The information below comes from the statement of deficiencies compiled by health inspectors and provided to AHCJ by the Centers for Medicare and Medicaid Services. It does not include the steps the hospital plans to take to fix the problem, known as a plan of correction. For that information, you should contact the hospital, your state health department or CMS. Accessing the document may require you to file a Freedom of Information Request. Information on doing so is available here.

HEALTHMARK REGIONAL MEDICAL CENTER 4413 US HWY 331 S DEFUNIAK SPRINGS, FL 32435 April 9, 2021
VIOLATION: GOVERNING BODY Tag No: A0043
Based on review of governing body minutes, interviews, document reviews, and policy reviews, the hospital governing body failed to ensure the hospital was in compliance with all Conditions of Participation and had adequate resources allocated to ensure quality assurance and peer reviews of medical services was conducted and that the chief executive officer appointed carried out the responsibilities of managing the hospital (refer to A0044 and A0057). The governing body failed to ensure the protection of patient rights related to grievances, advanced directives, and right to be free from restraints were maintained (refer to A0115, A0119, A0132, A0145, A0167, A0194, A0208). The hospital governing body failed to provide the resources to develop, implement, and maintain an effective Quality Assessment and Performance Improvement program (refer to A0263, A0273, A0309, and A0315). The governing body failed to have an organized nursing service, supervised by a registered nurse (refer to A0385, A0386, A0392, and A0397). The governing body also failed to provide pharmaceutical services to ensure drug storage areas were under competent supervision (refer to A0489, A0502, A0503, and A0505). The governing body failed to ensure the hospital had an appointed and qualified infection control professional (refer to A0748).

These governing body failures to carry out the responsibilities of managing the hospital to ensure patient safety and patient rights, resulted in a determination of Immediate Jeopardy. The hospital chief operating officer was notified of the Immediate Jeopardy on April 9, 2021 at approximately 3:47 PM. The Immediate Jeopardy was determined to start on 1/29/2021 and was ongoing.

The findings include:

Cross Reference A0044: Based on staff interview, review of Medical Staff Meeting minutes, patient record reviews and personnel file reviews, the hospital's governing body failed to ensure the medical staff requirements were met. The governing body failed to ensure medical staff by-laws were updated and reviewed, and that the by-laws were enforced according to Medical Staff Rules and Regulations, such as the rule that Allied Health Professionals (midlevel practitioners) were not a voting member of the Medical Staff Committee. The Medical Staff Meeting minutes consistently refer to Physician Assistant E as a Medical Doctor. The Medical Staff failed to ensure all patients admitted to the hospital had an Active Member of the Medical Staff assigned (Patient #1 and #2) and failed to ensure require meetings such as the Pharmacy and Therapeutics Committee and Peer Review Committees were being conducted. Cross-reference A0065.

Cross Reference A0057: Based on staff interviews and document review, the Governing Body failed to appoint a Chief Executive Officer (CEO) who is responsible for managing the hospital. The CEO is also the sole owner of the hospital and a member of the Governing Body (Board of Directors). The Governing Body failed to ensure the CEO was managing the hospital by failing to act upon knowledge of 2 sexual harassment allegations against the CEO; failing to ensure the CEO appointed key management staff such as an Infection Control Preventionist, Director of Quality Assurance, or a Risk Manager (Person in charge of tracking and investigating adverse incidents, complaints and grievances); and failing to act upon knowledge that the CEO placed 1 of 1 sampled family members in a patient room from about March 2020 until February 2021, and required the hospital staff to provide care and services to his family member without being admitted to the hospital (Patient #1).

Cross Reference A0065: Based on staff interview, clinical record review, personnel file review and review of Medical Staff By-Laws, the hospital failed to provide physician oversight for patients admitted by a mid-level practitioner in accordance with Medical Staff By-Laws for 4 of 5 sampled patients (#1, 2, 3, and 4).

Cross Reference A0115: Based on staff interviews, review of grievances, incident reports, medical records, staff training files and policies and procedures, the hospital failed to protect and promote patients' rights for the prompt resolution of grievances (refer to A0119). The hospital failed to protect patient rights by failing to ensure processes were developed and staff were trained in the areas of advance directives, abuse, neglect and restraints (refer to A0132, A0145, A0167, A0194 and A0208).

Cross Reference A0263: Based on staff interviews, policy reviews, incident reviews, review of staff training files, review of grievances, review of governing body meeting minutes, and the hospital's organizational chart, the hospital failed to maintain an ongoing program to measure, analyze, and track quality indicators to assess the process of care, hospital service and operations (refer to A0273). The hospital failed to ensure a hospital-wide quality assessment and performance improvement efforts addressed identified and reported 7 of 7 incidents related to patient safety (refer to A0309) and failed to provide resources to carry out the functions of a quality assurance program, including failing to hire and train staff to carry out the functions of a quality assurance program, ensure the quality measures are identified, and collection, assessment and reporting of data to ensure safe and effective patient care and services (refer to A0315).

Cross Reference A0309: Based on review of grievances, incident reports, policies, board of directors' minutes, and interviews, and a resignation letter, the hospital's governing board failed to carry out its executive responsibilities to ensure hospital-wide quality improvement and patient safety was implemented and maintained. The hospital failed to provide evidence of a functioning Quality Assurance and Performance Improvement (QAPI) committee that addressed patient safety. The hospital was unable to provide evidence of QAPI meetings since September 13, 2019. There was no one appointed as in charge of complaints and incidents or QAPI, there were uninvestigated complaints approximately 2 months old, and no evidence that submitted incident reports were being tracked or investigated. There was a currently employed nurse who had previously abandoned patients and was recorded going through discharged patient medications and putting them in her purse in December 2020. The governing body and administrative officials failed to ensure there was a Director of Nursing (DON) or acting DON, and failed to ensure someone was in charge of education to ensure staff training and competencies. The hospital staff were utilizing patient restraints without training. There was no evidence that required pharmacy committees were being held.

Cross Reference A0315: Based on staff interviews, document reviews, and policy reviews, the hospital's governing body and administrative staff failed to allocate resources to ensure the hospital is able to measure, assess, improve, and sustain performance and reduce risk to patients. The hospital failed to maintain quality staffing. In order to meet staffing needs, the hospital rehired a nurse considered a "no hire". The hospital failed to maintain staff leadership positions such as a Director of Nursing, staff in charge of complaints and incidents, staff in charge of staff training and competencies, an infection control coordinator or unit managers for 2 of 2 open units, Medical-Surgical unit and the Emergency Department.

Cross Reference A0385, Based on observations, staff interviews, policy reviews, staff record reviews, medical record reviews, and review of the organizational chart, the hospital failed to have a current permanent Director of Nursing or an acting Director of Nursing (refer to A0386) or nursing services organized with appointed and qualified nursing supervisors (refer to A0392). The hospital failed to demonstrate competency training of nurses, including but not limited to cardiac monitoring and restraints, allowed nurses to work in patient care without current Basic Cardiac Life Support training and rehired a nurse with a documented history of patient abandonment at the hospital (Licensed Practical Nurse CC) (refer to A0398). The hospital's lack of nursing leadership and nurse training resulted in a failure to provide ordered cardiac telemetry monitoring for 1 of 1 patients sampled for cardiac monitoring (#3) and 2 of 2 patients sampled for restraints (#2 and #4).

Cross Reference A0489: Based on observations, staff interviews, review of video evidence provided, and review of policies and procedures, the hospital failed to ensure the Condition of Pharmaceutical Services met the needs of patients and that drug storage was under competent supervision to prevent loss or damage of patient's home medications, to ensure controlled substances were locked and stored according to policy, and to ensure that outdated medications were not available for patient use in the emergency room (refer to A0502, A0503, and A0505).
VIOLATION: MEDICAL STAFF Tag No: A0044
Based on staff interview, review of Medical Staff Meeting minutes, patient record reviews and personnel file reviews, the hospital's governing body failed to ensure the medical staff requirements were met. The governing body failed to ensure medical staff by-laws were updated and reviewed, and that the by-laws were enforced according to Medical Staff Rules and Regulations, such as the rule that Allied Health Professionals (midlevel practitioners) were not a voting member of the Medical Staff Committee. The Medical Staff Meeting minutes consistently refer to Physician Assistant E as a Medical Doctor. The Medical Staff failed to ensure all patients admitted to the hospital had an Active Member of the Medical Staff assigned (Patient #1 and #2) and failed to ensure require meetings such as the Pharmacy and Therapeutics Committee and Peer Review Committees were being conducted. Cross-reference A0065.

Failure to ensure medical staff by-laws are enforced can lead to process breakdowns and inadequate medical care which can threaten patient safety.

The findings include:

The "Bylaws Rules and Regulations of the Medical Staff" was reviewed and revealed the last date of review by the Board of Directors was 02/08/2019 and was signed by a former Chief Operating Officer (COO) no longer working at the facility. The document contained the following information:

Article V a. Allied Health Professional (page 17) identified Licensed Advanced Practice Registered Nurse Practitioners and Certified Physician Assistants as "Allied Health Professionals" and paragraph 1. C. defined "Allied Health Professionals are not Members of the Medical Staff and cannot vote at Medical Staff Meetings. Under the heading, "2. Qualifications," in subsection b, "An Active Medical Staff Member will act in a supervisor role as a preceptor and will be ultimately responsible for patient care.

Review of the Medical Staff Rules and Regulations documented on page 21. "IX. Non-Physicians a. Admitting Privileges i. All patients admitted to the Facility for care will have an Active Member of the Medical Staff with Admitting Privileges assigned.

A review was conducted of the Personnel file for Physician's Assistant (PA) E. A review for state licensure revealed a clear and active license as a Physician's Assistant. Further review of the personnel file revealed a diploma for a, "Doctor of Medicine," on 6/26/2004. This individual was not licensed as a Medical Doctor in the State of Florida.

A review was conducted of the Medical Staff Meeting Minutes for 11/20/2019. Noted in Attendance as an Active Member of the Medical Staff was PA E, with the suffix, "M.D." which is an abbreviation referring to a Medical Doctor. Under the heading of, "New business," it stated, "Doctor SS presented an Executive Committee recommendation for Doctor AAA, initial appointment with courtesy privileges in Emergency Medicine for a one year period. Approved with Doctor FF making motion and Doctor (PA) E seconding."

A review was conducted of the Medical Staff Meeting Minutes for 1/15/2020. Noted in Attendance as an Active Member of the Medical Staff was PA E, with the suffix, "M.D."

A review was conducted of the Medical Staff Meeting Minutes for 6/17/2020. Noted in Attendance as an Active Member of the Medical Staff was PA E, with the suffix, "M.D." Under the heading of, "Old Business," it stated, "The minutes for January 15, 2020 were presented for review. Doctor SS made a motion to approve the minutes presented, seconded by Doctor (PA) E. The motion carried unanimously." Under the heading of, "Administrative Report," it stated, "Mister DDD (former Chief Operating Officer) mentioned scheduling Medical Staff Meetings quarterly, rather than monthly. He stated that although this matter had been discussed numerous times, it had never resolved. Doctor (PA) E made a motion to have quarterly meetings. Doctor CCC seconded the motion. The motion was approved unanimously. Under the heading of, "Quality Improvement Report," it stated, "Former Director of Nursing RR submitted two new policies related to Pandemic Screening:
ADM-10: Pandemic Emergency Plan - N95 respirators
ADM-11 - Pandemic Emergency Plan - COVID-19 (Coronavirus Disease 2019) and Employee Health. Doctor SS made a motion to recommend the policies for introduction to the Board of Directors. Doctor (PA) E seconded the motion. The motion was approved unanimously. Under the section titled, "New business," Doctor SS presented a couple of providers for consideration of appointments. Doctor (PA) E made a motion to approve the appointments and recommend consideration by the Board of Directors. The motion was seconded by Doctor GG and approved.

A review was conducted of the Medical Staff Meeting Minutes for 10/27/2020. Noted in Attendance as an Active Member of the Medical Staff was PA E, with the suffix, "M.D." Under the heading of, "Old Business," it stated, "The minutes for 1/17/2020 were presented for review. Doctor SS made a motion to approve the minutes as presented, seconded by Doctor (PA) E. The motion carried unanimously. Under the heading, "Quality Improvement Report," it stated, "In accordance with the Plan of Action submitted to Agency for Health Care Administration, Former DON RR submitted four policies related to Pandemic Screening:
'ADM-10: Pandemic Emergency Plan - N95 Respirators'
'IC-43: Pandemic Emergency Plan - Coronavirus Disease'
'IC-44: Pandemic Emergency Plan - Monitoring and Screening for COVID-19'
'IC-45: Admission of Suspected or Confirmed Patients'
Doctor SS made a motion to recommend the policies for approval by the Board of Directors. Doctor (PA) E seconded the motion. The motion was approved unanimously.

A review was conducted of the Medical Staff Meeting Minutes for 2/17/2021. Noted in Attendance as an Active Member of the Medical Staff was PA E, with the suffix, "M.D."

On 10/09/2020 - 10/19/2020, State licensed Physician Assistant E, (PA E) admitted Patient #1 to the hospital. PA E signed the physician order sheet for Patient #1 as "(his name) MD, PAC" (Medical Doctor, Certified Physician Assistant) on the Physician's Order Sheet on 10/09/2020 at 9:30 AM, at 10:00 AM, 1:30 PM, 10/11/2020 4:45 PM, 10/12/2020 at 1:00PM and 5:45 PM, 10/14/2020 at 12:30 PM and 10/19/20 at 2:46 PM. PA E also signed the physician Progress notes as "(his name) MD, PAC" on 10/13/2020 at 10:00 AM, 10/14/2020 at 10:00 AM, 10/15/2020 at 1:00 PM, 10/16/2020 at 6:00 PM, 10/17/2020 at 5:20 PM, 10/18/2020 at 11:15 AM, and the discharge summary on 10/19/2020 at 2:00 PM. No physician's co-signature was noted on any of these entries, and there was no evidence an active member of the Medical Staff was involved in the care.





Certified Registered Nurse Anesthetist (CRNA) G admitted Patient #2 to the hospital 3/8/2021 through 3/11/2021. Record review revealed no Doctor of Medicine or Doctor of Osteopathy, nor any physician meeting the qualifications described in the facility's medical staff bylaws or medical staff rules and regulations. Additionally, there was no active member of the Medical Staff involved in the care or admission of patient #2. During the course of patient #2's admission from 3/8/2021 through 3/11/2021, patient #2 was placed in restraints, intubated, sedated, and transferred to another hospital for a higher level of care. The documentation in patient #2's chart failed to identify any consultation with a member of the medical staff or any other physician.

On 4/2/2021, patient #4 was admitted by CRNA G for Hyperglycemia (elevated blood sugar) and pneumonia. There was no overseeing physician noted in the clinical record.

On 4/4/2021, patient #5 was admitted by Advanced Practice Registered Nurse (APRN) LL for pneumonia and heart failure. There was no overseeing physician noted in the clinical record.

Section 4 of the Medical Staff Bylaws Rules and Regulations documented: Quality Improvement Committees, the role of the QI committees defined as to oversee the management of the QI process and will ensure appropriate documentation, and will recommend improvements as indicated. Paragraph 1. B, indicated the processes measured shall include, at least the following: ii. The Pharmacy and Therapeutics Committee.

In an interview on 4/5/2021 at 12:42 PM, the Chief Operating Officer said that the minutes for the pharmacy and therapeutics committee requested during the entrance conference were not available and the pharmacist was also not familiar with committee minutes.

A review of the Governing Board Minutes from 01/28/2020 through 4/9/2021 failed to document or address any peer review process or completion of any peer review performed at the facility.

A review of Medical Staff Meeting Minutes from 11/20/2019 through most recent meeting dated 02/17/2021 did not mention any peer review or peer review committee.

The Medical Staff Bylaws Rules and Regulations last approved on 02/08/2019, stated on page 46 "Article XI Committees 1. Committee Membership a. The Medical Staff will appoint members to the Medical Staff Standing Committees unless otherwise provided by these Bylaws; 2. Standing Committees a. The Medical Staff Standing Committees are as follows: ii. Section 2 Peer Review" On page 49, Section 2, Peer Review committee - the section did not indicate a time frame for when peer reviews needed to occur but did say under subparagraph 2. "Duties of the Peer Review Committee are as follows: "review professional practices at the facility to reduce morbidity and mortality and to improve patient care." [Reference s. 395.0193(2)(g)] i. The Risk Manager, or designee using the Medical Staff approved criteria, will conduct the initial Morbidity and Mortality Review.

On 4/8/2021 at 9:45 AM, administrative assistant R provided requested peer review documentation and stated, "I'm just going to be honest with you, we've gotten behind in peer review and this is all we have." She provided a total of 5 appraisals from 11/20/2017 through present date. There was one peer review evaluation for doctor (Dr.) P dated 3/31/2021, a peer review evaluation for Dr. FF dated 12/01/2018, a peer review evaluation for Dr. GG dated 5/21/2018, a peer review evaluation for Dr. HH dated 11/20/2017, and a peer review evaluation for Dr. II dated 02/10/2018.
VIOLATION: CHIEF EXECUTIVE OFFICER Tag No: A0057
Based on staff interviews and document review, the Governing Body failed to appoint a Chief Executive Officer (CEO) who is responsible for managing the hospital. The CEO is also the sole owner of the hospital and a member of the Governing Body (Board of Directors). The Governing Body failed to ensure the CEO was managing the hospital by failing to act upon knowledge of 2 sexual harassment allegations against the CEO; failing to ensure the CEO appointed key management staff such as an Infection Control Preventionist, Director of Quality Assurance, or a Risk Manager (Person in charge of tracking and investigating adverse incidents, complaints and grievances); and failing to act upon knowledge that the CEO placed 1 of 1 sampled family members in a patient room from about March 2020 until February 2021, and required the hospital staff to provide care and services to his family member without being admitted to the hospital (Patient #1).

Failure to ensure the CEO was effectively managing the hospital could result in process breakdowns that threaten patient safety. Cross Reference: A0065 and A0386.

The findings included:

A review of the most recent Agency for Health Care Administration "Health Care Licensing Application" dated 11/13/2019, identified the Chief Executive Officer (CEO) as the 100% owner of the hospital, and also identifies the CEO as a member of the Governing Board.

A review of the hospital Organizational chart revealed that the CEO was directly responsible for the position of Chief Operating Officer (COO)who in turn was over the Director of Nursing, the Risk Manager, and the Chief Financial Officer (CFO). The positions of Infection Control and Quality Improvement reported to the Risk Manager. Per the organizational chart, the positions of Director of Nursing, the Risk Manager, Infection Control and Quality Improvement were all currently vacant. Also there were no unit supervisors for the two nursing units that were operational, emergency services and the medical-surgical unit.

On 4/8/2021 at 1:43 PM, the Chief Operating Officer (COO) explained she had been acting as COO for only two weeks and has just started identifying areas of concerns.

The CFO had recently tendered his resignation as both the CFO and as a member of the Board of Directors in a letter dated 3/18/21. The resignation letter mentioned concerns with the CEO/owner creating a hostile work environment, the CEO/owner claiming only he had decision making authority, and the CEO/owner making morally questionable decisions regarding hospital policy. In the letter, the CEO reiterated his concerns that the contractor hired for the building moisture remediation (a relative of the CEO), had "continued involvement in the day to day working and management of this facility with his known record and inability to pass a background screening check"

In an interview on 4/5/2021 at 3:22 PM, the former Director of Nursing (Nurse M, a registered nurse) said there is no Director of Medical Services and since she began working at the facility on 2/1/2021 there has not been a designated Infection Control person or a Risk Manager. Nurse M affirmed that she informed administration several times there had to be both an Infection Control and Risk Manager. Nurse M reported the owner/CEO has stated multiple times "I own the hospital, I can do what I want."

On 4/5/2021, in an interview which took place from 12:42 PM through approximately 3:00 PM, the acting Chief Financial Officer (CFO) described several concerns about the facility. The CFO had received 2 separate sexual harassment complaints from 2 different nurses, both of whom wished to remain anonymous. The complaints were dated February 1st and 2nd, 2021 and contained allegations that the CEO/owner had been sexually inappropriate while he was an inpatient. The CFO stated since there was no Risk Manager, he gave the complaints to the Governing Board chair (GB chair). The CFO added, "If someone comes to me with a complaint, I believe that I need to take care of it and in this case it involved the owner. I sent those complaints to the GB chair and then he took those complaints to the owner (who is also the CEO). At that time, the owner's (family member) was here in the hospital and he (the owner/CEO) was staying across the hall. He (owner/CEO) went back to his home in (name of town) and that was good; he wasn't here anymore. We removed the alleged threat, but there was no investigation that I'm aware of. As far as I know, the GB chair asked the owner/CEO about it, and he denied it and that was the end of it. I have attended the last few governing board meetings and that was never discussed. The sad part is that he (the owner/CEO) is on the board. He is the acting CEO and he is at all of those board meetings, so that would never be discussed at a board meeting. The owner/CEO was admitted as a patient for a couple of nights February 1 and 2. His (family member) was here at that time, but not as a patient, as a resident. It wasn't billed. They didn't bill for anything, they just looked after her. The owner's statement was that he's the owner of the hospital and she can stay here. And, full disclosure, my last day here is to be the 16th of April, I have turned in my resignation. The owner's family member staying here was never discussed, the CEO said, 'this is my facility and I can do what I want', that was the mindset that he has had."

