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Based on the review of policies and procedures, the hospital website, the Arizona Department of Health Licensing file, and staff interviews, it was determined that the Governing Body failed to ensure that the hospital had established in writing, an accurate description of the hospital's scope of services. This deficient practice is a potential risk to the health and safety of patients who are seeking specific medical treatment and services and are not able to receive them at the hospital upon arrival to the hospital.

Cross reference tags: A-0043, A-0315, A-0393, A-0941, A0951

Findings include:

The policy titled " Plan for the Provision of Patient Care Policy" revealed "...Scope of Service:
· Cardiac Catherization Lab/Special Procedures care provided Monday through Friday 0700-1730, On-call is utilized after hours and on weekends to provide 24-hour coverage
· Cardiac Imaging care provided Monday through Friday 0700-1730
· Cardiopulmonary care is provided 24 hours per day, 7 days a week
· Clinical Laboratory open 24 hours a day/7 days a week
· Diagnostic Imaging/Radiology: CT is staffed 24 hours a day; Diagnostic Radiography and Fluoroscopy is staffed 24 hours a day and a technologist is on-call; Magnetic Resonance Imaging is staffed 0700-1730 with a technologist on-call for after hours and recognized holidays; Nuclear Medicine staffed Monday through Friday 0700-1730, a tech on-call for after hours and recognized holidays. Coverage for cardiac studies on weekends is coordinated with a technologist; Women's Imaging is staffed 0700-1700; the Radiologist is available onsite Monday through Friday from 0800-1700 and via teleradiology after hours, weekends, and recognized holiday
· Dialysis is provided Monday through Friday 7-5 pm with "add-on" services as needed
· Emergency Department open 24 hours a day/365 days a year
· Tele/Medicine/Surgery Unit operational 24 hours a day/ 365 days a year
· Intensive Care Unit open 24 hours a day/ 365 days a year
· Women's and Perinatal Services: Level II Maternal/Child for low to moderate-risk maternal and neonatal patients, 8-bed Newborn Special Care Nursery provides care to newborns 32 weeks or greater gestation and operates 24/7 hours per day, the O/P Triage Unit is operational 24 hours a day, 7 days a week
· Perioperative Services: Operating Room routine hours Monday through Friday 0700-1500 and on an "as needed" basis on Saturday and Sunday; Preop/PACU hours Monday through Friday 0600-1700 and as needed on Saturday and Sunday...."

A review of the hospital website revealed: "...Key Services include:
· 24/7 Emergency Care
· Operating Rooms including Robotic Assisted Surgical Capacities
· Cardiac Catherization Lab
· Labor, Delivery, Postpartum & Neonatal Intensive Care
· Medical/Surgical, Telemetry, and Intensive Care Units
· Diagnostic Imaging, including MRI, CT, X-ray, Ultrasound, and Mammography...."

A review of the Arizona Department of Health (AZDHS), Medical Licensing Division facility file revealed Hospital License "H11725 was issued on 05/31/2022, listed among the number and types of licensed beds for the facility were eight (8) Neonatal Intensive Care Unit (NICU) beds. Additionally, the AZDHS Medical Licensing Approval letter dated 05/31/2022 revealed "...The licensed capacity and classification of services which you are authorized to provide are specified on the license and cannot be changed without prior approval by the Arizona Department of Health Services...." Further review of the facility's licensing file revealed no evidence that the facility had notified AZDHS regarding the closure of the NICU or changes in services offered and hours.

Observation on 10/03/2022 revealed the NICU unit was closed and non-operational.

Employee #2 confirmed on 10/03/2022 that Dialysis services had not been available since the hospital opened, however, a dialysis nurse was hired and services is projected to start on 10/04/2022.

Employee #5 confirmed during an interview on 10/03/2022 that the NICU has not been operational since 08/27/2022 due to a lack of staff to provide care to neonatal patients.

Employee #10 confirmed during an interview on 10/03/2022 that the Perioperative Department including the OR and PACU was only operational during the weekdays. Employee #10 confirmed that the hospital currently has not been providing surgical services at night or on weekends due to a lack of staff to take night and weekend calls.

Employee #21 confirmed during an interview on 10/11/2022 that fluoroscopy services have not been provided on nights or weekends as there is no radiologist in-house to perform the procedures.

Employee #2 confirmed during an interview on 10/14/2022 that the cardiac catheterization lab has not able to provide services at night or on weekends due to there being no staff to take night and weekend calls.

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 and Standard deficiencies found under the Conditions of Medical Staff, Quality Assurance and Performance Improvement (QAPI), Nursing Services, and Surgical Services as evidenced by:

Cross reference: A-0022: The Governing Body failed to establish, in writing an accurate description of the hospital's scope of services.

Cross reference: A-0049: The Governing Body failed to ensure Emergency Department physicians were arranging patient ED-to-ED transfers based on medical necessity and decision and not on Administration approval.

Cross reference: A-0273: The hospital failed to investigate and perform a root cause analysis on one patient's unanticipated death in the ED.

Cross reference: A-0283: The hospital failed to identify, measure, track, and take actions to improve patient ED-to-ED transfer in a timely.

Cross reference: A-0315: The Governing Body failed to ensure that the hospital supplied adequate staff and resources to provide needed services and care to patients.

Cross reference: A-0353: The Governing Body failed to ensure Medical Staff complied with the medical staff bylaws and rules & regulations when:
1. Arranging patient ED-to-ED transfers, and
2. Document daily progress notes on patients.

Cross reference: A-0386: The nurse executive failed to ensure an acuity plan in place that had a method to utilize patient acuity to indicate the types and numbers of nursing personnel required to provide nursing care and meet patient needs.

Cross reference: A-0392: The hospital failed to ensure that:
1. There was sufficient staff to provide one-to-one (1:1) sitters in the ED.
2. There was sufficient staff for two-night shifts in the Intensive Care Unit (ICU).

Cross reference: A-0393: The hospital failed to ensure there were sufficient numbers of nursing personnel available to meet the needs of patients as evidenced by:
1. Surgical Services are not provided at night and on the weekends, and
2. The Neonatal Intensive Care Unit is closed due to a lack of staff.

Cross reference: A-0398: The nurse executive failed to ensure nursing staff were trained, knowledgeable, and followed policies and procedures regarding:
1. IV medication administration,
2. Documentation of nursing assessments was performed, and
3. Implementation of a Staffing Acuity Plan.

Cross reference: A-0941: The hospital failed to ensure there was a sufficient number of personnel to provide surgical services as needed by patients.

Cross reference: A-0951: The hospital failed to ensure that surgical services were available when the need arise, including weekends and nights.

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 the review of policies and procedures, hospital documents, medical records, and staff interviews, it was determined that the Hospital failed to ensure Emergency Department (ED) physicians were managing and arranging patient transfers to other hospitals based on medical necessity and patient condition, and not based on the direction of the administrative personnel. This deficient practice poses a risk to the health and safety of patients when transfers are delayed or canceled by the administration which could lead to comprising patients' conditions.

