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 lack of a written procedure manual for review and interview with the facility personnel, the laboratory failed to have a written procedure manual for testing performed under the sub-specialties of mycology and histopathology. Findings include: 1. The laboratory performs patient testing in the sub-specialties of mycology and histopathology, with an approximate annual test volume of 510. 2. No evidence of an approved procedure manual was presented for review during the survey conducted on September 12, 2019. 3. The facility personnel confirmed that the laboratory could not locate the procedure manual during the survey. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 1 --