Ecu Health Multispecialty Clinic Belhaven

Summary Statement of Deficiencies 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 review of the operator's manual and user's manual, review of 2024 and 2025 temperature logs, and interview with the Quality Assurance (QA) Manager on 10/09 /2025, the laboratory failed to establish a room temperature range consistent with manufacturer requirements. Findings: Review of the "Medica ezra Operator's Manual" section 10.20 revealed, "...EasyRA...operated...15-30C (59-86F)..." Review of the "Medonic M series User's Manual" section 11.2 revealed, "...64 - 90F (18 - 32C)..." Review of laboratory temperature logs for 2024 and 2025 revealed, "...Temperatures... Room...55-85..." The laboratory does not meet manufacture required ranges for the Medica ezra 15-30C (59-86F) and the Medonic 64 - 90F (18 - 32C). During interview at approximately 3:41 p.m., the QA Manger confirmed incorrect temperature range listed on the temperature logs and the temperature range is missing the unit of measurement in degrees Fahrenheit. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 1 --

Summary Statement of Deficiencies D6004 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(a)(b) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (a) The laboratory director, if qualified, may perform the duties of the technical consultant, clinical consultant, and testing personnel, or delegate these responsibilities to personnel meeting the qualifications of 493.1409, 493.1415, and 493.1421, respectively. (b) If the laboratory director reapportions performance of his or her responsibilities, he or she remains responsible for ensuring that all duties are properly performed. This STANDARD is not met as evidenced by: Based on review of 2018 and 2019 testing personnel (TP) competency records, review of TP #1 education credentials, review of laboratory records and interview with TP #1, 2/6/20, the laboratory director (LD) failed to ensure technical consultant (TC) responsibilities were performed by personnel meeting the qualification requirements of a TC. Findings: Review of 2018 and 2019 TP competency records revealed TP #1 had evaluated the 2018 and 2019 competency of 12 of 12 TP. Review of TP #1 education credentials revealed an associate's degree in medical technology. The credentials do not qualify TP #1 to perform TC responsibilities, including the assessment of TP competency. Review of laboratory records revealed no documentation the LD had delegated TC responsibilities to TP #1. Interview with TP #1 at approximately 11:00 a.m. confirmed she had performed the 2018 and 2019 competency assessments for all TP. She stated the facility was unaware that she did not qualify to perform the TC responsibility of performing TP competency assessments. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 1 --