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Based on the review of clinical records, policies and procedures, hospital documents, medical records, observations, and staff interviews, it was determined that the Governing Body failed to ensure that the hospital operations and hospital functions provide a safe environment for the patient population. This Condition Level deficiency is the result of the Condition Level found under the Conditions of Medical Staff, Nursing Services, and Emergency Services as evidenced by:

Cross-reference: A-0049: The Governing Body failed to ensure Emergency Department Medical Providers provided proper care and interventions to one patient (Patient #1) who was admitted for a suicide attempt and intentional overdose and subsequently died in their care.

Cross-reference: A-0353: The Hospital failed to ensure that the Medical Staff followed the policies and procedures governing:
1. Order proper interventions for three (3) out of five (5) patients presenting to the ED with suicide attempts and intentional overdoses (Patients #1, #3, #6)
2. patient documentation with the end of shift sign-off for one patient (Patient #1)

Cross-reference: A-0392: The Hospital failed to ensure there were sufficient numbers of nursing personnel to provide care to one patient (Patient #1).

Cross-reference: A-0398: The Hospital failed to ensure that nursing personnel followed established policies and procedures when providing care to two (2) patients in the ED admitted for suicidal attempts and intentional overdose (Patients #1, #3).

Cross-reference: A-1104: The hospital failed to ensure that Emergency Department Medical Staff and Nursing Staff followed established policies and procedures when providing care to patients with suicidal intent and intentional overdose.

Cross-reference: A-1110: The hospital failed to ensure the Emergency Department had adequate and sufficient medical staff and nursing personnel in the Emergency Department.

The cumulative effect of these systemic deficient practices resulted in the facility's failure to meet the requirement for the Condition of Participation for Governing Body.

Based on review on review of policies and procedures, hospital documents, medical records, and staff interviews, it was determined the hospital failed to ensure Emergency Department Medical Providers provided proper care and interventions to one patient (Patient #1) who was admitted for suicide attempt and intentional overdose who subsequently died in their care.

Cross-reference to: A-0353, A-1104, A-1110

Findings include:

Policy titled, "Professional Staff Bylaws", revealed: "...The Professional Staff is also responsible for ensuring the following: 1. All individuals receive appropriate quality care without regard to gender, race, color, creed, sexual preference, religion, national origin, marital status, disability, existence of advanced directives, payor source or any other prohibited reason...."

Policy titled, "Professional Staff Rules and Regulations", revealed: "...Every patient is under the care of a doctor of medicine or osteopathy. All diagnostic and treatment services of the hospital shall be under the direction of a professional staff member...Members of the Professional Staff admitting and attending patients shall be held responsible for getting as much information as may be necessary to assure the protection of the patient from self-harm and to ensure the safety of other patients in the hospital...Each member of the Professional Staff is required to provide or arrange for the provision of appropriate and continuous care of his/her patients at all times...Each member also agrees to provide appropriate and necessary emergency and non-emergency medical treatment within the scope of his/her documented privileges to any patient seeking such treatment...The attending/admitting practitioner shall be responsible for the preparation of complete and legible medical record for each patient she/he admits to the Hospital...The Practitioners following the patient's care are responsible for updating the progress notes on a daily basis so that documentation accurately reflects the current information and care provided...Emergency Department records on all patients seen will be completed before the practitioner ends his/her shift...Emergency Services: The Professional Staff shall adopt a method of providing medical coverage in the emergency services area...."

Policy titled, "Triage, Assessment and Re-Assessment", revealed: "...Emergency Severity Index...Acuity Level: refers to a number assignment given to the patient based on triage assessment that determines patient priority. The Emergency Severity Index (ESI) system of five-levels is used to describe the level of urgency as well as the level of resources needed...ESI LEVEL 1: Immediately place into a patient room...REASSESSMENT: refers to patients' who have been previously assessed and will received scheduled reassessments while in waiting areas or treatment areas based on chief complaint, presenting signs and symptoms, pain level and interventions initiated according to guidelines...ESI Level 1: Critically ill with life threatening condition. No wait patient...."

The policy did not define or outline the frequency of reassessment after initial assessment for ESI Level 1 or 2 patients. The policy outlined reassessments for ESI Level 3 patients every 4 hours and ESI Level 4 patients every 8 hours.

Policy titled, "Constant Observer for Patients Under Harm Precautions", revealed: "...Facilities will used Competent Constant Observers (CCOs) to provide continuous observation of a patient under suicide/self-harm and harm to other precautions to support safety...If the patient is suicidal/at risk of self-harm, the Facility should assign a CCO immediately...Initiation of CCO...After completing a medical screening exam, the level of constant observation is ordered by the QMP or QMHP...The nurse assigned to the patient remains responsible for the nursing care throughout the shift regardless of the presence of a CCO...The nurse assigned to the patient will document the assessments and observations relative to the continued need for CCO use per unit assessment frequency protocols, and report findings to the Clinical Coordinator (or comparable role), who will relay the information to the House Supervisor (or comparable role)...."

Hospital document titled, "ED Activity Log dated 08/12/2022, revealed Patient #1 was triaged as an ESI Level 1.

Hospital document for the ED titled, "Charting Guidelines", revealed: "...Vital Signs must be documents (sic) every 2 hours unless patient status requires more frequent documentation...Reassessment should be completed and documented on every patient every 2 hours...Rounding must be documented hourly; please address pain, position, and potty needs...."

Hospital document titled, "ED-Environment Patient Safety Checklist" requires: "...Inform patient of the level of observation/self-harm precautions and associated restrictions. Provide patient green paper scrubs...Inspect patient belongings, initiate Patient Belongings Record: remove potentially harmful objects or contraband from patient and environment. This includes: patient medications, glass or sharp items, toiletry items containing alcohol, matches or lighter, aerosol spray cans, curling iron, hair dryer, razor, belts, straps, ties, shoe laces, dental floss and jewelry, and cell phones...Checklist must be completed on initial assessment and every shift..."

Patient #1's medical record dated 08/12/2022 contained the following documentation:

1343 EMS assessment, "...Pt in A-Fib on the monitor, and hypertensive...."

The cardiac monitor strip dated 08/12/2022 at 1418 revealed: "...Atrial fibrillation with rapid ventricular response abnormal rhythm ECG...."
1426 Admitting vitals to ED, "...Patient unresponsive upon EMS arrival, HR 104, RR 14, BP 139/94, Temp 98.3 F, cardiac rhythm-regular, respirations shallow...."

