Gina Sevigny Md Pa

Summary Statement of Deficiencies D0000 At the time of the announced, onsite recertification survey, Gina Sevigny MD was found to be NOT in compliance with the CLIA laboratory requirements of 42 CFR 493. 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 record review and staff interview, the laboratory failed to document the room temperature and humidity of the laboratory for 3 of 66 days reviewed in February 2024, August 2024, and January 2025; and failed to ensure the cryostat temperature was documented for 3 of 66 days reviewed in February 2024, August 2024, and January 2025. Findings include: Review of the daily laboratory accession log showed patient testing was performed on 2/23/24 (12 patients), 8/9/24 (12 patients), and 1/10/25 (6 patients). Review of the laboratory document titled "Cryostat Temperature Log Leica 1510S" showed no documentation of the daily cryostat temperature on 2/23/24, 8/9/24, and 1/10/25. Review of the laboratory document titled "Laboratory Room Temperature and Humidity Log" showed the daily room temperature and humidity of the laboratory was not documented on 2/23/24, 8/9/24, and 1/10/25. The facility policy titled "Daily Routine" states "1. Check and log temperature on cryostat. 2. Check and log room temperature." During an interview on 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 -- 3/20/25 at 10:23am with the Laboratory Director, it was confirmed that the temperature of the cryostat, room temperature and humidity was not documented those three days. -- 2 of 2 --

Summary Statement of Deficiencies D0000 At the time of the announced, onsite recertification survey, Gina Sevigny MD was found to be NOT in compliance with the CLIA laboratory requirements of 42 CFR 493. . D2007 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The samples must be examined or tested with the laboratory's regular patient workload by personnel who routinely perform the testing in the laboratory, using the laboratory's routine methods This STANDARD is not met as evidenced by: Based on record review and staff interview, the laboratory failed to rotate proficiency testing to include all testing personnel who perform patient testing for KOH and Scabies for two of two years reviewed (2019-2020). The findings include: Review of the Laboratory Personnel Report (CLIA) CMS 209 revealed that three people performed patient testing on KOH and Scabies specimens (Testing Person #2, #3, and #4). Review of KOH/Scabies proficiency testing worksheets showed Testing Person #4 participated in proficiency testing 8/29/19, 12/31/19, 7/24/20, 8/19/20, and 11/5 /20. There was no documentation showing participation from Testing Person #2, and #3. The laboratory policy titled "Parasitology Proficiency Testing Blind Review" states "Our laboratory will perform proficiency testing twice per year (every 6 months) on parasitological procedures to verify testing accuracy." The laboratory policy titled "Mycology Proficiency Testing Blind Review" states "Our laboratory will perform proficiency testing twice per year on mycology procedures to verify testing accuracy. This will be done by using the split sample method and/or by other qualified personnel diagnosing the same sample." During an interview on 2/4/21 with the MOHs technician, it was confirmed that no other Testing Persons other than #4 had performed proficiency testing. 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 --