Summary:
Summary Statement of Deficiencies D0000 The laboratory was found to be in substantial compliance with CLIA regulations 42 CFR Part 493. Standard level deficiencies were cited. 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 a review of the laboratory's policies, Center for Medicare & Medicaid Services (CMS) 116 form and staff interview, the laboratory failed to establish and follow written policies for non-gynecologic cytology cases to include an annual statistical evaluation of the number of cytology cases examined annually, number of specimens processed by specimen type and number of patient cases reported by diagnosis including the number reported as unsatisfactory for diagnostic interpretation. Findings included: 1. A review of the laboratory's policies revealed the laboratory failed to establish and follow written policies for an annual statistical laboratory evaluation of the number of cytology cases examined annually, number of specimens processed by specimen type and number of patient cases reported by 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 -- diagnosis including the number reported as unsatisfactory for diagnostic interpretation. On 10/30/2021 at 10:35 a.m., the laboratory was asked to provided documentation of the laboratory's annual statics for the number of cytology cases examined annually, the number of specimens processed by specimen type and the number of patient cases reported by diagnosis. No documentation was provided. 2. Review of the CMS 116 form, section VIII "Non-Waived Testing", had an estimated annual test volume of 400 tests for the sub-specialty of cytology (non-gynecologic). 3. During an interview on 10/30/24 at 11:40 a.m., the Laboratory Director confirmed the above findings. -- 2 of 2 --