Cross reference: A-0049, A-0353

Findings include:

The policy titled, "Emergency Treatment and Active Labor Act (EMTALA) policy," revealed: "...Appropriate transfer occurs when: the transferring hospital provides medical treatment within its capacity that minimizes the risks to the individual's health, and in the case of a woman in labor, the health of the unborn child; the receiving hospital: (A) has the appropriate space and qualified personnel for the treatment of the individual and (B) has agreed to accept the transfer of the individual and to provide appropriate medical treatment...the transfer is effected through qualified personnel and transportation and equipment, as required, including the use of necessary and medically appropriate life support measures during the transfer...Physician Certification refers to written certification by the treating physician ordering a transfer and made prior to the patient's transfer that, based on the information available at the time of transfer, the medical benefits reasonably expected from the provision of appropriate medical treatment at another facility outweigh the increased risks to the individual...Stable for transfer: A patient is stable for transfer if the treating physician has determined, within reasonable clinical confidence, that the patient is expected to leave the hospital and be received at a second facility, with no material deterioration in his/her medical condition; and the treating physician reasonably believes the receiving facility has the capability to manage the patient's medical condition and any reasonably foreseeable complication of that condition...Transfers of Individuals: A. Transfer Requirement: If a patient is determined to have an EMC (emergency medical condition) following an MSE (medical screening examination) and either: (a) the patient requests a Transfer; or (b) the treating physician determines that the hospital has exhausted its capabilities to stabilize the patient's EMC and that the benefits of an appropriate transfer outweigh the risks of such transfer, the Hospital shall take reasonable steps to initiate an appropriate transfer...."

The policy titled, "Patient Rights and Responsibilities," revealed: "...The patient's rights: ...Receive a referral by your physician to another health care institution, if the facility is not authorized or not able to provide physical health services or behavioral health services needed...."

The policy titled, "Patient Transport-Transfer to other Licensed Health Care Institution," revealed: "...Emergency Department (ED) patients being transferred under EMTALA guidelines: Should a patient require a higher level of care not available at the hospital, the ED physician may decide the ED patient requires transfer to another acute care facility...."

The policy titled, "Plan for the Provision of Patient Care," revealed: "...Chief Financial Officer: In collaboration with the Board of Trustees, the Medical Staff, Corporate leaders, hospital senior management and individual department directors, the Chief Financial Officer (CFO) is responsible for planning, directions and coordination of the organization's financial resources, including operating and capital budget preparation, ongoing resource allocation and monitoring of financial resources for hospital administration...Medical Staff: The Medical Staff is governed by established Medical Staff Bylaws. Medical staff is actively involved in the assessment, planning, implementing, and evaluating of patient care services to meet the mission, vision, and values of the facility...Provisions of Care, Treatment, and Services: All patients receive care and treatment provided by a licensed independent practitioner with medical staff membership and clinical privileges...."

Document titled, "Northwest Medical Center Sahuarita/Houghton Medical Staff Bylaws," revealed "...Basic Qualifications/Conditions of Medical Staff Membership: ...The only people who shall qualify for membership on the Medical Staff are those Practitioners legally licensed in Arizona who: ...Practice in such a manner as not to interfere with the orderly and efficient rendering of services by the Hospital or by other Practitioners within the Hospital...Basic Responsibilities of Medical Staff Membership: Each member of the Medical Staff shall: Provide his/her patients with continuous care at the generally recognized professional level of quality...."

Document titled, "Northwest Medical Center Sahuarita/Houghton Medical Staff Rules & Regulations," revealed: "...The management and coordination of each patient's care, treatment, and services shall be the responsibility of a Physician with appropriate privileges...Patient Transfers: Patient transfers will be prioritized based on an evaluation of each patient's needs at the time of the transfer...The Emergency Department Physician shall obtain the consent of the receiving hospital facility before the transfer of an individual. Said person shall also make arrangements for the patient transfer with the receiving hospital...."

A review of Community Health System (CHS) Transfer Center Call Summaries for seventeen (17) ED patients revealed the initial request for transfer was for only Northwest system facilities (Northwest Medical Center (Main), Oro Valley Hospital, or Northwest Sahuarita). There was documentation on four (4) of the seventeen (17) transfer summaries that permission was requested from the AOC (administrator on call) to look for placement outside the Northwest system after a significant amount of time with no placement, in one case (Patient #9) it was over 40 hours. One patient, Patient #1, had a transfer arranged to a hospital outside of the Northwest system and it was denied by the CFO and the patient's necessary surgery was delayed 48 hours.

Patient #1

A review of the CHS Transfer Center Call Summary for Patient #1 revealed: "...Initial Request Type: Transfer...Request Priority: Urgent...Initiated at 13:11 08/13/2022 Northwest Medical Center (Main)...Accepted 13:22 08/13/2022...08/13/2022 14:59 no beds yet....08/13/2022 22:18 (CDT) no changes, updated about bed status...08/13/2022 23:39 (CDT) Referring hospital ( NW Houghton) called to make TC (transfer center) aware that they have found a placement elsewhere due to the patient unable to wait for OR/surgery until Monday. Needs hip repaired before Monday. They provided an accepting MD for an ER-to-ER transfer for trauma services (St. Joseph's). LOOP (Left Out Of Process) MD conference as noted...08/13/2022 23:39 (CDT) spoke to Charge nurse at referring hospital and AOC (administrator on call) said patient is not allowed to go to St Joseph's or Northwest and will be admitted at sending...08/13/2022 23:40 (CDT) Called ER charge RN to verify patient acceptance at St Joseph's, Extended hold time will call back...08/13/2022 23:43(CDT) Spoke to Carondolet TC (for St Joseph's) they state AOC at NW Houghton has stated for a patient to remain at NW Houghton and transfer is to be canceled. Calling referring facility to confirm...."

Review of the medical record for Patient #1 a 92-year-old admitted to the facility's ED on 08/13/2022 following a fall in which the patient sustained a left hip fracture revealed the following notes:

Patient #1's ED physician note dated 08/13/2022 at 09:39 identified " ...The patient presents following a fall. The onset was just prior to arrival. The occurrence was a single episode. The fall was described as tripping and falling from ground level. The location where the incident occurred was at home. Location: Left hip. The character of the symptoms is pain, swelling, and loss of mobility. The degree at present is severe. There are exacerbating factors including changing position and movement. The relieving factor is immobilization. Risk factors consist of age...."

Patient #1's Radiology report dated 08/13/2022 at 11:42 identified: "...X-ray Hip Left with pelvis: Impression Acute displaced left intertrochanteric femur fracture( broken head of thigh bone in hip socket)...."

Patient #1's Radiology report dated 08/13/2022 at 12:31 identified: "...X-ray Chest: Impression Left mid to lower lung zone pneumonia associated with effusion (fluid in lung)...."

Patient #1's ED physician note dated 08/13/2022 at 15:46 identified: "...Calls-Consults: 08/13/2022 11:09 Provider #6 (orthopedic surgery) consult recommends Transfer patient to another facility as they do not have OR time here on the weekends and given age and acute fracture patient needs care this weekend...Plan: Transfer to other location: Time 08/13/2022 11:25 Facility Name NW Accepted by Provider #8, family counseled regarding diagnosis, {sic} diagnostic results, {sic} treatment plan, {sic} regarding prescription...."

Patient #1's ED physician note dated 08/13/2022 at 20:51 identified: "...NWMC called, pt will not get a bed today and likely not tomorrow. We escalated to AOC (Administrator On Call) and house supervisor, discussed with Provider #6-will arrange for surgery 1st thing Monday morning. OK to admit Houghton...."

Patient #1's ED Orthopedic Surgery Consult note dated 08/13/2022 at 21:13 identified: "...Discussed case with CFO, administrator on call. Patient has an acute hip fracture but we do not have OR coverage on the weekends. Transfer was recommended but reported to me no beds available. Patient will be admitted for first case OR on Monday 08/15/2022. Reviewed x-rays...Full consult to follow but operative plan is ORIF (open reduction internal fixation) with cephalomedullary nail (surgical stabilization of fracture)left hip...Request urinary catheter placement and placement of abduction pillow on patient to assist with pain control until fracture fixation possible...."

