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Based on staff interview and review of medical records, Medical Staff Bylaws, Medical Staff Policies, Governing Board and Medical Staff meeting minutes, and call schedules, it was determined the CAH failed to ensure its organizational structure was sufficient to direct patient care. This impeded the ability of the CAH to provide safe and effective care. Findings include:

Refer to C241 as it relates to the failure of the Governing Body to assume responsibility for determining and implementing Medical Staff policies.

These systemic negative practices seriously impeded the ability of the CAH to direct and oversee the Medical Staff.

Based on staff interview and review of medical records, Medical Staff Bylaws, Medical Staff Policies, Governing Board and Medical Executive meeting minutes, and call schedules, it was determined the CAH's Governing Body failed to assume responsibility for determining and implementing Medical Staff policies. This directly affected the care of 2 of 15 inpatients (#12 and #13) and 1 of 10 ED patients (#6), whose records were reviewed. The Governing Body failed to oversee the medical care provided to both inpatients and emergency patients. This resulted in the CAH's inability to ensure quality healthcare was provided. Findings include:

1. Patient #13 was a 78 year old male who presented to the ED on 8/27/15. A report by the PA, dated 8/27/15 at 4:46 PM, stated Patient #13 complained of pain in his mouth and throat as well as nausea and vomiting. The report stated he had history of chronic obstructive pulmonary disease requiring 4 liters of oxygen continuously. The report also stated Patient #13 had fallen 2 weeks prior, injuring his ribs. The PA diagnosed Patient #13 with a collapsed lung and possible pneumonia. An inpatient bed was not available so Patient #13 elected to return home with an appointment to see another PA in the CAH's clinic the following day.

Patient #13's medical record contained an H&P by a PA, dated 8/28/15 but not timed. It stated Patient #13 complained of increased shortness of breath and had a low oxygen saturation level at 85%. The H&P stated he was not in acute distress but he was admitted to the CAH on 8/28/15, as an inpatient.

A PA report, dated 8/29/15 at 11:40 AM, stated he was in no acute distress. A PA report, dated 8/29/15 at 5:13 PM, stated Patient #13's breath sounds had worsened at 4:00 PM so the PA came in and examined him. The report stated she examined Patient #13, then called a physician at an acute care hospital. The PA report stated the physician advised the PA to intubate Patient #13 and transfer him to the acute care hospital.

Patient #13 was taken to the CAH's ED. A PA report, dated 8/29/15 at 5:44 PM, stated Patient #13 developed respiratory failure in the CAH. The report stated Patient #13 was intubated and placed on a ventilator by the PA. The report stated a helicopter was on site and transferred him to an acute care hospital.

All care for Patient #13 was provided by PAs. No documentation was present that Patient #13 was examined or treated by a physician.

Patient #13's medical record was reviewed with the Performance and Quality Improvement Nurse on 8/31/15 beginning at 2:50 PM. He confirmed the events of Patient #13's hospital stay. He stated PAs had provided all of the medical care for this critically ill patient.

The Chief of Staff, a physician, was interviewed on 9/02/15 beginning at 8:00 AM. He stated the CAH did not have policies that outlined physicians' responsibilities to examine patients or to supervise/monitor the care provided by Allied Health Professionals. He stated physicians were supposed to see all inpatients within 24 hours of admission. He stated the physicians were a little slack about that. He stated a physician should have examined Patient #13 during his stay. He stated Patient #13's case did not meet the criteria for automatic peer review and his care would not necessarily be reviewed by a physician.

Patient #13's care was not provided or supervised by a physician.

2. Patient #12 was a 39 year old female who presented to the ED on 7/25/15 at 8:43 AM. A report by the PA, dated 7/25/15 at 1:36 PM, stated Patient #12 was admitted to a nearby alcohol treatment center on 7/19/15. The report stated Patient #12 had a history of a blood clot on her spleen. The report stated Patient #12 complained of worsening abdominal pain and distention for the past 2 days. The report stated while in the ED, Patient #12 received a "massive amount" of IV Fentanyl, a powerful narcotic, "...which induced drowsiness, sedation, dramatic improvement, but [did] not get resolution of her pain. It actually brought down her blood pressure so I am now giving 750 cc normal saline bolus...The patient is requesting hospitalization at our facility. I will now confer with [a PA], her primary care physician. Final disposition and care will be at primary care provider's discretion." A corresponding note by the PA, dated 7/26/15 at 12:27 AM, stated a central IV line was placed in the ED. Patient #12 was then admitted to the CAH as an inpatient.

A "Final Report" by another PA, dated 7/25/15 at 7:48 PM, documented vital signs were within normal limits at 5:28 PM. The report stated Patient #12 was in no acute distress and her lungs were clear. The report stated Patient #12's diagnoses were alcoholic cirrhosis and acute pancreatitis. The report stated an order to transfer Patient #12 to an acute care hospital to the care of a physician was written at 8:00 PM on 7/25/15. An admission H&P was not documented. A reason for the transfer was not documented. Examination by a physician and consultation with a physician were not documented.

Patient #12's medical record was reviewed with the Performance and Quality Improvement Nurse on 8/31/15 beginning at 2:50 PM. He confirmed the documentation and stated he did not know why Patient #12 was transferred. He confirmed Patient #12's record did not include documentation to show a physician had been involved in or had been consulted about her care.

Patient #12's care was not provided or supervised by a physician.

3. The CAH had 11 active PAs and NPs who cared for patients. The ED was staffed exclusively by these Allied Health Professionals. Patients were routinely admitted as inpatients and were discharged from the CAH by Allied Health Professionals. Physicians did round at times but the bulk of care at the CAH was provided by Allied Health Professionals. This was confirmed by interview with the Performance and Quality Improvement Nurse on 8/31/15 beginning at 2:50 PM.

