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Based on staff interview and administrative document review, the hospital failed to have an organizational structure which took full legal responsibility for determining, implementing and monitoring policies to ensure the provision of health care in a safe environment when:

1. No system was in place to ensure Medical Staff By-Laws, Rules and Regulations were followed and medical staff were professionally qualified for the positions to which they were appointed and for the performance of privileges granted.

a.) four (4) of eighteen (18) members of the medical staff (MD 5, MD 6, MD 7, MD 8) who had previously been granted privileges were reappointed without being reappraised for competence; (refer to C241)

b.) three (3) of eighteen (18) members of the medical staff (MD 10, MD 11, MD 12) were granted clinical privileges and allowed to practice without being proctored; and (refer to C241)

c.) five (5) out of a total of eighteen (18) members of the medical staff (MD 9, MD 10, MD 11, MD 12, MD 13) were granted privileges and given extended two (2) year provisional appointments where the maximum was two consecutive 6-month appointments.
(Refer to C-241)

2. Policies were not developed and implemented for the provision of services to patients in the areas of Nutrition Services, Pharmacy and Infection Control. (Refer to C-0270)

3. The hospital failed to have an effective quality assurance program for contracted services which were not evaluated for the quality of care provided to patients in the areas of Medical Staff, Nutrition Services, and Pharmacy. (Refer to C-0330)

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

Based on staff interview and administrative document review, the Critical Access Hospital (CAH) failed to have a governing body which took full legal responsibility for determining, implementing and monitoring policies when:

1. The Medical Staff By-Laws, Rules and Regulations were not followed to ensure members of the medical staff were professionally qualified for the positions to which they were appointed and for the performance of privileges granted.

a.) four (4) of eighteen (18) members of the medical staff (MD 5, MD 6, MD 7, MD 8) who had previously been granted privileges were reappointed without being reappraised for competence;

b.) three (3) of eighteen (18) members of the medical staff (MD 10, MD 11, MD 12) were granted clinical privileges and allowed to practice without being proctored (monitored while performing medical practice activities);

c.) five (5) of eighteen (18) members of the medical staff (MD 9, MD 10, MD 11, MD 12, MD 13) were granted privileges and given extended two (2) year provisional appointments, where the maximum in the By-Laws was two consecutive 6-month appointments.

2. There was no process to ensure the Pharmacist adhered to the agreed upon contract.

3. The hospital failed to implement and monitor policies governing the organization of the nutrition care services and develop quality programs to ensure compliance with hospital policy.

These failures resulted in the potential harm of patients receiving medical care from individuals not competent to provide care, pharmacy services provided to patients without the benefit of competent oversight by a Pharmacist, and the providing of nutritional services to patients in accordance with policies and procedures.

Findings:

1. On 6/1/15 at 1:30 p.m. and on 6/2/15 at 9 a.m., during a concurrent interview and review of the credentialing and peer review process, 18 physician credential files were reviewed with the Chief Executive Officer (CEO 3) and Medical Staff Coordinator (CC 1). The CEO 3 and CC 1 agreed the review of the credential files indicated: a.) four (4) out of a total of eighteen (18) members of the medical staff (MD 5, MD 6, MD 7, MD 8) who had previously been granted privileges were reappointed without being reappraised for competence, b.) three (3) out of a total of eighteen (18) members of the medical staff (MD 10, MD 11, MD 12) were granted clinical privileges and allowed to practice without being proctored, c.) five (5) out of a total of eighteen (18) members of the medical staff (MD 9, MD 10, MD 11, MD 12, MD 13) were granted privileges and given extended two (2) year provisional appointments where the maximum in the By-Laws was two consecutive 6-month appointments.

