Summary:
Summary Statement of Deficiencies D0000 An announced CLIA initial survey was conducted at Lakelands Family Practice and Pediatric Center on 06/27/2024 by the South Carolina Department of Environmental Control (SCDHEC). The laboratory was surveyed under 42 CFR Part 493 CLIA requirements. The facility was found to be out of compliance with the standards of the CLIA program. The following STANDARD LEVEL DEFICIENCES were found to be out of compliance: D5409 PROCEDURE MANUAL CFR(s): 493.1251(e) The laboratory must maintain a copy of each procedure with the dates of initial use and discontinuance as described in 493.1105(a)(2). This STANDARD is not met as evidenced by: During an onsite survey on 06/27/2024 procedures reviewed, records reviewed, and staff interviewed the laboratory failed to maintain a copy of each procedure with the dates of initial use and discontinuance. 2022 to 2024 two years reviewed. Findings included: 1. A written procedure titled Urinalysis with microscopics outlined how to perform an analysis on urine. 2. Review of proficiency testing records from American Proficiency Institute (API) revealed that hematology specialty was performed. No urinalysis proficiency testing documented. 3. During an interview with technical consultant on 06/27/2024 at 3:10 pm, it was confirmed that microscopic examination is not performed at Lakelands Family Practice & Pediatric Center. 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 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: (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 direct observation, manufacturer's label instructions, record review and staff interview the laboratory failed to follow manufacturer's instructions for acceptable room temperature range. Findings included: 1. During a tour of the laboratory on 06/27 /2024 at 12:49 pm, the surveyor observed the following blood collection tubes in the laboratory. a. 5 packs of Becton Dickinson (BD) Tiger Top tubes, Lot #4081991, expires 02/28/2025 b. 2 packs of BD Tiger Top tubes, Lot #4022609, expires 12/31 /2031 c. pack of BD Tiger Top tubes, Lot #3347114, expires 12/31/2024 d. 2 packs of BD Purple Top tubes, Lot#3314540, expires 02/28/2025 e. 2 packs of BD Purple Top tubes, Lot#4073992, expires 07/31/2025 f. 1 pack of BD Purple Top tubes, Lot#3163674, expires 10/31/2024 2. A review of the manufacturer's instructions labeled on the pack of the BD blood collection tubes revealed a room temperature requirement of 4-25C/39.2-77F. 3. Review of random laboratory environmental records 2023 revealed the laboratory's acceptable room temperature range of 68-90F /20-32C. The laboratory acceptable room temperature range exceeded the upper limit of 25C for the blood collection tubes. Key Celsius = C Fahrenheit = F D5415 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(c) Reagents, solutions, culture media, control materials, calibration materials, and other supplies, as appropriate, must be labeled to indicate the following: (1) Identity and when significant, titer, strength or concentration. (2) Storage requirements. (3) Preparation and expiration dates. (4) Other pertinent information required for proper use. This STANDARD is not met as evidenced by: Based on direct observations, and staff interview the laboratory failed to label complete blood count (CBC) controls with open and expiration dates for 2 out of 3 tubes. Findings included: 1. During a tour of the laboratory on 06/27/2024 at 12:49pm with technical consultant, the surveyor directly observed the following quality controls: a. Abbott, Cell-Dyn 18 Plus Control H, Lot#4092, expires 07/19/2024 b. Abbott, Cell-Dyn 18 Plus Control L, Lot#4092, expires 07/19/2024 No documentation of open and or expiration dates written on bottle. 2. A review of Assay Sheet for Cell- Dyn 18 Plus Controls, revealed quality controls expire within "8 consecutive-Day Open-Tube Stability". 3. In an interview with on 06/27/2024 at 12:49 pm in the laboratory with technical consultant the above findings were confirmed. D5429 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(1) For unmodified manufacturer's equipment, instruments, or test systems, the laboratory must perform and document maintenance as defined by the manufacturer and with at least the frequency specified by the manufacturer. -- 2 of 3 -- This STANDARD is not met as evidenced by: Based on instrument operator 's manual, records review, and staff interview the laboratory failed to perform and document maintenance as defined by the manufacturer. 29 out of 29 months reviewed lack documentation. Findings included: 1. Review of Cell-Dyn Emerald Quick Reference Card under "Daily Start Up" #6. Check the instrument maintenance log and perform any required maintenance. 2. Review of the laboratory's maintenance log of Cell-Dyn Emerald Operator's Manual, 9213301B-October-2018 log sheets revealed lack of documentation for semi-annual maintenance from January 2022 through May of 2024. 3. In an interview on 06/27 /2024 at 3:10pm with technical consultant the above findings were confirmed. D5783