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: a) Based on surveyor review of the Procedure Manual (PM), visual observation of the staining station and interview with the Office Manager (OM) the laboratory failed to follow its Mohs Hematoxylin & Eosin (H&E) Staining Protocol from 12/3/15 to the date of the survey. The finding includes: 1. The auto staining station in the laboratory did not correspond with the staining procedure in the PM. a) There were four dips of water following Gills Hematoxylin on the auto stainer, but the PM stated one dip. b) There were three dips of water following bluing reagent on the auto stainer, but the PM stated one dip. 2. The OM confirmed on 2/1/18 at 10:00 am the laboratory did not follow the PM. b) Based on surveyor review of the PM, Mohs Biannual Assessment (BA) records and interview with the OM, the laboratory failed to follow their BA procedure for the calendar years 2016 and 2017. The finding includes: 1. The PM stated BA was required quarterly but the laboratory performed BA three times in 2016 and twice in 2017. 2. The OD confirmed on 2/1/18 at 10:30 am the BA procedure was not followed. 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 --