HospitalInspections.org

Based on interview and record review, the facility did not comply with all applicable laws when:
1) The facility did not have a functioning surgical service per Health and Safety Code 1250(a), and
2) The facility did not ensure the facility's Infection Control physician had training in Infection Control per Health and Safety Code (HSC) 1288.85. (Refer to A0023)
This had the potential for the facility to be unable to provide surgical services to patients in need of surgery and compromise adequate Infection Control surveillance, investigation, reporting and ultimately appropriate patient care.

Findings:

During a tour of the facility perioperative area on 4/19/19 at 1:45 p.m., no surgeries were occurring and no staff were present. The DON stated no surgeries were currently occurring at the facility.

During an interview on 4/17/19 at 4:50 p.m., Administrator A stated the surgery department had been losing money and anesthesia (group of physicians providing anesthesia during surgery) had, "quit us." He stated the facility had lost their anesthesia group.

Review of the facility surgery on-call list (dated April, 2019) indicated no surgeons and no anesthesiologists were on the schedule. A nurse anesthetist was on the schedule in lieu of a physician.

Review of facility policy and procedure titled, "Perioperative Services" (effective date 9/9/18) indicated, "An anesthesiologist must be personally responsible to each patient for provision of anesthesia care....A nurse anesthetist works under the guidance of a physician."

Review of facility document titled, "Medical Staff Medical Executive Meeting Minutes," subtitled, "VIII. New/Other Business" (dated 3/29/19) indicated, "...Anesthesia group not available due to staffing issues. Actively recruiting for anesthesiologists and surgeons."

Based on interviews and document review, the facility failed to have a functioning governing body to:
1. Ensure the medical staff requirements were met (Refer to A0044);
2. Appoint members of the medical staff after considering the recommendations of existing members of the medical staff (Refer to A0046);
3. Assure that the medical staff had bylaws (Refer to A0047);
4. Approve medical staff bylaws and other medical staff rules and regulations (Refer to A0048);
5. Ensure that the medical staff is accountable to the governing body for the quality of care provided to patients (Refer to A0049);
6. Ensure the criteria for medical staff selection are based on individual character, competence, training, experience and judgment (Refer to A0050);
7. Ensure that under no circumstances is the accordance of staff membership in the hospital dependent solely upon certification or membership in a specialty body or society (Refer to A0051);
8. Ensure that every Medicare patient was under the care of a doctor of medicine or osteopathy, doctor of dental surgery or medicine, doctor of podiatric medicine, doctor of optometry, chiropractor, or clinical psychologist (Refer to A0064);
9. Ensure that patients are admitted to the hospital only on the recommendation of a licensed practitioner (Refer to A0065);
10. Ensure a physician is on duty or on-call at all times (Refer to A0067);
11. Ensure a physician is responsible for the care of each Medicare patient with respect to any medical or psychiatric problem (Refer to A0068);
12. Ensure that the contracted vendors for services furnished complied with all applicable Conditions of Participation (Refer to A0083);
13. Ensure that the services performed under contract were provided in a safe, effective manner (Refer to A0084); and
14. Ensure that the medical staff had written policies and procedures for appraisal of emergencies, initial treatment, and referral (Refer to A0093).

The cumulative effect of this systemic problem resulted in a lack of oversight of medical staff, patient care and hospital services.

Based on staff interviews and facility document review, the facility failed to maintain an ongoing QAPI (Quality Assessment and Performance Improvement) program when:

1) The facility implemented a new practice where medical/surgical nurses (not ICU trained nurses) administered Dopamine (medication to treat hypotension, low cardiac output, poor perfusion of vital organs) and Cardizem (medication to control rapid heartbeats or abnormal heart rhythms) intravenously (given to a patient via catheter inserted into a vein). IV Dopamine and IV Cardizem had previously been administered in the ICU by trained ICU nurses. Licensed Nurse (LN) F, LN G, LN H, LN P, and LN Q did not receive formal education or training and did not have documented competencies that verified they possessed the skills to safely administer these medications (Refer to A283);

2) The facility implemented a new practice where Respiratory Therapists (RT's) would intubate (place a breathing tube from the mouth into the lungs) patients in the event of an emergency (this procedure had previously been performed by a physician). The facility RT's did not have documented competencies that verified the RT's possessed all needed skills, identified in the facility policy and procedure, to safely perform this procedure (Refer to A283); and

3) The Quality Management Committee did not meet for over six months and did not evaluate the implementation/effectiveness of these two new practices (Refer to A273).

The cumulative effect of these systemic issues resulted in the facility's inability to ensure the provision of quality health care in a safe environment.

Based on interviews and document review, the facility failed to ensure:
1. The medical staff was organized in a manner approved by the Governing Body and accountable to it for the quality of medical care provided to patients. (Refer to A0347);
2. The medical staff adopted and enforced its bylaws (Refer to A0353);
3. The medical staff bylaws were approved by the Governing Body (Refer to A0354).

The cumulative effect of this systemic problem resulted in a lack of current medical staff governance structure and oversight by a Governing Body.

Based on staff interview and credentialing file review, the facility failed to ensure the facility's Infection Control physician had training in Infection Control per Health and Safety Code (HSC) 1288.85. This had the potential to compromise adequate Infection Control surveillance, investigation, reporting and ultimately appropriate patient care.

Findings:

During a a concurrent interview and credentialing file review on 4/24/19 at 11 a.m., Management Staff K stated: "He's [Physician N] the Chair" of the Infection Control Committee. Upon review of his credentialing file, Management Staff K stated Physician N did not have any infection control continuing education training documented in his credentialing file. At this same interview, Management Staff K presented the "most current" "Medical Staff Committees" organization chart. It indicated Physician N was the Chair of the "Lab/Infection Prevention Committee."

Review of HSC 1288.85 indicated: "(a) No later than January 1, 2010, a physician designated as a hospital epidemiologist or infection surveillance, prevention, and control committee chairperson shall participate in a continuing medical education (CME) training program offered by the federal Centers for Disease Control and Prevention (CDC) and the Society for Healthcare Epidemiologists of America, or other recognized professional organization. The CME program shall be specific to infection surveillance, prevention, and control. Documentation of attendance shall be placed in the physician's credentialing file."

Based on interviews and document review, the facility failed to have a functioning Governing Body to ensure the medical staff requirements were met. This resulted in a lack of medical staff oversight.

Findings:

During an interview on 4/15/19 at 10:30 a.m., Administrator A stated the facility was currently using the Medical Executive Committee (MEC) in lieu of a Governing Body. He stated there was no Governing Body at the facility at this time.

During an interview on 4/15/19 at 4:07 p.m., Manager B stated the MEC was serving as the hospital's Governing Body and reporting directly to the District Board as opposed to the hospital's Governing Body because there had been no Governing Body meetings since the facility contracted with the current management company on 9/9/18.

During an interview on 4/16/19 at 3 p.m. the President of the community's "District" Board (DBP) was asked several questions about the District Board (DB) and its relationship to the hospital and the hospital's Governing Body. When asked what the District's role or function was as it related to the hospital, the DBP stated it functioned as "an umbrella" in its oversight and that its role was "in a very shallow manner." He stated the District Board did not manage the hospital. When asked if the DB evaluated the medical staff and the care they provide to patients, the DBP stated the medical staff report to the hospital's Governing Body who then reports to the District Board. When asked if the DB had a role in medical staff appointments and selection, the DBP stated, "We do not." When asked if the DB had a role in ensuring the selection criteria for medical staff include individual character, competence, training, experience, and judgment, the DBP stated, "We do not," adding that it was the hospital who had the role in medical staff credentialing. When asked if the DB had a role in the creation, evaluation and enforcement of medical staff bylaws, the DBP stated, "No." When asked if members of the newly contracted management company attend any Governing Body or MEC meetings, the DBP stated, "No." When asked if members of the MEC report directly to the DB, the DBP stated they report to the hospital's Governing Body, not directly to the DB. When asked if the DB meets regularly with the MEC or the Chief of Staff, the DBP stated, "No." When asked if the DB appointed a hospital Chief Executive Officer (CEO), the DBP stated they approved the new management company who then appointed the CEO. When asked if the DB has a role in ensuring all patients are admitted under the care of a physician, dentist, podiatrist, optomotrist, chiropractor or psychologist and that physicians are on duty or on-call at all times, the DBP stated it was the management company's role to ensure quality. When asked if the DB had a role in ensuring all contracted services were provided in compliance with the Medicare Conditions of Participation and in a safe, effective manner, the DBP stated it was the role of the management company to deal with the hospital contracts. When asked if the DB had a role in ensuring the medical staff had policies and procedures related to appraisal of emergencies, initial treatment and referrals when appropriate, the DBP stated it was the role of the management company to develop policies and procedures. When asked why there had not been any hospital Governing Body meetings since August 2018, the DBP stated "it took a while to develop the Governing Body."

During an interview on 4/17/19 at 8:25 a.m., DB Member M was asked when the hospital's Governing Body last met. She stated they had not met since September 2018 "due to changes in management." When asked if the hospital had any Governing Body Bylaws, DB Member M stated they were "still in red-line format." When asked if the MEC was functioning as the hospital's Governing Body, she stated the committee reports to the hospital's Governing Body.

During an interview on 4/17/19 at 4:42 p.m., Administrator A was asked if the hospital had a Governing Body. He stated the hospital "moved to move MEC as the Governing Body."

During an interview on 4/18/9 at 3:12 p.m., Physician C was shown the "Medical Staff Bylaws (Draft) 2019." She confirmed they were still in draft form stating, "Yes they very much are." When asked if the Bylaws had been approved by the hospital's Governing Body, Physician C stated they had not.

During an interview on 4/24/19 at 2:45 p.m., Administrator A was asked about the approval process for policies and procedures. He stated the hospital policies and procedures had not been approved by the hospital Governing Body since a quorum of members could not be established, therefore it could not function. He added that the Medical Executive Committee and other administrative staff [Administrator A, the DON, Administrator I, and Administrator J] had been approving policies and procedures.

During a concurrent interview on 4/24/19 at 11 a.m., and document review of the most current "Hospital Committee Structure" organizational chart supplied by Management Staff K, Managment Staff K stated this organizational chart was the most recent. It indicated the hospital Governing Body was at the top of the chart with the Medical Executive Committee directly reporting to it.

