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, slide preparations, observation and interviews it was determined the laboratory failed to establish written policies and procedures to assess the competency of one of one Technical Supervisors (refer to D5209); failed to establish policies and procedures for the collection, labeling, storage and preservation, and transportation of Hologic ThinPrep Pap Tests (refer to D5311); failed to establish written policies and procedures for seven laboratory test processes (refer to D5403); failed to ensure that 81 of 92 written procedures were approved, signed and dated by the Laboratory Director (refer to D5407); failed to follow the manufacturer's instructions for processing gynecologic cytology specimens (refer to D5415); failed to ensure that reagents and solutions were used before their expiration date (refer to D5417); failed to establish performance specifications when the laboratory modified the Hologic ThinPrep Pap Test system manufacturer's instructions with an alternate method of processing gynecologic cytology specimens and when preparing gynecologic slides from Hologic ThinPrep Pap Test vials utilizing cytospin preparations (refer to D5423); failed to establish written policies and procedures to ensure that the search and review of prior negative gynecologic specimens received within the previous five years for each patient with a current malignancy was performed, and failed to document the search for prior negative gynecologic cytology cases (refer to D5625); failed to establish written policies and procedures for the 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 written policies and procedures to ensure Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 14 -- that a maximum workload limit was established and reassessed at least every six months by the Technical Supervisor for one of one Technical Supervisors (refer to D5633 and D5637); failed to establish written policies and procedures to ensure the workload limit for one of one Technical Supervisors, when examining slides in less than an 8-hour workday and with duties other than slide examination, would be prorated to determine the number of slides that may be examined (refer to D5641); failed to ensure that the laboratory maintained records for one of one Technical Supervisors of the total number of slides and the total number of hours spent evaluating slides per 24-hour period (refer to D5645); failed to establish written policies and procedures to ensure that records were available to document the workload limit for one of one Technical Supervisors (refer to D5647); failed to follow written policies and procedures to ensure that gynecologic cytology slide preparations were identified and reported as unsatisfactory (refer to D5655); and failed to establish written policies and procedures for the system of narrative descriptive nomenclature used by the laboratory to report gynecologic cytology test results (refer to D5657). 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 Supervisors in 2019, 2020 and to the date of the survey in 2021. Findings include: 1. The Survey Team requested and the laboratory failed to provide written policies and procedures to describe the laboratory's process for assessing the competency of one of one Technical Supervisors. 2. The Survey Team requested and the laboratory failed to provide records of competency assessment for one of one Technical Supervisors who performed microscopic evaluations during 2019, 2020 and to the date of the survey in 2021. Technical Supervisor includes: - Technical Supervisor 3. During an interview on May 11, 2021 at 11:15 AM, these findings were confirmed with the Laboratory Director/Technical Supervisor. D5311 SPECIMEN SUBMISSION, HANDLING, AND REFERRAL CFR(s): 493.1242(a) The laboratory must establish and follow written policies and procedures for each of the following, if applicable: (1) Patient preparation. (2) Specimen collection. (3) Specimen labeling, including patient name or unique patient identifier and, when appropriate, specimen source. (4) Specimen storage and preservation. (5) Conditions for specimen transportation. (6) Specimen processing. (7) Specimen acceptability and rejection. (8) Specimen referral. This STANDARD is not met as evidenced by: Based on review of laboratory policies and procedures and interviews it was determined that the laboratory failed to establish written policies and procedures for the collection, labeling, storage and preservation, and transportation of Hologic -- 2 of 14 -- ThinPrep Pap Tests. Findings include: 1. The Survey Team requested and the laboratory failed to provide written policies and procedures for the collection, labeling, storage and preservation, and transportation of Hologic ThinPrep Pap Tests submitted to the laboratory. 2. During an interview on May 11, 2021 at 8:15 AM, the Laboratory Manager provided to the Survey Team the Hologic ThinPrep Pap Test Quick Reference Guide and stated "this is what we use for collection instructions." 3. During an interview on May 11 at 12:30 PM, these findings were confirmed with the Laboratory Director/Technical Supervisor. 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)