Summary:
Summary Statement of Deficiencies D5629 CYTOLOGY CFR(s): 493.1274(c)(5) (c) Control procedures. The laboratory must establish and follow written policies and procedures for a program designed to detect errors in the performance of cytologic examinations and the reporting of results. The program must include the following: (c) (5) An annual statistical laboratory evaluation of the number of - (c)(5)(i) Cytology cases examined; (c)(5)(ii) Specimens processed by specimen type; (c)(5)(iii) Patient cases reported by diagnosis (including the number reported as unsatisfactory for diagnostic interpretation); (c)(5)(iv) Gynecologic cases with a diagnosis of HSIL, adenocarcinoma, or other malignant neoplasm for which histology results were available for comparison; (c)(5)(v) Gynecologic cases where cytology and histology are discrepant; and (c)(5)(vi) Gynecologic cases where any rescreen of a normal or negative specimen results in reclassification as low-grade squamous intraepithelial lesion (LSIL), HSIL, adenocarcinoma, or other malignant neoplasms. This STANDARD is not met as evidenced by: Based on review of the annual cytology statistics and confirmed by identifier #1 (refer to the Laboratory Personnel Report) at 10:59 am on 9/8/2023, the laboratory failed to document the annual gynecologic and non-gynecologic statistics for 2022. The findings include: 1. For 2022, the laboratory documented a quarterly evaluation of: a) the number of cytology cases examined; b) the number of specimens processed by specimen type; c) the number of patient cases reported by diagnosis (including the number reported as unsatisfactory for diagnostic interpretation); d) the number of gynecologic case with diagnosis of HSIL, adenocarcinoma, or other malignant neoplasm for which histology results were available for comparison; e) the number of gynecologic cases where cytology and histology are discrepant; and f) the number of gynecologic cases where any rescreen of a normal or negative specimen results in reclassification as low-grade squamous intraepithelial lesion (LSIL), HSIL, adenocarinoma, or other malignant neoplasms. 2. At the time of the survey, the Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 2 -- laboratory had not complied the above quarterly statistics into total annual statistics for 2022. -- 2 of 2 --