During an interview on 4/24/19 at 11:43 a.m., and concurrent document review of the "Special Governing Body Meeting Minutes," dated 4/23/19, Administrative Staff L stated, "It's the first one [Governing Body meeting] we have had" [with the current management team]. Also presented during this interview was an undated hospital organizational chart which indicated the District Board was at the top of the chart with the MEC directly reporting to it. Also presented was "[DB] Governing Body Bylaws Adopted (followed by several dates)...Amended 4/23/19--DRAFT--Need approval of the Medical Executive Committee and District Board."

Review of the "Hospital Committee Structure" organizational chart attached to the December 2018 agenda (no minutes) for the "Quality Council" (no specific date given), indicated the "Governing Body via Medical Executive Committee" was as the top of the chart.

Review of the hospital's Governing Body minutes indicated the last Governing Body meeting under the prior management company was held on August 6, 2018. The first and only Governing Body meeting under the new management company was held on April 23, 2019.

Review of the hospital's undated "Medical Staff Rules and Regulations indicated: "Adopted in accordance with the Medical Staff Bylaws to which these rules and regulations are attached." There were no medical staff bylaws attached to the rules and regulations.

Based on interviews and document review, the facility failed to have a functioning Governing Body to provide for the appointment of medical staff members. This resulted in a lack of oversight regarding the medical staff appointment process.

Findings:

During an interview on 4/15/19 at 10:30 a.m., Administrator A stated the facility was currently using the Medical Executive Committee (MEC) in lieu of a Governing Body. He stated there was no Governing Body at the facility at this time.

During an interview on 4/15/19 at 4:07 p.m., Manager B stated the MEC was serving as the hospital's Governing Body and reporting directly to the District board as opposed to the hospital's Governing Body because there had been no Governing Body meetings since the facility contracted with the current management company on 9/9/18.

During an interview on 4/16/19 at 3 p.m. the President of the community's "District" Board (DBP) was asked several questions about the District Board (DB) and its relationship to the hospital and the hospital's Governing Body. When asked what the District's role or function was as it related to the hospital, the DBP stated it functioned as "an umbrella" in its oversight and that its role was "in a very shallow manner." He stated the District Board did not manage the hospital. When asked if the DB had a role in medical staff appointments and selection, the DBP stated, "We do not." When asked why there had not been any hospital Governing Body meetings since August 2018, the DBP stated "it took a while to develop the Governing Body."

During an interview on 4/17/19 at 8:25 a.m., DB Member M was asked when the hospital's Governing Body last met. She stated they had not met since September 2018 "due to changes in management." When asked if the MEC was functioning as the hospital's Governing Body, she stated the committee reports to the hospital's Governing Body.

During an interview on 4/17/19 at 4:42 p.m., Administrator A was asked if the hospital had a Governing Body. He stated the hospital "moved to move MEC as the Governing Body."

During an interview on 4/24/19 at 2:45 p.m., Administrator A was asked about the approval process for policies and procedures. He stated the hospital policies and procedures had not been approved by the hospital Governing Body since a quorum of members could not be established, therefore it could not function. He added that the Medical Executive Committee and other administrative staff [Administrator A, the DON, Administrator I, and Administrator J] had been approving policies and procedures.

During a concurrent interview on 4/24/19 at 11 a.m., and document review of the most current "Hospital Committee Structure" organizational chart supplied by Management Staff K, Management Staff K stated this organizational chart was the most recent. It indicated the hospital Governing Body was at the top of the chart with the Medical Executive Committee directly reporting to it.

During an interview on 4/24/19 at 11:43 a.m., and concurrent document review of the "Special Governing Body Meeting Minutes," dated 4/23/19, Administrative Staff L stated, "It's the first one [Governing Body meeting] we have had" [with the current management team]. Also presented during this interview was an undated hospital organizational chart which indicated the District Board was at the top of the chart with the MEC directly reporting to it. Also presented was "[DB] Governing Body Bylaws Adopted (followed by several dates)...Amended 4/23/19--DRAFT--Need approval of the Medical Executive Committee and District Board."

Review of the "Hospital Committee Structure" organizational chart attached to the December 2018 agenda (no minutes) for the "Quality Council" (no specific date given), indicated the "Governing Body via Medical Executive Committee" was as the top of the chart.

Review of the hospital's Governing Body minutes indicated the last Governing Body meeting under the prior management company was held on August 6, 2018. The first and only Governing Body meeting under the new management company was held on April 23, 2019.

Based on interviews and document review, the facility failed to have a functioning Governing Body to ensure the medical staff had bylaws. This resulted in medical staff operating without bylaws.

Findings:

During an interview on 4/15/19 at 10:30 a.m., Administrator A stated the facility was currently using the Medical Executive Committee (MEC) in lieu of a Governing Body. He stated there was no Governing Body at the facility at this time.

During an interview on 4/15/19 at 4:07 p.m., Manager B stated the MEC was serving as the hospital's Governing Body and reporting directly to the District board as opposed to the hospital's Governing Body because there had been no Governing Body meetings since the facility contracted with the current management company on 9/9/18.

During an interview on 4/16/19 at 3 p.m. the President of the community's "District" Board (DBP) was asked several questions about the District Board (DB) and its relationship to the hospital and the hospital's Governing Body. When asked what the District's role or function was as it related to the hospital, the DBP stated it functioned as "an umbrella" in its oversight and that its role was "in a very shallow manner." He stated the District Board did not manage the hospital. When asked if the DB had a role in the creation, evaluation and enforcement of medical staff bylaws, the DBP stated, "No." When asked why there had not been any hospital Governing Body meetings since August 2018, the DBP stated "it took a while to develop the Governing Body."

During an interview on 4/17/19 at 8:25 a.m., DB Member M was asked when the hospital's Governing Body last met. She stated they had not met since September 2018 "due to changes in management." When asked if the hospital had any Governing Body Bylaws, DB Member M stated they were "still in red-line format." When asked if the MEC was functioning as the hospital's Governing Body, she stated the committee reports to the hospital's Governing Body.

During an interview on 4/17/19 at 4:42 p.m., Administrator A was asked if the hospital had a Governing Body. He stated the hospital "moved to move MEC as the Governing Body."

During an interview on 4/18/9 at 3:12 p.m., Physician C was shown the "Medical Staff Bylaws (Draft) 2019." She confirmed they were still in draft form stating, "Yes they very much are." When asked if the Bylaws had been approved by the hospital's Governing Body, Physician C stated they had not.

During an interview on 4/24/19 at 2:45 p.m., Administrator A was asked about the approval process for policies and procedures. He stated the hospital policies and procedures had not been approved by the hospital Governing Body since a quorum of members could not be established, therefore it could not function. He added that the Medical Executive Committee and other administrative staff [Administrator A, the DON, Administrator I, and Administrator J] had been approving policies and procedures.

During a concurrent interview on 4/24/19 at 11 a.m., and document review of the most current "Hospital Committee Structure" organizational chart supplied by Management Staff K, Managment Staff K stated this organizational chart was the most recent. It indicated the hospital Governing Body was at the top of the chart with the Medical Executive Committee directly reporting to it.

During an interview on 4/24/19 at 11:43 a.m., and concurrent document review of the "Special Governing Body Meeting Minutes," dated 4/23/19, Administrative Staff L stated, "It's the first one [Governing Body meeting] we have had" [with the current management team]. Also presented during this interview was an undated hospital organizational chart which indicated the District Board was at the top of the chart with the MEC directly reporting to it. Also presented was "[DB] Governing Body Bylaws Adopted (followed by several dates)...Amended 4/23/19--DRAFT--Need approval of the Medical Executive Committee and District Board."

Review of the "Hospital Committee Structure" organizational chart attached to the December 2018 agenda (no minutes) for the "Quality Council" (no specific date given), indicated the "Governing Body via Medical Executive Committee" was as the top of the chart.

Review of the hospital's Governing Body minutes indicated the last Governing Body meeting under the prior management company was held on August 6, 2018. The first and only Governing Body meeting under the new management company was held on April 23, 2019.

Based on interviews and document review, the facility failed to have a functioning Governing Body to approve medical staff bylaws and rules and regulations. This resulted in the failure of medical staff to operate under the guidance of current bylaws and rules and regulations.

Findings:

During an interview on 4/15/19 at 10:30 a.m., Administrator A stated the facility was currently using the Medical Executive Committee (MEC) in lieu of a Governing Body. He stated there was no Governing Body at the facility at this time.

During an interview on 4/15/19 at 4:07 p.m., Manager B stated the MEC was serving as the hospital's Governing Body and reporting directly to the District board as opposed to the hospital's Governing Body because there had been no Governing Body meetings since the facility contracted with the current management company on 9/9/18.

During an interview on 4/16/19 at 3 p.m. the President of the community's "District" Board (DBP) was asked several questions about the District Board (DB) and its relationship to the hospital and the hospital's Governing Body. When asked what the District's role or function was as it related to the hospital, the DBP stated it functioned as "an umbrella" in its oversight and that its role was "in a very shallow manner." He stated the District Board did not manage the hospital. When asked if the DB had a role in the creation, evaluation and enforcement of medical staff bylaws or rules and regulations, the DBP stated, "No." When asked why there had not been any hospital Governing Body meetings since August 2018, the DBP stated "it took a while to develop the Governing Body."

During an interview on 4/17/19 at 8:25 a.m., DB Member M was asked when the hospital's Governing Body last met. She stated they had not met since September 2018 "due to changes in management." When asked if the hospital had any Governing Body Bylaws, DB Member M stated they were "still in red-line format." When asked if the MEC was functioning as the hospital's Governing Body, she stated the committee reports to the hospital's Governing Body.

During an interview on 4/17/19 at 4:42 p.m., Administrator A was asked if the hospital had a Governing Body. He stated the hospital "moved to move MEC as the Governing Body."

During an interview on 4/18/9 at 3:12 p.m., Physician C was shown the "Medical Staff Bylaws (Draft) 2019." She confirmed they were still in draft form stating, "Yes they very much are." When asked if the Bylaws had been approved by the hospital's Governing Body, Physician C stated they had not.

During an interview on 4/24/19 at 2:45 p.m., Administrator A was asked about the approval process for policies and procedures. He stated the hospital policies and procedures had not been approved by the hospital Governing Body since a quorum of members could not be established, therefore it could not function. He added that the Medical Executive Committee and other administrative staff [Administrator A, the DON, Administrator I, and Administrator J] had been approving policies and procedures.

