Emory University Hospital Midtown

“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: 46188 Based on a review of a medical records, facility documents, Medical Staff Rules and Regulations, policies and procedures, video footage, and staff interviews, it was determined that the facility failed to ensure compliance with special responsibilities of Medicare hospitals in emergency cases, specifically EMTALA [Emergency Medical Treatment and Labor Act] requirements, when one (P1) of 20 patients reviewed presented to the facility’s emergency department (ED): 1. P1 was discharged via EMS [Emergency Medical Services] for a transfer to an inpatient psychiatric facility on 04/26/2026 at 8:41AM and was returned to the facility at 1:20PM. Facility staff continued the ED visit and failed to initiate a new ED visit. 2. P1 was discharged to an inpatient psychiatric facility on 04/26/2026 at 10:12PM via EMS. P1 was returned to F1’s ED after he (P1) used a razor blade to self-harm while en route to the inpatient psychiatric hospital. On return, EMS transferred P1 back to the ambulance to go to another facility. Facility staff failed to initiate a new ED visit and complete an appropriate medical screening exam. Findings included Cross Refer to A2406.”

“EMERGENCY ROOM LOG CFR(s): 489.20(r)(3) [The provider agrees,] in the case of a hospital as defined in §489.24(b) (including both the transferring and receiving hospitals), to maintain a central log on each individual who comes to the emergency department, as defined in §489.24(b), seeking assistance and whether he or she refused treatment, was refused treatment, or whether he or she was transferred, admitted and treated, stabilized and transferred, or discharged. §489.24 The provisions of this regulation apply to all hospitals that participate in Medicare and provide emergency services. This Standard is not met as evidenced by: 46188 Based on a review of the facility’s emergency department (ED) central log, policies and procedures, video footage, medical record, and staff interviews, it was determined that the facility failed to maintain a central log for one patient (P) (P1) of 20 patients reviewed when: 1. A review of P1’s medical record from F1 in the “ED Care Timeline” revealed that he (P1) was discharged via EMS for a transfer to an inpatient psychiatric facility on 04/26/2026 at 8:41AM. Continued review revealed that on 04/26/2026 at 1:20PM, the discharge disposition was removed when P1 was returned to the ED via EMS. A review of the ED’s central log failed to reveal documentation that P1 returned to the ED at 1:20PM. 2. P1 ’ s medical record revealed a disposition to transfer to an inpatient psychiatric facility on 04/26/2026 at 10:12PM via EMS [Emergency Medical Services]. P1 was returned to F1’s ED after he (P1) used a razor blade to self-harm while en route to the inpatient psychiatric hospital. P1 was not entered on the ED’s Central log when he was returned. Findings Included: A review of the facility’s ED Central Log failed to reveal entries for P1 on 04/26/2026 at 1:20PM or between 11:39 PM and 11:59PM. A review of the facility’s policy titled, “EMTALA [Emergency Medical Treatment and Labor Act] - Medical Screening, Treatment, and Related Issues”, no policy number, effective date 10/03/2023, revealed that the purpose of the policy was to set forth procedures to ensure that the facility with Dedicated Emergency Departments (DED) meet all requirements set forth in the Emergency Medical Treatment and Labor Act (EMTALA) for the examination and treatment of patients for whom a request for emergency care is made. Continued review revealed, H., Emergency Department Log, Signage, On-Call Roster: 1. All individuals who come to the ED for whom a request is made for examination, and treatment should be entered into the ED electronic log and have a medical record generate, regardless of eventual disposition. The purpose of the log is to track care provided to each individual who comes to the ED seeking care. A review of Public Safety Sergeant (PSS) LL’s body camera video footage was conducted on 05/14/2026 at 12:20 PM in the conference room. Timestamps included: 23:26:49 - P1 is seen walking into the facility’s ED wearing blue paper scrubs and EMS personnel follow behind P1. 23:40:42 - P1 is escorted out of the facility with EMS personnel and PSOs [Public Safety Officer] are following. 23:41:13 - P1 exited the facility’s ED. 23:41:41 - EMS personnel load P1 onto the back of the ambulance. A review of P1’s medical record failed to reveal documentation that P1 was in the ED on 04/26/2026 from 8:41 AM to 1:20 PM. Continued review failed to reveal that P1 was returned to the facility’s ED on 04/26/2026 after discharge at 10:12 PM. An interview with Nursing Director (ND) BB was conducted on 05/13/2026 at 9:27 AM in the conference room. ND BB said that all patients who enter through the ED or are on hospital property and seek assistance from the ED must be registered and offered a medical screening examination. A telephone interview with Registered Nurse (RN) GG was conducted on 05/13/2026 at 1:40 PM in the conference room. RN GG stated that P1 was discharged from the facility’s ED with an EMS crew and their personal belongings on 04/26/2026 early in night shift. RN GG then recalled that EMS returned P1 to the facility and she assisted the facility’s patient safety officers (PSO) to escort P1 into an ED room. Charge Nurse (CN) KK informed RN GG that P1 was heading to another facility’s ED when RN GG observed P1 on the EMS stretcher in restraints being escorted out of the facility’s ED. RN GG said that all patients who come through any entrance of the ED must be registered and provided with a medical screening examination by a provider. A telephone interview with Charge Nurse (CN) KK was conducted on 05/13/2026 at 2:05 PM. CN KK said that she is a CN in the ED and recalled P1. CN KK stated that P1 ran into the facility with two EMS personnel following behind him. CN KK recalled that P1 was taken to room 15. CN KK recalled that another PSO was speaking with the EMS supervisor, on the telephone, who informed EMS personnel to take P1 to another facility (F2) and requested PSOs to assist. CN KK recalled that P1 was eventually on a stretcher in restraints and taken out of the facility’s ED. CN KK said that all patients who come through the entrances, whether main or ambulance bay, seeking treatment must be registered and provided with a medical screening examination. A telephone interview with Medical Doctor (MD) OO was conducted on 05/14/2026 at 11:19 AM. MD OO was the oncoming night ED physician when P1 returned to the facility on 04/26/2026. MD OO said that all patients are registered when they present to the ED even if they decide to leave before treatment or against medical advice.”

“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: 46188 Based on a review of the facility’s emergency department (ED) central log, Medical Staff Rules and Regulations, policies and procedures, video footage, and staff interviews, it was determined that the facility failed to ensure that one patient (P) (P1) of 20 patients reviewed received an appropriate medical screening examination by a qualified individual when: 1. On 04/26/2026, P1 was brought to the facility’s ED by EMS [Emergency Medical Services] personnel at 1:20PM and staff assumed care from the previous discharge earlier in the day without entering P1 on the ED’s central log or conducting another medical screening examination (MSE). 2. On 04/26/2026 at 10:12PM P1 was discharged via EMS to an inpatient psychiatric facility. During transport, he (P1) used a razor blade to self-harm and was returned to the facility’s ED. Upon return, P1 was not entered onto the Central Log and did not receive an MSE [Medical Screening Exam]. Findings Included: A review of the facility’s ED Central Log failed to reveal an entry for P1 on 04/26/2026. A review of P1’s medical record failed to reveal documentation that P1 was in the ED on 04/26/2026 from 8:41AM to 1:20PM. Further, an MSE is not completed when P1 returned to the ED on 04/26/2026 at 1:20PM. Continued review failed to reveal that P1 was returned to the facility’s ED on 04/26/2026 after discharge at 10:12PM. An MSE is not documented in the record for P1’s return to the ED by EMS on 04/26/2026 sometime between 11:30PM and 11:55PM. A review of the facility’s Medical Staff Rules and Regulations, approved on 01/29/2025, revealed Article V, Emergency Services, Section B, Medical Screening Examination and Stabilizing Treatment: 1. All patients who come to the facility and request examination or treatment for a medical condition will be provided with a medical screening examination (MSE) to determine if the patient has emergency medical condition. The following persons are qualified to perform an MSE: a. In the Emergency Department at the facility, an MSE will be performed by a physician or by a physician’s assistant or advanced practice nurse in accordance with approved clinical guidelines/protocols. 3. If a patient is determined to have an emergency medical condition, the respective facility will provide stabilizing treatment or appropriately transfer the patient to another facility in accordance with the facility’s emergency treatment and transfer policies. A review of the facility’s policy titled, “EMTALA [Emergency Medical Treatment and Labor Act] - Medical Screening, Treatment, and Related Issues”, no policy number, effective date 10/03/2023, revealed that the purpose of the policy was to set forth procedures to ensure that the facility with Dedicated Emergency Departments (DED) meet all requirements set forth in the Emergency Medical Treatment and Labor Act (EMTALA) for the examination and treatment of patients for whom a request for emergency care is made. A review of Public Safety Sergeant (PSS) LL’s body camera video footage was conducted on 05/14/2026 at 12:20 PM in the conference room. The recording timestamps included: 23:26:49 - P1 is seen walking into the facility’s ED wearing blue paper scrubs and EMS personnel follow behind P1. 23:40:42 - P1 is escorted out of the facility with EMS personnel and PSOs [Public Safety Officer] are following. 23:41:13 - P1 exited the facility’s ED. 23:41:41 - EMS personnel load P1 onto the back of the ambulance. An interview was conducted on 05/13/2026 at 9:27 AM in the conference room. Nursing Director (ND) BB said that ND BB is the ND for the emergency department (ED). ND BB said that all patients who enter through the ED or are on hospital property and seek assistance from the ED must be registered and offered a medical screening examination. A telephone interview with Registered Nurse (RN) GG was conducted on 05/13/2026 at 1:40 PM in the conference room. RN GG recalled P1. RN GG recalled that P1 discharged from facility’s ED with EMS crew and P1’s personal belongings. RN GG recalled that sometime later RN GG heard commotion near the ED’s nurses’ station and saw public safety officers and P1. RN Assisted PSOs with escorting P1 into a room. CN KK informed RN GG that P1 was heading to another facility’s ED but did not inform RN GG of the reason. RN GG recalled seeing P1 taken back to the ambulance in restraints on a stretcher. RN GG said that all patients who come through any entrance of the ED must be registered and provided with a medical screening examination by a provider. A telephone interview with Medical Doctor (MD) OO was conducted on 05/14/2026 at 11:19 AM. MD OO was the oncoming ED physician when P1 returned to the facility. During handoff, MD OO had been informed that P1 had discharged to another facility via EMS but there had been a problem during transport whereby P1 self-harmed. MD OO was not aware that P1 had actually returned to the facility. MD OO was informed by CN KK that P1 had actually made it onto the facility’s property; however, per CN KK, the EMS supervisor instructed EMS to transport P1 to facility 2. MD OO said that all patients are registered when they present to the ED even if they decide to leave before treatment or against medical advice.”

“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: 47718 Based on a review of policy and procedures, medical records, and staff interviews, it was determined that the facility failed to ensure that one Patient (P) #1 of 21 sampled patients received an appropriate medical screening examination. Specifically, a review of the facility’s Inpatient Log and Emergency Department (ED) transfers from 7/1/22 to 9/30/22 failed to reveal P#1’s information on the logs. A review of P#1’s ED records only revealed an Admission/Registration Agreement form signed by P#1 on 8/22/22 at 10:02 p.m. No other documentation was found on the ED records. Cross Refer to A-2406 as it relates to the facility’s failure to provide an appropriate medical screening examination to P#1.”

“EMERGENCY ROOM LOG CFR(s): 489.20(r)(3) [The provider agrees,] in the case of a hospital as defined in §489.24(b) (including both the transferring and receiving hospitals), to maintain a central log on each individual who comes to the emergency department, as defined in §489.24(b), seeking assistance and whether he or she refused treatment, was refused treatment, or whether he or she was transferred, admitted and treated, stabilized and transferred, or discharged. §489.24 The provisions of this regulation apply to all hospitals that participate in Medicare and provide emergency services. This Standard is not met as evidenced by: 47718 Based on review of facility policy and procedures and facility logs it was determined that the facility failed to enter one (P#1) of 12 sampled patients with a pregnancy related complaint into the emergency department (ED) log when she arrived at the facility on 8/22/22 seeking medical treatment. Findings included: A review of the facility’s policy titled ’[Emergency Medical Treatment and Labor Act] EMTALA - Medical Screening, Treatment and Related Issues’, last reviewed 10/20/16 revealed: “Emergency Department Log, Signage, On-Call Roster 1. All individuals who come to the Emergency Department for whom a request is made for examination and treatment should be entered into the Emergency Department electronic log and have a medical record generated, regardless of eventual disposition. The purpose of the electronic log is to track the care provided to each individual who comes to the Emergency Department seeking care for an Emergency Medical Condition. A review of the facility’s Inpatient Log and Emergency Department (ED) transfers from 7/1/22 to 9/30/22 failed to reveal P#1’s information on the log.”

