HospitalInspections.org

Based on interview, and record review, the hospital failed to ensure that staff were appropriately trained and received orientation for their positions. The hospital also failed to have a process to track and ensure that staff were current with their certifications for Basic Life Support (BLS, level of care for medical care for victims with life-threatening illnesses or injuries, until full medical care by more qualified individual can be given, or at a facility that offers advanced life support), Advance Cardiac Life Support (ACLS, advanced life saving measures taken by certified health care professionals when a patient's heartbeat or breathing stops) and Pediatric Advanced Life Support (PALS, advanced life saving measures taken by certified health care professionals when an infant or child's heartbeat or breathing stops).

These practices resulted in a systemic failure and noncompliance with 42 CFR 482.11 Condition of Participation: Compliance with Federal, State and Local Laws. The hospital census was three.

The severity and cumulative effect of these practices had the potential to place all patients at risk for their health and safety, also known as Immediate Jeopardy (IJ).

By the survey exit date, 08/25/21 at 3:30 PM, the hospital was not able to provide an acceptable plan of correction (POC) to remove the risk of harm to patients, and the IJ remained.

Based on observation, interview, record review and policy review, the hospital failed to ensure that:
- Staff received job specific orientation for eight staff out of 25 staff personnel records reviewed;
- Nursing staff from an affiliate hospital had received orientation to the hospital prior to their scheduled shifts within the perioperative (preoperative, recovery room and operating room suites) unit;
- Three Registered Nurses (RNs) that staffed the Emergency Department (ED) were current with their certification in Basic Life Support (BLS, level of care for medical care for victims with life-threatening illnesses or injuries, until full medical care by more qualified individual can be given, or at a facility that offers advanced life support), of nine ED RNs personnel records reviewed;
- Six RNs that staffed the ED were current with their certification in Advanced Cardiac Life Support (ACLS, advanced life saving measures taken by certified health care professionals when a patient's heartbeat or breathing stops), of nine ED RNs personnel records reviewed;
- Two RNs that staffed the ED were current with their certification in Pediatric Advanced Life Support (PALS, advanced life saving measures taken by certified health care professionals when an infant or child's heartbeat or breathing stops), of nine ED RNs personnel records reviewed;
- One Licensed Practical Nurse (LPN) that staffed the ED was current with her certification in BLS of three LPNs personnel records reviewed;
- Three RNs that staffed the Geriatric psychiatry (Geropsych, a unit that focuses on treating mental health and psychiatric disorders in older adults) unit were current with their certification in BLS, of four Geropsych RNs personnel records reviewed;
- One RN that staffed the Operating Room (OR) was current with their certification in ACLS of two OR RNs personnel records reviewed; and
- One Surgical Tech was current with their certification in BLS of one Surgical Tech personnel file reviewed.
These failures placed all patients who received care at risk for their health and safety. The hospital census was three.

Findings included:

Review of personnel files on 08/18/21 at 2:15 PM and on 08/19/21 at 8:35 AM, showed that eight out of 25 staff personnel files reviewed had not received job specific orientation.

During an interview on 08/18/21 at 2:15 PM and on 08/19/21 at 8:35 AM, Staff CCC, Human Resources Generalist, stated that if job specific orientation was not in the employee personnel files then the employee had not received orientation.

During an interview on 08/17/21 at 9:44 AM, Staff H, Agency RN, stated that:
- She had worked on the Geropsych unit for four weeks.
- She had one day of orientation with a LPN.
- She had worked at a children's residential mental health facility in the past.
- She had not reviewed any policies.
- She had not received any restraint training.
- She was unfamiliar with the meaning of one hour face to face in regard to restraint and seclusion.
- She was unaware of fall risk interventions based on the fall risk score.
- She was unaware of how to update the patient's care plan.

Observation on 8/23/21 at 11:31 AM showed Staff OOO, affiliate hospital RN, with Patient #35 in preoperative Room #1 for post-procedure anesthesia recovery with the patient unconscious.

Although requested, the hospital failed to provide personnel files for Staff OOO, RN, and Staff PPP, LPN, to verify licensure and certification status

During an interview on 08/23/21 at 10:18 AM and 11:45 AM, Staff OOO, affiliate hospital RN, stated that she had not worked at this hospital before and received no orientation to the hospital and limited orientation to the perioperative unit.

During an interview on 8/23/21 at 12:55 PM, Staff PPP, LPN stated that she worked at an affiliate hospital and had not received any orientation specific to this hospital and received two days orientation limited to endoscopy procedures.

Review of the undated hospital document titled, "RN - Emergency Room, Medical Surgical, Geropsych Job Summary," showed that BLS and ACLS certifications were required with PALS certification required if worked in the ED.

Review of the undated hospital document titled, "Licensed Practical Nurse, Job Description," showed that they were to be CPR certified.

Review of personnel records on 08/18/21 at 2:15 PM and on 08/19/21 at 8:35 AM, showed two currently scheduled ED RN's (Staff SS, TT, WW and XX) out of nine ED RNs personnel records reviewed were not current on certifications and two currently scheduled ED LPNs (Staff E and AAA) out of three ED LPNs personnel records reviewed was not current on certifications. Staff SS, ED RN was not current in BLS, ACLS or PALS. Staff TT, ED RN was not current in BLS and ACLS. Staff WW, ED RN was not current in PALS. Staff XX, ED RN was not current in PALS. Staff AAA, LPN was not current in BLS. Staff H, Geropsych RN and Staff E, LPN were not current in BLS.

Review of the hospital document titled, "Daily Nurse Staffing Page," dated 08/16/21 showed Staff WW, RN (no current PALS) was the house supervisor and also the ED RN for the night shift.

Review of the hospital document titled, "Daily Nurse Staffing Page," dated 08/17/21 showed Staff E, LPN was scheduled as the ED LPN (no current BLS) for day shift and Staff XX, ED RN ( no current PALS) for the night shift. Staff H, RN (no current BLS) was scheduled in the Geropsych unit for day shift and Staff XX, ED RN (no current PALS) was scheduled as House Supervisor and ED RN for the night shift.

Review of the hospital document titled, "Daily Nurse Staffing Page," dated 08/19/21 showed Staff E, LPN was scheduled as the ED LPN (no current BLS) for day shift and Staff WW, RN (no current PALS) was scheduled as the House Supervisor and ED RN with Staff AAA, LPN (no current BLS).

Review of the hosptial document titled, "Daily Nurse Staff Page," dated 08/20/21 showed Staff TT, RN (no current BLS or ACLS) was scheduled as the House Supervisor and ED RN for night shift.

Review of the hospital document titled, "Daily Nurse Staffing Page," dated 08/21/21 showed Staff TT, RN (no current BLS or ACLS) was scheduled as the House Supervisor and Staff SS, RN (no current BLS, ACLS or PALS) was scheduled as the ED RN for the night shift.

The "Daily Nurse Staffing Pages" for 08/16/21 through 08/21/21 had nursing staff scheduled that were not current with their appropriate certifications.

Review of the hospital's policy titled, "Cardiopulmonary Resuscitation in the Operating Room," revised 09/2018 stated that all nursing personnel in surgery were certified in ACLS and attended recertification every two years.

Staff V, OR RN, was not current in ACLS and Staff U, Surgical Tech, was not current in BLS.

The hospital had performed surgical cases on 08/18/21 with both Staff V and Staff U scheudled for those cases.

During an interview on 08/25/21 at 1:28 PM, Staff BB, Chief Executive Officer (CEO) stated that prior to the survey he was unaware that staff were not current with their required certifications.


39562




44536

















41474

Based on observation, interview, record review and policy review, the hospital's Governing Body failed to:
- Ensure staff received job specific orientation for eight staff out of 25 staff personnel records reviewed. (A-0023)
- Ensure nursing staff from an affiliate hospital had received orientation to the hospital prior to their scheduled shifts within the perioperative (preoperative, recovery room and operating room suites) unit. (A-0023)
- Ensure three Registered Nurses (RNs) that staffed the Emergency Department (ED) were current with their certification in Basic Life Support (BLS, level of care for medical care for victims with life-threatening illnesses or injuries, until full medical care by more qualified individual can be given, or at a facility that offers advanced life support), of nine ED RNs personnel records reviewed. (A-0023)
- Ensure six RNs that staffed the ED were current with their certification in Advanced Cardiac Life Support (ACLS, advanced life saving measures taken by certified health care professionals when a patient's heartbeat or breathing stops), of nine ED RNs personnel records reviewed. (A-0023)
- Ensure two RNs that staffed the ED were current with their certification in Pediatric Advanced Life Support (PALS, advanced life saving measures taken by certified health care professionals when an infant or child's heartbeat or breathing stops), of nine ED RNs personnel records reviewed. (A-0023)
- Ensure one Licensed Practical Nurse (LPN) that staffed the ED was current with her certification in BLS of three LPNs personnel records reviewed. (A-0023)
- Ensure three RNs that staffed the Geriatric psychiatry (Geropsych, a unit that focuses on treating mental health and psychiatric disorders in older adults) unit were current with their certification in BLS, of four Geropsych RNs personnel records reviewed. (A-0023)
- Ensure one RN that staffed the Operating Room (OR) was current with their certification in ACLS of two OR RNs personnel records reviewed. (A-0023 and A-0944)
- Ensure one Surgical Tech was current with their certification in BLS of one Surgical Tech personnel file reviewed. (A-0023 and A-0944)
- Ensure that the facility functioned as a hospital in providing services to medical inpatients as defined in the Social Security Act section 1861 (e), instead functioned as a psychiatric hospital defined in Section 1861 (f) with a dedicated Emergency Department (ED). (A-0057)
- Ensure that the CEO effectively managed the hospital and that the hospital met all regulatory requirements. (A-0057)
- Ensure that the hospital developed and operated according to an annual operating budget. (A-0073)
- Ensure that a three year capital expenditure plan was completed. (A-0073)
- Ensure that contracted services furnished services that permitted the hospital to comply with all applicable conditions of participation. (A-0085 and A-0308)
- Ensure the hospital followed their policy and post Patient Rights signage on three of four units observed in the hospital. (A-0116)
- Post a notice that the hospital did not have a Doctor of Medicine (MD), or a Doctor of Osteopathic medicine (DO), present in the hospital 24 hours per day, seven days per week. (A-0131)
- Provide surgical patients with a properly executed informed consent with regard to procedural risks of low probability, but high severity, which required transfer of care to another hospital and physician. (A-0131 and A-0955)
- Ensure patients were informed of their rights to formulate an Advanced Directive (AD, a legal document where the patient can direct their medical care wishes should the patient become unable to make their own decisions) for nine patients (#3, #7, #8, #12, #13, #19, #20, #21 and #22) of 12 patient records reviewed. (A-0132)
- Ensure that all patients on the Geriatric psychiatry unit were provided care in a safe setting when contraband (items that are illegal, forbidden, or that can be used to harm self or others) was left out in the open, to be easily accessed by patients. (A-0144)
- Ensure that patients were provided care in a safe setting when one patient (#1) of one patient on line of sight (LOS, continuous visual contact with the patient) while awake observation status, was allowed to obtain an ink pen and stabbed herself. (A-0144 and A-0395)
- One patient (#2) was left unattended with direct access to contraband (items that are illegal, forbidden, or that can be used to harm self or others) lying on a table.
- Ensure the special precautions patient observation record was documented appropriately on two patients (#1 and #2) of two patients on special precautions. (A-0144 and A-0395)
- Ensure there was an effective, ongoing, hospital-wide, data driven Quality Assurance and Performance Improvement (QAPI, process for reporting and/or identifying adverse events, near misses or review of high risk, problem prone areas for patient safety) program that used data to monitor the quality, effectiveness and safety of care and services provided for 12 departments out of 22 departments reviewed. (A-0273)
- Ensure the Chief Nursing Officer (CNO) provided adequate oversight and supervision of nursing personnel as evidenced by the Geropsych, a unit that focuses on treating mental health and psychiatric disorders in older adults) unit was staffed with non-trained and non-qualified staff and the interim Geropsych director had no experience in the care of psychiatric patients. (A-0386)
- Ensure hospital policy was followed and all inpatient care units were staffed with at least one RN. (A-0392)
- Ensure staff followed hospital policy when a fall risk assessment and careplan update was not completed for one patient (#2) of one patient who experienced a fall while in the hospital. (A-0395)
- Ensure Licensed staff were oriented to hospital policies and procedures. (A-0398)
- Ensure the CNO fulfilled his responsibility for all licensed nursing personnel to know the hospital's policies and procedures in order for them to adhere to those policies and procedures. (A-0398)
- Ensure the CNO evaluated all nursing performance with a performance evaluation at least once a year. (A-0398)
- Ensure the Perioperative (preoperative, recovery room and operating room suites) staff were aware of procedure to notify hospital staff if in the event of an emergency within the perioperative area. (A-0398)
- Ensure staff administered medications according to physicians' orders and hospital policy for three patients (#2, #41 and #42) of three patients reviewed. (A-0405)
- Have a coding and indexing system that allowed for timely retrieval of medical records. (A-0441)
- Provide a secure environment that prevented patient's medical records from being accessed by unauthorized individuals. (A-0489)
- Ensure that the pharmacy had a functional Laminar Flow Hood (enclosed work bench which prevents contamination of medication when the medication is mixed or prepared). (A-0501)
- Provide up-to-date reference material on drug therapy in either electronic or hard copy format. (A-0510)
- Properly execute the approved Utilization Review (UR) plan. (A-0653)
Ensure endoscopes (lighted tube with a camera, used to visualize the inside of organs) were properly disinfected in accordance to hospital policy and recommended practice. (A-749 and A-0951)
- Ensure sterilizers (machines that use high heat and steam to kill harmful organisms) were inspected on a regular basis and in accordance to hospital policy and recommended practice. (A-749 and A-0951)
- Ensure items which were not disposable, and intended for use on multiple patients, were properly packaged to maintain sterile conditions. (A-749)
- Ensure staff performed hand hygiene in accordance to hospital policy and recommended practice (A-749).
- Ensure hand sanitizer dispensers were filled and functioning in three of six Emergency Department (ED) bays when a sink was not available. (A-749)
- Ensure medical equipment was free from residue and debris. (A-749)
- Ensure disposable, single-use items were discarded when opened. (A-749)
- Ensure food service personnel wore required hairnets while preparing and serving food. (A-749)
- Ensure kitchen utensils were free of paper and food residue. (A-749)
- Ensure food in the freezer was properly sealed to prevent exposure to air. (A-0749)
- Ensure expired food was removed from patient refrigerators and that the refrigerators were clean. (A-749)
- Ensure food products were properly labeled, dated and stored. (A-749)
- Ensure patient linens and supplies were stored in nonporous cleanable cabinets. (A-749)
- Ensure ice dispensers were clean and free of buildup. (A-749)
- Ensure ceilings were free of peeling paint and that ventilation access panels were free of rust. (A-749)
- Ensure that the staff member designated as the Infection Prevention Officer was appointed to the position by the Governing Body (GB) and that the appointment was based on the recommendations of medical staff leadership and nursing leadership. (A-0770)
- Ensure that the Infection Prevention Officer provided competency-based training and education on infection control and prevention guidelines and practices. (A-0775)
- Ensure the emergency call system in the perioperative (preoperative, recovery room and operating room suites) area was operational. (A-0956)
- Ensure adequate provisions for immediate post-operative care were available. (A-0957)
- Appropriate practices with regard to emergency preparation for malignant hyperthermia (a severe reaction to certain drugs used for anesthesia) were maintained. (A-0951)
- An appropriate updated physical examination of surgical patients was provided or documented. (A-0953)
- A complete and up-to-date operating room register was maintained and available. (A-0958)
- An appropriate post-operative note was immediately available following surgery and signed by the surgeon. (A-0959)
- Ensure that the Respiratory Therapy Department (medical specialty concerned with problems associated with the lungs or breathing) was provided medical direction by a doctor of medicine (MD) or osteopathy (DO) with the knowledge, experience and capabilities to supervise and administer the service properly. (A-1153)
- Provide written policies for the delivery of respiratory (pertaining to the lungs) care services that were developed and approved by the medical staff. (A-1160)

These practices resulted in a systemic failure and noncompliance with 42 CFR 482.12 Condition of Participation: Governing Body. The hospital census was three.

The severity and cumulative effect of these practices had the potential to place all patients at risk for their health and safety, also known as Immediate Jeopardy (IJ).

By the survey exit date, 08/25/21 at 3:30 PM, the hospital was not able to provide an acceptable plan of correction (POC) to remove the risk of harm to patients, and the IJ remained..
















39562

Based on observation, interview, record review and review of the Social Security Act of 1935, the Governing Body and the Chief Executive Officer (CEO) failed to ensure that the facility functioned as a hospital in providing services to medical inpatients as defined in the Social Security Act section 1861 (e), instead functioned as a psychiatric hospital defined in Section 1861 (f) with a dedicated Emergency Department (ED). As a result of this failure, patients that presented to the ED in need of medical inpatient care were transferred to other hospitals and/or were admitted as inpatients to the psychiatric unit if applicable. Patients who received surgical services were not able to be admitted if in the event they required such treatment after a surgical procedure. The hospital census was three with all three patients in the Geriatric Psychiatric (Geropsych, a unit which focuses on the treatment in mental health in older adults).

Findings included:

Review of the hospital's undated job description titled, "Chief Executive Officer," showed that the CEO was responsible:
- For all aspects of the operation of the hospital.
- For ensuring that the hospital maintained accreditation and licensure.
- For the development, implementation, and staff compliance with all hospital policies and procedures.
- Ensuring that the hospital staff maintain the appropriate licensing and provide quality patient care.
- For ensuring that the physical property would be maintained and that it remained in a good and safe state of repair and operation.

During an interview on 08/18/21 at 10:15 AM, Staff BB, Interim CEO and Regional Revenue Cycle Director, stated that he was responsible for all aspects of the hospital.