On 6/2/15 at 10:00 a.m., during an interview, the Human Resources Coordinator/Medical Staff (CC 2) stated she was the Medical Staff credential coordinator of the facility. CC 2 stated overseeing and managing the Medical Staff credential files was one of her responsibilities. CC 2 stated it was her understanding that MD 4 was the Chief of the Medical Staff of the facility and CEO 3 was the Chief Executive Officer of the facility. CC 2 stated both MD 4 and CEO 3 had been made aware of the numerous problems and issues with the physician credential files, including lack of documentation of peer review and the lack of documentation of proctoring. CC 2 stated the credentialing process had been performed in a casual manner including the process for assessing medical staff members for competence before and after they were granted privileges. CC 2 stated the peer review process had been instituted for medical staff members previously given privileges and recently reappointed, however, it was done on an irregular basis. CC 2 stated the proctoring process had been instituted for newly appointed medical staff members, however, it was done on an irregular and sporadic basis. CC 2 stated the credentialing process did not have the sufficient support, assistance or oversight from the Chief of the Medical Staff of the facility (MD 4).

On 6/1/15 at 11 a.m., during an interview, MD 4 stated he was the Chief of the Medical Staff of the facility. MD 4 stated he was aware of the fact that there were many problems, irregularities and issues with regard to the medical staff credential files. MD 4 stated CC 2 had made an effort to inform him and make him aware of the numerous problems and issues with the physician credential files. MD 4 stated CC 2 had made an effort to inform him and make him aware of the fact that the physician credential files were lacking documentation of peer review and documentation of proctoring for numerous physicians. MD 4 stated he knew these practices were a violation of the facility's bylaws, rules and regulations as well as the Medical Staff credentialing policy. MD 4 stated he had made an effort to ensure peer review was performed as required, however, it was usually done irregularly and on a causal basis. MD 4 stated that as the Chief of the Medical Staff he knew he had the responsibility to ensure these duties were performed. MD 4 stated he had discussed credentialing issues and his responsibilities as Chief of the Medical Staff on numerous occasions with CEO 3.

On 6/2/15 at 11 a.m., during an interview, CEO 3 stated he was the Chief Executive Officer of the facility and he understood he represented the governing body for the purposes of the interview. CEO 3 stated CC 2 was the Medical Staff credential coordinator of the facility. CEO 3 stated overseeing and managing the Medical Staff credential files was one of her responsibilities. CEO 3 stated as the Chief Executive Officer of the facility he had been made aware of the numerous problems and issues with the physician credential files including lack of documentation of peer review and the lack of documentation of proctoring. CEO 3 stated he knew the credentialing process had been performed in a casual manner including the process for assessing medical staff members for competence before and after they were granted privileges. CEO 3 stated he knew the peer review process had been instituted for Medical Staff members previously given privileges and recently reappointed, however, it was done on an irregular basis. CEO 3 stated he knew the proctoring process had been instituted for newly appointed Medical Staff members, however, it was done on an irregular basis. CEO 3 stated he had made numerous efforts to discuss the credentialing issues with the Chief of the Medical Staff of the facility (MD 4) as a means of making him aware of the fact that they both had the responsibility for ensuring these duties were performed. CEO 3 stated he had discussed the fact that the credentialing process did not have sufficient support, assistance or oversight from the MD 4 with the Board of Directors of the facility on numerous previous occasions. CEO 3 stated the Board of Directors of the facility had made numerous efforts to discuss the credentialing issues with the Chief of the Medical Staff (MD 4) as a means of making him aware of the fact that he, as the Chief of the Medical Staff, had the responsibility for ensuring these duties were performed.

A signed copy of the Medical Staff By-Laws and Rules and Regulations dated 4/25/12 indicated on page 5, "2.03 BASIC RESPONSIBILITIES OF STAFF MEMBERSHIP Each member of the Medical Staff shall: ... (b) Abide by the Medical Staff Bylaws and Rules and Regulations and lawful standards, policies, and rules of the Hospital and the Medical Staff; (c) Abide by all applicable laws and regulations of governmental agencies and integrate and utilize, wherever possible, applicable standards of the Joint Commission on Accreditation of Healthcare Organizations; (d) Discharge such Staff, committee, and service functions for which he/she is responsible by appointment, election, or otherwise; ... (g) Actively participate in and regularly cooperate with the Medical Staff in assisting the Hospital to fulfill its obligations related to patient care, including but not limited to patient care audits, peer review, utilization review, quality evaluation and related monitoring activities required of the Medical Staff, and in discharging such other functions as may be required from time to time; ... (j) Accept responsibility for participating in Medical Staff proctoring as an obligation of Staff membership. Proctoring availability and assignment shall be in accordance with regulations formulated by the Medical Executive Committee; (k) Participate in Continuing Medical Education programs appropriate to his/her specialty. As a minimum, members shall comply with Medical Board of California requirements, or comparable requirements of other applicable licensing agencies; ... and (o) Continuously meet the qualifications for membership as set forth in these Bylaws. (It is understood that a member may be required to demonstrate continuing satisfaction of any of the requirements of these Bylaws whenever the Medical Executive Committee has good cause to question whether the member continues to meet such requirement.)"

