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 the laboratory failed to establish policies and procedures for the random selection of ten percent of the gynecologic cases interpreted to be negative (refer to D5621); failed to establish policies and procedures for the evaluation and comparison of six annual statistics and failed to document three of six required annual statistics (refer to D5629); failed to establish policies and procedures for the establishment of individual workload limits and failed to reassess workload limits at least every six months (refer to D5633, D5635 and D5637); failed to establish policies and procedures to ensure the workload limit when examining slides in less than an 8-hour workday would be prorated to determine the number of slides that may be examined (refer to D5641); failed to maintain records of the total number of slides examined and the total number of hours spent examining slides (refer to D5645); failed to establish written policies and procedures to document the workload limit (refer to D5647); and failed to establish policies and procedures for the system of narrative descriptive nomenclature used by the laboratory to report gynecologic cytology test results (refer to D5657). 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, Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 8 -- 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)