Aspen Valley Hospital District

“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. This failure impacted six of 20 patients’ medical records reviewed. 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 document review and interviews, the facility failed to ensure patients received stabilizing treatment within the facility’s capabilities prior to discharge in four of eight patients reviewed who presented to the emergency department (ED) with alcohol intoxication.”

“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 six of 20 patients’ medical records reviewed. (Patients #2, #3, #7, #8, #14, and #19) (Cross-reference C-2407) Findings include: Facility policies: According to the Emergency Medical Treatment and Labor Act (EMTALA) - Screening, Stabilization, Transfer policy, a person who presents to the facility and requests emergency services must be evaluated by a physician and provided treatment, appropriate to their presenting signs and symptoms. The MSE is the process required to determine, with reasonable clinical confidence, whether the patient has an EMC. The MSE may include laboratory testing, imaging, and other types of testing. After the MSE is completed, physicians stabilize any emergency condition and when appropriate, transfer patients to a higher level of care. Documentation of the MSE shall be made on the ED physician and nursing documentation forms. According to the Emergency Department (ED) Guidelines for Inebriated Patients policy, inebriated patients who present to the ED will be evaluated for medical clearance and medically stabilized based on findings. Once the patient is medically cleared, the patient may be discharged to home with appropriate support or transferred to a detox facility. If patients cannot be medically cleared in the ED they will be admitted or transferred to the appropriate level of care. According to the Standards of Care in the ED policy, the purpose is to provide guidelines for standards of nursing care for ED patients. The registered nurse (RN) collects comprehensive data pertinent to the patient’s health and situation. The RN formulates a plan of care for the patient based on assessment, nursing diagnoses, and outcome identification. The RN collaborates with the team to implement the plan of care in a safe practice environment. The RN consults on the identified plan and effects change. The emergency nurse collaboratively evaluates and modifies the plan of care based on patient responses and attainment of expected outcomes. The RN assists in the appropriate discharge plan by evaluating the patient ’ s severity of illness or injury, ability to care for self, and available support mechanisms. For patients being discharged home who have received a sedative within four hours, they must display stable vital signs. Reference: According to the Alcohol Withdrawal (a physiological response to stopping drugs or alcohol) /Polysubstance Abuse Clinical Institute Withdrawal Assessment for Alcohol (CIWA) order set provided by the facility, if the CIWA is between four to seven, check CIWA every 30 minutes. If the CIWA is between zero to three, check the CIWA every two hours for 24 hours, then every shift. Administer lorazepam (a medication causing sedation and relaxation) two milligrams (mg) every 30 minutes as needed for anxiety if the CIWA is between four to seven. Administer phenobarbital (anti-seizure medication) 130 mg every four hours as needed for agitation. 1. The facility failed to ensure patients presenting to the facility for an EMC received an MSE per facility policy. A. Medical record review i. A review was conducted of Patient #7’s medical record which revealed Patient #7 had presented to the ED for alcohol intoxication on 6/19/24 at 11:14 a.m. At 11:14 a.m., physician assistant (PA) #3 documented Patient #7’s current and past history of isopropyl alcohol consumption (rubbing alcohol). The physical exam documentation revealed Patient #7 was alert and oriented with normal mood and behavior. The physical exam section read Patient #7 showed a normal heart rate and pulmonary effort. This evaluation by PA #3 was in contrast to the triage vitals at 11:20 a.m. which revealed a heart rate (HR) of 107 (normal is 60-100), respiratory rate (RR) of 24 (normal is 16-20), and the chief complaint which read Patient #7 was confused. PA #3’s physical exam was also in contrast to physician (Provider) #4’s physical exam at 11:14 a.m., which revealed Patient #7 appeared agitated and markedly disheveled. Provider #4’s physical exam also documented Patient #7 looked uncomfortable, was tachycardic (elevated heart rate), tachypneic (elevated respiratory rate), and felt depressed. PA #3’s evaluation was also in contrast to the RN neurological assessment at 11:43 a.m. which documented Patient #7 was confused, disoriented to time and situation, had poor safety awareness, and displayed poor judgment. PA #3’s note documented the pH (acid-base balance in the body) of Patient #7’s venous blood gas (VBG) (measures oxygen and carbon dioxide in the blood) was 7.59 (normal is 7.31 to 7.41). At 11:55 a.m., Provider #4 documented Patient #7 showed “marked respiratory alkalosis” (acid-base imbalance in the body) and they planned to give lorazepam (a sedative) to slow down their breathing and correct the acid-base imbalance. The record revealed Patient #7 was administered lorazepam 1 milligram (mg) at 11:57 a.m., 2 mg at 12:39 p.m., and another 2 mg at 2:41 p.m. Provider notes revealed Patient #7 was discharged at 3:27 p.m. to a detox facility. Although Patient #7 had presented for alcohol intoxication with an abnormal neurological examination and in respiratory alkalosis, the provider and nursing notes did not reveal a CIWA, repeat VBG, or a follow-up neurological exam. Patient #7’s medical record revealed the patient was discharged to an outpatient detox facility at 3:27 p.m., however, the patient was subsequently brought back to a different ER approximately two hours after discharge for unresponsiveness and a rapid RR. This lack of physical assessment, including laboratory testing and a repeat neurological examination, as well as the lack of consideration of other potential etiologies given Patient #7’s state of confusion revealed an inappropriate MSE. PA #3 and Provider #4 failure to order a repeat VBG to assess Patient #7’s health before discharge and the nursing staff’s failure to perform a CIWA to assess for alcohol withdrawal contributed to the overall failure to provide an appropriate MSE which was in contrast to the EMTALA - Screening, Stabilization, Transfer policy which read, all patients requesting medical care received an MSE by a physician, appropriate to their presenting signs and symptoms. The MSE continued until the provider was able to rule out an EMC. ii. A review