Summary:
Summary Statement of Deficiencies D0000 An announced onsite CLIA recertification survey was conducted on June 3, 2026, at the laboratory of Carolinas Physician Network (CPN) Inc. doing business as Rock Hill MOB Central Laboratory 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 June 3, 2026 recertification survey: D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 As specified in the personnel requirements in subpart M, the laboratory must establish and follow written policies and procedures to assess employee and, if applicable, consultant competency. This STANDARD is not met as evidenced by: Based on record review, lack of documentation, and staff interview, the laboratory failed to establish and/or follow written policies and procedures to assess employees microscopic, compared counts for 3 out of 3 years reviewed (2024, 2025, and 2026). Findings included: 1. Review of the CMS 116 application reveals urine microscopic tests are performed. 2. Surveyor requested and the laboratory failed to provide documentation of consistency between testing personnel (TP) for urine microscopic examination. 3. In an interview on June 3, 2026, at 3:45pm in the conference room with the technical consultants (TC), TC1 and TC2, the above findings were confirmed. D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(d) (d) Reagents, solutions, culture media, control materials, calibration materials, and 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 -- 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, lack of documentation, and staff interview, the laboratory failed to ensure thermometer (equipment), timers and reagents did not exceed their expiration date or of substandard quality as required per manufacturer 's instructions 493.1252. Findings included: 1. During a tour of the laboratory on June 3, 2026, at 3: 30 pm, surveyor directly observed a thermometer (Fisher brand Traceable), S/N: 240164002, and 4 Traceable Timers that lacked expiration documentation. 2. The following reagents are stored at room temperature: a. 1000 per case, of PST Gel and lithium Heparin (LH) Tubes, Lot 643808, expired 01/31/2027, Ref 367962, total of 5,200 tubes. b. 1000 per case, of SST Blood Collection Tubes, Lot #5324066, expired 11/30/2026, total of 14000 tubes. c. Hemoglobin A1c, Afinion Abbott, Lot # 10236205, exp 2027-12-09 d. Rapid Strep A tests, ICON DS Strep A, 22 packets e. Whole Blood Mononucleosis tests, Henry Schein, 25 Test Sticks, 1 box All have room temperature storage requirements. 3. In an interview on June 3, 2026, at 3:45pm in the conference room with the technical consultants (TC), TC1 and TC2, the above findings were confirmed. -- 2 of 2 --