“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: 47718 Based on the review of medical records, policies and procedures, and staff interviews, it was determined that the facility failed to provide an appropriate medical screening examination (MSE) for one patient (P#1) of 12 sampled patients with a pregnancy related complaint, a 37-week pregnant patient who presented to the facility’s ED with complaints of abdominal pain. P#1 waited an undetermined amount of time in the facility’s ED waiting room before being moved to the labor and delivery waiting room. P#1 then waited an undetermined amount of time in the labor and delivery waiting room without being seen. P#1 left without being seen after she had a change in her status, vaginal bleeding. P#1 was taken by private vehicle to Facility B, where it was determined that she had intrauterine fetal demise. Findings included: A review of the facility’s “[Emergency Medical Treatment and Labor Act] EMTALA - Medical Screening, Treatment, and Related Issues”, effective date 10/20/2016 stated that “Any individual who comes to the Emergency Department or Labor & Delivery requesting care should be offered an appropriate Medical Screening Examination to determine if the individual has an Emergency Medical Condition. If an Emergency Medical Condition exists, the Hospital should provide treatment to stabilize the condition or an appropriate transfer in accordance with the Hospital Policy on Transfers. PROCEDURE: An appropriate Medical Screening Examination should be provided to any individual who comes to the Emergency Department (and/or on Hospital Property) and: (1) the individual or a representative acting on the individual’s behalf requests an examination or treatment for a medical condition; or (2) it is apparent that the person needed an examination or treatment of a medical condition based on the individual’s appearance or behavior.” A review of the facility’s “OB Assessment Area, Care of the Patient policy”, effective date 7/20/2021 stated that an “RN [Registered Nurse] will conduct a basic screening assessment on all patients who present to the OB Assessment Area. The basic screening re-assessments are to be communicated as indicated by the patient’s condition. The results of the assessment would be documented on the triage flow sheet within the GE Centricity Perinatal (CPN) system. A basic screening assessment will include (but is not limited to): 1. Maternal vital signs 2. Documentation of fetal well-being (fetal heart rate, variability, presents of accels/decels) via a Non-Stress Trest (NST) on an electronic fetal monitor. 3. Frequency and duration of uterine contractions (if present) via NST 4. Vaginal examination: cervical dilation, effacement, fetal presentation and station of presenting part (unless otherwise contraindicated-frank bleeding, placenta previa, preterm PROM) 5. Status of membranes (date, time and color if ROM is reported) 6. Date and time of patient’s arrival and notification of provider I. Obstetrical findings, present or suspected, that require immediate provider notification are: “3. frank bleeding (vaginal bleeding greater than bloody show)” II. Obstetrical findings, present or suspected, that require prompt (within 60 minutes provider notification are: “1. vaginal bleeding” A review of Patient (P)#1’s Emergency Department (ED) records revealed that P#1 signed the Admission/Registration Agreement form on 8/22/22 at 10:02 p.m. There was no other medical record documentation available. During the electronic medical record review at the facility on 9/4/24 at 10:30 a.m., CD OO stated that P#1 had no ambulance trip reports and there was no video recording since P#1’s visit was in 2022, and the facility only kept video recordings for 30 days. During a facility tour of the Labor and Delivery (L&D) area on 9/3/24 at 10:40 a.m., Unit Director (UD) CC stated when the Emergency Department (ED) gets an OB patient who is more than 20 weeks pregnant, the ED staff would bring the patient directly to the OB floor where the patient would be triaged and given an available bed for further treatment. An interview was conducted in the facility’s Labor and Delivery (L&D) conference room on 9/4/24 at 10:15 a.m. with Patient Access Manager (PAM) MM who stated that whenever a patient in the Emergency Department (ED) waiting room complained of pain, the process would be to call the nurse’s desk and ask the unit clerk to let the nurses know that a patient was in pain. If the patient had not been seen after five to eight minutes, they would call the clinical staff in triage and let them know that the patient was in pain. If the patient had still not been seen, they would escalate the issue to the charge nurse and the unit director. PAM MM further stated that she was informed that P#1 got on the elevator and left. An interview was conducted in the conference room on 9/4/24 at 3:40 p.m. with Patient Account Representative (PAR) KK who stated that P#1 came from the facility’s main Emergency Department (ED) to Labor and Delivery (L&D) in a wheelchair with her partner. P#1 was bent over and appeared to be in pain, but she (P#1) did not complain of bleeding. PAR KK recalled that on that night, there were several patients in the labor and delivery waiting room complaining of abdominal pain and the L&D was very busy with no available beds. PAR KK recalled that she (PAR KK) called the nurse’s desk every 10 to 15 minutes and received the same answer; all nurses were with other patients and there were no available beds; and that the charge nurse was working to get beds. PAR KK also stated that when P#1 went to the bathroom, her (P#1) partner came to the desk and said “She (P#1) was bleeding in the bathroom”. PAR KK stated that her (PAR KK) shift was done so she (PAR KK) gave report to the oncoming staff. She (PAR KK) observed that P#1’s partner was leaving with P#1 in the elevator. An interview was conducted in the conference room on 9/4/24 at 3:55 p.m. with Patient Access Supervisor (PAS) LL who stated that on the day of P#1’s incident, the Labor and Delivery (L&D) was very busy and there were no rooms available. PAS LL stated that there were several patients in the waiting room with complaints of abdominal pain, including P#1. PAS LL also stated that she (PAS LL) remembered P#1 being in a wheelchair and quiet. PAS LL further stated that multiple calls were made to the charge nurse in L&D, but she was told that “there were no beds and that the L&D nurses were trying to get beds”. A telephone interview took place in the conference room on 9/5/24 at 1:10 p.m. with Medical Doctor (MD) NN who stated that he saw P#1 at the clinic in the morning on 8/22/22, and P#1 had no complaints. MD NN stated that P#1 had no bleeding, and to the best of his (MD NN) knowledge, there were no medical concerns during the course of P#1’s pregnancy. An interview was conducted in the conference room on 9/5/24 at 2:02 p.m., with Clinical Nurse Specialist (CNS) DD who stated that if the ED received a patient who was more than 20 weeks pregnant, the ED staff would bring the patient directly to the Obstetrics Emergency Department (OB ED), where the patient would be triaged. CNS DD stated that if L&D had no beds, they would utilize any available main operating rooms and also medical-surgical Registered Nurses (RN) to help with antepartum (before birth) patients, so the L&D nurses could focus on the women in labor. A telephone interview was conducted offsite on 9/5/24 at 6:30 p.m., with Registered Nurse (RN) QQ who was the Labor and Delivery nurse at Facility B. RN QQ stated that she received P#1 in a wheelchair and observed she (P#1) was visibly bleeding, and P#1 and her partner appeared very anxious and worried. RN QQ then called the on-call Medical Doctor (MD) PP, who came immediately and did an Ultrasound for Fetal Heart Tones and confirmed that there were no Fetal Heart Tones. RN QQ also stated that P#1 was urgently admitted for further treatment. A telephone interview was conducted offsite on 9/6/24 at 10:00 a.m., with Medical Doctor (MD) PP who stated that he was on call at Facility B on 8/22/2022 and was informed by the nurses about P#1. MD PP stated that when he (MD PP) came to the Labor and Delivery (L&D) triage area, he (MD PP) noted that P#1 was visibly bleeding, and the Ultrasound machine was ready for him. MD PP further stated that when he (MD PP) did the ultrasound for Fetal heart tones (Baby’s heart rate and rhythm), there was no fetal heart rate and no fetal cardiac activity. MD PP also stated that P#1 and her partner were appropriately anxious and flabbergasted. MD PP further stated that he (MD PP) ordered the radiology Ultrasound to confirm his diagnosis of Intrauterine Fetal Demise (fetus dies in the womb) and urgently admitted P#1 for labor induction (a medical procedure that stimulates labor and delivery). During an offsite telephone interview on 9/9/24 at 3:10 p.m., Medical Doctor (MD) RR explained that she had been on call for labor and delivery at Facility A on 8/22/22. She further explained that she was not notified of P#1 being in the ED or the Labor and Delivery ED at Facility A. MD RR further stated that she (MD RR) received a phone call from the Chief Resident at Facility A who told her (MD RR) that P#1 was seen at Facility B because when P#1 was at Facility A’s ED, she (P#1) was never seen by anyone.”

“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: 49398 Based on a review of facility policies and procedures; facility documents and logs; medical records, and staff interviews, it was determined that nursing staff: 1. Failed to document in the patient’s medical record for two (P#1 and P#2) of four sampled patients when: a) P#1’s bone flap collection, label verification and storage information was not documented in the medical record during an operative procedure on 7/30/22 b) The serial number of P#2’s allograft was not documented in the medical record c) Ten individual bags containing patients removed bone flaps were observed to not include all required identification information during a tour on 8/28/24. 2. Failed to ensure that products introduced into the sterile field for patient use were not expired when one (P#3) of four sampled patients was administered an injectable implant with of expiration date of 6/20/20 during an operative procedure on 7/3/24. Findings Included: Cross-refer to A-0411 as it related to the facility’s failure to ensure that nursing staff verified the expiration date of products prior to patient administration. Cross-refer to A-0450 as it related to the failure of nursing services to document required information in medical records and on collected specimens.”

“PHYSICAL ENVIRONMENT CFR(s): 482.41 The hospital must be constructed, arranged, and maintained to ensure the safety of the patient, and to provide facilities for diagnosis and treatment and for special hospital services appropriate to the needs of the community. This Condition is not met as evidenced by: 50527 Based on a review of policies and procedures, observation of the facility’s freezer and inventory carts, and staff interviews it was determined that the facility failed to maintain equipment and inventory utilized by to ensure an acceptable level of safety and quality when it was determined that the freezer used to store removed bone grafts was not maintained at the recommended temperature of -40 degrees Celsius (C). Findings: Cross refer to A-0724 as it relates to the facility’s failure to ensure that the bone graft freezer temperature was maintained within acceptable range.”

“REPORTING ADVERSE REACTIONS AND ERRORS CFR(s): §482.23(c)(5) - There must be a hospital procedure for reporting transfusion reactions, adverse drug reactions, and errors in administration of drugs. This Standard is not met as evidenced by: 49398 Based on review of policy and procedures, facility documents and interviews with staff it was determined that nursing staff failed to ensure injectable implants provided to the surgeon for administration to the patient were not expired when it was determined that one (P#3) of four sampled patients was administered an injectable implant with an expiration date of 6/20/20 during an operative procedure on 7/3/24. Findings included: A review of the facility’s policy ‘Inventory Management,’ no number, last reviewed 7/18/22, revealed that the policy’s purpose is to ensure that critical supplies are available for patient care. Procedures were listed as follows: 1. Perpetual Inventory-The Materials management department maintained an official inventory set up for the storage and distribution of selected items. The criteria used to determine which items will be included in the inventory are based on the length of time it takes to obtain a product, the frequency in which the item is used by various departments, and how critical it is to patients’ well-being. Perpetual inventory is conducted on a scheduled cycle and should only be accessed by Materials Management. 2. Just-in-time par-level management: Upon the issue of any items from the Storeroom, Materials Management staff will ensure the product is in date, and the packaging is sealed, thereby not breaking the sterile barrier of the product. Any products found to be expired or damaged will be discarded. Material management relied upon Vendors to ship products in date and undamaged condition. When conducting Cycle Counts in Centralized Storerooms, expiration dates and the packing of products will be inspected to prevent the issue of expired and damaged items. If a product is issued to Nursing/Ancillary areas, it becomes the responsibility of that area to routinely check expiration dates before use. In the even expired product is found expired or damaged, the supply will be discarded, and Materials Management is notified of for replacement. Every effort will be made by Materials Management staff when counting and replenishing supply carts to ensure product is in date. A review of the purchase Orders placed for Prolaryn Plus from 8/18 through 5/24 revealed that the facility purchased 62 boxes of Prolaryn Plus, part number 8044K0K5. The dates placed and batch/lot numbers are recorded on the purchase orders, along with expiration dates for ones purchased after 2/19/21 . A review of the Purchase Orders for the Prolaryn Plus 1 CC injectable implant revealed that the item’s part number is 8044K0K5. A further review showed that Lot number #100111385 was used on P#3 and came from the purchase order placed on 9/25/18. A review of the facility incident log for 4/1/24 through 8/22/24 revealed an incident report was made on 7/3/24 regarding P#3. The report revealed that a relief circulating RN noted that the injectable implant used in the procedure had an expiration date of 6/20/20. It was also determined that the circulating RN present in the case failed to chart the implant reference number in the medical record. The relieving circulating RN notified the surgeon and the charge nurse. An interview was conducted in the facility’s conference room on 8/28/24 at 10:25 a.m. with the Operating Room and Endoscopy Education Coordinator, RN JJ, who has been in the position since April. RN JJ explained that supplies were treated like medications when they are pulled to place on the surgical field. They check that it is the right product, the right patient, the right procedure, and quality inspection, including checking the expiration date and lot numbers. She learned that the expired product, ProLaryn Pro, was used on P#3 and cannot understand how that occurred if the nurse followed standard procedures. She stated that incident raised questions that are being followed up on by the facility. She further explained that the only time in her practice that an expired product or medication would be used is in a life-or-death situation. A phone interview was conducted on 8/28/24 at 1:00 p.m. with Material Management (MM) NN, who explained that she has a team of 12. She explained that each staff member was assigned to particular area to check inventory in the OR. The ProLaryn Plus Implant Injectable was stocked near the ENT Operating Rooms and taken from the shelves as needed by the OR staff. This item was routinely stocked on the ENT cart. Materials Management staff checked the cart daily for routinely stocked items, rotates stock, and labels any product near its expiration date. In the case of ProLaryn, she was unsure of how inventory that had expired remained on the ENT cart. When MM NN learned of the expired goods being used in the OR on P#3, the cart was checked, and no additional expired ProLaryn was found on the cart. Since the incident, Material management has started a spreadsheet to track all products and their expiration dates. A phone interview was conducted on 8/28/24 at 4:00 p.m. with Purchasing Manager (PM) QQ. His department is responsible for ordering the ProLaryn. It was ordered as needed. He was unaware that the expired ProLaryn was used in the operating room on P#3. A review of purchase orders for ProLaryn Plus from 2018 to present revealed that orders place prior to 1/28/21 included the batch number only. Purchase orders from 1/28/21 to 7/10/24 include the batch, manufacturing date, and expiration date. On 7/10/24, the facility ordered six. PM RR explained that expired products not on consignment, like ProLaryn, are discarded by the facility once they expire. A telephone interview was conducted on 8/30/24 at 2:00 p.m. with the Medical Doctor (MD) LL, who performed the surgery on P#3. MD LL remembered P#3 and was made aware of the expiration date on the ProLaryn Plus Injectable after he had already used the injectable in surgery. He said he expected the circulating RN to check the medication for expiration and the integrity of the box or supplies. In general, he does not routinely ask operating room staff to read out the expiration dates to himself or the surgical technician except on certain medications. He explained that he plans to make this a part of his general practice and procedure. He stated that the patient was doing well and that there were no complications from the procedure. He recalled that he informed the patient after being made aware of the incident but could not remember if he had put anything in the operative notes. He thought that the Lot number was recorded in the operative report. A telephone interview was conducted on 8/30/24 at 2:30 p.m. with relieving Circulating Registered Nurse (RN) CC for P#3. She has been an RN for five years and has worked as a circulating RN or scrub RN at the facility. She explained that when getting any item requested by the MD, she routinely checks the item for the expiration date and box integrity. Prior to opening the box, she repeated the expiration date with the Surgical Tech so the MD will also hear it. The first circulating nurse in the case with P#3 (RN RR) failed to complete the paperwork for the implants and had only provided a reference number. RN CC completed the paperwork. RN CC had to go back into EPIC and complete the charting on the product. At that point it was realized that the ProLaryn Plus RN RR had been pulled and given to MD LL and had an expiration date of 6/20/20. RN CC informed MD LL and the Charge Registered Nurse (RN) DD. RN DD told her to complete an incident report, which she did. RN CC shared a photograph of the label for the ProLaryn Pro, Lot #100111385, with an expiration date of 6/20/20. A phone interview was conducted on 9/4/24 at 11:00 a.m. with RN RR who was the circulating RN in P#3’s case. She recalled the incident with P#3 regarding the expired ProLaryn Plus. She learned about the incident after she had left for the day. She stated that the product was new to her and that there was a cart outside the OR for this product. She recalled that the surgeon requesting the product and explained that she generally read back the product, lot, and expiration date to the Scrub Technician (ST) but could not recall if she did this in the case of P#3. She stated that the normal process when getting an implant for the surgeon was to verbalize the request and then confirm the product with the scrub tech by reading out the product name, lot number, and expiration date. She explained that she did not enter the information into the record prior to turning the case over to the incoming circulating nurse as it was shift change. She remembered that RN CC had caught the expiration date after the product had already been administered to P#3 and that RN CC had written the incident report and reported it to MD LL and Charge RN DD.”