The Medical Staff By-Laws and Rules and Regulations indicated on page 8, "3.06 PROVISIONAL STAFF The Provisional Staff shall consist of practitioners who are newly appointed to the Medical Staff and who intend to admit or treat more than 10 patients per year. Except or as otherwise determined by the Governing Body, all initial appointments except Consulting Staff appointments, shall be to the Provisional category. Provisional members are expected to attend Staff meetings as required under Section 11.07-1, and... they may serve on Staff committees but may not vote. They may not vote at any general or special meeting of the Staff. A Provisional member may not serve as a general Staff officer or a committee chairperson."

The Medical Staff By-Laws and Rules and Regulations indicated on page 20, "5.08 PROCTORING 5.08-1 Appointment Of Proctors All initial appointees to the Medical Staff and all members granted new clinical privileges may be subject to a period of proctoring as recommended by the Credentials Committee/ Medical Executive Committee. Proctoring shall be conducted under the auspices of the Credentials Committee/Medical Executive Committee. The duty of the proctor is not to participate in patient care, but to review and report to the committee. The Chief of Staff shall appoint proctors, and the persons appointed shall be deemed members of the Credentials Committee/Medical Executive Committee with respect to serving as a proctor. 5.08-2 Guidelines The Credentials Committee/Medical Executive Committee shall develop Rules and Regulations (subject to approval by the Medical Executive Committee and the Governing Body) to implement the following guidelines relative to proctoring: Proctoring will begin immediately, with the first case scheduled or admitted, following appointment (including locum tenens appointments) to the Staff. Proctoring may be required whenever indicated for the evaluation of professional competence or performance. The applicant shall arrange for the proctor, from the proctoring panel designated by the Credentials Committee/ Medical Executive Committee. Proctors shall submit written reports on appropriate evaluation forms promptly following each case evaluated. The Credentials Committee/Medical Executive Committee shall require sufficient evaluations to provide adequate bases for determining competency or defining privileges. In circumstances where the Medical Executive Committee determines that proctoring at this Hospital would be unreasonably burdensome or otherwise not reasonably practical or possible, proctoring reports from other facilities may be accepted; provided, however:
Such reports must be on the Hospital's proctoring forms, or on such other forms as are determined by the Chief of Staff to provide comparable information as required by this Hospital; and such reports must relate to cases performed within the immediately preceding two year period. Each Provisional member shall be proctored in accordance with proctoring requirements established by the Medical Executive Committee, in accordance with the provisions of Section 5.08. A member remains in Provisional status until he/she meets all the qualifications and has successfully completed his/her proctoring program. Provisional appointments are for not less than six months, and a member may serve no more than two consecutive six month terms as a Provisional Staff member. The Chief of Staff shall certify satisfactory completion of the Provisional period to the Credentials Committee/Medical Executive Committee and the Chief Executive Officer."

2. On 6/1/15 at 2:15 p.m., during an observation of the emergency department (ED), six (6) vials of Fentanyl (a narcotic analgesic), containing 100 micrograms in 2 milliliters, lot number 052391, were found to have an expiration date of 5/2015.

On 6/1/15 at 2:17 p.m., during an interview, the emergency department Manager (EDM) stated, "The nurses at the end of the month are supposed to do outdates [removal of expired medications], and those are outdated." EDM stated the Fentanyl should have been removed.