Medical Staff Bylaws, dated 1/28/14, stated the Allied Health Professional Staff could admit patients consistent with approved clinical privileges. The bylaws stated the Allied Health Professional Staff could exercise privileges "...Provided that a physician member of the Medical Staff will have the ultimate responsibility for patient care."

Medical Staff Bylaws and Rules and Regulations did not state what care should be provided by physicians. Neither the Bylaws nor the Medical Staff Rules and Regulations outlined how the Medical Staff would supervise and monitor care provided by the Allied Health Professional Staff.

Progress notes were co-signed by physicians but no documentation was present to show physicians supervised care provided by the Allied Health Professional Staff. A formal process to oversee the work of the Allied Health Professional Staff had not been developed.

The Chief of Staff was interviewed on 9/02/15 beginning at 8:00 AM. He stated the CAH did not have policies that outlined physicians' responsibilities to examine patients or to supervise/monitor the care provided by Allied Health Professionals.

The Medical Staff Coordinator was interviewed on 9/02/15 beginning at 9:10 AM. She reviewed the Medical Staff Bylaws and policies. She stated a policy that outlined the responsibilities of physicians to provide care and to supervise the care provided by Allied Health Professionals had not been developed.

The Governing Body failed to ensure the duties of physicians, in relation to providing care and the oversight of care provided by Allied Health Professionals, were defined.

4. The Medical Staff Rules and Regulations, dated 1/28/14, stated "It is the responsibility of the scheduled on-call provider [physician] to respond to calls from the Emergency Department in accordance with Hospital policies and procedures.

ED schedules from April 2015 to September 2015 were reviewed. The schedules listed the PAs that were scheduled to work in the ED. No physicians were scheduled to staff the ED during this time. No physician on-call list was maintained for the CAH or the ED during this time.

During an interview on 9/02/15 at 11:30 AM, the PA on duty stated he owned the PA group which staffed the ED. He stated PAs provided all medical care to patients in the ED. He stated the PA group had an independent contract with a local physician. The PA stated, as part of the contract, the physician reviewed a random 10% of their records. He stated he did not call physicians for consultation when he was treating emergent patients. The PA stated he was unable to recall a situation when he had called a physician to come in to the facility to evaluate a patient or to discuss an emergent situation. The PA did not admit inpatients to the CAH. The PA stated he called 1 of 2 physicians groups' offices when required to discuss patients' potential admission. One of the physician groups worked for the CAH. The other was independent.

The Supervising Physician for the PAs who staffed the ED was interviewed on 9/02/15 beginning at 1:05 PM. He stated he reviewed 10% of ED records for the medical care provided. He stated he met with the PAs every 1 to 3 months to talk about the reviews. He stated he did this per his contract with the PA group that staffed the ED. He stated he did not review cases for the CAH and said the CAH did not have a record of his reviews. He stated he did not supervise the PAs for the CAH. He stated PAs could contact a physician by phone if they were uncomfortable about how to treat a patient.

The Governing Body failed to ensure a system had been developed for oversight of care provided by Allied Health Professionals in the ED.

5. Medical Executive meeting minutes, dated between 8/01/14 and 9/01/15, were reviewed. Meeting minutes did not include documentation of discussion of the provision of care by Allied Health Professionals. Additionally, the meeting minutes did not include documentation of discussion of the supervision and monitoring of the Allied Health Professional Staff.

Partners in Healthcare Board meeting minutes, dated between 8/01/14 and 9/01/15, were reviewed. No meeting minutes discussed the provision of care by Allied Health Professionals. No meeting minutes discussed the supervision and monitoring of the Allied Health Professional Staff.

The CEO was interviewed on 9/10/15 beginning at 1:50 PM. He stated the Partners in Healthcare Board was the CAH's Governing Body. He stated the board minutes probably did not address medical care and the supervision of Allied Healthcare Professionals because it was not perceived as a problem.

The Governing Body did not document oversight of the Medical Staff.

6. Patient #6 was a 29 year old female brought in to the ED by private auto on 5/30/15. She was found by her parents unconscious and unresponsive in the backseat of their car. Patient #6's medical history included developmental disability, atrial fibrillation, CHF, sleep apnea, and long term anticoagulant use.

The Emergency Documentation note, signed by the ED Supervisor, an RN, documented Patient #6 was with her family on a recreational drive when her parents realized she stopped talking to them. Her parents stated Patient #6 was in the back seat of their car, was not breathing, and was blue in color. The note documented the parents of Patient #6 started CPR and drove her to the CAH's ED.

According to the Emergency Documentation note, Patient #6 arrived in the ED at 6:46 PM. She was immediately removed from the vehicle by ED staff and taken to a room. Patient #6 was placed on a cardiac monitor and her heart rhythm was in ventricular fibrillation, a life threatening arrhythmia. CPR was continued and Patient #6 was assisted with breathing using a bag valve mask. ED staff started an IV in Patient #6's right forearm and placed an intraosseous needle (a large bore needle placed in a large bone for administration of medications and fluid) in her right lower leg.

The Medscape website, accessed 9/10/15, stated "Acute Ventricular Fibrillation (VF) is treated according to Advanced Cardiac Life Support (ACLS) protocols. The ACLS algorithm for ventricular fibrillation stated:

- Initiate CPR and attach a cardiac monitor/defibrillator
- Defibrillate the patient
- Continue CPR for 5 cycles or 2 minutes and establish IV access
- If ventricular fibrillation continues, defibrillate the patient
- Continue CPR for 5 cycles or 2 minutes, give Epinephrine 1 mg every 3 to 5 minutes, consider an advanced airway (Endotracheal tube)
- If ventricular fibrillation continues, defibrillate the patient- Continue CPR for 5 cycles or 2 minutes, give Amiodarone 300 mg for the first dose; then 150 mg for a second dose
- If ventricular fibrillation continues repeat the cycle, search for reversible causes of the heart rhythm

The Emergency Documentation note and IV Medication Administration form documented the following:

- 6:52 PM 1 ampule of Epinephrine was administered via IV
- 6:53 PM Patient #6 was intubated with an ET (endotracheal) tube
- 6:56 PM 1 ampule of Epinephrine was administered via IV
- 7:00 PM 1 ampule of Epinephrine was administered via IV
- 7:04 PM 1 ampule of Epinephrine was administered via IV
- 7:07 PM 1 ampule of Epinephrine was administered via IV
- 7:10 PM 1 ampule of Epinephrine was administered via IV
- 7:08 PM 2 grams of Magnesium Sulfate was administered via IV
- 7:09 PM 300 mg of Amiodarone (an antiarrhythmic medication) was administered via IV
- 7:12 PM 150 mg of Amiodarone was administered via IV

Additionally, Patient #6 was defibrillated 8 times during the ACLS code. The recorded EKG strips documented the first defibrillation occurred at 6:49 PM and the last defibrillation was at 7:14 PM.