Patient #1's Hospitalist note dated 08/13/2022 at 23:51 identified: "...Patient was initially supposed to be transferred to Northwest since no surgery is being done at Houghton over the weekend due to no staff. Patient was convinced by the CFO to stay at the hospital. Patient is scheduled to have surgery first thing Monday morning...."

Patient #1's Complete Orthopedic Consult dated 08/14/2022 at 12:07 identified: "...We talked about the fact that we can do surgery Monday morning at 07:30 AM. We initially tried to see if {patient} could get transferred for earlier care but we were unable to find an accepting facility that could do it {in}an earlier time. Patient will be about 48 hours at that point, we felt it was reasonable to plan the surgery for that time...."

Provider #4 confirmed during an interview on 10/11/2022 that he had made a physician-to-physician call to St Joseph's Hospital, an out-of-system facility, to arrange for Patient #1 to be transferred and the patient would receive the needed surgery the very next day (08/14/2022). Provider #4 confirmed that the transfer was not initiated by CHS Transfer Center but by Provider #4 and then the CHS Transfer Center was notified after St Joseph's had accepted the patient. Provider #4 confirmed that when the ED staff were made aware that St Joseph's was willing to accept Patient #1, the ED staff informed the provider that permission was needed from the acting AOC who happened to be in the role of the CFO. Provider #4 stated that he called the CFO and informed the CFO that there were no beds at NWMC and the patient needed surgery sooner than later, and St Joseph's had accepted the transfer and the family agreed to the transfer. Provider #4 stated the CFO was talking to the family via the provider and then the provider let the family speak with the CFO directly. Provider #4 stated the CFO told Provider #4 after speaking to the family, that the family had agreed to stay at NW Houghton and would wait for surgery on Monday and the patient was not to be transferred. Provider #4 stated that he had never been in a situation where the CFO was involved or intervened with the patient transfer.

Provider #5 confirmed during an interview on 10/13/2022 that when a patient is needing to be transferred to another facility, the Transfer Center is notified and requested to look at facilities within the Northwest/CHS system. Provider #5 confirmed a transfer will be delayed to wait for a bed to become available at another Northwest facility unless the patient's condition warrants an immediate placement elsewhere. Provider #5 confirmed that if a transfer is needed that is "out of the system" then the AOC (Administrator on Call) is notified. Provider #5 stated that the CFO was the acting AOC on the weekend and that Patient #1 was a patient in the ED.

Employee #23 confirmed during an interview on 10/13/2022 that a transfer to NWMC was initiated on 08/13/2022. Employee #23 confirmed that when the ED was notified there was no bed available at NWMC, one of the providers called an ED physician at St Joseph's and arranged for Patient #1 to be transferred there for the needed surgery. Employee #23 confirmed that when the CFO who was the acting AOC for the day was notified of the transfer, the CFO spoke to the family and the CFO denied the patient transfer.

Patient #9

Patient #9 was admitted to the ED on 07/14/2022 at 15:07 for gastritis, and bloody stool with a concern of a GI bleed.

Patient #9 ED physician note dated 07/14/2022 at 15:26 identified: "...patient presents to the ED for evaluation of rectal bleeding...Labs demonstrated a markedly elevated leukocytosis. The patient requires transfer to Northwest Medical Center for further evaluation and management. The patient was educated about the above, and the need for transfer and agrees with this plan. The case was discussed with GI who agrees with the transfer. The case was also discussed with the hospital service who is to accept the transfer...."

Patient #9 ED physician note date 07/16/2022 at 10:03 identified: "...pending transfer to NWH for GI for Melena(blood in stool) and concern of GIB... {sic} has been waiting for a bed now 43 hours...I have ordered serial {hemoglobins} and hemoglobin continues to decline...May need a transfusion today. I called AOC (CFO) {sic} voicemail but no return call. Spoke to house supervisor at Northwest who is unable to accommodate expediting the transfer due to lack of capacity, spoke to Provider #5 who agreed with the appropriateness for transfer outside the Northwest system at this point to prevent further delay in care. Spoke with transfer center, {sic}check with multiple hospitals around town to see who can take him the soonest..."

A review of the CHS Transfer Center Call Summary for Patient #9 revealed: "Initial Request Type: Transfer at 21:36 (CDT) 07/14/2022...Request Priority: Urgent...Accepting location: Northwest Medical Center 07/14/2022 at 22:01 (CDT)...Notes: 07/15/2022 04:05 (CDT) updated status and bed availability...07/16/2022 12:02 (CDT) Provider #7 called {wants} us to look anywhere for a transfer, said she got approval from AOC...07/16/2022 18:13 (CDT) discharged from referring hospital...." Further review of the Transfer Center Call Summary revealed no evidence of any other outside facilities being contacted for patient placement.

Patient #10

A review of the CHS Transfer Center Call Summary for Patient #10 revealed: "...Initial Request Type: Transfer at 21:38 (CDT) on 07/14/2022...Request Priority: Urgent...Accepting location: Northwest Medical Center on 07/14/2022 at 22:01 (CDT)...Notes: 07/15/2022 04:05 (CDT) updated status and current bed availability...07/16/2022 12:02 (CDT) Provider #7 called us wants us to look anywhere to transfer, said got approval from AOC...."

Patient #21

A review of the CHS Transfer Center Call Summary for Patient #21 revealed: "...Initial Request Type: Transfer on 08/07/2022 at 14:29 (CDT)...Request Priority: Urgent...Declined location: Northwest Medical Center...Notes: 08/07/2022 15:09 (CDT) Received call from Provider #9 (hospitalist) who states his AOC instructed him {no} to accept any more patients until more beds became available...Escalation: 08/07/2022 15:15 (CDT) Called AOC for privileges to go outside system-no answer...08/07/2022 16:45 (CDT) Escalated for privileges to go outside system, call to AOC...."

Patient #54

A review of the CHS Transfer Center Call Summary for Patient #54 revealed: "...Initial Request Type: Transfer 09/02/2022 00:008 (CDT)...Request Priority: Urgent...Notes: 09/02/2022 00:111 (CDT) Declined at Northwest Medical Center- no vascular surgeon until 09/09/2022...09/02/2022 01:06 (CDT) spoke with Provider #5 and let him know of facility declines, states try facilities in phoenix...Escalation: 09/02/2022 02:24 (CDT) call to AOC for approval to look in Phoenix reason: NO MD on call...."

Employee #19 confirmed during an interview on 10/12/2022 that when a patient is requiring a transfer to another facility for a service not offered by the facility or a higher level of care is required, the physician will initiate the transfer by calling the Transfer Center. Employee #19 confirmed the initial transfer request is sent to Northwest facilities to keep the patient in the Northwest system. Employee #19 stated that if the physician wants the Transfer Center to look outside the Northwest system facilities, the physician has to get approval from the AOC (Administrator on Call) before the Transfer Center looks outside the system.

Employee #23 confirmed during an interview on 10/13/2022 that when transferring a patient to the accepting facility Northwest facility is the first preference over out-of-the-system facilities. Employee #23 confirmed that if the physician wants to look at other facilities, not within the Northwest system, permission is necessary from the AOC before the Transfer Center can look elsewhere. Employee #23 confirmed patient care and patient transfers have been delayed due to patients waiting for bed placement at a Northwest facility. Employee #23 stated patients have waited days for a placement at a Northwest facility when there is availability at other out-of-system facilities.

