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 procedure manual and an interview with the practice manager and laboratory director at 1:20 PM on 8/28/2018, the laboratory failed to have a procedure manual for the tests and examinations performed by the laboratory. Findings are: 1. No procedure manual could be presented during the time of survey on 8/28/2018. 2. Interview with the practice manager and laboratory director confirmed there had been no procedure manual in place for the KOH/Wet prep and histopathology testing performed at this laboratory. 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 --