During a concurrent interview on 4/24/19 at 11 a.m., and document review of the most current "Hospital Committee Structure" organizational chart supplied by Management Staff K, Managment Staff K stated this organizational chart was the most recent. It indicated the hospital Governing Body was at the top of the chart with the Medical Executive Committee directly reporting to it.

During an interview on 4/24/19 at 11:43 a.m., and concurrent document review of the "Special Governing Body Meeting Minutes," dated 4/23/19, Administrative Staff L stated, "It's the first one [Governing Body meeting] we have had" [with the current management team]. Also presented during this interview was an undated hospital organizational chart which indicated the District Board was at the top of the chart with the MEC directly reporting to it. Also presented was "[DB] Governing Body Bylaws Adopted (followed by several dates)...Amended 4/23/19--DRAFT--Need approval of the Medical Executive Committee and District Board."

Review of the "Hospital Committee Structure" organizational chart attached to the December 2018 agenda (no minutes) for the "Quality Council" (no specific date given), indicated the "Governing Body via Medical Executive Committee" was as the top of the chart.

Review of the hospital's Governing Body minutes indicated the last Governing Body meeting under the prior management company was held on August 6, 2018. The first and only Governing Body meeting under the new management company was held on April 23, 2019.

Review of the hospital's undated "Medical Staff Rules and Regulations indicated: "Adopted in accordance with the Medical Staff Bylaws to which these rules and regulations are attached." There were no medical staff bylaws attached to the rules and regulations.

Based on interviews and document review, the facility failed to have a functioning Governing Body to ensure the medical staff was accountable to the Governing Body for the quality of patient care. This resulted in a lack of medical staff oversight.

Findings:

During an interview on 4/15/19 at 10:30 a.m., Administrator A stated the facility was currently using the Medical Executive Committee (MEC) in lieu of a Governing Body. He stated there was no Governing Body at the facility at this time.

During an interview on 4/15/19 at 4:07 p.m., Manager B stated the MEC was serving as the hospital's Governing Body and reporting directly to the District board as opposed to the hospital's Governing Body because there had been no Governing Body meetings since the facility contracted with the current management company on 9/9/18.

During an interview on 4/16/19 at 3 p.m. the President of the community's "District" Board (DBP) was asked several questions about the District Board (DB) and its relationship to the hospital and the hospital's Governing Body. When asked what the District's role or function was as it related to the hospital, the DBP stated it functioned as "an umbrella" in its oversight and that its role was "in a very shallow manner." He stated the District Board did not manage the hospital. When asked why there had not been any hospital Governing Body meetings since August 2018, the DBP stated "it took a while to develop the Governing Body."

During an interview on 4/17/19 at 8:25 a.m., DB Member M was asked when the hospital's Governing Body last met. She stated they had not met since September 2018 "due to changes in management." When asked if the hospital had any Governing Body Bylaws, DB Member M stated they were "still in red-line format." When asked if the MEC was functioning as the hospital's Governing Body, she stated the committee reports to the hospital's Governing Body.

During an interview on 4/17/19 at 4:42 p.m., Administrator A was asked if the hospital had a Governing Body. He stated the hospital "moved to move MEC as the Governing Body."

During an interview on 4/24/19 at 2:45 p.m., Administrator A was asked about the approval process for policies and procedures. He stated the hospital policies and procedures had not been approved by the hospital Governing Body since a quorum of members could not be established, therefore it could not function. He added that the Medical Executive Committee and other administrative staff [Administrator A, the DON, Administrator I, and Administrator J] had been approving policies and procedures.

During a concurrent interview on 4/24/19 at 11 a.m., and document review of the most current "Hospital Committee Structure" organizational chart supplied by Management Staff K, Management Staff K stated this organizational chart was the most recent. It indicated the hospital Governing Body was at the top of the chart with the Medical Executive Committee directly reporting to it.

During an interview on 4/24/19 at 11:43 a.m., and concurrent document review of the "Special Governing Body Meeting Minutes," dated 4/23/19, Administrative Staff L stated, "It's the first one [Governing Body meeting] we have had" [with the current management team]. Also presented during this interview was an undated hospital organizational chart which indicated the District Board was at the top of the chart with the MEC directly reporting to it. Also presented was "[DB] Governing Body Bylaws Adopted (followed by several dates)...Amended 4/23/19--DRAFT--Need approval of the Medical Executive Committee and District Board."

Review of the "Hospital Committee Structure" organizational chart attached to the December 2018 agenda (no minutes) for the "Quality Council" (no specific date given), indicated the "Governing Body via Medical Executive Committee" was as the top of the chart.

Review of the hospital's Governing Body minutes indicated the last Governing Body meeting under the prior management company was held on August 6, 2018. The first and only Governing Body meeting under the new management company was held on April 23, 2019.

Based on interviews and document review, the facility failed to have a functioning Governing Body to ensure the medical staff selection criteria was based on individual character, competence, training, experience and judgement. This resulted in a lack of oversight of the medical staff selection process.

Findings:

During an interview on 4/15/19 at 10:30 a.m., Administrator A stated the facility was currently using the Medical Executive Committee (MEC) in lieu of a Governing Body. He stated there was no Governing Body at the facility at this time.

During an interview on 4/15/19 at 4:07 p.m., Manager B stated the MEC was serving as the hospital's Governing Body and reporting directly to the District board as opposed to the hospital's Governing Body because there had been no Governing Body meetings since the facility contracted with the current management company on 9/9/18.

During an interview on 4/16/19 at 3 p.m. the President of the community's "District" Board (DBP) was asked several questions about the District Board (DB) and its relationship to the hospital and the hospital's Governing Body. When asked what the District's role or function was as it related to the hospital, the DBP stated it functioned as "an umbrella" in its oversight and that its role was "in a very shallow manner." He stated the District Board did not manage the hospital. When asked if the DB had a role in ensuring the selection criteria for medical staff include individual character, competence, training, experience, and judgment, the DBP stated, "We do not," adding that it was the hospital who had the role in medical staff credentialing. When asked why there had not been any hospital Governing Body meetings since August 2018, the DBP stated "it took a while to develop the Governing Body."

During an interview on 4/17/19 at 8:25 a.m., DB Member M was asked when the hospital's Governing Body last met. She stated they had not met since September 2018 "due to changes in management." When asked if the hospital had any Governing Body Bylaws, DB Member M stated they were "still in red-line format." When asked if the MEC was functioning as the hospital's Governing Body, she stated the committee reports to the hospital's Governing Body.

During an interview on 4/17/19 at 4:42 p.m., Administrator A was asked if the hospital had a Governing Body. He stated the hospital "moved to move MEC as the Governing Body."

During an interview on 4/24/19 at 2:45 p.m., Administrator A was asked about the approval process for policies and procedures. He stated the hospital policies and procedures had not been approved by the hospital Governing Body since a quorum of members could not be established, therefore it could not function. He added that the Medical Executive Committee and other administrative staff [Administrator A, the DON, Administrator I, and Administrator J] had been approving policies and procedures.

During a concurrent interview on 4/24/19 at 11 a.m., and document review of the most current "Hospital Committee Structure" organizational chart supplied by Management Staff K, Managment Staff K stated this organizational chart was the most recent. It indicated the hospital Governing Body was at the top of the chart with the Medical Executive Committee directly reporting to it.

During an interview on 4/24/19 at 11:43 a.m., and concurrent document review of the "Special Governing Body Meeting Minutes," dated 4/23/19, Administrative Staff L stated, "It's the first one [Governing Body meeting] we have had" [with the current management team]. Also presented during this interview was an undated hospital organizational chart which indicated the District Board was at the top of the chart with the MEC directly reporting to it. Also presented was "[DB] Governing Body Bylaws Adopted (followed by several dates)...Amended 4/23/19--DRAFT--Need approval of the Medical Executive Committee and District Board."

Review of the "Hospital Committee Structure" organizational chart attached to the December 2018 agenda (no minutes) for the "Quality Council" (no specific date given), indicated the "Governing Body via Medical Executive Committee" was as the top of the chart.

Review of the hospital's Governing Body minutes indicated the last Governing Body meeting under the prior management company was held on August 6, 2018. The first and only Governing Body meeting under the new management company was held on April 23, 2019.

Based on interviews and document review, the facility failed to have a functioning Governing Body to ensure medical staff appointments were not granted solely on the basis of certification or membership in a specialty body or organization. This resulted in a lack of oversight of the medical staff credentialing process.

Findings:

During an interview on 4/15/19 at 10:30 a.m., Administrator A stated the facility was currently using the Medical Executive Committee (MEC) in lieu of a Governing Body. He stated there was no Governing Body at the facility at this time.

During an interview on 4/15/19 at 4:07 p.m., Manager B stated the MEC was serving as the hospital's Governing Body and reporting directly to the District board as opposed to the hospital's Governing Body because there had been no Governing Body meetings since the facility contracted with the current management company on 9/9/18.

During an interview on 4/16/19 at 3 p.m. the President of the community's "District" Board (DBP) was asked several questions about the District Board (DB) and its relationship to the hospital and the hospital's Governing Body. When asked what the District's role or function was as it related to the hospital, the DBP stated it functioned as "an umbrella" in its oversight and that its role was "in a very shallow manner." He stated the District Board did not manage the hospital. When asked if the DB had a role in medical staff appointments and selection, the DBP stated, "We do not." When asked why there had not been any hospital Governing Body meetings since August 2018, the DBP stated "it took a while to develop the Governing Body."

During an interview on 4/17/19 at 8:25 a.m., DB Member M was asked when the hospital's Governing Body last met. She stated they had not met since September 2018 "due to changes in management." When asked if the hospital had any Governing Body Bylaws, DB Member M stated they were "still in red-line format." When asked if the MEC was functioning as the hospital's Governing Body, she stated the committee reports to the hospital's Governing Body.

During an interview on 4/17/19 at 4:42 p.m., Administrator A was asked if the hospital had a Governing Body. He stated the hospital "moved to move MEC as the Governing Body."

During an interview on 4/24/19 at 2:45 p.m., Administrator A was asked about the approval process for policies and procedures. He stated the hospital policies and procedures had not been approved by the hospital Governing Body since a quorum of members could not be established, therefore it could not function. He added that the Medical Executive Committee and other administrative staff [Administrator A, the DON, Administrator I, and Administrator J] had been approving policies and procedures.