The ACLS algorithm for people presenting with ventricular fibrillation was not followed. The Epinephrine dosage was documented as 1 ampule. However, it did not specify the actual dosage of Epinephrine administered.

Per the ACLS algorithm, after the first dose of Epinephrine, the next medication to be given was Amiodarone. However, 5 additional doses of Epinephrine and 1 dose of Magnesium Sulfate were administered prior to giving Patient #6 Amiodarone.

At 7:11 PM, the Emergency Documentation note stated Patient #6's family was counseled by the PA and the family requested to stop resuscitation efforts by the ED staff. Patient #6 was pronounced dead at 7:15 PM by the PA.

During an interview on 9/02/15 at 11:20 AM, the ED Supervisor reviewed the record and confirmed ACLS protocols and algorithms were not followed for Patient #6. She stated the PA was running the code.

During an interview on 9/02/15 at 11:30 AM, the PA in charge of the resuscitation reviewed the record and confirmed ACLS protocols and algorithms were not followed for Patient #6. He stated the CAH did not review cases where CPR was performed in order to determine whether hospital protocols were followed. He stated Patient #6's case was not reviewed.

The Supervising Physician for the PAs who staffed the ED was interviewed on 9/02/15 beginning at 1:05 PM. He stated he reviewed 10% of ED records for the medical care provided. He stated the records were chosen at random. He stated the reviews were not documented.

The Revenue Cycle Compliance Officer was interviewed on 9/10/15 beginning at 2:40 PM. She stated Patient #6's case was scheduled for external peer review but the record had not yet been sent for review, 3 months and 10 days after the event.

The Governing Body did not ensure a system was in place to review care provided to critically ill patients by Allied Health Professionals.

Based on staff interview and review of medical records, Medical Staff Bylaws, policies, Governing Board and Medical Staff meeting minutes and medical provider call schedules, it was determined the CAH failed to ensure physicians (MDs and DOs) provided medical direction and supervision of PAs and NPs, who provided care for inpatients, outpatients and patients treated in the ED. This lack of supervision negatively impacted the care of 2 of 15 inpatients (#12 and #13) and 1 of 10 ED patients (#6), whose records were reviewed. Additionally, this deficient practice had the potential to directly impact the care of all patients receiving treatment in the CAH and interfered with the CAH's ability to provide quality care to its patients. Findings include:

1. Patient #13's medical record described a 78 year old male who presented to the ED on 8/27/15. A report by the PA, dated 8/27/15 at 4:46 PM, stated Patient #13 complained of pain in his mouth and throat as well as nausea and vomiting. The report stated he had history of chronic obstructive pulmonary disease requiring 4 liters of oxygen continuously. The report also stated Patient #13 had fallen 2 weeks prior, injuring his ribs. The PA diagnosed Patient #13 with a collapsed lung and possible pneumonia. An inpatient bed was not available so Patient #13 was sent home with an appointment to see another PA in the CAH's clinic the following day.

An H&P by a PA, dated 8/28/15 but not timed, stated Patient #13 complained of increasing shortness of breath and his oxygen saturation level was low at 85%. The H&P stated he was not in acute distress but he was admitted to the CAH as an inpatient.

A PA report, dated 8/29/15 at 11:40 AM, stated he was in no acute distress. A PA report, dated 8/29/15 at 5:13 PM, stated Patient #13's breath sounds were worse at 4:00 PM so the PA came in and examined him. The report stated she examined Patient #13 and then called a physician at an acute care hospital. The PA report stated the physician advised the PA to intubate Patient #13 and transfer him to the acute care hospital.

Patient #13 was taken to the CAH's ED. A PA report, dated 8/29/15 at 5:44 PM, stated Patient #13 developed respiratory failure in the CAH. The report stated Patient #13 was intubated and placed on a ventilator by the PA and a helicopter was on site to transfer him to an acute care hospital.

All care for Patient #13 was provided by PAs. No documentation was present that Patient #13 was examined or treated by a physician. No documentation was present to show Patient #13's medical care was supervised by a physician or his care was reviewed by a physician.

Patient #13's medical record was reviewed with the Performance and Quality Improvement Nurse on 8/31/15 beginning at 2:50 PM. He confirmed the events of Patient #13's hospital stay. He stated PAs had provided all of the medical care for this critically ill patient. He confirmed there was no documentation by a physician in his medical record.

The Chief of Staff, an MD, was interviewed on 9/02/15 beginning at 8:00 AM. He stated the CAH did not have policies that outlined physicians' responsibilities to examine patients or to supervise/monitor the care provided by PAs and NPs. He stated physicians, MDs and DOs, were supposed to see all inpatients within 24 hours of admission. He stated the physicians were "a little slack about that." He stated a physician should have examined Patient #13 during his stay.

A physician did not provide care supervision for Patient #13.

