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 Biannual Assessment (BA) procedure, Procedure Manual (PM) and interview with the Office Manager (OM), the laboratory failed follow the BA procedure for the Calendar year 2016 and 2017. The finding includes: 1. PM stated to perform BA twice a year with five random cases for Histopathology, Cytology and Fluorescence in situ hybridization (FISH). 2. There was no evidence that BA was performed 3. The OM confirmed on 4/25/18 at 10:30 am that the BA procedure was not followed. D5469 CONTROL PROCEDURES CFR(s): 493.1256(d)(10)(g) Unless CMS Approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub. 7), that provides equivalent quality testing, the laboratory must-- Establish or verify the criteria for acceptability of all control materials. (i) When control materials providing quantitative results are used, statistical parameters (for example, mean and standard deviation) for each batch and lot number of control materials must be defined and available. (ii) The laboratory may use the stated value of a commercially assayed control material provided the stated value is for the methodology and instrumentation employed by the laboratory and is verified by the laboratory. (iii) Statistical parameters for unassayed control materials must be established over time by the laboratory through concurrent testing of control materials Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 3 -- having previously determined statistical parameters. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on surveyor review of the Quality Control (QC) records and interview with the Office Manager (OM), the laboratory failed to verify that the assayed QC materials were within the acceptable ranges before they were put into use for analytes performed on the Qualigen FastPack analyzer from 10/25/16 to the date of survey. The OM confirmed on 4/25/18 at 1:00 pm that the laboratory did not verify QC materials for analytes performed on Qualigen FastPack analyzer D5783