Last Updated: Dec 5, 2019
One of the regulatory issues on the minds of many Pennsylvania physicians involves the Patient Test Results Information Act and how the state plans to enforce compliance with the new law.
The law – known as Act 112 of 2018 – requires entities performing a diagnostic imaging service to directly notify the patient or patient’s designee when, in the judgment of the entity performing the test, a significant abnormality may exist.
Although Act 112 took effect on Dec. 23, 2018, the Pa. Department of Health (DOH) delayed enforcement of the law for one year to allow time for facilities to develop policies to address the new law. Enforcement will begin on Dec. 23, 2019.
PAMED Advocacy for Physicians on the Patient Test Results Law
At PAMED’s 2019 House of Delegates, physician and medical student delegates approved policy directing PAMED to work with specialty organizations with the goal of amending the Patient Test Results law. We believe that using the term “significant abnormality” to trigger patient notification is problematic because a significant abnormality is difficult, if not impossible, to define and may ultimately cause confusion for patients. We are pursuing changes that take into consideration the need for clarity, clinical relevance, and what is in the best interest of patients.
PAMED is part of a coalition of stakeholder organizations, including the Pennsylvania Chapter of the American College of Cardiology, that worked with legislators to draft amendments to the Patient Test Results law. On Dec. 2, 2019, that bill – House Bill 2103 – was introduced in the Pa. House by Rep. Barry Jozwiak. The legislation has been referred to the House Health Committee.
House Bill 2103 proposes to remove the “significant abnormality” language included in the current law. The bill would require the entity performing the diagnostic imaging service to provide written notice directly to the patient or patient’s designee at the time of service that the entity will complete a review of the test performed on the patient and will send the results to the practitioner who ordered the service.
DOH Guidance on Complying with Current Law
DOH has issued clarifying guidance on implementation and compliance for the Patient Test Result Information Act. Licensed facilities will need to establish a policy addressing requirements of the law. The policy must include:
- How and when patients will be notified if a significant abnormality is identified on a diagnostic test;
- What information must be provided in the notification; and
- What services the facility offers that fall within the Act’s definition of “diagnostic imaging services.”
DOH will also require a licensed facility’s policies to verify that a patient’s test result notification will contain each of the following items:
- The name of the ordering health care practitioner
- The date the test was performed
- The date the results were sent to the ordering health care practitioner
For entities that are not required to be licensed per the state’s Health Care Facilities Act, DOH will refer any Act 112-related complaints to the appropriate agency, including the Pa. Department of State’s licensing boards.
Read DOH’s clarifying guidance as well as answers to FAQs here.
We offer a Quick Consult fact sheet with additional information on the patient test results law. You’ll find details such as what is required to be in the notice, exceptions under the law, and acceptable methods of communication to the patient. Get the fact sheet.
PAMED members with questions can also contact our Knowledge Center at 855-PAMED4U (855-726-3348) or KnowledgeCenter@pamedsoc.org.