Emails provided for review included 2 letters submitted anonymously from nurses alleging sexual misconduct by the CEO were sent from a former Chief Operating Officer (COO) TT to the CFO, and forwarded the GB chair. The first letter alleged misconduct took place on 2/1/2021 and was noted as received by COO TT on 2/17/2021 at 4:40 PM. The letter was forwarded to the CFO in an email dated 2/17/2021 at 4:46 PM. The CFO forwarded the email to GB chair on 2/19/2021 at 1:14 PM. The second letter alleging sexual misconduct by the CEO was noted as received on 3/3/2021 by the CFO and forwarded to GB chair via email on 3/3/2021 at 12:26 PM. Both allegations indicate the CEO engaged in sexual misconduct toward nurses in a patient room on the medical surgical unit of the hospital.

During an interview on 4/7/2021 at approximately 12:49 PM, the Governing Body (GB) chair was asked when were the Governing Body by-laws last reviewed and replied, "I couldn't tell you I think the last amendment was several years ago maybe '95, maybe when I first started up, maybe 2003. I'm looking at them now, looks like there was an amendment in 2003 that's the only one I see." The GB chair was asked what authority the governing board has regarding the owner who is named as the CEO and responded, "I don't know what authority we would have to regulate his actions. I think the board of directors could address that matter with the CEO if there were something brought to our attention concerning his conduct. I guess with him being the sole stockholder, he could just change the board of directors. I would think if complaints were made to us, we would address those, how much authority we have could be problematic, I think we would have to address that."

An attempt to contact the person identified as the hospital owner/CEO was made by phone on 4/7/2021 at 12:41 PM and a voice message with phone number was left. No response was received at the time the survey ended. The CEO was not present in the hospital during the survey.

On 4/8/2021 at approximately 1:43 PM, in an interview the current COO and RN M were made aware attempts to speak to the CEO by phone were unsuccessful and that surveyors still need to talk to him. At the time the survey ended, the CEO had made no effort to speak with surveyors.

On 4/8/2021 at 12:01 PM, the CFO said, "At one point, the CEO told us no one in this facility calls AHCA (Agency for Health Care Administration - the state regulatory agency) about anything except for me."

On 4/7/2021 at 2:37 PM, RN M provided a one page document that she explained was the Governing Board by-laws. The policy, titled Review of By-laws, Rules and Regulations, policy #ADM-35 with an approval date of 9/22/2003 and no updated review date documented. The policy indicated "The Governing Board will approve all rules and regulations (policies and procedures) of Healthmark Regional Medical Center (HRMC). At least every 2 years, bylaws, rules and regulations will be approved with documentation in the minutes of the Governing Board. The CEO and COO or their designee will have authority of the governing board to act on its behalf in the event a policy or procedure is needed prior to the final board approval. The signature of the Chief Executive Officer and/or the Chief Operating Officer (or their designee) may sign the policy and procedure into effect with the Governing Board ratifying the policy at the next scheduled meeting. The Governing Board will review all of the Medical Staff Bylaws, Rules, and Regulations at least every 2 years, and the review will be documented in the minutes.

Review of the Bylaws Rules and Regulations of the Medical Staff as recommended to the board of directors and as approved by the board of directors documented the date Reviewed/Approved by the Board of Directors as February 8, 2019.

A review of the Governing Body minutes included a letter dated 10/01/2020 and signed by the CEO which stated, "This is to certify that when I am absent or not available, (Staff O, the daughter of the owner/CEO) is authorized and empowered to perform functions which are customarily performed by me, by the power vested as sole owner of Healthmark Corporation, Healthmark of Walton Incorporated and/or Healthmark Rural Health Clinic."

A review of Governing Body meeting minutes dated 4/9/2021 reflected that the CEO was aware of the ongoing survey and the COO had been "keeping him in the loop on hospital activities." The minutes reflected the CEO said, "the accusations in the letter to AHCA from (name) are ridiculous." The CEO asked if the Risk Manager position was dictated by AHCA. He also made a statement that the COO will be making decisions, "due to my declining health I want (the COO) to make all the decisions and keep me informed." Staff O, my daughter will be functioning as Administrative Assistant, she will be helping the COO and CFO. During a discussion of the financial report the minutes reflect the CEO suggested he may "take on the project myself, or the best course of action needed to achieve results. I want to be involved in spite of my health and I need to be informed of all financials." The minutes reflect the Governing Board chair said, "you are the owner and can decide for yourself how to proceed."

On 04/05/2021 at approximately 10:45am, during an interview Certified Nurse Assistant (CNA) A stated, "Patient #1 has been a patient here, a long term care resident, she was here when I started in October of 2020. I was told she has been here for months before I came. She went home for a week before Christmas and then came back. She just went home last month (February 2021) and has since passed. I helped Patient #1 with showers/positioning. For the longest time, we kept her in her room. It wasn't talked about and I took her out one day, as the Chief Executive Officer (CEO) wasn't here, and she absolutely loved it. The CEO didn't want me in there and I was yelled at a few times by him. He would say, "What are you doing in here? You shouldn't be in here." Patient #1 could feed herself, but she wasn't with it all the time. She could tell you she wanted to go home and said it many times. She asked me to call her husband to go home and I was told that the CEO said, she had to wait till the doctor cleared her. She wasn't a patient here, she lived here. He added, "I couldn't document on Patient #1. She wasn't a patient and for that reason was not in our system. I don't know how the nurses did it, as it's all computer charting. I know she had a binder, but it was just her meds and stuff." (Written statement provided).

On 04/05/2021 at 11:48 AM, during an interview Registered Nurse (RN) S stated, "We cared for Patient #1 for a long time. She was here in March of 2020. Then COVID-19 (Coronavirus Disease 2019) exploded and it was discussed about sending her to a skilled nursing facility (SNF) for rehabilitation. The Chief Executive Officer (CEO) didn't want that because he could not visit her in a SNF, so she stayed with us. She did have a week at home in October of 2020. She came back, then she was discharged home at the end of February of this year." Nurse S said, "We used paper charting for her. We didn't have a lot, only medical interventions. We documented in the Medication Administration Record (MAR) when medications were given. She got mostly maintenance medications, Vitamin D, Bee pollen and the occasional Tramadol, Ativan or Xanax as needed. These were given very occasional, not routinely. She knew how to use her call light and let her needs be known up until her discharge. She was kept here by the CEO, she wanted to go home. She stated frequently, 'I want to go home', and ask, 'Why am I here?' I would tell her to talk to the CEO. I knew she just wanted to go home, but the CEO wanted her here. He even stayed here at one time." Nurse S added, "Patient #1's provider was Physician Assistant (PA) E. He's a PA and Doctor, or that is what they call him here." She said, "We used paper charts and those usually go to Medical records, but I believe that Patient #1's chart went to the former DON RR's office instead." (Written statement provided).

On 04/06/2021 at approximately 3:10 PM, during an interview Nurse Technician (NT) VV stated, "Patient #1 was here for a long time. She was in a room down the hall. She did not receive any respiratory care so we were not involved, but we were aware that she was here as a long term resident."

On 4/6/2021 at approximately 1:28 PM, during an interview the Utilization Review/Discharge Planning Registered Nurse (RN) CC stated, "I was aware of Patient #1 being here as a resident. She was not an inpatient. Part of my job here was to try and find her a skilled nursing facility (SNF) or nursing home (NH). Unfortunately it was at the height of COVID and (the CEO) did not want that as he could not see her, so he kept her here."

On 04/06/2021 at approximately 4:55 PM, during an interview RN U stated, "I started working at this facility on 1/26/2021. I took care of Patient #1. I never understood what classification she was under as she wasn't an inpatient and there wasn't any paperwork. I asked staff, they said we do not chart daily assessments, we care for her, but no charting, except for medications given or held. I felt she knew why she was here, and wanted to go home. She asked about going home. I never knew why she was kept in her room all the time. The former Director of Nursing RR told me we have a patient here for long term care and she has Dementia. She said that she gets out of her room and wanders and that the patient needs to stay in her room."

On 04/08/2021 at approximately 12:10 PM, during an interview RN T, she said, "I cared for patient#1. She was here for a long time, many months, and was not an inpatient. It was not an official admission so we couldn't document in the computer. We, the nurses, just made a paper chart and documented medications on the medication administration record (MAR). They were her home medications. We also documented any procedures we provided." RN T revealed that she had not had any one as a resident before like patient#1 in the past 3 years of employment. (Written statement provided).

After record reviews, patient#1 was noted to have had the following dates of admission during her hospital stay from March 2020 through February 2021:
1/08/20 - 1/13/2020
3/17/2020 - 4/14/2020
5/21/2020 - 5/27/2020
10/09/2020 - 10/19/2020
11/24/2020 - 12/02/2020
VIOLATION: CARE OF PATIENTS - ADMISSION Tag No: A0065
Based on staff interview, clinical record review, personnel file review and review of Medical Staff By-Laws, the hospital failed to provide physician oversight for patients admitted by a mid-level practitioner in accordance with Medical Staff By-Laws for 4 of 5 sampled patients (#1, 2, 3, and 4).

Failure to provide oversight for mid-level practitioners creates the potential that patients might not receive adequate medical care and could be harmed. Third party insurance might not cover the hospital care provided by health care practitioners who are not physicians.

Findings include:

A review was conducted of the Personnel file for Physician's Assistant (PA) E. A review for state licensure revealed a clear and active license as a Physician's Assistant. Further review of the personnel file revealed a diploma for a, "Doctor of Medicine," on 6/26/2004. No state Medical license was noted for this individual. A review of the on-line Florida Department of Health Medical Quality Assurance Licensure Verification found only a license to practice as a Physician's Assistant. A review of the "Application for Reappointment Physician Assistant/Nurse Practitioner" was conducted for state licensed PA E. The application stated, "The administrator has elected to extend your temporary membership for those endeavors, which you specified (Physician Assistant with privileges at the Healthmark Regional Medical Center Emergency Treatment and Hospitalist as well as practice at the Healthmark Rural Health Clinic.) This action is taken in accordance with Article 7, Section 6, and Page 33 of the Medical Staff By-Laws." This was dated 3/23/21. In all areas of the application, PA E signed as "MD, PA-C" (Medical Doctor, Physician Assistant-Certified).

The current Medical Staff By-Laws were requested, and the hospital provided "The Medical Staff of Healthmark Regional Medical Center Rules and Regulations". The document was undated, but had been approved by the Board of Directors on 2/8/2019. Article V "Allied Health Professional (page 17) identified Licensed Advanced Practice Registered Nurse Practitioners and Certified Physician Assistants as "Allied Health Professionals"and paragraph 1. C. defined "Allied Health Professionals are not Members of the Medical Staff and cannot vote at Medical Staff Meetings. Beginning on page 10, under VI. Health Information - v. The Attending Physician must read, edit, sign and/or counter-sign all orders, H&P, and pre-operative notes that have been recorded by an Intern, Resident Physician or a Physician's Assistant. On page 21. "IX. Non-Physicians a. Admitting Privileges i. All patients admitted to the Facility for care will have an Active Member of the Medical Staff with Admitting Privileges assigned.

Patient #1:
Record review revealed Patient#1 had the following dates of admission by PA E.
1/08/20 - 1/13/2020
3/17/2020 - 4/14/2020
5/21/2020 - 5/27/2020
10/09/2020 - 10/19/2020
11/24/2020 - 12/02/2020

On 01/08/2020, PA E admitted Patient #1, for care and PA's signature is on multiple areas of the patient's record, including: History of Present Illness (HPI), Discharge Summary, Admission orders on 1/8/2020, orders on 1/9/2020 -1/13/2020, Inpatient Certification of Need of Care Form dated and signed by PA E on 01/08/2020. The orders were not counter-signed by a physician in accordance with Medical Staff By-Laws.

On 03/17/2020, PA E admitted Patient #1, for care and PA's signature is on multiple areas of the patient's record, including the Physician's Admission Order Sheet, which states to "Admit to Dr. (PA E's name)". The physician orders were not counter-signed by a physician in accordance with Medical Staff By-Laws.

On 05/21/2020, PA E admitted Patient #1, for care and PA's signature is on multiple areas of the patient's record including orders on the Physician Order Sheet on 05/21/2020. The physician orders were not counter-signed by a physician in accordance with Medical Staff By-Laws.

On 10/09/2020, PA E admitted Patient #1, for care and PA's signature is on multiple areas of the patient's record including Physician's Order Sheet on 10/11/2020, 10/12/2020, and 10/14/2020. The physician orders were not counter-signed by a physician in accordance with Medical Staff By-Laws.

Patient #2:
A review of patient #2's clinical record showed she presented to the hospital emergency department on 3/8/21 at 5:00 PM via ambulance and was diagnosed with acute rhabdomyolysis (the destruction or degeneration of muscle tissue, as from traumatic injury, excessive exertion, or stroke, accompanied by the release of breakdown products into the bloodstream and sometimes leading to acute renal failure) and admitted into observational status on 3/9/21 by Certified Registered Nurse Anesthetist (CRNA) G. On 3/11/21 the observational status was changed to an admission, and she was transferred later the same day. A review of Physician Order Sheets revealed numerous orders, all signed by the CRNA with no evidence of physician oversight. Some of the orders included IV (intravenous) antibiotics, Morphine, a Posey Vest restraint (a type of medical restraint used to restrain a patient to a bed or chair), antipsychotics, central IV line, insulin drip, Levophed (used to treat life-threatening low blood pressure), Propofol (used to sedate a patient who is under critical care and needs a mechanical ventilator), and endotracheal intubation (breathing tube inserted into the airway via the mouth). There was no overseeing physician noted anywhere in the clinical record, only CRNA G, who is an advanced-practice nurse who is certified in anesthesia.

On 4/6/2021 at 5:24 PM, interview with RN D revealed Patient #2 was diagnosed with rhabdomyolysis and ended up being intubated and transferred. She had been here 3 days and they had a Posey vest on her. Patient #2 was admitted under the Certified Registered Nurse Anesthetist.

Patient #4:
On 4/2/2021, patient #4 was admitted by CRNA G for Hyperglycemia (elevated blood sugar) and pneumonia. There was no overseeing physician noted in the clinical record.

Patient #5:
On 4/4/2021, patient #5 was admitted by APRN LL for pneumonia and heart failure. There was no overseeing physician noted in the clinical record.
VIOLATION: PATIENT RIGHTS Tag No: A0115
Based on staff interviews, review of grievances, incident reports, medical records, staff training files and policies and procedures, the hospital failed to protect and promote patients' rights for the prompt resolution of grievances (refer to A0119). The hospital failed to protect patient rights by failing to ensure processes were developed and staff were trained in the areas of advance directives, abuse, neglect and restraints (refer to A0132, A0145, A0167, A0194 and A0208).

The hospital failure to protect patients by failing to investigate grievances, by failing to train staff in abuse prevention, and appropriate physical restraint techniques put patients at risk for asphyxiation, death, skin breakdown, decreased circulation to restrained areas, pressure ulcer development and emotional harm. The cumulative effect of these failures resulted in a determination of Immediate Jeopardy at the Condition of Patient Rights. The hospital Chief Operating Officer was notified of the Immediate Jeopardy on April 9, 2021 at approximately 3:47 PM. The Immediate Jeopardy was determined to start on 1/29/2021 and was ongoing.

The findings include:

Cross Reference A0119: Based on staff interview, complaint review, medical record review, and policy review, the hospital failed to conduct or have a process in place for the prompt resolution of grievances related to patient care. This process failure affected 1 of 1 patients who submitted a grievance in the past 6 month, sampled patient #6.

Cross Reference A0132: Based on staff interview and clinical record reviews, the hospital failed to ensure that patients had the right to formulate advance directives, and failed to ensure hospital staff and practitioners were made aware of patient choice in advance directives for 1 of 1 patient (Patient #1).

Cross Reference A0145: Based on staff interview and policy review, the hospital failed to ensure that patient rights to be free from all forms of abuse were honored. The hospital failed to develop and implement an abuse policy and failed to train staff on abuse and neglect for 9 of 9 staff sampled for abuse training (staff A, H, J, S, T, U, CC, EE and VV).

Cross Reference A0167: Based on record review, policy review and staff interviews, the hospital failed to implement safe and appropriate restraint techniques as determined by hospital policy for 1 of 2 patients sampled for restraints (#2). The hospital failed to obtain a physician order prior to applying non-emergent restraints and failed to document an assessment after the restraint was applied. The restraint was applied on an unknown time either late on 3/8/21 or the early morning hours of 3/9/21 and a restraint flow sheet per hospital policy was not initiated until 7:00 PM on 3/10/21. The hospital failed to document proper positioning of the restraint, blood circulation in the area of the restraint, and failed to document skin integrity for 2 days. Improperly applied physical restraints put patients at risk for asphyxiation, death, skin breakdown, decreased circulation to restrained areas, pressure ulcer development and emotional harm.

Cross Reference A0194: Based on staff interviews, clinical record review, policy review, and review of nurse staff training files, the hospital failed to ensure staff were trained in the safe implementation of restraints and failed to ensure staff competencies in restraint techniques for 12 of 12 staff sampled for restraint review (staff A, C, H, M, S, T, U, CC, EE, MM, VV, and XX). This failure affected 2 of 2 sampled patients (#2 and #4).

Cross Reference A0208: Based on staff interviews, personnel record reviews, document review and policy review, the hospital failed to maintain documentation of training and competencies for 3 of 3 nursing personnel records reviewed (Staff C, U, and MM).
VIOLATION: PATIENT RIGHTS: REVIEW OF GRIEVANCES Tag No: A0119
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on staff interview, complaint review, medical record review, and policy review, the hospital failed to conduct or have a process in place for the prompt resolution of grievances related to patient care. This process failure affected 1 of 1 patients who submitted a grievance in the past 6 month, sampled patient #6.

The findings included:

On 4/5/2021 at approximately 10:30 AM, a request was made for patient grievances for the past 6 months. The hospital only provided 1 patient grievance from that timeframe, a complaint letter dated 2/23/2021 from a licensed clinical social worker at an Assisted Living Facility (ALF) concerning patient #6, a resident of the ALF. The complaint letter was in regard to the conduct of Dr. F in the emergency department. The letter indicated Dr. F was "rude and inappropriate" and administered 2 medications (Haldol and Ativan) to patient #6 for sedation/agitation and discharged the patient.

In a telephone interview on 4/12/2021 at 2:49 PM, the Licensed Clinical Social Worker from the ALF confirmed the hospital had not responded to her grievance. A letter was provided to the survey team from the assisted living facility executive director dated 4/12/2021 confirming she had attempted to reach the administrator of the hospital on [DATE] and again on 2/22/2021 to discuss the grievance concerning patient #6 with no success and documented "I have yet to hear from them."

A record review for patient #6 indicated she was treated in the hospital's emergency room on [DATE]. Nurse MM documented in the record Dr. F saw patient #6 at 1:30 AM. At 1:50 AM, nurse MM documented administration of 2mg (milligrams) Ativan (a schedule IV anti-anxiety medication) through intramuscular injection (IM) and Haldol (an antipsychotic medication) IM. The record indicated patient #6 was discharged on [DATE] at 2:15 AM. Their record included a list of previous medications, none of which were an antipsychotic.

On 4/5/2021 at 3:22 PM, the former Director of Nursing, Nurse M, a registered nurse (RN) stated since she began working at the hospital on [DATE] there has not been a designated Risk Manager (person in charge of tracking and investigating adverse incidents, complaints and grievances). Nurse M affirmed that she informed administration several times there had to be a Risk Manager. Nurse M reported the hospital owner/Chief Executive Officer has stated multiple times "I own the hospital, I can do what I want."

On 4/8/2021 at 1:43 PM, the surveyor asked the Chief Operating Officer (COO) to describe the quality review and complaint process. The COO explained she had been acting as COO for only two weeks and had just started identifying areas of concerns. The COO stated she was not aware of the complaint from the ALF dated 2/23/2021 concerning the conduct of Dr. F, and didn't recall seeing the follow-up letter from the ALF about Dr. F's conduct. She confirmed the hospital did not have a Risk Manager or anyone filling that role.

During an interview on 4/7/2021 at approximately 12:49 PM, the Chair of the Governing Board stated he was unaware of the grievance related to Dr. F.

A review of the current hospital organizational chart indicated there was no one identified in the roles of Risk Manager or Quality Improvement, the roles which would typically be assigned responsibility for ensuring analysis of patient grievances.

The hospital policy entitled "Risk Management Program/Patient Safety Plan - Grievances", dated 2/24/04 and approved 4/30/07 documented the Risk Management Program Responsibilities Procedure: "4. the Governing Board will oversee the patient grievance process. The Board will review and resolve grievances that are forwarded by the Risk Manager." "c. The Governing Board 'will promptly review and resolve each patient grievance' presented by the Risk Manager and will make a determination as to whether the grievance requires further action. i. the Governing Board 'will notify the patient, in writing of its decision' within 30 business days of the Boards review." The Role of the Risk Manager or his/her Designee documented, "b. the Risk Manager will make every effort to make initial contact by telephone of the party who made the grievance within 10 business days after receipt; c. The Risk Manager will complete a thorough investigation of the grievance within 30 days of receipt; d, the Risk Manager will determine the need for further consideration by the Governing Board utilizing the approved "Patient Grievance Review Criteria"
VIOLATION: PATIENT RIGHTS: ADVANCED DIRECTIVES Tag No: A0132
Based on staff interview and clinical record reviews, the hospital failed to ensure that patients had the right to formulate advance directives, and failed to ensure hospital staff and practitioners were made aware of patient choice in advance directives for 1 of 1 patient (Patient #1).