During a concurrent interview on 4/24/19 at 11 a.m., and document review of the most current "Hospital Committee Structure" organizational chart supplied by Management Staff K, Managment Staff K stated this organizational chart was the most recent. It indicated the hospital Governing Body was at the top of the chart with the Medical Executive Committee directly reporting to it.

During an interview on 4/24/19 at 11:43 a.m., and concurrent document review of the "Special Governing Body Meeting Minutes," dated 4/23/19, Administrative Staff L stated, "It's the first one [Governing Body meeting] we have had" [with the current management team]. Also presented during this interview was an undated hospital organizational chart which indicated the District Board was at the top of the chart with the MEC directly reporting to it. Also presented was "[DB] Governing Body Bylaws Adopted (followed by several dates)...Amended 4/23/19--DRAFT--Need approval of the Medical Executive Committee and District Board."

Review of the "Hospital Committee Structure" organizational chart attached to the December 2018 agenda (no minutes) for the "Quality Council" (no specific date given), indicated the "Governing Body via Medical Executive Committee" was as the top of the chart.

Review of the hospital's Governing Body minutes indicated the last Governing Body meeting under the prior management company was held on August 6, 2018. The first and only Governing Body meeting under the new management company was held on April 23, 2019.

Based on interviews and document review, the facility failed to have a functioning Governing Body to ensure that every Medicare patient was under the care of a Doctor of Medicine or Osteopathy, Doctor of Dental Surgery or Medicine, Doctor of Podiatric Medicine, Doctor of Optometry, Chiropractor, or Clinical Psychologist. This resulted in a lack of medical staff oversight regarding patient care.

Findings:

During an interview on 4/15/19 at 10:30 a.m., Administrator A stated the facility was currently using the Medical Executive Committee (MEC) in lieu of a Governing Body. He stated there was no Governing Body at the facility at this time.

During an interview on 4/15/19 at 4:07 p.m., Manager B stated the MEC was serving as the hospital's Governing Body and reporting directly to the District board as opposed to the hospital's Governing Body because there had been no Governing Body meetings since the facility contracted with the current management company on 9/9/18.

During an interview on 4/16/19 at 3 p.m. the President of the community's "District" Board (DBP) was asked several questions about the District Board (DB) and its relationship to the hospital and the hospital's Governing Body. When asked what the District's role or function was as it related to the hospital, the DBP stated it functioned as "an umbrella" in its oversight and that its role was "in a very shallow manner." He stated the District Board did not manage the hospital. When asked if the DB has a role in ensuring all patients are admitted under the care of a physician, dentist, podiatrist, optomotrist, chiropractor or psychologist, the DBP stated it was the management company's role to ensure quality. When asked why there had not been any hospital Governing Body meetings since August 2018, the DBP stated "it took a while to develop the Governing Body."

During an interview on 4/17/19 at 8:25 a.m., DB Member M was asked when the hospital's Governing Body last met. She stated they had not met since September 2018 "due to changes in management." When asked if the hospital had any Governing Body Bylaws, DB Member M stated they were "still in red-line format." When asked if the MEC was functioning as the hospital's Governing Body, she stated the committee reports to the hospital's Governing Body.

During an interview on 4/17/19 at 4:42 p.m., Administrator A was asked if the hospital had a Governing Body. He stated the hospital "moved to move MEC as the Governing Body."

During an interview on 4/24/19 at 2:45 p.m., Administrator A was asked about the approval process for policies and procedures. He stated the hospital policies and procedures had not been approved by the hospital Governing Body since a quorum of members could not be established, therefore it could not function. He added that the Medical Executive Committee and other administrative staff [Administrator A, the DON, Administrator I, and Administrator J] had been approving policies and procedures.

During a concurrent interview on 4/24/19 at 11 a.m., and document review of the most current "Hospital Committee Structure" organizational chart supplied by Management Staff K, Managment Staff K stated this organizational chart was the most recent. It indicated the hospital Governing Body was at the top of the chart with the Medical Executive Committee directly reporting to it.

During an interview on 4/24/19 at 11:43 a.m., and concurrent document review of the "Special Governing Body Meeting Minutes," dated 4/23/19, Administrative Staff L stated, "It's the first one [Governing Body meeting] we have had" [with the current management team]. Also presented during this interview was an undated hospital organizational chart which indicated the District Board was at the top of the chart with the MEC directly reporting to it. Also presented was "[DB] Governing Body Bylaws Adopted (followed by several dates)...Amended 4/23/19--DRAFT--Need approval of the Medical Executive Committee and District Board."

Review of the "Hospital Committee Structure" organizational chart attached to the December 2018 agenda (no minutes) for the "Quality Council" (no specific date given), indicated the "Governing Body via Medical Executive Committee" was as the top of the chart.

Review of the hospital's Governing Body minutes indicated the last Governing Body meeting under the prior management company was held on August 6, 2018. The first and only Governing Body meeting under the new management company was held on April 23, 2019.

Based on interviews and document review, the facility failed to have a functioning Governing Body to ensure that admitted patients were under the care of a licensed practitioner. the hospital the medical staff requirements were met. This resulted in a lack of medical staff oversight regarding patient care.

Findings:

During an interview on 4/15/19 at 10:30 a.m., Administrator A stated the facility was currently using the Medical Executive Committee (MEC) in lieu of a Governing Body. He stated there was no Governing Body at the facility at this time.

During an interview on 4/15/19 at 4:07 p.m., Manager B stated the MEC was serving as the hospital's Governing Body and reporting directly to the District board as opposed to the hospital's Governing Body because there had been no Governing Body meetings since the facility contracted with the current management company on 9/9/18.

During an interview on 4/16/19 at 3 p.m. the President of the community's "District" Board (DBP) was asked several questions about the District Board (DB) and its relationship to the hospital and the hospital's Governing Body. When asked what the District's role or function was as it related to the hospital, the DBP stated it functioned as "an umbrella" in its oversight and that its role was "in a very shallow manner." He stated the District Board did not manage the hospital. When asked if the DB has a role in ensuring all patients are admitted to the hospital under the care of a licensed practitioner, the DBP stated it was the management company's role to ensure quality. When asked why there had not been any hospital Governing Body meetings since August 2018, the DBP stated "it took a while to develop the Governing Body."

During an interview on 4/17/19 at 8:25 a.m., DB Member M was asked when the hospital's Governing Body last met. She stated they had not met since September 2018 "due to changes in management." When asked if the hospital had any Governing Body Bylaws, DB Member M stated they were "still in red-line format." When asked if the MEC was functioning as the hospital's Governing Body, she stated the committee reports to the hospital's Governing Body.

During an interview on 4/17/19 at 4:42 p.m., Administrator A was asked if the hospital had a Governing Body. He stated the hospital "moved to move MEC as the Governing Body."

During an interview on 4/24/19 at 2:45 p.m., Administrator A was asked about the approval process for policies and procedures. He stated the hospital policies and procedures had not been approved by the hospital Governing Body since a quorum of members could not be established, therefore it could not function. He added that the Medical Executive Committee and other administrative staff [Administrator A, the DON, Administrator I, and Administrator J] had been approving policies and procedures.

During a concurrent interview on 4/24/19 at 11 a.m., and document review of the most current "Hospital Committee Structure" organizational chart supplied by Management Staff K, Management Staff K stated this organizational chart was the most recent. It indicated the hospital Governing Body was at the top of the chart with the Medical Executive Committee directly reporting to it.

During an interview on 4/24/19 at 11:43 a.m., and concurrent document review of the "Special Governing Body Meeting Minutes," dated 4/23/19, Administrative Staff L stated, "It's the first one [Governing Body meeting] we have had" [with the current management team]. Also presented during this interview was an undated hospital organizational chart which indicated the District Board was at the top of the chart with the MEC directly reporting to it. Also presented was "[DB] Governing Body Bylaws Adopted (followed by several dates)...Amended 4/23/19--DRAFT--Need approval of the Medical Executive Committee and District Board."

Review of the "Hospital Committee Structure" organizational chart attached to the December 2018 agenda (no minutes) for the "Quality Council" (no specific date given), indicated the "Governing Body via Medical Executive Committee" was as the top of the chart.

Review of the hospital's Governing Body minutes indicated the last Governing Body meeting under the prior management company was held on August 6, 2018. The first and only Governing Body meeting under the new management company was held on April 23, 2019.

Based on interviews and document review, the facility failed to have a functioning Governing Body to ensure a physician was on duty or on-call at all times. This resulted in a lack of medical staff oversight.

Findings:

During an interview on 4/15/19 at 10:30 a.m., Administrator A stated the facility was currently using the Medical Executive Committee (MEC) in lieu of a Governing Body. He stated there was no Governing Body at the facility at this time.

During an interview on 4/15/19 at 4:07 p.m., Manager B stated the MEC was serving as the hospital's Governing Body and reporting directly to the District board as opposed to the hospital's Governing Body because there had been no Governing Body meetings since the facility contracted with the current management company on 9/9/18.

During an interview on 4/16/19 at 3 p.m. the President of the community's "District" Board (DBP) was asked several questions about the District Board (DB) and its relationship to the hospital and the hospital's Governing Body. When asked what the District's role or function was as it related to the hospital, the DBP stated it functioned as "an umbrella" in its oversight and that its role was "in a very shallow manner." He stated the District Board did not manage the hospital. When asked if the DB has a role in ensuring a physician was on duty or on-call at all times, the DBP stated it was the management company's role to ensure quality. When asked why there had not been any hospital Governing Body meetings since August 2018, the DBP stated "it took a while to develop the Governing Body."

During an interview on 4/17/19 at 8:25 a.m., DB Member M was asked when the hospital's Governing Body last met. She stated they had not met since September 2018 "due to changes in management." When asked if the hospital had any Governing Body Bylaws, DB Member M stated they were "still in red-line format." When asked if the MEC was functioning as the hospital's Governing Body, she stated the committee reports to the hospital's Governing Body.

During an interview on 4/17/19 at 4:42 p.m., Administrator A was asked if the hospital had a Governing Body. He stated the hospital "moved to move MEC as the Governing Body."

