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 laboratory personnel interview and toxicology proficiency testing record review on November 27, 2018, the laboratory failed to have a mechanism that at least twice annually verified the accuracy of its patient acetaminophen and tapentadol testing. Findings included: a. To meet the CLIA requirement at 42 C.F.R. 493.1236 (c), the toxicology section of the laboratory enrolled in proficiency testing provided by the College of American Pathologists (CAP) and other proficiency testing providers. b. The laboratory maintained documentation that it had enrolled, completed, and reported proficiency testing results for all toxicology analytes the laboratory performed and reported, except for the analytes acetaminophen and tapentadol. The laboratory maintained no mechanism to verify the accuracy of its acetaminophen and tapentadol patient testing at least twice annually. c. According to laboratory personnel, the laboratory screened approximately 100 patient toxicology specimens weekly, and performed approximately 800 various patient toxicology confirmation tests weekly. D5400 ANALYTIC SYSTEMS CFR(s): 493.1250 Each laboratory that performs nonwaived testing must meet the applicable analytic systems requirements in 493.1251 through 493.1283, unless HHS approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub.7), that provides equivalent quality testing. The laboratory must monitor and evaluate the overall quality of the analytic systems and correct identified problems as specified in Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 9 -- 493.1289 for each specialty and subspecialty of testing performed. This CONDITION is not met as evidenced by: D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) The procedure manual must include the following when applicable to the test procedure: (1) Requirements for patient preparation; specimen collection, labeling, storage, preservation, transportation, processing, and referral; and criteria for specimen acceptability and rejection as described in 493.1242. (2) Microscopic examination, including the detection of inadequately prepared slides. (3) Step-by-step performance of the procedure, including test calculations and interpretation of results. (4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other materials used in testing. (5) Calibration and calibration verification procedures. (6) The reportable range for test results for the test system as established or verified in 493.1253. (7) Control procedures. (8)