Brian G Fabian Md Pa

Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at Brian G Fabian on 05/12 /25 - 05/13/25. The laboratory is not in compliance with 42 CFR Part 493, Requirement for Laboratories. The following Conditions were cited: D5400 493.1250 Condition: Analytic Systems D6076 493.1441 Condition: Laboratory Director High Complexity 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 record review and interview, the laboratory failed to document the room temperature and humidity to ensure correct operating conditions for Histopathology testing for two of ten patient testing days in March 2025 (See D5413), and the laboratory failed to document the Hematoxylin and Eosin (H&E) Histopathology staining materials for intended reactivity for two of ten patient testing days in March 2025 (See D5473). 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 Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 3 -- 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 record review and interview, the Laboratory failed to document the room temperature and humidity to ensure correct operating conditions for Histopathology testing for two of ten patient testing days in March 2025. This is a repeat deficient practice from the 03/29/2023 recertification survey. Findings included: 1. The accepted

Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at Brian G Fabian MD PA on 03/29/2023. 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 review of manufacturer's instructions, lack of documentation, and interview with the Practice Manager, the laboratory failed to document the room temperature to ensure the correct operating conditions for the cryostat for two out of two years review (2021 - 2023). Findings included: Review of the manufacturer's instructions for the cryostat revealed "Operating temperature range ( ambient temperature): 18 degrees Celsius to 40 degrees Celsius." No documentation of room temperature from January 15, 2021 to March 29, 2023 could be provided. On 03/29/23 at 12:00 p.m., the Practice Manager stated the laboratory monitored the room temperature but did not document the room temperature on a log. . 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 --