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1000 NORTH 15TH STREET

HUMBOLDT, IA 50548

QUALITY ASSURANCE

Tag No.: C0337

Based on review of the Quality Plan, Quality activities, and staff interview, the Critical Access Hospital (CAH) administrative staff failed to evaluate 1 of 3 contracted patient care services (Magnetic Resonance Imaging (MRI)), for quality of care. 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 contracted staff performed 244 MRI procedures from 7/1/2019 to 6/30/2020.

Findings include:

1. Review of the CAH's "Quality Improvement Plan, 2020," dated November 2019, revealed in part, "Goal: To continually seek higher levels of performance or ensure continued performance excellence from all services offered by Humboldt County Memorial Hospital to optimize the care given to patients and the community we serve ... The role of the Quality Committee is to ensure continued performance excellence from all services offered ...". The Quality Improvement Plan failed to identify MRI as a patient service.

2. Review of "Critical Access Hospital Annual Report," dated 7/1/19 to 6/30/20 failed to identify MRI as a patient care service.

3. Review of the Continuous Quality Improvement Reports from July 2019 through July 2020 revealed the reports 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 the contracted patient care services for Magnetic Resonance Imaging (MRI).

4. During an interview on 8/26/2020 at 3:45 PM, the Director of Quality confirmed the reports 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 patient care services for Magnetic Resonance Imaging (MRI).

MAINTENANCE

Tag No.: C0914

Based on observation and staff interviews, the Critical Access Hospital (CAH) failed to remove outdated supplies from the Cardiac Rehabilitation and Pulmonary Rehabilitation Department. Failure to remove outdated patient supplies from the CAH's Cardiac and Pulmonary Rehab supplies, available for use in patient care, could potentially result in staff using the expired items for patient care after the manufacturers' expiration date, after which the manufacturer will no longer guarantee the safety and quality of the supply. The CAH identified an average of approximately 863 patient visits per year in the Cardiac Rehab Department, and 373 patient visits in the Pulmonary Rehab Department from July 1,2019 to June 30,2020.

Findings include:

1. Review of the policy "Wellness Hub Crash Cart," effective 12/2019, revealed in part, "... all supplies in the cart that need to be counted per the Cardiopulmonary staff, checked for outdates, initialed, and dated ... The Cardiopulmonary Department will be responsible for replacing the used contents in the supply drawers."

2. Observations of the Emergency Crash Cart in Cardiac/Pulmonary Department revealed:

a. 1 of 1 Tracheal Tube 8.0 mm, expired 01/2020 (used for the purpose of establishing a patent airway)
b. 2 of 2 Adult Colorimetric CO2 Detector, expired 02/2020 (measures exhaled carbon dioxide)

Observations of the Supply cabinet in Cardiac/Pulmonary Department revealed:

a. 6 of 26 2x2 Electrode (adhesive pads that attach to a person's skin and transmit electrical impulses)


3. During a tour of the Cardiac/Pulmonary Department on 8/25/2020 at 01:30 PM, the Certified Pulmonary Therapist (CRT) acknowledged the identified expired supplies in the Emergency Crash Cart. The CRT revealed the clinic staff should have checked the supplies monthly for expired supplies.

4. During an interview on 8/25/2020 at 2:00 PM, the Occupational Therapy Director (OTD), acknowledged the identified expired supplies in the supply cabinet in the Cardiac/Pulmonary Department.

5. During an interview on 8/25/19 at 2:20 PM, the Chief Nursing Executive (CNE), acknowledged the identified expired supplies and revealed that the clinic staff should have checked the supplies monthly for expiration dates.

