Bracciano Dermatology Plc

Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at BRACCIANO DERMATOLOGY PLC from March 12, 2026 to April 8, 2026. The laboratory is not in compliance with 42 CFR Part 493, Requirement for Laboratories. The following Condition was cited: D5400 493.1240 Condition: Analytic Systems D5400 ANALYTIC SYSTEMS CFR(s): 493.1250 Each laboratory that performs nonwaived testing must meet the applicable analytic systems requirements in 493.1251 through 493.1283, unless HHS approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub.7), that provides equivalent quality testing. The laboratory must monitor and evaluate the overall quality of the analytic systems and correct identified problems as specified in 493.1289 for each specialty and subspecialty of testing performed. This CONDITION is not met as evidenced by: Based on observation, record review, and interview, the laboratory failed to monitor and remove expired chemicals and failed to correctly identified problems from July 2025 to March 12, 2026. See D5417 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 Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 4 -- interruptions in electrical current that adversely affect patient test results and test reports. This STANDARD is not met as evidenced by: Based on the review of the procedure manual, record review, and interview, the laboratory failed to document the room temperature and humidity for two days (08/22 and 08/29) out of three days (08/08, 08/22 and 08/29) of micrographical oriented histographic surgery (Mohs) surgical procedures performed in August 2025. Finding included: 1- Review of the Laboratory Daily Maintenance policy stated in step in "7. Temperature Charts and Logs are checked daily or whenever in use." 2- Review of the 2025 Room Temperature/Humidity Log revealed that there was no documentation for temperature on 08/22/2025 and 08/29/2025. This log also stated at the bottom of the form the following steps: "1. The room temperature will be checked at the beginning of each workday ... 2. The humidity will be documented at the beginning of each workday." 3- Review of the (Mohs) Patient log revealed that on 08/22/2025 the laboratory tested 15 patients, and on 08/29/2025 the laboratory tested 10 patients. A total of 25 patients were tested with no room temperature/humidity documentation by the laboratory technician. 4- During an interview on 03/12/2025 at 12:45 PM, the Practice Administrator confirmed that room temperature and humidity was not recorded. D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(d) (d) Reagents, solutions, culture media, control materials, calibration materials, and other supplies must not be used when they have exceeded their expiration date, have deteriorated, or are of substandard quality. This STANDARD is not met as evidenced by: Based on observation, record review, and interview with the office manager, the laboratory failed to ensure the Scott Tap Water Substitute (lot number 2421544), was not expired prior to performing 279 patient tested from 08/17/2025 to 03/12/2026, and failed to ensure the Blue Tissue Marking Dye (lot number 23170) was not expired prior to performing 324 patient test from 07/01/2025 to 03/12/2026 for Histopathology (Hematoxylin and Eosin stain) high complexity testing. This is a repeat citation from the 05/13/2024 recertification survey. Findings included: 1. Review of the

Summary Statement of Deficiencies D0000 An on-site announced CLIA recertification survey was conducted at Bracciano Dermatology PLC on 05/13/2024. The laboratory is not in compliance with 42 CFR Part 493, Requirements for Laboratories. The following is a description of the standard level deficiency: D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(d) Reagents, solutions, culture media, control materials, calibration materials, and other supplies must not be used when they have exceeded their expiration date, have deteriorated, or are of substandard quality. This STANDARD is not met as evidenced by: Based on observation, record review, and interview with the office manager, the laboratory failed to ensure the Scott's Tap Water Substitute (Lot number 2310024) used for histopathology (hematoxylin and eosin stain) testing was not expired prior to performing 40 patient tests from 04/20/2024 - 05/10/2024. Findings included: A tour of the laboratory on 05/13/2024 at 1:15 PM revealed an expiration date of 04/20/2024 on the container of Scott's Tap Water Substitute (Lot number 2310024)) used for hematoxylin and eosin testing. A review of the patient micrographically oriented histographic surgery (Mohs) log revealed 40 tests had been performed after the 04/20 /2024 expiration date. The testing was performed on 04/26/24 (12 tests), 05/03/24 (14 tests), and 05/10/24 (14 tests). On 05/13/2024 at 1:30 PM, the Office Manager confirmed patients were tested using the expired reagent. 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 --