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 review of the procedure manual and interview, the laboratory failed to follow the procedure for cryostat maintenence requirements and quality assurance review for slide labeling. Findings: 1. Review of procedure for crystat maintenence revealed cryostat should be defrosted every six months and air filter to be changed every 3 months. 2. Reveiew of maintenence records for the cryostat from 1/16/2019 to 12/29/2020 revealed only one entry for defrost on 5/27/2020 and no entries for air filter replacement. 3. Review of procedure for quality assurance revealed labels and Mohs maps are to be reviewed with another person to confirm before completion. Mohs map should be initialed by reviewer. 4. Review of Mohs maps revealed no initials by review present on maps provided at the time of survey. Testing personnel (TP) #1 stated he was reviewing the slides himself and not having a second person reviewing map and labels. 5. Interview with TP#1 January 22, 2021 at 11:05 a.m. confirmed, the laboratory failed to follow the procedure for cryostat maintenence requirements and quality assurance review for slide labeling. 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 --