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Based on document review and staff interview, the Critical Access Hospital (CAH) administrative staff failed to ensure the CAH's Medical Staff approved the blood bank agreement. The laboratory administrative staff reported the laboratory had 15 units of blood products available to CAH patients at the beginning of the survey. Failure to ensure a current, approved blood bank agreement was in place could potentially interrupt the availability of blood products needed for emergencies resulting in patient harm and/or death.

Findings include:

1. Review of the "Pricing Agreement, [Blood Bank I's name] Blood Center," revealed in part, "Term of this Commitment Form begins January 1, 2016..."

The CAH's Chief Executive Officer signed the agreement on 2/15/2016 (44 days after the contract went into force). The agreement lacked documentation the CAH's Medical Staff approved the agreement.


2. During an interview on 8/21/19 at 1:42 PM, the Chief Nurse Executive verified the CAH's Medical Staff failed to approve the Blood Product Supply Agreement, which commenced January 1, 2016).

Based on observation and staff interviews, Critical Access Hospital (CAH) staff failed to remove outdated supplies from the radiology department. Failure to remove outdated patient supplies, available for use in patient care, resulted in staff using the expired item for patient care in 6 of 6 patients (Patient #2, Patient #3, Patient #4, Patient #5, Patient #6, and Patient #7) after the manufacturer's expiration date, indicating the staff should not use the supplies for patient care. The CAH identified the radiology staff performed approximately 9 transvaginal ultrasound (a type of ultrasound used to examine female reproductive organs) procedures per month.

Findings include:

1. Observations on 8/20/2019 at 11:10 AM, during a tour of the Radiology Department, revealed an open box labeled Chemical Indicator (a qualitative chemical indicator designed to monitor the minimum effective concentration of the disinfectant during the trophon high level disinfection process of a transvaginal [through the vagina] ultrasound probe), which expired 7/31/19.

2. Review of "Chemical Indicator Instructions for Use," dated 5/2018, revealed in part, "Discard any unused Chemical Indicators after the expiration date." "Do not use Chemical Indicator after expiration date as shown on packaging."

3. Review of document "Trophon EPR High Level Disinfection Log," dated 10/13/16, revealed in part, "NEW CHEMICAL INDICATOR BOX: When opening a new box of CHEMICAL INDICATORS, document: LOT BATCH [number and Expiration] DATE." The CAH staff documented the chemical indicator's lot batch number and the chemical indicator's expiration date as "7-31-19" on the log.

Further review of the disinfection log revealed the CAH staff performed 6 trophon high level disinfection cycles between 8/1/2019 - 8/13/2019 utilizing the expired chemical indicator:

a. Patient #2, Cycle #164, 08/01/2019 2:04 PM

b. Patient #3, Cycle #165, 08/01/2019 2:58 PM

c. Patient #4, Cycle #166, 08/02/2019 8:36 AM

d. Patient #5, Cycle #168, 08/06/2019 2:10 PM

e. Patient #6, Cycle #169, 08/06/2019 3:03 PM

f. Patient #7, Cycle #170, 08/13/2019 9:53 AM


4. During an interview at the time of the tour, Radiology Technologist A acknowledged the Chemical Indicator strips, available for use in trophon high level disinfection, expired 7/31/2019 and the radiology staff utilized the Chemical indicator strips after the expiration date in 6 high level disinfection cycles August 1 - 13, 2019.

5. During an interview at the time of the tour, the Director of Imaging acknowledged the radiology staff failed to remove the expired indicators from the patient care area and the radiology staff utilized the expired chemical indicator in 6 of 6 high level disinfection cycles. The Director of Imaging reported the radiology department lacked a policy on checking for expired supplies.