was conducted of Patient #8’s medical record which revealed Patient #8 had presented to the ED due to being cold on 9/14/23 at 9:30 p.m. The provider notes documented Patient #8 had a history of alcohol use disorder and appeared to be “mildly intoxicated.” The provider’s review of symptoms and physical exam revealed the patient had chills but was alert and oriented. The provider documented Patient #8 was “clinically sober” at the time of their evaluation, although this time was not specified, and was to be allowed to sleep in the ED until 6:30 a.m. the following day. The provider ordered a blood alcohol level which was 291 (normal is under 10) but did not order any other laboratory testing. At 9:33 p.m., the triage vitals obtained by an RN revealed Patient #8’s temperature was 96.2 degrees Fahrenheit (F) (normal is 98.6). The record did not reveal another assessment of Patient #8’s temperature. The nursing notes also did not reveal a CIWA to assess if Patient #8 was withdrawing from alcohol. On 9/15/23 at 1:28 a.m., an RN note documented Patient #8 was walking and “urinated in the corner of the room.” The RN documented Patient #8 dressed independently and had a “stable independent gait.” At 1:30 a.m. (two minutes later), the RN documented Patient #8 was discharged from the facility in stable and ambulatory (walking) condition. This discharge on 9/15/23 at 1:28 a.m. without a follow-up evaluation by the provider before discharge was in contrast to the provider’s note which read Patient #8 was to be discharged at 6:30 a.m. The failure to physically assess, including ongoing physical assessment and laboratory testing, when the patient was intoxicated revealed an inappropriate MSE. The provider’s failure to determine clinical sobriety by conducting a thorough clinical evaluation and/or blood alcohol screening prior to discharge contributed to the overall failure to provide an appropriate MSE which was in contrast to the EMTALA - Screening, Stabilization, Transfer policy which read, all patients requesting medical care received an MSE by a physician, appropriate to their presenting signs and symptoms. The MSE continued until the provider was able to rule out an EMC. A review of the records revealed Patient #8 was readmitted to the ED on 9/15/23 at 8:42 p.m. for an unwitnessed fall causing a head injury. The readmission occurred 17 hours and 14 minutes after Patient #8 was discharged earlier that day. During this second admission, Patient #8 refused all laboratory testing and imaging. At 8:42 p.m., the provider documented Patient #8 was “grossly intoxicated” and the patient was fighting and combative. Although Patient #8 had a history of alcohol use, the nursing documentation failed to reveal a CIWA or attempt to perform a CIWA to assess their current state of withdrawal. On 9/16/23 at 9:35 p.m., Patient #8 refused all imaging and treatment and left the ED against medical advice. The failure to assess the current state of withdrawal when the patient was intoxicated revealed an inappropriate MSE which was in contrast to the EMTALA - Screening, Stabilization, Transfer policy which read, all patients requesting medical care received an MSE by a physician, appropriate to their presenting signs and symptoms. The MSE continued until the provider was able to rule out an EMC. iii. A review was conducted of Patient #2’s medical record which revealed Patient #2 had presented to the ED for acute alcohol intoxication on 6/30/24 at 11:22 p.m. The provider notes documented Patient #2 had a history of alcoholism and alcohol withdrawal seizures. The provider ordered labs, including a blood alcohol level which, was 336. On 7/1/24 at 12:47 a.m., the provider documented Patient #2 did not display signs of alcohol withdrawal. At 6:22 a.m., the provider documented Patient #2 did not show clinical signs of intoxication. At 8:40 a.m., a second ED provider documented Patient #2 was well-appearing, with atraumatic extremities, no spinal tenderness, and a soft abdomen. They documented Patient #2 was afebrile, hemodynamically stable, breathing comfortably, and was able to be discharged. The record did not reveal a follow-up neurological assessment before discharge to ensure the patient was clinically sober and safe for discharge. On 6/30/24 at 11:40 p.m., RN #1 documented Patient #2’s blood pressure (BP) was 132/95 (normal is 120/80), on 7/1/24 at 5:00 a.m. (five hours and 20 minutes later) the BP was 133/84, and at 9:28 a.m. (four hours and 28 minutes later) the BP was 145/103. The systolic BP (pressure in the arteries when the heart contracts) had increased 12 points and the diastolic BP (pressure in the arteries when the heart relaxes) had increased 19 points. The record did not reveal additional vital signs taken after 9:28 a.m. Patient #2 was discharged home at 10:42 a.m., five hours and 42 minutes after the last set of vitals signs the provider had evaluated (the 5:00 a.m. vitals), and one hour and 14 minutes after their vital signs were last assessed by RN #1. During a review of Patient #2’s medical record on 7/24/24 at 10:19 a.m., RN #2 stated discharge vitals were important to assess for changes in condition before patients were discharged. Patient #2’s record did not reveal RN #1 had performed a CIWA. During a review of Patient #2’s medical record on 7/24/24 at 10:19 a.m., RN #2 stated they would have performed a series of CIWAs to assess the patient’s risk of deterioration when withdrawing from alcohol. They stated staff needed to assess the signs and symptoms of withdrawal to provide the appropriate treatment. The lack of physical assessment, including a follow-up neurological exam, and failure to perform a CIWA and obtain discharge vitals revealed an inappropriate MSE. The provider’s failure to determine clinical sobriety by conducting a thorough clinical evaluation and/or blood alcohol screening before discharge contributed to the overall failure to provide an appropriate MSE which was in contrast to the EMTALA - Screening, Stabilization, Transfer policy which read, all patients requesting medical care received an MSE by a physician, appropriate to their presenting signs and symptoms. The MSE continued until the provider was able to rule out an EMC. iv. A review was conducted of Patient #3’s medical record which revealed Patient #3 had presented to the ED for acute alcohol intoxication on 11/1/23 at 6:23 p.m. Provider #3 documented Patient #3 had a history of alcoholism. The notes revealed Provider #3 ordered labs, including blood alcohol level (BAL), which was 432. At 10:21 p.m., another provider documented Patient #3 was no longer demonstrating signs of withdrawal. At 10:16 p.m., three hours and 53 minutes after Patient #3 presented to the ED for alcohol intoxication, an RN performed a CIWA which resulted in a score