Priority Medical Clinic, Llc

Summary Statement of Deficiencies D3031 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(3) Analytic systems records. Retain quality control and patient test records (including instrument printouts, if applicable) and records documenting all analytic systems activities specified in 493.1252 through 493.1289 for at least 2 years. This STANDARD is not met as evidenced by: Based on review of Abbott Emerald Cell-Dyn hematology analyzer quality control (QC) records from the date of installation on 7/21/2022 through 4/25/2023, the manufacturer's assay information sheet with acceptable control ranges, and interview with the laboratory director on 4/25/2023 at 2:00 p.m., the laboratory failed to retain the manufacturer's assay information sheets for four of five lots of Abbott Cell-Dyn 18 Plus hematology controls, in use for 32 of 40 weeks reviewed. Findings include: 1. Review of Abbott Emerald Cell-Dyn hematology analyzer QC records from the date of installation on 7/21/2022 through 4/25/2023 revealed the following five lots of Abbott Cell-Dyn 18 Plus hematology controls were in use for quality control testing from 7/21/2022 through 4/25/2023: Lot #2150 was in use for 5 weeks from 7/21/2022 until 8/26/2022. Lot #2206 was in use for 5 weeks from 8/26/2022 until 9/29/2022. Lot #2234 was in use for 10 weeks from 9/29/2022 until 12/12/2022. Lot #2318 was in use for 12 weeks from 12/12/2022 until 3/2/2023. Lot #3037 was in use for 8 weeks from 3/2/2023 through 4/25/2023. 2. Review of the manufacturer's assay information sheet, with acceptable control ranges, revealed only the assay information sheet for Lot #3037, currently in use on the day of the survey, was retained. The manufacturer's assay information sheets with acceptable control ranges for Lots #2150, #2206, #2234, and #2318, in use for quality control testing for 32 of 40 weeks reviewed, were not available for review on the day of the survey, 4/25/2023. 3. In an interview on 4/25 /2023 at 2:00 p.m., the laboratory director confirmed the manufacturer's assay information sheets with acceptable control ranges for Lots #2150, #2206, #2234, and #2318 were not available. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 3 -- D3037 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(4) Proficiency testing records. Retain all proficiency testing records for at least 2 years. This STANDARD is not met as evidenced by: Based on review of the six hematology proficiency testing (PT) events performed since the last survey on 8/4/2021 and interview with the laboratory director on 4/25 /2023 at 2:30 p.m., the laboratory failed to retain analyzer printouts for hematology proficiency testing samples for two of the six PT events performed since 8/4/2021. Findings include: 1. Review of the hematology proficiency testing records for Events 2 and 3 of 2021, Events 1, 2, and 3 of 2022, and Event 1 of 2023 revealed the laboratory failed to retain the hematology analyzer printouts for Event 3 of 2021 and Event 2 of 2022 (2 of 6 events). 2. In an interview on 4/25/2023 at 2:30 p.m., the laboratory director confirmed hematology analyzer printouts for Proficiency Testing Event 3 of 2021 and Event 2 of 2022 were not retained. 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) 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 D6053 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(9) The technical consultant is responsible for evaluating and documenting the performance of individuals responsible for moderate complexity testing at least semiannually during the first year the individual tests patient specimens. This STANDARD is not met as evidenced by: Based on review of the Centers for Medicare and Medicaid Services (CMS) 209 personnel form and personnel records since the last survey on 4-3-19 and interview with the technical consultant on 8-4-21 at 11:00 a.m., the technical consultant failed to evaluate and document the performance of Testing Personnel #2 and #3, responsible for moderate complexity testing, at least semiannually during the first year these individuals tested patient complete blood count (CBC) specimens. Findings include: Review of the CMS 209 personnel form and personnel records since the last survey on 4-3-19 revealed no semiannual evaluations by the technical consultant for the performance of moderate complexity CBC testing for Testing Personnel #2, since this individual's initial evaluation on 10-6-20, and for Testing Personnel #3, since this individual's initial evaluation on 8-5-20. In an interview with the technical consultant on 8-4-21 at 11:00 a.m., the technical consultant confirmed semiannual evaluations were not performed for Testing Personnel #2 and #3. 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 D5437 CALIBRATION AND CALIBRATION VERIFICATION CFR(s): 493.1255(a) Unless otherwise specified in this subpart, for each applicable test system the laboratory must perform and document calibration procedures-- (1) Following the manufacturer's test system instructions, using calibration materials provided or specified, and with at least the frequency recommended by the manufacturer; (2) Using the criteria verified or established by the laboratory as specified in 493.1253(b) (3)-- (2)(i) Using calibration materials appropriate for the test system and, if possible, traceable to a reference method or reference material of known value; and (2)(ii) Including the number, type, and concentration of calibration materials, as well as acceptable limits for and the frequency of calibration; and (3) Whenever calibration verification fails to meet the laboratory's acceptable limits for calibration verification. This STANDARD is not met as evidenced by: Based on review of manufacturer's instructions for calibration in the Beckman Coulter AcT diff hematology analyzer operator's guide, calibration records since the last survey on 10-4-17, and patient complete blood count (CBC) reports, the laboratory failed to follow manufacturer's instructions when the calibration of white blood cell (WBC) count, red blood cell (RBC) count, and hemoglobin failed on 9-20-18. A total of 691 patient CBC results were reported from 9-20-18 through 4-3-19. Findings include: Review of calibration records for the Beckman Coulter AcT diff hematology analyzer since 10-4-17 revealed the calibration of WBC, RBC, and hemoglobin failed on 9-20-18. Manufacturer's instructions for calibration in the Beckman Coulter AcT diff hematology analyzer operator's guide state for failed calibration results, call your Beckman Coulter Service Representative for assistance. On the day of the survey, 4-3- 19, there was no documentation of

Summary Statement of Deficiencies D0000 A revisit survey (completed by mail) was conducted on 6/22/18 for all previous deficiencies cited on 10/4/17. All deficiencies have been corrected, and no new noncompliance was found. The facility is in compliance with all regulations surveyed. 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 --