stabilized. vi. A review was conducted of Patient #4’s medical record which revealed Patient #4 had presented to the ED for a lateral tibial plateau fracture after an MVA on 6/21/24. At 6:45 p.m., the RN note documented Patient #4 rated their pain 10/10. During Patient #4’s stay in the ED from 6:33 p.m. to 11:30 p.m. (four hours and 57 minutes in duration), they were given Dilaudid (a narcotic pain medication used to treat moderate to severe pain) at 7:19 p.m., 8:53 p.m., and 10:37 p.m.). They were also given acetaminophen/hydrocodone (another narcotic pain medication for moderate to severe pain) at 9:16 p.m. The RN notes in the Medication Administration Record (MAR) documented that the narcotic pain medications were “effective,” but the medical record failed to reveal a thorough assessment of the severity and quality of Patient #4’s pain in response to the pain medications (administered between 7:19 p.m. and 10:37 p.m.) before they were discharged at 11:30 p.m. The lack of a thorough and ongoing pain assessment revealed an inappropriate MSE which was in contrast to the EMTALA policy which read, patients presenting to the ED received an MSE to determine whether an EMC existed. An MSE was not an isolated event but an ongoing process which involved continued monitoring according to the patient ’ s needs until the patient was stabilized. vii. A review was conducted of Patient #7’s medical record which revealed Patient #7 had presented to the ED for tachycardia (high heart rate) on 7/10/24. At 9:39 p.m., the ED Assessment documented an EMT had performed Patient #7’s assessment with the RN’s cosign documented in the medical record on 7/11/24 at 6:08 a.m. (eight hours and 29 minutes later). There was no further evidence in the medical record to verify if the RN was physically present to provide oversight at the time of the EMT’s assessment. The medical record failed to reveal medical supervision of the EMT during this patient assessment which was in contrast to the CCR for EMS Scope of Practice which read, medical supervision of the EMS provider was provided by a provider or RN who was immediately available and physically present to provide oversight or guidance during the performance of medical acts. The lack of RN assessment revealed an inappropriate MSE which was in contrast to the EMTALA policy which read, patients presenting to the ED received an MSE to determine whether an EMC existed. Such screening was done within the capabilities of available personnel. viii. A review was conducted of Patient #19’s medical record which revealed Patient #19 had presented to the ED for third-trimester bleeding on 7/30/24. At 1:38 a.m., the ED Assessment documented an EMT had performed Patient #19’s assessment with the RN’s cosign documented in the medical record on 7/30/24 at 6:36 a.m. (five hours and 58 minutes later). There was no further evidence in the medical record to verify if the RN was physically present to provide oversight at the time of the EMT’s assessment. The medical record failed to reveal medical supervision of the EMT during this patient assessment which was in contrast to the CCR for EMS Scope of Practice which read, medical supervision of the EMS provider was provided by a provider or RN who was immediately available and physically present to provide oversight or guidance during the performance of medical acts. The lack of RN assessment revealed an inappropriate MSE which was in contrast to the EMTALA policy which read, patients presenting to the ED received an MSE to determine whether an EMC existed. Such screening was done within the capabilities of available personnel. B. Interviews i. On 8/7/24 at 1:00 p.m., an interview was conducted with RN #1. RN #1 stated every patient in the ED received an initial assessment. They stated they used the emergency severity index (ESI) to determine acuity which guided the frequency of patient reassessment. RN #1 stated reassessments were also performed based on changes in condition, specific needs, and after every intervention. They stated they obtained vitals in patients with an ESI of 1 or 2 every five minutes at first then modified the frequency based on provider orders. RN #1 stated if a patient was in the ED for over an hour, the patient would have at least two sets of vitals in their medical record. They stated the discharge process involved ensuring patients had stable vitals within 15 minutes of discharge. RN #1 stated ensuring discharge vitals were taken, and at that patient’s baseline, was important to ensure patients were stable and safe for discharge. This was in contrast to the medical records for Patients #2, #3, and #16 which did not reveal the assessment of all vital signs before discharge. RN #1 stated pain was assessed using a pain scale. They stated pain reassessments were performed 15 minutes after the administration of intravenous (IV) medications and 45 minutes after oral medications. RN #1 stated if patients still had elevated levels of pain after receiving pain medications, the nurse informed the provider and considered additional comfort measures. They stated if pain was not reassessed, there was a risk of uncontrolled pain and pain crisis. This was in contrast to the medical records for Patients #1, #2, #3, #4, and #17, which did not reveal a reassessment of pain. ii. On 8/12/24 at 4:03 p.m., an interview was conducted with RN #5. RN #5 stated they evaluated pain at the time of triage using a pain scale. They stated they re-evaluated pain and included vital signs in this reassessment as the vitals could indicate the patients’ pain was not adequately controlled. RN #5 stated pain reassessments performed after medication interventions, including for non-narcotic medications, included taking vital signs every hour and a determination of the medication’s efficacy. They stated vital signs outside of normal limits could indicate uncontrolled pain or anxiety. RN #5 stated obtaining vital signs and reassessing patients after the administration of pain medications was important to ensure pain was addressed and to ensure patients were not experiencing side effects from the medications. They stated for instance, narcotic pain medications such as Dilaudid and Vicodin, could result in respiratory distress (trouble breathing) and NSAID medications like Toradol had the potential for liver and gastric pain. RN #5 stated vital signs were to be taken per assigned acuity and at a minimum, three times per shift. They stated RN assessments were performed constantly and documented in the RN Rounding Notes. RN #5 stated frequent patient assessment was important as more acutely ill patients were more medically unstable with the potential for fast and acute change. iii. On 8/7/24 at 1:26 p.m. and 8/12/24 at 4:57 p.m., interviews were conducted with RN and ED Manager (Manager) #2. Manager #2 stated patients were assessed by RNs during the triage process. They stated RNs were responsible for performing all assessments as this was not within the EMT scope of practice, which was in contrast to the medical records for Patients #7 and #19. Manager #2 stated RN reassessments were triggered by any medical interventions. They stated for patients kept in the ED over 12 hours, they expected an RN assessment at the beginning of each shift and in response to changes in condition. Manager #2 stated the RN assessments and reassessments were important to ensure nurses knew their patients as knowing the patient was essential to providing quality medical care and providing interventions in response to changes in condition. Manager #2 also stated pain was assessed at triage and after any medical interventions. They stated this reassessment was important to know if the interventions were successful at reducing or controlling patients’ pain levels. Manager #2 stated for patients with a history of suicidal ideation and intentional overdose, they expected frequent vital signs, for example, blood pressure was to be taken every 15 minutes, and an assessment was to be performed of the patient’s level of orientation and consciousness. This was in contrast to the medical record for Patient #16, who had presented for suicidal ideation and intentional overdose, which did not reveal frequent monitoring of vital signs. Manager #2 also stated the risks of not addressing vital signs outside of normal limits, for example an elevated blood pressure, included a stroke (lack of oxygen to the brain tissue). Manager #2 stated if a patient had a BP in the 110s, the RNs notified the provider to understand what interventions were necessary. Manager #2 stated discharge vitals were obtained an hour or less before discharge if the patients were stable. They stated if the vital signs were out of range at this time, the provider was notified, interventions were performed, and the patient was reassessed. Manager #2 stated this process of assessing and reassessment was important to ensure patients received the necessary medical care to address an EMC. iv. On 8/13/24 at 5:09 p.m., an interview was conducted with chief nursing officer (CNO) #3. CNO #3 stated patient assessments and reassessments were performed at least once every shift and at shift change which was important to ensure there was a documented baseline for comparison in case of a change in condition. CNO #3 stated they also expected to see reassessments performed with any change in condition. They stated vital signs were taken at triage, at shift change, with any change in condition, and at discharge. CNO #3 stated reassessments were necessary to catch subtle changes in condition which could worsen exponentially if not caught early. CNO #3 stated EMTs were not able to perform patient assessments as this was not within their scope of practice or training which was in contrast to the medical records for Patients #7 and #19. They stated there was a risk the EMTs might miss significant patient findings due to a lack of knowledge and training. CNO #3 stated pain assessments were performed at triage and 30 minutes after an intervention. They stated pain assessment, including quantifying pain, was important to ensure interventions effectively addressed pain. CNO #3 stated RNs assessed all vitals, including pain prior to discharge. They stated discharge assessments and vitals were important to ensure the chief complaint had been addressed and resolved and there were no changes in condition. v. On 8/7/24 at 4:00 p.m. an interview was conducted with ED physician (Physician) #4. Physician #4 stated medical screening exams were performed on patients in the ED to determine the presence of life-threatening conditions. They stated an initial evaluation was necessary to understand the patient’s condition and a reevaluation was important to understand if the patient had improved or had changes. Physician #4 stated an RN reassessment was based on acuity and may not be necessary. However, Physician #4 stated they expected RNs to assess vitals at triage and discharge. They stated this was important for quality patient care as the physicians integrated the information from the nurses into their patient assessments. Physician #4 stated they reassessed pain after pain medications were administered although this may not have been documented in the medical record. They stated their goal was for pain to decrease by at least 50 percent during their time in the ED. Physician #4 stated, however pain was a subjective measurement and they validated the patients’ scoring of their pain with a physical exam and observation so there was not necessarily a correlation between a pain score and a medical intervention.”

“STABILIZING TREATMENT CFR(s): 489.24(d)(1-3) (1) General. Subject to the provisions of paragraph (d)(2) of this section, if any individual (whether or not eligible for Medicare benefits) comes to a hospital and the hospital determines that the individual has an emergency medical condition, the hospital must provide either- (i) within the capabilities of the staff and facilities available at the hospital, for further medical examination and treatment as required to stabilize the medical condition. (ii) For for transfer of the individual to another medical facility in accordance with paragraph (e) of this section. (2) Exception: Application to inpatients. (i) If a hospital has screened an individual under paragraph (a) of this section and found the individual to have an emergency medical condition, and admits that individual as an inpatient in good faith in order to stabilize the emergency medical condition, the hospital has satisfied its special responsibilities under this section with respect to that individual (ii) This section is not applicable to an inpatient who was admitted for elective (nonemergency) diagnosis or treatment. (iii) A hospital is required by the conditions of participation for hospitals under Part 482 of this chapter to provide care to its inpatients in accordance with those conditions of participation. (3) Refusal to consent to treatment. A hospital meets the requirements of paragraph (d)(1)(i) of this section with respect to an individual if the hospital offers the individual the further medical examination and treatment described in that paragraph and informs the individual (or a person acting on the individual’s behalf) of the risks and benefits to the individual of the examination and treatment, but the individual (or a person acting on the individual’s behalf) does not consent to the examination or treatment. The medical record must contain a description of the examination, treatment, or both if applicable, that was refused by or on behalf of the individual. The hospital must take all reasonable steps to secure the individual’s written informed refusal (or that of the person acting on his or her behalf). The written document should indicate that the person has been informed of the risks and benefits of the examination or treatment, or both. This Standard is not met as evidenced by: 47962 Based on interviews and document review, the facility failed to ensure patients presenting to the emergency department (ED) with an emergency medical condition (EMC) received stabilizing treatment according to facility policy. This failure impacted five of 22 patients’ medical records reviewed. (Patients #1-4 and #17) Findings include: Facility policies: According to the Emergency Medical Treatment and Labor Act (EMTALA) policy, any patient who comes to the hospital requesting emergency services is entitled to and will receive a medical screening examination (MSE) to determine whether an EMC exists. Patients who are determined to have an EMC shall be provided with stabilizing treatment and transferred, admitted, or discharged. Services shall be the same for all individuals who present with the same signs and symptoms. All persons with an EMC shall receive further examination and treatment, within the capabilities of the staff and facilities to stabilize the patient. Patients with an unresolved EMC shall not be discharged unless the patient is “stable for discharge.” For patients with an unresolved EMC, the patient is stable for discharge when it is determined by the physician that the patient’s continued care could reasonably be performed as an outpatient, provided the patient is given a plan for appropriate follow-up care with the discharge instructions. According to the Standards of Practice of Care policy, the nursing process is used to reflect the patients’ current conditions and treatment plans and includes evaluating patient responses to interventions and outcomes. Discharge assessments by the registered nurse (RN) include physical status upon discharge and response to treatment. The patients will be continually assessed for changes and progress toward meeting outcome goals and discharge objectives. Patient responses to medical and nursing interventions is evaluated and documented. 1. The facility failed to ensure patients who presented to the ED for care were provided stabilizing treatment or further examinations to determine if stabilizing treatment was necessary prior to discharge. A. Medical record review i. A review was conducted of Patient #17’s medical record which revealed Patient #17 had presented to the ED for suicidal and homicidal ideations (thoughts of harming or ending the life of oneself or others) on 6/10/24. On 6/10/24 at 9:42 p.m., the RN Rounding Comments documented Patient #17 was agitated, in pain in “multiple places from multiple injuries”, and had requested pain medication. The Medication Administration Record (MAR) documented olanzapine (medication used to regulate mood, behavior, and thoughts) was administered to Patient #17 on 6/10/24 at 9:42 p.m. On 6/11/24 at 12:23 a.m., the physician notes documented Patient #17 had complained of general diffuse pain and had requested olanzapine and gabapentin (relieves nerve pain). The physician notes revealed Patient #17 was given olanzapine and would be reassessed at an unspecified time. On 6/11/24 at 6:27 a.m., the RN Rounding Comments documented Patient #17 slept after the medication administration. The record failed to reveal a thorough assessment of Patient #17’s pain or a follow-up assessment to determine if the patient required further treatment for the patient’s reported pain. On 6/11/24 at 9:22 a.m., the physician note documented Patient #17 had baseline postsurgical ankle pain and had been given ibuprofen (a non-steroidal anti-inflammatory medication (NSAID)). The MAR documented ibuprofen was given on 6/11/24 at 9:21 a.m. The record failed to reveal a thorough assessment or follow-up assessment of Patient #17’s pain to determine if the patient was stable for discharge. ii. A review was conducted of Patient #3’s medical record which revealed Patient #3 had presented to the ED for a lateral tibial plateau fracture (a break of the larger leg bone below the knee which breaks into the knee joint itself) on 7/30/24. At 10:54 a.m., the RN note documented Patient #3 rated their left knee pain 6/10. At 12:30 p.m., the RN note documented Patient #3 rated their upper leg pain 5/10. The patient was discharged at 12:34 p.m. without having had any pain interventions or further assessment of their knee pain. The medical record failed to reveal treatment for Patient #3’s pain and evidence of stabilization prior to discharge. iii. A review was conducted of Patient #2’s medical record which revealed Patient #2 had presented to the ED for a lateral tibial plateau fracture on 7/3/24. At 11:17 a.m., the RN Triage note documented Patient #2’s blood pressure (BP) was 172/113 (normal is 120/80). The medical record failed to reveal Patient #2’s elevated BP was treated or reassessed to ensure Patient #2 was stabilized prior to discharge. At 11:17 a.m., the RN Triage note documented Patient #2’s pain was 5/10. At 12:25 p.m. (one hour and eight minutes later), the RN notes documented the RN administered an intramuscular (IM) injection of ketorolac (NSAID) for pain. At 12:30 p.m. (five minutes after the pain medication was administered), Patient #2 was discharged. The medical record failed to reveal evidence that Patient #2’s pain was adequately treated and that they were stabilized prior to discharge. iv. A review was conducted of Patient #1’s medical record which revealed Patient #1 had presented to the ED for a wrist fracture after a motor vehicle accident (MVA) on 7/23/24. At 1:41 p.m., the RN Triage Assessment documented Patient #1 rated their pain as 4/10. At 2:50 p.m. (one hour and nine minutes after triage), the RN administered ibuprofen to Patient #1. At 5:03 p.m. (two hours and 13 minutes after the pain medication was administered), Patient #1 was discharged. The medical record failed to reveal evidence that Patient #1’s pain was adequately treated and that they were stabilized prior to discharge. v. A review was conducted of Patient #4’s medical record which revealed Patient #4 had presented to the ED for a lateral tibial plateau fracture after an MVA on 6/21/24. At 6:45 p.m., the RN note documented Patient #4 rated their ankle pain 10/10. At 6:50 p.m., the RN note documented Patient #4 rated their head pain 10/10. During Patient #4’s stay in the ED from 6:33 p.m. to 11:30 p.m., they were given Dilaudid (a narcotic pain medication used to treat moderate to severe pain) three times and acetaminophen/hydrocodone (another narcotic pain medication for moderate to severe pain) one time. The RN notes in the MAR documented the narcotic pain medications were “effective” without documentation of pain reduction or stabilization. The medical record failed to reveal evidence that Patient #4’s pain was adequately treated and that they were stabilized prior to discharge. This review of the medical records which revealed a lack of stabilizing treatment for Patients #1-4 and #17 was in contrast to the EMTALA policy which read, patients with an EMC were provided with further examination and stabilizing treatment until stable for discharge or transferred to another facility. B. Interviews i. On 8/7/24 at 1:00 p.m., an interview was conducted with RN #1. RN #1 stated patients with pain were provided with medical interventions including pain medications until the level of pain decreased. RN #1 stated this process was important to reduce pain and stop a pain crisis. RN #1 stated patients were discharged once their symptoms had improved and their vitals were at baseline. They stated ensuring stability at discharge was important for patient safety. ii. On 8/12/24 at 4:03 p.m., an interview was conducted with RN #5. RN #5 stated patients with pain were treated and stabilized in the ED. They stated reassessment of vital signs was important to ensure pain was treated and blood pressure and oxygen saturation values stabilized, especially after interventions with narcotics (opioid pain medications such as Dilaudid). iii. On 8/7/24 at 1:26 p.m., an interview was conducted with RN and ED Manager (Manager) #2. Manager #2 stated they expected nurses to reassess pain prior to discharge. They stated patients were assessed before discharge to ensure patients were stable and the medical interventions provided effectively addressed the presenting complaints. Manager #2 stated patient stabilization was necessary to ensure patients did not experience a respiratory (breathing) or cardiac (heart) emergency while at the facility or decompensate after discharge and return to the facility. iv. On 8/13/24 at 5:09 p.m., an interview was conducted with chief nursing officer (CNO) #3. CNO #3 stated pain assessments were performed at triage and 30 minutes after an intervention. They stated pain assessment, including the quantification of pain with a pain scale, was important to ensure interventions effectively addressed pain. CNO #3 stated they were not sure how patients were considered stabilized if the patients who presented with pain were prescribed pain medication to pick up at the pharmacy after discharge, but were not provided pain medications while at the facility. CNO #3 also stated RNs assessed all vitals, including pain prior to discharge. They stated reassessments were necessary to catch subtle changes in condition which could worsen exponentially if not caught early. CNO #3 stated discharge assessments, including vitals, were important to ensure the patients’ chief complaints had been addressed and resolved and there were no changes in condition. CNO #3 stated they ensured patients were stable before discharge as the patients’ conditions could decline if they were not stabilized before discharge. v. On 8/7/24 at 4:00 p.m. an interview was conducted with ED physician (Physician) #4. Physician #4 stated they expected the nurses to assess vitals at triage and discharge. Physician #4 stated they reassessed pain after pain medications were administered as they wanted patients’ pain to decrease by at least 50 percent during their time in the ED. This statement was in contrast to a review of the medical records for Patients #1-4 and #17 which did not reveal this pain reassessment. Physician #4 also stated pain was a subjective measurement and they validated the patients’ pain scores with a physical exam and observation so there was not always a correlation between a high pain score and a medical intervention. Physician #4 stated stabilizing treatment varied based on the patients’ conditions and was case dependent. They stated for patients with fractures, for example, stability was determined by a repeat assessment including vital signs, improvement in pain, and ensuring the patient felt comfortable returning home. This was in contrast to the medical records for Patients #1-4 and #17 which did not consistently reveal pain and vital sign reassessments to determine if additional stabilizing treatment was required prior to discharging from the ED. Physician #4 stated stability at discharge was important to ensure patients had received the necessary interventions to improve their health. These interviews which revealed inconsistent expectations for and performance of pain and vital signs reassessment to ensure patients were stabilized prior to discharge were in contrast to the EMTALA policy which read, patients with an EMC were provided with further examination and stabilizing treatment until stable for discharge or transferred to another facility.”

