Summary:
Summary Statement of Deficiencies D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 As specified in the personnel requirements in subpart M, the laboratory must establish and follow written policies and procedures to assess employee and, if applicable, consultant competency. This STANDARD is not met as evidenced by: Based on the lack of Competency Assessment (CA) records and surveyor interview with the Office Manager (OM), the laboratory failed to perform CA on two out of three TP in the calendar years 2017 and 2018. The finding includes: 1. TP #2 and #3 performing the Technical Component for Histology testing did not have a CA in the calendar years 2017 and 2018. 2. The OM confirmed on 1/30/19 at 1:15 pm that CA was not performed. 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 surveyor review of the Procedure Manual (PM), observation of the Staining Station (SS) and interview with the Office Manager (OM), the laboratory failed to follow Mohs Staining Procedure from 2/15/17 to the date of the survey. The findings include: 1. The SS in the laboratory did not correspond with the staining procedure in the PM. a) The PM stated hematoxylin for step one, but the SS had 100% alcohol. b) Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 2 -- The PM stated water for step two, but the SS had Sub X. c) The PM stated 0.5% Acid Alcohol for step three, but the SS had Sub X. d) The PM stated running tape water for step four, but the SS had 100% alcohol. e) The PM stated Scotts water for step five, but the ASS had 100% alcohol. f) The PM stated running tap water for step six, but the ASS had 100% alcohol. g)The PM stated 95% alcohol for step seven, but the ASS had 100% alcohol. 2. The OM confirmed on 1/30/19 at 10:00 am that PM procedure did not match with SS. -- 2 of 2 --