of three. At 10:30 p.m. (14 minutes later), a CIWA was performed with a score of six. This score which revealed a mild withdrawal, and was elevated from the previous scoring 14 minutes earlier, was in contrast to the provider’s documentation at 10:21 p.m. that Patient #3 was no longer demonstrating signs of withdrawal. The record did not reveal further checks of Patient #3’s CIWA score. Although Patient #3’s record did not reveal provider orders for CIWA, this review was in contrast to the CIWA order set provided by the facility which read, if the CIWA was three, the CIWA was checked every two hours for 24 hours. If the CIWA was six, the CIWA was checked every thirty minutes. On 11/1/23 at 6:55 p.m. and 10:32 p.m. and on 11/2/23 at 2:40 a.m., staff administered lorazepam 1mg intravenously (IV) to Patient #3 to treat anxiety. On 11/2/23 at 7:01 a.m., a second provider documented Patient #3 was alert and “mildly tremulous.” This provider ordered phenobarbital (prevents seizures) 130mg IV which was administered at 7:33 a.m. and again at 8:22 a.m. At 8:53 a.m., the provider documented the tremor had improved. At 8:53 a.m., the provider also documented Patient #3’s heart rate was in the 120s-130s for minutes then back down to 90-100. The provider documented they gave Patient #3 one liter (L) of normal saline (NS). On 11/2/23 at 10:15 a.m., during a crisis assessment with a social worker, the social worker documented Patient #3 had “shaky hands due to withdrawal.” The social worker also documented “shaky speech and tone associated with withdrawal symptoms.” They documented Patient #3 felt anxious. At 10:57 a.m., the provider’s note documented Patient #3 became “very tachycardic” with a heart rate in the 120-150 range with attempts to ambulate (walk). The provider documented the tremor was no longer present, although Patient #3 stated they were anxious. At 11:09 a.m., staff administered another liter of NS and diazepam (causes sedation and relaxation) 10mg to Patient #3. At 11:56 a.m. and 12:51 p.m., the RN documented Patient #3 displayed mild hand tremors. At 1:15 p.m. (two hours and six minutes after receiving diazepam), the provider and nursing notes documented Patient #3 chose to be discharged from the facility, their HR was 104. The failure to perform timely and ongoing CIWA checks revealed an inappropriate MSE which was in contrast to the EMTALA - Screening, Stabilization, Transfer policy which read, all patients requesting medical care received an MSE by a physician, appropriate to their presenting signs and symptoms. The MSE continued until the provider was able to rule out an EMC. v. A review was conducted of Patient #14’s medical record which revealed Patient #14 had presented to the ED for intractable (not easily controlled) vomiting on 1/19/24 at 3:52 p.m. The provider documented Patient #14’s complaint of alcohol withdrawal symptoms after stopping their alcohol consumption two days earlier. The provider’s review of systems (ROS) and physical evaluation revealed the patient was nervous and anxious, had abdominal tenderness, nausea, and vomiting, and was dysphoric (state of unease) but alert. The triage vitals obtained at 4:11 p.m. revealed Patient #14 was tachycardic with a HR of 114 (normal 60-100). The provider diagnosed the patient with severe alcohol withdrawal, alcoholic ketoacidosis (excess acid in the body which can cause gastrointestinal symptoms, increased respiratory rate, and death), hypokalemia (low potassium), and hyponatremia (low sodium). At 8:00 p.m. (four hours and eight minutes after admission), the RN administered lorazepam 1mg IV. At 8:50 p.m., the patient was admitted for inpatient care. Although Patient #14 had presented to the ED due to symptoms of alcohol withdrawal, the record failed to reveal nurses had performed a CIWA. This was in contrast to an interview on 7/24/24 at 10:19 a.m. with RN #2 during which they stated they assessed the level of withdrawal with a CIWA to provide the appropriate treatment and ensure patients did not deteriorate. The failure to perform a CIWA revealed an inappropriate MSE which was in contrast to the EMTALA - Screening, Stabilization, Transfer policy which read, all patients requesting medical care received an MSE by a physician, appropriate to their presenting signs and symptoms. The MSE continued until the provider was able to rule out an EMC. vi. A review was conducted of Patient #19’s medical record which revealed Patient #19 had presented to the labor and delivery (L&D) unit for vaginal bleeding during pregnancy on 12/13/23 at 12:04 p.m. At 12:08 p.m., the RN documented Patient #19’s blood pressure was 99/56 (normal is 120/80). At 12:44 p.m., the RN entered an order which was cosigned by a physician for vital signs to be taken every two hours. However, a review of the medical record revealed Patient #19 was discharged at 3:29 p.m. (three hours and 21 minutes later) without additional vital signs being assessed. The lack of ongoing assessment including obtaining discharge vitals revealed an inappropriate MSE which was in contrast to the EMTALA - Screening, Stabilization, Transfer policy which read, all patients requesting medical care received an MSE by a physician, appropriate to their presenting signs and symptoms. The MSE continued until the provider was able to rule out an EMC. B. Interviews i. On 7/25/24 at 9:00 a.m., an interview was conducted with RN #1. RN #1 stated the facility had protocols for emergency severity index (ESI, a tool that determines acuity) assignments which listed the frequency of vital assessments however, RN #1 based the frequency and complexity of vitals and patient assessments on their clinical judgment. They stated a patient scheduled for more frequent vital signs was not indicative of a higher acuity. RN #1 stated a gap in patient assessment, including monitoring vital signs, was not a patient care concern. RN #1 stated abnormal vital signs were not concerning in unstable patients or in patients for whom abnormal vital signs were not connected to their chief complaint. They stated the risk of a patient having an elevated heart rate, for example, depended on their clinical picture, however, this on its own would not concern them. RN #1 stated the risk of gaps in vitals, for example in patients with hypoxia (low oxygen) and oxygen saturation in the 70s, was minimal as they believed these gaps were documentation errors or due to patient non-compliance. RN #1 stated if intoxicated and obtunded (reduced level of alertness or consciousness) patients were hypoxic, there was a lower level of risk than for other patients. However, they stated patients with hypoxia were at risk of shortness of breath, organ dysfunction, and mental dysfunction. RN #1 stated they chose not to use CIWA to assess alcohol