During an interview on 4/24/19 at 2:45 p.m., Administrator A was asked about the approval process for policies and procedures. He stated the hospital policies and procedures had not been approved by the hospital Governing Body since a quorum of members could not be established, therefore it could not function. He added that the Medical Executive Committee and other administrative staff [Administrator A, the DON, Administrator I, and Administrator J] had been approving policies and procedures.

During a concurrent interview on 4/24/19 at 11 a.m., and document review of the most current "Hospital Committee Structure" organizational chart supplied by Management Staff K, Managment Staff K stated this organizational chart was the most recent. It indicated the hospital Governing Body was at the top of the chart with the Medical Executive Committee directly reporting to it.

During an interview on 4/24/19 at 11:43 a.m., and concurrent document review of the "Special Governing Body Meeting Minutes," dated 4/23/19, Administrative Staff L stated, "It's the first one [Governing Body meeting] we have had" [with the current management team]. Also presented during this interview was an undated hospital organizational chart which indicated the District Board was at the top of the chart with the MEC directly reporting to it. Also presented was "[DB] Governing Body Bylaws Adopted (followed by several dates)...Amended 4/23/19--DRAFT--Need approval of the Medical Executive Committee and District Board."

Review of the "Hospital Committee Structure" organizational chart attached to the December 2018 agenda (no minutes) for the "Quality Council" (no specific date given), indicated the "Governing Body via Medical Executive Committee" was as the top of the chart.

Review of the hospital's Governing Body minutes indicated the last Governing Body meeting under the prior management company was held on August 6, 2018. The first and only Governing Body meeting under the new management company was held on April 23, 2019.

Based on interviews and document review, the facility failed to have a functioning Governing Body to ensure that a physician was responsible for the care of all Medicare patients with medical or psychiatric problems. This resulted in a lack of medical staff oversight regarding patient care.

Findings:

During an interview on 4/15/19 at 10:30 a.m., Administrator A stated the facility was currently using the Medical Executive Committee (MEC) in lieu of a Governing Body. He stated there was no Governing Body at the facility at this time.

During an interview on 4/15/19 at 4:07 p.m., Manager B stated the MEC was serving as the hospital's Governing Body and reporting directly to the District board as opposed to the hospital's Governing Body because there had been no Governing Body meetings since the facility contracted with the current management company on 9/9/18.

During an interview on 4/16/19 at 3 p.m. the President of the community's "District" Board (DBP) was asked several questions about the District Board (DB) and its relationship to the hospital and the hospital's Governing Body. When asked what the District's role or function was as it related to the hospital, the DBP stated it functioned as "an umbrella" in its oversight and that its role was "in a very shallow manner." He stated the District Board did not manage the hospital. When asked why there had not been any hospital Governing Body meetings since August 2018, the DBP stated "it took a while to develop the Governing Body."

During an interview on 4/17/19 at 8:25 a.m., DB Member M was asked when the hospital's Governing Body last met. She stated they had not met since September 2018 "due to changes in management." When asked if the hospital had any Governing Body Bylaws, DB Member M stated they were "still in red-line format." When asked if the MEC was functioning as the hospital's Governing Body, she stated the committee reports to the hospital's Governing Body.

During an interview on 4/17/19 at 4:42 p.m., Administrator A was asked if the hospital had a Governing Body. He stated the hospital "moved to move MEC as the Governing Body."

During an interview on 4/24/19 at 2:45 p.m., Administrator A was asked about the approval process for policies and procedures. He stated the hospital policies and procedures had not been approved by the hospital Governing Body since a quorum of members could not be established, therefore it could not function. He added that the Medical Executive Committee and other administrative staff [Administrator A, the DON, Administrator I, and Administrator J] had been approving policies and procedures.

During a concurrent interview on 4/24/19 at 11 a.m., and document review of the most current "Hospital Committee Structure" organizational chart supplied by Management Staff K, Management Staff K stated this organizational chart was the most recent. It indicated the hospital Governing Body was at the top of the chart with the Medical Executive Committee directly reporting to it.

During an interview on 4/24/19 at 11:43 a.m., and concurrent document review of the "Special Governing Body Meeting Minutes," dated 4/23/19, Administrative Staff L stated, "It's the first one [Governing Body meeting] we have had" [with the current management team]. Also presented during this interview was an undated hospital organizational chart which indicated the District Board was at the top of the chart with the MEC directly reporting to it. Also presented was "[DB] Governing Body Bylaws Adopted (followed by several dates)...Amended 4/23/19--DRAFT--Need approval of the Medical Executive Committee and District Board."

Review of the "Hospital Committee Structure" organizational chart attached to the December 2018 agenda (no minutes) for the "Quality Council" (no specific date given), indicated the "Governing Body via Medical Executive Committee" was as the top of the chart.

Review of the hospital's Governing Body minutes indicated the last Governing Body meeting under the prior management company was held on August 6, 2018. The first and only Governing Body meeting under the new management company was held on April 23, 2019.

Based on interviews and document review, the facility failed to have a functioning Governing Body to ensure that all in-house and contracted services were provided in compliance with Medicare Conditions of Participation. This resulted in a lack of oversight of hospital services.

Findings:

During an interview on 4/15/19 at 10:30 a.m., Administrator A stated the facility was currently using the Medical Executive Committee (MEC) in lieu of a Governing Body. He stated there was no Governing Body at the facility at this time.

During an interview on 4/15/19 at 4:07 p.m., Manager B stated the MEC was serving as the hospital's Governing Body and reporting directly to the District board as opposed to the hospital's Governing Body because there had been no Governing Body meetings since the facility contracted with the current management company on 9/9/18.

During an interview on 4/16/19 at 3 p.m. the President of the community's "District" Board (DBP) was asked several questions about the District Board (DB) and its relationship to the hospital and the hospital's Governing Body. When asked what the District's role or function was as it related to the hospital, the DBP stated it functioned as "an umbrella" in its oversight and that its role was "in a very shallow manner." He stated the District Board did not manage the hospital. When asked if the DB had a role in ensuring all contracted services were provided in compliance with the Medicare Conditions of Participation and in a safe, effective manner, the DBP stated it was the role of the management company to deal with the hospital contracts. When asked why there had not been any hospital Governing Body meetings since August 2018, the DBP stated "it took a while to develop the Governing Body."

During an interview on 4/17/19 at 8:25 a.m., DB Member M was asked when the hospital's Governing Body last met. She stated they had not met since September 2018 "due to changes in management." When asked if the hospital had any Governing Body Bylaws, DB Member M stated they were "still in red-line format." When asked if the MEC was functioning as the hospital's Governing Body, she stated the committee reports to the hospital's Governing Body.

During an interview on 4/17/19 at 4:42 p.m., Administrator A was asked if the hospital had a Governing Body. He stated the hospital "moved to move MEC as the Governing Body."

During an interview on 4/24/19 at 2:45 p.m., Administrator A was asked about the approval process for policies and procedures. He stated the hospital policies and procedures had not been approved by the hospital Governing Body since a quorum of members could not be established, therefore it could not function. He added that the Medical Executive Committee and other administrative staff [Administrator A, the DON, Administrator I, and Administrator J] had been approving policies and procedures.

During a concurrent interview on 4/24/19 at 11 a.m., and document review of the most current "Hospital Committee Structure" organizational chart supplied by Management Staff K, Managment Staff K stated this organizational chart was the most recent. It indicated the hospital Governing Body was at the top of the chart with the Medical Executive Committee directly reporting to it.

During an interview on 4/24/19 at 11:43 a.m., and concurrent document review of the "Special Governing Body Meeting Minutes," dated 4/23/19, Administrative Staff L stated, "It's the first one [Governing Body meeting] we have had" [with the current management team]. Also presented during this interview was an undated hospital organizational chart which indicated the District Board was at the top of the chart with the MEC directly reporting to it. Also presented was "[DB] Governing Body Bylaws Adopted (followed by several dates)...Amended 4/23/19--DRAFT--Need approval of the Medical Executive Committee and District Board."

Review of the "Hospital Committee Structure" organizational chart attached to the December 2018 agenda (no minutes) for the "Quality Council" (no specific date given), indicated the "Governing Body via Medical Executive Committee" was as the top of the chart.

Review of the hospital's Governing Body minutes indicated the last Governing Body meeting under the prior management company was held on August 6, 2018. The first and only Governing Body meeting under the new management company was held on April 23, 2019.

Based on interviews and document review, the facility failed to have a functioning Governing Body to ensure that hospital services were provided in a safe and effective manner. This resulted in a lack of oversight of hospital services.

Findings:

During an interview on 4/15/19 at 10:30 a.m., Administrator A stated the facility was currently using the Medical Executive Committee (MEC) in lieu of a Governing Body. He stated there was no Governing Body at the facility at this time.

During an interview on 4/15/19 at 4:07 p.m., Manager B stated the MEC was serving as the hospital's Governing Body and reporting directly to the District board as opposed to the hospital's Governing Body because there had been no Governing Body meetings since the facility contracted with the current management company on 9/9/18.

During an interview on 4/16/19 at 3 p.m. the President of the community's "District" Board (DBP) was asked several questions about the District Board (DB) and its relationship to the hospital and the hospital's Governing Body. When asked what the District's role or function was as it related to the hospital, the DBP stated it functioned as "an umbrella" in its oversight and that its role was "in a very shallow manner." He stated the District Board did not manage the hospital. When asked if the DB had a role in ensuring all contracted services were provided in compliance with the Medicare Conditions of Participation and in a safe, effective manner, the DBP stated it was the role of the management company to deal with the hospital contracts. When asked why there had not been any hospital Governing Body meetings since August 2018, the DBP stated "it took a while to develop the Governing Body."

During an interview on 4/17/19 at 8:25 a.m., DB Member M was asked when the hospital's Governing Body last met. She stated they had not met since September 2018 "due to changes in management." When asked if the hospital had any Governing Body Bylaws, DB Member M stated they were "still in red-line format." When asked if the MEC was functioning as the hospital's Governing Body, she stated the committee reports to the hospital's Governing Body.

During an interview on 4/17/19 at 4:42 p.m., Administrator A was asked if the hospital had a Governing Body. He stated the hospital "moved to move MEC as the Governing Body."

During an interview on 4/24/19 at 2:45 p.m., Administrator A was asked about the approval process for policies and procedures. He stated the hospital policies and procedures had not been approved by the hospital Governing Body since a quorum of members could not be established, therefore it could not function. He added that the Medical Executive Committee and other administrative staff [Administrator A, the DON, Administrator I, and Administrator J] had been approving policies and procedures.

