UNM Hospital

“PATIENT RIGHTS: RESTRAINT OR SECLUSION CFR(s): 482.13(f) Restraint or Seclusion: Staff Training Requirements. The patient has the right to safe implementation of restraint or seclusion by trained staff. This Standard is not met as evidenced by: 47302 Based on record reviews and interviews, the facility failed to ensure that staff followed policy to safely restrain patients for 2 (P[patient]7 and P8) out of 2 (P7 and P8) patients reviewed who experienced an incident with an employee. This deficient practice could lead to patients being injured by improper restraint use. The findings are: A. Record review of facility’s policy titled, “Security Officers - Use of Physical Force,” dated 08/30/2021 under “Guideline Steps,” it stated, “Security Officers may be called to protect patients, visitors, students and staff from a violent situation prior to the arrival of Law Enforcement. Security Officers may use force ONLY when absolutely necessary to protect themselves and others from immediate and imminent bodily harm. In any such event Security Department Officers shall limit their use of force to the minimum force reasonably necessary to accomplish their intended objective, to overcome resistance encountered, and to protect themselves and others from physical harm.” B. Record review of the facility’s video footage from the adult psychiatric unit 1 dated 12/19/24 at 10:04 am, revealed two security officers (S[staff] 28 and S29) stationed on the unit. At 10:04 am and 51 seconds, P8 is seen coming out of a patients room approaching S29 and punching him in the chest. At 10:04 am and 56 seconds P8 is taken to the floor by S29, medical staff arrived to assist and are seen tending to the P8. P8 can be seen laying face down on the floor, S29 is also face down with his upper body on P8. At 10:07 am, S29 stands up and the view of the P8 is obstructed in the video. At 10:09 am and 34 seconds the crash cart (cart stocked with emergency supplies such as medications and life saving equipment) is brought over to the patient and the view of P8 remains obstructed by staff attending to the scene. At 10:15 am the crash cart is removed from the scene, view of patient remains obstructed. C. Record review of P8’s medical record with an admission date of 12/03/24 revealed a “Rapid Response Team [facility’s emergency response team] Note” dated 12/19/24 at 10:11 am, that revealed P8 was taken to the ground after an altercation with the security guard. Staff had to “yell at the security guard to get off the patient because the patient was ‘purple and not breathing’.” Patient had lost consciousness, stopped breathing for almost a minute and had lost control of his bowels. P8 was taken from psychiatric unit to the emergency department for evaluation. D. During an interview on 08/21/25 at 10:15 am, with S(staff)24, non-clinical it was explained that the incident described in Finding B., was investigated by the facility and the actions of the security officer were found to have contributed to P8 losing consciousness. E. During an interview on 08/21/25 at 1:45 pm, with S(staff)25, clinical, S25 recounted the incident in Finding B. and explained that P8 was stating he couldn’t breathe and was struggling to get up. The security officer was holding patient down with his chest and the security officer had his arm wrapped around P8’s neck. The security officer responded to the patient, “If you can talk, you can breathe.” F. Record review of P7’s medical record for visit date 06/04/25 revealed that patient was discharged on 06/04/25 at 6:27 pm. G. Record review of the facility’s video footage from the emergency department lobby dated 06/04/25 at 6:09 pm and 40 seconds, revealed P7 walking out of emergency department and sitting in the lobby by the front doors. At 6:21 pm and 12 seconds a nurse walks up to patient with a clipboard and hands P7 paperwork. P7 drops the paperwork on the floor and is gesturing with two fingers in the air.The nurse picks up the paperwork from the floor and hands it to P7 again.The nurse walks away from P7 at 6:22 pm and 30 seconds and then S29, non-clinical, approaches P7, taps P7’s leg and leans over P7. S29 grabs P7 by the right shoulder at 6:22 pm and 41 seconds and pulls P7 out of the chair. At 6:22 pm and 50 seconds, S29 is pushing and lifting P7 out of lobby with both hands, P7’s is being lifted by S29, so his feet are unable to touch the floor in order to walk. S29 releases P7, shoves P7 and P7 stumbles. S29 and P7 converse, S29 points his finger at P7 and P7 walks away at 6:23 pm. H. During an interview on 08/21/25 at 10:15 am, with S24, non-clinical, it was explained that the incident described in Finding G. was investigated by the facility and the actions of the security officer did not follow facility policy regarding the use of force.”

“MEDICAL STAFF PERIODIC APPRAISALS CFR(s): 482.22(a)(1) The medical staff must periodically conduct appraisals of its members. This Standard is not met as evidenced by: 52579 Based on observation, record reviews, and interviews, the facility failed to conduct a periodic appraisal of practitioners to determine individual practitioners’ qualifications and competency to perform activities within the applicable scope of practice. This deficient practice resulted in complications of a lifesaving device which may have contributed to cardiovascular decompensation (the inability of the circulatory system to maintain adequate function) in 1(P(patient)4) out of 3 (P4 through P6) charts reviewed. The findings are: A. Record review of P4’s medical chart under, “Medical Notes,” dated 08/21/25, revealed documentation showing the use of several types of equipment including ventilatory assistance equipment (a device to help restore or improve breathing function), dialysis treatment (a treatment that cleans your blood by removing waste and extra fluid when your kidneys cant) and medications prescribed to P4 as their condition changed. P4 also required ECMO (extracorporeal membrane oxygenation - a life support system that temporarily takes over the work of the heart and lungs allowing them to rest and heal) placement on 06/24/25. B. Record review of medical provider notes dated 07/07/25, revealed the medical provider documented a “crack in connection of venous cannula (A venous cannula is a tube of the ECMO that is inserted in the large blood vessels of the neck to allow blood with low oxygen to be drawn from the veins and blood with high oxygen to be returned to the arteries) repaired by surgery with silicone glue.” C. Record review of P4’s, “Medical Provider Notes,” dated 07/09/25, noted “infant decompensation (inability of the heart to maintain adequate circulation) possibly related to air within the (ECMO) circuit (a sterile, plastic tubing from the patient to the ECMO machine.” D. Record review of P4’s,”Medical Provider Notes,” dated 07/14/25, revealed a notation by the medical provider, documenting the presence of “a large clot (a thick mass of blood that is stuck together) in the ECMO circuit.” E. Record review of P4’s, “Cardiology (the branch of medicine that deals with diseases and abnormalities of the heart) Consult Notes,” dated 07/15/25, revealed that the cardiologist documented a cracked cannula with the following statement: “The ECMO course has been complicated by a cracked cannula which potentially has led to air within the circuit and cardiovascular decompensation (the inability of the circulatory system to maintain adequate function). F. Record review of P4’s, “Medical Provider Notes,” dated 07/20/25, revealed that the medical provider documented “Bedside RN and ECMO staff concerned about continued circuit clotting, possible decannulation (removal of plastic tubing from patient to the ECMO machine) today, 7/20/25, with possible dialysis catheter placement (the insertion of a tube into a large vein for a medical treatment that performs the normal function of kidneys).” G. Record review of P4’s, “Medical Provider Discharge (deceased) Summary,” dated 07/21/25, revealed that the medical provider documented the following: “She [P4] had several circuit changes on ECMO, mainly for air entrainment (air bubbles in the circuit) from a cracked venous cannula, and once for clot burden (large blood clots) in the circuit. On 7/20/25 it was elected to separate her [P4] from ECMO after a four-week run given worsening circuit clot burden, clamp trials (short periods of removing the artificial breathing machine from a patient and allowing them to breathe on their own) that were reassuring on an oscillator (a type of machine that provides breathing assistance) and a strong hesitance to perform a fifth circuit change given the temporary deleterious (harm or damage) effects of that maneuver on her lungs (an ECMO circuit change may cause blood clots and swelling in the lungs) in the past from hyper-inflammation (increased swelling).” H. During an interview on 08/20/25 at 9:45 am, S(Staff)3, clinical, stated she has never had a situation where an ECMO venous cannula was cracked before this incident. I. During an observation on 08/20/25 at 10:00 am, S(Staff)9, clinical, demonstrated the components of ECMO, the cannula and the circuit. S9 demonstrated how a circuit would be changed by using 2 clamps, snipping the portion to be changed using the dull edged scissors provided, in the kit, adding a connector and linking the new tubing. A sharp instrument, like a scalpel, may damage the ECMO tubing and is not recommended. J. During an interview with S(Staff)9, clinical, on 08/20/25 at 10:10am, she stated she attends mandatory ECMO yearly training and is an ECMO expert. S9 has the following credentials: license for Registered Respiratory Therapist, ECMO specialist for adults and pediatrics, Advanced Cardiac Life Support certification, and annual training for ECMO completed 11/08/24. She stated the training is optional for medical providers and they do not usually attend. S9 stated the hospital policy for changing a circuit on an ECMO does not involve the use of a scalpel because of the possibility of damaging the ECMO tubing. K. During an interview with S(Staff)8, clinical, on 08/20/25 at 10:15 am, he stated he was familiar with the cracked cannula, and he was present when another provider, S(Staff)18, clinical, used a scalpel when changing a circuit and damaged the venous cannula of the ECMO on P4. S8 stated the hospital policy does not list using a scalpel when changing an ECMO circuit. S8 stated that P4 had 4 circuit changes during the hospital course. L. During an interview with S(Staff)11, clinical, on 08/21/25 at 10:46 am, he stated he had been briefed on the incident regarding the cracked ECMO circuit. S11 stated S18 had been suspended after this incident occurred and is pending a review and determination of his fitness for duty. M. During an interview with S(Staff)10, clinical, 08/21/25 at 11:38 am, she stated she was familiar with the case and that she is on the committee to investigate the use of a scalpel on an ECMO venous canula. She plans to complete a root cause analysis. S10 stated medical providers are not required to demonstrate their professed competencies upon hire or at any time during their employment, nor are they required to attend yearly ECMO training. S10 stated some of the reasons an ECMO circuit might be changed are blood clots that form in the tubing or air bubbles. S10 stated a circuit, unless damaged, can remain in use for about 4 weeks. N. During an interview with S(Staff)27, non-clinical, on 08/21/25 at 12:30pm, the personnel file for S18 was requested to review ECMO training and competency but it was not provided. O. Record review of UNM’s Hospital Policy dated 03/28/23, titled “Emergent Extracorporeal membrane Oxygenation (ECMO) Circuit Change in pediatrics and Neonate” revealed that the policy applies to appropriately licensed health care providers based on their scope of practice as determined by licensure and education (ECLS [extracorporeal life support] Physicians). Under the heading “Guideline for Emergent Circuit Change” the following procedure is outlined: 1. Isolate patient from ECLS circuit. 2. Staff member to hold up ECLS lines off patient bed. 3. ECLS Physician will clean lines from cannula site towards ECLS circuit with betadine or chlorhexidine (antiseptic solution). 4. Don (put on) sterile gloves 5. Apply sterile towels underneath cleaned ECLS lines. 6. Place ECLS lines on sterile towels. 7. Don bouffant (hair covering). 8. Re-apply sterile gloves. 9. Don a sterile gown. 10. Drape patient using medium or femoral (a sterile covering that is placed at the upper thigh) drape. 11. ECLS Specialist hands over clamps, scissors, connectors, syringes, bowl, normal saline, and chlorhexidine/betadine. 12. Using sterile scissors, cut hole through drape used to access sterile lines underneath. 13. Prep lines again using betadine or chlorhexidine. 14. ECLS Specialist brings new circuit into room and hands over new sterile lines. 15. Connectors should be applied to the new ECLS circuit lines. 16. Fill Toomy (an instrument used for squirting sterile saline) syringes with sterile saline (a solution of sterile water and salt). 17. Time-out and roles identified. 18. Designated staff will clamp old circuit with two clamps each, leaving at least 3 inches in between each clamp. 19. Cut into old circuit with sterile scissors, proximal (closest to the point of attachment) to old circuit clamps, to allow space for tubing manipulation. 20. Grab new circuit and connect using wet to wet connections via saline filled Toomy syringes. 21. Remove all clamps. 22. Re-institute ECLS flow (the removal of blood from the veins to the ECMO machine for oxygen and the return of the blood to the arteries with oxygen) and sweep gas on new circuit (gas that flows from the ECMO oxygenator). 23. Check activated clotting time (ACT)(a test measuring how quickly the blood clots) and arterial blood gas (ABG)(a test that measures oxygen in the blood). P. Record review of facilty’s document labeled, “Corrective Action Plan: ECMO Review,” dated 08/15/25, provided by S10, clinical, it was noted that the document listed a problem identified as “sterile scalpel utilized near cannula. Category of root cause Human factors.” S10 stated this was a document she had prepared when analyzing the root cause of the cracked ECMO circuit.”

