Masonboro Urgent Care, Pc

Summary Statement of Deficiencies D6030 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(12) (e)(12) Ensure that policies and procedures are established for monitoring individuals who conduct preanalytical, analytical, and postanalytical phases of testing to assure that they are competent and maintain their competency to process specimens, perform test procedures and report test results promptly and proficiently, and whenever necessary, identify needs for remedial training or continuing education to improve skills; This STANDARD is not met as evidenced by: Based on review of laboratory polices and procedures, the absence of a yearly personnel competency record, and interview with Testing Personnel (TP) #1 /Registered Nurse (RN) Office Administrator 02/07/2025, the Laboratory Director (LD) failed to ensure laboratory policies and procedures were followed for evaluating yearly competency for 1 of 6 TP (TP #5) for 2024. Findings: Review of "Laboratory Policies and Procedures...Quality Assurance...Personnel Training and Qualifications" revealed: "The Laboratory Director: ...ensures that all laboratory personnel are competent to perform test procedures..." "Personnel Evaluation: ...at least semiannually during the first year...Thereafter, testing personnel are evaluated yearly." No yearly competency evaluation records available to review for TP #5 for 2024. Interview with TP #1/RN Office Administrator at approximately 11:55 A.M. confirmed no yearly competency evaluation record available to review for TP #5 for 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 D2006 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b) The laboratory must examine or test, as applicable, the proficiency testing samples it receives from the proficiency testing program in the same manner as it tests patient specimens. This testing must be conducted in conformance with paragraph (b)(4) of this section. If the laboratory's patient specimen testing procedures would normally require reflex, distributive, or confirmatory testing at another laboratory, the laboratory should test the proficiency testing sample as it would a patient specimen up until the point it would refer a patient specimen to a second laboratory for any form of further testing. This STANDARD is not met as evidenced by: Based on review of laboratory procedure, review of 2021, 2022 and 2023 personnel records, review of 2021 and 2022 AAFP (American Academy of Family Physicians) PT (proficiency testing) records, review of 2023 WSLH (Wisconsin State Laboratory of Hygiene) PT records and interview with TP (testing personnel) #1, 4/27/23, the laboratory failed to ensure all TP participated in PT each year of testing. Findings: Review of laboratory procedure "PROFICIENCY TESTING" revealed "...When a laboratory enrolls in PT, it will receive five "unknown" samples three times a year for the tests ordered. PT samples are tested in the same way as patient samples.". Review of 2021 AAFP PT records for Complete Blood Count (CBC) and iSTAT Chemistry testing revealed TP #1 performed PT events, A and B. Event C was performed by a TP whom is no longer employed. Review of 2021 personnel records revealed 4 TP were employed in 2021, TP #4 began testing in July of 2021. TP #3 did not participate in the 2021 PT events. Review of 2022 AAFP PT records for Complete Blood Count (CBC) and iSTAT Chemistry testing revealed TP #2 performed PT events A and C. Event B was performed by a TP whom is no longer employed. Review of 2022 personnel records revealed 6 TP were employed in 2022, TP #5 and TP #6 began testing in October of 2022. TP #3 and TP #4 did not participate in the 2022 PT events. 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 -- Review of 2023 WSLH (Wisconsin State Laboratory of Hygiene) PT records for CBC and iSTAT Chemistry testing revealed TP #2 performed the first event for the CBC and iSTAT testing. Review of 2023 personnel records revealed 6 TP were employed at time of survey. Interview with TP #1 at approximately 1:30 p.m. confirmed all testing personnel had not participated in PT for 2021, 2022 and 2023. She stated she had hired a new laboratory supervisor and wanted to use the PT samples to aid in her training. She also stated she was unaware that more than 1 TP could participate in a PT event if each TP was assigned different sample to test. 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 laboratory procedure, review of 2021, 2022, and 2023 iSTAT chemistry analyzer records and interview with TP #1, 4/27/23, the laboratory failed to perform and document the recording of the temperature when receiving new cartridges or control shipments for the iSTAT chemistry analyzer for approximately 28 months. Findings: Review of manufacturer's instructions revealed "Required procedure for handling new cartridge or control shipments: 1. Open box marked "Refrigerate Upon Arrival". Find card with temperature strip attached. Read strip immediately...2. Record temperature reading on "Receipt of New Cartridges" log...". Review of laboratory procedure for the iSTAT analyzer revealed "Receipt of New Cartridge...For acceptance of newly received cartridge lots, perform the following: 1. Check Temperature Monitor...Action: Fill out the record of receipt and forward materials to refrigerator. If all windows are white or if only the "A" window is blue transit temperatures were satisfactory. Record this on the Receipt of New Cartridges Log.". Review of 2021, 2022, and 2023 iSTAT chemistry analyzer records revealed no documentation of a "record of receipt" for new cartridge or control shipments. The records also failed to include documentation of temperature recordings for new cartridge or control shipments. Interview with TP #1 at approximately 12:15 p.m. confirmed the laboratory had not recorded temperature readings for receipt of new cartridge or control shipments. She stated they had done it in the past but were informed by an offsite technical consultant that it was not required. -- 2 of 2 --

Summary Statement of Deficiencies D5775 COMPARISON OF TEST RESULTS CFR(s): 493.1281(a)(c) (a) If a laboratory performs the same test using different methodologies or instruments, or performs the same test at multiple testing sites, the laboratory must have a system that twice a year evaluates and defines the relationship between test results using the different methodologies, instruments, or testing sites. (c) The laboratory must document all test result comparison activities. This STANDARD is not met as evidenced by: Based on the absence of documentation and interview with the practice / laboratory manager on 5/3/19 at 9:40 a.m., the laboratory failed to perform and maintain documentation of Hemoglobin (Hgb) and Hematocrit (Hct) comparison testing between the Medonic M Series and Abbott i-STAT hematology analyzers at least twice a year. The laboratory manager and director acknowledged during interview at 9: 45 a.m. that they failed to perform the required Hgb and Hct twice a year method comparison between the two analyzers. They further acknowledged that the failure to perform the required comparison testing was an oversight and not an intentional act. 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 --