Summary:
Summary Statement of Deficiencies D2007 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The samples must be examined or tested with the laboratory's regular patient workload by personnel who routinely perform the testing in the laboratory, using the laboratory's routine methods This STANDARD is not met as evidenced by: Based on a record review and an interview with the laboratory testing person, the laboratory failed to test the Medical Laboratory Evaluation (MLE) proficiency testing (PT) samples for complete blood counts (CBCs) by the same personnel who perform patient testing during 2017. Findings: 1. A MLE PT record review revealed the laboratory failed to test the CBC PT samples by the same testing personnel who performed patient testing during the 2017 events 1 and 2. 2. An interview on April 9, 2018 at 10:30 AM, with the laboratory testing person, confirmed the laboratory failed to test the CBC proficiency samples from MLE by personnel who routinely test patient CBCs since the last survey. 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 Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 2 -- 493.1253. (7) Control procedures. (8)