“The Initial Comments (ID Tag 0000) are informational only and are a representation of the facility’s general characteristics. An on-site Life Safety Code survey was conducted on July 9, 2024, for state re-licensure and CMS re-certification as a Critical Access Hospital. The building was constructed in 2007 and is a one-story Type II (000) construction. The hospital building is protected throughout by a total coverage fire sprinkler system designed to the requirements of the National Fire Protection Association (NFPA) 13, with the water supply supplemented by a 500 gpm pressure booster pump. The 11-bed hospital is separated from the two adjacent clinics (business) occupancy by two-hour fire-rated construction. Smoke compartment C - 16,725 SQFT Smoke Compartment B - 16,424 SQFT. Smoke compartment A is classified as a business and separated by a two-hour fire-rated assembly and separate NFPA 13 system. Smoke compartments D & E are classified as a business and are separated by a two-hour fire-rated assembly and separate NFPA 13 system. The campus has 3 separate fire sprinkler risers. The facility was surveyed to meet the requirements of the 2012 Life Safety Code (NFPA 101), Chapter 19, Existing Health Care Occupancies; 2012 Health Care Facilities Code (NFPA 99); and referenced standards. The deficiencies cited were discussed with facilities managers during the exit conference conducted at the end of the on-site survey. The Facilities Manager reported the census of 2 patients during the survey.”

“Emergency Lighting CFR(s): NFPA 101 Emergency Lighting Emergency lighting of at least 1-1/2-hour duration is provided automatically in accordance with 7.9. 18.2.9.1, 19.2.9.1 This Standard is not met as evidenced by: 49177 Through document review during the survey, it was determined that the facility failed to meet the protection requirements in accordance with NFPA 101. This was evidenced by: 1) Emergency Lighting (Monthly & Annual)(101 7.9.3.1.1): Not Done NFPA 101 7.9.3.1.1 Testing of required emergency lighting systems shall be permitted to be conducted as follows: (1) Functional testing shall be conducted monthly, with a minimum of 3 weeks and a maximum of 5 weeks between tests, for not less than 30 seconds, except as otherwise permitted by 7.9.3.1.1(2). (2)*The test interval shall be permitted to be extended beyond 30 days with the approval of the authority having jurisdiction. (3) Functional testing shall be conducted annually for a minimum of 11/2 hours if the emergency lighting system is battery-powered. (4) The emergency lighting equipment shall be fully operational for the duration of the tests required by 7.9.3.1.1(1)and (3). (5) Written records of visual inspections and tests shall be kept by the owner for inspection by the authority having jurisdiction. This deficiency has the potential to affect occupants, who might include residents, staff, and visitors within the entire facility. The deficient item was discussed with the maintenance team at the exit conference.”

“Cooking Facilities CFR(s): NFPA 101 Cooking Facilities Cooking equipment is protected in accordance with NFPA 96, Standard for Ventilation Control and Fire Protection of Commercial Cooking Operations, unless: * residential cooking equipment (i.e., small appliances such as microwaves, hot plates, toasters) are used for food warming or limited cooking in accordance with 18.3.2.5.2, 19.3.2.5.2 * cooking facilities open to the corridor in smoke compartments with 30 or fewer patients comply with the conditions under 18.3.2.5.3, 19.3.2.5.3, or * cooking facilities in smoke compartments with 30 or fewer patients comply with conditions under 18.3.2.5.4, 19.3.2.5.4. Cooking facilities protected according to NFPA 96 per 9.2.3 are not required to be enclosed as hazardous areas, but shall not be open to the corridor. 18.3.2.5.1 through 18.3.2.5.4, 19.3.2.5.1 through 19.3.2.5.5, 9.2.3, TIA 12-2 This Standard is not met as evidenced by: 49177 Through observation during the survey, it was determined that the facility failed to meet the healthcare facilities code requirements in accordance with NFPA 101 and 54. This was evidenced by: 1) missing gas cable on kitchen appliance NFPA 101, 9.1.1 Gas. Equipment using gas and related gas piping shall be in accordance with NFPA 54, National Fuel Gas Code, or NFPA 58, Liquefied Petroleum Gas Code, unless such installations are approved existing installations, which shall be permitted to be continued in service. NFPA 54 9.6.1.1 Commercial Cooking Appliances. Commercial cooking appliances that are moved for cleaning and sanitation purposes shall be connected in accordance with the connector manufacturer ’ s installation instructions using a listed appliance connector complying with ANSI Z21.69/CSA 6.16, Connectors for Movable Gas Appliances. The commercial cooking appliance connection installation shall be configured in accordance with the manufacturer ’ s installation instructions. 9.6.1.2 Restraint. Movement of appliances with casters shall be limited by a restraining device installed in accordance with the connector and appliance manufacturer ’ s installation instructions. This deficiency could affect occupants, who might include residents, staff, and visitors within the smoke compartment. The deficient item was discussed with the facility maintenance director during the exit conference.”

“Fire Alarm System - Testing and Maintenance CFR(s): NFPA 101 Fire Alarm System - Testing and Maintenance A fire alarm system is tested and maintained in accordance with an approved program complying with the requirements of NFPA 70, National Electric Code, and NFPA 72, National Fire Alarm and Signaling Code. Records of system acceptance, maintenance and testing are readily available. 9.6.1.3, 9.6.1.5, NFPA 70, NFPA 72 This Standard is not met as evidenced by: 49177 Through document review during the survey, it was determined that the facility failed to meet the protection requirements in accordance with NFPA 101 and 72. This was evidenced by: 1) Fire alarm Annual: 2.6.24 Microtek, Report not adequate information per NFPA 72 requirements. The report shows smoke, heat, and elevator recall not tested. The strobes were not Synchronized, and the Pharmacy strobe did not activate 2) Fire alarm Semi-Annual: Not Provided 3) Fire alarm Sensitivity test (2 Years) (72 14.4.5.3.2): Not Provided Based on a record review, it was determined that the facility failed to maintain the fire alarm system components and devices in accordance with the Life Safety Code Section 9.6 and NFPA 72. NFPA 101, Section 9.6.1.5* To ensure operational integrity, the fire alarm system shall have an approved maintenance and testing program complying with the applicable requirements of NFPA 70, National Electrical Code, and NFPA 72, National Fire Alarm and Signaling Code. NFPA 101 19.3.4.1 to comply with section 9.6. Section 9.6.1.3, fire alarm system testing and maintenance to comply with NFPA 72. NFPA 72 14.2.1.2.2 System defects and malfunctions shall be corrected. NFPA 72 Table14.4.5 Testing Frequencies This deficiency could affect occupants, who might include residents, staff, and visitors within the entire facility. The deficient item was discussed with the maintenance team at the exit conference.”

“Sprinkler System - Maintenance and Testing CFR(s): NFPA 101 Sprinkler System - Maintenance and Testing Automatic sprinkler and standpipe systems are inspected, tested, and maintained in accordance with NFPA 25, Standard for the Inspection, Testing, and Maintaining of Water-based Fire Protection Systems. Records of system design, maintenance, inspection and testing are maintained in a secure location and readily available. a) Date sprinkler system last checked _____________________ b) Who provided system test ____________________________ c) Water system supply source __________________________ Provide in REMARKS information on coverage for any non-required or partial automatic sprinkler system. 9.7.5, 9.7.7, 9.7.8, and NFPA 25 This Standard is not met as evidenced by: 49177 Through document review during the survey, it was determined that the facility failed to meet the protection requirements in accordance with NFPA 101, and 25. This was evidenced by: 1) Fire Sprinkler Weekly/Monthly: Not Provided 2) Fire Sprinkler Annual: 5.18.2024 Cooper Fire. Dry barrel heads need replacement per report heads dated 2006 3) Fire Sprinkler Semi-Annual: Not Provided 4) Need inspection reports for Chemical system in MRI trailer 5) remove the grounding cable from the fire sprinkler system Based on a record review, it was determined that the facility failed to maintain the fire sprinkler system components and devices in accordance with the Life Safety Code Section 9.6 and NFPA 72. NFPA 101, 9.7.5 Maintenance and Testing. All automatic sprinkler and standpipe systems required by this Code shall be inspected, tested, and maintained in accordance with NFPA 25, Standard for the Inspection, Testing, and Maintenance of Water-Based Fire Protection Systems. NFPA 25, Chapter 5 Sprinkler Systems Table 5.1.1.2 shall be used to determine the minimum required frequencies for inspection, testing, and maintenance. NFPA 25, Chapter 13 Common Components and Valves Table 13.1.1.2 shall be used to determine the minimum required frequencies for inspection, testing, and maintenance. NFPA 25 4.3.1* Records shall be made for all inspections, tests, and maintenance of the system and its components and shall be made available to the authority having jurisdiction upon request. 4.3.2 Records shall indicate the procedure performed (e.g., inspection, test, or maintenance), the organization that performed the work, the results, and the date. NFPA 25 5.3.1.1.1.6* Dry sprinklers that have been in service for 10 years shall be replaced, or representative samples shall be tested and then retested at 10-year intervals. NFPA 101 9.7.3.1 In any occupancy where the character of the fuel for fire is such that extinguishment or control of fire is accomplished by a type of automatic extinguishing system in lieu of an automatic sprinkler system, such system shall be installed in accordance with the appropriate standard, as determined in accordance with Table 9.7.3.1. NFPA 101, 9.7.1.1* Each automatic sprinkler system required by another section of this Code shall be in accordance with one of the following: (1) NFPA 13, Standard for the Installation of Sprinkler Systems NFPA 13 10.6.8* In no case shall the underground piping be used as a grounding electrode for electrical systems. This deficiency could affect occupants, who might include residents, staff, and visitors within the entire facility. The deficient item was discussed with the maintenance team at the exit conference.”

“Corridors - Construction of Walls CFR(s): NFPA 101 Corridors - Construction of Walls 2012 EXISTING Corridors are separated from use areas by walls constructed with at least 1/2-hour fire resistance rating. In fully sprinklered smoke compartments, partitions are only required to resist the transfer of smoke. In nonsprinklered buildings, walls extend to the underside of the floor or roof deck above the ceiling. Corridor walls may terminate at the underside of ceilings where specifically permitted by Code. Fixed fire window assemblies in corridor walls are in accordance with Section 8.3, but in sprinklered compartments there are no restrictions in area or fire resistance of glass or frames. If the walls have a fire resistance rating, give the rating _____________ if the walls terminate at the underside of the ceiling, give brief description in REMARKS, describing the ceiling throughout the floor area. 19.3.6.2, 19.3.6.2.7 This Standard is not met as evidenced by: 49177 Through observation during the survey, it was determined that the facility failed to maintain hazardous areas in accordance with NFPA 101. This was evidenced by: 1) The receiving dock wall is not smoke-tight, has multiple penetrations, and transfer grill 2) The waste room firewall needs to be patched 3) The sterile humidifier room is not smoke-tight needs ceiling or wall patched NFPA 101 19.3.6.2.3* Corridor walls shall form a barrier to limit the transfer of smoke. NFPA 101 4.5.8 Maintenance. Whenever or wherever any device, equipment, system, condition, arrangement, level of protection, or any other feature is required for compliance with the provisions of this Code, such device, equipment, system, condition, arrangement, level of protection, or other feature shall thereafter be maintained, unless the Code exempts such maintenance. This deficiency could affect occupants, including residents, staff, and visitors within the entire building. Deficient items were discussed with the facility maintenance director during the exit conference.”

“Utilities - Gas and Electric CFR(s): NFPA 101 Utilities - Gas and Electric Equipment using gas or related gas piping complies with NFPA 54, National Fuel Gas Code, electrical wiring and equipment complies with NFPA 70, National Electric Code. Existing installations can continue in service provided no hazard to life. 18.5.1.1, 19.5.1.1, 9.1.1, 9.1.2 This Standard is not met as evidenced by: 49177 Through observation during the survey, it was determined that the facility failed to maintain hazardous areas in accordance with NFPA 101 and 70. This was evidenced by: 1) remove storage from the waste room near electrical panels NFPA 101 9.1.2 Electrical Systems. Electrical wiring and equipment shall be in accordance with NFPA 70, National Electrical Code, unless such installations are approved existing installations, which shall be permitted to be continued in service. NFPA 70 110.26 Spaces About Electrical Equipment (A) Working Space. Working space for equipment operating at 600 volts, nominal, or less to ground and likely to require examination, adjustment, servicing, or maintenance while energized shall comply with the dimensions of 110.26(A)(1), (A)(2), and (A)(3) or as required or permitted elsewhere in this Code. (B) Clear Spaces. Working space required by this section shall not be used for storage. When normally enclosed live parts are exposed for inspection or servicing, the working space, if in a passageway or general open space, shall be suitably guarded. This deficiency could affect occupants, including residents, staff, and visitors within the smoke compartment. Deficient items were discussed with the facility maintenance director during the exit conference.”