On 6/3/15 at 8:03 a.m., during an interview, the contracted Pharmacist (CP) stated, "I am only in acute one day a month. I do as much as I can. I can't go through [all medications] every single time, so I spot check. I go through the locked box. I go through the narcotics counts very closely. Because I'm only there once a month they [nurses] have to check too. It isn't feasible for me to go through every single drug every single time. I do go through the double locked meds [medications kept in an locked area inside another locked area]."

The hospital's contract with the pharmacy service initiated 4/1/13, indicated, "...Perform medication room audits and inspect for proper storage, temperature controls, and medication expiration dates."

The hospital's policy and procedure entitled, "Disposition of Discontinued, Outdated, or Poorly Labeled Medications", dated 3/25/13, indicated, "Nursing or Pharmacy will remove all outdated and discontinued medication..."

On 6/4/15, at 10:31 a.m., during an interview with the Chief Executive Officer (CEO 3) and the Chief Nursing Officer (CNO) the hospital's quality assurance program was discussed. The fact that specific services required by the contractors (Medical staff, Dietary, and Pharmacy) were not being provided was discussed. CEO 3 stated, "We need to be more proactive about these things." The CNO stated, "We don't have a formalized way to hold contractors accountable."

3. On 6/3/15 at 11:00 a.m., during an interview, the CEO acknowledged he was responsible for the operation of the hospital and contracted services. Concern with the nutrition services was discussed. CEO stated that he had not had any problems with the registered dietitians' (RD) work. CEO acknowledged that there was no formal evaluation of the nutrition care process to ensure hospital policy was followed.

Based on observation, interview, clinical and administrative document review, the hospital failed to ensure policies were developed and implemented for the provision of services to patients when:

1. Policies and procedures to direct patient nutrition care were not implemented. (Refer to C-0271)

2. Policies ensuring expired medications were not available for use were not implemented. (Refer to C-0276)

3. Policies were not developed and implemented to ensure the humidity and air exchanges in the endoscopy room were monitored. (Refer to C-0278)

4. The infection control program failed to ensure ice machines were maintained in a sanitary condition. (Refer to C-0278)

5. The services furnished under contract by the Dietician were not evaluated to ensure the hospital was complying with the conditions of participation. (Refer to C-0292)

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

Based on observation, interview and administrative document review, the hospital failed to implement written patient care policies for nutrition care.

Failure to implement policies directing nutrition care puts all patients at risk of compromised nutritional status which could impair the healing process.

Findings:

Review of the Consulting Dietitian Agreement, dated October 1, 2014, indicated standards of professional practice and duties of consulting dietitian shall be established by the hospital, and the consultant dietitian shall complete nutritional assessments according to the hospital policies and procedures.

On 6/3/15 at 11a.m., during an interview, the Chief Executive Officer (CEO 3) stated there were no written policies and procedures to specify the professional practices and duties the hospital expected the consultant dietitian to follow to provide nutrition care to the patients, as written in the contract.

On 6/3/15 at 2:00 p.m., during a telephone interview, the consultant dietitian acknowledged there was a contract, but no policies for nutrition services were provided to provide direction for nutrition assessment content, follow up time frames, care planning, and follow up criteria.

The hospital provided a policy with no hospital identification, titled "Nutrition screening/dietitian referral," dated 12/18/06, indicated, "in order to provide appropriate and timely nutrition assessment and interventions, nursing staff will screen all patients upon admission. The dietitian will be notified by phone or FAX when the dietitian is not on the premises, for all patients. The registered dietitian will complete the nutrition assessment within 24 hours of being notified. The assessment will include recommendations for and/or changes in the nutrition intervention for the patient in question."

Based on observation, staff interview, clinical record and administrative document review, the hospital failed to ensure that policies governing the use of drugs were followed when expired medications were found available for use in patient care areas.

These failures resulted in the potential for patients to suffer harm due to ineffective or unavailable medications.

Findings:

On 6/1/15 at 2:15 p.m., during an observation of the emergency department (ED), six (6) vials of Fentanyl (a narcotic analgesic), containing 100 micrograms in 2 milliliters, lot number 052391, were found to have an expiration date of 5/2015.

