Outer Banks Health Urgent Care Nags Head

Summary Statement of Deficiencies D5431 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(2) For unmodified manufacturer's equipment, instruments, or test systems, the laboratory must perform and document function checks as defined by the manufacturer and with at least the frequency specified by the manufacturer. Function checks must be within the manufacturer's established limits before patient testing is conducted. This STANDARD is not met as evidenced by: Based on review of manufacturer's instructions, review of 2022, 2023, and 2024 i- STAT records, and interview with the "offsite manager" 4/17/24, the laboratory failed to perform and document thermal probe checks at least every six months as required by the manufacturer. Findings: Review of "Procedure Manual for the i-STAT 1 System" revealed "... Every 6 Months Procedures ... Update i-STAT 1 Analyzer Software Update the software as provided by Abbott Point of Care. Perform an external Electronic Simulator test after software update. Verify thermal probe reading as described below. Thermal Probe Check Procedure ... Acceptable: a value from -0.1 to +0.1, inclusive ..." Review of the laboratory's 2022, 2023, and 2024 i-STAT records revealed no documentation of thermal probe checks. During interview at approximately 1:00 p.m., the "offsite manager" confirmed that the laboratory had not performed the thermal probe checks during 2022, 2023, and 2024. 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 D2000 ENROLLMENT AND TESTING OF SAMPLES CFR(s): 493.801 Each laboratory must enroll in a proficiency testing (PT) program that meets the criteria in subpart I of this part and is approved by HHS. The laboratory must enroll in an approved program or programs for each of the specialties and subspecialties for which it seeks certification. The laboratory must test the samples in the same manner as patients' specimens. For laboratories subject to 42 CFR part 493 published on March 14, 1990 (55 FR 9538) prior to September 1, 1992, the rules of this subpart are effective on September 1, 1992. For all other laboratories, the rules of this subpart are effective January 1, 1994. This CONDITION is not met as evidenced by: Based on review of 2020 and 2021 API (American Proficiency Institute) proficiency testing records and interview with the TP (testing personnel) and the TC (technical consultant) 4/20/21, the laboratory failed to enroll in proficiency testing for analytes tested on the i-STAT analyzer. Review of 2020 and 2021 API proficiency testing records revealed the laboratory was not enrolled in proficiency testing for sodium, potassium, chloride, blood urea nitrogen, creatinine, and glucose performed on the i- STAT analyzer using the blue Chem 8 cartridges. During interview at approximately 9:50 a.m., TP #1 confirmed that the laboratory uses the blue Chem 8 cartridges for testing performed on the i-STAT. During interview at approximately 3:00 p.m., the TC stated she was unaware the i-STAT blue Chem 8 cartridge was no longer waived and proficiency testing was required. D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) The procedure manual must include the following when applicable to the test Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 4 -- procedure: (1) Requirements for patient preparation; specimen collection, labeling, storage, preservation, transportation, processing, and referral; and criteria for specimen acceptability and rejection as described in 493.1242. (2) Microscopic examination, including the detection of inadequately prepared slides. (3) Step-by-step performance of the procedure, including test calculations and interpretation of results. (4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other materials used in testing. (5) Calibration and calibration verification procedures. (6) The reportable range for test results for the test system as established or verified in 493.1253. (7) Control procedures. (8)