University Pediatrics

Summary Statement of Deficiencies D0000 The following deficiencies are a result of a desk review of proficiency testing scores obtained from the national database and verified with the proficiency testing company. The facility was found to be out of compliance with the conditions of the CLIA program. The following CONDITION LEVEL DEFICIENCIES were found: D2016 - 42 C.F.R. 493.803 Condition: Successful participation [proficiency testing] D6000 - 42 C.F.R. 493.1403 Condition: Laboratories performing moderate complexity testing; laboratory director; 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: Based on proficiency testing desk review of the Certification and Survey Provider 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 -- Enhanced Reporting (CASPER) Report 155 Individual Laboratory Profile and Wisconsin State Laboratory of Hygiene (HemeReg 1 and HemeReg 2), the laboratory failed to achieve satisfactory performance on two of two testing events for the analyte of hematocrit, resulting in an initial unsuccessful performance (Refer to D2130). D2130 HEMATOLOGY CFR(s): 493.851(f) (f) Failure to achieve satisfactory performance for the same analyte in two consecutive events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on proficiency testing desk review of the Certification and Survey Provider Enhanced Reporting (CASPER) Report 155 Individual Laboratory Profile and Wisconsin State Laboratory of Hygiene Proficiency Institute's proficiency reports (HemeReg 1 and HemeReg 2), the laboratory failed to achieve satisfactory performance for two of two events in 2025 for the analyte of hematocrit. The findings included: 1. A review of the Certification and Survey Provider Enhanced Reporting (CASPER) Report 155 Individual Laboratory Profile report, the laboratory received the following unsatisfactory performances for hematocrit on two of two events: 2025 M1 0% 2025 M2 60% 2. A review of the Wisconsin State Laboratory of Hygiene proficiency testing results from 2025 confirmed the findings. D6000 MODERATE COMPLEXITY LABORATORY DIRECTOR CFR(s): 493.1403 The laboratory must have a director who meets the qualification requirements of 493. 1405 of this subpart and provides overall management and direction in accordance with 493.1407 of this subpart. This CONDITION is not met as evidenced by: Based on proficiency testing desk review of the Certification and Survey Provider Enhanced Reporting (CASPER) Report 155 Individual Laboratory Profile and Wisconsin State Laboratory of Hygiene proficiency reports (HemeReg 1 and HemeReg 2), the laboratory director failed to provide overall management and direction of the laboratory services resulting in an initial proficiency testing failure for the analyte hematocrit (refer to D6016.) D6016 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(i) (e)(4)(i) The proficiency testing samples are tested as required under Subpart H of this part; This STANDARD is not met as evidenced by: Based on proficiency desk review of the Certification and Survey Provider Enhanced Reporting (CASPER) Report 155 Individual Laboratory Profile and Wisconsin State Laboratory of Hygiene (2025 HemeReg 1 and 2025 HemeReg 2) proficiency reports, -- 2 of 3 -- the laboratory director failed to ensure successful participation in a HHS approved proficiency testing program for the analyte of hematocrit for two of two events in 2025, resulting in an initial unsuccessful performance (refer to D2130). -- 3 of 3 --

