Summary:
Summary Statement of Deficiencies D5217 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(c)(1) At least twice annually, the laboratory must verify the accuracy of any test or procedure it performs that is not included in subpart I of this part. This STANDARD is not met as evidenced by: Based on review of 2018, 1st event (A) proficiency testing report from CAP (College of American Pathologists), laboratory proficiency testing records, and patients test reports for Meprobamate; and interview with Technical Supervisor-2 (General Supervisor-2), the laboratory failed to verify the accuracy of testing for Meprobamate. Findings include: a. The laboratory chose to participate in CAP's proficiency testing program, "UT" Urine Toxicology, as the means to satisfy the requirement to verify the accuracy of the laboratory-developed LC/MS test for Meprobamate in urine specimen. b. For the 1st event of 2018, the laboratory failed to identify Meprobamate present in Sample UT-05; and thus, accuracy was not verified. c. The Technical Supervisor-2 (General Supervisor-2), affirmed (10/05/18) the aforementioned failure in reporting Meprobamate. d. The reliability and quality of results reported for Meprobamate could not be assured when proficiency testing failed to verify. Based on the laboratory's test run report of 16,203 tests for the timeframe April to October 4, 2018, the laboratory reported approximately 3,240 Meprobamate results each month. A few examples reporting as Negative for Meprobamate are as follows: Date Accession # ----------------------------------------- 1/07/18 21365 2/19/18 23362 3/04/18 24608 4/06 /18 24980 5/13/18 25535 6/20/18 25812 7/05/18 26141 8/13/18 26667 . D5791 ANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1289(a)(c) (a) The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess, and when indicated, correct problems 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 -- identified in the analytic systems specified in 493.1251 through 493.1283. (c) The laboratory must document all analytic systems assessment activities. This STANDARD is not met as evidenced by: Based on review of laboratory proficiency testing records for 2018: event 1 and patients test reports, the lack of laboratory documents, and interview with General supervisor-2 (Technical Supervisor-2), the laboratory failed to assess the problem identified in the laboratory-developed LC/MS testing and determine