Pennsylvania Act 112 – Imaging Entities Now Required to Report to Patients on “Significant Abnormalities”

The Patient Test Result Information Act – commonly referred to as Act 112 – now requires Pennsylvania imaging entities to directly communicate with patients if the entity finds “significant abnormalities” in the patient’s test results, as well as to continue to follow normal reporting procedure to inform the ordering physician. The catalyst for this legislation, signed by PA Governor Tom Wolf on October 24, 2018, was the perceived risk that the increased workload of health care providers increases the prospects that test results may be overlooked or misread. PA State Representative Marguerite Quinn, who introduced the bill, expressed worry over “two situations in which abnormal test results were not communicated to the patient, resulting in the unnecessary death of both people” in a February 20, 2015 memo. These circumstances caused her to press for better communication between imaging centers and any person who receives outpatient diagnostic imaging services.

A “significant abnormality” is defined by the Pennsylvania Medical Society (PAMED) as “a finding by a diagnostic imaging service of an abnormality which would cause a reasonably prudent person to seek additional or follow-up medical care within three months.”

Act 112 became effective on December 23, 2018 and will require imaging entities who provide outpatient services to notify their patients within 20 days of the date their results were sent to the ordering physician. The notification does not need to include a copy of the test results, but does need to include certain information, described below:

• The name of the ordering practitioner
• The date the test was performed
• The date the results were sent to the ordering practitioner
• The following statements:
  • You are receiving this notice as a result of a determination by your diagnostic imaging service that further discussions of your test results are warranted and would be beneficial for you.
  • The complete results of your test or tests have been or will be sent to the health care practitioner that ordered the test or tests. It is recommended that you contact your health care practitioner to discuss your results as soon as possible.
• The contact information needed for the patient to obtain a full report of the results

PAMED, together with the Hospital and Healthsystem Association of Pennsylvania (HAP), reached out to the Pennsylvania Department of Health (DOH) via a joint letter requesting that the DOH delay issuing sanctions under this law to permit additional time for the State to provide educational support regarding Act 112’s requirements. The DOH accepted the recommendation and will be moving forward with the formulation of educational services in the near future.

An important consideration: imaging centers and other entities who will be affected by Act 112 are still required to comply with the Act beginning December 23, 2018. The DOH’s decision does not preclude implementation of the law’s effect in so far as the Agency only has authority to decide on what sanctions, if any, to apply to violators. Any and all entities who provide outpatient diagnostic imaging services should ensure their policies comply with the requirements of Act 112 beginning December 23 in order to avoid any unnecessary complications.

However, there are some exceptions to Act 112, which include:

• Routine obstetrical ultrasounds used to monitor the development of a fetus
• Diagnostic imaging services performed on a patient who is being treated on an inpatient basis or in an emergency room
• Diagnostic radiographs

The broader question is whether other States will elect to adopt legislation similar to the Patient Test Result Information Act. The Health Law Partners will continue to monitor these developments.

For more information regarding the Patient Test Result Information Act, please contact Carey Kalmowitz, Esq. or Adrienne Dresevic, Esq.