Uw La Crosse Student Health Center

Summary Statement of Deficiencies D6021 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(5) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(5) Ensure that quality assessment programs are established and maintained to assure the quality of laboratory services provided. This STANDARD is not met as evidenced by: Based on surveyor review of laboratory records and interview with the Technical Consultant and the Laboratory Director, the laboratory had not established a quality assessment program that monitored non-conforming events throughout the laboratory including pre-analytic, analytic, and post-analytic processes to ensure ongoing improvement. Findings include: 1. Review of laboratory records showed no evidence the laboratory tracked errors in laboratory operations to assure continued quality improvement. 2. Interview with the Technical Consultant and the Laboratory Director on October 22, 2024, at 10:45 AM confirmed the laboratory had not established or implemented a quality assessment program that tracked and monitored errors in the receipt and processing of samples through the reporting of test results. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 1 --

Summary Statement of Deficiencies D2009 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(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 laboratory director, the laboratory director or designee and testing personnel did not attest to the routine integration of PT samples into the patient workload using the laboratory's routine methods for six of six PT events in 2022. Findings include: 1. Review of WSLH PT records from 2022 showed the laboratory director or designee did not sign the attestation form for the following events: 2022-HemeReg1 2022-HemeReg2 2022- HemeReg3 2022-MiscQA-POC1 2022-Bacti_Viral1 2022-Bacti_Viral2 2. Interview with the laboratory director on October 20, 2022 at 11:40 AM confirmed the laboratory director or designee and testing personnel did not attest to the routine integration of PT samples into the patient workload using the laboratory's routine methods for six of six PT events in 2022. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 1 --

Summary Statement of Deficiencies D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(d) Reagents, solutions, culture media, control materials, calibration materials, and other supplies must not be used when they have exceeded their expiration date, have deteriorated, or are of substandard quality. This STANDARD is not met as evidenced by: Based on surveyor observation of testing reagents, review of patient reports and interview with testing personnel, staff A, the laboratory used potassium hydroxide (KOH) past the expiration date on the bottle. Findings include: 1. Observation of the KOH reagent available on April 12, 2021 at 10:15 AM showed the expiration date printed on the bottle was January 31, 2021 (2021-01-31). 2. Review of patient test reports from February and March 2021 showed the laboratory performed four patient KOH tests. 3. Interview with staff A on April 12, 2021 at 10:15 AM confirmed testing personnel performed patient testing using the observed bottle of KOH past the expiration date of the reagent. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 1 --