Village Internal Medicine

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 review of manufacturers' instructions and interview with staff (Nurse #1) 9 /23/21, the laboratory failed to follow manufacturer's instructions for the SARS-CoV- 2 testing performed to ensure authorized Fact Sheets for patients and providers were included with SARS-CoV-2 test reports. The laboratory began using the CareStart COVID-19 Antigen Test on 5/6/21, and currently uses the Quidel QuickVue SARS Antigen Test for SARS-CoV-2. Manufacturer's instructions for the CareStart COVID- 19 Antigen Test state on page 2 "Conditions of Authorization for Laboratory ... Authorized laboratories using your product must include with test result reports, all authorized Fact Sheets. ..." Manufacturer's instructions for the Quidel QuickVue SARS Antigen Test state on pages 7-8 "Conditions of Authorization for the Laboratory and Patient Care Settings...Authorized laboratories using your product must include with test result reports, all authorized Fact Sheets. ..." Interview with Nurse #1 at approximately 11:00 a.m. confirmed the laboratory does not provide the authorized Fact Sheets to patients and providers with the SARS-CoV-2 test result reports. She stated they were unaware that Fact Sheets should be provided to patients and providers. D3031 RETENTION REQUIREMENTS 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 Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 5 -- 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 2019, 2020, and 2021 hematology quality control (QC) records and testing personnel (TP #1) interview 9/23/21, the laboratory failed to retain hematology QC assay sheets for at least two years. Findings: Review of hematology QC records revealed the following EIGHTCHECK-3WP X-TRA QC assay sheets were not retained for at least two years: a. Lot #00840710, 00840711, 00840712 - expiration 7/1/20 b. Lot #03360710, 03360711. 03360712 - expiration 3/10/21 Exit interview with TP #1 at approximately 2:30 p.m. confirmed the laboratory failed to retain the QC assay sheets. D5211 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(a) The laboratory must review and evaluate the results obtained on proficiency testing performed as specified in subpart H of this part. This STANDARD is not met as evidenced by: Based on review of the laboratory's policies and procedures, review of 2019, 2020, and 2021 API (American Proficiency Institute) proficiency testing records, and interview with testing personnel (TP #1) 9/23/21, the laboratory failed to document review and evaluation of all proficiency testing results received for 3 of 18 proficiency testing events. Findings: The laboratory's "PROFICIENCY TESTING PROCEDURE" states "... TEST GRADES: Test grades are provided by API. Printout results and provide to the Laboratory Director to review and sign. Follow the

Summary Statement of Deficiencies D2009 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(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 2017 and 2018 American Proficiency Institute (API) proficiency testing (PT) records, and testing personnel (TP) interview 08/02/18, the laboratory director and/or testing personnel failed to sign attestation statements for laboratory PT testing performed. Review of 2017 and 2018 API PT records the laboratory director and/or testing personnel failed to sign attestation statements for the following API PT events in which the laboratory participated. 1. API 2017 Chemistry Miscellaneous 2nd Event, laboratory director failed to sign attestation statement. 2. API 2018 Chemistry Core 2nd Event, laboratory director and testing personnel failed to sign attestation statement. 3. API 2018 Hematology/Coagulation 1st Event, laboratory director and testing personnel failed to sign attestation statement. 4. API 2018 Hematology /Coagulation 2nd Event, laboratory director and testing personnel failed to sign attestation statement. Interview with TP #1 at approximately 12:20 p.m. confirmed testing personnel and/or laboratory director failed to sign attestation statements for all API testing events in which the laboratory participated. D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) The procedure manual must include the following when applicable to the test procedure: (1) Requirements for patient preparation; specimen collection, labeling, storage, preservation, transportation, processing, and referral; and criteria for specimen acceptability and rejection as described in 493.1242. (2) Microscopic Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 4 -- examination, including the detection of inadequately prepared slides. (3) Step-by-step performance of the procedure, including test calculations and interpretation of results. (4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other materials used in testing. (5) Calibration and calibration verification procedures. (6) The reportable range for test results for the test system as established or verified in 493.1253. (7) Control procedures. (8)