“MEDICAL RECORD SERVICES CFR(s): 482.24(c)(1) All patient medical record entries must be legible, complete, dated, timed, and authenticated in written or electronic form by the person responsible for providing or evaluating the service provided, consistent with hospital policies and procedures. This Standard is not met as evidenced by: 49398 Based on a review of facility policies and procedures, facility logbooks, medical records, observations and staff interviews, it was determined that nursing services failed: 1. To document in the patient’s medical record per facility policy for two (P#1 and P#2) of four sampled patient records when: a. P#1’s bone flap collection, label verification, and storage information was not documented in the record. b. The serial number of P#2’s allograft (tissue, organ, or cells transplanted from a donor to a patient) was not documented in the electronic medical record. These failures could result in the inability of the facility to trace donors in the event of an unexpected event or outcome. 2. To document required information on 10 of twenty bags containing removed bone flaps observed in the freezer on 8/28/24. Findings Included: A review of the facility’s policy titled “Cranial Bone Flap Banking,” effective 2/4/20, revealed that the purpose of the policy was to assure proper storage and handling of cranial bone flap for re-implantation. PROCEDURE: 1. When the flap is obtained, the nurse will confirm with a second person the accuracy of the label and enter a note in the patient record that the bone flap has been stored according to hospital policy. At the time of the reimplantation, the nurse will confirm with a second person that the identifying information matches the patient’s and enter a note stating that the patient’s autologous bone flap was reimplanted according to hospital policy. 2. Overall authority, accountability, and responsibility of the tissue autograft handling belong to the Department of Nursing, Operating Room, in conjunction with the Tissue Bank. A review of the facility’s “Culture and tissue handling, OR” no policy number, last reviewed on 8/7/23, revealed that specimens obtained during a surgical procedure in the operating room must be properly collected, identified, transported, and stored to ensure accurate disease diagnosis and appropriate treatment. Implementation: Circulating nurse o Using the read-back method, ask the surgeon to confirm patient and specimen identification, including the specimen type, the source and location the specimen will be taken from, required tests, special handling needs, and the date and time. o Complete all labels and laboratory request forms with at least two patient identifiers, the specimen type, the source and location the specimen was taken from, the date and time of the collection, the surgeon’s name, the type of preservative, and required tests. o Label the specimen containers. Complications associated with culture and tissue handling in the OR may include: o Loss, mislabeling, or misidentification of a specimen o Need for a second procedure Documentation includes patient identifiers, history, diagnosis, culture preferences, type of specimen, required tests, date and time of collection, type of specimen, required tests, date and time of collection, information pertinent to the specimen or source, name of the surgeon, contact information, name of the nurse performing the preparation, and documentation of the specimen for transport. A review of the facility’s “Cranial Bone Flap Autograph Tracking Sheet Logbook” dated 9/30/22 through 8/23/24 revealed that P#1’s bone flap records did not have a documented tissue expiration date or witness signature. A review of the Complaint Log dated 4/1/24 through 8/22/24 revealed that on 8/22/24, an incident reported regarding P#2. The report revealed that on 8/21/24, the circulating RN removed two frozen tissue allografts out of the designated freezer and failed to complete the Human Requisition Form (HRF). The surgeon, surgery date, patient location, and serial number were missing from the HRF. In addition, the Circulating RN failed to document the implantation in the electronic medical record and failed to document the serial number for both allographs. A tour of the facility OR was conducted on 8/28/24 at 4:00 p.m. with RN JJ. The tour revealed a locked InVita cabinet where the GRAFIX is stored. The InVita Cabinet is kept locked and requires a nurse to have the authority to access these grafts. A review of P#1’s medical record revealed that P#1 was a 60-year-old male who was admitted to the facility’s Emergency Department on 9/30/22 at 6:07 a.m. with a chief complaint of fall-related head injury. A review of “Progress Notes” dated 9/30/22 at 1:43 p.m., revealed that P#1 was taken to the operating room to undergo a right-sided decompressive hemicraniotomy (resection of an extensive bone flap) to allow room for brain swelling. Continued review of the progress note revealed that a 12 by (x) 15-centimeter (cm) craniotomy (a surgical procedure to remove a portion of the skull) was created. A drain was placed, and the skin was closed. P#1 was transferred post-operatively back to the ICU on 9/30/22 at 3:58 p.m. Further review of P#1’s medical record failed to reveal documentation related to the collection, hand-off, and storage of P#1’s bone flap. A review of “Clinical Notes” dated 11/11/22 at 12:40 p.m. revealed that a provider rounded on P#1 and noted that P#1 was in good spirits and was going to the operating room today for a Cranioplasty (a surgical procedure that repairs or reshapes the skull to correct defects). A review of the “Case Request” dated 11/11/22 revealed that a request to cancel P#1’s scheduled 11/11/22 cranioplasty procedure was made. Further review revealed that the case was canceled for the noted reason “Other - the bone flap for the cranium was missing a sticker, and the doctor could not put an unidentified flap in the patient.” Review of “Clinical Notes” dated 11/11/22 at 8:31 p.m. Medical Doctor (MD) UU noted, “Although we were informed yesterday by OR staff that P#1’s bone flap was located and ready for replacement, it could not be found today when preparing for surgery. We inspected the freezer where bone flaps are stored and could not find a bone flap with P#1’s patient identification. There were several bone flaps with incomplete or missing patient identification, but we could not be certain which, if any, of these belonged to P#1. As a result, we were unfortunately forced to cancel the surgery. The circumstances of the cancellation were discussed in detail with the patient, his spouse (who was present), and other family over the phone. They were understandably upset by the situation, and we encouraged them to reach out to patient advocacy. We additionally made the OR front desk aware of the situation and discussed it with neurosurgery leadership. I advised the patient and his family that he may eat and that we will plan on proceeding with cranioplasty in several weeks once a synthetic three-dimensional (3D) printed implant can be generated based on his latest CT scan. All questions were answered to their satisfaction, and we advised them that we would continue to be available for any other questions or concerns. Neurosurgeon (NS) AA has been notified”. A continued medical record review revealed that the 3D-printed synthetic cranioplasty was arranged with the vendor and would be available for implant on 11/23/22. A review of the “Op Note” dated 11/23/22 at 9:28 a.m. revealed that P#1 was brought to the operating room at 7:25 a.m. for a cranioplasty. A review of “Case 131994 (CRANIOPLASTY)” dated 11/23/24 revealed that a Stryker customized permanent implant, model number 7850030, and Plate 2 Hole 16-millimeter (mm) bar, model number 5305216, was implanted into P#1’s right frontal lobe. The patient was awakened from anesthesia and extubated. He was then taken to the recovery room in stable condition. P#1 and his family received and acknowledged understanding of the provided discharge instructions. On 11/30/22 at 1:39 p.m., P#1 was discharged to an acute care skilled nursing facility in stable condition with a final diagnosis of multi-compartmental intracranial hemorrhage and cerebral edema. A review of P#2 revealed that she was admitted on 8/19/24 for a diabetic foot infection and a left leg incision and drainage. P#2 was taken to the operating room on 8/21/24 for incision and drainage and the application of a biological graft to the right heel ulcer. Two GRAFIX 5x5 frozen implants were placed on the right foot, and no complications were noted. P#2 was discharged on 8/22/24 at 1:46 p.m. to home. During a tour of the facility on 8/28/24 beginning at 4:00 p.m. accompanied by RN JJ, twenty individual bags of removed patient bone flaps were observed in the bone flap freezer. Upon further observation the following identification information was not included on the individual bags: Missing patient name of label of one individual bag. Missing patient admission date on four individual bags. Missing collection date on four individual bags. Missing expiration date on six individual bags. Incorrect expiration date on one individual bag. Expiration date should be five years from collection date. Missing physician name on six individual bags. Missing label on two individual bags. During an interview on 8/27/24 at 3:30 p.m. with Neurosurgeon (NS) AA in a hallway, he stated that he was the surgeon who cared for P#1 in 2022. He said that he went to the OR, checked the bone flap freezer, and located three bone flap bags that did not have labels, as the labels were lying at the bottom of the freezer. NS AA canceled P#1’s cranioplasty because he could not say with 100 percent (%) certainty which bone flap belonged to P#1. He met with P#1 and his family and explained what happened. He said they were upset about the situation, but he assured them he could get an expedited synthetic flap made. P#1 and his family agreed to the synthetic flap, and P#1 underwent a cranioplasty a week later. NS AA added that he also treated P#1’s infection 14 months later. He said that P#1’s infection was not related to the surgery or the implant, as it occurred 14 months later. Typically, implant infections occur within 90 days of the surgical procedure. He said that this bone flap storage situation has not reoccurred since the incident in 2022 and that changes were made to how the bone flaps were labeled and stored. During an interview on 8/27/24 at 3:45 p.m. with Registered Nurse (RN) BB in a supply room, RN BB stated that she does not document the bone flap verification in the patient’s medical record. Still, she can rely on her text messages if she needs to review confirmation. She added that documentation and labeling of the bone flap is the responsibility of the RN. RN BB said that she reviews the bone flap logbook weekly to ensure compliance, but there are times when the RN has not fully completed the forms. She added that if the second witness’s signature is missing, she will try to hunt down the surgeon or the surgical tech on the case and ask them if they recall the patient and the bone flap. She will ask the staff members to add their witness signatures to the form if they can remember the patient. RN BB said that it could be days or weeks later that she could obtain any missing information from the form. During an interview on 8/27/24 at 4:11 p.m. with RN KK in a supply room, RN KK stated that she is an RN who primarily circulates on neurosurgery cases. RN KK said she is unfamiliar with the bone flap process and relies on the OR bone flap instruction book to label and store the bone flap properly. RN KK said she is unsure whether she should document anything about the bone flap in the patient’s medical record. During an interview on 8/27/24 at 4:30 p.m. in a supply room, RN GG stated that he has been an OR nurse for the facility since 2021. RN GG explained that he did not know the process for bone flap storage and documentation. He explained that he does not usually circulate on craniotomy cases and is unaware if he has ever had training on bone flaps. During an interview on 8/28/24 at 10:00 a.m. in a conference room, RN FF stated that she had been an OR Nurse for five years and primarily circulates in neurology, spine, craniotomy, and orthopedic surgical cases. RN FF said that when she circulates on craniotomy cases, she relies on the procedure book to verify how she collects, packages, labels, and stores the patient’s bone flaps. RN FF could not recall whether she charts information about the bone flap in the patient’s medical record. She said she would never forget a step in the craniotomy process because she has the procedure book, which gives step-by-step instructions. When this surveyor presented RN FF with P#1’s incomplete bone flap form and asked her to explain why the bone flap expiration date and witness signature were missing, RN FF said that she was unsure why she did not complete the required documentation. An interview was conducted in the facility’s conference room on 8/28/24 at 10:25 a.m. with the Operating Room and Endoscopy Education Coordinator, RN JJ., who has been in the position since April. She explained that she expected the circulating nurse handling ‘bone flaps’ to follow policy and that if they were unfamiliar with the process, a procedure book by the freezer would walk them through it. RN JJ explained that only nurses with badge access can remove an allograph from the InVita cabinet. The Circulating RN completes the “human Requisition Form” before removing any allograft from the cabinet. The form is then placed in a folder on the side of the cabinet and picked up daily by the Blood Bank. If the form is incomplete, the person picking up the forms must try to identify the person who removed the allographs from the cabinet to get the form completed. An incident form is completed whenever information was missing from a form. The human allograph should be documented in EPIC along with the serial number. When these things are not completed, EPIC will not properly interface with the Tissue Tracking System, known as the UDI Tracker. RN JJ explained that she has provided in-services to the OR staff and that the Impact Log Form attached to each GRAFIX allograph is the serial number highlighted in yellow. A note also tells the RN not to chart anything in the LOT number section in EPIC. The RN must chart the serial number located on the implant log form. She further explained that there are guides in EPIC that have been created to help the OR staff chart human tissue correctly. Security can identify who went into the cabinet. RN JJ explained that she only recently became aware of the issue with P#2 when the “GRAFIX allografts” were retrieved without circulating nurses properly completing the paperwork, so a SAFE report was made. When a report was made, the nurse managers generally see it and if necessary, it was escalated to her. She explained that when an issue arises, the OR Nurses should report it to the shift nurse manager or the Unit Director. The shift Nurse Manager is generally responsible for ‘closing the loop.’ A telephone interview was conducted on 8/28/24 at 2:00 p.m. with Operating Room Unit Director (ORD) II in she explained that she is new to the Director position. She expects the circulating RNs to follow the facility’s policies and procedures when handling specimens and patient tissue. She added that nursing staff should know where to chart information on the patient’s bone flap in the medical record and be accountable for knowing specimens are at all times during their surgical cases. ORD II explained that said she did not know where bone flap information should be charted in the medical record. ORD II explained that staff education is conducted quarterly. During an interview on 8/29/24 at 10:51 a.m. with Pathology Director (PD) WW in the blood bank hallway, PD WW explained that bone is one of the few human tissues that does not degrade if the temperature is too warm or cold. The bone flap is not used for the cells but for support and structure.”

