Humboldt Family Walk-In Clinic

Summary Statement of Deficiencies D1001 CERTIFICATE OF WAIVER TESTS CFR(s): 493.15(e) 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: Based on observation of the laboratory, review of the manufacturer's package insert, the United States (U.S.) Food and Drug Administration (FDA) database, laboratory patient activity logs, and staff interviews, the laboratory did not follow the manufacturer's instructions for the CorDx COVID-19 Ag Test kit when it performed approximately 265 COVID-19 Ag tests on patients under the age of two since testing began on 09/17/2024. The findings include 1. Observation of the laboratory on 01/15 /2025 at 9:15 a.m. revealed the CorDx COVID-19 Ag Test kit used for patient testing. During the observation, the technical consultant state that the laboratory performed COVID-19 testing on all patient age groups with the CorDx COVID-19 Ag Test kit. Testing person three stated that the laboratory began using the test kit in September 2024. 2. A review of the CorDx COVID-19 Ag Test kit manufacturer package insert in the section "WARNINGS, PRECAUTIONS, AND SAFETY INFORMATION" revealed, "Do not use on anyone under 2 years of age." 3. A review of the FDA database revealed the CorDx COVID-19 Ag Test kit was classified as CLIA waived effective 07/02/2024. 4. A review of a patient activity log from 09/17/2024 through 12 /31/2024 revealed that the laboratory had tested approximately 265 patients, and three of the patients tested were under two years old. 5. An interview with the technical consultant on 01/15/2025 at 11:30 a.m. confirmed the survey findings. Word Key: COVID-19 - Severe acute respiratory syndrome Coronavirus (SARS-CoV-2) Ag - Antigen CLIA - Clinical Laboratory Improvement Amendments 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 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 a review of the Centers for Medicare and Medicaid Casper Report 155 (CMS 155) and the laboratory's Wisconsin State Laboratory of Hygiene (WSLH) and American Proficiency Institute (API) proficiency testing (PT) evaluation reports, the laboratory failed to maintain satisfactory performance for two consecutive PT events for the hemoglobin (HGB) analyte resulting in the first unsuccessful PT occurrence for the HGB analyte (Refer to D2130). D2130 HEMATOLOGY CFR(s): 493.851(f) 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 -- 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 a desk review of the CMS 155, the laboratory's 2023 WSLH PT evaluation report, and the 2024 API PT evaluation report, the laboratory failed to maintain satisfactory performance for two consecutive events for the HGB analyte. The findings include: 1. A review of the CMS 155 report revealed the following unsatisfactory HGB scores: 2023 Event Three 0% 2024 Event One 20% 2. A review of the WSLH PT evaluation report for 2023 Event Three revealed an overall score of 0% for the HGB analyte. 3. A review of the API PT evaluation report for 2024 Event One revealed an overall score of 20% for the HGB analyte. -- 2 of 2 --

Summary Statement of Deficiencies D0000 During a recertification survey that was completed on 12/14/2023, the laboratory was found out of compliance with the following conditions: 42 CFR 493.1421 Condition: Laboratories performing moderate complexity testing; testing personnel D6063 LABORATORY TESTING PERSONNEL CFR(s): 493.1421 The laboratory must have a sufficient number of individuals who meet the qualification requirements of 493.1423, to perform the functions specified in 493. 1425 for the volume and complexity of tests performed. This CONDITION is not met as evidenced by: Based on review of the Department of Health and Human Services Centers for Medicare and Medicaid Services Laboratory Personnel Report (CLIA) (Form CMS- 209), testing person (TP) personnel record review, and staff interview, TP three did not qualify as a TP for moderately complex patient testing due to lack of acceptable documentation of highest level of education prior to patient testing. (Refer to D6065) D6065 TESTING PERSONNEL QUALIFICATIONS CFR(s): 493.1423(b)(1)(2)(3)(4)(i) (b) Meet one of the following requirements: (b)(1) Be a doctor of medicine or doctor of osteopathy licensed to practice medicine or osteopathy in the State in which the laboratory is located or have earned a doctoral, master's, or bachelor's degree in a chemical, physical, biological or clinical laboratory science, or medical technology from an accredited institution; or (b)(2) Have earned an associate degree in a chemical, physical or biological science or medical laboratory technology from an accredited institution; or (b)(3) Be a high school graduate or equivalent and have successfully completed an official military medical laboratory procedures course of at least 50 weeks duration and have held the military enlisted occupational specialty of 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 -- Medical Laboratory Specialist (Laboratory Technician); or (b)(4)(i) Have earned a high school diploma or equivalent; and This STANDARD is not met as evidenced by: Based on review of the Form CMS-209, personnel record review, and staff interviews the laboratory failed to ensure that TP three (one of three) had acceptable documentation of highest level of education on the date of the survey (12/14/2023). The findings include: 1. Review of the Form CMS-209 revealed TP three listed (new since previous survey) as performing moderately complex patient testing. 2. Review of the TP personnel records revealed TP three (hired 09/2023) had a diploma from a foreign institution with no documentation of degree equivalency available on the date of the survey (12/14/2023). 3. Interview on 12/14/2023 at 12:00 pm with the technical consultant confirmed the laboratory did not have degree equivalency to verify education requirements for TP three that performed moderately complex patient testing in 2023. -- 2 of 2 --