Findings include:

A review was conducted of a physical clinical chart binder for Patient #1. Review revealed that there was an orange Do Not Resuscitate (DNR) sticker on the outside of the chart. There was no living will or advance directives located in the chart or any documentation of advance directives in any notes. The chart contained some medication administration records from December 12/10/2020 through 12/28/2020 and 1/2/2021 through 2/23/2021. The chart included both documentation during inpatient admission, and documentation during times patient #1 lived on the medical-surgical unit without being admitted . On 2/22/2021 at 5:00 PM the, "History and Physical," was completed by PA E along with a note for patient #1's discharge to home with Home Health, which was signed by PA E, as, "DR, PAC."

On 4/5/2021 at 5:10 PM, the surveyor asked RN M, the former Director of Nursing, verified that there was no Advanced Directives in patient's record, and the record was from when the patient resided on the unit, and was not an inpatient. She said, she would try and locate any Advance Directives for Patient #1..

Additional inpatient records were identified for Patient #1 for the following dates:
1/08/2020 - 1/13/2020
3/17/2020 - 4/14/2020
5/21/2020 - 5/27/2020
10/09/2020 - 10/19/2020
11/24/2020 - 12/02/2020

A review of the admission from 1/08/20 - 1/13/2020 found Patient #1 was admitted by Physician Assistant (PA) E. There was no Living Will for review. Her advanced directives were documented as FULL CODE by the nurse admission note.

A review of the admission from 3/17/2020 to 4/14/2020 found Patient #1 was admitted by PA E, and there was no Living Will/Advance Directives were in this record.

A review of the admissions from 5/21/2020 - 5/27/2020 found Patient #1 was admitted by PA E. There was no Living Will noted. The, "Advance Directives and Admissions Inquiry Form," had a patient label with the patient's name, medical record number, date of birth, attending physician, bed number, sex, race, and a partial Social Security Number. The document was incomplete. The only areas completed were the witness signature line and date. There were also check boxes which stated "I acknowledged the receipt of the following materials: Educational Handout regarding Advance Directives and A copy of the Patient's Bill of Rights and Responsibilities. The checkboxes were blank for both.

A review of the admission from 10/09/2020 - 10/19/2020 was conducted. Patient #1 was admitted by PA E. The Living Will form was blank. The "Advance Directives and Admissions Inquiry Form," had a patient label with the patient's name, medical record number, date of birth, attending physician, bed number, sex, race, and a partial Social Security Number. The document was incomplete. The only areas that were completed were the witness signature line and date. There were also a checkboxes which stated "I acknowledged the receipt of the following materials: Educational Handout regarding Advance Directives and A copy of the Patient's Bill of Rights and Responsibilities. The checkboxes were blank for both.

A review of the admission from 11/24/2020 - 12/02/2020 was conducted. Patient #1 was admitted by Physician P. The Living Will section was blank. The "Advance Directives and Admissions Inquiry Form," had a patient label with the patient's name, medical record number, date of birth, attending physician, bed number, sex, race, and a partial Social Security Number. The document was incomplete. The only areas that were completed were the witness signature line and date. There were also a check boxes which stated "I acknowledged the receipt of the following materials: Educational Handout regarding Advance Directives and A copy of the Patient's Bill of Rights and Responsibilities. The checkboxes were blank for both. The Initial nursing assessment had "FULL CODE" documented on 11/24/20 at 10:29 by RN EE, but later the same day at 12:02 PM, RN EE documented "DNR" on the on the Nursing Shift Assessment.
11/24/20 22:11 FULL CODE documented by LPN C.
11/25/20 07:45 DNR documented by RN EE
11/26/20 07:52 FULL CODE documented by RN Z.
11/26/20 00:02 FULL CODE, DNR, Do Not Intubate
11/27/20 through discharge on 12/02/20 DNR is documented on each Nurse Assessment.

Patient #1 was also admitted to Hospice with a start date 09/28/2020 ended 10/12/2020. The Hospice clinical record identified under Advanced Directives that Patient #1 was a Full Code. On 10/02/20 at 10:24 PM the Hospice Medical Social Worker documented, "Family needs further education on Hospice philosophy and goals, as they both do not seem to be accepting of patient's terminal status as evidenced by their insisting upon a Full Code Status and no final arrangements have been completed." The second Hospice service dates were 2/26/2021 ended 3/6/2021. During this admission, the Hospice clinical record identified under Advanced Directives "none".

On 4/6/2021 at approximately 2:00 PM, during a follow-up interview, RN M stated, "I am sure she was a Full Code." RN M stated, she asked what Patient #1's advanced directives were because the nurses need to know what to do, and I was told that the CEO, her (family member), wanted her to be a Full Code. "That is what I know, I'm not sure why there is a DNR sticker on her chart".
VIOLATION: PATIENT RIGHTS: FREE FROM ABUSE/HARASSMENT Tag No: A0145
Based on staff interview and policy review, the hospital failed to ensure that patient rights to be free from all forms of abuse were honored. The hospital failed to develop and implement an abuse policy and failed to train staff on abuse and neglect for 9 of 9 staff sampled for abuse training (staff A, H, J, S, T, U, CC, EE and VV).

The findings include:

The hospital policies on abuse and neglect to include prevention, investigation and response were requested during the entrance conference on 4/5/2021. The abuse policies were re-requested several times during the 5 day survey including during interview with Registered Nurse (RN) M on 4/7/2021 at 12:07 PM and from the Chief Operating Officer (COO) on 4/8/2021 at 1:43 PM.

On 4/7/2021 at 2:37 PM, RN M was able to locate Policy SC-28, entitled "Child Abuse and/or Neglect" last reviewed on 08/2010 by the DON who resigned in December 2020, RN RR, and Policy SC-29, "Elder Abuse and/or neglect" last revised on 08/15/2005. At that time, the surveyor asked RN M if there were any abuse policies that were not specific to elders or children and she replied she was not able to find any.

A red binder at the nurses' station labeled 'Human Resources Policy/Procedure was reviewed. The first sheet indicated it was the annual review and was dated January 13, 2016. Signed by a former COO, staff DDD, a former Director of Nursing (DON) RR who signed on the Risk Manager line. The table of contents identified the Abuse or Sexual Misconduct Policy as HR-45, but when reviewing the manual, discovered there was no HR-45 or policy for abuse or sexual misconduct in the binder.

On 4/8/2021 during an interview beginning at 12:01 PM, the surveyor asked about a policy delineating staff response if a patient were to report abuse, and the Chief Financial Officer, staff J, replied, "We would have to figure out how to submit that report. There is currently no process for reporting quality concerns or required federal or state required reports for abuse or anything else."

On 04/05/2021 at 10:45 AM, during an interview Certified Nurse Assistant (CNA) A stated, "I have worked here since October 2020.. I didn't have any orientation education or training on anything, no abuse or neglect, patient's rights, risk management."

On 04/05/2021 at 11:48 AM, during an interview Registered Nurse (RN) S stated, "I have not had any education or annual training for over a year or more on Risk Management or abuse and neglect. I have been here 5 years and it has been awhile since I had any education."

On 4/6/21 at approximately 1:28 PM, during an interview RN CC stated, "I have worked here 7 years. I have not had any education or training since my orientation 7 years ago."

On 04/06/2021 at approximately 3:10 PM, during an interview Nurse Technician (NT) VV stated, "The only education I did in 2020 was my NT competencies, I have not asked about any education as 2020 has been a wild year. The nurses give me direction."

On 04/06/2021 at approximately 4:55 PM, during an interview RN U stated, "I have worked here since 1/25/2021, became a nurse in 2016. Reviewed New Employee Orientation packet with the nurse. She added, I was given the packet and read most of it, no other education/training, and no abuse training that I remember

On 04/07/2021 at approximately 7:40 AM, during an interview RN EE. She said, " I did not have any orientation that was classroom or documentation/paper instructions." "I believe I did get a job description, but no education for abuse, Risk Management, patient's rights that I remember."

On 04/08/2021 at approximately 12:10 PM, during an interview RN T, she said, "I have not had education on abuse, neglect, restraints, and cardiac monitoring."

On 04/09/2021 at approximately 2:50 PM, during an interview RN H stated, "I started at facility in November 2020, has been a nurse for over 35 years, and was retired and decided to come back as a part time/prn staff nurse. I did not get any orientation. I just got thrown in, that's how they do it here."
VIOLATION: PATIENT RIGHTS: RESTRAINT OR SECLUSION Tag No: A0167
Based on record review, policy review and staff interviews, the hospital failed to implement safe and appropriate restraint techniques as determined by hospital policy for 1 of 2 patients sampled for restraints (#2). The hospital failed to obtain a physician order prior to applying non-emergent restraints and failed to document an assessment after the restraint was applied. The restraint was applied on an unknown time either late on 3/8/21 or the early morning hours of 3/9/21 and a restraint flow sheet per hospital policy was not initiated until 7:00 PM on 3/10/21. The hospital failed to document proper positioning of the restraint, blood circulation in the area of the restraint, and failed to document skin integrity for 2 days. Improperly applied physical restraints put patients at risk for asphyxiation, death, skin breakdown, decreased circulation to restrained areas, pressure ulcer development and emotional harm.

The findings included:

A request was made for a list of patients with restraint usage. The hospital was unable to provide this information. During an interview on 4/6/2021 at 5:24 PM, Registered Nurse (RN) D was able to recall a recent patient in restraints, Patient #2. RN D revealed Patient #2 was diagnosed with rhabdomyolysis and ended she ended up being intubated and transferred. The patient had been here 3 days and they had a Posey vest (a type of medical restraint used to restrain a patient to a bed or chair) on her. RN D added that she wanted to take every Posey vest in this place and throw it away. Patient #2 was admitted under the Certified Registered Nurse Anesthetist.

A review of patient #2's clinical record showed she presented to the hospital emergency department on 3/8/21 at 5:00 PM via ambulance and was diagnosed with acute rhabdomyolysis (the destruction or degeneration of muscle tissue, as from traumatic injury, excessive exertion, or stroke, accompanied by the release of breakdown products into the bloodstream and sometimes leading to acute renal failure) and admitted into observational status on 3/9/21 by Certified Registered Nurse Anesthetist (CRNA) G.

The first annotation related to the Posey vest restraint was found in Nursing Progress Notes upon transfer to the medical-surgical unit. Registered Nurse (RN) S documented on 3/9/2021 at 8:42 AM, "Admission completed as able at this time. Posey vest was used in Emergency Department last evening, it remains in place but is not tied. Patient making no efforts to get out of bed."

An order for, "Posey vest restraint for patient safety," initialed by Certified Registered Nurse Anesthetist G (CRNA G), was added to an admission order set signed by Advanced Practice Registered Nurse (APRN) LL. The date and time the order was written cannot be determined due to a hole punch in the original document, but these orders were noted by nurse S on 3/9/2021 at 9:44AM. Another order was written on 3/10/21 at 11:24 AM by CRNA G that stated, "Posey vest for patient safety off for 2 hours every 4 hours." There was no annotation in the record of any assessment made immediately following administration of the restraints on patient #2.

Licensed Practical Nurse (LPN) C documented patient #2 with [bed] side rails up x4 and Posey vest restraint in place on 3/9/2021 at 7:00 PM, 10:30 PM, 11:30 PM, and on 3/10/2021 at 4:00 AM. No assessment was made during any of these entries regarding proper placement of the vest restraint or the patient's circulation. At the 3/10/2021 4:00 AM, LPN C noted, "Patient changes position often on her own, vest is loose enough to move freely in bed" and "patient still moves in random fashion yet this has decreased during the last few hours and has remained more calm and restful".

LPN XX documented patient #2 in Posey vest restraint on 3/10/2021 at 7:25 AM and documented the vest was released on 3/10/2021 at 9:25 AM. LPN XX documented Posey restraint reapplied due to patient trying to get out of bed and pulling on tubes on 3/10/2021 at 10:25 AM and released on 3/10/2021 at 11:15 AM. LPN XX documented Posey restraint applied due to patient trying to get out of bed on 3/10/2021 at 1:05 PM and then released at 3:00 PM. On 3/10/2021 at 6:00 PM, LPN XX documented applying Posey vest restraint for patient safety.

On 3/10/2021 at 7:30 PM, LPN XX documented "report given to oncoming shift, patient stable at this time." This statement conflicted with the oncoming shift nurse, Nurse U, who documented on 3/10/2021 at 7:10 PM "Patient is lying in her bed with eyes closed, was nonresponsive except to pain stimuli. Patient was having labored shallow breathing. Patient Glasco Coma Scale (GCS) was a 6 (The GCS Score is the basis for a common classification of acute traumatic brain injury. A 6 would indicate a severe injury). Patient had Rhonchi (low pitched continuous breathing sounds that resemble snoring or gurgling) and wheezing in both lungs. Oxygen saturation was only 83% with patient receiving 2 Liters oxygen via nasal cannula. Patient oxygen turned up to 4 Liters, head of bed was raised which brought her up to 90% (Normal arterial blood oxygen saturation levels in humans are 95-100 percent). Will call house supervisor and CRNA G to make them aware for further orders. Will continue to monitor."

On 3/10/2021 at 7:00 PM, RN U initiated a physical restraint flow sheet and the only documentation on the flowsheet occurred as hourly checks beginning at 7:00 PM and ending at 11:00 PM. The flowsheet identified the behavior necessitating the restraints as "pulling on Foley [urinary catheter tubing] + [plus] IV" (A Posey vest restraint does not restrict arm or hand movements) at 7:00 PM with two lines in each hourly check at 8:00 PM, 9:00 PM, 10:00 PM and 11:00 PM to indicate the same reason. Each hour mark noted the restraints were continued. Each hourly annotation indicated the patient's position was on her back, the restraints were checked for fit, the restraints were not released and documented attempts to orient patient as "unresponsive." There was no further documentation of the Posey restraint in patient #2's record.

In an interview on 4/8/2021 at 11:04 AM, Nurse M, the former Director of Nursing, described the care provided to patient #2, "She was put in a Posey at the nurses' request (RN MM), she had altered mental status, her labs were way out of range, she was combative, so that the nurse asked for the Posey. They gave her sedation, I don't remember exactly what, by IV (intravenous route). There weren't appropriate restraint checks or releases."




A review was conducted of policy number, "NADM-117," subject, "Nursing Safety," approved 11/1/2001 with no review dates noted. The policy statement was, "All nursing service activity will be conducted under well established safety guidelines." The procedure statement was as follows:
For complete hospital policy of safety, see Policy and Procedures ADM-28, "General Safety Guidelines.
A. Physical safety barriers
C. Physical restraints: The charge nurse shall assume the responsibility of preventing activities of patient which are injurious to themselves or others by means of restraints. The nurse will notify the physician of the need for physical restraints. If the patient must be restrained immediately for safety, the nurse will do so, then contact the physician to obtain an order. See Restraint Policy and Procedure NADM035.

A review was conducted of the policy, subject, "Use of Restraints," policy number, "NADM-53," approved 12/7/2004 with no review dates noted on the policy. The policy statement was as follows: "Health mark Regional Medical Center Nursing Services will assure all direct patient care providers will have ongoing education and training in the proper and safe use of restraints. The Director of Nursing will assure each nurse department manager provides initial and ongoing education and training annually in the proper and safe use of restraints."
The procedure statement was:
I. General
A. All patients admitted to Healthmark Regional Medical Center have a right not to be restrained. Restraints are only to be used as a last resort and only after less restrictive interventions have been attempted and proven to be ineffective in providing safety to patients whose behavior presents a threat to themselves or others.
B. The least restrictive effective intervention is to be utilized to control the patient's behavior which places them or others at risk for injury. Some interventions, less restrictive than restraints are:
1. Medication
2. Removal of the stimulus causing the behavior
3. Attendance by family/friends
4. More frequent checks by staff
5. Change in patient location nearer the nurses' station
6. Lights on in room or bathroom
C. Behaviors which place the patient at risk for injury and the interventions which have been attempted to prevent injury must be documented in the Medical Record prior to placing the patient in restraints.
* NOTE: IF, IN THE JUDGEMENT OF THE CHARGE NURSE, THERE IS AN IMMEDIATE, SERIOUS DANGER OF THE PATIENT HARMING HIM/HERSELF, STAFF, OR OTHERS, RESTRAINTS MAY BE APPLIED IMMEDIATELY (SEE PROTOCOLS).
D. Initial and continued utilization of restraints shall be based on the assessed needs of the patient. The patient shall only be restrained to the point necessary to ensure the patient's/staff's safety. For example, a Posey vest may be adequate to restrain a combative frail patient, while 4- point, Twice-as-tough-cuff limb restraints and multiple belt restraints could be necessary to restrain a combative Baker Act [involuntary psychiatric admission] patient who is strong and determined.
G. Education/Competency evaluations on the use of restraints in included in Nursing Orientation, and at least annually thereafter. The staff member's Nurse Manager is responsible for facilitating annual updates.
K. The Restraint Flowsheet is utilized for documentation. Documentation may be continued, if necessary, in the nurses' notes.
L. The entire time the patient is restrained, assessments, patient care and documentation are done as follows:
a. Document patient's behavior
b. Check circulation in area(s) of restraint(s) - loosen or reposition restraint(s) as necessary.
c. Check for the proper positioning of the restraint(s) if necessary.
d. Check the patient's position (for comfort position of function, safety, etc.) - reposition the patient if necessary.
e. Skin integrity - Remove or reposition restraint(s) as necessary to prevent/reduce any skin trauma. Document and, if appropriate, report to the physician all adverse findings and any interventions.
2. Every 2 hours (and as needed):
A Nutrition 0 offer appropriate drink/snack/meal
b. Elimination - offer urinal/bedpan, assist to toilet, etc.
c. Hygiene - as appropriate for the patient, provide/offer bath, clean linens, face/hand cloths, toothbrush, grooming supplies, etc.
d. ROM (Range of Motion)/Activity - If possible, provide for ambulation with assistance. If this is not possible, as appropriate move from bed to chair (or vice versa), give ROM, etc.
e. Mental Status/Orientation - monitor patient's mental status/orientation for improvement/degenerations. Appropriately evaluate, document, and report any changes to the physician.
f. Release restraints - this may be done during ambulation, when the patient is being taken to the bathroom, bathed, etc.
II. Initiating Restraints:
A. Protocol
A patient may be restrained by initiating a protocol. A protocol is a set of criteria based on professional practice standards and approved by the medical staff. These criteria identify specific patient populations and specific circumstances under which restrained may be utilized without a physician's order.
1. A physician's order is not required, however, the physician must be notified as soon as feasible that the restraint protocol has been initiated. The contact must document the contact in the Nurses' Notes.
2. When the use of restraints has been ordered for a patient the patient's care plan will be modified.
3. The circumstances (the patient's behavior, etc) that cause the restraint protocol to be initiated must be thoroughly documented.
4. When the patient no longer meets the criteria under which the restraints were applied (for example, if their behavior changes or the patient is no longer intubated) the restraints must be removed.
5. All assessment, patient care an documentation requirements as outlines in section I, A-M are adhered to.
6. ONLY the charge nurse may initiate restraint protocol.
7. When restraint protocols are initiated because of the patient's behavior (protocols A-D) the chare nurse must assess the patient and evaluate the possible physical causes of the behavior (e.g. hypoxia, hypo/hyperglycemia, dehydration, diarrhea, drug toxicity, electrolyte imbalance, etc. ) As appropriate the charge nurse will notify the physician of pertinent findings, obtain orders, and/or develop appropriate nursing interventions as soon as possible. The assessment and any ensuing physician contact will be documented in the Nurses' notes.
VIOLATION: PATIENT RIGHTS: RESTRAINT OR SECLUSION Tag No: A0194
Based on staff interviews, clinical record review, policy review, and review of nurse staff training files, the hospital failed to ensure staff were trained in the safe implementation of restraints and failed to ensure staff competencies in restraint techniques for 12 of 12 staff sampled for restraint review (staff A, C, H, M, S, T, U, CC, EE, MM, VV, and XX). This failure affected 2 of 2 sampled patients (#2 and #4).

Improperly applied physical restraints put patients at risk for asphyxiation, death, skin breakdown, decreased circulation to restrained areas, pressure ulcer development and emotional harm. Cross Reference: A0167 and A0208.

The findings included:

A review of patient #2's record indicated numerous entries related to the administration of a Posey vest restraint (a type of medical restraint used to restrain a patient to a bed or chair). The first annotation related to the Posey vest restraint was documented on 3/9/2021 at 8:42 AM by Registered Nurse (RN) S who wrote, "Posey vest was used in ER last evening, it remains in place but is not tied. Patient making no efforts to get out of bed." Licensed Practical Nurse (LPN) C documented patient #2 in Posey vest restraint on 3/9/2021 at 10:30 AM, 11:30 AM, and on 3/10/2021 at 4:00 AM. LPN XX documented patient #2 in Posey vest restraint applied on 3/10/2021 at 7:25 AM and released at 9:25 AM, applied on 3/10/2021 at 10:25 AM and released at 11:15 AM, applied on 3/10/2021 at 1:05 PM and then released at 3:00 PM. On 3/10/2021 at 6:00 PM, LPN XX documented applying Posey vest restraint for patient safety. On 3/10/2021 at 7:00 PM, RN U initiated a physical restraint flow sheet and the only documentation on the flowsheet occurred as hourly checks beginning at 7:00 PM and ending at 11:00 PM. Cross-reference A0167.