PATIENT CARE POLICIES

Tag No.: C1008

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, reviewed all patient care policies annually for 24 of 24 patient care departments (Radiology, Medical/Surgical/Swing Bed, Cardiopulmonary/Respiratory Therapy/Sleep Study/Cardiac Rehabilitation, Surgery/PACU [Post Anesthesia Care Unit]/Pain Clinic, Anesthesia, Physical Therapy/Occupational Therapy/Speech Therapy, Pharmacy, Laboratory, Dietitian, Nutrition, Diabetes Education, Emergency Room, Safety, Infection Control, Outpatient Infusion, Ambulance/Emergency Medical Services, Health Information Management, Maintenance, Outpatient Specialty Clinic, Quality/Risk Management, Environmental Services, Materials Management, Care Coordination, and Informatics/Employee 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 the CAH policy "Policy and Procedure Protocol," last modified 03/30/2020, revealed in part, "... Policies are developed and reviewed annually (at least once per calendar year), and as needed, with the advice of a group of professional personnel that includes one or more doctors, nurse practitioners, clinical nurse specialists (if on staff at HCMH [Humboldt County Memorial Hospital]), and a group of multidisciplinary HCMH department leaders ... Procedure for Review and Revisions of an Existing Policy or Procedure ... If the policy or procedure does not need any revisions, the reviewer will chose NO REVISION NECESSARY ... Any revisions that alter the document's content, therefore it's meaning, must be done so in a new version of the document ... After the review process, the document must be submitted for APPROVAL. This will present the document along with a written description/summary of what changes were made to the document and why, if applicable, to the Policy Committee for APPROVAL.

2. Review of "Policy Committee Meeting" minutes, dated from 07/16/2019 through 07/21/2020, lacked annual approval for all policies for Pharmacy, Laboratory, Dietitian, Nutrition, Safety, Infection Control, Maintenance, Environmental Services, Materials Management, and Care Coordination.

3. During an interview on 08/26/2020 at 9:40 AM, the Chief Nursing Executive (CNE) indicated the CAH's system is set up to alert the department managers to review all policies in their department annually. The department manager then revised policies as needed. If no revisions were necessary then a new version of the policy was created and the new version of the policy would go to the Policy Committee where a physician and a mid-level provider attend for approval of the revised policies. All Policy Committee members, except Physician A, have access to the policies on line and can look at all existing policies when department policies were scheduled for annual review. The CNE confirmed only new or revised policies were brought to the Policy Committee and not all existing policies.

During an interview on 08/27/2010 at 8:50 AM, Physician A revealed they were involved in policy review by attending the Policy Committee Meetings where new and revised policies were reviewed and approved. Physician A confirmed they did not have access to CAH policies on line but if they wanted to look at a policy CAH staff would print it off for them.

4. Review of documentation lacked evidence all department policies (Radiology, Medical/Surgical/Swing Bed, Cardiopulmonary/Respiratory Therapy/Sleep Study/Cardiac Rehabilitation, Surgery/PACU [Post Anesthesia Care Unit]/Pain Clinic, Anesthesia, Physical Therapy/Occupational Therapy/Speech Therapy, Pharmacy, Laboratory, Dietitian, Nutrition, Diabetes Education, Emergency Room, Safety, Infection Control, Outpatient Infusion, Ambulance/Emergency Medical Services, Health Information Management, Maintenance, Outpatient Specialty Clinic, Quality/Risk Management, Environmental Services, Materials Management, Care Coordination, and Informatics/Employee Education) were reviewed annually by the required group of professionals including a physician.

PATIENT CARE POLICIES

Tag No.: C1010

Based on review of records, policy, and staff interviews the Critical Access Hospital's (CAH) Administrative staff failed to ensure each patient that received anesthesia services had a properly executed informed consent in 3 of 5 closed surgical records reviewed. (Patients # 1, #2 , #3) Failure to document the time an anesthesia informed consent was obtained for patients who received anesthesia inhibits the hospital's ability to ensure the informed consent process took place prior to the administration of anesthesia. The CAH leadership staff identified approximately 69 surgical procedures in the past fiscal year.

Findings include:

1. Review of Patient #1's medical record, dated 6/12/2020, revealed "Consent for Anesthesia " lacked the time the patient and witness signed the consent.

Review of Patient # 2's medical record, dated 3/18/2020, revealed the "Consent for Anesthesia" lacked the time the minor patient's parent and witness signed the consent.

