Adverse Event Letter: What Is It and What Is Its Significance?

You get a telephone call or email from a potential client advising that he or she or a family member was in the hospital recently and a problem occurred in the course of his or her medical care causing injury or death. You are advised that shortly after the event he or she was given a letter from a hospital representative expressing the hospital’s concern for what happened and briefly discussing the event. The client or family member has now contacted you about looking into a medical negligence case in the matter. The letter that was provided by the hospital is very likely what is commonly referred to as an “adverse event letter.” It is a very strong indicator that there is a medical negligence case that should be investigated.

MCARE Act and Pennsylvania Patient Safety Authority

In March 2002, the Pennsylvania Legislature enacted the Medical Care Availability and Reduction of Error Act, P.L. 154, No. 13 of 2002. As part of this new law, the legislature created the Pennsylvania Patient Safety Authority. The Patient Safety Authority was created to help Pennsylvania medical facilities (hospitals, ambulatory surgical facilities, birthing centers, abortion facilities and nursing homes) to reduce medical errors and the resulting harm to patients. A provision of Act 13 set forth that health care facilities in Pennsylvania were required to report to the Patient Safety Authority all adverse events resulting in patient harm as well as all “near misses” in which the patient was not harmed. Where a patient is harmed, the event is termed a “serious event.” Act 13 defines a serious event as “an event, occurrence or situation involving the clinical care of a patient in a medical facility that results in death or compromises patient safety and results in an unanticipated injury requiring the delivery of additional health care services to the patient.” A near miss or “incident” was defined as “any event, occurrence or situation involving the clinical care of the patient in a medical facility which could have injured the patient but did not either cause an anticipated injury or require the delivery of additional health care services to the patient.” A provision of Act 13, Section 308, mandated that medical facilities in Pennsylvania are also required to notify in writing a patient or his or her family of a “serious event.” Hence, a medical facility is required under the MCARE Act to notify its patient when a serious event occurs. It is important to note that not all letters received by a patient from a medical facility about events occurring during an admission is an adverse event letter. Starting in 2009, Pennsylvania medical facilities are required to notify in writing patients who develop a medical facility-acquired infection. While this occurrence can certainly be a basis for a medical negligence case, in most instances involving a facility-acquired infection, it is usually difficult to prove negligence.