December 18, 2018
New legislation requiring notification to patients about test results will take effect on December 23, 2018. Titled the Patient Test Result Information Act (“Act 112”), the law requires any entity that performs an outpatient diagnostic imaging service in which a significant abnormality may exist to directly notify the patient or their designee within 20 days. The full text of the Act can be accessed here.
Signed by Governor Wolf on October 24, 2018, the legislation was introduced out of a concern that healthcare providers face an increasing caseload, which thereby increases the chance that a test result will be read incorrectly or inadvertently overlooked. According to PA State Representative Marguerite Quinn, who introduced the bill, “I know of two situations in which abnormal test results were not communicated to the patient, resulting in the unnecessary death of both people.” See Marguerite Quinn, House Co-Sponsorship Memoranda (Feb. 20, 2015).
Act 112 does not require that the entity performing a diagnostic imaging service provide a copy of the written report to the patient, but delineates specific information to be conveyed. Notice to the patient must state:
(1) The name of the ordering health care practitioner.
(2) The date the test was performed.
(3) The date the results were sent to the ordering health care practitioner.
(4) 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 to 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.
(5) The contact information necessary for the patient to obtain a full report.
2018 Act 112
This notification must be transmitted to the patient no later than twenty (20) days after the information was provided to the ordering health care provider. The method of communication is also stated in the Act, and can include U.S. Mail, email, automatic alert from a medical record system, fax, or provided to the patient at the time of the test. If the abnormal result is conveyed in person, the patient must sign and acknowledge receipt of the information.
Exceptions to this notification requirement include routine obstetrical ultrasounds; diagnostic imaging performed on an inpatient, or emergency room patient; and diagnostic radiographs. Diagnostic radiograph is defined as an x-ray.
The statute attempts to define “significant abnormality” as “a finding by a diagnostic imaging service of an abnormality or anomaly which could cause a reasonably prudent person to seek additional or follow-up medical care within three months”. This is decidedly vague, which leaves some room for judgment and interpretation by both the entity and the practitioner.
Prior to the passage of Act 112, radiologists would typically notify the ordering physician of the results of a particular study. The physician, who has a relationship with the patient, would then review the study, and provide those results to the patient, in context. Act 112 now requires deviation from that communication flow and could cause patients to overreact or request unnecessary tests. Moreover, there is potential for discrepancy and perhaps confusion for a patient, where an entity considers an abnormality “significant”, but the treating physician does not. Similarly, Act 112 creates a risk of exposure where the healthcare provider considers a finding significant, and the diagnostic imaging service entity did not report to the patient.
Notably, if a physician orders a study, performs the imaging in their office, and reports the results to the patient, there is no need for separate communication.
Finally, it is a bit unclear how the law will be enforced. Act 112 sets forth compliance requirements but does not set forth penalties for failure to comply. Act 112 states that the Department of Health will conduct compliance reviews and establish a complaint procedure. However, the consequences of noncompliance are undefined. One concern is that Plaintiffs’ attorneys could attempt to use this new law to establish a negligence per se standard when the law is not followed, thereby potentially increasing liability exposures for both practitioners and entities offering such diagnostic services.
All entities providing diagnostic imaging services, including hospital outpatient centers and independent imaging centers need to ensure that mechanisms are in place to provide the required information to patients in the time period required.
Disclaimer: This post does not offer specific legal advice, nor does it create an attorney-client relationship. You should not reach any legal conclusions based on the information contained in this post without first seeking the advice of counsel.
About the Authors:
Donna Nadel Kramer is a Principal in the Firm’s Professional Liability Department and Medical Malpractice Defense Practice Group. Her practice focuses on the defense of physicians, nurses, hospitals, health systems, and other health care providers in litigation involving alleged malpractice and/or negligence. Her cases involve complex medical fact patterns, minor to catastrophic injuries, and often substantial financial exposure. Learn More.
Elizabeth M. Hein is an Associate in the Firm’s Health Care Practice Group, providing legal services to the Firm’s health care clients in litigation, regulatory and compliance matters. Her litigation practice includes assisting in the defense of complex commercial, regulatory and antitrust matters, medical staff litigation, and injunctive proceedings. Her health care consulting services include federal and state regulatory compliance, Fraud-and-Abuse and False Claims Act analysis and consultation, not-for-profit governance, licensing and accreditation, federal and state payment regulation, EMTALA, HIPAA, HITECH, HCQIA, and ACA statutory and regulatory compliance. Learn More.