“FACILITIES, SUPPLIES, EQUIPMENT MAINTENANCE CFR(s): 482.41(c)(2) Facilities, supplies, and equipment must be maintained to ensure an acceptable level of safety and quality. This Standard is not met as evidenced by: 49398 Based on a review of the facility’s policies; observations; facility reports and logs; and interviews with staff it was determined that the facility failed to ensure that the bone flap storage freezer was maintained at the recommended temperature of at least negative 40 (-40) degrees when it was determined that on 11/14/22 from 7:25 a.m. to 3:15 p.m. and on 4/25/24 from 11:00 a.m. to 4:05 p.m., the temperature was greater than the recommended temperature. A review of the facility’s policy “Bone Flap Banking” no policy number, last reviewed 9/19/23 revealed that the Purpose of the policy was to assure proper storage and handling of cranial bone flap for replantation. Policy Statement: Cranial Bone Flap autographs will be recovered, processed, stored, and transplanted/re-implanted in a manner that minimizes microbial growth, reduces the risk of errors, and meets guidelines established by the American Association of Tissue Banks (AATB) and the FDA. Procedure: 1) the selected package or container for storing the bone will provides an adequate barrier to microbial contamination, will be compatible with the desired type of preservation and storage conditions, and will be impervious to moisture. 2) Aerobic and anaerobic tissue cultures should d be ordered by the attending surgeon if desired (optional) 3) The selected package or container will be labeled according to AATB guidelines, including the following information: a. Cranial bone flap b. For autologous Use Only c. Donor name, age, sex d. Hospital medical record number e. Hospital name and address f. Name of surgeon g. Date and time collected h. Date and time of expiration i. Disinfection steps/additives j. C&S of bone flap sent ___Yes ___No k. Pt. evaluated for infectious disease ___Yes ___No l. Bone flap store in -40-degree (minimum) freezer 5) Autografts will be stored in a temperature-monitored -40-degree centigrade freezer that allows for storage of up to 5 years. (Freezer cannot be an under-the-counter product.) 6) Autografts will be released only to the donor for reimplantation and pending confirmation that all processing, labeling, and storage criteria have been reviewed and met. 7) When the flap is obtained, the nurse will confirm with a second person the accuracy of the label and enter a note in the patient record that the bone flap has been stored according to hospital policy. At the time of the reimplantation, the nurse will confirm with a second person that the identifying information matches the patient’s and enter a note stating that the patient’s autologous bone flap was reimplanted according to hospital policy. 8) Temperature monitoring of the cranial bone flap freezer will be ongoing through a wireless connection with the Tissue Bank/Blood Bank. 9) When placing a bone flap in the freezer or removing a bone flap from the freezer, appropriate PPE must be worn. This consists of reusable insulated safety gloves appropriate for use with a -40-degree centigrade freezer. Gloves must be located adjacent to the freezer, easily accessible by staff 10) Overall authority, accountability and responsibility of the tissue autograft handling belongs to the Department of Nursing, Operating Room, in conjunction with the Tissue Bank. A review of the facility policy “Reporting Medical Equipment Problems to GE Medical Engineering,” no policy number, last reviewed 1/10/22. Purpose- to provide a mechanism for the facility’s healthcare staff to make service requests (SRs) on applicable biomedical and imaging devices and track the status of service thereof. Procedure: How to obtain service: for the universal submission of service requests (SEs), please call 1-866-366-7511. GE Healthcare call center dedicated to the facility, which is available 24 hours per day, seven days a week, and have your biomedical device asset/Control ID or your imaging device system ready. Once you have obtained a Service Request (SR) number, complete a Yellow Maintenance Requested hangtag by indicating the date, department, reporter, phone number, description of the problem, and GE Case # /SR and attach it to the device. How to report unusual occurrences/patient incidents/ SAFE events 1) Complete “how to obtain service” 2) Mark “yes” to the question “Was the device involved in a patient incident?” on the yellow Maintenance Requested hangtag. 3) Follow instructions on the reversed side of a Yellow Maintenance Requested hangtag including the recoding of applicable medical record Numbers, Contacting Risk Management, and Completion of an Incident Report in SAFE. A review of the facility’s policy titled ‘CTCT TempTrak Equipment and Environmental Monitoring’, last approved 2/22/24 revealed that the storage device was used for blood, blood components, tissue, derivatives and reagents are monitored. Sensors placed in or on the equipment take readings every five minutes. Different alarm profiles for each type of equipment allow customization of in-range readings. An alarm bell rings or light flashes when the reading is out-of-range for a specified period of time. Action by a technologist is required to clear the alarm. The action taken is recorded along with the date and name of the technologist clearing the alarm. The Temp Trak software provides historical data for all readings, alarms, and corrective action taken for any out-of-range readings. In place of recording manual temperature and humidity readings, a review of the previous day’s readings is documented. Reports are available at any time to satisfy regulatory requirements. On 8/28/24 beginning at 4:00 p.m. accompanied by RN JJ, a tour continued to the area where the Freezer stores the “bone flaps.” It is a so-low freezer CH45-5, Serial number 1718368. The freezer top has a label that states, “Human tissue storage unit- Do not open without authorization.” The temperature was -52 degrees Centigrade-Inspected-GE Healthcare Due date: 2/2026, GE Healthcare 601529045. On the right side of the freezer is a Bluetooth sensor that she explained goes to the blood bank, monitors the temperature 24/7, and records the temperature every five minutes. A review of the TempTrack logs for 2022 through August 2024 revealed that the report shows a temperature every five minutes. The sensor number was recorded as 244222/2 The TempTrack sensor history report for November 2022 log revealed that on 11/14/22, at 7:20 a.m., a temperature of -40.9 degrees C was recorded. On 11/14/22, the freezer temperature remained above -40 degrees C for 97 readings from 7:20 a.m. until 3:25 p.m. The temperature ranged from -40.9 degrees C at 7:20 a.m. to +7.4 degrees C at 1:15 p.m.; at 3:25 p.m., the freezer temperature was -41.2 degrees C. The TempTrack sensor history report for the April 2024 log revealed that on 4/23/24 at 11:00 a.m., it reported a temp of -37.9 degrees C, and the temperature remained above -40 degrees C for 63 readings from 11:00 a.m. until 4:10 p.m. The freezer readings ranged from -37.9 degrees C at 11:00 a.m. to +31.9 Centigrade at 2:10 p.m. until 4:10 pm when the freezer temperature was -41.2 degrees C. A review of the “Bone Flap Freezer Temperature Out of Range Log” created on 12/5/22 revealed no entries on the log where flaps were removed from the freezer and taken to the blood bank. A review of the lab chest freezer CH series, a so-low user manual, revealed that it was for indoor use, with a temperature range of 15 degrees centigrade to 32 degrees centigrade. A review of the TempTrack Sensor Audit Report from the facility’s blood bank revealed: Audit ID # 98010 on 11/14/22 at 1:45 a.m. freezer 1 door was recently opened. At this time, all sensors have been reviewed, and at this time, the sensors are all in range. Audit ID # 98038 for 11/15/22 at 12:29 a.m. revealed that the auto flap freezer notified maintenance OR defrosting. Audit ID # 114794 from 4/23/24 at 12:18 a.m. showed that the refrigerator door was recently opened. At this time, all sensors have been reviewed. At this time, all sensors are within an acceptable range. Audit ID # 114830 from 4/24/24 at 12:21 a.m. revealed that the freezer door was recently opened. Skull freezer defrosting. At this time, all sensors have been reviewed. At this time, all sensors are within an acceptable range. An interview was conducted in the facility’s conference room on 8/28/24 at 10:25 a.m. with the Operating Room and Endoscopy Education Coordinator, RN JJ., who has been in the position since April and was interviewed in the facility’s conference room. She explained that she expected the circulating nurse handling ‘bone flaps’ to follow policy and that if they were unfamiliar with the process, a procedure book by the freezer would walk them through it. RN JJ explained that next to the Bone Flap Freezer is an instruction manual and a logbook to record any flaps in the freezer. A review of the instruction manual revealed that under “storing” flaps “may be frozen or cryopreserved stored at -40 degrees centigrade or colder for up to five (5) years.” During an interview on 8/29/24 at 10:42 a.m. with Biomedical Technician (BM) VV in the blood bank hallway, BM VV stated that he works for General Electric and is subcontracted by the facility to conduct maintenance checks and repairs on facility biomedical equipment. BM VV said annual checks are performed on all biomedical equipment, including the bone flap freezer in the facility OR. He explained that the blood bank monitors the bone flap freezer’s temperature, and if there is an issue with the freezer, he will not know about it unless the OR staff creates a service ticket. He said that per the manufacturer’s guidelines, the temperature range is -50 degrees Celsius (C), but it is up to the OR staff to set the temperature range based on what is being stored inside it. When this surveyor asked him to explain the provided maintenance records for the bone flap freezer, he said the records showed that scheduled annual maintenance checks were conducted. An interview was conducted on 8/29/24 at 2:50 pm with the Nurse Manager for Orthopedics and Neurology, RN PP; she has been in the role since 2022, primarily Ortho’s, pain, podiatry, loaners, contact representatives, assignments, and schedules. She recalled that she consulted with a sister hospital, and adopted the same equipment, documentation, and labels for the storage of bone flaps. There were no in-services done and they learned on their own in 2022. There were not too many issues, The blood bank keeps track of the temperature with Bluetooth monitoring. The blood bank calls the OR if it’s out of range. The freezer defrosts several times a year. On 11/11/22, bone flaps were transferred to the blood bank. A whole batch went to the blood bank at that particular time, recorded on the bottom of the individual patient log pages. Biomed came and replaced the battery in the alarm. She could not remember if it was because it was beeping, so she contacted the blood bank. An interview was conducted on 8/29/24 at 10:30 a.m. with Blood Bank (BB) SS and discussed how the “flap freezer” temperature is monitored. She explained that the TempTrack is kept in the blood bank and monitored 24/7. The blue tooth sensor records a temperature every 5 minutes, and these results are then recorded electronically on a daily log. She explained that the OR sets the freezer temperature range. If the TempTrack senses a temperature above or below the set temperature, it will send an audible alarm to the blood bank. She believed the set temperature range was -40 degrees Celsius to -80 degrees C. If the blood bank staff hears an alarm, they called the OR to have someone check the freezer. If the alarm continued, the OR was called again. She explained that the OR staff is responsible for checking the freezer and issuing a maintenance request. She was unaware that the freezer TempTrack was out of range for any extended period. BB SS explained that there have been times when the OR staff has had to defrost the “flap” freezer, and when this occurs, they bring the flaps to the blood bank freezer for storage. During an interview on 8/29/24 at 10:51 a.m. with Pathology Director (PD) WW in the blood bank hallway, PD WW explained that bone is one of the few human tissues that does not degrade if the temperature is too warm or cold. The bone flap is not used for the cells but for support and structure.”

“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: 49398 Based on review of Medical Staff Bylaws, Quality Assessment Performance Improvement (QAPI) Plan, Medical Executive Committee meeting minutes, Quality Improvement Committee meeting minutes, Governing Body meeting Minutes and staff interviews, it was determined that the facility failed to develop, implement, and maintain an effective, ongoing, data-driven quality assessment and performance improvement program for the Emergency Department (ED) In addition, the facility failed to ensure performance improvement data was collected, tracked, and analyzed in order to implement changes that effected improvements in quality of care and patient safety in the ED. Cross refer to A0283 as it relates to the facility’s failure to ensure that ED specific performance improvement data was collected, analyzed and tracked and activities implemented to improve health outcomes and patient safety. Cross refer to A0308 as it relates to the Governing Body’s failure to ensure that ED specific quality improvement performance improvement projects were developed and implemented. Findings Included:”

“PATIENT RIGHTS: INFORMED DECISION CFR(s): 482.13(b)(3) The patient has the right to formulate advance directives and to have hospital staff and practitioners who provide care in the hospital comply with these directives, in accordance with §489.100 of this part (Definition), §489.102 of this part (Requirements for providers), and §489.104 of this part (Effective dates). This Standard is not met as evidenced by: 49398 Based on a review of policy and procedures, medical records, and staff interviews it was determined that the facility failed to ensure that patients’ rights were promoted and protected when four (P#1, P#2, P#3, and P#4) of four sampled patients (P#1, P#2, P#3, and P#4) were not given the opportunity to formulate an advanced directive upon admission. Findings Included: A review of the facility’s policy titled “Advance Directives for Healthcare (Durable Power of Attorney for Healthcare and Living Will)”, effective 7/8/2018, revealed that the facility recognized the right of an adult patient to execute an Advance Directive for Health Care. That facility staff shall notify adult patients upon admission of their rights to formulate an advance directive. A review of the facility’s policy titled “Patient’s Rights and Responsibilities”, no number, last reviewed 9/8/21, revealed that the facility would establish guidelines for patient care that recognizes each patient as an individual with unique healthcare needs, values, and cultural perspectives. To respect, promote, and protect the basic human rights of each individual. * Formulate advance directives and expect hospital staff will honor these directives. * Receive information in a manner that meets their needs when they are impaired by vision, speech, hearing or cognitive impairments. A review of Patient (P) #1’s medical record failed to reveal documentation that that P#1 and/or a representative received information or given the opportunity to formulate an advanced directive. A review of three additional medical records (P#2, P#3, P#4) failed to reveal documentation that the patient or representative received information about advanced directives or were provided the opportunity to formulate an advanced directive. During an interview on 8/6/24 at 11:10 a.m. with the Director of Patient Access (DPS) FF, in a conference room, DPS FF stated that Patient Access (PA) staff were required to obtain patient signatures for all consents and patient rights responsibilities. DPS FF explained that clinical staff were responsible for inquiring about advanced directives and documentation of such in the record. DPS FF added that when a patient provided the clinical team with an advanced directive, it was sent to PA staff to be uploaded to the patient’s medical record. During an interview on 8/6/24 at 1:56 p.m. with Emergency Department Unit Nursing Director (UND) KK, in a conference room, UND KK stated that ensuring that patients are asked about their advanced directive is a collaborative effort between the clinical staff and the PA staff.”