Review of the document titled, "Social Security Act of 1935," showed that:
-Section 1861 (e) (1), the term "hospital" means an institution which (e) is primarily engaged in providing, by or under the supervision of physicians, to inpatients (A), diagnostic services and therapeutic services for medical diagnosis, treatment, and care of injured, disabled, or sick persons (B), or rehabilitation services for the rehabilitation of injured, disabled, or sick persons.
-Section 1861 (f) defines a psych hospital (f) the term "psychiatric hospital" means an institution which -
(1) is primarily engaged in providing, by or under the supervision of a physician, psychiatric services for the diagnosis and treatment of mentally ill persons;
(2) satisfies the requirements of paragraphs (3) through (9) of subsection (e);
(3) maintains clinical records on all patients and maintains such records as the Secretary finds to be necessary to determine the degree and intensity of the treatment provided to individuals entitled to hospital insurance benefits under part A: and
(4) meets such staffing requirements as the Secretary finds necessary for the institution to carry out an active program of treatment for individuals who were furnished services in the institution.
In the case of an institution which satisfies paragraphs (1) and (2) of the preceding sentence and which contains a distinct part which also satisfies paragraphs (3) and (4) of such sentence, such distinct part shall be considered to be a "psychiatric hospital."

Review of the document titled, "Exhibit 286 Hospital Database Worksheet," dated 08/16/21 showed that the hospitals' status was listed as a Medicare short term hospital staffed for 10 beds with an average daily census of four. The hospital provided services for Geropsych, a dedicated ED, inpatient surgical services, and inpatient rehab services.

Observation on 08/16/21 at 2:42 PM, of the inpatient medical/surgical unit, showed eight available patient rooms with no patients currently admitted and no staff were present on the unit.

Record review of the hospital's census report from 08/16/20 to 08/16/21 showed the last inpatient admission to the medical/surgical unit was on 01/07/21.

Review of the hospital's daily nurse staffing schedule, from 08/16/21 through 08/19/21, showed no nursing staff scheduled for the medical/surgical unit.

During an interview on 08/16/21 at 5:40 PM, Staff BB, Interim CEO, stated that the medical surgical unit wasn't "officially closed," but the hospital had not accepted medical or surgical inpatient admissions to that unit since 01/2021. He also stated that the hospital had not had a Swing Bed (Medicare program in which a patient can receive acute care, then if needed, skilled nursing care in the same facility) patient since 08/2019. Staff BB stated that the medical/surgical unit had been closed due to a lack of staff.

During an interview on 08/18/21 at 3:20 PM, Staff BB, Interim CEO stated that the hospital currently functioned as a Geropsych inpatient unit with an ED that was able to stabilize and transfer the patients as they were not capable of medical inpatient admissions.

During an interview on 08/18/21 at 9:45 AM, Staff DD, Physician, stated that this hospital only admits patients to the Geropsych unit. All other patients that could be admitted for medical reasons were transferred because the medical/surgical unit was not staffed.







39147







39562

Based on interview and record review the facility failed to provide an approved annual operating budget for 2021. This failure could prevent the facility from identifying sources of financing and anticipated expenditures, and result in inadequate hospital finances. The facility census was three.

Findings included:

Even though requested, the hospital failed to provide an annual operating budget and a three year capital expenditure plan.

Review of the hospital's document titled, "Bylaws of Noble Health Fulton, Inc.," signed 03/26/20, showed that the Board of Directors would meet annually to conduct the business of the corporation, to include the management and activities of the hospital.

Review of the hospital's undated job description titled, "Chief Executive Officer (CEO)," showed that the CEO would serve as the Vice President (VP) of the Governing Body, and would be responsible for presenting an annual budget that showed the hospital's expected revenue and expenditures to the Governing Body.

During an interview on 08/18/21 at 10:15 AM, Staff BB, Interim Chief Executive Officer (CEO) and Regional Revenue Cycle Director, stated that the hospital did not currently have an annual operating budget. The Chief Financial Officer (CFO) resigned in July 2021. The governing body was supposed to meet monthly, this had not occurred. They had met and discussed the need for an annual budget, but it had not been completed, and a timeline for completion had not been established.

Based on interview and record review the facility failed to provide an approved annual operating budget for 2021. This failure could prevent the facility from identifying sources of financing and anticipated expenditures, and result in inadequate hospital finances. The facility census was three.

Findings included:

Even though requested, the hospital failed to provide an annual operating budget and a three year capital expenditure plan.

Review of the hospital's document titled, "Bylaws of Noble Health Fulton, Inc.," signed 03/26/20, showed that the Board of Directors would meet annually to conduct the business of the corporation, to include the management and activities of the hospital.

Review of the hospital's undated job description titled, "Chief Executive Officer (CEO)," showed that the CEO would serve as the Vice President (VP) of the Governing Body, and would be responsible for presenting an annual budget that showed the hospital's expected revenue and expenditures to the Governing Body.

During an interview on 08/18/21 at 10:15 AM, Staff BB, Interim Chief Executive Officer (CEO) and Regional Revenue Cycle Director, stated that the hospital did not currently have an annual operating budget. The Chief Financial Officer (CFO) resigned in July 2021. The governing body was supposed to meet monthly, this had not occurred. They had met and discussed the need for an annual budget, but it had not been completed, and a timeline for completion had not been established.

Based on interview and record review, the facility failed to have an institutional plan and budget prepared under the direction of the Governing Body and by a committee consisting of representatives of the Governing Body, the administrative staff and the medical staff of the hospital. This failure had the potential to affect the quality of care and safety of all patients. The hospital census was three.

Findings included:

Even though requested, the hospital failed to provide an annual operating budget and a three year capital expenditure plan.

Review of the hospital's document titled, "Bylaws of Noble Health Fulton, Inc.," signed 03/26/20, showed that the Board of Directors would meet annually to conduct the business of the corporation, to include the management and activities of the hospital.

Review of the hospital's undated job description titled, "Chief Executive Officer (CEO)," showed that the CEO would serve as the Vice President (VP) of the Governing Body, and would be responsible for presenting an annual budget that showed the hospital's expected revenue and expenditures to the Governing Body.

During an interview on 08/18/21 at 10:15 AM, Staff BB, Interim Chief Executive Officer (CEO) and Regional Revenue Cycle Director, stated that the hospital did not currently have an annual operating budget. The Chief Financial Officer (CFO) resigned in July 2021. The governing body was supposed to meet monthly, this had not occurred. They had met and discussed the need for an annual budget, but it had not been completed, and a timeline for completion had not been established.

Based on interview, record review and policy review, the hospital's Governing Body failed to ensure that contracted services furnished services that permitted the hospital to comply with all applicable conditions of participation. This failure had the potential to cause inadequate monitoring of services and poor patient outcomes. The hospital census was three.

Findings included:

Review of the hospital's policy titled, "Quality Assessment & Performance Improvement (QAPI, process for reporting and/or identifying adverse events, near misses or review of high risk, problem prone areas for patient safety) - Patient Safety Plan," revised 02/2020, showed the following:
- The scope of the QAPI and Patient Safety Plan addresses all areas, including care provided by clinical contracted services.
- The Board of Managers, the Medical Executive Committee and leadership will review the QAPI plan, at a minimum, annually. The Board of Managers will give final approval of the plan.
- The hospital strives to achieve optimal clinical outcomes for all its patients while providing care in the safest environment possible. The hospital collects data on the following: anesthesia/moderate sedation; utilization management; sentinel events; adverse events; and critical and/or pertinent processes, both clinical and supportive.
- QAPI is a continuous process and the goal of QAPI involved the identification and measurement of variances in current practice and services that can lead to less than optimal performance; identification and implementation of changes to enhance existing performance; and consistent monitoring of changes to ensure sustained gains.

MMMReview of the hospital's document "Environment of Care Manual, Equipment Management," with included policy titled, "Medical Equipment Management Plan," reviewed 03/2021, stated that at least one aspect of the program would be monitored quarterly and reported to the Safety Committee for inclusion in QAPI.

Review of the hospital's document titled, "Patient Care Contracted Services, QAPI," dated 01/2021, showed eight clinical contracted services listed. Information was to be reported quarterly at QAPI meetings and an annual review by the Chief Executive Officer (CEO) and Chief Nursing Officer (CNO). Out of the eight clinical contracted services listed, only two of the services, Radiology and MRI, reported data to the QAPI program.

Review of the hospital's undated document titled, "Contract Name," showed that the hospital contracted with 51 different services.

Even though requested, the hospital was unable to provide evidence that all of the contracted services were incorporated into the hospital program and were reviewed annually.

Even though requested, the hospital QAPI Director was not able to be interviewed due to illness.

MMMDuring an interview on 8/17/21 at 3:25 PM, Staff W, stated that the hospital had not executed a formal contract with a biomedical engineer, but had a verbal agreement that facilitated the inspection of equipment not otherwise covered by service and maintenance contracts. The biomedical engineer does not participate in the hospital's QAPI program.

MMMDuring an interview on 08/23/21 at 12:50 PM, Staff TTT, Certified Registered Nurse Anesthetist (CRNA, registered nurses who have obtained graduate-level education and board certification in anesthesia), stated that the anesthesia services were contracted with the hospital. He was not aware of any involvement in the hospital's QAPI program.

During an interview on 08/18/21 at 11:00 AM, Staff EE, Regional Risk Management Director, stated that she had no idea if contracted services were incorporated into the hospital QAPI program. The hospital was in the process of tracking event reports in QAPI, it had not been formalized yet. She was not in charge of QAPI at this hospital, that staff person was on sick leave.

During an interview on 08/25/21 at 1:30 PM, Staff BB, Interim CEO, stated that the Quality Director had been in her position since June of 2021 and she was in the process of getting the QAPI program organized. He recalled that at the June Medical Executive Meeting, the QAPI director presented QAPI information and was in the process of putting QAPI plans together. The Medical Executive Committee approves the yearly QAPI plan.















44536

Based on observation, interview, record review and policy review, the hospital failed to ensure that:
- Patient's Rights signage was posted on the Medical Surgical Unit, in the Main Hospital/Emergency Department Entrance, or in the Emergency Department. (A-0116)
- Patients were aware that there was no physician on-site 24 hours a day, seven days a week. (A-0131)
-Surgical patients were provided with a properly executed informed consent with regard to procedural risks of low probability, but high severity, which required transfer of care to another hospital and physician. (A-0131)
- Patients were given the opportunity to formulate an Advance Directive (AD, a legal document where the patient can direct their medical care wishes should the patient become unable to make their own decisions) for nine patients (#3, #7, #8, #12, #13, #19, #20, #21 and #22) of 12 patient records reviewed. (A-0132)
- One patient (#1) on line of sight (LOS, continuous visual contact with the patient) while awake observation status, was protected from self harm when she obtained an ink pen and stabbed herself. (A-0144)
- Patient observation records for one patient (#1) were documented appropriately. (A-0144)
- A storage area which contained multiple items that posed ligature (anything which could be used for the purpose of hanging or strangulation), suffocation, poisoning, and choking risks was kept locked at all
times. (A-0144)
- Contraband (items that are illegal, forbidden, or that can be used to harm self or others) items lying on a table were not accessible to one patient (#3) of one patient left attended. (A-0144)

These practices resulted in a systemic failure and noncompliance with 42 CFR 482.13 Condition of Participation: Patient's Rights. The hospital census was three.

The severity and cumulative effect of these practices had the potential to place all patients at risk for their health and safety, also known as Immediate Jeopardy (IJ).

By the survey exit date, 08/25/21 at 3:30 PM, the hospital was not able to provide an acceptable plan of correction (POC) to remove the risk of harm to patients, and the IJ remained..

Based on observation and policy review the hospital failed to follow their policy and post Patient Rights signage on three of four units observed in the hospital. The hospital census was three.

Findings included:

Review of the hospital's undated document titled, "Patient Statement of Rights and Responsibilities," showed that a list of the patient rights would be posted on the Geriatric Psychiatry (Geropsych, a unit that focuses on treating mental health and psychiatric disorders in older adults) Unit.

Review of the hospital's document titled, "Patient Rights," revised 04/2017, showed the following:
- The purpose of the patient rights signage was to assure that a patient and/or designee support person was informed of their rights and responsibilities upon receiving care and services at the hospital. To assure that staff, physicians, volunteers, family, visitors and other health care providers were informed of these rights and responsibilities.
- Rights and responsibilities are codified in the State and Federal regulations, as well as accreditation standards.
- A copy of the Patient's Rights was to be posted in the reception area.

Observation on 08/16/21 at 1:30 PM, showed that there were no patient's rights signage posted in the Emergency Department (ED) and main entrance.

Observation on 08/18/21 at 9:50 AM, showed that there were no patient's rights signage posted in the ED.

Observation on 08/16/21 at 2:42 PM, showed that there were no patient's rights signage posted in the Medical/Surgical unit.

During an interview on 08/16/21 at 3:15 PM, Staff EE, Risk Management Regional Director stated that despite the medical/surgical unit currently closed the hospital planned to open it in the future.


32280

Based on observation, interview, record review and policy review, the hospital failed to post, conspicuously, a notice that the hospital did not have a Doctor of Medicine (MD), or a Doctor of Osteopathic medicine (DO), present in the hospital 24 hours per day, seven days per week. The hospital also failed to provide surgical patients with a properly executed informed consent with regard to procedural risks of low probability, but high severity, which required transfer of care to another hospital and physician. These failures hindered the patients' right to make informed decisions based on complete information. The hospital census was three.

Findings included:

Although requested, the hospital failed to provide a policy for notifying patients that the hospital did not have a MD or DO available in the hospital 24 hours per day, seven days per week.

Review of the hospital's undated document titled, "Patient Rights and Responsibilities," stated that patients would be informed about their health care problems, treatment options, and likely or unanticipated outcomes so they can take part in developing, implementing and revising their plan of care.

Review of the hospital's undated document titled, "Physician Schedule," showed the following:
- For the month of May 2021, there was no MD/DO present in the hospital for 29 out of 31 night shifts (7:00 PM to 7:00 AM). The Emergency Department (ED) provider was a Nurse Practitioner (NP) or a Physician Assistant (PA).
- For the month of June 2021, there was no MD/DO present in the hospital for 30 out of 30 night shifts. The ED provider was a NP or PA.
- For the month of July 2021, there was no MD/DO present in the hospital for 31 out of 31 night shifts. The ED provider was a NP or PA.
- For the month of August 2021, there was no MD/DO present in the hospital for 31 out of 31 night shifts. The ED provider was a NP or PA.

Observation on 08/16/21 at 10:00 AM, showed the registration entrance to the ED and the ED bays had no notice or signage to make patients aware that there was not a MD/DO present in the hospital 24 hours per day, seven days per week.

During an interview on 08/16/21 at 10:30 AM, Staff D, Licensed Practical Nurse (LPN), stated that the hospital did not have signage or give notice to ED patients that there was not a MD/DO present 24 hours a day, seven days per week.

During an interview on 08/25/21 at 1:30 PM, Staff BB, Interim CEO, stated that physicians were not on site at the hospital 24 hours per day, seven days a week. He was not aware there needed to be signage stating that there was not an MD/DO on site at the hospital 24 hours per day, seven days per week.

Review of the hospital's policy titled, "Medical Staff Rules and Regulations (#ADMS.04 Nueterra 2012/final revisions 3/2015)," approved by the hospital Medical Executive Committee on 01/13/21, stated that for surgical procedures, the physician included additional or alternative interventions that may be warranted as part of the informed consent discussion with the patient.

Review of the hospital's Fulton Medical Center policy titled, "Documentation Required for Surgical Case," revised 09/2018 stated that all preoperative information was included in the patient's medical record prior to being admitted to the surgical suite. Included in the required information was a signed informed consent for procedure.

Review of the hospital's Noble Health Callaway Community Hospital policy titled, "Requirements of Informed Consent," revised 10/2018 stated that potential risks, complications, drawbacks and potential problems associated with recuperation would be discussed with patients prior to invasive procedures.

Observation on 08/23/21 at 10:40 AM showed Staff SSS, Surgeon obtained written consent from Patient #36 to perform a colonoscopy (a procedure in which a flexible fiber-optic instrument is inserted through the anus in order to examine the colon). He reviewed with the patient the risk of perforation (hole or tear) of the colon and cardiac event (sudden, unexpected loss of heart function, breathing, and consciousness) during the colonoscopy. No further discussion occurred as to potential of extension of the procedure, administration of blood products, inability to admit to this hospital, or the need to transfer to another hospital.

Review of current Patient #36's medical record showed a document titled, "Consent to Operation or Other Medical Procedures," which indicated consent for "Colonoscopy with possible biopsies and/or polypectomies (a procedure used to remove polyps from the inside of the colon)." The document also included statements that the patient who signed understood that unexpected events "may require an extension of the original procedure or the performance of a different procedure." No documentation was included in the surgical consent regarding possible transfer to another hospital and another physician's care if inpatient evaluation and treatment was required. No regard to patient preference was included as to which facility was desired for transfer.

Review of discharged Patient #11's medical record showed the patient signed a consent for a colonoscopy performed by Staff SSS, Surgeon, on 8/16/21 with nurse witness at 11:20 AM. The surgeon did not sign, date, or time the surgical consent.

During an interview on 08/23/21 at 11:42 AM, Staff SSS, Surgeon, stated that:
- He was aware that the hospital did not admit patients for medical/surgical nursing care.
- Patients would be transferred to another hospital if a perforation or other complication occurred during a colonoscopy.
- He was not be able to admit patients at any of the hospitals he named for potential transfer, as he was not credentialed at them.
- No discussion was included in his informed consent with patients regarding transfer to another hospital should a perforated bowel or other complication occur during a colonoscopy. He believed this created "unnecessary worry" for the patient.
- He was aware that authorization to administer or decline blood products was included in the hospital's surgical consent. He believed the discussion of the potential of needed blood products during informed consent also created "unnecessary worry" for the patient.
- He was not aware that this hospital's website stated that the surgery department performed colon resections (the surgical removal of part or all of the colon) and exploratory laparotomies (a general surgical operation where the abdomen is opened and the abdominal organs are examined for injury or disease).
- It made better "business sense" that patients were transferred when inpatient care was required due to the lack of resources at this hospital and the available resources at other hospitals



44536



.


45073

Based on interview, record review and policy review, the hospital failed to ensure patients were informed of their rights to formulate an Advanced Directive (AD, a legal document where the patient can direct their medical care wishes should the patient become unable to make their own decisions) for nine patients (#3, #7, #8, #12, #13, #19, #20, #21 and #22) of 12 patient records reviewed. The hospital census was three.

