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 the laboratory's policies and procedures, personnel records, and confirmed by interview with Certified Medical Assistant (CMA) #1 at 12:05 pm on 05 /14/2025, the laboratory failed to establish and follow written policies and procedures for assessing competency for personnel reading biopsy slides for one out of one testing personnel (TP #1). The findings include: 1. CMA #1 stated the laboratory collects tissue samples for biopsy testing. The samples are sent to a reference laboratory for processing and some of the cases are returned to be read by TP #1. 2. Review of personnel records for TP #1 did not include documentation of competency assessment performance for reading biopsy slides from 2023-2024. 3. At the time of the survey, CMA #1 confirmed the laboratory did not assess and document performance of competency for reading biopsy slides for TP #1 from 2023-2024. In addition, the laboratory did not have a written policy for assessing and documenting performance of competency evaluation for reading biopsy slides. D5217 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(c)(1) At least twice annually, the laboratory must verify the accuracy of any test or procedure it performs that is not included in subpart I of this part. This STANDARD is not met as evidenced by: 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 -- Based on lack of accuracy verification records and confirmed by interview with Certified Medical Assistant (CMA) #1 at 12:05 pm on 05/14/2025, the laboratory failed to verify the accuracy of reading biopsy slides twice annually for four out of four time periods from 01/01/2023- 12/31/2024. The findings include: 1. CMA #1 stated that the laboratory collects and sends biopsy specimens to a reference laboratory for processing. Once processed, the slides for select cases are sent back to the laboratory to be read. 2. At the time of the survey, CMA #1 confirmed the laboratory did not perform accuracy testing for reading biopsy slides twice annually from 01/01/2023- 12/31/2024. 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 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)