“PATIENT RIGHTS: RESTRAINT OR SECLUSION CFR(s): 482.13(e)(8) Unless superseded by State law that is more restrictive-- (i) Each order for restraint or seclusion used for the management of violent or self-destructive behavior that jeopardizes the immediate physical safety of the patient, a staff member, or others may only be renewed in accordance with the following limits for up to a total of 24 hours: (A) 4 hours for adults 18 years of age or older; (B) 2 hours for children and adolescents 9 to 17 years of age; or (C) 1-hour for children under 9 years of age; This Standard is not met as evidenced by: 51995 Based on record review and interview, the facility failed to ensure that restraint orders were renewed for pediatric patients in behavioral restraints (a device that restricts movement due to violent behavior) for 1 (P (patient) 10) of 3 (P10, P11, and P12) patients reviewed for self-inflicted harm. This deficient practice could possibly result in pediatric patients not being released from behavioral restraints in a timely manner. The findings are: A. Record review of the facility’s “Restraint Policy” dated 01/07/2025, Under 1.1 “Patients Rights” stated “1.1.2. Staff will monitor and meet the patients’ needs while in restraints. 1.1.3. Staff will reassess and encourage release from restraints.” Under 2.7 stated “Physical/Mechanical or medical restraint or Seclusion for patients with violent and/or self-destructive symptom that jeopardizes the immediate physical safety of the patient, staff or others” “2.7.1 Orders: . . . 2.7.1.3. Orders are time limited as follows: . . . 2.7.1.3.2. One (1) hour for children under 17 years of age and below.” B. Record review of P10’s electronic medical record revealed the following: 1. On 09/30/2024, a soft restraints (fabric and velcro placed on wrists and ankles to limit movement) order was placed at 10:33 PM for violent behavior. The order stated “order must be renewed q1h [every hour] for children eight (8) years of age and younger.” The order was discontinued on 10/08/2024 at 12:16 PM. 2. The Flowsheet titled “restraint information” dated 09/30/2024 at 10:35 PM revealed P10 was placed in four-point soft restraints (restraints that limit all arms and legs). Refer to tag A0175. 3. P10, a child under the age of nine (9) years old, the record did not have any evidence that the order was renewed every hour while restrained on 09/30/2024. C. During an interview with Staff (S) 5, clinical, on 01/16/2025 at 3:47 PM, S5 confirmed P10’s soft restraint orders should have been renewed.”

“PATIENT RIGHTS: RESTRAINT OR SECLUSION CFR(s): 482.13(e)(10) The condition of the patient who is restrained or secluded must be monitored by a physician, other licensed practitioner or trained staff that have completed the training criteria specified in paragraph (f) of this section at an interval determined by hospital policy. This Standard is not met as evidenced by: 51995 Based on record review and interview, the facility failed to ensure that staff monitor pediatric patients in behavioral restraints (a device that restricts movement) for 1 (P (patient) 10) of 3 (P10, P11, and P12) patients reviewed for self-inflicted harm. This deficient practice could possibly result in pediatric patients not getting their basic needs met while restrained such as bathroom, hydration, and other required assessments. The findings are: A. Record review of the facility’s “Restraint Policy” dated 01/07/2025, Under “1.1 “Patients Rights” stated “1.1.2. Staff will monitor and meet the patients’ needs while in restraints. 1.1.3. Staff will reassess and encourage release from restraints.” Under 2.7.1 stated “2.7.7.5.3. Q 5 [every 5] minutes documentation of the following for children < [less than] 18 years old. 2.7.7.5.3.1. Rationale for continuation of restraint. 2.7.7.5.3.2. Evaluation of status in restraints.” B. Record review of P10’s electronic medical record revealed the following: -On 09/30/2024, a soft restraint (fabric and velcro placed on wrists and ankles to limit movement) order was placed at 10:33 PM for violent behavior. The order stated, “order must be renewed q1h [every hour] for children eight (8) years of age and younger.” The order was discontinued on 10/08/2024 at 12:16 PM. -The Flowsheet titled “restraint information” dated 09/30/2024 at 10:35 PM revealed 10 was placed in four-point soft restraints (restraints that limit all arms and legs); under “restraint skin assessment” stated, “Pulses intact, skin intact.” The flowsheet did not contain any restraint documentation or restraint assessments for restraint monitoring from 09/30/2024 through 10/08/2024. -On 10/15/2024 at 6:26 AM, a soft restraints order was placed for violent behavior. The order was discontinued at 11/10/2024 at 5:20 PM. -On 10/18/2024 at 8:50A M, Provider note stated “While admitted she (P10) has had a couple of episodes of agitation . . .and required to be put in soft restraints 2X [times]” -The flowsheet titled “Restraint information,” dated 10/15/2024 collected at 6:00 AM revealed the flowsheet did not contain any evidence that a skin assessment was performed. The flowsheet did not contain any restraint documentation or restraint assessments for restraint monitoring from 10/25/2024 to 11/10/2024. C. During an interview with Staff (S) 5, clinical, on 01/16/2025 at 3:47 PM, S5 confirmed that every 15-minute monitoring was not documented for P10. S5 explained that staff should be monitoring the patient in restraints per policy.”