withdrawal. They stated CIWAs were not appropriate for use in the ED as they were subjective and led to inaccuracies. RN #1 stated they assessed patients’ speech and tremors to determine alcohol withdrawal. They stated if they were aware of a history of alcohol withdrawal seizures, they communicated with the provider to ensure seizure precautions were in place. This was in contrast to a review of Patient #2’s record which did not reveal seizure precautions in place although Patient #2 presented for alcohol intoxication with a history of alcohol withdrawal seizures. ii. On 7/24/24 at 1:00 p.m., an interview was conducted with labor and delivery (L&D) RN #5. RN #5 stated RNs assessed vital signs per provider orders in the L&D. They stated discharge vitals were assessed less than an hour before a patient was discharged. RN #5 stated vital signs were important for patient evaluation to understand infection risk, their current presentation, and the overall health of the pregnancy. iii. On 7/24/24 at 10:19 a.m., an interview was conducted with charge RN (RN) #2. RN #2 stated they expected RNs to assess vitals every four hours and at discharge unless there was a clinical reason to deviate from this practice, which was in contrast to the interview with RN #1. RN #2 stated discharge vitals were taken at the time the patient was discharged and not more than an hour before the patient left the facility. They stated discharge vitals were expected to be within normal limits to ensure patients were medically stable for discharge. This was in contrast to the medical records for Patients #2, #7, #8, and #19, which failed to reveal vital signs taken at a frequency appropriate to the patients’ clinical presentations. However, RN #2 stated RNs were allowed to use their clinical judgment with patient assessment, including vital signs. They stated the assigned RN could decide if vital signs outside of normal limits, for instance, Patient #2’s elevated blood pressure, fit with the clinical picture and would not necessitate a change in the treatment plan. RN #2 stated the CIWA assessed the level and risk of alcohol withdrawal. They stated there were risks to withdrawing from alcohol which included seizures, brain damage, airway issues, aspiration (food, solids, or liquids that enter the airway or lungs), or metabolic abnormalities. RN #2 stated the ED did not have a CIWA policy. However, RN #2 stated nurses performed multiple CIWAs on intoxicated patients to paint a clinical picture and prevent patients from deteriorating which was in contrast to a review of the medical records for Patients #2, #3, #7, #8, and #14. RN #2 stated nurses exercised their clinical judgment on when and how to assess alcohol withdrawal based on patients’ presentations and medical histories. RN #2 stated the CIWA was important because if clinical and medical staff were not aware of patients’ current levels of withdrawal, they were not able to provide the appropriate medical treatment. RN #2 stated Patient #7 was a local patient known to consume isopropyl alcohol. RN #2 stated Patient #7 presented in a metabolically abnormal state as a result of ingesting isopropyl alcohol. They stated the medical staff assessed Patient #7’s venous blood gases, blood chemistry, liver enzymes, and respiration to determine the treatment plan. They stated Patient #7’s blood alcohol level was never elevated as it measured levels of ethanol. RN #2 stated even though this patient consumed isopropyl alcohol, a CIWA could have been performed to assess the level of withdrawal. They stated as the facility was familiar with Patient #7, the medical staff allowed the patient to resolve their own “acidosis” (although this was in contrast to Patient #7’s medical record which documented the patient was in respiratory alkalosis) by maintaining low oxygen saturation rates. During a review of Patient #7’s medical record which revealed gaps in the assessment of oxygen saturation, including periods when Patient #7’s oxygen saturation decreased below 90%, RN #2 stated the patient was placed on supplemental oxygen and monitoring during their ED stay. They stated, however, the timeline for oxygen therapy was unclear from Patient #7’s medical record. RN #2 stated Patient #7 was most likely non-compliant with the pulse oximeter and nasal cannula which resulted in abnormal or missing vital signs. However, RN #2 also stated Patient #7 had been placed on a cardiac monitor with alarms, roomed in front of the nursing station, and was on a 1:1 supervision with an RN, so the nursing staff would have been able to assess vitals continuously and catch the patient removing medical equipment. RN #2 stated on 6/19/24, Patient #7 was medically cleared although their vital signs were not within normal limits and they still required supplemental oxygen to maintain their oxygen saturation. RN #2 stated the treatment goal for chronically intoxicated patients like Patient #7 was to treat their presenting symptoms and get them home. They stated allowing patients with a history of alcoholism to consume alcohol prevented the health risks associated with withdrawal. iv. On 7/24/24 at 12:41 p.m., an interview was conducted with Provider #3. Provider #3 stated patients who presented with alcohol intoxication and in withdrawal were put on a monitor and potentially given medications such as benzodiazepines (sedative medications) or phenobarbital depending on their disposition. They stated patients who went home were not given medications as they could not guarantee the patient would not drink again at home. Provider #3 stated patients were admitted or discharged based on medical stability which they determined through laboratory testing, vital signs, and psychosocial aspects. They stated although RNs performed CIWAs to determine the level of alcohol withdrawal, they did not require this assessment when determining treatment. Provider #3 stated discharge vitals were performed to ensure patients had not experienced a change from their baseline condition. Provider #3 stated the importance of discharge vitals depended on patients’ presenting complaints and if patients were overall stable, they were not as concerned with missing vitals. Provider #3 stated they preferred for discharge vitals to be within normal limits to ensure patient stability however, this was not always possible. Provider #3 stated Patient #7 was a difficult patient with strange behaviors. They stated Patient #7 commonly presented to the ED with an elevated heart rate and heavy breathing. Provider #3 stated Patient #7 had sleep apnea (breathing starts and stops while sleeping) which led to their hypoxia. They stated on 6/19/24, staff treated Patient #7 with medications for their withdrawal symptoms which successfully calmed the patient down. Provider #3 