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October 15, 2021 - Standing Order for COVID-19 Testing - Rescission of February 2, 2021 Order
Pursuant to the authority contained in the Michigan Public Health Code, Act 368 of 1978, MCL 333.1101 et seq, including Executive Reorganization Order 2016-4, MCL 333.26369, and consistent with the epidemic order under MCL 333.2253 issued by Director Hertel, I, Natasha Bagdasarian, MD, MPH, Chief Medical Executive for the State of Michigan, hereby issue the following Standing Order authorizing individuals to administer COVID-19 testing in the State of Michigan (Order):
The purpose of this Order is to authorize qualified persons to administer certain COVID-19 tests to individuals in the State of Michigan. This Order is intended to provide authorization for COVID-19 testing that is not otherwise approved. This Order supplements and does not supplant any existing authorization for testing. This Order allows administration of testing for SARS-CoV-2, the virus that causes COVID-19, subject to the terms set forth below. This Order does not create a physician-patient relationship between the undersigned Chief Medical Executive and any individual, nor is it intended to replace an existing relationship that an individual may already have with their treating provider(s).
2. Legal Authority
Michigan law imposes on the Michigan Department of Health and Human Services (MDHHS) a duty to continually and diligently endeavor to "prevent disease, prolong life, and promote the public health," and gives the Department "general supervision of the interests of the health and life of the people of this state." MCL 333.2221(1), (2)(a). MDHHS may "[e]xercise authority and promulgate rules to safeguard properly the public health; to prevent the spread of diseases and the existence of sources of contamination; and to implement and carry out the powers and duties vested by law in the department." MCL 333.2226(d). The Chief Medical Executive is required to "assist in the development and implementation of the Department's public health mission and values to protect, promote, and preserve the health of Michigan residents." MCL 333.26369. Further, on February 2, 2021, MDHHS Director Elizabeth Hertel issued an epidemic order under MCL 333.2253 authorizing the Chief Medical Executive to issue standing orders for certain COVID-19 tests.
This Order authorizes any person appropriately trained to administer a COVID-19 test to collect and process or to submit for laboratory analysis specimens to be tested for any individual in accordance with the conditions of this Order. This Order further authorizes the laboratory to provide test results directly to the individual who was tested for COVID-19.
4. Testing Procedure
A person administering a COVID-19 test pursuant to this Order must:
1. Evaluate individuals for symptoms of COVID-19 consistent with testing workflows from MDHHS, or, where such workflow is unavailable, the Centers for Disease Control and Prevention.
2. Provide Testing Information/Fact Sheet(s).
3. Offer opportunity for questions.
4. Ensure consent for testing has been obtained.
5. Administer the test pursuant to the manufacturer instructions.
6. Document the following:
a. Date, time, and location of test;
b. Name, title, and professional license number (if applicable) of person administering the test or of individual ordering test;
c. Name of test and manufacturer lot and number;
d. Results of the test;
e. Presenting symptoms, if any;
f. Verification of signed consent form.
7. Notify individual of test results.
8. Submit required data and test results to MDHHS and applicable local health department. Promptly input information into the Michigan Disease Surveillance System (MDSS) via the secure online portal.
9. In the event of a positive test result, immediately notify the designated point of contact at the local health department for contact tracing to begin and appropriate control measures to be established pursuant to the applicable state and local epidemic orders. If applicable, notify ordering provider of positive test result.
This Order authorizes administration of all CLIA-waived, FDA-authorized SARS-CoV-2 tests,including tests which have received emergency use authorization for COVID-19 to beadministered to individuals in the State of Michigan.
6.Rescission of Order
The February 2, 2021, order entitled "Standing Order for COVID-19 Testing" is rescinded as ofthe effective date of this Order. Nothing in this Order shall be construed to affect anyprosecution or enforcement based on conduct that occurred before the effective date of thisOrder.
This order takes effect immediately and remains in effect until rescinded.
Date: October 15, 2021
Natasha Bagdasarian, MD, MPH
Chief Medical Executive