Based on review of policies, meeting minutes, and staff interviews, the Critical Access Hospital (CAH) administrative staff failed to ensure the required group of professionals, including a physician and a mid-level provider, reviewed all patient care policies annually for 15 of 23 patient care departments (Administration, Cardiac Rehabilitation, Specialty Clinics, Environmental Services, Infection Prevention, Laboratory, Information Systems, Anesthesia, Imaging, Nutritional Services, Skilled Nursing, Pharmacy, Physical Rehabilitation, Health Information Management, and Diabetic Education). The CAH administrative staff identified a census of 8 patients at the beginning of the survey. Failure to ensure the required group of professionals reviewed all patient care policies annually could potentially result in failure to identify patient care needs not addressed in the CAH policies/procedures.

Findings include:

1. Review of CAH policy "Policy Manual Review," revised 7/2018, revealed in part, "...All new policies will be developed with the advice of a group of professional personnel, including a physician, nurse practitioners, clinical nurse specialist, if they are on staff....called the CAH policy review committee...Policies are reviewed, as needed but at least annually, by the CAH policy review committee...."

2. Review of Policy Review Committee Meeting minutes, dated May 22, 2018, revealed in part, Approve Diabetic Education Manual.

The Diabetic Education policies lacked evidence of annual approval of policies.

Review of Policy Review Committee Meeting minutes, dated August 28, 2018, revealed in part, Approve policy manuals for Administration, Cardiac Rehabilitation, Specialty Clinics, Infection Prevention, Laboratory, and Information Systems. The meeting minutes revealed Environmental Services had no policies to review in the manual. The meeting minutes lacked documentation a physician and a mid-level provider attended the meeting to approve the stated policy manuals.

Review of Policy Review Committee Meeting minutes, dated May 28, 2019, revealed in part, Approve policy manuals for Anesthesia, Imaging, Nutritional Services, Skilled Nursing, Pharmacy, Physical Rehabilitation, Safety, and Emergency Preparedness, and Health Information Management. The meeting minutes lacked documentation a mid-level provider attended the meeting to approve the stated policy manuals.

3. During an interview on 8/21/2019 at 9:40 AM, the Chief Nursing Officer confirmed the lack of annual policy review for Administration, Cardiac Rehabilitation, Specialty Clinics, Infection Prevention, Laboratory, Information Systems, Anesthesia, Imaging, Nutritional Services, Skilled Nursing, Pharmacy, Physical Rehabilitation, Health Information Management, and Diabetic Education by a physician and a mid-level provider.

During an interview on 8/21/2019 at 9:50 AM, the Chief Operating Officer acknowledged the lack of Environmental Services policies by a physician and a mid-level provider as there are no Environmental Services policies at this time.

Based on document review and staff interview, the Critical Access Hospital (CAH) administrative staff failed to ensure timely physician notification for the occurrence of a medication error for 3 of 11 medication errors reviewed. (Patient #3). Failure to notify the physician of medication errors could potentially result in the provider not knowing about the medication error and either failing to take steps to address the consequences of the medication error, or the provider making a medical decision without the knowledge of the medication error, either way potentially resulting in inappropriate treatment or even a fatal reaction. The CAH administrative staff reported a census of 8 patients on entrance, and an average daily census of 2 patients per day.

Findings include:

1. Review of the policy "Medication Errors," last approved 05/2017, revealed in part: "An error type can be wrong dose ...wrong administration technique ...When a medication error occurs that reaches the patient, the error will be reported directly to the physician."

2. Review of medication errors from April 2019 to August 2019 revealed:

a. The nursing staff made a medication error on 7/04/2019 at 9:47 AM which involved Patient #1. Patient #1's medication error paperwork lacked documentation that the nursing staff notified the practitioner responsible for Patient #1's medical care of the medication error.

b. The nursing staff made a medication error on 7/09/2019 at 11:45 AM which involved Patient #1. Patient #1's medication error paperwork lacked documentation that the nursing staff notified the practitioner responsible for Patient #1's medical care of the medication error.

c. The nursing staff made a medication error on 8/03/2019 at 05:34 AM which involved Patient #1. Patient #1's medication error paperwork lacked documentation that the nursing staff notified the practitioner responsible for Patient #1's medical care of the medication error.