A review of employee records for RN U and LPN C found no training competencies were done upon hire or annually. No training for restraints was documented. No competency skills verifications were documented since at least 2018. A review of RN MM's training file indicated restraint training took place on 1/7/2018 and 9/26/2018, but none since, and no restraint competencies were found. Cross Reference A0208.

On 04/05/2021 at 10:45 AM, during an interview, Certified Nurse Assistant (CNA) A stated, "I have worked here since October 2020. I got thrown in as I was the only CNA, so the nurses oriented me and after a few days I was on my own. If I had any questions the nurses would help me. I didn't have any orientation education or training on anything, no abuse or neglect, patient's rights, risk management. I would report any concerns to my DON (Director of Nursing), but we don't have one, she left 2 weeks ago, I would let my supervisor know immediately. Since I have been here, we have had 4 DON's.

On 04/05/2021 at 11:48 AM, during an interview, Staff S, Registered Nurse (RN) stated, "I have not had any education or annual training for over a year or more on Risk Management or abuse and neglect. I have been here 5 years and it has been awhile since I had any education.

On 04/06/2021 at approximately 1:28 PM, during an interview, RN CC stated, "I have worked here 7 years. I have not had any education or training since my orientation 7 years ago. I think we had some workplace violence like active shooter and things like that, that's the last thing I can remember. It concerns me as the last place I worked at we had a long list to do for annual evaluation, it bothers me. I do not feel we have a voice here, and before we had such a turnover in leadership, I could talk to some leaders for answers, but not now."

On 04/06/2021 at approximately 3:10 PM, during an interview, Nurse Technician (NT) VV stated,"I did work for the previous DON as a secretary and the past 6 months I have been working as a NT (nurse tech), mainly paperwork in the ER or Medical-Surgical unit, putting charts together and answering phones and assisting staff. The only education I did in 2020 was my NT competencies, I have not asked about any education as 2020 has been a wild year."

On 04/06/2021 at approximately 4:55 PM, during an interview, RN U stated, "I have worked here since 1/25/2021, and became a nurse in 2016." The surveyor reviewed a New Employee Orientation packet with the nurse. She added, "I was given the packet and read most of it, no other education/training, and no abuse training that I remember". She added, "I was paired with a nurse for two weeks, they did ask me if I needed more time, because it is a lower level of acuity and I felt that I always had someone to go to and ask."

On 04/07/2021 at approximately 7:40 AM, during an interview, RN EE stated, "I started here 6-7 months ago, trained in Thailand as a nurse, worked there for 4 years, and 3 years in United States. I did not have any orientation that was classroom or documentation/paper instructions. I was buddied up with another nurse and they trained me and showed me their computer system, I believe I did get a job description, but no education for abuse, Risk Management, patient's rights that I remember."

On 04/07/2021 at approximately 7:46 AM, during an interview LPN C stated she had not had restraint training since she was in school, about 6 years ago, and has had no restraint training since working at the hospital.

On 04/08/2021 at approximately 12:10 PM, during an interview, RN T stated, "I have not had education on abuse, neglect, restraints, or cardiac monitoring. I had restraint training 4 years ago in nursing school. We don't use restraints often here, we have used them but rarely. I think we have a policy, not sure. I have used soft wrist restraints in the past on patients coming down off drugs and yesterday in the ER. I had to apply soft wrist restraints on a combative patient (patient #4) that we had to intubate, and transfer him out to higher level of care.

On 04/09/2021 at approximately 2:50 PM, during an interview, RN H stated that she started here in November 2020, has been a nurse for over 35 years, and was retired and decided to come back as a part time/PRN (as needed) staff nurse. I did not get any orientation. I just got thrown in. That's how they do it here. I buddied up with a nurse each day for a few days and that was my orientation. I have a lot of experience and got on with it, so basically there was no orientation or education and we did not have any competencies on anything.

During an interview on 4/8/2021 at 11:04 AM RN M, the former Director of Nursing said, "I know that there needs to be some additional training when you've identified concerns with restraints and I don't have any explanation as to why I didn't do it myself. There is no manager or anyone to help put the processes in place to make sure that it happens."

A policy titled "Use of Restraints" and identified as policy #NADM-53 with an approval date of 12/7/2004 and no review date indicated, "Nursing Services will assure all direct patient care providers will have ongoing education and training in the proper and safe use of restraints. The Director of Nursing will assure each nurse department manager provides initial and ongoing education and training annually in the proper and safe use of restraints. Section G of the policy described education/competency evaluations on the use of restraints is included in Nursing Orientation, and at least annually thereafter. Section K of the instruction indicated the restraint flow sheet is utilized for documentation. Documentation may be continued, if necessary in the nurses' notes. Section L described which documentation will be every hour (and as needed), and every 2 hours. The policy required the physician to be notified as soon as feasible that the restraint protocol has been initiated and this contact must be documented in the Nurses' notes.
VIOLATION: PATIENT RIGHTS: RESTRAINT OR SECLUSION Tag No: A0208
Based on staff interviews, personnel record reviews, document review and policy review, the hospital failed to maintain documentation of training and competencies for 3 of 3 nursing personnel records reviewed (Staff C, U, and MM).

The findings included:

During an interview on 4/5/2021 at 3:22 PM, RN M, the former Director of Nursing stated that there hasn't been training for some time because the previous DON who had been here for years (RN RR) got so overloaded. "There is an annual training competency and all the modules in the training are there, but it's my understanding it just dropped through the cracks." In a follow-up interview on 4/8/2021 at 11:04 AM RN M said, "I know that there needs to be some additional training when you've identified concerns with restraints and I don't have any explanation as to why I didn't do it myself. There is no manager or anyone to help put the processes in place to make sure that it happens."

During an interview on 4/6/2021 at 5:26 PM, Nurse D, a Registered Nurse (RN), stated "I've asked the staff when their last competency was, and they don't have anything." "There's no orientation, and there is no competency training or computer training."

A review of employee records for RN U and LPN C found no training competencies were done upon hire or annually. No training for restraints was documented. No competency skills verifications were documented since at least 2018.

A review of RN MM's training file indicated restraint training took place on 1/7/2018 and 9/26/2018, but none since, and no restraint competencies were found.

A review of the facility organizational chart revealed the hospital currently had no one employed in the positions of Director of Nursing or Quality Improvement/Education.

A policy titled "Use of Restraints" and identified as policy #NADM-53 with an approval date of 12/7/2004 and no review date documented: Healthmark Regional Medical Center Nursing Services will assure all direct patient care providers will have ongoing education and training in the proper and safe use of restraints. The Director of Nursing will assure each nurse department manager provides initial and ongoing education and training annually in the proper and safe use of restraints. Section G of the policy described education/competency evaluations on the use of restraints is included in Nursing Orientation, and at least annually thereafter. Section K of the instruction indicated the restraint flow sheet is utilized for documentation. Documentation may be continued, if necessary in the nurses' notes. Section L described which documentation will be every hour (and as needed), and every 2 hours.
VIOLATION: QAPI Tag No: A0263
Based on staff interviews, policy reviews, incident reviews, review of staff training files, review of grievances, review of governing body meeting minutes, and the hospital's organizational chart, the hospital failed to maintain an ongoing program to measure, analyze, and track quality indicators to assess the process of care, hospital service and operations (refer to A0273). The hospital failed to ensure a hospital-wide quality assessment and performance improvement efforts addressed identified and reported 7 of 7 incidents related to patient safety (refer to A0309) and failed to provide resources to carry out the functions of a quality assurance program, including failing to hire and train staff to carry out the functions of a quality assurance program, ensure the quality measures are identified, and collection, assessment and reporting of data to ensure safe and effective patient care and services (refer to A0315).

The cumulative effect of these failures resulted in a determination of Immediate Jeopardy at the Condition of Quality Assurance and Performance Improvement. The failure to maintain leadership and a quality assurance program that ensures grievances and incidents are tracked and investigated and staff are trained can directly threaten patient safety. The hospital Chief Operating Officer was notified of the Immediate Jeopardy on April 9, 2021 at approximately 3:47 PM. The Immediate Jeopardy was determined to start on 01/29/2021 and was ongoing.

The findings include:

Cross Reference A0273: Based on review of grievances, incident reports, policies, personnel records, and staff interviews, the hospital failed to maintain an ongoing program to measure, analyze, and track quality indicators to assess the process of care, hospital service and operations. The hospital was unable to locate Quality Assurance and Performance Improvement (QAPI) committee meeting minutes for past 1.5 years. The hospital failed to appoint a person to be in charge of QAPI since the resignation of the previous director in December 2020. In the past 6 months, the hospital had received 3 complaints, all of which were uninvestigated, had evidence of a currently employed nurse stealing medications in December 2020, and had 7 total incident reports all related to falls with no evidence the incidents were tracked or analyzed. A review of 9 of 9 sampled personnel training records found no training in incident reporting (staff A, B, C, D, M, S, U, MM and PP)

Cross Reference A0309: Based on review of grievances, incident reports, policies, board of directors' minutes, and interviews, and a resignation letter, the hospital's governing board failed to carry out its executive responsibilities to ensure hospital-wide quality improvement and patient safety was implemented and maintained. The hospital failed to provide evidence of a functioning Quality Assurance and Performance Improvement (QAPI) committee that addressed patient safety. The hospital was unable to provide evidence of QAPI meetings since September 13, 2019. There was no one appointed as in charge of complaints and incidents or QAPI, there were uninvestigated complaints approximately 2 months old, and no evidence that submitted incident reports were being tracked or investigated. There was a currently employed nurse who had previously abandoned patients and was recorded going through discharged patient medications and putting them in her purse in December 2020. The governing body and administrative officials failed to ensure there was a Director of Nursing (DON) or acting DON, and failed to ensure someone was in charge of education to ensure staff training and competencies. The hospital staff were utilizing patient restraints without training. There was no evidence that required pharmacy committees were being held.

Cross Reference A0315: Based on staff interviews, document reviews, and policy reviews, the hospital's governing body and administrative staff failed to allocate resources to ensure the hospital is able to measure, assess, improve, and sustain performance and reduce risk to patients. The hospital failed to maintain quality staffing. In order to meet staffing needs, the hospital rehired a nurse considered a "no hire". The hospital failed to maintain staff leadership positions such as a Director of Nursing, staff in charge of complaints and incidents, staff in charge of staff training and competencies, an infection control coordinator or unit managers for 2 of 2 open units, Medical-Surgical unit and the Emergency Department.
VIOLATION: PROGRAM SCOPE, PROGRAM DATA Tag No: A0273
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on review of grievances, incident reports, policies, personnel records, and staff interviews, the hospital failed to maintain an ongoing program to measure, analyze, and track quality indicators to assess the process of care, hospital service and operations. The hospital was unable to locate Quality Assurance and Performance Improvement (QAPI) committee meeting minutes for past 1.5 years. The hospital failed to appoint a person to be in charge of QAPI since the resignation of the previous director in December 2020. In the past 6 months, the hospital had received 3 complaints, all of which were uninvestigated, had evidence of a currently employed nurse stealing medications in December 2020, and had 7 total incident reports all related to falls with no evidence the incidents were tracked or analyzed. A review of 9 of 9 sampled personnel training records found no training in incident reporting (staff A, B, C, D, M, S, U, MM and PP)

This hospital-wide QAPI failure resulted in a likelihood of serious consequences due to the lack of staff training and uninvestigated incidents and grievances. Cross Reference: A0263, A0273, A0119, A0057, A0502.

The findings included:

A review of the hospital organizational chart demonstrated the facility had no person in the roles of the Director of Nursing, the Risk Manager (the position in charge of patient complaints, adverse incidents and investigations), Infection Control and Quality Improvement/Education.

On 4/5/2021 at 3:22 PM, an interview took place with nurse M, who was formerly the Director of Nursing (DON) but resigned effective 3/26/2021 but had offered to return to the facility due to the complaint survey and to assist with creating a corrective action plan. Nurse M said, "There hasn't been a risk manager. When nurse RR was here she was the risk manager, utilization review, infection control, a bit of everything. I told them I would not do all that when I came on as DON because I felt it was a conflict of interest. That would have been in February 2021. I had gone to the administration several times and told them there has to be someone in charge of the infection control program and there has to be a risk manager. To my knowledge, the positions were not advertised." Because the facility was still admitting and there had to be infection control reports, The Chief Financial Officer (CFO) had someone in medical records doing the HAI (healthcare associated infection) reports." Nurse M said she was not trained on the incident reporting system when she was hired and said, "There was no training that I was aware of to educate people how to report incidents or to know what to report. They had some very healthy training on risk management and other on-boarding processes previously, but this was just not implemented. It's my understanding it hadn't happened in a couple of years. Nurse RR had been here for a very long time. There hasn't been training for some time because nurse RR got so overloaded. There is an annual training competency and all the modules in the training are there, but it's my understanding it just dropped through the cracks. I looked through the position description and I understand what is in there, but pretty much Nurse RR did everything, it's like she walked out the door and took the whole hospital with her."

Review of the resignation letter signed by nurse RR on 12/21/2020 listed her titles as registered nurse, risk manager, quality improvement, utilization review, discharge planning, infection control, employee health, nursing director. In the letter, nurse RR wrote, "In the next 30 days I will, with your approval, strive to complete the backlogged minutes for the Quality Improvement Committees for 2020."

During an entrance conference on 4/5/2021 at approximately 10:30 AM, a request was made for minutes from the Quality Assurance and Performance Improvement (QAPI) committee, copies of grievances and incident reports for the past 6 months. The hospital was unable to find the minutes from QAPI meetings for 2020, but did find meeting minutes from September 13, 2019. The hospital provided at total of 7 incident reports, 1 patient grievance and 2 staff grievances alleging sexual harassment by the Chief Executive Officer (CEO), and evidence from December 2020 of a nurse stealing discharged patient medications. A review of the documented incident reports found that all 7 were related to falls and the forms were submitted by staff from 9/30/2020 to 4/4/2021.

Incident report review:
On 9/30/2020 patient #10 was reported to have had an unwitnessed fall from bed on the medical-surgical unit discovered at 6:15 AM, and reported to physician at 6:45 AM. Then Director of Nursing/Risk Manager, Nurse RR, reviewed the report on 10/2/2020 and documented the event as an "adverse incident/untoward event".

On 11/10/2020 at 10:40 PM, patient #11 reported to have a fall in the emergency room which was documented/reviewed by nurse RR on 11/11/2020. The event was documented as the patient was already discharged and waiting for a ride at the time of fall, classified as "visitor fall."

An incident report with no patient identification indicated that a patient fell in the radiology department while getting x-rays. The form documented the patient fell on [DATE] at 5:00 PM. There was no risk manager review and no physician notification documented on the form. Accompanying the form was an x-ray report for patient #9 with a date/time of 2/13/2021 at 4:40 PM, indicating the patient had a left shoulder grade 5 AC (acromioclavicular) separation (occurs when the clavicle is severely displaced and is a severe type of joint injury).

An incident report dated 3/8/2021 for patient #7 indicated the patient fell in the emergency room bathroom on 3/8/2021 at 3:00 PM, and the physician was notified at 3:00 PM. There was no department manager/director review or signature and no risk manager review documented on the form.

An incident report dated 3/20/2021 for patient #8 indicated the patient was assisted to the floor on the medical surgical unit on 3/20/2021 at 10:30 PM, the physician was notified at 10:45 PM. There was no department manager/director review or signature and no risk manager review documented on the form.

An incident report dated 4/4/2021 indicated patient #4 was found sitting on the bathroom floor in the emergency room on [DATE] at 4:13 PM. The form indicated the physician was notified on 4/4/2021 at 7:15 PM. There was no department manager/director review or signature and no risk manager review documented on the form.

An incident report dated 4/4/2021 indicated patient #4 was found sitting on the floor with the call light on at 8:54 PM. The form indicated the physician was notified on 4/4/2021 at 7:15 PM. There was no department manager/director review or signature and no risk manager review documented on the form.

A review of the governing board minutes failed to demonstrate that any report or review of quality measures related to medical errors or adverse patient events took place from 1/28/2020, over a year ago, through the time of the survey. The last annual report was submitted to the state agency on 1/28/2020 and indicated there had been no adverse incidents.

Grievance review:
A review of a grievances consisted of one complaint letter concerning patient #6, dated 2/23/2021 concerning the conduct of doctor (Dr.) F in the emergency department. The grievance documented a complaint from a licensed clinical social worker at an assisted living facility (ALF) about a resident of the ALF brought to the emergency department for care on 2/20/2021. The letter indicated Dr. F was "rude and inappropriate" and administered 2 medications (Haldol and Ativan as a chemical restraint) to patient #6 for sedation/agitation and discharged the patient. (A review of the Home Medication List from the admission showed that the patient was ordered a medication similar to Ativan, called Xanax; however, she was not on any medications similar to the antipsychotic Haldol). In a telephone interview on 4/12/2021 at 2:49 PM, the licensed clinical social worker from the ALF confirmed the facility had not responded to her grievance. A letter was provided to the survey team from the assisted living facility executive director dated 4/12/2021 confirming she had attempted to reach the administrator of this facility on 2/21/2021 and again on 2/22/2021 to discuss the grievance concerning patient #6 with no success and documented "I have yet to hear from them." Cross Reference: A0119

Regarding the employee grievances, emails provided for review included 2 letters submitted anonymously from nurses alleging sexual misconduct by the CEO. The emails were sent from a former Chief Operating Officer (COO) TT to the CFO, and forwarded the Governing Board (GB) chair. The first letter alleged misconduct took place on 2/1/2021 and was noted as received by COO TT on 2/17/2021 at 4:40 PM. The letter was forwarded to the CFO in an email dated 2/17/2021 at 4:46 PM. The CFO forwarded the email to GB chair on 2/19/2021 at 1:14 PM. The second letter alleging sexual misconduct by the CEO was noted as received on 3/3/2021 by the CFO and forwarded to Governing Body (GB) chair via email on 3/3/2021 at 12:26 PM. Both allegations indicate the CEO engaged in sexual misconduct toward nurses in a patient room on the medical surgical unit of the hospital.

During an interview about the complaints on 4/7/2021 at approximately 12:49 PM, the GB chair stated, "I would think if complaints were made to us, we would address those, how much authority we have could be problematic, I think we would have to address that." Cross Reference: A0057

On 4/8/2021 at 1:43 PM in an interview, the COO was asked to describe the quality review process. The COO explained she had been acting as COO for only two weeks at the time of the interview and has just started identifying areas of concerns. She explained if there was a concern such as a patient death that involved a provider she would "call the medical director if we actually had one." She explained Dr. P is the acting medical director, but Dr. F has been approached about being the medical director. She said she was not aware of the complaint received by the facility dated 2/23/2021 concerning conduct of Dr. F and didn't recall seeing the follow up letter from the ALF about Dr. F's conduct. The COO confirmed the facility did not have a risk manager or anyone filling that role and added, "my greatest concern is that we need to be staffed with an actual medical director who is on board with the facility, job descriptions are out of date and training is not what I'm accustomed to." At 2:19 PM, the COO said Dr. P is listed as the hospital's Chief Medical Officer, but that is "in name only."

On 4/5/2021 in an interview which took place from 12:42 PM, through approximately 3:00 PM, the CFO described several concerns about the facility which have not been investigated. He began by explaining there were two allegations from employees alleging they witnessed the CEO who is also the owner of the hospital engage in sexually inappropriate behavior including exposing his genitals to the employees. "I gave the sexual harassment complaints to chairman (of the governing board)." The CFO also described recent concerns related to the pharmacy inventory from December 2020. The CFO confirmed he reviewed the camera footage from the security camera over the nurses' station and saw Pharmacist QQ come out of the pharmacy area with the box of expired medication. The CFO said he recognized the box of medication. He stated Pharmacist QQ and Licensed Practical Nurse (LPN) C were going through all of the medication. He stated he then saw LPN C put a bag of them in her purse. He stated he then showed it to Nurse RR (the former Director of Nursing/Risk Manager/Quality Improvement Director). He stated, "Nurse RR was here then and I don't know, I don't think it went anywhere, but they knew about that." "The pharmacist left in February; nothing was reported to the board of pharmacy concerning the previous pharmacist. We do not have a risk manager." When asked if the facility had risk and quality committees, he responded, "We do, but none of these issues have ever been discussed in any of these committees." The facility was ultimately unable to provide evidence of these committee meetings.

A flash-drive with video evidence of the event of 12/17/2020 described above was provided by the CFO for review. On 4/7/2021 at 5:40 AM, LPN C, from the video above, was observed working as the sole nurse on the medical-surgical unit. Cross Reference: A0502




Staff Education:
In an interview on 4/5/2021 at 10:50 AM, nurse H who reported working in the facility for approximately 6 months said she doesn't remember being trained in reporting incidents, adding, "I know that there is such a thing because of my long history of being a nurse, but I don't know what they use here."

