Summary:
Summary Statement of Deficiencies D2010 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(2) The laboratory must test samples the same number of times that it routinely tests patient samples. This STANDARD is not met as evidenced by: Based on an interview with the laboratory manager and proficiency testing (PT) record review, the laboratory testing personnel failed to test the PT samples for complete blood counts (CBCs) from the American Academy of Family Physicians (AAFP) in the same number of times that it tests patient specimens since the last survey on July 17, 2016. Findings: 1. A PT record review from AAFP for CBCs performed on the Medonic test system revealed the testing personnel tested the PT samples three to five times before submitting the results. 2. An interview on March 14, 2018, at 9:10 AM, with the laboratory manager, confirmed the laboratory failed to test the CBC PT samples in the same manner as patient specimens. 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)