Piedmont Henry Hospital

“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: 52769 Based on review of policies and procedures, medical records, and patient and staff interviews, it was determined that the facility failed to ensure that an appropriate discharge plan was implemented for one patient (P) (P#1) of four patients reviewed (P#1, P#2, P#3, and P#4). Specifically, the facility failed to ensure that P#1 received discharge medications in a timely manner which led to P#1 not having medication from time of discharge on 11/1/25 until the medications were delivered on 11/5/25. Findings include: A review of the facility policy titled “Implementing Discharge Planning, “ effective 8/7/25 revealed discharge planning allowed for comprehensive, interprofessional, and individualized communication and preparation based on the patient’s needs and risks. It promoted optimal recovery, reduced the risk of readmission, and supported safe patient transfer to the home or to another health care setting. The procedure began with screening during initial admission assessment. A discharge plan was developed early in admission that involved the patient and family that were informed of the expected discharge date as soon as possible. Throughout admission, continuous assessment of the patient and family needs were managed prior to discharge such as the need for caregivers, finances, and community services. Both written and verbal discharge education was provided to the patient upon discharge. A review of the facility policy titled “Nursing Patient Assessment/Reassessment Policy,” number 18266318, effective 6/26/25 revealed discharge planning was a multidisciplinary hospital-wide process that began when the patient entered the hospital environment. Early assessment of potential discharge needs was accomplished using various screening tools. The discharge plan was regularly evaluated during the patient’s hospitalization or timeliness and appropriateness. Upon discharge, all the identified needs in the interdisciplinary care plan was addressed by the appropriate discipline. Assessments were completed upon admission at a variety of entry points and continued throughout the hospital stay. The nurse reviewed assessment data each shift to determine the patient’s progress towards discharge and to identify if new or modified interventions were necessary. A review of the facility policy titled “Care Management Plan for Discharge Planning and Transitions of Care,” number 19234400, effective 11/4/25 revealed the purpose was to define an interdisciplinary approach for identifying and providing for post-discharge needs and continuity of care for the patient and their families after discharge. Case management staff assessed high risk patients such as those that included homelessness, uninsured, underfunded, and with a length of stay greater than five days. Discharge planning was provided by, or under the supervision of a registered nurse, social worker, or other appropriately qualified personnel. Discharge planning evaluations were reviewed for the likely need of services that included home health services, specialized medical equipment and related supplies, pharmaceuticals and related supplies. Patients were assisted in making timely discharge plans in the event for the need for post-hospital transitional services. When an inpatient was discharged to another facility, the proper referral forms, transfer forms, and pertinent medical records, and discharge instructions accompanied the patient. Documentation of discharge planning and instructions were noted in the patient’s medical record. A review of the facility policy titled “Complaint/Grievance Process Policy,” number 18204290, effective 5/20/25 revealed a complaint was made verbally to the organization by a patient or patient’s representative that was resolved at the time of the complaint by staff present and the patient was satisfied. A grievance was a formal or informal written or verbal complaint that was made to the organization by a patient or the patient’s representative regarding the patient’s care. A written response was required for the initial acknowledgement of grievance within a timeframe of ten calendar days. If the grievance was not resolved, the investigation was not complete, and the facility responded to the patient that the facility was still working to resolve the complaint and that the facility would follow up with another written response within 30 calendar days. A review of the facility’s policy titled “Rights and Responsibilities of Patients Policy,” number 16455823, last revised 8/22/24, revealed that all patients had the right to considerate, respectful care at all times and under all circumstances. The patient had the right to request consultation with a specialist. This should have been arranged through referral by the patient’s attending physician. The patient had the right to refuse care. The patient was responsible for his/her actions and the outcomes of those actions if he/she refused treatment or did not follow the agreed upon treatment plan. A review of medical record revealed that P#1 was admitted to the facility on 10/19/25 with a ground level fall with upper and lower extremity weakness. A review of Case Manager (CM) CC’s note on 10/24/25 at 11:00 a.m., revealed there were no acute rehabilitation charity beds available for P#1 to be discharged to. CM CC updated P#1 and his family. A review of a social worker (SW)’s clinical note documented on 11/1/25 at 2:52 p.m., revealed that a family member requested that P#1 be set up with follow-up appointments and home health before discharge. The SW explained that home health could not be set up because P#1 was indigent. Continued review revealed that P#1’s family or the personal care home (PCH) could set up the appointments. A review of the discharge summary revealed that P#1 was prescribed the following home medications: “ amlodipine 2.5 mg tablets (relaxes and widens blood vessels to lower blood pressure) - one tablet by mouth in the morning “ Dexamethasone 4MG tablets (steroid that treats inflammation) - one tablet by mouth two times daily with meals for two days, then one tablet daily with breakfast for three days, then 1/2 tablet daily with breakfast for three days. “ dextran 70-hypromellose (PF)0.1 - 0.3% (lubricant used to relieve dry eye) -one drop into both eyes every three hours as needed. A review of a clinical note dated 10/31/25 revealed that P#1 was transported to a Personal Care Home (PCH) using transportation on 11/1/25 at 2:00 p.m. A review of the Director of Case Management (DOM) BB clinical notes documented on 11/1/25 at 2:52 p.m., revealed that she received a call from the PCH stating that they were not aware that P#1 used a condom catheter (external catheter that helps manage urine incontinence) and was upset that he was not sent with supplies. DOM BB documented that the bedside nurse called the PCH to give report but no answered the call.. DOM BB documented that the PCH could have asked for supplies at that time. A review of the Manager of Case Management (MCM) AA’s notes on 11/4/25 at 4:36 p.m., revealed that she sent a text message to the PCH broker (the owner of the company) asking if P#1’s medications had been received. MCM AA did not receive a reply. Further review revealed that another social worker documented that she was notified by DOM BB that P#1 had not received his medication at the time of discharge on 11/1/25. A review of case manager (CM) CC’s clinical notes revealed the following timeline: - 11/4/25 - 12:23 p.m. CM CC called and spoke to the pharmacy to verify if medication was delivered to the facility. The pharmacy only received the fax with the facilities vouchers for payment. The pharmacy representative stated that the electronic prescription went to another pharmacy, but they could pull the order over and have the medications filled and delivered to the facility that day. - 12:34 CM CC called the PCH owner and updated her that P#1’s medications would be delivered to the facility and that CM CC would also obtain condom catheters and a leg bag for P#1. - 3:39 p.m. - P#1’s medication was delivered by the pharmacy to CM CC at the facility. - 3:47 p.m. - CM CC texted PCH broker and asked if she could pick up the medication. CM CC received no text or call back until 11/5/25 at 1:40 p.m. stating that the broker did not have her phone at the time of the text message. - 11/5/25- 2:00 p.m. - CM CC dropped off P#1’s medication to the PCH. A continued review of the CM CC’s note documented on 11/5/25 at 4:50 p.m., revealed that she reviewed P#1’s discharge package that accompanied P#1 to the PCH and identified documents that did not belong to P#1. During a telephone interview with the complainant on 12/2/25 at 12:50 p.m. she stated that she understood the discharge process for the facility because she was a case manager at one of their facilities. The complainant reported that P#1 was sent to the PCH without a cervical-collar (neck brace used for support) after having a fresh spinal cord injury. The complainant further reported that P#1 was not sent to the PCH home with his medication and was without medication from the time of discharge 11/1/25 to 11/5/25 when someone picked up medication and took it the PCH. During an interview with the Manager of Case Management (MCM) AA on 12/1/25 at 2:42 p.m. in the conference room, she explained that one of her responsibilities as the MCM was to give assignments to case managers (CM). MCM AA further explained that her team was in charge of patients discharge planning. MCM AA reported that the facility only sent patients to personal care homes (PCH) that were licensed. MCM AA further reported that she requested an emailed copy of the license before sending patients the PCH. MCM AA reported that she remembered P#1 and that his prescription was sent to the wrong pharmacy. MCM AA further reported that P#1 was discharged from the facility without his medication. MCM AA explained that once the prescription was sent to the correct pharmacy, she delivered it on 11/5/25 to the skilled PCH that P#1 was discharged to on 11/1/25. MCM AA acknowledged that P#1 should not have been discharged until his medication was delivered to the facility. During an interview with the Director of Case Management (DCM) BB on 12/1/25 at 3:11 p.m. in the conference room, she explained that she was responsible for overseeing the case management department. DCM BB further explained that her team assessed and reassessed patients for discharge throughout their stay. DCM BB reported that she was aware that P#1 was a functional quadriplegic (partial or total loss of motor function in all four limbs and the torso) and had no insurance. DCM BB reported that her team tried to find P#1 a charity bed without success. DCM BB further reported that the personal care home (PCH) agreed to accept the patient under a contract with the hospital paying them for 90 days. DCM BB explained that it is not policy for patients that are discharged to a PCH to leave with medication, but to have it within 24 hours. DCM BB acknowledged that P#1 did not get his medication within 24 hours. During an interview with case manager (CM) CC on 12/2/25 at 9:32 a.m. in the conference room, she reported that her responsibilities included discharging patients. CM CC reported that she sent P#1’s prescription to a pharmacy to be filled before discharge. CM CC further reported that the pharmacy typically delivered the medication to the patient but did not have anyone available to deliver the medication on 10/30/25. CM CC explained that patients were normally discharged from the facility with their medications. CM CC further reported that she did not work the next day when P#1 was discharged and was not aware if he received his medication. An interview was conducted with social worker (SW) DD on 12/2/25 at 9:46 a.m. in the conference room. SW DD reported that her responsibilities included ensuring a safe discharge for patients by making sure that they had everything they needed to transition to another facility. During an interview with P#1 on 12/2/25 at 12:38 p.m. in his room, he confirmed that he was first admitted to the facility 10/19/25 after a ground level fall. P#1 reported that staff in the emergency room (ER) mixed up his identity with another patient in the ER who had a similar injury to his. P#1 explained that he requested to have the surgery about eight days after his admission and was told that he missed the ‘window period’ to have surgery. P#1 reported that case managers were mean to him and kept asking him where he was going for discharge and told him that he could not stay at the facility. P#1 reported that he believed case management was mean to him because he did not have insurance. P#1 further reported that at one point, one of the case managers told him to shut up and let her talk. P#1 reported that he was discharged to a personal care home (PCH) in Fayetteville without medical supplies to include a condom catheter, cervical collar or medication. P#1 explained that he was placed in a room with another individual that was coughing. P#1 further explained that the PCH smelled like weed (slang for cannabis). P#1 reported that the PCH told him they were sending him back to the hospital on 11/5/25 because he could not control his bowels. P#1 further reported that he was sent back to the ER by ambulance and has since had spinal surgery. During an additional interview with MCM AA on 12/2/25 at 12:31 p.m. she explained that case manager (CM) CC brought it to her attention the DOM BB that P#1 was not discharged with his home medication. During a follow up interview with CM CC on 12/2/25 at 1:50 p.m. she explained that DOM BB alerted her that P#1 did not have his discharge medication sent with him to the PCH. CM CC reached out to the pharmacy that the facility partners with to inquire about P#1’s medication. The pharmacy reported that they did not receive the prescription at their pharmacy but was able to go into the system and extract it. CM CC reported that she believed the prescription went to another affiliated pharmacy at a different address but does not know which one. CM CC revealed that the pharmacy the facility partnered with did bedside deliveries to patients in-house and before discharge. During a follow-up interview with DOM BB on 12/2/25 at 2:08 p.m. she reported that she did not remember what prompted her to call the PCH 11/1/25 to see if P#1 received his discharge medication. She further reported that she did not hear back from the PCH broker who owned the business that day.”

