Woodridge Clinic

Summary Statement of Deficiencies D1002 REPORTING OF SARS-CoV-2 TEST RESULTS During the Public Health Emergency, as defined in 400.200 of this chapter, each laboratory that performs a test that is intended to detect SARS-CoV-2 or to diagnose a possible case of COVID-19 (hereinafter referred to as a "SARS-CoV-2 test") must report SARS-CoV-2 test results to the Secretary in such form and manner, and at such timing and frequency, as the Secretary may prescribe. This CONDITION is not met as evidenced by: Based on review of laboratory records, email correspondence with business administrator, and lack of documentation, the laboratory failed to report positive SARS-CoV-2 test results as required for a total of 15 of 84 patients (PT) for two of two days reviewed in March 2021. Findings Include: 1. SARS-CoV-2 testing documentation marked, "Woodridge Covid Report Through 012022" was reviewed. 2. Documentation revealed SARS-CoV-2 positive test results were not reported as required for 3 of 29 PT tested on 03/17/2021. Patient Notes Reason for visit PT 5 - Positive Cough, congestion PT 11 - Positive headache, light headed, diarrhea PT 26 - Positive referral 3. Documentation revealed SARS-CoV-2 positive test results were not reported as required for 12 of 55 PT tested on 03/19/2021. Patient Notes Reason for visit PT 6 - Positive Covid Test PT 9 - Positive retest PT 10 - Positive possible infection PT 11 - Positive Covid Test PT 14 - Positive Sore Throat PT 15 - Positive Covid quick screen PT 19 - Positive Potential exposure PT 28 - Positive Covid Test PT 29 - Positive Covid Test PT 30 - Positive Exposure to covid positive persons PT 31 - Positive Feeling sick PT 44 - Positive Covid-19 4. Fifteen positive test results were not reported as required during the period of review. 5. The laboratory performed 84 SARS-CoV-2 tests during the period of review. 6. On 06/06/2022 at 10: 00 am, an email was sent to the Woodridge Clinic Business Administrator requesting proof of positive SARS-CoV-2 test results being submitted as required. The laboratory failed to provide evidence of reporting. 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 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: Based on lack of documentation, direct observation, interview with Testing Personnel (TP 1), the laboratory failed to provide training documentation for performing SARS- CoV-2 testing following manufacturers' instructions for two of two testing personnel. Findings Include: 1. On 05/25/2022 at 9:39 am, interview with (TP 1) revealed a total of two laboratory Testing Personnel (TP) at the Woodridge Clinic in Woodridge. 2. On 05/25/2022 at 9:45 am, direct observation revealed two SARS-CoV-2 test kits in use: Accula Test SARS-CoV-2 Sienna COVID-19 Antigen Rapid Test Cassette (Nasopharyngeal Swab) 3. Review of the Accula Test SARS-CoV-2 Instructions for Use (IFU) states: F. All operators using your product must be appropriately trained in performing and interpreting the results of your product, use appropriate personal protective equipment when handling this kit, and use your product in accordance with the authorized labeling. 4. Review of the Sienna COVID-19 Antigen Rapid Test Cassette (Nasopharyngeal Swab) IFU states: F. All operators using your product must be appropriately trained in performing and interpreting the results of your product. Use appropriate personal protective equipment when handling this kit, and use your product in accordance with the labeling. 5. The laboratory failed to provide training documentation of the Accula Test SARS-CoV-2 and the Sienna COVID-19 Antigen Rapid Test Cassette (Nasopharyngeal Swab) for TP 1 and TP 2 upon request. 6. On 05 /25/2022 at 10:20 am, interview with TP 1 confirmed the laboratory personnel did not have access to training documentation of the Accula Test SARS-CoV-2 or the Sienna COVID-19 Antigen Rapid Test Cassette (Nasopharyngeal Swab) kits. 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 --