3. During an interview on 8/20/2019 at 02:18 PM, the Director of Quality acknowledged the medication error paperwork for Patient #1 lacked documentation that the nursing staff notified the patient's provider of the medication error.

Based on observation, policy review, and staff interview, the Critical Access Hospital (CAH) x-ray staff failed to ensure 1 of 1 radiation exposure cord was secured to not allow staff access into the x-ray room during completion of tests of patients. The CAH x-ray staff reported completing an average of 300 x-rays per month. Failure to secure radiation exposure cords could allow staff access to the x-ray room while performing an x-ray procedure and exposing staff to unnecessary radiation.

Findings include:

1. During tour of the radiology department on 8/20/2019 at 10:55 AM, with the Director of Imaging, revealed 1 of 1 exposure cord in Imaging Room 1, that was not secured and reached to the edge of the room allowing X-ray staff to stand in the x-ray room during x-ray procedures.

2. Review of CAH policy "IMAGING Departmental Safety" dated revised 4/17/2019, revealed in part, "...purpose of this policy is to ensure the safety of the staff ... while in the Imaging Department." The policy lacked guidance related to radiation safety for staff while performing x-ray procedures.

3. During an interview on 8/20/2019 at 10:55 AM. the Director of Imaging confirmed the radiation exposure cord was not secured and would allow staff to access into the x-ray room during x-ray procedures.

Based on document review, and staff interviews, the Critical Access Hospital's (CAH) administrative staff failed to ensure 1 of 1 General Surgeon (General Surgeon H) had surgical privileges to perform novasure ablations and dilation/curettage procedures prior to performing the surgical procedures. Failure to ensure General Surgeon H had surgical privileges to perform novasure ablations and dilation/curettage procedures could potentially result in CAH staff allowing General Surgeon H to perform a procedure that he lacked competence and skill to safely perform. The CAH staff identified General Surgeon H performed 4 novasure ablations (Patient #9, Patient #18, Patient #19, and Patient # 20) and 6 dilation/curettage procedures (Patient #13, Patient #14, Patient #15, Patient #16, Patient #17, and Patient # 12) from 2/2019 to 7/2019.

Findings include:

1. Review of General Surgeon H's surgical privileges (a list of procedures the medical staff and governing body of the CAH approved the General Surgeon to perform at the CAH), dated 3/22/2018 to 3/31/2020, revealed General Surgeon H lacked approval by the medical staff and governing body to perform novasure ablations (the surgical destruction of the lining tissues of the uterus) and dilations/curettage (D&C) procedures (a gynecological surgical procedure to remove a part of the uterus and/or contents of the uterus by scraping). The Medical Staff approved General Surgeon H's privileges on 3/20/18. The Board of Trustees approved General Surgeon H's privileges on 3/22/18.

2. Review of the Bylaws of the Medical Staff, approved 11/13/2018 by the Medical Staff and 11/20/2018 by the Governing Body, revealed in part, "... Every practitioner practicing at this Hospital by virtue of Medical Staff membership or otherwise, shall in connection with such practice, be entitled to exercise only those clinical privileges specifically granted to him/her by the board ...."

3. Review of medical records revealed the following:

a. General Surgeon H performed a D&C procedure on Patient #13 on 2/13/19.
b. General Surgeon H performed a D&C procedure on Patient #14 on 4/8/19.
c. General Surgeon H performed a D&C procedure on Patient #15 on 4/16/19.
d. General Surgeon H performed a D&C procedure on Patient #16 on 4/23/19.
e. General Surgeon H performed a D&C procedure on Patient #17 on 8/13/19.
f. General Surgeon H performed a D&C procedure on Patient #12 on 8/21/19.

g. General Surgeon H performed a novasure ablation on Patient #9 on 5/9/19.
h. General Surgeon H performed a novasure ablation on Patient #18 on 6/4/19.
i. General Surgeon H performed a novasure ablation on Patient #19 on 6/19/19.
j. General Surgeon H performed a novasure ablation on Patient #20 on 7/18/19.


