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Based on review of documents and staff interview, the Critical Access Hospital (CAH) administrative staff failed to ensure the Network Hospital designated a qualified member of the Network Hospital staff to serve on the CAH's quality assurance committee and medical staff committee in accordance with the Network Agreement. The CAH administrative staff identified a census of 9 patients at the beginning of the survey. Failure to ensure the Network Hospital staff served on the CAH's quality assurance and medical staff committees, in accordance with the Network Agreement, could potentially result in the inability of the CAH to determine the level of assistance to be provided by the Network Hospital and the responsibilities of the CAH staff related to quality assurance and medical staff.

Findings include:

1. Review of the Network Agreement, dated July 1, 2017, revealed the following in part, ". . . [Network Hospital] shall designate a qualified member of its staff ("Member"), and CAH agrees to appoint the Member to serve as an ad hoc member on CAH's quality assurance committee and medical staff committee...."

2. Review of CAH's Quality Council meeting minutes from February 14, 2019 through November 14, 2019 lacked evidence the Network Hospital had a representative on the CAH's Quality Council committee.

Review of CAH's Medical Staff meeting minutes from February 13, 2019 through November 12, 2109 lacked evidence the Network Hospital had a representative on the CAH's Medical Staff committee.

3. During an interview on 12/11/2019 at 9:30 AM, the Assistant Administrator, Nursing acknowledged the CAH's Quality Council committee and on the CAH's Medical Staff committee lacked a representative of the Network Hospital on the committees.

Based on observation, staff interview, and document review, the Critical Access Hospital (CAH) administrative staff failed to ensure the CAH had 25 or less beds available for inpatient use. Failure to ensure the CAH staff maintained 25 or less inpatient beds could potentially result in the CAH staff potentially admitting more patients than they had the staff capacity to care for, potentially resulting in the CAH staff failing to ensure each patient received the necessary care. The CAH administrative staff identified a census of 9 inpatients on entrance.

Findings include:

1. Observations during a tour of the Medical-Surgical inpatient unit on 2/09/2019 at 9:20 AM revealed 22 inpatient beds available for patient care. Further observations during a tour of the Family Birth Center unit on 12/09/2019 at 9:30 AM revealed 4 OB inpatient beds available for patient care.

2. Review of CAH's "Critical Access Acute Census Management policy," approved 08/2019, revealed, in part, "[CAH] census will be maintained at or below 25 inpatient acute and/or swing patients ... including OB... A crib used for a pediatric patient will count toward the 25 bed limit thus an inpatient hospital bed will need to be placed out of service while the crib is in use".

3. During at interview on 12/09/2019 at 1:20 PM, Assistant Administrator of Nursing acknowledged the bed count of 22 Med/Surg/Swing beds and 4 Labor, Delivery, Recovery, Postpartum (LDRP) beds resulted in 26 beds available for inpatient use.

I. Based on observations, document review, and staff interview, the Critical Access Hospital (CAH) failed to maintain hot water temperatures between 110 and 120 degrees Fahrenheit in 2 of 3 the Outpatient Infusion Clinic (OIC) room sinks tested (Room #1 and Room #3). Failure to maintain water temperatures between 110 and 120 degrees Fahrenheit (F) in patient care areas could potentially result in the hot water burning patients. The CAH identified the OIC had approximately 2,832 patient visits per year.

Findings include:

1. Observations on 12/10/2019 beginning at approximately 2:50 PM during a tour of the OIC revealed the following:

a. Exam Room #1, water temperature in the sink used by patients was 122.0 degrees Fahrenheit (F) . Further observation and retesting of the hot water temperature in the sink at 3:15 PM with Engineer B revealed a temperature of 123.4 degrees F.

b. Exam Room #3, water temperature in the sink used by patients was 126.9 degrees F. Further observation and retesting of the hot water temperature in the sink at 3:15 PM with RN C and Engineer B revealed a temperature of 129.1 degrees F.

2. During an interview at the time of the observations, Engineer B confirmed the water temperatures exceeded 120 degrees F.

3. Review of the policy "Maintenance and Monitoring of Water Systems," last approved 10/2019, revealed in part, "...If any temperatures are above 120 degrees the hot water system will need adjusted to maintain the correct temp...below 120 degrees."







