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. D5633 CYTOLOGY CFR(s): 493.1274(d)(1) (d)(1) The technical supervisor establishes a maximum workload limit for each individual who performs primary screening. This STANDARD is not met as evidenced by: Based on review of laboratory Center for Medicare and Medicaid Services (CMS) -209 survey form, laboratory policy, daily slide count logs in 2025, and confirmed in interview, the technical supervisor failed to establish a maximum workload limit for one of two personnel performing non-gynecological cytology slide screening from June-August 2025. Findings included: 1. Review of CMS-209 form submitted at time of survey (10/09/2025), revealed two testing personnel (TS-1 and TS-3), performing non-gynecological cytology. 2. Review of laboratory policy, "Introduction- Workload Limits" (Approved by the Laboratory Director on 01/06/2025) revealed the following: "Principle Workload limits on the number of slides to be screened by a primary screener will be in accordance with CLIA 493.1274(d). In order to ensure the accurate screening of non-gynecological cytology slides, workload limits on the number of slides screened, and performance evaluation of the pathologist who performs screening of cytology slides will be undertaken." 3. Review of laboratory non- gynecological cytology daily slide count logs, revealed the following: "Limitations: 1. Only 100 slides can be screened in a 24 hr period. 2. Maximum of 12.5 slides per hour. 3. All Non-gyn will be read by a pathologist." The surveyor requested documentation of an established workload limit for the specific testing personnel (TS- 3) performing non-gynecological primary screening from June-August 2025. No documentation was provided. 4. In an interview in the facility conference room on 10 /09/2025 at 01:35 PM, the technical supervisor (TS-1), confirmed a maximum 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 -- workload limit was not established for one of two personnel (TS-3) performing non- gynecological cytology primary screening from June-August 2025. Word Key TS- Technical Supervisor Hr- Hour Non-gyn- Non-gynecological D5645 CYTOLOGY CFR(s): 493.1274(d)(3) (d)(3) The laboratory must maintain records of the total number of slides examined by each individual during each 24-hour period and the number of hours spent examining slides in the 24-hour period irrespective of the site or laboratory. This STANDARD is not met as evidenced by: Based on review of laboratory Center for Medicare and Medicaid Services (CMS) -209 survey form, laboratory policy, daily slide count logs (June 2025-August 2025), and staff interview, the laboratory failed to ensure documentation of the total number of hours the technical supervisor spent screening non-gynecologic cytology slides during each 24-hour period, for 46 of 46 days reviewed in 2025 (June 2025- September 2025). Findings included: 1. Review of CMS-209 form submitted at time of survey (10/09/2025), revealed two technical supervisors (TS-1 and TS-3), in cytology. 2. Review of laboratory policy, "Introduction- Workload Limits" (Approved by the Laboratory Director on 01/06/2025) revealed the following: " ...Procedure 1. A workload log will be kept for each work period detailing the number of hours spent examining cytology slides and the total of slides examined." 2. Review of laboratory non-gynecological cytology daily slide count logs from June 2025-August 2025, revealed the laboratory failed to document hours spent screening slides by a technical supervisor (TS-3) for the following 46 of 46 days in 2025: June 2025 a. 06/06/2025; 06/09/2025; 06/17/2025; 06/18/2025; 06/19/2025; 06/23-27/2025 July 2025 b. 07/01- 03/2025; 07/07-11/2025; 07/14-18/2025; 07/21-25/2025; 07/28-31/2025 August 2025 c. 08/04-08/2025; 08/11-15/2025; 08/19-22/2025; 08/25-29/2025 The surveyor requested the above documentation of hours spent screening by TS-3, and none was provided. 3. In an interview in the facility conference room on 10/09/2025 at 01:10 PM, the laboratory manager confirmed the laboratory failed to ensure documentation of the total number of hours the technical supervisor (TS-3) spent screening non- gynecologic cytology slides during each 24-hour period, for 46 of 46 days reviewed in 2025 (June 2025-September 2025). -- 2 of 2 --