4. During an interview on 8/20/2019 at 9:15 AM, the Director of Nursing (DON), when questioned about new procedures, stated "the newest procedure being done was novasure ablations by [General Surgeon H's name]." The DON reviewed a list of surgical privileges available to the surgery staff and determined General Surgeon H's privilege list lacked surgical privileges to perform novasure ablations and D&Cs.

5. During an interview on 8/21/2019 at 3:50 PM, General Surgeon H acknowledged his current privilege list lacked privileges to perform novasure ablations and D&Cs at the CAH. When questioned about General Surgeon H's process for requesting and reviewing his privileges, General Surgeon H indicated he filled out the privilege list form himself, and that he failed to request privileges to perform novasure ablations and D&Cs at the CAH.

Based on review of closed surgical patient medical records and staff interviews, the Critical Access Hospital (CAH) anesthesia staff failed to ensure they accurately documented the time of the post-anesthesia evaluation for 3 of 5 patients which required anesthesia for a surgical procedure (Patient #8, Patient #10, and Patient #12). Failure to accurately document the time anesthesia staff completed the post-anesthesia evaluation could potentially result in the patients developing complications and the other medical providers failing to adequately address the complications, as the other medical providers lacked a clear timeline for the patient's care. The CAH staff identified 304 patients received anesthesia from 01/07/2019 to 08/21/2019.

Findings include:

1. Review of closed surgical patient medical records revealed:

a. Patient #8 underwent surgical repair of an umbilical hernia on 5/1/19. The CAH staff took Patient #8 to the Operating Room (OR) at 10:32 AM. Following the surgical procedure, the CRNA took Patient #8 to the Post-Anesthesia Care Unit (PACU) at 11:20 AM. The CRNA documented they completed the post-anesthesia evaluation at 11:12 AM. (8 minutes before Patient #8 left the OR)

b. Patient #10 underwent a laproscopic appendectomy (surgical removal of the appendix) on 5/2/19. The CAH staff took Patient #10 to the Operating Room at 4:39 PM. Following the surgical procedure, the CRNA took Patient #10 to the Post-Anesthesia Care Unit (PACU) at 6:04 PM. The CRNA documented they completed the post-anesthesia evaluation at 6:00 PM. (4 minutes before Patient #10 left the OR)

c. Patient #12 underwent dilation and curettage (scraping the walls of the uterus) on 8/21/19. The CAH staff took Patient #12 to the Operating Room (OR) at 12:36 PM. Following the surgical procedure, the CRNA took Patient #12 to the Post-Anesthesia Care Unit (PACU) at 1:23 PM. The CRNA documented they completed the post-anesthesia evaluation at 1:18 PM. (5 minutes before Patient #12 left the OR)


3. During an interview on 08/21/2019 at 1:30 PM, the Certified Registered Nurse Anesthetist (CRNA, a nurse with advanced training in administering anesthesia medications) acknowledged they documented the post-anesthesia evaluation for Patient #8, Patient #10, and Patient #12 prior to the time the CRNA documented the patients leaving the OR. The CRNA revealed the post-anesthesia evaluation occurred after the patients left the OR, but the CRNA failed to document the correct time that the CRNA performed the post-anesthesia evaluation.

4. During an interview on 08/22/2019 at 8:00 AM the Director of Acute Care Services acknowledged the CRNA failed to accurately document the time the CRNA conducted the post-anesthesia evaluation for Patient #8, Patient #10, and Patient #12.

Based on document review, policy review and staff interview, the Critical Access Hospital (CAH) administrative staff failed to ensure 1 of 5 active physicians (Physician C) , 2 of 2 applicable courtesy physicians (Physician B and Physician F) and 3 of 3 consulting physicians (Physician D, Physician E, and Physician G) selected for review, received outside entity peer review to evaluate the appropriateness of diagnosis and treatment furnished to patients at the Critical Access Hospital. Failure to ensure all medical staff members received outside entity peer review affects the CAH's ability to assure physicians provide quality care to the CAH patients.

