University Health Services Laboratory

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 the proficiency testing testing records from the American Proficiency Institute (API) for 2025 and interview with the Technical Supervisor (TS #1), the laboratory failed to ensure that the Laboratory Director (LD) reviewed, signed and dated the attestation declaration for eight (8) PT events completed in 2025. Findings include: 1. Upon review of the records for API PT for 2025, it was revealed that the LD failed to review sign and date the following API PT events: a. Immunology 2025 events #1 & #2 b. Hematology 2025 events #1 & #2 c. Microbiology 2025 events #1 & #2 d. Chemistry 2025 events #2 & #3 2. Interview with the LD and TS #1 on 11/04/2025 at 3:20 pm confirmed the lack of review and signature by the LD. 3. The laboratory attests to performing 45630 moderate and high complexity tests annually. D2094 ROUTINE CHEMISTRY CFR(s): 493.841(e) (e)(1) For any unsatisfactory analyte or test performance or testing event for reasons other than a failure to participate, the laboratory must undertake appropriate training and employ the technical assistance necessary to correct problems associated with a proficiency testing failure. (2) For any unacceptable analyte or testing event score, remedial action must be taken and documented, and the documentation must be maintained by the laboratory for two years from the date of participation in 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 3 -- This STANDARD is not met as evidenced by: Based on review of the American Proficiency Institute (API) Proficiency Testing (PT) results for 2024 and 2025 and interview with the Technical Supervisor (TS #1), the laboratory failed to ensure

Summary Statement of Deficiencies D2016 SUCCESSFUL PARTICIPATION CFR(s): 493.803(a)(b)(c) (a) Each laboratory performing nonwaived testing must successfully participate in a proficiency testing program approved by CMS, if applicable, as described in subpart I of this part for each specialty, subspecialty, and analyte or test in which the laboratory is certified under CLIA. (b) Except as specified in paragraph (c) of this section, if a laboratory fails to participate successfully in proficiency testing for a given specialty, subspecialty, analyte or test, as defined in this section, or fails to take remedial action when an individual fails gynecologic cytology, CMS imposes sanctions, as specified in subpart R of this part. (c) If a laboratory fails to perform successfully in a CMS- approved proficiency testing program, for the initial unsuccessful performance, CMS may direct the laboratory to undertake training of its personnel or to obtain technical assistance, or both, rather than imposing alternative or principle sanctions except when one or more of the following conditions exists: (1) There is immediate jeopardy to patient health and safety. (2) The laboratory fails to provide CMS or a CMS agent with satisfactory evidence that it has taken steps to correct the problem identified by the unsuccessful proficiency testing performance. (3) The laboratory has a poor compliance history. This CONDITION is not met as evidenced by: Proficiency Testing (PT) desk review of the American Proficiency Institute (API) proficiency testing showed the laboratory had two consecutive unsuccessful participation 1st and 2nd event 2022 in Endocrinology for the analyte Human Chorionic Gonadotropin (HCG). Refer to D2099 and D2107. D2099 ENDOCRINOLOGY CFR(s): 493.843(b) Failure to attain an overall testing event score of at least 80 percent is unsatisfactory Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 2 -- performance. This STANDARD is not met as evidenced by: Proficiency Testing (PT) desk review of the American Proficiency Institute (API) proficiency testing showed the laboratory failed to attain an overall testing event score of 80 percent for two consecutive events in the specialty Endocrinology. Findings include: 1. 1st event 2022 Endocrinology = 60% 2. 2nd event 2022 Endocrinology = 60% D2107 ENDOCRINOLOGY CFR(s): 493.843(f) Failure to achieve satisfactory performance for the same analyte or test in two consecutive testing events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Proficiency Testing (PT) desk review of the American Proficiency Institute (API) proficiency testing showed the laboratory has had unsuccessful performance for two consecutive testing events for the analyte Human Chorionic Gonadotropin (HCG) in the specialty Endocrinology. Findings includes: 1. 1st Event 2022, HCG = 60% 2. 2nd Event 2022, HCG = 60% -- 2 of 2 --