“NURSING SERVICES CFR(s): 482.23 The hospital must have an organized nursing service that provides 24-hour nursing services. The nursing services must be furnished or supervised by a registered nurse. This Condition is not met as evidenced by: 47302 Based on record review, interview and observation the facility failed to meet the Condition of Participation for nursing services. Staff failed to followed standards of practice for medication administration and the facility failed to show that medication errors were handled appropriately. These deficient practices could lead to increased medication errors. The findings are: A. Refer to Tag A-0405 for not following standards of practice for medication administration. B. Refer to Tag A-0508 for not ensuring medication errors were handled appropriately.”

“ADMINISTRATION OF DRUGS CFR(s): 482.23(c)(1), (c)(1)(i) & (c)(2) (1) Drugs and biologicals must be prepared and administered in accordance with Federal and State laws, the orders of the practitioner or practitioners responsible for the patient’s care as specified under §482.12(c), and accepted standards of practice. (i) Drugs and biologicals may be prepared and administered on the orders of other practitioners not specified under §482.12(c) only if such practitioners are acting in accordance with State law, including scope of practice laws, hospital policies, and medical staff bylaws, rules, and regulations. (2) All drugs and biologicals must be administered by, or under supervision of, nursing or other personnel in accordance with Federal and State laws and regulations, including applicable licensing requirements, and in accordance with the approved medical staff policies and procedures. This Standard is not met as evidenced by: 47302 Based on record review, observation, and interview the facility failed to ensure staff were following standards of practice for medication administration for 1 (P [patient] 1) out of 3 (P1-P3) reviewed for medication administration. This deficient practice can lead to an increase in medication errors which could possibly cause patient harm. The findings are: A. Record review of the facility’s policy titled, “Controlled Substances” dated 11/9/2023 under, “Administration and Documentation” stated, “8.4 At the time the medication is due for administration, the nurse or other appropriate healthcare professional will remove the medication from the AMMS [automated medication management system, locked medication dispensing cabinet] under the correct patient profile and administer the dose to the patient following the rights [right patient, right drug, right dose, right time, right route, right indication, right documentation] of medication administration. 8.4.1 Staff removing the controlled substance from the AMMS will always refer to the medication administration record (MAR) when removing the medication.” B. Record review of P1’s medical record for admission dated 11/15/2024 through 11/27/2024 revealed the following: 1. Review of “Orders” revealed an order for hydromorphone (opioid pain medication) 0.25 mg (milligrams) ordered on 11/25/2024 at 6:27 PM and discontinued on 11/27/2024 at 6:09 PM. 2. Review of the medication administration record revealed hydromorphone 2 mg was administered on 11/27/2024 at 2:09 PM. 3. Review of a “History + Physical” note dated 11/27/2024 at 5:48 PM under, “Assessment/Plan” stated, “. . . # Metabolic encephalopathy [confusion related to issues of metabolism], acute. # Likely [secondary to] opioid overdose. Patient with acute AMS [altered mental status] and respiratory distress after undergoing IR [interventional radiology] drain exchange earlier today. She is fairly petite, received 50 mcg [micrograms] of fentanyl [opioid pain medication] and 2.0 mg of hydromorphone in close proximity. Upon arrival to MICU [medical intensive care unit], she became more responsive and able to speak with additional pushes of Narcan [drug used to reverse effects of opioid pain medication]. Her acute metabolic encephalopathy most likely in the setting of opioid overdose. . .” 4. Review of “Death Forms” revealed that the patient’s date and time of death was 11/27/2024 at 11:20 PM. C. During an interview on 12/11/2024 at 9:46 AM with S (staff) 8, clinical, S8 explained that the AMMS located on Unit A has a non-profile setting (a setting that doesn’t require each patient to have an individual profile in the machine). The non-profile setting does not limit the available medications to the patient profile but allows staff to have access to all the medications in the AMMS for all patients. D. During an interview on 12/11/2024 at 10:20 AM with S6, clinical it was confirmed that the dose provided to P1 was an error. It was explained that the 2 mg order for hydromorphone came from a different patient’s chart. E. Record review of the facility’s policy titled, “Medication Error, Potential Adverse Drug Events and Adverse Drug Reaction Reporting” dated 11/8/2023, under “Procedure” stated “5. The Medication Safety Committee reviews PSP [Patient Safety Portal, incident reports] and PSP trends on a bimonthly basis, or more frequently based on the committee meeting schedule. Medication use improvements and recommendations are made based on PSP review, medication safety literature, and best practice recommendations. 6. Medication error prevention strategies will be developed based on review of PSP data, medication safety literature, and best practice guidelines and implemented for areas of the medication use system including selection and procurement, storage, ordering, preparing, dispensing, administration, monitoring, and evaluation of medications/medication therapy. F. During an observation on 12/10/2024 at 11:00 AM at the nurse’s station on Unit A, three medical records were opened in the electronic medical record system allowing access to more than one patient’s information. G. During an interview on 12/10/2024 at 11:00 AM with S10, clinical, it was confirmed that staff have not received any education regarding medication administration or having multiple charts open since the incident on 11/27/2024 involving P1.”

“PHARMACY: REPORTING ADVERSE EVENTS CFR(s): 482.25(b)(6) Drug administration errors, adverse drug reactions, and incompatibilities must be immediately reported to the attending physician and, if appropriate, to the hospital’ s quality assessment and performance improvement program. This Standard is not met as evidenced by: 47302 Based on record review and interview the facility failed to ensure medication errors were handled appropriately for all patients receiving care in the hospital. This deficient practice could possibly lead to persistent issues when medication errors happen. The findings are: A. Record review of the facility’s policy titled, “Medication Error, Potential Adverse Drug Events and Adverse Drug Reaction Reporting” dated 11/8/2023, under “Procedure” stated “. . . 1.4. Report the event through the Patient Safety Portal (PSP) system. Medication errors, incompatibilities, or other medication related events that do not reach the patient are considered “Unsafe conditions” or a “Near Miss” and should be reported through the PSP system. . . 6. Medication error prevention strategies will be developed based on review of PSP data, medication safety literature, and best practice guidelines and implemented for areas of the medication use system including selection and procurement, storage, ordering, preparing, dispensing, administration, monitoring, and evaluation of medications/medication therapy.” B. Record review of an untitled and undated document provided by the facility when an incident log was requested revealed a list of file names and then a list of files with dates. One of the file names included, “Medication Related [sic]”. Unable to verify with this information if medication related incidents were appropriately reported, investigated and taken to the hospitals quality assessment and performance improvement program when needed. C. During an interview on 12/10/2024 at 1:46 PM with S(staff)1, non-clinical, it was explained that the facility would not be providing an incident log.”