“HVAC CFR(s): NFPA 101 HVAC Heating, ventilation, and air conditioning shall comply with 9.2 and shall be installed in accordance with the manufacturer’s specifications. 18.5.2.1, 19.5.2.1, 9.2 This Standard is not met as evidenced by: 49177 Through document review during the survey, it was determined that the facility failed to meet the protection requirements in accordance with NFPA 101, 80, 90A, and 105. This was evidenced by: 1) Fire Dampers report (4-6 years)(101 8.5.5.4.1 & 80 19.4): Not Done NFPA 101 8.5.5.4.1 Air-conditioning, heating, ventilating ductwork, and related equipment, including smoke dampers and combination fire and smoke dampers, shall be installed in accordance with NFPA 90A, Standard for the Installation of Air-Conditioning and Ventilating Systems, and NFPA 105, Standard for Smoke Door Assemblies and Other Opening Protectives. NFPA 80 19.4* Periodic Inspection and Testing. 19.4.1 Each damper shall be tested and inspected 1 year after installation. 19.4.1.1 The test and inspection frequency shall then be every 4 years, except in hospitals, where the frequency shall be every 6 years. NFPA 105 6.5 Periodic inspection and testing. 6.5.1 Smoke dampers for dedicated and non-dedicated smoke control systems shall be inspected and tested in accordance with NFPA92A, Standard for Smoke-Control Systems Utilizing Barriers and Pressure Differences. 6.5.2* Each damper shall be tested and inspected one year after installation. The test and inspection frequency shall then be every 4 years, except in hospitals, where the frequency shall be every 6 years. This deficiency has the potential to affect occupants, who might include residents, staff, and visitors within the entire facility. Deficient items were discussed with the facility maintenance director during the exit conference.”

“Fire Drills CFR(s): NFPA 101 Fire Drills Fire drills include the transmission of a fire alarm signal and simulation of emergency fire conditions. Fire drills are held at expected and unexpected times under varying conditions, at least quarterly on each shift. The staff is familiar with procedures and is aware that drills are part of established routine. Where drills are conducted between 9:00 PM and 6:00 AM, a coded announcement may be used instead of audible alarms. 19.7.1.4 through 19.7.1.7 This Standard is not met as evidenced by: 49177 Through document review during the survey, it was determined that the facility failed to meet the protection requirements in accordance with NFPA 10. This was evidenced by: 1) Fire Drills not provided for 2nd shift, 2nd and 3rd quarter. 1st and 2nd shift drills are not varied. NFPA 101 19.7.1.6 Drills shall be conducted quarterly on each shift to familiarize facility personnel (nurses, interns, maintenance engineers, and administrative staff) with the signals and emergency action required under varied conditions. This deficiency has the potential to affect occupants, who might include residents, staff, and visitors within the entire facility. The deficient item was discussed with the maintenance team at the exit conference.”

“Maintenance, Inspection & Testing - Doors CFR(s): Maintenance, Inspection & Testing - Doors Fire doors assemblies are inspected and tested annually in accordance with NFPA 80, Standard for Fire Doors and Other Opening Protectives. Non-rated doors, including corridor doors to patient rooms and smoke barrier doors, are routinely inspected as part of the facility maintenance program. Individuals performing the door inspections and testing possess knowledge, training or experience that demonstrates ability. Written records of inspection and testing are maintained and are available for review. 19.7.6, 8.3.3.1 (LSC) 5.2, 5.2.3 (2010 NFPA 80) This Standard is not met as evidenced by: 49177 Through observation during the survey, it was determined that the facility failed to meet the protection requirements in accordance with NFPA 101 and NFPA 80. This was evidenced by: 1) exam room 7 requires a fire closure on the fire door 2) The drop fire window for the kitchen needs to be inspected NFPA 101, 8.3.3.1 Openings required to have a fire protection rating by Table 8.3.4.2 shall be protected by approved, listed, labeled fire door assemblies and fire window assemblies and their accompanying hardware, including all frames, closing devices, anchorage, and sills in accordance with the requirements of NFPA 80, Standard for Fire Doors and Other Opening Protectives, except as otherwise specified in this Code. NFPA 80, 5.2 Inspections. 5.2.1 Fire door assemblies shall be inspected and tested not less than annually, and a written record of the inspection shall be signed and kept for inspection by the AHJ. 5.2.15.3 Where a fire door, frame, or any part of its appurtenances is damaged to the extent that it could impair the door ’ s proper emergency function, the following actions shall be performed: (1)The fire door, frame, door assembly, or any part of its appurtenances shall be repaired with labeled parts or parts obtained from the original manufacturer. (2)The door shall be tested to ensure emergency operation and closing upon completion of the repairs. These deficiencies can potentially affect occupants, including residents, staff, and visitors throughout the facility. The deficient item was discussed with the maintenance team at the exit conference.”

“Electrical Systems - Maintenance and Testing CFR(s): NFPA 101 Electrical Systems - Maintenance and Testing Hospital-grade receptacles at patient bed locations and where deep sedation or general anesthesia is administered, are tested after initial installation, replacement or servicing. Additional testing is performed at intervals defined by documented performance data. Receptacles not listed as hospital-grade at these locations are tested at intervals not exceeding 12 months. Line isolation monitors (LIM), if installed, are tested at intervals of less than or equal to 1 month by actuating the LIM test switch per 6.3.2.6.3.6, which activates both visual and audible alarm. For LIM circuits with automated self-testing, this manual test is performed at intervals less than or equal to 12 months. LIM circuits are tested per 6.3.3.3.2 after any repair or renovation to the electric distribution system. Records are maintained of required tests and associated repairs or modifications, containing date, room or area tested, and results. 6.3.4 (NFPA 99) This Standard is not met as evidenced by: 49177 Through document review during the survey, it was determined that the facility failed to maintain the electrical systems in accordance with NFPA 99. This was evidenced by: 1) The facility does not inspect wet locations every 6 months as required by NFPA 99 6.3.2.2.8.5. 2) The facility does not meet the record-keeping requirements per NFPA 99 6.3.4.2 3) Receptacle Testing (99 6.3.4.1): Not Provided NFPA 99 6.3.2.2.8.5(B)(4) (B) Fixed receptacles, equipment connected by cord and plug, and fixed electrical equipment shall be tested as follows: (1) When first installed (2) Where there is evidence of damage (3) After any repairs (4) At intervals not exceeding 6 months NFPA 99 6.3.4.2 Record Keeping. 6.3.4.2.1* General. 6.3.4.2.1.1 A record shall be maintained of the tests required by this chapter and associated repairs or modification. 6.3.4.2.1.2 At a minimum, the record shall contain the date, the rooms or areas tested, and an indication of which items have met, or have failed to meet, the performance requirements of this chapter. NFPA 99 6.3.4.1.1 Where hospital-grade receptacles are required at patient bed locations and in locations where deep sedation or general anesthesia is administered, testing shall be performed after initial installation, replacement, or servicing of the device. 6.3.4.1.2 Additional testing of receptacles in patient care rooms shall be performed at intervals defined by documented performance data. 6.3.4.1.3 Receptacles not listed as hospital-grade at patient bed locations and in locations where deep sedation or general anesthesia is administered shall be tested at intervals not exceeding 12 months. This deficiency has the potential to affect occupants, who might include residents, staff, and visitors within the entire facility. The deficient item was discussed with the maintenance team at the exit conference.”

“Electrical Systems - Essential Electric Syste CFR(s): NFPA 101 Electrical Systems - Essential Electric System Maintenance and Testing The generator or other alternate power source and associated equipment is capable of supplying service within 10 seconds. If the 10-second criterion is not met during the monthly test, a process shall be provided to annually confirm this capability for the life safety and critical branches. Maintenance and testing of the generator and transfer switches are performed in accordance with NFPA 110. Generator sets are inspected weekly, exercised under load 30 minutes 12 times a year in 20-40 day intervals, and exercised once every 36 months for 4 continuous hours. Scheduled test under load conditions include a complete simulated cold start and automatic or manual transfer of all EES loads, and are conducted by competent personnel. Maintenance and testing of stored energy power sources (Type 3 EES) are in accordance with NFPA 111. Main and feeder circuit breakers are inspected annually, and a program for periodically exercising the components is established according to manufacturer requirements. Written records of maintenance and testing are maintained and readily available. EES electrical panels and circuits are marked, readily identifiable, and separate from normal power circuits. Minimizing the possibility of damage of the emergency power source is a design consideration for new installations. 6.4.4, 6.5.4, 6.6.4 (NFPA 99), NFPA 110, NFPA 111, 700.10 (NFPA 70) This Standard is not met as evidenced by: 49177 Through document review during the survey, it was determined that the facility failed to meet the protection requirements in accordance with NFPA 101, 99, and 110. This was evidenced by: 1) Generator fuel quality (annually) (110 8.3.8): Not Provided NFPA 99 15.5.1.3 Emergency Generators and Standby Power Systems. Emergency generators and standby power systems, where required for compliance with this code, shall be installed, tested, and maintained in accordance with NFPA 110, Standard for Emergency and Standby Power Systems. NFPA 110 8.3.8 A fuel quality test shall be performed at least annually Using tests approved by ASTM standards. This deficiency could affect occupants, including residents, staff, and visitors within the entire facility. The deficient item was discussed with the maintenance team at the exit conference.”

“Features of Fire Protection - Other CFR(s): NFPA 101 Features of Fire Protection - Other List in the REMARKS section any NFPA 99 Chapter 15 Features of Fire Protection requirements that are not addressed by the provided K-Tags, but are deficient. This information, along with the applicable Life Safety Code or NFPA standard citation, should be included on Form CMS-2567. Chapter 15 (NFPA 99) This Standard is not met as evidenced by: 49177 Through observation during the survey, it was determined that the facility failed to meet the protection requirements in accordance with NFPA 99. This was evidenced by: 1) Defend in Place strategy is being utilized for patient care, fire sprinkler and fire alarm systems do not meet NFPA 99 requirements for Defend in Place. NFPA 99 15.7.4.3 Defend in Place. For new and existing facilities, where the response to a fire is to defend in place within a safe place in the building, occupant notification shall be in accordance with the facility fire plan. 15.7.4.3.1* Where buildings are required to be subdivided into smoke compartments, fire alarm notification zones shall coincide with one or more smoke compartment boundaries or shall be in accordance with the facility fire plan. 15.8.1.2* Defend in Place. For new and existing facilities, where the response to a fire is to defend in place within a safe place in the building and not to automatically evacuate the building, sprinkler system zones shall coincide with smoke compartment boundaries or shall be in accordance with the facility fire plan. This deficiency could affect occupants, who might include residents, staff, and visitors within all smoke compartments. Deficient items were discussed with the facility maintenance director during the exit conference.”

“EMERGENCY SERVICES CFR(s): The CAH provides emergency care necessary to meet the needs of its inpatients and outpatients. This Condition is not met as evidenced by: 50313 Based on the manner and degree of the standard level deficiency referenced to the Condition, it was determined the Condition of Participation §485.618 Emergency Services out of compliance. C-0886 Drugs and biologicals commonly used in life-saving procedures, including analgesics, local anesthetics, antibiotics, anticonvulsants, antidotes and emetics, serums and toxoids, antiarrhythmics, cardiac glycosides, antihypertensives, diuretics, and electrolytes and replacement solutions. Based on observations, interviews, and document review, the facility failed to ensure expired medications were removed and replaced to provide usable equipment in an emergency. Specifically, expired medications were not removed and replaced to be readily available for use in an emergency in one of three code carts. C-0888 LIFE-SAVING EQUIPMENT AND SUPPLIES [Equipment, supplies, and medication used in treating emergency cases are kept at the CAH and are readily available for treating emergency cases. The items available must include the following:] (2) Equipment and supplies commonly used in life-saving procedures, including airways, endotracheal tubes, ambu bag/valve/mask, oxygen, tourniquets, immobilization devices, nasogastric tubes, splints, IV therapy supplies, suction machine, defibrillator, cardiac monitor, chest tubes, and indwelling urinary catheters. Based on observations, interviews, and document reviews, the facility failed to discard expired emergency medical supplies per manufacturer instructions for use (IFU). Specifically, expired emergency supplies were not removed and replaced to be readily available for use in an emergency in one of three code carts.”

“PROVISION OF SERVICES CFR(s): §485.635 Condition of Participation: Provision of Services This Condition is not met as evidenced by: 50313 Based on the manner and degree of the standard level deficiency referenced to the Condition, it was determined the Condition of Participation §485.635 Provision of Services was out of compliance. C-1006 The CAH’s health care services are furnished in accordance with appropriate written policies that are consistent with applicable State law. Based on observations, interviews, and document review, the facility failed to ensure expired medical supplies were not readily available for patient use in five out of five observations. C-1046 Nursing services must meet the needs of patients. (1) A registered nurse must provide (or assign to other personnel) the nursing care of each patient, including patients at a SNF level of care in a swing-bed CAH. The care must be provided in accordance with the patient ’ s needs and the specialized qualifications and competence of the staff available. C-1048 A registered nurse or, where permitted by State law, a physician assistant, must supervise and evaluate the nursing care for each patient, including patients at a SNF level of care in a swing-bed CAH. Based on observations, interviews, and document review, the facility failed to ensure a registered nurse (RN) reviewed and evaluated the nursing care provided by a licensed practical nurse (LPN) in accordance with the Colorado Revised Statutes (CRS). C-1049 All drugs, biologicals, and intravenous medications must be administered by or under the supervision of a registered nurse, a doctor of medicine or osteopathy, or, where permitted by State law, a physician assistant, in accordance with written and signed orders, accepted standards of practice, and Federal and State laws. Based on observations, interviews and document review, the facility failed to ensure a licensed practice nurse (LPN) worked within the scope of practice of the Colorado Revised Statutes (CRS) and facility policy.”

“INFECTION PREVENT & CONTROL & ABT STEWAR PROG CFR(s): The CAH must have active facility-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 coordination with the facility-wide quality assessment and performance improvement (QAPI) program. 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 §485.640 Infection Prevention and Control and Antibiotic Stewardship Programs was out of compliance. C-1206 - The infection prevention and control program, as documented in its policies and procedures, employs methods for preventing and controlling the transmission of infections within the CAH and between the CAH and other healthcare settings. Based on observations, document reviews, and interviews, the facility failed to follow instructions for use (IFU), national guidelines, and facility policy for the use of detergent solution and the decontamination of surgical instruments to prevent the spread of infection in one out of one observation in the sterile processing department (SPD).”