2. Patient #12's medical record described a 39 year old female who presented to the ED on 7/25/15 at 8:43 AM. A report by a PA, dated 7/25/15 at 1:36 PM, stated Patient #12 was admitted to an alcohol treatment center on 7/19/15 at a nearby facility. The report stated Patient #12 had a history of a blood clot on her spleen. The report stated Patient #12 complained of worsening abdominal pain and distention for the past 2 days. The report stated Patient #12 received a "massive amount" of IV Fentanyl, a narcotic, "...which induced drowsiness, sedation, dramatic improvement, but [did] not get resolution of her pain. It actually brought down her blood pressure so I am now giving 750 cc normal saline bolus... The patient is requesting hospitalization at our facility. I will now confer with [a PA], her primary care physician. Final disposition and care will be at primary care provider's discretion." A corresponding note by the PA, dated 7/26/15 at 12:27 AM, stated a central IV line was placed while the patient was in the ED. Patient #12 was then admitted to the CAH as an inpatient.

A "Final Report" by another PA, dated 7/25/15 at 7:48 PM, documented vital signs were within normal limits at 5:28 PM. The report stated Patient #12 was in no acute distress and her lungs were clear. The report stated Patient #12's diagnoses were alcoholic cirrhosis and acute pancreatitis. Finally, the report stated an order to transfer Patient #12 to an acute care hospital was written at 8:00 PM on 7/25/15. An admission H&P was not documented. A reason for the transfer was not documented. Examination by a physician, or consultation with a physician, was not documented. No documentation was present to show Patient #13's medical care was supervised by a physician or her care was reviewed by a physician.

Patient #12's medical record was reviewed with the Performance and Quality Improvement Nurse on 8/31/15 beginning at 2:50 PM. He confirmed the documentation and stated he did not know why Patient #12 was transferred. He confirmed Patient #12's record did not include documentation to show a physician was involved in, was consulted about her care, or supervised her care.

A physician did not provide care supervision for Patient #12.

3. Patient #6 was a 29 year old female brought in to the ED by private auto on 5/30/15. She was found by her parents unconscious and unresponsive in the backseat of their car. Patient #6's medical history included developmental disability, atrial fibrillation, CHF, sleep apnea, and long term anticoagulant use.

The Emergency Documentation note, signed by the ED Supervisor, an RN,documented Patient #6 was with her family on a recreational drive when her parents realized she stopped talking to them. Her parents stated Patient #6 was in the back seat of their car, was not breathing, and was blue in color. The note documented the parents of Patient #6 started CPR and drove her to the CAH's ED.

According to the Emergency Documentation note, Patient #6 arrived in the ED at 6:46 PM. She was immediately removed from the vehicle by ED staff and taken to a room. Patient #6 was placed on a cardiac monitor and her heart rhythm was in ventricular fibrillation, a life threatening arrhythmia. CPR was continued and Patient #6 was assisted with breathing using a bag valve mask. ED staff started an IV in Patient #6's right forearm and placed an intraosseous needle (a large bore needle placed in a large bone for administration of medications and fluid) in her right lower leg.

The Medscape website, accessed 9/10/15, stated "Acute Ventricular Fibrillation is treated according to Advanced Cardiac Life Support (ACLS) protocols. The ACLS algorithm for ventricular fibrillation stated:

- Initiate CPR and attach a cardiac monitor/defibrillator
- Defibrillate the patient
- Continue CPR for 5 cycles or 2 minutes and establish IV access
- If ventricular fibrillation continues, defibrillate the patient
- Continue CPR for 5 cycles or 2 minutes, give Epinephrine 1 mg every 3 to 5 minutes, consider an advanced airway (Endotracheal tube)
- If ventricular fibrillation continues, defibrillate the patient- Continue CPR for 5 cycles or 2 minutes, give Amiodarone 300 mg for the first dose; then 150 mg for a second dose
- If ventricular fibrillation continues repeat the cycle, search for reversible causes of the heart rhythm

The Emergency Documentation note and IV Medication Administration form documented the following:

- 6:52 PM 1 ampule of Epinephrine was administered via IV
- 6:53 PM Patient #6 was intubated with an ET (endotracheal) tube
- 6:56 PM 1 ampule of Epinephrine was administered via IV
- 7:00 PM 1 ampule of Epinephrine was administered via IV
- 7:04 PM 1 ampule of Epinephrine was administered via IV
- 7:07 PM 1 ampule of Epinephrine was administered via IV
- 7:10 PM 1 ampule of Epinephrine was administered via IV
- 7:08 PM 2 grams of Magnesium Sulfate was administered via IV
- 7:09 PM 300 mg of Amiodarone (an antiarrhythmic medication) was administered via IV
- 7:12 PM 150 mg of Amiodarone was administered via IV

Additionally, Patient #6 was defibrillated 8 times during the ACLS code. The recorded EKG strips documented the first defibrillation occurred at 6:49 PM and the last defibrillation was at 7:14 PM.

The ACLS algorithm for people presenting with ventricular fibrillation was not followed. The Epinephrine dosage was documented as 1 ampule. However, it did not specify the actual dosage of Epinephrine administered.

Per the ACLS algorithm, after the first dose of Epinephrine, the next medication to be given was Amiodarone. However, 5 additional doses of Epinephrine and 1 dose of Magnesium Sulfate were administered prior to giving Patient #6 Amiodarone.

The Emergency Documentation note documented at 7:11 PM, Patient #6's family was counseled by the PA and the family requested to stop resuscitation efforts by the ED staff. Patient #6 was pronounced dead at 7:15 PM by the PA.

During an interview on 9/02/15 at 11:20 AM, the ED Supervisor reviewed the record and confirmed ACLS protocols and algorithms were not followed for Patient #6. She stated the PA was running the code.

During an interview on 9/02/15 at 11:30 AM, the PA reviewed the record and confirmed ACLS protocols and algorithms were not followed for Patient #6. He stated the CAH did not review cases where CPR was performed in order to determine whether hospital protocols were followed. He stated Patient #6's case was not reviewed.

A physician did not provide care supervision for Patient #6.

