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 2017 and 2018 American Proficiency Institute (API) proficiency testing (PT) records 07/03/18, the laboratory director and testing personnel failed to sign attestation statements for laboratory PT testing performed. Review of 2017 and 2018 API PT records revealed the laboratory participated in 2 of 4 API PT testing events. There were no attestation statements signed by the laboratory director and testing personnel for the 2 API PT testing events in which they participated: 1. API 2017 Hematology/Coagulation - 1st Event 2. API 2018 Hematology/Coagulation - 1st Event D5024 HEMATOLOGY CFR(s): 493.1215 If the laboratory provides services in the specialty of Hematology, the laboratory must meet the requirements specified in 493.1230 through 493.1256, 493.1269, and 493. 1281 through 493.1299. This CONDITION is not met as evidenced by: Based on review of laboratory procedure manual, review of Abbott Cell-Dyn Emerald "Quick Reference Guide" and "log reports", review of maintenance log book, review of calibration records, and testing personnel (TP) interview 07/03/2018, the laboratory failed to monitor and evaluate the overall quality of testing on the Abbott Cell-Dyn 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 -- Emerald hematology analyzer. 1. The laboratory failed to have a comprehensive quality control policy for the Abbott Cell-Dyn Emerald hematology analyzer (see D5403). 2. The laboratory failed to document and perform required maintenance on the Abbott Cell-Dyn Emerald hematology analyzer (see D5429). 3. The laboratory failed to document and perform calibration on the Abbott Cell-Dyn Emerald hematology analyzer (see D5439). 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)