“QAPI CFR(s): Condition of Participation: Quality Assessment and Performance Improvement Program The CAH must develop, implement, and maintain an effective, ongoing, CAH-wide, data-driven quality assessment and performance improvement (QAPI) program. The CAH must maintain and demonstrate evidence of the effectiveness of its QAPI program. (a) Definitions. For the purposes of this section- Adverse event means an untoward, undesirable, and usually unanticipated event that causes death or serious injury or the risk thereof. Error means the failure of a planned action to be completed as intended or the use of a wrong plan to achieve an aim. Errors can include problems in practice, products, procedures, and systems; and Medical error means an error that occurs in the delivery of healthcare services. This Condition is not met as evidenced by: 47962 Based on interviews and document review, the facility failed to ensure the quality assessment and performance improvement (QAPI) program identified and implemented performance improvement activities, including high-risk, problem-prone areas. This failure affected the provision of services, infection control, and emergency services. (Cross-reference C-0886, C-0888, C-1006, C-1046, C-1048, C-1049, C-1206) Findings include: References: According to the Quality Assurance and Performance Improvement Program, the mission is to ensure the provision of quality healthcare by identifying and acting upon performance improvement (PI) opportunities. QAPI establishes the clinical and support service quality assurance and performance improvement structure. The facility ensures a planned, continuous, and systematic method for collecting and analyzing data and developing performance improvement activities that will positively impact patient outcomes. Quality of care and patient safety are foundational components of the QAPI Program. The facility will continuously assess and improve quality utilizing the Plan Do Study Act (PDSA) model of improvement to evaluate processes and systems, having a multidisciplinary team approach for PI projects, aggregating and analyzing data to identify improvement opportunities, and evaluating improvement opportunities based on the assessed value of each opportunity. To accomplish its objectives, the facility has developed a formal QAPI reporting structure that includes key entities. Each entity has specific responsibilities in the governance of the QAPI Program. The Board of Directors (Board) adopts the QAPI Program and Plan and provides input and direction. Leadership ensures that the facility has adequate resources to support the QAPI program and ensures that the QAPI program properly identifies and corrects areas of needed improvement. The Quality Council receives and analyzes periodic QAPI data/reports to ensure that the QAPI process is ongoing and effective. Leadership supports an effective framework for planning, directing, providing, and improving the quality of healthcare services and providing the right number of competent staff to meet the needs of the organization. QAPI staff develop and administer the QAPI Program to meet all regulatory requirements, present periodic summary reports to the Board, implement evidence-based, best practices, and collect, aggregate, and analyze information to improve patient outcomes. QAPI staff also assist in choosing performance indicators that promote ongoing measurement and assessment of quality and patient safety. Clinical staff understand and protect patient rights to provide safe and effective care while being responsive to individual patient needs. The facility identifies areas for improvement from continuous monitoring of current practices. PI projects may also be suggested by staff. Strategic operational decisions may result in performance improvement activities. Expansion or creation of new services or regulatory compliance can result in the need to improve processes. According to the Colorado Revised Statutes (CRS) intravenous (IV) Therapy/Venous Blood Sampling Scope of Practice, licensed professional nurses (LPNs) with IV authority may perform the following procedures under the supervision of a professional nurse or physician: utilize peripheral veins for intravenous access with a peripheral short catheter, and administer intravenous fluids, including dextrose 5%, normal saline, lactated ringers, sodium chloride 0.45%, sodium chloride 0.2%, premixed intravenous fluids containing electrolytes and vitamins, and pre-mixed (meaning IV solution prepared and labeled by a pharmacist or manufacturer) antibiotics, and monitor the systemic effects of intravenous therapy. LPNs are not authorized to perform access or deaccess of implanted central venous access ports (ports). According to the Infusion LPN job description, the LPN must be proficient in IV insertions for adults and management of ports. The LPN’s essential duties, functions, and responsibilities include accessing ports, completing dressing changes, performing injections and IV therapy, and administering medications according to pharmacy guidelines. 1. The facility failed to ensure the QAPI program identified and implemented performance improvement activities, including high-risk, problem-prone areas. A. Observations i. On 6/18/24, observations of the infusion center revealed staff were unable to continuously monitor patients receiving ketamine infusions, and a crash (emergency) cart was not available for patient emergencies. Observations revealed an exam room without windows, any other means of visualizing patients when the exam room door was closed, or a call light for patients to be able to contact staff during their medical treatments. During an interview with LPN #4 on 6/18/24 at 11:12 a.m., LPN #4 stated clinical staff left patients alone in the room and the staff re-entered at 10-minute intervals to assess vital signs. Observations at this time did not reveal a crash (emergency) cart or suctioning equipment located within the infusion department which LPN #4 verified in her interview. (Cross-reference C-1046). This lack of patient monitoring and emergency equipment in the infusion center was in contrast to the QAPI plan which read, the facility continuously monitored current practices to identify areas for improvement which would positively impact patient outcomes. ii. On 6/13/24, observations of the infusion center revealed several powdered antibiotics in the Pyxis (automated medication dispenser) which required reconstitution by staff, including LPN #4, although only pre-mixed IV solutions are within the LPN scope of practice. During an interview on 6/17/24 at 1:43 p.m. with LPN #4, LPN #4 stated they reconstituted antibiotics with IV fluids as this was within the LPN scope of practice. During an interview on 6/17/24 at 3:37 p.m. with the director of infusion, oncology, and pharmacy (Director) #7, they stated LPN #4’s job duties had been approved by facility leadership and Director #7 provided oversight to LPN #4. (Cross-reference C-1048, C-1049) The observations and interviews with LPN #4 and Director #7 were in contrast to the QAPI plan which read, the facility provided the right number of competent staff to meet the facility’s needs and continuously monitored current practices to identify areas for improvement which would positively impact patient outcomes. iii. On 6/11/24, observations of the sterile processing department (SPD) revealed staff failed to follow manufacturers’ instructions for use (IFUs) when processing surgical instruments and devices. Observations revealed sterile processing technician (Tech) #1 incorrectly processed a tray of surgical instruments by failing to follow multiple steps of the instruments’ IFUs during the pre-cleaning and cleaning steps. Observations also revealed Tech #1 incorrectly processed a laparoscope (an instrument inserted through the abdominal wall to enable viewing of the organs) when they failed to follow all of the IFUs, namely failing to rinse detergent from the soaked and scrubbed device. At this time, Tech #1 stated they did not know what national standards the facility used to process surgical instruments or how to access the instrument IFUs. (Cross-reference C-1206) This failure to follow the IFUs in the SPD was in contrast to the QAPI plan which read, the facility provided the right number of competent staff to meet the facility’s needs and continuously monitored current practices to identify areas for improvement which would positively impact patient outcomes. iv. On 6/10/24, observations in the radiology department revealed the adult crash cart (a wheeled container carrying medicine and equipment for use in emergency resuscitations) contained expired emergency supplies, including devices to ensure an open airway. (Cross reference C-0888) This observation of expired emergency supplies was in contrast to the QAPI plan which read, the facility continuously and systematically monitored current practices, collected and analyzed data, and developed performance improvement activities to positively impact patient outcomes, quality of care, and patient safety. v. On 6/10/24, observations in trauma bay #1 revealed the adult crash cart contained expired emergency medications which included amiodarone (a medication used to treat a fast or irregular heartbeat), naloxone (a medication used to reverse an opioid overdose), and lidocaine (a medication used to treat sudden cardiac arrest caused by dangerous heart rhythms). (Cross reference C-0886) These observations of expired emergency medications were in contrast to the QAPI plan which read, the facility continuously and systematically monitored current practices, collected and analyzed data, and developed performance improvement activities to positively impact patient outcomes, quality of care, and patient safety. vi. From 6/10/24 to 6/13/24, observations revealed expired medical supplies in multiple areas within the facility. (Cross reference C-1006) a. Observations conducted in the inpatient supply area revealed expired surgical gowns. b. Observations conducted in operating room (OR) #1 revealed expired tissue control devices and sterile gloves. c. Observations conducted of the OR malignant hyperthermia (dangerous elevation of body temperature) cart revealed expired IV tubing. d. Observations conducted of the post-anesthesia care unit (PACU) pain cart revealed an expired hypodermic needle. e. Observations conducted in the infusion center supply area revealed expired bone marrow aspirate kits (tools needed to extract bone marrow from the body). These observations of expired medical supplies were in contrast to the QAPI plan which read, the facility continuously and systematically monitored current practices, collected and analyzed data, and developed performance improvement activities to positively impact patient outcomes, quality of care, and patient safety. B. Document review i. Upon request, the facility was unable to provide policies on assessment and reassessment and cardiac monitoring within the infusion center. (Cross reference C-1046) This lack of patient care policies within the infusion center was in contrast to the QAPI plan which read, the facility continuously monitored current practices to identify areas for improvement which would positively impact patient outcomes. ii. Medical record review a. A review of medical records revealed clinical staff in the infusion center failed to safely monitor patients during ketamine (a controlled substance used to make people sleepy, relaxed, reduce pain, and improve mood) infusions. The nursing progress notes read Patients #29, #31, and #32 were placed on cardiac monitors and their vital signs were assessed every 10 minutes while receiving ketamine infusions. However, the medical record did not reveal evidence of electrocardiogram (EKG) (records the electrical signals in the heart) monitoring throughout treatment or any assessment or interpretation of heart rhythms. The review also failed to reveal changes in monitoring or additional interventions made for Patient #31, who had a history of hypertension (elevated blood pressure) and had an increase in blood pressure during at least one of their treatments. (Cross reference C-1046) This review of the medical records was in contrast to the QAPI plan which read, the facility continuously and systematically monitored current practices, collected and analyzed data, and developed performance improvement activities to positively impact patient outcomes, quality of care, and patient safety. b. A review of medical records revealed LPN #4 assessed and treated patients outside of the LPN scope of practice. Medical records revealed LPN #4 administered IV solutions, including a controlled substance, and performed patient assessments and monitoring. For example, LPN #4 administered and monitored Patient #29’s, #31’s, and #32’s ketamine (a controlled substance) infusions on multiple occasions, even during induction (the beginning phase) when increased monitoring was required. The review of records revealed LPN #4 also reconstituted and administered ceftriaxone (an antibiotic) to Patient #28. During an interview with Director #7 on 6/17/24 at 3:37 p.m., they stated LPNs were allowed to administer Ketamine and reconstitute and administer antibiotics. (Cross-reference C-1046, C-1048, C-1049) This review of the medical records was in contrast to the QAPI plan which read, the facility provided the right number of competent staff to meet the facility’s needs and continuously and systematically monitored current practices, collected and analyzed data, and developed performance improvement activities to positively impact patient outcomes, quality of care, and patient safety. c. A review of the medical records failed to reveal registered nurse (RN) supervision or oversight of LPN #4. A review of the records for Patients #28, #29, #31, and #32 revealed LPN #4 practiced independently without oversight by an RN or medical provider. During an interview with Director #7 on 6/17/24 at 3:37 p.m., they stated they provided oversight to LPN #4. (Cross-reference C-1048) This review of the medical records and interview with Director #7 was in contrast to the QAPI plan which read, the facility provided the right number of competent staff to meet the facility’s needs and continuously monitored current practices to identify areas for improvement which would positively impact patient outcomes. C. Interviews i. On 6/12/24 at 3:39 p.m., an interview was conducted with the director of quality (Director) #17. Director #17 stated members of the quality program continuously monitored the facility and staff’s practices for performance improvement opportunities. This was in contrast to the multiple observations of expired medications and supplies, lack of proper patient monitoring in the infusion center, lack of a crash cart in the infusion center, staff practicing outside their scope of practice, and a lack of LPN supervision. Director #17 stated the quality team asked staff members “why” questions and observed departmental practices to identify problem-prone areas. They stated they had provided ongoing education to staff on quality’s role within the facility and had encouraged staff members to report incidents to identify quality improvement opportunities. Director #17 stated they had identified high-risk, high-volume, or problem-prone areas by encouraging staff to report incidents, keeping open lines of communication with staff, and rounding on the floor which was in contrast to multiple observations, interviews, and document review which revealed concerns with infection control, nursing services, and emergency services. Director #17 stated the facility failed to monitor for expired medications and supplies. They stated the quality and leadership team had started rounding with a checklist but recognized staff needed more support to ensure they removed expired medications and supplies. Director #17 stated the concerns identified survey helped identify opportunities to improve in the SPD, including aligning SPD policies with current, evidence-based practices. They stated proper oversight of the SPD was important to ensure SPD staff were compliant with regulations and leadership trusted but verified staff’s competencies and adherence to guidelines. Director #17 stated leadership was responsible for ensuring compliance with regulations and the goals of the quality program. This interview was in contrast to the QAPI plan which read, the facility continuously monitored current practices to identify areas for improvement which would positively impact patient outcomes. The quality team ensured the QAPI process was ongoing and effective. ii. On 6/24/24 at 9:51 a.m. an interview was conducted with DON #5. DON #5 stated they provided oversight to Director #17 in their role as the quality director and were part of the quality team. They stated quality was responsible for identifying areas of improvement within the facility. DON #5 stated the quality team met with staff members from different departments each month to ensure issues were identified and addressed. They stated quality identified low volume, high risk quality improvement opportunities in a similar fashion; leadership staff rounded throughout the different departments, observed facility processes, and encouraged two way communication with staff. This statement was in contrast to the multiple observations, interviews, and document review which revealed concerns with infection control, nursing services, and emergency services. DON #5 stated they did not provide oversight to the infusion center or the infusion center staff as this was the responsibility of Director #7. DON #5 stated with the absence of a nurse manager in the infusion center, creating a lack of oversight, and a lack of communication between infusion center staff and the quality team, the facility failed to identify opportunities for performance improvement. They stated they were not aware patients receiving ketamine infusions failed to receive the monitoring needed to ensure safe and quality patient care. DON #5 stated they were also unaware LPN #4’s job duties exceeded the LPN scope of practice and LPN #4 was not supervised by an RN. DON #5 stated nurses were responsible for overseeing nurses. DON #5 also stated it was necessary for the infusion center to have a crash cart as patients who received ketamine infusions were at a higher risk of dissociation and hemodynamic changes. They stated additionally, any infusion patient could develop anaphylaxis (a severe allergic reaction resulting in difficulty or loss of breathing) for which emergency medications and supplies would be necessary. DON #5 stated the SPD needed strong leadership to identify quality concerns. They stated OR manager (Manager) #3 currently provided oversight to the SPD but did not have a sterile processing background. DON #5 stated the facility needed an SPD supervisor with a background in sterile processing to ensure the SPD technicians followed national guidelines and facility policies. This interview was in contrast to the QAPI plan which read, the facility continuously monitored current practices to identify areas for improvement. The quality team ensured the QAPI process was ongoing and effective. Leadership ensured the facility had adequate resources to support the QAPI program and ensured the QAPI program properly identified areas of needed improvement to positively impact patient outcomes. iii. On 6/18/24 at 8:42 a.m., an interview was conducted with chief operating officer (COO) #9. COO #9 stated their background was in nursing and they were an RN. They stated they were part of the quality team and governing body. COO #9 stated continuous leadership rounding and encouraging communication with floor staff were key components in the quality program. COO #9 stated the QAPI program and quality team were important for the facility to provide the best patient care. They stated the quality department identified concerns before they negatively impacted patient care, which was in contrast to the multiple observations of expired medications and supplies, lack of proper patient monitoring in the infusion center, lack of a crash cart in the infusion center, staff practicing outside their scope of practice, and a lack of RN supervision. COO #9 stated they oversaw Director #7 and the infusion center. They stated they had not had concerns with the quality or frequency of patient monitoring in the infusion center nor did they feel a crash cart was necessary in the infusion center as emergency department (ED) staff were close by. They stated Director #7 had researched the LPN scope of practice and created a job description for LPN #4, which COO #9 then approved. In contrast to interviews with DON #5, COO #9 stated DON #5 was also involved in the creation of the LPN job description and role. In contrast to the CRS for the LPNs scope of practice and a review of the medical records, COO #9 stated LPN #4 practiced within their scope and was always overseen by the infusion center RNs. Also in contrast to the interview with DON #5, COO #9 stated the director of infusion, oncology, and pharmacy (Director) #7 provided adequate supervision to LPN #4. COO #9 stated the infection control concerns identified in the SPD were due to inadequate staffing in the SPD. They stated the staff shortage had led to a decrease in quality control. COO #9 stated it was important to follow national guidelines and manufacturers’ IFUs to ensure patients received the best care. This interview was in contrast to the QAPI plan which read, the facility provided the right number of competent staff to meet the facility’s needs and continuously monitored current practices to identify areas for improvement which would positively impact patient outcomes. iv. On 6/24/24 at 11:45 a.m. an interview was conducted with chief executive officer and chief medical officer (CEO) #19. CEO #19 stated the facility had expanded their quality program recently as quality of care was central to the facility’s operations. They stated they had not previously been aware of quality concerns which impacted patient safety. CEO #19 stated the quality program was important to ensure the facility provided the best patient care. This interview was in contrast to the QAPI plan which read, leadership ensured the facility had adequate resources to support the QAPI program and ensured the QAPI program properly identified areas of needed improvement to positively impact patient outcomes.”

“DRUG AND BIOLOGICALS CFR(s): Drugs and biologicals commonly used in life-saving procedures, including analgesics, local anesthetics, antibiotics, anticonvulsants, antidotes and emetics, serums and toxoids, antiarrythmics, cardiac glycosides, antihypertensives, diuretics, and electrolytes and replacement solutions. This Standard is not met as evidenced by: 50313 Based on observations, interviews, and document review, the facility failed to ensure expired medications were removed and replaced to provide usable equipment in an emergency. Specifically, expired medications were not removed and replaced to be readily available for use in an emergency in one of three code carts. Findings include: Facility policy: According to the Medications Outdated policy, medications shall be removed from regular stock prior to their expiration dates to ensure safe and effective medication for patients. Crash cart drawers and medication kits will have a label denoting the earliest drug to expire. Pharmacy will check the crash carts and medication kits monthly for outdates. Any outdated drugs, drawers, or kits will be replaced/restocked prior to the expiration date. 1. The facility failed to ensure expired medications were removed and replaced to provide usable equipment in an emergency. A. Observations i. Observations conducted on 6/10/24 at 3:24 p.m. revealed the adult crash cart (a wheeled container carrying medicine and equipment for use in emergency resuscitations) in trauma bay #1 contained a sealed medication tray with expired medications. The following medications were expired in the crash cart: five vials of amiodarone (a medication used to treat a fast or irregular heartbeat) 150 mg/3 ml expired 5/2024, four vials of naloxone (a medication used to reverse an opioid overdose) 0.4 mg/1 ml expired 5/2024, and two vials of lidocaine (a medication used to treat sudden cardiac arrest caused by dangerous heart rhythms) 2% 100mg/5 ml expired 5/1/24. This was in contrast to the Medications Outdated policy which read, medications should have been removed from regular stock prior to their expiration dates to ensure safe and effective medication for patients. B. Interviews i. An interview was conducted on 6/10/24 at 3:30 p.m. with RN #10. RN #10 stated expired medications should not be administered to patients because the efficacy of the medication could not be guaranteed beyond the expiration date. RN #10 stated administration of expired medications could have harmed patients, altered the patient’s treatment outcome, and potentially caused patient decompensation. ii. An interview was conducted on 6/11/24 at 11:13 a.m. with RN #12. RN #12 stated if an expired medication was administered, the medication might not work the way it was supposed. RN #12 stated patients who received administration of expired medications were at risk of experiencing life-threatening adverse reactions. iii. An interview was conducted on 6/10/24 at 3:45 p.m. with pharmacist (Pharmacist) #11. Pharmacist #11 stated medication outdates were checked monthly by the pharmacy technicians. Pharmacist #11 stated the pharmacy department was responsible for removing all expired medications from the crash cart. Pharmacist #11 stated patients who were administered expired medications were at risk for adverse reactions since the effectiveness of expired medications could not be guaranteed.”