Reviews were conducted of the personnel files for Certified Nurse Assistant (CNA) A, CNA B, RN D, Technician PP, RN MM, RN U, RN S and LPN C none of which had documentation for Risk Management or Incident Education.

On 4/9/2021 at 2:43 PM, an interview was conducted with RN M, the former DON. At that time, she stated that there was currently no one looking into patient safety, medical errors or adverse incidents in the facility.

The most recent facility Policy and Procedure Manuals Annual Review was dated 12/03/2018. Policy #RM-02 with an approval date of 2/24/2004 and a most recent review date of 12/2004, titled Incident Reporting - patient, visitor, stated, "unusual occurrences will be reported to the risk manager within 72 hours and preferably by the end of the shift in which the occurrence occurred. The RM will determine if an unusual occurrence meets the definition of an "adverse event" or an "injury" as it effects a patient. The policy defined unusual occurrence as an event or situation in which the circumstances are unexpected to a patient (or a visitor) within the normal operations of the facility or the anticipated disease/treatment process of a patient. The potential for injury is sufficient to be considered an unusual occurrence; actual injury need not have occurred. Examples included: injuries or falls to patients (or visitors), medication errors, skin breakdown, and procedure or treatment errors that affect patients. In the directions for filling out the incident report form, side two paragraph 4. A. indicated the individual completing the form will sign the form and include his/her title and initials.

The Policy titled Quality Improvement Committee was last updated 07-2019 (initials indicated Nurse M signed the review) identified the role of the Governing Board (GB) to ensure the hospital-wide QI program to evaluate provision of care. 3. "The GB shall assure there is a planned, systemic, hospital-wide approach to assessment and improvement of its performance to enhance and improve the quality of care provided to the public. The governing Board, Medical Staff, and Administrative Officials are responsible and accountable for ensuring the following: that an on-going program for QI and patient safety, including the reduction of medical errors, is defined, implemented and maintained., that clear expectations of safety are established."

Policy #RM-04 approved/revised on 4/30/2007 titled Risk Management Program. Patient Safety Plan - Grievances described the facility policy as established and maintained "to provide the investigation and analysis of the frequency and cause of general categories and specific types of adverse incidents to patients." The policy defined adverse or untoward events, injury, and "patient grievance" as "any written complaint by a patient relating to patient care or the quality of medical services, except for those matters pertaining to the cost of care." Responsibilities of the risk management program included the governing board designates a risk manager, or his/her designee, with the responsibility for the implementation and oversight of the RM program and the patient safety plan. The RM will have access to all incident reports, summary reports, policy and procedure manuals, patient medical records, board committee reports and minutes, personnel records, and in-service education records upon request and as appropriate. The GB will oversee the patient grievance process. The board will review and resolve grievances that are forwarded by the risk manager. And "the governing board will notify the patient in writing of its decision within 30 business days of the boards review." The policy describes the risk manager responsibilities and annual reports required to AHCA (Agency for Health Care Administration), description of 15 day "Code 15" reporting requirements.
VIOLATION: EXECUTIVE RESPONSIBILITIES Tag No: A0309
Based on review of grievances, incident reports, policies, board of directors' minutes, and interviews, and a resignation letter, the hospital's governing board failed to carry out its executive responsibilities to ensure hospital-wide quality improvement and patient safety was implemented and maintained. The hospital failed to provide evidence of a functioning Quality Assurance and Performance Improvement (QAPI) committee that addressed patient safety. The hospital was unable to provide evidence of QAPI meetings since September 13, 2019. There was no one appointed as in charge of complaints and incidents or QAPI, there were uninvestigated complaints approximately 2 months old, and no evidence that submitted incident reports were being tracked or investigated. There was a currently employed nurse who had previously abandoned patients and was recorded going through discharged patient medications and putting them in her purse in December 2020. The governing body and administrative officials failed to ensure there was a Director of Nursing (DON) or acting DON, and failed to ensure someone was in charge of education to ensure staff training and competencies. The hospital staff were utilizing patient restraints without training. There was no evidence that required pharmacy committees were being held.

The failure to ensure an active QAPI addressing patient safety concerns could likely lead to serious outcomes and violations of patient rights. Cross Reference: A0167, A0194, A0208, A0263, A0397 and A0502.

The findings included:

Prior to her resignation on 12/21/2020, the governing board had appointed a single individual, nurse RR, to be in charge of numerous positions to include: Risk Manager, Quality Improvement Director, Utilization Review, Infection Control, Employee Health, and Director of Nursing (DON).

Review of the resignation letter signed by Registered Nurse (RN) RR on 12/21/2020 listed her titles as registered nurse, Risk Manager, quality improvement, utilization review, discharge planning, infection control, employee health, and nursing director. In the letter, nurse RR identified reasons for leaving the hospital as "the lack of time needed to update policies related to infection control and nursing, not to mention the new 2020 hospital regulations. The constant turnover of qualified nursing staff in part due to the recent additional stress of caring for yourself (indicating the CEO) and (a first name not otherwise identified) as residents of the facility. Along with constant chastisement and interference in the performance on Med/Surg nursing personnel duties. Also, I am leaving due to the lack of monetary compensation for my services. In the next 30 days I will, with your approval, strive to complete the backlogged minutes for the Quality Improvement Committees for 2020, maintain employee health records. I will continue to work on the open legal cases as Risk Manager. I will continue to keep current and educate the hospital's personnel with the latest COVID-19 (Coronavirus Disease 2019) data. I will continue to assist with the utilization review and discharge planning issues as needed. I will continue to manage the nursing department day to day operations including striving to recruit and retain personnel, while maintaining daily staffing levels." The resignation letter identified her last working day as 01/29/2021.

A review of patient grievances from the past 6 months consisted of one complaint letter concerning patient #6, dated 2/23/2021 concerning the conduct of Dr. F in the emergency department and documented a complaint from a licensed clinical social worker at an assisted living facility (ALF) about a resident of the ALF brought to the emergency department for care on 2/20/2021. The letter indicated Dr. F was "rude and inappropriate" and administered 2 medications (Haldol and Ativan as a chemical restraint) to patient #6 for sedation/agitation and discharged the patient. (A review of the Home Medication List from the admission showed that the patient was ordered a medication similar to Ativan, called Xanax; however, she was not on any medications similar to the antipsychotic Haldol). In a telephone interview on 4/12/2021 at 2:49 PM, the licensed clinical social worker from the ALF confirmed the facility had not responded to her grievance. A letter was provided to the survey team from the assisted living facility executive director dated 4/12/2021 confirming she had attempted to reach the administrator of this facility on 2/21/2021 and again on 2/22/2021 to discuss the grievance concerning patient #6 with no success and documented "I have yet to hear from them."

On 4/8/2021 at 1:43 PM in an interview, the Chief Operating Officer (COO) was asked to describe the quality review process. The COO explained she had been acting as COO for only two weeks at the time of the interview and has just started identifying areas of concerns. She explained if there was a concern such as a patient death that involved a provider she would "call the medical director if we actually had one." She explained Dr. P is the acting medical director, but Dr. F has been talked to about being the medical director. She said she was not aware of the complaint received by the facility dated 2/23/2021 concerning conduct of Dr. F and didn't recall seeing a letter about Dr. F's conduct. The COO said she was unaware of any concerns related to restraint use with patients. She confirmed the facility did not have a Risk Manager or anyone filling that role and added, "my greatest concern is to be staffed with an actual medical director who is on board with the facility, job descriptions are out of date and training is not what I'm accustomed to." She said they were looking for a policy on abuse and the facility was ultimately unable to produce an abuse/neglect prevention policy. At 2:19 PM, the COO added Dr. P is listed as the hospital's Chief Medical Officer, but that is "in name only."

A review of incident reports provided by facility upon request indicated there were 7 incident report forms turned in by staff from 9/30/2020 to 4/4/2021. All reports concerned falls; no other incidents were reported, and no evidence was provided to indicate the incidents were tracked or investigated. On 4/5/2021 in an interview beginning at 12:42 PM the CFO recalled another uninvestigated anonymous staff complaint. He stated the person didn't sign the complaint and nurse RR (the former Risk Manager) said since it was not signed, she couldn't use it. "There should be a policy on how to report incidents." Cross-Reference A0263.

On 4/5/2021 at 12:42 PM the CFO said in an interview, "there were some patient medications that were left behind, and I asked the previous pharmacist (pharmacist QQ) about those toward the end of December (2020)." The CFO described a video recording of the med-surge counter and pharmacist QQ came out with the box of expired meds. The CFO stated he recognized the box as the box of abandoned medications. Pharmacist QQ and LPN C on staff were going through all of those meds, and in the middle of going through those I saw licensed practical nurse (LPN) C with a bag of them and put them in her purse. I showed that to pharmacist QQ and it turned into a screaming match with attorneys brought up. "The pharmacist left in February; nothing was reported to the board of pharmacy concerning the previous pharmacist. We do not have a Risk Manager." The CFO stated he showed the video to nurse RR (the former Director of Nursing/Risk Manager). "Nurse RR was here then and I don't know, I don't think it went anywhere, but they knew about that." The CFO explained none of these issues have ever been discussed in any committees. He continued, "The pharmacy was not brought up in any committees either. Everybody knew (the previous pharmacist) was crazy but it was never discussed in any of the committees." A flash-drive with video of the event described was provided by the chief financial officer (CFO) for review. There was no evidence provided by the facility to indicate these events were investigated.

A review of LPN C's employee file included a notation dated 11/2/2018 that she "walked off the job on 11/1/2018 without giving report on patients or speaking with supervisor. Refused to make appointment to return to speak with DON." The record indicated LPN C was terminated and documented as "not recommended for re-hire." Nurse M reviewed the record and agreed the event noted in LPN C's employee file dated 11/2/2018 was a reportable offense and was not reported to the Board of Nursing. LPN C was re-hired by the facility on 9/14/2020 and was observed working on 4/7/2020 between 5:40 AM to 7:00 AM and was the only staff member assigned to the medical surgical unit during that time with 3 inpatients. During this observation, several medications were observed unsecured including a Ziplock-type bag containing Xanax (a schedule IV controlled substance) which LPN C reported finding in a patient room and 3 medication cups with pills and a vial including one Xanax pill on a bedside table in the hallway next to the nurses' station which LPN C said she had put out for morning medication administration. Cross-Reference A0502.

In an interview on 4/6/2021 at 3:52 PM RN M, former DON, discussed the management of nursing staff. RN M revealed she was appointed to the position of DON in February 2021 and resigned in March 2021. While DON, she watched the recording from December where LPN C was taking medications and putting them in her bag. RN M expressed her shock that the nurse was still employed and then expressed that LPN C had been given a raise after that incident. RN M stated she initiated the disciplinary process just prior to her resignation, and she informed RN D and the CFO. As the DON, I had the authority to terminate, but "you have to jump through hoops and catch a lot of static over it."

On 4/5/2021 at approximately 12:42 PM, the Chief Financial Officer (CFO) and Chief Operating Officer (COO) brought documents requested during the entrance conference to the surveyor work area. The COO said the minutes for the pharmacy and therapeutics committee were not available and the pharmacist was also not familiar with committee minutes.

On 4/5/2021 at 3:22pm, an interview took place with nurse M, who was formerly the DON but resigned effective 3/26/2021 and offered to return to the facility to assist with creating a corrective action plan. Nurse M said, "There hasn't been a Risk Manager. When nurse RR was here she was the Risk Manager, utilization review, infection control, a bit of everything. I told them I would not do all that when I came on as DON. I told them I thought it was a conflict and the law says you have to have a Risk Manager and you have to have one. That would have been in February 2021. I had gone to the administration several times and told them there has to be an infection control and there has to be a Risk Manager. To my knowledge, the positions were not advertised. Because we were still admitting and there had to be infection control reports, (the CFO) had someone doing the HAI (healthcare associated infection) reports by someone in medical records." Nurse M said she was not trained on the incident reporting system when she was hired and said, "there was no training that I was aware of to educate people how to report incidents or to know what to report. They had some very healthy training on risk management and other on-boarding processes. It's my understanding it hadn't happened in a couple of years. Nurse RR had been here for a very long time. There hasn't been training for some time because nurse RR got so overloaded. There is an annual training competency and all the modules in the training are there, but it's my understanding it just dropped through the cracks. I looked through the position description and I understand what is in there, but pretty much Nurse RR did everything, it's like she walked out the door and took the whole hospital with her."

A request was made for a list of patients with restraint usage. The hospital was unable to provide this information. During an interview on 4/6/2021 at 5:24 PM, Registered Nurse (RN) D was able to recall a recent patient in restraints, Patient #2. RN D revealed Patient #2 was diagnosed with rhabdomyolysis and ended she ended up being intubated and transferred. She had been here 3 days and they had a Posey vest (a type of medical restraint used to restrain a patient to a bed or chair) on her. Patient #2 was admitted under the Certified Registered Nurse Anesthetist. A review of patient #2's record indicated numerous entries related to the administration of a Posey vest restraint during her hospital stay from 3/8/2021 through her transfer on 3/11/2021. The restraint documentation failed to consistently demonstrate symptoms prior to restraint reapplication and assessments post restraint to include proper positioning, blood circulation in the area of the restraint, and skin integrity. Hospital approved restraint flow sheet was not initiated until 7:00 PM on 3/10/2021. Cross-reference A0167

A review of employee records for RN U and LPN C found no training competencies were done upon hire or annually. No training for restraints was documented. No competency skills verifications were documented since at least 2018. A review of RN MM's training file indicated restraint training took place on 1/7/2018 and 9/26/2018, but none since, and no restraint competencies were found. Cross-reference A0208.

Interviews conducted with 10 of 10 staff from 04/05/2021 to 04/09/2021 revealed a lack of restraint training, Certified Nurse Assistant (CNA) A, LPN C, RN H, RN M, RN S, RN T, Nurse Technician V, RN U, RN CC, RN EE. Cross-reference A0194.

In a follow-up interview on 4/8/2021 at 11:04 AM RN M said, "I know that there needs to be some additional training when you've identified concerns with restraints and I don't have any explanation as to why I didn't do it myself. There is no manager or anyone to help put the processes in place to make sure that it happens."

Interviews were conducted with several staff members who indicated that competency skills verifications were not being done to include: CNA A at 04/05/2021 at 10:45 AM, RN CC on 04/06/2021 at approximately 1:28 PM, RN U on 04/06/2021 at approximately 4:55 PM, RN T on 04/08/2021 at approximately 12:10 PM and RN H on 04/09/2021 at approximately 2:50 PM. Cross Reference A0397 for full interviews.

During an interview on 4/6/2021 at 5:24 PM, nurse D, a Registered Nurse, said "I've asked the staff when their last competency was and they don't have anything. We have RNs that don't even have their BLS (basic life support training). I just held a class and told them I wasn't taking no for an answer. I told them we can't have people doing patient care without even BLS (Basic Life Support). I brought it to the Chief Financial Officer (CFO)'s attention because he is the only person I could go to and he got it set up and paid for it. There's no orientation and there is no competency training or computer training."

A review of the facility organizational chart demonstrated the facility had no person in the role of Risk Manager, Infection Control, Director of Nursing or Quality Improvement /Education at the time of the survey.

On 4/9/2021 at 2:43 PM an interview was conducted with RN M, the former DON. At that time, she stated that there was currently no one looking into patient safety, medical errors or adverse incidents in the facility.

The Policy titled Quality Improvement Committee was last updated 07-2019 (initials indicated Nurse M signed the review) identified the role of the Governing Board to ensure the hospital-wide QI program to evaluate provision of care. 3. "The Governing Board shall assure there is a planned, systemic, hospital-wide approach to assessment and improvement of its performance to enhance and improve the quality of care provided to the public. The governing Board, Medical Staff, and Administrative Officials are responsible and accountable for ensuring the following: that an on-going program for QI and patient safety, including the reduction of medical errors, is defined, implemented and maintained., that clear expectations of safety are established."





A review was conducted of policy number, "QI-01," subject, "Quality Assurance and Performance Review [Quality Improvement (QI) Program]." Approved 2/24/2005 and last reviewed 7/2019. The policy statement was, the facility, "is committed to the development, and the implementation of an effective, ongoing, data-driven, hospital-wide quality assessment and performance improvement program. A Patient Safety Plan will be developed and maintained in accordance with s. 395.1012(1), Florida State Statute, and Federal Rule 42 CFR 482.1, Quality Assurance and Performance Improvement Plan. The Patient Safety Plan will be incorporated into the Risk Management Program." The facility's, "Quality Improvement Program will be accomplished to enhance and improve the quality of health care provided to the public by incorporating," the facility's, "Mission Statement as follows: 'Provide comprehensive quality oriented heath care services designed to meet the needs of individuals of all ages regardless of race, creed, color, sex, handicap or national origin in a cost efficient, safe manner. Promote excellence in the delivery of care/services through the proper utilization of resources by competent practitioners under the supervision of the patient's physician. Meet or exceed the needs and expectations of the clients/customers which includes the following: Patients, families, physicians, referral sources, payers and regulators.'"
Under the, "Procedure section," it stated,
"A. The Role of the Governing Board
1. The Governing Board will ensure that there is an effective, hospital-wide, Quality Improvement (QI) Program to evaluate the provision of patient care.
2. The Governing Board "designates the Quality Improvement Director, or his/her designee, with the responsibility for the implementation and oversight of the QI program working closely with each department director, the medical staff, the QI committees and administration.
3. The Governing Board shall assure there is a planned, systemic, hospital wide approach to the assessment and improvement of its performance to enhance and improve the quality of health care provided to the public.
a. The QI system shall be based on the mission and plans of the organization, the needs and expectations of the patients and staff, provide up-to-date sources of information and the performance of the processes and their outcomes.
b. Each system for quality improvement, which shall be include utilization review, must be defined in writing, approved by the Governing Board and enforced.
c. All data collection and dissemination for quality assessment and performance review purposes will be considered confidential information.
d. The Governing Board shall be responsible for services furnished in the hospital under contracts, and ensure all contracted services comply with all applicable conditions of participation and standards.
4. The Governing Board, the Medical Staff and Administrative Officials are responsible and accountable for ensuring the following:
a. That an ongoing program for quality improvement and patient safety, including the reduction of medical errors, is defined, implemented and maintained.
b. That the hospital wide quality assessment and performance improvement efforts address priorities for improved quality of care and patient safety; and that all improvement actions are evaluated.
c. The clear expectations for safety are established.
d. That adequate resources are allocated for measuring, assessing, improving, and sustaining the hospital's performance and reducing risk to patients.
e. That the determination of the number of distinct improvement projects is conducted annually.
B. Role of the Medical Staff
1. The," facility, "Medical Staff Peer Review process as outlined in the Bylaws are an intricate part of the overall QI program, whereby staff members do not initially review their own cases for QI program purposes.
2. The," facility, "Medical Staff will participate as appointed in quality improvement activities via the Medical Staff approved QI committees.
C. The Role of the QI Committees
1. The QI committee will oversee the management of the QI process, and will ensure appropriate documentation on process outcomes, prioritize issues chosen for improvement and satisfaction of the patients.
i. The processes measured shall include, at least the following:"
"2. The Pharmacy and Therapeutics QI Committee
a. Use of medications including prescribing, preparation and dispensing, administration and monitoring effects.
b. Other processes as defined in the Medical Staff Bylaws, rules and regulations."
"4. The Risk Management/Patient Safety QI Committee
a. Risk Management Activities
b. Patient safety concerns
c. Other processes as defined in the Medical Staff bylaws, rules and regulations."
2. The QI committee member shall consisted of at least the following:
a. Two (2) Physicians - Active Staff
b. The QI director
c. A representative from administration
d. A representative from Nursing Administration
e. The Risk Manager
f. Any other members as appointed.
3. The QI Committees primary functions are to:
a. Assess the level of performance of existing activities and procedures
b. Set priorities for improvement; a
c. Determine action to improve performance
d. Act as a resource I the QI reporting process
e. Assist patient care department sin defining specific guidelines for a systematic review processes
f. Make recommendations, as needed regarding specific plans of correction.
D. The Role of the Quality Improvement Director, or his/her designee
1. The QI director is designated by the Governing Board to oversee the facility's Quality Assurance and Performance Improvement (QI) activities.
2. The QU Director will:
A, Coordinate QI committee meetings at least once per quarter.
b. Maintain the documentation of the QI Committees agendas and minutes in a secure and confidential area of the hospital for five (5) year;
c. Report to the Governing Board QI Program activities at least once per quarter.
E. The Role of the Department Directors
1. Within each patient care department the Department Director will:
a. Develop written, measurable criteria and norms
b. Develop a description of the methods used for identifying problems
c. Develop a description of the methods used for assessing problems;
d. Develop a description of the methods for monitoring activities to assure that desired results are archived and sustained; and
e. Maintain documentation of the activities and results of the program.
f. Develop a particular method(s) to evaluate contracted patient care services(s) provided within the department;
g. Report findings and plans of corrections, as necessary, to the appropriate QI Committee(s).
2. Each Department Director will support the QI Program by assuring each department participates in the TQM process via the QU Committee as follows:
a. Utilization Review QI Committee - Utilization Review Department, Financial Department, Discharge Planning Department;
b. Medical Records QI Committee - Health Information (HIM) Department, Financial Department, Nursing Department;
c. Pharmacy and Therapeutics Committee - Pharmacy Department, Nursing Department
d. Infection Control QI Committee - Infection Control, Employee Health, Environmental Services, Dietary Department, Surgical Department, Laboratory Department, Pharmacy Department."
"H. Patient Safety/Risk Management QI Committee - Risk Management, Maintenance Department, Infection Control, Nursing Department, Dietary Department, Laboratory Department, Radiology Department, Cardiopulmonary Department, Pharmacy."
"F. The Role of Individual Employees
1. Each individual employee is expected to:
a. Participate as assigned in the Total Quality Management QI program by being part of the solution, not part of the problem as follows:
i. Conduct QI Audits within the department as assigned
ii. Help to identify areas for improvement as indicated.
iii. Follow established protocols, policies and procedures.
iv. Participate in QI plans of correction as indicate.
v. report abnormal findings to QI Audits
vi. Participate in an ongoing promotion of patient safety
vii. Perform other QI assignments as assigned.
VIOLATION: PROVIDING ADEQUATE RESOURCES Tag No: A0315
Based on staff interviews, document reviews, and policy reviews, the hospital's governing body and administrative staff failed to allocate resources to ensure the hospital is able to measure, assess, improve, and sustain performance and reduce risk to patients. The hospital failed to maintain quality staffing. In order to meet staffing needs, the hospital rehired a nurse considered a "no hire". The hospital failed to maintain staff leadership positions such as a Director of Nursing, staff in charge of complaints and incidents, staff in charge of staff training and competencies, an infection control coordinator or unit managers for 2 of 2 open units, Medical-Surgical unit and the Emergency Department.

