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 surveyor review of the Procedure Manual (PM), Performance Appraisal Worksheet (PAW) and interview with the Testing Personnel (TP) the laboratory failed to follow Competency Assessment Procedure (CAP) from 8/10/16 to the date of survey. The findings include: 1. The CAP specified that testing personnel will be evaluated through director observation and review of laboratory work records (a) The PAW did not specify how sections one and two evaluations were preformed. (b) The PAW did not specify what work records were reviewed in section three. 2. The TP confirmed on 8/15/18 at 10:30 AM that the laboratory did not follow the PM. 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 --