Summary:
Summary Statement of Deficiencies D0000 Off-site revisit survey, April 01, 2026, found the deficiencies cited during the February 20, 2026 on-site survey are corrected and the laboratory is in compliance with 42 CFR Part 493 Requirements for Laboratories. 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 review of laboratory procedures, records for 2024 and the absence of records for 2025, and interview with the Technical Consultant (TC) on 02/20/2026, the laboratory director failed to perform the required 12 month competency assessment for the TC for 2025. Findings: Review of the laboratory procedure "Technical Consultant Training" page 1 revealed, "...Competency will be assessed by the Laboratory Director initially, at 6 months, 12 months, and annually thereafter." Review of laboratory records revealed the absence of a 12 month competency assessment for the TC for 2025. During interview at approximately 11:24 a.m. the TC confirmed the 12 month competency assessment was not completed for 2025. D5433 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(b)(1) (b)(1)(i) Establish a maintenance protocol that ensures equipment, instrument, and test system performance that is necessary for accurate and reliable test results and test result reporting. (b)(1)(ii) Perform and document the maintenance activities specified in paragraph b(1)(i) of this section. 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 -- This STANDARD is not met as evidenced by: Based on review of laboratory Policy #18/version #01, laboratory maintenance logs for 2024, 2025, and 2026, and interview with the Technical Consultant (TC) on 02/20 /2026, the laboratory failed to perform and document incubator maintenance at least weekly per laboratory policy from 04/17/2024 to 02/20/2026, approximately 96 weeks. Findings: Review of laboratory Policy #18/version #01 "Incubator Maintenance" revealed "It is the policy of the Pender County Health Department Laboratory to perform and document maintenance on the incubator at least weekly..." Review of the "LABORATORY MAINTENANCE/TASKS LOG" for 2024, 2025, and 2026 revealed incubator maintenance was not performed and documented at least weekly per laboratory Policy #18/version #01 from 04/17/2024 to 02/20/2026, approximately 96 weeks. During interview with the TC at approximately 2:59 p.m. the TC confirmed the incubator maintenance was not performed and documented at least weekly per laboratory policy. -- 2 of 2 --