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Based on document review 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 24 of 24 patient care departments (Anesthesia, Emergency Room, Infection Control, Medical/Surgical Nursing, Obstetrics, Pain Clinic, Pharmacy, Respiratory Therapy/Pulmonary, Sleep Study, Skilled Nursing, Surgery/Central Supply, Dietary, Emergency Preparedness, Housekeeping/Laundry, Maintenance, Health Information Management, Medical Staff, Medical Staff Credentialing, Ambulance, Cardiac Rehabilitation, Diabetic Education, Laboratory, Radiology, and Senior Life Solutions). 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. The CAH administrative staff identified a census of 4 patients at the beginning of the survey.

Findings include:

1. Review of the CAH policy "Policy and Procedure Development, Revisions, Approval, and Retention," dated 8/2017, revealed in part, "Approval/Implementation Process ... Medical Staff, CAH Committee and Board of Trustees review/approve listing of new, revised, deleted policies/procedures...."

Review of the CAH policy "CAH Advisory Committee", dated 8/2017, revealed in part, "Review and approve on an ongoing basis and annually all written policies and services related to patient care and other services affecting patient health and safety ... DECISION MAKING: At least one physician and mid-level provider must be present for decision making...."

Review of Medical Staff Bylaws, dated 10/27/15, revealed in part, "The CAH Advisory Committee shall be a standing committee and shall consist of, minimally, the medical director for CAH, advanced practice clinician, the Chief Executive Officer, the Vice President of Patient Care Services/Director of Nursing, and a representative of the Mercy Network. Duties: Review and approve an ongoing basis and annually all written policies related to patient care services and other services affecting patient health and safety...."

2. Review of the "Critical Access Advisory Board" committee meeting minutes dated March 21, 2018; June 20, 2019; September 19, 2018, and December 19, 2018 revealed a list of new or revised policies for Anesthesia, Emergency Room, Infection Control, Medical/Surgical Nursing, Obstetrics, Pain Clinic, Pharmacy, Respiratory Therapy/Pulmonary, Sleep Study, Skilled Nursing, Surgery/Central Supply, Dietary, Emergency Preparedness, Housekeeping/Laundry, Maintenance, Health Information Management, Medical Staff, Medical Staff Credentialing, Ambulance, Cardiac Rehabilitation, Diabetic Education, Laboratory, Radiology, and Senior Life Solutions.

Review of September 19, 2019 Critical Access Advisory Board committee meeting minutes revealed a mid-level provider did not attend the meeting where a list of new or changed policies for Health Information Management, Medical Staff, and Medical Staff Credentialing was approved.

The minutes for the Critical Access Advisory Board lacked evidence the CAH staff annually approved all patient care policies for Anesthesia, Emergency Room, Infection Control, Medical/Surgical Nursing, Obstetrics, Pain Clinic, Pharmacy, Respiratory Therapy/Pulmonary, Sleep Study, Skilled Nursing, Surgery/Central Supply, Dietary, Emergency Preparedness, Housekeeping/Laundry, Maintenance, Health Information Management, Medical Staff, Medical Staff Credentialing, Ambulance, Cardiac Rehabilitation, Diabetic Education, Laboratory, Radiology, and Senior Life Solutions.

3. During an interview on 5/1/19 at 9:05 AM, the Quality Control Coordinator verified the Critical Access Advisory Board Committee only reviewed and approved new policies and policies with revisions. The Quality Control Coordinator further acknowledged any existing policies the CAH staff did not revise during the year did not receive annual review by the required group of professionals, including a physician and a mid-level provider.

During an interview on 5/1/19 at 9:35 AM, Advanced Registered Nurse Practitioner A (ARNP A) acknowledged during the Critical Advisory Board Committee meetings, the committee members only reviewed the list of new policies and policies with revisions. The Critical Advisory Board did not review existing patient care policies without any changes.

Based on observation, document review, and staff interview, the Critical Access Hospital's (CAH) ambulance staff failed to follow the manufacturer's directions when ambulance staff utilized 3 of 3 FreeStyle Lite Blood Glucose Monitoring System for more than one patient in 3 of 3 ambulances. Failure to follow the FreeStyle Lite Blood Glucose Monitoring System manufacturer's instructions for use may result in inadequate instrument cleaning leading to inadequate disinfection of the FreeStyle blood glucose monitor and the potential for spreading infectious diseases between patients, potentially leading to a life-threatening infection. The CAH ambulance staff reported from January 1, 2019 to April 30, 2019 - 40 blood glucose tests performed in Ambulance #1, 1 blood glucose test performed in Ambulance #2, and 1 blood glucose test performed in Ambulance #3.

