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Based on document review and interview, it was determined that the Governing Body failed to effectively provide oversight of its Medical Staff services to assure the provision of quality care/services to the Hospital's patients. Therefore, the Condition of Participation 42 CFR 482.12, Governing Body, was not met. This has the potential to affect all inpatients and outpatients serviced by the Hospital.

Findings include:

1. The Board of Directors failed to ensure that the Medical Staff were accountable to the Board of Directors for the quality of care provided to patients. See A-0049

Based on document review and interview, it was determined for 3 of 3 patients (Pt #1, Pt #2, Pt #3) reviewed for quality of care, the Board of Directors failed to ensure that the Medical Staff was accountable to the Board of Directors for the quality of care provided to patients. This has the potential to affect all inpatients and outpatients serviced by the Hospital.

Findings include:

1. The Hospital's Quality Assurance and Performance Improvement Plan for fiscal year 2019 (the Hospital's fiscal year ending is June 30th- the Plan was approved by the Board of Directors, the President of the Medical Staff, and the Chief Executive Officer August of 2018) was reviewed on 3/13/19 at approximately 4:00 PM. On page seven, the Plan stated, "Medical Staff Leaders and Administrative Staff: 2. Develop a peer review process to ensure that all clinical professionals meet... that duties and responsibilities are performed in accordance with standards and expectations set forth by clinical leadership and are based on nationally recognized best practices... 4. Ensure that findings, conclusions, recommendations, and actions taken to improve the performance of clinical services are implemented or communicated to the appropriate responsible staff."

2. See A-286

3. See A-340

Based on document review and interview, it was determined that the Hospital failed to ensure adverse patient events were investigated and reported, in accordance with its Quality Assurance and Performance Improvement (QAPI) Plan. Therefore, the Condition of Participation 42 CFR 482.21, QAPI, was not met. This has the potential to affect all inpatients and outpatients serviced by the Hospital.

1. The Hospital failed to ensure adverse patient morbidity/mortality events were thoroughly investigated, tracked, trended, and evaluated to assure the safe provision of care and services, in accordance with its QAPI Plan. See A-286

Based on document review and interview, it was determined for 3 of 3 expired patients (Pt #1, Pt #2, Pt #3 reviewed for adverse events, the Hospital failed to ensure adverse patient morbidity/mortality events were thoroughly investigated, tracked, trended, and evaluated to assure the safe provision of care and services, in accordance with its Quality Assurance and Performance Improvement (QAPI) Plan. This has the potential to affect all inpatients and outpatients serviced by the Hospital.

Findings include:

1. The Hospital policy titled, "Incident Reporting" (reviewed by the Hospital 3/2019, with no changes related to the citation) was reviewed on 3/13/19 at approximately 11:00 AM. The policy stated, "Definitions: Incident is any happening which is not consistent with the routine operation of the hospital... It is everyone's responsibility to notify their supervisor immediately of any incident... for the safety of patients... An Incident Report must be completed by the person discovering the incident... as soon as possible but no later than the end of their current shift... To document incidents, track and trend variations from the standard of care...

2. The Hospital's Quality Assurance and Performance Improvement Plan for fiscal year 2019 (the Hospital's fiscal year ending is June 30th- the Plan was approved by the Board of Directors, the President of the Medical Staff, and the Chief Executive Officer on August of 2018) was reviewed on 3/13/19 at approximately 4:00 PM. On page six, the Plan stated, "4. Reviewing serious reportable events and root cause analyses; if appropriate, recommend corrective action."

3. Pt #1 Date of admission: 3/4/18 Date of death: 3/5/18. Pt #1's record was reviewed on 3/12/19-3/13/19.

a. According to Pt #1's record, Pt #1 presented to the Emergency Department (ED) on 3/4/18 at approximately 8:59 PM with the chief complaint (CC) of: Nausea, Vomiting, Diarrhea, dark stools, and brown emesis for four days. Pt #1 underwent laboratory, radiological testing, electrocardiogram (EKG), and medication administration. On 3/5/18 at 1:45 AM, Pt #1 was admitted to the Intensive Care Unit (ICU) with the diagnoses of Abdominal Pain and SIRS (Systemic Inflammatory Response Syndrome). According to Pt #1's record, ED physician (MD#5) stated, "Abdominal Pain ... Cramping .... Generalized ... Also has episodic chest pain ... No Pain Distress ... Respiratory Normal ... Cardiovascular Normal ..." Pt #1's record stated that MD#5 spoke with the Hospitalist (MD#2) on 3/5/18 at midnight and stated Pt #1 was admitted to ICU in stable condition.

