Summary:
Summary Statement of Deficiencies D2134 CYTOLOGY CFR(s): 493.855(a) The laboratory must ensure that each individual is tested at least once per year and obtains a passing score. To ensure this annual testing of individuals, an announced or unannounced testing event will be conducted on-site in each laboratory at least once each year. Laboratories will be notified of the time of each announced on-site testing event at least 30 days prior to each event. Additional testing events will be conducted as necessary in each State or region for the purpose of testing individuals who miss the on-site testing event and for retesting individuals as described in paragraph (b) of this section. This STANDARD is not met as evidenced by: Based review of cytology proficiency testing records, laboratory records and interview with the Laboratory Director/Technical Supervisor A the laboratory failed to ensure that one of three Technical Supervisors who examined gynecologic cytology slide preparations in 2022 and 2023 was tested and obtained a passing score on a gynecologic cytology proficiency testing event for 2022. Findings include: 1. The Survey Team requested and the laboratory failed to provide records to document one of three Technical Supervisors was enrolled and participated in an approved gynecologic cytology proficiency testing event in 2022. Technical Supervisor includes: -Technical Supervisor C 2. During an interview on January 8, 2024 at 11:40 AM, the Laboratory Director/Technical Supervisor A stated that Technical Supervisor C reported results on 66 gynecologic cytology tests in October 2022 through February 2023. The Laboratory Director/Technical Supervisor A further stated that Technical Supervisor C failed to test and obtain a passing score on a gynecologic proficiency testing event for 2022 and was no longer employed by the laboratory. Tests include: - GC22-00001 - GC22-00015 -GC22-00033 - GC22-00034 -GC22-00038 - GC22- 00040 -GC22-00043 - GC22-00048 -GC22-00071 - GC22-00076 -GC22-00080 - GC22-00084 -GC22-00090 - GC22-00091 -GC23-00047 - GC23-00052 -GC23- 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 -- 00073 - GC23-00074 -GC23-00146 - GC23-00150 -GC23-00157 - GC23-00161 - GC23-00167 - GC23-00173 -GC23-202 -GC23-208 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 the laboratory failed to establish written policies and procedures for 13 laboratory test processes (refer to D5403); failed to test staining materials for intended reactivity of the Diff-Quick stain used to stain nongynecologic cytology slides for each day of use (refer to D5473); failed to establish and follow written policies and procedures to identify nongynecologic specimens with a high potential for cross- contamination and stain them separately from other nongynecologic specimens and filtering or changing the stains following staining (refer to D5619); failed to establish written policies and procedures for a program to compare clinical information with cytology reports and to compare all gynecologic cytology reports with a diagnosis of HSIL or malignant neoplasms with available histopathology (refer to D5623); failed to establish written policies and procedures to ensure the search and review of prior negative gynecologic specimens received within the previous five years for each patient with a current HSIL or malignancy was performed (refer to D5625); failed to establish and follow written policies and procedures for an annual statistical evaluation of the required laboratory statistics (refer to D5629); failed to establish and follow written policies and procedures for a program to evaluate the case reviews of the Technical Supervisors against the laboratory's overall statistical values (refer to D5631); failed to establish and follow written policies and procedures for the establishment, reassessment and documentation of individual workload limits (refer to D5633, D5637 and D5647); failed to establish and follow written policies and procedures to ensure that workload limits would be prorated when examining slides in less than eight hours (refer to D5641); failed to establish and follow written policies and procedures to ensure the laboratory maintained records of the total number of slides examined and the total number of hours spent examining slides per 24-hour period (refer to D5645); failed to establish and follow written policies and procedures to ensure unsatisfactory slide preparations were identified and reported as unsatisfactory for evaluation (refer to D5655); and failed to establish written policies and procedures to ensure corrected test reports indicated the basis for correction on the corrected test report (refer to D5659). D5201 CONFIDENTIALITY OF PATIENT INFORMATION CFR(s): 493.1231 The laboratory must ensure confidentiality of patient information throughout all phases of the total testing process that are under the laboratory's control. This STANDARD is not met as evidenced by: Based on review of laboratory policies and procedures and interview with the Laboratory Director/Technical Supervisor A the laboratory failed to establish written -- 2 of 14 -- policies and procedures to ensure confidentiality of patient information. Findings include: 1. The Survey Team requested and the laboratory failed to provide written policies and procedures to detail how the laboratory would ensure confidentiality of patient information. 2. During an interview on January 9, 2024 at 3:15 PM, these findings were confirmed with the Laboratory Director/Technical Supervisor A. D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) A written procedures manual for all tests, assays, and examinations performed by the laboratory must be available to, and followed by, laboratory personnel. Textbooks may supplement but not replace the laboratory's written procedures for testing or examining specimens. This STANDARD is not met as evidenced by: Based on review of 18 laboratory policies and procedures, maintenance records and interview the laboratory failed to follow one written policy and procedure. Findings include: 1. The laboratory failed to follow the procedure GYN AND NON-GYN CYTOPATHOLOGY QUALITY ASSURANCE AND QUALITY CONTROL SURVEILLANCE, which stated: "Documentation of evidence of daily review of the technical quality of preparation as well as stain quality by the cytology technical staff, cytotechnologist(s), and pathologist(s)." a. The laboratory failed to test staining materials for intended reactivity of the Diff-Quick stain used to stain nongynecologic cytology slides for each day of use. Refer to D5473 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)