Summary:
Summary Statement of Deficiencies D5469 CONTROL PROCEDURES CFR(s): 493.1256(d)(10)(g) (d)(10) Establish or verify the criteria for acceptability of all control materials. (d)(10) (i) When control materials providing quantitative results are used, statistical parameters (for example, mean and standard deviation) for each batch and lot number of control materials must be defined and available. (d)(10)(ii) The laboratory may use the stated value of a commercially assayed control material provided the stated value is for the methodology and instrumentation employed by the laboratory and is verified by the laboratory. (d)(10)(iii) Statistical parameters for unassayed control materials must be established over time by the laboratory through concurrent testing of control materials having previously determined statistical parameters. This STANDARD is not met as evidenced by: Based on laboratory observation, a review of the laboratory's procedures, manufacturer's quality control (QC) package inserts, a review of the laboratory's instrument QC records, and staff interviews, the laboratory failed to ensure that the hematology instrument QC ranges matched the manufacturer's QC package insert ranges for randomly reviewed analytes for three of three lots reviewed in 2026. The findings include: 1. Observation of the laboratory on 09/16/2026 at 9:45 a.m. revealed the Sysmex XN-430 (Serial number 12003) instrument used for Complete Blood Count with automated differential (CBC w/Diff) patient testing. 2. A review of the laboratory's procedure titled "QUA Quality Control Plan" revealed, "The QC is monitored with Sysmex remotely through BCQM (Beyond Care Quality Monitoring), peer reporting, as well as internally checking the instrument." 3. A review of the manufacturer's QC package inserts labeled "XN-L CHECK Hematology Control for Sysmex XN-L Analyzers" and the laboratory's Sysmex XN-430 instrument QC printouts revealed the following: Lot 60381401 (Level 1) 02/12/2026-05/19/2026 RBC (10^6/uL) Package Insert: 2.14-2.36 Instrument: 2.11-2.37 HCT % Package Insert: 14.8-17.0 Instrument: 15.0-17.2 PLT (10^3/uL) Package Insert: 36-85 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 -- Instrument: 33-83 WBC (10^3/uL) Package Insert: 2.14-2.89 Instrument: 2.22-2.78 Lot 60381401 (Level 2) 02/12/2026-05/19/2026 RBC (10^6/uL) Package Insert: 4.11- 4.45 Instrument: 4.07-4.49 HCT % Package Insert: 32.8-37.0 Instrument: 33.1-37.7 PLT (10^3/uL) Package Insert: 184-259 Instrument: 177-257 WBC (10^3/uL) Package Insert: 6.25-7.64 Instrument: 6.32-7.50 Lot 60381403 (Level 3) 02/12/2026- 05/19/2026 RBC (10^6/uL) Package Insert: 4.99-5.40 Instrument: 4.95-5.47 HCT % Package Insert: 41.4-46.7 Instrument: 42.3-47.9 PLT (10^3/uL) Package Insert: 469- 596 Instrument: 465-591 WBC (10^3/uL) Package Insert: 15.54-18.62 Instrument: 15.68-18.16 Lot 61221401 (Level 1) 05/07/2026-08/06/2026 RBC (10^6/uL) Package Insert: 2.17-2.40 Instrument: 2.14-2.40 HCT % Package Insert: 14.3-17.6 Instrument: 15.5-17.9 PLT (10^3/uL) Package Insert: 36-86 Instrument: 34-84 WBC (10^3/uL) Package Insert: 2.07-2.80 Instrument: 2.16-2.72 Lot 61221402 (Level 2) 05/07/2026- 08/06/2026 RBC (10^6/uL) Package Insert: 4.13-4.47 Instrument: 4.07-4.49 HCT % Package Insert: 31.2-35.2 Instrument: 33.5-35.9 PLT (10^3/uL) Package Insert: 182- 256 Instrument: 174-252 WBC (10^3/uL) Package Insert: 6.12-7.49 Instrument: 6.23- 7.39 Lot 61221403 (Level 3) 05/07/2026-08/06/2026 RBC (10^6/uL) Package Insert: 5.05-5.48 Instrument: 5.00-5.52 HCT % Package Insert: 41.0-46.2 Instrument: 41.8- 47.2 PLT (10^3/uL) Package Insert: 463-590 Instrument: 454-576 WBC (10^3/uL) Package Insert: 14.95-17.91 Instrument: 15.11-17.51 Lot 62071401 (Level 1) 08/05 /2026-09/16/2026 RBC (10^6/uL) Package Insert: 2.15-2.37 Instrument: 