Patient #1 medical record ED Provider #4 note dated 08/12/2022 at 1930 revealed: "...PT{sic} BIBA (brought in by ambulance) for intentional OD (overdose) on approx {sic} 10-15 fentanyl pills. PT {sic} unresponsive upon EMS arrival. 8 mg of nasal narcan given. This 50 year old [male] presents after having a fentanyl overdose. [He] states that [h]e took 10-15 loose fentanyl pills because [he] did not want to live anymore and [he] has been so depressed. [He] says [he] does not usually use fentanyl, [he] got them from a friend who did know that [he] took them. [He] does use methamphetamines occasionally but did not use any today. After the intentional fentanyl overdose [he] apparently was unconscious and having difficulty breathing and [his] friends called 911. EMS found the patient to be in respiratory distress and unresponsive and they gave [him] a total of 8 mg of Narcan intranasally. On arrival [he] is awake but somewhat lethargic and able to answer questions and still voicing suicidal thoughts...Vital signs: temperature 98.3 degrees taken at 1426, remainder of vitals at 1800: heart rate 110 beats per minute, blood pressure 126/111, respiratory rate 16, oxygen saturation 96% nasal cannula oxygen...Neurological: oriented X4, LOC (level of consciousness) appropriate for age, CN II-XII intact, motor strength equal and normal bilaterally, sensation equal and normal bilaterally, speech normal...Psychiatric: cooperative, affect appropriate for age, normal judgement, normal psychiatric thoughts...Medical Decision Making: This 50 year old [male] took an intentional overdose of fentanyl prior to arrival. [He] required 8 mg of Narcan to revive [him] after being found unconscious and with agonal respirations (gasping for air when not getting enough oxygen). On arrival [he] is awake and able to answer simple questions. We have maintained [him] on oxygen and IV fluid and allowed [him] to recover from [his] opiate overdose without any further narcan. [He] has been watched for 6 hours. [He] is medically clear for psychiatric evaluation of [his] suicide attempt...Blood sugar 171, BUN 24, the rest of [his] labs are normal. No evidence of co-ingestants, acetaminophen and salicylates levels are negative and alcohol is nondetected...Impression: Intentional opiate overdose, Suicide attempt...consultation: Psychiatric assessment team...Disposition: per psychiatric assessment team...."

Patient #1's medical record dated 08/12/2022 revealed orders for labs, psychiatric assessment, IV fluid, and assessment were given. Further review of the [medical provider] orders revealed no evidence of an order for oxygen being placed.

Patient #1's medical record dated 08/12/2022 revealed the only toxicology tests performed were for acetaminophen, salicylate, and alcohol.

Further review of the [medical provider] orders revealed no evidence of suicide precautions being initiated upon Patient #1 arrival to the ED. Further review of the [medical provider] orders revealed an order was placed almost 8 hours after Patient #1 arrival for a Constant Observer dated 08/12/2022 at 1900.

Patient #1's medical record dated 08/12/2022 revealed the ED [physician] ordered a consult with the Psychiatric Assessment Team at 1931.

Patient #1's Psychiatric Assessment Team note dated 08/12/2022 at 2149 revealed: "...After the intentional fentanyl overdose [he] apparently was unconscious and having difficulty breathing and [his] friends called 911. EMS found the patient to be in respiratory distress and unresponsive and they gave [him] a total of 8 mg of Narcan intranasally. On arrival [he] is awake but somewhat lethargic and able to answer questions and still voicing suicidal thoughts...patient appeared sedated, with slurred speech and a lethargic affect...."

Further review of Patient #1 medical record revealed no other medical provider note or assessment was written after the 08/12/2022 1930 entry by Provider #4.

A [medical provider] note was written on 08/13/2022 at 0529 by Provider #6 which revealed: "...This is a patient received in sign out from Provider #5. [He] was originally seen by Provider #4. 50 year old [male] with suicidal thoughts and intentional overdose on 10-15 fentanyl pills. [He] was found unresponsive by friends and family members and required 8 mg of Narcan to revive [him]. On arrival here, [he] was talking and protecting [his] airway. [He] was observed on the monitor for just over 6 hours and deemed medically clear. [He] was awaiting transfer for inpatient psychiatric admission. [He] had a sitter since [he] was still actively suicidal. [His] last definite normal time was at 0230. The sitter told me that the initial sitter said that [he] had been up to use the bathroom. The current sitter looked in on [him] several times and [he] appeared to be sleeping. [She] went in for a closer look to be sure [he] was okay around 0500 and found [him] pulseless and apneic (not breathing). CODE BLUE was called. CPR was initiated. [He] was vomiting and this was suctioned. [He] oxygenated with a BVM (bag-valve-mask). [He] received 4 A (ampules) of epinephrine, 1 amp (ampule) of bicarb, and 2 mg of narcan. Every pulse check revealed aystole (no heart rhythm). [His] fingerstick was 198. Time of death was called at 0517. The patient had been stripped down to his boxer shorts prior to being moved back into room 29. It seems unlikely that he would have had extra fentanyl on him. It is possible that hi] fentanyl overdose outlast the Narcan, but less likely since [he] had already been here for about 10 hours. There was no PCP or contact information for family listed on [his] face sheet...."

An addendum note was written by Provider #6 on 08/13/2022 at 0831 which revealed: "...The patient's [wife] called for an update on [him] around 0615 am. I spoke to [her] on the phone and explained what had happened, expressing to [her] several times how sorry I was. [She] arrived here to the hospital about an hour later. I spoke to [her] again, explaining the events that occurred with me, and the proper events to the best of my knowledge and assuring her that everything would be thoroughly looked into. I again expressed my condolences...."

A review of the medical record revealed the following vital signs for Patient #1:

08/12/2022 1426 Patient unresponsive upon EMS arrival, HR 104, RR 14, BP 139/94, Temp 98.3 F, cardiac rhythm-regular, respirations shallow
08/12/2022 1502 HR 102, RR 10, BP 141/94, cardiac rhythm-sinus tachycardia
08/12/2022 1516 HR 102, RR 9, respiratory reassessment-no changes from previous assessment
08/12/2022 1600 HR 103, RR 7, BP 120/86, cardiac rhythm-sinus tachycardia
08/12/2022 1800 HR 110, RR 16, BP 126/111, heart rhythm-irregular, level of consciousness-sleeping
08/12/2022 1900 HR 103, RR 16, BP 131/112, cardiovascular reassessment-no changes from previous assessment, respiratory reassessment-no changes from previous assessment
08/12/2022 2000 HR 104, RR 14, BP 129/101
08/12/2022 2100 HR 105, RR 15, BP 110/82
08/13/2022 0000 HR 103, BP 107/86, cardiovascular reassessment-no changes from previous assessment, respiratory reassessment-no changes from previous assessment

Patient #1's medical record did not contain documentation of notification of elevated diastolic blood pressure, tachycardia, abnormal rhythm, decreased respirations, and no improvement in cardiac and respiratory status to the provider. Additionally, no interventions were implemented in response to abnormal vital signs.

