Summary:
Summary Statement of Deficiencies D0000 An on-site validation survey was conducted on August 26, 2026 with the following standard level deficiencies cited. D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(b) (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: (b)(1) Water quality. (b)(2) Temperature. (b)(3) Humidity. (b)(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 direct observation, review of manufacturer's instructions, written policies and procedures, laboratory temperature logs, and interview with the location manager, the laboratory failed to define temperatures in accordance with manufacturer's instructions for 2 of 2 years (2025 and 2026). Findings Included: 1) On 8/26/2026 at 11:01 AM, the following temperature dependent laboratory reagents and supplies were observed stored on top of the Cryostats and in storage cabinets available for use: a. 14 Cardinal Health Frozen Section Media bottles, Lot Number 154608, Manufacturer storage temperature requirements 15 to 30 degrees Celsius. b. 5 Epedia Tissue Marking Dye bottles, Lot Numbers A870334, A869230, A870592, A869239, A869218, Manufacturer storage temperature requirements 15 to 30 degrees Celsius. c. 10 Cardinal Health Microscope Slides, Lot Number 011325-9, Manufacturer storage temperature requirements 15 to 30 degrees Celsius. 2) Review of the laboratory's policy titled 'ADCS Clinics LLC, D/B/A/ Advanced Dermatology and Cosmetic Surgery Policy #CP-L 1017' stated the following on page 2: "E. Laboratory 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 -- Temperature ... 2. Laboratory room temperature must remain in the range of 5 to 35 degrees Celsius ..." 3) Review of the temperature logs for 2025 and 2026 revealed an acceptable temperature range of 5 to 35 degrees Celsius. 4) In an interview on 8/26 /2026 at 11:30 AM, the location manager and laboratory assistant confirmed the defined acceptable temperature range was set too wide, and not in accordance with manufacturer's instructions. D6102 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(12) (e)(12) Ensure that prior to testing patients specimens, all personnel have the appropriate education and experience, receive the appropriate training for the type and complexity of the services offered, and have demonstrated that they can perform all testing operations reliably to provide and report accurate results; This STANDARD is not met as evidenced by: Based on review of the laboratory's submitted Form Centers for Medicare and Medicaid Services (CMS) 209, laboratory competency assessment records, review of the laboratory's written policies, test records, and interview with the location manager, the laboratory director (LD) failed to ensure prior to testing patients' specimens, all personnel have the appropriate training and competency to conduct testing for 1 of 2 years. Findings Included: 1) Review of the laboratory's submitted Form CMS-209 revealed 2 Testing Personnel (TP) 2) Review of the laboratory's competency assesment records revealed an assessment performed in 2026 for TP#2, as per the CMS-209, but no assessment in 2025. 3) Review of the laboratory's policy titled 'ADCS Clinics, LLC, D/B/A Advanced Dermatology and Cosmetic Surgery Policy #CP-L 1020' stated the following: "Procedure ... 4. Initial competency will be executed by the lab director upon hire, six months, and annually thereafter ... 7. The Bi-annual KOH and/or Scabies Competency and Proficiency Testing for Laboratory Testing Personnel Form shall be retained in the Office Location for at least 2 years." 4) Review of the laboratory's test record log titled 'Advanced Dermatology and Cosmetic Surgery KOH Log' revealed the following patient(s) tested in 2025 by TP#2: a. 1 patient tested on 10/18/2026, Date of Birth: 8/13/1980, Site: Hand, Results: Eggs, Provider: Name of TP#2, Internal Control Picture Verification: Yes 5) In an interview on 8/26/2026 at 11:30 AM, the location manager and laboratory assistant confirmed TP#2 performed testing in 2025 and did not have record of competency assessments performed at that site for that year. -- 2 of 2 --