Summary:
Summary Statement of Deficiencies D5401 PROCEDURE MANUAL CFR(s): 493.1251(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 the lack of laboratory written policies and procedures and interview with the office manager (OM); it was determined that the laboratory failed to have an established written policies and procedures for KOH, scabies, and dermatopathology. The findings included: 1. On the day of the survey on June 20, 2024, at approximately 12:00 p.m., the laboratory failed to provide written policies and procedures for KOH, scabies, and dermatopathology testing. 2. For seven (7) out of 7 randomly selected patient test results for KOH, scabies, and dermatopathology performed in the lab, no policies and procedures were available at the time of survey. 3. The OM affirmed on June 20, 2024 at approximately 12:00 p.m. that the laboratory did not have an established written policies and procedures available for performance of KOH, scabies, and dermatopathology testing. 4. Based on the annual testing declaration submitted on June 20, 2024, the laboratory performed of 1,030 tests. D5793 ANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1289(b)(c) (b) The analytic systems quality assessment must include a review of the effectiveness of