Summary:
Summary Statement of Deficiencies D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) (a) A written procedures manual for all tests, assays, and examinations performed by the laboratory must be available to, and followed by, laboratory personnel. Textbooks may supplement but not replace the laboratory's written procedures for testing or examining specimens. This STANDARD is not met as evidenced by: Based on review of the laboratory policies and procedures, five (5) randomly selected patients Mohs test reports, and interviews with the Mohs manager and the Laboratory Regional Director; the laboratory failed to maintain written policies and procedures reflecting the current practice. 1. The laboratory policies and procedures presented at the time of the inspection on July 29, 2025 were not reflecting the current practice including laboratory safety procedures. The policies and procedures were outdated, not personalized for Pacific Dermatology, and were not approved, signed, and dated by the laboratory director. 2. On July 29, 2025, at approximately 12:15 p.m., the Mohs manager and Laboratory Regional Director affirmed that the laboratory failed to have policies and procedures reflecting the current practice as stated in #1 above. 3. The laboratory's testing declaration form, signed by the laboratory director on July 18, 2025, stated that the laboratory had performed 15,000 Mohs tests annually. D6106 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(14) (e)(14) Ensure that an approved procedure manual is available to all personnel responsible for any aspect of the testing process; and This STANDARD is not met as evidenced by: Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 2 -- Based on interview with the Mohs manager and the Regional Director on July 29, 2025, and lack of updated policies and procedures reflecting the current practice, including laboratory safety procedures, the laboratory director failed to ensure that an approved, signed, and dated, policy procedure manual that accurately reflects current laboratory practices for all personnel are available. Findings include: D5401. -- 2 of 2 --