On 6/1/15 at 2:17 p.m., during an interview, the emergency department Manager (EDM) stated, "The nurses at the end of the month are supposed to do outdates, and those are outdated. They were missed."

On 6/3/15 at 8:03 a.m., during an interview, the contracted Pharmacist (CP) stated, "I am only in acute one day a month. I do as much as I can. I can't go through every single time, so I spot check. I go through the locked box. I go through the narcotics counts very closely. Because I'm only there once a month, they [nurses] have to check too. It isn't feasible for me to go through every single drug every single time. I do go through the double locked meds."

The hospital's contract with the pharmacy service initiated 4/1/13, indicated, "...Perform medication room audits and inspect for proper storage, temperature controls, and medication expiration dates."

The hospital's policy and procedure entitled, "Disposition of Discontinued, Outdated, or Poorly Labeled Medications", dated 3/25/13, indicated, "Nursing or Pharmacy will remove all outdated and discontinued medication..."

Based on observation and staff interview, the hospital failed to ensure there was a system in place for controlling infections when:

1. The humidity and number of air exchanges were not monitored in the room used for endoscopy (exams for the throat, stomach and bowel) procedures.

2. The kitchen bin style ice machine and two of two chute ice machines were not maintained in sanitary condition.

This failure had the potential for infectious organisms to grow and be transmitted to patients.

Findings:

1. On 6/1/15 at 3 p.m., during an observation of the operating room (OR) used for endoscopies, there was no gauge for measuring the humidity of the room.

On 6/4/15 at 3 p.m., during an interview, the Chief Nursing Officer (CNO) stated she had asked the former CNO, who is now in charge of endoscopy, about the OR humidity. The former CNO told the current CNO that humidity didn't matter because it was being used for endoscopy not surgery. The current CNO stated the hospital followed the infection control guidelines set forth by the Association for Professionals in Infection Control and Epidemiology (APIC) for endoscopy procedures. The CNO stated the Infection Control Nurse gave her the APIC guidelines for humidity in endoscopy rooms showing the humidity needed to be between 30 and 60%. The APIC guidelines indicated the endoscopy room must have at least six (6) air exchanges per hour. The CNO stated the hospital had no records for the air exchange rate for the endoscopy room.

The APIC Text book online, dated 2015, indicated "Gastrointestinal endoscopy room...6 minimum total air exchanges per hour...30-60% relative humidity."

The facility did not have a policy related to humidity in the endoscopy room.

2. On 6/2/15 at 8:20 a.m., during an observation and concurrent interview, Maintenance III staff (MS1), stated he was responsible for cleaning the ice-making part of the kitchen bin style ice machine every 6 months. MS1 stated he sprayed a bleach solution on the ice making components and cleaned with a tooth brush. MS1 stated he used a nickel safe ice machine cleaner and rinsed the machine after cleaning. MS1 acknowledged he did not run a sanitizing solution through the ice making components when servicing the ice machine. The bin ice machine harvester (ice making component responsible for forming the ice cubes) was corroded and pitted with no visible smooth surface.

MS1 acknowledged the harvester surface was in bad condition and that the ice machine was old. MS1 stated he had not brought the condition of the ice machine to the attention of anyone and just cleaned regularly.

On 6/2/15 at 8:40 a.m., during an observation and concurrent staff interview, the dining room chute ice machine had a white scale on the bottom of the plastic chute (ice dispensing area). The white scaly deposits were approximately ¼ inch high completely around the lip of the chute dispenser. Maintenance III staff (MS1) stated they had hard water and the white scale was the hard water deposit. MS1 acknowledged the chute needed to be cleaned to remove all of the deposits.