“PATIENT RIGHTS: INFORMED CONSENT CFR(s): 482.13(b)(2) The patient or his or her representative (as allowed under State law) has the right to make informed decisions regarding his or her care. The patient’s rights include being informed of his or her health status, being involved in care planning and treatment, and being able to request or refuse treatment. This right must not be construed as a mechanism to demand the provision of treatment or services deemed medically unnecessary or inappropriate. This Standard is not met as evidenced by: 50656 Based on facility record review and staff interviews, the facility failed to to inform a patient of the risks of leaving the emergency room against medical advice for 2 (P (patient)13, and 28) out of 19 (P11-P29) patient charts reviewed for presenting to the emergency room. This deficient practice is likely to result in unsafe patient outcomes for all patients who leave the facility against medical advice. The findings are: A. Record review of the facility’s policy titled, “Patient Discharge and Departure - Release of Patient from Hospital & [and] Leaving Against Medical Advice” dated, 05/12/2023, under, “Description/Overview” stated, “. . . Patients leaving the hospital AMA should have appropriate follow up appointments, medical equipment and supplies, discharge medications from the outpatient pharmacy of the patient’s choice, home health care and other services needed by the patient at discharge.” Under, “Procedure for departure against medical advice or away without notice” stated, “1. Discharging a patient (AMA) 1.1. Ask the patient to stay and talk with the physician or APP [Advanced Practice Provider]. 1.2. Notify the physician or APP if he/she is unaware the patient wishes to leave against medical advice. 1.3. The discharging clinician should make all reasonable efforts to accommodate the patients concerns, if possible so they can remain hospitalized. 1.4. Ask the patient to sign the Patient Departure/Discharge Against Medical Advice Form (form can be found under Clinical Forms> Discharge). If the patient refuses, all individuals who witnessed the situation should sign the form where it indicates that the patient refused to sign.” B. Record review of the facility’s document titled, “Patient Departure/Discharge Against Medical Advice” dated 06/24/2015 there were four blank lines that indicated a place for, “Description of the Potential Risks/Complications of Refusal of Examination/Treatment (to be completed by health care professional).” C. Record review of P13’s medical record for the visit date 05/04/2024 revealed: 1. Emergency department note dated 05/04/2024 at 6:11 AM stated “[Patient] presents to [name of facility] as a transfer from [name of transferring facility] for evaluation of bilateral [both eyes] visual changes over the last 24 to 48 hours. Concern for possible retinal detachment [a serious condition that can cause vision loss if not treated] from sending facility and need for ophthalmology [eye doctor] evaluation. Per chart review patient has experienced waxing and waning symptoms of bilateral visual disturbance to include left-sided peripheral blurry vision and right central vision changes. VSS [vital signs stable].” The record did not contain any evidence of a plan or further orders in the providers note. 2. Emergency department nursing discharge summary dated 05/04/2024 at 10:06 AM stated “Left Against Medical Advice. . . Pt [patient] son had taken pt to their car. Pt son came to inform staff that they were not wanting to continue to be in the waiting room and that they could be reached by phone if they were needed. Notified MD [medical doctor] of this.” 3. Orders for visit date 05/04/2024 did not reveal evidence of a request for ophthalmology consult. 4. The record did not contain any evidence of an AMA form signed or discussion of risks or benefits with the patient and/or family. D. Records review of form for P28 labeled “Patient Departure/Discharge Against Medical Advice” (AMA form). The section with the header “Description of the Potential Risks/Complications of Regusal [SIC] of Examination/Treatment (to be completed by Healthcare professional)” was blank. E. During an interview with Clinical Staff member Staff (S)16 on 08/15/2024 at 11:48 AM confirmed that an explanation regarding the potential risks and complications of leaving the emergency room without examination or treatment is documented on the AMA form. This is a requirement as an attestation that the patient had been advised and understands the potential risks and complications of leaving the emergency room without being fully examined and treated. When asked if this was a routine process for patients leaving AMA, S16 stated “Yes, I thoroughly explain the health risks of leaving AMA up to the possibility that they may die if that’s the case.” When asked if documentation of this patient education is required at the facility, S16 replied “Yes, it is. . . They should have a clear understanding of the risks before they leave AMA.” F. During an interview on 08/15/2024 at 2:45 PM with S12, non-clinical, it was explained that facility policy does not require staff to fill out the AMA form in its entirety.”

“PATIENT RIGHTS: FREE FROM ABUSE/HARASSMENT CFR(s): 482.13(c)(3) The patient has the right to be free from all forms of abuse or harassment. This Standard is not met as evidenced by: 47302 Based on record review, interview, and observations the facility failed to prevent abuse of 2 (P[patient]6 and P30) out of 2 (P6 and P30) patients reviewed for patient rights. This deficient practice could lead to physical and mental harm to any patient that presents to the hospital. The findings are: A. Record review of the facility’s policy titled, “Security Officers - Use of Physical Force” dated 08/30/2021, under “Guideline Steps” stated, “Security Officers may be called to protect patients, visitors, students and staff from a violent situation prior to Law Enforcement arrival. Security Officers may use force ONLY when absolutely necessary to protect themselves and others from immediately imminent bodily harm.” B. During an observation of the Emergency Room (ER) on 8/13/2024 at 4:15 PM, surveyor heard a commotion in the hallway in the ER and P30 sat in a chair when a security guard approached P30 and stated, “Do you want to be restrained?” A nurse outside of a room stated, “We got him calmed, please go.” C. During an interview on 08/15/2024 at 1:05 PM with Staff (S)13, non-clinical, when questioned regarding the observation noted above, S13 stated, “That was not the appropriate approach.” S13 explained that security officers should always start with a calming approach. D. Refer to Tag-2406 Finding B for P6 presenting to the emergency room for medical condition. E. Record review of the security footage outside of the emergency room entrance for date 05/05/2024 at 11:45 PM, P6’s belongings were on a bench outside of the emergency room entrance, S18, non-clinical goes to gather P6’s belongings, P6 appeared to attempt to stop S18 from getting her belongings. As P6 grabbed at S18 to stop him, S9, non-clinical, grabbed P6 from behind around her trunk and pulled her back. P6 was released and appeared to stomp toward S18 foot but missed. S9 and S18 then grabbed P6 under the arms, P6 can be seen forcefully being removed from hospital premises. S7, non-clinical, followed behind with P6’s belongings. S9 and S18 left P6 on a concrete foundation near a bus stop with her belongings. F. During an interview on 08/13/2024 at 2:16 PM with P6 regarding the incident on 05/05/24, P6 explained that she was hurt by hospital staff, and she already had an injured knee and normally uses a cane. G. During an interview on 08/13/2024 at 3:20 PM with S17, clinical, confirmed that force had been used by security to remove some patients from the emergency room. H. During an interview on 08/15/2024 at 6:45 AM with S7, non-clinical staff, it was confirmed P6 was removed by force because she was agitated and resisting the security guards when removing P6 from the ER. S7 confirmed that P6 was not safe at the bus stop with it being after midnight and did not have a ride. I. During an interview on 08/15/2024 at 7:33 AM with S8 it was confirmed that P6 had to be carried out by security because she was not supporting her own weight. J. During an interview on 08/15/2024 at 1:05 PM with S13, non-clinical, it was asked if the security officers handled the situation appropriately. S13 explained that it was handled appropriately but there were some lessons learned from the event; such as, once a patient is removed from the emergency room, security officers can stand back and wait for cops to arrive to remove them from the premises. K. During an interview on 08/15/2024 at 2:30 PM with S14, non-clinical, it was asked if security escorts people to the bus stop often. S14 stated, “Yes.” 49835”

“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: 47302 Based on record review and interview the facility failed to meet the Emergency Medical Treatment and Labor Act (EMTALA) requirements of explaining risks of refusing treatment and/or examination and failed to ensure a medical screening exam was done for all patients that present to the Emergency Department. This deficient practice is likely to lead to poor outcomes related to patients not being informed of risks and not being evaluated when seeking emergency medical care. The findings are: A. The facility failed to perform a medical screening exam. Refer to tag A-2406. 50656”