During a concurrent interview on 4/24/19 at 11 a.m., and document review of the most current "Hospital Committee Structure" organizational chart supplied by Management Staff K, Managment Staff K stated this organizational chart was the most recent. It indicated the hospital Governing Body was at the top of the chart with the Medical Executive Committee directly reporting to it.

During an interview on 4/24/19 at 11:43 a.m., and concurrent document review of the "Special Governing Body Meeting Minutes," dated 4/23/19, Administrative Staff L stated, "It's the first one [Governing Body meeting] we have had" [with the current management team]. Also presented during this interview was an undated hospital organizational chart which indicated the District Board was at the top of the chart with the MEC directly reporting to it. Also presented was "[DB] Governing Body Bylaws Adopted (followed by several dates)...Amended 4/23/19--DRAFT--Need approval of the Medical Executive Committee and District Board."

Review of the "Hospital Committee Structure" organizational chart attached to the December 2018 agenda (no minutes) for the "Quality Council" (no specific date given), indicated the "Governing Body via Medical Executive Committee" was as the top of the chart.

Review of the hospital's Governing Body minutes indicated the last Governing Body meeting under the prior management company was held on August 6, 2018. The first and only Governing Body meeting under the new management company was held on April 23, 2019.

Based on interviews and document review, the facility failed to, 1) Have a functioning Governing Body to ensure the medical staff had written policies and procedures related to the appraisal of emergencies, initial treatment, and referral and 2) Ensure trained ICU (intensive care unit) nurses were consistently on the staffing schedule and available to work. This failure resulted in a lack of medical staff oversight and had the potential to inadequately treat patients in the event of an emergency and caused potential for inadequate staffing of the ICU in the event a patient became unstable (while on the medical/surgical unit) and needed emergent care in the ICU.

Findings:

1) During an interview on 4/15/19 at 10:30 a.m., Administrator A stated the facility was currently using the Medical Executive Committee (MEC) in lieu of a Governing Body. He stated there was no Governing Body at the facility at this time.

During an interview on 4/15/19 at 4:07 p.m., Manager B stated the MEC was serving as the hospital's Governing Body and reporting directly to the District board as opposed to the hospital's Governing Body because there had been no Governing Body meetings since the facility contracted with the current management company on 9/9/18.

During an interview on 4/16/19 at 3 p.m. the President of the community's "District" Board (DBP) was asked several questions about the District Board (DB) and its relationship to the hospital and the hospital's Governing Body. When asked what the District's role or function was as it related to the hospital, the DBP stated it functioned as "an umbrella" in its oversight and that its role was "in a very shallow manner." He stated the District Board did not manage the hospital. When asked if the DB had a role in ensuring the medical staff had policies and procedures related to appraisal of emergencies, initial treatment and referrals when appropriate, the DBP stated it was the role of the management company to develop policies and procedures. When asked why there had not been any hospital Governing Body meetings since August 2018, the DBP stated "it took a while to develop the Governing Body."

During an interview on 4/17/19 at 8:25 a.m., DB Member M was asked when the hospital's Governing Body last met. She stated they had not met since September 2018 "due to changes in management." When asked if the hospital had any Governing Body Bylaws, DB Member M stated they were "still in red-line format." When asked if the MEC was functioning as the hospital's Governing Body, she stated the committee reports to the hospital's Governing Body.

During an interview on 4/17/19 at 4:42 p.m., Administrator A was asked if the hospital had a Governing Body. He stated the hospital "moved to move MEC as the Governing Body."

During an interview on 4/24/19 at 2:45 p.m., Administrator A was asked about the approval process for policies and procedures. He stated the hospital policies and procedures had not been approved by the hospital Governing Body since a quorum of members could not be established, therefore it could not function. He added that the Medical Executive Committee and other administrative staff [Administrator A, the DON, Administrator I, and Administrator J] had been approving policies and procedures.

During a concurrent interview on 4/24/19 at 11 a.m., and document review of the most current "Hospital Committee Structure" organizational chart supplied by Management Staff K, Managment Staff K stated this organizational chart was the most recent. It indicated the hospital Governing Body was at the top of the chart with the Medical Executive Committee directly reporting to it.

During an interview on 4/24/19 at 11:43 a.m., and concurrent document review of the "Special Governing Body Meeting Minutes," dated 4/23/19, Administrative Staff L stated, "It's the first one [Governing Body meeting] we have had" [with the current management team]. Also presented during this interview was an undated hospital organizational chart which indicated the District Board was at the top of the chart with the MEC directly reporting to it. Also presented was "[DB] Governing Body Bylaws Adopted (followed by several dates)...Amended 4/23/19--DRAFT--Need approval of the Medical Executive Committee and District Board."

Review of the "Hospital Committee Structure" organizational chart attached to the December 2018 agenda (no minutes) for the "Quality Council" (no specific date given), indicated the "Governing Body via Medical Executive Committee" was as the top of the chart.

Review of the hospital's Governing Body minutes indicated the last Governing Body meeting under the prior management company was held on August 6, 2018. The first and only Governing Body meeting under the new management company was held on April 23, 2019.


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2) Review of the facility licensed nurse scheduled titled, "Long Term Acute Care Department Schedule" (dated February 24 through April 6, 2019) indicated no trained ICU nurses were on the schedule (and available to work in the ICU) approximately thirty-eight day shifts and approximately 14 night shifts during that timeframe.

During a tour of the medical/surgical unit (med/surg) unit on 4/16/19 at 8:30 a.m., Licensed Nurse H (LN H) stated she and LN T were working on the unit. She stated she and LN T were not ICU trained nurses. She stated the ICU had been closed since September, 2018. When asked what she would do if a patient Coded (cardiac or respiratory arrest requiring a team of providers to rush to the patient and begin immediate resuscitative efforts) and became too unstable to remain on the med/surg unit, she stated they would transfer the patient out (to another hospital). She stated the ICU was not up and running.

During a tour of the Intensive Care Unit (ICU) and concurrent interview on 4/16/19 at 11:05 a.m., the ICU had no patients and no staff. The DON stated the ICU was still open and the expectation (of the facility) was that it was, "ready to go" (if a patient needed ICU care). At 11:30 a.m., the DON was asked what would happen if a patient crashed (physical decline) and became too unstable for the med/surg floor. The DON stated the plan was to have an experienced ICU nurse provide 1:1 (one patient to one nurse) patient care on the medical/surgical floor (rather than transfer them to the ICU).

During an interview on 4/16/19 at 3 p.m., the District Board President was asked about the status of the ICU. He stated the ICU was available now and had an on-call staff.

During an interview on 4/16/19 at 4:55 p.m., LN T stated he was not an ICU trained nurse. When asked what he would do if a patient Coded, he stated he would call a physician. When asked what he would do if a patient needed to transferred to the ICU, he stated he would call the physician and the doctor would decide whether to transfer the patient to the ICU or to another level of care (another hospital).

During an interview on 4/17/19 at 1:15 p.m., Physician U stated the ICU was not ready now. He stated the facility would not keep unstable patients. When asked what would happen if a patient became unstable and need an arterial line (specialized monitoring via a catheter in an artery), he stated the facility would send them out (to another hospital).

During an interview on 4/18/19 at 1:30 p.m., Physician D was asked about the status of the ICU. Physician D stated the hospital currently had very few patients and the interim plan (while the census was low) was to have a single patient in a room with 1:1 staffing (one nurse to one patient).

During an interview on 4/17/19 at 8:30 a.m., District Board Member M was asked about the status of the ICU. She stated the ICU was,"ready to go" but she was unsure how the facility scheduled (the nurses). District Board Member M was shown the licensed nurse schedule titled, "Long Term Acute Care Department Schedule" (dated February 24 through April 6, 2019), that had shifts not covered by ICU trained nurses highlighted in yellow (approximately thirty-eight day shifts and approximately 14 night shifts). She stated she was unaware so many shifts were not covered by ICU nurses.

Review of facility document titled, "Medical Staff Medical Executive Meeting Minutes," subtitled, "VIII. New/Other Business" (dated 3/29/19) indicated, "ICU will be staffed in the future and is completely ready for use."

During an interview on 4/16/19 at 4 p.m., Manager B stated the facility did not have a policy and procedure addressing staffing in the ICU.

Based on staff interviews, and facility document review, the facility failed to maintain an ongoing QAPI (Quality Assessment and Performance Improvement) program when the Quality Management Committee did not meet for over six months. This failure had the potential to result in the facility's inability to ensure the provision of quality health care in a safe environment when registered nurses, who were not ICU trained, administered IV Cardizem (medication to treat abnormal heart rate) and IV Dopamine (medication to treat hypotension and poor perfusion of vital organs ) without having documented competencies (skill required to perform job function) to safely give those medications and respiratory therapists did not have documentation of all required competencies regarding intubating (placing a tube from the mouth into the lung for breathing) patients.

Findings:

During an interview on 4/16/19 at 5 p.m., Manager B stated the QAPI committee had not met in 2019. When asked if it had been approximately six months since the last meeting (10/18), she stated, "yes."

During an interview on 4/17/19 at 12:20 p.m., LN F stated she was not an ICU trained nurse. She stated that nurses could administer pressors (Dopamine is a pressor; vasopressors are a powerful class of drugs that induce vasoconstriction [constriction of blood vessels] and thereby elevate arterial pressure) on the medical/surgical unit (versus the ICU) but could not titrate (make changes to the dose) them. She stated she had given Cardizem IV in the past. When asked how she was trained to administer this medication, she stated the prior DON had instructed her (while on the unit).

During an interview on 4/18/19 at 2:15 p.m., Pharmacist (Pharm) E stated IV Cardizem and IV Dopamine had previously been administered only in the ICU. When asked the reason for this, Pharm E stated it was for safety reasons. He stated his expectation for administering Cardizem IV and Dopamine IV on the med/surg unit were that they would be given by an ICU trained nurse, the MD would titrate the rate (not nurses, as done in the ICU), the patient would be monitored with telemetry (heart monitoring), Dopamine would be only for renal perfusion (lower dose) and nurse ratio would be 1:1 (one nurse to one patient).

