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 surveyor review of Wisconsin State Laboratory of Hygiene (WSLH) proficiency testing (PT) records and interview with the Technical Consultant /Technical Supervisor (Staff A), the Laboratory Director or designee did not attest to the routine integration of PT samples into the patient workload using the laboratory's routine methods for one of two hematology PT events to date in 2025. Findings include: 1. Review of WSLH PT records revealed no evidence the Laboratory Director or designee signed the attestation forms for the second hematology PT event in 2025. 2. Interview with Staff A on October 8, 2025, at 9:20 AM confirmed the Laboratory Director or designee did not attest to the routine integration of PT samples into the patient workload using the laboratory's routine methods for the second hematology PT event in 2025. 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 6 -- This STANDARD is not met as evidenced by: Based on surveyor review of laboratory proficiency testing (PT) records, Wisconsin State Laboratory of Hygiene (WSLH) PT records, and interview with the Technical Consultant/Technical Supervisor (Staff A), the laboratory did not retain documentation of the handling, preparation, processing, examination, and each step in the testing and reporting of results for one of one hematology PT event in 2023 that occurred within the past two years. Findings include: 1. Review of the laboratory's PT records showed no evidence of testing records, reporting forms, and signed attestation statements for the third hematology PT event in 2023. 2. Review of WSLH PT website revealed the "PT Evaluation Report" for the third hematology PT event in 2023 was built October 23, 2023, less than two years ago. 3. Interview with Staff A on October 8, 2025, at 9:20 AM stated the laboratory inadvertently disposed of the PT records from 2023, and confirmed that laboratory did not retain documentation of the handling, preparation, processing, examination, and each step in the testing and reporting of results for one of one hematology PT event in 2023 occurring within the past two years. 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 surveyor review of laboratory records and interview with the Technical Consultant/Technical Supervisor (Staff A), the laboratory did not retain patient test records, including instrument printouts, quality control (QC), maintenance records, including function checks, and comparison studies for testing performed in the laboratory from October 1, 2023, through December 31, 2023, three months out of the two years that records are required to be retained. Findings include: 1. Review of laboratory records revealed no evidence of analytic systems records for testing performed from October 1, 2023, through December 31, 2023, including: -Sysmex "XS-1000i Maintenance Log" including documentation of