On 6/2/15 at 8:45 a.m., during a concurrent interview and observation of the acute unit chute style ice machine, there were white to yellow colored deposits in the bottom of the drip tray. The plastic chute had white scaly appearing deposits. MS1 stated the facility had hard water and this substance was the hard water deposit. MS1 acknowledged the chute and drip tray needed to be cleaned to remove all of the deposits. In a concurrent interview with the Chief Nursing Officer (CNO) and the Infection Control Nurse (IC), both acknowledged they were not aware of the poor condition of the ice machine and the potential of infection when the ice making components were not cleanable or the ice machines were not sanitized as specified by the manufacturer. The IC acknowledged she was not aware of the condition of the ice machine or how the ice machine was being cleaned and sanitized as part of the infection control surveillance program.

The manufacturer's directions for use, issued 5/6/2009, indicated that proper maintenance required the nickel free ice machine cleaner to be run through the ice machine followed by a sanitizing solution of bleach.

The Food and Drug Administration (FDA) Food Code 2013, section 4-501, indicated Section 4-201 states equipment and utensils must be designed and constructed to be durable and capable of retaining their original characteristics so the such items can continue to fulfill their intended purpose for the duration of their life and to maintain their easy cleanability. If they cannot maintain their original characteristics (smooth surface), they may become difficult to clean, allowing for the harborage (provide shelter) of pathogenic (cause illness) microorganisms (bacteria).

Based on observation, staff interview, and administrative document review, the hospital failed to ensure nutrition services, furnished under contract, allowed the Hospital to comply with applicable Conditions of Participation as evidenced by no evaluation of contracted registered dietitian services.

Failure to evaluate contracted services puts all patients at risk of compromised nutrtional status which could lead to compromised medical status.

Findings:

On 6/3/15 at 11:00 a.m., during an interview, the Chief Executive Officer (CEO 3) stated the Consultant Dietitian Agreement, dated October 1, 2014, did not include provisions for evaluation of services provided by the consultant dietitian. CEO 3 acknowledged this agreement only referred to standards to be established for nutrition care but there were no standards developed, approved by medical staff and governing body. CEO 3 stated the contract renewal was an informal process.

On 6/3/15 at 2:00 p.m., during a telephone interview, the consultant dietitian (RD) stated he was not involved in quality evaluation of the food service operation or the clinical nutrition services he provided. The RD acknowledged there needed to be quality evaluation of the food service operation and the clinical nutrition services.

On 6/4/15, at 10:31 a.m., during an interview with the Chief Executive Officer (CEO 3) and the Chief Nursing Officer (CNO) the hospital's quality assurance program was discussed. The fact that specific services required by the contractors (Medical staff, Dietary, and Pharmacy) were not being provided was discussed. CEO 3 stated, "We need to be more proactive about these things." The CNO stated, "We don't have a formalized way to hold contractors accountable."

Based on staff interview and administrative document review, the hospital failed to have an effective quality assurance program for contracted services which were not evaluated for the quality of care provided to patients when:

1. Ongoing monitoring of medical staff credentialing was not conducted and members of the medical staff were appointed without a review process to determine they were professionally qualified for the positions to which they were appointed and for the performance of privileges granted. (Refer to C-0337)

2. The services provided by the contracted Pharmacist was not evaluated to determine they met the requirements for compliance with the conditions of participation. (Refer to C-0337)

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

Based on staff interview and administrative document review, the hospital failed to have an effective quality assurance program that evaluated the quality and appropriateness of care provided to patients when:

1. Ongoing monitoring of medical staff credentialing was not conducted and members of the medical staff were appointed without a review process to determine they were professionally qualified for the positions to which they were appointed and for the performance of privileges granted as evidenced by:

a.) four (4) of eighteen (18) members of the medical staff (MD 5, MD 6, MD 7, MD 8) who had previously been granted privileges were reappointed without being reappraised for competence;

b.) three (3) of eighteen (18) members of the medical staff (MD 10, MD 11, MD 12) were granted clinical privileges and allowed to practice without being proctored; and

c.) five (5) out of a total of eighteen (18) members of the medical staff (MD 9, MD 10, MD 11, MD 12, MD 13) were granted privileges and given extended two (2) year provisional appointments where the maximum was two consecutive 6-month appointments.
(Refer to C-241)


2. The services provided by the contracted Pharmacist was not evaluated to determine services provided were in compliance with the conditions of participation.