Review of LN G, LN F, LN H, LN P and LN Q's (all non-ICU trained nurses who documented giving IV Dopamine or Cardizem) employee files on 4/24/19 at 3:10 p.m. indicated they had no documented competencies for giving IV Cardizem or IV Dopamine.

During review of the Daily Staffing on 2/14/19, Manager O confirmed LN G's patient assignment consisted of two patients when she administered IV Dopamine (not a 1:1 ratio).,

During an interview on 4/15/19 at 11:20 a.m., the Respirator Therapy Supervisor (RTS) stated he had approximately seven RT staff and Physician U had recently given them an instructive course on intubating patients. He stated the course was approximately one hour long and staff practiced intubation on a dummy (mannequin). He stated RT staff's intubation competency was verified on the mannequin, not a live patient, after the course. He stated this was a new practice at the facility and "normally," a pulmonary doctor, a hospitalist (physician in the hospital) or an anesthesiologist intubated patients, not RT's. The RTS stated this new model was based on a hospital in another town that allowed their RT's to intubate patients.
RTS was asked if any of his RT's had actually intubated a live patient (versus practice on a mannequin), and he stated, "I don't know."

Review of facility policy titled "Endotracheal-Intubation," subtitled, "Competency to Perform Intubations" (effective date 9/9/18) indicated, "...The RCP must complete a test demonstrating required knowledge and expertise in airway management to include the following: ...ii. Ability to describe the anatomical or other risk factors that may predict a difficult intubation, iii. Ability to formulate and verbalize an appropriate alternative plan, if initial attempts at intubation are unsuccessful, using the hospital's intubation algorithm..." Under subtitle, "Procedural skills:" the policy indicated, "The following minimum procedural skills must be demonstrated in the presence of the designated House Doctor/Pulmonary Director ...i. The successful (without complication) endotracheal intubation with an actual patient, if available, or if not available, with a mannequin, iii. The use of alternative methods of intubation, including use of the Laryngeal Mask Airway (LMA), and bronchoscopy guided intubations..."

During a policy review and concurrent interview on 4/24/19 at 4 p.m., Administrator A was asked to review the Endotracheal-Intubation policy and procedure (effective date 9/9/18). Administrator A confirmed the RT supervisor and RT staff competency checklists (dated 10/12/18) did not include verification of the required knowledge and expertise in airway management (listed in the policy above) or the minimum procedural skills (listed in the policy above) were not verified (documented) on the RT staff's competency checklists.

During an interview on 4/23/19 at 5 p.m., Administrator A reviewed the QAPI binder and confirmed QAPI minutes (verifying the meeting occurred) were documented for 10/2018 but no QAPI minutes were located for 12/2018. Administrator A reviewed the December, 2018 agenda and confirmed it did not contain agenda items related to IV Cardizem/Dopamine administration on the med/surg unit, RT intubation, or ICU staffing were not included in the agenda.

Review of facility policy titled Quality Management Plan (reviewed 4/2019) indicated, " The Quality Management Committee shall meet on at least a monthly basis..." The policy indicated, "The organizational program, established by the medical staff and interdisciplinary Quality management Committee, with support and approval from the Governing Body, shall have the responsibility for monitoring every aspect of patient care and service..." The policy indicated a goal of Quality Management was, "...systematically measures, assesses and improves its performance to achieve optimal patient health outcomes..." and, "...Fosters the safety of patients and the quality of care, treatment and services."

Based on staff interviews and facility document review, the facility failed to maintain an ongoing QAPI (Quality Assessment and Performance Improvement) program when:

1) The facility implemented a new practice where medical/surgical nurses (not ICU trained nurses) administered Dopamine (medication to treat hypotension, low cardiac output, and poor perfusion of vital organs) and Cardizem (medication to control rapid heartbeats or abnormal heart rhythms) intravenously (given to a patient via catheter inserved into a vein). IV Dopamine and IV Cardizem had previously been administered in the ICU by trained ICU nurses. Licensed Nurse (LN) F, LN G LN H, LN P, and LN Q did not receive formal education or training and did not have documented competencies that verified they possessed the skills to safely administer these medications; and

2) The facility implemented a new practice where Respiratory Therapists (RT's) would intubate (place a breathing tube into the lung, through the mouth) patients in the event of an emergency (this procedure had previously been performed by a physician). The facility RT's did not have documented competencies (required skills to perform a task) that verified the RT possessed all needed skills, identified in the facility policy and procedure, to safely perform the new procedure.

These failures had the potential to result in the delivery of unsafe patient care due to inadequate training of nursing and respiratory staff and potentially resulted in the facility's inability to ensure the provision of quality health care in a safe environment when these system changes were not monitored and evaluated.

Findings:

1) During a tour of the Intensive Care Unit (ICU) and concurrent interview on 4/16/19 at 11:05 a.m., the ICU had no patients and no staff. The DON stated the ICU was still open and the expectation (of the facility) was that it was, "ready to go" (if a patient needed ICU care). At 11:30 a.m., the DON was asked what would happen if a patient became too unstable for the medical/surgical unit. The DON stated the plan was to have an experienced ICU nurse provide 1:1 (one patient to one nurse) patient care on the medical/surgical Unit (rather than transfer them to the ICU).

During the same interview, the DON was asked if the facility had a policy and procedure regarding patient care whereby an ICU trained nurse provided 1:1 care to an ICU patient on the medical/surgical unit. The facility did not provide a policy and procedure.

Review of facility document titled, "(Hospital Name) and Patient Medication Administration for Current Visit" (dated 2/25/19) indicated Patient 3 (who was on the med/surg unit) received Cardizem IV from 2/21/19 through 2/24/19 (approximately three days). The document indicated Licensed Nurse F (LN F) administered Cardizem IV to Patient 3 on 2/23/19 at 6:52 p.m.

During an interview on 4/17/19 at 12:20 p.m., LN F stated she was not an ICU trained nurse. She stated that nurses could administer pressors (Dopamine is a pressor; vasopressors are a powerful class of drugs that induce vasoconstriction [constriction of blood vessels] and thereby elevate arterial pressure) on the medical/surgical unit (versus the ICU) but could not titrate (make changes to the dose) them. She stated she had given Cardizem IV in the past. When asked how she was trained to administer this medication, she stated the prior DON had instructed her (while on the unit).

During an interview on 4/18/19 at 2:15 p.m., Pharmacist (Pharm) E stated IV Cardizem and IV Dopamine had previously been administered only in the ICU. When asked the reason for this, Pharm E stated it was for safety reasons. He stated Cardizem and Dopamine could cause a patient's blood pressure to, "bottom out" (drop dangerously low). He stated he had an issue with nurses administering those medication on the med/surg unit. He stated it was not okay for non-ICU trained nurses to give Cardizem IV because they needed training. He stated a med/surg nurse might not know what to do in the event something went wrong. He stated his expectation for administering Cardizem IV and Dopamine IV on the med/surg unit were that they would be given by an ICU trained nurse, the MD would titrate the rate (not nurses, as done in the ICU), the patient would be monitored with telemetry (heart monitoring), Dopamine would be only for renal perfusion (lower dose) and nurse ratio would be 1:1 (one nurse to one patient).

During the same interview, Pharm E was informed LN F (who was not an ICU trained nurse) had administered IV Cardizem on the med/surg floor. He stated he was not okay with that.

During an interview on 4/18/19 at 9:30 a.m., Manager B was asked if the QAPI Committee addressed ICU medication (like IV Cardizem and IV Dopamine) being given on the med/surg unit (versus the ICU). She stated the facility had addressed it in the Education Committee.

Review of facility document titled, "Interdisciplinary Education Meeting" (dated January, February, and March 2019) did not include documentation that administration of IV Cardizem/Dopamine had been addressed.

During an interview on 4/18/19 at 3:05 p.m., Physician C was asked about the new practice of giving Cardizem IV and Dopamine IV on the med/surg unit. She stated Cardizem IV would be administered by an ICU trained nurse, nurse staffing would be 1:1, the patient would be monitored with telemetry, and the MD (not the nurse) would titrate dosing. Physician C was asked if the facility had a policy and procedure on this practice; the facility did not provide a policy and procedure.

Review of facility document titled, "(Hospital Name) Patient Medication Administration for Current Visit" (dated 2/17/19) indicated LN G documented she administered Dopamine IV on 2/14/19 at 1:09 p.m. to Patient 2.

During an interview on 4/19/19 at 5 p.m., LN G (who was not an ICU nurse) stated she had no prior experience administering IV Dopamine IV. She stated she was with LN S (who was an ICU nurse). LN G stated she and LN S checked with pharmacy to see if she was allowed to administer Dopamine IV on the med/surg unit prior to hanging the medication. LN G stated she hung the Dopamine with LN S. When asked what she would monitor for (side effects or adverse reactions) when administering IV Dopamine, she stated she did not remember. When asked what training she had received prior to administering Dopamine IV, she stated she would check the physician orders, check the protocol and policy for what was allowed (at the facility), and check the patient's urine output and blood pressure. She stated she and LN S looked up Dopamine (on the computer) and called the pharmacy (for information) prior to giving the medication. LN G stated she also looked up (researched) Dopamine IV at home, after she had administered the medication.

During review of the Daily Staffing on 2/14/19, Manager O confirmed LN G's patient assignment consisted of two patients (not 1:1 ratio) when she administered IV Dopamine Patient 2. Manager O confirmed LN G was not an ICU trained nurse and 1:1 staffing had not occurred.

Review of facility document titled, "(Hospital Name) Patient Medication Administration for Current Visit" (dated 2/17/19) indicated LN R documented she administered Dopamine IV on 2/14/19 at 11:12 a.m. Review of untitled facility document listing all ICU trained nurses (provided by Manager B) indicated LN R not on the list (and not an ICU trained nurse).

During and interview on 4/24/19 at 12 p.m., LN H stated medication like Cardizem and Dopamine IV were previously given in the ICU. LN H (who was not an ICU nurse) stated she had given Cardizem IV on the med/surg unit a couple of times. When asked what type of training she received prior to administering the medication, she stated the prior DON had provided teaching at the bedside (versus in a class). She stated she had a two patients assignment (not a 1:1 nurse/patient ratio) at the time she administered Iv Cardizem.

