HospitalInspections.org

The Hospital was out of compliance with the Condition of Participation: Quality Assessment and Performance Improvement Program (QAPI).

Findings included:

The Hospital's Governing Body (Governing Board) failed for one (1) Registered Nurse First Assistant (RNFA) in a sample of one (1) Registered Nurse First Assistants to ensure the Quality Assessment and Performance Improvement (QAPI) Program reflected the complexity of the Hospital's Surgical Services; in accordance with TAG: A-0940, Condition of Participation: Surgical Services and TAG: A-0945 that required surgical privileges must be delineated for all practitioners performing surgical tasks including RNFAs in accordance with demonstrated competence as established by the Medical Staff's credentialing process.

Refer to TAG: TAG: A-0308.

Based on records reviewed and interviews the Hospital's Governing Body (Governing Board) failed for one (1) Registered Nurse First Assistant (RNFA) in a sample of one (1) Registered Nurse First Assistants to ensure the Quality Assessment and Performance Improvement (QAPI) Program reflected the complexity of the Hospital's Surgical Services; in accordance with TAG: A-0940, Condition of Participation: Surgical Services and TAG: A-0945 that required surgical privileges must be delineated for all practitioners performing surgical tasks including RNFAs in accordance with demonstrated competence as established by the Medical Staff's credentialing process.

Findings included:

The document titled Quality-Patient Safety and Patient Care Assessment Plan, dated 2021-2022, indicated the Governing Board (Governing Body) of the Hospital was ultimately responsible for the safety of patients. The Governing Board delegated to senior leadership and the Medical Staff the oversight of and improvement of patient safety. Although all staff and physicians were accountable for the safety and outcomes of patients, the primary responsibility, and resources to identify and reduce harm in patient care services resided in the Quality, Patient Safety & Regulatory Council; Quality & Patient Safety Committee; and the Medical Executive Committee & Chiefs of Service.

Medical Staff By-Laws, dated 3/31/2021, indicated Affiliate Staff consisted of specified professional personnel including, but not limited to physician assistants, nurses practicing in expanded role, psychologists, and other medical personnel in categories designated by the Governing Board in consultation with the Hospital Chief Executive Officer. Affiliate Staff included individuals who were qualified to render direct medical care or care under the supervision of a Medical Staff member. The Medical Staff By-Laws indicated terms of appointment were for two years, unless otherwise stated.

The form titled Department of Surgery, Registered Nurse First Assist, dated 9/2/2015, indicated the Registered Nurse Assist (RNFA) Medical Staff Status as Affiliate Staff. The Department of Surgery, Registered Nurse First Assist form indicated Qualifications, Education and Certification requirements included:

1.) Demonstrated proficiency in perioperative nursing practice as both scrub and circulating nurse,

2.) Current professional liability to include RNFA,

3.) Current CNOR (Certified Nurse for the Operating Room),

4.) Review and approval of the Hospital Credential Committee for role of RNFA.

The Department of Surgery, Registered Nurse First Assist form indicated the RNFA acknowledged:

1.) Exercising clinical privileges granted, the RNFA was contained by Hospital and Medical Staff policies rules and regulations applicable generally, applicable to the situation and restriction of clinical privileges granted was waved in an emergency governed by the applicable section of the Medical Staff By-Laws or related documents, and

2.) The understanding that requests for additional privileges were in accordance with the Medical Staff By-Laws.

The form titled Clinical Guidelines for the Registered Nurse First Assistant, signed by supervising physicians dated 2010 and 2015, indicated the RNFA was a Registered Nurse who through additional extensive education and training practiced in collaboration with, interdependently with, a surgeon licensed in the Commonwealth of Massachusetts, in providing perioperative patient experience. The Clinical Guidelines for the Registered Nurse First Assistant indicated:

1.) Tasks performed under direct supervision of the surgeon was immediately available and physically present in the same room,

2.) Tasks performed under direct supervision of the surgeon was immediately available and physically present in the Surgical Suite, 482.51(a)(4) (COP) 482.51(a)(4) A-0945; [COP, Hospital Federal Regulation Condition of Participation for Surgical Services], and

3.) Review and approval of the Hospital Credential Committee for the role of RNFA.

During an interview at 3:00 P.M. on 9/7/2021, Registered Nurse First Assistant (RNFA) #1 said she did a case (performing delineated surgical tasks) as an RNFA last week.

During an interview at 9:00 A.M. & 9:45 A.M. on 9/8/2021 the Vice President for Patient Care Services said RNFA #1 was credentialed in 2012 as an RNFA and RNFA #1 was the only RNFA (employed) at the Hospital. The Vice President for Patient Care Services said RNFA #1 was not reviewed by the Credentialing Committee (Medical Staff, following the initial credentialing in 2021) because RNFAs were not considered Advanced Practitioners (by the definition in the Hospital's By-Laws). The Vice President for Patient Care Services said Advanced Practice (staff) were considered Affiliate Staff and RNFA #1 was considered a Registered Nurse with additional competencies.

The e-mail dated, at 10:36 A.M. on 9/8/2021, indicated the Medical Staff Office reviewed the 12/2010 (Credentials Committee) Minutes and forms were approved by Credentials (Credentials Committee) stating that it was a CMS (Center for Medicare and Medicaid, Hospital Federal) regulation. The e-mail indicated the Medical Staff Office did not find anything after that approving anyone for the role.

The Hospital provided no current documentation to indicate:

1.) Medical Staff By-Laws, Medical Staff Rules & Regulations or Medical Staff Policy included criteria, qualifications, and competencies for determining the privileges for performing delineated surgical tasks to be granted by the Governing Board to Registered Nurse First Assistants.

2.) The Medical Staff established a credentialing process within the Hospital's QAPI program, RNFA privileges for performing delineated surgical tasks were reviewed and updated at least every two years.

3.) Hospital policies and procedures, in accordance with scope of practice, State laws and regulations for RNFAs to perform delineated surgical tasks.

4.) A roster listing each practitioner's specific surgical privileges and available in the surgical suite included RNFA's privileges for performing delineated surgical tasks.

5.) RNFA #1 had professional liability to include RNFA,

6.) RNFA #1 was CNOR (Certified Nurse for the Operating Room),

7.) The Hospital Medical Executive Committee (Credentials Committee) reviewed and approved RNFA #1 in the role of RNFA to perform delineated surgical tasks.