“QUALITY IMPROVEMENT ACTIVITIES CFR(s): 482.21(b)(2)(ii), (c)(1), (c)(3) (b) Program Data (2) [The hospital must use the data collected to - .....] (ii) Identify opportunities for improvement and changes that will lead to improvement. (c) Program Activities (1) The hospital must set priorities for its performance improvement activities that-- (i) Focus on high-risk, high-volume, or problem-prone areas; (ii) Consider the incidence, prevalence, and severity of problems in those areas; and (iii) Affect health outcomes, patient safety, and quality of care. (3) The hospital must take actions aimed at performance improvement and, after implementing those actions, the hospital must measure its success, and track performance to ensure that improvements are sustained. This Standard is not met as evidenced by: 49398 Based on review of the Quality and Patient Safety Plan, committee meeting minutes, and interviews with staff it was determined that the facility failed to collect and monitor ED specific data to identify opportunities for improvement; implement activities to improve health outcomes, patient safety, or quality of care. Findings included: A review of “Quality and Patient Safety Plan Emory Healthcare Fiscal Year 2024” revealed that the facility quality plan’s strategic priority areas for 2024 are inclusive of patient experience, patient safety, patient, access, infection prevention, community outreach, and clinical quality. Further review revealed that quality metrics related to the Emergency Department included patient experience and length of stay. The plan failed to include additional metrics related to the Emergency Department or EMTALA. Further review of the plan revealed that the Patient Quality Committee of the EHC Board (PQC) is responsible for oversight and governance of quality and patient safety at EHC. System and entity-specific activities are reported to the PQC through various committees and teams. Senior Executive Management Groups include entity and system Executive Operating Teams. These groups are responsible for the direct management oversight of quality and patient safety activities across the system. A review of the Medical Executive Committee (MEC) meeting minutes dated, 1/16/24, 2/20/24, 4/16/24, and 5/21/24; Quality Council Committee meeting minutes dated, 9/26/23, 10/24/23, 11/28/23, 1/23/24, and 5/28/24; and Governing Body meeting minutes dated, 8/10/23, 10/17/23, 12/23/23, and 2/28/24, failed to reveal quality improvement discussions including quality indicators, data-driven assessments, and quality performance improvement activities related to the ED. During an interview on 8/6/24 at 8:30 a.m. with the Corporate Director of Quality Operations (CDQ) OO, Chief Medical Officer (CMO) PP, CMO QQ, and CMO RR, all of whom are members of the Corporate Patient Quality Committee PQC). CMO QQ stated that the purpose of PQC is to review facility-wide scorecards that measure quality metrics which include patient experience, employee retention, financial data, root cause analysis (RCA) data, and infections of various departments. CMO QQ said that the PQC meets one to two times a year. CMQ explained that PQC’s most recent quality improvement (QI) projects have been high-performance reviews, Magnet status, and credentialing balancing scorecards. He added that the information they discuss was relayed to the MEC during their meetings. CMO PP further added that PCQ has been reviewing facility-wide policies, health equity, and patient experience in the Emergency Department. When this surveyor asked the PQC members if the Emergency Department was being monitored by the PCQ through quality indicators, data-driven assessments, or quality performance improvement activities, CDQ OO said that patient experience and length of stay in the Emergency Department were being monitored. The PQC members failed to provide any further information regarding how the committee was monitoring patient health outcomes in the Emergency Department. The PQC members acknowledged that they are responsible for implementing, monitoring, and reporting performance quality improvement measures to the Medical Executive Committee and Governing Body. The PQC members acknowledged that they are responsible for implementing, monitoring, and reporting performance quality improvement measures to the Medical Executive Committee and Governing Body. CDQ OO was a member of the Medical Executive Committee. During an interview on 8/6/24 at 1:37 p.m. with ED Medical Director (EMD) LL, in a conference room, EMD LL explained that she conducted medical record audits when there was a patient complaint made regarding care. EMD LL was asked to explain what quality indicators were being tracked and trended in the Emergency Department. EMD LL said she was unsure because she had been on maternity leave. When EMD LL was asked by this surveyor to explain how she conducts physician oversight to ensure patients are receiving appropriate care, EMD LL said that she just knows her physicians are always doing what they are supposed to. She added that she knows 100 percent (%) that the providers are conducting appropriate MSEs, discharging patients, and appropriately transferring patients 100% of the time. When this surveyor asked EMD LL to tell us how she could be 100% sure without any oversight or surveillance projects that track and trend quality performance, EMD LL said because the physicians take online EMTALA training annually.”

“QAPI GOVERNING BODY, STANDARD TAG CFR(s): 482.21 ... 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) ... The hospital must maintain and demonstrate evidence of its QAPI program for review by CMS. This Standard is not met as evidenced by: 49398 Based on a review of Governing Board Bylaws, Medical Staff Bylaws, meeting minutes, quality reports, and staff interviews it was determined that the Governing Body failed to ensure that the Emergency Department was being monitored as part of the facility Quality Assessment and Performance Improvement Program (QAPI). Findings Included: A review of the facility’s Governing Body Bylaws, last amended 2/28/24, revealed that Article III, Meetings of Directors, 3.1, Duties, the Corporation shall: The Board of Directors is responsible for the conduct of the business of the Corporation and is authorized to exercise all powers inherent in the Corporation. 4.A.3. Functions of Clinical Services: Clinical services are organized for the purpose of implementing processes: (i) to monitor and evaluate the quality and appropriateness of the care of patients served by the service; (ii) to monitor the practice of individuals with Clinical Privileges in a given service; and (iii) to provide appropriate specialty coverage in the Emergency Department, consistent with the provisions in these Bylaws and related documents. The Medical Executive Committee is delegated the primary authority over activities related to the Medical Staff and to Performance Improvement activities. The Medical Executive Committee is responsible for the following: (5) participation of the Medical Staff in Hospital Performance Improvement activities and the quality of professional services being provided by the Medical Staff; (c) consulting with Hospital administration on quality-related aspects of contracts for patient care services; (d) providing oversight and guidance with respect to Continuing Medical Education activities; (e) reviewing or delegating the review of quality indicators to facilitate uniformity regarding patient care services; (f) providing leadership in activities related to patient safety; (g) providing oversight in the process of analyzing and improving patient satisfaction; 5.C. PERFORMANCE IMPROVEMENT FUNCTIONS (1) The Medical Staff is actively involved in the measurement, assessment, and improvement of at least the following: (a) medication management oversight; (d) utilization review; (e) medical record review; and (f) quality management system. (2) A description of the committees that carry out monitoring and Performance Improvement functions, including their composition, duties, and reporting requirements, is contained in the Medical Staff Organization Manual. 5.D. CREATION OF STANDING COMMITTEES AND SPECIAL COMMITTEES (2) Any function required to be performed by these Bylaws that is not assigned to an individual, a standing committee, or a special committee shall be performed by the Medical Executive Committee. A review of “Quality and Patient Safety Plan Emory Healthcare Fiscal Year 2024” revealed that the facility quality plan’s strategic priority areas for 2024 are inclusive of patient experience, patient safety, patient, access, infection prevention, community outreach, and clinical quality. Further review revealed that quality metrics related to the Emergency Department included patient experience and length of stay. No other metrics related to the Emergency Department or EMTALA were revealed. Further review revealed that the Patient Quality Committee of the EHC Board (PQC) is responsible for oversight and governance of quality and patient safety at EHC. System and entity-specific activities are reported to the PQC through various committees and teams. The Patient Quality Committee (PQC) meets four times per year, preferably on a quarterly basis depending on Emory Healthcare Board Member and EHC Quality Division leadership availability. The meeting agenda typically includes a Story of Harm, updates on strategic initiatives and results on the Balanced Scorecard (BSC), a review of minutes from Clinical Safety Steering Committee (CSSCo) meetings, and a Review of Patient and Employee Survey Results. Entity Medical Executive Committees (MECs) are responsible for credentialing & privileging physician assistants & advanced practice nurses who practice within the hospital. These approvals are presented to and approved by the PQC. Senior Executive Management Groups include entity and system Executive Operating Teams. These groups are responsible for the direct management oversight of quality and patient safety activities across the system. A review of the Medical Executive Committee (MEC) meeting minutes dated, 1/16/24, 2/20/24, 4/16/24, and 5/21/24; Quality Council Committee meeting minutes dated, 9/26/23, 10/24/23, 11/28/23, 1/23/24, and 5/28/24; and Governing Body meeting minutes dated, 8/10/23, 10/17/23, 12/23/23, and 2/28/24, failed to reveal quality improvement discussions including quality indicators, data-driven assessments, and quality performance improvement activities related to the ED. During an interview on 8/6/24 at 8:30 a.m. with the Corporate Director of Quality Operations (CDQ) OO, Chief Medical Officer (CMO) PP, CMO QQ, and CMO RR, all of whom are members of the Corporate Patient Quality Committee PQC. When this surveyor asked the PQC members if the Emergency Department was being monitored by the PCQ through quality indicators, data-driven assessments, or quality performance improvement activities, CDQ OO said that patient experience and length of stay in the Emergency Department were being monitored. The PQC members failed to provide any further information regarding how the committee was monitoring patient health outcomes in the Emergency Department. The PQC members acknowledged that they are responsible for implementing, monitoring, and reporting performance quality improvement measures to the Medical Executive Committee and Governing Body. The PQC members acknowledged that they are responsible for implementing, monitoring, and reporting performance quality improvement measures to the Medical Executive Committee and Governing Body. CDQ OO is also a member of the Medical Executive Committee.”

“DISCHARGE PLANNING- TRANSMISSION INFORMATION CFR(s): Discharge of the patient and the provision and transmission of the patient’s necessary medical information. (b) The hospital must discharge the patient , and also transfer or refer the patient where applicable, along with all necessary medical information pertaining to the patient’s current course of illness and treatment, post-discharge goals of care, and treatment preferences, at the time of discharge, to the appropriate post-acute care service providers and suppliers, facilities, agencies, and other outpatient service providers and practitioners responsible for the patient’s follow-up or ancillary care. This Standard is not met as evidenced by: 49398 Based on a review of facility policies and procedure, medical records, and staff interviews, it was determined that the facility failed to implement appropriate discharge planning when two (P#6 and P#15) of 24 sampled (P#1, P#2, P#3, P#4, P#5, P#6, P#7, P#8, P#9, P#10, P#11, P#12, P#13, P#14, P#15, P#16, P#17, P#18, P#19, P#20, P#21, P#22, P#23, and P#24) patients reviewed failed to receive discharge education. Specifically, P#6 and P#15 medical records failed to reveal documented information in the discharge education regarding necessary medical information pertaining to the patient’s current course of illness and treatment, post-discharge goals of care, treatment preferences to the appropriate post-acute care services providers or agencies, and ancillary care. Findings included: A review of the facility’s policy titled “Discharge of Patients”, effective 5/17/23, revealed that the purpose of the policy was to ensure a smooth and safe discharge process for patients, minimize risks, prevent unplanned readmissions, and maintain compliance with regulatory guidelines. PROCEDURE: 1.The attending physician or designee is responsible for discharging the patient, performing a medication reconciliation, and providing a summary of the patient’s medical condition and care plan. 2.All patients will receive written and verbal post-discharge care instructions, including prescriptions, supplies, and follow-up appointment details, through the EeMR After Visit Summary (AVS). 3.Responsibilities of the nursing staff at discharge include: c. Provide and explain discharge instructions, including discharge prescriptions and supplies/DME and any follow-up appointment details. e. Complete all required documentation, both electronic and on paper as applicable, and discharge the patient from EeMR once the patient is physically out of the unit. A manual discharge requires the completion of the date, time, and discharge disposition. i. If transport is requested at discharge, the discharge disposition must be entered prior to requesting transport. The date/time will auto-populate when the transporter completes the transfer in EeMR. g. Inform and encourage the patient to enroll in MyChart. A review of P#6’s medical record revealed that P#6 presented to the facility’s ED on 7/11/24 at 12:51 a.m. with a chief complaint of suicide. P#6 was assigned an acuity level of two. A review of an “Attending Physician Note” on 7/11/24 at 2:38 a.m. revealed that P#6 had suicidal ideations without a plan. Continued review revealed that P#6 became verbally aggressive with the physician and security was notified. P#6 was escorted off the premises. Continued review of the medical record failed to reveal further psychiatric or mental status examination by a providerP#6 was set for discharge from the facility on 7/11/24 at 2:42 a.m. A review of P#15’s medical record revealed that P#15 presented the facility’s ED on 3/14/24 at 4:02 p.m. with a chief complaint of suicide. P#15 was assigned an acuity level of two. Review of the medical record revealed that P#15 had visual hallucinations and suicidal ideations, positive for alcohol use, and requested information for alcohol rehabilitation. Continued review of the medical record revealed that P#15 wished to be dead in the past month, had non-specific active suicidal thoughts in the past month, and suicidal behavior. P#15 had a Columbia Suicide Severity Rating Scale (CSSRS) risk as moderate. Continued review of the medical record failed to a psychiatric or mental status examination by a provider. P#15 was discharged from the facility on 3/14/24 at 6:11 p.m. with discharge instructions about alcohol use. Continued review failed to reveal any rehabilitation recommendations or additional outpatient services. During an interview on 7/31/24 at 3:30 p.m., with Security Officer (SO) EE, in a conference room, SO EE explained that although not ideal, the ED staff had to discharge behavioral health patients due to aggressive behavior for the safety of the staff. He explained that staff had been injured by aggressive patients in the past. During a telephone interview on 8/1/24 at 10:30 a.m. with Registered Nurse (RN) CC, RN CC explained that the manner behavioral health patients were discharged depended on the situation. Providers signed a 1013 hold if the patient exhibited true expressions of suicidal or homicidal ideations. . If a patient was overly aggressive or not cooperating with the provider, the patient was discharged. During an interview on 8/6/24 at 1:28 p.m. with ED Unit Nursing Director (UND) KK, in a hallway, UND KK explained that all discharge education instructions should be printed out and include resource phone numbers, follow-up instructions, prescription information, and diagnosis information. He added that a QR code prints on the last page of the discharge instructions. UND KK was asked to explain under what circumstances a patient’s discharge instructions would not include specific discharge education but only a QR code. UND KK added that it should never happen unless the patient eloped or left without treatment. He said that it would surprise him if patients were not receiving discharge education and only a QR code.”

“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: 49398 Based on a review of facility policies and procedures, medical records, and staff interviews, it was determined that the facility failed to provide an appropriate, ongoing Medical Screening Examination (MSE) for six (P#1, P#6, P#10, P#11, P#15, and P#16) of 24 sampled patients presenting with behavioral health complaints. Findings included: P#1 arrived at the facility emergency department (ED) on 7/19/24 at 7:30 p.m. with complaints of suicidal ideations as reported by emergency medical services (EMS) staff. A provider assessed P#1 at 10:22 p.m. P#1 was escorted from the premises at 11:00 p.m. after becoming aggressive with staff. A psychiatric or mental status examination was not performed. P#6 presented to the facility’s ED on 7/11/24 at 12:51 a.m. with a chief complaint of suicide. A review of an “Attending Physician Note” on 7/11/24 at 2:38 a.m. revealed that P#6 had suicidal ideations without a plan. After becoming verbally aggressive with the provider, P#6’s disposition was documented as discharge on 7/11/24 at 2:42 a.m. The medical record failed to reveal further psychiatric or mental status examination by a provider. P#10 presented to the facility’s ED on 5/15/24 at 12:41 a.m. with a chief complaint of suicide and chest pain. Form 1013 (involuntary hold) was initiated after a provider assessment. The 1013 was rescinded by the subsequent provider. P#10’s disposition was documented as against medical advice (AMA) and discharged on 5/15/24 at 8:10 p.m. P#11 presented to the facility’s ED on 5/7/24 at 3:24 p.m. with a chief complaint of psychiatric evaluation. The provider recommended treatment and admission. P#11’s disposition was entered as an AMA from the facility on 5/8/24 at 3:09 a.m. P#15 presented the facility’s ED on 3/14/24 at 4:02 p.m. with a chief complaint of suicide. P#15 was discharged from the facility on 3/14/24 at 6:11 p.m. with discharge paperwork that had discharge instructions about alcohol use. P#16 presented to the facility’s ED on 2/2/24 at 9:59 p.m. with a chief complaint of a headache. The patient had a history of schizophrenia. P#16 was discharged from the facility on 2/3/24 at 1:23 a.m. Cross refer to A2406 as it relates to the facility’s failure to provide an appropriate, ongoing Medical Screening Examination (MSE) for P#1, P#6, P#10, P#11, P#15, and P#16.”

