Last Updated: Sep 10, 2019
One of the biggest 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 Act 112
In response to physician concerns about Act 112, the Pennsylvania Medical Society (PAMED) has recently taken these steps:
- On Sept. 3, 2019, we reached out to the Pa. Department of State via letter, requesting a meeting to discuss implementation of the Patient Test Results Information Act. According to recently issued DOH guidance on Act 112 (see below for more details on DOH guidance on Act 112 compliance), any Act 112-related complaints against entities not licensed by DOH will be referred to the appropriate state licensure board for investigation and enforcement. In our letter, we asked to meet with the Department of State to gain a better understanding of how it will enforce Act 112 and establish procedures for handling complaints.
- PAMED is currently advocating with lawmakers with the goal of amending Act 112. 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 amendments to the law to take into consideration the need for clarity, clinical relevance, and what is in the best interest of patients.
DOH Guidance on Act 112 Compliance
DOH has issued clarifying guidance on Act 112 implementation and compliance. 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.
PAMED Resources on Act 112
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.