Findings include:

1. Observation on 4/29/19 at 3:03 PM in 3 of 3 ambulances, with the Co-Director Paramedic Ambulance, revealed the ambulance staff utilized 1 FreeStyle Lite Blood glucose monitor in each of the 3 ambulances to check an ambulance patient's blood sugar.

2. Review of the FreeStyle Lite manufacturer's booklet, dated 11/2016, revealed in part, "Intended Use ... It is intended to be used by a single person and should not be shared ... The device must not be used on more than one person including other family members due to the risk of spreading infection. All parts of the device and its accessories are considered biohazardous and can potentially transmit infectious diseases, even after performing the cleaning process."

3. During an interview on 4/29/19 at 3:05 PM while on tour of 3 of 3 ambulances, the Co-Director Paramedic Ambulance reported the ambulance staff used 1 FreeStyle Lite Blood Glucose Monitor in each of the 3 ambulances to check the blood glucose levels of multiple patients.

Based on review of policies/procedures, documentation, and staff interviews, 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 (Ambulance, Anesthesia, Respiratory Therapy, Sleep Study, Cardiac Rehabilitation, Physical Therapy, Occupational Therapy, Speech Therapy, Food Service, Pain Clinic, Laboratory, Radiology, Nursing Services, Senior Life Solutions, Emergency Room, Pharmacy, and Surgery). 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 4 inpatients at the start of the survey.

Findings include:

1. Review of the CAH policy "CAH ANNUAL EVALUATION," dated 8/2017, revealed in part, "[Regional Health Services Howard County] will carry out a periodic evaluation of its total CAH program. The evaluation is done at least once a year and includes the review of the following ... Representative sample of both active and closed clinical records ..."

2. Review of the "Annual CAH Program Evaluation FY July 1, 2017 to June 30, 2018"revealed the annual program evaluation lacked documentation the CAH staff reviewed a sample of both active and closed clinical records for Ambulance, Anesthesia, Respiratory Therapy, Sleep Study, Cardiac Rehabilitation, Physical Therapy, Occupational Therapy, Speech Therapy, Food Service, Pain Clinic, Laboratory, Radiology, Nursing Services, Senior Life Solutions, Emergency Room, Pharmacy, and Surgery.

3. During an interview on 5/1/19 at 9:50 AM, the Director Quality Control, Chief Nursing Officer, and Quality/Performance Excellence Specialist verified the annual evaluation of the CAH Annual Program Evaluation lacked documentation the CAH staff performed a review of a sample of both active and closed clinical records for Ambulance, Anesthesia, Respiratory Therapy, Sleep Study, Cardiac Rehabilitation, Physical Therapy, Occupational Therapy, Speech Therapy, Food Service, Pain Clinic, Laboratory, Radiology, Nursing Services, Senior Life Solutions, Emergency Room, Pharmacy, and Surgery.

Based on review of the Quality Plan, Quality activities, and staff interview, the Critical Access Hospital (CAH) administrative staff failed to evaluate 3 of 8 contracted patient care services for quality of care, including Echocardiogram, Nuclear Medicine, and Magnetic Resonance Imaging (MRI). Failure to monitor and evaluate all patient care services for quality of care could potentially expose patients to inappropriate and/or substantial care. The CAH administrative staff identified the contracted staff performed 206 Echocardiogram procedures, 30 Nuclear Medicine procedures, and 345 MRI procedures from 5/1/2018 to 4/30/2018.

Findings include:

1. Review of the "Quality Plan," dated 8/1/2018, revealed in part, "The Quality Program encompasses all patient care services affecting patient health and safety are evaluated, including those furnished under contract or agreement."

2. Review of the Quality Improvement Committee Meeting minutes from March 6, 2018 through March 5, 2019 revealed the meeting minutes lacked documentation which showed the CAH staff evaluated services provided to CAH patients through ongoing monitoring, conclusions, recommendations, and actions taken to improve quality/performance for contracted services, including Echocardiogram, Nuclear Medicine, and MRI.

3. During an interview on 5/1/19 at 10:00 AM, the Director of Quality Control acknowledged the contracted services for Echocardiogram, Nuclear Medicine, and MRI failed to participate in the CAH's quality assurance process, which included ongoing monitoring, conclusions, recommendations, and actions taken to improve quality/performance for the contracted services.