“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: 49398 Based on a review of facility policies and procedures, medical records, and staff interviews, it was determined that the facility failed to provide an appropriate Medical Screening Examination (MSE) for six (P#1, P#6, P#10, P#11, P#15, and P#16) of 24 sampled patients medical records reviewed that did not receive a comprehensive psychiatric evaluation, mental status examination by the emergency department provider or a consulting provider. Findings Included: Medical Record Reviews: A review of Patient #1’s “Emergency Medical Services Patient Care Record”, dated 7/19/2024 revealed that his chief complaint was suicidal ideations (SI) (thoughts of harming self) and foot pain. The local fire department communicated to EMS that reported that P#1 wanted to kill himself by overdosing on fentanyl. The patient reported SI with a plan to overdose. The patient admitted to drug use and alcohol use. The patient had outbursts of being agitated and punching on the jumpbag. The patient was placed on the stretcher. The patient agreed to wear the pulse oximeter. The patient refused blood pressure or other vital sign assessments, while en route. The patient did not answer being asked if he had homicidal ideation (HI) (thoughts of harming others). The patient was transported nonemergent to a facility where transfer of care was given to a registered nurse (RN). Further review revealed that P#1 had been released on 7/11/24 from an inpatient behavioral health facility for HI. A review of P#1’s medical record from Facility #1 revealed that P#1 was a 51-year-old male who was admitted to the facility on 7/19/24 at 7:30 p.m. with a chief complaint of insomnia. P#1 had a past medical history of bipolar disorder (a mental illness that causes unusual shifts in a person’s mood, energy, activity levels, and concentration), hypertension (high blood pressure), and schizophrenia (a serious mental health condition that affects how people think, feel and behave). A further review of P#1’s medical record revealed that P#1 was negative for self-injury or SI. Continued review of P#1’s record, dated 7/19/24 at 7:53 p.m., revealed that a suicide risk assessment of P#1 was attempted, and P#1 refused to answer the assessment questions. A review of “ED Triage Notes”, dated 7/19/24 at 7:46 p.m., revealed that P#1 reported that he was cold and wanted to rest. No acute respiratory or other acute distress is noted. P#1 was uncooperative and agitated and the charge nurse was notified. P#1 refused to get off of the EMS stretcher and into a wheelchair. He also refused to answer additional questions. The EMS crew reported that P#1 endorsed SI. The provider assessed the P#1 at 8:00 p.m. The provider reported that P#1 did not express SI and if the patient was truly suicidal, he needed to be evaluated for that. P#1 continued to refuse to answer screening questions and P#1 was moved to hallway 6. P#1 will be monitored until he is transported to his room assignment. Further review revealed at 8:30 p.m., P#1 refused a vital sign reassessment. Continued review of P#1’s record revealed that P#1 refused to answer assessment questions for a suicide risk assessment at 7/19/24 at 8:36 p.m. Review of “ED Notes”, dated 7/19/24 at 9:22 p.m., revealed that P#1 refused a vital sign assessment. At 9:31 p.m., P#1 refused to answer questions and refused to uncover his face. Monitoring was ongoing with a sitter at the bedside. A review of “ED Care Timeline”, dated 7/19/24 at 10:22 p.m., revealed that a medical screening examination (MSE) was conducted by a Medical Doctor (MD). P#1 informed the physician that he had been having difficulty sleeping and that he (P#1) was tired of hearing voices. P#1 denied SI or HI. The psychiatric / behavioral evaluation included in the review of systems revealed that P#1 was positive for hallucinations and sleep disturbance and negative for suicidal ideations. A review of “ED Notes”, dated 7/19/24 at 10:47 p.m., revealed that P#1 reported hallucinations and reported that his medication was stolen. The provider was notified that P#1 refused to answer questions. On 7/19/24 at 11:00 p.m. P#1 became agitated and started screaming at the registered nurse (RN) using derogatory language and racial slurs. Public safety responded to P#1’s bedside. The provider was notified. The patient had no complaints and denied SI and HI. P#1 did not appear acutely psychotic and was safe for discharge. Further review of “ED Notes” on 7/19/24 at 11:00 p.m., revealed that P#1 was physically abusive to the public safety officers and was escorted out of the treatment area by public safety officers. P#1 was discharged home on 7/19/24 at 11:21 p.m. with a final diagnosis of insomnia and schizophrenia. A review of the “ED Provider Note” dated 7/20/24, revealed that P#1 was doing well at the time and had been sleeping. P#1 was offered food and olanzapine (an antipsychotic medication that is used to treat schizophrenia and bipolar disorder) to help with sleep. Patient became agitated and belligerent with the nurse using foul language. Public Safety was called escorted P#1 off the premises. A review of P#1’s medical record from Facility #2 revealed that P#1 was a 51-year-old male was admitted to the facility on 7/23/24 with a chief complaint of suicidal ideations and hallucinations. A telephone interview was conducted on 8/1/24 at 10:02 a.m. with Registered Nurse (RN) BB, RN BB said she recalled P#1 being brought to the facility by Emergency Medical Services (EMS) because it was around shift change. RN BB recalled that P#1 refused to get off the EMS stretcher therefore she went outside to conduct her triage assessment of P#1. She said that EMS stated to her that P#1 was brought in with a chief complaint (CC) of suicidal ideation (SI) with a plan. RN BB explained that EMS staff were unable to elaborate on the specifics of P#1’s suicide plan was. RN BB explained that she conducted her assessment and made triage decisions based on information obtained from the patient directly including vital signs. RN BB said she asked P#1 if he was suicidal and he told her, “No. I just want to sleep. I have been hearing voices and I can’t sleep”. RN BB added that P#1 pulled the blanket over his eyes and refused to answer any further questions. RN BB changed the chief complaint from suicidal ideations to insomnia. She added that his chief complaint was insomnia, and he never verbally expressed a desire to commit suicide. P#1 continued to refuse to get off the stretcher and the charge nurse was notified. RN BB said a provider went outside and was unsuccessful in completing P#1’s assessment due to his uncooperativeness. Nearly an hour later they were able to bring P#1 into the facility. RN BB was aware that P#1 had a history of psychological issues and initiated a psychological protocol in case the provider ordered one. The psychological protocol included blood work, 15-minute checks, and public safety notifications. RN BB attempted to perform a suicide risk assessment several times, but P#1 refused to answer the questions. RN BB stated she was not present for P#1’s discharge and never saw when public safety in Zone 1. A telephone interview was conducted on 8/1/24 at 10:30 a.m. with RN CC. RN CC said she recalled P#1 coming in through the EMS bay and that security was nearby because P#1 had refused to get off the stretcher. She said P#1 was brought in for a mental health evaluation due to SI and homicidal ideations (HI). She recalled asking P#1 if he wanted to harm himself and he replied, no. She said that when she got to the third or fourth question of the suicidal risk assessment, P#1 quit talking. RN CC recalled that P#1 was very short with the provider. The provider informed P#1 if he (P#1) was not suicidal now that she would have to discharge him. RN CC said that P#1 became verbally abusive and threatening. RN CC explained to P#1 that she would prepare him for discharge after which P#1 became increasingly agitated and began calling her racial slurs. RN CC said when P#1 began making racial remarks towards her and his aggression escalated, she called public safety because she was concerned for her safety. RN CC did not know the exact process for how staff should handle abusive patients. She said she typically escalates an aggressive situation to her Charge Nurse and Security. RN CC did not observe staff physically cause harm to P#1; they only escorted him off the property. She explained that the discharge process for behavioral health patients depended on the situation. Providers initiated a 1013 hold if patients exhibited true expressions of SI/HI. If a patient was overly aggressive or not cooperative with the provider, the patient would be discharged. A telephone interview was conducted on 8/1/24 at 11:15 a.m. with Medical Doctor (MD) DD. MD DD stated that she could not remember very much about P#1. MD DD took some time to review P#1’s MR and recalled P#1 presenting with a chief complaint of insomnia but did not recall much interaction that she had with P#1. MD DD recalled that P#1 had become agitated and abusive towards staff, and security had to be called. MD DD did not feel that sedation was appropriate for him. She said that when she spoke with P#1 he seemed calm and had a clear thought process. She said she asked P#1 if he felt suicidal, and he responded, no but refused to say much beyond that so she had no choice but to discharge him. MD DD said she was unaware that P#1’s chief complaint on arrival was SI with a plan. She added that the triage nurse would have been the one to change the chief complaint on the record prior to her assessing P#1. MD DD explained that when she reviewed P#1’s record she was aware that a week prior he had been released from an inpatient behavioral health facility for SI/HI, but she assumed since he was recently released that he was stable because the facility had discharged him and gave him medication for his condition. She added that P#1 did not have any complaints about SI as far as she knew because his chief complaint was insomnia and that is what she assessed him for. MD DD said that when she assesses a patient with SI/HI, she assesses the patient’s presentation, psychosis, and forward-thinking. In addition, she considered the patient’s past medical history and patient interactions with staff. If the patient was aggressive, she tried to talk the patient down, continue their care, and offer them food, whatever would de-escalate the situation. If the patient remained aggressive sometimes, she medicated them, or restrained them if violent and had security alerted if they are a threat to themselves or staff. A review of P#6’s medical record revealed that P#6 presented to the facility’s ED on 7/11/24 at 12:51 a.m. with a chief complaint of suicide. A review of an “Attending Physician Note” on 7/11/24 at 2:38 a.m. revealed that P#6 had suicidal ideations without a plan. Continued review revealed that P#6 got verbally aggressive with the physician and public safety was notified P#6 was escorted off the premises. Continued review of the medical record failed to reveal further psychiatric or mental status examination by a provider. P#6’s disposition was documented as discharge from the facility on 7/11/24 at 2:42 a.m. The medical record failed to reveal further psychiatric or mental status examination by a provider. A review of P#10’s medical record revealed that P#10 presented to the facility’s ED on 5/15/24 at 12:41 a.m. with a chief complaint of suicide and chest pain. Continued review of the medical record revealed that a physician had concerns that P#10 was experiencing acute psychosis and placed P#10 on a 1013 hold (involuntary temporary hold)., A psychological exam and mental status examination on 5/15/24 at 6:57 a.m. A new provider assumed P#10’s care at 5/15/24 at 7:00 p.m. Continued review of the medical record revealed P#10 was removed from the 1013 hold on 5/15/24 at 7:55 p.m. by a provider. A review of an “ED Note” dated 5/15/24 at 7:56 p.m. by an RN revealed that P#10 requested to leave the facility because he felt that he was not being helped P#10 got up aggressively toward the RN yelling. The RN notified the provider. Continued review of the medical record revealed that on 5/15/24 at 7:56 p.m. a provider documented that P#10 was calm and did not currently appear to be severely disorganized. There was no justification for using chemical or physical restraints and allowed P#10 to leave against medical advice (AMA) and that P#10 could return at any time for further concerns. P#10’s disposition was documented as AMA and discharged on 5/15/24 at 8:10 p.m. Continued review of the medical record failed to reveal an AMA form on file. There is no assessment of patient insight or judgment. There are no questions regarding potential delusions, hallucinations, or paranoid thoughts. The thought process is not noted, and there are no further questions about suicide ideation, the duration of those thoughts, or further plans. No further questions are found regarding homicidal ideation or whether he has harmed others before. A review of P#11’s medical record revealed that P#11 presented to the facility’s ED on 5/7/24 at 3:24 p.m. with a chief complaint of psychiatric evaluation. The history of present illness documented, “...presents to the emergency department after being found at Marta trying to assault and playing and acting aggressively. He was reported to have been punched in the face. EMS administered 5 mg of Versed and 5 mg Haldol IM. No other known medical history. Upon my evaluation, patient is somnolent but states his name. He has signs of head trauma on my examination...” The physical exam documented, “...left periorbital ecchymosis and peri-orbital edema...” A cervical collar was applied. The medical record documented at 2:06 a.m., “...acute displaced fracture of the ramus of the right mandible with associated soft tissue swelling. Patient signed out to [ED MD 2] pending reassessment of mental status and mandibular fracture consult as needed.” A review of an “ED Provider Note” on 5/8/24 at 3:09 a.m. revealed that the RN observed that P#11 had ambulated toward the exit and asked P#11 to return to the patient room. Continued review revealed that at 3:20 a.m. the provider highly suspected P#11 had mental illness and would require a psychiatric admission. The provider discussed treatment and admission and P#11 was not interested. P#11 eloped from the ED. P#11’s disposition was entered as an AMA from the facility on 5/8/24 at 3:09 a.m. Continued review of the medical record failed to reveal an AMA form on file. Continued review of the medical record failed to reveal a psychiatric or mental status examination documented by a provider. Additionally, there was no physical evaluation of the cervical, thoracic or lumbar spine to evaluate for injury post-trauma. A phone interview was conducted with RN XX on 8/7/24 at 1:45 p.m. RN XX stated that they worked in the Emergency Department (ED) from 3 p.m. to 3 a.m. on the day of the incident and remembered P#11. During that time, RN XX explained that they were new graduate nurses working with a preceptor. They were not the patient’s primary nurse. RN XX recalled that P#11 was brought in by Emergency Medical Services (EMS) with a cut on their forehead. RN XX stated that the patient recalled that the incident started at a cellular store where an employee at the store had thrown something at P#11. EMS picked P#11 near the MARTA station. RN XX recalled that P #11 was confused and yelling at everyone. P#11 was in the medical area of the ED in zone 3 -room 49, which only has curtains and no doors. P#11 was asleep most of the shift. Around 3:00 a.m. P#11 stated they wanted to leave. RN XX was told by MD WW to remove P#11’s Intravenous Line (IV). P#11 was acting aggressively, walking around and yelling at others. RN XX was instructed to call security. P#11 left before security arrived. RN XX stated that the ED does have an Against Medical Advice Form (AMA) used when a patient has been seen by the MD but has decided to leave the hospital. In this situation, RN XX stated she was in the process of filling out the form when P#11 left the ED. MD WW did not attempt to talk with P#11 when they were informed P#11 requested to leave. RN XX explained that they had been told to call security if a patient became aggressive because staff have been hurt in the past. RN XX further explained that the Charge Nurse: “Just let them go.” And explained the ED can’t hold someone against their will. RN XX stated they were told that you can’t 1013 a patient unless they are suicidal. A telephone interview was conducted on 8/7/24 at 2:45 p.m. with MD WW. MD WW recalled some information about P#11. MD WW stated that P#11 did not start off in the mental health area and was sedated. She recalled that P#11 was waiting to be seen by a specialist for a fracture. P#11 was agitated and did not want to wait. MD WW recalled thinking P#11 was homeless and was concerned if he left that, he would not follow up for care. MD WW stated that a closed fracture like P#11’s had been not emergent and would not have required immediate surgery. MD WW stated that when there is a patient with mental health issues, MD WW would assess the patient’s risk for harm to self or others. MD WW stated that she evaluates a patient’s agitation to ascertain if they are psychotic or just do not want to be treated. She added that when a patient wants to leave, that she cannot hold the patient against their will. MD WW believed that P#11 would not stay and felt there was no clear justification to hold him. MD WW explained she uses the AMA form after she has met with the patient and explained the risks and benefits and the patient still wants to leave. MD WW tries not to use the form on a standard basis and prefers to discharge patients and provide them with prescriptions and follow-up care rather than signing them out of AMA. MD WW recalled that P#11 had just walked out of the ED before any further discussion could be conducted. MD WW added that the facility is aware of the increase in mental health patients. A review of P#15’s medical record revealed that P#15 presented the facility’s ED on 3/14/24 at 4:02 p.m. with a chief complaint of suicide. P#15 was assigned an acuity level of two. Review of the medical record revealed that P#15 had visual hallucinations, suicidal ideations, was positive for alcohol use, and requested information for alcohol rehabilitation. Continued review of the medical record revealed that P#15 wished to be dead in the past month, had non-specific active suicidal thoughts in the past month, and suicidal behavior. Continued review of the medical record revealed that P#15 had a Columbia Suicide Severity Rating Scale (CSSRS) risk as moderate. P#15 was discharged from the facility on 3/14/24 at 6:11 p.m. with discharge paperwork that had discharge instructions about alcohol use. Continued review failed to reveal any rehabilitation recommendations. P#15’s record failed to reveal a psychiatric or mental status examination. A review of P#16’s medical record revealed that P#16 presented to the facility’s ED on 2/2/24 at 9:59 p.m. with a chief complaint of a headache. P#16 was assigned an acuity level of four. P#16 had a past medical history of schizophrenia (a mental health condition that affects how an individual behaves, thinks, and feels). A physician note revealed that the headaches were likely part of delusions due to schizophrenia. P#16 was discharged from the facility on 2/3/24 at 1:23 a.m. Continued review of the medical record failed to reveal a psychiatric or mental status examination by a provider. A telephone interview was conducted on 8/8/24 at 3:22 p.m. with MD BBB. MD BBB stated that he along with other physicians has spoken to the United Nursing Director (UND) KK, the ED Medical Director (EMD) LL, and the Assistant Medical Director, as well as the facility Chief Executive Officer and Vice Chair of Operations, about the dangerousness of Zone 1’s behavioral health hallway area where the psychiatric patients are being placed in the hallway and not in private rooms. MD BBB stated that the nurses sit back with no security for both patients and the staff have no safe exit if events escalate. MD BBB is concerned that despite other Physicians also expressing their concerns, no changes have been made to protect staff and patients. MD BBB is concerned that staff and patients are at risk of harm. MD BBB further explained that there is no designated space to talk privately to these patients, who need to be interviewed in a private area and preferably not out in the open. This only adds to the difficulty of providing quality care to these patients. MD BBB says the setup for the psychiatric patient is not conducive to providing quality care with the privacy and protection needed for both patients and staff. MD BBB discussed that staff can only call security for an escort out of the ED if staff and patients are threatened and they are unable to safely provide care. Policies and Procedures: A review of the facility’s policy titled, “[Emergency Medical Treatment and Labor Act ] EMTALA - Medical Screening, Treatment and Related Issues”, no number, last reviewed 10/20/2016. The scope includes all EHC workforce members, including employees, volunteers, house staff, and medical staff members. Staff members are responsible for adhering to these guidelines in their interactions with patients, families, visitors, or any individual who comes to the EHC facilities. Purpose: The policy sets forth procedures to ensure that the Hospital meets all the requirements set forth in the Emergency Medical Treatment and Labor Act (“EMTALA) Policy: Any individual who comes to the Emergency Department (ED) or Labor & Delivery (L&D) requesting care should be offered an appropriate Medical Screening Examination (MSE) to determine if the individual has an Emergency Medical Condition (EMC). If an EMC exists, the Hospital should provide treatment to stabilize the condition or an appropriate transfer in accordance with the Hospital Policy on Transfers. The Hospital should: 1. Provide an appropriate Medical Screening Exam to anyone coming to the Emergency Department or Labor & Delivery seeking medical care for a suspected Emergency Medical Condition; Procedure: An appropriate Medical Screening Examination should be provided to any individual who comes to the Emergency Department (and/or on Hospital Property} and: (1) the individual or a representative acting on the individual’s behalf requests an examination or treatment for a medical condition or (2) it is apparent that the person needs an examination or treatment of a medical condition based on the individual’s appearance or behavior. Medical Screening Examination 1. “Medical Screening Examination” or (“MSE”) means the process required to reach, with reasonable clinical confidence, the point at which it can be determined whether or not the patient has an Emergency Medical Condition. An MSE is not an isolated event. It is an ongoing process that begins but does not end with Triage. Triage entails the clinical assessment of the individual’s presenting signs and symptoms in order to prioritize when the individual will be seen by a physician or other QMP. All individuals coming to the ED should be provided an MSE appropriate to the individual’s presenting signs and symptoms, as well as the capability and capacity of the Hospital. Depending on the individual’s presenting signs and symptoms, an appropriate MSE can involve a wide spectrum of actions, ranging from a simple process involving only a brief history and physical examination to a complex process that also involves performing ancillary studies and procedures, such as (but not limited to) lumbar punctures, clinical laboratory tests, CT scans, and/or other diagnostic tests and procedures. In making a decision regarding any MSE and whether an individual has an Emergency Medical Condition, the physician or other QMP should take into account the assessment of a triage nurse or other medical personnel and/or any information obtained from any other action taken as part of the MSE which may include, but is not limited to, laboratory results or diagnostic tests. 2. The medical record should reflect continued monitoring according to the individual’s needs until it is determined whether or not the individual has an EMC and, if he/she does until he/she is stabilized or appropriately transferred. There should be evidence of this ongoing monitoring prior to discharge or transfer. 5. The ED attending physician and the ED Charge Nurse are accountable for determining the order in which patients receive an MSE and for ensuring that an MSE is performed. 7. Individuals with psychiatric symptoms: The medical records should indicate both medical and psychiatric or behavioral components of the MSE. The MSE for psychiatric purposes is to determine if the psychiatric symptoms have a physiologic etiology. The psychiatric MSE includes an assessment of suicidal or homicidal thoughts or gestures that indicates danger to self or others. Refusal of Examination or Treatment 1. There are two designations given to a patient when refusing examination and/or treatment: a. Left Without Being Seen (LWBS)- Patient left the emergency department or L&D prior to Medical Screening Exam {MSE). b. Against Medical Advise (AMA)- Patient leaves the hospital, emergency department or L&D after the MSE is performed. If at any time during an ED or L&D visit, a patient refuses an MSE and/or treatment or leaves the ED or L&D before the examination and/or treatment can be completed, the ED or L&D personnel should make every attempt to inform the patient of the risks of refusing examination and/or treatment or of leaving before the examination and/or treatment can be completed. The staff’s attempts to inform the patient of the risks should be documented in the medical record. If possible, the patient should be asked to wait for the physician or QMP, who can discuss the risks of leaving the Hospital with the patient. If the patient decides to leave prior to the completion of his/her care, all efforts will be made to provide information, resources, and follow-up to assist in ongoing wellness. 2. The circumstances of the patient’s refusal or departure should be documented in the medical record and the hospital, ED or L&D staff should take every reasonable step to complete and have the patient sign a Refusal of Examination/Treatment Form if the patient leaves without being seen (LWBS) or AMA. If the patient refuses to sign a Refusal of Examination/Treatment Form or leaves before one can be prepared prior to the patient’s departure, the Form should still be completed and annotated with (1) the date and time of the request for signature from the patient; and (2) when the patient left. This should be made part of the patient’s medical record. A review of the facility’s policy titled, “Unauthorized Departure: Discharge of Patient Against Medical Advice (AMA) / Elopement / Left Without Being Seen (LWBS) no policy number, last reviewed 4/13/2022 purpose was to establish standardized processes when an adult patient with or without decision-making capacity elects to leave or seeks discharge against medical advice (AMA) from inpatient units, the Emergency Department (ED) and Labor & Delivery (L&D) or has left without being seen (LWBS). Section 1. Patients with decision-making capacity who wish to leave an inpatient unit, the ED, or L&D Against Medical Advice (AMA). Under Georgia law, a patient is deemed unable to make decisions for himself or herself if a licensed physician personally examines the patient and documents in the medical record that the patient lacks sufficient understanding or the capacity to make significant responsible decisions regarding his or her own medical treatment OR lacks the ability to communicate such decisions by any means. It is the physician’s responsibility to determine and document the patient’s capacity. Please see Section II below regarding Elopement Precautions for patients who lack decision-making capacity for their own or others’ safety. See Section III below regarding patients in the Emergency Department or Labor and Delivery who Leave Without Being Seen (LWBS) before a Medical Screening Exam can be done. PROCEDURE: I. Patients with decision-making capacity (AMA Discharge) 1. When a patient informs a member of the staff that he/she is leaving, the patient’s physician or advanced practice provider (APP) and the charge nurse are notified of the patient’s intent to leave and the reason(s) why. 2. The clinical provider assesses the patient’s medical decision-making capacity and discusses with the patient the risks of staying or leaving, including the risks of having or not having treatment. 4. The nurse, physician, or APP informing the patient of risks will document in the patient’s medical record the following information: * the potential risks of leaving AMA * discharge instructions (limited to the extent the patient has not had a full workup, but at a minimum, will offer to resume treatment if they return) * any prescriptions 5. The physician, APP, nurse, or designee requests that the patient read and sign the form entitled “Release of Patient Against Medical Advice,” 6. In the event the patient or parent/guardian, if applicable, refuses to sign the form, this fact should be noted on the form and the witnesses present when the form was offered must sign their complete names and include the date. The original form is placed in the patient’s medical record. 7. Staff will complete a SAFE report for inpatient AMA Discharges. 8. For patients with capacity that leave with or without notifying staff from the Emergency Department or Labor & Delivery, steps 4 - 7 should be followed. Patients that leave AMA should be given discharge instructions and any appropriate prescriptions or supportive care items and follow the standard protocol of AMA discharge in the electronic medical record system. II. Patients without decision-making capacity, suicidal or require involuntary psychiatric evaluation or treatment (Elopement) 1. Medical Decision-Making Capacity Determination: When there is a reasonable concern for the immediate safety of a patient, a licensed physician or APP who has personally examined the patient should determine if the patient lacks sufficient understanding or capacity to make significant responsible decisions regarding his or her medical treatment and obtain consent from an authorized surrogate. If a person authorized to consent is not readily available, based on implied consent, the physician must follow the Emory Healthcare Restraint policy when “any delay in treatment could reasonably be expected to jeopardize the life or health of the person affected or safety risk could reasonably result in disfigurement or impaired faculties.” (Emergency treatment statute at OCGA 31-9-3.) 2. For suicidal patients, non-suicidal patients requiring involuntary psychiatric evaluation or treatment, or safety risk patients determined to lack medical decision-making capacity on elopement precautions who attempt to leave the hospital, implement Medically/Non- Violent/Therapeutically Unsafe/ Disruptive Behavior Restraints. If behavior escalates and or forced medication administration must occur, implement Violent or Self-Destructive Behavior/Seclusion Restraints. (Reference the Restraint Policy and Safety Behavioral Assessment and Policy). 3. If such a patient departs undetected (Elopement), then the Security Alert - Missing Inpatient response protocol should be followed (refer to policy “Security Alert - Missing Inpatient”). 4. Staff will complete a SAFE report for all elopements as part of the Security Alert - Missing Inpatient Protocol. 5. This process for patients that elope is the same for inpatients, ED, and L&D patients. III. Left Without Being Seen (LWBS) in the Emergency Department and Labor & Delivery 1. In the ED and in L&D, if a patient leaves before the Medical Screen Examination is initiated by the designated medical staff provider, i.e. the patient has Left without Being Seen (LWBS), the care team will document in the record that the patient left and discharge as a LWBS in the electronic medical record. Refer to the policy: EMTALA-Medical Screening, Treatment, and Related Issues (“Refusal of Examination or Treatment” section). A review of the facility’s policy titled “Safety Risk: Assessment, Precautions & Interventions for Patient Care”, effective 10/1/22, revealed that the purpose of the facility was to promote comfort and protect the safety of patients and healthcare providers when treating patients with safety-related, psychiatric (non-suicidal) or substance abuse/addiction behavior issues. Further review revealed that the medical staff and employees of the facility would attempt to identify patients with safety concerns upon triage, initial interview, history obtained from the patient or others, transfer to an inpatient unit, or anytime during the hospitalization by identifying actions or verbalization. Safety risk precautions and interventions should be implemented when necessary to facilitate medical care and to protect the safety and well-being of patients, staff, and visitors. I. Screening and Assessment A. Care Team Evaluation: Patients who display behaviors or are suspicious of behaviors that are concerning for risk of harm to themselves, or others should be assessed for the following situations and may require the implementation of safety risk precautions and interventions. The list includes but is not limited to: 1. Patients without medical decision-making capacity (dementia, delirium, unstable non-suicidal psychiatric illness) 2. Observed or reasonable suspicion of self-injurious behaviors 3. Observed or reasonable suspicion of self-induced illness (i.e. purging, tampering with equipment, specimens, etc. 4. Patients whose level of sedation is consistently different than the anticipated effect of prescribed medications or staff have reasonable cause to believe the patient is self-medicating or using illicit drugs 5. Staff find illicit drug contraband or drug paraphernalia in-patient room 6. Staff have reasonable cause for believing the patient has items in his/her possession that may be dangerous or illegal 7. Impaired mental status (such as judgment, impulse control, or significant psychosis) which places the patient at risk of being unable to manage his/her own safety or security 8. Non-suicidal patients identified as requiring involuntary inpatient psychiatric hospitalization awaiting psychiatric assessment or transfer to an emergency receiving facility B. Medical Decision-Making Capacity Determination: When there is a reasonable concern for the immediate safety of a patient, a licensed physician or APP who has personally examined the patient should determine if the patient lacks sufficient understanding or capacity to make significant responsible decisions regarding his or her medical treatment and obtain consent from an authorized surrogate. If a person authorized to consent is not readily available, based on implied consent, the physician must follow the Emory Healthcare Restraint policy when “any delay in treatment could reasonably be expected to jeopardize the life or health of the person affected or safety risk could reasonably result in disfigurement or impaired faculties.” (Emergency treatment statute at OCGA 31-9-3.) C. Suicide Risk Behavior: When a patient displays behavior or expresses feelings or thoughts that indicate current suicide risk, the nurse should perform and document the suicide risk assessment, notify the physician of the assessment score, and implement suicide risk precautions and interventions as ordered (reference the Suicide Risk Assessment, Precautions, and Intervention Protocol). D. Violent Behavior: If a patient exhibits behaviors meant to intimidate, harass, or be disruptive and involves verbal or physical abuse, staff should follow the workplace violence algorithm (see related document Workplace Violence algorithm) to immediately de-escalate the situation and notify the needed supportive resources. If the patient’s violent behavior is determined to be related to their medical condition, safety risk precautions and interventions should be implemented in addition to the violence risk precautions (Refer to Workplace Violence Policy).”