“MEDICAL SCREENING EXAM CFR(s): 489.24(a) & 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: 47302 Based on record review and interview the facility failed to provide a medical screening exam for 1 (P [patient] 6) out of 20 (P6, and P11-P29) patient reviewed for presenting to the emergency room. This deficient practice could possibly lead to patient’s medical conditions being untreated, resulting in harm. The findings are: A. Record review of the facility’s policy titled, “Emergency Medical Treatment & [and] Labor Act (EMTALA)” dated 10/13/2023 under “General Information” stated, “1. EMTALA requires hospitals with emergency rooms to provide a Medical Screening Examination (MSE) to every patient who comes to the hospital requesting emergency examination or treatment and to provide the patient with the necessary stabilizing treatment that is within the capabilities and capacity of the hospital until the patient is stable for transfer or discharge. 2. All patients who come to [Name of facility] Hospital Emergency Departments requesting emergency medical treatment shall receive an appropriate MSE to determine whether an emergency medical condition exists, without regard to a patient’s ethnicity, religion, national origin, citizenship, age, gender, sexual orientation, pre-existing medical condition(s), physical or mental disability, insurance status, economic status or ability to pay for medical treatment. There is an implied request when the individual does not specifically request examination and treatment, but a reasonably prudent person would believe the individual needs examination and treatment. . . 5. Triage is not equivalent to an MSE. Triage merely determines the order in which patients will be provided an MSE, not the presence or absence of an emergency medical condition.” B. Record review of P6’s medical record for visit dated 05/04/2024 revealed the following: 1. Emergency department note stated, “[Patient], well known to ED, presenting to ED from [name of psychiatric facility] not currently on a psych hold, presenting to ED reporting headache x [times] 3 days. Patient reporting it feels like her typical migraines.” 2. Under, “Physical examination” in the emergency department note it stated, “Vital Signs Per nurse’s notes. Constitutional: Alert, no acute distress. . . . Musculoskeletal: Moves all extremities. Neurological: Alert and oriented to person, place, time, and situation, No focal neurological deficit [impairments of nerve, spinal cord, or brain function that affects a specific region of the body] observed, normal speech observed. Psychiatric: Mood and affect: Hostile, Behavior: Uncooperative, Abnormal / Psychotic thoughts: not suicidal, not homicidal.” There is no evidence that the patient had a complete neurological exam to include assessment of gait and movement, cranial nerve function, or stroke scale. 3. Under, “Medical Decision Making” in the emergency department note it stated, “Differential Diagnosis: not abdominal pain not fever, not anxiety. Rationale: [Patient], well known to ED for aggressive/manipulative behavior. Sent from [psychiatric facility] for evaluation of headache x 3 days. Initially called to [area of emergency department for triage] after patient throwing fit, stating she is not on a psychiatric hold and that she is not suicidal and does not need to be dressed out [changed from regular clothing to hospital provided paper scrubs]. Called [psychiatric facility] and confirmed with them that patient is not on a psychiatric hold. Returned to [area of emergency department for triage] to inform patient, informed that we will treat her for her headache, but she will be placed out in the waiting room. Patient then started screaming ‘I’m not going out there’, and then started threatening myself, nursing staff and security. Attempted many times for de-escalation without success. Patient is safe alert [facility generated alert to inform staff that patient is either known to be aggressive and a threat or that patient lacks decisional capacity], A&O [alert and oriented] and not currently on psychiatric hold, patient escorted out by security.” 4. Under, “Plan” it stated patient’s disposition from the emergency department was “Discharged (emergent medical condition stabilized or does not exist): to home. . . Counseled: Patient, Regarding diagnosis, Regarding diagnostic results, Regarding treatment plan, Regarding prescription, Patient indicated understanding of instructions.” 5. The record did not contain any evidence of information regarding diagnosis, diagnostic results, treatment plan, or prescriptions. 6. The record did not contain any evidence of vital signs or full history and physical taken during visit on 05/04/2024. C. During an interview on 08/13/2024 at 2:16 PM with P6, she confirmed that she presented to the emergency department for a really bad migraine, and she was removed from the emergency department because she refused to “dress out”. D. During an interview on 08/15/2024 at 7:33 AM with S(staff)8, clinical, it was asked if taking vital signs is a part of the triage process. S8 stated regarding P6, “Well she was brought in by ambulance and we just use the last set of vital signs they got on her.” It was asked if those vital signs are charted. S8 stated, “There’s no room in the triage note to document this. . . Wait, I think she refused vital signs.” It was asked if the refusal of vital signs was charted, S8 stated, “No, she was disruptive.” E. During an interview on 08/15/2024 at 11:30 AM with S10, non-clinical, it was confirmed that the P6’s medical record did not contain any of the ambulance documents for the visit dated 05/04/2024. F. During an interview on 08/19/2024 at 9:12 AM with S15, clinical, it was asked why P6 was not considered psychiatric emergency. S15 stated, “I felt that it wasn’t a psychiatric emergency because she was being manipulative. In the past, she has been restrained and sent to a room. Which is what she wanted, and she was demanding. I didn’t deem this a psychiatric emergency because she was being manipulative.” S15 explained that the “SAFE” alert on P6 was in place because she had been violent in the past and was in place to make staff aware. 50656”

“PATIENT RIGHTS: FREE FROM ABUSE/HARASSMENT CFR(s): 482.13(c)(3) The patient has the right to be free from all forms of abuse or harassment. This Standard is not met as evidenced by: 49835 Based on record review and interviews, the facility failed to meet the needs for 3 (P (Patient) 1, P6 and P8) of 10 (P1 - P10) patients reviewed for neglect. 1. Failed to ensure patients were able to eat and meet nutritional and hydration needs for P1. 2. Failed to provide recommended treatment for P6 3. Failed to reposition P8. These deficient practices has the potential of harm and death to all patients admitted. The findings are: Failed to ensure adequate nutritional and hydration needs for P1: A. Record review of P1’s medical records revealed P1 was admitted on 09/15/2023. Diet ordered on 9/15/2023, at 6:13 pm, was IDDS (Diabetic Diet) minced and moist (texture) with thin liquids. On 9/16/2023 at 12:31 pm diet order changed to ADA (diabetic) dysphagia Pureed (food for patients unable to swallow whole food). 1. Occupational Therapist evaluation dated 09/19/2023, at 10:01 am, stated P1 needs assistance with ADL’s (activities of daily living which include, personal hygiene, dressing, toileting, transferring, and eating.) 2. On 09/20/2023, Normal Saline (0.9% salt in water) was ordered by provider to run continuously intravenously, (a catheter inserted in the vein to administer medications and fluids). 3. Nutrition note dated 09/21/2023, stated P1 needs a staff member to assist with meal intake also high protein shakes were ordered. 4. Review of the flowsheets titled, “Activities of Daily Living,” revealed the patient only had three (3) meals over the course of seven days. 5. Provider order dated 09/22/2023, naso-gastric (NG tube, a feeding tube placed down the nose into the stomach) tube to be placed for nutrition and hydration. B. During an interview on 02/12/2024, at 9:30 am, with Staff (S)2, Executive Director of Clinical Services, confirmed that meal intake was not evident in the chart and meal intake should have been documented to monitor for nutritional needs. Failed to provide recommended treatment for P6: C. Record review of P6’s medical records on a physical therapy note dated 02/1/2024, at 4:32 pm, Occupational Therapist notified Physical Therapist that patient was experiencing drop foot (foot that can no longer stand up and falls forward) on the right foot. Physical therapy assessed and wrote “ PF [plantar fascitis] night splint and splint wearing schedule [in form of turn clock that outlines splint to be on for 2 hours and off for 2 hours] provided to patient, RN [Registered Nurse] notified.” 1. Review of flowsheet titled, “Musculoskeletal,” revealed the splint was not applied to the right foot from 02/01/2024 to 02/10/2024. D. During an interview on 02/08/2024, at 12:04 pm, with P6 and patient’s child, they both stated that the nurses were supposed to be applying a boot to the patient’s right foot, on and off every two (2) hours and they have not been doing this. Failed to reposition P8: E. Refer to tag A-0398 for findings for P8.”

“SUPERVISION OF CONTRACT STAFF CFR(s): 482.23(b)(6) All licensed nurses who provide services in the hospital must adhere to the policies and procedures of the hospital. The director of nursing service must provide for the adequate supervision and evaluation of all nursing personnel which occur within the responsibility of the nursing service, regardless of the mechanism through which those personnel are providing services (that is, hospital employee, contract, lease, other agreement, or volunteer). This Standard is not met as evidenced by: 47302 Based on record review and interview the facility failed to ensure that staff were following policy regarding skin care for 1(P [Patient]8) of 10 (P1-P10) patients reviewed for skin care. This deficient practice could lead to patients developing pressure injuries (local damage to the skin and underlying tissue from prolonged pressure). The findings are: A. Record review of facility’s policy titled, “Pressure Injury Prevention” dated 11/28/2023 on page 3 under “Repositioning” it stated, “Nurses are responsible for turning patients at risk for skin breakdown and documenting the change in position.” Additionally, on page 4 it stated, “Care for patients at increased risk per Braden [Structured risk assessment tools used to identify adult individuals at risk for pressure injury and to quantify that risk to support decision-making] or Braden Q Subscale [scale for children ages 3 weeks to 8 years] scores. In addition to the standard prevention measures, incorporate the following:. . . 1.9.3 Reposition every 2 hours and post a turn clock [clock created by therapy to define which direction a patient should be positioned in their bed or in equipment] at the bedside.” B. Record review of P8’s medical record for admission date 10/09/2023 revealed the following: 1. Orders revealed an order dated 10/10/2023 at 9:46 PM, ordered generated automatically based on protocols in system, to turn patient every two (2) hours. 2. Document titled, “RN [Registered Nurse] Wound Svcs [Services] Progress Note Form” dated 10/12/2023, at 1:15 PM, revealed a Braden Score of 10 indicating patient was at high risk for developing pressure injuries. Under, “Plan of Care” it stated, “. . . RN wound care received system consult due low Braden score being charted. . . No pressure injuries noted. Recommend preventative mepilex [absorbent type of dressing] foam dressings and [every 2] hour turns, and support surface ASAP [as soon as possible]. Patient currently in stretcher, and at high risk for breakdown.” 3. Review of flowsheets titled, “Activities of Daily Living” from 10/09/2023-10/14/2023 revealed that patient was only turned four (4) times on 10/14/2023. The record did not contain any evidence that patient was turned at all from 10/09/2023-10/13/2023. C. During an interview on 02/12/2024, at 2:40 PM, with Staff (S)4, Executive Director of Clinical Services it was confirmed that there was no evidence of turns in P8’s chart. D. During an interview on 02/13/2024, at 11:24 AM, with S7, Registered Nurse (RN) it was confirmed that patients are turned every two hours if they are at risk for pressure injury and when patients are turned it is charted in the flowsheets.”

