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 interviews it was determined that the laboratory failed to follow written policies and procedures to assess the competency of Technical Supervisors (refer to D5209); failed to establish written policies and procedures for one laboratory process (refer to D5403); failed to document testing of staining materials for intended reactivity (refer to D5473); failed to follow written policies and procedures for staining nongynecologic specimens that have a high potential for cross-contamination (refer to D5619); failed to establish written policies and procedures to maintain and annually evaluate required statistics (refer to D5629); failed to establish written policies and procedures for establishing, reassessing, and prorating workload limits for three of three Technical Supervisors (refer to D5633, D5637 and D5641); failed to establish written policies and procedures for documenting and maintaining workload records (refer to D5643 and D5645); failed to establish written policies and procedures to ensure that unsatisfactory nongynecologic slide preparations were identified and reported as unsatisfactory (refer to D5655); and failed to establish written policies and procedures to ensure reports contained narrative descriptive nomenclature (refer to D5657). The cumulative effect of these systemic problems resulted in the laboratory's inability to ensure the accuracy and reliability of patient test results in the subspecialty of Cytology. D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 9 -- 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 interviews it was determined that the laboratory failed to follow written policies and procedures to assess the competency of three of three Technical Supervisors in 2018, 2019 and to the date of the survey in 2020. Findings include: 1. The laboratory failed to follow the procedure titled PATHOLOGIST PROFESSIONAL COMPETENCY which described how Technical Supervisor competency would be assessed based on the following activities: - Peer review concordance - Continuing education activities - Annual quality assurance evaluations 2. The Survey Team requested and the laboratory failed to provide records of competency assessment for three of three Technical Supervisors who performed microscopic evaluations in 2018, 2019 and to the date of the survey in 2020. Technical Supervisors include: - Laboratory Director /Technical Supervisor A - Technical Supervisor B - Technical Supervisor C 3. During an interview on 2/25/20 at 10:40 AM, Laboratory Director/Technical Supervisor A confirmed that there were no records of competency assessment for the Technical Supervisors. 4. During an interview on 2/26/20 at 11:15 AM, Laboratory Director /Technical Supervisor A and the Operations Director confirmed these findings. 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)