Summary:
Summary Statement of Deficiencies D5429 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(1) For unmodified manufacturer's equipment, instruments, or test systems, the laboratory must perform and document maintenance as defined by the manufacturer and with at least the frequency specified by the manufacturer. This STANDARD is not met as evidenced by: Based on review of laboratory policies and procedures, laboratory records and interview, it was determined that the laboratory failed to establish a maintenance protocol for one of one cytology slide preparation machines from 2016, 2017 and to the date of the survey in 2018. Findings include: 1. The Survey Team requested and the laboratory failed to provide written policies and procedures to describe how the "Hologic ThinPrep 2000" cytology specimen slide preparation machine would be cleaned and maintained. 2. The survey team requested and the laboratory failed to provide maintenance records for the "Hologic ThinPrep 2000" from 2016, 2017 and to the date of the survey in 2018. 3. During an interview on 04/05/2018 at 10:05 AM, the Laboratory Director/Technical Supervisor confirmed that there were no maintenance records for the "Hologic Thin Prep 2000" machine. 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, Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 4 -- 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 laboratory policies and procedures, laboratory records and interview, it was determined that the laboratory failed to establish written policies and procedures for an annual statistical evaluation of three of three required statistics for nongynecologic cytology specimens in 2016, 2017 and to the date of the survey in 2018. Findings include: 1. The Survey Team requested and the laboratory failed to provide written policies and procedures for an annual statistical laboratory evaluation of three required statistics for the nongynecologic specimens: 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, to include unsatisfactory. 2. During an interview on 04/03/2018 at 10:00 AM, the Laboratory Director/Technical Supervisor confirmed these findings and stated that the laboratory had the statistics in the computer but did not have a procedure for an evaluation of the statistics. D5631 CYTOLOGY CFR(s): 493.1274(c)(6) (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) (6) An evaluation of the case reviews of each individual examining slides against the laboratory's overall statistical values, documentation of any discrepancies, including reasons for the deviation, and, if appropriate,