Summary:
Summary Statement of Deficiencies D5032 CYTOLOGY CFR(s): 493.1221 If the laboratory provides services in the subspecialty of Cytology, the laboratory must meet the requirements specified in 493.1230 through 493.1256, 493.1274, and 493.1281 through 493.1299. This CONDITION is not met as evidenced by: Based on review of laboratory policies and procedures, laboratory records and interview it was determined that the laboratory failed to establish written policies and procedures to assess the competency of the Technical Supervisor (refer to D5209): failed to follow written policies and procedures for the evaluation and comparison of annual statistics (refer to D5629); failed to follow written policies and procedures for the establishment of individual workload limits, failed to reassess workload limits at least every six months and failed to document a workload limit (refer to D5633, D5637 and D5647); and failed to maintain records of the total number of slides examined and the total number of hours spent examining slides (refer to D5645). 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 laboratory policies and procedures, lack of laboratory records and interview it was determined that the laboratory failed to establish written policies and procedures to assess the competency of one of one Technical Supervisor. The Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 6 -- laboratory failed to assess the competency of one of one Technical Supervisor in 2020, 2021 and to the date of the survey in 2022. Findings include: 1. The Survey Team requested and the laboratory failed to provide written policies and procedures to assess the competency of the Technical Supervisor. 2. The Survey Team requested and the laboratory failed to provide documentation of competency assessments for one of one Technical Supervisor in 2020, 2021 and to the date of the survey in 2022. 3. During an interview on January 10, 2022 at 2:45 PM, these findings were confirmed by the Laboratory Director/Technical Supervisor and Laboratory Consultant. 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)