Further review of the medical record revealed Patient #1 was moved from Room 4 a monitored bed to an unmonitored Room 29 on 08/12/2022 at 2200.

Review of the medical record revealed no order was placed to move Patient #1 from a monitored bed to an unmonitored bed.

Review of the medical record revealed Constant Observer Flowsheet for Patient #1 dated 08/12/2022 revealed: "...Section Two: Completed by the Constant Observer-Observation is continuous, with real time 15 minute documentation to include ACTIVITY, BEHAVIOR, LOCATION CODE(S) and INITIALS...."

Policies and standing order sets for patients who present to the ED with an opioid overdose was requested. A general order set for "Overdose" was provided. The order set was not specific to any particular type of overdose and contained orders for ED cardiac monitoring, laboratory, and urine studies only. A second order set for "ED Behavioral Health" was provided that included orders to call the physician for changes in medical conditions and every four-hour updates, Maalox, labs, and psychiatric assessment. Neither order set was ordered by the ED provider for Patient #1. The facility did not provide any policies or protocols for treatment of patients who present to the ED for treatment of an opioid overdose. A policy on opioid prescribing was provided which outlined limitations for prescribing opioids to ED patients.

Review of the facility Root Cause Analysis revealed an interview was conducted on 09/01/2022 with Provider #4 which revealed: "...Pt{sic} endorsed taking 10-15 blue pills, fentanyl, given Narcan prior to arrival, was groggy, alert, said doesn't take opiates; usual labs. Poison Control usually says 6 hours, told pt{sic} this. Re-eval 1920-1930 talk w/pt{sic}, he fell back asleep...PAT (Psychiatric Assessment Team) Eval ordered, talked w/PAT Evaluator, pt{sic} too groggy still, PAT had same experience, leave [him] there a couple more hours. Turned pt{sic} to Provider #5, talked w/[RN] that PAT will return in a couple of hours. Pt{sic} in ED Room 4...I didn't put in Annex orders since we didn't have the BH Annex (has been closed for staffing related reasons). I did not authorize pt{sic} to be moved to another room. I was supposed to leave at 1900, I left work at 2145, pt{sic} was still on monitor...."

Review of the Root Cause Analysis revealed an interview was conducted with Provider #5 on 09/01/2022 which revealed: "...Was a '4 Doctor Day' incredibly busy. I overheard Provider #4 and PAT evaluator talk about needing whole PAT Evaluation. I was never asked to move the pt{sic}, didn't realize pt {sic} was moved, I did not see or evaluate the patient...The pt {sic} is never moved without Annex orders. "Medically cleared" means okay for PAT evaluation. With Annex closed, pts{sic} are scattered in the ED...."

Review of the Root Cause Analysis revealed an interview with Provider #6 was conducted on 09/01/2022 which revealed: "...At 2300 shift sign out to me. We see patients like this all the time who are waiting PAT evaluation...I discussed with the [Nightshift RN] when pt{sic} was moved. Pt{sic} was in boxer shorts, not green scrubs. About 0230 Sitter change. Sitter #1 had talked w/pt {sic}. I had no way to call family, when [wife] called to check on [him], I had to tell [her] that [he] had passed. '4 Doctor Day' means were were down a doctor, we usually have 5 doctors. I stayed after my shift 4 hours, I had a critical pt{sic} in the waiting room and another with a dislocated shoulder, delayed 2 hours...."

Root Cause Analysis interview conducted with Provider #2 on 09/01/2022 revealed: "...Prior to Annex closure, we had a process, need to fine tune terminology 'medical clearance.' PAT Evaluators are really partnering w/these overdose pts{sic} throughout their ED stay. This pt{sic} was still on O2, not ready to come out of Room 4(a monitored room). We are not searching body cavities. Need to bring our Best Practices from Annex to ER, put in an order for BH Annex monitoring, every time the same way wherever the pt{sic} goes...."

Review of the Patient Safety and Quality (PSQ)Committee Minutes dated 10/20/2022 revealed: "...Unexpected death: ER behavioral patient under constant observation every 15 minutes found pulseless, apneic, code arrest, passed away...Actions: Evaluate pertinent orders, documents, training and processes...."

Review of the Department of Emergency Medicine Meeting Minutes dated 11/11/2022 revealed: "...Quality Report: ...Had Sentinel event in ED with unexpected death. Behavioral health patient under constant observation every 15 minutes found pulseless, apneic, code arrest, passed away. Root cause analysis done and evaluating pertinent orders, documents, training, and processes...."

Review of the facility Sentinel Event Log revealed no evidence of Patient #1 unanticipated death being reported.

The "Department of Health and Human Services, Substance Abuse and Mental Health Services Administration (SAMHSA), Opioid Overdose Prevention Toolkit" revealed: "...STEP 3: ADMINISTER NALOXONE...Naloxone should be administered to anyone who presents with signs of opioid overdose...All naloxone products are effective in reversing opioid overdose, including fentanyl-involved opioid overdose, although overdoses involving potent (e.g., fentanyl) or large quantities of opioids may require more doses of naloxone...DURATION OF EFFECT. The duration of effect of naloxone depends on dose, route of administration, and overdose symptoms and is shorter than the effects of some opioids...More than one dose of naloxone may be needed...People who have taken longer acting or more potent opioids may require additional intravenous bolus doses or an infusion of naloxone...FENTANYL-INVOLVED OVERDOSES. Suspected opioid overdoses, including suspected fentanyl-involved overdoses, should be treated according to standard protocols...STEP 5: MONITOR THE PERSON'S RESPONSE...All people should be monitored for recurrence of signs and symptoms of opioid toxicity for at least 4 hours from the last dose of naloxone or discontinuation of the naloxone infusion. People who have overdosed on long-acting opioids should have more prolonged monitoring...Because naloxone has a relatively short duration of effect, overdose symptoms may return...."

The "Medical Examiner Report" dated 08/16/2022 for Patient #1 revealed: "...OPINION...In consideration of the known circumstances surrounding this death, the available medical history, and the examination of the remains, the cause of death is intoxication by the combined effects of fentanyl and methamphetamine. The manner of death is suicide...."