Provider #5 confirmed during an interview on 10/13/2022 that if a patient needs to be transferred out to another facility, the accepting facility is another Northwest hospital over an out-of-system facility. Provider #5 stated the AOC needs to be notified when transferring a patient to an out-of-system facility.

Based on the record review and interviews, it was determined the hospital failed to have a quality assessment and performance improvement program that reflected the complexity of the hospital's organization and services involving all hospital departments as evidenced by:

Cross reference: A-0273: failure to perform a Root Cause Analysis (RCA) was performed regarding an unexpected death in the Emergency Department.

Cross reference: A-0283: failure to identify a need to improve Emergency Department transfer times.

Cross reference: A-0315: failure to ensure that adequate resources were allocated to improve and sustain the hospital's performance and reduce risks to patients.

The cumulative effect of these systemic deficient practices resulted in the facility's failure to meet the requirement for Condition of Participation for Quality Assessment and Performance Improvement.

Based on the review of policies and procedures, hospital documents, medical records, and staff interviews, it was determined the hospital failed to investigate and perform a root cause analysis on one (1) patient's unanticipated death in the Emergency Department. This deficient practice could pose a potential risk to the health and safety of patients if the hospital failed to identify potential risks and root causes of unexpected events and deaths involving patient care.

Cross reference: A-0263

Findings include:

The policy titled, "Quality Assessment and Performance Improvement Plan," revealed: "...Priorities for safety and quality improvement are identified based upon improvement opportunities identified from internal monitoring and analysis, comparisons to external benchmarks, strategic objectives, analysis of safety events, regulatory requirements and root cause analysis investigations...The hospital's priorities for patient safety and quality focus on the following domains with the goals of improving health outcomes and prevention of medical errors: {sic}Reduce unanticipated mortalities; {sic}reduce unplanned readmissions; zero patient harm; exceptional patient experience; improve efficiency, timeliness, and effectiveness of care; Maximize pay for performance opportunities (managed care pay for performance, HAC/Readmission penalties); meet regulatory requirements for licensure, accreditation, and /or certification; monitor clinical contract performance...."

Patient #4 was admitted to the Emergency Department (ED) on 07/20/2022 with a complaint of abdominal pain and syncope. Patient #4 was in the ED for 32 hours and 35 minutes. On 07/21/2022, Patient #4 suffered a cardiac arrest and was declared dead in the ED at 11:46.

A review of the Medical Executive Committee Meeting Minutes for August 2022 revealed no evidence that Patient #4's unexpected death was reviewed and analyzed.

A review of the Hospital's sentinel event log from June through September 2022 failed to reveal evidence that Patient #4's unexpected death was reported and reviewed.

A review of the hospital's QAPI Committee Meeting Minutes from June through September 2022 revealed no evidence of an investigation or root cause analysis was performed regarding Patient #4's unanticipated death in the ED.

Employee #1 confirmed during an interview on 10/05/2022 that an investigation or root cause analysis was not performed regarding Patient #4's unanticipated death in the ED.

Based on the review of policies and procedures, hospital documents, and staff interviews, it was determined the hospital failed to identify, measure, track, and correct the flow of patient transfer times in the Emergency Department. This deficient practice poses a risk to the health and safety of patients if continuous quality improvement practices are not implemented that could affect the provision of quality care to the patient population.

Cross reference: A-0263

Findings include:

The policy titled, "Quality Assessment and Performance Improvement Plan," revealed: "...Priorities for safety and quality improvement are identified based upon improvement opportunities identified from internal monitoring and analysis, comparisons to external benchmarks, strategic objectives, analysis of safety events, regulatory requirements and root cause analysis investigations...The hospital's priorities for patient safety and quality focus on the following domains with the goals of improving health outcomes and prevention of medical errors: {sic} Reduce unanticipated mortalities; reduce unplanned readmissions; zero patient harm; exceptional patient experience; improve efficiency, timeliness, and effectiveness of care; Maximize pay for performance opportunities (managed care pay for performance, HAC/Readmission penalties); meet regulatory requirements for licensure, accreditation, and /or certification; monitor clinical contract performance...."

A review of the Emergency Department (ED) Activities Logs for July, August, and September 2022 revealed eighteen (18) patients' transfer outs to other healthcare facilities had extended wait times of seventeen (17) hours to fifty-five (55) hours.

A review of the hospital's QAPI committee meeting minutes revealed no evidence of extended ED to ED-transfer times was identified as an issue to investigate for quality performance improvement.

A review of the Board of Trustees Meeting Minutes for July, August, and September 2022 revealed no evidence that extended ED-to-ED transfer times were addressed by the Board for quality performance improvement.

Employee #1 confirmed during an interview on 10/12/2022 that ED-to-ED transfer wait times and procedures were not identified as a a qualifier for QAPI monitoring by the facility.

Based on the review of policies and procedures, hospital documents, and staff interviews, it was determined the Governing Authority failed to ensure that the hospital was provided with adequate personnel and resources to provide the adequate scope of services and care to patients. This deficient practice poses a risk to the health and safety of patients if the hospital is unable to provide the proper care and resources to meet the patient's medical needs.

Cross reference: A-0022, A-0043, A-0393, A-0393, A-0941, A-0951

Findings include:

The policy titled, " Plan for the Provision of Patient Care Policy," revealed "...Scope of Service:
· Cardiac Catherization Lab/Special Procedures care provided Monday through Friday 0700-1730, On-call is utilized after hours and on weekends to provide 24-hour coverage
· Cardiac Imaging care provided Monday through Friday 0700-1730
· Cardiopulmonary care provided 24 hours per day, 7 days a week
· Clinical Laboratory open 24 hours a day/7 days a week
· Diagnostic Imaging/Radiology : CT is staffed 24 hours a day; Diagnostic Radiography and Fluoroscopy is staffed 24 hours day and a technologist is on-call; Magnetic Resonance Imaging is staffed 0700-1730 with a technologist on-call for after hours and recognized holidays; Nuclear Medicine staffed Monday through Friday 0700-1730, a tech on-call for after hours and recognized holidays. Coverage for cardiac studies on weekend are coordinated with technologist; Women's Imaging staffed 0700-1700; Radiologist is available onsite Monday through Friday from 0800-1700 and via teleradiology after hours, weekends, and recognized holidays
· Dialysis is provided Monday through Friday 7-5 pm with "add on" services as needed
· Emergency Department open 24 hours a day/365 days a year
· Tele/Medicine/Surgery Unit operational 24 hours a day/ 365 days a year
· Intensive Care Unit open 24 hours a day/ 365 days a year
· Women's and Perinatal Services: Level II Maternal/Child for low to moderate risk maternal and neonatal patients, 8 bed Newborn Special Care Nursery provides care to newborns 32 weeks or greater gestation operates 24/7 hours per day, the O/P Triage Unit is operational 24 hours a day, 7 days a week
· Perioperative Services: Operating Room routine hours Monday through Friday 0700-1500 and on an "as needed" basis on Saturday and Sunday; Preop/PACU hours Monday through Friday 0600-1700 and as needed on Saturday and Sunday...."