b. On 3/5/19, the Hospitalist (MD#3's) "Admission History and Physical" note stated that: Pt #1 was seen at the bedside and "had already been intubated since 6 a.m. urgently by (Anesthesiologist - Anes #1) ... Admitting Diagnosis ... (Pt #1) has evidence of acute respiratory failure status post intubation and evidence of clear-cut sepsis per leukocytosis, tachycardia and severe metabolic acidosis with lactic acidosis as well as per (Pt #1's) elevated lactic acid on admission ... discussed with (physician at outlying Hospital) about patient's transport ... (land instead of air due to weather conditions)" MD#3 stated Pt #1's "surrogate decision-maker was spoke to, in person, about Pt #1's dismal prognosis and severity of (Pt #1's) condition."

c. On 3/5/18, MD#3's Discharge Summary/Death Note stated, Pt #1" ...I received a phone call from the ambulance crew at 10:30 AM, that the patient had already had five rounds of epinephrine per discussion with (ambulance member) ... 300 IV (intravenous) amiodarone, four shocks and also patient had Neo-Synephrine pacing. The code was called off at 10:30 AM ... The coroner per discussion with (ambulance member) will be contacted."

d. On 3/14/19 at approximately 10:05 AM, an interview was conducted with the Hospitalist (MD#2- on call 3/4/18 7:00 PM to 3/5/18 7:00 AM). MD#2 had reviewed the record of Pt #1 and recalled "some" information on Pt #1. "We (the Hospitalists) may have talked about (Pt #1), but I don't remember everything. I just remember the nurses calling me and giving them orders." MD#2 did not state whether or not he tried to come in to see Pt #1. MD#2 stated, "The ER doctor calls us (the Hospitalists) and tells us what's going on and writes the admission orders. If there is a change and they (the staff) feel we need to come in, I'll come in." MD#2 stated the Hospitalists have 24 hours to do the initial H&P, regardless of whether admitted to ICU or to Medical/Surgical.

e. The nurse who cared for Pt #1 was unavailable for interview.

f. On 3/14/19 at approximately 10:40 AM, an interview was conducted with the Intensive Care Unit (ICU) Registered Nurse (RN-E#10- present when Pt #1 was a patient and assisted with care). E#10 verbalized recollection of Pt #1. "I remember (Pt #1) vitals being stable through the night, feeling malaise, restless, and couldn't get comfortable. Then Pt #1 just went down (decreased blood pressure) requiring IV vasopressors (increases blood pressure and boluses (one time administration of fluid volumes). I was at the nurses' station and heard them (RN- E#11- another RN who was present the night Pt #1 was admitted- also unavailable for interview) call for help. They ended up transferring (Pt #1) (to an outlying Hospital) by ambulance. They couldn't do the helicopter because of the weight (Pt #1's weight)."

g. On 3/14/19 at approximately 1:00 PM, an interview was conducted with the Hospitalist (MD#3). MD#3 had reviewed the record of Pt #1 and stated recollection of the events (3/5/18). "(Anes#1) intubated (Pt #1) and I came in. I instructed the Social Worker to have the kids (of Pt #1) come in because (Pt #1) was so bad. The (Surrogate decision maker) still wanted treatment and wanted us to transfer (Pt #1 to an outlying Hospital), so we set that up. (Pt #1) died enroute. That didn't surprise me. (Pt #1) was really sick."

4. Internal documents related to Pt #1 were presented by the Hospital and reviewed on 3/15/19 at approximately 2:55 PM, with the Director of Quality Management (E#3).

a. An untitled document included a timeline of Pt #1's care, physician orders, and assessments from Pt #1's arrival at the ED (3/4/18 at 8:56 PM) until Pt #1's transfer to an outlying Hospital (3/5/18 at 10:00 AM).

b. An untitled, undated, and unsigned document, which contained Pt #1's name, account number and date of admission stated, "Have (MD#15) review medical record - appropriate time frame for transfer?...? What did nursing do to overcome the questionable process of night physician vs (versus) waiting for assistance to transfer?"