Theses failures resulted in the potential of providing substandard quality of services to patients.

Findings:

1. On 6/1/15 at 1:30 p.m. and on 6/2/15 at 9 a.m., during a concurrent interview and review of the credentialing and peer review process, 18 physician credential files were reviewed with the Chief Executive Officer (CEO 3) and Medical Staff Coordinator (CC 1). The CEO 3 and CC 1 agreed the review of the credential files indicated: a.) four (4) out of a total of eighteen (18) members of the medical staff (MD 5, MD 6, MD 7, MD 8) who had previously been granted privileges were reappointed without being reappraised for competence, b.) three (3) out of a total of eighteen (18) members of the medical staff (MD 10, MD 11, MD 12) were granted clinical privileges and allowed to practice without being proctored, c.) five (5) out of a total of eighteen (18) members of the medical staff (MD 9, MD 10, MD 11, MD 12, MD 13) were granted privileges and given extended two (2) year provisional appointments where the maximum in the By-Laws was two consecutive 6-month appointments.

On 6/2/15 at 11 a.m., during an interview, the Chief Executive Officer (CEO 3) stated he understood he represented the governing body for the purposes of the interview. CEO 3 stated the Human Resources Coordinator/Medical Staff (CC 2) was the Medical Staff Credential Coordinator of the facility. CEO 3 stated overseeing and managing the Medical Staff credential files was one of her responsibilities. CEO 3 stated as the Chief Executive Officer of the facility, he had been made aware of the numerous problems and issues with the physician credential files including lack of documentation of peer review and the lack of documentation of proctoring. CEO 3 stated he knew the credentialing process had been performed in a casual manner, including the process for assessing medical staff members for competence before and after they were granted privileges. CEO 3 stated he knew the peer review process had been instituted for Medical Staff members previously given privileges and recently reappointed, however, it was done on an irregular and sporadic basis. CEO 3 stated he knew the proctoring process had been instituted for newly appointed Medical Staff members, however, it was done on an irregular and sporadic basis. CEO 3 stated he had made numerous efforts to discuss the credentialing issues with the Chief of the Medical Staff of the facility (MD 4) as a means of making him aware of the fact that they both had the responsibility for ensuring these duties were performed. CEO 3 stated he had discussed the fact that the credentialing process did not have sufficient support, assistance or oversight from the MD 4 with the Board of Directors of the facility on numerous previous occasions. CEO 3 stated the Board of Directors of the facility had made numerous efforts to discuss the credentialing issues with the Chief of the Medical Staff (MD 4) as a means of making him aware of the fact that he as the Chief of the Medical Staff had the responsibility for ensuring these duties were performed.

2. On 6/1/15 at 2:15 p.m., during an observation of the Emergency Department (ED), six (6) vials of Fentanyl (a narcotic analgesic), containing 100 micrograms in 2 milliliters, lot number 052391, were found to have an expiration date of 5/2015.

On 6/1/15 at 2:17 p.m., during an interview, the Emergency Department Manager (EDM) stated, "The nurses at the end of the month are supposed to do outdates, and those are outdated."

On 6/3/15 at 8:03 a.m., during an interview, the contracted Pharmacist (CP) stated, "I am only in acute one day a month. I do as much as I can. I can't go through [all medications] every single time, so I spot check. I go through the locked box. I go through the narcotics counts very closely. Because I'm only there once a month they [nurses] have to check too. It isn't feasible for me to go through every single drug every single time. I do go through the double locked meds [medications kept in an locked area inside another locked area]."

The hospital's contract with the pharmacy service initiated 4/1/13, indicated, "...Perform medication room audits and inspect for proper storage, temperature controls, and medication expiration dates."

On 6/4/15, at 10:31 a.m., during an interview with the Chief Executive Officer (CEO 3) and the Chief Nursing Officer (CNO) the hospital's quality assurance program was discussed. The fact that specific services required by the contractors (Medical staff, Dietary, and Pharmacy) were not being provided was discussed. CEO 3 stated, "We need to be more proactive about these things." The CNO stated, "We don't have a formalized way to hold contractors accountable."