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II. Based on observation and staff interviews, the Critical Access Hospital (CAH) failed to remove outdated supplies from the Medical/Surgical Unit (Med/Surg), The Pain Clinic, Family Medical Center, South, and Family Medical Center, North. Failure to remove outdated patient supplies from the CAH's Med/Surg, The Pain Clinic, Family Medical Center, South and Family Medical Center, North supplies, resulted in expired supplies remaining available for use in patient care, potentially resulted in staff using the expired items for patient care after the manufacturers' expiration date (the date after which the manufacturer will no longer guarantee the safety and quality of the supply). The CAH identified a census of 9 inpatients on entrance, an average of 47 patient visits per month in the Pain Clinic, 19,299 patients visits per year in the Family Medical Center, South, and 16,904 patient visits per year in the Family Medical Center, North.

Findings include:

1. Observations during a tour of the Med/Surg Unit on 12/09/2019 at 10:10 AM, revealed the following expired supplies:

Crash Cart
a. 2 of 2 Blue top lab draw vials, 2 expired 04/30/2019
b. 2 of 2 Red top lab draw vials, expired 03/31/2019

Intraosseous (IO) pack in the crash cart
a. 1 of 1 IO needle set 15 G x 25mm blue package, expired 11/30/2019
b. 1 of 1 IO needle set 18mm x 15mm pink package, expired 01/20/2019
c. 1 of 1 2 % Lidocaine (a medication used to numb tissue as a local anesthetic) syringe 100mg, expired 10/2019
d. 2 of 2 Saline flushes, expired 11/1/2019

Pediatric Crash Cart
a. 1 of 2 pediatric defibrillator pads, expired 11/02/2019
b. 3 of 3 disposable oxygen saturation finger monitor(SAT), 2 expired 11/2018 and 1 expired 10/31/2019

2. During an interview at the time of the tour, the Director of Inpatient Services revealed they expected the Med/Surg staff to check the supplies every month and remove any outdated supplies. The Director of Inpatient Services acknowledged the Med/Surg staff failed to remove the expired supplies from the Med/ Surg unit. The Director of Inpatient Services then acknowledged that since the Med/Surg staff failed to remove the expired supplies from the unit, the Med/Surg staff could potentially use the expired supplies for patient care.

3. Observations during a tour of the Pain Clinic on 12/11/2019 at 1:00 PM revealed the following expired supplies:

Crash Cart
a. 4 of 4, 22 gauge x 1 1/2 inch IV catheters, 4 expired 05/2017
b. 5 of 5, 22 gauge x 1 inch IV catheters, expired 05/2017
c. 5 of 5, 20 gauge IV catheters, 3 expired 07/2018, 2 expired 04/2019
d. 5 of 5, 18 gauge IV catheters, expired 04/2019
e. 4 of 4 Saline flushes, expired 08/2017

4. During an interview at the time of the tour, the Director of Pain Clinic revealed they expected the pain clinic staff to check the supplies every month and remove any outdated supplies. Director of Pain Clinic acknowledged the pain clinic staff failed to remove the expired supplies from the Pain Clinic. The Director of Pain Clinic then acknowledged that since the pain clinic staff failed to remove the expired supplies from the department, the pain clinic staff could potentially use the expired supplies for patient care.

5. Observations during a tour of the Family Medicine Clinic, South, revealed the following in the Procedure Room:
a. 9 of 9 Integra Miltex dermal curettes (used to scrape lesions from patients skin), all expired 11/2019
b. 26 of 26 Protexis PI sterile surgical gloves, size 8, expired 10/2019
c. 1 of 9 Protexis PI sterile surgical gloves, size 7, expired 06/2019

6. During an interview at the time of the tour, the Director of North/South Clinics verified the expired supplies and the clinic staff failed to remove the expired supplies.

7. Observations during a tour of the Family Medical Clinic, North on 12/11/2019 at 10:50 AM, revealed the following expired supplies:

Procedure Room
a. 22 of 22, 25 gauge x 2 inch injection needles, expired 10/2019

8. During an interview at the time of the tour, the Director of North/South Clinics revealed they expected the clinic staff to check the supplies every month and remove any outdated supplies. The Director of North/South Clinics acknowledged the clinic staff failed to remove the expired supplies from the clinic. The Director of North/South Clinics then acknowledged that since the clinic staff failed to remove the expired supplies from the department, the clinic staff could potentially use the expired supplies for patient care.

Based on review of Board of Trustees meeting minutes and staff interviews, the Board of Trustees (governing body) failed to ensure the Board of Trustees administered policies to determine and maintain quality health care at the Critical Access Hospital.

The Board of Trustees failed to ensure the Medical Staff followed their bylaws in the credentialing of 4 of 4 mid-level providers that only worked in the out-patient clinics. (Refer to C-241)


The cumulative effect of these systemic failures and deficient practices resulted in the facility's inability to ensure the quality health care provided to patients.