“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: 46188 Based on review of the medical record, policy and procedures, staff interviews, and the incident log, it was determined that the facility failed ensure that nursing staff filed incident reports when one Patient (P) (P#1) of three (P#2 and P#3) patients alleged that an act of physical abuse occurred where a staff member struck the patient (P#1) in the face. As a result, the facility failed to ensure an effective assessment, tracking, and investigation of the incident occurred. Findings include: A review of a “Hospital Medicine Progress Note” by Medical Doctor (MD) AA dated 3/16/24 at 11:25 a.m., revealed that P#1 had swelling above her left eye and per nursing staff no mention of falls or trauma. P#1 reported that someone did something to her, refused medications, and displayed signs of confusion and increased agitation. A review of a “Hospital Medicine Progress Note” by MD AA dated 3/18/24 at 10:54 a.m., revealed that P#1 was more cooperative and calmer. MD AA noted swelling along the left upper eye lid with improving bruising. The results of the CT head revealed no fracture or bleed with nonspecific minimal left periorbital soft tissue swelling in thought to cellulitis versus trauma. A review of the facility policy titled, “Adverse Patient-Visitor Safety Events, Response and Investigation”, effective 2/19/24, revealed that the purpose of the policy was to detail that the facility facilitates timely and complete investigation and reporting of events that pose an actual or potential safety risk to patients, families, visitors, and staff. Procedure: “ A patient safety event includes occurrences or conditions associated with care or services that result (or could potentially) result in harm due to acts of commission or omission. “ Adverse events include events that may cause loss to the organization and may also meet the definition of a patient safety event. “ As an integrated part of monitoring and promoting patient safety, all patient safety events (unsafe conditions, near miss, no harm-precursor, serious safety, never/sentinel, and DCH/externally reportable events) and adverse events are to be entered as soon as they are observed. “ Event reporting should be initiated by the first staff person/employee, (including physicians, residents, students, volunteers, ect.) having knowledge of the event as immediately as possible. During an interview on 4/19/24 at 12:49 p.m. in the conference room, Patient Care Technician (PCT) GG said that she has been employed for three years at the facility. PCT GG said that if a patient told her that someone hit the patient, PCT GG would report it to the Charge Nurse (CN). PCT GG recalled that she visited P#1 after returning to work from having a few days off and noticed that P#1 had bruising around their eye. PCT GG recalled that P#1 was pleasant and that PCT GG did not ask her about the bruise because it has been a couple of days since she last saw P#1 and thought that other staff members addressed it. PCT GG recalled that P#1 also wore thick glasses and was unsure whether the glasses caused the bruising or not. PCT GG does not recall P#1 telling her that any staff member hit her and if P#1 did, PCT GG said she would report it. During a telephone interview on 4/19/24 at 1:21 p.m., Registered Nurse (RN) EE said that she has been an RN for four years and employed at the facility for almost six months. RN EE recalled that P#1 had a bruise around her eye and slight swelling but when RN EE spoke to P#1 about it, P#1 would not talk about it. RN EE recalled that she reported the situation to Medical Doctor (MD) AA, who came to assess P#1. RN EE recalled that she and MD AA were trying to assess if the injury was sustained from the patient’s eyeglasses and her sleeping in them. RN EE recalled that P#1 often slept in her glasses and usually favored her left side. RN EE recalled that the eyeglasses were thick and had a bulky frame. RN EE recalled that MD AA did order imaging to further assess P#1’s allegation of injury. RN EE said that she did not file an incident report because she was unsure whether the injury was related to the glasses or not. During a telephone interview on 4/19/24 at 1:36 p.m., MD AA recalled that she was informed that P#1 had swelling on the left eye and reported that someone did it to her. MD AA recalled that when she assessed P#1 and attempted to gather more details, P#1 would not elaborate and initially refused treatment for it such as imaging. MD AA recalled following up with nursing staff to see if any mention of this was reported by the nightshift staff but was told there was no mention of it. MD AA recalled that she was concerned if P#1 hit her face against the bed rail. MD AA recalled that eventually P#1 agreed to a scan of her face and head. MD AA recalled that the imaging of P#1’s face and head revealed no fractures and that the swelling did get better. MD AA recalled speaking to P#1’s family member about the incident and follow-up treatment and that P#1’s family member expressed no concerns or questions. During a telephone interview on 4/19/24 at 2:18 p.m., Charge Nurse (CN) HH said that she assists the unit and staff with any support for nursing guidance, admission/discharge issues, and navigation of any patient concerns. CN HH said that she does not recall P#1. CN HH said that if a patient, whether confused or not, reported that they were hit by staff and CN HH saw the bruise, she would alert the medical care team. CN HH said that she was not informed of a patient who was hit by a staff member this year. CN HH said that she would also file an incident report of the allegation. During a telephone interview on 4/19/24 at 1:51 p.m., Registered Nurse (RN) FF recalled P#1. RN FF recalled that she was told in nursing shift report that P#1 said someone attacked her but P#1, herself, never said it to RN FF. RN FF recalled seeing P#1’s left eye and noted that it was slightly bruised and had some swelling. RN FF recalled that when she inquired about the eye incident to P#1, P#1 would not engage in conversation about it. RN FF said that she did not file an incident report on it because she was told that a previous RN and a physician were already investigating it. During an interview on 4/23/24 at 12:21 p.m. in the conference room, Charge Nurse (CN) JJ said that she has been employed at the facility for eight years and a CN for two years. CN JJ said that if a staff member reported that a patient was hit by staff, then she would tell them to first assess the patient for any injuries, obtain a set of vital signs, contact the physician, and then complete an incident report. CN JJ said that the family would also need to be notified either by the nurse or physician. CN JJ said that she would tell the reporting staff member to perform these actions regardless of whether the patient was oriented or confused, especially if there was noted bruising or swelling. CN JJ said that the CN or the assistant nurse manager would follow up to make sure an incident report was filed. During an interview on 4/23/24 at 12:26 p.m. in the conference room, Unit Manager (UM) KK said that she has been with the facility for three months. UM KK said that if a staff reported that a patient alleged that a staff member injured them, she would expect that staff would first assess the patient, notify the physician so that further assessment and treatment may be rendered, alert management, and file an incident report so that an investigation may occur. UM KK said that family should also be notified by either nursing or the medical care team. UM KK said that the charge nurse or the assistant nurse manager would usually follow up to ensure an incident report was filed. UM KK said that every allegation of physical abuse or assault must be investigated, and it does not matter whether the patient has a history of mental illness or not. A review of the facility’s Incident Log dated 11/23/23 through 4/18/24 revealed no entries related to P#1.”