“INFECTION CONTROL SURVEILLANCE, PREVENTION CFR(s): The infection prevention and control program includes surveillance, prevention, and control of HAIs, including maintaining a clean and sanitary environment to avoid sources and transmission of infection, and addresses any infection control issues identified by public health authorities; and This Standard is not met as evidenced by: 49193 Based on record review, observation and interview, the facility failed to ensure staff performed hand hygiene and maintain sanitary equipment for all patients reviewed. This deficient practice is likely to result in contamination of equipment, transmission of communicable diseases, and infection control issues placing patients at risk. The findings are: A. Record review of facility’s policy titled “Standard precautions” dated 04/25/2019, section 2.6.1.5 stated, “Do not wear the same pair of gloves for the care of more than one patient.” B. Record review of facility’s policy titled “ Hand Hygiene” dated 02/06/2023, section 1. Stated, “Hand hygiene must be performed: Before and after touching a patient or the patient surroundings (even if gloves are worn)”. C. During an observation on 12/19/23, at 9:30 AM, in the Emergency Department (ED) waiting room Staff (S)18, Patient Care Tech took vitals on two unidentified patients without changing gloves, performing hand hygiene, and cleaning the blood pressure cuff in between uses. D. During an interview with S18 on 12/19/23, at 9:31 AM, S18 confirmed vitals were taken on two unidentified patients without changing gloves, performing hand hygiene, and cleaning the blood pressure cuff in between uses. When asked S18 if that was standard procedure, S18 indicated that either a sleeve on the patient’s arm is to be used, the cuff is to stay with the patient while their admitted or the cuff needs to be disinfected in between uses. D. During an interview with S15, Patient Care Tech on 12/21/23, at 4:20 PM, S15 confirmed that he wears the same pair of gloves when taking vitals for all patients in the waiting room and the same blood pressure cuff is used for all patients in the waiting room and is not cleaned between uses.”

“QAPI CFR(s): 482.21 The hospital must develop, implement and maintain an effective, ongoing, hospital-wide, data-driven quality assessment and performance improvement program. The hospital’s governing body must ensure that the program reflects the complexity of the hospital’s organization and services; involves all hospital departments and services (including those services furnished under contract or arrangement); and focuses on indicators related to improved health outcomes and the prevention and reduction of medical errors. The hospital must maintain and demonstrate evidence of its QAPI program for review by CMS. This Condition is not met as evidenced by: 47302 Based on record review and interview the facility failed to incorporate the Emergency Department (ED) services as it relates to EMTALA (Emergency Medical Treatment and Labor Act) into the hospital wide quality assessment and performance improvement program. This deficient practice effects all patients that receive care from the hospital and can lead to issues in service delivery not being addressed and lead to poor patient outcomes. The findings are: A. Refer to Tag A-0273.”

“INFECTION PREVENTION CONTROL ABX STEWARDSHIP CFR(s): 482.42 The hospital must have active hospital-wide programs for the surveillance, prevention, and control of HAIs and other infectious diseases, and for the optimization of antibiotic use through stewardship. The programs must demonstrate adherence to nationally recognized infection prevention and control guidelines, as well as to best practices for improving antibiotic use where applicable, and for reducing the development and transmission of HAIs and antibiotic resistant organisms. Infection prevention and control problems and antibiotic use issues identified in the programs must be addressed in collaboration with the hospital-wide quality assessment and performance improvement (QAPI) program. This Condition is not met as evidenced by: 47302 Based on record review, observation, and interview the hospital failed to ensure sources of infection were maintained in a manner that prevented the spread of infection for all patients that entered the emergency department. This deficient practice can lead to patients developing hospital acquired infections and lead to poor outcomes. The findings are: A. Refer to Tag A-0750.”

“PATIENT RIGHTS: INFORMED CONSENT CFR(s): 482.13(b)(2) The patient or his or her representative (as allowed under State law) has the right to make informed decisions regarding his or her care. The patient’s rights include being informed of his or her health status, being involved in care planning and treatment, and being able to request or refuse treatment. This right must not be construed as a mechanism to demand the provision of treatment or services deemed medically unnecessary or inappropriate. This Standard is not met as evidenced by: 47302 Based on record review and interview the facility failed to ensure patients were informed of the risks and benefits of leaving the hospital prior to medical evaluation and did not make attempts to obtain written informed refusal of medical evaluation for 3 (P [patient]1, P6, and P12) of 9 (P1, P2, P4, P5, P6, P12, P13, P14, and P15) patients reviewed for leaving the hospital without being seen and/or against medical advice. The findings are: A. Record review of facility policy titled, “EMTALA [Emergency Medical Treatment and Active Labor Act]” dated 05/2014 on page 5 under, “Right to Refuse MSE [Medical Screening Exam], stabilizing treatment and/or transfer” it is stated, “5.1 A patient retains the right to refuse a MSE, necessary stabilizing treatment and further medical examination, as well as transfer to another facility. [Hospital name] will not transfer a patient with an unstabilized EMC [Emergency Medical Condition] (includes a pregnant patient having contractions, a patient in severe pain, a psychiatric disturbance or symptoms of substance abuse) unless the patient so requests and [Hospital name] staff does all of the following: 5.1 .I Offers the patient further medical examination and treatment within the staff and facilities available to [Hospital name] as may be required to identify and stabilized [sic] an EMC; 5. I .2 Informs the patient of the risks and benefits of such examination and treatment, and of the risks and benefits of withdrawal prior to receiving such examination and treatment; 5.1.3 Takes all reasonable steps to secure the patient’s written informed refusal for such examination and treatment; and 5.1.4 Documents the above actions in the Central Log and medical record along with a description of the examination, treatment, or both, if applicable, that was refused. 5.2 Patients who leave [name of facility] without notifying hospital clinical staff shall be appropriately noted in the medical record, if any, and the Central Log. The documentation must reflect that the patient had been at the hospital and the time the patient was discovered to have left the premises.” B. Record review of facility document titled, “Patient Departure/Discharge Against Medical Advice” undated it is stated, “I, [space for patient name], hereby acknowledge that on [space for date] my physician or other health care professional involved in my examination and treatment fully explained my condition, the risks and benefits of treatment, and the potential risks and/or complications (including serious injury or even death) that could arise from my refusal to follow medical advice regarding continued hospitalization for examination and treatment. I also understand that other unknown risks and/or complications (including serious injury or even death) are possible if I refuse continued hospitalization for further medical examination and treatment. I have been fully informed about and understand my medical condition, the benefits of medical treatment, and the potential risks and/or complications (including serious injury or even death) involved in leaving the hospital against the advice of my physician and/or other healthcare professional. I have been given adequate opportunity to ask questions and all of my questions have been answered to my satisfaction. . .” The rest of the document contains signature lines for the patient and healthcare professional to sign, it also contains a box that can be marked that stated, “Patient Refused to Sign.” C. Record review of P1’s electronic medical record for admission date 11/27/2023 revealed the following: 1. Document titled for date 11/27/2023 at 8:05 PM, “[Hospital name] FirstNet Tracking and Triage Form” stated patients presented for, “BIBPD [brought in by police department] for intoxication while walking down 550 [road in city] trying to get home. Pt [patient] was almost hit a few times by drivers so OD [police department] brought in patient for wellness check not in custody. Pt [sic] lives alone.” It is also documented, “Is the patient presenting suicidal/self-harm/harm of others ideation OR presenting for behavioral conditions as the primary reason for this visit?: [sic] No”. 2. Document titled, “ED (Emergency Department) Nursing Discharge Summary Form” for date 11/27/2023 at 10:05 PM it was documented, “Reason Patient Not Seen: Left Without Being Seen (LWBS) (Comment: PT not able to be located in ED . . .)” 3. P1’s electronic medical record did not contain evidence that the risks and benefits of leaving the hospital nor did it contain a written informed refusal. D. Record review of video footage from the night of 11/27/2023 revealed P1 was brought in by police at 7:44 PM in hand cuffs. Patient is seen exiting ambulance bay doors at 8:09 PM, patient re-enters the emergency department by catching a door and sat in a chair in the hallway at 8:12 PM. Staff was seen interacting with patient from 8:13 PM to 8:46 PM. Patient’s audio cannot be heard but staff was heard stating, “your ride is on the way.” At 8:53 PM patient got up from chair and walked out ambulance bay doors. E. Record review of P6’s electronic medical record for admission date 11/27/2023 revealed the following: 1. Document titled, “Status Change Notification Form” for date 11/27/2023 at 5:12 PM it was documented, “Status Change Observed: Patient requested to leave. IV [intravenous catheter] removed and patient LWBS.” 2. P6’s electronic medical record did not contain evidence that the risks and benefits of leaving the hospital nor did it contain a written informed refusal. F. During an interview with S2, ED Manager on 12/06/2023 at 4:30 PM it was asked if the charting found in P6’s medical record was complete, since it did not include documentation that the patient was counseled on risks nor did it include documentation that the provider was notified of the patients desire to leave. S2 confirmed that it was not complete documentation and stated, “it [that type of documentation] happens often.” G. Record review of P12’s electronic medical record for admission date 07/01/2023 revealed the following: 1. Patient visit list revealed documentation that patient’s “Discharge Disposition” was “Left Against Medical Advice-7” 2. P12’s electronic medical record did not contain evidence that the risks and benefits of leaving the hospital nor did it contain a written informed refusal. H. During an interview with S6, Quality Consultant on 12/05/2023at 11:20 AM it was confirmed that P12 did not have a written informed refusal in their record for leave against medical advice. I. During an interview with S2, ED Manager on 12/06/2023 at 4:30 PM it was asked if the facilities document titled, “Patient Departure/Discharge Against Medical Advice” is utilized in cases where the patient leaves prior to being seen by the provider. S2 explained that they do not get a written refusal to be seen in those cases as they consider them a patient who leaves without being seen rather than a patient who is leaving against medical advice.”