Further review of the policy, "Plan for the Provision of Patient Care," revealed: "...Emergency Department Staffing Requirements: The department is managed by a RN {sic} with leadership experience. Day to day {sic} operations are supervised by the Supervisor or the Charge Nurse. Staffing consists of RNs, and/or Paramedics, Nurse Tech {sic}and ED Tech. A{sic} RN is assigned to triage 24 hours a day...The department utilizes flex staffing, increasing staff during peak hours and heavier patient volume times of the year. A minimum of two (2) RNs are always on duty...Intensive Care Unit Staffing Requirements: Staffing in the ICU is based on the AZDHS standards at a 1:2 RN to patient ratio. Based on patient acuity, the ratio may flex to a 1:1...The patient ratio is based on the frequency of vital signs, the quantity and {sic}complexity of nursing care and interventions as well as the amount of observation time the patient requires. There is always a minimum of two RNs present in the Critical Care Unit...Perinatal Care Staffing Requirements: ...
Staffing Ratio Care Provided
1:1-2 Antepartum Testing
1:2 Laboring Patients
1:1 Patients in second stage of labor
1:1 Ill patients with complications/may include unstable pre-term patients
1:2 Oxytocin induction or augmentation of labor
1:1 Coverage for initiating epidural anesthesia
1:1 Circulation for Cesarean Delivery
1:1 Recovery of the Cesarean Section or delivered patient
1:1 Postoperative recovery of the Cesarean Section or delivered patient
1:6 Antepartum/postpartum patients without complications
1:1-3 Patients with complications but in stable condition
1:1-3 Recently born infants and those needing close observation
1:6-8 Newborns needing only routine care
1:4-5 Normal mother-newborn couplet care
1:3-4 Newborns requiring continuing care
1:2-3 Newborns requiring immediate care
1:1-2 Newborns requiring intensive care
1-2:1 Newborns requiring multi-system support
1-2:1 Unstable newborns requiring complex critical care...

Staffing Standards: ... Perinatal Services required minimal staffing: Labor & Delivery RN's (2), Level II RN (1), Scrub Tech (1), with Women's Center Nursing Leadership always available when requested as back-up {sic}...
Tele/Medicine/Surgical Unit: ...Staffing Requirements: Tele/Medicine/Surgical Unit is staffed with Registered Nurses and Nurse Techs, The Tele/Medicine/Surgical Unit has unique staffing patterns designated to care for its unit-specific population as defined by acuity data...Perioperative Services:...Staffing Requirements: OR staffing is as follows: A minimum of two(2) OR personnel are assigned to every surgical procedure, only RNs are assigned to circulate, Additional {sic} personnel are {sic} assigned to patients as indicated by acuity and activity level required...Preop/PACU staffing is as follows: There is one RN assigned for every two recovery beds, One RN may be assigned up {sic} to 4 patients, who have met discharge criteria...."

A review of the hospital website revealed: "...Key Services include:
· 24/7 Emergency Care
· Operating Rooms including Robotic Assisted Surgical Capacities
· Cardiac Catherization Lab
· Labor, Delivery, Postpartum & Neonatal Intensive Care
· Medical/Surgical, Telemetry, and Intensive Care Units
· Diagnostic Imaging, including MRI, CT, X-ray, Ultrasound, and Mammography...."

A review of Emergency Department (ED) Activity Logs for July, August, and September 2022, revealed a total of forty-four (44) patients were transferred to other facilities for necessary surgical interventions as the facility did not provide surgical services at night or on the weekends. Additionally, one (1) patient was transferred to another facility because there was not a radiologist on duty on the weekend and the patient needed a procedure done under fluoroscopy.

A review of Patient #3's medical record revealed the patient was admitted to the ED on 07/18/2022 with post-op surgical complications. It was determined by the ED physicians that Patient #3 needed to be admitted to the hospital for TPN, IV antibiotics, IV hydration, and eventual surgical interventions. It was determined by the ED physicians that Patient #3 would require a peripherally inserted central catheter (PICC) line. The facility did not have the PICC line insertion equipment or staff required to place the line. The ED physician determined the patient would need to be transferred out to another facility for the needed PICC line placement. The patient remained in the ED until 07/21/2022 when a bed placement was found at Northwest Main campus.

A review of Patient #38's medical record revealed that the patient was admitted to the ED on 09/13/2022 for a fracture left hip and required inpatient admission for an orthopedic surgical intervention. However, the patient also required dialysis services, and the hospital was unable to provide dialysis services and was subsequently transferred to another hospital that could provide the dialysis services needed by the patient.

A review of L&D staffing assignments for the month of September revealed on the 09/03/2022 night shift there were 2 RNs and 1 Scrub tech scheduled. There were 4 patients in the L&D unit 1 patient was being monitored for antepartum issues, 1 patient was in labor, 1 patient had a vaginal delivery on the day shift, and 1 patient had had a cesarean section at 18:17. One nurse was assigned to the antepartum patient and the laboring patient. The second nurse had the fresh post-Cesarean section and the post-vaginal delivery patient. Per the Plan for the Provision of Patient Care policy, the post-Cesarean section patient should have been a 1:1 RN assignment. The nurse had the post-Cesarean and a vaginal delivery that was discharged at 2200 that night. However, the nurse had a 1:2 assignment from 1900-2200.

Further review of the L&D staffing assignments revealed on 09/05/2022 a newborn neonate was transferred to another facility as there was no NICU staff to care for the newborn.

Further review of the L&D staffing assignments revealed on 09/11/2022 there were 2 RNs from 1900-0700 and 1 Scrub tech. One nurse had 2 patients, one patient was in labor and the other patient had delivered via cesarean section at 17:52. Both patients according to the Plan for the Provision of Patient Care policy should have been a 1:1 RN assignment.

Further review of the L&D staffing assignments revealed on 09/28/2022 day shift 2 RNs and 1 Scrub tech were scheduled. One RN had 2 patients that were in labor. One of those patients delivered via Cesarean section at 12:59 and the other patient delivered vaginally at 17:25. The RN assigned had a 1:2 assignment. Per the Plan for the Provision of Patient Care, the nurse assignment for both of those patients should have been a 1:1 RN assignment.

A review of surgical schedules for the month of September 2022, revealed only two (2) of the hospital's four (4) Operating Rooms were in regular use. Additionally, on days that the GI lab was open for endoscopy procedures, only one (1) OR room was operating.

Observations on 10/03/2022 revealed that the Neonatal Intensive Care Unit (NICU) was closed and not operational.

Employee #2 confirmed on 10/03/2022 that dialysis services were not provided since the hospital opened in June 2022. However, employee #2 claimed that a dialysis nurse was hired and has a start date of 10/04/2022.

Employee #5 confirmed during an interview on 10/03/2022 that the NICU has not been operational since 08/27/2022 due to a lack of staff to provide care to the neonatal patient. Employee #5 further stated that 3 RNs are always scheduled for every shift in L&D. The Director will come in and assist as well as nurses from other units will be pulled to assist with a staffing shortfall.

Employee #9 confirmed during an interview on 10/03/2022 that no surgeries are performed during nights or weekends because there is not enough available staff in OR and PACU during these times.

Employee #10 confirmed during an interview on 10/03/2022 that the Perioperative Department including the OR and PACU was only operational during the weekdays. Employee #10 confirmed that the hospital currently is not able to provide surgical services during nights and weekends due to a lack of staff to take night and weekend calls. Employee #10 stated there would need to be a minimum of twelve (12) OR staff to be able to run all four (4) OR rooms and take the call at night and on weekends. Employee #10 stated that currently there are three (3) Preop/PACU nurses available to prep patients for surgery and recover patients after surgery. Employee #10 stated there would need to be a minimum of five (5) nurses for Preop/PACU to meet the needs of four (4) ORs and to take the call at night and on the weekends.

Employee #21 confirmed during an interview on 10/11/2022 that fluoroscopy services were not currently provided at night or on weekends as there is no radiologist in-house to perform the procedures during these times.