2.12-2.38 HCT % Package Insert: 15.1-17.3 Instrument: 15.3-17.7 PLT (10^3/uL) Package Insert: 36-87 Instrument: 35-85 WBC (10^3/uL) Package Insert: 2.14-2.89 Instrument: 2.23-2.79 Lot 62071402 (Level 2) 08/05/2026-09/16/2026 RBC (10^6 /uL) Package Insert: 3.93-4.26 Instrument: 3.88-4.28 HCT % Package Insert: 30.9- 34.8 Instrument: 31.3-35.7 PLT (10^3/uL) Package Insert: 187-263 Instrument: 177- 257 WBC (10^3/uL) Package Insert: 6.04-7.38 Instrument: 6.10-7.24 Lot 62071403 (Level 3) 08/05/2026-09/16/2026 RBC (10^6/uL) Package Insert: 5.05-5.47 Instrument: 4.99-5.51 HCT % Package Insert: 41.4-46.7 Instrument: 42.5-48.1 PLT (10^3/uL) Package Insert: 469-596 Instrument: 459-583 WBC (10^3/uL) Package Insert: 14.97-17.94 Instrument: 15.09-17.47 4. An interview with the technical consultant one on 09/16/2026 at 11:30 pm confirmed the survey findings. Word Key: RBC= Red Blood Cell 10^6/uL= million/microliter HCT= Hematocrit %= percent PLT=Platelet Count 10^3/uL=thousand/microliter WBC=White Blood Cell D6005 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(c) (c) The laboratory director must: (c)(1) Be onsite at least once every 6 months, with at least 4 months between the minimum two on-site visits. Laboratory directors may elect to be on-site more frequently and must continue to be accessible to the laboratory to provide telephone or electronic consultation as needed; and (c)(2) Provide documentation of these visits, including evidence of performing activities that are part of the laboratory director responsibilities. This STANDARD is not met as evidenced by: Based on a review of the Centers for Medicare and Medicaid (CMS) Laboratory Personnel Report (Form CMS-209), Clinical Laboratory Improvement Amendments (CLIA) Certificate of Compliance, lack of documentation, and staff interviews, the laboratory director failed to conduct on-site laboratory visits at least every six months with a minimum of four months between the required visits in 2025 and 2026. The findings include: 1. A review of the Form CMS-209 submitted for the on-site survey (09/16/2026) revealed that the laboratory director listed was the same on the -- 2 of 3 -- laboratory's CLIA Certificate of Compliance (Effective date 12/21/2024, Expiration date 12/20/2026). 2. The laboratory did not provide documentation on the survey date (09/16/2026) for the required laboratory director's on-site visits for 2025 and 2026. 3. An interview with the laboratory's technical consultant one on 09/16/2026 at 11:15 a. m. confirmed the survey findings. D6023 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(6) (e)(6) Ensure the establishment and maintenance of acceptable levels of analytical performance for each test system; This STANDARD is not met as evidenced by: Based on a review of the laboratory's hematology quality control (QC) records for May, June, July, August, and September 2026, and an interview with the technical consultant, the director failed to ensure the establishment and maintenance of acceptable levels of analytic performance for QC testing on the hematology instrument used for Complete Blood Count with automated differential (CBC w/Diff) patient testing in 2026. Refer to D5469. The findings include: 1. Review of the laboratory's QC records from the hematology instrument revealed that the QC ranges on the instrument QC printouts for RBC, HCT, PLT, and WBC for May, June, July, August, and September 2026 (three of three lots reviewed) differed from those stated in the manufacturer's QC package insert. No documentation was available to show how the laboratory established the QC ranges in use or how staff evaluated daily QC runs for acceptability. 2. An interview with the technical consultant on 09/16/2026 at 11:30 a.m. confirmed the above survey findings -- 3 of 3 --