Failure to allocate resources can lead to process breakdowns and inadequate medical care which can threaten patient safety.

The findings included:

A review of the facility organizational chart demonstrated the facility had no person in the roles of risk management (risk management is the process employed to uncover, mitigate, and prevent risks in healthcare institutions), quality improvement, education, Director of Nursing, or medical-surgical care at the time of the survey.

On 4/5/2021 in an interview which took place from 12:42 PM through approximately 3:00 PM, the Chief Financial Officer (CFO) described several concerns about the facility including, "we do not have a risk manager."

Review of a resignation letter signed by nurse RR on 12/21/2020 listed her titles as registered nurse, risk manager, quality improvement, utilization review, discharge planning, infection control, employee health, nursing director. In the letter, nurse RR identified reasons for leaving the hospital as "the lack of time needed to update policies related to infection control and nursing, not to mention the new 2020 hospital regulations. The constant turnover of qualified nursing staff in part due to the recent additional stress of caring for yourself (indicating the CEO) and (a first name not otherwise identified) as residents of the facility. Along with constant chastisement and interference in the performance on Med/Surg nursing personnel duties. Also, I am leaving due to the lack of monetary compensation for my services. In the next 30 days I will, with your approval, strive to complete the backlogged minutes for the Quality Improvement Committees for 2020, maintain employee health records. I will continue to work on the open legal cases as risk manager. I will continue to keep current and educate the hospital's personnel with the latest COVID-19 [Coronavirus Disease 2019] data. I will continue to assist with the utilization review and discharge planning issues as needed. I will continue to manage the nursing department day to day operations including striving to recruit and retain personnel, while maintaining daily staffing levels."

On 4/5/2021 at 3:22 PM, an interview took place with registered nurse (RN) M who was hired as the Director of Nursing (DON) in February 2021, but resigned effective 3/26/2021, and offered to return to the facility to assist with the survey and creating a corrective action plan. RN M said, "There hasn't been a risk manager. When nurse RR was here she was the risk manager, utilization review, infection control, a bit of everything. I told them I would not do all that when I came on as DON. I told them I thought it was a conflict and the law says you have to have a risk manager and you have to have one. That would have been in February 2021. I had gone to the administration several times and told them there has to be an infection control and there has to be a risk manager. To my knowledge, the positions were not advertised. Because we were still admitting and there had to be infection control reports, (the CFO) had someone doing the HAI (healthcare associated infection) reports by someone in medical records." RN M said she was not trained on the incident reporting system when she was hired and said, "there was no training that I was aware of to educate people how to report incidents or to know what to report. They previously had some very healthy training on risk management and other on-boarding processes. It's my understanding it hadn't happened in a couple of years. (Nurse RR) had been here for a very long time. There hasn't been training for some time because (nurse RR) got so overloaded. There is an annual training competency and all the modules in the training are there, but it's my understanding it just dropped through the cracks. I looked through the position description and I understand what is in there, but pretty much (Nurse RR) did everything, it's like she walked out the door and took the whole hospital with her."

There was a notation dated 11/2/2018 in licensed practical nurse (LPN) C's staff file that she "walked off the job on 11-1-18 without giving report on patients or speaking with supervisor. Refused to make appointment to return to speak with DON." The record indicated LPN C was terminated and documented as "not recommended for re-hire." RN M reviewed the record and agreed the event noted in LPN C's employee file dated 11/2/2018 was a reportable offense and was not reported to the board. LPN C was re-hired by the facility on 9/14/2020 and was observed working on 4/7/2020 between 5:40 AM to 7:00 AM and was the only staff member assigned to the medical surgical unit during that time with 3 inpatients.

In an interview on 4/8/2021 at 1:43 PM, the Chief Operating Officer, (COO), was asked who has responsibility over patient quality concerns and she identified that used to be nurse RR, and said "we haven't really delved into that." The COO was asked who would review a concern if it involved a medical provider and responded, "I would call the medical director if we actually had one." At 2:19 PM the COO agreed that Dr. P is listed as the hospital's chief medical officer, but that was "in name only."

In an interview on 4/8/2021 at 12:01 PM, the CFO, who is also a member of the governing board, confirmed there was currently no process for quality review. When asked what would happen if a staff member came forward with a quality concerns, he replied, "It would go from staff member to department head to nurse RR, but today, it would go to RN (registered nurse) D and come to me or the COO and usually they come to me with problems, we correct them if we can. I don't know what things have to be reported. Nurse RR did that and we tried to ask her how and what to do, nurse M had issues trying to contact her as well." The CFO went on to describe "The problem with the whole facility is the CEO will say to the department head, nursing say, we need nurses, and if the average salary of the nurse is $30, he'd say pay $25 and this is all we're going to pay and there's no way we can hire people at 75% of the going rate and we can't get people in here. The quality of staff, any of them, billers, anything, we are paying the biller $12 an hour and so how is that set up to be a good system? It's a failure just set up to happen. I'm supposed to be doing CFO issues and I'm doing IT (Information Technology), I'm doing the building construction project, I'm taking care of HVAC (air-conditioning) issues, they said to me to find out what's wrong with it and then there are so many different things. The COO started out as the billing department manager, then our clinic manager resigned so she accepted being over both. So, she had a 60 hour a week job and a 50 hour/ week job and now she is also the COO, probably a 70 hour/week job - she has all three of those jobs. There is no way, that is a set up for failure every time."

The Policy titled Quality Improvement Committee was last updated 07-2019 (initials indicated Nurse RR signed the review) identified the role of the Governing Board (GB) to ensure the hospital-wide QI program to evaluate provision of care. The policy included the following: "3. The GB shall assure there is a planned, systemic, hospital-wide approach to assessment and improvement of its performance to enhance and improve the quality of care provided to the public. The Governing Board, Medical Staff, and Administrative Officials are responsible and accountable for ensuring the following: that an on-going program for QI and patient safety, including the reduction of medical errors, is defined, implemented and maintained, that clear expectations of safety are established."
VIOLATION: MEDICAL STAFF PERIODIC APPRAISALS Tag No: A0340
Based on review of Governing Board and Medical Staff Meeting Minutes, staff interview, and review of completed appraisal (peer review) documentation, the hospital failed to ensure periodic appraisals were performed for practitioners granted privileges and the hospital's Governing Board failed to complete a review of the appraisal procedures. Only 5 physician appraisals were completed since 11/20/2017 through present date.

The findings included:

On 4/8/2021 at 9:45 AM, administrative assistant R provided requested peer review documentation and stated, "I'm just going to be honest with you, we've gotten behind in peer review and this is all we have." She provided a total of 5 appraisals from 11/20/2017 through present date. There was one peer review evaluation for doctor (Dr.) P dated 3/31/2021, a peer review evaluation for Dr. FF dated 12/01/2018, a peer review evaluation for Dr. GG dated 5/21/2018, a peer review evaluation for Dr. HH dated 11/20/2017, and a peer review evaluation for Dr. II dated 02/10/2018.

A review of the Governing Board Minutes from 01/28/2020 through 4/9/2021 failed to document or address any peer review process or completion of any peer review performed at the facility.

A review of Medical Staff Meeting Minutes from 11/20/2019 through most recent meeting dated 02/17/2021 did not mention any peer review or peer review committee.

The Medical Staff Bylaws Rules and Regulations last approved on 02/08/2019, stated on page 46 "Article XI Committees 1. Committee Membership a. The Medical Staff will appoint members to the Medical Staff Standing Committees unless otherwise provided by these Bylaws; ...d. Minutes of each Medical Staff Standing Committee will be taken and maintained by the Quality Improvement Department and reported to the Medical Staff and the Board Quarterly unless otherwise stated. 2. Standing Committees a. The Medical Staff Standing Committees are as follows: ii. Section 2 Peer Review" On page 49, Section 2, Peer Review committee - the section did not indicate a time frame for when peer reviews needed to occur but did say under subparagraph 2. "Duties of the Peer Review Committee are as follows: "review professional practices at the facility to reduce morbidity and mortality and to improve patient care." [Reference s. 395.0193(2)(g)] i. The Risk Manager, or designee using the Medical Staff approved criteria, will conduct the initial Morbidity and Mortality Review.

A review of the facility organizational chart indicated there was no one identified in the role of Risk Manager.

During an interview on 4/7/2021 at approximately 12:49 PM, the chair of the governing board (GB chair) said he was aware the facility was currently without a Risk Manager.

On 4/5/2021 in an interview which took place from 12:42 PM through approximately 3:00 PM, the Acting Chief Financial Officer (CFO) said, "we do not have a Risk Manager."

On 4/8/2021 at 1:43 PM in an interview, the Chief Operating Officer confirmed the facility did not have a Risk Manager or anyone filling that role.

On 4/5/2021 at 3:22 PM, an interview took place with nurse M, who was formerly the Director of Nursing (DON) but resigned effective 3/26/2021 and offered to return to the facility to assist with creating a corrective action plan. Nurse M said, "There hasn't been a Risk Manager. When nurse RR was here, she was the Risk Manager, Utilization Review, Infection Control, a bit of everything. I told them I would not do all that when I came on as DON.
VIOLATION: NURSING SERVICES Tag No: A0385
Based on observations, staff interviews, policy reviews, staff record reviews, medical record reviews, and review of the organizational chart, the hospital failed to have a current permanent Director of Nursing or an acting Director of Nursing (refer to A0386) or nursing services organized with appointed and qualified nursing supervisors (refer to A0392). The hospital failed to demonstrate competency training of nurses, including but not limited to cardiac monitoring and restraints, allowed nurses to work in patient care without current Basic Cardiac Life Support training and rehired a nurse with a documented history of patient abandonment at the hospital (Licensed Practical Nurse CC) (refer to A0398). The hospital's lack of nursing leadership and nurse training resulted in a failure to provide ordered cardiac telemetry monitoring for 1 of 1 patients sampled for cardiac monitoring (#3) and 2 of 2 patients sampled for restraints (#2 and #4).

The cumulative effect of these failures created the likelihood of serious harm, injury, illness, and death resulting in a determination of Immediate Jeopardy at the Condition of Nursing Services. The hospital Chief Operating Officer was notified of the Immediate Jeopardy on April 9, 2021 at approximately 3:47 PM. The Immediate Jeopardy was determined to start on 01/29/2021 and was ongoing.

The findings include:

Cross Reference A0386: Based on interviews and review of the organizational chart, the hospital failed to have an acting Director of Nursing responsible for the operation of nursing services since 03/26/2021.

Cross Reference A0392: Based on staff interviews and review of the organizational chart, the hospital failed to have an acting Director of Nursing responsible for the operation of nursing services and failed to have supervisory personnel for each nursing department. The hospital failed to ensure a Registered Nurse was on duty at all times on each nursing unit for 1 of 2 nursing units currently open, the Medical-Surgical Unit.

Cross Reference A0397: Based on observation, staff interviews, clinical record review, policy review, personnel record review and review of the organizational chart, the hospital failed to ensure licensed nurses were assigned based on their specialized qualifications and competence. Untrained nursing staff were assigned to patients on cardiac monitors without training and without current certification in Basic Life Support. No staff were assigned to watch the cardiac monitors. This failure affected 1 of 1 current patients on cardiac monitoring, #3. The hospital failed to ensure staff were trained in the safe implementation of restraints and failed to ensure staff competencies in restraint techniques for 12 of 12 staff sampled for restraint review (Staff A, C, H, M, S, T, U, CC, EE, MM, VV and XX). This failure affected 2 of 2 sampled patients (#2 and #4). The hospital failed to provide adequate supervision and evaluation of all sampled nursing personnel.
VIOLATION: ORGANIZATION OF NURSING SERVICES Tag No: A0386
Based on interviews and review of the organizational chart, the hospital failed to have an acting Director of Nursing responsible for the operation of nursing services since 03/26/2021.

The findings included:

During an interview with the emergency room (ER) shift charge nurse, registered nurse (RN) I, on 4/5/2021 at 11:00 AM, nurse I was asked to describe the chain of command and said, "I don't have another step between me and DON (Director of Nursing) right now. Currently we don't have a DON, (nurse M) was the DON and she left recently. I believe it's advertised on Indeed Indeed [an American worldwide employment website for job listings] right now, they're looking for one."

On 4/6/2021 at 5:24 PM, RN D stated, "What is the chain of command? I have not seen it written anywhere. I called up when I came here and asked if they needed PRN (as needed) help over the winter. It's changed a lot since I was here before. Nurse RR asked if I would come here and do the scheduling. They didn't have any nurses and they would not use agency. When I got here, nurse RR told me Friday was her last day. She never came in and oriented me, never showed me a schedule, nothing. She finally came in and emptied out her office. I asked if I was going to be shown what to do and I never got anything. I got no orientation and no job description. As far as I know, I'm the scheduler, but I don't have a job description. Nurse RR is gone and there's nobody." "There is no leadership to tell us what is appropriate." RN D expressed concerns with the hospital admitting patients with inappropriate acuity levels, especially with the medical surgical floor often only having an LPN on duty. Nurse D added she only lives here in the winter and was planning to leave the state and return to her summer home in a few weeks.

In an interview on 4/8/2021 at 4:00 PM, RN M, former DON, confirmed she is not working in the capacity of Director of Nursing. She explained she returned to the facility after resigning from that role to help the facility through the survey process and to assist in writing a corrective action plan. She confirmed the facility does not have a director of nursing at this time, nor anyone acting in that capacity. RN M was hired on 2/1/2021 to the roll of DON and resigned 03/26/2021.

A review of the facility organizational chart demonstrated the facility had no person in any nursing services role listed on the chart which included Director of Nursing, or supervisors of intensive care, surgical care, emergency care, or medical surgical care and no one in the role of educator. (The surgery and intensive care areas are currently closed).
VIOLATION: STAFFING AND DELIVERY OF CARE Tag No: A0392
Based on staff interviews and review of the organizational chart, the hospital failed to have an acting Director of Nursing responsible for the operation of nursing services and failed to have supervisory personnel for each nursing department. The hospital failed to ensure a Registered Nurse was on duty at all times on each nursing unit for 1 of 2 nursing units currently open, the Medical-Surgical Unit.

The findings include:

A review of the facility organizational chart demonstrated the facility had no person in any nursing services role listed on the chart which included Director of Nursing, and nursing supervisors of: intensive care, surgical care, emergency care, and medical surgical care and no one listed in the role of educator. At the time of the survey, several areas of the hospital were closed due to building mitigation efforts related to water damage. Neither the operating room nor the ICU were open during the survey, only the emergency room and the medical-surgical unit, neither of which had a nursing supervisor.

During an interview with the emergency room (ER) charge nurse, Registered Nurse (RN) I, on 4/5/2021 at 11:00 AM, nurse I described the chain of command and said, "I don't have another step between me and the DON (Director of Nursing) right now. Currently we don't have a DON, (RN M) was the DON and she left recently. I believe it's advertised on Indeed [an American worldwide employment website for job listings] right now, they're looking for one."

On 4/6/2021 at 5:24 PM, RN D said, "What is the chain of command? I have not seen it written anywhere. I called up when I came here and asked if they needed PRN (as needed) help over the winter. It's changed a lot since I was here before. Nurse RR asked if I would come here and do the scheduling. They didn't have any nurses and they would not use agency. When I got here, RN RR told me Friday is my last day. She never came in and oriented me, never showed me a schedule, nothing. She finally came in and emptied out her office. I asked if I was going to be shown what to do and I never got anything. I got no orientation and no job description. As far as I know, I'm the scheduler, but I don't have a job description. Nurse RR is gone and there's nobody."

Review of the resignation letter signed by Registered Nurse (RN) RR on 12/21/2020 listed her titles as registered nurse, Risk Manager, quality improvement, utilization review, discharge planning, infection control, employee health, and nursing director. In the letter, nurse RR identified reasons for leaving the hospital as "the lack of time needed to update policies related to infection control and nursing, not to mention the new 2020 hospital regulations. The constant turnover of qualified nursing staff in part due to the recent additional stress of caring for yourself (indicating the Chief Executive Officer, owner) and (a first name not otherwise identified) as residents of the facility. Along with constant chastisement and interference in the performance on Med/Surg nursing personnel duties." "I will continue to assist with the utilization review and discharge planning issues as needed. I will continue to manage the nursing department day to day operations including striving to recruit and retain personnel, while maintaining daily staffing levels."

In an interview on 4/8/2021 at 4:00 PM, nurse M confirmed she is not working in the capacity of Director of Nursing. She explained she returned to the facility after resigning from that role to help the facility through the survey process and to assist in writing a corrective action plan. She confirmed the facility does not have a Director of Nursing at this time, nor anyone acting in that capacity.

On 4/7/2021 at 5:40 AM, LPN C was observed sitting at the nurses' station on the medical-surgical unit. There were no other staff in the area. LPN C stated she was the only nurse on duty. There was a cardiac telemetry monitor observed behind the nurses' station and patient #3 was on cardiac monitoring which showed premature ventricular contractions and bradycardia (a slower than normal heart rate) of 59. LPN C stated she hadn't had a break. She said, "It's a problem because there's not enough staff."

In a follow up interview on 4/7/2021 at 7:00 AM, the surveyor asked LPN C if there was a telemetry technician or someone who monitors cardiac telemetry and LPN C replied, "no, I monitor telemetry." LPN C said her BLS (Basic Live Support) was current, but she was not an RN (Registered Nurse) so she cannot be certified for ACLS (Advanced Cardiac Life Support), but did take a class.

On 4/6/2021 at 5:24 PM, during an interview RN D, the nursing scheduler stated on night shift, the emergency room (ER) is staffed with an RN, and that there might also be a tech in the ER. On the Medical-Surgical Unit "there is an LPN without a CNA, without anyone. The nurse is by herself and there is no one there if she has a problem."
VIOLATION: PATIENT CARE ASSIGMENTS Tag No: A0397
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on observation, staff interviews, clinical record review, policy review, personnel record review and review of the organizational chart, the hospital failed to ensure licensed nurses were assigned based on their specialized qualifications and competence. Untrained nursing staff were assigned to patients on cardiac monitors without training and without current certification in Basic Life Support. No staff were assigned to watch the cardiac monitors. This failure affected 1 of 1 current patients on cardiac monitoring, #3. The hospital failed to ensure staff were trained in the safe implementation of restraints and failed to ensure staff competencies in restraint techniques for 12 of 12 staff sampled for restraint review (Staff A, C, H, M, S, T, U, CC, EE, MM, VV and XX). This failure affected 2 of 2 sampled patients (#2 and #4). The hospital failed to provide adequate supervision and evaluation of all sampled nursing personnel.

The failure to ensure overall staff training to include cardiac monitoring, BLS and appropriate restraint techniques, and the lack of nursing supervision resulted in a likelihood that patients could be seriously harmed or die. Cross Reference: A0167 and A0208.

The findings include:

On 4/7/2021 at 5:40 AM, LPN C was observed sitting at the nurses' station on the medical-surgical unit. A pillow was next to LPN C on the counter by the computer keyboard. There were no other staff in the area. At this time, 3 medication cups were observed on a bedside table in the hallway approximately 15 feet from where LPN C was sitting. Two of the medication cups were filled with pills, and the third cup had pills and a vial. The cups were labeled with patient room numbers. The pills were still in their packaging. In an interview, LPN C said she prepared those morning medications for patients. LPN C was asked if any of the medications in the cups were controlled substances and she pulled out one pill in packaging which was labeled Alprazolam 1mg (class IV, anti-anxiety medication). LPN C was asked about documenting medication administration and said most of them (medications) don't scan (into the electronic health record).