Employee #2 confirmed during an interview on 10/14/2022 that the cardiac catheterization lab does not provide services at night or on weekends due to staffing.

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 were arranging patient transfers to other hospitals based on approval from the Administrator on Call (AOC) or CFO of the facility and not based on the medical necessity and physician's medical decision.

Cross reference: A-0353: Medical Staff did not comply with the medical staff bylaws and rules ®ulations when:
1. Arranging patient transfers to other licensed facilities, and
2. Documenting daily physician patient progress notes.

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, the Department determined the administrator failed to ensure Medical Staff followed the policies and procedures governing:
1.Patient transfers.
2. Documentation of daily physician patient progress notes.
These deficient practices pose a risk to the health and safety of patients who do not comply with the proper policies and procedures of the facility on patient transfers and documentation.

Cross reference: A-0043, A-0049, A-0338

Findings include:

1.

The policy titled, "Emergency Treatment and Active Labor Act (EMTALA) policy," revealed: "...Appropriate transfer occurs when: the transferring hospital provides medical treatment within its capacity that minimizes the risks to the individual's health, and in the case of a woman in labor, the health of the unborn child; the receiving hospital: (A) has the appropriate space and qualified personnel for the treatment of the individual and (B) has agreed to accept transfer of the individual and to provide appropriate medical treatment...the transfer is effected through qualified personnel and transportation and equipment, as required, including the use of necessary and medically appropriate life support measures during the transfer...Physician Certification refers to written certification by the treating physician ordering a transfer and made prior to the patient's transfer that, based on the information available at the time of transfer, the medical benefits reasonably expected from the provision of appropriate medical treatment at another facility outweigh the increased risks to the individual...."

The policy titled, "Patient Rights and Responsibilities," revealed: "...The patient's rights: ...Receive a referral by your physician to another health care institution, if the facility is not authorized or not able to provide physical health services or behavioral health services needed...."

The policy titled, "Patient Transport-Transfer to other Licensed Health Care Institution," revealed: "...Emergency Department (ED) patients being transferred under EMTALA guidelines: Should a patient require a higher level of care not available at the hospital, the ED physician may decide the ED patient requires transfer to another acute care facility...."

Document titled, "Northwest Medical Center Sahuarita/Houghton Medical Staff Bylaws," revealed "...Basic Qualifications/Conditions of Medical Staff Membership: ...The only people who shall qualify for membership on the Medical Staff are those Practitioners legally licensed in Arizona who: ...Practice in such a manner as not to interfere with the orderly and efficient rendering of services by the Hospital or by other Practitioners within the Hospital...Basic Responsibilities of Medical Staff Membership: Each member of the Medical Staff shall: Provide his/her patients with continuous care at the generally recognized professional level of quality...."

Document titled, "Northwest Medical Center Sahuarita/Houghton Medical Staff Rules & Regulations," revealed: "...The management and coordination of each patient's care, treatment, and services shall be the responsibility of a Physician with appropriate privileges...Patient Transfers: Patient transfers will be prioritized based on an evaluation of each patient's needs at the time of the transfer...The Emergency Department Physician shall obtain the consent of the receiving hospital facility before the transfer of an individual. Said person shall also make arrangements for the patient transfer with the receiving hospital...."

A review of the Community Health System (CHS) Transfer Center Call Summaries for seventeen (17) ED patients revealed the initial request for transfer was for only Northwest system facilities (Northwest Medical Center (Main), Oro Valley Hospital, or Northwest Sahuarita).

A review of the transfer summaries on four (4) out of the seventeen (17) patient medical records revealed that a call was made to the AOC (Administrator on Call) before placement was made to patients outside the Northwest facilities, which included Patient #9 who stayed for more than 40 hours before transfer to another receiving facility out-of-network of Northwest and Patient #1 who had a delayed in surgical services for 48 hours due to AOC interventions.

Employee #19 confirmed in an interview conducted on 10/12/2022 that the initial transfer request is sent to Northwest facilities to keep the patient within the Northwest system. However, Employee #19 further stated that AOC approval is needed if patients who have transfer orders will be moved to an out-of-system facility of Northwest hospitals.

Employee #23 confirmed during an interview on 10/13/2022 that patient transfers are to be within the Northwest hospital network even though other hospital areas have available beds to accept patient transfers from the provider, which increases the waiting times a patient could be transferred based on patient medical needs.

Provider #5 confirmed during an interview on 10/13/2022 that if a patient needs to be transferred out to another facility, the directive was to transfer patients to Northwest hospital network as the first preference, and notification needs to be made to the AOC prior to a transfer is made to the out-of-system facility.

2.

A hospital document titled, " Northwest Medical Center Sahuarita/Houghton Medical Staff Rules & Regulations," revealed: "...Progress notes shall be written or dictated at least daily on all patients except on the day of admission...."

A review of seventeen (17) ED patients medical records revealed five (5) patients that were on ED holds' status did not have daily physician progress notes written.

Patient #3 had no daily progress note on 09/05/2022.

Provider #5 confirmed during an interview conducted on 10/14/2022 that daily progress notes are to be written on all patients.

Based on the review of hospital policies and procedures, documents, medical records observations, and interviews, it was determined that the Hospital failed to meet the requirement of the Conditions of Participation for Nursing Services as evidenced by the following references to standard-level deficiencies:

Cross reference: A-0386: Failure to ensure a staffing acuity plan included a method to determine the types and numbers of nursing personnel required to provide nursing care and meet patient needs.

Cross reference: A-0392:
1. Failure to ensure sufficient staff was available to provide one-to-one (1:1) sitters in the Emergency Department.
2. Failure to ensure sufficient staff was provided for two-night shifts in the Intensive Care Unit.

Cross reference: A-0393: Failure to ensure there were sufficient numbers of nursing personnel available to meet the needs of patients as evidenced by:
1. Surgical services are not provided at night or on the weekends, and
2. The NICU closed due to a lack of staff.

Cross reference: A-0398: Failure to ensure that nursing personnel were knowledgeable and followed policies and procedures regarding:
1. IV medication administration,
2. Documentation of nursing assessments, and
3. Implementation of a staffing acuity plan.

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

Based on reviews of policies and procedures, hospital documents, and staff interviews, the Department determined that the Administrator failed to ensure that an established acuity plan is implemented to determine the types and numbers of nursing personnel needed to provide patient care. This deficient practice poses a threat to the health and safety of patients if the number of nursing personnel could not meet the needs of the patients.

Cross reference: A-0385

Findings include:

Policy titled, "Acuity Staffing Assignment and Monitoring," revealed: "...Patient acuity is measured at least twice in a 24 hour period. The acuity is then utilized when assignments are made by the Clinical Nurse Leader or designee. The following factors, in addition, to the acuity are also part of the full picture and evaluated when making assignments. A. Scope of practice, B. Physical, emotional, spiritual, and educational needs of the patient, C. Intent to provide continuity of care, D. Competency/skill level of licensed staff, E. Support staff and skill level, F. Geographical location of the patient...." Further review of the acuity policy revealed no evidence of an acuity matrix or acuity tool to determine a patient's acuity to assist with staffing.

Review of the staffing assignments for September 2022 for the Emergency Department, Intensive Care Unit, Labor and Delivery Unit, Med-Surg Unit, Operating Room and PACU revealed no patient acuity documented on the assignments sheets.

Employee #12 confirmed during an interview on 10/03/2022 that patient acuity is not use to determine staffing assignments in units.

