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Based on document review and staff interview it was determined the Governing Body failed to ensure the facility enforced the approved Medical Staff Bylaws regarding the privileges of 10 physicians with expired Board Certifications, of a total of 17 sampled actively credentialed members of the medical staff.

Findings included:

The review of the Heart of Florida Regional Medical Center Medical Staff Bylaws, revised March 2019, revealed the statement, "The failure of any practitioner to obtain Board Certification or maintain Board Certification as required herein shall result in the automatic termination of his/her Medical Staff membership and clinical privileges without any hearing rights."

The Medical Staff Roster - 2019 was provided in response to a request to provide a list of all currently credentialed members of the medical staff with active privileges. The review of the Medical Staff Roster revealed the names of licensed practitioners #s A, B, C, D, E, F, G, H, I, J, K, L, M, O, P, Q, and R.

The review of the records for #C revealed the physician was approved for privileges in Orthopedic Surgery. The Board Certification for #C expired 12/31/2017.

The review of the records for #I revealed the physician was approved for privileges in Pediatrics. The Board Certification for #I expired 12/31/2018.

The review of the records for #J revealed the physician was approved for privileges in Endocrinology, Diabetes and Metabolism. The Board Certification for #J expired 12/31/2018.

The review of the records for #K revealed the physician was approved for privileges in Ophthalmology. The Board Certification for #K expired 12/31/2018.

The review of the records for #L revealed the physician was approved for privileges in Family Medicine. The Board Certification for #L expired 12/31/2018.

The review of the records for #M revealed the physician was approved for privileges in Internal Medicine. The Board Certification for #M expired 12/31/2018.

The review of the records for #O revealed the physician was approved for privileges in Medical Oncology. The Board Certification for #O expired 12/31/2018.

The review of the records for #P revealed the physician was approved for privileges in Cardiac Electrophysiology. The Board Certification for #P expired 12/31/2018.

The review of the records for #Q revealed the physician was approved for privileges in Cardiovascular Disease. The Board Certification for #Q expired 12/31/2018.

The review of the records for #R revealed the physician was approved for privileges in Internal Medicine. The Board Certification for #R expired 4/30/19.

An interview was conducted with the Director of Medical Staff Services on 5/31/19 at 3:00 p.m. The Director confirmed all of the above-listed physicians remained on the medical staff at the present time despite having expired Board Certifications. The Director indicated all members of the medical staff were sent copies of the revised Medical Staff Bylaws via email on March 26, 2019.

The Chief Quality Officer confirmed the finding the facility failed to automatically terminate the medical staff membership of the above-listed 10 physicians who failed to maintain Board Certification in compliance with the Medical Staff Bylaws in an interview conducted on 5/31/19 at 4:00 p.m.

Based on document review, policy review, and staff interview, it was determined the Governing Body failed to ensure the Behavioral Health Telemedicine Services were furnished through a written agreement.

Findings included:

The policy titled, Tele-psych: Virtual Behavioral Health, reference number 780-300, effective 12/2018, indicated the virtual behavioral health services were available via tele-medicine technologies to any qualified medical provider who desired behavioral health guidance. The marketing document attached to the policy described behavioral health consulting services that would be provided by a licensed and remotely located Qualified Mental Health Counselor in accordance with state law where the hospital is located. Neither the policy nor the marketing document specified the names, credentials or qualifications of the person who would be providing those services to this facility.

The facility was unable to respond to a request to produce a written agreement between the facility and the Behavioral Health entity.

The Director of Emergency Services indicated he had spoken to a person at the managing entity of the facility located in another state, who indicated the program was internal to the managing entity and therefore no agreement with the facility was necessary.

The Chief Quality Officer confirmed the finding the facility was not in compliance with the requirement to maintain a written agreement between the facility and the telemedicine entity.

Based on record review and interview with the Laboratory Manager, the Nurses administering blood transfusions failed to have complete documentation in 2 (#4 and #6) out of 6 random blood transfusion Patients reviewed and 3 (#1, #3, and #4) out of 5 transfusion reactions.

Findings Included:

Review of 6 random blood transfusion patients revealed that #4 had a missing start time and #6 was missing a temperature.

Five Patient transfusion reactions were reviewed. Patient #1 had a missing start time and did not indicate who started it as well as missing temperature and volume transferred. Patient #3 did not indicate if there was a transfusion reaction and did not indicate the volume transfused. Patient #4 did not have temperatures recorded.

In an interview on 05/31/19 at 3:00 PM, the Laboratory Manager confirmed that the Nursing notes for blood transfusions were not complete.

Based on review of nationally recognized guidelines and staff interviews, it was determined the facility infection preventionist staff failed to develop and implement policies to ensure sterilized surgical instruments used on patients were tracked.

Findings included:

A review of nationally recognized guidelines for the sterilization and disinfection of instruments used on patients showed the Association for the Advancement of Medical Instrumentation (AAMI) recommends appropriate documentation and reporting practices that enable trackability of each facility-sterilized medical device to the patient on whom it was used.

The Safe Medical Devices Act of 1990 recommends that to ensure patient safety and compliance with reporting requirements, the health care facility should establish recall procedures to expedite the retrieval of processed items that are suspected to be non-sterile and to ensure adequate follow-up actions such as quarantine of the sterilizer, notification of physicians and affected clinical departments, and surveillance of patients. The recall order should include the following documentation:
a. include all items processed back to the last negative biological (Bl);
b. be immediately communicated to affected departments and followed by a written order;
c. identify by sterilization lot number the products to be recalled;
d. identify the persons or departments to whom the order is addressed;
e. require the recording, in terms of kind and quantity, of the products obtained in the recall; and
f. specify the action to be taken by the persons receiving the order (e.g., destruction or return of product).

The facility was unable to respond to a request to provide a policy explaining how sterilized surgical instruments used on patients were tracked.

On 05/31/19 at approximately 3:45 PM, while on tour of the perioperative department, an interview conducted with the sterile processing technician and director of the peri-operative department, confirmed the facility was not tracking surgical instruments used on patients.