Carolina Urology Healthcare, Pllc

Summary Statement of Deficiencies D2007 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The samples must be examined or tested with the laboratory's regular patient workload by personnel who routinely perform the testing in the laboratory, using the laboratory's routine methods This STANDARD is not met as evidenced by: Based on review of 2019, 2020 and 2021 American Proficiency Institute (API) proficiency testing (PT) records and interview with TC #2(technical consultant) 11/16 /21, the laboratory failed ensure all testing personnel (TP) who routinely test patient samples participated in PT. Findings: Review of 2019 and 2020 API PT records revealed one TP, who is no longer employed, performed 4 of 6 PT events. Review of 2021 APT PT records revealed TP #4 (TC #2) performed 3 of 3 PT events. Review of 2019, 2020 and 2021 API PT records revealed TP #3, hired in July of 2019, did not participate in PT events for 2019, 2020 and 2021. Interview with TC #2 at approximately 1:00 p.m. confirmed PT was not performed by all TP who routinely test patient samples. D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) The procedure manual must include the following when applicable to the test 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) 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 -- The reportable range for test results for the test system as established or verified in 493.1253. (7) Control procedures. (8)

Summary Statement of Deficiencies D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(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: (1) Water quality. (2) Temperature. (3) Humidity. (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 the review 2017 Daily Envoronmental Log records, manufacturer's instructions, and staff interview on 10/23/18, the laboratory failed to establish and document acceptable criteria for conditions required for accurate and reliable test systems operations. Findings: Review of Carolina Urology Healthcare, PLLC's Qualigen Package Insert REF:25000040 for Prostate Specific Antigen (PSA), and REF:25000041 for Testosterone, it reads "...the refrigerator temperature for proper storage of the reagent kits must be maintained between 2 Degrees to 8 Degrees Celsius...". During review of recorded 2017 Daily Environmental Log for January, February and March the refrigerator temperature readings were above the manufactures acceptable range for kit storage. Findings: January 2017 11 of 21 the temperatures were above 8 Degrees C: 1/3, 1/10-1/12, 1/23-1/27, and 1/30-1/31/17. February 2017 17 to 20 of the temperatures were above 8 Degrees C: 2/1-2/3, 2/6-2 /10, 2/13-2/17, and 2/20-2/23/17. March 2017 2 of 23 of the temperatures were above 8 Degrees C: 3/1, and 3/3/17. During interview at 11:30 a.m. of the practice manager interview and testing personnel, it was revealed that the testing personnel failed to acknowledge that the refrigerator temperatures were above the manufacturer's package insert instructions. 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 --