“EMERGENCY AND SUPPLIES CFR(s): Equipment and supplies commonly used in life-saving procedures, including airways, endotracheal tubes, ambu bag/valve/mask, oxygen, tourniquets, immobilization devices, nasogastric tubes, splints, IV therapy supplies, suction machine, defibrillator, cardiac monitor, chest tubes, and indwelling urinary catheters. This Standard is not met as evidenced by: 50313 Based on observations, interviews, and document reviews, the facility failed to discard expired emergency medical supplies per manufacturer instructions for use (IFU). Specifically, expired emergency supplies were not removed and replaced to be readily available for use in an emergency in one of three code carts. Findings include: Facility policy: According to the Expired Supplies policy, staff will monitor supply expiration dates and remove expiring supplies from inventory prior to the expiration date. Each clinical department manager is responsible for the handling of departmental supplies. Each clinical department manager will assign staff to monitor and remove expiring supplies prior to the expiration date. References: The Chloraprep Single Swab packaging read, do not use if expired. The Becton Dickinson (BD) 16 gauge (16 G), 18 G, and 20 G Insyte Autoguard peripheral intravenous (IV) catheter package read, sterile, do not reuse, and do not use if expired. The BD 0.9% Sodium Chloride Injection (saline flush) package read, sterile, do not use if expired. The i-Gel Supraglottic Airway, sizes two through five packaging read sterile, intended for single use, do not use if expired. The McKesson 3 cc luer lock tip syringe package read, sterile syringe, do not reuse. Do not use if expired. The McKesson Sterile Lubricating Jelly 3 g packet read, sterile if unopened, do not use if expired. The McKesson Bougie Endotracheal Tube Introducer package read, single-patient use only, do not use if expired. The Molnlycle Biogel PI Micro Sterile Gloves package read, do not use if the packaging is damaged. Do not use if expired. 1. The facility failed to ensure medical supplies used in emergencies were not expired, were discarded according to the medical device’s IFU, and were not readily available for patient use. A. Observations i. Observations conducted on 6/10/24 at 4:05 p.m. revealed the adult crash cart (a wheeled container carrying medicine and equipment for use in emergency resuscitations) in the radiology department contained expired emergency supplies. Among the expired supplies were five Molnlycke Biogel PI Micro Sterile Gloves ( disposable gloves that have been sterilized to remove dangerous germs and protect against bacteria and viruses) expired between 8/28/23 through 5/28/24, seven i-gel (an airway device used in anesthesia and resuscitation) sizes 2-5 expired between 6/2023 through 9/2023, three Kendall Defibrillation Electrodes (adhesive pads placed on the chest to treat sudden cardiac arrest) expired 6/2023 through 2/2024, one Teleflex Endotracheal Tube Oral/Nasal (a flexible tube inserted through the mouth or nose into the windpipe to help patients breathe) expired 5/2024, two Covidien Adult Colorimetric CO2 Detectors (a device used to confirm the placement of a breathing tube) expired 12/2022, and two McKesson Bougie Endotracheal Tube Introducers (a tools that helps place a breathing tube into a patient’s windpipe) expired 1/10/24. In total, sixty-five individual supplies were expired. This was in contrast to the Expired Supplies policy which read, staff should have monitored supply expiration dates and removed expiring supplies from inventory prior to the expiration date. This was also in contrast to the IFUs for the Chloraprep Single Swab, the BD) 16 gauge (16 G), 18 G, and 20 G Insyte Autoguard peripheral intravenous (IV) catheter, the BD 0.9% Sodium Chloride Injection (saline flush), the i-Gel Supraglottic Airway, sizes two through five, the McKesson 3 cc luer lock tip syringe, the McKesson Sterile Lubricating Jelly 3 g, the McKesson Bougie Endotracheal Tube Introducer, and the Molnlycle Biogel PI Micro Sterile Gloves which read, do not use if expired. B. Interviews i. An interview was conducted on 6/10/24 at 3:30 p.m. with RN #10. RN #10 stated staff should have conducted monthly checks of the medical supplies in crash carts to ensure supplies were not expired. RN #10 stated expired supplies should not be used because they may not work beyond the expiration date. ii. An interview was conducted on 6/12/24 with RN #13. RN #13 stated when medical supplies expired, their sterility and integrity became uncertain. RN #13 stated the risk of using expired supplies would have been a patient not receiving intended medical treatment and an increased likelihood of an adverse reaction. iii. An interview was conducted on 6/11/224 at 9:16 a.m. with the materials manager (Manager) #18. Manager #18 stated medical supplies were checked in the central supply room for expiration dates weekly to ensure supplies were not expired. Manager #18 stated once supplies were distributed to the emergency department, inpatient unit, or radiology department, staff in those departments would have been responsible for checking expiration dates on medical supplies.”

“PATIENT CARE POLICIES CFR(s): (1) The CAH’s health care services are furnished in accordance with appropriate written policies that are consistent with applicable State law. This Standard is not met as evidenced by: 50313 Based on observations, interviews, and document review, the facility failed to ensure expired medical supplies were not readily available for patient use in five out of five observations. Findings include: Facility Policy: The Expired Supplies policy read, staff will monitor supply expiration dates and remove expiring supplies from inventory prior to the expiration date. Inventory management (survey and removal from stock) of expiring supplies will be completed on a monthly basis. Staff assigned to inventory management will remove any supplies from use that are expiring within the next thirty days. The Malignant Hyperthermia (MH) Cart policy read, the Operating Room (OR) will have a cart stocked for the management of malignant hyperthermia (a life-threatening reaction to anesthesia that can occur during or after surgery) at all times. The MH cart will be maintained by the Anesthesia Department staff, OR staff and pharmacist jointly and checked monthly by the perioperative nurse on duty for expired inventory and/or expired medications. 1. The facility failed to ensure expired supplies were removed and not readily available for patient use. A. Observations i. Observations conducted on 6/10/24 at 3:50 p.m. in the inpatient supply area revealed fourteen surgical gowns ( personal protective garments worn by healthcare workers during surgeries to protect patients from the transfer of body fluids and germs) expired on 9/2023. ii. Observations conducted on 6/11/24 at 8:10 a.m. in operating room #1 revealed seven Stratafix Knotless Tissue Control Devices expired on 5/31/2024, and fifteen Biogel Sterile Gloves (disposable gloves that have been sterilized to remove dangerous germs and protect against bacteria and viruses), size 6.5-8, expired on 8/28/23 through 5/28/24. iii. Observations conducted on 6/22/24 at 9:24 a.m. of the OR Malignant Hyperthermia Cart revealed one Alaris Pump Infusion set (a flexible plastic tube that connects a bag of fluids or medication to a patient’s vein) expired on 5/28/24. This was in contrast to the Malignant Hyperthermia Cart policy which read the OR should have had a cart stocked for the management of MH at all times. iv. Observations conducted on 6/11/24 at 9:42 a.m. of the PACU Pain Cart revealed one Smith Medical 22 g Hypodermic NEEDLE-PRO (a needle safety device) expired on 11/28/23. v. Observations conducted on 6/13/24 at 2:34 p.m. in the Infusion Center supply area revealed two HEME FRESH Blood/Bone Marrow Aspirate Kits (a kit that contains tools needed to extract bone marrow from the body) expired on 4/20/24. This was in contrast to the Expired Supplies policy which read staff should have monitored supply expiration dates and removed expiring supplies from inventory prior to the expiration date. B. Interviews i. An interview was conducted on 6/10/24 at 3:30 p.m. with RN #10. RN #10 stated staff should have conducted monthly checks of the medical supplies in crash carts to ensure supplies were not expired. RN #10 stated expired supplies should not be used because they may not work beyond the expiration date. ii. An interview was conducted on 6/12/24 with RN #13. RN #13 stated when medical supplies expired, their sterility and integrity became uncertain. RN #13 stated the risk of using expired supplies would have been a patient not receiving intended medical treatment and an increased likelihood of an adverse reaction. iii. An interview was conducted on 6/11/224 at 9:16 a.m. with the materials manager (Manager) #18. Manager #18 stated medical supplies were checked in the central supply room for expiration dates weekly to ensure supplies were not expired. Manager #18 stated once supplies were distributed to the emergency department, inpatient unit, or radiology department, staff in those departments would have been responsible for checking expiration dates on medical supplies.”