Employee #5 confirmed during an interview conducted on 12/28/2022 that Narcan is a short acting drug and should be repeated every 20-60 minutes with emergence of symptoms such as lethargy, somnolence, difficulty in arousal, unconscious, unresponsiveness. Employee #5 confirmed that if a patient is requiring multiple doses of narcan to keep symptoms under control, an IV drip of narcan should be initiated. Employee #5 confirmed that the effects of the narcan used with Patient #1 would have been expected to have worn off within 2 hours of the patient's arrival to the ED. Employee #5 confirmed the peak time for fentanyl is 20-240 minutes, half-life of large doses of fentanyl can be up to 12 hours. Employee #5 stated that since the effect of narcan is relatively short, repeat doses are typically administered within 20-60 minutes of the first effective dose, assuming the patient has a re-emergence of symptoms and requires additional doses.

Provider #1 confirmed during an interview conducted on 12/28/2022 that the half-life of narcan is 2 hours. Provider #1 confirmed the ED does not have a specific protocol for fentanyl overdoses but most providers treat and watch patients for 6 hours and then discharge from the ED if no complications. Provider #1 stated the ED does not do fentanyl levels as a routine as that type of lab is sent out and takes up to a week to get a result. Provider #1 confirmed that the usual treatment for a opioid overdose that has received narcan in the field by EMS prior to arrival is to monitor and let the drug wear off on its own, and watch the patient up to 6 hours. Provider #1 stated if the patient requires additional narcan in the ED, then the 6 hour timeframe is reset to the time of the last dose of narcan. Provider #1 stated the ED physicians prefer to let the patient wake up on their own and let the drug wear off naturally. Provider #1 stated a progress note should be written at every provider hand-off. Provider #1 stated assessments on patients should be done at least every 8 hours if the patient is stable and more frequently if patient is unstable or staff report an issue with the patient. Provider #1 stated patients should be awake and alert at the 12 hour mark after narcan and fentanyl, unless the patient has taken additional drugs or something else in conjunction with the original fentanyl ingestion. Provider #1 confirmed that abnormal vital signs include: oxygen saturation less than 90%, systolic blood pressure greater than 160, diastolic blood pressure greater than 90, heart rate greater than 100, and temperature greater than 100.

Employee #1 confirmed during an interview conducted on 12/28/2022 that the medical providers were short staffed one physician on 08/12/2022 during the time Patient #1 was in the ED. Employee #1 confirmed that the medical record revealed no [medical provider] reassessments were done after 1930 on 08/12/2022. Employee #1 confirmed that there were no physician orders placed for continued assessment for signs/symptoms of fentanyl overdose as required at a minimum of every 2 hours, immediately ordering a constant observer and suicide precautions, or order additional doses of narcan. Employee #1 confirmed that an order to administer oxygen is required and that staff administered oxygen without an order for Patient #1. Employee #1 confirmed that a constant observer as not initiated with Patient #1 at time of admission for a suicide attempt and that the medical record did not contain documentation of suicide precautions implemented until almost eight hours after the patient was admitted. Employee #1 confirmed that the facility does not have standard protocols, policy and procedure, and order sets for treating individuals who present to the ED with an opioid overdose. Employee #1 confirmed that Patient #1 unanticipated death had not been reviewed at the medical staff meeting as of 12/28/2022 and that the case was to go to Peer Review sometime in January, 2023.

Patient #1 was admitted to the ED on 08/12/2022 at 1426 following a suicide attempt and intentional overdose of fentanyl and was brought in by EMS after receiving 8 mg of narcan in the field prior to admission. Medical providers did an intial assessment at time of arrival to the ED, Patient #1 was given an ESI score of 1 indicating a critically ill patient. Medical staff did not re-evaluate Patient #1 until 1930. No other medical provider assessment was evident in the medical record until the patient was found unresponsive and in asystole at approximately 0500 on 08/13/2022 when a CODE BLUE was called and the patient was pronounced dead at 0517. Medical staff did not order suicide precautions or constant observer for Patient #1 until 1930 on 08/12/2022. Medical staff did not reassess the patient for re-emergence of fentanyl overdose symptoms despite numerous healthcare professionals documented in the medical record the patient remained drowsy, sleepy, slurring words for most of the 15 hours the patient was in the ED. [Medical providers] did not address or prescribe interventions to treat Patient #1 abnormal vital signs, abnormal cardiac rhythm of atrial fibrillation, or continued decreased level of consciousness. [Medical providers] did not initiate standing order sets for Overdose and ED Behavioral Health for Patient #1 at time of admission.

Based on the review of clinical records, policies and procedures, hospital documents, medical records, observations, and staff interviews, it was determined that the Medical Staff failed to provide quality patient care as stated in the by-laws as evidenced by:

Cross-reference: A-0049: Emergency Department (ED) physicians did not provide proper care and interventions when treating a patient that was admitted for a suicide attempt and an intentional overdose that subsequently died in their care.

Cross-reference: A-0353: Medical Staff did not comply with the medical staff bylaws and rules & regulations with
1. Order proper interventions for three (3) patients out of five (5) presenting to the ED with suicide attempts and intentional overdoses.(Patients #1,#3, #6)
2. patient documentation with the end of shift sign off for one patient (Patient #1)

Cross-reference: A-1104: Medical Staff failed to follow established ED policies and procedures when providing care to ED patients.

Cross-reference: A-1110: The hospital failed to ensure there were adequate and sufficient medical staff and nursing personnel on duty in the ED.

The cumulative effect of these systemic deficient practices resulted in the hospital's failure to meet the requirements for the Condition of Participation for Medical Staff.

Based on the review of policies and procedures, hospital documents, medical records, and staff interviews, it was determined the hospital failed to ensure Medical Staff followed the policies and procedures governing:
1. ordering proper interventions for three (3) patients out of five (5) presenting to the ED with suicide attempts and intentional overdoses.(Patients #1,#3, #6)
2. patient documentation with end of shift sign off for one patient (Patient #1)

Cross reference to: A-0049, 1104

Findings include:

Policy titled, "Professional Staff Rules and Regulations", revealed: "...Every patient is under the care of a doctor of medicine or osteopathy. All diagnostic and treatment services of the hospital shall be under the direction of a professional staff member...Members of the Professional Staff admitting and attending patients shall be held responsible for getting as much information as may be necessary to assure the protection of the patient from self-harm and to ensure the safety of other patients in the hospital...Each member of the Professional Staff is required to provide or arrange for the provision of appropriate and continuous care of his/her patients at all times...Each member also agrees to provide appropriate and necessary emergency and non-emergency medical treatment within the scope of his/her documented privileges to any patient seeking such treatment...The attending/admitting practitioner shall be responsible for the preparation of complete and legible medical record for each patient [she/he] admits to the Hospital...The Practitioners following the patient's care are responsible for updating the progress notes on a daily basis so that documentation accurately reflects the current information and care provided...Emergency Department records on all patients seen will be completed before the practitioner ends his/her shift...Emergency Services: The Professional Staff shall adopt a method of providing medical coverage in the emergency services area...."