c. Another untitled, undated, and unsigned piece of paper which contained Pt #1's name, account number, and admission date of 3/4/18 stated, "(MD#15) reviewed medical record and agreed - the patient should have been transferred sooner, possible from the Emergency Department ... It was requested that (MD#16- Medical Director ED) to speak to (MD#5- ED physician) in (MD#5's) care of the patient ..." The untitled, undated, and unsigned piece of paper stated, "The conclusion is that... had the worst case-scenario outcome, succumbing inside an ambulance nearly 13.5 hours after seeking help. I highly recommend root-analysis of this case and rectification of the above behavioral traits, as soon as possible." An email, dated 3/15/18, stated MD#16 had reviewed the "evaluation and thoughts on the patient (Pt #1)."

d. An interview was conducted with E#3 during the review of the internal documentation. E#3 was unable to state when and/or who submitted the untitled, undated, unsigned documents (mentioned above). E#3 stated, "No, this was not discussed at any committees. It was informal and isn't documented anywhere else. I don't know of anything else having been done. No, a RCA (root cause analysis) wasn't done."

5. Pt #2 Date of admission: 3/31/18. Date of death: 4/2/18. Pt #2's record was reviewed on 3/13/19 at approximately 11:20 AM.

a. According to Pt #2's record, Pt #2 presented to the ED on 3/31/18 at approximately 5:05 PM, via ambulance, with the complaint of a ground level fall with hitting the head, left shoulder pain, and left hip pain. Pt #2 underwent radiological testing, computed tomography testing, laboratory testing, and had an electrocardiogram (heart tracing- results stated normal sinus rhythm with a 1st degree atrioventricular block; otherwise normal electrocardiogram). Pt #2 was admitted to observation status with diagnoses of Left Humeral Head Fracture, Left Forehead Hematoma, and Left Hip Fracture. The orthopedic surgeon (MD#1) was consulted.

b. On 4/1/18, MD#1's consultation note stated, "I recommend (Pt #2) continue the shoulder immobilizer for (Pt #2) left shoulder fracture. As far as (Pt #2) hip, I recommend that (Pt #2) undergo left hip hemiarthroplasty. This will allow (Pt #2) to weight bear as tolerated as soon as surgery is over ... (Pt #2) is on Pradaxa (a blood thinner). Will have (MD#4) see the patient for medical clearance and we will discuss this with anesthesia as well since (Pt #2) is on Pradaxa ..."

c. On 4/1/18, Hospitalist's (MD#4- no longer with the Hospital) History & Physical documentation stated, "Complicating this hospitalization is a new diagnosis of a primary lung cancer which was diagnosed ... 03/22 (2018) ... Assessment: 1 ... Will need surgical repair of the left hip fracture in the morning ... Chronic anticoagulation therapy with Pradaxa. This has been discontinued prior to expected surgery in the morning ... The patient was admitted to an inpatient bed ... Diagnosis and prognosis discussed with patient and family ..."

d. On 4/2/18, Anesthesiologist (Anes#1) documentation note stated Pt #2's EKG findings were without "ST elevation- a sign of heart attack) and was designated an ASA (American Society of Anesthesiology - classification system that indicate the severity of patients underlying disease and potential for suffering complications from general anesthesia) score of "IV ... E" (IV- a patient with severe systemic disease that is a constant threat to life. E- denotes Emergency surgery: an emergency is defined as existing when delay in treatment of the patient would lead to a significant increase in the threat to life or body part.) A line was drawn through the III designation) and marked that the anesthesia choice, procedure, benefits, side effects, and possible complications were explained."

e. On 4/2/18, the intraoperative anesthesia record stated that at 1:21 PM, Pt #1's heart rate decreased to 38 beats per minutes and the QRS (heartbeat measurements) widened and that Atropine was given. At 1:28 PM, a code blue (cardiac arrest) was called and cardiopulmonary resuscitation was started. At 1:47 PM, the code blue was ended by the ED physician (MD#5). Pt #2 expired.

f. An interview was conducted with Anes#1 on 3/14/19 at approximately 12:05 PM. "I reviewed (Pt #2's) record and I do remember (Pt #2). (Pt#2) had metastatic lung cancer and was very high risk (for surgery). The probability of death was 2 days without surgery. It (the cause of death) was probably a clot (blood) or embolism (blood or fat). I saw her before surgery and did a thorough exam (examination). There were no cardiac concerns, as the EKG was ok."