4. The CAH had 11 active Allied Health Professionals (NPs and PAs) who cared for patients. The ED was staffed exclusively by PAs. Patients were routinely admitted as inpatients and were discharged from the CAH by PAs and NPs.

Medical Staff Bylaws and Rules and Regulations, dated 1/28/14, did not define how physicians would supervise and monitor care provided by the Allied Health Professional Staff.

According to the Chief of Staff, during an interview on 9/02/15, beginning at 8:00 AM, physicians "made rounds," but the majority of patient care at the CAH was provided by Allied Health Professionals. He stated there were no policies defining how physicians would supervise and monitor care provided by PAs and NPs.

The CAH did not direct physicians to supervise PAs and NPs.

Based on staff interview and review of policies and call schedules, it was determined the CAH failed to ensure a physician was available for consultation, assistance with medical emergencies, or patient referral. This resulted in the potential for delays in patient care. Findings include:

Physician call schedules between 4/01/15 and 9/30/15 were not present in the CAH.

Policies that outlined physicians' responsibilities in relation to assistance with medical emergencies, and patient referral were not present.

The Chief of Staff, was interviewed on 9/02/15 beginning at 8:00 AM. He stated the CAH did not have policies that outlined physicians' responsibilities in relation to assistance with medical emergencies, and patient referral. He stated individual physician groups had a physician on call but he acknowledged the CAH did not maintain a formal call schedule.

Without formal policies and call schedules, the CAH could not guarantee physicians were available for consultation, assistance with medical emergencies, and patient referral.

Based on staff interview and review of medical records, the CAH's bylaws, and policies, it was determined the CAH failed to ensure health care services were furnished in accordance with appropriate written policies that were consistent with applicable State law. This directly affected the care provided to 2 of 15 inpatients (#12 and #13), whose records were reviewed and had the potential to affect all emergency patients. This resulted in the failure of the CAH to provide services in accordance with state standards of practice. Findings include:

1. Idaho Administrative Code found at IDAPA 16.03.14200.01(h) requires the "Governing Body to adopt bylaws in accordance with Idaho Code...which specify at least the following: h. The bylaws shall specify that every patient be under the care of a physician." The CAH's Governing Body bylaws did not specify this. The lack of bylaws led to situations where patients were not under the care of a physician. For example:

a. Patient #13 was a 78 year old male who presented to the ED on 8/27/15. A report by the PA, dated 8/27/15 at 4:46 PM, stated Patient #13 complained of pain in his mouth and throat as well as nausea and vomiting. The report stated he had history of chronic obstructive pulmonary disease requiring 4 liters of oxygen continuously. The report also stated Patient #13 had fallen 2 weeks prior, injuring his ribs. The PA diagnosed Patient #13 with a collapsed lung and possible pneumonia. An inpatient bed was not available so Patient #13 elected to return home with an appointment to see another PA in the CAH's clinic the following day.

Patient #13's medical record contained an H&P by another PA, dated 8/28/15 but not timed. It stated Patient #13 complained of increasing shortness of breath and had a low oxygen saturation level at 85%. The H&P stated he was not in acute distress but he was admitted to the CAH on 8/28/15, as an inpatient.

A PA report, dated 8/29/15 at 11:40 AM, stated he was in no acute distress. A PA report, dated 8/29/15 at 5:13 PM, stated Patient #13's breath sounds had worsened at 4:00 PM so the PA came in and examined him. The report stated she examined Patient #13 and then called a physician at another hospital. The PA report stated the physician advised the PA to intubate Patient #13 and transfer him to the acute care hospital.

Patient #13 was taken to the CAH's ED. A PA report, dated 8/29/15 at 5:44 PM, stated Patient #13 developed respiratory failure in the CAH. The report stated Patient #13 was intubated and placed on a ventilator by the PA. The report stated a helicopter was on site and transferred him to an acute care hospital.

All care for Patient #13 was provided by PAs. No documentation was present that Patient #13 was examined or treated by a physician.

Patient #13's medical record was reviewed with the Performance and Quality Improvement Nurse on 8/31/15 beginning at 2:50 PM. He confirmed the events of Patient #13's stay at the CAH. He stated PAs provided all of the medical care for this critically ill patient.

The Chief of Staff, a physician, was interviewed on 9/02/15 beginning at 8:00 AM. He stated the hospital did not have policies that outlined physicians' responsibilities to examine patients or to supervise/monitor the care provided by non-physician practitioners. He stated a physician should have examined Patient #13 during his stay.

b. Patient #12 was a 39 year old female who presented to the ED on 7/25/15 at 8:43 AM. A report by the PA, dated 7/25/15 at 1:36 PM, stated Patient #12 was admitted to a nearby alcohol treatment center on 7/19/15. The report stated Patient #12 had a history of a blood clot on her spleen. The report stated Patient #12 complained of worsening abdominal pain and distention for the past 2 days. The report stated while in the ED, Patient #12 received a "massive amount" of IV Fentanyl, a powerful narcotic, "...which induced drowsiness, sedation, dramatic improvement, but [did] not get resolution of her pain. It actually brought down her blood pressure so I am now giving 750 cc normal saline bolus...The patient is requesting hospitalization at our facility. I will now confer with [a PA], her primary care physician. Final disposition and care will be at primary care provider's discretion." A corresponding note by the PA, dated 7/26/15 at 12:27 AM, stated a central IV line was placed in the ED. Patient #12 was then admitted to the CAH as an inpatient.

A "Final Report" by another PA, dated 7/25/15 at 7:48 PM, documented vital signs were within normal limits at 5:28 PM. The report stated Patient #12 was in no acute distress and her lungs were clear. The report stated Patient #12's diagnoses were alcoholic cirrhosis and acute pancreatitis. The report stated an order to transfer Patient #12 to an acute care hospital to the care of a physician was written at 8:00 PM on 7/25/15. An admission H&P was not documented. A reason for the transfer was not documented. Examination by a physician and consultation with a physician were not documented.