Findings included:

Review of the hospital's policy titled, "Advanced Directives," revised 01/2019, showed that every patient or their designated health care decision maker had the right to express their wishes regarding resuscitation.

Review of the hospital's undated document titled, "Patient Statement of Rights and Responsibilities," showed that patients had the right to formulate, review, and revise their advanced directives. Patients had the right to receive information upon admission on the extent to which the hospital was able, unable or willing to honor those directives.

Review of Patient #3, #8, #12, #13 and #22's medical records showed that they were not asked if they had an advanced directive or offered information about advanced directives.

Review of Patient #7's medical record showed that she did have an advanced directive, but the information was not entered into her medical record.

During an interview on 08/18/21 at 9:55 AM, Patient #19, stated that she was not asked if she had an advanced directive, or given information about advanced directives.

During an interview on 08/18/21 at 10:15 AM, Patient #20's mother stated that she was not asked if she had an advanced directive or offered information about advanced directives.

Observation on 08/18/21 at 10:20 AM, showed that Patient #21 was not asked during the registration process, or during his admission if he had an advanced directive. He was not given information regarding advanced directives.

During an interview on 08/17/21 at 3:10 PM, Staff Y, Registration Manager, stated that registration staff were to ask patients if they had an advanced directive during the registration process, if the patient said they did have an advanced directive then registration staff would take a copy of it at that time so it could be entered into the medical record. If the patient did not have an advanced directive they would mark no to the question and move on. Nursing staff were to ask patients if they would like information on advanced directives if no was marked on their admission information.

During an interview on 08/16/21 at 2:50 PM, Staff E, Licensed Practice Nurse (LPN), stated that nursing staff did not ask patients if they had an advanced directive or offer information regarding advanced directives as this was performed by the registration staff.

Although requested, the hospital failed to provide a policy that directed staff on the process for obtaining advanced directives, and whose responsibility it was to provide education to patients who wished to formulate an advanced directive.

Based on observation, interview, record review and policy review, the hospital failed to provide care in a safe setting when:
- Staff failed to lock a storage area which contained multiple items that posed ligature (anything which could be used for the purpose of hanging or strangulation), suffocation, poisoning, and choking risks.
- One patient (#1) of one patient on line of sight (LOS, continuous visual contact with the patient) while awake observation status, was allowed to obtain an ink pen and stabbed herself.
- One patient (#2) was left unattended with direct access to contraband (items that are illegal, forbidden, or that can be used to harm self or others) lying on a table.
- The special precautions patient observation record was not documented appropriately and the observation category and the reason for special precautions was left blank on two patients (#1 and #2) of two patients on special precautions.

The lack of oversight of patients had the potential to place all current and future patients at risk for serious harm or injury. The hospital census was three.

Findings included:

Review of the hospital's policy titled, "Patient Rights," effective 04/2020, showed that all patients had the right to receive care in a safe setting.

Review of the hospital's policy titled, "Contraband, Sharps, and Prohibited Items," effective 09/2018, showed that:
- Staff were to manage the availability of contraband on the Geriatric Psychiatric Unit (Geropsych) to ensure the safety of the patients.
- Contraband would include any items that could be used as a weapon, such as glass, mirrors, hard plastic items (that could be sharpened), matches, lighters, chemicals, tools, rope, or string.
- Prohibited items would include cell phones, laptops, cameras, electronic devices, and tobacco products.

Review of the hospital's policy titled, "Patient Observation Categories, Special Precautions," dated 09/2018, showed the following directives for staff:
- At the time of admission, the admitting psychiatrist would assign a special precautions category. Special precautions guidelines were as follows: Special Precautions I (Routine), Special Precautions II (Impulsive Behavior Precautions), Special Precautions III (Visual Contact) and Special Precautions IV (One to One [1:1, continuous visual contact with close physical proximity]-Within Arm's Length).
- A physician's order was necessary for a patient to be placed on special precautions and a physician's order was necessary to discontinue a specific special precautions category.
- Special Precautions I (Routine), were for patients that were depressed (extreme sadness that doesn't go away), anxious (a feeling of fear or worry experienced intermittently), etc., but had engaged in the treatment process and were displaying insight (to understand a specific cause and effect) and impulse control (failure to resist an urge or temptation). Staff would make an entry every 30 minutes on the special precautions, patient observation record and the nurse supervising the patient would make an entry on the nurse rounding for safety purpose at least once every two hours.
- Special Precautions II (Impulsive Behavior Precautions), were for patients who were viewed as a risk for impulsive (to act with little or no forethought or consideration of consequences) acts. Patient's that were maintained fairly well with the program guidelines, but continued to need guidance and role modeling; staff would make an entry every 15 minutes on the special precautions, patient observation record and the nurse supervising the patient would make an entry on the nurse rounding for safety purpose at least once every two hours.
- Special Precautions III (Visual Contact), were for patients who give specific evidence that a suicide (to cause one's own death) attempt was suspected, showing minimal impulse control and who were experiencing high levels of mood swings. The patient was monitored line of sight (LOS, continuous visual contact with the patient) at all times, did not have to be "arm's length" observation, and a staff member could do this status with more than one patient. The patient's room would be searched for objects that could be dangerous, and those which the patient could use for self-harm or mutilation, such as paper clips, breakable objects, pencils/pen, etc. Staff would make an entry every 15 minutes on the special precautions, patient observation record and the nurse supervising the patient would make an entry on the nurse rounding for safety purpose at least once every two hours.
- Special Precautions IV (1:1-Within Arm's Length), were for extremely disturbed patients who were in imminent danger of harming themselves or others. This was a strict 1:1 observation (arm's length) with staff constantly monitoring the patient at all times, even when in the bathroom. The patient's room would be searched for objects considered dangerous. There would be one staff member assigned to each 1:1 patient. Staff would make an entry every 15 minutes on the special precautions, patient observation record and the nurse supervising the patient would make an entry on the nurse rounding for safety purpose at least once every two hours. The "Suicide Flowsheet" would be completed every shift.

Observation on 08/16/21 at 3:00 PM, in the dayroom area of Geropsych, showed that:
- The electrical wall receptacles had infant/child safety plugs inserted into the outlets, no secure covering attached.
- There were several board games, including a chess and checkers set with chess pieces and plastic checkers, a scrabble board with wooden letter tiles, and a set of wooden dominoes, left sitting on top of a cabinet.
- A cardboard box of 800 crayons, and a cardboard box of 250 markers, left sitting on top of a cabinet.

Observation on 08/16/21 at 3:05 PM, in the hallway of Geropsych, showed that a bathroom door was unlocked with a stack of 20-30 paper towels sitting on the safety rail under the sink.

Observation on 08/16/21 at 3:05 PM, in the hallway of Geropsych, showed a storage area (labeled bathroom) door unlocked and shelves that contained:
- Four 32 ounce bottles, and two three ounce bottles, of mouth wash;
- Three 10 ounce cans, and five three ounce cans, of shaving cream;
- Nine three ounce bottles of liquid shampoo/body wash;
- 12 three ounce bottles of baby powder;
- Two large rolls of 30 gallon clear plastic trash bags;
- A handheld shower head and hose, approximately eight feet in length;
- One 30 gallon black trash bag containing patient belongings; and
- One blow dryer with an eight foot cord.

Observation on 08/16/21 at 3:10 PM, on Geropsych, showed two patients (#1 and #2) located in the dayroom alone, with a remote control lying on the table. Staff H, Agency Registered Nurse (RN), was the only staff member present on the unit and she was at the nurse's station charting.

Observation on 08/16/21 at 3:15 PM, in room 305 of Geropsych, showed two shelves next to the sink, secured by four phillips head screws each, and receptacle covers secured with flat head screws.

During an interview on 08/16/21 at 3:15 PM, Staff I, Patient Care Technician (PCT), stated that the board games should have been locked in a cabinet, and the storage/supply room door should have been locked.

Observation on 08/16/21 at 3:30 PM, in the seclusion (the involuntary confinement of a patient alone in a room or area from which the patient was physically prevented from leaving) room of Geropsych, showed a honeycomb vent on the ceiling directly above the bed.

Review of Patient #1's medical record showed the following:
- A Psychiatric History and Physical (H&P), dated 07/30/21, showed that the patient was a 77 year old female admitted to the hospital on 07/29/21 for making suicidal statements, suicidal thoughts and saying that she wanted to cut her arms.
- Staff reported that the patient had been crawling on the floor, yelling at staff, trying to hit staff, being aggressive and stated she wanted to kill other people.
- On 07/29/21, a physician's order for admit with LOS supervision while awake. There was no physician's order to discontinue from 07/29/21 through 08/17/21.
- On 08/17/21, a physician's order for 1:1 supervision.

Review of Patient #1's Special Precautions Patient Observation Records showed the following:
- Where staff were to document whether the patient was on LOS while awake, LOS at all times or 1:1 (within arm's length) and reason for special precautions was left blank on 07/29/21 through 8/3/21.
- On 08/4/21, documentation showed the patient was 1:1 (within arm's length) and the reason for special precautions was suicidal ideations (SI). The medical record showed no physician order for 1:1.
- On 08/06/21, documentation showed LOS at all times and the reason was SI. The medical record showed no physician order to discontinue 1:1 and place the patient on LOS at all times.
- From 08/07/21 through 08/16/21, no special precautions were documented.
- On 08/17/21, documentation showed the patient was 1:1 (within arm's length) and the reason for special precautions was left blank.
- On 08/18/21, no special precaution was documented.

Review of the hospital's document titled, "Quality Improvement Incident Report," dated 08/18/21, showed that Patient #1 reported on 08/17/21 at 6:55 AM, that she had cut herself with a pen during the night. The client had small scratches under her abdominal fold. Room searches were completed and two pens were found in the room. The patient was placed on 1:1 observation.

Observation with concurrent interview on 08/17/21 at 2:08 PM, showed Staff HH, PCT, sitting outside of Patient #1's doorway. Patient #1 was lying in bed on her side, with her back facing Staff HH, covered with a blanket with only the back of her head visible. Staff HH stated that Patient #1 was a 1:1 and staff could sit in the doorway to observe the patient when the patient was in bed sleeping. When a 1:1 patient was awake, staff had to be within arm's reach of the patient.

During an interview on 08/19/21 at 10:30 AM, Staff EEE, PCT, stated that staff did not receive any education after Patient #1 was found with pens in her room. There was no increase in room checks or any process changes. If a patient was a 1:1, they were to be within arm's reach at all times, even when the patient was sleeping or in the bathroom. She had received no education on how to fill out the special precautions patient observation record. The nurses were supposed to fill out the precautions level and the reason for the special precaution. She had no training on sexually acting out (to behave badly, especially as a means of venting emotions such as fear or frustration) behavior or homicidal ideations (HI, thoughts or attempts to cause another's death). Patient rooms were checked for contraband on the night shift after patients were awakened in the morning, beds were made and the room was cleaned.

Review of Patient #2's medical record showed the following:
- She was an 85 year old female admitted to the hospital Geriatric psychiatry (Geropsych, a unit that focuses on treating mental health and psychiatric disorders in older adults) unit on 08/11/21 for physical and verbal aggression at the nursing home where she resided.
- The patient's diagnosis was unspecified dementia with behavioral disturbance.
- A physician order for line of sight supervision while awake was documented on 08/11/21. There was no documentation in nursing notes that this was implemented.
- On 08/17/21 at 5:20 AM, Staff PP documented that Patient #2 lost her footing and fell in her room. The patient had a skin tear on her left elbow and a CT of her head and neck and x-ray of left elbow were completed. There was no documentation that showed nursing staff completed a physical or neurological assessment after the fall and no vital signs were documented. There was no documentation to show the plan of care was modified and interventions identified to prevent further injuries. There was no indication that a post fall huddle was conducted.
- On 08/17/21 at 11:55 AM, the patient was placed on line of sight supervision at all times per physician order.

Review of Patient #2's Special Precautions Patient Observation Records from 08/16/21 through 08/25/21 showed the following:
- On 08/16/21, no special precautions were checked and no reason for special precautions was identified. On 08/11/21, the patient was placed on line of sight while awake per physician order. There was no documentation in the patient's record to show that order had been discontinued.
- On 08/17/21, line of sight at all times was noted, but the reason for special precautions was blank.
- From 08/18/21 through 08/22/21, no special precautions were checked and no reason for special precautions was identified.
- On 08/23/21, line of sight while awake was noted, but the reason for special precautions was blank.
- On 08/24/21 and 08/25/21, line of sight at all times was noted, but the reason for special precautions was blank.

During an interview on 08/19/21 at 9:40 AM, Staff EEE, PCT, stated that staff were made aware yesterday that all patients on the Geropsych unit were a fall risk due to the medications they were on and should have a yellow arm band on. Staff should guide patients when walking.

During an interview on 08/17/21 at 9:45 AM, Staff H, Agency RN, stated the following:
- She had worked on the Geropsych unit for four weeks.
- She had one day of orientation with a Licensed Practical Nurse (LPN).
- She had worked at a children's residential mental health facility in the past.
- She had not reviewed any policies.
- She was unaware of fall risk interventions based on the fall risk score.
- She was unaware of how to update the patient's care plan.

During an interview on 08/25/21 at 2:00 PM, Staff X, Chief Nursing Officer (CNO), stated that the Geropsych RN was responsible for filling out the precautions and reason for special precautions on the special precautions patient observation record. The RN should relay to staff every shift, those patients that were on precautions and the reason. Patient's that were on 1:1 precautions should be within arm's reach at all times. Rooms on the Geropsych should be checked daily for contraband.






39562

Based on interview, record review and policy review, the hospital failed to have systemic practices in place to ensure that there was an effective, ongoing, hospital-wide, data driven Quality Assurance and Performance Improvement (QAPI, process for reporting and/or identifying adverse events, near misses or review of high risk, problem prone areas for patient safety) program that worked in conjunction with the Governing Body, and used data to monitor the quality, effectiveness and safety of care and services provided. The hospital also failed to ensure that all contracted services were included in a hospital-wide QAPI program where data could be used to identify opportunities for improvement, and actions were taken aimed at performance improvement, monitoring and reporting, to provide patients with quality care and safety. These failures had the potential to adversely affect the quality of care, safety and care outcomes of all patients in the hospital. The hospital census was three.

The severity and cumulative effects of these systemic practices resulted in the hospital's non-compliance with 42 CFR 482.21 Condition of Participation: QAPI Program and resulted in the hospital's failure to ensure quality health care and safety.

Based on interview, record review and policy review, the hospital failed to ensure there was an effective, ongoing, hospital-wide, data driven Quality Assurance and Performance Improvement (QAPI, process for reporting and/or identifying adverse events, near misses or review of high risk, problem prone areas for patient safety) program that used data to monitor the quality, effectiveness and safety of care and services provided for 12 departments out of 22 departments reviewed. These failures had the potential to put all patients at risk for sub standard quality of healthcare and adverse outcomes. The hospital census was three.

Findings included:

Review of the hospital's policy titled, "Quality Assessment & Performance Improvement - Patient Safety Plan," revised 02/2020, showed that QAPI was a continuous process. The goal of QAPI involved identification and measurement of variances in current practice and services that could lead to less than optimal performance; identification and implementation of changes to enhance existing performance; and consistent monitoring of changes to ensure sustained gains.

Review of the hospitals 2021 monthly performance improvement data from each department showed the following:
- The following departments showed no reported data: Materials Management, Registration, Human Resources, Medical/Surgical, Emergency Department, Geriatric psychiatry (Geropsych), Geropsych Activities, Laboratory, Medical Center Clinic, Employee Health, Operating Room and Specialty Clinic.
- The following departments showed reported data in January: Social Work and Case Management.
- The following department showed reported data in January and February: Physical Therapy.
- The following departments showed reported data from January through March: Health Information Management and Risk Management.
- The following departments showed reported data from January through May: Pharmacy and Infection Control.
- The following department showed reported data from January through June: Respiratory Therapy.
- The following departments showed reported data from January through July: Radiology and Housekeeping.
There was no evidence to show that Discharge Planning, Utilization Review or Organ Procurement were included in the QAPI program.

Even though requested, the hospital QAPI Director could not be interviewed due to illness.

During an interview on 08/18/21 at 11:00 AM, Staff EE, Regional Risk Management Director, stated that the hospital was in the process of tracking event reports in QAPI, it had not been formalized yet. She was not in charge of QAPI at this hospital, that staff person was on sick leave.

During an interview on 08/25/21 at 2:00 PM, Staff X, Chief Nursing Officer (CNO), stated that no one was tracking readmission rates. There had been no active Utilization Review department since January.

During an interview on 08/25/21 at 1:30 PM, Staff BB, Interim CEO, stated that the Quality Director had been in her position since June of 2021 and she was in the process of getting the QAPI program organized. He recalled that at the June Medical Executive Meeting, the QAPI director presented QAPI information and was in the process of putting QAPI plans together. The Medical Executive Committee approved the yearly QAPI plan.

Based on interview, record review and policy review, the hospital's Governing Body failed to ensure that contracted services furnished services that permitted the hospital to comply with all applicable conditions of participation. This failure had the potential to cause inadequate monitoring of services and poor patient outcomes. The hospital census was three.

Findings included:

Review of the hospital's policy titled, "Quality Assessment & Performance Improvement (QAPI, process for reporting and/or identifying adverse events, near misses or review of high risk, problem prone areas for patient safety) - Patient Safety Plan," revised 02/2020, showed the following:
- The scope of the QAPI and Patient Safety Plan addressed all areas, including care provided by clinical contracted services.
- The Board of Managers, the Medical Executive Committee and leadership would review the QAPI plan, at a minimum, annually. The Board of Managers would give final approval of the plan.
- The hospital strived to achieve optimal clinical outcomes for all its patients while providing care in the safest environment possible. The hospital collected data on the following: anesthesia/moderate sedation; utilization management; sentinel events; adverse events; and critical and/or pertinent processes, both clinical and supportive.
- QAPI is a continuous process and the goal of QAPI involved the identification and measurement of variances in current practice and services that could lead to less than optimal performance; identification and implementation of changes to enhance existing performance; and consistent monitoring of changes to ensure sustained gains.