Policy titled, "Triage, Assessment and Re-Assessment", revealed: "...Emergency Severity Index...Acuity Level: refers to a number assignment given to the patient based on triage assessment that determines patient priority. The Emergency Severity Index (ESI) system of five-levels is used to describe the level of urgency as well as the level of resources needed...ESI LEVEL 1: Immediately place into a patient room...REASSESSMENT: refers to patients' who have been previously assessed and will received scheduled reassessments while in waiting areas or treatment areas based on chief complaint, presenting signs and symptoms, pain level and interventions initiated according to guidelines...ESI Level 1: Critically ill with life threatening condition. No wait patient...."

The policy did not define or outline the frequency of reassessment after initial assessment for ESI Level 1 or 2 patients. The policy outlined reassessments for ESI Level 3 patients every 4 hours and ESI Level 4 patients every 8 hours.

Policy titled, "Constant Observer for Patients Under Harm Precautions", revealed: "...Facilities will used Competent Constant Observers (CCOs) to provide continuous observation of a patient under suicide/self-harm and harm to other precautions to support safety...If the patient is suicidal/at risk of self-harm, the Facility should assign a CCO immediately...Initiation of CCO...After completing a medical screening exam, the level of constant observation is ordered by the QMP or QMHP...The [nurse] assigned to the patient remains responsible for the nursing care throughout the shift regardless of the presence of a CCO...The [nurse] assigned to the patient will document the assessments and observations relative to the continued need for CCO use per unit assessment frequency protocols, and report findings to the Clinical Coordinator (or comparable role), who will relay the information to the House Supervisor (or comparable role)...."

1.
Patient #3 presented to the ED with a suicide attempt with cutting of wrists. Review of Patient #3 medical record revealed that no Suicide Precautions were ordered at time of admission.

Patient #6 presented to the ED with a suicide attempt with intentional overdose. Review of Patient #6 medical record revealed that no Suicide Precautions were ordered at time of admission and no constant observer was ordered during admission.

Employee #4 confirmed during an interview on 12/28/2022 that all patients with suicide attempts should have suicide precautions ordered by the medical provider at time of admission as well as constant observer orders.

Patient #1 presented to the ED with a suicide attempt with intentional overdose and subsequently died 15 hours later while in the ED. Review of Patient #1 medical record revealed patient had taken 10-15 fentanyl pills with an intent to die. Patient #1 was brought in by EMS to the ED after receiving 8 mg of naloxone in the field prior to admission. Upon arrival to the ED, Patient #1 ECG revealed atrial fibrillation with rapid ventricular response (abnormal rhythm ECG). Admitting vitals revealed a temperature of 98.3 F, Blood pressure of 139/94, Heart rate of 104, Respiratory rate of 14, oxygen saturation 96% on oxygen. Further review of vital signs from 1500 on 08/12/2022 to 0000 on 08/13/2022 for Patient #1 revealed abnormal blood ranging from 126/111 to 141/94, abnormal heart rate ranging from 103 to 110, and abnormal respiratory rates from 7 to 10.

Further review of Patient #1 medical record revealed a medical provider admission note by Provider #4 dated 08/12/2022 at 1930 documented vital signs were assessed by the provider at time of admission, 1426, and at 1800 on 08/12/2022.

Review of the medical provider orders for Patient #1 revealed orders for Suicide Precautions and Constant Observer were ordered at 1930 and not at the required time of admission.

Further review of the medical provider orders revealed no orders were written to address Patient #1 irregular heart rhythm, or abnormal vital signs. Further review revealed no orders were placed for the patient to receive oxygen.

Further review of the medical record revealed Patient #1 was not assessed or reassessed throughout the 15 hours the patient was in the ED for a re-emergence of symptoms of fentanyl overdose and a need for redosing of naloxone.

2.
Review of Patient #1 medical record revealed that Patient #1 was in the ED over 3 provider shift changes (Provider #4, #5, and #6). Review of the medical record revealed that there were no medical provider notes including assessment of Patient #1 for Provider #5 and Provider #6.

Provider #1 confirmed during an interview on 12/28/2022 that abnormal vital signs include: oxygen saturation less than 90%, systolic blood pressure greater than 160, diastolic blood pressure greater than 90, heart rate greater than 100, and temperature greater than 100. Provider #1 stated a progress note should be written at every provider hand-off. Provider #1 stated assessments on patients should be done at least every 8 hours if the patient is stable and more frequently if patient is unstable or staff report an issue with the patient.

Employee #1 confirmed during an interview on 12/28/2022 that the medical record revealed no medical provider reassessments were done after 1930 on 08/12/2022. Employee #1 confirmed that there were no [physician] orders placed for continued assessment for signs/symptoms of fentanyl overdose as required at a minimum of every 2 hours, immediately ordering a constant observer and suicide precautions, or order additional doses of narcan. Employee #1 confirmed that an order to administer oxygen is required and that staff administered oxygen without an order for Patient #1. Employee #1 confirmed that a constant observer as not initiated with Patient #1 at time of admission for a suicide attempt and that the medical record did not contain documentation of suicide precautions implemented until almost eight hours after the patient was admitted.

Based on review of policy and procedure, hospital documents, medical records, and staff interviews, it was determined that the hospital failed to:

A-0392: ensure there were sufficient numbers of [nursing] personnel to provide care to one patient (Patient #1).

A-0398: ensure that [nursing] personnel followed established policies and procedures when providing care to two (2) patients in the ED admitted for suicidal attempts and intentional overdose. (Patients #1, #3).

The cumulative effect of these systematic deficient practices resulted in the facility's failure to meet the requirement for Condition of Participation for Nursing Services, which poses a potential risk to the health and safety of patients by not ensuring there are sufficient number of qualified personnel to meet the needs of the patients and ensuring a safe environment for patients.

Based on review of policies and procedures, hospital documents, medical records and staff interviews, it was determined that the hospital failed to ensure there were sufficient numbers of nursing personnel to provide care to one patient (Patient #1).

Cross reference to: A-1110

Findings include:

Policy titled, "Constant Observer for Patients Under Harm Precautions", revealed: "...Facilities will used Competent Constant Observers (CCOs) to provide continuous observation of a patient under suicide/self-harm and harm to other precautions to support safety...If the patient is suicidal/at risk of self-harm, the Facility should assign a CCO immediately...Initiation of CCO...After completing a medical screening exam, the level of constant observation is ordered by the QMP or QMHP...The nurse assigned to the patient remains responsible for the nursing care throughout the shift regardless of the presence of a CCO...The nurse assigned to the patient will document the assessments and observations relative to the continued need for CCO use per unit assessment frequency protocols, and report findings to the Clinical Coordinator (or comparable role), who will relay the information to the House Supervisor (or comparable role)...."