“DATA COLLECTION & ANALYSIS CFR(s): 482.21(a), (b)(1),(b)(2)(i), (b)(3) (a) Program Scope (1) The program must include, but not be limited to, an ongoing program that shows measurable improvement in indicators for which there is evidence that it will improve health outcomes ... (2) The hospital must measure, analyze, and track quality indicators ... and other aspects of performance that assess processes of care, hospital service and operations. (b)Program Data (1) The program must incorporate quality indicator data including patient care data, and other relevant data such as data submitted to or received from Medicare quality reporting and quality performance programs, including but not limited to data related to hospital readmissions and hospital-acquired conditions. (2) The hospital must use the data collected to-- (i) Monitor the effectiveness and safety of services and quality of care; and .... (3) The frequency and detail of data collection must be specified by the hospital’s governing body. This Standard is not met as evidenced by: 47302 Based on record review and interview the facility failed to incorporate the Emergency Department (ED) services as it relates to EMTALA (Emergency Medical Treatment and Labor Act) into the hospital wide quality assessment and performance improvement program. This deficient practice effects all patients that receive care from the hospital and can lead to issues in service delivery not being addressed and lead to poor patient outcomes. The findings are: A. During record review of facility’s “Quality Assessment and Performance Improvement [QAPI] Program” dated July 2023 - June 2024 on page 3 under, “Scope” it is stated, “[Hospital name] maintains a coordinated quality assurance program that integrates the review activities of all hospital services to enhance the quality and safety of patient care. [Hospital name] leadership and staff are committed to providing quality healthcare and services and achieve customer satisfaction by meeting or exceeding requirements, expectations, and perceptions, and conducting performance improvement initiatives. Organizational Framework The organizational framework for clinical quality and safety activities is diagrammed in Figure 1 and serves as a foundation for achievement of the QAPI and communication about all quality and safety improvement initiatives. It facilitates a unified, collaborative, consistent, organization-wide program for interdisciplinary improvement efforts and promotes close collaboration and communication among and between the [Hospital name] strategic areas, service lines, departments, administration, medical staff, and Board of Directors.” On page 4 it is stated, “Mission - The mission of the QAPI is to foster communication and oversight of all quality and safety improvement activities that support [Hospital name] as a center of excellence that consistently delivers high-quality, safe healthcare. Vision - By deepening our understanding of our care structures, processes, and outcomes, we focus our continuous quality improvement efforts where they will most effectively be translated into better care quality and safety for our patients, families, and the community.” B. Record review of facility’s meeting minutes from “ED team meetings” dated December 2022 through November 2023 revealed no evidence of discussions related to EMTALA data or quality measures. C. Record review of facility’s meeting minutes from “[Hospital name] Medical Staff and Hospital Quality Committee Minutes” dated May 2023 through October 2023 revealed no evidence of discussions related to EMTALA data or quality measures. D. Record review of facility’s meeting minutes from, “[Hospital name] Medical Executive Committee Meeting Minutes” dated November 14, 2023 revealed no evidence of discussions related to EMTALA data or quality measures. E. During an interview on 12/04/2023 at 4:30 PM with S8, COO (Chief Operating Officer) it was asked if the facility had anything QAPI related to EMTALA data. S8 confirmed there was nothing specifically related to EMTALA in their quality meetings. F. During an interview on 12/06/2023 at 4:20 PM with S8, COO it was confirmed the facility does not routinely collect data regarding EMTALA such as; patients that leave against medical advice, transfers, and patients who leave without being seen.”

“INFECTION CONTROL SURVEILLANCE, PREVENTION CFR(s): The infection prevention and control program includes surveillance, prevention, and control of HAIs, including maintaining a clean and sanitary environment to avoid sources and transmission of infection, and addresses any infection control issues identified by public health authorities; and This Standard is not met as evidenced by: 47302 Based on record review, observation, and interview the hospital failed to ensure hazardous waste (waste that can be dangerous or have a harmful effect on human health) was maintained in a manner that prevented the spread of infection for all patients that entered the emergency department and did not ensure staff was washing hands and equipment. This deficient practice can lead to patients developing hospital acquired infections and lead to poor outcomes. The findings are: Not handling biohazards per policy: A. Record review of facility policy titled, “Infectious Waste [hazardous waste] Disposal” dated 12/28/2021 on page 2 it stated, “4.2 Containment of infectious waste must be in a manner and location which affords protection from animal intrusion, does not provide a breeding place or a food source for insects and rodents, and minimizes exposures to the public. 4.3 To provide the maximum amount of protection to patients and personnel, all infectious waste will be contained at the point of generation and segregated from all other solid waste. 4.4 All infectious waste must be sealed and tied in red, infectious waste plastic bags (to prevent expulsion of liquid) and placed in a red, Lined rigid container with a secure fitting lid. . . 4.6 Solid infectious waste must be contained in plastic bags inside rigid containers. 4.7 Infectious waste, once removed from the collection receptacle must be stored in the Soiled Utility room located on the unit.” B. During an observation in the Emergency Department (ED) on 12/06/2023 at 7:15 AM S (staff) 11, housekeeper was removing red biohazard bags from emergency rooms 12, 13, and 14, dropped them on the floor in the hallway and then put them in the regular trash. C. During an interview on 12/06/2023 at 7:18 AM with S11, housekeeper it was asked if it was policy to put biohazard bags on the floor in the hallway. S11 stated, “I’m picking them up right now.” D. During an interview on 12/06/2023 at 7:22 AM with S9, ED Charge Nurse it was asked if it was standard practice for the housekeepers to throw the biohazard bags on the floor, S9 explained it was normal practice as they are cleaning the rooms. It was then asked if it was normal for them to put the biohazard bags in the regular trash, S9 stated, “Oh, no [they] shouldn’t have done that.” E. During an interview on 12/06/2023 at 4:30 PM with S2, ED Manager it was asked where the biohazard bags should go once removed from the patient rooms, S2 explained that they should always go into a hard bin and not on the floor. F. During an observation of the ED waiting room on 12/06/2023 at 11:45 AM a basin with the word “urine” written on it was seen on the floor, there was a biohazard bag with a specimen cup of yellow liquid in it. Waiting room was observed until 12:06 PM and no staff member checked basin. G. During an interview on 12/06/2023 at 11:57 AM with S10, Patient Access (registration clerk) it was asked how often that basin is checked for patient samples. S10 explained that it is usually checked often or sometimes patients bring her samples directly. H. During an interview on 12/06/2023 at 4:30 PM with S2, ED Manager and S16, ED Medical Director it was asked what the process was for a patient to give a urine specimen. S2, ED Manager explained that it is preferably handed to staff. S2, ED Manager confirmed that the basin on the floor of the ED waiting room was not effective infection control. Not washing hands or equipment: I. Record review of facility policy titled, “Standard Precautions” dated 08/16/2021 on page 1 under, “Implementation Procedures” it is stated, “1. Standard Precautions 1.1. Standard Precautions are the primary strategy for preventing transmission of pathogens [any organism or agent that can produce disease] from one person to another. 1.2. Standard Precautions apply to all patients receiving care regardless of their diagnosis or presumed infection. If there are questions about precautions, contact the Infection Prevention and Control Department (IPCD). 1.3. Staff shall be familiar with and comply with standard precautions and related infection control practices detailed in this manual as well as the Bloodborne Pathogens [any organism or agent that can produce disease originating from a blood source] Exposure Control Plan. Individuals who are consistently non-compliant shall be subject to disciplinary action. 1.4. Standard Precautions combines the major features of Universal Precautions and Body Substance Isolation [refers to the practice of contacting with patients bodily fluids by wearing nonporous articles such as gowns and gloves] and is based on the principal that all blood, body fluids, secretions, excretions (except sweat), non-intact skin, and mucous membranes may contain transmissible infectious agents. 1.5. Standard precautions include: 1.5.1. Hand hygiene 1.5.2. Use of personal protective equipment (PPE) when indicated to prevent exposure to blood, bodily fluids, and other potentially infectious material (OPIM) 1.5.3. Safe injection practices 1.5.4. Safe handling of potentially contaminated equipment or surfaces in the patient environment 1.5.5. Respiratory hygiene/cough etiquette. 2.HAND HYGIENE (HH) 2.1. Hand hygiene is an essential element of Standard Precautions. 2.2. Hand hygiene includes both handwashing with either soap and water or use of alcohol-based products (gels, rinses, foams). Please see Hand Hygiene Procedure in the Infection Control Manual for more details.” J. Record review of ED video recording of 11/27/2023 at 7:51 PM an unidentified staff member was seen providing patient care, removing IV (intravenous) catheter, giving an injection, and going in and out of patient rooms without washing their hands and without wearing gloves. The video revealed that equipment, chairs and stretchers were not cleaned between patients. K. During an interview on 12/07/2023 at 3:56 PM with S2, ED Manager it was asked if staff should be washing their hands and wearing gloves during patient care and if equipment should be cleaned between patients. It was confirmed that staff should be washing hands, wearing gloves and cleaning equipment between patients.”

