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 testing personnel competency assessment records, review of the competency assessment policy and interview with testing personnel (TP) #1, the laboratory failed to have a complete competency assessment policy and evaluate the competency of 2 of 3 clinical consultants (CC) from 2017 to the day of survey. Findings Include: 1. On the day of survey, 09/19/2019, the laboratory could not provide a complete competency assessment policy for the CC's from of 2017 to the date of survey. 2. The laboratory could not provide competency assessments performed on 2 of 3 CC in 2017, 2018 and 2019. 3. The TP#1 confirmed the finding above on 09/19/2019 around 9:30 am. 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 3 -- 493.1253. (7) Control procedures. (8)