stated Patient #7 was stable for discharge and at their baseline when they were discharged to a detox facility, which was in contrast to a review of Patient #7’s medical record which revealed Patient #7 was tachycardic, tachypneic, and required supplemental oxygen to prevent hypoxia. v. On 7/24/24 at 2:10 p.m., an interview was conducted with physician (Provider) #6. Provider #6 stated an MSE was provided to all patients in the ED to rule out a potential EMC. They stated this process included obtaining vital signs, a chief complaint, patient assessments, laboratory testing, determining a diagnosis, providing stabilizing treatment, and discharging the patient with a follow-up plan. Provider #6 stated an appropriate and comprehensive MSE was important to ensure patients received quality medical care. Provider #6 stated they required the nurses to assess patients every 20 minutes or more frequently as needed. They stated nurses obtained vitals every five to 10 minutes for unstable patients and at admission and discharge for stable patients. Provider #6 stated they expected frequent assessment of the vital signs of intoxicated patients however, they were aware the nursing staff failed to meet this expectation. Provider #6 stated frequent assessment was important to preventing a change in condition and ensuring quality patient care. Provider #6 stated vitals were important as providers used this information to assess the impact of the patient’s treatment. They stated blood pressure was commonly elevated upon admission due to pain or anxiety and once these factors were addressed, blood pressure returned to baseline levels. Provider #6 stated fluctuating vitals were a concern as well as there was the potential for dehydration (loss of body fluid) or cardiac (heart) abnormalities. They stated all vitals were expected to be within normal limits before discharge. Provider #6 stated without a nursing assessment of the patient’s vitals, the provider could not be sure of the patient’s condition or a change in condition. Provider #6 stated RNs were able to perform CIWAs on intoxicated patients withdrawing from alcohol. They stated the symptoms of withdrawal included tachycardia, tremors, hypertension, nausea, and vomiting. Provider #6 stated if alcohol withdrawal was untreated, patients could have delirium tremens (severe alcohol withdrawal symptoms such as shaking, confusion, and hallucinations), or seizures. They stated they did not often utilize a CIWA as intoxicated patients were only in the ED for a short time and were not yet in withdrawal. Provider #6 stated when a patient presented to the ED for alcohol intoxication, they ordered laboratory testing such as blood alcohol level, complete blood count, chemistry panel, and occasionally tox screen. However, Provider #6 stated for repeat patients with a well-known medical history, they ordered only a blood alcohol level. Provider #6 stated if they had ordered a VBG, they would repeat this testing before discharge to ensure patients were medically improving. They stated they assessed sobriety and appropriateness for discharge with a trial of ambulation, the ability to converse, and having a safe place to go. These interviews were in contrast to the EMTALA - Screening, Stabilization, Transfer policy which read, all patients requesting medical care received an MSE by a physician, appropriate to their presenting signs and symptoms. The MSE continued until the provider was able to rule out an EMC.”

“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: 47960 Based on document review and interviews, the facility failed to ensure patients received stabilizing treatment within the facility’s capabilities prior to discharge in four of eight patients reviewed who presented to the emergency department (ED) with alcohol intoxication. (Patients #7, #3, #2, and #8) (Cross-reference C-2406) Findings include: Facility policies: The EMTALA- Screening, Stabilization, and Transfer policy read, within the staff and facilities available at the hospital, provide such further medical examination and such treatment as may be required to stabilize the medical condition. The Standards of Care in the ED policy read, the registered nurse (RN) collected data pertinent to the patient’s health and modified the plan of care based on patient responses. The RN assisted in the appropriate discharge plan and ensured patients who had received a sedative within four hours of discharge displayed stable vital signs. Reference: According to the Alcohol Withdrawal (a physiological response to stopping drugs or alcohol) /Polysubstance Abuse Clinical Institute Withdrawal Assessment for Alcohol (CIWA) order set provided by the facility, if the CIWA is between four to seven, check CIWA every 30 minutes. If the CIWA is between zero to three, check the CIWA every two hours for 24 hours, then every shift. Administer lorazepam (a medication causing sedation and relaxation) two milligrams (mg) every 30 minutes as needed for anxiety if the CIWA is between four to seven. Administer phenobarbital (anti-seizure medication) 130 mg every four hours as needed for agitation. 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. Medical record review revealed Patient #7 presented to the ED on 6/19/24 at 11:19 a.m. with complaints of alcohol intoxication and confusion. Patient #7 had a history of alcohol abuse with withdrawal delirium, alcoholism, and isopropyl alcohol (rubbing alcohol) poisoning. At 11:22 a.m., the patient was placed on a cardiac monitor. At 11:24 p.m., the RN documented Patient #7’s oxygen saturation was 95% on room air. At 12:00 p.m., the RN notes documented Patient #7 was on two liters (L) /minute (min) of supplemental oxygen with an oxygen saturation of 97%. At 1:31 p.m., the patient was on four L/min (an increase of two L/min) with an oxygen saturation of 92%. At 2:53 p.m., the vital signs flow sheet read Patient #7 was on two L/min of supplemental oxygen. At 1:45 p.m., Patient #7’s oxygen saturation decreased to 87% (a decrease of 5%), and at 2:00 p.m., their oxygen saturation was 88%. At 2:15 p.m. and 2:30 p.m., Patient #7’s oxygen saturation was not assessed. At 2:45 p.m. (30 minutes later), Patient #7’s oxygen saturation was 79% (a decrease of 8%). At 2:53 p.m., Patient #7’s oxygen saturation had increased to 92% on two L/min supplemental oxygen. At 3:52 p.m., Patient #7 was discharged with no evidence their oxygen saturation was assessed while on room air to ensure the patient was saturating appropriately off supplemental oxygen. Additionally, there was no evidence Patient #7 was discharged on supplemental oxygen, which had been necessary throughout their ED stay to prevent hypoxia. According to the vital signs flow sheet, at 11:30 a.m., Patient #7’s respiration rate (RR) had increased to 