“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 AMENDED Based on a review of facility policies and procedures, medical records, observations, and staff interviews, it was determined that the facility failed to ensure that nursing staff adhered to policies and procedures related to patient observation/monitoring for two (Patient (P) #1 and P#4) of six (P#1, P#2, P#3, P#4, P#5, and P#6) patients reviewed. Specifically, staff failed to provide adequate supervision of P#1 and P#4, both under observation for SI when on 10/12/25, they both went into a single-occupancy patient restroom and occupied the restroom for over two minutes until staff intervened. This failure led to possible inappropriate activity between P#1 and P#4. This failure had the potential to result in the patient self-harming. Findings Included: A review of the facility’s policy titled “Care of Behavioral Health Patients Policy,” policy #18576722, last revised 8/4/25, revealed that the purpose of the policy was to provide guidance for safe, appropriate, and effective care for patients who demonstrate behaviors suggestive of risk for suicide, risk of harm to others, substance abuse/addiction, or other behaviors that pose a serious and significant safety risk. 2. Constant Observation Contact observation is performed by a Constant Observer (sitter) who is provided by the facility and who remains within close proximity to the patient at all times. o The constant observer should maintain the ability to constantly visualize the patient at all times. A review of the facility’s document titled “Patient Care Tech/Sitter Orientation”, dated 10/13/2025, revealed the following: General guidelines: 1. Patients must be observed at all times and never left alone. Responsibilities: 1. Keep the patient safe by observing the patient at all times. Continued review revealed, Care of Behavioral Health Patients, continuous observation is required for patients who are at risk of harming themselves or others. Follow the guidelines below to provide a safe environment for them: o Never leave the patient alone. You must have visual contact with them at all times and should be within four to six feet of the patient. High risk behavioral health required documentation, you will be required to complete the Behavioral Observation Flowsheet in Epic for each patient you are assigned. You will document your observations every 15 minutes. Required documentation should be completed every hour on patients who are not deemed high risk. You will be making the following observations: o Awake vs asleep o Change in the patient’s condition o Change in the patient’s mental status o Safety of the patient o Comfort level of the patient o Physical needs of the patient o Sitter must remain in the pod and not behind the nurse’s station 1. A review of P#1’s medical record revealed a Form 1013 (a form to certify that an individual appears to be mentally ill requiring involuntary treatment) dated 10/9/25 at 9:44 p.m. by a Medical Doctor (MD) in the ED. A review of the “Emergency Dept (ED) Notes” dated 10/9/25 at 10:30 p.m., by a Registered Nurse (RN) revealed a psychosocial assessment. P#1 was placed on safety precautions, elopement risk, and suicide risk due to self-destructive ideas. The RN noted safety interventions for a sitter, visual checks, and continuous 1:1 observation for P#1. A review of “ED Notes” dated 10/10/25 at 9:00 a.m. by an RN revealed that P#1 remained on 2:1 continuous observation and was awaiting a psychiatric assessment. A review of “ED Notes” dated 10/10/25 at 11:35 a.m. by an RN revealed that P#1 denied SI or homicidal ideations (HI). The RN noted that P#1 was on a 2:1 continuous observation. A review of P#1’s medical record failed to reveal observation documentation from 10/11/25 at 10:00 p.m. to 10/12/25 at 7:00 a.m. Continued review of P#1’s medical record revealed Form 1013 was rescinded on 10/12/25 at 11:19 a.m. 2. A medical record review of P#4 revealed that P#4 presented to the facility’s ED on 10/12/25 at 4:30 a.m. with a complaint of suicidal ideation (SI) with use of alcohol and substances. Continued review of P#4’s medical record revealed that on 10/12/25 at 7:27 a.m., a medical doctor (MD) ordered a 1013. A review of an “ED Note” dated 10/12/25 at 12:15 p.m. by RN AA revealed that upon RN AA returning to the unit after retrieving a patient’s valuables from a safe, she was made aware that an incident of inappropriate sexual behavior may have occurred between P#4 and P#1. A review of an “ED Note” dated 10/12/25 at 12:33 p.m., by RN AA revealed that RN AA contacted the nursing supervisor and local law enforcement. Continued review of P#4’s medical record revealed that P#4 was escorted out of the facility with local law enforcement on 10/12/25 at 5:37 p.m. A camera surveillance footage review was conducted on 11/13/25 with the Director of Quality, the Risk Manager, and the Major of Public Safety. Camera surveillance footage dated 10/12/25 from 11:45 a.m. to 1:04 a.m. in the facility’s emergency department (ED) E Pod was viewed and revealed the following: 12:58 PM: P#4 exited the restroom into the hallway to an area off camera. 12:59 PM - 1:02 PM: P#4 went back in the restroom. P#1 went to nurses’ station and interacted with staff. Then P#1 went into the restroom. 1:02 PM: Staff came out into the hallway. P#1 exited the restroom. Staff go toward the restroom to interact with P#1 and P#4. P#4 stuck his head out of restroom door. During a telephone interview on 11/12/25 at 3:35 p.m. in the conference room, Patient Care Technician (PCT) FF. PCT FF said that a part of her responsibility was to function as a safety sitter when requested. PCT FF recalled that on 10/12/25, the 1013 for P#1 was rescinded because he was getting discharged. PCT FF recalled that Registered Nurse (RN) AA left the unit to retrieve P#1’s paperwork and clothes. PCT FF recalled that when P#1 got his clothes, he went to get dressed and wait for his family to come and get him. PCT FF recalled that P#1 reported to have four dollars and then RN AA left to retrieve it. PCT FF recalled that at one-point PCT FF noticed that P#4 went to the restroom, and when she looked around and did not see P#1, she went to go and check on them. PCT FF recalled that she discovered P#1 was in the restroom with P#4 and told them this was not allowed. PCT FF recalled that she told P#1 he was not supposed to be in the restroom with another patient and then P#1 said that he liked men and ignored PCT FF. PCT FF recalled notifying security, who was at the nurses’ station where P#1 reported the allegation of sexual assault. PCT FF recalled that RN AA also came back and reported the incident to the Charge Nurse (CN) and Nursing Supervisor. PCT FF recalled that the Public Safety Officer (PSO) reported the incident to her supervisor as well. PCT FF said that P#1 did not look distress and was in fact happy and still moving around the unit. PCT FF said that after the allegation was made, P#1 and P#4 were separated, and eventually local law enforcement was contacted, and they came to perform an investigation. PCT FF said that when patients are under a 1013 observation, staff should document on the patient at least every hour unless they are on a one-to-one watch, then documentation is done every 15 minutes. PCT FF said that staff usually document every 15 minutes regardless because it is hard to remember sometimes and it is just easier. During an interview on 11/13/25 at 9:53 a.m. in a conference room, Public Safety Officer (PSO) GG recalled the event on 10/12/25, when PCT FF reported to PSO GG that she saw P#1 follow P4 into a restroom and P#1 would not listen to PCT FF’s directions. PSO GG recalled that she explained to P#1 that he was not allowed to go into the restroom while other patients were occupying it. PSO GG recalled that she argued with P4 while he stuck his head out of the restroom door, and P#1 was already in the waiting room/area. PSO GG recalled that P#1 reported to PSO GG about the allegation of sexual assault by P4. PSO GG recalled that she then reported it to her supervisor and the hospital house supervisor. PSO GG recalled that no officer was assigned to the unit, E Pod, because there was no patient with a 1013 status as P#1’s was rescinded. PSO GG said that she ended up at the unit because she was just conducting rounds of the area and another officer requested help in looking for P#1’s belongings, so PSO GG went to check the unit. PSO GG recalled that she arrived at the unit, RN AA was off the unit and PCT FF was the only one present. PSO GG said that she later learned RN AA was off the unit because she went to get a stretcher for another patient and went to go retrieve some money from the hospital vault that belonged to P#1. PSO GG recalled that local law enforcement (LEO) arrived at the unit around 5:15 p.m. PSO GG recalled that LEO conducted their own investigation, could not obtain a video without a warrant, and took P4 into custody for other warrants not related to this situation. PSO GG recalled that when P#1’s family member came to pick up P#1, he did not seem upset or in distress about the situation. PSO GG recalled informing P#1’s family member about what occurred, and he said that he thought that P#1 was lying because P#1 had a history of it including running away. PSO GG said that it was her understanding that once P#1 left the facility, they were followed by LEO to another facility to obtain a rape kit and examination. A telephone interview was conducted with Emergency Department (ED) Nurse Practitioner (NP) BB on 11/13/25, at 10:30 a.m. NP BB explained that P#1 had already been taken off the 1013 monitoring, and P#1’s family had been notified about his pending discharge before the alleged incident was reported to her. NP BB stated that she was notified of the alleged sexual assault and subsequently NP BB returned to reassess P#1. NP BB reported that during this reassessment, P#1 appeared upset and was no longer smiling, which NP BB interpreted as a possible sign that he had been assaulted. NP BB stated that she did not assess P#1’s skin for bruising and did not write orders for a complete head-to-toe assessment because she was focused on evaluating his mental state. NP BB explained that orders for a full physical assessment would come from the attending physician if deemed necessary and would be completed by a nurse. NP BB stated that she cleared P#1 for discharge, as P#1 denied suicidal ideation, or any intent to harm himself, and did not appear to be in any distress. During a telephone interview on 11/13/25 at 10:32 a.m. in the conference room, Registered Nurse (RN) AA. RN AA recalled that when she cared for P#1, he was the only patient in the E Pod along with a dementia patient. RN AA recalled that later P#4 was brought to the unit. RN AA recalled that P#1 interacted with #P4 welcoming him to the unit and made random conversation. RN AA recalled that P#1 and P#4 went in and out of their rooms into the waiting area throughout the shift. RN AA recalled that she was in the process of getting P#1’s Form 1013 rescinded which required her to leave the unit to obtain the physician’s signature, print the discharge paperwork, and then contact P#1’s family member. RN AA recalled that security was bringing P#1’s belonging to him and then P#1 mentioned that he had money in the hospital vault. RN AA recalled that she left to go retrieve the money and to obtain a stretcher for another patient that was being admitted to her care. RN AA recalled that when she returned, she saw PSO GG and PCT FF and learned about the allegation of sexual assault reported by P#1. RN AA recalled that she contacted her Charge Nurse and the Nursing Supervisor. RN AA recalled that she ensured that P#1 and P#4 were separated. RN AA said that she did not look at the restroom but did assess P#1 and did not notice any visible marks. RN AA recalled that P#1 did not report any sodomy or oral sex in the allegation but that P4 touched him inappropriately. RN AA recalled that local law enforcement (LEO) came to the unit and conducted their investigation. RN AA recalled that P4 was put in handcuffs and taken into custody. RN AA said that while he was also taken for the sexual assault allegation, LEO said that he was ultimately taken for other warrants. RN AA recalled that when P#1’s uncle came, he did not seem liked he was upset or cared about the allegation of sexual assault. RN AA recalled that P#1 was acting normal, requesting food, and jumping around the unit. RN AA recalled that Medical Doctor (MD) DD and Nurse Practitioner (NP) BB were contacted and saw P#1 prior to his discharge. RN AA recalled that a sexual assault nurse examiner (SANE) was contacted over the telephone, and a referral was made for P#1 to follow up, and she believed that P#1’s family member was supposed to take P#1 to this outside facility. RN AA said that documentation on a patient with a 1013 status depends on if they are required to be on a one-to-one observation or not. RN AA said that if the patient is on a one-to-one observation, then the sitter is supposed to document every 15 minutes, but if they are not then it should be done at least every hour. During an interview on 11/13/25 at 2:30 p.m. in the conference room, the Director of Quality said that when a patient is put on 1013 status, the physician can further order the observation status for a patient. The Director of Quality said that not at all 1013 status patients are required to be on a 1:1 constant observation and it would depend on their suicide risk assessment. The Director of Quality said that most patients are on a 2:1 constant observation. The Director of Quality said that if a patient is on a 1:1 observation then staff should document every 15 minutes. The Director of Quality said that if the patient is not on a 1:1 observation, then organization protocol is to document every hour.”

“GOVERNING BODY CFR(s): 482.12 There must be an effective governing body that is legally responsible for the conduct of the hospital. If a hospital does not have an organized governing body, the persons legally responsible for the conduct of the hospital must carry out the functions specified in this part that pertain to the governing body ... This Condition is not met as evidenced by: 46188 Based on review of medical records, Governing Body Bylaws, meeting minutes, Medical Staff Bylaws, quality reports, policy and procedures, and staff interviews, it was determined that the Governing Body failed to ensure that patient’s rights were protected and failed to ensure that an effective QAPI program was implemented when one (P#1) of five (P#1, P#2, P#3, P#4, P#5) patients reviewed experienced a serious adverse event, death on 8/19/22 at 4:45 p.m. The facility failed to complete a root cause analysis (RCA) of the serious adverse event. In addition, facility staff failed to complete an incient report when P#1 suffered a syncopal event and hit her head. Findings included: Cross refer to A-0263 as it relates to the facility’s failure to ensure that an effective, ongoing, quality assessment and performance improvement (QAPI) program was implemented when one (P#1) of five (P#1, P#2, P#3, P#4, P#5) patients reviewed experienced a serious adverse event, death, on 8/19/22 at 4:45 p.m. The facility failed to produce a completed root-cause-analysis (RCA) of the incident. Cross refer to A-0309 as it relates to the failure of the Governing Body, Medical Staff, and Administration to ensure that an effective, ongoing program for quality assessment and performance improvement (QAPI) was implemented. Cross-refer to A-1100 as it relates to the facility’s failure to ensure that departments render timely emergency services. A review of the facility’s “Amended and restated Bylaws, adopted 1/13/20, revealed in Article IV, Board of Directors, Section 1. The affairs of the Corporation are governed by the Board of Directors. Section 2. Obligations and Responsibilities: a. providing general strategic, managerial, operational, financial, and clinical oversight of the Corporation; and (b) credentialing members of the Corporation’s medical staff. Continued review revealed, Article VII, 4, Duties, Responsibilities, roles, and expectations of officers may be specified in governance protocols. Continued review revealed, Article IX, Medical Staff are organized according to the bylaws recommended by the facility’s medical staff. They shall have the appropriate delegated authority and responsibility for the care of patients, subject to the ultimate authority of the Corporation Board and to such limitations as contained in the bylaws, rules, regulations, and policies of the Corporation, PHC, and in the bylaws, rules, and regulations of the medical staff. A review of the facility’s “Medical Staff Bylaws”, last approved 5/1/2023, revealed, Article Five, Medical Staff Committees and Performance Improvement Functions, 5.D.2, Duties: The Medical Executive Committee (MEC) is delegated with the primary authority over activities related to the functions of the Medical Staff and performance improvement activities regarding the professional services provided by individuals with clinical privileges. The MEC is responsible for the following: a. Recommending directly to the Board on at least 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. d. Reviewing (or delegating the review of) quality indicators to ensure uniformity regarding patient care services. e. Providing leadership in activities related to patient safety. Continued review revealed, 5.E., Performance Improvement Functions: 1. The Medical Staff is actively involved in performance improvement functions, including reviewing data and recommending and implementing and implementing processes to address the following: a. Patient safety, including processes to respond to patient safety alerts, meet patient safety goals, and reduce patient safety risks. b. The Hospital’s and individual practitioners’ performance on Centers for Medicare and Medicaid Services (CMS) core measures c. Medial assessment and treatment of patients k. Sentinel events, including root cause analyses and responses to unanticipated adverse events p. Coordination of care, treatment, and services with other practitioners and Hospital personnel A review of the facility’s policy titled, “Reporting Serious Safety Events to External Agencies,” last approved 1/7/22, policy #10904519, revealed the purpose was to establish guidance to the staff regarding recognition and reporting of serious safety events to appropriate internal departments and external agencies. 3. Definitions Adverse Event - An incident in which harm result to a person receiving health care. Sentinel Event - An unexpected occurrence involving death or serious physical or psychological injury or the risk thereof. The phrase “or the risk thereof” includes any process variation for which a recurrence would carry a significant chance of a serious adverse outcome. 4. Policy- The facility will report those adverse events required by the Georgia Department of Community Health (DCH). 5. Responsibilities- 5.1 Facility Healthcare Employees shall recognize and report serious safety events to the appropriate internal departments according to the internal reporting procedure. 6. Procedures 6.1 Internal Reporting 1. Upon the identification of a potential adverse event or sentinel event, which may be reportable to an external agency, the entity Director of Risk Management, the Nursing supervisor, and the Administrator on Call will be notified immediately 2. The individual reporting the event will complete a report in the Safety Event Reporting System and provide any and all documentation related to the event. 5. The root cause analysis (RCA) is used as a process for identifying the basic or causal factor(s) that underlies variation in performance, including the occurrence or possible occurrence of an adverse event. 6. The RCA team is required to complete the RCA within 45 days of event identification. During an interview on 10/2/24 at 10:01 a.m. in the conference room, the Director of Quality (DQ) XX said that a root-cause-analysis (RCA) was not conducted on the incident pertaining to P#1. DQ XX said that staff reviewed the incident after staff filed an incident report on the death of P#1 and conducted an interview with all parties involved. DQ XX said that the result of that investigation was that the facility performed care to best of their capabilities.”