“NURSING SERVICES CFR(s): Nursing services must meet the needs of patients. (1) A registered nurse must provide (or assign to other personnel) the nursing care of each patient, including patients at a SNF level of care in a swing-bed CAH. The care must be provided in accordance with the patient’s needs and the specialized qualifications and competence of the staff available. This Standard is not met as evidenced by: 47962 Based on observations, interviews, and document review, the facility failed to ensure patients received care in accordance with their needs. Specifically, the facility failed to ensure nurses continuously and appropriately monitored patients receiving ketamine infusions per guidelines. The facility also failed to ensure emergency equipment, including a crash cart and suctioning equipment, was immediately available in the infusion center to ensure the delivery of safe patient care. The facility additionally failed to ensure nursing staff initiated blood transfusions at the appropriate rate per facility policy. (Cross-reference C-1048 and C-1049) Findings include: Facility policy: According to the Blood and Blood Component Administration policy, begin the transfusion slowly (50 milliliters (mL) per hour) for the first 15-30 minutes, slowly increasing the rate (10mL per hour) so that the blood is completely transfused. References: According to UptoDateLexiDrug (provided by the facility) Ketamine medication information, ketamine is a schedule (controlled) III medication. Monitor heart rate, blood pressure, respiratory rate, and cardiac function (continuously monitored in patients with increased blood pressure or cardiac decompensation). Nursing physical assessment and monitoring requires monitoring of cardio/respiratory status. Cardiac monitoring and blood pressure monitoring are required. Ketamine causes increased blood pressure, heart rate, and cardiac output; cardiac arrhythmia (abnormal rhythm), cardiac decompensation (failure), and decreased blood pressure and heart rate. Ketamine can exacerbate underlying myocardial dysfunction which can result in increased blood pressure, heart rate, and cardiac output. Onset is rapid and a peak in blood pressure occurs within a few minutes of administration. Ketamine can cause respiratory depression (slowing down or absence of breathing) or apnea (temporary cessation of breathing) which can occur in slow sub-anesthetic intravenous (IV) infusion. The onset is typically, one to two minutes after IV administration. In the case of respiratory depression and apnea during slow subclinical IV infusions, onset occurred 25 minutes after the start of ketamine infusion. According to the Ketamine Package Insert, adverse reactions associated with ketamine administration include elevation of blood pressure and pulse rate, hypotension (low blood pressure), bradycardia (slow heart rate), and arrhythmia. Resuscitative (revive from death or unconsciousness) equipment should be ready for use. According to the Colorado Revised Statute (CRS) IV Therapy/Venous Blood Sampling and Scope of Practice for a Licensed Professional Nurse (LPN), the LPN scope of practice includes the following, observing and monitoring adult patients receiving IV solutions and administration of IV fluids, pre-mixed IV fluids containing electrolytes and vitamins, and premixed antibiotic solutions. 1. The facility failed to ensure nurses continuously and appropriately monitored patients receiving ketamine infusions in accordance with guidelines. A. Observations i. On 6/18/24 at 11:12 a.m., observations of the infusion center revealed an exam room without windows or other means of visualizing patients when the door was closed. This room did not contain a call light or other means for patients to contact staff during the infusion. During an interview with LPN #4 on 6/18/24 at 11:12 a.m., LPN #4 stated this room was most often used for ketamine infusions as the patients were given privacy once the door was closed. LPN #4 stated they placed patients in the room, exited, closed the door, and re-entered at 10-minute intervals to assess vital signs. This observation was in contrast to the Ketamine UptoDateLexiDrug information which read, ketamine infusions had the potential for respiratory and cardiac reactions which happened within minutes. Nursing staff were required to physically assess and monitor the patient’s cardio/respiratory status throughout treatment. B. Document review i. Upon request, the facility was unable to provide policies on assessment and reassessment and cardiac monitoring within the infusion center. ii. Medical records a. A review was conducted of Patient #29’s medical records. Patient #29 was a 53-year-old who presented for a series of ketamine infusions. Review revealed Patient #29 had a past medical history of chronic pain and major depressive disorder. The ketamine order, dated 8/31/23, from an outside provider revealed they required the patient to have electrocardiogram (EKG) (records the electrical signals in the heart) monitoring while receiving ketamine, from the time of admission to discharge. The nursing progress notes read Patient #29 was placed on a cardiac monitor and their vital signs were assessed every 10 minutes while receiving ketamine infusions. However, after Patient #29’s first visit for a ketamine infusion on 7/11/23, the medical record did not reveal evidence of EKG monitoring throughout treatment or any assessment or interpretation of heart rhythms. This lack of monitoring and assessment was in contrast to the provider’s order for Patient #29 and in contrast to the Ketamine UptoDateLexiDrug information which read, ketamine had the potential to cause changes in heart rate and rhythm and respiratory depression, both within minutes of administration. Nursing assessments and monitoring required cardiac monitoring and cardio/respiratory status to be monitored. Patient #29’s medication administration record (MAR) revealed LPN #4 administered Patient #29’s ketamine infusion during their induction (starting doses) phase on 7/17/23 and 7/19/23. LPN #4 also administered Patient #29’s ketamine infusion on 10/24/23, 1/3/24, and 5/1/24. The progress notes revealed LPN #4 additionally monitored Patient #29 on 7/17/23, 10/24/23, 1/3/24, and 5/1/24 while they received their ketamine infusion. This review of the medical record for Patient #29 was in contrast to an interview with registered nurse (RN) #6 on 6/17/24 at 4:00 p.m., which revealed LPNs were not allowed to administer Ketamine during the induction phase of the treatment and also the Colorado Revised Statutes on LPNs scope of practice, which revealed administering ketamine infusions and cardiac monitoring (if required for patients) were outside the LPNs’ scope of practice. b. A review was conducted of Patient #31’s medical records. Patient #31 was a 49-year-old with who presented for a series of ketamine infusions. Review revealed a past medical history of chronic pain and chronic depression. The medical record did not reveal a history and physical (a doctor’s assessment of a patient) over the past year. However, a consultation note with a neurologist on 3/8/24 (during the time Patient #31 was in the maintenance phase of ketamine) revealed a history of hypertension (high blood pressure) which was being treated with several blood pressure medications, although this diagnosis was not written into Patient #31’s “problem list” (relevant diagnoses). This history of hypertension was in contrast to an interview with the director of oncology, infusion, and pharmacy (Director) #7 on 6/18/24 at 2:16 p.m. during which they stated none of the ketamine infusion patients had diagnoses of hypertension. The nursing progress notes read Patient #31 was placed on a cardiac monitor and their vital signs were assessed every 10 minutes while receiving ketamine infusions. However, the medical record did not reveal evidence of EKG monitoring throughout treatment or any assessment or interpretation of heart rhythms. Additionally, on 3/28/24, Patient #31’s blood pressure (BP) at 1:42 p.m. was 146/90 (normal was 120/80), at 2:00 p.m. the BP had increased to 164/100, and at 2:10 p.m., the BP had increased to 170/99. The progress note on 3/28/24 by an RN read Patient #31 had tolerated the infusion well with no signs or symptoms of an adverse reaction. The progress note did not reveal any evidence the RN had identified Patient #31 was hypertensive or had implemented any interventions or additional monitoring for the increased blood pressure. This lack of monitoring and assessment was in contrast to the Ketamine UptoDateLexiDrug information which read, ketamine had the potential to cause changes in blood pressure, heart rate and rhythm, and worsen heart problems within minutes of administration. Nursing assessments and monitoring required monitoring of cardio/respiratory status and cardiac monitoring was required. Additionally, the MAR and nursing progress notes revealed on 11/2/23 and 12/28/23, LPN #4 administered and monitored Patient #31’s ketamine infusion. This review of the medical record for Patient #31 was in contrast to the Colorado Revised Statutes on LPNs scope of practice, which revealed administering ketamine infusions and cardiac monitoring (if required for patients) were outside the LPNs’ scope of practice. c. A review was conducted of Patient #32’s medical records. Patient #32 was a 77-year-old who presented for a series of ketamine infusions. Review revealed they had a past medical history of major depressive disorder. The order from the provider revealed they required the patient to have electrocardiogram (EKG) monitoring while receiving ketamine, from the time of admission to discharge. The nursing progress notes read Patient #32 was placed on a cardiac monitor and their vital signs were assessed every 10 minutes while receiving ketamine infusions. However, the medical record did not reveal evidence of EKG monitoring throughout treatment or any assessment or interpretation of heart rhythms. This lack of monitoring and assessment was in contrast to the Ketamine UptoDateLexiDrug information which read, ketamine had the potential to cause changes in heart rate and rhythm and respiratory depression, both within minutes of administration. Nursing assessments and monitoring required monitoring of cardio/respiratory status and cardiac monitoring was required. The MAR and progress notes also revealed on 1/3/24 and 2/27/24, LPN #4 administered and monitored Patient #32’s ketamine infusions. This review of the medical record for Patient #32 was in contrast to the Colorado Revised Statutes on LPNs scope of practice, which revealed administering ketamine infusions and cardiac monitoring (if required for patients) were outside the LPNs’ scope of practice. C. Interviews i. On 6/17/24 at 1:43 p.m., an interview was conducted with LPN #4. LPN #4 stated they received training in IV administration in school and they were certified to administer IV therapies. They stated they were generally aware the LPNs’ scope of practice was limited due to having fewer years of education than RNs. LPN #4 stated they were jointly overseen by Director #7 and director of nursing (DON) #5, however, Director #7 had advised LPN #4 which nursing practices were permissible within the LPN scope of practice. LPN #4 stated LPNs were not allowed to perform initial patient assessments so they were not able to administer any of the induction series, during which time the patient was assessed and monitored for reactions. LPN #4 stated they were only able to administer ketamine as part of the maintenance phase, which was in contrast to a review of the medical records for Patient #29. They stated their scope allowed them to administer scheduled (controlled) medications, including ketamine infusions, as long as they were not administering any of the induction series (the initial six doses of ketamine). This statement was in contrast to the Colorado Revised Statutes on LPNs scope of practice, which revealed administering ketamine infusions, or any controlled medication, was outside the LPNs’ scope of practice. LPN #4 stated ketamine infusions were performed to treat depression, post-traumatic stress disorder (PTSD), chronic pain, and autoimmune (the body attacks healthy cells) disorders. They stated ketamine infusions required the patients’ blood pressure, pulse rate, respirations, and oxygen saturation to be continuously monitored due to the possibility of an adverse reaction. However, LPN #4 stated they and the other nursing staff typically placed patients in a private room which allowed the patient a more restful treatment, connected them to a cardiac monitor, started the ketamine infusion, and then left the room. LPN #4 stated they re-entered at 10-minute intervals to document the vital signs. This was in contrast to a later interview on 6/18/24 at 8:42 a.m. during which LPN #4 stated they connected the patient to a cardiac monitor to record vital signs but did not perform cardiac monitoring. LPN #4’s performing cardiac monitoring on patients was in contrast to the Colorado Revised Statutes on LPNs’ scope of practice, which revealed cardiac monitoring was outside the LPNs’ scope of practice. However, not continuously monitoring a patient, including not cardiac monitoring, when infusing ketamine was in contrast to the Ketamine UptoDateLexiDrug information which read, nursing assessments and monitoring required cardiac monitoring and cardio/respiratory status to be monitored. LPN #4 stated it was important to ensure they performed only those patient care tasks that were within their scope to protect patient safety. However, they stated there was no risk to an LPN administering ketamine without RN oversight as Director #7 had determined these medications and practices were safely within LPN #4’s scope of practice, which was in contrast to the Colorado Revised Statutes on LPNs’ scope of practice. ii. On 6/17/24 at 4:00 p.m., an interview was conducted with oncology (cancer) RN #6. RN #6 stated patients who received ketamine infusions were not on cardiac monitoring. They stated they used the leads (adhesive electrodes applied to the skin) only to record the patients’ heart rates. RN #6 stated they and the other RNs made sure LPN #4 stayed within their scope when they provided patient care. They stated if they were unsure about the extent of LPN #4’s scope, they used outside resources to determine the answer. For example, they stated LPNs were not to provide cardiac monitoring as this was not within their scope, which was in contrast to an interview with LPN #4 and in contrast to a review of the medical records which read LPN #4 placed patients on a cardiac monitor. RN #6 stated LPN #4 was able to administer ketamine during the maintenance phase only, which was in contrast to the Colorado Revised Statutes on LPNs’ scope of practice. They also stated if the LPN practiced outside of their scope, there were no risks to the patients as patient care was always overseen by the RNs, which was in contrast to a review of the medical records for Patients #29, #31, and #32. iii. On 6/24/24 at 2:34 p.m., an interview was conducted with oncology physician (Physician) #15. Physician #15 stated they oversaw the medical care of patients in the oncology and infusion center. They stated however, they were more familiar cancer medications than ketamine. Physician #15 stated they had recently been provided the monitoring requirements for ketamine infusions and moving forwards, ketamine infusions would require close patient monitoring. They stated the facility’s practice of taking vitals on ketamine patients every 10 minutes was not acceptable as there was a risk of arrhythmia (changes in heart rhythm), low blood pressure, and respiratory arrest (patient stops breathing). Physician #15 stated cardiac monitoring was real-time monitoring of cardiac rhythm, heart rate, and oxygen saturation. They stated cardiac monitoring was to be continuously performed and recorded as there was otherwise no point in placing the patient on a cardiac monitor. Physician #15 stated they wanted the nursing staff to cardiac monitor patients on a ketamine infusion, monitor these patients one to one, document the interpretation of the heart rate and rhythm throughout treatment, and place an EKG strip in the medical record. This was in contrast to a review of the medical records for Patients #29, #31, and #32 which did not reveal this monitoring. Physician #15 stated this whole process, including documentation of heart rate and rhythm, was important to provide quality patient care. iv. On 6/18/24 at 9:11 a.m., an interview was conducted with DON #5. DON #5 stated they oversaw all nursing staff, except those in the infusion center who were overseen by Director #7. DON #5 stated they felt it was best practice for nursing staff to report to nursing leadership. DON #5 stated ketamine infusions had the potential to affect respiration, exacerbate cardiac issues by increasing heart rate, and cause supraventricular tachycardia (SVT) (faster heart rate). They stated there was no policy on cardiac monitoring for infusion patients; however, continuous cardiac monitoring for patients receiving ketamine therapy was important to visualize changes from the baseline EKG which was in contrast to a review of the medical records for Patients #29, #31, and #32. DON #5 stated the infusion center did not have a central monitoring system and there was no way to safely monitor a ketamine patient in a private room. They stated this process of monitoring patients was important to ensure patient safety. v. On 6/17/24 at 3:37 p.m., an interview was conducted with Director #7. Director #7 stated they oversaw the infusion center and LPN #4. They stated patients were to be continuously monitored with a cardiac monitor while receiving ketamine. During a later interview on 6/18/24 at 8:24 a.m., Director #7 stated none of the medications in the infusion center required cardiac monitoring so the infusion center did not use or perform cardiac monitoring. This was in contrast to her earlier statement and additionally in contrast to Ketamine UptoDateLexiDrug information which read, nursing assessments and monitoring required cardiac monitoring and cardio/respiratory status to be monitored. Director #7 stated they had researched the LPN scope of practice when they created the LPN position. They stated chief operating officer (COO) #9, who was an RN, and DON #5 determined the scope of LPN #4’s practice and COO #9 had approved the LPN job description which outlined their job duties and responsibilities. Director #7 stated LPN #4’s ability to administer medications and monitor patients was limited as LPNs did not have the training to understand the anatomy and physiology of patients with complex medical needs. They stated they were not aware administering scheduled medications was outside of the LPNs’ scope of practice. Director #7 stated although there could be a risk to the patients with LPN #4 administering ketamine and monitoring patients throughout the infusion, they felt comfortable with LPN #4’s practice as they had been educated on medication administration and the side effects of medications. Director #7 stated the biggest risk of infusing ketamine infusions, which was psychosocial dissociation, happened during the induction phase which LPN #4 did not oversee, which was in contrast to the Ketamine UptoDateLexiDrug information which read, ketamine had the potential to cause changes in heart rate and rhythm and respiratory depression, both within minutes of administration, and required close monitoring and assessment by nursing staff. vi. On 6/26/24 at 12:49 p.m., an interview was conducted with director of quality (Director) #17. Director #17 stated the facility did not require history and physicals (H&P) for the ketamine infusion patients. This lack of H&Ps which created a lack of knowledge on the medical histories of infusion patients was in contrast to Director #7’s statement on 6/18/24 at 2:16 p.m. that none of the ketamine infusion patients had diagnoses of hypertension while Patient #31’s medical record revealed a prior diagnosis of hypertension. This was important as the Ketamine UptoDateLexiDrug information read, ketamine had the potential to cause changes in heart rate and rhythm, within minutes of administration, and required close monitoring and assessment by nursing staff. vii. On 6/18/24 at 8:42 a.m., an interview was conducted with COO #9. COO #9 stated they were an RN with a background in nursing. They stated the infusion center had a private room for patients to receive treatment in a quiet environment. COO #9 stated patients in this room were not visible to or able to be monitored by staff without staff entering the room. COO #9 stated cardiac monitoring was only required for ketamine patients with a cardiac history and if patients experienced a problem during treatment, they were brought to the emergency department (ED). This statement was in contrast to the interview with LPN #4 and their own earlier statement which revealed patients were checked on every 10 minutes and nursing staff would be unaware of a patient emergency without being physically present in the patient room. COO #9 stated Director #7 oversaw LPN #4 although DON #5 was available for questions. COO #9 stated LPN #4 used a cardiac monitor only to monitor the vitals of patients receiving ketamine infusions and did not provide cardiac monitoring. This statement was in contrast to the earlier interview with LPN #4 and also in contrast to the review of the medical records for Patients #29, #31, and #32. COO #9 stated the risk of an LPN exceeding their scope of practice was patient harm. 2. The facility also failed to ensure emergency equipment, including a crash cart and suctioning equipment, was immediately available in the infusion center to ensure safe patient care. A. Observations i. On 6/18/24 at 11:12 a.m., additional observations of the infusion center did not reveal a crash (emergency) cart or suctioning equipment located within the infusion department. This was in contrast to the Ketamine Package Insert which read, as ketamine had the potential to cause changes in heart rate and rhythm, resuscitative equipment was to be ready for use. During an interview conducted on 6/18/24 at 11:12 p.m., LPN #4 stated they were concerned with the lack of availability of emergency equipment as this was necessary to ensure safe patient care. B. Interviews i. On 6/24/24 at 2:34 p.m., an interview was conducted with Physician #15. Physician #15 stated they had not seen a problem with the lack of emergency equipment on hand in the infusion center. They stated the center stored many medications for use in emergencies and if a patient suffered ill effects during treatment, ED staff were able to reach the patient within one to two minutes. ii. On 6/18/24 at 8:42 a.m., an interview was conducted with the chief operating officer (COO) #9. COO #9 stated if a patient had an adverse event while receiving their infusion, the infusion was stopped, and the patient was brought to the emergency department. This was in contrast to the Ketamine Package Insert which read, as ketamine had the potential to cause changes in heart rate and rhythm, resuscitative equipment was to be ready for use. 3. The facility failed to ensure nursing staff initiated blood transfusions at the appropriate rate per facility policy. A. Medical record review i. A review of Patient #33’s medical record revealed Patient #33 was a 64-year-old who presented to the infusion center for a blood transfusion (the transfer of blood products) for iron deficient anemia (a lack of healthy red blood cells). On 5/29/24, the RN notes read the RN started transfusing Patient #33’s first unit of blood at 9:18 a.m. at a rate of 10mL per hour. The note read the RN also started the second unit of blood at 11:55 a.m. at 10mL per hour. This review of Patient #33’s medical record was in contrast to the Blood and Blood Component Administration policy which read, the blood transfusion was started slowly (50 mL per hour) for the first 15-30 minutes and the rate was slowly increased. B. Interviews i. On 06/26/2024 at 10:57 a.m., an interview was conducted with RN #16. RN #16 stated they had experience with the administration of blood products. They stated it was important to start the blood transfusion at a low rate to allow nursing staff to monitor the patients for reactions. RN #16 stated the potential reactions to blood products included an allergic reaction, difficulty breathing, back pain, and could progress to patient death. ii. On 6/26/24 at 11:49 a.m., an interview was conducted with DON #5. DON #5 stated blood transfusions were started slowly to ensure nursing staff recognized infusion reactions, which ranged from an allergic reaction up to and including death, early on. They stated nursing staff assessed patients for hypotension (low blood pressure), hypertension, tachycardia (high heart rate), and respiratory distress. DON #5 stated if the blood was administered at a higher rate than the policy specified, the staff were less likely to observe the early signs of an infusion reaction which put the patient at greater risk.”

“NURSING SERVICES CFR(s): A registered nurse or, where permitted by State law, a physician assistant, must supervise and evaluate the nursing care for each patient, including patients at a SNF level of care in a swing-bed CAH. This Standard is not met as evidenced by: 50313 Based on observations, interviews, and document review, the facility failed to ensure a registered nurse (RN) reviewed and evaluated the nursing care provided by a licensed practical nurse (LPN) in accordance with the Colorado Revised Statutes (CRS). Findings include: Facility policy: According to the Medication Administration policy, only authorized staff members may administer medications. Nursing staff may administer medications according to their licensure and per department policies. Reference: According to the CRS IV Therapy/Venous Blood Sampling Scope of Practice, LPNs with IV authority may perform the following procedures under the supervision of a professional nurse or physician: utilize peripheral veins for intravenous access with a peripheral short catheter, and administer intravenous fluids, premixed intravenous fluids containing electrolytes and vitamins, and pre-mixed antibiotics, and monitor the systemic effects of intravenous therapy. 1. The facility failed to ensure the nursing care provided by LPNs was supervised by an RN or physician. A. Document review i. A review of Patient #28’s medical record revealed Patient #28 had outpatient appointments in the infusion center on 6/10/24 and 6/12/24 for an intravenous (IV) infusion of Ceftriaxone (a medication used to kill bacterial infections and to prevent bacterial growth). On 6/10/24 and 6/12/2024 LPN #4 administered the Ceftriaxone infusions and performed assessments before, during, and after the infusion of Ceftriaxone. There was no evidence in Patient #28’s medical record that LPN #4’s care of Patient #28, including IV access and IV antibiotic administration was supervised by an RN or physician. ii. A review of Patient #29’s medical record revealed Patient #29 had outpatient appointments in the infusion center on 7/17/23, 10/25/23, 1/3/24, and 5/1/24 for an IV infusion of Ketamine (a medication used for sedation or to treat depression that causes intoxication, hallucinations, and disassociation). On 7/17/23, 10/25/23, 1/3/24, and 5/1/24 LPN #4 inserted Patient #29’s peripheral IV and administered Patient #29’s Ketamine infusions. There was no evidence in Patient #29’s medical record that LPN #4’s care of Patient #29, including IV access and IV medication administration was supervised by an RN or physician. This was in contrast to the CRS IV Therapy/Venous Blood Sampling Scope of Practice which read, LPNs with IV authority were permitted to perform the following procedures under the supervision of a professional nurse or physician: utilize peripheral veins for intravenous access with a peripheral short catheter, and administer intravenous fluids, premixed intravenous fluids containing electrolytes and vitamins, and pre-mixed antibiotics, and monitor the systemic effects of intravenous therapy. B. Interviews i. An interview was conducted on 6/17/2024 at 1:43 p.m. with LPN #4. LPN #4 stated they independently inserted peripheral IVs and accessed PICC lines and Ports without RN supervision. LPN #4 stated the director of the infusion center (Director) #7 checked in as things came up, with no set time for supervision or oversight of LPNs. LPN #4 also stated the director of nursing (DON) #5 was available if things came up. LPN #4 stated they utilized RNs in the infusion center if they had questions. LPN #4 stated they independently reconstituted IV antibiotic medications including Ceftriaxone, and administered IV medications such as Ceftriaxone and Ketamine. LPN #4 stated they were not permitted to administer the first dose of a new medication for a patient because this required an initial assessment. LPN #4 stated they were permitted to perform follow-up assessments independently. This was in contrast to the CRS IV Therapy/Venous Blood Sampling Scope of Practice which read, LPNs with IV authority were permitted to perform the following procedures under the supervision of a professional nurse or physician: utilize peripheral veins for intravenous access with a peripheral short catheter, and administer intravenous fluids, premixed intravenous fluids containing electrolytes and vitamins, and pre-mixed antibiotics, and monitor the systemic effects of intravenous therapy. ii. An interview was conducted on 6/17/24 at 4:00 p.m. with RN #6. RN #6 stated they worked in the infusion center with LPN #4. RN #6 stated it was the RNs role to make sure patients were appropriate for LPNs to care for. RN #6 stated they were available if LPN #4 had a question, or if LPN #4 was not comfortable performing a task. iii. An interview was conducted on 6/18/24 at 9:11 a.m. with the director of nursing (DON) #5. DON #5 stated they did not have direct oversight over LPN #4 in the infusion center, although they did oversee all of nursing. DON #5 stated if an LPN accessed a port, it should have been under RN supervision. DON #5 stated Director #7 was not a registered nurse, and there should have been a registered nurse overseeing LPN #4’s patient care and procedures. iv. An interview was conducted on 6/17/24 at 3:37 p.m. with Director #7. Director #7 stated that a nurse manager would have been responsible for LPN #4’s supervision of care, but there was not currently a nurse manager in the infusion center. Director #7 stated RNs in the infusion center were available to answer LPN #4’s questions. Director #7 stated RNs would review any new intravenous medications with LPN #4 before LPN #4 was permitted to administer those intravenous medications independently.”

