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December 21, 2020

The Pennsylvania Department of Health, 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 the Department of Health. 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 healthcare practitioner.

The Department of State is responsible for licensing healthcare 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 healthcare practitioner licensed by the Department of State may also be the holder of a clinical lab permit from the Department of Health. In some of those instances, the ability to order and administer tests is within the licensed practitioner’s scope of practice as determined by the Department of State, while in others it may not be within the scope.

With the recent increase in COVID-19 cases, access to testing is imperative. Testing plays a key role in the Commonwealth’s ongoing efforts to contain and mitigate the pandemic by identifying COVID- positive individuals to help prevent further transmission of the virus. It is also important for licensed healthcare practitioners to have the ability to test their patients prior to performing elective and non-elective procedures, should they so choose.

For these reasons, and to eliminate any uncertainty during the pandemic, the Department of State requested, and the Governor approved, that the following Pennsylvania-licensed practitioners be authorized to order and administer COVID-19 tests for the duration of the emergency declaration and an additional 90 days IF they have been issued a clinical lab permit from the Pennsylvania Department of Health to conduct diagnostic lab testing:

  • Chiropractors
  • Dentists
  • Optometrists
  • Pharmacists
  • Podiatrists

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.

Licensees may also wish to refer to the following previously released waivers that address scope-of-practice in the context of COVID-19:

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