“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: 46188 Based on review of the facility’s quality assessment performance improvement (QAPI) plan, Governing Body Bylaws, incident report, QAPI meeting minutes, Medical Staff Bylaws, policy and procedures, and staff interviews, it was determined that the facility failed to maintain an effective QAPI program when one (P#1) of five (P#2, P#3, P#4, P#5) patents reviewed experienced a serious adverse event, death on 8/19/22 at 4:45 p.m. Findings included: Cross refer to A-0286 as it relates to the facility’s failure to track, analyze, and implement corrective actions in response to adverse events. Cross refer to A-0309 as it relates to the failure of the governing body, medical staff, and administrative staff to be accountable to ensure that an ongoing quality improvement and patient safety program was implemented and maintained.”

“EMERGENCY SERVICES CFR(s): 482.55 The hospital must meet the emergency needs of patients in accordance with acceptable standards of practice. This Condition is not met as evidenced by: 46188 Based on review of medical records, policy and procedures and interviews with staff, it was determined that the facility failed to ensure that the emergency services rendered by facility departments were provided in a timely manner when one (P#1) presented to the facility for treatment. Despite clinical presentation and abnormal diagnostic and laboratory test results P#1 was not assessed by a consultative physician until after five hours and surgical intervention was not attempted until 17 hours after arrival. Findings included: Cross-refer to A-1103 related to the failure of the faciilty to ensure that departments were integrated to provide emergency care.”

“PATIENT RIGHTS: INFORMED CONSENT CFR(s): 482.13(b)(2) The patient or his or her representative (as allowed under State law) has the right to make informed decisions regarding his or her care. The patient’s rights include being informed of his or her health status, being involved in care planning and treatment, and being able to request or refuse treatment. This right must not be construed as a mechanism to demand the provision of treatment or services deemed medically unnecessary or inappropriate. This Standard is not met as evidenced by: 46188 Based on a review of policy and procedures,Quality Manual, and medical records it was determined that the facility failed to ensure that patient’s rights were promoted and protected when 10 (P#6, P#7, P#8, P#10, P#11, P#12, P#13, P#14, P#15, P#16) of 15 (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) patients records reviewed failed to include a signed Patient Rights and Consent Form. Findings included: A review of the facility’s policy titled, “Rights and Responsibilities of Patients Policy”, policy #16455823, last revised 8/22/24, revealed that the purpose of the policy was to acknowledge patients’ rights and responsibilities and the facility’s responsibility to respond to each patient with personal dignity and respect. Continued review revealed that it is the policy of the facility that all patients have the right to considerate, respectful care at all times and under all circumstances, with recognition of their personal dignity and autonomy. The facility will develop, implement and adhere to policies intended to assure practices that will respect the rights of all patients regardless of race, creed, sex, sexual orientation, gender identity, or expression, national origin, religion, age, disability, diagnosis, or sources of payment for care. Continued review revealed, Four, Policy: A. Access to Treatment - The facility respects and supports the patient’s right to impartial access to treatment and services that are consistent with relevant laws and regulations and medically indicated, regardless of race, creed, sex, sexual orientation, gender identity or expression, national origin, religion, age, disability, diagnosis, or sources of payment for care. O. Safety/Security - The patient has a right to the provision of care in a safety setting. The Patient Safety Committee, Environment of Care Committee, Infection Control Committee, the Security Department and Risk Management Programs seek to eliminate risks to the patient. A review of the facility’s Quality Manual, last revised on 1/11/2024, revealed that the facility was committed to ongoing improvement in patient satisfaction, clinical outcomes, administrative processes, and community involvement. Continued reviewed, Eight, Quality Objectives, the facility has established quality metrics for hospitals and priorities are selected which support the system’s efforts in continually improving outcomes. Corrective/preventative actions are developed for continual improvement with results monitored, measured, analyzed, and reported to management for review at the Quality/Safety/Service (QSS) meetings. A continued review revealed that the Director of Quality & Safety Integration (DQSI) is the management representative responsible for ensuring that the quality management system is effectively implemented and maintained and that the quality oversight processes ensure that corrective and preventative actions are carried out and measured for effectiveness. The DQSI reports to the senior leadership on the status of the QMS. At a minimum, the following processes are presented for management review at the QSS meeting included: Medical record delinquency A review of the electronic records revealed the following: A review of P#6 medical record revealed that P#6 arrived at the facility’s ED on 8/5/22 with a chief complaint of vaginal bleeding, pelvic pain, and low back pain. Further review revealed that at 11:31 a.m., P#6’s ED disposition was set to surgery. At 1:33 p.m., P#6 was admitted to peri-op. The record failed to reveal a signed consent to treat for P#6. A review of P#7’s medical record revealed arrived in the facility’s ED on 10/1/22 at 9:11 a.m. with a chief complaint of abdominal pain and was discharged home on 10/1/22 at 11:55 a.m. The record failed to reveal a signed consent to treat for P#7. A review of P#8 medical record revealed P#8 arrived at the facility’s ED on 10/12/23 at 1:55 a.m. with a chief complaint of vaginal bleeding while 16 weeks pregnant. P#8 was discharged home on 10/12/23 at 6:17 a.m. The record failed to reveal a signed consent to treat for P#8. A review of P#10’s medical record revealed that she arrived at the facility’s ED on 11/12/22 at 11:10 p.m. with a chief complaint of vaginal bleeding at 18 weeks gestation. P#10 was discharged home on 11/13/22 at 10:32 a.m. The record failed to reveal a signed consent to treat for P#10. A review of P#11’s medical record revealed that P#11 arrived at the facility’s OB-ED on 8/28/23 at 10:11 a.m. with a chief complaint of strong pelvic pain. P#11 was discharged home on 8/28/23 at 1:03 p.m. The record failed to reveal a signed consent to treat for P#11. A review of P#12’s medical record revealed that P#16 arrived at the facility’s ED on 2/29/24 at 1:13 p.m. with a chief complaint of abdominal pain and pregnancy. P#12 was discharged home on 2/29/24 at 7:01 p.m. The record failed to reveal a signed consent to treat for P#12. A review of P#13’s medical record revealed that P#13 arrived in the facility’s ED on 9/3/24 at 8:40 p.m. with a chief complaint of vaginal bleeding while 14 weeks pregnant. Further review revealed that on 9/4/24 at 12:59 a.m., P#13’s status was changed to “admit to inpatient” with diagnosis of sepsis. The record failed to reveal a signed consent to treat for P#13.. A review of P#14’s medical record revealed that she arrived at the facility’s ED on 12/16/22 at 7:39 p.m. with a chief complaint of abdominal pain while 23 weeks pregnant. On 12/17/22 at 1:14 a.m., P#14 was admitted to the medical-surgical floor with a diagnosis of sepsis. The record failed to reveal a signed consent to treat for P#14. A review of P#15’s medical record revealed that P#15 arrived in the facility’s ED on 7/10/23 at 11:40 p.m. with a chief complaint of shortness of breath (SOB), chest pain (CP), and back pain. On 7/11/23 at 8:49 a.m., P#15 was admitted to the cardiac-telemetry unit. The record failed to reveal a signed consent to treat for P#15. A review of P#16’s medical record revealed that she arrived at the facility’s OB-ED on 7/2/24 at 1:25 a.m. with a chief complaint of premature labor at 18 weeks. Further review revealed that P#16 had a fetal demise while in the OB-ED and was then taken to surgery for a D&C after the placenta was retained in the uterus. The record failed to reveal a signed consent to treat for P#16.”

“PATIENT SAFETY CFR(s): 482.21(a), (c)(2), (e)(3) (a) Standard: Program Scope (1) The program must include, but not be limited to, an ongoing program that shows measurable improvement in indicators for which there is evidence that it will ... identify and reduce medical errors. (2) The hospital must measure, analyze, and track ...adverse patient events ... (c) Program Activities ..... (2) Performance improvement activities must track medical errors and adverse patient events, analyze their causes, and implement preventive actions and mechanisms that include feedback and learning throughout the hospital. (e) Executive Responsibilities, The hospital’s governing body (or organized group or individual who assumes full legal authority and responsibility for operations of the hospital), medical staff, and administrative officials are responsible and accountable for ensuring the following: ... (3) That clear expectations for safety are established. This Standard is not met as evidenced by: 46188 Based on review of the facility’s quality assessment performance improvement (QAPI) plan, QAPI Committee meeting minutes, policy and procedures, incident report, QAPI meeting minutes, Medical Staff Bylaws, medical records and staff interviews, it was determined that the facility failed to ensure that the quality assessment performance improvement (QAPI) program tracked, analyzed the cause and implemented corrective actions in response to adverse patient events when one (P#1) of five (P#1, P#2, P#3, P#4, P#5) patients reviewed: 1. Experienced a syncopal event that resulted in a fall and the facility failed to initiate an incident report 2. Had a serious adverse event, death on 8/19/22 at 4:45 p.m. and the facility failed to complete a root cause event (RCA). Findings included: A review of the facility’s Quality Manual, last revised on 1/11/2024, revealed that the facility was committed to ongoing improvement in patient satisfaction, clinical outcomes, administrative processes, and community involvement. Continued reviewed, Eight, Quality Objectives, the facility has established quality metrics for hospitals and priorities are selected which support the system’s efforts in continually improving outcomes. Corrective/preventative actions are developed for continual improvement with results monitored, measured, analyzed, and reported to management for review at the Quality/Safety/Service (QSS) meetings. At a minimum, the following processes are presented for management review at the QSS meeting included: “ Infection prevention and control program metrics “ Threats to patient safety “ Patient flow issues, including reporting of patients held in the Emergency Department for extended periods of time “ Unanticipated deaths “ Adverse events/Near misses “ Data submitted to or received from Medicare quality reporting and quality performance programs included maternal morbidity and sepsis A review of the facility’s policy titled, “Reporting Serious Safety Events to External Agencies,” last approved 1/7/22, policy #10904519, revealed the purpose was to establish guidance to the staff regarding recognition and reporting of serious safety events to appropriate internal departments and external agencies. 3. Definitions Adverse Event - An incident in which harm result to a person receiving health care. Sentinel Event - An unexpected occurrence involving death or serious physical or psychological injury or the risk thereof. The phrase “or the risk thereof” includes any process variation for which a recurrence would carry a significant chance of a serious adverse outcome. 4. Policy- The facility will report those adverse events required by the Georgia Department of Community Health (DCH). 5. Responsibilities- 5.1 Facility Healthcare Employees shall recognize and report serious safety events to the appropriate internal departments according to the internal reporting procedure. 6. Procedures 6.1 Internal Reporting 1. Upon the identification of a potential adverse event or sentinel event, which may be reportable to an external agency, the entity Director of Risk Management, the Nursing supervisor, and the Administrator on Call will be notified immediately 2. The individual reporting the event will complete a report in the Safety Event Reporting System and provide any and all documentation related to the event. 5. The root cause analysis (RCA) is used as a process for identifying the basic or causal factor(s) that underlies variation in performance, including the occurrence or possible occurrence of an adverse event. 6. The RCA team is required to complete the RCA within 45 days of event identification. A review of the facility’s QSS committee meeting minutes from 09/2022 through 07/2024 failed to include discussion of an RCA related to P#1. A review of the facility’s Incident Log dated 6/1/22 through 9/24/22 revealed one entry related to P#1, file #429896, event date of 8/19/22, listed as a cardiac/circulatory/respiratory event with a severity level of death. Continued review of the facility’s Incident Log failed to reveal an entry related to P#1’s syncopal (temporary loss of consciousness) episode on 8/19/22, where she sustained a hematoma (bruise) to the forehead. Continued review of the facility’s Incident Report file #429896 revealed that Anesthesia and Quality were tasked for the review of the incident and a debrief was conducted with all parties involved. A review of the ‘History and Physical’ dated 8/18/22 at 11:41 p.m. included that P#1 was sitting on the bedside commode in the ED room and was feeling dizzy and eventually passed out, hitting her forehead. A request was made on 10/1/24 at 8:42 a.m. to conduct an interview with OB-GYN MD AA and OB-GYN MD DD. The Director of Quality later informed the survey team that OB-GYN MD AA and OB-GYN MD DD have refused and retained legal counsel. A request was made on 10/1/24 at 8:42 a.m. to conduct an interview with ED MD BB, however the Director of Quality later informed the survey team that ED MD BB was out of the country. A request was made on 10/1/24 at 8:42 a.m. to conduct an interview with IMS MD GG, however the Director of Quality later informed that survey team that IMS MD GG was no longer on staff with the facility. During a telephone interview on 10/1/24 at 3:22 p.m., Critical Care Medicine (CCM) Physician Assistant (PA) HH said that she has been a CCM PA for 10 years. CCM PA HH recalled P#1, and that CCM PA HH was called in the early morning to evaluate P#1 due to hypotensive (low blood pressure). CCM PA HH recalled that P#1 was on a medical-surgical unit and that P#1 was hypotensive despite receiving multiple liters of intravenous (IV) fluids overnight. CCM PA HH recalled that nursing staff also reported that P#1 passed out at some point during her time at the facility. During an interview on 10/2/24 at 10:01 a.m. in the conference room, the Director of Quality (DQ) XX said that a root-cause-analysis (RCA) was not conducted on the incident pertaining to P#1. DQ XX said that staff reviewed the incident after staff filed an incident report on the death of P#1 and conducted an interview with all parties involved. DQ XX said that the result of that investigation was that the facility performed care to best of their capabilities.”