Review of the medical record revealed Constant Observer Flowsheet for Patient #1 dated [08/12/2022] revealed: "...Section Two: Completed by the Constant Observer-Observation is continuous, with real time 15 minute documentation to include ACTIVITY, BEHAVIOR, LOCATION CODE(S) and INITIALS...."

Review of ED [Nursing] Staff Schedule/Assignment for 08/12/2022 revealed no documentation of assignments for [Constant Observer/Sitters].

Review of the Root Cause Analysis revealed an interview with Provider #6 was conducted on 09/01/2022 which revealed: "...About 0500, [Sitte]r in ED "Green Zone" ("pseudo-Annex") watching at least one other patient, they are looking like they are sleeping...."

Employee #1 confirmed on 12/28/2022 that the Constant Observer assigned to Patient #1 was also assigned one other patient at the same time as Patient #1.

Based on review of policies and procedures, hospital documents, medical records and staff interviews, it was determined the hospital failed to ensure that nursing personnel followed established policies and procedures when providing care to two (2) patients in the ED admitted for suicidal attempts and intentional overdose. (Patients #1, #3)

Cros-reference to: A-1110

Findings include:

Policy titled, "Triage, Assessment and Re-Assessment", revealed: "...Emergency Severity Index...Acuity Level: refers to a number assignment given to the patient based on triage assessment that determines patient priority. The Emergency Severity Index (ESI) system of five-levels is used to describe the level of urgency as well as the level of resources needed...ESI LEVEL 1: Immediately place into a patient room...REASSESSMENT: refers to patients' who have been previously assessed and will received scheduled reassessments while in waiting areas or treatment areas based on chief complaint, presenting signs and symptoms, pain level and interventions initiated according to guidelines...ESI Level 1: Critically ill with life threatening condition. No wait patient...."

The policy did not define or outline the frequency of reassessment after initial assessment for ESI Level 1 or 2 patients. The policy outlined reassessments for ESI Level 3 patients every 4 hours and ESI Level 4 patients every 8 hours.

The policy titled, "Patient Assessment and Plan of Care - St. Mary's Hospital", revealed: "...A Nursing assessment is the systematic collection and analysis of clinical data...The RN utilizes the assessment data to identify the patient's actual or potential health conditions and needs. The physiological assessment may include respiratory assessment, skin integrity, level of consciousness, neurological assessment, gastrointestinal, genitourinary, cardiovascular, musculoskeletal, reproductive (as applicable) vital signs (BP, HR, RR, and O2 Sat), and MEWS Score...Modified Early Warning System (MEWS)...MEWS is a tool that enables nurses to critically assess and monitor patients in order to ensure that the required level of clinical care is implemented expeditiously...Calculation of a MEWS score at this hospital is indicated by the patient's respiratory rate, heart rate, systolic blood pressure, level of consciousness, temperature, urine output and change in condition...Reassessment occurs at regular intervals during the patient ' s course of care and is conducted based on the patient's condition and response to care provided...Assessment and Re-assessment timing by unit...Emergency Department...For patients in the Emergency Center the Level of Care determines the patients assessment and reassessment needs...Plan of Care...Patients will receive individualized care based on the initial assessment, response to interventions, and ongoing evaluation...."

The policy did not define abnormal vital signs that were to be used for determining a patient's reassessment needs or MEWS score. The policy did not outline the reassessment needs for an ESI Level 1 patient.

Policy titled, "Constant Observer for Patients Under Harm Precautions", revealed: "...Facilities will used Competent Constant Observers (CCOs) to provide continuous observation of a patient under suicide/self-harm and harm to other precautions to support safety...If the patient is suicidal/at risk of self-harm, the Facility should assign a CCO immediately...Initiation of CCO...After completing a medical screening exam, the level of constant observation is ordered by the QMP or QMHP...The nurse assigned to the patient remains responsible for the nursing care throughout the shift regardless of the presence of a CCO...The nurse assigned to the patient will document the assessments and observations relative to the continued need for CCO use per unit assessment frequency protocols, and report findings to the Clinical Coordinator (or comparable role), who will relay the information to the House Supervisor (or comparable role)...."

Review of the medical record revealed [Constant Observer] Flowsheet for Patient #1 dated [08/12/2022] revealed: "...Section Two: Completed by the Constant Observer-Observation is continuous, with real time 15 minute documentation to include ACTIVITY, BEHAVIOR, LOCATION CODE(S) and INITIALS...."

Hospital document for the ED titled, "Charting Guidelines", revealed: "...Vital Signs must be documents (sic) every 2 hours unless patient status requires more frequent documentation...Reassessment should be completed and documented on every patient every 2 hours...Rounding must be documented hourly; please address pain, position, and potty needs...."

Hospital document titled, "ED-Environment Patient Safety Checklist" requires: "...Inform patient of the level of observation/self-harm precautions and associated restrictions. Provide patient green paper scrubs...Inspect patient belongings, initiate Patient Belongings Record: remove potentially harmful objects or contraband from patient and environment. This includes: patient medications, glass or sharp items, toiletry items containing alcohol, matches or lighter, aerosol spray cans, curling iron, hair dryer, razor, belts, straps, ties, shoe laces, dental floss and jewelry, and cell phones...Checklist must be completed on initial assessment and every shift..."

Patient #3 presented to the ED for suicidal attempt by cutting wrists. Review of the medical record revealed an ESI score of 3. Review of vital signs revealed vitals were recorded at time of admission at 0855 and at time of discharge at 1640. Review of policy revealed an ESI 3 requires vitals every 4 hours.

Patient #1 review of [nursing] flowsheet revealed vital signs were documented every 15 minutes for the first hour after admission and then every 1-2 hours until 08/13/2022 at 0000. No further vital signs or assessments were documented after 0000 on 08/13/2022.

Patient #1 medical record revealed abnormal vital signs recorded of blood pressures ranging from 126/111 to 141/94, heart rate from 102 to 110 and respiratory rate from 7 to 10 with no [nursing] documentation present that the medical provider was made aware of the abnormal vital signs.

Further review of the medical record revealed Patient #1 was administered oxygen and review of the medical provider orders revealed no oxygen order was present.

Review of the medical record revealed the ED-Environment Patient Safety Checklist was not initiated until 2200 on 08/12/2022 and not at time of admission at 1426.

