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 a lack of cytology procedures and confirmed by the laboratory director in an interview on April 26, 2018, at approximately 11:15 am, the laboratory failed to establish policies and procedures for a program to evaluate and compare the laboratory statistics annually to detect errors in the performance of cytological examinations and reporting results. The procedure must include: 1. Cytology cases examined; 2. Specimens processed by specimen type; 3. Patient cases reported by diagnosis (including the number reported as unsatisfactory for diagnostic interpretation). D5641 CYTOLOGY CFR(s): 493.1274(d)(2)(ii) (d) Workload limits. The laboratory must establish and follow written policies and 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 -- procedures that ensure the following: (d)(2)(ii) For the purposes of establishing workload limits for individuals examining slides in less than an 8-hour workday (includes full-time employees with duties other than slide examination and part-time employees), a period of 8 hours is used to prorate the number of slides that may be examined. The formula-- Number of hours examining slides X 100 / 8 is used to determine maximum slide volume to be examined; This STANDARD is not met as evidenced by: Based on a lack of cytology procedures and confirmed by the laboratory director during the laboratory survey on April 26, 2018, at approximately 11:15 am, the laboratory failed to have a policy and procedure for the individual who exams slides in less than an 8-hour workday. -- 2 of 2 --