Based on document review and staff interviews, the Critical Access Hospital's (CAH) Governing Board failed to ensure appointment for 5 of 5 mid-level providers to the CAH's medical staff in accordance with the Medical Staff Bylaws (Advanced Registered Nurse Practitioner (ARNP) F, ARNP G, ARNP H, Physician's Assistant (PA) I, and ARNP K). Failure of the Board of Trustees to ensure all providers caring for patients at the CAH were qualified to provide medical care may result in patients receiving substandard or inappropriate care. The CAH's administrative staff identified the following number of patients seen from November 1, 2018 to December 10, 2019 in the walk-in clinic: ARNP F 1,963; ARNP G 1,404; ARNP H 569; PA I; and ARNP K 0 without clinical privileges approved by the Governing Board.

Findings include:

1. Review of the Medical Staff roster failed to list ARNP F, ARNP G, ARNP H, PA I, and ARNP K as members of the Medical Staff.

2. Review of Medical Staff credential files lacked evidence of credential files for ARNP F, ARNP G, ARNP H, PA I, and ARNP K.

3. Review of Governing Board Bylaws, approved July 25, 2019, revealed the following in part:

"...The Board shall cause to be created a medical staff organization to be known as the Medical Staff of Boone County Hospital, whose membership shall be comprised of all licensed physicians and such other licensed practitioners as the Board shall approve from time to time. Membership in this Medical Staff organization shall be a prerequisite to the exercised of clinical privileges in the Hospital..."

"Medical Staff Membership and Clinical Privileges ... Final action on all matters relating to Medical Staff membership status, clinical privileges and corrective action shall be taken by the Board after considering the Staff recommendations ..."

"The terms and conditions of membership status in the Medical Staff, and of the exercise of clinical privileges, shall be as specified in the Medical Staff Bylaws."


4. Review of the Medical Staff Bylaws, approved by the Medical Staff August 16, 2018 and approved by the Board of Trustees January 24, 2019, revealed the following in part,

"...The responsibilities of the Medical Staff are: To provide an appropriate level of professional performance of all members of the Medical Staff and other Practitioners authorized to practice in the Hospital through the appropriate delineation of the clinical privileges that each Practitioner may exercise in the Hospital and through an ongoing review and evaluation of each Practitioner's performance in the Hospital ..."

"Nature of Medical Staff Membership, No Practitioner, including those with a contract of employment with Boone County Hospital, shall admit or provide medical or health related services to patients unless he/she is a Member of the Boone County Medical Staff and/or has been granted clinical privileges in accordance with the procedures outlined in these Bylaws and the Medical Staff Rules and Regulations. Appointment to the Medical Staff shall confer only such clinical privileges as have been granted in accordance with these Bylaws and no Practitioner shall provide services to Boone County Hospital patients for which privileges have not been granted."


5. Review of Medical Staff Rules and Regulations, approved by the Medical Staff August 16, 2018 and approved by the Board of Trustees January 24, 2019, revealed the following in part, "Only practitioners granted clinical privileges may treat patients at this Hospital."

6. Review of the Midlevel Provider Employment Agreement for ARNP F, dated January 31, 2018, revealed the agreement lacked evidence of any clinical privileges granted to provide care to Boone County Hospital patients by the Medical Staff and the Governing Board.

Review of the Midlevel Provider Employment Agreement for ARNP G, dated August 1, 2019, revealed the agreement lacked evidence of any clinical privileges granted to provide care to Boone County Hospital patients by the Medical Staff and the Governing Board.

Review of the Midlevel Provider Employment Agreement for ARNP H, dated August 1, 2019, revealed the agreement lacked evidence of any clinical privileges granted to provide care to Boone County Hospital patients by the Medical Staff and the Governing Board.

Review of the Midlevel Provider Employment Agreement for PA I, dated November 1, 2019, revealed the agreement lacked evidence of any clinical privileges granted to provide care to Boone County Hospital patients by the Medical Staff and the Governing Board.

Review of the Midlevel Provider Employment Agreement for ARNP K, dated November 1, 2019, revealed the agreement lacked evidence of any clinical privileges granted to provide care to Boone County Hospital patients by the Medical Staff and the Governing Board.


7. Review of a letter "Reappointment to the Boone County Hospital Medical Staff," dated March 15, 2018, addressed to ARNP F, revealed in part, "...You are due for reappointment to the medical staff at Boone County Hospital. Your current appointment will expire on August 23, 2018...."

8. During an interview on 12/11/2019 at 9:00 AM, the Administrative Assistant and the Assistant Administrator, Nursing confirmed the midlevel providers (ARNPs and PA) who provided care to patients at the Boone County Family Medicine walk-in clinic were not listed on the Medical Staff Roster.

