Summary:
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 observation of the laboratory, review of laboratory records and staff interview, the laboratory failed to retain complete blood count (CBC) quality control (QC) limits for two years for 27 of 42 lots. The findings include: 1. Observation of the laboratory on January 5, 2022 at approximately 10:15 am revealed the Sysmex XS 1000iC (serial number A1055) in use for patient testing for CBC. 2. Review of the laboratory's CBC QC records revealed no retention of the QC limits for 27 of 42 lots surveyed. Lot numbers affected are 93230804, 93230805, 93230806, 00140804, 00140805, 00140806, 00700804, 00700805, 00700806, 01260804, 01260805, 01260806, 01820804, 01820805, 01820806, 02380804, 02380805, 02380806, 02940804, 02940805, 02940806, 03500804, 03500805, 03500806, 10400804, 10400805, and 10400806. The lots were in use from January 6, 2020 until April 30, 2021 with patient testing performed. 3. Interview with the laboratory supervisor on January 5, 2022 at approximately 5:00 pm confirmed the laboratory failed to retain quality control limits for 27 of 42 lots in 2020 and 2021. The supervisor further confirmed that patient testing was performed during the entire period. D5024 HEMATOLOGY CFR(s): 493.1215 If the laboratory provides services in the specialty of Hematology, the laboratory must meet the requirements specified in 493.1230 through 493.1256, 493.1269, and 493. 1281 through 493.1299. 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 -- This CONDITION is not met as evidenced by: The laboratory failed to follow the procedure for entry of complete blood count quality control ranges (Refer to D5401) and failed to have an effective quality assessment process for detecting errors in complete blood count quality control (Refer to D5793). D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) A written procedures manual for all tests, assays, and examinations performed by the laboratory must be available to, and followed by, laboratory personnel. Textbooks may supplement but not replace the laboratory's written procedures for testing or examining specimens. This STANDARD is not met as evidenced by: Based on observation of the laboratory, review of the laboratory procedure manual, laboratory quality control (QC) records, and staff interview, the laboratory failed to follow the procedure for entry of quality control limits for complete blood count (CBC) for six of fifteen lots in 2021 and 2022. The findings include: 1. Observation of the laboratory on January 5, 2022 at approximately 10:15 am revealed the Sysmex XS1000iC (serial number A1055) in use for patient CBC testing. 2. Review of the laboratory's procedure titled "Sysmex XS-1000 Series Quality Control" revealed the following: "Sysmex uses 'Limit Range %" as a part of the QC process in the XS-1000 Series instrument. Sysmex recommends that the Limit Range % be set in accordance with the Sysmex Evidence-Based Control Limits." "This model-specific limit %'s will be entered and verified as recommended." 3. Review of the laboratory's QC records for lot numbers 12640804-level one, 12640805-level two, 12640806- level three, 13200804-level one, 13200805-level two, and 13200806-level three revealed the laboratory did not enter the Limit Range % when setting up the new QC lot numbers, resulting in the use of incorrect quality control limits from October 7, 2021 until January 5, 2022 for all parameters. Approximately 120 patients were reported during the period when the incorrect QC limits were in use. See below for selected parameters for incorrect ranges for red blood cell (RBC), white blood cell (WBC), Hematocrit (HCT), Hemoglobin (HGB) and Platelet (PLT): Lot 1264--Previous Lot Package insert Range used RBC Level 1 2.23-2.46 0.0-4.68 RBC Level 2 4.15-4.50 0.0-8.62 RBC Level 3 4.95-5.36 0.0-11.8 WBC Level 1 2.65-3.31 0.0-5.88 WBC Level 2 6.31-7.55 0.0-13.98 WBC Level 3 15.21-17.85 0.0-32.38 HCT Level 1 17.3- 19.9 0.0-36.4 HCT Level 2 36.0-40.6 0.0-76.2 HCT Level 3 45.2-50.9 0.0-95.6 HGB Level 1 5.6-6.3 0.0-11.6 HGB Level 2 12.2-13.3 0.0-25.4 HGB Level 3 15.5-16.8 0.0- 32.2 PLT Level 1 42-76 0-120 PLT Level 2 202-257 0-468 PLT Level 3 490-599 0- 1108 Lot 1320--Current Lot Package insert Range used RBC Level 1 2.25-2.48 0.0- 4.66 RBC Level 2 4.19-4.54 0.0-8.64 RBC Level 3 5.00-5.42 0.0-10.36 WBC Level 1 2.66-3.32 0.0-5.98 WBC Level 2 6.23-7.46 0.0-13.84 WBC Level 3 14.73-17.3 0.0- 32.38 HCT Level 1 16.9-19.4 0.0-36.4 HCT Level 2 35.0-39.5 0.0-74.6 HCT Level 3 45-50.7 0.0-96.2 HGB Level 1 5.5-6.2 0.0-11.6 HGB Level 2 12.1-13.1 0.0-25.0 HGB Level 3 15.7-17.0 0.0-32.6 PLT Level 1 44-79 0-118 PLT Level 2 205-261 0-464 PLT Level 3 488-597 0-1088 4. Interview with the laboratory supervisor on January 5, 2022 at approximately 5pm confirmed the laboratory failed to follow the procedure for correct quality control limit setting for six of fifteen lots in 2021 and 2022. -- 2 of 3 -- D5793 ANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1289(b)(c) (b) The analytic systems quality assessment must include a review of the effectiveness of