Uw Eau Claire Student Health Service

Summary Statement of Deficiencies D6004 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(a)(b) 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. (a) The laboratory director, if qualified, may perform the duties of the technical consultant, clinical consultant, and testing personnel, or delegate these responsibilities to personnel meeting the qualifications of 493.1409, 493.1415, and 493.1421, respectively. (b) If the laboratory director reapportions performance of his or her responsibilities, he or she remains responsible for ensuring that all duties are properly performed. This STANDARD is not met as evidenced by: Based on surveyor review of the Clinical Laboratory Improvement Amendments (CLIA) Application for Certification (Form CMS-116), email correspondence with the technical consultant, and interview with the technical consultant, the laboratory director did not ensure compliance with regulations requiring notification to Health and Human Services (HHS) or its designee no later than thirty days after changing laboratory directors for one of one new laboratory directors. Findings include: 1. Review of the Form CMS-116 retrieved from Aspen Web CLIA database showed the laboratory director was Kimberly Frodl. 2. Email correspondence with the technical consultant on October 21, 2024, at 9:40 AM stated the new laboratory director was Laura Bentley. Further correspondence stated Dr. Bentley started as the laboratory director in June or July 2024. 3. Review of the Form CMS-116 submitted by the laboratory prior to the survey showed the laboratory director was Laura Bentley. 4. Interview with the technical consultant on November 4, 2024, at 10:15 AM confirmed Dr. Bentley became the laboratory director on July 29, 2024, and the laboratory did not notify HHS or its designee within thirty days of changing the laboratory director. 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 D5407 PROCEDURE MANUAL CFR(s): 493.1251(d) Procedures and changes in procedures must be approved, signed, and dated by the current laboratory director before use. This STANDARD is not met as evidenced by: Based on surveyor review of laboratory procedures and interview with testing personnel, the laboratory director did not approve, sign, and date the Cepheid GeneXpert Polymerase Chain Reaction (PCR) procedure before testing personnel used the procedure for patient testing in May 2021. Findings include: 1. Review of the "GeneXpert Xpress SARS-CoV-2 by PCR" procedure showed no evidence the laboratory director approved the procedure. 2. Interview with testing personnel (staff A) on September 19, 2022 at 2:00 PM confirmed the director had not signed and dated the "GeneXpert Xpress SARS-CoV-2 by PCR" procedure before testing personnel used the procedure for patient testing in May 2021. 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 D5215 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(b)(2) The laboratory must verify the accuracy of any analyte, specialty or subspecialty assigned a proficiency testing score that does not reflect laboratory test performance (that is, when the proficiency testing program does not obtain the agreement required for scoring as specified in subpart I of this part, or the laboratory receives a zero score for nonparticipation, or late return or results). 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, the laboratory did not evaluate two of two analytes that received a score of 0% for provider-performed microscopy (PPM) in event one of 2020. Findings include: 1. Review of PPM proficiency testing records for 2020-MiscQA_POC1 showed the laboratory received 0% scores for "Pinworm Preparation" and "Vaginal Wet Prep" due to a submission error when resulting the analytes to the PT provider. Further review showed no evidence the laboratory evaluated the results from the PT provider's participant summary to verify the accuracy of their responses. 2. Interview with the technical consultant on April 26, 2021 at 1:45 PM confirmed the laboratory did not evaluate two of two analytes that received a score of 0% for PPM in event one of 2020. 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 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 personnel records and interview with the Technical Consultant, competency evaluation of testing personnel listed on the Center for Medicare and Medicaid Services (CMS)-209 Form was not documented in 2016 or 2017 for non- waived testing. Findings include: 1. Review of personnel records shows no documented evaluation of competency for one of two testing personnel listed on the CMS-209 Form for 2016 or 2017. 2. Interview with the Technical Consultant on September 26, 2018 at 9:00 AM confirmed no competency evaluations were available for one of two testing personnel for non-waived testing in 2016 or 2017. 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 --