Summary:
Summary Statement of Deficiencies D2006 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b) The laboratory must examine or test, as applicable, the proficiency testing samples it receives from the proficiency testing program in the same manner as it tests patient specimens. This testing must be conducted in conformance with paragraph (b)(4) of this section. If the laboratory's patient specimen testing procedures would normally require reflex, distributive, or confirmatory testing at another laboratory, the laboratory should test the proficiency testing sample as it would a patient specimen up until the point it would refer a patient specimen to a second laboratory for any form of further testing. This STANDARD is not met as evidenced by: Based on review of the laboratory's policies and procedures, review of 2016, 2017, and 2018 API (American Proficiency Institute) proficiency testing records, and interview with TP (testing personnel) 8/8/18, the laboratory failed to test proficiency samples in the same manner that proficiency samples were tested. Findings: 1. The laboratory's "Proficiency Testing" policy states "... PROCEDURE: 1. Proficiency testing will be rotated among the techs so that everyone working in a lab discipline participates in the testing throughout the year. ..." Review of 2016, 2017, and 2018 API proficiency testing records revealed that TP #1 signed the attestation statement as the testing personnel for the 2016 2nd and 3rd hematology test events, the 2017 1st, 2nd, and 3rd hematology test events, and the 2018 1st and 2nd hematology test events. During interview at approximately 12:10 p.m., TP #1 confirmed that she tested all the proficiency samples and TP #2 did not participate in proficiency testing. She verified that TP #2 performs testing on patient specimens. 2. The laboratory's "Proficiency Testing" policy states "... PROCEDURE: ... 4. Proficiency test samples will be tested in exactly the same manner as patient samples are tested. ... b. Samples will only be repeated (e.g. with panic values) if a patient sample would have been repeated under the same circumstances. ..." The laboratory's list of critical values states "1. Repeat all 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 -- critical values before reporting. ..." Review of 216, 2017, and 2018 API proficiency testing records revealed the laboratory failed to repeat critical values obtained on the following proficiency samples: a. 2016 3rd hematology test event - critical values on sample #12 for WBC (white blood cell count), hemoglobin, and hematocrit; b. 2017 2nd hematology test event - critical values on sample #6 for WBC, hemoglobin, and hematocrit; c. 2017 3rd hematology test event - critical values on sample #15 for WBC, hemoglobin, and hematocrit; d. 2018 1st hematology test event - critical values on sample #1 for WBC, hemoglobin, and hematocrit; e. 2018 2nd hematology test event - critical values on sample #8 for hemoglobin and hematocrit. During interview at approximately 12:10 p.m., TP #1 confirmed that they do not repeat critical values obtained on proficiency samples. 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 review of 2017 and 2018 laboratory records and interview with TP (testing personnel) 8/8/18, the laboratory failed to retain all quality control records for at least two years. Findings: Review of 2017 and 2018 Coulter AcT diff 2 hematology quality control records revealed the laboratory failed to maintain the assay sheets for the following lot numbers of Coulter 4C-ES control material: abnormal low 069000, normal 079000, and abnormal high 089000, expiration date 5/7/18. During interview at approximately 3:00 p.m., TP #1 confirmed that the assay sheets were not available for review. 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)