Summary:
Summary Statement of Deficiencies D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 As specified in the personnel requirements in subpart M, the laboratory must establish and follow written policies and procedures to assess employee and, if applicable, consultant competency. This STANDARD is not met as evidenced by: Based on review of the laboratory's policies and procedures, review of personnel records, and interview with the GS (general supervisor) 3/12/19, the laboratory failed to establish and follow written policies and procedures for evaluating the competency of the general supervisor. Review of policies and procedures revealed the laboratory did not have a written policy for evaluating the competency of the GS for the performance of supervisory responsibilities. Review of personnel records revealed the GS had competency evaluations in October 2017 and April - June 2018 for test performance. The competency evaluations did not include supervisory responsibilities. During interview at approximately 6:00 p.m., the GS confirmed competency evaluations conducted in 2017 and 2018 did not include supervisory responsibilities. 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. 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 -- This STANDARD is not met as evidenced by: Based on review of manufacturer's instructions and interview with staff 3/12/19, the laboratory failed to follow the manufacturer's instructions for the preparation of specimens for testing on the AU5800. Review of manufacturer's product inserts revealed the manufacturer specifies turbid specimens should be centrifuged before analysis. Examples: a. The product insert for the Thermo Scientific CEDIA Cocaine Assay states "... Specimen Collection and Handling... Centrifuge specimens with high turbidity before testing. ..." b. The product insert for the Thermo Scientific DRI Ethyl Alcohol Assay states "... An effort should be made to keep pipetted samples free from gross debris. It is recommended that highly turbid specimens be centrifuged before analysis. ..." c. The product insert for the Syva Emit II Plus Cannabinoid Assay states "... 5 Specimen Collection and Preparation ... Specimens with high turbidity should be centrifuged before analysis. ..." During interview at approximately 3:10 p.m., the laboratory director and the general supervisor stated they don't usually receive turbid specimens. They stated they do not have a centrifuge and they do not centrifuge specimens before testing. 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)