Based on the review of hospital policies and procedures, hospital documents, medical records, and staff interviews, it was determined that the Hospital failed to ensure that:
1. Sufficient staffing for 1:1 patient needs is available to use as needed in the ED.
2.Adequate personnel is at hand in the Intensive Care Unit (ICU) to provide medical interventions when necessary. These deficient practices pose a risk to the health and safety in caring for patients with mental disorders and meeting the needs of patients admitted to the ICU.

Cross reference: A-0315, A-0385

Findings include:

1.

The policy titled, "Suicide Risk Assessment and Interventions Colombia Protocol in Non-Behavioral Health Setting," received on 10/05/2022, revealed: "...One to One (1:1) Observation: Intervention for high risk for suicide. Continuous observation and staff are able to see the patient in clear view and staff can respond immediately to intervene and assure safety at all times...."

A hospital document titled, "Houghton House Supervisor Daily Report," dated 08/04/2022 identifies: "...ED... ICU NT sitting with SI x2...."

A hospital document titled, "Houghton House Supervisor Daily Report," dated 08/05/2022 identifies: "...ED... ICU NT as {sic} sitter with 2 SI patients...."

A medical record dated 08/03/2022, for Patient #45, revealed orders for Suicide Precautions per unit policy.

A medical record dated 08/03/2022, for Patient #51, revealed orders for Suicide Precautions per unit policy.

The medical record revealed a document titled "Checklist Sitter 1:1," in each Patient #45's and Patient #51's charts both of which were signed and initialed by Employee #32 on 08/04/2022, for the times 1600 through 2100, by Employee #30 from 2100 until 0700 on 08/05/2022, and by Employee #31 on 08/04/2022, for the times 1125 through 1600, and on 08/05/2022 from 0700 until 1535.

The medical record for Patient #52, dated 07/30/2022, reveals: "...patient is actively suicidal with a plan, homicidal thoughts as well...Initiate 1:1 cont. Obs...."

The medical record revealed a document titled, "Checklist Sitter 1:1," in each of Patient #52's and Patient #53's charts, both of which were signed and initialed by Employee #33 on 07/30/2022, from 2032 through 2206, by Employee #34 for 2214 through 2326, and by Employee #35 for 2345 until 0530 on 07/31/2022.

Employee #1 confirmed during an interview conducted on 10/12/2022, that SI stands for suicidal ideation, and there was one sitter assigned to two patients who were on one-to-one observation, in both instances.

2.

The policy titled, "Plan for the Provision of Patient Care," revealed: "...Intensive Care Unit Staffing Requirements: Staffing in the ICU is based on the AZDHS standards at a 1:2 RN to patient ratio. Based on patient acuity, the ratio may flex to a 1:1...The patient ratio is based on the frequency of vital signs, the quantity, and complexity of nursing care and interventions as well as the amount of observation time the patient requires. There is always a minimum of two RNs present in the Critical Care Unit...."

Document titled, "Staffing Assignment ICU," revealed upon review for the month of September on 09/04/2022 night shift there was 1 RN assigned to 2 ACT patients in the unit. Further review revealed the RN was the only nursing personnel assigned to the unit, there was no other nursing personnel assigned to the ICU that shift.

Further review of the ICU schedule on 09/05/2022 night shift revealed that there was 1 RN assigned to the 2 Med-Surg patients in the unit. Further review revealed the RN was the only nursing personnel assigned to the unit, there was no other nursing personnel assigned to the ICU that shift.

Employee #13 confirmed during an interview on 10/03/2022 there should always be 2 RNs present in the ICU at all times.

Based on the review of policies and procedures, hospital documents, observations, and staff interviews, it was determined that the Hospital failed to ensure that sufficient numbers of nursing personnel were available to meet the needs of patients as evidenced by:
1. Surgical services are not provided during nights or on weekends.
2. The NICU closed due to a lack of staff.
These deficient practices pose a risk to the health and safety of patients if the hospital does not have adequate numbers of necessary staff to provide needed services and care to meet the needs of patients.

Cross reference: A-022, A-0043, A-0315, A-0385

Findings include:

1.

The policy titled, " Plan for the Provision of Patient Care Policy," revealed, "...Scope of Service:
Perioperative Services: Operating Room routine hours Monday through Friday 0700-1500 and on an "as needed" basis on Saturday and Sunday; Preop/PACU hours Monday through Friday 0600-1700 and as needed on Saturday and Sunday...."

A review of the September 2022 staffing schedule for Preop/PACU revealed that 3 RNs were available to cover both units, with no call scheduled for nights or weekends.

A review of the September 2022 staffing schedule for the Operating Room revealed 9 RNs available to cover 2 operating rooms, with no call scheduled for nights or weekends.

Observation conducted on 10/03/2022 revealed 4 operating rooms were available in the Perioperative area.

Employee #9 confirmed during an interview on 10/03/2022 that surgeries were not available for night or weekend surgeries because there are no available staff to provide the surgical services.

Employee #10 confirmed during an interview on 10/03/2022 that the Perioperative Department including the OR and PACU was only operational during the weekdays. Employee #10 confirmed that there is currently only enough staff to run two (2) of the four (4) operating rooms. Employee #10 confirmed that the hospital currently was not providing surgical services at night or on weekends due to a lack of staff to take night and weekend calls.

Employee #10 conformed on 10/03/2022 that currently there are nine (9) OR staff to run the two (2) OR rooms. Employee #10 stated there would need to be a minimum of twelve (12) OR staff to be able to run all four (4) OR rooms and take the call at night and on weekends. Employee #10 stated currently there are three (3) Preop/PACU nurses available to prep patients for surgery and recover patients after surgery. Employee #10 stated there would need to be a minimum of five (5) nurses for Preop/PACU to meet the needs of four (4) ORs and to take the call at night and on the weekends.

2.

The policy titled, " Plan for the Provision of Patient Care Policy," revealed, "...Scope of Service: ...Women's and Perinatal Services: Level II Maternal/Child for low to moderate-risk maternal and neonatal patients, 8-bed Newborn Special Care Nursery provides care to newborns 32 weeks or greater gestation and operates 24/7 hours per day, the O/P Triage Unit is operational 24 hours a day, 7 days a week...."

Observation while on tour on 10/03/2022 revealed the NICU was closed and non-operational.

Employee #5 confirmed during an interview on 10/03/2022 that the NICU had not been operational since 08/27/2022 due to lack of staff to provide care to neonatal patients.

Based on a review of hospital policy and procedure, medical record, and interview, it was determined the Nurse Executive failed to ensure the following deficient practices did not occur:

Cross reference: A-0385

1. Saline flushes used for intravenous lines were not appropriately documented. This deficient practice poses the potential risk of inaccurate input and output recordings, failure to recognize a malfunctioning venous access device, and tubing and catheters for medication and blood administration being improperly cleared between administrations.

2. Patients waiting in the Emergency Department (ED) for an inpatient bed, were not appropriately assessed and reassessed according to the admitting unit policy. This deficient practice poses the potential risk of healthcare workers being unaware of a decline or change in patient status, patients not receiving appropriate treatment for a change in status, and an increase in morbidity and mortality.

3. Staff were not knowledgeable about the acuity plan and how to implement it. This deficient practice poses a potential risk to the health and safety of patients when the registered nurse does not know how to utilize, and implement the acuity plan for the purpose of determining a patient's acuity and safe patient assignments.

Findings Include:

1. Hospital policy titled, "Venous Access Device Flushes Protocol," received on 10/05/2022, reveals: "...Record the flush on the MAR according to documentation guidelines...."