50 (normal is 16-20), which was 26 respirations higher than at the patient’s initial RR assessment. Then at 11:45 a.m., Patient #7’s RR increased to 56. At 12:30 p.m., Patient #7’s RR decreased to 18, and at 1:00 p.m., increased to 29. At 2:15 p.m., Patient #7’s RR increased to 31, and at 3:30 p.m., the final assessment of their vitals revealed a RR of 30. There was no evidence to show how the patient’s RR was stabilized prior to discharge at 3:52 p.m. According to the vital signs flow sheet, from 11:30 a.m. to 3:30 p.m., Patient #7’s heart rate (HR) ranged from 104 to 114 beats per minute (bpm) (normal is 60-100). There was no evidence to show how the patient’s heart rate was stabilized prior to discharge at 3:52 p.m. According to the lab results flow sheet, at 11:52 a.m., a critical lab value from a VBG test was reported to the provider. The patient’s Ph was 7.59 (normal values listed in the medical record were 7.310-7.410), which indicated the patient was experiencing respiratory alkalosis (acid-base imbalance in the body), PCO2 of 22.5 mmHg (normal values listed in the medical record were 34.0-46.0), PO2 of 48 mmHg (normal values listed in the medical record were 30-40), total CO2 of 40.2 mmol/L (normal values listed in the medical record are 23.0-30.0) and carbon monoxide of 1.6% (normal values listed in the medical record are <=1.4). There was no evidence VBG levels were reassessed and the patient’s respiratory alkalosis was stabilized prior to discharge. Patient #7’s medical record revealed the patient was discharged to an outpatient detox facility at 3:27 p.m., however, the patient was subsequently transferred to a different ER approximately two hours after discharge for unresponsiveness and a rapid RR. ii. Medical record review revealed Patient #3 presented to the ED on 11/01/23 at 6:35 p.m. with complaints of alcohol intoxication and suicidal ideation. Provider #3 documented Patient #3 had a history of alcoholism. The notes revealed Provider #3 ordered labs, including blood alcohol level (BAL), which was 432 (normal is under 10). At 10:16 p.m., three hours and 53 minutes after Patient #3 presented to the ED for alcohol intoxication, an RN performed a CIWA which resulted in a score of three. At 10:30 p.m. (14 minutes later), a CIWA was performed with an increased score of six, which indicated mild withdrawal. Review of Patient #3’s medical record revealed they were actively withdrawing from alcohol (Cross-reference C-2406) although given lorazepam 1 mg three times at approximately four-hour intervals and then approximately five hours later, two doses of phenobarbital 130 mg an hour apart. This medication schedule was in contrast to the CIWA order set which read, lorazepam 2 mg was to be administered every 30 minutes as needed for anxiety for a CIWA score between four and seven. Phenobarbital 130 mg was to be administered every four hours as needed for agitation. At 1:15 p.m., the provider and nursing notes documented Patient #3 chose to be discharged from the facility, however, the record did not reveal further assessments of Patient #3’s CIWA score to determine if the patient needed further treatment to be stable for discharge. At 6:35 p.m. on 11/1/23, Patient #3 had a HR of 130, then at 7:45 p.m., the HR decreased to 100. At 8:00 p.m. Patient #3’s HR increased to 118, then the HR decreased to 92 at 8:15 p.m. At 9:30 p.m. Patient #3’s HR decreased to 82. At 2:30 a.m. on 11/2/23, Patient #3 had a HR of 102 then at 7:30 a.m., the HR increased to 109, at 10:15 a.m. Patient #3’s HR increased to 136, then at 10:30 a.m., the HR decreased to 119. At 1:15 p.m. Patient #3 had a HR of 104 and was discharged at 1:28 p.m. with no evidence of a stable HR. iii. Medical record review revealed Patient #2 presented to the ED on 6/30/24 at 11:22 p.m. with complaints of alcohol intoxication and suicidal ideation. The provider notes documented Patient #2 had a history of alcoholism and alcohol withdrawal seizures. The provider ordered labs, including a blood alcohol level, which was 336. There was no evidence of a CIWA performed throughout the patient’s stay to determine if the patient was withdrawing from alcohol and required stabilizing treatment. At 11:40 p.m. on 6/30/24, Patient #2 had a blood pressure (BP) of 132/95 (normal is 120/80). The next blood pressure assessment was on 7/1/24 at 5:00 a.m., which was 133/84. At 9:28 a.m. Patient #2’s BP increased to 145/103. At 10:42 a.m. Patient #2 was discharged with no evidence of stabilization for the elevated BP. iv. Medical record review revealed Patient #8 presented to the ED on 9/14/23 at 9:30 p.m. with complaints of cold exposure and alcohol use. The provider notes documented Patient #8 had a history of alcohol use disorder and appeared to be “mildly intoxicated.” The provider ordered a blood alcohol level which was 291 but did not order any other laboratory testing. At 9:37 p.m. on 9/14/23 Patient #8 had a temperature of 96.2 degrees Fahrenheit (F) (normal temperature is 98.6) and was shivering. At 1:30 a.m. on 9/15/23 Patient #8 was discharged with no evidence of a reassessment of the temperature to determine if stabilizing treatment was needed. In addition, there was no assessment to determine if the patient was withdrawing from alcohol and required stabilizing treatment. The review of the medical records for Patients #7, #3, #2, and #8 were in contrast to the EMTALA - Screening, Stabilization, Transfer policy which read, within the staff and facilities available at the hospital, provide such further medical examination and such treatment as may be required to stabilize the medical condition and the Standards of Care in the ED policy, which read, the RN collected data pertinent to the patient’s health and modified the plan of care based on patient responses. The RN assisted in the appropriate discharge plan and ensured patients who had received a sedative within four hours of discharge displayed stable vital signs. B. Interviews i. On 7/24/24 at 10:29 a.m., an interview was conducted with registered nurse (RN) #2. RN #2 said Patient #7 was well known to the ED staff due to frequent visits. RN #2 said Patient #7 presented with a rapid respiration rate when intoxicated and it was normal procedure to let the patient “work out the respiratory alkalosis on their own”. RN #2 said the ED staff would look at the patient’s VBG results, chemistry, liver enzymes and make sure the breathing was within normal limits (WNL). RN #2 said Patient #7 always presented to the ED as metabolically unstable and they would correct it. RN #2 said it was an expectation to obtain patients’ vital signs at discharge or when transferred to another facility. RN #2 said it was important to obtain vital signs at discharge or transfer to make sure nothing had changed and the patient