Summary Statement of Deficiencies 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 observation of the laboratory, review of the Center for Medicare and Medicaid Service Laboratory Personnel Report (CLIA) form (Form CMS - 209), review of proficiency testing (PT) record and interview with the laboratory liaison, the laboratory failed to test PT samples by personnel who routinely perform complete blood count (CBC) testing for three of three PT events in 2021. The findings include: 1. Observation of the laboratory on 06.01.2022 at 11:00 am revealed the use of Beckman Coulter AcT diff in use for complete blood count (CBC) patient testing. 2. Review of the Form CMS - 209 revealed three technical personnel performing moderate complexity CBC patient testing. 3. Review of the laboratory's 2021 proficiency testing (PT) attestation records revealed the same testing person performed PT testing for each event. 4. Interview with the laboratory liaison on 06.01.2022 at 2:00 pm confirmed the laboratory failed to test PT samples by personnel who routinely perform CBC patient testing in 2021. D5217 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(c)(1) At least twice annually, the laboratory must verify the accuracy of any test or procedure it performs that is not included in subpart I of this part. This STANDARD is not met as evidenced by: 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 -- Based on observation of the laboratory, lack of documentation, review of patient test records and interview with the laboratory liaison, the laboratory failed to verify the accuracy of the microscopic wet prep in 2020 and 2021. The findings include: 1. Observation of the laboratory on 06.01.2022 at 11:00 am revealed a microscope in use for moderate conplexity wet prep patient testing. 2. Request for 2020 and 2021 twice a year verification of accuracy for microscopic wet prep revealed no documents were available. 3. Review of patient test reports revealed microscopic wet prep performed on 01.06.2020 and 04.22.2021. 4.Interview with the laboratory liaison on 06.01.2022 at 2:00 pm confirmed that the laboratory failed to verify the accuracy of the microscopic wet prep twice a year in 2020 and 2021. -- 2 of 2 --

Summary Statement of Deficiencies D5421 ESTABLISHMENT AND VERIFICATION OF PERFORMANCE CFR(s): 493.1253(b)(1) Each laboratory that introduces an unmodified, FDA-cleared or approved test system must do the following before reporting patient test results: (1)(i) Demonstrate that it can obtain performance specifications comparable to those established by the manufacturer for the following performance characteristics: (1)(i)(A) Accuracy. (1)(i) (B) Precision. (1)(i)(C) Reportable range of test results for the test system. (1)(ii) Verify that the manufacturer's reference intervals (normal values) are appropriate for the laboratory's patient population. This STANDARD is not met as evidenced by: Based on observation of the laboratory, review of the validation records for the Beckman Coulter AcT Diff complete blood count (CBC) instrument, the laboratory's procedure and checklist for validation of new equipment and interview with the laboratory director, the laboratory failed to verify the manufacturer's patient normal ranges for the Beckman Coulter AcT Diff CBC instrument in 2017. 1. Observation of the laboratory on October 19, 2018 at 9:40 am revealed the Beckman Coulter AcT Diff CBC instrument (system id # 43043803) in use for patient testing. 2. Review of the validation records performed on October 19, 2017 for the Beckman Coulter AcT Diff CBC instrument revealed the manufacturer's patient normal ranges was not verified. 3. Review of the laboratory's procedure and checklist for validation of new equipment revealed that verification of the manufacturer's patient normal ranges is not part of the validation protocol. 4. Interview with the laboratory director on October 19, 2018 at 12:00 pm confirmed that the laboratory uses the manufacturer's patient normal ranges for the Beckman Coulter Act Diff CBC instrument and verification of manufacturer's patient normal range is not included as part of the validation protocol. The laboratory failed to verify the manufacturer's patient normal ranges for the Beckman Coulter AcT diff CBC instrument in 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 --