Dermatology Associates Of Tallahassee Pa

Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at Dermatology Associates of Tallahassee, PA on 07/31/2026. The laboratory was surveyed under 42 CFR Part 493 CLIA requirements. Standard deficiencies cited are as follows: D6005 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(c) (c) The laboratory director must: (c)(1) Be onsite at least once every 6 months, with at least 4 months between the minimum two on-site visits. Laboratory directors may elect to be on-site more frequently and must continue to be accessible to the laboratory to provide telephone or electronic consultation as needed; and (c)(2) Provide documentation of these visits, including evidence of performing activities that are part of the laboratory director responsibilities. This STANDARD is not met as evidenced by: Based on record review and and interview, the Laboratory Director (LD) failed to establish a policy to be onsite at least once every six months, with at least 4 months between the minimum two on-site visits and documenting the onsite visits during the year 2025 until 07/31/2026. Findings included: 1:) Review of the procedure manual signed by the LD on 01/12/2026 revealed that it did not have policy to specify when the LD must be onsite and document the bi-annual visits. 2:) During interview on 07 /31/2026 at approximately 11:15 AM, the Laboratory Manager confirmed there was no policy to monitor the LD visits to the laboratory. Laboratory Manager did state LD is onsite on daily/weekly basis for procedures and slide reading, but there is no documenation of the LD Bi-Annual visit. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 1 --

Summary Statement of Deficiencies D0000 An onsite announced CLIA recertification survey was conducted at Dermatology Associates of Tallahassee PA, a laboratory in Tallahassee, FL, on 02/02/2024. The laboratory is not in compliance with 42 CFR Part 493, Requirements for Laboratories. D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 As specified in the personnel requirements in subpart M, the laboratory must establish and follow written policies and procedures to assess employee and, if applicable, consultant competency. This STANDARD is not met as evidenced by: 49973 Based on review of the Employee Training and Evaluation Standard Operating Procedure (SOP) and interview with the Laboratory Manager (LM), the laboratory failed to have an approved policy or documentation for the competency assessment of testing personnel (TP) for 2022-2024. The findings include: During a review of employee trainings, there was no documentation to to verify that TP #B received any competency assessments during 2022 or 2023. During an interview on 02/02/24 at 11: 15 a.m., the LM verified that TP #B had never been competency assessed. Upon review of the laboratory's Employee Training and Evaluation SOP (last approved by the Laboratory Director in 2024), there was no competency assessment processes for testing personnel listed. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 1 --

Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at Dermatology Associates of Tallahassee PA on January 31, 2020. The laboratory is not in compliance with 42 CFR Part 493, Requirements for Laboratories. The following is a description of the standard level deficiencies: D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(b) The laboratory must define criteria for those conditions that are essential for proper storage of reagents and specimens, accurate and reliable test system operation, and test result reporting. The criteria must be consistent with the manufacturer's instructions, if provided. These conditions must be monitored and documented and, if applicable, include the following: (1) Water quality. (2) Temperature. (3) Humidity. (4) Protection of equipment and instruments from fluctuations and interruptions in electrical current that adversely affect patient test results and test reports. This STANDARD is not met as evidenced by: Based on record review and interview with the Histotechnologist, the Laboratory failed to document humidity for 2 of 2 (2018 - 2019 ) years reviewed. Findings Included: Review of temperature logs revealed no humidity documented from January 2018 through December 2019. During an interview on 01/31/2020 at 10:30 AM, Histotechnologist # 3 confirmed that the humidity was not documented. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 1 --