During an interview on 12/11/2019 at 9:45 AM, the Assistant Administrator, Nursing confirmed the walk-in clinic patients are Boone County Hospital patients.

During an interview on 12/11/2019 at 10:55 AM, the Administrative Assistant confirmed ARNP F had previously been credentialed but her appointment to the Medical Staff expired August 23, 2018. The Administrative Assistant also confirmed ARNP F, ARNP G, ARNP H, PA I, and ARNP K provide care to patients at the walk-in clinic and were not credentialed by the Medical Staff and Governing Board and were not included on the Medical Staff Roster.

During an interview on 12/11/2019 at 2:10 PM, the Chief Financial Officer (CFO) and the Assistant Administrator, Clinic Operations confirmed ARNP F, ARNP G, ARNP H, PA I, and ARNP K provide care to patients at the walk-in clinic and did not have clinical privileges approved by the Medical Staff and Governing Board. The CFO also confirmed the CAH administrative staff did not follow the Medical Staff Bylaws regarding approval of clinical privileges for ARNP F, ARNP G, ARNP H, PA I, and ARNP K.

Based on document review, policy review and staff interview, the Critical Access Hospital (CAH) administrative staff failed to ensure a physician periodically reviewed the care provided for Boone County Family Medicine (BCFM) walk-in clinic patients, in conjunction with the mid-level provider, for 4 of 4 applicable mid-level providers selected for review (ARNP F, ARNP G, ARNP H, and PA I).

The hospital staff identified the mid-level providers provided care to patients from November 1, 2018 to December 11, 2019 as follows:

- Advanced Registered Nurse Practitioner (ARNP) F: 1,963 patients
- ARNP G: 1,404 patients
- ARNP H: 569 patients
- Physician Assistant I: 951 patients

Failure to ensure a physician periodically reviewed mid-level provider's patient medical records, in conjunction with the mid-level provider, could potentially result in misdiagnosing patient and/or providing inappropriate or substandard patient care.

Findings include:

1. Review of the CAH policy, "Mid-level and Physician Medical Record Review," reviewed November 2019, revealed in part "... Boone County Hospital (BCH) will establish a process for the analysis and review of Mid-level for patient care record review. The periodic record review will occur with the Midlevel provider and the physician ... reviews the CAH'S patient records, providers medical orders, and providers medical care services to the patients of the CAH. This analysis process will be conducted annually and the information sent to the BCH Professional Review and Credentialing committee for review and approval of the patient care ... This record review will be face-to-face and review clinical care, medical orders and outcomes ..."

2. During an interview on 12/11/19, at 9:00 AM, the Assistant Administrator and Assistant Administrator, Nursing confirmed ARNP F, ARNP G, ARNP H, and PA I provided patient care in the provider-based BCFM walk-in clinic.

3. During an interview on 12/11/19, at 1:55 PM, the Director of BCFM Walk-In Clinic reported the physicians conducted medical record review, to evaluate the quality of patient care provided by the mid-levels, but confirmed the physicians failed to conduct the medical record review in conjunction with ARNP F, ARNP G, ARNP H, and PA I.

4. During an interview on 12/11/19, at 2:50 PM, the Quality Director reported she received medical record review, conducted by physicians, to evaluate the care provided at the BCFM Walk-In Clinic, by ARNP F, ARNP G, ARNP H, and PA I, but acknowledged the review of the quality of patient care did not go to the credentialing committee for review, because the walk-in clinic mid-levels are not credentialed.

The Director of the BCFM walk-in clinic confirmed the CAH lacked documentation to show the physicians participated in mid-level provider chart review in conjunction with the Mid-level Providers ARNP F, ARNP G, ARNP H, and PA I.

Based on document review, policy review and staff interview, the Critical Access Hospital (AH) administrative staff failed to ensure a mid-level provider participated in a periodic review of the care provided for Boone County Family Medicine (BCFM) walk-in clinic patient medical records, in conjunction with a physician, for 4 of 4 mid-level providers selected for review (ARNP F, ARNP G, ARNP H, and PA I).

The hospital staff identified the mid-level providers provided care to patients from November 1, 2018 to December 11, 2019 as follows:

- Advanced Registered Nurse Practitioner (ARNP) F: 1,963 patients
- ARNP G: 1,404 patients
- ARNP H: 569 patients
- Physician Assistant I: 951 patients

Failure to ensure a physician periodically reviewed mid-level provider's patient medical records, in conjunction with the mid-level provider, could potentially result in misdiagnosing patient and/or providing inappropriate or substandard patient care.

