Summary:
Summary Statement of Deficiencies D0000 An announced onsite CLIA initial survey was conducted on July 2, 2025, at the laboratory of F. Marion Dwight, MD DBA Bamberg Family Practice by the South Carolina Department of Public Health (SC DPH) Bureau of Nursing Homes and Medical Services. The laboratory was found to be out of compliance with Medicare condition 42 CFR Part 493, CLIA Requirements for Laboratories. The following is a list of deficiencies cited as a result of the July 2, 2025, CLIA initial survey: 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 direct observation, reagent package insert, records review, CMS 116 form and staff interview, the laboratory failed to ensure that expired products were not available for use. Finding included: 1. While on a tour of the laboratory on July 2, 2025, at 1:30pm, the surveyor observed a temperature/humidity monitoring device with an expiration date of January 21, 2021, being used to monitor the temperature and humidity of the laboratory. 2. Review of the package insert for the McKesson Consult Diagnostics Strep A Test Dipstick reveals a required storage temperature 2 -30 degrees Celsius. 3 Review of the CMS 116 form reveals the McKesson Strep A Dipstick test as being performed at F. Marion Dwight, MD DBA Bamberg Family Practice. 4. In an interview on July 2, 2025 at 1:40pm in the laboratory conference room with the Technical Consultant (TC) and Testing Personnel (TP), the findings were confirmed. 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 --