Summary:
Summary Statement of Deficiencies D5211 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(a) The laboratory must review and evaluate the results obtained on proficiency testing performed as specified in subpart H of this part. This STANDARD is not met as evidenced by: Based on a surveyor's review of the College of American Pathologists (CAP) Proficiency Testing (PT) reports and confirmed in an interview with the laboratory Supervisor, the Laboratory Director failed to review the proficiency test results performed in March of 2019. Findings: 1. At approximately 11:30AM on June 18, 2019, the laboratory Supervisor confirmed that there was no documented review of the March 2019 PT results. 2. CAP DAI-A March 2019 Toxicology Adulterant PT was not signed off even though an extensive remediation was done on the failure of 2 out of 3 Creatinine results. 3. CAP DMPM-A March 2019 Drugs of Abuse PT had no documented review of PT scores. 4. CAP ETB-A March 2019 ETG PT had no documented review of PT scores. D5215 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(b)(2) The laboratory must verify the accuracy of any analyte, specialty or subspecialty assigned a proficiency testing score that does not reflect laboratory test performance (that is, when the proficiency testing program does not obtain the agreement required for scoring as specified in subpart I of this part, or the laboratory receives a zero score for nonparticipation, or late return or results). This STANDARD is not met as evidenced by: Based on a review of the laboratory's proficiency testing (PT) records from the 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 -- College of American Pathologists (CAP) and confirmed in an interview with the Laboratory Supervisor, the laboratory failed to evaluate and verify the accuracy of the PT results for the analytes that were not scored by the PT program. Findings: 1. At approximately 11:00 AM on June 18, 2019, the laboratory Supervisor confirmed that for CAP PT event DMPM-A in March of 2019 proficiency tests results had no review or evaluation for educational challenge (code 26) and results outside the method instrument reportable range (code 22). 2. CAP March 19, 2019 ETB-A proficiency tests results had no review or evaluation for results listed as outside the method instrument reportable range (code 22). 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 a lack laboratory's proficiency testing (PT) records or twice year verification records and confirmed in an interview with the laboratory Supervisor, the laboratory failed to evaluate and verify the accuracy of the of 44 toxicology analytes and 4 adulterants tested in the year 2018. Findings: At approximately 11:00 AM on June 18, 2019 the laboratory Supervisor confirmed that the laboratory failed to perform PT or twice year verification for the year 2018. 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)