“QAPI EXECUTIVE RESPONSIBILITIES CFR(s): 482.21(e)(1), (e)(2), (e)(5) The hospital’s governing body (or organized group or individual who assumes full legal authority and responsibility for operations of the hospital), medical staff, and administrative officials are responsible and accountable for ensuring the following: 1) That an ongoing program for quality improvement and patient safety, including the reduction of medical errors, is defined, implemented, and maintained . (2) That the hospital-wide quality assessment and performance improvement efforts address priorities for improved quality of care and patient safety and that all improvement actions are evaluated. (5) That the determination of the number of distinct improvement projects is conducted annually. This Standard is not met as evidenced by: 46188 Based on review of Medical Staff Bylaws, QAPI Plan, policy and procedures and staff interviews, it was determined that the Governing Body, Medical Staff, and Administration failed to ensure that an ongoing program for quality improvement and patient safety was implemented when it was determined that a root-cause-analysis report was not available in response to an adverse event that occurred on 8/19/22. Findings included: A review of the facility’s “Medical Staff Bylaws”, last approved 5/1/2023, revealed, Article Five, Medical Staff Committees and Performance Improvement Functions, 5.D.2, Duties: The Medical Executive Committee (MEC) is delegated with the primary authority over activities related to the functions of the Medical Staff and performance improvement activities regarding the professional services provided by individuals with clinical privileges. The MEC is responsible for the following: Recommending directly to the Board on at least the following: Participation of the Medical Staff in Hospital performance improvement activities and the quality of professional services being provided by the Medical Staff. Reviewing (or delegating the review of) quality indicators to ensure uniformity regarding patient care services. Providing leadership in activities related to patient safety. Continued review revealed, 5.E., Performance Improvement Functions: 2.1. The Medical Staff is actively involved in performance improvement functions, including reviewing data and recommending and implementing and implementing processes to address the following: a. Patient safety, including processes to respond to patient safety alerts, meet patient safety goals, and reduce patient safety risks. b. The Hospital’s and individual practitioners’ performance on Centers for Medicare and Medicaid Services (CMS) core measures c. Medial assessment and treatment of patients Sentinel events, including root cause analyses and responses to unanticipated adverse events. Coordination of care, treatment, and services with other practitioners and Hospital personnel A review of the facility’s “Amended and restated Bylaws, adopted 1/13/20, revealed in Article IV, Board of Directors, Section 1. The affairs of the Corporation are governed by the Board of Directors. Section 2. Obligations and Responsibilities: a. providing general strategic, managerial, operational, financial, and clinical oversight of the Corporation; and (b) credentialing members of the Corporation’s medical staff. Continued review revealed, Article VII, 4, Duties, Responsibilities, roles, and expectations of officers may be specified in governance protocols. Continued review revealed, Article IX, Medical Staff are organized according to the bylaws recommended by the facility’s medical staff. They shall have the appropriate delegated authority and responsibility for the care of patients, subject to the ultimate authority of the Corporation Board and to such limitations as contained in the bylaws, rules, regulations, and policies of the Corporation, PHC, and in the bylaws, rules, and regulations of the medical staff. A review of the facility’s policy titled, “Reporting Serious Safety Events to External Agencies,” last approved 1/7/22, policy #10904519, revealed the purpose was to establish guidance to the staff regarding recognition and reporting of serious safety events to appropriate internal departments and external agencies. 3. Definitions Adverse Event - An incident in which harm result to a person receiving health care. Sentinel Event - An unexpected occurrence involving death or serious physical or psychological injury or the risk thereof. The phrase “or the risk thereof” includes any process variation for which a recurrence would carry a significant chance of a serious adverse outcome. 4. Policy- The facility will report those adverse events required by the Georgia Department of Community Health (DCH). 5. Responsibilities- 5.1 Facility Healthcare Employees shall recognize and report serious safety events to the appropriate internal departments according to the internal reporting procedure. 6. Procedures 6.1 Internal Reporting 1. Upon the identification of a potential adverse event or sentinel event, which may be reportable to an external agency, the entity Director of Risk Management, the Nursing supervisor, and the Administrator on Call will be notified immediately 2. The individual reporting the event will complete a report in the Safety Event Reporting System and provide any and all documentation related to the event. 5. The root cause analysis (RCA) is used as a process for identifying the basic or causal factor(s) that underlies variation in performance, including the occurrence or possible occurrence of an adverse event. 6. The RCA team is required to complete the RCA within 45 days of event identification. A review of the facility’s Quality Manual, last revised on 1/11/2024, revealed that the facility was committed to ongoing improvement in patient satisfaction, clinical outcomes, administrative processes, and community involvement. A continued review revealed that the Director of Quality & Safety Integration (DQSI) is the management representative responsible for ensuring that the quality management system is effectively implemented and maintained and that the quality oversight processes ensure that corrective and preventative actions are carried out and measured for effectiveness. The DQSI reports to the senior leadership on the status of the QMS. At a minimum, the following processes are presented for management review at the QSS meeting included: “ Infection prevention and control program metrics “ Threats to patient safety “ Patient flow issues, including reporting of patients held in the Emergency Department for extended periods of time “ Unanticipated deaths “ Adverse events/Near misses “ Data submitted to or received from Medicare quality reporting and quality performance programs included maternal morbidity and sepsis During an interview on 10/2/24 at 10:01 a.m. in the conference room, the Director of Quality (DQ) XX said that a root-cause-analysis (RCA) was not conducted on the incident pertaining to P#1. DQ XX said that staff reviewed the incident after staff filed an incident report on the death of P#1 and conducted an interview with all parties involved. DQ XX said that the result of that investigation was that the facility performed care to best of their capabilities.”

“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 policy and procedures, medical records, and staff interviews, it was determined that facility policy and procedures were not followed when facility staff failed to notifiy the provider of critical lab results and for one (P#1) of five (P#1, P#2, P#3, P#4, P#5) patients reviewed. These failures contributed to a delay in the treatment of P#1. Findings included: A review of the facility’s policy titled, “Reporting of Critical Laboratory Values”, policy #15163755, last revised 2/2/24, revealed that the purpose of the policy was to provide a standard process to ensure that effective and accurate verbal communication occurs between health care staff regarding all tests that require rapid or immediate communication of the result to the appropriate personnel. Continued review revealed, 5.4., Provider Responsibility: 3. Receiving Critical Results 1. It is the provider’s duty to receive and act upon all critical results provided by laboratory staff and/or nursing staff. It is an expectation that the provider will act within the period of time that meets the clinical needs of the patient to provide safe and high value care. Continued review revealed, 5.5., Nursing Responsibility: When a nurse receives a critical result, the ordering provider should be notified of the critical result within 30 minutes. If the ordering provider is not available, notify the attending provider. Document in the electronic health record (EHR) that the result was called to the provider. A review of P#1’s medical record revealed that she presented to the facility’s Emergency Department (ED) on 8/18/22 at 6:40 p.m. with a chief complaint of vaginal bleeding. Continued review of P#1’s medical record revealed that a white blood cell (WBC) count of 56.50 (normal was 3.40-10.8 10*3/uL) resulted from a specimen collected on 8/18/22 at 7:31 p.m. The record failed to reveal that a provider was notified of the abnormal value. Continued review of P#1’s medical record revealed that on 8/19/22 at 3:22 a.m., P#1 had a white blood cell (WBC) count of 80.10. Continued review of the record failed to reveal that the provider had been notified of the abnormal results. Continued review of P#1’s medical record revealed that IMS MD GG ordered a STAT lactic acidon 8/19/22 at 5:06 a.m. and it was collected on 8/19/22 at 9:18 a.m. The results revealed that the lactate level was 4.85 mmol/L (normal is 0.50 to 2.20). Continued review of the record failed to reveal that the provider was notified of the abnormal results. Continued review of P#1’s medical record revealed that on 8/19/22 at 9:18 a.m., P#1 had a WBC count of 100.70. Documentation failed to reveal that the provider was notified of the abnormal results. Continued review of P#1’s medical record revealed that lactic acid was collected on 8/19/22 at 1:04 p.m. resulting in a level of 9.95 mmol/L. Continued review failed to reveal documentation of provider notification of abnormal results. During a telephone interview on 10/1/24 at 9:50 a.m., Emergency Department (ED) Physician Assistant (PA) PP said that she has been a PA for 17 years and worked in emergency medicine for 15 years. ED PA PP said that she does not recall P#1. ED PA PP said that her role and responsibilities at work depend on which area of the emergency department (ED) she is scheduled to work. ED PA PP said that she does not recall P#1. ED PA PP said that for a patient presenting with the VS that P#1 presented with, she would have to gauge if it was due to an infection versus fluid loss. ED PA PP said that once a patient leaves triage, sometimes lab may call the RNs in triage to report severe abnormal values. ED PA PP said that many severe abnormal lab values are reported to the Flow Coordinator and reassessment RN who see the patients after triage. An interview was conducted on 10/1/24 at 10:41 a.m. in the facility’s conference room with ED Nursing Director (ND) TT. ED ND TT explained that the triage nurse is an individual who generally has one year of experience or more as a Registered Nurse (RN). ED ND TT explained that all nurses in this role receive training in the triage process, Emergency Severity Index (ESI) levels, and the Sepsis Screening tool. ED ND TT explained that during the triage process, there is generally a mid-level provider, i.e., Physician’s Assistant (PA) or Nurse Practitioner (NP), also at the screening station. ED ND TT explained that once the triage process is completed, a patient will be taken to the protocol room, where lab work and any additional tests are completed. The ED has its own technicians who take the blood samples. ED ND TT said that most ED lab work is considered STAT and completed within 30 minutes, and the turnaround time for results is generally around 45 minutes. ED ND TT explained that if there is an abnormal result, the lab typically will call the Primary RN or the Charge RN with abnormal values, and they are responsible for communicating this to the ED Provider. During an interview on 10/1/24 at 11:26 a.m. in the conference room, the Director of Critical Care (DCC) SS said that she has been employed at the facility for five years and serves as the Director representative for the Sepsis Operations Team (SPOT). DCC SS said that the facility now has a dedicated phlebotomist to respond to Code Red Sepsis calls and this was recent as of six weeks ago. DCC SS said that if there was a delay in laboratory collection, nursing staff should continue to make calls and follow up to ensure a collection will be done, but also not delay care in administering any medications to the patient. DCC SS said leadership has tried many different interventions to reduce in lab collection time for the STAT labs such as performing an overhead page or having the RRT collect the lab, but leadership also did not want to increase contamination levels. DCC SS said that there is now an increased amount of phlebotomist dedicated to the emergency department (ED). During an interview on 10/2/24 at 9:11 a.m. in the conference room, rapid response team (RRT) Registered Nurse (RN) KK said that she has been an RN for 10 years and three years with the RRT. RRT RN KK said that the RRT responds when nursing or medical staff call them for anything regarding patient concerns or care to facilitate movement to a higher level of care. RRT RN KK said that when nurses receive any critical lab values, they should inform the provider so that they are aware and provide any changes to the current medical treatment. RRT RN KK said that that nurses have a spot in EPIC to chart all provider notifications.”