Patient #12's medical record was reviewed with the Performance and Quality Improvement Nurse on 8/31/15 beginning at 2:50 PM. He confirmed the documentation and stated he did not know why Patient #12 was transferred. He confirmed Patient #12's record did not include documentation to show a physician had been involved in or had been consulted about her care.

CAH policies were not developed in accordance with state laws related to patients being under the care of a physician.

2. Idaho Administrative Code found at IDAPA 16.03.143700.02(a) states "There shall be adequate medical and nursing personnel to care for patients arriving at the emergency room. Minimum personnel and qualifications of such personnel shall be as follows:

a. A physician in the hospital or on call twenty-four (24) hours a day and available to see emergency patients as needed."

CAH policies did not require a physician to be on call 24 hours per day or require a physician to be available to see emergency patients.

ED schedules from April 2015 to September 2015 were reviewed. The schedules listed the PAs that were scheduled to work in the ED. No physicians were scheduled to staff the ED during this time. No physician on-call list was maintained for the hospital or the ED during this time.

During an interview on 9/02/15 at 11:30 AM, the PA on duty stated he owned the PA group which staffed the ED. He stated PAs provided all medical care to patients in the ED. He stated he did not call physicians for consultation when he was treating emergent patients. The PA stated he was unable to recall a situation when he had called a physician to come in to the facility to evaluate a patient or to discuss an emergent situation.

The Supervising Physician for the PA group that staffed the ED was interviewed on 9/02/15 beginning at 1:05 PM. He stated physicians were not on call to come to the ED.

CAH policies were not developed in accordance with state laws related to emergency services.

Based on staff interview and review of policies, it was determined the CAH failed to ensure guidelines for the medical management of health problems that included the conditions requiring medical consultation and/or patient referral, had been developed. This resulted in a lack of guidance to providers. Findings include:

The CAH had 11 active PAs and NPs who cared for patients. The ED was staffed exclusively by these Allied Health Professionals. Patients were routinely admitted as inpatients and were discharged from the CAH by Allied Health Professionals.

A policy that addressed guidelines for the medical management of health problems including the conditions requiring medical consultation with physicians and/or patient referral was not present.

The Medical Staff Coordinator was interviewed on 9/02/15 beginning at 9:10 AM. She stated a policy that addressed the conditions requiring medical consultation and/or patient referral had not been developed.

The CAH did not develop a policy to address medical consultation.

Based on policy review, observation, and staff interview it was determined the CAH failed to ensure the implementation of procedures to avoid potential transmission of infections and communicable diseases. This had the potential to impact all staff and patients in the CAH. Failure to follow policies and standard precautions had the potential to allow for transmission of infections. Findings include:

The CAH had a policy titled, "INFECTION PREVENTION, FACILITY-WIDE." The policy was dated and signed by the the Infection Control RN and CEO on 7/17/15. Within the section of the policy titled "Personal Hygiene," the policy stated hand hygiene is indicated "...Any time soiling occurs (requires soap and water)."

A policy titled, "INFECTION CONTROL IN THE KITCHEN," unsigned, but last revised on 8/05/15 included "...Hair restraints shall be used."

The policies were not followed. Examples include:

1. A tour of the CAH's kitchen was conducted on 9/02/15, beginning at approximately 11:00 AM. Kitchen staff was observed preparing food, assembling patient trays, and serving lunch to facility staff.

During observation of the kitchen staff, an unknown delivery person entered the kitchen through a back door that was accessible from the outside of the hospital. He was carrying a box of bananas and walked to the table where staff was preparing patient trays. He then placed the box on the floor and waited for a member of the kitchen staff to sign a form indicating delivery of the food. After the staff signed the form, the delivery person opened the walk-in refrigerator, picked up the box of bananas and placed them in the refrigerator. The delivery person's hands were visibly soiled. He failed to wash his hands or don a head cover prior to entering the kitchen.

An interview with the Food Services Manager was conducted on 9/02/15, beginning at 11:25 AM. He confirmed it was the practice of the facility that all personnel should perform hand hygiene and don a clean head cover prior to entering the kitchen.

2. During observation of kitchen staff on 9/03/15 at approximately 9:55 AM, a dairy company delivery person was noted to exit the kitchen's walk-in refrigerator, carrying a tray containing dairy products. He set the tray on the kitchen floor. The delivery person's hands were visibly soiled. He was wearing a baseball cap that was also visibly soiled.

Upon questioning, the delivery person stated he delivered dairy products to the CAH, and removed expired dairy products from the CAH's refrigerator. He stated he had not received instruction from the CAH regarding appropriate hygiene practices prior to entering the kitchen, such as hand washing and donning head cover.

An interview with the Food Services Manager was conducted on 9/03/15, beginning at 10:05 AM. He confirmed people who delivered food products to the CAH were allowed to enter the kitchen. Additionally, he confirmed the delivery people were not instructed regarding hygiene practices prior to entering the kitchen.

The CAH did not implement a process to ensure patients and staff were protected from possible transmission of infections and communicable diseases.

Based on observation, policy review, and staff interview it was determined the CAH failed to ensure the implementation of procedures to ensure the nutritional needs of patients were met, in accordance with recognized dietary practices. This had the potential to impact all patients in the facility. Failure to follow recognized dietary practices had the potential to affect the quality of foods served in the CAH. Findings include:

1. The CAH's policy FS-262R1, titled, "INFECTION CONTROL IN THE KITCHEN," unsigned, but last revised on 8/05/15, stated "No food will be kept or used beyond its recommended shelf life." Additionally, it stated "All equipment, utensils, and working surfaces will be cleaned and sanitized after use."