Then LPN C went to the desk near where she was sitting earlier and brought a small clear bag with loose blue pills that she said she pulled out of patient #5's tissue box. This bag was found to contain 9 Xanax and 1 Tylenol PM. Another bag of pills labeled Motrin 800mg was observed on the medication cart, and LPN C reported, "the baggy of Motrin is for me, to be honest, because I'm sick." (photographic evidence obtained)

While LPN C was standing at the medication cart facing away from the nurses' station, there was a cardiac telemetry monitor observed behind the nurses' station and patient #3 was on cardiac telemetry monitoring which showed premature ventricular contractions and bradycardia (a slower than normal heart rate) of 59. The call bell for room 108 sounded, and LPN C walked to the patient room, away from the monitor and leaving the medication cups unattended. The telemetry monitor was not addressed or observed by LPN C at any time during the observations/interview with LPN C. LPN C returned to the medication cart and said she hadn't had a break. She said, "It's a problem because there's not enough staff." During medication administration, LPN C said they do not scan the patient. LPN C explained, "I'll be honest with you I was just using the Kardex. If I was on a regular medication pass, I scan the bracelet, ask their allergies, but I normally just take the Kardex, and I don't take it every time I'm here, to be honest. Do I need to do that?"

In a follow up interview on 4/7/2021 at 7:00 AM, the surveyor asked LPN C if there was a telemetry technician or someone who monitors telemetry and LPN C replied, "no, I monitor telemetry." LPN C said her BLS (Basic Life Support) was current, but she is not an RN (registered nurse) so she cannot be certified for ACLS (Advanced Cardiac Life Support), but did take a class.

During a telephone interview with RN M, a former Director of Nursing (DON) on 4/7/2021 at 12:07 PM, the surveyor asked if there was a policy related to finding medications and/or controlled substances in possession of a patient, and RN M replied, "if it is not in a policy that it needs to be reported, then it should be" and she confirmed that LPN C had not filled out an incident report concerning the controlled substances found with patient #5. Nurse M also confirmed the nurse on duty is responsible for monitoring telemetry when ordered and the nurse responsible for telemetry monitoring should be ACLS certified to be able to recognize if a problem comes up, but added "we haven't been able to keep up with making them get certified."

During the interview, the surveyor requested a copy of the hospital cardiac telemetry policy. The request was repeated several times during the survey, but the facility was ultimately unable to provide a policy related to cardiac telemetry monitoring of patients.

A record review was conducted for Patient #3 who was admitted on [DATE] and had physician orders for telemetry (cardiac monitoring).

The next day, on 4/8/2021 beginning at 12:10 PM, an interview was conducted with Registered Nurse (RN) T, who was the only nurse assigned to the medical-surgical unit. The surveyor asked RN T about her current competency for cardiac monitoring and BLS certification. RN T replied, "I can't read it well, the monitor, but have plenty of resources, have the ER (emergency room ) staff, Respiratory Therapy can read it, and the doctor is only a phone call away." RN T reported "I let my BLS expire in January or February, they had a class here and I didn't attend, so I have completed the online BLS yesterday, and have to be checked off today." During the interview, the surveyor observed that no staff was in visual line with the cardiac monitor. The surveyor observed the cardiac monitor and it was not activated. The surveyor inquired why patient #3 was not on the Telemetry. Certified Nursing Assistant (CNA) A replied, "The students were working with the instructor today and didn't put the patient on the monitor, they said she was asleep and didn't want to wake her up." CNA A stood up and grabbed a sheet of paper with multiple electrode pads sitting on the desk and stated to the nurse, "I will go and put them on her." RN T remained seated and did not say anything. When the patient's monitor was functioning and CNA A came back to nurses station, the surveyor inquired as to the length of time patient #3 had been off the cardiac monitor. CNA A said she got here at 07:00 AM and she is now on the monitor at 12:25 PM. The surveyor verified with RN T that patient had not had any monitoring during that time, and RN T replied, "No, she is on it now."

Restraints and training:
A request was made for a list of patients with restraint usage. The hospital was unable to provide this information. During an interview on 4/6/2021 at 5:24 PM, RN D was able to recall a recent patient in restraints, Patient #2. RN D revealed Patient #2 was diagnosed with rhabdomyolysis and ended she ended up being intubated and transferred. She had been here 3 days and they had a Posey vest vest (a type of medical restraint used to restrain a patient to a bed or chair) on her. RN D added, that she wanted to take every Posey vest in this place and throw it away. Patient #2 was admitted under the Certified Registered Nurse Anesthetist (CRNA).

A review of patient #2's clinical record showed she (MDS) dated [DATE] at 5:00 PM via ambulance and was diagnosed with acute rhabdomyolysis (the destruction or degeneration of muscle tissue, as from traumatic injury, excessive exertion, or stroke, accompanied by the release of breakdown products into the bloodstream and sometimes leading to acute renal failure) and admitted into observational status on 3/9/21 by CRNA G.

An order for, "Posey vest restraint for patient safety," initialed by Certified Registered Nurse Anesthetist G (CRNA G), was added to an admission order set signed by Advanced Practice Registered Nurse (APRN) LL. The date and time the order was written cannot be determined due to a hole punch in the original document, but these orders were noted by nurse S on 3/9/2021 at 9:44AM. Another order was written on 3/10/21 at 11:24 AM by CRNA G that stated, "Posey vest for patient safety off for 2 hours every 4 hours." There was no annotation in the record of any assessment made immediately following administration of the restraints on patient #2.

A review of patient #2's record indicated numerous entries related to the administration of a Posey vest restraint. The first annotation related to the Posey vest restraint was documented on 3/9/2021 at 8:42 AM by Registered Nurse (RN) S who wrote, "Posey vest was used in ER last evening, it remains in place but is not tied. Patient making no efforts to get out of bed." Licensed Practical Nurse (LPN) C documented patient #2 in Posey vest restraint on 3/9/2021 at 10:30 AM, 11:30 AM, and on 3/10/2021 at 4:00 AM. LPN XX documented patient #2 in Posey vest restraint applied on 3/10/2021 at 7:25 AM and released at 9:25 AM, applied on 3/10/2021 at 10:25 AM and released at 11:15 AM, applied on 3/10/2021 at 1:05 PM and then released at 3:00 PM. On 3/10/2021 at 6:00 PM, LPN XX documented applying Posey vest restraint for patient safety. On 3/10/2021 at 7:00 PM, RN U initiated a physical restraint flow sheet and the only documentation on the flowsheet occurred as hourly checks beginning at 7:00 PM and ending at 11:00 PM. Cross-reference A0167.

The nursing documentation failed to document proper positioning of the restraint, blood circulation in the area of the restraint, and failed to document skin integrity for 2 days. There is no assessment at the time the restraint was initially applied, at an unknown time either late on 3/8/21 or the early morning hours of 3/9/21 in the emergency room . A restraint flow sheet per hospital policy was not initiated until 7:00 PM on 3/10/21

A review of employee records for RN U and LPN C found no training competencies were done upon hire or annually. No training for restraints was documented. No competency skills verifications were documented since at least 2018. A review of RN MM's training file indicated restraint training took place on 1/7/2018 and 9/26/2018, but none since, and no restraint competencies were found. Cross Reference A0167, A0194, and A0208.

On 04/05/2021 at 10:45 AM, during an interview, Certified Nurse Assistant (CNA) A stated, "I have worked here since October 2020. I got thrown in as I was the only CNA, so the nurses oriented me and after a few days I was on my own. If I had any questions the nurses would help me. I didn't have any orientation education or training on anything, no abuse or neglect, patient's rights, risk management. I would report any concerns to my DON (Director of Nursing), but we don't have one, she left 2 weeks ago, I would let my supervisor know immediately. Since I have been here, we have had 4 DON's. " I have been asked to do Foley catheters [urinary catheters], to put one in, they asked me to go to the ER and put one in, and take out IV's. I told them I could not do that, as it was not my scope and I refused. They offered to train me as a nurse tech in the ER, and I didn't feel comfortable with that."

On 04/05/2021 at 11:48 AM, during an interview, Staff S, Registered Nurse (RN) stated, "I have not had any education or annual training for over a year or more on Risk Management or abuse and neglect. I have been here 5 years and it has been awhile since I had any education.

On 04/06/2021 at approximately 1:28 PM, during an interview, RN CC stated, "I have worked here 7 years. I have not had any education or training since my orientation 7 years ago. I think we had some workplace violence like active shooter and things like that, that's the last thing I can remember. It concerns me as the last place I worked at we had a long list to do for annual evaluation, it bothers me. I do not feel we have a voice here, and before we had such a turnover in leadership, I could talk to some leaders for answers, but not now."

On 04/06/2021 at approximately 3:10 PM, during an interview, Nurse Technician (NT) VV stated,"I did work for the previous DON as a secretary and the past 6 months I have been working as a NT (nurse tech), mainly paperwork in the ER or Medical-Surgical unit, putting charts together and answering phones and assisting staff. The only education I did in 2020 was my NT competencies, I have not asked about any education as 2020 has been a wild year."

On 04/06/2021 at approximately 4:55 PM, during an interview, RN U stated, "I have worked here since 1/25/2021, and became a nurse in 2016." The surveyor reviewed a New Employee Orientation packet with the nurse. She added, "I was given the packet and read most of it, no other education/training, and no abuse training that I remember". She added, "I was paired with a nurse for two weeks, they did ask me if I needed more time, because it is a lower level of acuity and I felt that I always had someone to go to and ask."

On 04/07/2021 at approximately 7:40 AM, during an interview, RN EE stated, "I started here 6 to 7 months ago, trained in Thailand as a nurse, worked there for 4 years, and 3 years in United States. I did not have any orientation that was classroom or documentation/ paper instructions. I was buddied up with another nurse and they trained me and showed me their computer system, I believe I did get a job description, but no education for abuse, Risk Management, patient's rights that I remember."

On 04/07/2021 at approximately 7:46 AM, during an interview LPN C stated she had not had restraint training since she was in school, about 6 years ago, and has had no restraint training since working at the hospital.

On 04/08/2021 at approximately 12:10 PM, during an interview, RN T stated, "I have not had education on abuse, neglect, restraints, or cardiac monitoring. I had restraint training 4 years ago in nursing school. We don't use restraints often here, we have used them but rarely. I think we have a policy, not sure. I have used soft wrist restraints in the past on patients coming down off drugs and yesterday in the ER. I had to apply soft wrist restraints on a combative patient (patient #4) that we had to intubate, and transfer him out to higher level of care.

On 04/09/2021 at approximately 2:50 PM, during an interview, RN H stated that she started here in November 2020, has been a nurse for over 35 years, and was retired and decided to come back as a part time/PRN (as needed) staff nurse. I did not get any orientation. I just got thrown in. That's how they do it here. I buddied up with a nurse each day for a few days and that was my orientation. I have a lot of experience and got on with it, so basically there was no orientation or education and we did not have any competencies on anything.

In an interview on 4/8/2021 at 11:04 AM, RN M, the former DON said, "I have not found any documentation to indicate that nursing policies and procedures have been annually reviewed, I think the last was 2018, typically what you see is policy from like 2004 and they just sign off on it." During this interview, nurse M described the care provided to patient #2, "She was put in a Posey at the nurses' request (nurse MM), she had altered mental status, her labs were way out of range, she was combative, so that the nurse asked for the Posey. They gave her sedation, I don't remember exactly what, by IV (intravenous route). There weren't appropriate restraint checks or releases." Nurse M was asked if any training occurred as a result of concerns with patient #2's care and she responded, "I know that there needs to be some additional training so that it's not repeated. I know that needs to happen when you've identified concerns with restraints and I don't have any explanation as to why I didn't do it myself. There is no manager or anyone to help put the processes in place to make sure that it happens." Nurse M explained a meeting took place on 3/24/2021 related to concerns with care provided to patient #2 and doctor F, APRN LL (nurse practitioner), CFO, nurse D, CRNA G (nurse anesthetist) and nurse M attended. Nurse M said, "The COO was made aware of the meeting and I tried to explain it wasn't just a nursing problem. There needed to be education and nurses signing to their understanding and we were going to make copies to give each nurse, but the next day was my last day. This plan was made and everyone took notes, but I doubt anything happened with the plan."

During an interview on 4/6/2021 at 5:24 PM, nurse D, a registered nurse, said "I've asked the staff when their last competency was, and they don't have anything. We have RNs that don't even have their BLS (basic life support training). I just held a class and told them I wasn't taking no for an answer. I told them we can't have people doing patient care without even BLS. I brought it to the CFO's attention because he is the only person I could go to and he got it set up and paid for it. There's no orientation and there is no competency training or computer training."

A review of the facility organizational chart demonstrated the facility had no person in any nursing services role listed on the chart which included Director of Nursing, intensive care, surgical care, emergency care, or medical surgical care.

During an interview with the emergency room (ER) charge nurse, RN I, on 4/5/2021 at 11:00 AM, the surveyor asked RN I to describe the chain of command and RN I replied, "I don't have another step between me and the DON (director of nursing) right now. Currently we don't have a DON, (RN M) was the DON and she left recently. I believe it's advertised on Indeed [an American worldwide employment website for job listings] right now; they're looking for one."

During the interview on 4/6/2021 at 5:24 PM, nurse D asked, "What is the chain of command? I have not seen it written anywhere. I called up when I came here and asked if they needed PRN (as needed) help over the winter. It's changed a lot since I was here before. Nurse RR (DON who resigned in December 2020) asked if I would come here and do the scheduling. They didn't have any nurses and they would not use agency. When I got here, nurse RR told me Friday is my last day. She never came in and oriented me, never showed me a schedule, nothing. She finally came in and emptied out her office. I asked if I was going to be shown what to do and I never got anything. I got no orientation and no job description. As far as I know, I'm the scheduler, but I don't have a job description. Nurse RR is gone and there's nobody."

Policy PH-12 with a most recent review date of 7/27/2009 indicated that all drugs stored in this hospital shall be accessible only to authorized personnel. 1. All drugs, except those intended for crash cart use, will be stored in lockable containers or areas. 2. Controlled drugs will be double locked at all times prior to use (see Controlled Drug Distribution policy). 5. All medications at nursing stations shall be in a lockable storage at all times. Medications are stored either in lockable medication carts or the medication room. Floor stock is located in the drug dispensing carts. Authorized personnel include Registered Nurses (RN), licensed practical/vocational nurses (LPN/LVN), licensed psychiatric technician (LPT), respiratory therapist (RT), Pharmacist, pharmacy technicians, and pharmacy interns. 6. When unattended medication carts are to be locked.
Policy #PT-04 "Patient's Own Medication" with most recent review date of 5/19/2009 indicated "medications that have been brought in by the patients at admission will be sent home with the family as described in NADM-72, III, Q, 3, If not, the medications will be stored in the Pharmacy Department as described in NADM-72.

A policy titled "Use of Restraints" and identified as policy #NADM-53 with an approval date of 12/7/2004 and no review date indicated, "Nursing Services will assure all direct patient care providers will have ongoing education and training in the proper and safe use of restraints. The Director of Nursing will assure each nurse department manager provides initial and ongoing education and training annually in the proper and safe use of restraints. Section G of the policy described education/competency evaluations on the use of restraints is included in Nursing Orientation, and at least annually thereafter. Section K of the instruction indicated the restraint flow sheet is utilized for documentation. Documentation may be continued, if necessary in the nurses' notes. Section L described which documentation will be every hour (and as needed), and every 2 hours. The policy required the physician to be notified as soon as feasible that the restraint protocol has been initiated and this contact must be documented in the Nurses' notes.
VIOLATION: FORM AND RETENTION OF RECORDS Tag No: A0438
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**


Based on staff interviews and clinical record reviews, the hospital failed to maintain a medical record for 1 of 1 sampled patient who resided in the hospital for many months beginning in March 2020 and extending until February 2021, but the care was only intermittently documented (patient #1). During this timeframe, patient #1 was intermittently admitted to the hospital. The hospital failed to maintain a complete and accurately written records for 5 of 5 admission records sampled for patient #1.

Findings include:

On 04/05/2021 at approximately 10:45 AM, an interview was conducted with Certified Nurse Assistant (CNA) A. He said, "Patient #1 had been a patient here, a long term care resident, she was here when I started in October of 2020. I was told she has been here for months before I came. She went home for a week before Christmas and then came back. She just went home last month and has since passed. I helped Patient #1 with showers/positioning." "She wasn't a patient here, she lived here." The staff talked to a few people here, including the former DON, Risk Manager, Quality Improvement Director, Utilization Review Director, Discharge Director, Infection Control Director, Employee Health RR, and CFO J, and it was brought up to the CEO. The CEO wanted her to stay here." He added, "I couldn't document on Patient #1. She wasn't a patient and for that reason was not in our system. I don't know how the nurses did it, as it's all computer charting. I know she had a binder, but it was just her meds and stuff." (Written statement provided).

On 04/05/2021 at approximately 11:48 AM an interview was conducted with Registered Nurse (RN) S. She said, "We cared for Patient #1 for a long time. She was here in March of 2020. Then COVID-19 (Coronavirus Disease 2019) exploded and it was discussed about sending her to a skilled nursing facility (SNF) for rehabilitation. The Chief Executive Officer (CEO) didn't want that because he could not visit her in a SNF, so she stayed with us. She did have a week at home in October of 2020. She came back, then she was discharged home at the end of February of this year. She was a very sweet lady." Nurse S said, "We used paper charting for her. We didn't have a lot, only medical interventions. We documented in the Medication Administration Record (MAR) when medications were given. She got mostly maintenance medications, Vitamin D, Bee pollen and the occasional Tramadol, Ativan or Xanax as needed. These were given very occasional, not routinely." She said, "We used paper charts and those usually go to Medical records, but I believe that Patient #1's chart went to the former DON RR's office instead." (Written statement provided).

On 4/6/2021 at approximately 1:28 PM, during an interview the Utilization Review/Discharge Planning Registered Nurse (RN) CC stated, "I was aware of Patient #1 being here as a resident. She was not an inpatient."

On 04/06/2021 at approximately 4:25 PM, during an interview RN U stated, "I started working at this facility on 1/26/2021. I took care of Patient #1. I never understood what classification she was under as she wasn't an inpatient and there wasn't any paperwork. I asked staff, they said we do not chart daily assessments, we care for her, but no charting, except for medications given or held."

On 04/08/2021 at approximately 12:10 PM, during an interview RN T stated, "I cared for patient #1. She was here for a long time, many months, and was not an inpatient. It was not an official admission so we couldn't document in the computer. We, the nurses, just made a paper chart and documented medications on the medication administration record (MAR). They were her home medications. We also documented any procedures we provided." RN T revealed that she had not had any one as a resident before like patient #1 in the past 3 years of employment. (Written statement provided).

After record reviews, patient#1 was noted to have had the following dates of admission:
1/08/20 - 1/13/2020
3/17/2020 - 4/14/2020
5/21/2020 - 5/27/2020
10/09/2020 - 10/19/2020
11/24/2020 - 12/02/2020

A review of the medical record documentation for Patient #1's admission from 1/08/2020 to 1/13/2020 was conducted. She was admitted by Physician Assistant (PA) E. The attending Physician was Doctor CCC. There was no Living Will for review. Her advanced directives were documented as FULL CODE by the nurse admission note. The Discharge Instructions had no patient or representative's signature or date for receipt.
All of the consents for Patient #1 were signed by the former Chief Nursing Officer (CNO), Registered Nurse (RN) ZZ. Including:
Consent to Treatment
Authorization for Treatment
Medicare/Tricare Acknowledgment of Receipt Statement
Notice to Medicaid Patients
The "PIN Number" (Patient Information Number) form for Patient medical information protection of confidentiality was incomplete as no PIN number and no patient signature were present, only RN ZZ and an illegible witness signed the consents.
Medication Administration Record (MAR) dated for 01/09/2020 through 01/11/2020, no other MAR's verified, on 01/09/2020 medications unable to scan, and on 01/10/2020 medications not available for administration.
01/13/2020 at 7:10 AM Patient #1's Blood pressure (B/P) was documented as 196/83 with no notification of provider or treatment given, and patient discharged later that day.
Physician orders were signed by PA E, and were not co-signed by a physician.

A review of the medical record documentation for Patient #1's admission from 3/17/2020 to 4/14/2020 was conducted. She was admitted by PA E. There was no physician assessment or re-assessment from 3/17/20 until 3/25/20. The, "Inpatient Certification of Need of Care Form," was signed with an illegible signature on the Attending Physician's Signature line.
The, "Consent to Medical Services," dated 3/30/2020 at 10:45 AM, for a surgical procedure was signed by Physician SS. The signature of the patient is blank. In the area for comments if patient is unable to sign the form was blank. No other consents were found in this record. No Living Will/Advance Directives were in this record. The Discharge Instructions were not dated or signed. There was a correspondence dated April 3, 2020 that stated, "Any correspondence regarding Patient #1's condition should be directed ONLY to her physician and CEO. May tell children about patient, however, Do Not take phone in room." This was signed by RN/CNO ZZ.
Clostridium difficile tests ordered on [DATE] for Patient #1 and she was treated with Vancomycin and placed on contact precautions. In review of laboratory tests, the Clostridium difficile order was never completed as there were no test results.
Physician orders were signed by PA E, and were not co-signed by a physician.