Review of the hospital's document "Environment of Care Manual, Equipment Management," with included policy titled, "Medical Equipment Management Plan," reviewed 03/2021, stated that at least one aspect of the program would be monitored quarterly and reported to the Safety Committee for inclusion in QAPI.

Review of the hospital's document titled, "Patient Care Contracted Services, QAPI," dated 01/2021, showed eight clinical contracted services listed. Information was to be reported quarterly at QAPI meetings and an annual review by the Chief Executive Officer (CEO) and Chief Nursing Officer (CNO). Out of the eight clinical contracted services listed, only two of the services, Radiology and MRI, reported data to the QAPI program.

Review of the hospital's undated document titled, "Contract Name," showed that the hospital contracted with 51 different services.

Even though requested, the hospital was unable to provide evidence that all of the contracted services were incorporated into the hospital program and were reviewed annually.

Even though requested, the hospital QAPI Director was not able to be interviewed due to illness.

During an interview on 8/17/21 at 3:25 PM, Staff W, stated that the hospital had not executed a formal contract with a biomedical engineer, but had a verbal agreement that facilitated the inspection of equipment not otherwise covered by service and maintenance contracts. The biomedical engineer does not participate in the hospital's QAPI program.

During an interview on 08/23/21 at 12:50 PM, Staff TTT, Certified Registered Nurse Anesthetist (CRNA, registered nurses who have obtained graduate-level education and board certification in anesthesia), stated that the anesthesia services were contracted with the hospital. He was not aware of any involvement in the hospital's QAPI program.

During an interview on 08/18/21 at 11:00 AM, Staff EE, Regional Risk Management Director, stated that she had no idea if contracted services were incorporated into the hospital QAPI program. The hospital was in the process of tracking event reports in QAPI, it had not been formalized yet. She was not in charge of QAPI at this hospital, that staff person was on sick leave.

During an interview on 08/25/21 at 1:30 PM, Staff BB, Interim CEO, stated that the Quality Director had been in her position since June of 2021 and she was in the process of getting the QAPI program organized. He recalled that at the June Medical Executive Meeting, the QAPI director presented QAPI information and was in the process of putting QAPI plans together. The Medical Executive Committee approves the yearly QAPI plan.










44536

Based on observation, interview, record review and policy review, the hospital failed to ensure that:
- The Chief Nursing Officer (CNO) provided adequate oversight and supervision of nursing personnel as evidenced by the Geriatric psychiatry (Geropsych, a unit that focuses on treating mental health and psychiatric disorders in older adults) unit was staffed with non-trained and non-qualified staff and the interim Geropsych director had no experience in the care of psychiatric patients. (A-0386)
- Hospital policy was followed and all inpatient care units were staffed with at least one Registered Nurse (RN) (A-0392)
- Staff followed hospital policy when a fall risk assessment and careplan update was not completed for one patient (#2) of one patient who experienced a fall while in the hospital. (A-0395)
- Nursing staff adequately supervised patients when the special precautions patient observation record was not documented appropriately and the observation category and reason for special precautions was left blank on two patients (#1 and #2) of two patients on special precautions. (A-0395)
- Licensed staff were oriented to hospital policies and procedures. (A-0398)
- The CNO fulfilled his responsibility for all licensed nursing personnel to know the hospital's policies and procedures in order for them to adhere to those policies and procedures. (A-0398)
- The CNO evaluated all nursing performance with a performance evaluation at least once a year. (A-0398)
- Perioperative (preoperative, recovery room and operating room suites) staff were aware of procedure to notify hospital staff if in the event of an emergency within the perioperative area. (A-0398)
- Staff administered medications according to physicians' orders and hospital policy for three patients (#2, #41 and #42) of three patients reviewed. (A-0405)

These practices resulted in a systemic failure and noncompliance with 42 CFR 482.23 Condition of Participation: Nursing Services. The hospital census was three.

The severity and cumulative effect of these practices had the potential to place all patients at risk for their health and safety, also known as Immediate Jeopardy (IJ).

By the survey exit date, 08/25/21 at 3:30 PM, the hospital was not able to provide an acceptable plan of correction (POC) to remove the risk of harm to patients, and the IJ remained.

Based on observation, interview, record review and policy review, the hospital failed to ensure that the Chief Nursing Officer (CNO) provided adequate oversight and supervision of nursing personnel, as evidenced by the Geriatric Psychiatric (Geropsych, a unit that focuses on treating mental health and psychiatric disorders in older adults) Unit was staffed with non-trained and non-qualified staff and the interim Geropsych director had no experience in the care of psychiatric patients. These failures had the potential to affect the quality of care and safety of all patients in the hospital. The hospital census was three.

Findings included:

Review of the hospital's document titled, "Job Title: Director of Nursing," dated 03/10/11, Copyright 2004 Nueterra Healthcare Management, LLC, showed the following responsibilities:
- Established policy and standards of nursing care and practice (with the approval of the Continuous Quality Improvement Committee) at the hospital.
- Collaborated with the Safety Committee to develop and monitor orientation policies and procedures to provide competent staff.
- Provided an adequate monitor of qualified staff. Coordinated, assigned, and/or provided relief coverage according to needs of the clinical areas.
- Monitored licensure of professional nursing personnel and CPR status.
- Performed annual evaluations and monitored job performance of nursing staff to confirm compliance with policies and personal protection.
- Arranged maintenance and repair of medical equipment.
- Qualifications for the position included a minimum of three years management experience with emphasis on ambulatory surgery in both the operating room and recovery area.

During an interview on 08/16/21 at 3:00 PM, Staff X, CNO, stated that he was the interim Geropsych Director and the interim Emergency Department (ED) Director. He stated that the Geropsych Director position had been vacant prior to the beginning of his employment with the hospital and upon accepting the CNO position, he became the interim of both open director positions. His nursing background included working on a progressive care unit and Home Health. He had no Geropsych or ED experience.

Even though requested the hospital failed to provide a job description for Staff X as interim Geropsych Director or a job description as interim ED Director. The hospital also failed to provide evidence that the Governing Body appointed Staff X as interim director of these departments.

Review of the hospital's policy titled, "Behavioral Health Orientation," dated 09/2018, showed that it was the policy of the Geropsych Behavioral Health Unit (BHU) to provide all new staff members with a solid knowledge of the unit's mission, values and goals for the patients they served. All new staff members would attend the new employee orientation upon hire, then complete a unit specific orientation overseen by the unit manager.

Review of the hospital's policy titled, "Behavioral Health Competencies According to Position," dated 09/2018, showed that once a staff member completed their Geropsych BHU skills check-off and orientation with a satisfactory performance, they were approved to work until their first annual evaluation. Each Geropsych BHU staff member would be evaluated annually on their job performance, competencies, status of licensure and up to date certifications.

Review of the hospital's undated documents titled, "New Employee Orientation," showed no Geropsych unit specific orientation material.

Review of the hospital's personnel file for Staff H and PP, Agency RNs, showed that they were hired on 07/19/21 and had no hospital or unit specific orientation to the Geropsych unit in their files.

During an interview on 08/17/21 at 9:44 AM, Staff H, Agency RN, stated the following:
- She had worked on the Geropsych unit for four weeks.
- She had one day of orientation with a Licensed Practical Nurse (LPN).
- She had worked at a children's residential mental health facility in the past.
- She had not reviewed any policies.
- She had not received any restraint training.
- She was unfamiliar with the meaning of one hour face-to-face in regard to restraint and seclusion.
- She was unaware of fall risk interventions based on the fall risk score.
- She was unaware of how to update the patient's care plan.
- She had not signed any paperwork at this hospital.

During an interview on 08/24/21 at 8:30 AM (the hospital received notification of the IJ on 08/23/21), Staff H, Agency RN, stated that she had not received any hospital orientation and no Geropsych unit specific orientation since she was hired. She was the only RN working on the Geropsych unit this shift.

During an interview on 08/25/21 at 10:30AM, UUU, Nurse Educator, stated that she did not realize there was not adequate Geropsych education when she was hired on and that they were in the process of developing education. She also stated that orientation and education for agency staff had just started within the past few weeks. Prior to that, agency staff had being placed on the schedule immediately, which left no time for orientation or education.

During an interview on 08/25/21 at 2:00 PM, Staff X, CNO, stated that he had been the CNO since 09/2020. There were no unit specific competencies for the Geropsych unit; he had not been able to locate them. He had not completed any nursing evaluations since he had been here.

Based on interview, record review and policy review the hospital failed to follow their internal policy that ensured all inpatient care units were staffed with at least one Registered Nurse (RN). This failure placed all patients at risk for their health and safety. The hospital census was three.

Findings included:

Review of the hospital's policy titled, "Nurse Staffing Plan," revised 03/2020 showed:
- Each unit would have a registered nurse available each shift in house.
- The ED would be staffed with two RNs or one RN and one Licensed Practical Nurse (LPN) on the 7A-7P shift and 7P-7A shift.
- Geriatric psychiatry (Geropsych, unit that focuses on treating mental health and psychiatric disorders in older adults) unit would be staffed with at least one RN at all times.

Record review of the hospital document titled, "Daily Nurse Staffing Page," dated 08/19/21 showed Staff DDD, LPN was on the schedule to staff the Geropsych unit for the 7A-7P shift. Staff AAA, LPN was on the schedule to staff the Geropsych unit for the 7P-7A shift.

The Geropsych unit was not staffed with RN coverage for both day and night shift for 08/19/21.

During an interview on 08/23/21 at 12:20 PM, Staff X, CNO stated that an RN was always scheduled as the House Supervisor and was expected to function as the ED RN and to provide coverage to the Geropsych if needed.





41865

Based on observation, interview, record review and policy review, the hospital failed to ensure that nursing staff followed their policy and procedure for completing a fall risk assessment and updating the patient care plan after a patient fall for one patient (#2) of one patient who experienced a fall while in the hospital. The hospital also failed to ensure nursing staff adequately supervised patients when the special precautions patient observation record was not documented appropriately and the observation category and reason for special precautions was left blank on two patients (#1 and #2) of two patients on special precautions.

This failure had the potential to place all patients admitted to the hospital at risk for their health and safety. The hospital census was three.

Findings included:

Review of the hospital's policy titled, "Fall Assessment," dated 07/2019, showed the following directives for staff:
- All patients received a Comprehensive Nursing Admission Assessment at admission to include a risk for falls.
- The nurse would identify patients' risk of falling by utilizing the Fall Risk Assessment Tool and initiate interventions based on risk score. Low Risk: 0-5, Moderate Risk: 6-13, High Risk: greater than 13.
- Fall risk would be identified by a bracelet.
- Patients were evaluated for risk of falls continually throughout treatment for development of new risk factors at admission, clinical presentation changes where the patient demonstrates signs of cognitive level changes, changes in ambulation and gait and after a fall. The fall risk would be addressed each shift.
- The patient's care plan would include an individualized fall care plan based on his/her risk and assessment findings.
- In the event of a fall the nurse would document a physical assessment, neurological (neuro, relating to or affecting the nervous system) assessment, vital signs (body temperature, blood pressure, heart rate, and breathing rate) and observable injuries. The plan of care would be modified and interventions identified to prevent further injury. A huddle would be conducted between nurses and techs involved as soon as possible after the stabilization of the patient to review fall prevention interventions and the care plan updated/revised accordingly.
- All hospital staff would receive training on the Fall Prevention Program during their annual education and all new hire employees would receive the training as part of their initial orientation.

Review of the hospital's policy titled, "Patient Observation Categories, Special Precautions," dated 09/2018, showed the following directives for staff:
- At the time of admission, the admitting psychiatrist would assign a special precautions category. Special precautions guidelines were as follows: Special Precautions I (Routine), Special Precautions II (Impulsive Behavior Precautions), Special Precautions III (Visual Contact) and Special Precautions IV (One to One [1:1, continuous visual contact with close physical proximity]-Within Arm's Length).
- A physician's order was necessary for a patient to be placed on special precautions and a physician's order was necessary to discontinue a specific special precautions category.
- Special Precautions I (Routine), were for patients that were depressed (extreme sadness that doesn't go away), anxious (a feeling of fear or worry experienced intermittently), etc., but had engaged in the treatment process and were displaying insight (to understand a specific cause and effect) and impulse control (failure to resist an urge or temptation). Staff would make an entry every 30 minutes on the special precautions, patient observation record and the nurse supervising the patient would make an entry on the nurse rounding for safety purpose at least once every two hours.
- Special Precautions II (Impulsive Behavior Precautions), were for patients who were viewed as a risk for impulsive (to act with little or no forethought or consideration of consequences) acts. Patient's that were maintained fairly well with the program guidelines, but continued to need guidance and role modeling; staff would make an entry every 15 minutes on the special precautions, patient observation record and the nurse supervising the patient would make an entry on the nurse rounding for safety purpose at least once every two hours.
- Special Precautions III (Visual Contact), were for patients who give specific evidence that a suicide (to cause one's own death) attempt was suspected, showing minimal impulse control and who were experiencing high levels of mood swings. The patient was monitored line of sight (LOS, continuous visual contact with the patient) at all times, did not have to be "arm's length" observation, and a staff member could do this status with more than one patient. The patient's room would be searched for objects that could be dangerous, and those which the patient could use for self-harm or mutilation, such as paper clips, breakable objects, pencils/pen, etc. Staff would make an entry every 15 minutes on the special precautions, patient observation record and the nurse supervising the patient would make an entry on the nurse rounding for safety purpose at least once every two hours.
- Special Precautions IV (1:1-Within Arm's Length), were for extremely disturbed patients who were in imminent danger of harming themselves or others. This was a strict 1:1 observation (arm's length) with staff constantly monitoring the patient at all times, even when in the bathroom. The patient's room would be searched for objects considered dangerous. There would be one staff member assigned to each 1:1 patient. Staff would make an entry every 15 minutes on the special precautions, patient observation record and the nurse supervising the patient would make an entry on the nurse rounding for safety purpose at least once every two hours. The "Suicide Flowsheet" would be completed every shift.

Review of Patient #2's medical record showed the following:
- She was an 85 year old female admitted to the hospital Geriatric psychiatry (Geropsych, a unit that focuses on treating mental health and psychiatric disorders in older adults) unit on 08/11/21 for physical and verbal aggression at the nursing home where she resided.
- The patient's diagnosis was unspecified dementia with behavioral disturbance.
- A physician order for LOS supervision while awake was documented on 08/11/21. There was no documentation in nursing notes that this was implemented.
- On 08/11/21 at 10:27 PM, Staff PP, Agency Registered Nurse (RN), documented the patient's fall risk was nine, a moderate fall risk. There was no documentation that showed interventions were initiated.
- On 08/11/21 at 10:25 PM, Staff PP documented the patient's interdisciplinary plan of care as aggression and altered neurological function. There was no documentation of an individualized fall care plan based on the patient's moderate fall risk score.
- On 08/13/21 at 7:59 PM, Staff OO, RN, increased the patient's fall risk to 11, a moderate fall risk, due to impulsive behavior. There was no documentation of an individualized fall care plan based on the patient's increased fall risk score.
- On 08/15/21, four days after admission, Staff OO, documented the patient's interdisciplinary plan of care to include potential for injury related to falls/restraints.
- On 08/17/21 at 5:20 AM, Staff PP documented that Patient #2 lost her footing and fell in her room. The patient had a skin tear on her left elbow and a CT of her head and neck and x-ray of left elbow were completed. There was no documentation that showed nursing staff completed a physical or neurological assessment after the fall and no vital signs were documented. There was no documentation to show the plan of care was modified and interventions identified to prevent further injuries. There was no indication that a post fall huddle was conducted.
- On 08/17/21 at 11:55 AM, the patient was placed on LOS supervision at all times per physician order.

Review of Patient #2's Special Precautions Patient Observation Records from 08/16/21 through 08/25/21 showed the following:
- On 08/16/21, no special precautions were checked and no reason for special precautions was identified. On 08/11/21, the patient was placed on LOS while awake per physician order. There was no documentation in the patient's record to show that order had been discontinued.
- On 08/17/21, LOS at all times was noted, but the reason for special precautions was blank.
- From 08/18/21 through 08/22/21, no special precautions were checked and no reason for special precautions was identified.
- On 08/23/21, LOS while awake was noted, but the reason for special precautions was blank.
- On 08/24/21 and 08/25/21, LOS at all times was noted, but the reason for special precautions was blank.

Review of Patient #1's medical record showed the following:
- A Psychiatric History and Physical (H&P), dated 07/30/21, showed that the patient was a 77 year old female admitted to the hospital on 07/29/21 for making suicidal statements, suicidal thoughts and saying that she wanted to cut her arms.
- Staff reported that the patient had been crawling on the floor, yelling at staff, trying to hit staff, being aggressive and stated she wanted to kill other people.
- On 07/29/21, a physician's order for admit with LOS supervision while awake. There was no physician's order to discontinue from 07/29/21 through 08/17/21.
- On 08/17/21, a physician's order for 1:1supervision.

Review of Patient #1's Special Precautions Patient Observation Records showed the following:
- Where staff were to document whether the patient was on LOS while awake, LOS at all times or 1:1 (within arms length) and reason for special precautions was left blank on 07/29/21 through 8/3/21.
- On 08/4/21, documentation showed the patient was 1:1 (within arms length) and the reason for special precautions was suicidal ideations (SI). The medical record showed no physician order for 1:1.
- On 08/06/21, documentation showed LOS at all times and the reason was SI. The medical record showed no physician order to discontinue 1:1 and place the patient on LOS at all times.
- From 08/07/21 through 08/16/21, no special precautions were documented.
- On 08/17/21, documentation showed the patient was 1:1 (within arm's length) and the reason for special precautions was left blank.
- On 08/18/21, no special precaution was documented.

Review of the hospital's personnel file for Staff H and PP, Agency RNs, showed that they were hired on 07/19/21 and had no hospital or unit specific orientation to the Geropsych unit in their files.

Observation on 08/17/21 at 9:00 AM on the Geropsych unit showed Patient #2 sitting in the dayroom. She was not wearing a yellow fall risk bracelet.