“ADEQUACY OF LABORATORY SERVICES CFR(s): 482.27(a) The hospital must have laboratory services available, either directly or through a contractual agreement with a certified laboratory that meets the requirements of part 493 of this chapter. This Standard is not met as evidenced by: 46188 Based on a review of medical records, policies and procedures, and staff interviews, it was determined that the facility failed to adhere to the facility’s laboratory policies when one (P#1) of five (P#1, P#2, P#3, P#4, P#5) patients was ordered a STAT (now) lactic acid blood draw on 8/19/22 at 5:06 a.m., and it was not collected until 8/19/22 at 9:18 a.m. This failure resulted in a delay of care and treatment for P#1. Findings include: A review of the facility’s policy titled “Collection Priority”, policy #12543509, last revised 4/6/20, revealed that the purpose was to provide uniform guidelines to specify which conditions under which laboratory tests are ordered STAT, timed, and routine, and the priority in which they are collected. Further review revealed that it applied to all laboratory personnel who were responsible for collecting blood samples to be processed, analyzed, and/or tested. V. Procedure at the discretion of the ordering physician; labs are routinely ordered as STAT, timed, or routine. A. STAT Orders a. Take priority over all other collection priorities, except stroke alerts, code blue, sepsis alert, and code STEMI. b. Collected within 30 minutes of the order. c. Specimen is delivered to the lab immediately after collection. B. Timed Orders a. Take priority over all routine orders. b. Collected within 30 minutes before or after the specified time. C. Routine Orders d. Every effort should be made to collect routine orders within two hours of order. D. Code Alerts a. The phlebotomist responds to all Stroke, STEMI, Sepsis, and code Blue within minutes of them being called over PBX intercom. c. Code Sepsis blood cultures must be collected within two hours. A review of an Internal Medicine (IMS) Consultation Note dated 8/19/22 at 5:14 a.m. by IMS MD GG revealed that he had been consulted to see P#1 about acute-severe sepsis with refractory hypotension consistent with shock. IMS MD GG ordered a lactic acid, STAT, on 8/19/22 at 5:06 a.m. and it was collected on 8/19/22 at 9:18 a.m. The results revealed that the lactate level was 4.85 (normal is 0.50 to 2.20).Continued review of P#1’s medical record revealed that lactic acid was collected on 8/19/22 at 1:04 p.m. resulting in a level of 9.95. During an interview on 10/1/24 at 11:26 a.m. in the conference room, the Director of Critical Care (DCC) SS said that she has been employed at the facility for five years and serves as the Director representative for the Sepsis Operations Team (SPOT). DCC SS said that if there was a delay in laboratory collection, nursing staff should continue to make calls and follow up to ensure a collection will be done, but also not delay care in administering any medications to the patient. DCC SS said leadership has tried many different interventions to reduce in lab collection time for the STAT labs such as performing an overhead page or having the RRT collect the lab, but leadership also did not want to increase contamination levels. DCC SS said that there is now an increased amount of phlebotomist dedicated to the emergency department (ED). During a telephone interview on 10/1/24 at 3:22 p.m., Critical Care Medicine (CCM) Physician Assistant (PA) HH said that she has been a CCM PA for 10 years. CCM PA HH said that she has had lab collection times take longer than the allotted time for STAT orders to be completed and usually has to reach out to the nurse to have them follow up with lab. During an interview on 10/2/24 at 9:11 a.m. in the conference room, rapid response team (RRT) Registered Nurse (RN) KK said that she has been an RN for 10 years and three years with the RRT. RRT RN KK said that the RRT responds when nursing or medical staff call them for anything regarding patient concerns or care to facilitate movement to a higher level of care. RRT RN KK said that when patients are placed on a sepsis protocol, the labs are STAT and often collected by lab. RRT RN KK said that lab has been late in the past to collect these on time and sometimes it has taken the lab over an hour to collect it. During an interview on 10/2/24 at 9:45 a.m. in the conference room, Lab Manager (LM) VV said that she has been employed at the facility for three years, and in her current position for three months. LM VV said that phlebotomy collects the labs for all patients with the exception of the emergency department (ED), intensive care unit (ICU), and mother-baby units. LM VV said that when lab orders are received, lab technicians have a certain amount of time to collect them. LM VV said that for timed orders staff have 30 minutes before and after the time to collect them, and STAT orders are immediate and done under 30 minutes. LM VV said that if there are many STAT orders placed, then lab assistants can go up to the units to help the phlebotomists in the collection process. LM VV said that phlebotomists have specific assignments and areas they are assigned to each day that they are responsible for. LM VV said that if some units are busier than others, then it is the expectation that other phlebotomists assist others. LM VV said that leadership has been working on staffing to ensure that there is enough coverage now to reduce late collection times. LM VV said that if late collection time is a daily occurrence, then she would verify the numbers and identify if there is a need to staff up in one department/unit. LM VV said that the process for clinical staff is to contact the phlebotomist first to inquire on the collection time of a lab, then down to the main lab if there are still issues in collection time, and if it is not resolved at this point, then to contact the supervisor or LM VV at which it is usually resolved.”

“INTEGRATION OF EMERGENCY SERVICES CFR(s): 482.55(a)(2) [If emergency services are provided at the hospital --] (2) The services must be integrated with other departments of the hospital. This Standard is not met as evidenced by: 46188 Based on review of medical records, policy and procedures and interviews with staff it was determined that the facility failed to ensure that all departments were integrated to provide safe and timely care. P#1 presented to the ED 8/18/2022 at 6:40 P.M. with complaints after a medically induced abortion days prior. Despite P#1 having critical lab values, abnormal blood pressure readings and abnormal ultrasound findings she was not assessed by an obstetrician until 11:41 P.M., five hours after arrival to the ED. P#1 taken to the operating room on 8/19/2022 at 2:00 P.M. or approximately 17 hours after initial presentation to the ED. Findings included: A review of patient #1’s medical record revealed that she arrived at the facility on 8/19/2022 at 6:40 P.M. via car, escorted by a family member. The patient was admitted to the hospital’s ED on 8/18/2022 at 6:53 P.M. The patient ‘s arrival complaint was listed as “Vaginal bleeding /Abdominal pain.” The patient’s updated complaint was listed as “Chief Complaints Updated: Vaginal Bleeding (Pt. Reports beginning abortion process on Sunday and states she has had extreme vaginal bleeding. Filling a pad in under an hour, states she is dizzy and passes out once).” The patient’s vital signs were listed at 6:52 P.M. was Temperature 98. Degrees Fahrenheit, Heart rate 105 (Tachycardia- fast heart rate), Blood Pressure 86/60 (hypotension- Low blood pressure); Respirations-18; Oxygen-96% and Pain Assessment was left Blank. The patient was triaged (the process of sorting patients by the urgency of their needs for care and treatment) by the Registered Nurse CC. The patient was triaged as an ESI (Emergency Severity Index- a scale used in the emergency department where patients are classified and prioritized based on severity of their injuries and or disease)- 3 urgent (a patient is urgent and requires multiple resources to investigate or treat). Further review of the medical record revealed in part the following orders were entered by ED PA (Physician Assistant) PP on 8/18/2022 at 6:54 P.M. Nursing “Obtain LMP/GYN (Last Menstrual Period/Gynecology) surgery history, pregnancy history; Assess and document bleeding , amount , color and duration; NPO (Nothing by mouth ); Nursing- save any tissue or products of conception, place in pathology specimen container, Vital Signs ED Routine; ...if symptomatic or hypotensive place in treatment area and notify MD; CBC auto differential (Complete blood count-measures red blood cells, white blood cells, and platelets -stop bleeding by helping blood to clot); ABO/Rh (test identifies blood group, Rh factor (positive or negative); hCG, quantitative, pregnancy (test that provides a positive or negative test for pregnancy ); Urinalysis complete with reflex cultures ( Lab test to check for bacteria or other germs in a urine sample); Type and screen (pre-transfusion test determines a patient’s blood type and RH type); Ultrasound combo pelvis complete ( a noninvasive diagnostic exam that produces images that are used to assess organs and structures within the female pelvis).” Documentation by ED PA PP revealed “First Provider Evaluation.” The orders placed by the ED PA PP were acknowledged by ED RN EE 8/28/22 at 8:33 P.M. There was no documentation in the medical record to indicate that EDMD BB was notified the patient was hypotensive upon arrival to the hospital’s ED. Additionally, there was no documentation by nursing as per orders to assess and document bleeding amount, color and duration; obtain LMP/GYN surgery history, pregnancy history. According to review of the ED patient Care Timeline revealed that on 8/18/2022 at 8:14 P.M., Physician ED MD BB was the assigned attending physician for P#1. On 8/18/2022 at 9:38 P.M., ED MD BB documented in part, “History Chief Complaint Patient Presents with Vaginal Bleeding Pt. Reports beginning abortion process on Sunday and states she has had extreme vaginal bleeding. Filling a pad in under an hour. States she is dizzy and passed out once. The history is provided by the patient: Vaginal Beeding: This is a new problem. The condition started 3 days ago. The problem is constant. The pain is moderate. The quality of the pain is described as cramping. The pain is at a severity of 6/10. The pain is the same all the time. ..The condition improved by nothing. Associated symptoms include abdominal pain. ...Patient ...presenting to the emergency room with complaints of vaginal bleeding and abdominal pain for the past few days. Patient states that she did an elective abortion (the interruption of pregnancy at the request of the woman) started taking abortion pills 5 days ago. Patient states over the past 2 (two) to 3 (three) days she started having heavy vaginal bleeding and abdominal cramping. States she also feel lightheaded and fainted once. The Review of Systems, revealed in part “ ... Gastrointestinal: Positive for abdominal pain ...Genitourinary: Positive for vaginal bleeding ...Neurological: Positive for light-headedness. Physical Exam (Examination): ...Mouth: Mucous membranes dry ...Cardiovascular: Tachycardia present ...Abdominal: There is abdominal tenderness in the periumbilical area and suprapubic area ...Genitourinary: ...No active vaginal bleeding on pelvic exam. Skin: ... is pale ...MDM (Medical Decision Making) ... Hypocalcemia (Low Calcium level); Leukocytosis (a condition where the white blood cells count blood is higher than normal); ...vasovagal syncope) a sudden drop in heart rate and blood pressure leading to fainting) Patient reports ...took Cytotec for 2 days. On exam patient appears to be dehydrated and pale. Pelvic ultrasound shows possible retained products of conception (any placental or fetal tissue left in the uterus after miscarriage, planned pregnancy termination or preterm/delivery) Continued review of the “ED Provider Note” revealed that ED MD BB noted to start P#1 on intravenous (IV) fluids, that the pelvic ultrasound showed possible retained products of conception (RPOC), P#1’s Hematocrit and Hemoglobin (H&H) was within normal limits, significantly elevated white blood cell (WBC) count at 56.50 (normal is 4.5 to 11) with no known source at this time. ED MD BB discussed the case with Obstetrical-Gynecology (OB-GYN) MD AA who agreed to start P#1 on IV antibiotics and admit for further evaluation. Continued review revealed that P#1 got up to urinate and had a syncopal episode and sustained a hematoma (bruise) to the forehead, a computed tomography (CT) of the head was ordered for further evaluation. Documentation by EDMD BB revealed, “ ...11:33 P.M. EDMD BB discussed with OB-GYN MD AA all pertinent aspects of the case including HPI (History of Present illness) details, physical exam findings, testing completed, medications given, the pt’s current condition, my clinical impression, and need for admission for further evaluation and treatment. The doctor agrees to accept the patient at this time for admission.” Documentation by OB-GYN MD AA, on 8/18/2022 at 11:41 P.M. revealed in part, “ ...28 y. o. (year old) female on whom I have been asked to consult for evaluation and treatment of Pelvic pain and syncopal episode at home and in the ER (Emergency Room) today. She reports she had an elective termination on 8/13 with medication management. She reports she started having heavy bleeding at home today and was changing her pad every hour before coming to the ER. ER MD reported minimal vaginal bleeding on exam (examination), but foul odor noted. The patient reports cramping also. She was sitting on the bedside commode in the ER room and was feeling dizzy and eventually passed out hitting her forehead ... She is able to give the history to me ...Obstetrical History OB History ... Gravida (number often to indicate the number pregnancies a woman has had) 1; Para (number of births a female has had after 20 weeks gestation) 1; Term (full term); Living 1” The abnormal laboratory resulted on 8/18/22 were : WBC 56.60 (Hospital reference range 3.4 -10.80); Platelet Count -109 (Hospital reference range:130-400); Creatinine: 1.29 (Hospital reference range-.30-1.00); Glucose: 117 (Hospital reference range: 74-100), and pregnancy test 11,628 -positive. Continued documentation by OB-GYN MD AA revealed in part, Physical Exam: “The patient appears well, alert, oriented x3, in no distress ... ABD (abdomen): soft, non-tender; bowel sounds normal ...Pelvic: examination done by (ERMD). Further documentation revealed under the section titled “Assessment/Plan: revealed, in part, “ ...Repeat CBC, BMP, PT.PTT in am ...Make NPO for possible D&C tomorrow. Principal Problem: Retained products of conception following abortion.” A review of the ED Patient Care Timeline revealed that on 8/19/2022 at 4:16 A.M. Patient #1 was admitted to an observation Unit and new orders were acknowledged. The orders revealed in part, New -Head CT (Computed Tomography -Imaging diagnostic test to obtain detailed images of the body) without contrast, Place in observation “Full Code (individual who wants everything done to save their life in the event of an emergency)” Laboratory work, medication for pain and nausea, Zosyn and Flagyl antibiotics. Continued review of the medical record revealed that on 8/19/2022 at 5:14 A.M. OBGYNMD AA ordered a consult for IMS MD Hospitalist GG to evaluate patient #1. The patient was listed to be room 3210/3210-01 (Observational Unit). IMS MD Hospitalist GG documented in part, “Pt. (patient) Reports beginning abortion process on Sunday and states she has had extreme vaginal bleeding. Filling a pad in under an hour. States she is dizzy and passed out once.” Further documentation by IMS MD Hospitalist GG revealed in part, History of Present illness, “ ...OB GYN MD AA consulted me due to concern of persistent hypotension despite appropriate IV fluids. Patient reports lightheadedness upon sitting up and generalized abdominal pain. He also documented the following abnormal Blood pressures, pulse and respirations:2:05 A.M.