Findings include:

1. Review of the CAH policy, "Mid-level and Physician Medical Record Review," reviewed November 2019, revealed in part "... Boone County Hospital (BCH) will establish a process for the analysis and review of Mid-level for patient care record review. The periodic record review will occur with the Midlevel provider and the physician ... reviews the CAH'S patient records, providers medical orders, and providers medical care services to the patients of the CAH. This analysis process will be conducted annually and the information sent to the BCH Professional Review and Credentialing committee for review and approval of the patient care ... This record review will be face-to-face and review clinical care, medical orders and outcomes ..."

2. During an interview on 12/11/19, at 9:00 AM, the Assistant Administrator and Assistant Administrator, Nursing confirmed ARNP F, ARNP G, ARNP H, and PA I provided patient care in the provider-based BCFM walk-in clinic.

3. During an interview on 12/11/19, at 1:55 PM, the Director of BCFM Walk-In Clinic reported the physicians conducted medical record review, to evaluate the quality of patient care provided by the mid-levels, but confirmed the physicians failed to conduct the medical record review in conjunction with ARNP F, ARNP G, ARNP H, and PA I.

4. During an interview on 12/11/19, at 2:50 PM, the Quality Director reported she received medical record review, conducted by physicians, to evaluate the care provided at the BCFM Walk-In Clinic, by ARNP F, ARNP G, ARNP H, and PA I, but acknowledged the review of the quality of patient care did not go to the credentialing committee for review, because the walk-in clinic mid-levels are not credentialed.

The Director of the BCFM walk-in clinic confirmed the CAH lacked documentation to show the physicians participated in mid-level provider chart review in conjunction with the Mid-level Providers ARNP F, ARNP G, ARNP H, and PA I.

Based on review of policies/procedures, meeting minutes, documents, 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 3 of 27 patient care departments (Anesthesia, Pain Clinic, and Surgery Clinic). The CAH administrative staff identified a census of 9 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 the CAH policy "Policy and Procedure Development and Review," dated 9/2019, revealed in part, "...All policies will be presented to the Critical Access Hospital Advisory Committee for review and approval prior to implementation and presented for annual review and approval...."

2. Review of "Critical Access Hospital Advisory Committee" Meeting Minutes, dated from February 14, 2019 through November 14, 2019, revealed the meeting minutes lacked evidence the committee approved the policies for Anesthesia, the Pain Clinic, and the Surgery Clinic.

3. During an interview on 12/11/2019 at 9:10 PM, the Assistant Administration, Nursing acknowledged the required group of professionals approved the policies for Anesthesia, the Pain Clinic, and the Surgery Clinic.

I. Based on document review and staff interviews, the Critical Access Hospital's (CAH) administrative staff failed to ensure surgical services staff maintained a sufficient quantity of surgical instruments for Surgeon C to avoid requiring the surgical services staff to utilize Immediate Use Steam Sterilization (IUSS) for 3 of 5 incidents of IUSS reviewed. Inappropriate use of IUSS instead of maintaining a sufficient quantity of surgical instruments to meet the surgical case volume resulted in the surgical services staff utilizing a shortened sterilization process to sterilizie the surgical instruments, which could potentially result in the sterilization process failing to kill all bacteria, viruses, and fungi, which potentially could cause a life-threatening infection in the next patient. The CAH's Director of Surgery reported Surgeon C performed 34 surgeries from November 12, 2018 to November 12, 2019.

Findings include:

1. During a tour of the surgical department on 12/10/19 at 01:07 PM, Staff D revealed surgical staff performed IUSS for Surgeon C because the CAH lacked a sufficient number of tibia spreaders or lamina spreaders (specialized surgical instruments) to perform a third procedure if Surgeon C performed more than 2 surgical procedures in a day.

2. Review of the AORN Guidelines (Association of periOperative Registered Nurses, a nationally recognized guideline agency) for Sterilization, copyright 2018, revealed in part, " ...Immediate use steam sterilization may be associated with increased risk of infection to patients ... Immediate use steam sterilization (IUSS) should be kept to a minimum ...[IUSS] should not be used as a substitute for sufficient instrument inventory ..."

3. Review of the surgical services policy, "Immediate Use Steam Sterilization (IUSS)," last effective 01/2019, revealed in part, " ... Surgical Services staff will utilize IUSS when no other alternative exists to deliver a product to the sterile field ... Immediate use steam sterilization is not a substitute for insufficient inventory ..."

4. Review of the document, "IUSS Record for 11/2018-11/2019, dated 12/11/19, revealed 5 instances of IUSS which revealed the surgical staff used IUSS on 2 instances to sterilize a tibia spreader and on 1 instance to sterilize a lamina spreader.