g. An interview was conducted with Orthopedic Surgeon (MD#1) on 3/14/19 at approximately 4:00 PM. MD#1 confirmed remembering Pt #2. "(Pt #2) was high risk. Every day the surgery was postponed would increase morbidity and mortality, substantially. (Pt #2) was also on Pradaxa (a blood thinner), which at this time does not have a reversal agent. The risk of not doing surgery far outweighed the risk of doing surgery. The outcome was very guarded and they (the patient and family) knew that. The surgery was done and I had (PA#1) close (suture the incision) for me and left. Then, my understanding is (Pt #2's) heart rate changed and (Pt #2) coded and died."

h. An interview was conducted with E#3 throughout 3/12/19 to 3/15/19. E#3 stated, "No, this was not discussed at any committees (Pt #2's death). No, a RCA (root cause analysis) wasn't done."

6. Pt #3 Date of admission: 11/8/18. Date of death: 11/10/18. Pt #3's record was reviewed 3/13/19 at approximately 12:30 PM.

a. According to Pt #3's record, Pt #3 presented to the ED on 11/8/18 at approximately 11:35 AM with the complaints of: decreased alertness, increased confusion, altered mental status, and vomited twice. Pt #3 underwent laboratory and radiological testing and was admitted with the diagnoses of Altered Mental Status, Hypoxemia, and Pneumonia. Pt #3 was admitted to the Med/Surg unit at approximately 2:15 PM.

b. According to Pt #3's record, on 11/9/18 a History & Physical dictated at 9:55 AM stated, ..."the Assessment/Plan was 1. Left lower lobe pneumonia. Acquired in a nursing facility... 2. Lactic acidosis with septicemia secondary to 1 ... 3. Acute renal failure secondary to 2 ... 4. Hypoxic respiratory failure secondary to 1. (Pt #3's) oxygen saturation is now adequate on high-flow oxygen. We will not intubate (Pt #3) as (Pt#3) a DNR/DNI (do not resuscitate/do not intubate) as confirmed by the patient's (child who is power of attorney) ... The patient was admitted to an inpatient bed ... diagnosis and prognosis discussed with the patient's (child) ... (Pt #3) prognosis is poor."

c. According to Pt #3's record, on 11/10/18 "Nursing Progress Notes Reports" documentation stated, "being notified that Pt #3's heart rate was in the 30's, entered Pt #3's room and was gasping for air, sat pt up in bed. This RN listening to HR (heart rate) .... Listening to HR. No HR heard by either RN. No respirations heard ... Hospitalist notified of pt's death. Release of body obtained." The coroner was notified and released the body.

d. According to Pt #3's record, on 11/10/18 MD#4's "Discharge Summary" stated, "Date of death November 10, 2018 ... with findings of left lower lobe pneumonia, septicemia, and lactic acidosis ... (Pt#3) continued to have a slow downhill course despite these measures... (Pt #3) died early in the morning on November 10th. Primary cause of death 1. Left lower lobe pneumonia 2. Lactic acidosis with sepsis secondary to 1..."

e. Internal documentation was presented by the Hospital and reviewed on 3/15/19 at approximately 2:55 PM, with the Director of Quality Management (E#3). The document included a timeline of Pt#3's care. According to Pt #3's internal document, "Questions were raised about the following: The nursing's perception of the Sepsis Screening Tab, as they were incorrectly performed and re-education was necessary; vital sign reporting; staffing, as the nurse felt the patient should have been in ICU and the doctor did not feel that way; nursing was aware of chain of command that could be utilized, but did not use it; Discovered ED did not utilize the same sepsis screening tool; A Sepsis champion to be appointed."

f. During a interview with E#3, conducted in conjunction with Pt #3's internal document review, E#3 stated, "No, we didn't do a peer review or any kind of RCA."