was medically stable. RN #2 said medically stable meant the patient’s vital signs were within normal limits. The interview with RN #2 was in contrast to the four patient medical records reviewed which revealed the patients did not reach stabilization of vital signs prior to discharge from the ED. ii. On 7/24/24 at 12:41 p.m., an interview was conducted with physician assistant (PA) #3. PA #3 said it was important to obtain vital signs at discharge to make sure the patient did not have a decline in condition. PA #3 said it was important to stabilize patients to ensure they were safe to be discharged or transferred. PA #3 explained stability was determined by a patient’s lab work, vital signs, and psychosocial aspects within normal limits. iii. On 7/24/24 at 2:10 p.m. an interview was conducted with ED Provider #6. Provider #6 said it was important to obtain vital signs to ensure the treatment that was provided to the patient was effective and guided the providers in what they should do next for the patient. Provider #6 stated the expectation was for nurses to obtain vital signs frequently and at the time of discharge. Provider #6 explained a patient would be considered stable for discharge if they were able to walk, if the patient made sense when speaking, and if the vital signs were within normal limits. Provider #6 said a patient with oxygen saturation in the 70s to 80s on room air would not be discharged without oxygen provided. Provider #6 explained if VBGs were ordered on a patient and were out of range, the patient should not have been discharged without a repeat VBG to ensure the results were within normal limits. Provider #6 said it was important to obtain a repeat VBG to ensure the patient was getting better, not worse and this should have been done before any kind of decision to transfer or discharge was made. Provider #6 explained a patient who experienced respiratory alkalosis would meet admission criteria due to the high risk for severe withdrawal symptoms. The interview with Provider #6 was in contrast to the four patient medical records reviewed which revealed the patients did not reach stabilization of vital signs prior to discharge from the ED.”

“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 deficiencies 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-1208 - The infection prevention and control includes surveillance, prevention, and control of HAIs, including maintaining a clean and sanitary environment to avoid sources and transmission of infection, and that the program also addresses any infection control issues identified by public health authorities. Based on observations, document reviews, and interviews, the facility failed to ensure a functional and sanitary environment for surgical services to avoid sources and transmission of infections and communicable diseases. Specifically, the facility failed to ensure surgical instruments were processed in accordance with facility policies, national guidelines, and manufacturer instructions for use (IFU) in three out of three observations in the sterile processing department (SPD).”

“INFECTION PREVENT SURVEIL & CONTROL OF HAIs CFR(s): The infection prevention and control includes surveillance, prevention, and control of HAIs, including maintaining a clean and sanitary environment to avoid sources and transmission of infection, and that the program also addresses any infection control issues identified by public health authorities; and This Standard is not met as evidenced by: 49541 Based on observations, document reviews, and interviews, the facility failed to ensure a functional and sanitary environment for surgical services to avoid sources and transmission of infections and communicable diseases. Specifically, the facility failed to ensure surgical instruments were processed in accordance with facility policies, national guidelines, and manufacturer instructions for use (IFU) in three out of three observations in the sterile processing department (SPD). Findings include: Facility policy: The Central Sterilization Infection Control policy read, pre-cleaning is performed to remove visible soil and debris from instruments using enzymatic detergent solution and brushes. References: According to the Association for the Advancement of Medical Instrumentation (AAMI) Sterile Processing - Knowledge, Skills, Competencies, provided by the facility, 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. If a brush is too large, it will not fit into the lumen; if it is too small, it will not have complete contact with the lumen walls and, consequently, will not clean them thoroughly. According to the Association of periOperative Registered Nurses (AORN) (2012-2023), Guidelines for Perioperative Practice: Instrument Cleaning, 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. All instruments opened onto the sterile field in the operating or procedure room should be cleaned and decontaminated whether or not they have been used. Contamination of unused instruments on the sterile field can occur without the occurrence being noticed. The da Vinci Surgical System IFU read, the OR should wipe off excess soil. Insert luer tip fully into the primary flush port and twist to secure. Start water and begin to flush. While flushing, rotate the tip through its full range of motion. Flush and rotate for at least 20 seconds. Continue tip motion and flush until the water runs clear. Rinse entire instrument with cold running water for at least 60 seconds. The INTEGRA LIFESCIENCE surgical instruments IFU read, immerse fully opened and/or disassembled instruments in an enzymatic solution. It is essential to keep the box locks and hinges open during any manual or automated cleaning process. Using a small clean hand-held brush, remove soil from all surfaces of the instrument while fully immersed in the solution. Remove the soil from the ratchets, jaws, tips, box locks, and/or hinge mechanism. The box lock and hinge portion of an instrument must be thoroughly cleaned after each use. Thoroughly rinse instruments by immersing in deionized water and wiping with a clean, soft cloth. Use an ultrasonic cleaner to remove soil from hard to reach surfaces such as grooves, crevices, lumens, instruments with moving parts, etc., after gross soil has been removed. The BD MEDICAL/ CAREFUSION / V. MUELLER General Surgical Instrument IFU read, place the device In the open/relaxed position with flush port open. Completely Immerse the device in the detergent solution and allow It to soak for a minimum of five (5) minutes. 