Last Updated: Dec 22, 2020
On Dec. 21, 2020, the Pennsylvania Department of State (DOS) issued a regulatory waiver, approved by Governor Wolf, that authorizes the following Pennsylvania-licensed practitioners to order and administer COVID-19 tests for the duration of the current emergency declaration and an additional 90-days:
This waiver only applies if the practitioner has been issued a clinical lab permit from the Pennsylvania Department of Health (DOH) to conduct diagnostic lab testing. Otherwise, all ordering and administration of COVID-19 tests would occur through the existing rules that allow other practitioners to perform functions, tasks and procedures delegated to them by a medical doctor or osteopathic physician in appropriate circumstances.
DOH, through its Bureau of Laboratories, regulates clinical labs throughout the Commonwealth. The Bureau's regulations establish various requirements and quality assurance standards which clinical labs must meet. No one may operate a clinical lab in Pennsylvania without first obtaining a permit from DOH. In addition to having a permit, clinical labs may only accept and collect specimens from patients for testing if the tests were ordered by a licensed health care practitioner.
DOS is responsible for licensing health care practitioners and defining the scope of each profession's practice as established by each boards' governing statutes or "practice acts." There are instances where a health care practitioner licensed by DOS may also be the holder of a clinical lab permit from DOH. In some of those instances, the ability to order and administer tests is within the licensed practitioner's scope of practice as determined by DOS, while in others it may not be within the scope.
The full waiver can be accessed here.
While PAMED understands this waiver was issued with the current pandemic in mind, PAMED believes that the ordering and administration of these tests should rest with physicians to ensure continuity of care.