Summary:
Summary Statement of Deficiencies D2009 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The individual testing or examining the samples and the laboratory director must attest to the routine integration of the samples into the patient workload using the laboratory's routine methods. This STANDARD is not met as evidenced by: Based on review of 2018 American Proficiency Institute (API) proficiency testing (PT) records and interview with technical supervisor (TS) 07/23/18, the laboratory director and testing personnel failed to sign attestation statements for the PT performed. Review of 2018 API remedial kit PT records revealed no attestation statement for the PT performed. Review of 2018 API - 2018 Chemistry - Miscellaneous - 1st Event PT records revealed no attestation statement for the PT performed. Interview with TS at approximately 2:30 p.m. confirmed the testing personnel and the laboratory director did not sign attestation statements for the PT performed. 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 laboratory records, review of American Proficiency Institute (API) proficiency testing (PT) records and interview with technical supervisor (TS) 07 /23/18, the laboratory failed to verify the accuracy of all testing performed on the Mindray BS 200 at least twice annually as required. 1. Review of laboratory records 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 -- revealed the laboratory failed to verify the accuracy of the following testing performed on the Mindray BS 200 at least twice annually from September 2016 until January 2018, a period of approximately 15 months. a. Alcohol b. Amphetamines c. Benzodiazepines d. Cannabinoids e. Cocaine Metabolites f. Methadone g. Opiates h. Propoxyphene Review of 2018 API PT records revealed the laboratory had participated in 2 API PT events in 2018; an API remedial event, approximately January 23, 2018, and the API PT 2018 Chemistry - Miscellaneous - 1st Event for the above named analytes. Both events were scored acceptable. 2. Review of laboratory records revealed the laboratory failed to verify the accuracy of creatinine testing performed on the Mindray BS at least twice annually from September 2016 until time of survey 7/23/18, a period of approximately 22 months. Interview with TS at approximately 10:30 a.m. confirmed the laboratory failed to verify the accuracy of all testing performed on the Mindray BS 200 at least twice annually as required. 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)