1. The facility failed to ensure surgical instruments were cleaned and processed in accordance with the facility policies and manufacturer’s IFU. Specifically, the facility failed to manually clean and soak all surgical instruments in an enzymatic detergent prior to sterilization. A. Observations i. On 4/23/24 at 9:25 a.m., observations were conducted in the SPD. Observations revealed surgical instruments from the da Vinci tray being processed and cleaned by sterile processing technician (Tech) #1. The distal tips of the da Vinci surgical instruments were grossly soiled with dried blood and tissue. Tech #1 stated the instruments should have been pre-cleaned in the operating room (OR) prior to being transported to SPD. Tech #1 flushed the da Vinci instruments with tap water for 5 seconds but did not rotate the distal tips. Tech #1 placed the da Vinci instruments into the surgical sink filled with an enzymatic detergent solution and used a small pipe cleaner that did not fit the diameter of the lumen to manually clean the cannula. Tech #1 briefly ran the instrument under running water for three to five seconds and placed the instruments on a nearby counter. ii. On 4/23/24 at 10:11 a.m., observations were conducted in the SPD. Observations revealed surgical instruments from the foot set tray being processed and cleaned by Tech #1. Tech #1 placed the hinged surgical instruments in a closed position into the surgical sink filled with an enzymatic detergent solution. Tech #1 removed the surgical instruments from the enzymatic detergent solution, brushed the tips of the instruments above the water line, missed the hinges and crevices, and placed the instruments in a nearby empty sink to be rinsed. Tech #1 then ran the instruments under tap water and placed the instruments in the automatic washer to be mechanically cleaned. Tech #1 stated the instruments did not require ultrasonic cleaning. Further observation revealed Tech #1 only visually inspected multiple instruments during the manual cleaning process. Tech #1 stated it was standard practice to only manually brush instruments that were visibly soiled. Tech #1 stated instruments that were not used in the surgical case did not require to be manually cleaned. iii. On 4/23/24 at 1:16 p.m., observations were conducted in the SPD. Observations revealed surgical instruments from the foot set tray being processed and cleaned by Tech #2. Tech #2 flushed the lumens of the instruments with 10 milliliters (ml) of enzymatic detergent solution, brushed the outside surfaces with a soft bristle brush without brushing the internal lumens, and placed the instrument in a nearby empty sink to be rinsed. Tech #2 removed the surgical instruments from the enzymatic detergent solution, brushed the tips of the instruments, missed the hinges and crevices, and placed the instruments in a nearby empty sink to be rinsed. Further observation revealed Tech #2 only visually inspected multiple instruments during the manual cleaning process. Tech #2 stated they would only manually brush instruments that were visibly soiled. iv. The observations conducted on 4/23/24 revealed surgical instruments were processed incorrectly per the facility’s policy and manufacturer’s IFU. Examples included: Observations on 4/23/24 were in contrast to the Central Sterilization Infection Control policy which read, pre-cleaning was performed to remove visible soil and debris from instruments using enzymatic detergent solution and brushes. Observations on 4/23/24 were in contrast to the AORN Guidelines for Perioperative Practice which read, all instruments opened onto the sterile field in the operating or procedure room should be cleaned and decontaminated whether or not they have been used. Observations on 4/23/24 were in contrast to the daVinci IFU which read, the OR was to wipe off excess soil. The luer tip was inserted fully into the primary flush port and twisted to secure. While flushing, the tip was rotated through its full range of motion. Flushing and rotating were done for at least 20 seconds. Tip motion and flushing were continued until the water ran clear. The instrument was expected to be rinsed with cold running water for at least 60 seconds. Observations on 4/23/24 were in contrast to the INTEGRA LIFESCIENCE surgical instruments IFU which read, the instruments were immersed fully opened and/or disassembled in an enzymatic solution. It was essential to keep the box locks and hinges open during any manual or automated cleaning process. A small clean hand-held brush was used to remove soil from all surfaces of the instrument while fully immersed in the solution. The soil was removed from the ratchets, jaws, tips, box locks, and/or hinge mechanism. The box lock and hinge portion of an instrument was thoroughly cleaned after each use. Instruments were thoroughly rinsed by immersing in deionized water and wiped clean with a soft cloth. An ultrasonic cleaner was used to remove soil from hard to reach surfaces such as grooves, crevices, lumens, instruments with moving parts, etc., after gross soil was removed. Observations on 4/23/24 were in contrast to the BD MEDICAL/ CAREFUSION / V. MUELLER General Surgical Instrument IFU which read, the device was to be placed in the enzymatic solution in the open/relaxed position with flush port open. B. Interviews i. On 4/24/24 at 1:41 p.m., an interview was conducted with Tech #2. Tech #2 stated all surgical instruments were to have been manually washed after the procedure to remove any bioburden (organic material from a prior procedure). Tech #2 stated all surgical instruments with a lumen were expected to be flushed with enzymatic detergent solution and water. Tech #2 stated all of the instruments located in the surgical instrument casket were considered contaminated and were to have been manually cleaned and processed. Tech #2 stated when surgical instruments were not correctly manually cleaned after the procedure, the instruments could have been contaminated with bioburden and potentially caused a surgical infection. This interview was in contrast to multiple observations of the SPD on 4/23/24 which revealed IFUs were not followed. ii. On 4/29/24 at 1:11 p.m., an interview was conducted with Manager #3, Manager #3 stated each surgical instrument had an IFU on how to clean and process the instrument properly. Manager #3 stated it was important to follow the manufacturer’s IFU to ensure all of the surgical instruments were processed properly. Manager #3 stated all instruments opened in the operating room were considered contaminated and should have been cleaned and decontaminated. Manager #3 stated when instruments were not cleaned correctly, there could have been bioburden left behind, and the instruments would not be sterilized after the steam sterilization cycle. Manager #3 stated surgical instruments not processed correctly could have caused a surgical infection or serious injury. This interview was in contrast to multiple observations of the SPD on 4/23/24 which revealed IFUs were not followed.”