5. During an interview on 12/10/19 at 02:02 PM, the Director of Surgery confirmed that of the 5 instances the surgical staff used IUSS from 11/2018-11/2019, 3 instances occurred because the CAH lacked sufficient qualities of tibia spreaders and lamina spreaders to allow the surgical staff to perform a full sterilization cycle on all of the instruments, and instead used IUSS as a subsitute for purchasing sufficient quantities of instruments to allow Surgeon C to perform more than 2 surgeries in a single day.




II. Based on observation, staff interview, and document review, the Critical Access Hospital (CAH) failed to ensure Emergency Department (ED) staff followed their policy to pre-treat used surgical instruments prior to cleaning. Failure to pre-treat used surgical instruments prior to cleaning may result in blood or other organic material being retained on the instruments which can then block the disinfectant or sterilizing agent from making complete contact with the surface of the instruments and killing all germs. These potentially unsterile instruments could potentially infect the next patient because the staff assumed the instruments are sterile. The CAH's administrative staff identified the ED had an average of 7,200 visits per year.

Findings include:

1. Observations during a tour of the ED on 12/09/19 beginning at 9:30 AM revealed a red metal box in the dirty utility room that contained a small tray, multiple forceps, scissors, and hemostats (approximately 25 instruments total.)

2. During an interview at the time of the tour, the ED Director explained ED staff brings used instruments to the dirty utility room and places them in one of two red metal boxes. OR staff then picks up the box of instruments and takes them to the central sterile department to be cleaned and sterilized. ED Director stated ED staff does not use any type of spray to keep the dirty instruments moist. ED Director confirmed that these instruments currently in the red metal box were from procedures that had been done prior to the week-end (up to three days ago).

3. Review of policy, "Surgical Services Transport of Contaminated Instruments to Central Sterile (CS)," revealed in part, "...spray enzyme pretreatment on all instruments immediately after use."



III. Based on observation, document review, and staff interviews, the Critical Access Hospital's (CAH) administrative staff failed to ensure 2 of 5 surgical staff (Surgeon A and Certified Registered Nurse Anesthetist [CRNA] B) wore surgical attire that covered all hair during surgery for 1 of 1 patients (Patient #1). Failure of the CAH to ensure surgical staff wore appropriate surgical attire could potentially result in bacteria, fungi, or viruses on the surgical staff members' hair or skin entering the environment and potentially resulting in the patient developing a life-threatening surgical site infection. The CAH's Director of Surgery identified the surgical services staff performed an average of 1340 surgical procedures per year.

Findings include:

1. Observations on 12/10/19 beginning at 10:45 AM, during a surgical procedure for Patient #1, revealed the following:

a. Surgeon A wore a skull cap. The skull cap consisted of a cap covering Surgeon A's forehead and central part of Surgeon A's hair. The skull cap did not cover lower half of the left sideburn, the right sideburn, and both ears were exposed.

b. CRNA B wore a skull cap. The skull cap consisted of a cap covering CRNA B's forehead and central part of CRNA B's hair. The skull cap did not cover the lower approximately two inches of CRNA B's hair on the back of CRNA B's head and both ears were exposed.


2. Review of the AORN Guidelines (Association of periOperative Registered Nurses, a nationally recognized guideline agency) for Surgical Attire, copyright 2018, revealed in part, "...A clean surgical head cover or hood that confines all hair and completely covers the ears, scalp skin, sideburns and nape of the neck should be worn...."

3. Review of policy, "Surgical Attire," last revised 09/2019, revealed in part, "...Head Coverings: Wear a clean surgical head cover or hood that confines all hair and completely covers the ears, scalp skin, sideburns, and nape of the neck...."

4. During an interview on 12/10/19 at 14:00 PM, Director of Surgery revealed the CAH followed the AORN guidelines for surgical attire. The Director of Surgery confirmed the AORN guidelines required all hair and skin to be covered in restricted areas, and acknowledged that Surgeon A and CRNA B wore skull caps, which did not fully cover all of their hair and ears, as required by the AORN standards and CAH policy.




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IV. Based on observation, document review, and staff interviews, the Critical Access Hospital (CAH) medical/surgical staff failed to ensure environmental services staff sanitized their hands after glove use and removal during 1 of 1 observed cleaning of an occupied patient room (room #221). Failure to ensure environmental services staff followed approved infection control standards of practice in accordance with the Centers for Disease Control (CDC) recommendations could potentially result in the environmental services staff failing to remove bacteria which contaminated their hands during the patient room cleaning procedure and potentially transmit the bacteria to another patient, potentially causing a life-threatening infection. The CAH's administrative staff identified an average census of 9 inpatients per day.