A medical record review of Patient #2's chart revealed no flushes documented.

Employee #29 confirmed during an interview conducted on 10/05/2022, that there were no flushes documented in Patient #2's medical record.

Employee #2 confirmed during an interview conducted on 10/04/2022, that flushes were not documented in Patient #2's medical record.

2. Policy titled, "Interdisciplinary Assessment-Reassessment Policy," received on 10/05/2022, reveals: "...To define and screen the appropriate care, treatment and services to meet the initial needs of the patient as well as his/her changing needs while in the inpatient or outpatient setting...Medical Surgical Unit Reassessment Time Frame ...Q6 hours ...."

Patient #4 was initially seen in the ED on 07/20/2022 at 0338 by Provider #3. Patient #4 received orders "...Admit to Inpatient...General Admit Non-ICU Adult..." on 07/20/2022 at 11:24, however, s/he remained in the ED.

A review of Patient #4's medical record revealed the absence of documentation of nursing assessments from 07/20/2022 at 1855 to 07/21/2022 at 0651, Patient #4's death.

Employee #29 confirmed in an interview on 10/12/2022, that the patient had orders to admit the patient to the medical/surgical unit. However, no patient assessments were documented after 07/20/2022 at 1855.

3. Policy titled, "Acuity Staffing Assignment and Monitoring," revealed: "...The facility has a process for assessing the acuity of patients and adjusting staffing and assignments based upon {sic} the nursing care required for the patient population...Purpose: To provide guidelines for meeting patients' needs for nursing care based upon{sic} the patient's acuity and the staff available to care for them...This acuity is then utilized when assignments are made by the Clinical Nurse Leader or designee...."

Employee #11 confirmed during an interview on 10/03/2022 that s/he was not aware of an acuity policy. Employee #11 stated that s/he had never seen the acuity plan nor had s/he ever been oriented to how to utilize the acuity plan.

Employee #12 confirmed on 10/03/2022 that s/he was not shown an acuity plan and or not oriented in how to utilize the acuity plan for the provider.

Based on the review of hospital policies/procedures, medical records, and interviews, it was determined that the hospital failed to comply with the provisions of Surgical Services, related to the availability of services and staffing requirements as evidenced by:

Cross reference: A-0941: The hospital failed to ensure there were sufficient numbers of personnel to offer surgical services as needed by patients twenty-four hours a day/ seven days a week.

Cross reference: A-0951: The hospital failed to ensure surgical services were available to meet the needs of patients twenty-four hours a day/ seven days a week.

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

Based on the review of policies and procedures, hospital documents, and staff interviews, it was determined that the Hospital failed to ensure there were sufficient numbers of personnel to offer surgical services as needed by patients. This deficient practice poses a risk to the health and safety of patients if patients require necessary and emergency surgical interventions and the hospital is unable to provide surgical services.

Cross reference: A-0022, A-0043, A-0315, A-0393

Findings include:

The policy titled, "Plan for the Provision of Patient Care Policy," revealed: "...Scope of Service: ...Perioperative Services: Operating Room routine hours Monday through Friday 0700-1500 and on an "as needed" basis on Saturday and Sunday; Preop/PACU hours Monday through Friday 0600-1700 and as needed on Saturday and Sunday...."

A review of the September 2022 staffing schedule for Preop/PACU revealed 3 RNs available to cover both units.

A review of the September 2022 staffing schedule for the Operating Room revealed 9 RNs available to cover 2 operating rooms.

Observation conducted on 10/03/2022 revealed 4 operating rooms were available in the Perioperative area.

Employee #9 confirmed during an interview on 10/03/2022 that there are no surgeries for nights or on weekends because there are not enough OR and PACU staff to take night and weekend calls.

Employee #10 confirmed during an interview on 10/03/2022 that the Perioperative Department including the OR and PACU was only operational during the weekdays. Employee #10 confirmed that there is currently only enough staff to run two (2) of the four (4) operating rooms. Employee #10 confirmed that the hospital currently was not providing surgical services at night or on weekends due to a lack of staff to take night and weekend calls. Employee #10 stated currently there are nine (9) OR staff to run the two (2) OR rooms. Employee #10 stated there would need to be a minimum of twelve (12) OR staff to be able to run all four (4) OR rooms and take calls at night and on weekends. Employee #10 stated currently there are three (3) Preop/PACU nurses available to prep patients for surgery and recover patients after surgery. Employee #10 stated there would need to be a minimum of five (5) nurses for Preop/PACU to meet the needs of four (4) ORs and to take call at night and on the weekends.

Based on policies and procedures, hospital documents, medical records, and staff interviews, it was determined the Hospital failed to ensure surgical services were available to meet the needs of patients. This deficient practice poses a risk to the health and safety of patients when necessary surgical interventions are not provided or are delayed for patients.

Cross reference: A-0022, A-0043, A-0315

Findings include:

The policy titled, "Plan for the Provision of Patient Care Policy," revealed: "...Scope of Service: ...Perioperative Services: Operating Room routine hours Monday through Friday 0700-1500 and on an "as needed" basis on Saturday and Sunday; Preop/PACU hours Monday through Friday 0600-1700 and as needed on Saturday and Sunday...Perioperative staff interacts with all departments in the organization to provide optimal service to patients and their families. The staff works closely with the ED and inpatient care units...."

A review of staffing schedules for the month of September 2022 for the Perioperative Department revealed no staff were available or scheduled for night and weekend calls to assist with emergency surgeries after hours or on a needed basis.

Emergency Department (ED) Activity Logs were reviewed for the months of July, August, and September 2022. In the month of July, there were sixteen (16) patients that required emergency surgical interventions and were transferred to other hospitals as there was no surgical personnel available to provide the necessary surgeries. In the month of August 2022, there were eleven (11) patient transfer outs to other facilities because no surgical personnel was available to provide the necessary surgical interventions on weekends and on nights. In the month of September 2022, there were sixteen (16) patients needing emergency surgeries and were transferred out as there was no surgical personnel to provide the necessary surgical intervention.

Further review of the ED Activity Logs revealed in on 08/12/2022 a patient (Patient #55) was admitted to the ED for an ostomy prolapse that required surgical intervention. There was no surgical coverage available at the facility until Monday, 08/15/2022. The patient refused to be admitted to the facility to wait until 08/15/2022 for surgery and left the facility Against Medical Advice (AMA).

A review of Patient #1's medical records revealed that on 08/13/2022 s/he needed immediate surgery based on the physician's diagnosis, and medical assessment, and was scheduled to be transferred to another facility the following day due to no availability of surgical staff on nights or weekends. However, hospital administration denied the transfer and had the patient admitted to the facility, and surgery was not performed until 09/15/2022.

Employee #9 confirmed during an interview on 10/03/2022 that there was no surgical staff to take night and weekend calls for the Perioperative Department and therefore no surgeries are performed evenings, nights, or weekends.

Employee #10 confirmed during an interview on 10/03/2022 that there is enough Perioperative staff available to run two (2) of the four (4) facility operating rooms. Employee #10 confirmed that often surgeries are held up until PACU staff are available to recover the next surgical case, as there is not enough PACU staff to recover patients safely. Employee #10 confirmed that there are no surgeries performed, even emergency surgeries, at night or on the weekends, as there is no surgical staff available to take the required night and weekend calls.

Provider #5 confirmed during an interview on 10/13/2022 that often surgical patients have to be transferred out to other facilities for surgical interventions because there is no surgery offered at night or on the weekends.