- Blood pressure (B/P) 89/58; Pulse: 105; 3:13 A.M. - Pulse 105, Respiration: 30; 4:27 A.M. BP 79/42; and 4:33 A.M. BP 72/38, Pulse: 18; and Respirations: 25. IMS MD Hospitalist GG documented, in part, Physical Examination: General Appearance: “Appears Ill ... Throat: Dry oral mucosa ...Abdomen: Soft, right lower quadrant abdominal tenderness, rebound noted, involuntary guarding noted, hypoactive bowel sounds active in all quadrants.” The patient’s most recent laboratory work on 8/19/2022 at 3:22 A.M., WBC increased to 80.10 and Platelet count further decreased to 71. The patient’s Creatinine Level was 1.29 (indicating possible kidney failure); Glucose 117; and calcium level was 6.5. He also documented an Assessment -Hospital Problem list: 1. (Principal) Retained products of conception following; 2. Leukocytosis; 3. Tachycardia; 4. Sepsis; 5. Shock; 6. ARF (acute renal failure). Further documentation revealed the “PLAN”: Sepsis (the body’s response to extreme to an infection. It is a Life- threatening medical emergency), Acute-Severe. Complicated by refractory hypotension consistent with shock; initiate Levophed. Discussed case with ICU (Intensive care unit) pending evaluation; escalate antibiotics-Zosyn, vancomycin doxycycline, blood cultures, obtain serum lactic acid (occurs when lactic acid builds up in the blood, body produces more lactic acid and body tissues are deprived of oxygen), CT abdomen pelvis with IV contrast-concern for possible abscess versus acute abdomen-peritoneal signs on exam; Place on telemetry; Shock Acute. Likely secondary to sepsis (Continue IV fluids, Exam bed placed in Trendelenburg (used as first line intervention in the treatment of acute hypotension and/or shock); Leukocytosis Acute worsening; Acute renal failure Acute. Likely to sepsis. IMS MD hospitalist GG documented the findings were discussed with OB GYNMD AA, “Pending ICU evaluation.” Documentation by the RN dated 8/19/2022 at 6:29 AM revealed, “Awaiting assignment for patient to be transferred. Review of the Rapid Response Note dated 8/19/2022 at 6:45 A.M. the RRT (Rapid Response Team) was called by the Intensivist for hypotension: Started patient on levo (Levophed) gtt (drip) and transferred to ICU Room 2210. Review of the record revealed that at 7:05 A.M. the patient’s BP was 65/50. Review of the Critical care note dated 8/19/2022 at 7:14 A.M. CCM (Critical Care Management) PA HH documented that a critical care consult was placed because IMS was asked to look at P#1 for septic shock. She documented in part, “She was admitted for volume resuscitation and IV antibiotics with plans of D&C. Overnight 8/18-19 she was hypotensive despite 5.5 L (liters) of IV fluids. Patient transferred to the ICU for pressors (type of medication used in the ICU to treat conditions such as shock). Review of the medical record revealed that on 8/19/2022 at 12:05 P.M., OB GYN Surgeon DD, notified CCM MD II, the patient’s condition was deteriorating, and the patient was now on 2 pressors, the blood pressure was 80/40’s. She also documented the patient’s WBC had increased from 80.1 to 100.70. A review of an “Operative Note” dictated on 8/19/22 at 3:25 p.m., revealed that General Surgeon (GEN) MD JJ performed an exploratory laparotomy on P#1 and listed the pre- and post- operative diagnosis as ischemic (less-than-normal amount of blood flow) gut. Continued review of the “Operative Note” revealed that P#1 was already in the operative room (OR) by gynecologic service and GEN MD JJ was consulted for evaluation of what appeared to be ischemic small bowl. GEN MD JJ noted that there was no frank necrosis, but some injury as expected. GEN MD JJ noted that there was nothing that could be done at that point, as a complete small bowel resection was not consistent with life and there was still a possibility that the ischemic injury can reverse itself. GEN MD JJ noted that P#1 was severely acidotic and hypotensive requiring medication with low platelets and that a Disseminated Intravascular Coagulation (DIC) panel was still running. GEN MD JJ noted that gynecologic service will continue with an operation and perform a hysterectomy, which GEN MD JJ agreed was in P#1’s best interest. The section of the medical record titled “Admission Orders” was reviewed. The review revealed that on 8/18/2022 at 11:33 OB GYN MD AA, wrote orders which stated, “Place in Observation (patient is being closely monitored in the ED while medical professionals further evaluate their condition to determine if they need to be admitted as an inpatient)”. Further review of the section titled “Updates’ revealed the admitting provider was OBGYN MD AA, and the diagnosis was “Retained products of conception following abortion” The patient’s class was listed as “observation”. Further review of the ED Patient Care Timeline revealed at 11:39 OB GYN MD AA an ED admit order was placed and completed to place the patient in observation for gynecology. At 11:57 an inpatient bed was assigned PHH -3NE (Observation unit). On 8/19/22 at 1:3 9 a.m., OB GYN MD AA, listed the patient as an ED Boarder Patient (The practice holding patients in the ED or another temporary location after the decision to admit or transfer has been made). Review of the admission orders revealed on 8/19/2022 at 1:27 P.M., revealed a verbal order per OB GYN MD AA, on 8/19/2022 at 1:27 P.M. was communicated to a Registered Nurse to admit Patient #1 as an inpatient. A review of a “Discharge Summary - Expired” dated 8/19/22 at 6:37 p.m., by a PA FF revealed that P#1’s immediate cause of death was listed as septic shock due to retained products of conception. Continued review revealed that the manner of death was listed as natural. The County Coroner’s Office Report for Patient #1 dated 8/19/2022 was reviewed. Patient #1 cause of death was listed as “Sepsis due to retained products of conception.” A review of the facility’s document, “Order Set for Sepsis”, revealed an order set and treatment course checklist. Continued review revealed that the categories of sepsis are separated by suspected/presumed sepsis, severe sepsis normotensive/lactate, severe sepsis/septic shock MAP greater than 65 and/or Lactate greater than four. A review of the facility’s Sepsis 1-hour bundle- Initial Resuscitation for Sepsis and Septic Shock revealed that: Medical Emergency- Initiate bundle upon recognition of sepsis/septic shock 1. measure lactate level- remeasure if initial lactate is elevated (greater than two) 2. Obtain blood cultures before administering antibiotics 3. Administer broad spectrum of antibiotics 4. Begin rapid administration of 30 mL/kg crystalloid for hypotension or lactate greater than or equal to four. 5. Apply vasopressors if hypotensive during or after fluid resuscitation to maintain a mean arterial pressure greater than or equal 65 mm Hg A review of the facility’s Sepsis three-hour Bundle revealed that within three hours, a patient should receive antibiotics and normal saline bolus, lactic acid STAT, and blood cultures. A review of the facility’s policy titled, “Piedmont Henry Hospital Emergency Department Patient Assessment and Reassessment Policy”, policy #10603466, last revised 10/22/21, revealed that the purpose of the policy was to establish guidelines for assessing and reassessing patients who present to the emergency department (ED). Continued review revealed, Definitions: Assessment - the collection/interpretation of data for the purpose of matching an individual’s need with the appropriate setting, care level, or intervention. Assessments are completed upon admission to the hospital at a variety of entry points and continued throughout the hospital stay. In the ED, an assessment is performed based on the patient’s acuity upon arrival and their chief complaint. Continued review revealed, Procedure, Triage: The purpose of the triage is to prioritize incoming patients and identify those patients who cannot wait to be seen. The Emergency Severity Index (ESI) is used to determine which patient prioritization and determine what resources are necessary in order to determine an ED disposition. Triage level can be changed to a higher acuity but not downgraded. A final assessment/reassessment will occur within 60 minutes of discharge, admission to a unit, or transfer to another hospital. Frequency of reassessments are based on ESI level. ESI level two: high-risk situation, confused/lethargic, disoriented, severe pain/distress, abnormal vital signs. Frequency of reassessment is every two hours and components to include full vital signs (heart rate, blood pressure, O2 saturation, respiratory rate, pain score), note patients general appearance, and mental status. ESI level three: considered stable, but requires therapeutic observation or treatment and require two or more resources. Frequency of reassessment is every four hours and components to include full vital signs (heart rate, blood pressure, O2 saturation, respiratory rate, pain score), note patients general appearance, and mental status. Continued review revealed, Responsibilities: Triage Nurse “ Provide the initial assessment of the patient in relation to the patient’s acuity and chief complaint. “ Perform all reassessments for the patients that are in the waiting room waiting. “ Primary personnel responsible for monitoring the waiting room dashboard to ensure that patients are receiving timely reassessments in coordination with the department’s Flow Coordinator. Charge Nurse/Flow Coordinator “ Assist in the flow and coordination of patients and providers. “ Tertiary personnel monitoring the waiting room dashboard to ensure that patients are getting the care they require. Triage Provider “ Assist with reassessments as needed by the triage nurse. A review of the facility’s policy titled “Scope of Care/Service: Facility -Ultrasound”, policy #15651448, last revised 2/12/22, revealed that the hours of operation for the ER and Inpatients- 24 hours per day/7 days per week. A further review revealed, Descriptions of Assessment and Reassessment Practices, including timeframes: Patient assessment is made to provide the best care possible and the most relevant information to the Radiologist and to allow for the best possible exam and results. The order is reviewed by the technologist prior to the exam, and the patient is questioned about his or her reason for the exam, which is documented in PACS for the radiologist to review. The Radiologist will communicate with the referring physician if needed regarding the proper exam and/or if any immediate follow-up is required of the patient or the referring physician. A review of the facility’s policy titled, “Assessment/Reassessment/Prioritization of Obstetrical Emergency Department Patients Policy”, policy #5953504, last revised 6/4/19, revealed that the purpose of the policy was to provide guidance for triaging and assigning patients an acuity level. Continued review revealed, Assessment, Examples of High-Risk Situations: “ Active vaginal bleeding (not spotting or show) “ Unstable high risk medical conditions A review of the facility’s policy titled, “Obstetrical ED Patient Assessment and Reassessment”, policy #14881883, last revised 11/28/23, revealed that the purpose of the policy was to establish guidelines for assessing and reassessing patients who present to the Obstetrical Emergency Department (OBED). Continued review revealed, Procedure, Triage, the purpose of triage is to prioritize incoming patients and identify those patients who cannot wait to be seen. Continued review revealed, Responsibilities: OBED Nurse: “ Provide the initial assessment of the patient in relation to the patient’s acuity and chief complaint. Perform assessments of the patients in the OBED and report findings to the appropriate provider. OBED Provider “ Perform initial assessments and examinations on patients in OBED as per EMTALA guidelines. A review of the facility’s policy titled, “Obstetrical Patients in the Emergency Department Policy”, policy #7351718, last revised 12/16/19, revealed that the purpose of the policy was to define the guidelines for all obstetrical (OB) patients presenting to the emergency department (ED). Continued review revealed, Six, Procedures, OB patients who present ot the ED with: Gestation less than 20 weeks “ A qualified medical provider will perform an evaluation and medical screening exam in the ED. “ The ED physician will notify the patient’s attending OB, on-call, or in-house. A review of the facility’s policy titled, “Obstetrical Patients in the Emergency Department Policy”, policy #12824579, last revised 12/29/22, revealed that the purpose of the policy was to define the guidelines for all obstetrical (OB) patients presenting to the Emergency Department (ED). Continued review revealed, Six, Procedures, OB patients who present to the ED with: Gestation less than 20 weeks “ A qualified medical provider will perform an evaluation and MSE in the ED. “ The ED physician will notify the patient’s attending obstetrician, on-call, or in-house. “ Hospitals with an OB ED may see patients with gestation less than 20 weeks. Other complaints or who are not exhibiting obvious signs and symptoms of labor “ A qualified medical professional will perform and evaluation and MSE in the ED in accordance with ED protocol. A review of the facility’s policy titled, “Guidelines for Management of Obstetric and Gynecologic Patients that Present to the Main ED”, policy #11533615, last revised 3/25/19, revealed, A., Management of Pregnant Patients Less than 20 Weeks, One, Threatened Miscarriage. Patients who present to the Emergency Department (ED) with vaginal bleeding and are found to have an intrauterine pregnancy on ultrasound are considered to have threatened miscarriage. These patients should be assessed by the ED physician. The assessment should include a CBC, quantitative pregnancy test, Rh screen and Pelvic ultrasound. Pelvic exam should be performed for any patient with bleeding, discharge, and/or pain. These patients should be advised on the possibility of miscarriage and referred for follow-up based on the following stratification: a. Less than 12 weeks gestation: if unassigned then give the patient list of OB/GYN practices in the community. c. Inevitable abortion: Patients who present with rupture of membranes, presentation of fetal body part or precipitous delivery. Contact the OB/GYN Hospitalist for unassigned patients or the OB/GYN on call for those assigned to a particular group on staff. Continued review revealed, Three, How to Manage Ultrasound Findings b. If there is a pregnancy visualized but not fetal heart tones (FHTs) (missed ab, incomplete ab), then proceed to pelvic exam to determine rate of bleeding/cervical status, check Rh status and refer appropriately. Continued review revealed, Four, Admissions, the admitting service should be based on the primary indication for admission, if it is an OB issue, then the OB/GYN should be called for admission. If the indication for admission is not OB, the patient should be admitted to the appropriate service based on that indication. A review of the facility’s policy titled, “Guidelines for Management of Obstetric and Gynecologic Patients that Present to the Main ED”, policy #14256833, last revised 8/30/23 revealed, A., Management of Pregnancy Patients Less than 16 Weeks, One, Threatened Miscarriage. Patients who present to the Emergency Department (ED) with vaginal bleeding and are found to have an intrauterine pregnancy on ultrasound are considered to have threatened miscarriage. These patients should be assessed by the ED physician. The assessment should include a CBC, quantitative pregnancy test, Rh screen and Pelvic ultrasound. Pelvic exam should be performed for any patient with bleeding, discharge, and/or pain. These patients should be advised on the possibility of miscarriage and referred for follow-up based on the following stratification: c. Less than 12 weeks gestation: if unassigned then give the patient list of OB/GYN practices in the community. d. Inevitable abortion: Patients who present with rupture of membranes, presentation of fetal body part or precipitous delivery. Contact the OB/GYN Hospitalist for unassigned patients or the OB/GYN on call for those assigned to a particular group on staff. Continued review revealed, Three, How to Manage Ultrasound Findings d. If there is a pregnancy visualized but not fetal heart tones (FHTs) (missed ab, incomplete ab), then proceed to pelvic exam to determine rate of