Findings include:

1. Review of the "Medical/Surgical/Swing/Skilled Bed Infection Control Policies, III. Hand Hygiene",approved on 01/2019, revealed in part... "Hand hygiene should be performed: before and after any patient care...after removing gloves... (sic).""

2. Observations on 12/09/2019, beginning at 10:45 AM during cleaning of patient room #221, revealed the following:

--10:55 AM Environmental Services Tech (EVS Tech) #A removed their non-sterile gloves and failed to perform hand hygiene before donning clean non-sterile exam gloves.

--11:07 AM EVS Tech #A removed their non-sterile gloves and failed to perform hand hygiene prior to retrieving keys from their pocket and items from the cleaning cart for new cleaning supplies .

--11:18 AM EVS Tech #A removed their non-sterile gloves and failed to perform hand hygiene before donning clean non-sterile exam gloves.

--11:30 AM EVS Tech #A removed their non-sterile gloves and failed to perform hand hygiene prior to exiting patient room #221.

4. During an interview on 12/09/2019 at 11:50 AM, the Director of Inpatient Services agreed they expected the Environmental Services staff to perform hand hygiene according to the CAH's Hand Hygiene policy.

5. During an interview on 12/10/2019 at 10:00 AM, the Infection Control Coordinator discussed the hand hygiene policy. They clarified CDC guidelines are used for hand hygiene and glove usage. They educate hospital staff using CDC guidelines. They agreed the Environmental Services staff should to perform hand hygiene according to the CAH's Hand Hygiene policy.

6. During an interview on 12/11/2019 at 2:05 PM, the Environmental Services Supervisor recognized the Environmental Services staff are expected to perform hand hygiene after glove removal according to the Hand Hygiene policy.









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Based on review of policies/procedures, documentation, and staff interview, the Critical Access Hospital (CAH) failed to ensure the periodic evaluation of its total CAH program included the number of patients served and the volume of services provided at the CAH for 7 of 27 services provided (Pain Clinic, Surgery Clinic, Wound/Hyperbaric Clinic, BCFM Clinic, Specialty Clinic and Infusion Center, Occupational Therapy, and Speech Therapy). Failure to include the number of patients served and the volume of services provided at the CAH could potentially result in the CAH failing to meet the needs of their patients. The CAH staff identified a current census of 9 inpatients at the beginning of the survey.

Findings include:

1. Review of CAH policy "Governing Critical Access Hospital," dated revised 08/2019, revealed in part, "...Specific items to be reviewed, but not limited to include: The utilization of CAH services, including at least the number of patients served and the volume of services provided.

2. Review of CAH Board Meeting Minutes from Fiscal Year 2019 revealed the annual program evaluation lacked documentation of the number of patients served and the volume of services for Pain Clinic, Surgery Clinic, Wound/Hyperbaric Clinic, BCFM Clinic, Specialty Clinic and Infusion Center, Occupational Therapy, and Speech Therapy.

3. During an interview on 12/11/2019 at 1:30 PM, the Assistant Administrator, Nursing, verified the annual program evaluation lacked the number of patients served and the volume of services provided. The Assistant Administrator, Nursing, acknowledged the annual program evaluation lacked documentation of the number of patients served and the volume of services for Pain Clinic, Surgery Clinic, Wound/Hyperbaric Clinic, BCFM Clinic, Specialty Clinic and Infusion Center, Occupational Therapy, and Speech Therapy.

Based on review of policies/procedures, documentation, and staff interview, the Critical Access Hospital (CAH) administrative staff failed to ensure the periodic evaluation of its total program included a representative sample of both active and closed clinical records for 17 of 17 patient care services provided (Radiology, Dietary, Emergency Department, BCFM Clinic, Surgical Services, Family Birth Center, Pain Clinic, Walk In Clinic, Surgery Clinic, Diabetes Education, Wound/Hyperbaric Clinic, Rehabilitation Clinic (PT, OT, Speech), CardioPulmonary Rehab, Specialty Clinic and Infusion Center, Anesthesia, Swing Bed, and Inpatient Services.). Failure to include a representative sample of both active and closed clinical records for all patient care services provided in the annual Total Program Evaluation could potentially result in failure to identify potential changes needed in services provided at the CAH. The CAH staff identified a current census of 9 inpatients at the start of the survey.

Findings include:

1. Review of CAH policy "Governing Critical Access Hospital," dated revised 08/2019, in Part III "Periodic Evaluation of the Critical Access Program" revealed in part, "...A sampling of both active and closed clinical patient records, not less than 10%, to determine appropriateness of services provided...."

