Summary:
Summary Statement of Deficiencies D5637 CYTOLOGY CFR(s): 493.1274(d)(1)(ii) (d) Workload limits. The laboratory must establish and follow written policies and procedures that ensure the following: (d)(1)(ii) Each individual's workload limit is reassessed at least every 6 months and adjusted when necessary. This STANDARD is not met as evidenced by: Based on review of laboratory policies and procedures, lack of workload limit reassessment records and interviews the laboratory failed to establish and follow written policies and procedures to reassess and adjust when necessary, a maximum workload limit at least every six months for the Technical Supervisor who performed primary screening of cytology specimens. The Technical Supervisor failed to reassess a maximum workload limit for one of one Technical Supervisors in 2023 and January 1, 2024 to the date of the survey in 2024. Findings include: 1. The Survey Team requested and the laboratory failed to provide written policies and procedures to reassess and adjust when necessary, a maximum workload limit at least every six months for the Technical Supervisor. 2. The Survey Team requested and the laboratory failed to provide documentation the Technical Supervisor reassessed a maximum workload limit based on performance, for one of one Technical Supervisors in 2023 and January 1, 2024 to the date of the survey in 2024. Technical Supervisor includes: -Laboratory Director/Technical Supervisor a. During a phone interview on November 19, 2024 at 2:30 PM, the Laboratory Director/Technical Supervisor explained that workload records reflected a review of the stain quality and the number of slides evaluated but there were no records to reflect a workload limit reassessment based on microscopic evaluation performance. 3. During a phone interview on November 20, 2024 at 10:30 AM, these findings were confirmed with the Laboratory Director/Technical Supervisor. D5655 CYTOLOGY 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 -- CFR(s): 493.1274(e)(4) (e) Slide examination and reporting. The laboratory must establish and follow written policies and procedures that ensure the following: (e)(4) Unsatisfactory specimens or slide preparations are identified and reported as unsatisfactory. This STANDARD is not met as evidenced by: Based on review of laboratory policies and procedures, interview, and review of specimen slides and corresponding laboratory records the laboratory failed to establish and follow written policies and procedures to ensure unsatisfactory nongynecologic cytology slide preparations were identified and reported as unsatisfactory. The laboratory failed to identify and report two of three nongynecologic cytology cases as "Unsatisfactory for evaluation" July through November 11, 2024. Findings include: 1. The Survey Team requested and the laboratory failed to provide written policies and procedures to ensure unsatisfactory nongynecologic cytology slide preparations were identified and reported as unsatisfactory. 2. During a phone interview on November 20, 2024 at 10:30 AM, the Laboratory Director/Technical Supervisor stated the following: -"If there are not enough cells on the ThinPrep (cytology) slide, I look on the two other IHC (immunohistochemical) slides for cell numbers." 3. The Survey Team reviewed 294 negative nongynecologic cytology cases/slides and the corresponding final cytology test reports from July through November 11, 2024 and identified two nongynecologic cases as "Unsatisfactory-scant cellularity." Cases include: 024-1029 and 024-1049 a. The Laboratory Director/Technical Supervisor reviewed the Survey Team findings on the PATHOLOGIST CASE REVIEW FORM signed and submitted on November 27, 2024 as: -"Pap stained slide: Unsat Note: Additional cells present in IHC slides overall: satisfactory" D9999 -- 2 of 2 --