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 a review of laboratory policy, the Centers for Medicare and Medicaid Services form CMS-209, laboratory personnel records and staff interview, the laboratory failed to assess and document interim competency for two of eight testing personnel (TP) and annual competency for one of eight testing personnel (TP) in 2024. The findings include: 1. A review of the policy "Competency Testing on Laboratory Personnel" revealed the following requirement: "During the first year of an individual's duties, competency must be assessed after initial training and semiannually. After an individual has performed their duties for one year, competency must be assessed annually." 2. A review of the form CMS-209 revealed eight testing personnel listed for moderately complex testing. 3. A review of the laboratory's personnel records revealed the following: - TP 3- no documented annual competency in 2024 - TP 5- no documented interim competency in 2024 - TP 6- no documented interim competency in 2024 4. An interview with the Laboratory Regional Operations Manager on April 16, 2025 at 12:45 pm confirmed the above survey findings. D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) (b) The procedure manual must include the following when applicable to the test procedure: (b)(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. (b)(2) Microscopic 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 -- examination, including the detection of inadequately prepared slides. (b)(3) Step-by- step performance of the procedure, including test calculations and interpretation of results. (b)(4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other materials used in testing. (b)(5) Calibration and calibration verification procedures. (b)(6) The reportable range for test results for the test system as established or verified in 493.1253. (b)(7) Control procedures. (b)(8)