During an interview on 08/17/21 at 9:45 AM and 08/18/21 at 2:15 PM, Staff H, Agency RN, stated the following:
- She had worked on the Geropsych unit for four weeks.
- She had one day of orientation with a Licensed Practical Nurse (LPN).
- She had worked at a children's residential mental health facility in the past.
- She had not reviewed any policies.
- She was unaware of fall risk interventions based on the fall risk score.
- Patient #2 was a moderate fall risk and she had fallen yesterday morning.
- She assumed that a patient that was a moderate fall risk should have a yellow fall risk armband on and knew that Patient #2 did not have one on.
- She was unaware of how to review or make changes to patient care plans.
- She had not received any restraint training.
- She was unfamiliar with the meaning of one hour face to face in regard to restraint and seclusion.
- She had not signed any paperwork at this hospital.

During an interview on 08/19/21 at 8:30 AM, Staff DDD, LPN, stated that the physician determined what level of observation a suicidal behavioral health patient was on. When the patient contracted for safety and the physician felt comfortable with the patient's safety, the physician would change the level of observation.

During an interview on 08/19/21 at 9:30 AM, Staff NN, Patient Care Technician (PCT), stated the following:
- It was the RN's responsibility to fill out the top portion of the special precautions patient observation record.
- She had not received any training on how to fill out the special precautions record.
- She had been oriented to suicide precautions (SP, precautions taken to ensure patients are safe and free of self-injury or self-harm) and contraband (items that are illegal, forbidden, or that can be used to harm self or others), but was not aware of any other precautions such as homicidal (thoughts or attempts to cause another's death) precautions or sexually acting out (to behave badly, especially as a means of venting emotions such as fear or frustration) behavior.
- A patient that was on a 1:1 had to be within arms reach at all times, even while sleeping and in the bathroom.

During an interview on 08/19/21 at 9:40 AM, Staff EEE, PCT, stated that staff were made aware yesterday that all patients on the Geropsych unit were a fall risk due to the medications they were on and should have a yellow arm band on. Staff should guide patients when walking.

During an interview on 08/25/21 at 9:00 AM, Staff X, Chief Nursing Officer, stated the following:
- After a patient fall, the nurse caring for the patient was to fill out a post fall checklist that instructed the nurse to complete a post fall risk assessment, update the care plan and document interventions started to prevent future falls.
- The house supervisor was to be notified after a patient fall and makes sure the post fall checklist was completed.
- Staff have not been consistent on documenting a post fall assessment and updating the care plan.
- His expectation of nursing staff was to complete and document a physical and neurological assessment, vital signs, fall risk assessment and update the care plan post fall.
- A fall risk care plan should be initiated when a patient was a moderate or high fall risk.

Based on interview and policy review the hospital failed to ensure that:
- Licensed staff were oriented to hospital policies and procedures.
- The Chief Nursing Officer (CNO) fulfilled his responsibility for all licensed nursing personnel to know the hospital's policies and procedures in order for them to adhere to those policies and procedures.
- The CNO evaluated all nursing performance with a performance evaluation at least once a year.
- Perioperative (preoperative, recovery room and operating room suites) staff were aware of procedure to notify hospital staff if in the event of an emergency within the perioperative area.
These failures had the potential to affect the quality of care and safety of all patients in the hospital. The hospital census was three.

Findings included:

Review of the hospital's policy titled, "Behavioral Health Orientation," dated 09/2018, showed that it was the policy of the Geriatric psychiatry (Geropsych, a unit that focuses on treating mental health and psychiatric disorders in older adults) unit to provide all new staff members with a solid knowledge of the unit's mission, values and goals for the patients they serve. All new staff members will attend the new employee orientation upon hire, then complete a unit specific orientation overseen by the unit manager.

Review of the hospital's policy titled, "Behavioral Health Competencies According to Position," dated 09/2018, showed that once a staff member completes their Geropsych skills check-off and orientation with a satisfactory performance, they are approved to work until their first annual evaluation. Each Geropsych staff member will be evaluated annually on their job performance, competencies, status of licensure and up to date certifications.

Review of the hospital's undated documents titled, "New Employee Orientation," showed no Geropsych specific orientation material.

During an interview on 08/17/21 at 9:44 AM, Staff H, Agency RN, stated that:
- She had worked on the Geropsych unit for four weeks.
- She had not reviewed any policies.
- She had not received any restraint training.
- She was unfamiliar with the meaning of one hour face to face in regard to restraint and seclusion.
- She was unaware of fall risk interventions based on the fall risk score.
- She was unaware of how to update the patient's care plan.

Review of personnel files on 08/18/21 at 2:15 PM and on 0/19/21 at 8:35 AM, showed that eight out of 25 staff personnel files reviewed had not received job specific orientation and four had not received an annual evaluation out of four staff personnel files reviewed for annual evaluations.

During an interview on 08/25/21 at 2:00 PM, Staff X, CNO, stated that he had been the CNO since 09/2020. There were no unit specific competencies for the Geropsych; he had not been able to locate them. He had not completed any nursing evaluations since he had been here.

During an interview on 08/18/21 at 2:15 PM and on 08/19/21 at 8:35 AM, Staff CCC, Human Resources Generalist, stated that if job specific orientation was not in the employee personnel files then the employee had not received orientation.

Observation on 8/23/21 at 11:31 AM showed Staff OOO, affiliate hospital RN, with Patient #35 in preoperative Room #1 for post-procedure anesthesia recovery with the patient unconscious.

During an interview on 08/23/21 at 10:18 AM and 11:45 AM, Staff OOO, affiliate hospital RN, stated that she had not worked at this hospital before and received no orientation to the hospital and limited orientation to the perioperative unit.

During an interview on 8/23/21 at 12:55 PM, Staff PPP, LPN stated that she worked at an affiliate hospital and had not received any orientation specific to this hospital and received two days orientation limited to endoscopy (a procedure to examine the interior of a hollow organ or cavity of the body with a lighted tube with a camera)procedures.

Observation on 08/19/21 at 8:50 AM, with Staff W, Environmental Services and Staff T, RN, Regional Surgical Services Director, showed that when the emergency call button within the perioperative procedure room was engaged, no notification was sent to any area within the hospital.

Observation on 08/23/21 at 12:00 PM with Staff LL, RN, Regional Vice President of Patient Care Services, showed that when the call light within the preoperative area was engaged, no notification was sent to any area within the hospital.

During an interview on 8/17/21 at 11:05 AM, Staff T, RN, Regional Surgical Services Director, stated that the patient call lights and emergency call lights in the perioperative area were nonoperational and that administrative leadership was aware the system did not work. She stated that phones were used in the operative suites to call for assistance in the event of emergency and that patients were given a bell to ring if assistance was needed.

During an interview on 8/23/21 at 11:45 AM, Staff OOO, affiliate hospital RN, stated that in the event of a patient emergency, she dialed x444 for a rapid response as that was the process at the affiliate hospital. She was unaware that there was not a phone in the patient room and did not have a portable phone. She was unaware that the call-light system was not operational. She was unaware that the phone located at the perioperative nurses' station was nonfunctional and she was unaware that the correct procedure was to dial x549.

Staff OOO, affiliate hospital RN did not have appropriate and complete orientation to the perioperative area before she was responsible for the care of patients that had undergone general anesthesia and was not aware of the policies or procedures for the department.









39562




41474




44536

Based on interview, record review and policy review, the hospital failed to ensure staff administered medications according to physicians' orders and medication administration policies for three patients (#2, #41 and #42) of three patients reviewed. These failed practices had the potential to cause harm and/or ineffective medication therapy to patients admitted to the hospital. The hospital census was 3.

Findings included:

Review of the hospital's policy titled, "Medication Administration," revised 09/2018, showed the following:
- No medication would be administered to any patient without a verbal or written order by a licensed medical practitioner to whom appropriate privileges had been granted by the hospital medical staff.
- Before administering any medication, the nurse would mentally review the six rights: right patient, right medication, right dose, right route, right time, right reason.
- If the scanning system was unavailable, the nurse would use two patient identifiers of name and birth date. If the patient was unable to verbalize confirmation, another form of identification would be utilized. Other acceptable forms of identification were unique patient identification number and date of birth from chart.
- Any adverse effects or specific patient response to a medication would be documented in the nurses' notes.

Review of Patient #2's medical record showed the following:
- She was an 84-year-old female with a medical history of high blood pressure (BP, a measurement of the pressure of blood flow in two different parts of the heart, normal is approximately 90/60 to 120/80).
- An order for Losartan (a medication used to treat high BP) 50 milligram (mg, unit of measure) tablet, once a day (8:00 AM); check BP prior to administration.
- On 08/16/21, the patient's BP was 126/75 at 7:22 AM; Losartan was administered at 8:12 AM, no BP was documented at 8:12 AM, prior to administration.
- On 08/17/21, Losartan was administered at 7:48 AM; no BP was documented prior to administration.
- On 08/18/21, Losartan was administered at 7:20 AM; no BP was documented prior to administration.
- On 08/19/21, the patient's BP was 118/64 at 1:23 AM; Losartan was administered at 8:08 AM, no BP was documented at 8:08 AM, prior to administration.
- On 08/20/21, the patient's BP was 125/76 at 7:16 AM; Losartan was administered at 7:48 AM, no BP was documented at 7:48 AM, prior to administration.
- On 08/21/21, the patient's BP was 137/70 at 7:26 AM; Losartan was administered at 8:00 AM, no BP was documented at 8:00 AM, prior to administration.
- On 08/22/21, the patient's BP was 101/58 at 7:17 AM; Losartan was administered at 7:45 AM, no BP was documented at 7:45 AM, prior to administration.
- On 08/23/21, Losartan was administered at 7:46 AM; no BP was documented prior to administration.
- On 08/24/21, Losartan was administered at 8:40 AM; no BP was documented prior to administration.

Review of Patient #41's medical record showed the following:
- He was a 79-year-old male with a medical history of high BP.
- An order for Lisinopril (a medication used to treat high BP) 20 mgs. two times a day (8:00 AM and 8:00 PM); check BP prior to administration. Amlodipine (a medication used to treat high BP and chest pain) five mgs. once a day (8:00 AM); check BP prior to administration.
- On 08/20/21, Lisinopril was administered at 7:28 PM; no BP was documented prior to administration.
- On 08/21/21, the patient's BP was 139/68 at 7:33 AM; Amlodipine was administered at 7:45 AM and Lisinopril at 8:00 AM and 7:21 PM, no BP was documented prior to administration of the medications.
- On 08/22/21, the patient's BP was 144/77 at 7:20 AM and 119/71 at 11:53 PM; Amlodipine was administered at 8:00 AM and Lisinopril at 8:00 AM and 7:49 PM, no BP was documented prior to administration of the medications.
- On 08/23/21, the patient's BP was 136/84 at 11:21 PM; Amlodipine was administered at 7:58 AM and Lisinopril at 7:57 AM and 8:22 PM, no BP was documented prior to administration of the medications.
- On 08/24/21, Amlodipine was administered at 8:55 AM and Lisinopril at 8:53 AM, no BP was documented prior to administration of the medications.

Observation on 08/24/21 at 8:45 AM showed Staff H, Agency Registered Nurse (RN), approached Patient #2 with her morning medications. She looked at Patient #2's armband and asked the patient her date of birth. There was no other form of identification to verify the patients name and date of birth. She gave Patient #2 her medications, which included Losartan. Staff H did not obtain the patient's BP prior to administration of Losartan as ordered.

Observation on 08/24/21 at 9:00 AM showed Staff H approached Patient #41 with his morning medications. She looked at Patient #41's armband and asked the patient his date of birth. She used the patient's medication administration record (MAR, a list of medications ordered for the patient by the physician, also where the nurse documents administration of medications) to verify the patient's identification. She gave Patient #41 his medications, which included Lisinopril and Amlodipine. Staff H did not obtain the patient's BP prior to administration of Lisinopril and Amlodipine as ordered.

During an interview on 08/24/21 at 9:30 AM, Staff H, Registered Nurse (RN), stated that prior to giving a cardiac medication, she used the vital signs obtained from the patient care technician (PCT) that morning. They start getting vital signs at 7:00 AM, so it was close to when morning medications were given. She did not document the patient's vital signs in the MAR. She was not able to use the barcode scanner for medication administration because it was not functioning.

During an interview on 08/25/21 at 2:30 PM, Staff X, Chief Nursing Officer (CNO), stated that his expectation of nursing staff was to follow physician medication orders as specified. Nursing staff should obtain the patient's BP 15 minutes or less prior to administration of a cardiac medication and document on the MAR in the comments as ordered. The Geriatric Psychiatric (Geropsych, a unit that focuses on treating mental health and psychiatric disorders in older adults) unit did not have a functioning medication cart with a scanner. He had given staff verbal instructions on how to administer medications without the use of the scanner.

Review of Patient #42's medical record showed the following:
-He was an 85 year old male who was admitted on 08/21/21 with a medical history of coronary artery disease (CAD, the narrowing or blockage of the coronary arteries usually caused by the buildup of cholesterol and fatty deposits on the inner walls of the arteries), high blood pressure, stroke and gastro-esophageal reflux disease (GERD, a digestive disease in which stomach acid or bile irritates the food pipe lining).
- A medication order dated 08/21/21 for Crestor (a medication used to treat high cholesterol that may reduce the risk of heart attack and stroke) with a line drawn through the medication name, acknowledged by Staff OO, RN and comment of not given by Staff DDD, Licensed Practical Nurse (LPN) with reason of medication unavailable and discontinued by Staff B, Pharmacist with reason of do not stock with a substitution order for Lipitor (a medication used to treat high cholesterol that may reduce the risk of heart attack and stroke) by a physician and reviewed and verified by Staff B on 08/23/21.
-A medication order dated 08/21/21 for Pantoprozole with a line drawn through the medication name, acknowledged by Staff OO, RN and comment of not given by Staff DDD, LPN with reason of medication unavailable and discontinued by Staff B, Pharmacist on 08/23/21 with reason of do not stock with a substitution order for Prilosec (a medication used to treat GERD) by a physician, reviewed and verified by Staff B on 08/23/21.

During an interview on 08/24/21 at 9:50 AM, Staff B, Pharmacist stated that she was on call at all times unless she was on scheduled time off and that these two medications for Patient #42 had not been given over the weekend after his admission because they did not stock those specific medication. She stated there was a substitute list that the nursing staff were to use or they were to call her if after hours or on the weekend. She stated that she initiated the substitution for these medications for the patient on Monday 08/23/21 when she returned to work and the patient received his first dose on that day.

During an interview on 08/30/21 at 5:34 PM, Staff OO, RN stated that when a medication was ordered but wasn't a routinely stocked medication the nursing staff called the physician on call to order a substitution, she wasn't aware of a substitution list and that she never called the pharmacist on the weekend. Staff OO stated that sometimes there was a delay with the return call from the hospitalist.







39562

Based on observation, interview, and policy review the hospital failed to have a coding and indexing system that allowed for timely retrieval of medical records. The hospital census was three.

Findings included:

Although requested, the hospital failed to provide a policy for coding, indexing and timely retrieval of medical records by diagnosis and procedure.

During concurrent observation and interview on 08/18/21 at 9:47 AM, Staff S, Medical Records Clerk, stated that she was unable to search for medical records by date, diagnosis or procedure for four of four patients discharged five years ago who received blood transfusion, and five of five patients who expired while hospitalized five years ago.

During an interview on 08/17/21 at 9:42 AM, Staff S, stated that Med Host electronic medical record (EMR) system did not have the ability to conduct a record search by date, diagnosis or procedure.

Based on observation, interview, and policy review the hospital failed to provide a secure environment that prevented patient's medical records from being accessed by unauthorized individuals. The hospital also failed to follow their policy when they allowed two former department employees to have continued access to the medical records department access code that allowed potential access to patient's confidential information. The hospital census was three.

Findings included:

Review of the hospital policy titled, "Secure Filing of Medical Records", approved 06/2021, stated that medical records will be kept in a secure and confidential manner allowing access only to authorized personnel.

Observation on 08/17/21 at 9:39 AM, showed Staff R, Materials Management Clerk and Survey Escort, entered the access code into the lock key pad for the medical records department to allow State Surveyor entry.

During an interview on 08/17/21, 9:39 AM, Staff R, stated that she had access to the department access code because she used to work in the department. She stated that four staff members had access to the medical records lock code, herself; Staff S, Medical Records Clerk; Staff RRR, Registration Clerk; and Staff W, Environment Services Manager.

During an interview on 08/17/2021 at 9:39 AM, Staff S, Medical Records Clerk, confirmed that she and three other staff members had access to the medical records lock code. She stated, she had access; Staff R, Materials Management Clerk; Staff W, Environment Services Manager; and Staff RRR, Registration Clerk, had access to the department code. Staff S reported, she was the only medical records department employee.

Based on observation, interview, record review and policy review, the hospital failed to ensure that the pharmacy had a functional, currently maintained Laminar Flow Hood (enclosed work bench which prevents contamination of medication when the medication is mixed or prepared) for use within the pharmacy department and failed to provide up-to-date reference material on drug therapy in either electronic or hard copy format.

The severity and cumulative effect of these failures resulted in the hospital being out of compliance with 42 CFR 482.25 Condition of Participation: Pharmaceutical Services.

The hospital census was three.

Based on observation, interview, record review and policy review, the hospital failed to ensure that the pharmacy had a functional Laminar Flow Hood (enclosed work bench which prevents contamination of medication when the medication is mixed or prepared). This failure placed all patients at risk for cross contamination with infection and harm who received mixed or prepared medications. The hospital census was three.

Findings included:

Review of the hospital's policy titled, "Intravenous [IV, within the vein] Therapy Procedure - Admixing of Intravenous Medications," revised 10/2018, showed the following direction:
- The purpose of the procedure is to establish requirement for compounding of parenteral (administered or occurring elsewhere in the body then the mouth and gastrointestinal tract).
- The pharmacy is responsible for mixing all intravenous solutions used in the institution except in emergency situations.
- All admixtures made in the pharmacy will be performed in a laminar air flow hood.

