Summary:
Summary Statement of Deficiencies D2115 TOXICOLOGY CFR(s): 493.845(d) Failure to return proficiency testing results to the proficiency testing program within the time frame specified by the program is unsatisfactory performance and results in a score of 0 for the testing event. This STANDARD is not met as evidenced by: Based on review of laboratory proficiency testing records, records from API (American Proficiency Institute), and patients reports; the lack of laboratory documents, and interview with the Testing Person, the laboratory failed to return proficiency testing results to API within the specified time frame. Findings include: a. The laboratory chose to enroll in API's program for testing in Toxicology for Amphetamine, Benzodiazepine, Cocaine, Methadone, and Opiate using the Siemens Viva-E analyzer (serial number 10-2363). b. API stated samples were mailed on 10/15 /18 with the last date of 11/02/18 for reporting results. c. Laboratory records revealed testing was performed on 11/08/18. d. API informed the laboratory that the results were submitted after the required date and would not be graded. e. The Testing person affirmed (11/27/18) the aforementioned failure to report results within API's specified timeframe. . 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 proficiency testing records, the lack of proficiency Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 6 -- testing evaluations, and interview with the Testing person, the laboratory failed to verify the accuracy of testing in Toxicology. Findings include: a. The laboratory chose to enroll in API proficiency testing program as the means to satisfy the requirement to at least twice annually verify the accuracy of testing for Amphetamine, Benzodiazepine, Cocaine, Methdadone, and Opiate. b. The laboratory's results for event 2, 2018, were not graded by API. See D2115 c. Laboratory written policy included the form titled "PT Investigation Form"; however, the laboratory failed to provide the document for evaluating the laboratory's results in comparison to API's Participant Data Summary. d. The Testing person affirmed (11/27/18) the aforementioned lack of laboratory document; and thus, the laboratory failed to verify the accuracy of testing. e. The reliability and quality of testing for Amphetamine, Benzodiazepine, Cocaine, Methdadone, and Opiate could not be assured. The laboratory stated reporting 7,000 results during the timeframe July - November 2018. Examples are as follows: Date Number of patients tested ---------------------------------------------------- 7/17/18 13 8/23/18 10 9/18/18 26 10/10 /18 20 11/20/18 18 . 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)