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 confirmed in an interview with the pathologist/technical supervisor, the laboratory failed to establish, reassess and document a workload limit for the laboratory director /technical supervisor (refer to D5633, D5637, D5639, D5641, D5645 and D5647);the pathologist failed to perform and document the quality control (QC) acceptability of the Hematoxylin and Eosin (H & E), special stains and immunostain stain used for histopathology slides (refer to D5601). 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 Histology and Cytology. 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: Based on review of the twice year verification records for histology and an interview with the pathologist/technical supervisor, the laboratory failed to verify the accuracy for the urine cytology from June 3, 2021 through September 8, 2022. FINDINGS: The pathologist/technical supervisor confirmed on September 8, 2022 at approximately 10: Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 7 -- 30 AM that the laboratory failed to verify the accuracy for the urine cytology from January 1, 2021 through September 8, 2022. a. Approximately 400 cases were reported during this time period. D5291 GENERAL LABORATORY SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1239(a) The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess, and, when indicated, correct problems identified in the general laboratory systems requirements specified at 493.1231 through 493.1236. This STANDARD is not met as evidenced by: Based on review of the Quality Assessment (QA) policy and a interview with the pathologist/technical supervisor, the laboratory failed to follow their establish QA policy and perform a annual QA review for the calendar year 2021. FINDINGS: 1. The laboratory to follow their establish QA policy and perform a annual QA review for the calendar year 2021. a. 2021 annual QA review documentation was not available for review. 2. The pathologist/technical supervisor, confirmed on September 8, 2022 at approximately 11:00 AM, the laboratory failed to follow their establish QA policy and perform a annual QA for 2021. 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)