Cardiac Solutions - Peoria

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 proficiency testing (PT) records from 2023 and 2024 and interview with the testing personnel (TP-1), the laboratory failed to test PT samples by testing personnel who routinely perform patient testing in the laboratory, using the laboratory's routine methods. Findings include: 1. The laboratory participates in PT for testing performed in the specialty of Hematology. 2. The CMS-209, Laboratory Personnel Form presented during the survey conducted on July 12, 2024 listed 22 testing personnel who routinely perform patient testing. 3. Review of PT records from 2023 and 2024 indicated the same testing personnel (TP-1) tested all PT samples during each testing event in 2023 (2023-1, 2023-2, 2023-3) and the first event of 2024 (2024-1). 4. TP-1 interviewed on 7/16/24 at 12:30 PM confirmed that the same testing personnel (TP-1) participated in each testing event as indicated above. 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 lack of manufacturer's package inserts presented for review for testing 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 -- performed on the Cell-Dyn Emerald hematology analyzer and interview with the testing personnel (TP-1), the laboratory failed to retain the manufacturer's package insert for at least 2 years for seven out of seven lots of Quality Control (QC) material used on the analyzer during 2022, 2023 and 2024, and for two of two calibrations performed on the analyzer on 6/24/22 and 9/21/23. Findings include: 1. No evidence was presented for review to indicate the laboratory retained the manufacturer's assay information sheets for at least 2 years for 7 out of 7 lots of QC material used on the Cell-Dyn Emerald hematology analyzer during 2022, 2023 and 2024 (through the date of the survey). 2. No documentation was presented for review to indicate the laboratory retained the manufacturer's assay information sheets for at least 2 years for two of two calibrations performed on the analyzer on 6/24/22 and 9/21/23. 3. The TP- 1 interviewed on July 12, 2024 at 1:20 PM confirmed the laboratory failed to retain the manufacturer's assay information sheets for at least 2 years for each lot of QC used on the analyzer during 2022, 2023 and 2024, and for calibrations performed on 6/24 /22 and 9/21/23. 4. The laboratory reports approximately 3,000 CBC (Complete Blood Count) tests annually. D5439 CALIBRATION AND CALIBRATION VERIFICATION CFR(s): 493.1255(b) Unless otherwise specified in this subpart, for each applicable test system the laboratory must do the following: Perform and document calibration verification procedure - (b)(1) Following the manufacturer's calibration verification instructions; (b)(2) Using the criteria verified or established by the laboratory under 493.1253(b)(3) -- (b)(2)(i) Including the number, type, and concentration of the materials, as well as acceptable limits for calibration verification; and (b)(2)(ii) Including at least a minimal (or zero) value, a mid-point value, and a maximum value near the upper limit of the range to verify the laboratory's reportable range of test results for the test system; and (b)(3) At least once every 6 months and whenever any of the following occur: (b)(3)(i) A complete change of reagents for a procedure is introduced, unless the laboratory can demonstrate that changing reagent lot numbers does not affect the range used to report patient test results, and control values are not adversely affected by reagent lot number changes. (b)(3)(ii) There is major preventive maintenance or replacement of critical parts that may influence test performance. (b)(3)(iii) Control materials reflect an unusual trend or shift, or are outside of the laboratory's acceptable limits, and other means of assessing and correcting unacceptable control values fail to identify and correct the problem. (b)(3)(iv) The laboratory's established schedule for verifying the reportable range for patient test results requires more frequent calibration verification. This STANDARD is not met as evidenced by: Based on lack of calibration verification documentation from 2024 for the Cell-Dyn Emerald hematology analyzer, review of the manufacturer's instructions and interview with the testing personnel (TP-1), the laboratory failed to perform and document calibration verification procedures as required by the manufacturer during 2024. Findings include: 1. The manufacturer's instructions for the Cell-Dyn Emerald analyzer state, "Calibration verification criteria include: ...At least every six months." 2. No documentation was presented for review during the survey conducted on 7/12 /24 to indicate the laboratory performed calibration verification procedures at least every six months during 2024 on the Cell-Dyn Emerald analyzer. The previous calibration verification was performed on 9/21/23. 3. The facility personnel interviewed on July 12, 2024 at 1:25 PM confirmed the laboratory failed to perform -- 2 of 4 -- and document calibration verification procedures every six months as required during 2024. 