Review of the undated hospital document titled, "American Society of Health System Pharmacists (ASHP) Guidelines on Compounding Sterile Preparations," showed that:
- Low risk compound sterile preparations (CSP) included simple admixtures that are to be compounded using aseptic technique (process that is maintained free of germs or bacteria) within an ISO Class 5 PEC (Laminar Flood Hood) that is located within an ISO Class 7 (an isolation level requirement according to the quantity and size of the particles per volume of air) buffer area with an ISO Class 8 (an isolation requirement clean room) ante (before, near the front) area.
- Low-risk CSP's for use within 12 hours may occur within a segregated compounding area in which the ISO Class 5 PEC is not located within an ISO Class 7 buffer area.
- A segregated compounding area is a designated space, either a demarcated area or room, in which compounding is restricted to preparing low-risk, nonhazardous CSPs with a beyond-use time of no more than 12 hours from the time of preparation.

Observation on 08/18/21 at 2:13 PM in the pharmacy department, showed a nonfunctional Laminar Flow Hood with no line of demarcation and a preventative maintenance sticker dated 2018.

During an interview on 08/18/21 at 2:30 PM, Staff B, Pharmacist stated that:
- The hood had not worked since her employment date of 04/2020.
- The hood smoked and made a loud sound when it was turned on.
- Hospital leadership was aware of the issues with the hood and that it hadn't been maintained since 2018 due to non-payment of that servicing.
- There were at least three medications that required mixing inside a Laminar Flow Hood and that she mixed one of these medications at least one to two times per week.
- She currently used the hood as a clean surface only as she was unable to turn the hood on due to the smoke.

During an interview on 08/25/21 at 1:28 PM, Staff BB, Interim Chief Executive Officer stated that he was unaware that the Laminar Flow Hood was outdated for preventative maintenance or the reason it was outdated.

Based on observation, interview and policy review, the hospital failed to provide up-to-date reference material on drug therapy in either electronic or hard copy format. This failure had the potential to affect the quality of care and safety of all patients. The hospital census was three.

Findings included:

Review of the hospital's policy titled, "Medication Administration," dated 10/2019, showed that if the nurse had questions regarding drugs or administration of drugs the nurse should consult reference materials. Under the section "Special Considerations for Pediatric Patients," nurses should use Lexicomp (a purchased online resource that provides evidence based drug reference material for medical professionals) online resource for questions regarding the drug, dosage or calculation for pediatric patients.

Observation on 08/16/21 at 10:00 AM, in the Emergency Department (ED), showed a 2016 Drug Handbook was the only drug reference resource available to the nursing staff.

Observation on 08/25/21 at 9:00 AM, in the Geriatric psychiatry (Geropsych, a unit that focuses on treating mental health and psychiatric disorders in older adults) unit, showed two Drug Handbooks dated 2015 and 2016 were the only drug reference resources available to the nursing staff.

During an interview on 08/16/21 at 10:00 AM, Staff E, Licensed Practical Nurse (LPN), stated that if she had a question about a drug, she would use the 2016 Drug Handbook for reference or she would use her personal cell phone to "google" the drug. She was not aware of any online drug reference tools available for the nursing staff.

During an interview on 08/24/21 at 11:00 AM, Staff B, Pharmacist, stated that the hospital did not purchase up-to-date drug reference manuals for nursing staff. She felt this was problematic and an ongoing issue of concern.

During an interview on 08/26/21 at 2:00 PM, Staff X, Chief Nursing Officer (CNO), stated that he was aware the nursing staff used outdated drug reference books. The hospital did not have Lexicomp online drug reference to use for pediatric drug reference.




45073

Based on interview, policy review, and meeting minute review the hospital failed to ensure that the current Utilization Review (UR) Plan was in place and that an active UR Committee reviewed patient medical records for appropriate care and services.

The severity and cumulative effect of these deficient practices resulted in the hospital's non-compliance with 42 CFR 482.20 Condition of Participation: Utilization Review.

The facility census was three.

Please refer to A-653.

Based on interview, policy review, and meeting minute review the hospital failed to properly execute the approved Utilization Review (UR) plan. This deficient practice had the potential to affect all patients. The facility census was three.

Findings included:

Review of the hospital's policy titled, "Utilization Review," reviewed 10/2018, showed that monthly utilization reviews would be conducted by the Program Director or his/her designee to evaluate the over or under utilization of program services. The information obtained through the utilization reviews would be reported to the hospital's Performance Improvement Committee/Utilization Review.

Review of the hospital's policy titled, "Utilization Management Plan," reviewed 06/2021, showed that:
- The Utilization Review Committee (URC) was responsible for utilization management.
- The responsibilities of the URC were to develop, maintain and execute an effective Utilization Management Plan, to review and revise the plan annually, and to ensure that the functions required of the Plan were continuously performed and documented in a proper and timely fashion.
- The URC would meet and report to the MEC quarterly or more frequently as determined by the committee Chair.
- The URC would maintain the minutes and records of each committee meeting and would include the actions taken regarding the patient's records reviewed and the reasons for such actions.

Review of the hospital's policy titled, "Utilization Management Program," last reviewed 10/2018, showed that:
- Review of patient's charts would be performed for compliance with Federal and/or State regulations, and contracted agreements, to ensure that the appropriate tests and treatments were conducted in a timely manner, and the appropriate level of care was utilized.
- The Utilization Manger would maintain a database with information to be reported as requested, and that information would be included in the Utilization Management Quarterly Reports.
- The URC would notify the Medical Executive Committee (MEC) of concerning trends, reports and resource utilization.
- A quarterly report would be prepared and distributed by the Utilization Manger, the URC Chairperson and the Director of Quality would approve the report, and the quarterly reports would be reviewed during the MEC meeting.

Review of a hospital provided document titled, "Utilization Review," date 01/2021, showed that:
- The January URC meeting was never called to order and that it was deferred due to "organization issues".
- All staff were to "bring their own materials and update their own materials" but only two staff members present had the appropriate materials.
- The meeting was deferred, until "more is sorted out", and was re-scheduled for 01/21/21.

Although requested, no other URC meeting minutes were available from 01/2021 to 08/2021.

During an interview on 08/18/21 at 11:30 AM, Staff X, Chief Nursing Officer (CNO), stated that there was currently no UR being performed. He stated that a previous Quality/Risk Management personnel, who had the UR responsibilities, resigned in 12/2020. He stated that there was an attempt to hand off the UR responsibilities to a Health Information Management (HIM) personnel at that time, however, that staff member had no prior experience in UR, and the hospital had recently secured a new Electronic Health Record (EHR) system that required a significant amount of the HIM staff member's time. Subsequently, for several months the UR responsibilities became a "bouncing ball". Currently, the Director of Quality was working to "bring it back up-to-date".

During an interview on 08/24/21 at 2:00 PM, Staff BB, Chief Executive Officer (CEO), stated that he did not have any direct involvement in the UR process and that the program was currently being run the Director of Quality. He was unaware of when the next URC meeting was scheduled to be held.

The Director of Quality was unable to be interviewed due to a long-term illness related absence.

Based on observation, interview, record review and policy review, the hospital failed to have systemic practices in place to ensure that:
- Endoscopes (lighted tube with a camera, used to visualize the inside of organs) were properly disinfected in accordance to hospital policy and recommended practice. (A-0749)
- Sterilizers (machines that use high heat and steam to kill harmful organisms) were inspected on a regular basis and in accordance to hospital policy and recommended practice. (A-0749)
- Items which were not disposable, and intended for use on multiple patients, were properly packaged to maintain sterile conditions. (A-0749)
- Staff performed hand hygiene in accordance to hospital policy and recommended practice (A-0749)
- Hand sanitizer dispensers were filled and functioning in three of six Emergency Department (ED) bays when a sink was not available. (A-0749)
- Medical equipment was free from residue and debris. (A-0749)
- Disposable, single-use items were discarded when opened. (A-0749)
- Food service personnel wore required hairnets while preparing and serving food. (A-0749)
- Kitchen utensils were free of paper and food residue. (A-0749)
- Food in the freezer were properly sealed to prevent exposure to air. (A-0749)
- Expired food was removed from patient refrigerators and that refrigerators were clean. (A-0749)
- Food products were properly labeled, dated and stored. (A-0749)
- Patient linens and supplies were stored in nonporous cleanable cabinets. (A-0749)
- Ice dispensers were clean and free of buildup. (A-0749)
- Ceilings were free of peeling paint and that ventilation access panels were free of rust. (A-0749)
- A designated infection control officer who implemented policies governing control of infections and communicable diseases was appointed by the Governing Body. (A-0770)
- Education and competency-based training were provided to all staff in accordance with infection control prevention guidelines and practices. (A-0775)

These failures had the potential to adversely affect the quality of care, safety, and care outcomes of all patients within the hospital.

The severity and cumulative effects of these systemic practices resulted in the hospital's non-compliance with 42 CFR 482.42 Condition of Participation: Infection Prevention and Control and resulted in the hospital's failure to ensure quality health care and safety.

The hospital census was three.

Based on observation, interview, record review and policy review, the hospital failed to have systemic practices in place to ensure that:
- Endoscopes (lighted tube with a camera, used to visualize the inside of organs) and colonoscopes (a flexible fiber-optic instrument inserted through the anus in order to examine the colon) were properly disinfected in accordance to recommended practice and hospital policy.
- Sterilizers (machines that use high heat and steam to kill harmful organisms) were inspected on a regular basis in accordance to recommended practice and hospital policy.
- Items which were not disposable, and intended for sterile (without bacteria) use, were properly stored to maintain sterile conditions when opened packages were left on the anesthesia (a state of controlled, temporary loss of sensation or awareness that is induced for medical purposes) supply cart.
- Staff performed hand hygiene during the care of four patients (#2, #20, #21 and #41) of four patients observed.
- Hand sanitizers were filled, and functioning in three of six Emergency Department (ED) bays when a sink was not available.
- Medical equipment was free of residue and debris for one Intravenous (IV, within the vein) pole when an IV pole had rust on the base and wheels.
- Disposable, single-use items were discarded when opened.
- Food service personnel wore required hairnets while they prepared and served food.
- Kitchen utensils were free of paper and food residue.
- Food in the freezer were properly sealed to prevent exposure to air.
- Identified and removed expired food in two of two patient refrigerators.
- Identified and removed outdated supplies.
- Identify that patient refrigerators were dirty.
- Label, date and properly seal opened foods.
- Patient linens and supplies were stored in nonporous cleanable cabinets.
- Ice dispensers were clean and free of buildup.
- Ceilings were free of peeling paint and that ventilation access panels were free of rust.

During an interview on 08/17/21 at 9:05 AM, Staff U, Surgical Technician, stated that endoscopes were manually cleaned and processed with a high-level disinfectant product a minimum of every seven days. A log was kept to track the serial number of each endoscope and the date it was last processed with high-level disinfectant.

Review of the hospital's endoscope processing log showed no patient identifier as to which endoscope was used on a specified patient on which date. Findings included:
- Colonoscope with serial number ending 564 was not logged as processed with high-level disinfectant between 06/21/21 and 08/19/21 (59 days).
- Colonoscope with serial number ending 592 was not logged as processed with high-level disinfectant between 06/23/21 and 07/26/21 (28 days), as well as between 07/26/21 and 08/16/21 (21 days).
- Colonoscope with serial number ending 590 was not logged as processed with high-level disinfectant between 05/24/21 and 06/07/21 (14 days), as well as between 06/21/21 and 07/26/21 (31 days) and between 07/26/21 and 08/09/21 (14 days).
- Endoscope with serial number ending 614 was not logged as processed with high-level disinfectant between 05/24/21 and 06/14/21 (21 days), as well as between 06/14/21 and 08/19/21 (66 days).
- Endoscope with serial number ending 611 was not logged as processed with high-level disinfectant between 06/28/21 and 08/19/21 (52 days).

The dates without documented processing compared to dates on which endoscopic procedures were performed potentially affected 10 patients who received endoscopic procedures at the hospital between 05/24/21 and 08/19/21.

Review of the hospital's policy titled "Infection Control," revised 02/2016 showed that equipment should be maintained according to manufacturer specifications and inspected regularly for expiration dates.

Review of the hospital's document "Environment of Care Manual, Equipment Management," with included Policy titled "Medical Equipment Management Plan," reviewed 03/2021 stated that equipment planning included ongoing monitoring, inspection, preventative maintenance, and testing of equipment. The policy also stated that the hospital had contracted a certified biomedical engineer to perform all repairs and tests, schedule preventative maintenance work requests, provide preventative maintenance work routines and track equipment history.

Observation on 08/17/21 at 9:00 AM showed two steam sterilizers, a low temperature sterilizer, and an instrument washing/decontamination machine with biomed inspection stickers dated 04/2017 and 12/2018.
During an interview on 08/17/21 at 3:25 PM, Staff W, Plant Services Manager, stated:
- The equipment was maintained under a service contract with the manufacturer. The equipment inspections were required annually and outdated. The equipment last received preventative maintenance and inspections as follows:
- The washer/decontamination machine on 07/30/2020.
- The low temperature sterilizer on 08/10/2020.
- The medium steam sterilizer on 07/22/2020.
- The large steam sterilizer on 07/22/2020.

Review of the hospital's policy titled "Scope of Services of the Surgical Services Department," revised 10/2018 showed the AORN, AAMI, the Center for Disease Control (CDC) and Public Health Department standards were referenced in the formulation and review of policies, procedures and the standards of practice in the Surgical Services Department.

Review of the hospital's policy titled "Infection Control," revised 02/2016 showed that single-use patient supplies should be used only once and discarded properly.

Review of the AORN "Guideline for Environmental Cleaning," dated 2020 showed that single-use items should be discarded after each patient use.

Observation on 08/17/21 at 9:00 AM showed opened single-use sterile supplies were observed on the anesthesia cart and ventilator (a machine that supports breathing) cart in Operating Room #1. Opened supplies consisted of endotracheal tube endotracheal tube (a tube inserted through the mouth or nose, that extends into the lungs, to maintain an open passageway for oxygen), laryngeal mask airway (LMA, a device inserted into the area behind the mouth and nose, connecting them to the food pipe (the pharynx) to allow ventilation, oxygenation, and administration of anesthetic gases, without the need for inserting a tube in the windpipe), 18 gauge needle, anesthesia breathing circuit (a medical device used to deliver oxygen, remove carbon dioxide, and deliver inhalational anesthetic agents), suction (to remove thick mucus and secretions from the airway, that a person is not able to clear by coughing) tubing and suction yankauer (an oral suctioning tool). An opened sterilizer-processed package of laryngoscope blades (used as the primary tool for examination of the interior of the larynx and for placement of an endotracheal tube), intended for multi-use and re-sterilized after each patient use, were also observed on the anesthesia cart in Operating Room #1.

Review of the AORN "Guideline for Environmental Cleaning," dated 2021, section 2.1 showed that non-intact and non-waterproof surfaces were difficult to clean and promote cross contamination.

Observation on 08/17/21 at 9:00 AM and 08/23/21 at 12:32 showed potentially contaminated and non-cleanable surfaces. Observations included:
- Paper and sleeve protected papers secured to the wall with medical tape in Operating Room #1.
- Residue and debris on an IV pole with rust on the base and wheels in Operating Room #1.
- Cracked and taped plastic covers for the medical gas shut-off valve in the preoperative and operative suite hallways.

Review of the hospital's policy, "Hand Hygiene," revised 08/2013, showed the following:
- Hand hygiene was considered the most important method of preventing infections.
- Appropriate hand hygiene included diligent cleaning and trimming of fingernails, which may harbor dirt and germs that can contribute to the spread of infections.
- After hands were properly washed and rinsed, hands were to be dried thoroughly with a paper towel. If a hand faucet was used, the water was turned off using a clean, dry paper towel.
- A combination of hand washing facilities and alcohol based hand gel dispensers are located throughout the hospital and are readily accessible to employees, patients, and visitors in patient care areas.
- All personnel must routinely perform hand hygiene with antimicrobial soap or alcohol based gel, in view of the patient when at all possible, when entering and exiting patient rooms and exam rooms, and in between contact with patients or the patients environment, after contact with any item or object that is likely to be contaminated with blood or body fluids.
- Hand hygiene should be performed immediately after the removal of gloves.

Observation on 08/24/21 at 11:28 and 11:29 AM showed Staff SSS, Surgeon and Staff TTT, Certified Nurse Anesthetist (CRNA), both used the hand washing sink located in the operative procedure room. The paper towel dispenser was nonfunctional and they were unable to dry their hands or aseptically (process that is maintained free of germs or bacteria) turn off the water. A nonfunctional paper towel dispenser was also observed by the hand washing sink in the post-anesthesia care unit.

Observation on 8/18/21 at 10:15 AM, showed Staff E, Licensed Practice Nurse (LPN), did not perform hand hygiene before entering the room, during or after completing care to Patient #20.

During an interview on 08/18/21 at 10:35 AM, Staff E, LPN, stated that per the hospital's policy hand hygiene was to be performed before entering a patient's room, after performing care to the patient and during care to a patient if their hands became soiled.

Observation on 08/18/21 at 10:20 AM, Staff CC, Registered Nurse (RN), did not perform hand hygiene before entering the room, during or after completing care to Patient #21.

During an interview on 08/18/21 at 10:40 AM, Staff CC, RN, stated that the hospital policy was for hand hygiene to be performed before entering a patient room and after completing care. She stated that she did not perform hand hygiene before or after care to Patient #21.

Observation on 08/16/21 at 2:30 PM, in the ED, showed that there were no sinks located in ED bays #1, #2, and #6. Hand sanitizer dispensers were empty in ED bay #1 and outside of the ED bay #4.

During an interview on 08/16/21 at 3:00 PM, Staff E, LPN, stated that there were no sinks in ED bays #1, #2, and #6. She stated that hand hygiene before entering bays #1, #2, and #6 would be done in the ED corridor, if hands became visibly soiled while caring for a patient in bays #1, #2, or #6 she would proceed to the ED corridor to wash her hands.

Observation on 08/25/21 at 9:00 AM, on the Geriatric Psychiatry Unit (Geropsych, a unit that focuses on treating mental health and psychiatric disorders in older adults), showed that Staff H, RN, did not perform hand hygiene before applying gloves for medication administration or after removing her gloves following medication administration for two Patient's (#2 and #41) of two patients observed receiving medications.

During an interview on 08/25/21 at 9:30 AM, Staff H, RN, stated that she should have performed hand hygiene before applying gloves for medication administration and after removing her gloves following medication administration.

Review of the hospital's policy titled, "Nutritional Care of the Patient," revised 10/2018, showed direction for food service personnel were to wear hairnets or clean caps.