bleeding/cervical status, check Rh status and refer appropriately. Continued review revealed, Four, Admissions, the admitting service should be based on the primary indication for admission, if it is an OB issue, then the OB/GYN should be called for admission. If the indication for admission is not OB, the patient should be admitted to the appropriate service based on that indication. A request was made on 10/1/24 at 8:42 a.m. to conduct an interview with OB-GYN MD AA and OB-GYN MD DD. The Director of Quality later informed the survey team that OB-GYN MD AA and OB-GYN MD DD have refused and retained legal counsel. A request was made on 10/1/24 at 8:42 a.m. to conduct an interview with ED MD BB, however the Director of Quality later informed the survey team that ED MD BB was out of the country. A request was made on 10/1/24 at 8:42 a.m. to conduct an interview with IMS MD GG, however the Director of Quality later informed that survey team that IMS MD GG was no longer on staff with the facility. An interview was conducted on 10/1/24 at 10:41 a.m. in the facility’s conference room with ED Nursing Director (ND) TT. ED ND TT explained that the triage nurse is an individual who generally has one year of experience or more as a Registered Nurse (RN). ED ND TT explained that all nurses in this role receive training in the triage process, Emergency Severity Index (ESI) levels, and the Sepsis Screening tool. ED ND TT explained that during the triage process, there is generally a mid-level provider, i.e., Physician’s Assistant (PA) or Nurse Practitioner (NP), also at the screening station. ED ND TT explained that once the triage process is completed, a patient will be taken to the protocol room, where lab work and any additional tests are completed. The ED has its own technicians who take the blood samples. ED ND TT said that most ED lab work is considered STAT and completed within 30 minutes, and the turnaround time for results is generally around 45 minutes. ED ND TT explained that if there is an abnormal result, the lab typically will call the Primary RN or the Charge RN with abnormal values, and they are responsible for communicating this to the ED Provider. ED ND TT explained that the Sepsis Screening is a drop-down tool in the electronic medical record EPIC, and if the nurse marks “no” suspected infection, the drop-down questions do not populate to proceed further. ED ND TT explained that if any abnormal lab results indicate “sepsis,” an alert will trigger a BPA alert, requiring the RN to note that the provider was notified of the abnormal results. ED ND TT explained that once the ED Provider examines the patient and determines that a patient may need to be admitted, they will contact that Provider to discuss the patient. When a Provider agrees to accept the patient, that Provider writes the admitting orders and is the Provider contacted if additional orders are needed while the patient is waiting to be transferred to an inpatient bed. ED ND TT explained that once a decision is made to admit the patient and a Provider agrees to admit, the ED Provider initiates the bed request. ED ND TT said that the location of a medical-surgical floor or critical care unit is a decision made between the ED Provider and the Admitting Provider, then bed control will assign a bed. ED ND TT said that once a bed is assigned, an ED nurse will call the nursing unit to give a report. ED ND TT said that a delay in transfer may occur if any outstanding tests need to be completed, i.e., x-ray or CT. ED ND TT further explained that vasopressors can be administered in the ED and Intensive care areas but not generally on the medical-surgical floor. ED ND TT explained that patients waiting to be transferred to an inpatient bed are considered boarding, and a patient in observation is a level of admission where it is anticipated that the length of stay will be under 24 hours. During a telephone interview on 10/1/24 at 1:13 p.m., General Surgeon (GS) JJ said that he vaguely recalls P#1 and the time he encountered her. GS JJ recalled that P#1 was already in the operating room (OR) when GS JJ was consulted. GS JJ recalled that he was consulted for concerns of an ischemic gut possibly related to disseminated intravascular coagulation (DIC). GS JJ said that an ischemic gut is usually caused by a decrease of blood flow and oxygenation that could be caused by a clot, obstruction, low blood pressure, medication, or poisons. GS JJ said that in the case of DIC, it is the concept of many smaller clots that cause a decrease in blood flow. GS JJ said that when another provider identifies an issue while operating on a patient they cannot manage or treat, they will consult another provider to see if the problem is fixable or not. GS JJ said that he does not recall P#1’s case after the consultation, but that based on a review of his notes at the time of consult, there was nothing that could be done for P#1 regarding the ischemic gut. During an interview on 10/1/24 at 2:59 p.m., Critical Care Medicine (CCM) Medical Doctor (MD) II said that he has been a provider working in CCM for eight years.CCM MD II said that when the emergency department (ED) consults CCM, the advanced practice provider (APP) and or MD will go and evaluate the patient for critical care (CC) needs. CCM MD II said that he would decide if the patient required CC needs and then input an admission order for either the intensive care unit (ICU) or intermediate care unit (IMCU), as appropriate. CCM MD II said that once the admission order is placed, then the bed control will take over in placing the patient in a bed. CCM MD II said that if the ICU was at capacity, then the patient would have to remain in the ED or could overflow into the IMCU, but only if it were appropriate for the level of care staff could provide. CCM MD II recalled that he was the CCM attending and that he evaluated P#1 due septic shock following an abortion. CCM MD II recalled that P#1 presented to the CCM team requiring blood pressure medication to keep it elevated as P#1 had low blood pressures. CCM MD II recalled that P#1 did require surgical intervention by the obstetrical (OB) team. CCM MD II said that he did not recall the OB team mentioning any delays to the CCM team or a rationale for when the surgery was scheduled. CCM MD II said that for patients who require immediate surgical intervention, despite being unstable, all medical providers would decide for immediate intervention or not based on outweighing the benefits and risks. CCM MD II said that he did not recall the OB team discussing concerns of P#1 being unstable for immediate surgery with him. CCM MD II said that the major principles of managing sepsis are fluid resuscitation, source control, early antibiotic administration, and maintaining blood pressure levels. CCM MD II said that a part of the sepsis protocol is ordering and collecting labs such as blood cultures and a lactic acid, both of which are STAT labs. CCM MD II said that it is critical to recognize sepsis early as you would want to get a treatment started early. CCM MD II said that disseminated intravascular coagulation (DIC) is a condition that is secondary to some underlying process, such as sepsis or thrombocytopenia (a condition where the number of platelets in the blood is abnormally low, which can lead to excessive or prolonged bleeding). CCM MD II said that treatment is treating the underlying cause of the DIC. CCM MD II said that the degree of suspicion for DIC by the provider would determine if any labs for DIC were ordered STAT or routine.”

“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: 47949 Based on a review of hospital medical records, Medical Staff Rules and Regulations, Emergency Services reports, policies and procedures, and staff interviews, it was determined that the hospital failed to ensure that two patients (#21 and #31) of 34 sampled medical records received an appropriate medical screening examination (MSE) that was provided within the capability of the hospital’s emergency department, including ancillary services routinely available to the emergency department, to determine if an emergency medical condition existed. Refer to findings under A2406.”

“POSTING OF SIGNS CFR(s): 489.20(q) [The provider agrees,] in the case of a hospital as defined in §489.24(b), to post conspicuously in any emergency department or in a place or places likely to be noticed by all individuals entering the emergency department, as well as those individuals waiting for examination and treatment in areas other than traditional emergency departments (that is, entrance, admitting area, waiting room, treatment area) a sign (in a form specified by the Secretary) specifying the rights of individuals under section 1867 of the Act with respect to examination and treatment for emergency medical conditions and women in labor; and to post conspicuously (in a form specified by the Secretary) information indicating whether or not the hospital or rural primary care hospital (e.g., critical access hospital) participates in the Medicaid program under a State plan approved under Title XIX. This Standard is not met as evidenced by: 47949 Based on a review of the facility’s policies, procedures, tour of the unit, and staff interviews, the facility failed to have signs posted in the labor and delivery emergency unit waiting room specifying the rights of individuals under special responsibilities of Medicare hospitals in emergency cases and information indicating whether the hospital participates in the Medicaid program. Findings include: A review of the facility’s policy titled, “Transfer Activities in Accordance with EMTALA Requirements,” number 11101630, last approved 1/27/2022, revealed the purpose was to establish guidance for providing appropriate medical screening examinations, stabilizing treatment and appropriate transfer of patients in accordance with the Emergency Medical Treatment and Labor Act (EMTALA), and all regulations promulgated thereunder. Further review revealed the following: Signage: A. Signs shall be posted in a place or places likely to be noticed by all individuals entering the Emergency Department as well as those individuals waiting for examination and treatment in areas other than the Emergency Department (entrance, waiting room, admitting area, treatment area). B. Such signs must: 1. Specify the rights of the individuals with emergency conditions and women in labor who come to the hospital for healthcare services; 2. Indicate whether the facility participates in the Medicaid program; and 3. Be clear and in simple terms and language understandable by the population served by the hospital. During a tour of the labor and delivery emergency unit, on 9/25/2024 at 11:11 a.m., EMTALA signage was observed on the wall behind the patient registration desk. EMTALA signage was not observed in a conspicuous location likely to be noticed by all individuals waiting for examination and treatment in the area. That is, there was no EMTALA signage posted in the waiting room. The Director of Women’s Services (Dir.) WW was informed of these findings during the tour. Dir. WW acknowledged that there was no EMTALA signage posted in the waiting room and said she could not recall if there had ever been signage posted.”

“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: 47949 Based on a review of hospital records, policies and procedures, Medical Staff Rules and Regulations, and Emergency Medical Services reports, it was determined the facility failed to provide an appropriate medical screening examination (MSE) within the capability of the hospital’s Emergency Department (ED), including ancillary services routinely available to the ED to determine whether or not an emergency medical condition (EMC) existed for two patients (#21 and #31) with a complaint of suicidal ideation (SI) of 34 sampled medical records. Findings include: 1. The facilities “MEDICAL STAFF BYLAWS, POLICIES, AND RULES AND REGULATIONS OF PIEDMONT HENRY HOSPITAL, Adopted by the MEC (Medical Executive Committee) on September 13, 2018, Approved by the Board on March 13, 2019, was reviewed. The policy revealed in part, “11. A. GENERAL: Emergency services and care will be provided to any person who comes to the emergency department, as that term is defined in the EMTALA [Emergency Medical Treatment and Labor Act] regulations, whenever there are appropriate facilities and qualified personnel available to provide such services or care. ... 11. B. MEDICAL SCREENING EXAMINATIONS: (1) Medical screening examinations, within the capability of the Hospital, will be performed on all individuals who come to the Hospital requesting examination or treatment to determine the presence of an emergency medical condition. Qualified Medical Personnel (“QMP”) who can perform medical screening examinations within applicable Hospital policies and procedures are defined as: (a) Emergency Department: (i) members of the Medical Staff with clinical privileges in Emergency Medicine; (ii) other Active Staff members; and (iii) appropriately credentialed Advanced Practice Professionals. ... 2. The results of the medical screening examination must be documented before the patient leaves the Emergency Department.” 2. The facility’s Policy titled “Piedmont Henry Hospital Emergency Department Patient Assessment and Reassessment Policy” PolicyStatID 10603466, Origination Date 4/20/2010, Last approved: 10/22/2021, Version Effective Date: 10/22/2021; Last revised 10/22/2021. The policy revealed in part, “Definitions: Assessment- the collection/interpretation of data for the purpose of matching an individual’s need with the appropriate setting, care level, or intervention. ... In the ED, an assessment is performed based on the patient’s acuity upon arrival and their chief complaint. ... Reassessment- the collection/interpretation of ongoing data to determine the patient’s response to care delivery or interventions. Reassessments may be performed at more frequent intervals based on the patient’s response to treatment or if there is any significant change in the patient’s condition or diagnosis. ... Procedure: Triage: The purpose of triage is to prioritize incoming patients and identify those patients who cannot wait to be seen. Patients who do not require immediate life-saving treatment are sorted based on presenting complaint and/or severity of illness/injury. The Emergency Severity Index (ESI) is used to determine which patient prioritization and determine what resources are necessary in order to determine an ED disposition ...ESI Level 2 Frequency of Reassessments 2 hours ...ESI Level 3 Frequency of Reassessments 4 hours ...*Re-assessments will occur based on ESI level and/or as appropriate for patient condition. Re-assessments completed within 30 mins [minutes] of the designated re-assessment time will be considered compliant with this policy.” 