A tour of the CAH's kitchen and food storage areas was conducted by the Food Services Manager on 9/02/15 beginning at 11:10 AM. Recognized dietary practices were not followed. Examples include:

a. Stored food items past the manufacturer's printed expiration date included:
- Cream of Rice, expired 6/16/15
- Couscous, expired 8/15/15
- Brown sugar, expired March, 2015
- Special K cereal, individual boxes, expired 5/12/15
- Individual servings of honey, expired 6/09/15
- Individual servings of jelly, expired 1/25/15
- Rotini pasta, expired 3/19/15

b. Stored food items without a manufacturer's printed expiration date included:
- Long grain rice
- Mexican rice
- Pancake mix
- Sweet and sour sauce
- Ketchup
- Individual servings of peanut butter
- Individual servings of tartar sauce
- Bag of walnuts

c. A working surface was noted to contain a puddle of fluid, and a wet, visibly soiled wiping cloth. The Food Services Manager stated he did not know how long the puddle and wiping cloth had been there.

During an interview on 9/02/15 at 11:25 AM, the Food Services Manager stated an inventory of stored foods was completed weekly, and all expired foods were discarded. He stated he was not aware of the expired foods in the storage room, or of the foods that did not include an expiration date. He was unable to explain the reason some foods did not include an expiration date. He stated all food items past the manufacturers' printed expiration date, and all food items without a manufacturers' printed expiration date would be discarded by the end of the day.

d. A second visit was made to the food storage area on 9/03/15 at 9:30 AM. Food items without a manufacturers' printed expiration date were noted to have a new label affixed. Each label included the date the item was received by the CAH. Additionally, the labels included a date 6 months after the date of receipt, which was labeled as the expiration date. The Food Services Manager stated he was unable to determine the manufacturers' expiration dates, therefore, items would be discarded 6 months after delivery to the CAH. However, he confirmed he was unable to determine if an item's manufacturer's expiration date was prior to the expiration date on the label.

When asked how the delivery date was determined, the Food Services Manager stated each item included a sticker with the date of delivery. However, the sticker included only the month and day, not the year. A box of graham cracker crumbs included a sticker with the delivery date of 5/7. It did not include the year. The item included a handwritten notation, "Open 5/8/14, Exp [expired] 11/8/14," indicating it was received by the CAH more than a year prior.

e. Additional items that were expired or did not contain a manufacturers' expiration date remained in the food storage area on 9/03/15, included:

- Rotini, expired 3/19/15
- Individual servings of jelly, expired 7/09/15
- Individual servings of syrup, no expiration date

During an interview on 9/03/15 at 10:05 AM, the Food Services Manager confirmed the food storage area included items without a manufacturer's printed expiration date. Additionally, he confirmed the sticker that indicated the date items were received did not include the year, and it was possible items were more than a year old.

The CAH's kitchen and food storage areas were not maintained in accordance with the CAH's policies which reflected recognized dietary practices.



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2. A policy titled, "INFECTION CONTROL IN THE KITCHEN," unsigned, but last revised on 8/05/15, included "...Unauthorized personnel are kept out of the food service area." The policy was not followed. Examples include:

a. A tour of the CAH's kitchen was conducted on 9/02/15, beginning at approximately 11:00 AM. Kitchen staff was observed preparing food, assembling patient trays, and serving lunch to facility staff.

During observation of the kitchen staff, an unknown delivery person entered the kitchen through a back door that was accessible from the outside of the hospital. He was carrying a box of bananas and walked to the table where staff was preparing patient trays. He then placed the box on the floor and waited for a member of the kitchen staff to sign a form verifying delivery of the food. After the staff signed the form, the delivery person opened the walk-in refrigerator, picked up the box of bananas and placed them in the refrigerator. The delivery person did not obtain permission prior to entering the food preparation area of the kitchen.

An interview with the Food Services Manager was conducted on 9/02/15, beginning at 11:25 AM. He confirmed the delivery person would not have been considered authorized personnel and should not have been in the food preparation area of the kitchen.

b. During observation of kitchen staff on 9/03/15 at approximately 9:55 AM, a dairy company delivery person was noted to exit the kitchen's walk-in refrigerator, carrying a tray containing dairy products. He set the tray on the kitchen floor. When questioned, he stated he delivered dairy products to the CAH, and removed expired dairy products from the CAH's refrigerator.

An interview with the Food Services Manager was conducted on 9/03/15, beginning at 10:05 AM. He confirmed people who delivered food products to the CAH were allowed to enter the kitchen.

The CAH did not implement a process to prevent unauthorized individuals from entering the food preparation area of the kitchen.

Based on policy review, record review, patient interview and staff interview, it was determined the CAH failed to provide an ongoing program of activities, directed by a qualified professional, to Swing Bed patients. This directly affected 4 of 6 (#19, #20, #21 and #27) Swing Bed patients whose records were reviewed, and had the potential to result in unmet needs for all Swing Bed patients. Findings include:

1. The CAH's policy SB-101R3, "ACTIVITIES ASSESSMENT," revised, and signed by the Transitions RN and the CNO on 11/24/14, stated "The Transition RN is designated as the activity director responsible to see that patient's [sic] needs are met."

The Transition RN was interviewed on 9/01/15 at 11:35 AM. She stated she was responsible for the Swing Bed activity program. She confirmed she was not licensed or certified as a therapeutic recreation specialist, activities professional or occupational therapist and did not have prior experience in a recreational program. Additionally, she stated she did not work in consultation with a qualified recreation professional.

The CAH did not have a qualified activities director.

2. The CAH's policy SB-101R3, "ACTIVITIES ASSESSMENT" also stated "An activity room is available and will be offered to each patient at hours convenient to the patient...on a daily basis and including weekends with supervision." The policy was not followed. Examples include:

Swing Bed patient records included a "SWING BED ACTIVITY FORM." The form included areas to document activities, and indicate if the patient participated in, or refused activities offered on each day of their Swing Bed stay.

a. Patient #19 was a 94 year old female admitted to Swing Bed services on 6/04/15, with diagnoses of pneumonia and debility. She was discharged on 6/08/15.