A review of Patient #1's medical record documentation for the admission from 5/21/2020 through 5/27/2020 was conducted. Patient #1 was admitted by PA E. The Attending Physician was documented at Doctor SS. There was no Living Will noted.
The PIN Number form for Patient medical information protection was incomplete as there was no PIN number chosen. The "Advance Directives and Admissions Inquiry Form," had a patient label with the patient's name, medical record number, date of birth, attending physician, bed number, sex, race, and a partial Social Security Number. The document was incomplete. The only areas completed were the witness signature line and date. There were also a checkboxes which stated "I acknowledged the receipt of the following materials: Educational Handout regarding Advance Directives and A copy of the Patient's Bill of Rights and Responsibilities. The checkboxes were blank for both. There was a, "HIPAA [Health Insurance Portability and Accountability Act] Notice of Privacy Practices Form, Patient Acknowledgment Form," dated 5/21/20 which had a witness signature that was illegible. The, "Inpatient Certification of Need of Care Form," had a signature that was illegible on Attending Physician's Signature line.
MARs were incomplete, only MARs for 05/22/2020 through 05/23/2020, no discharge plan or Plan of care, only nurse progress notes for 05/22/2020 for 24 hours, and no other dates verified in record.
Physician orders were signed by PA E, and were not co-signed by a physician.

A review of Patient #1's medical record documentation for the admission from 10/09/2020 through 10/19/2020 was conducted. Patient #1 was admitted by PA E. The Attending Physician was documented as PA E. The Living Will form was blank. There were Discharge Instructions 5 pages long with no signature of receipt. All consents had stamped on them, "PATIENT UNABLE TO SIGN," on the patient signature line, witnessed and dated 10/9/2020:
Consent to Treatment
Authorization for Treatment
Medicare/Tricare Acknowledgment of Receipt Statement
The, "PIN Number form for Patient medical information protection of confidentiality," was incomplete as there was no PIN number selected. The, "Advance Directives and Admissions Inquiry Form," had a patient label with the patient's name, medical record number, date of birth, attending physician, bed number, sex, race, and a partial Social Security Number. The document was incomplete. The only areas that were completed were the witness signature line and date. There were also a checkboxes which stated "I acknowledged the receipt of the following materials: Educational Handout regarding Advance Directives and A copy of the Patient's Bill of Rights and Responsibilities. The checkboxes were blank for both. There was a, "HIPAA Notice of Privacy Practices Form, Patient Acknowledgment Form," dated 10/09/20 which had a witness signature and no other. There was a, "COVID-19, Zika Fever & [DIAGNOSES REDACTED] (EVD) Screening Tool," signed by a witness and dated 10/09/20. The, "Inpatient Certification of Need of Care Form," dated 10/09/2020 was signed by PA E on the Attending Physician's Signature line.
There were only MARs for 10/16/2020 through 10/17/2020, no Progress notes, no Plan of Care, no Discharge Plan, no Physician assessment/reassessment, no discharge instructions. Physician orders were signed by PA E, and were not co-signed by a physician.

A review of Patient #1's medical record documentation for the admission from 11/24/2020 through 12/02/2020 was conducted. Patient #1 was admitted by Physician P. The Living Will section was blank. All consents were stamped, "PATIENT UNABLE TO SIGN," on the patient signature line which was witnessed and dated 11/24/2020, including:
Consent to Treatment
Authorization for Treatment
Medicare/Tricare Acknowledgment of Receipt Statement
Notice to Medicaid Patients
The, "PIN Number form for Patient medical information protection of confidentiality," form was incomplete as it had no PIN number selected and the signature line was BLANK. There was a date and witness signature. The, "Advance Directives and Admissions Inquiry Form," had a patient label with the patient's name, medical record number, date of birth, attending physician, bed number, sex, race, and a partial Social Security Number. The document was incomplete. The only areas that were completed were the witness signature line and date. There were also checkboxes which stated "I acknowledged the receipt of the following materials: Educational Handout regarding Advance Directives and A copy of the Patient's Bill of Rights and Responsibilities. The checkboxes were blank for both. There was a, "HIPAA Notice of Privacy Practices Form, Patient Acknowledgment Form," dated 11/24/20 which had a witness signature and no other. There was a, "COVID-19, Zika Fever & [DIAGNOSES REDACTED] (EVD) Screening Tool," signed by a witness and dated 11/24/20.

On 12/07/2020 Patient #1 was admitted for 1 day for the care of Chest Pain and was admitted by PA E. The only documents were a Face Sheet (hold demographic and billing information for the facility), an electrocardiogram (electrical scan of the heart muscles action) dated 12/07/2020 which had normal results, and a laboratory test for Troponin level (a test that can detect damaged heart muscle, possibly indicating a heart attack) that was normal.

A review was conducted of a physical chart binder for Patient #1. Review revealed that there was a "Do Not Resuscitate" sticker on the chart. There were no living will or advance directives located in the chart or any documentation of advance directives in any notes. A review of the nurses' notes in this chart revealed:

The current Medical Staff By-Laws were requested, and the hospital provided "The Medical Staff of Healthmark Regional Medical Center Rules and Regulations". The document was undated, but had been approved by the Board of Directors on 2/8/2019. Beginning on page 10, under VI. Health Information - v. The Attending Physician must read, edit, sign and/or counter-sign all orders, H&P, and pre-operative notes that have been recorded by an Intern, Resident Physician or a Physician's Assistant. On page 12: c. the Health Information Management Department Manager is responsible for analyzing the Medical Records for completeness.
VIOLATION: Condition of Participation: Pharmaceutical Se Tag No: A0489
Based on observations, staff interviews, review of video evidence provided, and review of policies and procedures, the hospital failed to ensure the Condition of Pharmaceutical Services met the needs of patients and that drug storage was under competent supervision to prevent loss or damage of patient's home medications, to ensure controlled substances were locked and stored according to policy, and to ensure that outdated medications were not available for patient use in the emergency room (refer to A0502, A0503, and A0505).

The findings:

Cross Reference A0502 - Based on observations, review of hospital video evidence, staff interviews, and policy review, the hospital failed to keep all drugs in a secure area and locked when appropriate. The hospital failed to secure patient home medications in the hospital pharmacy per policy. Unsecured Xanax (a schedule IV narcotic) was found sitting on a counter in a small Ziplock style bag and unattended in a medication cup in a hallway. The nurse on duty at the time had previously been identified on a recording going through discharged patient medications and putting them in her purse. Patient home medications were stored in the unit medication room instead of in the pharmacy per policy for 2 of 3 current patients.

Cross Reference A0503 - Based on observations, staff interviews, and policy reviews, the hospital failed to keep all drugs listed in Schedule IV (lorazepam and Xanax) in a locked, secure area (Xanax found in medicine cup in hallway and in a small bag at the nursing desk and 15 vials of lorazepam in an unlocked refrigerator).

Cross Reference A0505 - Based on observation, staff interview, and policy review, the hospital failed to ensure outdated or otherwise unusable drugs were not available for patient use in the emergency department (5 sampled medications).
VIOLATION: SECURE STORAGE Tag No: A0502
Based on observations, review of hospital video evidence, staff interviews, and policy review, the hospital failed to keep all drugs in a secure area and locked when appropriate. The hospital failed to secure patient home medications in the hospital pharmacy per policy. Unsecured Xanax (a schedule IV narcotic) was found sitting on a counter in a small Ziplock style bag and unattended in a medication cup in a hallway. The nurse on duty at the time had previously been identified on a recording going through discharged patient medications and putting them in her purse. Patient home medications were stored in the unit medication room instead of in the pharmacy per policy for 2 of 3 current patients.

The findings included:

On 4/5/2021 at 12:42 PM, during an interview regarding medication disposition for discharged patients, the Chief Financial Officer (CFO) stated, "There were some patient medications that were left behind and I asked him (the previous pharmacist QQ) about them toward the end of December (2020)." He said he reviewed the video recording from the security camera over the nurses' station and saw Pharmacist QQ come out of the pharmacy area with the box of expired medication. The CFO said he recognized the box of medication. He stated Pharmacist QQ and Licensed Practical Nurse (LPN) C were going through all of the medication. He stated he then saw LPN C put a bag of them in her purse. He stated he showed the footage to Pharmacist QQ and it turned into a screaming match in which the pharmacist mentioned attorneys. He stated he then showed it to Nurse RR (the former Director of Nursing/Risk Manager/Quality Improvement Director). He stated, "Nurse RR was here then and I don't know, I don't think it went anywhere, but they knew about that."

A flash-drive with video evidence of the event of 12/17/2020 described above was provided by the CFO for review.

On 4/6/2021 at 2:07 PM, CRNA G was asked if he knew about the medication incident involving pharmacist QQ and the LPN C. CRNA G replied, "I was working the day that it happened." CRNA G explained Pharmacist QQ was trying to give LPN C the patient's home medications because they were supposed to have been disposed, but they weren't. He added, "Patients would come in with fentanyl patches, Lyrica (a schedule V controlled substance) and the patient would ask what happened to the medications and they would go to the old man - that is, the owner. The owner just asked one of the Advanced Practice Registered Nurses (APRN X) to write him (a prescription) for narcotics the other day and he got so irate at her, I'm surprised she's still working." CRNA G went on to elaborate on Pharmacist QQ and LPN C's behavior, saying, "They took the patient's home medications, told them they had to be disposed of and stole them."

During an interview and observation with LPN C on 4/7/2021 at 5:40 AM, 3 medication cups with pills in them and one cup with pills and a vial in it were observed on a bedside table near a wall in the hallway outside the nurses station, approximately 15 feet from where LPN C was sitting. There were no other staff present. The cups were labeled with room numbers. LPN C said she prepared those morning medications for patients, but was observed sitting at the desk when surveyors approached at approximately 5:40 AM. LPN C stated one of the pills, Xanax, was a controlled substance and showed that was in the cup labeled 107. The pills were still in their packaging (photographic evidence obtained). While discussing the medications observed, LPN C went to the desk and brought a Ziplock type bag with loose pills that she claimed she pulled out of patient #5's tissue box. This bag was found to contain 9 Xanax and 1 Tylenol PM. Another bag of pills labeled Motrin 800mg was observed on the medication cart, and LPN C reported, "the baggy of Motrin is for me to be honest because I'm sick." LPN C left the area to accompany surveyors to the medication storage room, and when LPN C walked away, the medication cart in the hallway was not locked.

On 4/7/2021 at approximately 6:00am, an observation was made in the Medication Room on the medical-surgical unit. Inside the door to the left there was a peg board with hooks labeled with the patient room numbers. There was a plastic bag hanging from the hook labeled "room 101" and inside this bag were home medications for Patient #5 (Room 107). LPN C explained that is how patient home medications are stored and then the medications are returned when the patient is discharged . The medication refrigerator was observed with an unlocked padlock. The refrigerator was opened and observed to have an affixed drawer containing 15 vials of lorazepam (a controlled substance) and the drawer was observed to be unlocked. LPN C showed how another nurse had accounted for a patient's home medications by putting them in a small Ziplock style bag labeled with 2 nurses' signatures. (photographic evidence obtained)

The previous Pharmacist QQ had resigned and was unavailable for interview. The newly hired Pharmacist Q started on 03/01/2021. On 4/7/21 at 3:37 PM, an interview was conducted with newly hired Pharmacist Q who reported that when she walked in the door, "it was a disaster. I had to come in and organize everything and get files in order". Pharmacist Q stated she goes out to the nursing units daily to see what they need. She stated that the previous pharmacist QQ would tell the nurses that drugs were on back order, when they were not. "He had no organization and had duplicate copies of invoices and hand written notes, things stuffed in his office and clutter in every corner." Pharmacist Q stated she was able to go through the narcotic log with Pharmacist QQ before he left, but "I was unable to verify his poor documentation and unable to verify medications that he wrote were sent to the ER actually went there." She stated she was working on new processes and a more secure system.

A review of the Florida Department of Health Medical Quality Assurance Licensure website, https://mqa-internet.doh.state.fl.us/MQASearchServices/HealthCareProviders. accessed on 4/8/21 found a current license for the previous pharmacist QQ. The website documented prior disciplinary action consisting of 1 year of probation back in 1989 for discrepancies found on a narcotic audit that occurred on 5/23/1988. There were 1,240 tablets of Oxycodone, Dilaudid and Morphine unaccounted for.

Policy PH-10 with a most recent review date of 7/27/2009 listed "All drug storage areas within this hospital will be inspected at least monthly by the pharmacist. The purpose is to ensure proper storage of medications."

Policy PH-12 with a most recent review date of 7/27/2009 indicated that all drugs stored in this hospital shall be accessible only to authorized personnel. 1. All drugs, except those intended for crash cart use, will be stored in lockable containers or areas. 2. Controlled drugs will be double locked at all times prior to use (see Controlled Drug Distribution policy). 5. All medications at nursing stations shall be in a lockable storage at all times. Medications are stored either in lockable medication carts or the medication room. Floor stock is located in the drug dispensing carts. Authorized personnel include Registered Nurses (RN), licensed practical/vocational nurses (LPN/LVN), licensed psychiatric technician (LPT), respiratory therapist (RT), Pharmacist, pharmacy technicians, and pharmacy interns. 6. When unattended medication carts are to be locked.

Policy #PT-04 "Patient's Own Medication" with most recent review date of 5/19/2009 indicated "medications that have been brought in by the patients at admission will be sent home with the family as described in NADM-72, III, Q, 3, If not, the medications will be stored in the Pharmacy Department as described in NADM-72."




A review was conducted of policy number, "PT-03," subject, "Drug procurement and Inventory Control," with no recorded approval date and last reviewed 5/19/2009. The policy statement was as follows: "Responsibility for control of medications within this hospital rests with the Pharmacy department. Policies and procedures are designed to ensure the safe and accurate dispensing of medications throughout the hospital. These policies will be approved by the pharmacy and therapeutics committee." Under the, "Procedure," section and subsection, "Storage," it stated, "Medications are stored in a secure manner."
Mediations are stored under proper conditions as stated by the medication manufacturer to assure stability of that medication.
The Pharmacy Department is locked at all times. Access is limited to pharmacists and Pharmacy Department personnel under the direct supervision of a Pharmacist.
Lockable medication carts are used to store unit of use medications as described in PT-14, Unit Dose medication Distribution System. These carts will be locked when not attended.
Medication rooms on patient care units used for storage of floor stock medications will remain locked. Access is limited to licensed nursing personnel.
Medications contained in floor stock are stored in a secured, locked cabinet. Responsibility for security of the floor stock rests with the supervising nurse or licensed practitioner overseeing the unit in which the floor stock is stored."
VIOLATION: CONTROLLED DRUGS KEPT LOCKED Tag No: A0503
Based on observations, staff interviews, and policy reviews, the hospital failed to keep all drugs listed in Schedule IV (lorazepam and Xanax) in a locked, secure area (Xanax found in medicine cup in hallway and in a small bag at the nursing desk and 15 vials of lorazepam in an unlocked refrigerator).

The findings included:

During an interview and observation with LPN C on 4/7/2021 at 5:40 AM, 3 medication cups with pills in them and one cup with pills and a vial in it were observed on a bedside table near a wall in the hallway outside the nurses station, approximately 15 feet from where LPN C was sitting. There were no other staff present. The cups were labeled with room numbers. LPN C said she prepared those morning medications for patients, but was observed sitting at the desk when surveyors approached at approximately 5:40 AM. LPN C stated one of the pills, Xanax, was a controlled substance and showed that was in the cup labeled 107. The pills were still in their packaging (photographic evidence obtained). While discussing the medications observed, LPN C went to the desk and brought a Ziplock type bag with loose pills that she claimed she pulled out of patient #5's tissue box. This bag was found to contain 9 Xanax and 1 Tylenol PM. (photographic evidence obtained)

On 4/7/2021 at approximately 6:00am, an observation was made in the Medication Room on the medical-surgical unit with LPN C. The medication refrigerator was observed with an unlocked padlock. The refrigerator was opened and observed to have an affixed drawer containing 15 vials of lorazepam (a controlled substance) and the drawer was observed to be unlocked.

Policy PH-10 with a most recent review date of 7/27/2009 listed "All drug storage areas within this hospital will be inspected at least monthly by the pharmacist. The purpose is to ensure proper storage of medications.

Policy PH-12 with a most recent review date of 7/27/2009 indicated that all drugs stored in this hospital shall be accessible only to authorized personnel. 1. All drugs, except those intended for crash cart use, will be stored in lockable containers or areas. 2. Controlled drugs will be double locked at all times prior to use (see Controlled Drug Distribution policy).
VIOLATION: UNUSABLE DRUGS NOT USED Tag No: A0505
Based on observation, staff interview, and policy review, the hospital failed to ensure outdated or otherwise unusable drugs were not available for patient use in the emergency department (5 sampled medications).

The findings included:

On 4/5/2021 at approximately 11:00 AM, an observation of the emergency department medication storage room took place with registered nurse (RN) I, the shift charge nurse in the emergency room . During the observation, a bag filled with 12 plastic vials labeled as Tussinex (a controlled substance) with an expiration date of 3/18/21 was observed in the narcotic locker hanging on the wall and RN I said that should get discarded. There was no other Tussinex in the narcotic locker. A label on the bag indicated "Use these LAST, use other bag first." (photographic evidence obtained)

A previously opened 20ml single dose (not labeled for multi-patient use) vial of Potassium Chloride was observed on top of the medication cart with "3/19" written in black marker. RN I said they had to use single dose vials for multidose because until recently, they didn't have the pre-packaged bags of potassium. Observations inside the medication refrigerator in the emergency room medication storage area revealed an open vial of diltiazem hydrochloride injection (cardiac medication) 5/mg/ml concentration labeled for single use, opened and labeled in black ink "03/21/2021," There was a 2nd open vial of diltiazem labeled for single use with an open date of 2/25/2021 and a discard date of 3/25/2021 written in black ink, and an expired NovoLog insulin pen was observed with a preprinted expiration date of 03/2021 and written in black marker 3/17/2021.

The previous Pharmacist QQ had resigned and was unavailable for interview. The newly hired Pharmacist Q started on 03/01/2021. On 4/7/21 at 3:37 PM, during an interview was conducted with newly hired Pharmacist Q who reported that when she walked in the door, "it was a disaster. I had to come in and organize everything and get files in order". Pharmacist Q stated she goes out to the nursing units daily to see what they need. She stated that the previous pharmacist QQ would tell the nurses that drugs were on back order, when they were not. "He had no organization and had duplicate copies of invoices and hand written notes, things stuffed in his office and clutter in every corner." Pharmacist Q stated she was going through everything, organizing and was working on new processes.

Policy #PT-24 with most recent review date of 5/19/2009 titled "Unusable and Outdated drugs indicated "All discontinued patient drugs; contaminated drugs, improperly stored drugs and containers with worn, illegible or missing labels shall be returned to the Pharmacy Department for proper disposal. These drugs shall be stored in an isolated area in the pharmacy department that has been designated for the storage of such unusable drugs. The drugs shall remain there until they can be returned to the manufacturer or proper disposal or pick up can be made. The procedure described: All drug storage areas of the hospital will be inspected, including satellite pharmacies, surgery, night medication locker and other patient care areas.

Policy NADM-67 with an approval date of 12-16-2013 and no review date documented, titled QI audits for Medications, Supplies, and Biologicals listed in Procedure 1. "Each Nursing Department Supervisor and/or assigned personnel will continue to perform their weekly QI Audits for expired medications, supplies, and biologicals to ensure that these items are not available for patient use.

Policy PH-10 with a most recent review date of 7/27/2009 listed "All drug storage areas within this hospital will be inspected at least monthly by the pharmacist. The purpose is to ensure proper storage of medications.
VIOLATION: INFECTION CONTROL OFFICER(S) Tag No: A0748
Based on staff interviews, review of hospital organizational chart, review of governing body meeting minutes and review of a resignation letter from the former infection control nurse, the hospital failed to have a person appointed as the infection preventionist since January 29, 2021, during the Public Health Emergency Coronavirus Disease 2019 pandemic.

The findings included:

Review of a resignation letter signed by nurse RR on 12/21/2020 listed her titles as registered nurse, Risk Manager, Quality Improvement, Utilization Review, discharge planning, infection control, employee health, and Nursing Director. The letter identified reasons for leaving the hospital as "the lack of time needed to update policies related to infection control and nursing, not to mention the new 2020 hospital regulations." The letter identified her last working day as 1/29/2021.

An interview occurred on 4/5/2021 at 3:22 PM with Registered Nurse (RN) M who was formerly the Director of Nursing (DON) but resigned effective 3/26/2021 and offered to return to the hospital to assist with the survey. RN M said that she started working at the hospital February 1, 2021 and there has not been an infection control person. She said she informed administration several times there has to be an infection control person. She added as far as she knew, the position was not advertised. RN M said because there was not an infection control person designated, the Chief Financial Officer (CFO) directed a staff member from medical records to complete reports concerning healthcare associated infections.

On 4/8/2021 at 12:01 PM, during an interview related to the roles of staff in ensuring quality care at the hospital, the CFO said as far as infection control is concerned, that was nurse RR's job.

A review of the hospital organizational chart indicated there was no one identified in the role of infection control.

A review of the Governing Body meeting minutes from the December 2020, when the previous infection preventionist, RN RR resigned, through the most recent meeting of 4/9/2021 failed to locate the appointment of a new infection preventionist.