Summary:
Summary Statement of Deficiencies D0000 An Initial survey was performed at Nanopin Technologies, INC., CLIA # 19D2217087, on March 17, 2022. Nanopin Technologies, INC. was found not in compliance with the following CONDITION LEVEL DEFICIENCIES: 42 CFR 493.1205 CONDITION: Virology 42 CFR 493.1441 CONDITION: Laboratories performing high complexity testing; Laboratory Director 42 CFR 493.1447 CONDITION: Laboratories performing high complexity testing; Technical Supervisor D5010 VIROLOGY CFR(s): 493.1205 If the laboratory provides services in the subspecialty of Virology, the laboratory must meet the requirements specified in 493.1230 through 493.1256, 493.1265, and 493. 1281 through 493.1299. This CONDITION is not met as evidenced by: Based on observation by surveyor, review of laboratory's policies, validation studies, patient final test reports, and interview with personnel, the laboratory failed to ensure the quality of testing in the specialty of Virology. Findings: 1. The laboratory failed to ensure complete detailed written instructions for providers to maintain integrity of samples were established. Refer to D5317. 2. The laboratory failed to establish a complete policy and procedure manual. Refer to D5401. 3. The laboratory failed to establish complete policies and procedures. Refer to D5403. 4. The laboratory failed to establish complete performance specifications for SARS COV-2 testing. Refer to D5423 I. 5. The laboratory failed to establish specimen stability for SARS COV-2 testing. Refer to D5423 II. 6. The laboratory failed to include on the final report for non-FDA approved tests a disclaimer indicating the test hae not been cleared or approved by the U.S. Food and Drug Administration (FDA). Refer to D5805. D5317 SPECIMEN SUBMISSION, HANDLING, AND REFERRAL CFR(s): 493.1242(d) Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 14 -- If the laboratory accepts a referral specimen, written instructions must be available to the laboratory's clients and must include, as appropriate, the information specified in paragraphs (a)(1) through (a)(7) of this section. This STANDARD is not met as evidenced by: Based on review of the laboratory's instructions for collection and interview with personnel, the laboratory failed to ensure complete detailed written instructions for providers to maintain integrity of samples were established. Findings: 1. In interview on March 17, 2022 at 9:37 am, the Testing Personnel stated the laboratory is involved in a pilot program where patients come to the laboratory for a collection packet, self- collect their sample while onsite in their office or building's bathroom, and return the sample to the lab. The Testing Personnel stated patients are given written instructions of how to collect the sample. 2. Review of the "How to Collect an Anterior Nasal Swab Specimen for COVID-19 Testing" instructions revealed the following information was not included: a) Specimen storage and preservation b) Specimen acceptability and rejection 3. In further interview on March 17, 2022 at 9:37 am, the Testing Personnel confirmed the written instructions given to patients (providers) did not include the identified information. D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) A written procedures manual for all tests, assays, and examinations performed by the laboratory must be available to, and followed by, laboratory personnel. Textbooks may supplement but not replace the laboratory's written procedures for testing or examining specimens. This STANDARD is not met as evidenced by: Based on review of the laboratory's procedures and interview with personnel, the laboratory failed to establish a complete policy and procedure manual. Findings: 1. Review of the laboratory's procedures revealed the laboratory did not have written policies and procedures that included the following: a) Performance specification: detailed procedures for performing accuracy and precision (day-to-day, run-to-run, and within-run, as well as, operator variance), reportable and reference range, sensitivity and specificity studies and actions to take when data from the studies fail to meet acceptability criteria b) Complaint Investigations to include how to address, document, and handle complaints or problems reported to the laboratory c) Communication to include system to identify and document problems with breakdown in communication d) Reporting of SARS COV-2 test results to state public health agency, to include, but not limited to who is responsible, and frequency of reporting to the state. 2. In interview on March 17, 2022 at 11:30 am, the Testing Personnel stated the policies in their binder were all the ones they had. The Testing Personnel confirmed the laboratory did not include the identified policies in their manual. 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 -- 2 of 14 -- specimen acceptability and rejection as described in 493.1242. (2) Microscopic 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)