4. The laboratory reports 3,000 CBC tests annually. D5469 CONTROL PROCEDURES CFR(s): 493.1256(d)(10)(g) Unless CMS Approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub. 7), that provides equivalent quality testing, the laboratory must-- Establish or verify the criteria for acceptability of all control materials. (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. (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. (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. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on review of quality control (QC) records, review of QC policies for testing performed on the Cell-Dyn Emerald hematology analyzer and interview with the testing personnel (TP-1), the laboratory failed to verify the criteria for acceptability of quality control materials for 2 of 2 QC lots used in 2024 and failed to retain QC documentation from 7 out of 7 parallel lot tests performed during 2022, 2023 and 2024. Findings include: 1. The laboratory performs CBC testing on the Cell-Dyn Emerald hematology analyzer, with a reported annual test volume of 3,000. 2. The laboratory's established QC policy states, "Parallel Test is to be performed each time new controls are opened. Run sample, you will compare the results that print to the number received with the new QC material. Results printed should match within Mean Range for the associated Assay Value for each control. Once confirmed that the Low, Normal and High results match within Mean Range, place results in CBC Binder." The laboratory uses a 'CBC QC Parallel Testing Log' to document QC lot information, including but not limited to, an area to document the acceptability of the results for each new lot of QC material. 3. The laboratory failed to document the acceptability of control materials for 2 out of 2 QC lots (lot# 4008 and 4092) used in 2024. 4. The laboratory failed to provide evidence of QC results printed from the analyzer and Assay Value sheets for 7 out of 7 QC lots used during 2022, 2023 and 2024. 5. The TP-1 interviewed on July 12, 2024 at 1:10 PM confirmed the laboratory failed to follow the established policy indicated above to verify and document the criteria for acceptability of each control lot used on the Cell-Dyn Emerald hematology analyzer during 2022, 2023 and 2024. D5891 POSTANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1299(a) The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess and, when indicated, correct problems identified in the postanalytic systems specified in 493.1291. This STANDARD is not met as evidenced by: -- 3 of 4 -- Based on lack of Quality Assessment (QA) documentation and interview with the testing personnel (TP-1), the laboratory failed to follow established policies and procedures for an ongoing mechanism to monitor, assess and, when indicated, correct problems identified in the postanalytic systems. Findings include: 1. Final test result information for CBC (Complete Blood Count) testing is manually transcribed by laboratory personnel into the patient's Electronic Health Record (EHR). 2. The laboratory's Quality Assessment policy states, "At least once annually, a spot check of transmitted or transcribed test results needs to be performed. Each instrument needs to have its test result(s) checked against the result(s) scanned, transmitted or transcribed to the patient's medical record (electronic or hard copy). Use the form below to indicate the performance and acceptance of the accuracy of these transmissions." 3. No documentation from 2022, 2023 and 2024 was presented for review to indicate the laboratory followed the policy referenced above to ensure patient test results and patient-specific data were accurately and reliably transcribed into the patient's EHR. 4. The facility personnel interviewed on July 12, 2024 at 1:50 PM confirmed the laboratory failed to follow established policies and procedures for an ongoing mechanism to monitor, assess and, when indicated, correct problems identified in the postanalytic systems. 5. The laboratory performs approximately 3,000 tests annually under the specialty of Hematology. D6046 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(8) (b) The technical consultant is responsible for-- (b)(8) Evaluating the competency of all testing personnel and assuring that the staff maintain their competency to perform test procedures and report test results promptly, accurately and proficiently. This STANDARD is not met as evidenced by: Based on review of 2023 and 2024 competency documentation and interview with the testing personnel (TP-1), the technical consultant failed to perform 12 of 12 competencies for 2023 and 2024. Findings include: 1. Competency documentation reviewed for 12 of 12 testing personnel from 2023 and 2024 revealed the competency evaluations were performed by TP-1 and not the Technical Consultant. 2. Interview with TP-1 on July 12, 2024 at 12:00 PM confirmed the Technical Consultant failed to evaluate the competency of 12 out of 12 testing personnel during 2023 and 2024. -- 4 of 4 --