Summary:
Summary Statement of Deficiencies D2009 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) (b)(1) The individual testing or examining the samples and the laboratory director must attest to the routine integration of the samples into the patient workload using the laboratory's routine methods. This STANDARD is not met as evidenced by: Based on review of blood gas proficiency testing (PT) records and interview with the technical consultant (TC), the laboratory failed to ensure that each testing person who performed the test signed the attestation worksheet showing that PT samples were tested in the same manner as the patients. Findings: 1. The blood gas PT records from 2023 and 2024 were reviewed. The attestation worksheet for PT event SEM-A 2023 listed two testing personnel. The worksheet only had one of the two signatures required. 2. During the exit interview on 04/08/2025 at 11:45 AM, the TC confirmed that the signature of the second testing person was not on the attestation worksheet. D2014 TESTING OF PROFICIENCY TESTING SAMPLES (b)(6) The laboratory must document the handling, preparation, processing, examination, and each step in the testing and reporting of results for all proficiency testing samples. The laboratory must maintain a copy of all records, including a copy of the proficiency testing program report forms used by the laboratory to record proficiency testing results including the attestation statement provided by the PT program, signed by the analyst and the laboratory director, documenting that proficiency testing samples were tested in the same manner as patient specimens, for a minimum of two years from the date of the proficiency testing event. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 11 -- This STANDARD is not met as evidenced by: I. Based on review of the proficiency testing (PT) records and interview with the technical consultant (TC), the laboratory failed to ensure the accuracy of the records maintained. Findings: 1. The blood gas PT records from 2023 through 2024 were reviewed. 2. The records from the SO-C 2024 PT event showed that the name of testing person (TP)#1 was typed on the attestation worksheet with no signature. TP#2 is listed as the operator on the blood gas analyzer instrument printout. The TC stated that the ID# from the previous TP#1 had not been updated prior to TP#2 testing the PT samples. 3. During the survey on 04/07/2025 at 1:00 PM, the TC confirmed that the incorrect ID# of the TP was listed on the attestation worksheet and the blood gas analyzer instrument printout. II. Based on review of the PT records and interview with the TC, the laboratory failed to maintain a copy of all instrument printouts showing the results obtained during each PT event. Findings: 1. The hematology, coagulation, and urinalysis PT records from 2023 through 2024 were reviewed. 2. The following events were missing the instrument printouts showing the original test results: SEM-A 2023; RT4-A 2023; SCM-A 2023, CRS-A 2023, and SCS-A. 3. During the survey on 04/08/2025 at 11:45 AM, the TC confirmed that the original instrument printouts with the results of the PT samples had not been included with the PT records for 2023. 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. In addition, retain the following: This STANDARD is not met as evidenced by: Based on laboratory record review and interview with the chemistry department supervisor, the laboratory failed to retain all analytic systems records for at least 2 years. Findings: 1. The laboratory performs chemistry testing on a Beckman UniCel DxI 800 Access Immunoassay System (DxI). The instrument calculates the due date of the next calibration for each analyte on the instrument. Calibration records are printed and stored in a binder. 2. A review of calibration records for the "DxI #2" from January through April 2025 showed that the analytes digoxin (Dig), ferritin, free triiodothyronine (FT3), and human chorionic gonadotropin (hCG5) must be calibrated every 28 days. 3. Record review showed that the calibration performed on 01/01/2025 for Dig expired on 01/29/2025. The next record available showed that Dig was calibrated on 02/16/2025. There was no record that Dig had been calibrated between the expiration date of the previous calibration (01/29/2025) and 02/16/2025; 4. Record review showed that the calibration performed on 01/29/2025 for ferritin expired on 02 /26/2025. The next record available showed that ferritin was calibrated on 03/23/2025. There was no record that ferritin had been calibrated between the expiration date of the previous calibration (02/26/2025) and 03/23/2025; 5. Record review showed that the calibration performed on 02/16/2025 for FT3 expired on 03/16/2025. The next record available showed that FT3 was calibrated on 04/02/2025. There was no record that FT3 had been calibrated between the expiration date of the previous calibration (03/16/2025) and 04/02/2025; and 6. Record review showed that the calibration performed on 01/31/2025 for HCG5 expired on 02/28/2025. The next record available showed that HGC5 was calibrated on 03/09/2025. There was no record that HCG5 had been calibrated between the expiration date of the previous calibration (02/28 /2025) and 03/09/2025. 7. During an interview on 04/10/2025 at 11:45 AM, the -- 2 of 11 -- chemistry department supervisor stated that they had searched the calibration records onboard the "DxI #2" instrument, however the instrument had not maintained the missing calibration records. They confirmed that the laboratory failed to maintain all analytic systems records for at least 2 years. D5211 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(a) The laboratory must review and evaluate the results obtained on proficiency testing performed as specified in subpart H of this part. This STANDARD is not met as evidenced by: I. Based on review of proficiency testing (PT) records and interview with the quality assurance supervisor (QAS), PT results evaluations were missing, not reviewed, or not investigated for seven of 97 microbiology and immunology PT events reviewed. Findings: 1. The laboratory was enrolled in PT with Wisconsin State Laboratory of Hygiene (WSLH) and the College of American Pathologists (CAP). 2. The results evaluations were missing for four of 12 WSLH PT events reviewed (2023 Immunology3, 2024 Immunology1, 2024 Bacti_Viral1, and 2024 Bacti-Viral3) and two of 85 CAP PT events reviewed (2024 LN39-A and VR3-A). 3. The results evaluation from the CAP VR3-B event were not signed as reviewed by the laboratory director or designee. 4. The results evaluation for the CAP 2024 COV2Q-B event showed that one of three samples had an incorrect result (67%). There was no documentation of an investigation into the root cause of the incorrect result. 5. During the survey on 04/10/2025 at 1:00 PM, the QAS confirmed that some of the PT evaluations were missing or not signed as reviewed and that there was no documentation of an investigation into the root cause of the incorrect result from the 2024 COV2Q-B PT event. II. Based on record review and interview, the blood bank