Review of Patient # 3's medical record, dated 5/13/2020, revealed the "Consent for Anesthesia" lacked the time the patient and witness signed the consent.

2. Review of policy "Informed Consent", dated approved 7/31/2015, revealed in part, "... patients must be given the opportunity to give an "informed consent" prior to the administration of anesthesia ... Obtaining Informed Consent ... date and time of witnessing the signature is completed.."

3. During an interview on 8/26/2020 at approximately 10:33 AM, at the time of the medical record review, Clinical Informatics RN D, acknowledged the "Consent for Anesthesia" forms for Patients #1, #2, and #3 lacked the time the consent was obtained.

During an interview on 8/26/2020 at approximately 3:15 PM, CRNA C acknowledged the "Consent for Anesthesia" forms for Patient #1, Patient #2, and Patient #3 lacked documentation of the time the informed consent was obtained.

ANESTHETIC RISK AND EVALUATION

Tag No.: C1144

Based on document review, closed medical records and staff interviews, the Critical Access Hospital (CAH) failed to ensure examination of the patient by a physician immediately before surgery to evaluate the risks prior to the performance of the surgical procedure in 1 of 5 closed patient medical records reviewed. (Patient # 4) Failure of a physician to examine a patient immediately before surgery could result in surgery performed on an unstable patient. The CAH hospital staff identified approximately 69 surgical procedure in the past fiscal year.


Findings include:

1. Review of policy "SDS (Same Day Surgery) - Preoperative workup medical staff bylaws," approved 7/14/2015 and "Medical Staff Rules and Regulations" dated reviewed and approved Jan 2020, revealed in part, "... history and physical examination shall be recorded no more than seven days before ... an admission for each patient ... an interval admission note that includes all additions to the history ... subsequent changes in the physical findings must always be recorded."

Review of document "SDS - Guidelines for Physicians" dated approved 7/14/2020, revealed in part, "... History and Physical (H&P) examinations ...must be updated if more than 7 days old."


2. Review of Patient # 4's closed medical record revealed Patient #4 had a H&P performed by Physician A on 4/29/2020 in preparation for a scheduled surgical procedure. Patient #4 had the surgical procedure, a right knee scope, performed on 5/7/2020, 8 days following the initial H&P, by Surgeon B. Patient # 4's closed medical record lacked evidence of an examination by a physician immediately before surgery to evaluate the risks of the surgical procedure to be performed.


3. During an interview on 8/26/20 at 10:30 AM, the Clinical Informatics RN acknowledged she was unable to locate documentation or evidence of an examination by a physician immediately before surgery in Patient # 4's closed medical record.

During an interview on 8/27/2020 at 9:25 AM, the Director of Quality verbalized, having looked everywhere, she could not find any documented evidence that Surgeon B examined Patient #4 prior to surgery.

INFECTION PREVENT & CONTROL ORG & POLICIES

Tag No.: C1204

Based on observation, policy review, and staff interview, the Critical Access Hospital (CAH) failed to ensure that the infection preventionist(s)/infection control professional(s) responsible for the infection prevention and control program individual (or individuals), had been appointed by the Governing Body, and that the appointment was based on the recommendations of medical staff leadership and nursing leadership. Failure to comply with regulations could potentially hinder the infection prevention and control program including surveillance, prevention, and control of hospital-acquired infections (HAI)s, including maintaining a clean and sanitary environment to avoid sources and transmission of infection, and address any infection control issues, potentially causing harm to patients and their safety.

Findings include:

1. Review of Policies and Procedures revealed that no policy existed regarding an appointment for the Infection Control Preventionist by the Governing Board.

2. Interview with Infection Control Preventionist on 08/26/2020 confirmed that the Infection Control Preventionist had not been appointed by the Governing Board.

3. Interview with Chief Nursing Executive (CNE) on 08/26/2020 confirmed that the Infection Control Preventionist had not been appointed by the Governing Board.

4. Interview with Director of Quality on 08/26/2020 confirmed that the Infection Control Preventionist had not been appointed by the Governing Board.