Review of facility document titled, "(Hospital Name) and Patient Medication Administration for Current Visit" (dated 2/25/19) indicated LN P and LN Q had administered IV Cardizem to Patient 3 on 2/23/19 and 2/24/19 respectively. Review of untitled facility document listing all ICU trained nurses indicated LN P and LN Q were not on the list (and not ICU trained nurses).

During an interview on 4/23/19 at 5 p.m., Administrator A was asked if med/surg nurses had been given formal training regarding administration of IV Cardizem and Dopamine and he stated, "no." He stated he was planning to conduct a class but he did not have the time. When asked about nurse staffing ratios when giving these medications, he stated two patients to one nurse (not 1:1 as required by Pharm E) was adequate and was based on an acuity tool.

Review of LN G, LN F, LN H, LN P and LN Q's (all non-ICU trained nurses) employee files on 4/24/19 at 3:10 p.m. indicated they had no documented competencies for giving IV Cardizem or IV Dopamine.

Review of facility document titled, "Diltiazem Hydrochloride (Cardizem) - diltiazem hydrochloride injection" (revised 11/2017) indicated Cardizem can cause hypotension (low blood pressure), asystole (heart stops beating), heart block. The document indicated infusions, "exceeding 24 hours...are not recommended." (Patient 3 was administered IV Cardizem over multiple days).

According to the American College of Cardiology, "major side effects" of Cardizem are hypotension (low blood pressure), heart block, and HF (heart failure). "Continuous IV therapy should not be administered for longer than 24 hours."
(https://www.acc.org/tools-and-practice-support/clinical-toolkits/atrial-fibrillation-afib/rate-rhythm-dosing-table/diltiazem)

Review of facility document titled, "Dopamine Hydrochloride and 5% Dextrose Injection, USP Aqueous solutions For Acute Correction Of Hemodynamics In shock States," subtitled, "Precautions," further subtitled, "General" (revised May 2014) indicated, "1. Monitoring - careful monitoring of the indices is necessary during dopamine HCL infusion...blood pressure, urine flow, and when possible, cardiac output and pulmonary wedge pressure." (Cardiac output and pulmonary wedge pressure require special monitoring provided in an ICU);
"6. Hypotension - At lower infusion rated (renal doses), if hypotension occurs, the infusion rate should be rapidly increased until adequate blood pressure is obtained. If hypotension persists, Dopamine HCL should be discontinued..."

Review of facility document titled, "Medical Staff Medical Executive Meeting Minutes," subtitled, "VIII. New/Other Business" (dated 3/29/19) indicated, "...Working on policies, specifically, drips (vasopressor medication) located on unit (med/surg) and cardiac medications given on unit with proper nursing education.

2) During an interview on 4/15/19 at 11:20 a.m., the Respiratory Therapy Supervisor (RTS) stated he had approximately seven RT staff and Physician U had recently given them an instructive course on intubating patients. He stated the course was approximately one hour long and staff practiced intubation on a dummy (mannequin). He stated RT staff's intubation competency was verified on the mannequin, not a live patient, after the course. He stated this was a new practice at the facility and "normally," a pulmonary doctor, a hospitalist (physician in the hospital) or an anesthesiologist intubated patients, not RT's. The RTS stated this new model was based on a hospital in another town that allowed their RT's to intubate patients.
RTS was asked if any of his RT's had actually intubated a live patient (versus practice on a mannequin), and he stated, "I don't know."

During an interview on 4/17/19 at 1:15 p.m., Physician U was asked about the new process where RT staff would intubate patients in the event of an emergency. Physician U stated having the RT staff intubate patients was new to him. He stated he had given a training in December to get RT staff familiar with the procedure. He stated the RT's had not intubated patients in the past. He stated the class was one to two hours long and RT staff practiced intubating a mannequin, but the mannequin was too stiff.

During an interview on 4/17/19 at 4 p.m., Respiratory Therapist (RT) V was asked to describe her role in a Code (patient experiences cardiac and/or respiratory arrest , requiring a team of providers to rush to the patient and begin immediate resuscitative efforts). RT V stated, "I would intubate" (the patient).When asked if she had intubated a patient before, she stated, "no" but stated she had observed physicians (perform the procedure) in the past. She stated she received a one to two hour training with Physician U (where the mannequin was used) and stated, "they are going to do more training," possibly in another facility.

During an interview on 4/18/19 at 10:40 a.m., the RT Supervisor (RTS) was questioned about RT staff training and readiness to intubate patients. He stated he was not aware if any of the RT's had intubated patients in the past but when the facility operating room opens (unknown date), the RT's would have an opportunity to observe a live intubation. He stated it was a concern (for him) that the RT's were intubating patients. When asked if the training process was written out, he state "no." He stated he would like to improve the scope of training to enhance experience prior to intubation.

During an interview on 4/19/19 at 4 p.m., the RT W stated he had not intubated a patient in the past (and he was an RT since 2002). He stated was trained by Physician U to intubate patients and he practiced a few times on a mannequin. He stated his competencies were verified at that time.

Review of facility policy titled "Endotracheal-Intubation," subtitled, "Competency to Perform Intubations" (effective date 9/9/18) indicated, "...The RCP must complete a test demonstrating required knowledge and expertise in airway management to include the following: ...ii. Ability to describe the anatomical or other risk factors that may predict a difficult intubation, iii. Ability to formulate and verbalize an appropriate alternative plan, if initial attempts at intubation are unsuccessful, using the hospital's intubation algorithm..." Under subtitle, "Procedural skills:" the policy indicated, "The following minimum procedural skills must be demonstrated in the presence of the designated House Doctor/Pulmonary Director ...i. The successful (without complication) endotracheal intubation with an actual patient, if available, or if not available, with a mannequin, iii. The use of alternative methods of intubation, including use of the Laryngeal Mask Airway (LMA), and bronchoscopy guided intubations..."

Review of the facility RT supervisor and staff RT's "Intubation Competency" checklists (dated 10/12/18) indicated the competency to perform intubations did not include verification of the required knowledge and expertise in airway management (listed in the policy above) or the
minimum procedural skills (listed in the policy above) were not verified (documented) on the RT staff's competency checklists.

During a policy review and concurrent interview on 4/24/19 at 4 p.m., Administrator A was asked to review the Endotracheal-Intubation policy and procedure (effective date 9/9/18). Administrator A confirmed the RT supervisor and RT staff competency checklists (dated 10/12/18) did not include verification of the required knowledge and expertise in airway management (listed in the policy above) or the minimum procedural skills (listed in the policy above) were not verified (documented) on the RT staff's competency checklists.

During an interview on 4/16/19 at 5 p.m., Manager B stated the QAPI committee had not met in 2019. When asked if it had been approximately six months since the last meeting (10/18), she stated, "yes."

During an interview on 4/23/19 at 5 p.m., Administrator A reviewed the QAPI binder and confirmed QAPI minutes (verifying the meeting occurred) were documented for 10/2018 but no QAPI minutes were located for 12/2018. Administrator A reviewed the December, 2018 agenda and confirmed it did not contain agenda items that addressed IV Cardizem/Dopamine administration on the med/surg unit or RT intubation.

Review of facility policy titled Quality Management Plan (reviewed 4/2019) indicated, " The Quality Management Committee shall meet on at least a monthly basis..." The policy indicated, "The organizational program, established by the medical staff and interdisciplinary Quality management Committee, with support and approval from the Governing Body, shall have the responsibility for monitoring every aspect of patient care and service..." The policy indicated a goal of Quality Management was, "...systematically measures, assesses and improves its performance to achieve optimal patient health outcomes..." and, "...Fosters the safety of patients and the quality of care, treatment and services."

Based on interviews and document review, the facility failed to ensure the medical staff was organized in a manner approved by the Governing Body and accountable to it for the quality of medical care provided to patients. This resulted in a lack of Governing Body oversight of the medical staff.

Findings:

During an interview on 4/15/19 at 10:30 a.m., Administrator A stated the facility was currently using the Medical Executive Committee (MEC) in lieu of a Governing Body. He stated there was no Governing Body at the facility at this time.

During an interview and concurrent document review on 4/18/9 at 3:12 p.m., Physician C was shown the "Medical Staff Bylaws (Draft) 2019." She confirmed they were still in draft form and stated: "Yes they very much are." When asked if the Bylaws had been approved by the hospital's Governing Body, Physician C stated they had not.

Review of the hospital's Governing Body minutes indicated the last Governing Body meeting under the prior management company was held on August 6, 2018. The first and only Governing Body meeting under the new management company was held on April 23, 2019.

Review of the hospital's "Medical Staff Bylaws (Draft) 2019," indicated they were in draft form and had not been approved by the facility's Governing Body.

Based on interviews and document review, the facility failed to ensure the medical staff adopted and enforced its bylaws. This resulted in the lack of a current governance structure.

Findings:

During an interview on 4/15/19 at 1:52 a.m., Manager B stated the facility came under new management effective 9/9/18.

During an interview and concurrent document review on 4/18/9 at 3:12 p.m., Physician C was shown the "Medical Staff Bylaws (Draft) 2019." She confirmed they were still in draft form and stated: "Yes they very much are." When asked if the Bylaws had been approved by the hospital's Governing Body, Physician C stated they had not.

Review of the hospital's "Medical Staff Bylaws (Draft) 2019," indicated they were in draft form and had not been approved by the facility's Governing Body.

Based on interviews and document review, the facility failed to ensure the medical staff bylaws were approved by the Governing Body. This resulted in a lack of Governing Body oversight of the medical staff and its governance structure.

Findings:

During an interview on 4/15/19 at 10:30 a.m., Administrator A stated the facility was currently using the Medical Executive Committee (MEC) in lieu of a Governing Body. He stated there was no Governing Body at the facility at this time.

During an interview on 4/15/19 at 1:52 p.m., Manager B stated the facility came under new management effective 9/9/18.

During an interview and concurrent document review on 4/18/9 at 3:12 p.m., Physician C was shown the "Medical Staff Bylaws (Draft) 2019." She confirmed they were still in draft form and stated: "Yes they very much are." When asked if the Bylaws had been approved by the hospital's Governing Body, Physician C stated they had not.

Review of the hospital's Governing Body minutes indicated the last Governing Body meeting under the prior management company was held on August 6, 2018. The first and only Governing Body meeting under the new management company was held on April 23, 2019.

Review of the hospital's "Medical Staff Bylaws (Draft) 2019," indicated they were in draft form and had not been approved by the facility's Governing Body.