Review of [nursing] note dated 08/13/2022 at 0643 revealed: "...This [RN] received {sic} PT{sic} at 2200 moved into a room as patient was cleared by pat evaluator for transferring to another facility and patient was medically cleared. [RN] moved patient to a psych room for constant observation as needed the monitored room for another patient and the patient was medically cleared on the monitor for 7 hours with no episodes of desaturation...."

Review of the medical record revealed there was no [medical provider] order to move patient from a monitored bed to an unmonitored bed.

Employee #1 confirmed on 12/28/2022 that [nursing] staff did not follow established policies and procedure when providing care for suicidal attempts and intentional overdose patients.

Based on review of policies and procedures, hospital documents, medical records, and staff interviews , it was determined the hospital failed to meet the emergency needs of patients within acceptable standards of practice as evidenced by:

A-1104: The hospital failed to ensure that Emergency Department Medical Staff and Nursing Staff followed established policies and procedures when providing care to patients with suicidal intent and intentional overdose.

A-1110: The hospital failed to ensure the Emergency Department had adequate and sufficient medical staff and nursing personnel in the Emergency Department.

The cumulative effects of these deficient practices resulted in the hospital failing to meet the condition of participation for emergency services.

Based on policies and procedures, hospital documents, medical records and staff interviews, it was determined that the hospital failed to ensure that Emergency Department Medical Staff and Nursing Staff followed established policies and procedures when providing care to patients with suicidal intent and intentional overdose.

Cross reference to: A-0353, A-0398

Findings include:

Policy titled, "Professional Staff Rules and Regulations", revealed: "...Every patient is under the care of a doctor of medicine or osteopathy. All diagnostic and treatment services of the hospital shall be under the direction of a professional staff member...Members of the Professional Staff admitting and attending patients shall be held responsible for getting as much information as may be necessary to assure the protection of the patient from self-harm and to ensure the safety of other patients in the hospital...Each member of the Professional Staff is required to provide or arrange for the provision of appropriate and continuous care of his/her patients at all times...Each member also agrees to provide appropriate and necessary emergency and non-emergency medical treatment within the scope of his/her documented privileges to any patient seeking such treatment...The attending/admitting practitioner shall be responsible for the preparation of complete and legible medical record for each patient she/he admits to the Hospital...The Practitioners following the patient's care are responsible for updating the progress notes on a daily basis so that documentation accurately reflects the current information and care provided...Emergency Department records on all patients seen will be completed before the practitioner ends his/her shift...Emergency Services: The Professional Staff shall adopt a method of providing medical coverage in the emergency services area...."

Policy titled, "Triage, Assessment and Re-Assessment", revealed: "...Emergency Severity Index...Acuity Level: refers to a number assignment given to the patient based on triage assessment that determines patient priority. The Emergency Severity Index (ESI) system of five-levels is used to describe the level of urgency as well as the level of resources needed...ESI LEVEL 1: Immediately place into a patient room...REASSESSMENT: refers to patients' who have been previously assessed and will received scheduled reassessments while in waiting areas or treatment areas based on chief complaint, presenting signs and symptoms, pain level and interventions initiated according to guidelines...ESI Level 1: Critically ill with life threatening condition. No wait patient...."

The policy did not define or outline the frequency of reassessment after initial assessment for ESI Level 1 or 2 patients. The policy outlined reassessments for ESI Level 3 patients every 4 hours and ESI Level 4 patients every 8 hours.

The policy titled, "Patient Assessment and Plan of Care - St. Mary's Hospital", revealed: "...A Nursing assessment is the systematic collection and analysis of clinical data...The RN utilizes the assessment data to identify the patient's actual or potential health conditions and needs. The physiological assessment may include respiratory assessment, skin integrity, level of consciousness, neurological assessment, gastrointestinal, genitourinary, cardiovascular, musculoskeletal, reproductive (as applicable) vital signs (BP, HR, RR, and O2 Sat), and MEWS Score...Modified Early Warning System (MEWS)...MEWS is a tool that enables nurses to critically assess and monitor patients in order to ensure that the required level of clinical care is implemented expeditiously...Calculation of a MEWS score at this hospital is indicated by the patient's respiratory rate, heart rate, systolic blood pressure, level of consciousness, temperature, urine output and change in condition...Reassessment occurs at regular intervals during the patient ' s course of care and is conducted based on the patient's condition and response to care provided...Assessment and Re-assessment timing by unit...Emergency Department...For patients in the Emergency Center the Level of Care determines the patients assessment and reassessment needs...Plan of Care...Patients will receive individualized care based on the initial assessment, response to interventions, and ongoing evaluation...."

The policy did not define abnormal vital signs that were to be used for determining a patient's reassessment needs or MEWS score. The policy did not outline the reassessment needs for an ESI Level 1 patient.

Policy titled, "Constant Observer for Patients Under Harm Precautions", revealed: "...Facilities will used Competent Constant Observers (CCOs) to provide continuous observation of a patient under suicide/self-harm and harm to other precautions to support safety...If the patient is suicidal/at risk of self-harm, the Facility should assign a CCO immediately...Initiation of CCO...After completing a medical screening exam, the level of constant observation is ordered by the QMP or QMHP...The nurse assigned to the patient remains responsible for the nursing care throughout the shift regardless of the presence of a CCO...The nurse assigned to the patient will document the assessments and observations relative to the continued need for CCO use per unit assessment frequency protocols, and report findings to the Clinical Coordinator (or comparable role), who will relay the information to the House Supervisor (or comparable role)...."

Review of the medical record revealed [Constant Observer] Flowsheet for Patient #1 dated [08/12/2022] revealed: "...Section Two: Completed by the [Constant Observer-Observation] is continuous, with real time 15 minute documentation to include ACTIVITY, BEHAVIOR, LOCATION CODE(S) and INITIALS...."

Policies and standing order sets for patients who present to the ED with an opioid overdose was requested. A general order set for "Overdose" was provided. The order set was not specific to any particular type of overdose and contained orders for ED cardiac monitoring, laboratory, and urine studies only. A second order set for "ED Behavioral Health" was provided that included orders to call the [physician] for changes in medical conditions and every four-hour updates, Maalox, labs, and psychiatric assessment. Neither order set was ordered by the ED provider for Patient #1. The facility did not provide any policies or protocols for treatment of patients who present to the ED for treatment of an opioid overdose. A policy on opioid prescribing was provided which outlined limitations for prescribing opioids to ED patients.

Hospital document for the ED titled, "Charting Guidelines", revealed: "...Vital Signs must be documents (sic) every 2 hours unless patient status requires more frequent documentation...Reassessment should be completed and documented on every patient every 2 hours...Rounding must be documented hourly; please address pain, position, and potty needs...."