Observation and concurrent interview on 08/23/21 at 11:31 AM, showed Staff QQQ, Cook, without a hairnet in place while he prepared food in the kitchen. Staff QQQ stated that since his hair was "really short" there was no need to wear one and that he had confirmed that with the local health inspector. He stated that he was the only one on duty in the kitchen and that he cooked and served the food to staff and inpatient care units.

Observation on 08/23/21 at 11:50 AM, showed the table top can opener with paper and food residue on the blade.

Observation on 08/23/21 at 12:00 PM, showed the kitchen freezer with one opened box of frozen sausage patties with the plastic bag that contained the sausage patties unsealed and opened to air.

Review of the hospital's policy titled, "Patient Snacks," revised 09/2018, stated the following:
- Safe food-handling practices will be observed when making, delivering and serving patient snacks.
- The Department of Nutrition and Dietetics will monitor the nourishment storage area and the patient refrigerator to ensure that the area is stocked with adequate food and beverages, and to ensure that these items are fresh.
- The refrigerator will be used only for food and beverages intended for patient use.
- Any foods/beverages found in the patient refrigerator that are from outside sources or that are not properly sealed and labeled will be discarded.

Review of the hospital's policy titled, "Establishing & Maintaining Inventory Levels," dated 09/2018, showed that inventoried supplies should be checked periodically for outdates. Outdated supplies should be removed from the inventory level and returned to the vendor for credit or discarded.

Observation on 08/16/21 at 3:00 PM in the ED, showed the following:
- Three infusion sets with burette (sterile infusion set with a graduated chamber used for slow intravenous [IV, in the vein] administration of a precise volume of infusion or injectable medication over a given time) expired 07/09/21.
- 24 gauge IV catheter expired 06/30/20.
- The triage room housed the patient refrigerator, patient snacks and condiments. The inside of the refrigerator was soiled with sticky spilled liquid.
- There were two undated sandwich containers and two yogurt containers that expired 06/21/21 inside the refrigerator.
- Patient snacks were sitting on the counter in a plastic container with drawers and contained undated graham crackers, peanut butter containers, buttery spread and coffee creamer.

Observation on 08/17/21 at 10:00 AM on the Geropsych Unit showed the following:
- The patient refrigerator had a gallon of 2% milk that expired 08/16/21, plastic container of mayonnaise that expired 08/10/21 and a salad brought in by a staff member dated 08/10/21.
- Three hot dog buns in an undated plastic bag, opened undated bag of tortilla chips on the counter in the nurse's station.
- Opened container of red, white and blue sprinkles in a cabinet in the nurse's station.
- Inside the crash cart was a bone marrow aspiration/intraosseus infusion needle (a needle used to inject medications, fluids, or blood products directly into the marrow of a bone) that expired 08/05/21.

During an interview on 08/17/21 at 10:05 AM, Staff H, RN, stated that staff were not allowed to put food in the patient refrigerator and the salad should not have been in there. She did not check the refrigerator for outdated food.

Observation on 08/17/21 at 2:30 PM, in the stress test room, showed a four drawer wooden dresser (porous, uncleanable surface) with supplies and linen.

Observation on 08/16/21 at 2:50 PM, on the Geropsych Unit, showed that the hospital failed to keep the exterior of the ice dispenser clean and free of buildup.

Observation on 08/16/21 at 3:30 PM, in the seclusion (the involuntary confinement of a patient alone in a room or area from which the patient was physically prevented from leaving) room of Geropsych, showed peeling paint on the ceiling, and rust along the edges of a locked access panel located in the ceiling.

During an interview on 08/16/21 at 2:50 PM, Staff I, Certified Nurse Assistant (CNA), stated that she was not aware of who was responsible for the cleaning and maintenance of the exterior of the ice dispenser, but housekeeping was routinely on Geropsych two to three times a day. The unit had recently been closed in order to refinish the units floors.



39147





39562




44536































41474

Based on interview the hospital failed to ensure that the staff member designated as the Infection Prevention Officer was appointed to the position by the Governing Body (GB) and that the appointment was based on the recommendations of medical staff leadership and nursing leadership. This failure had the potential to affect all patient's health and safety. The facility census was three.

Findings included:

Although requested, the hospital was unable to produce any documentation of the GB's appointment of Staff M, Director of Laboratory Services/Infection Prevention Officer, to the position of Infection Prevention Officer.

During an interview on 08/25/21 at 2:00 PM, Staff BB, Chief Executive Officer (CEO), stated that he was unaware that an Infection Prevention Officer needed to be appointed by the GB. He stated that he could not obtain any documentation showing that Staff M, Director of Laboratory Services/Infection Prevention Officer, had been appointed by the GB.

Based on interview and record review the hospital failed to ensure that the Infection Prevention Officer provided competency-based training and education on infection control and prevention guidelines and practices. This failure had the potential to affect all patient's health and safety. The facility census was three.

Findings included:

Review of 14 staff personnel records showed that six staff had not received any infection control training and five staff had not received current annual re-training.

During an interview on 08/25/21 at 9:50 AM, Staff CCC, Human Resource Generalist stated that if evidence of training completions were not in the personnel files then the training did not occur.

During an interview on 08/23/21 at 1:30 PM, Staff M, Director of Laboratory Services/Infection Prevention Officer, stated that she was not involved in the onboarding of new employees, that new hire orientation was completed at a sister hospital, and that infection control education was provided at that time. She stated that she was not responsible for annual re-education with hospital staff as it was completed through the online education system Health Stream.

During an interview on 08/25/21 at 10:30 AM, Staff UUU, Contracted Nurse Educator, stated that new staff orientation, and introductory education topics, were completed at a sister hospital. She stated that the Director of Quality, at the sister hospital, would complete the initial infection control PowerPoint presentation, video and discussion but more in-depth education would be the responsibility of the Infection Prevention Officer. She stated that the hospital was not currently using Health Stream as an education system. She also stated that the hospital had recently identified a new learning management system, however it was not currently in place.


32280

Based on observation, interview, policy review, and record review the hospital failed to provide a safe environment for surgical patients. When they failed to ensure that:
- The emergency call system in the perioperative (preoperative, recovery room and operating room suites) area was operational. (A-0956)
- Adequate provisions for immediate post-operative care were available. (A-0957)
- Semi-critical endoscope (lighted tube with a camera, used to visualize the inside of organs) devices were properly disinfected in accordance with stated hospital guidelines and recommended practice. (A-0951)
- Preventative maintenance and inspections were accomplished on sterilizers (machines that use high heat and steam to kill harmful organisms) and instrument washing equipment. (A-0951)
- Surgical patients were provided properly executed informed consents with regard to transfer to another hospital if inpatient care was required. (A-0955)
- Appropriate practices with regard to emergency preparation for malignant hyperthermia (a severe reaction to certain drugs used for anesthesia) were maintained. (A-0951)
- An appropriate updated physical examination of surgical patients was provided or documented. (A-0953)
- Staff were certified in emergency life support and advanced life support techniques in accordance with hospital policy. (A-0944)
- A complete and up-to-date operating room register was maintained and available. (A-0958)
- An appropriate post-operative note was immediately available following surgery and signed by the surgeon. (A-0959)

These practices resulted in a systemic failure and noncompliance with 42 CFR 482.23 Condition of Participation: Nursing Services. The hospital census was three.

The severity and cumulative effect of these practices had the potential to place all patients at risk for their health and safety, also known as Immediate Jeopardy (IJ).

By the survey exit date, 08/25/21 at 3:30 PM, the hospital was not able to provide an acceptable plan of correction (POC) to remove the risk of harm to patients, and the IJ remained.

Based on observation, record review and policy review the hospital failed to follow policy and ensure that all staff in the perioperative (preoperative preparation, recovery room and operative suites) area maintained the required licensure and certification for life saving emergency response. This failure placed all patients who received surgical services at risk for their health and safety. The hospital census was three.

Findings included:

Review of the hospital's policy titled, "Cardiopulmonary Resuscitation in the Operating Room," revised 09/2018 stated that all nursing personnel in surgery were certified in Advanced Cardiac Life Support (ACLS, specific life saving measures taken by certified health professionals when a patient's heartbeat or breathing stops) and attended recertification every two years.

Review of the undated hospital document titled, "JOB TITLE: OR Surgical Technologist," stated that surgical technologist were certified in Basic Life Support (BLS, level of medical care for victims with life-threatening illnesses or injuries, until full medical care by more qualified individuals can be given, or at a facility that offers advanced life support).

Observation on 08/23/21 at 9:45 AM showed that Staff OOO, affiliate hospital Registered Nurse (RN), and Staff PPP, Affiliate Hospital Licensed Practical Nurse (LPN), provided direct patient care in the surgery department.

Although requested, the hospital failed to provide personnel files for Staff OOO, RN, and Staff PPP, LPN, to verify licensure and certification status.

Review of personnel records on 08/18/21 at 2:15 PM and on 08/19/21 at 8:35 AM showed that perioperative Staff V, RN, did not have current certification in ACLS; Staff T, RN, did not have current certification in BLS or ACLS; and Staff U, Surgical Technologist, did not have current certification in BLS.

Based on observation, interview, record review and policy review the hospital failed to ensure that:
- Documentation of emergency preparedness for malignant hyperthermia (a severe reaction to certain drugs used for anesthesia) was completed and up-to-date.
- Documentation for disinfectant practices on equipment used for 10 out of 10 discharged patients who received endoscopic (a procedure to examine the interior of a hollow organ or cavity of the body with a lighted tube with a camera) procedures was maintained and up-to-date.
- Maintenance of equipment used for sterilization of surgical instruments was completed and up-to-date.
- A safe, clean environment was provided in accordance to infection control practices.

These failures placed all surgical patients at risk of inadequate response to an episode of malignant hyperthermia and exposure to hospital acquired infection (HAI, infection that was transmitted to the patient while in the hospital) and surgical site infections (infection that occurs after surgery in the part of the body where the surgery took place). The hospital census was three.

Findings included:

Review of the hospital's policy titled, "Malignant Hyperthermia (MH) Cart," last approved 10/2019 stated that the MH cart lock was inspected and recorded daily when surgeries or procedures were performed. The policy also stated that the MH cart will be inspected once a month for inventory and expired drugs.

Review of the hospital's document titled "Malignant Hyperthermia Daily Log" located on the top of the dedicated Malignant Hyperthermia supply and drug cart showed the last documented date checked for supply or medication outdates was 03/30/21. The log lacked documentation that the lock was checked on 18 days that surgical procedures were performed during the months of 04/2021, 05/2021, 06/2021, 07/2021 and 08/2021.

During an interview on 08/17/21 at 9:05 AM, Staff T, RN, Director of Surgical Services, stated that she was aware that the Malignant Hyperthermia cart was not documented as checked for outdated and adequate supply levels according to hospital policy or recommended practices.

Although requested, the hospital failed to provide a policy of procedures used for manually cleaned and disinfected endoscopes [lighted tube with a camera, used to visualize the inside of organs) and colonoscopes (a flexible fiber-optic instrument inserted through the anus in order to examine the colon).

During an interview on 08/17/21 at 9:10 AM, Staff U, Surgical Technician, stated that endoscopes and colonoscopes were cleaned and processed manually with a high-level disinfectant product after each patient procedure and a minimum of every seven days if stored and not used. A log was used to track the serial number of each scope and the date it was last cleaned and processed with high-level disinfectant.

Review of the hospital's binder referred to by Staff U, Surgical Technician, as the "scope processing log" showed no patient identifier as to which scope was used on a specified patient on which date. Dates failed to be documented as follows:
- Colonoscope with serial number ended 564 was not logged as reprocessed with high-level disinfectant between 06/21/21 and 08/19/21 (59 days).
- Colonoscope with serial number ended 592 was not logged reprocessed with high-level disinfectant between 06/28/21 and 07/26/21 (28 days), as well as between 07/26/21 and 08/16/21 (21 days).
- Colonoscope with serial number ended 590 was not logged as reprocessed with high-level disinfectant between 05/24/21 and 06/7/21 (14 days), as well as between 06/21/21 and 07/26/21 (31 days) and between 07/26/21 and 08/9/21 (14 days).
- Endoscope with serial number ended 614 was not logged reprocessed with high-level disinfectant between 05/24/21 and 06/14/21 (21 days), as well as between 06/14/21 and 08/19/21 (66 days).
- Endoscope with serial number ended 611 was not logged as reprocessed with high-level disinfectant between 06/28/21 and 08/19/21 (52 days).
The dates without documented scope reprocessed compared to dates on which endoscopic procedures were performed potentially affected 10 patients who received endoscopic procedures at the hospital between 05/24/21 and 08/19/21.

Review of the hospital's policy titled "Infection Control," revised 02/2016 showed that equipment should be maintained according to manufacturer specifications and inspected regularly for expiration dates.

Review of the Association for the Advancement of Medical Instrumentation® (AAMI) "National Standards Institute (NSI)/AAMI ST79:2017 Comprehensive guide to steam sterilization and sterility assurance in health care facilities," section 12.1, showed the recommended practice was regular maintenance based on the manufacturer's recommended schedule.

Observation on 08/17/21 at 9:00 AM showed two steam sterilizers, a VPro60 chemical sterilizer and an instrument washing machine with Biomed inspection stickers dated 04/2017 and 12/2018.

During an interview on 08/17/21 at 3:25 PM, Staff W, Plant Services Manager, stated:
- The equipment was maintained with an annual preventative maintenance contract with the manufacturer.
- The equipment inspections were required annually and were currently outdated.
- The washer/decontamination machine's last documented inspection occurred 07/30/2020.
- The VPro 60 chemical sterilizer's last documented inspection occurred 08/10/2020.
- The Amsco 400 series sterilizer's last documented inspection occurred 07/22/2020.
- The Eagle 3000 sterilizer's last documented inspection occurred 07/22/2020.

Review of the Association of Perioperative (preoperative, recovery room and operating room suites) Registered Nurses (AORN) "Guideline for Environmental Cleaning," dated 2021, section 4.4, showed recommended practice that operating and procedure rooms were terminally cleaned (thorough environmental cleaning that is performed at the end of each day when the area is being used) at the end of each day that the rooms were used.

During an interview on 08/17/21 at 9:00 AM, Staff T stated that the perioperative area was terminally cleaned by housekeeping staff after each day that procedures or surgeries were performed. She stated that Staff W tracked terminal cleaning procedures.

During an interview on 08/19/21 at 8:40 AM, Staff W stated that housekeeping staff terminally cleaned the surgical services areas at the completion of each day that procedures or surgeries were performed. He notified housekeeping staff on the days that terminal cleaning was required. The staff who performed terminal cleaning had a detailed checklist of the areas which were to be cleaned based on AORN recommendations of terminal cleaning in the operating room.

Review of hospital documents provided with dated and completed terminal cleaning checklists showed that between 05/11/21 and 08/17/21 the surgical area was used eight separate days without documentation of a proper terminal cleaning.

Based on observation, record review and policy review the hospital failed to ensure staff documented a history and physical (H&P, a document in a patient's medical record that contains the physician's initial assessment and treatment plan) within 30 days before registration for one of three current surgical patients and two of four discharged surgical patients and provided and documented a comprehensive, updated physical examination within 24 hours after admission and prior to invasive or surgical procedure for two of three current surgical patients and three of four discharged surgical patients. These failures placed all surgical patients at risk of unknown assurance that they could safely undergo anesthesia (a state of controlled, temporary loss of sensation or awareness that is induced for medical purposes) for planned invasive procedures based on their current health status and for the potential of missed necessitated pre-surgical interventions. The hospital census was three.

Findings included:

Review of the hospital's policy titled, "History and Physical - Surgery," reviewed 10/2018 showed:
- Every patient who had a procedure had a complete history and physical and 24-hour update, if applicable, documented in their medical record before the surgery or procedure took place.
- The surgeon was responsible for dictating or writing the preoperative history and physical.
- The history and physical must be dictated and transcribed or in short handwritten form and completed on the day of surgery or immediately prior to surgery.
- A comprehensive history and physical was expected, but in the event of emergency a minimum of physical examination of heart and lungs and vital signs were required.

Review of the hospital's policy titled, "Medical Staff Rules and Regulations (#ADMS.04 Nueterra 2012/final revisions 3/2015)," approved by the hospital Medical Executive Committee on 01/13/21, stated that patients scheduled for an invasive procedures must have had a history and physical within 30 days prior to the admission. The admitting surgeon or procedural physician provided an updated history and physical within 24 hours prior to any surgery or invasive procedure. The update was available in the medical record and indicated any changes in patient condition or attested that no change occurred in the patient's condition since the last history and physical was performed.

Observation on 08/23/21 at 10:40 AM showed Staff SSS, Surgeon, talked with Patient #36 prior to a colonoscopy (a procedure in which a flexible fiber-optic instrument is inserted through the anus in order to examine the colon) procedure. He reviewed the patient's health history. No physical assessment of the patient was performed including omission of auscultation (the act of listening to sounds arising within organs to aid in diagnosis) of heart and lung sounds.

Review of current Patient #36's medical record showed he was scheduled for a colonoscopy procedure on 08/23/21 to be performed by Staff SSS, Surgeon. The record included an H&P from the patient's family medicine physician, Staff Z, dated 06/10/21 (more than 30 days prior to the scheduled colonoscopy). The record included an incomplete, handwritten physician history and physical form by Staff SSS without details of present illness, without a review of systems, and without documentation of a comprehensive physical examination with Patient #36's current health status.

Review of current Patient #35's medical record showed he was scheduled for a colonoscopy procedure on 08/23/21 to be performed by Staff SSS, Surgeon. The record included an H&P exam from the Staff Z, physician, dated 08/02/21. The record included a handwritten physician history and physical form by Staff SSS without review of systems or physical examination sections completed.

Review of discharged Patient #43's medical record showed that the patient had an inguinal hernia (a bulging of the contents of the abdomen through a weak area in the lower abdominal wall) repair by Staff SSS, Surgeon on 08/02/21. The surgery was performed under general anesthesia (treatment with certain medications that puts the patient into a deep sleep so that they do not feel any pain during surgery). The medical record included an H&P by Staff SSS dated 07/12/21 and an unsigned, incomplete, handwritten H&P form. Another form signed by Staff SSS, dated 08/02/21, and was included in the record stated "H&P Reviewed and no change made". No documentation existed that a comprehensive physical examination of the patient occurred within 24 hours of the surgical procedure.