“NURSING SERVICES CFR(s): §485.635(d)(3) All drugs, biologicals, and intravenous medications must be administered by or under the supervision of a registered nurse, a doctor of medicine or osteopathy, or, where permitted by State law, a physician assistant, in accordance with written and signed orders, accepted standards of practice, and Federal and State laws. This Standard is not met as evidenced by: 50313 Based on observations, interviews and document review, the facility failed to ensure a licensed practice nurse (LPN) worked within the scope of practice of the Colorado Revised Statutes (CRS) and facility policy. Findings include: Facility policy: According to the Medication Administration policy, only authorized staff members may administer medications. Nursing staff may administer medications according to their licensure and per department policies. According to the Vascular Access Device-Implanted Ports policy, implanted ports (a device that is surgically placed under the skin to provide long-term medication access to veins extending near or inside the heart) are utilized for intravenous (a procedure that involves inserting a needle or tube into the vein) access. Only registered nurses may access or de-access an implanted port. References:: According to the Infusion LPN job description, the LPN must be proficient in IV insertions for adults, and management of Ports. The LPN’s essential duties, functions, and responsibilities include accessing ports, completing dressing changes, performing injections and IV therapy, and administering medications according to pharmacy guidelines. According to the CRS IV Therapy/Venous Blood Sampling Scope of Practice, LPNs are not authorized to perform access or deaccess of implanted central venous access ports (ports). The LPN scope of practice permits the administration of the following intravenous fluids: dextrose 5%, normal saline, lactated ringers, sodium chloride 0.45%, sodium chloride 0.2%, pre-mixed (meaning IV solution prepared and labeled by a pharmacist or manufacturer) intravenous fluids containing electrolytes and vitamins, and pre-mixed antibiotic solutions. 1. The facility failed to ensure LPNs with intravenous (IV) authority practiced within their scope for IV access and administration of medications in accordance with the CRS. A. Observations i. Observations conducted on 6/13/24 at 9:35 a.m. in the infusion center revealed two antibiotics, Ertapenem (a medication used to treat severe infections caused by bacteria) and Ceftriaxone (a medication used to kill bacterial infections and to prevent bacterial growth) were available in the Pyxis. These medications were only available in a powdered form and required mixing with saline before they were administered to a patient. B. Record Review i. A review of Patient #28’s medical record revealed LPN #4 administered two grams of Ceftriaxone intravenously to Patient #28 in the infusion center on 6/10/24 and 6/12/24. ii. A review of Patient #29’s medical record revealed LPN #4 administered IV Ketamine (a medication used to cause sedation or treat depression)) to Patient #29 in the infusion center on 7/17/23, 7/19/23, 10/25/23, 11/27/23, 1/4/24, and 5/1/24. This was in contrast to the CRS IV Therapy/Venous Blood Sampling Scope of Practice which read LPNs were not authorized to administer intravenous fluids except for dextrose 5%, normal saline, lactated ringers, sodium chloride 0.45%, sodium chloride 0.2%, pre-mixed intravenous fluids containing electrolytes and vitamins, and pre-mixed antibiotic solutions. C. Interviews i. An interview was conducted on 6/13/24 at 9:35 a.m. with RN #14. RN #14 stated the Pyxis (an automated dispensing system that stores and manages medications in patient care units) located in the infusion center contained two antibiotics, Erapenem and Ceftriaxone. RN #14 stated the two antibiotics were in powder form and would have required reconstitution with normal saline prior to administration. RN #14 stated LPNs were permitted to reconstitute powdered antibiotics within their scope of practice. This was in contrast to the CRS IV Therapy/Venous Blood Sampling Scope of Practice which read, LPNs were only permitted to administer pre-mixed antibiotic solutions. ii. An interview was conducted on 6/17/24 at 1:43 p.m. with LPN #4. LPN #4 stated they were required to obtain an additional IV certification before administering IV infusions and obtaining IV access. LPN #4 stated they had accessed and deaccessed patients’ ports in the infusion center. LPN #4 stated there were restrictions for LPN’s scope of practice with IV infusions because LPNs received less education than RNs. LPN #4 stated if they had questions about their scope of practice for medication administration or IV infusions they would have asked the director of the infusion center, consulted pharmacy, or contacted the director of nursing. LPN #4 stated they routinely reconstituted powdered antibiotics, including ceftriaxone, with saline prior to IV administration. LPN #4 stated the LPN scope of practice did not permit mixing medications, including antibiotics, due to a lack of education and the need to perform dosing calculations. LPN #4 stated reconstituting was not mixing because they used the entire vial of medication with saline. LPN #4 stated they routinely administered maintenance doses of Ketamine to patients intravenously. LPN #4 stated they were not permitted to administer the initial loading doses of Ketamine to patients. LPN #4 stated Ketamine could cause hypotension (abnormally low blood pressure), hypertension (abnormally high blood pressure), and could cause a patient’s oxygen level to decrease suddenly. LPN #4 stated it was important to practice within the LPN scope of practice for patient safety. LPN #4 stated the risks of not properly administering infusions included cardiac problems, dizziness, fluid overload, and death. This was in contrast to the Vascular Access Device-Implanted Ports policy which read, only registered nurses may access or de-access an implanted port. This was also in contrast to the CRS IV Therapy/Venous Blood Sampling Scope of Practice which read, LPNs are not authorized to perform access or deaccess of Ports or to administer intravenous fluids except for dextrose 5%, normal saline, lactated ringers, sodium chloride 0.45%, sodium chloride 0.2%, pre-mixed intravenous fluids containing electrolytes and vitamins, and pre-mixed antibiotic solutions. iii. An interview was conducted on 6/18/24 at 9:11 a.m. with the director of nursing (DON) #5. DON #5 stated they had not assisted in creating LPN #4’s job description or scope of practice at the facility. DON #5 stated they did not have direct oversight over the nurses in the infusion center or LPN#4, although they would have been available as a resource. They stated if an LPN had accessed a port in the infusion center, this should have been under the direct oversight of an RN. DON #5 stated only trained staff with appropriate scope of practice should have accessed ports because ports were central lines with a high potential for hospital-acquired infections. DON #5 stated there would have been a risk of patient harm if an RN or LPN utilized the wrong size syringe or lumen when accessing a port. iv. An interview was conducted on 6/18/2024 at 8:43 a.m. with the chief operational officer (COO) #9. COO#9 stated when the facility hired LPN #4, Director #7 researched the LPN scope of practice. COO #9 stated Director #7 informed the facility that LPN #4 was not permitted to perform initial assessments or to administer chemotherapy. COO #9 stated they had no concerns about LPN #4’s scope of practice at the facility. COO #9 stated the risk of practicing outside the scope of practice would have been patient harm if LPN #4 had not used resources well. v. An interview was conducted on 6/17/2024 at 3:37 p.m. with the director of oncology, infusion, and pharmacy (Director) #7. Director #7 stated the LPN scope of practice did not specify which medications would have been in the scope of practice for LPN #4. Director #7 stated they based LPN #4’s scope of practice for medication administration on whether the medication was new for a patient or whether the medication would have required an initial assessment by an RN. Director #7 stated there were high-risk medications, such as chemotherapy (a drug treatment that uses powerful chemicals to kill fast-growing cells, such as cancer cells), that would have been unsafe for an LPN to administer. Director #7 stated it was unsafe for an LPN to administer high-risk medications because these required an understanding of the anatomy and physiology of a patient and involved complex processes. Director #7 stated it was within the LPN scope of practice to reconstitute antibiotics by adding saline to a vial of powdered antibiotics. Director #7 stated patients receiving IV Ketamine in the infusion center would have been on the cardiac monitor during the infusion. Director #7 stated RNs would have been available while LPN #4 administered Ketamine to a patient. Director #7 stated there could be a concern if an LPN performed cardiac monitoring for a patient instead of an RN. Director #7 stated DON #5 and COO #9 created the scope of practice for LPN #4 for the infusion center, and that RNs were available to answer LPN #4’s questions. Director #7 stated the risk of an LPN administering medications outside the scope of practice would have been patient harm from a lack of knowledge of patient anatomy and physiology or how to handle an emergency situation.”

“INFECTION PREVENT & CONTROL POLICIES CFR(s): The infection prevention and control program, as documented in its policies and procedures, employs methods for preventing and controlling the transmission of infections within the CAH and between the CAH and other healthcare settings; This Standard is not met as evidenced by: 49541 Based on observations, document reviews, and interviews, the facility failed to follow instructions for use (IFU), national guidelines, and facility policy for the use of detergent solution and the decontamination of surgical instruments to prevent the spread of infection in one out of one observation in the sterile processing department (SPD). Findings include: Facility policies: The Inspection and Sorting of Instruments Policy read, inspection and sorting of instruments should be done simultaneously during the decontamination/cleaning and prep/packaging for High-Level Disinfection and/or Sterilization process. Instruments must be completely cleaned per the manufacturers instruction for use to ensure proper function and effective re-processing. References: According to the Association for the Advancement of Medical Instrumentation (AAMI) Sterile Processing - Knowledge, Skills, Competencies, cleaning is the most important step in sterile processing; thorough cleaning removes most microorganisms and other organic material from contaminated items. Unless an item is clean, it cannot be effectively disinfected or sterilized. Any soil, no matter how little, can prevent disinfectant or sterilant from contacting the surface of an item. We can assess visible contamination by examining items carefully, but microorganisms are invisible so we consider items contaminated even when we cannot see any soil. The best resource for determining how best to manage an item is the manufacturer’s IFU. The AAMI Point of Use and Transporting Soiled Instruments section Instrument Care read, all instruments, instrument trays, and sets that are opened for a sterile procedure are considered contaminated, even if they did not come in direct contact with the patient. At the end of a procedure in the operating room (OR), both used and unused instruments are returned to the set from which they came, and the entire set is considered contaminated and returned for processing. Infectious microorganisms are invisible so we cannot always determine contamination by visual inspection. The Association of periOperative Registered Nurses (AORN) (2012-2023), Guidelines for Perioperative Practice: Instrument Cleaning read, failure to clean, inspect, disinfect or sterilize an item may lead to transmission of pathogenic microorganism from a contaminated device and create risk for patient injury, including surgical site infection. Follow the cleaning product manufacturer’s written IFU for water quality, solution concentration and dilution, water temperature, contact time, conditions of storage and shelf life and use life. The AORN (2013-2019) Guidelines for Perioperative Practice: Guideline for Instrument Cleaning read, facilities were to provide education and verify competency for specific knowledge and skills related to the cleaning and care of surgical instruments including the following: location and understanding of manufacturers’ IFUs for the reusable surgical instrument or medical device, decontamination equipment, cleaning chemicals and disinfectants, inspection equipment, and cleaning verification tools; organizational procedures for decontamination and cleaning verification. Ongoing development of knowledge and skills and documentation of personnel participation is a regulatory requirement for both hospital and ambulatory settings. The Integra Miltex IFU read, personnel should follow accepted guidelines as recommended in ANSI/AAMI ST79. Precleaning instructions read, Remove gross contaminants with a steady stream of lukewarm/cool water (below 110°F/43°C). Rinse each instrument thoroughly. Rinse instruments thoroughly under warm distilled or demineralized water. Do not use steel wool, wire brushes, pipe cleaners or abrasive detergents to remove soil as these will damage the instrument and lead to corrosion. Stryker Video Devices Processing IFU read, rinse the device with critical water until all detergent residue is removed. Once all detergent residue is removed, continue to rinse for 10 seconds. Drain excess water from the device and dry it using a clean, lint-free cloth or pressurized air. Visually inspect the device for cleanliness, paying close attention to hard-to-reach areas. The Revital-Ox 2X Concentrate Enzymatic Detergent read, the detergent is a low foaming, neutral pH, free rinsing detergent formulated for cleaning of flexible and rigid endoscopes, related accessories and other reusable medical devices prior to high level disinfection or sterilization. After soaking, rinse the device thoroughly with warm water including lumens/channels 1. The facility failed to ensure surgical instruments were cleaned and processed in accordance with facility policies and manufacturers’ IFU. Specifically, the facility failed to manually clean and soak all surgical instruments in an enzymatic detergent prior to sterilization. A. Observations i. On 6/11/24 at 2:37 p.m., observations were conducted in the SPD. Observations revealed surgical instruments from a laparoscopic surgery set tray were processed and cleaned by sterile processing technician (Tech) #1. Tech #1 placed surgical instruments from the surgical instrument tray directly into the automatic washer. Tech #1 stated it was the facility’s policy to not manually clean surgical instruments that were not used in the surgical case. Tech #1 submerged the remaining surgical instruments (the soiled instruments used during the surgical procedure), in a detergent solution before being scrubbed. Multiple surgical instruments were grossly soiled with blood during the manual cleaning process. Tech #1 stated that the instruments should have been pre-cleaned in the OR prior to being transported to SPD. Tech #1 used a metal wire brush to manually clean the instruments. Surgical instruments were not rinsed before or after being soaked in the detergent solution, and before being placed in the automatic washer. Tech #1 stated that the instruments did not need to be rinsed prior to being placed in the automatic washer. Tech #1 placed the remaining instruments in a metal basket and placed the instruments in the automatic washer. Multiple hinged surgical instruments overlapped and were in a closed position. Further observation revealed Tech #1 reprocessing a Skriker AIM HD laparoscope. The laparoscope was grossly soiled with blood during the manual cleaning process. Tech #1 submerged laparoscopes in a detergent solution before scrubbing them with a surgical sponge. Tech #1 removed the laparoscopes from the detergent and placed them on a nearby counter to dry. Tech #1 stated the laparoscopes did not need to be rinsed before being placed in the autoclave for sterilization. Tech #1 stated they did not know what national standards the facility used to process surgical instruments or how to access the IFUs. ii. The observations conducted on 6/11/24 revealed surgical instruments were processed incorrectly per the facility’s policy, national guidelines, and manufacturers’ IFU. Examples included: Observations on 6/11/24 were in contrast to the AAMI Point of Use and Transporting Soiled Instruments section Instrument Care which read, all instruments, instrument trays, and sets that were opened for a sterile procedure were considered contaminated, even if they did not come in direct contact with the patient. At the end of a procedure in the operating room (OR), both used and unused instruments were returned to the set from which they came, and the entire set was considered contaminated and returned for processing. Observations on 6/11/24 were in contrast to the AORN (2013-2019) Guidelines for Perioperative Practice: Guideline for Instrument Cleaning which read, facilities were to provide education and verify competency for specific knowledge and skills related to the cleaning and care of surgical instruments including the following: location and understanding of manufacturers’ IFUs for the reusable surgical instrument or medical device. Observations on 6/11/24 were in contrast to the Integra Miltex IFU which read, personnel should have followed accepted guidelines as recommended in ANSI/AAMI ST79. Precleaning instructions read, removed gross contaminants with a steady stream of lukewarm/cool water (below 110°F/43°C). Instruments were rinsed thoroughly under warm distilled or demineralized water. Cleaning instructions read, do not use steel wool, wire brushes, pipe cleaners or abrasive detergents to remove soil as these will damage the instrument and lead to corrosion. Observations on 6/11/24 were in contrast to the Stryker Video Devices Processing IFU which read, rinse the device with critical water until all detergent residue was removed. Once all detergent residue was removed, continue to rinse for 10 seconds. Observations on 6/11/24 were in contrast to the Revital-Ox 2X Concentrate Enzymatic Detergent which read, after soaking, rinse the device thoroughly with warm water including lumens/channels. B. Interviews i. On 6/11/24 at 3:02 p.m., an interview was conducted with Tech #1. Tech #1 stated the instruments brought from the OR earlier that day were soiled and not precleaned at the point of use. Tech #1 stated they were unaware they needed to manually clean instruments that were not visibly soiled. Tech #1 stated they were not informed on how to reprocess the instruments per the manufactures’ IFU. ii. On 6/11/24 at 3:02 p.m., an interview was conducted with infection prevention nurse (IP) #2. IP #2 stated they were new to the facility and did not have the opportunity to assess the SPD. IP #2 stated they did not have experience in the SPD and requested additional training with the facilities leadership. IP #2 stated the surgical instruments were to be cleaned and processed per the manufacturers’ IFU. IP #2 stated that it was important to follow the manufacturers’ IFUs to ensure that instruments were cleaned properly. IP #2 stated instruments that were not cleaned properly would put the patient at risk for a surgical site infection (SSI). iii. On 6/13/24 at 7:55 a.m., an interview was conducted with Manager #3. Manager #3 stated the facility followed AAMI and AORN guidelines in the SPD. Manager #3 stated surgical instruments should have been precleaned in the OR to remove visible contamination. Manager #3 stated all surgical instruments should have been cleaned per the manufacturers’ IFU. Manager #3 stated they were unaware all surgical instruments were to be manually cleaned. Manager #3 stated the facility would only manually clean surgical instruments that were used in the surgical case and that unused instruments were placed directly in the automatic washer to be cleaned. Manager #3 stated hinged instruments should have been opened and not overlapping with other instruments before being placed in the automatic washer. Manager #1 stated when surgical instruments were not correctly manually cleaned after the procedure, the instruments could have been contaminated with bioburden (organic material from a prior procedure) and potentially caused a surgical infection. Manager #1’s interview was in contrast to the observations on 5/2/24 which showed surgical instruments were not processed per the manufacturers’ IFU. Manager #1’s interview was in contrast to the AAMI Point of Use and Transporting Soiled Instruments section Instrument Care which read, all instruments, instrument trays, and sets that were opened for a sterile procedure were considered contaminated, even if they did not come in direct contact with the patient. At the end of a procedure in the operating room (OR), both used and unused instruments were returned to the set from which they came, and the entire set was considered contaminated and returned for processing.”