“PATIENT RIGHTS: INFORMED DECISION CFR(s): 482.13(b)(3) The patient has the right to formulate advance directives and to have hospital staff and practitioners who provide care in the hospital comply with these directives, in accordance with §489.100 of this part (Definition), §489.102 of this part (Requirements for providers), and §489.104 of this part (Effective dates). This Standard is not met as evidenced by: 49398 Based on a review of policy and procedures, medical records, and staff interviews it was determined that the facility failed to ensure that patients’ rights were promoted and protected when four (P#1, P#2, P#3, and P#4) of four sampled patients (P#1, P#2, P#3, and P#4) were not given the opportunity to formulate an advanced directive upon admission. Findings Included: A review of the facility’s policy titled “Advance Directives for Healthcare (Durable Power of Attorney for Healthcare and Living Will)”, effective 7/8/2018, revealed that the facility recognized the right of an adult patient to execute an Advance Directive for Health Care. That facility staff shall notify adult patients upon admission of their rights to formulate an advance directive. A review of the facility’s policy titled “Patient’s Rights and Responsibilities”, effective 9/8/2021, revealed the following: * Patients had a right to make informed decisions regarding their care. * To participate in the development and implementation of their plan of care. * Accept the consequences and responsibility for refusing treatment or not following their prescribed treatment plan. * The right to request and/or refuse treatment with the right to receive a clear explanation of the consequences of refusal of treatment. During a review of Patient (P) #1’s medical record, it was revealed that the Advanced Directive was not completed or signed by P#1 or a patient representative. Continued review of P#1’s medical record revealed that the patient was admitted on 12/17/23 and the patient’s consent for treatment was illegibly signed and unwitnessed on 1/4/24. During an interview on 3/27/24 at 1:33 p.m. in the medical-surgical unit, 51, Registered Nurse (RN) PP stated that she reviewed patient rights with new admission patients by asking them if they would like a copy of the documentation. When RN PP was asked if there was anything else she did to educate patients on patient rights, RN PP stated that she would physically point out to the patient where the patient rights information was located on the unit. When asked if she could show the surveyor where the rights were posted, RN PP was unable to locate it. A telephone interview was conducted on 3/27/2024 at 4:07 p.m. with Senior Patient Access Manager (PAC) LL in the boardroom. PAC LL stated that she had worked at the facility for 21 years. She explained that patients were notified about the Medicare Important Message when they completed and signed the Rights of Responsibilities at registration. She said the forms were electronically scanned into the facility’s electronic medical record system. PAC LL also explained that patients were asked whether they had an Advanced Directive, and if so, a copy was scanned into the electronic medical record system. However, she stated it was not common to ask patients about Advance Directives at registration because the system did not prompt staff to do so. She further said that if patients did not have an Advanced Directive, they were provided with resources to obtain one. A review of three additional medical records (P#2, P#3, P#4) failed to reveal documentation that the patient or representative received information about advanced directives or provided the opportunity to formulate an advanced directive.”

“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: 49398 Based on a review of policy and procedures, medical records, and staff interviews it was determined that the facility failed to ensure that restrained patients were monitored in intervals of two hours as per the facility’s policy. Specifically, the facility failed to conduct and document restraint assessments for one (P#3) of four (P#1, P#2, and P#4) sampled patients. Findings Included: A review of the facility’s policy titled “Patient’s Rights and Responsibilities”, effective 9/8/2021, revealed the following: * Be free from restraint/seclusion used as a means of coercion, discipline, convenience, or retaliation by staff. * Be free from any restraint or seclusion that was not clinically necessary or necessary in an emergency to ensure their immediate physical safety or the safety of others. A review of a policy, “Restraint”, effective 4/12/2023, revealed the following: * All patients would receive notice of rights related to restraints. * Before restraints were initiated, restraint use must be explained to the patient and/or family/significant other to make the restraint/seclusion experience less traumatic. * Restraint devices included but were not limited to wrist-soft limb restraint (soft, non-rigid, cloth-like material), and ankle-soft limb restraint. * All staff designated by the hospital as having direct patient care responsibilities or participating in the application of restraints, implementation of seclusion, monitoring, assessment, or care of a patient in restraint or seclusion must be trained and able to demonstrate competency prior to applying restraints, in the application of restraints, implementation of seclusion, monitoring, assessment and providing care for a patient in restraint or seclusion. A review of P#3’s medical record (MR) revealed that an order was entered on 3/13/24 at 6:55 a.m. for soft limb restraints of the right and left upper extremities. The order was continuous for 24 hours. A review of “Flowsheets” revealed that restraints were applied on 3/13/24 at 6:00 a.m. by Registered Nurse (RN) BB. Further review revealed that restraints were to be discontinued at 5:00 p.m. RN CC assessed the restraints every two hours until 12:00 p.m. P#3’s MR failed to reveal restraint assessments at 2:00 p.m. and 4:00 p.m. Further review of the “Flowsheets” under the tab “Clinical Indication”, failed to reveal a clinical indication documented at 10:00 a.m. and 12:00 p.m. Additionally, there was not a less restrictive alternative documented at 10:00 a.m. An interview was conducted with RN BB on 3/27/24 at 3:15 p.m. in the conference room. RN BB had been employed with the facility for 27 years. RN BB explained the procedure for the placement and documentation of soft restraints. RN BB stated that she did not initially look at the time the restraint order was entered. Once restraints were placed on the patient, charting would start on the hour. RN BB said that restraints were assessed every two hours, and results were documented under the restraint tab on the nurse’s flow sheet. A telephone interview was conducted with RN CC on 3/27/24 at 6:20 p.m. RN CC had been employed with the facility for four or five months. RN CC explained the procedure for placement and documentation of soft restraints. RN CC stated that the Electronic Portfolio of International Credentials (EPIC) system (facility’s electronic medical record) initiated a prompt every 12 hours to complete restraint education, which was done before restraints were placed on a patient except in the case of an emergency such as intubation (placement of a plastic tube into the windpipe to maintain an open airway and assist with breathing). RN CC also stated that once education was completed and restraints were placed, the restraints were checked and documented every two hours on the hour. RN CC further said that there should never be a time when restraints were not documented because the EPIC system would usually prompt you to chart restraint information. All documentation was placed under the restraint tab”