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, observation and interviews it was determined that the laboratory failed to follow the manufacturer's instructions for evaluating Hologic ThinPrep Pap Test specimens (refer to D5411); failed to test staining materials for intended reactivity to ensure predictable staining characteristics (refer to D5473); failed to establish policies and procedures to prevent cross-contamination during staining of nongynecologic specimens that have a high potential for cross-contamination (refer to D5619); failed to establish policies and procedures for a program to determine the causes of discrepancies between the cytology diagnosis and the histopathology diagnosis (refer to D5623); failed to establish policies and procedures for the review of negative gynecologic specimens for each patient with a current high-grade squamous intraepithelial lesion (HSIL) or malignancy (refer to D5625); failed to establish policies and procedures for the annual evaluation and comparison of six of six laboratory statistics, and failed to document six of six required annual statistics (refer to D5629); failed to establish policies and procedures to assess and reassess workload limits (refer to D5633 and D5637); failed to establish policies and procedures to ensure workload limits for two of two Technical Supervisors, when examining slides in less than an 8-hour workday, would be prorated (refer to D5641); failed to establish policies and procedures to ensure the laboratory maintained records of the number of slides examined and the number of hours spent examining slides in each 24-hour period (refer to D5645); failed to establish policies and procedures to ensure that unsatisfactory gynecologic and nongynecologic slide preparations were identified and Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 12 -- reported as unsatisfactory (refer to D5655); failed to establish policies and procedures to ensure gynecologic and nongynecologic cytology test reports contained narrative descriptive nomenclature (refer to D5657); and failed to maintain the identity of the personnel who performed the required daily maintenance (refer to D5787). 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. 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)