Summary:
Summary Statement of Deficiencies D3031 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(3) Analytic systems records. Retain quality control and patient test records (including instrument printouts, if applicable) and records documenting all analytic systems activities specified in 493.1252 through 493.1289 for at least 2 years. This STANDARD is not met as evidenced by: Based on surveyor's review of the laboratory's LCMS analysis records and confirmed in an interview with the laboratory technical consultant and testing personnel, the laboratory failed to save the final analysis of results after all maniputlations for the Shimadzu-8050 LCMS system from August 11, 2017 through July10, 2019. FINDINGS: 1. The laboratory testing person confirmed at approximately 3:30PM on July 10, 2019 that when he analyzes all the data and manipulates the integration and cleans up the results he does not save the final analysis document. He only saves the raw data files. 2. While it may be theoretically possible to reconstruct the data from the raw data files, it is unlikely to be successful. 3. Approximately 1800 patients results were released during this time period. 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 surveyor's review of the College of American Pathologists (CAP) proficiency testing (PT) and American Proficiency Institute (API) records and confirmed in an interview with the technical/general supervisor and testing personnel, Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 4 -- the laboratory failed to evaluate and verify the accuracy of the of 31 out of 75 toxicology analytes in the year 2018. FINDINGS: The technical supervisor and testing personnel, confirmed on July 10, 2019 at approximately 2:00 PM, that the laboratory failed to evaluate and verify the accuracy of the of 31 toxicology analytes in the year 2018. a. The laboratory uses the CAP modules the Urine Drug Screening (UDS) and Drug Monitoring Pain Management (DMPM) for twice year verification. The laboratory failed to verify 31 out of 75 toxicology analytes for screening and confirmatory mass spectrometry testing. 2. Approximately 1500 patients specimens were tested during this time-period D5311 SPECIMEN SUBMISSION, HANDLING, AND REFERRAL CFR(s): 493.1242(a) The laboratory must establish and follow written policies and procedures for each of the following, if applicable: (1) Patient preparation. (2) Specimen collection. (3) Specimen labeling, including patient name or unique patient identifier and, when appropriate, specimen source. (4) Specimen storage and preservation. (5) Conditions for specimen transportation. (6) Specimen processing. (7) Specimen acceptability and rejection. (8) Specimen referral. This STANDARD is not met as evidenced by: Based on lack of a pre-analytic procedures for the collection and storage of urine specimens and confirmed in an interview with the technical/general supervisor and testing personnel, the laboratory failed to establish written procedures and policies for urine specimens. FINDINGS: The technical/general supervisor and testing personnel confirmed on July 11, 2019 at approximately 2:30 PM, that the laboratory failed to have written procedures for urine specimens to include: patient preparation, urine collection, verification of urine specimen, labeling of the specimen, storage and preservation, specimen acceptability and rejection and data entry of information into the electronic medical records (EMR). D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) A written procedures manual for all tests, assays, and examinations performed by the laboratory must be available to, and followed by, laboratory personnel. Textbooks may supplement but not replace the laboratory's written procedures for testing or examining specimens. This STANDARD is not met as evidenced by: Based on a review of the laboratory procedure manual, pipet calibration records, and an interview with the technical supervisor and the testing persons the laboratory is not following their procedure for performing pipet calibrations every six months and does not have a procedure for twice year verification of toxicology analytes not cover by the laboratory ' s Proficiency Testing (PT) Provider. Findings: 1. At approximately 2: 30 PM on July10, 2019 the surveyor observed surveyor that the laboratory did not follow their procedure to calibrate their pipets. Pipet calibration records for 2017 and 2018 show only one calibration performed each year. 2. At approximately 3:00 PM on July 10, 2019 the testing person confirmed that the laboratory had no procedure for twice year verification for analytes not covered by the College of American Pathologist PT Program. -- 2 of 4 -- 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)