7. Interviews were conducted with the Director of Quality Management (E#3) throughout 3/12/19 to 3/15/19. E#3 stated, "No, we don't have specific things to trigger a peer review (Morbidity/Mortality) It's all pretty informal. I get a list of deaths that are assigned to Quality. I'm not sure how they are assigned, but I have an Audit RN look at the record and the Audit RN lets me know if it needs to be looked at more closely. I review it with the Audit RN and we do a timeline We "huddle" with E#4- VP of Operations and Physician Services) and maybe (E#2- VP of Patient Care Service and Chief Nursing Officer) or (E#18- Director of Med/Surg and ICU). We don't really have an RCA (root cause analysis) policy. No, we don't report these to any of the committees (QAPI, ED, Surgical Services, or Medical Executive Committee). No, we don't track them and we probably should. We (Administration, Quality, and the Doctors) would decide on a case-by-case basis. But, I see that isn't working and there are opportunities for potential improvement that we are not finding."

8. Interviews were conducted with the Vice President of Operations and Physician Services (E#4) throughout 3/12/19 to 3/15/19. E#4 stated, "We have identified an opportunity to improve our peer review (Morbidity/Mortality). It (peer review) has not been a strong point. It's been mostly informal and has not been well documented." E#4 verbally agreed the cases of Pt #1, Pt #2, and Pt #3 were not peer reviewed and were not discussed at the Emergency Services, Surgical Services, QAPI, and/or Medical Executive Committee levels. E#4 agreed with E#3's (Director of Quality Management) interview.

Based on document review and interview, it was determined the Hospital failed to ensure its Medical Staff operated in accordance with its Bylaws, to assure the safe provision of patient care and services. Therefore the Condition of Participation 42 CFR 482.22, Medical Staff, was not met. This has the potential to affect all inpatients and outpatients serviced by the Hospital.

Findings include:

1. The Hospital failed to ensure its Focused Profession Practice Evaluation /Ongoing Professional Practice Evaluation processes were implemented, in accordance with its Medical Staff Bylaws. See A-340

2. See A-286

Based on document review and interview, it was determined for 3 of 3 Physicians (Medical Doctor- MD#2, MD#10, and MD#11), reviewed for initial Focused Professional Practice Evaluation (FPPE) and for 3 of 3 Physicians (Medical Doctor- MD#1, MD#3, and MD#5) reviewed for Ongoing Professional Practice Evaluation (OPPE), the Hospital failed to ensure its FPPE/OPPE processes were implemented, in accordance with its Medical Staff Bylaws, to assure the safe provision of patient care and services. This has the potential to affect all physicians and/or midlevel providers credentialed by the Hospital and all patients serviced by the Hospital.

Findings include:

1. The Medical Staff Bylaws (Revised by the Hospital January 1, 2019, with no changes related to FPPE) were reviewed on 3/13/19 at approximately 2:00 PM. The Bylaws stated, "Part III: Credentials Procedures Manual, Section 4. Competency Evaluation... All initially requested privileges shall be subject to a period of focused competency evaluation. The Division Chair with the approval of the MEC, (Medical Executive Committee) will define the circumstances which require monitoring and evaluation... following his or her initial grant of clinical privileges... including but not limited to: chart review, the tracking of performance monitors/indicators, external peer review, simulations, morbidity/mortality reviews... will also establish the duration for such focused competency evaluation and triggers that indicate the need for performance monitoring... The medical staff will also engage in ongoing competency evaluation to identify professional practice trends that affect quality of care and patient safety..."

2. Physician credential files were reviewed on 3/14/19 at approximately 12:20 PM, with the Medical Staff Specialist (E#9).
a. MD#1 with a reappointment date: 2/5/19.
b. MD#2 with an initial appointment date: 6/21/17.
c. MD#3 with a reappointment date: 6/21/17.
d. MD#5 with a reappointment date: 1/4/18.
e. MD#10 with an initial 120 day provisional appointment date of 1/10/19 and initial appointment date of 3/5/19.
f. MD#11 with an initial appointment date: 1/4/18.
g. MD#2, MD#10, and MD#11's credential files lacked any FPPE initiation and/or monitoring.

3. An interview was conducted the Vice President of Operations and Physician Services (E#4) on 3/15/19 at approximately 8:05 AM. E #4 reviewed the above mentioned Physician's credentialing files and stated, "(MD#2) should have had FPPE and didn't. That would be the same for all of them (MD#10 and MD#11). We have not been doing a good job with our OPPE either (for MD#1, MD#3, and MD#5). Our Peer Review process is mostly informal and not documented and not tracked. We are going to have to change this." When asked how the Hospital could ensure the care and services being provided were meeting quality and patient safety standards, E#4 stated, "Again, we have not been doing good job with our peer review."