North Carolina Administrative Code
Title 10A - DEPARTMENT OF HEALTH AND HUMAN SERVICES
Chapter 41 - EPIDEMIOLOGY HEALTH
Subchapter A - COMMUNICABLE DISEASE CONTROL
41A .0107 - [Effective until 8/28/2021]REPORTING OF COVID-19 DIAGNOSTIC TEST RESULTS

Universal Citation: 10A NC Admin Code 41A .0107

41A .0107. [Effective until 8/28/2021]REPORTING OF COVID-19 DIAGNOSTIC TEST RESULTS

(a) For purposes of this Rule, the following definitions shall apply:

(1) "COVID-19 diagnostic test" means any nucleic acid or antigen test that identifies SARS-CoV-2, the virus that causes COVID-19.

(2) "Electronic laboratory reporting" means the automated messaging of laboratory reports sent to the Division of Public Health using a machine-readable electronic communication protocol.

(3) "Healthcare provider" means a healthcare provider as defined in G.S. 130A-476(g).

(4) "Laboratory" means a facility that performs testing on specimens obtained from humans for the purpose of providing information for health assessment and for the diagnosis, prevention, or treatment of disease and is certified by the United States Department of Health and Human Services under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) and implementing regulations. This definition includes a healthcare provider who performs testing in an on-site facility that meets these requirements.

(b) Each person in charge of a laboratory providing diagnostic service in this State shall report the results of all COVID-19 diagnostic tests to the Division of Public Health using electronic laboratory reporting. For purposes of COVID-19, a novel coronavirus under Rule .0101(c)(1) of this Section, the required method of reporting set out in Rules .0101(c) and .0102(d)(3) of this Section shall not apply. The report shall include all of the elements required to be reported under the United States Department of Health and Human Services, laboratory data reporting guidance, which is hereby incorporated by reference, including any subsequent amendments and editions, and available free of charge at https://www.hhs.gov/sites/default/files/covid-19-laboratory-data-reporting-guidance.pdf.

(c) The requirements set forth in Paragraph (b) of this Rule shall be considered met if a laboratory:

(1) submits a COVID-19 Laboratory Data Automation Registration form to the Division of Public Health and acts to onboard to electronic laboratory reporting. This form shall be submitted within seven calendar days of the date the laboratory starts performing COVID-19 diagnostic testing and shall contain the following elements:

(A) the name, address, phone number, and CLIA number of the laboratory;

(B) the name, address, and phone number of the person in charge of the laboratory or that person's designee;

(C) the type of test performed, testing capacity, and whether the laboratory will use a third-party laboratory to perform part or all of the testing; and

(D) if the laboratory will use a third-party laboratory to perform part or all of the testing, the information in Subparagraphs (c)(1)(A)-(B) for the third-party laboratory; and

(2) until onboarding to electronic laboratory reporting is complete:

(A) reports the results of positive COVID-19 diagnostic tests to the Division of Public Health, including all elements required in Paragraph (b) of this Rule, by telefax; and

(B) reports the aggregate number of positive and negative nucleic acid COVID-19 diagnostic tests and the aggregate number of positive and negative antigen COVID-19 diagnostic tests per day to the Division of Public Health through an online survey available at: https://files.nc.gov/covid/documents/eCATR-Reference-Guide.pdf.

(d) The requirements set forth in Paragraph (b) of this Rule shall be considered met if a laboratory that completes fewer than 50 total COVID-19 diagnostic tests per week submits results as set out in Subparagraph (c)(2) of this Rule.

(e) Healthcare providers who order COVID-19 diagnostic testing in this State shall:

(1) report the results of positive COVID-19 diagnostic tests by telefax to the local health director in the county or district where the patient resides. The report shall contain:

(A) patient first and last name, date of birth, address, county of residence, phone number, sex, race, and ethnicity;

(B) provider name, address, phone number, and NPI;

(C) the specimen collection date, the test order date, and the test result date;

(D) the test result; and

(E) all other available elements required in Paragraph (b) of this Rule; and

(2) report the aggregate number of positive and negative nucleic acid COVID-19 diagnostic tests and the aggregate number of positive and negative antigen COVID-19 diagnostic tests per day to the Division of Public Health through an online survey.

(f) The requirements set forth in Paragraph (e) of this Rule shall be considered met if a healthcare provider:

(1) verifies that the laboratory that receives the specimen for testing will report the test result in accordance with Paragraph (b) of this Rule; and

(2) includes patient first and last name, date of birth, address, county of residence, phone number, sex, race, ethnicity, and specimen collection date on the lab order.

(g) The requirement for healthcare providers to report COVID-19 diagnostic test results, as set out in Paragraph (e) of this Rule, is separate from the requirement for physicians to report suspected infections of COVID-19, a novel coronavirus, including positive COVID-19 diagnostic test results, in accordance with G.S. 130A-135 and Rules .0101(a) and .0102(a) of this Section.

(h) Laboratories and healthcare providers who are required to report under this Rule shall report positive COVID-19 diagnostic test results immediately upon receiving the result and negative COVID-19 diagnostic test results within 24 hours of receiving the result. Results reported to a local health department under this Rule shall be forwarded to the Division of Public Health within 24 hours of receipt by the local health department.

(Authority G.S. 130A-134; 130A-135; 130A-139; 130A-141; 130A-141.1; S.L. 2020-4, s. 4.10(a)(1); P.L. 100-578; 42 C.F.R. 493;
Emergency Adoption by North Carolina Register Volume 35, Issue 08, October 15, 2020 effective September 25, 2020. Temporary Adopted by North Carolina Register Volume 35, Issue 12, December 15, 2020 effective December 1, 2020.)
Disclaimer: These regulations may not be the most recent version. North Carolina may have more current or accurate information. We make no warranties or guarantees about the accuracy, completeness, or adequacy of the information contained on this site or the information linked to on the state site. Please check official sources.