2. Review of CAH Board Meeting Minutes Fiscal Year 2019 revealed the annual program evaluation lacked documentation the CAH staff reviewed a sample of both active and closed clinical records for Radiology, Dietary, Emergency Department, BCFM Clinic, Surgical Services, Family Birth Center, Pain Clinic, Walk In Clinic, Surgery Clinic, Diabetes Education, Wound/Hyperbaric Clinic, Rehabilitation Clinic (PT, OT, Speech), CardioPulmonary Rehab, Specialty Clinic and Infusion Center, Anesthesia, Swing Bed, and Inpatient Services.

3. During an interview on 12/11/2019 at 1:30 PM, the Assistant Administrator, Nursing verified the annual program evaluation lacked documentation the CAH staff performed a review of a sample of both active and closed records for Radiology, Dietary, Emergency Department, BCFM Clinic, Surgical Services, Family Birth Center, Pain Clinic, Walk In Clinic, Surgery Clinic, Diabetes Education, Wound/Hyperbaric Clinic, Rehabilitation Clinic (PT, OT, Speech), CardioPulmonary Rehab, Specialty Clinic and Infusion Center, Anesthesia, Swing Bed, and Inpatient Services.

Based on document review, policy review, and staff interview, the Critical Access Hospital (CAH) administrative staff failed to ensure 1 of 1 active radiologists selected for review, received outside entity peer review by the appropriate entity, to evaluate the appropriateness of diagnosis and treatment furnished to patients at the Critical Access Hospital. (Radiologist E)

The CAH administrative staff identified Radiologist E provided care to 2,625 patients from 1/1/19 to 12/11/19.

Failure to ensure all medical staff members received outside entity peer review by the appropriate entity, affects the CAH's ability to assure physicians provide quality care to the CAH patients. The CAH administrative staff identified 8 credentialed radiologists provided services to to CAH patients.

Findings include:

1. Review of the CAH network agreement, effective 8/8/17, revealed the CAH had an agreement with Network Hospital A to function as the Network Hospital for the CAH. Review of the agreement revealed in part, " ... Upon request by CAH, external peer review and credentialing services will be provided by Network Hospital A ..."

2. Review of the CAH Peer Review Services Agreement, effective 2/5/15, revealed in part, "... [Network Hospital A] employs or contracts with physicians who are qualified and capable of evaluating the diagnosis and treatment of the CAH and/or associated clinics physicians. The CAH desires for [Network Hospital A] to provide such evaluation and the Network Hospital agrees to provide evaluation services pursuant to the terms and conditions outlined herein."

3. Review of the CAH Radiology Review Service Agreement, effective 5/24/19, revealed in part "... This Radiology Peer Review Service Agreement is between [Contracted Radiology Professional Group A] and the CAH for the provision ... of quality assurance related peer review services ..."

4. Review of the CAH policy "Medical Staff Professional Clinical Quality Review Process," reviewed/revised 2/2017, revealed in part " ... To establish and provide a collaborative approach ... to objectively and systematically monitor and evaluate the appropriateness of diagnosis and treatment quality of patient care, and clinical outcomes of all levels of the CAH clinical Medical Staff. The quality monitoring data will be utilized as one of the aspects of the credentialing process for physicians and independent licensed practitioners ..."

5. Review of external peer review completed for Radiologist E revealed the documentation failed to identify Network Hospital A conducted the external peer review. The CAH's medical staff and governing body approved Radiologist's reappointment to medical staff on 1/17/19 and 1/24/19.

6. During an interview on 12/11/19, at 2:10 PM, the Radiology Director reported the CAH has an agreement with Contracted Radiology Professional Group A to conduct external peer review for the radiologists, and the results are forwarded to the Quality Director. The Radiology Director confirmed the external peer review results reviewed, as part of credential file review, had been conducted by Contracted Radiology Professional Group A. She thought Health Information Management (HIM) may send radiology records to Network Hospital A for review, but not sure.

7. During an interview on 12/11/19, at 2:40 PM, HIM clerk J reported she is the employee assigned to send CAH patient medical records to the network hospital for external peer review but does not send any patient radiology records for external peer review because she had been told she no longer needed to. The HIM Director confirmed HIM does not submit radiology results to the network hospital for external peer review because she thought radiology submitted their own.

The Radiology Director confirmed Contracted Radiology Professional Group A conducted the external peer review for Radiologist E, and all of radiologists on the active medical staff, and the CAH lacked any external peer review conducted by their network hospital for Physician E.