“PATIENTS RIGHTS CFR(s): A CAH must protect and promote each patient’s rights. This Condition is not met as evidenced by: 47962 Based on the manner and degree of the standard level deficiency referenced to the Condition, it was determined the Condition of Participation §485.614, PATIENT RIGHTS, was out of compliance. C-2523 The patient has the right to receive care in a safe setting. Based on observations, interviews, and document review, the facility failed to ensure patients received care in a safe setting. Specifically, the facility failed to ensure items which could be used for harm to self or others including ligature risks (anything which could be used to create an attachment point such as a cord, rope, or other material for the purpose of hanging or strangulation) were identified and removed from patient care rooms and the restroom and patients with acute psychiatric complaints were monitored according to policy. This failure was identified in four of five patients reviewed who presented with psychiatric complaints. (Patients #2, #6, #13, #17)”

“PRIVACY AND SAFETY CFR(s): The patient has the right to receive care in a safe setting. This Standard is not met as evidenced by: 47962 Based on observations, interviews, and document review, the facility failed to ensure patients received care in a safe setting. Specifically, the facility failed to ensure items which could be used for harm to self or others including ligature risks (anything which could be used to create an attachment point such as a cord, rope, or other material for the purpose of hanging or strangulation) were identified and removed from patient care rooms and the restroom and patients with acute psychiatric complaints were monitored according to policy. This failure was identified in four of five patients reviewed who presented with psychiatric complaints. (Patients #2, #6, #13, #17) Findings include: Facility policies: According to the Suicide Screening and Follow-Up policy, by implementing routine screening practices in all patient care settings, the facility will improve the identification of those at risk for suicide to reduce suicide in all patient populations. Emergency Department (ED) staff will complete suicide screening for patients over 12 years of age at every visit unless the patient is unable due to the severity of their medical condition or cognitive state. If a patient screens high risk, clinical staff will verbally communicate the score to the patient ’ s provider. According to the Depression Screening and Follow-up policy, ED staff will aim to complete depression screening for patients over 12 years of age at every visit per clinician discretion, unless the patient is unable. The facility aims to identify those patients suffering from depression and other mental health disorders to reduce suicide in all patient populations. According to the Mental Health Hold policy, any person deemed to pose a threat to themselves or others shall be placed in an exam room as close to the nursing station as possible. Equipment, linen, or supplies the patient could harm themself or others with should be removed from the room. Patients placed on a 72-hour hold after admission must be placed on one-to-one (1:1) observation in order to prevent the patient from leaving the hospital from an unsecured unit. According to the Nursing Standards of Patient Care policy, the purpose is to ensure that each patient receives appropriate nursing care and interventions, relevant to meet the patient ’ s needs. Each patient will receive nursing care and interventions to achieve the desired outcome for the patient. Each patient will be provided nursing care based on the identified needs and diagnosis, have a plan of care that respects their rights, will have nursing care and interventions available to meet their needs, will receive individualized care and interventions based on identified needs, will receive nursing care and interventions at the most beneficial or necessary time, will receive nursing care and interventions to achieve the desired outcome for the patient, will be provided safety measures and nursing care designed to reduce the risk of an intervention, reduce the risk in the care environment, and will receive respectful and caring nursing service. Reference: According to the Patient Rights and Responsibilities handout, the facility will treat patients with respect, in a safe setting. 1. The facility failed to remove ligature risks from patient care rooms and failed to monitor suicidal patients according to policy. A. Observations revealed patient rooms and the patient restroom in the emergency department (ED) contained ligature risks as well as other items which could be used for harm to self or others. i. Observations conducted on 4/29/24 at 3:35 p.m. and 5/2/24 at 9:14 a.m. revealed the patient rooms in the ED contained call lights connected to the wall by a cord. Patient rooms also contained monitoring equipment with attached cords, as well as examination equipment affixed to the wall. The patient bathroom in the ED contained a pull cord affixed to the wall for patients to use if they needed assistance, and a trash can which contained a plastic liner and visible waste. B. Document Review i. The facility was unable to provide evidence of policies and procedures pertaining to keeping psychiatric patients in the ED safe. a. Upon request on 5/1/24 at 8:55 a.m., the facility revealed they did not have a suicide precautions protocol or policy. At this time, an interview was conducted with ED nurse manager (Manager) #2 who stated there was not a standard procedure for patients admitted to the ED for suicidal (wanting to kill oneself) ideations (SI). b. Upon request on 5/1/24 at 8:55 a.m., the facility revealed they did not have a policy on sitters for psychiatric patients in the ED. At this time, an interview was conducted with Manager #2 who stated there was no ED policy for sitters and staff struggled to find sitters for psychiatric patients. ii. A review of medical records revealed patients with psychiatric complaints, including those who wanted to harm themselves or others, had unmonitored access to items with which to harm themselves and others in the rooms and their belongings and also were not continuously monitored by staff during their time in the ED. a. A review of Patient #2’s medical record revealed Patient #2 was a 17-year-old, admitted to the ED on 2/5/24 for depression. The record revealed Patient #2 had a long history of depression and had been uncommunicative over the past several days according to their parent. The triage note on 2/5/24 at 9:20 p.m. failed to reveal evidence the Columbia Suicide Severity Rating Scale (C-SSRS) which evaluated suicide risk had been performed, although Patient #2’s parent was afraid the patient was suicidal. In the triage Suicide Risk section, the nurse wrote “unable to obtain” without any additional documentation. This lack of suicide screening was in contrast to the Suicide Screening and Follow-Up policy which read, ED staff completed suicide screening for patients over 12 years of age to reduce the risk of suicide. From 2/5/24 at 9:05 p.m. to 2/6/24 at 8:46 a.m. (11 hours and 19 minutes), until the patient was transferred to an inpatient psychiatric facility, Patient #2 had access to their personal belongings and remained in their own clothing which allowed for unmonitored access to items which they could use for harm to self or others. The record also did not reveal evidence the room was made safe for Patient #2 or continuous patient monitoring occurred by staff during their time in the ED. b. A review of Patient #6’s medical record revealed Patient #6 was a 12-year-old, admitted to the ED on 4/2/24 for homicidal (wanting to kill others) ideations (HI). Patient #6 had a history of HI and attempts, along with a history of self-injury. The record revealed Patient #6 had been placed on a mental health 72-hour hold (M1) by a behavioral health center before arriving at the facility. From 4/2/24 at 12:24 p.m. to 4/3/24 at 8:38 a.m. (20 hours and 14 minutes), Patient #6 had access to their personal belongings and remained in their own clothing. The record also did not reveal evidence the room was made safe for Patient #6 which allowed for unmonitored access to items which they could use for harm to themselves or others. Additionally, the record revealed Patient #6 was monitored by their parents and failed to reveal staff involvement in continuously monitoring the patient during their time in the ED. This failure to remove belongings and lack of 1:1 monitoring by staff was in contrast to the Mental Health Hold policy which read, equipment, linen, or supplies the patients could use for self-harm were to be removed from the room and patients on a 72-hour hold were placed on 1:1 observation to prevent the patient from leaving the hospital. c. A review of Patient #13’s medical record revealed Patient #13 was a 44-year-old, admitted to the ED on 11/25/23 after a suicide attempt. The C-SSRS performed during triage on 11/25/24 at 12:35 a.m. revealed Patient #13 was at high risk for suicide. The record revealed Patient #13 was placed on an M1 hold on 11/25/23 at 2:06 a.m. due to being a danger to themself and had multiple plans to end their own life. Until 11/25/23 at 11:04 a.m. (eight hours and 58 minutes after the M1 hold was placed), when they were transferred to an inpatient psychiatric facility, Patient #13 had access to their personal belongings and remained in their own clothing. The record also did not reveal evidence the patient room or bathroom was made safe for Patient #13 or that staff continuously monitored Patient #13 during their time in the ED which allowed for unmonitored access to items which they could use for harm to self or others. This failure to remove belongings and lack of 1:1 monitoring by staff was in contrast to the Mental Health Hold policy which read, equipment, linen, or supplies the patients could use for self-harm were to be removed from the room and patients on a 72-hour hold were placed on 1:1 observation to prevent the patient from leaving the hospital. d. A review of Patient #17’s medical record revealed Patient #17 was a 39-year-old, admitted to the ED on 1/17/24 for suicidal ideations. The C-SSRS performed during triage on 1/17/24 at 6:30 p.m. revealed Patient #17 was at high risk for suicide. The record revealed Patient #17 was placed on an M1 hold on 1/17/24 at 10:00 p.m. due to being a danger to themself and had plans to end their own life. Until 1/18/24 at 8:10 a.m. (10 hours and 10 minutes after the M1 hold was placed), Patient #17 remained in their own clothing and had access to their personal belongings, including a box of nicotine pouches, a “sleep mask/gator,” and a charger for their phone. The record also did not reveal evidence the patient room or bathroom was made safe for Patient #17 or that staff continuously monitored Patient #17 during their time in the ED which allowed for unmonitored access to items which they could use for self-harm. Additionally, on 1/18/24 at 9:52 p.m., the nursing rounding notes revealed the patient walked to the cafeteria for food. This failure to remove belongings for more than 10 hours after the M1 hold was placed and the lack of 1:1 monitoring by staff was in contrast to the Mental Health Hold policy which read, equipment, linen, or supplies the patients could use for self-harm were to be removed from the room and patients on a 72-hour hold were placed on 1:1 observation to prevent the patient from leaving the hospital. This review of medical records for Patients #2, #6, #13, and #17 was in contrast to the Patient Rights and Responsibilities handout and the Nursing Standards of Patient Care policy which read, the facility treated patients respectfully, in a safe setting. Each patient received appropriate nursing interventions to achieve the desired outcome. Each patient had a plan that respected their rights and was provided safety measures and nursing care designed to reduce the risk of intervention and reduce risk in the care environment. C. Interviews i. On 4/29/24 at 4:21 p.m. and on 5/1/24 at 11:04 a.m., interviews were conducted with registered nurse (RN) #1. RN #1 stated patients in the ED were screened with the C-SSRS to ensure they were not suicidal. They stated if a patient presented with suicidal ideations and was screened as high risk on the C-SSRS, the patient’s room would be cleared of any unnecessary medical equipment and cords, and the patient’s belongings would be taken away to ensure patient safety, which was in contrast to a review of the medical records for Patients #2, #6, #13, and #17. They stated personal items were removed as patients’ belongings could contain items such as medications, weapons, or items with strings, and their clothing was also removed to ensure patients did not elope from the facility before they were treated. RN #1 stated patients were at risk of death by self-strangulation if they were allowed access to personal belongings with strings. RN #1 stated patients with psychiatric complaints were placed in a room close to the nurses’ station. They stated family was an acceptable choice for monitoring patients with psychiatric complaints if staff felt the family would not cause the patient to escalate in harmful behaviors. RN #1 stated although there was a risk patients could physically harm their families, due to a lack of staff sitters, family members were needed to assist with monitoring. In contrast to the review of medical records and observations made in the ED, which did not reveal continuous staff monitoring but did reveal ligature risks in the patient rooms and restroom, RN #1 stated safety was an important consideration when monitoring psychiatric patients. ii. On 5/1/24 at 8:55 a.m., an interview was conducted with Manager #2. Manager #2 stated there was no facility policy on sitters for patients with psychiatric complaints. They stated patients were placed in a room close to the nursing station and observed by the nurses. Manager #2 stated for children with psychiatric needs, the facility expected the parents to be at the bedside to inform staff if the children escalated. Manager #2 stated staff would not continuously monitor or observe these patients as this was the parents’ role, as revealed in the record review for Patients #2 and #6. Manager #2 stated as the expectation and goal was that the family would monitor the patients, the nursing notes would not document the monitoring or observation. Manager #2 stated having parents monitor pediatric patients was important as the children were distressed, potentially impulsive, in a strange environment, and needed the constant presence of family. However, Manager #2 stated there was a risk patients with psychiatric complaints would revert to erratic behavior, would elope, or harm themselves or others if they were not closely monitored by staff. Manager #2 stated staff accompanied patients with psychiatric complaints to the restroom, although the staff then waited outside the closed door. They stated the room was not cleared before patient use, the call light remained in the bathroom, and the patients were not monitored inside. This statement along with observations of the restroom, revealed patients were allowed unmonitored access to items which they could use for harm to self or others. Manager #2 also stated Patient #17, after being placed on the M1 hold, was accompanied to the cafeteria to allow them to select their own food, and staff did not believe this put the patient at additional risk of self-harm. Manager #2 stated there was no standard procedure for patients admitted to the ED for suicidal ideation. They stated it would be helpful however, to have a standard procedure for patients screened as high risk on the C-SSRS to ensure consistent application of suicide precautions. Manager #2 stated currently, patient belongings were not removed and patient rooms were not cleared unless it was deemed necessary, and was only done on a case-by-case basis. They stated for patients on an M1 hold however, belongings were removed, patients were given gowns, and rooms were cleared. This was in contrast to a review of medical records for Patients #6, #13, and #17 which did not reveal this was done. Manager #2 stated Patient #13 must not have arrived with belongings apart from their clothing, although they stated there was no way to know given the medical record did not reveal the removal of any belongings. Manager #2 stated there was a risk patients could have used any personal belongings or items left in the patient room or restroom to cause harm, especially if the patients were at risk for self-harm by strangulation. iii. On 5/1/24 at 2:23 p.m., an interview was conducted with ED physician (Physician) #3. Physician #3 stated for patients with psychiatric needs, it was important to make sure their room was made safe and to monitor the patient if there was a concern they wanted to harm themselves and had a plan to do so. This statement was in contrast to a review of the medical records for Patients #2, #6, #13, and #17, which did not reveal evidence patient rooms were made safe or the patients were continuously monitored. Physician #3 stated ideally, there would be a safe room for psychiatric patients which would not allow patient access to anything in which they could harm themselves. Physician #3 stated if a patient was on a mental health hold, their belongings were to be removed to ensure everyone’s safety, which was in contrast to a review of the medical records for Patients #6, #13 and #17. Physician #3 stated for pediatric patients with psychiatric complaints, they preferred for the parents to monitor the patient. They stated they assessed the situation, patient, and their family, and if Physician #3 felt the family was not a safe option due to safety concerns such as abuse, someone else, including a friend, could monitor the patient. Physician #3 stated sometimes their assessment of the family or friend was wrong and they did need to “backtrack” with who was allowed to monitor the patient. These statements were in contrast to the Nursing Standards of Patient Care policy which read, each patient was provided safety measures and nursing care designed to reduce the risk of intervention and reduce risk in the care environment. Physician #3 then stated patient monitoring was important to prevent patients from leaving the facility or self-harming, including hanging themselves, obtaining weapons with which to harm themselves, or using their own belongings to harm themselves.”