Summary:
Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at Migliozzi Pathology Associates, LLC on 05/27/2025. The laboratory is not in compliance with 42 CFR Part 493, Requirements for Laboratories. The following is a description of the standard level deficiencies: D6130 TECHNICAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1451(c)(2)(3) (c)(2) Must establish the workload limit for each individual examining slides; (c)(3) Must reassess the workload limit for each individual examining slides at least every 6 months and adjust as necessary; This STANDARD is not met as evidenced by: Based on record review and interview, the Technical Supervisor failed to establish workload limits or reassess workload limits every 6 months for one of one testing person performing cytology slide examinations from 09/01/2023 through 05/2025. Finding include: 1. The CMS-116 Application for Certification form, signed by the Lab Director 05/27/2025 was reviewed. The form documented the laboratory examined or performed 400 cytology tests per year. 2. The CMS 209 Laboratory Personnel Report, signed by the Lab Director 05/27/2025 was reviewed. The Lab Director was documented as the Cytology Technical Supervisor. 3. There was no documentation of workload limits or policy and procedure regarding establishing workload limits or reassessing workload limits for testing persons performing cytology slide examinations. 4. Interview with the Laboratory Director on 05/27/2025 at 10:45 a.m. confirmed the above data. D6166 CYTOTECHNOLOGIST RESPONSIBILITIES CFR(s): 493.1485(b) (b) For each 24-hour period, the total number of slides examined or reviewed in the 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 -- laboratory as well as the total number of slides examined or reviewed in any other laboratory or for any other employer; and This STANDARD is not met as evidenced by: Based on record review and interview, the cytology testing person failed to maintain records documenting the total number of slides examined for this laboratory and another laboratory where slides were examined from 09/01/2023 through 05/27/2025. Findings include: 1. The CMS-116 Application for Certification form, signed by the Lab Director 05/27/2025 was reviewed. The form documented the laboratory examined or performed 400 cytology tests per year. 2. The CMS 209 Laboratory Personnel Report, signed by the Lab Director 05/27/2025 was reviewed. The Lab Director was documented as performing cytology slide examinations. 3. There was no documentation of the number of cytology slides examined in a 24 hour period for this laboratory or any other laboratory. 4. Interview with the Lab Director on 05/27/2025 at 10:45 a.m. confirmed (a) they read cytology slides at another location and (b) the above data. D6167 CYTOTECHNOLOGIST RESPONSIBILITIES CFR(s): 493.1485(c) (c) The number of hours spent examining slides in each 24-hour period. This STANDARD is not met as evidenced by: Based on record review and interview, the testing person failed to document the number of slides examined in a 24 hour period from 09/01/2023 through 05/27/2025. Findings include: 1. The CMS-116 Application for Certification form, signed by the Lab Director 05/27/2025 was reviewed. The form documented the laboratory examined or performed 400 cytology tests per year. 2. The CMS 209 Laboratory Personnel Report, signed by the Lab Director 05/27/2025 was reviewed. The Lab Director was documented as performing cytology slide examinations. 3. There was no documentation of the number of cytology slides examined in a 24 hour period. 4. Interview with the Lab Director on 05/27/2025 at 10:45 a.m. confirmed the above. -- 2 of 2 --