Summary:
Summary Statement of Deficiencies D0000 An announced CLIA initial survey was conducted on June 11, 2025, at the laboratory of Jeter & Skinner Family Practice of Florence 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 Standard Level deficiencies cited as a result of the June 11, 2025, CLIA initial survey: 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 records review, procedure manual, and staff interview, the laboratory failed to ensure the laboratory's room temperature and humidity were within acceptable limits for 36 out of 36 months reviewed. Findings included: 1. Review of temperature and humiditity logs for the laboratory reveals a failure to effectively monitor the laboratory environment. 2. Review of temperature and humidity logs for the laboratory reveals the absence of acceptable ranges for both temperature and humidity. 3. During a staff interview on June 11, 2025 at 12:30pm with the Laboratory Director (LD), the surveyor requested documentation of established acceptable temperature and humidity ranges. None was available at the time of the survey. 4. Review of the temperature logs for the laboratory refrigerator/freezer 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 -- reveals the following acceptable ranges: a. refrigerator temp : 36 to 46 degrees F, 2 to 8 degrees C b. freezer temp: -4 to -21 degrees F, -20 to -40 degrees C 5. Review of the recorded temperatures for the refrigerator/freezer reveals freezer temps outside of the posted acceptable range 238 out of 238 days recorded for 2023. 6. Review of the recorded temperatures for the refrigerator/ freezer reveals freezer temps outside of the posted acceoptable range 242 out of 242 days recorded for 2024. -- 2 of 2 --