Woodridge Clinic Lemont

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 9 of 50 patients (PT) for one of one days reviewed in January 2021. Findings Include: 1. SARS-CoV-2 testing documentation marked, "Lemont Covid Report 01/09/2021" was reviewed. 2. Documentation revealed SARS-CoV-2 positive test results were not reported as required for 9 of 50 PT tested on 01/09/2021. Patient Notes Reason for visit PT 1 - Positive Not feeling well PT 11 - Positive Covid 19 test PT 12 - Positive Not feeling well PT 14 - Positive Had a test Thursday was negative but feeling a little sick today PT 17 - Positive Exposed to Covid and feeling a little sick PT 18 - Positive Potential Exposure on airline flight PT 36 - Positive Feeling Sick PT 38 - Positive Rapid Test PT 50 - Positive Covid Test 3. Nine positive test results were not reported as required during the period of review. 4. The laboratory performed 50 SARS-CoV-2 tests during the period of review. 5. On 06/06/2022 at 10:00 am, an email was sent to the Woodridge Lemont 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 Lab Director (LD), Office Receptionist 1 (OR 1), and Testing Personnel (TP 1), the laboratory failed to provide training documentation for performing SARS-CoV-2 testing following manufacturers' instructions for four of four testing personnel. Findings Include: 1. On 05/25/2022 at 12:00 pm, interview with Office Receptionist 1 (OR 1) revealed a total of four laboratory Testing Personnel (TP) at the Woodridge Clinic Lemont. 2. On 05/25/2022 at 12:15 pm, direct observation revealed one SARS-CoV-2 test kit in use: Celltrion DiaTrust COVID - 19 Ag Rapid Test 3. Review of the Celltrion DiaTrust COVID - 19 Ag Rapid Test 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 labeling. 4. The laboratory failed to provide training documentation of the Celltrion DiaTrust COVID - 19 Ag Rapid Test for TP 1, TP 2, TP 3, and TP 4 upon request. 5. On 05/25/2022 at 12:15 pm, interview with the Lab Director and TP 1 confirmed the laboratory personnel did not have access to training documentation of the Celltrion DiaTrust COVID-19 Ag Rapid Test. 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 --