Hospital document titled, "ED-Environment Patient Safety Checklist" requires: "...Inform patient of the level of observation/self-harm precautions and associated restrictions. Provide patient green paper scrubs...Inspect patient belongings, initiate Patient Belongings Record: remove potentially harmful objects or contraband from patient and environment. This includes: patient medications, glass or sharp items, toiletry items containing alcohol, matches or lighter, aerosol spray cans, curling iron, hair dryer, razor, belts, straps, ties, shoe laces, dental floss and jewelry, and cell phones...Checklist must be completed on initial assessment and every shift..."

Patient #3 presented to the ED for suicidal attempt by cutting wrists. Review of the medical record revealed an ESI score of 3. Review of vital signs revealed vitals were recorded at time of admission at 0855 and at time of discharge at 1640. Review of policy revealed an ESI 3 requires vitals every 4 hours. Review of medical provider orders revealed no Suicide Precautions were ordered at time of admission.

Patient #6 presented to the ED for suicide attempt with an intentional overdose. Review of the medical record revealed no Suicide Precautions or [Constant Observer] were ordered by the [medical provider] at time of admission.

Patient #1 presented to the ED on 08/12/2022 at 1426 for an attempted suicide with an intentional overdose of fentanyl. Review of the medical record revealed an ESI score of 1. Review of the vital sign record for Patient #1 revealed vital signs were conducted at time of admission at 1426 and then every 15 minutes for the first hour and then every 1- 2 hours through 0000 on 08/13/2022. Further review of the vital signs revealed no documented vital signs after the 0000 08/13/2022 entry until the patient was found unresponsive and in asystole at 0500 on 08/13/2022.

Patient #1 review of nursing flowsheet revealed vital signs were documented every 15 minutes for the first hour after admission and then every 1-2 hours until 08/13/2022 at 0000. No further vital signs or assessments were documented after 0000 on 08/13/2022.

Further review of Patient #1 medical record revealed abnormal vital signs recorded of Blood pressures ranging from 126/111 to 141/94, heart rate from 102 to 110 and respiratory rate from 7 to 10 with no nursing documentation present that the medical provider was made aware of the abnormal vital signs.

Further review of the medical record revealed Patient #1 was administered oxygen and review of the medical provider orders revealed no oxygen order was present.

Review of the [medical provider] orders revealed Suicide Precautions and [Constant Observer] orders were placed at 1930 on 08/12/2022 and not at time of admission at 1426.

Review of the [medical record] revealed the ED-Environment Patient Safety Checklist was not initiated until 2200 on 08/12/2022 and not at time of admission at 1426.

Review of the [medical provider] notes revealed an admission note was written by Provider #4 with no further assessments documented by any medical provider after 1930 on 08/12/2022. Patient #1 was in the ED for 15 hours over 3 medical provider shift changes (Provider #4, #5 and #6). There were no provider sign off assessments documented for Provider #5 and Provider #6.

Review of the Root Cause Analysis for Patient #1 death revealed the [Constant Observer or sitter] assigned to Patient #1 also was assigned an additional patient at the same time.

Review of [nursing] note dated 08/13/2022 at 0643 revealed: "...This [RN] received {sic} PT{sic} at 2200 moved into a room as patient was cleared by pat evaluator for transferring to another facility and patient was medically cleared. [RN] moved patient to a psych room for constant observation as needed the monitored room for another patient and the patient was medically cleared on the monitor for 7 hours with no episodes of desaturation...."

Review of the medical record revealed there was no [medical provider] order to move patient from a monitored bed to an unmonitored bed.

Employee #1 confirmed on 12/28/2022 that [medical staff and nursing staf]f did not follow established ED policies and procedures.

Based on review of policies and procedures, hospital documents, medical records, and staff interviews, it was determined that the hospital failed to ensure the Emergency Department had adequate and sufficient medical staff and nursing personnel in the Emergency Department.

Cross-reference to: A-0043, A-0049, A-0385, A-0392

Findings include:

Patient #1 was admitted to the ED on 08/12/2022 at 1426 for a suicide attempt and intentional overdose. Patient #1 subsequently died while in the ED on 08/13/2022 at 0517.

Policy titled, "Constant Observer for Patients Under Harm Precautions", revealed: "...Facilities will used Competent Constant Observers (CCOs) to provide continuous observation of a patient under suicide/self-harm and harm to other precautions to support safety...If the patient is suicidal/at risk of self-harm, the Facility should assign a CCO immediately...Initiation of CCO...After completing a medical screening exam, the level of constant observation is ordered by the QMP or QMHP...The nurse assigned to the patient remains responsible for the nursing care throughout the shift regardless of the presence of a CCO...The nurse assigned to the patient will document the assessments and observations relative to the continued need for CCO use per unit assessment frequency protocols, and report findings to the Clinical Coordinator (or comparable role), who will relay the information to the House Supervisor (or comparable role)...."

Review of the medical record revealed [Constant Observer] Flowsheet for Patient #1 revealed: "...Section Two: Completed by the [Constant Observer-Observation] is continuous, with real time 15 minute documentation to include ACTIVITY, BEHAVIOR, LOCATION CODE(S) and INITIALS...."

Review of the [Nursing] Staff Schedule for 08/12/2022 to 08/13/2022 did not reveal [Constant Observer] assignments.

Review of[ Medical Staff] Provider Schedules for August 2022 revealed the following staffing:
Out of the 31 days that Medical Staff were scheduled for the month there were 9 days with 5 physicians and 2 midlevel providers scheduled; 3 days with 5 physicians and 1 midlevel provider scheduled; 11 days with 4 physicians and 1 midlevel provider scheduled; 8 days with 4 physicians and 2 midlevel providers scheduled.

A review of the [Medical Staff] Provider schedule for 08/12/2022 revealed there were 4 physicians and 1 midlevel provider scheduled.

Review of the Root Cause Analysis in regards to Patient #1 unanticipated death revealed an interview was conducted with Provider #5 on 09/01/2022 which revealed: "...Was a '4 [Doctor ]Day' incredibly busy...."

Review of the Root Cause Analysis revealed an interview with Provider #6 was conducted on [09/01/2022] which revealed: "...'4 [Docto]r Day' means we were down a doctor, we usually have 5 doctors...About 0500, [Sitter] in ED "Green Zone" ("pseudo-Annex") watching at least one other patient, they are looking like they are sleeping...."

Employee #1 confirmed on 12/28/2022 that the [Constant Observer] assigned to Patient #1 was also assigned one other patient at the same time as Patient #1. Employee #1 confirmed that there is supposed to be 5 physicians and at least 1 midlevel provider scheduled in the ED. Employee #1 confirmed that on 08/12/2022 [Medical Staff] was short one physician for the 24 hour period.