Summary Statement of Deficiencies D5469 CONTROL PROCEDURES CFR(s): 493.1256(d)(10)(g) (d)(10) Establish or verify the criteria for acceptability of all control materials. (d)(10) (i) When control materials providing quantitative results are used, statistical parameters (for example, mean and standard deviation) for each batch and lot number of control materials must be defined and available. (d)(10)(ii) The laboratory may use the stated value of a commercially assayed control material provided the stated value is for the methodology and instrumentation employed by the laboratory and is verified by the laboratory. (d)(10)(iii) Statistical parameters for unassayed control materials must be established over time by the laboratory through concurrent testing of control materials having previously determined statistical parameters. This STANDARD is not met as evidenced by: Based on review of the laboratory's hematology quality control records from September 2023 to December 2024 and staff interview, the laboratory failed to have documentation of verifying 5 of 7 new lots of quality control material prior to previous lot expiration. The findings included: 1. A review of the laboratory's quality control records from September 2023 to December 2024 identified the following 5 lots of control material that were placed into use without documentation of verifying values prior to use: a) Lot: 22308 Verified: 09/22/2023 Previous lot expired: 09/21 /2023 (Lot 22305) b) Lot: 22311 Verified: 12/23/2023 Previous lot expired: 12/22 /2023 (Lot 22308) c) Lot: 22405 Verified: 06/25/2025 Previous lot expired: 06/24 /2025 (Lot 22402) d) Lot: 22402 Verified: not verified e) Lot: 22411 Verified: 12/24 /2024 Previous lot expired: 12/23/2024 (22408) 2. The technical consultant confirmed the findings by phone on 07/22/2025 at 0938 hours. 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 D0000 Noted deficiencies and plans of correction were discussed with the laboratory representative(s) at the exit conference. The facility was found to be in compliance with applicable Conditions in the CLIA program, and recertification is recommended. D2007 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The samples must be examined or tested with the laboratory's regular patient workload by personnel who routinely perform the testing in the laboratory, using the laboratory's routine methods This STANDARD is not met as evidenced by: Based on review of the laboratory's submitted Form CMS 209, review of the laboratory's personnel records, review of the laboratory's proficiency testing records from 2022 and 2023, and staff interview it was revealed the laboratory failed to have documentation of 1 of 2 testing personnel participating in proficiency testing in 2022 and 2023. The findings include: 1. A review of the laboratory's submitted Form CMS 209 revealed the laboratory identified 2 testing personnel. 2. A review of the laboratory's personnel records revealed: Testing personnel number 1 was employed starting in 2014. Testing personnel number 2 was employed starting in 2017. 3. A review of the laboratory's American Academy of Family Physician's (AAFP) proficiency testing records from 2022 (A, B and C) and the laboratory's Wisconsin State Laboratory of Hygiene proficiency testing records from 2023 (event 1) revealed all testing was performed by testing personnel number 1 (as listed on Form CMS 209). 4. The laboratory was asked to provide documentation of testing personnel number 2 participating in proficiency testing. No documentation was provided. 5. An interview with the technical consultant on 05/03/2022 at 920 hours in the break room - after her review of the records- confirmed the findings. D3031 RETENTION REQUIREMENTS 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 -- 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. This STANDARD is not met as evidenced by: Based on review of the laboratory's new lot verification records from 2022 and 2023, it was revealed the laboratory failed to retain the the records for the verification of new lots of Boule Condiff - Trilevel quality control for 5 lots in 2022. The findings include: 1. A review of the laboratory's quality control records from 2022 revealed the laboratory failed to retain documentation of performing new lot verifications for the following lots of quality control material: Lot: 22110 Lot: 22111 Lot: 22202 Lot: 22205 Lot: 22206 2. The laboratory was asked to provide the missing documentation. No documentation was provided. 3. An interview with the technical consultant on 05 /03/2023 at 1015 hours in the break room revealed the was unable to locate the records. This confirmed the findings. -- 2 of 2 --

Summary Statement of Deficiencies D0000 The laboratory was surveyed and found to be in compliance with the conditions of participation found in the CLIA regulations at 42 CFR 493 and recertification is recommended. D1001 CERTIFICATE OF WAIVER TESTS CFR(s): 493.15(e) Laboratories eligible for a certificate of waiver must-- (1) Follow manufacturers' instructions for performing the test; and (2) Meet the requirements in subpart B, Certificate of Waiver, of this part. This STANDARD is not met as evidenced by: Review of manufacturer's instructions, patient final reports and interview of facility personnel found the laboratory failed to follow the manufacturer's instructions when using the QuickVue SARS Antigen test for 5 of 5 patients tested in September 2021. The findings included: 1. Review of the manufacturer's instructions found under the heading CONDITIONS OF AUTHORIZATION FOR LABORATORY "Authorized laboratories using your product must include with the test result reports, all authorized Fact Sheets." 2. Review of patient results found no fact sheets included with the final report for five of five patient reports reviewed. 3. Interview with Testing Personnel #1 (as listed on Form CMS-209) on September 10, 2021 at 09:35 hours in the laboratory confirmed the findings. Key: CMS - Centers for Medicare and Medicaid Services 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 D0000 Noted deficiencies and plans of correction were discussed with the laboratory representative at the entrance and exit conferences. The facility representative was given an opportunity to provide evidence of compliance with the noted deficiencies, and no such evidence was provided prior to survey exit. The facility was found to be in compliance with applicable Conditions of Participation in the CLIA program, and recertification is recommended. Note: The CMS-2567 (Statement of Deficiencies) is an official, legal document. All information must remain unchanged except for entering the