Summary:
Summary Statement of Deficiencies 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: 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: Facility was sent a Cease and Desist Order (CDO) on September 3, 2020. The Laboratory Director was notified via phone and email on September 2, 2020. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 3 -- Complaints were received from Madison and Ocean County Health Department on September 25, 2020 that the facility was still testing and not reporting COVID 19 results to the State of NJ as per N.J.A.C. 8:57 Subchapter 1, reporting of cases (and their laboratory test results) for immediately reportable diseases is required within 24 hours of obtaining the result. Currently the CDRSS is the data repository of all communicable diseases (with the exception of HIV, TB and STDs) and is designed to accept electronic laboratory reporting (ELR) in the CDC-recommended, PHIN compliant format of Health Level 7 (HL7), utilizing LOINCs and SNOMED codes as applicable. Laboratories conducting testing for COVID-19 must report the test results using their existing or recently added reporting mechanism, whether that is via ELR using HL7 standard messaging protocol or entry of results directly into the CDRSS. The Laboratory sent evidence on September 29, 2020 COVID 19 testing was still being performed. a) Based on surveyor observation, review of records and interview with the Office Manager (OM) the Laboratory was testing patients with a CDO at the time of the survey . The findings include: 1. The Laboratory was using the Healgen COVID 19 IgG/IgM Rapid Test Cassette at the time of the survey. The Laboratory was directed to Cease and Desist testing at the time of the survey. 2. The Laboratory failed to report Healgen COVID 19 results to the State of NJ. 3. The Laboratory modified the sample type in the Information for Use (IFU) which stated serum, plasma or venous blood must be used, but the Laboratory used finger stick samples. 4. There was no documented evidence Performance Specifications were validated. 5. There was no documented evidence Quality Control (QC) was performed. 6. There was no documented evidence Testing Personnel (TP) were trained. TP stated four TP performed COVID 19 tests. 7. TP stated they test 400 patients a day for COVID 19. 8. COVID 19 results were not reported to the state of NJ as required per N.J.A.C. 8:57 Subchapter 1, which states reporting of cases (and their laboratory test results) for immediately reportable diseases is required within 24 hours of obtaining the result. 9. A review of the Laboratory Information revealed 1136 patients were tested during the CDO. 10. The OM confirmed at 10:40 am on 9/30/2020 that the laboratory was testing outside its CLIA certificate with a CDO. b) Based on surveyor observation of the Waived COVID 19 Antigen Test, Patient Results and interview with the Office Manager (OM), the laboratory failed to follow the IFU when they performed Quidel Sofia SARS Antigen FIA COVID 19 tests from June 2020 to the date of the survey. The findings include: The laboratory did not follow the IFU as below: 1. Sample collection and handling procedures require specific training" The Quidel Sofia SARS Antigen FIA IFU stated,"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" 2. Calibration is required every 30 days but there was no documented evidence it was performed. IFU stated, "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. " 3. "Authorized laboratories using your product will have a process in place for reporting test results to healthcare providers and relevant public health authorities, as appropriate," but COVID 19 results were not reported to NJ State as required by N.J.A.C. 8:57 Subchapter 1. 4. The OM confirmed at 11:00 am on 9/30/2020 that the laboratory did not follow IFU or CDO. c) Based on surveyor observation, review of records and interview with the OM the Laboratory was testing outside its Certificate Waiver at the time of the survey. The findings include: 1. The Laboratory had Throat Cultures (TC) plates labeled with patient names in the incubator. TC are Moderately Complexed tests. 2. There was no documentation of QC of the agar or bacitracin discs, selectivity or specificity of the agar. The Laboratory was directed to Cease and Desist testing at -- 2 of 3 -- the time of the survey. 3. There was no documented evidence TC Proficiency Testing was done. 4. The incubator temperature was out of range three days in September but there was no evidence of