The CAH administrative staff identified the physicians provided care to the following number of patients during Fiscal Year 2018:

- Physician B: 5 patients
- Physician C: 1,155 clinic patients, 36 clinic procedures, 36 surgical procedures
- Physician F: 42 clinic patients, 54 surgical procedures
1/1/2018 to 12/31/18:
- Physician G: 6 patients

The CAH administrative staff identified the physicians provided care to the following number of patients from 6/28/17 to 8/21/19:

- Physician D: 2,592 patients
- Physician E: 1,613 patients

Findings include:

1. Review of the CAH's network agreement, date 7/1/02. revealed in part " ... [Network Hospital] shall assist [CAH] in reviewing the quality and appropriateness of the diagnoses and treatment furnished by [CAH] physicians ..."

2. Review of a CAH policy "Provider Peer Review," revised 8/2018, revealed in part "The CAH will ensure two records involving each provider is reviewed by the network hospital during each credentialing period. External peer review will be completed by [Network Hospital] for [CAH]. The network hospital is required to conduct peer review under the Critical Access Hospital Conditions of Participation ..."

3. Review of external peer review completed for the applicable physicians selected for review revealed the following:

a. The medical staff approved Physician B for reappointment to the Medical Staff on 9/18/18. The Board of Trustees approved Physician B for reappointment to the Medical Staff on 9/27/18. Physician B's file lacked the results of any external peer review conducted prior to Physician B's reappointment to the Medical Staff.

b. The medical staff approved Physician C for reappointment to the Medical Staff on 3/20/18. The Board of Trustees approved Physician B for reappointment to the Medical Staff on 3/22/18. Physician C's credential file only contained the results of 1 external peer review conducted prior to Physician C's reappointment to the Medical Staff.

c. The medical staff approved Physician D for reappointment to the Medical Staff on 6/19/18. The Board of Trustees approved Physician D for reappointment to the Medical Staff on 6/28/18. Physician D's file lacked the results of any external peer review conducted prior to Physician D's reappointment to the Medical Staff.

d. The medical staff approved Physician E for reappointment to the Medical Staff on 6/19/18. The Board of Trustees approved Physician D for reappointment to the Medical Staff on 6/28/18. Physician D's file lacked the results of any external peer review conducted prior to Physician D's reappointment to the Medical Staff.

e. The medical staff approved Physician F for reappointment to the Medical Staff on 6/19/18. The Board of Trustees approved Physician D for reappointment to the Medical Staff on 6/19/18. Physician D's file lacked the results of any external peer review conducted prior to Physician D's reappointment to the Medical Staff.

f. The medical staff approved Physician G for reappointment to the Medical Staff on 12/18/18. The Board of Trustees approved Physician G for reappointment to the Medical Staff on 12/20/18. Physician G's file lacked the results of any external peer review conducted prior to Physician G's reappointment to the Medical Staff.


4. During an interview on 8/21/19 at 1:35 PM, the Chief Nursing Officer acknowledged the CAH had the results of only 1 external peer review for Physician C and lacked any external peer review for Physician B and Physician F prior to their reappointment to the Medical Staff. She reported she would check with the department managers to see if they had any external peer review for Physician D, Physician E, and Physician G.

5. During an interview on 8/21/19 at 3:25 PM, the Chief Operating Officer provided a compilation of peer review results, which included Physician D and Physician E, but acknowledged the peer review results applied to all of the physicians practicing in Physician D and Physician E's group, but lacked information specific to Physician D's and Physician E's patient care at the CAH.

6. During an interview on 8/22/19 at 8:40 AM, the Laboratory Director reported he receives a quarterly external peer review results for Physician G, but the information provided to the CAH staff for Physician G was compiled from Physician G's work at all of the hospitals in the network. The information provided was not specific to the care Physician G provided to patients at the CAH.

7. During an interview on 8/22/19 at 9:20 AM, the Chief Nursing Officer confirmed the CAH failed to complete external peer review for Physician B, Physician C, Physician D, Physician E, Physician F, and Physician G prior to their reappointment.