3. The facility’s policy titled “Care of Behavioral Health Patients Policy” Retired: PolicyStatID 9472000, Origination Date 3/19/2019, last revised 3/19/2019. The policy revealed in part, “Definitions ...At Risk Patient- A patient who does not have an active Form 1013 or Form 2013, but who has a behavioral health history or has exhibited behavior during an admission that may indicate that the patient is at risk of causing harm to him/herself or to others ... Constant Observation- Direct visual monitoring at all times including during procedures located in other areas of the facility... This level may be initiated by nursing staff or medical staff but may only be discontinued by medical staff. ... Constant Observer (Sitter)- Individual designated adult, who is over eighteen (18), and who provides Constant Observation in close proximity to the patient or via video monitoring with, 360 degree viewing, to ensure the safety of a patient. Supervision of Constant Observers will be provided by the primary nurse assigned to the patient. ... Implementation: 1. Suicide Risk Assessment: All patients will be screened at the time of intake to determine risk for suicide and harm to self or others per the suicide assessment tool in the medial record. Scores are automatically calculated in the suicide risk flowsheet. The physician of any patient who is screened as moderate or high risk should be notified. There are three levels of suicide risk: High Risk, Moderate Risk, and Low Risk. The appropriate interventions will be followed according to the patient score/stratification ... Level of Risk: Intervention ... Moderate Risk: Notify MD that psychiatric consult is needed and/or possible 1013 form executed Psychiatric consult and/or 1013 ...Behavioral Health Case Management Referral; Provide Behavioral Health Services Resource List; Reassess every 24 hours. ... Safety Precautions for the Behavioral Health Patient: ...The following behaviors may indicate the patient is an At Risk Patient in need of additional Safety Precautions: Observed or reasonable suspicion of self-injurious behaviors; Observed or reasonable suspicion of self-induced illness (i.e. purging, tampering with equipment, specimens, etc.); Expression of threats of violence to self or others; Exhibiting a level of sedation that is consistently different than the anticipated effect of prescribed medications or staff members have reasonable cause to believe that the patient is self-medicating or using illicit drugs; Observed drug contraband or drug paraphernalia in patient room; or Staff belief that the patient has items in his/her possession that may be dangerous or illegal. If a patient exhibits any of the At Risk Patient behaviors, a physician or a licensed independent practitioner’s order is required for a patient to be placed on safety precautions and safety precautions must be noted on the patient’s chart. To insure the immediate safety of the patient or others, the primary nurse may place a patient in safety precautions and then immediately contact the physician or licensed independent practitioner and request an order for safety precautions. The physician may order a Constant Observer (sitter) or a belongings search or both if indicated according to the patient’s particular behavioral issue. 1. Belongings Search: If a belongings search is deemed necessary to protect the patient, the reason for the search must be recorded in the patient’s medical record ....” 4. The facility’s policy titled “Leaving Against Medical Advice Policy” Origination date 7/1/2013, Last revised: 1/6/2023, and Last Approved: 11/24/2023 was reviewed. The policy revealed in part, “ ... Definitions: Against Medical Advice (AMA)- A mentally competent adult patient leaves the hospital or discharges him/herself despite being advised of possible adverse medical effects by medical personnel. Elopement- An adult patient leaves his/her designated area without permission or knowledge of physician or hospital staff ... 6. Procedures: Leaving Against Medical Advice: 1. If patient informs nursing staff that he/she is leaving, the immediate supervisor and/or immediate nursing leader will be notified of the patient’s desire to leave. 2. The immediate supervisor and/or immediate nursing leader, a physician or designee will inform the patient of the risks of leaving as defined by the physician. 3. The physician/nurse informing patients of risks will document the conversation with the patient in the medical record. 4. The patient’s nurse should have the patient read and sign from entitled “Leaving Hospital Against Advice.” 2. Elopement of Patients with Decision Making Capacity: When it becomes known that a patient is missing from his/her designated room or unit, staff will take the following actions: 1. Notify immediate supervisor, immediate nursing leader, and/or Unit Manager. ... 3. Notify Public Safety immediately. Give a description of the patient. Security will notify officers to begin searching all areas of the facility. 4. Search the unit. 5. Notify the patient’s physician when missing status is confirmed. 6. Notify the family or next of kin and request they notify the hospital immediately if they make contact with the patient and/or know patient’s location. 7. Document in the medical record time patient noted to be missing, response to search efforts, notifications and times. Elopement of Medically Compromised or Behavioral Health Patients Without Decision Making Capabilities: If the adult patient who elopes has altered mental status, [or] lacks Decision Making Capacity[,] ... additional procedures should be implemented as follows: 1. Nursing staff will notify Nursing Supervisor and initiate a low-key rapid search of the unit searching room-to room, utility rooms, exam rooms, lounges, waiting areas, and adjacent stairwells. 2. Nursing Supervisor will notify local law enforcement and Public Safety that the patient is missing, provide a detailed description, and explain safety-related concerns. ... 4. Time patient noted to be missing, response to all search efforts, notifications and times will be documented in the medical record. ... Leaving the Emergency Department Without Being Seen: 1. If a patient wishes to leave from triage prior to receiving a medical screening, the triage/treatment area nurse will notify the charge nurse and make an attempt to encourage the patient to stay and be seen. 2. The patient will be advised of the risks involved in leaving without having a medical screening performed. 3. If a record has been made, the nurse will document the conversation in the medical record. 4. If the patient has not informed the staff that they are leaving/intend to leave: a. Call the patient’s name up to three (3) times. b. Notify the charge nurse or flow coordinator that the patient is missing. c. Perform a low key search of the surrounding area. d. Attempt to contact the patient and emergency contact via the contact information in the chart, if available. e. Document in the medical record time patient noted to be missing, response to search efforts, notifications and times.” 5. A review of Patient #21’s medical record revealed that he arrived at the hospital on 6/3/2022 at 9:42 p.m., via car. At 10:00 p.m., the Nurse Practitioner ordered the following laboratory tests: Basic Metabolic Panel, Rapid Toxicology Drug Screen Urine; Ethanol level. The Nurse Practitioner documented at 10:01 p.m., “First Provider Evaluation.” Further review of the medical record revealed there was no documentation that an appropriate medical screening examination was conducted by a Qualified Medical Professional (QMP). At 10:03 p.m., the patient was admitted to the ED. The patient’s arrival complaint was listed as “mental health.” The patient’s “Chief Complaints Updated” revealed in part, “Suicidal (Pt reports he was here earlier, but left because he wanted to drink, and smoke, because he wasn’t feeling well. Pt reports SI [Suicidal Ideation], thought of wanting to slit his wrists. Patient is talking to his hand, denies HI [Homicidal Ideation], but then in a high pitched voice states his hand ... wants to kill everybody here. Pt denies any drug use today, other than alcohol.)” Documentation by the ED triage nurse revealed the patient was triaged as an ESI acuity 2 (Emergent- triage level that requires immediate nursing assessment and rapid treatment). The ED RN documented at 10:03 p.m. that the patient was placed in room ACT-07. On 6/4/2022 at 12:07 a.m., the following abnormal laboratory blood tests results were reported: “Ethyl (B): 212 mg/dL,” which is High (hospital reference range: 0-10); at 12:10 a.m., the Sodium was 133, which is low (hospital reference range:136-145); and Anion Gap (Acidosis in the blood) was 16, which is High (hospital reference range: 7-14). A review of the Suicidal Risk Assessment- Columbia Suicide Severity Rating Scale (C-SSRS- Screens for suicidal ideation and behavior) revealed: 1. Wish to be Dead-(Past 1 month): Y (yes); 3. Active Suicidal Ideation with any methods (Not Plan) without intent to act in past 1 (one) month: Y (yes); 6. Suicidal Behavior (Lifetime): Y (yes) 6 (six) months ago states he drank some antifreeze. 6.Suicidial Behavior (3 months): N (no). Calculated C-SSRS Risk Score: Moderate Risk. The interventions for Suicide Moderate Risk included for staff to: “Notify MD that psychiatric consult is needed and/or possible” and “1013 form executed” (this form is used when someone is considered a risk to themselves or others due to a mental crisis). Continued review of the medical records revealed, as of 6/4/2022, the patient had a past medical history of Bipolar 1 disorder (involves manic episodes that last at least a week, so severe that the individual requires immediate medical care), Schizo affective schizophrenia (Chronic mental health condition, combination of symptoms of schizophrenia and mood disorder), and hypertension (high blood pressure). Patient #21’s final diagnoses included: “R45.851 Suicidal ideations” and “Procedure and treatment not carried out due to patient leaving prior to being seen by health care provider.” The “ED Re-evaluation note by ...ED MD, dated 6/4/2022 at 4:28 a.m., revealed in part, Re-evaluation[:] Pt seen walking out. Asked the unit desk sec ... to call Security. Security at front of ED reports that pt has already left. Searches for pt was futile.” According to the Updated Chief Complaints, the patient presented to the hospital complaining of homicidal and suicidal ideations/thoughts. The suicidal risk assessment determined the patient to be at moderate risk. There was no documentation in the medical record to indicate the ED physician was notified that a psychiatric consult was needed; that the patient was placed on safety or suicide precautions for his safety and others; that constant observation was initiated or that a belongings search was done to protect the patient and others since he was assessed to be a harm to himself and others, as required by hospital policies. The failure to complete an appropriate MSE after assessing Patient #21 with suicidal and homicidal ideation, and an elevated alcohol level that potentially impairs a person’s judgement, failure to assess/reassess the patient on 6/3/2022 between 9:59 p.m. to 4:53 a.m. prior to the patient being discharged, and to fully implement the hospital’s policies, “Care of Behavioral Patients Policy”, “Piedmont Henry Hospital Emergency Department Patient Assessment and Reassessment Policy” and the “Leaving Against Medical Advice Policy” contributed to the patient not receiving an appropriate MSE to determine that an emergency medical condition exist. 6. A review of the Emergency Medical Service (EMS) ambulance report, dated 1/4/2023, section titled, “Patient Care Narrative” revealed in part, “ ...responded .... 41-year-old female having suicidal thoughts. Pt [patient] stated that she has been having these thoughts for a couple weeks. Pt stated that she is a cutter but has not cut in 1.5 years. No cuts were noted on the PT. Pt stated that she wanted to go to the hospital and be seen because she did not like these thoughts.” A review of Patient #31’s medical record revealed that she presented to the hospital’s ED on 1/4/2023 at 7:06 a.m., via ambulance. The ED Notes dated 1/4/2023 at 7:15 a.m., documented the patient was in bed: ETR-21. At 7:16 a.m., the patient was admitted to the ED. Documentation by the ED RN revealed, “Arrival Complaint ...Suicidal thoughts lobby.” Continued review revealed that on 1/4/2023 at 7:17 a.m., “Chief Complaints Updated: Suicidal (Pt presents with suicidal thoughts since last night. Pt denies having a plan. Pt has history of SI and depression does not take meds.)” The patient was triaged by the RN as an ESI acuity 2 (Emergent- requires immediate nursing and rapid treatment). Review of the Flowsheets (ED Patient Care Timeline), dated 1/4/2023 at 7:17 a.m., revealed the patient’s heart rate was 112 and elevated. On 1/4/2023 at 7:18 a.m., the ED RN communicated to the ED MD the following verbal orders with readback mode for Patient #31: Assess and document suicide risk screening; Assess and document social history to include ETOH (alcohol) and drug use; Ensure patient is placed in a safe environment/room; Assess and Document Home Medications; Notify physician immediately of patient’s arrival; Blood glucose POCT (Point of Care Testing); Lab - Acetaminophen level; CBC auto differential; Comprehensive metabolic panel; Ethanol level; Salicylate level (test that measures salicylates in the blood ); Pregnancy, urine; Urinalysis complete with reflex culture; Drug Screen Urine, Qualitative Consult - IP (In Patient) consult to psych (Psychiatric) assessment team ... Question: Reason for Consult? Answer: suicidal. The following abnormal laboratory tests for Patient #31 were completed and results were: Ethanol level: 248 mg/dL high (hospital reference range: 0-10 mg/dL); Potassium: 3.0, which is low (hospital reference range: 3.5-5.1 mmol/L); Chloride: 108, which is high (hospital reference range: 98-107 mmol/L); Glucose: 66, which is low (hospital reference range: 74-100 mg/dL); and BUN (Blood Urea Nitrogen)/Creatine: 9, which is low (hospital reference range: 12- 20). Review of the ED Notes, dated 1/4/2023 at 11:05 a.m., documented “Called for room assignment no answer. Will call again.” A note at 11:34 a.m. stated: “Patient called for room assignment, did not answer. Used intercom and physically checked waiting areas. Will attempt to call patient at phone number listed. No answer on phone number listed.” Review of the flowsheets, dated 1/4/2023 at 12:02 p.m., documentation by the ED RN, revealed: ED LWBS (left without being seen) and Patient Discharged. The hospital failed to provide an appropriate medical screening examination to determine if an emergency medical condition existed after assessing Patient #31, with suicidal thoughts and an elevated alcohol level that potentially impairs a person’s judgement; implement physician orders to assess the patient and document suicide risk screening; ensure patient is placed in a safe environment/room; ensure that their policies and procedures were followed as evidenced by failing to notify the Charge Nurse, Floor Coordinator, Law Enforcement, and public safety that Patient #31, who presented to the hospital’s ED medically compromised (tachycardic pulse of 112, and elevated alcohol level) with behavioral health issues, and without decision making capabilities due to suicidal ideations left the hospital’s ED without being seen by a physician and was missing and failed to assess/reassess the patient on 1/4/2023 between 7:06 a.m. to 12:02 p.m. prior to the patient being discharged. These failures contributed to the patient not receiving an appropriate MSE to determine that an emergency medical condition exist. 7. On 10/1/24 at 9:50 am., a telephone interview was conducted with ED Physician’s Assistant (PA) PP. She said when assigned the screening shift, she would sit at the computer station in the triage area between 1-2 triage nurses. She said the nurses would lead with the questions and she would ask clarifying questions as needed. She would do a brief examination and order additional testing if applicable. If the patient’s signs and symptoms called for the need to be roomed immediately, she would call the charge RN to see if the patient could be placed in a room. She said this would be dependent on the patient’s physical look and vital signs. PA PP went on to say that there was no MD oversight while in triage unless you went directly to the physician and that triage was self-driven by the mid-level. She further explained that she typically would not see the patient again after they were triaged and that there were reassessment nurses who retake vital signs and reviewed lab results for patients in the waiting room. 8. An interview was conducted, on 10/1/2024 at 10:48 a.m., in the facility’s conference room with ED Nursing Director (Dir.) TT. Dir. TT explained that the triage nurse is an individual who generally has one year of experience or more as a Registered Nurse (RN). Dir. TT explained that all nurses in this role receive training in the triage process and Emergency Severity Index (ESI) levels. Dir. TT explained that during the triage process, there is generally a mid-level provider, i.e., Physician’s Assistant (PA) or Nurse Practitioner (NP), also at the screening station. Dir. TT explained that the ESI score is based on the triage nurses’ patient assessment. A patient with an ESI of 3 is a patient that generally needs three (3) or more resources, i.e., radiology, laboratory, and a procedure. A patient with an ESI 2 is typically a patient who presents with severe pain or abnormal vital signs.”