Review of discharged Patient #10's medical record showed that the patient had a benign, fatty tissue removed from his right arm by Staff SSS, Surgeon, on 08/16/21. The record also showed an H&P dated 08/02/21 and a handwritten physician history and physical form with only the words "No changes since office visit" written; both signed by Staff SSS. No documentation existed that a comprehensive physical examination of the patient occurred within 24 hours of the surgical procedure.

Review of discharged Patient #9's medical record showed the patient had a colonoscopy performed by Staff SSS, Surgeon on 08/16/21. The record included an H&P from Staff Z dated 11/18/20 (more than eight months prior to the colonoscopy). The handwritten history and physical form signed by Staff SSS lacked a history of the patient and details of the patient's present illness and medication status.

Review of discharged Patient #11's medical record showed the patient had a colonoscopy performed by Staff SSS, Surgeon on 08/16/21. The record included an H&P performed by Staff Z, physician, dated 03/01/21 and a handwritten H&P by Staff SSS with an incomplete physical examination.

Multiple failures were identified related to the surgeons' responsibilities to ensure that an H&P was completed by the performing surgeon, was completed not more than 30 days prior to the date of the patients' procedure, and that a comprehensive update of the patients' current physical status was completed and documented within 24 hours prior to procedures performed.

Based on observation, interview, record review, and policy review the hospital failed to provide surgical patients with a properly executed informed consent with regard to procedural risks of low degree of probability but high degree of severity which required transfer of care to another hospital and physician. This failure hindered the patients' right to make informed decisions based on complete information. The hospital census was three.

Findings included:

Review of the hospital's policy titled, "Medical Staff Rules and Regulations (#ADMS.04 Nueterra 2012/final revisions 03/2015)," approved by the hospital Medical Executive Committee on 01/13/21, stated that for surgical procedures, the physician included additional or alternative interventions that may be warranted as part of the informed consent discussion with the patient.

Review of the hospital's Fulton Medical Center policy titled, "Documentation Required for Surgical Case," revised 09/2018 stated that all preoperative information was included in the patient's medical record prior to being admitted to surgical suite. Included in the required information was a signed informed consent for procedure.

Review of the hospital's Noble Health Callaway Community Hospital policy titled, "Requirements of Informed Consent," revised 10/2018 stated that potential risks, complications, drawbacks and potential problems associated with recuperation would be discussed with patients prior to invasive procedures.

Observation on 08/23/21 at 10:40 AM showed Staff SSS, Surgeon obtained written consent from Patient #36 to perform a colonoscopy (a procedure in which a flexible fiber-optic instrument is inserted through the anus in order to examine the colon). He reviewed with the patient the risk of perforation (hole or tear) of the colon and cardiac event (sudden, unexpected loss of heart function, breathing, and consciousness) during the colonoscopy. No further discussion occurred as to potential of extension of the procedure, administration of blood products, the hospital accepted no inpatient admissions, or the need to transfer to another hospital.

Review of current Patient #36's medical record showed a document titled, "Consent to Operation or Other Medical Procedures," which indicated consent for "Colonoscopy with possible biopsies and/or polypectomies (a procedure used to remove polyps from the inside of the colon)." The document also included statements that the patient who signed understood that unexpected events "may require an extension of the original procedure or the performance of a different procedure." No documentation was included in the surgical consent regarding possible transfer to another hospital and to another physician's care if inpatient evaluation and treatment was required. No regard to patient preference was included as to what other hospital was desired for transfer.

Review of discharged Patient #11's medical record showed that the patient signed a consent for colonoscopy performed by Staff SSS, Surgeon, on 8/16/21 with nurse witness at 11:20 AM. The surgeon did not sign, date, or time the surgical consent.

During an interview on 08/23/21 at 11:42 AM, Staff SSS, Surgeon, stated that:
- He was aware that the hospital did not admit patients for medical/surgical nursing care.
- Patients would be transferred to another hospital if a perforation or other complication occurred during a colonoscopy.
- He was not be able to admit or treat patients at any of the hospitals to which patients were transferred, as he was not credentialed at them.
- No discussion was included in his informed consent with patients regarding transfer to another hospital should a perforated bowel or other complication occur during a colonoscopy. He believed this created "unnecessary worry" for the patient.
- He was aware that authorization to administer or decline blood products was included in the hospital's surgical consent. He believed the discussion of the potential of needed blood products during informed consent also created "unnecessary worry" for the patient.
- He was not aware that this hospital's website stated that the surgery department performed colon resections (the surgical removal of part or all of the colon) and exploratory laparotomies (a general surgical operation where the abdomen is opened and the abdominal organs are examined for injury or disease); and that both of those surgeries required inpatient treatment and recovery.
- It made better "business sense" that patients were transferred when inpatient care was required due to the lack of resources at this hospital and the available resources at other hospitals.

Based on observation and interview, the hospital failed to provide an emergency call system in the perioperative (preoperative, recovery room and operating room suites) area. This failure placed all patients who received surgical services at risk for untimely response during an emergency. The hospital census was 3.

Findings included:

Observation on 08/19/21 at 8:50 AM with Staff W, Manager of Plant and Environmental Services, and Staff T, Registered Nurse (RN), Regional Director of Surgical Services showed that when the emergency call button within the procedure room was engaged, no notification was sent to any area within the hospital.

During an interview on 8/17/21 at 11:05 AM, Staff T, RN, stated that the patient call lights and emergency call lights in the perioperative area were nonoperational and that administrative leadership was aware the system did not work. She stated that phones were used in the operative suites to call for assistance in the event of emergency and that preoperative patients were given a bell to ring if assistance was needed.

During an interview on 8/19/21 at 8:40 AM, Staff W stated that the call light and emergency call systems in the entire perioperative area were removed in 2013.

During an interview on 8/23/21 at 11:45 AM, Staff OOO, affiliate hospital RN, stated that in the event of a patient emergency, she would dial the emergency number for a rapid response (a changing situation that requires more staff to address the current needs of the patient). She was unaware that there was not a phone in the preoperative patient rooms and did not have a portable phone. She was unaware that the call-light system was not operational or that the phone in the perioperative nurses' station was also not operational.

Observation and concurrent interview on 08/23/21 at 12:00 PM with Staff LL, RN, Regional Vice President of Patient Care Services showed that when the call light within the preoperative area was engaged, no notification was sent to any area within the hospital. Staff LL stated that the perioperative area should have a way to notify other staff when emergency assistance was needed.

Based on observation and interview, the hospital failed to provide necessary equipment for the recovery of patients after anesthesia (a state of controlled, temporary loss of sensation or awareness that is induced for medical purposes). This failure placed all patients who received surgical services at risk for a decline in health status due to the potential of compromised breathing and circulation created by conscious sedation (a combination of medications to aid in relaxation and block pain during a medical or dental procedure) and general anesthesia (treatment with certain medications that puts the patient into a deep sleep so that they do not feel any pain during surgery). The hospital census was three.

Findings included:

Observation on 8/23/21 at 11:31 AM showed Staff TTT, Certified Registered Nurse Anesthetist (CRNA), and Staff V, Registered Nurse (RN), accompanied Patient #35 from procedure room to Preoperative Room #1 on a gurney (a wheeled stretcher used for transporting hospital patients) for post-procedure anesthesia recovery. The patient was unconscious. There was not a vital signs (body temperature, blood pressure, heart rate, and breathing rate) monitor available for immediate post-procedure assessment. Staff TTT, attached Patient 35's oxygen tubing to the oxygen flowmeter (regulates the flow of oxygen delivery) on the wall, stated that it was not functioning, and instructed Staff V to obtain a portable oxygen cylinder. Staff V exited the room. Staff OOO, affiliate hospital RN, entered the room with a vital signs monitor at 11:34 AM. Staff V re-entered the room at 11:35 AM and stated that the wall oxygen flowmeter should work. Staff TTT stated the wall oxygen delivery remained nonfunctional. Staff V exited the room and re-entered at 11:36 AM with a portable oxygen cylinder.

Patient #35 was without an assessment of post-procedure vital signs for three minutes and was without supplemental oxygen for the first five minutes immediately post-procedure.

During an interview on 8/23/21 at 11:45 AM, Staff OOO, affiliate hospital RN stated:
- She was unaware that Patient #35 would be returned to Preoperative Room #1 for anesthesia recovery and did not have the vital signs monitor available.
- She was unaware that the wall oxygen delivery system in the preoperative area was nonfunctional.
- In the event of a patient emergency, she dialed x444 for a rapid response. She was unaware that the hospital's emergency extension was x549.
- She was unaware that there was not a phone in the patient room and did not have a portable phone. She was unaware that the call-light system was not operational. She was unaware that the phone located at the perioperative nurses' station was also nonfunctional.
- She was aware that while Patient #35 recovered, all other staff in the perioperative area were located in the procedure room engaged in a procedure where Patient #36 was unconscious.

Based on interview, policy review and record review the hospital failed to follow their policy and maintain a complete and up-to-date operating room register. This failure placed all surgical patients at risk for their health and safety due to the hospital's inability to immediately track and provide important surgical procedural data. The hospital census was three.

Findings included:

Review of the hospital's policy titled "Surgical Services OR Patient Log," reviewed 09/2018 showed that the computerized Operating Room Log was available upon request and must be completed and up to date with required information per CMS 482.51(b) regulation.

A surgical roster for the past six months was requested for review. The documents provided showed individual printed pages from the scheduling portion of the two electronic health record systems used by the hospital from 02/2021 through 08/2021. None of the provided documents included the total operative time of the procedures performed, the names of surgeons or any nursing personnel engaged in patient care, the type of anesthesia used, the name of the anesthesia provider, the implantation (or not) of any tissue or mesh products, or the patients' postoperative diagnosis.

During an interview on 08/17/21 at 9:00 AM, Staff T, Registered Nurse (RN), Director of Surgical Services, stated that she did not know where an operating room register for the cases performed over the past six months was located and was not certain of the regulatory requirement for information to include in the operating room register. She stated that one of the recovery room nurses had some type of log saved on a computer located in the Post Anesthesia Care Unit (PACU), but she did not know what information the log contained and could not access it. She also stated the recovery room nurse who maintained the referenced log was not available for interview and had not left instructions on how the log was retrieved for review.

Based on interview, policy review and record review the hospital failed to provide an immediate postoperative report on two out of three current patients and three out of four discharged patients. This failure placed all surgical patients at risk for their safety when operative findings were not immediately accessible in the event of emergent transfer.

Findings included:

Review of the hospital's procedure titled, "Documentation Required for a Surgical Case," revised 09/2018 showed that an operative record was written or dictated before the patient transfer to the next level of care.

During an interview on 08/17/21 at 9:00 AM Staff T, Registered Nurse (RN), Regional Director of Surgical Services stated that the hospital does not utilize an electronic medical record in the operating room. All documentation within the perioperative (preoperative, recovery room and operating room suites) area was completed by hand-written documentation on paper.

Review of current Patient #35's medical record showed a document titled "Brief Post Operative Progress Note" with no documentation, no physician signature, date or time. No other progress note or annotation of procedural findings was located in the record.

Review of current Patient #36's medical record showed a document titled "Brief Post Operative Progress Note" with no documentation, no physician signature, date or time. No other progress note or annotation of physician's procedural findings was located in the record.

Review of discharged Patient #9's medical record showed a document titled "Brief Post Operative Progress Note" with incomplete documentation (postoperative diagnosis only). No other progress note or annotation of physician's procedural findings was located in the record.

Review of discharged Patient #10's medical record showed no Brief Post Operative Progress Note or annotation of physician's procedural findings located within the record.

Review of discharged Patient #11's medical record showed a document titled "Brief Post Operative Progress Note" with incomplete documentation (postoperative diagnosis only), not dated or timed. No other progress note or annotation of physician's procedural findings was located in the record.

These findings presented a risk for all surgical patients as an accountability of the surgeons' techniques used, procedural findings, biopsies and pertinent specifics of procedures were not immediately tangible if transferred to another hospital.

Based on observation, interview and policy review, the hospital failed to ensure that the Respiratory Therapy Department (medical specialty concerned with problems associated with the lungs and breathing) was provided medical direction by a doctor of medicine (MD) or osteopathy (DO) with the knowledge, experience and capabilities to supervise and administer the service properly. The hospital also failed to provide written policies for the delivery of respiratory care services that were developed and approved by the medical staff. These failures had the potential to lead to negative patient outcomes, and could affect all patients who required respiratory care. The hospital census was three.

The severity and cumulative effect of these failures resulted in the hospital being out of compliance with 42 CFR 482.57 Condition of Participation: Respiratory Services.

Based on observation, interview and policy review, the hospital failed to ensure that the Respiratory Therapy Department (medical specialty concerned with problems associated with the lungs or breathing) was provided medical direction by a doctor of medicine (MD) or osteopathy (DO) with the knowledge, experience and capabilities to supervise and administer the service properly. This failure had the potential to lead to negative patient outcomes, and could affect all patients who required respiratory care. The hospital census was three.

Findings included:

Review of the hospital's policy titled, "Role of the Medical Director," dated 09/2018, showed the following:
- Medical direction for respiratory care services will be provided by an active member of the medical staff, appointed by the Medical Executive Committee and approved by the Board.
- The Medical Director was responsible for monitoring and evaluating the quality, safety and appropriateness of respiratory services. Based on these findings, he/she will be responsible for seeing that appropriate actions are taken.
- The appointed Director of Respiratory Services provides overall direction in the provision of respiratory care services and was responsible for seeing that established policies are carried out.

During an interview on 08/17/21 at 2:05 PM, Staff C, Respiratory Therapy Director, stated the following:
- She has been the director since October of 2020 and she works full time, Monday through Friday.
- She was the only Respiratory Therapist (RT), in the hospital. There was no one to cover for her in her absence.
- She did all the breathing treatments during the day time hours, if she was able to get away. The RN's did the treatments at night and on the weekends.
- She also staffed the outpatient cardiac and pulmonary testing area.
- The hospital offered exercise stress tests (a procedure in which the patient walks on a treadmill to cause the heart to work progressively harder and an electrocardiogram [ECG or EKG, test that checks for problems with the electrical activity within the heart] monitors the heart's electrical rhythms), Dobutamine Cardiac Stress testing (a procedure used for patients who are unable to exercise in which medication is put into the vein that causes the heart to beat faster mimicking exercise), holter monitors (a portable ECG used to record the electrical activity of the heart continuously over 24 hours or longer), ECG's and pulmonary function tests (noninvasive test that shows how well the lungs are working).
- There was not a crash cart (mobile cart which contains emergency medical supplies and medication) in the cardiac stress test area. If a crash cart was needed they would use the one in the Geriatric psychiatry (Geropsych, a unit that focuses on treating mental health and psychiatric disorders in older adults) unit.
- She was not aware of a medical director of Respiratory services.

During an interview on 08/18/21 at 9:30 AM, Staff E, LPN, stated that nursing staff were trained to administer breathing treatments. Nursing staff were not trained on the ventilator (a machine that supports breathing) or bi-level positive airway pressure (Bi-PAP, a non-invasive machine that pressurized room air to help a person to take in oxygen and exhale carbon dioxide, used to treat lung disease and respiratory weakness) machine. If a patient in the ED was in need of a ventilator or Bi-PAP, and the RT was not available, she would call 911 for assistance.

During an interview on 08/19/21 at 10:15 AM, Staff BB, Interim CEO, stated that there was not a designated Medical Director for Respiratory Services and he was not aware of how long that has been.

Based on observation, interview and policy review, the hospital failed to provide written policies for the delivery of respiratory (pertaining to the lungs) care services that were developed and approved by the medical staff. These failures had the potential to lead to negative patient outcomes, and could affect all patients who required respiratory care. The hospital census was three.

Findings included:

Review of hospital policies showed no direction for staff that addressed pulmonary function testing (non-invasive test that shows how well the lungs are working), therapeutic percussion and vibration (a procedure performed to help loosen and move mucus and secretions from the lungs and airways), bronchopulmonary drainage (a form of chest physical therapy to remove lung secretions) and mechanical ventilator (a machine that supports breathing) and oxygenation support.

During an interview on 08/18/21 at 9:30 AM, Staff E, LPN, stated that nursing staff were trained to administer breathing treatments. Nursing staff were not trained on the ventilator or Bipap machine. If a patient in the ED was in need of a ventilator or bi-level positive airway pressure (Bi-PAP, a non-invasive machine that pressurizes room air to help a person to take in oxygen and exhale carbon dioxide, used to treat lung disease and respiratory weakness) and the Respiratory Therapist was not available, she would call 911 for assistance.

During an interview on 08/17/21 at 2:05 PM, Staff C, Respiratory Therapy Director, stated the following:
- She has been the director since October of 2020 and she works full time, Monday through Friday.
- She did not know where the preventive maintenance manuals were located for the respiratory equipment.
- She was the only Respiratory Therapist (RT), in the hospital. There was no one to cover for her in her absence.
- She did all the breathing treatments during the day time hours, if she is able to get away. The RN's did the treatments at night and on the weekends.
- She also staffed the outpatient cardiac and pulmonary testing area.
- The hospital offered exercise stress tests (a procedure in which the patient walks on a treadmill to cause the heart to work progressively harder and an electrocardiogram [ECG or EKG, test that checks for problems with the electrical activity within the heart] monitors the heart's electrical rhythms), Dobutamine Cardiac Stress testing (a procedure used for patients who are unable to exercise in which medication is put into the vein that causes the heart to beat faster mimicking exercise), holter monitors (a portable ECG used to record the electrical activity of the heart continuously over 24 hours or longer), ECG's and pulmonary function tests (noninvasive test that shows how well the lungs are working).
- There was not crash cart (mobile cart which contains emergency medical supplies and medication) in the cardiac stress test area. If a crash cart was needed they would use the one in the behavioral health unit.
- She was not aware of a medical director of Respiratory services.
- She was working on writing policies. There was not a policy for pulmonary function testing, therapeutic percussion and vibration, bronchopulmonary drainage, mechanical ventilator and oxygenation support.