Phytogenics Specialty Pharmacy

Summary Statement of Deficiencies D0000 An onsite complaint visit, #2021014174, conducted on 11/19/2021 at PHYTOGENICS SPECIALTY PHARMACY found the laboratory was not in compliance with 42 CFR 493, Requirements for Clinical Laboratories. D1000 CERTIFICATE OF WAIVER TESTS CFR(s): 493.15(c) Certificate of waiver tests. A laboratory may qualify for a certificate of waiver under section 353 of the PHS Act if it restricts the tests that it performs to one or more of the following tests or examinations (or additional tests added to this list as provided under paragraph (d) of this section) and no others: (1) Dipstick or Tablet Reagent Urinalysis (non-automated) for the following: (i) Bilirubin; (ii) Glucose; (iii) Hemoglobin; (iv) Ketone; (v) Leukocytes; (vi) Nitrite; (vii) pH; (viii) Protein; (ix) Specific gravity; and (x) Urobilinogen. (2) Fecal occult blood; (3) Ovulation tests-visual color comparison tests for human luteinizing hormone; (4) Urine pregnancy tests - visual color comparison tests; (5) Erythrocyte sedimentation rate-non-automated; (6) Hemoglobin- copper sulfate-non-automated; (7) Blood glucose by glucose monitoring devices cleared by the FDA specifically for home use; (8) Spun microhematocrit; and (9) Hemoglobin by single analyte instruments with self-contained or component features to perform specimen/reagent interaction, providing direct measurement and readout. This STANDARD is not met as evidenced by: Based on observation, record review and interview, the laboratory performed tests under their Certificate of Waiver that were not within the waived category. Findings include: -During the laboratory tour on 11/19/2021, the surveyor observed at 1:40 PM that there was a box of Biohit SARS-CoV-2 IgM/IgG ANTIBODY TEST KIT and a box of SARS-CoV-2 ANTIGEN RAPID TEST KIT, both from the Biohit Healthcare manufacturer. -Review of U.S. Food and Drug Administration (FDA) web site revealed: a) Biohit SARS-CoV-2 IgM/IgG antibody test kit had Emergency Use Authorization (EUA) and was classified as a moderate complexity test. b) SARS-CoV- 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 -- 2 ANTIGEN RAPID TEST KIT had no EUA, which makes this test to be classified as a High Complexity test. - Patient record review revealed the laboratory used: a) Biohit SARS-CoV-2 IgM/IgG ANTIBODY TEST KIT from 01/27/2021 to 08/27/2021 and performed 36 tests. b) SARS-CoV-2 ANTIGEN RAPID TEST KIT from 02/08/2021 to 08/27/2021 and performed 53 tests. During an interview on 11/19/2021 at 1:45 PM, the owner explained that she was not aware that the tests used were not under the category of waived tests, she stopped using them since August 2021. -- 2 of 2 --

Summary Statement of Deficiencies D0000 A remote special focused COVID 19 survey was conducted on 10/13/2021 at PHYTOGENICS SPECIALTY PHARMACY, a clinical laboratory. The laboratory was not in compliance with Code of Federal Regulations (CFR), Part 493, requirements of clinical laboratories. The following condition was cited: -D1002 REPORTING OF SARS-Co-V-2 TEST RESULTS. 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 a lack of reporting records and pharmacy office manager (POM) interview, the laboratory failed to report Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) test results to the Florida Department of Health (DOH) from 02/23 /2021 to 10/13/2021 for a total of 114 tests. Findings include: Review of the laboratory SARS-CoV-2 testing information sent by email on 10/01/2021 by the POM, revealed that the laboratory performed 42 tests with Biohit SARS-CoV-2 ANTIGEN RAPID TEST KIT and 72 tests with Biohit SARS-CoV-2 IgG/IgM ANTIBODY TEST KIT for a total of 114 tests. During an interview on 10/13/2021 at 2:00 PM, the POM explained that the pharmacy started testing on 02/23/2021 and that the laboratory hired a consultant for the SARS-CoV-2 testing, this consultant was fired in August 2021 and no testing was done after that date. The POM confirmed that the laboratory had no records of reporting to the DOH for the tests performed. 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 --