Summary:
Summary Statement of Deficiencies D0000 An announced CLIA initial survey was conducted at Justin Ross Wasserman MD PA on 12/04/20. The laboratory is not in compliance with 42 CFR Part 493, Requirements for Laboratories. The following is a description of the standard level deficiencies: D5481 CONTROL PROCEDURES CFR(s): 493.1256(f)(g) (f) Results of control materials must meet the laboratory's and, as applicable, the manufacturer's test system criteria for acceptability before reporting patient test results. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on record review and interview with the Laboratory Consultant the laboratory failed to document results of quality control (QC) for hematoxylin and eosin (H&E) stains from 06/20 - 12/04/20. Findings included: Record review of the "Pathologist Job Description and Daily Procedure"revealed "A daily QC slide will accompany the daily slides, the pathologist is responsible for filling out the daily H&E QC form." Interview on 12/04/20 at 2:15 p.m. with the Laboratory Consultant confirmed that the results of stain quality controls were not documented from 06/20 to 12/04/20. 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 --