Patient #19's activity calendar stated she was to be offered activities of choice on a daily basis, to include visit with family, visit with staff, look at pictures, read book, and weekend activities. However, her activity form stated her only activity on 6/04/15, and 6/05/15, was visiting with family/friends. The form did not state additional activities were offered and refused.

b. Patient #20 was an 82 year old male admitted to Swing Bed services on 6/16/15, with a diagnosis of pneumonia. He was discharged on 6/26/15.

Patient #20's activity calendar stated he was to be offered activities of choice on a daily basis, to include visit with family, visit with staff, watch television and use box of activities and toys from home. However, his activity form was blank on 6/18/15, 6/19/15, 6/22/15, 6/23/15, and 6/24/15, indicating he did not participate in, or refuse activities.

c. Patient #21 was a 74 year old male admitted to Swing Bed services on 4/27/15, with a diagnoses of septic knee joint and DM. He was discharged on 5/03/15.

Patient #21's activity calendar stated he was to be offered activities of choice on a daily basis, to include visit with family, visit with staff, watch television and read. However, his activity form stated his only activity on 4/27/15, and 4/30/15, was visiting with family, and his only activities on 5/01/15 were visiting with family and visiting with staff. The form did not state additional activities were offered and refused.

d. Patient #27 was an 80 year old female admitted to Swing Bed services on 8/18/15, with a diagnosis of left patellar fracture with an infected joint. She was a current patient as of 9/03/15.

Patient #27 was interviewed on 9/01/15 beginning at 10:25 AM. She was alert and oriented. She stated she had been hospitalized since 8/14/15 and was on Swing Bed services since 8/18/15. She stated she had to stay another month to receive IV antibiotics. She stated she was not aware if she had an activities plan or not. She stated she had been invited to go to lunch in the cafeteria with a staff person but she declined. She stated no other activities had been offered. A half finished puzzle was on a table in her room. She stated her husband had completed most of it.

During an interview on 9/01/15 at 9:05 AM, the Transition RN, who acted as the activity director for Swing Bed patients, stated the Swing Bed activity program did not include group activities or planned activities in the activity room. She confirmed most patient activities were limited to visiting with family and staff, watching television and reading.

The CAH did not provide a program of activities to meet the needs of Swing Bed patients.

Based on policy review, medical record review, and staff interview, it was determined the CAH failed to ensure a comprehensive care plan was developed for 4 of 6 Swing Bed patients (#18, #19, #20, and #21), whose records were reviewed. This resulted in a lack of direction to staff caring for Swing Bed patients. Findings include:

The CAH's policy SB-105R4, "NURSING CARE PLAN: ACUTE CARE/SWING BED," revised, and signed by the Nursing Supervisor and the CNO on 10/13/14, stated "All patients admitted to NCMC will have a comprehensive nursing care plan within 24 hours of admission related to admitting diagnosis." This policy was not followed. Examples include:

1. Patient #18 was a 90 year old female admitted to Swing Bed services on 4/23/15, with admitting diagnoses of profound weakness and urinary tract infection.

Patient #18's diagnoses included urinary tract infection. However, her care plan did not include assessment, interventions or patient education related to her urinary tract infection.

During an interview on 9/01/15, beginning at 9:05 AM, the Transitional Care RN, who was responsible for the Swing Bed program, reviewed Patient #18's record and confirmed her care plan should have addressed her urinary tract infection.

2. Patient #19 was a 95 year old female admitted to Swing Bed services on 6/04/15, with admitting diagnoses of pneumonia, debility, and atrial fibrillation.

Patient #19 was on continuous oxygen therapy, and took an anticoagulant (blood thinner) to treat her atrial fibrillation. However, her care plan did not include assessment, interventions or patient education related to oxygen therapy or anticoagulant therapy.

During an interview on 9/01/15, beginning at 9:05 AM, the Transitional Care RN reviewed Patient #19's record and confirmed her care plan should have addressed oxygen therapy and anticoagulant therapy.

3. Patient #20 was an 82 year old male admitted to Swing Bed services on 6/16/15, with admitting diagnosis of pneumonia.

Patient #20's record included a Braden Scale score. The Braden Scale predicts a patient's risk of developing pressure ulcers, based on the patient's sensory perception, skin moisture, activity, mobility, nutrition and assistance needed to move. A Braden Scale score of 18 or less indicates a risk of developing pressure ulcers. Patient #20's Braden Scale score was 17. However, his care plan did not include assessment, interventions or patient education related to prevention of pressure ulcers.

During an interview on 9/01/15, beginning at 9:05 AM, the Transitional Care RN reviewed Patient #20's record and confirmed his care plan should have addressed his risk of developing pressure ulcers.

4. Patient #21 was a 74 year old male admitted to Swing Bed services with admitting diagnoses of infected knee wound, DM and CHF.

Patient #21 was on oxygen therapy, and was placed on insulin to treat his DM. However, his care plan did not include assessment, interventions or patient education related to oxygen therapy or diabetes, including insulin administration.

During an interview on 9/01/15, beginning at 9:05 AM, the Transitional Care RN reviewed Patient #21's record and confirmed his care plan should have addressed oxygen therapy and diabetes.

The CAH failed to develop comprehensive care plans for Swing Bed patients.

Based on policy review and staff interview, it was determined the CAH failed to ensure dental services were available to Swing Bed patients. This resulted in the potential for patients' dental needs to go unmet. Findings include:

The CAH's policy SB-109 "DENTAL SERVICES," revised, and signed by the Transition RN and the CNO on 11/26/14, stated "For more urgent situations...the program staff will call the dentist of the patient's choice or use a dentist identified by the hospital as willing to meet the patient's needs in such situation."

During an interview on 9/01/15 at 4:05 PM, the Transition RN, who was responsible for the Swing Bed program, stated the CAH did not have a contract or agreement with a dentist to provide dental services to Swing Bed patients.

The CAH failed to ensure a dentist was available to meet the needs of Swing Bed patients.