Summary:
Summary Statement of Deficiencies D0000 An announced onsite CLIA recertification survey was conducted on 05/05/2026, at the laboratory of Hometown Pediatrics of Clinton 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 at 42 CFR Part 493, CLIA requirements for laboratories. The following is a list of deficiencies cited as a result of the recertification survey on 05/05/2026: 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 records review, lack of documentation, and staff interview, the laboratory failed to ensure that expired equipment was not availabhle for use by the laboratory staff. Findings included: 1. Review of laboratory documentation reveals a lack of requirement to monitor expiration dates for the timers used in the laboratory. 2. Examination of timers in use at the time of the survey reveals that 5 out of 9 timers exceeded their expiration date. 3. In an interview with the Technical Consultant (TC) on May 5, 2026 at 12:50pm during the laboratory tour, the findings were confirmed. D6066 TESTING PERSONNEL QUALIFICATIONS CFR(s): 493.1423(b)(4)(ii) (b)(6)(ii) Have documentation of laboratory training appropriate for the testing performed prior to analyzing patient specimens. Such training must ensure that the individual has- (b)(6)(ii)(A) The skills required for proper specimen collection, including patient preparation, if applicable, labeling, handling, preservation or 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 -- fixation, processing or preparation, transportation, and storage of specimens; (b)(6)(ii) (B) The skills required for implementing all standard laboratory procedures; (b)(6)(ii) (C) The skills required for performing each test method and for proper instrument use; (b)(6)(ii)(D) The skills required for performing preventive maintenance, troubleshooting, and calibration procedures related to each test performed; (b)(6)(ii) (E) A working knowledge of reagent stability and storage; (b)(6)(ii)(F) The skills required to implement the quality control policies and procedures of the laboratory; (b) (6)(ii)(G) An awareness of the factors that influence test results; and (b)(6)(ii)(H) The skills required to assess and verify the validity of patient test results through the evaluation of quality control sample values prior to reporting patient test results. This STANDARD is not met as evidenced by: Based on records review, lack of documenmtation, and staff interview, the laboratory failed to have documentation of staff's acedemic records. Findings included: 1. Review of the CMS 209 form reveals 12 TP. 2. Review of staff's acedemic records reveals a lack of documentation of education records for 1 out of 12 TP on the day of survey. 3. In an interview with the TC in the laboratory office on May 5, 2026 at 12: 30pm, the findings were confirmed. -- 2 of 2 --