“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: 47302 Based on interview and record review the facility was found not in compliance with the Emergency Medical Treatment and Labor Act (EMTALA). This effects all patients that present to the emergency department and can lead to patients not being aware of the risks during emergency care. The findings are: A. The facility failed to ensure patients were made aware of risks of refusing a medical screening exam. Refer to tag A-2407. B. The facility failed to obtain a consent for patients being transferred to another facility. Refer to tag A-2409”

“APPROPRIATE TRANSFER CFR(s): 489.24(e)(1)-(2) (1) General If an individual at a hospital has an emergency medical condition that has not been stabilized (as defined in paragraph (b) of this section), the hospital may not transfer the individual unless - (i) The transfer is an appropriate transfer (within the meaning of paragraph (e)(2) of this section); and (ii)(A) The individual (or a legally responsible person acting on the individual’s behalf) requests the transfer, after being informed of the hospital’s obligations under this section and of the risk of transfer. The request must be in writing and indicate the reasons for the request as well as indicate that he or she is aware of the risks and benefits of the transfer. (B) A physician (within the meaning of section 1861(r)(1) of the Act) has signed a certification that, based upon the information available at the time of transfer, the medical benefits reasonably expected from the provision of appropriate medical treatment at another medical facility outweigh the increased risks to the individual or, in the case of a woman in labor, to the woman or the unborn child, from being transferred. The certification must contain a summary of the risks and benefits upon which it is based; or (C) If a physician is not physically present in the emergency department at the time an individual is transferred, a qualified medical person (as determined by the hospital in its bylaws or rules and regulations) has signed a certification described in paragraph (e)(1)(ii)(B) of this section after a physician (as defined in section 1861(r)(1) of the Act) in consultation with the qualified medical person, agrees with the certification and subsequently countersigns the certification. The certification must contain a summary of the risks and benefits upon which it is based. (2) A transfer to another medical facility will be appropriate only in those cases in which - (i) The transferring hospital provides medical treatment within its capacity that minimizes the risks to the individual’s health and, in the case of a woman in labor, the health of the unborn child; (ii) The receiving facility (A) Has available space and qualified personnel for the treatment of the individual; and (B) Has agreed to accept transfer of the individual and to provide appropriate medical treatment. (iii) The transferring hospital sends to the receiving facility all medical records (or copies thereof) related to the emergency condition which the individual has presented that are available at the time of the transfer, including available history, records related to the individual’s emergency medical condition, observations of signs or symptoms, preliminary diagnosis, results of diagnostic studies or telephone reports of the studies, treatment provided, results of any tests and the informed written consent or certification (or copy thereof) required under paragraph (e)(1)(ii) of this section, and the name and address of any on-call physician (described in paragraph (g) of this section) who has refused or failed to appear within a reasonable time to provide necessary stabilizing treatment. Other records (e.g., test results not yet available or historical records not readily available from the hospital’s files) must be sent as soon as practicable after transfer; and (iv) The transfer is effected through qualified personnel and transportation equipment, as required, including the use of necessary and medically appropriate life support measures during the transfer. This Standard is not met as evidenced by: 47302 Based on record review and interview the facility failed to obtain a consent to transfer to another facility for 2 (P(patient)17 and P20) of 5 (P7, P8, P10, P17, P20) patients reviewed for being transferred from the Emergency Department (ED) to another facility. This deficient practice could lead to patients not being properly informed of the reason and risks of being transferred. The findings are: A. Record review of facility policy titled, “EMTALA [Emergency Medical Treatment and Active Labor Act]” dated 05/2014 on page 4 under “Transfers from [Hospital name] to a second hospital outside of [Hospital name]” it is stated “3.2 Complete the transfer paperwork. . . . 3.5 The treating provider who is ordering the transfer must certify in writing that, based on the information available at the time of transfer, the medical benefits reasonably expected from the provision of appropriate medical treatment at another medical facility outweigh the increased risks to the individual and, in the case of a woman in labor, to the unborn child, from effecting the transfer. The certification, which shall be documented on the “Transfer Summary Form,” includes a summary of the risks and benefits upon which the certification is based and the reason(s) for the transfer. If the treating provider is not physically present at the time of transfer, another provider can sign the certification as long as that provider is in agreement with the certification and the treating provider subsequently, countersigns the certification.” B. Record review of P17’s electronic medical record for admission dated 11/29/2023 revealed the following: 1. Document titled, “ED Note - Provider” dated 11/29/2023 at 2:17 PM did not reveal evidence that patient was being transferred to another facility. 2. Document titled, “Text-Admit/Discharge/Transfer Forms” dated 11/30/2023 at 3:43 AM stated, “Patient has received a medical screening, patient will be transferred by qualified personnel and transportation equipment as required, including the use of necessary appropriate life support measures. Receiving facility has agreed to accept transfer and to provide appropriate medical treatments. Receiving facility has available space and qualified personnel for the treatment of the patient. Risks and benefits of transfer explained to patient. Risks and benefits of transfer explained to legal representative.” This note was entered by a registered nurse. There was no evidence the patient or legal representative signed a consent form for the transfer, no evidence of prior acceptance by the receiving hospital and no signed physician certification. C. Record review of P20’s electronic medical record for admission date 10/09/2023 revealed the following: 1. Document titled, “Text-Admit/Discharge/Transfer Forms” dated 10/09/2023 at 10:48 PM stated, “Patient has received a medical screening, patient will be transferred by qualified personnel and transportation equipment as required, including the use of necessary appropriate life support measures. Receiving facility has agreed to accept transfer and to provide appropriate medical treatments. Receiving facility has available space and qualified personnel for the treatment of the patient. Risks and benefits of transfer explained to patient.” This note was entered by a registered nurse. 2. Document titled “Transfer Consent” dated 10/09/2023 under “Transfer Requirements” it is stated “Note: The patient may not be transferred unless each of the following requirements are met:” There is one box checked that stated, “The receiving facility has available space and qualified personnel for treatment of the patient.” There are three boxes that were not checked that stated, “The receiving facility has agreed to accept transfer to provide appropriate medical treatment. . . . The receiving facility will be provided with appropriate medical records at the examination and treatment of the patient. The patient will be transferred by qualified personnel and transportation equipment as required, including the use of necessary and medically appropriate life support measures.” On the second page of this consent form there was a line for the patient to sign and was blank. The record did not contain any documentation of why the patient did not sign the consent form. D. During an interview on 12/06/2023 at 9:49 AM with S (staff) 6, Quality Coordinator confirmed the consent form for P20 was not filled out in its entirety and confirmed there was no other documentation in the chart. E. During an interview on 12/07/2023 at 3:48 PM with S8, Chief Operating Officer it was confirmed that a consent form could not be found for P17.”