Duty to tell the patient- Of even greater concern to health care providers is the PSA requirement that every licensed health care facility inform every patient affected by a “serious preventable adverse event or adverse event specifically related to an allergic reaction, no later than the end of the episode of care, or, if discovery occurs after the end of the episode of care, in a timely fashion.” [17] The notification can be given to a family member if the notice would “seriously and adversely affect the patient’s health.” If an adult patient is not informed of a serious preventable adverse event or adverse event specifically related to an allergic reaction, the facility shall assure that the medical record states the reason for not informing the patient. Pursuant to the Act, “The time, date, participants and content of the notification shall be documented in the patient’s medical record.” The content of the notification shall be in accordance with the rules and regulations to be set forth by the Commissioner of the Department of Health and Senior Services. [17] Most facilities have policies in place regarding notification.

Use in other settings- The PSA provides that any documents “concerning serious preventable adverse events, near misses, preventable events and adverse events that are otherwise not subject to mandatory reporting pursuant to subsection c. of this section shall not be (1) subject to discovery or admissible as evidence or otherwise disclosed in any civil, criminal or administrative action or proceeding; (2) considered a public record.” Neither can this information be used in any “adverse employment action or in the evaluation of decisions made in relation to accreditation, certification, credentialing or licensing of an individual.”

However, this restriction does not apply where the health care provider has shown “recklessness, gross negligence or willful misconduct, or in which there is evidence, based on other similar cases known to the facility, of a pattern of significant substandard performance that resulted in serious preventable adverse events.”[18] In such cases the facility, professional boards or Attorney General may take disciplinary action. Moreover, no court has yet ruled on the conflicts between the provisions of the PSA and other law, for example, the general rule of evidence that one’s own statements may be used against them.[19] Therefore caution is advised when making oral or written statements regarding adverse events.

Frequently Asked Questions- Having received an overview of the Act’s provisions it may be helpful to address some of the questions frequently asked by healthcare providers who are uncertain of how this law may impact them:

What events must be reported under the PSA?

Any “serious preventable adverse event” or “adverse event related to an allergic reaction” as defined above. These must be reported by the doctor/provider to the facility and by the facility to the patient and N.J. Dept. of Health and Senior Services. [16]

Who must be told?

Generally, a competent adult patient must be informed. However, in the case of a minor or incapacitated patient their parent, guardian or family may be told. Moreover, if there is a “good faith” basis to believe that providing the information to the patient would seriously and adversely affect the patient’s health, then the patient’s family may be given the information instead.[17]

When must the patient be told?

During the episode of care, or if the event is discovered after the episode, in a “timely fashion.”[17]

Do I have to tell them myself?

Consult the procedure at your health care facility as to whether you are personally obligated to inform the patient. The facility is required by statute to “assure” that the patient is informed of all serious preventable adverse events or adverse events related to an allergic reaction.[20] Therefore, if a healthcare provider(s) does not inform the patient or their family, regardless of whether they were involved in the event, then a facility administrator will have to notify the patient or family.

However, as a practical matter, if you contributed to the adverse event it may be better for you to explain it than to entrust the explanation to a third party who may not even be a health care provider and/or may not fully understand what happened and why the event occurred. Asking a “risk manager” to speak for you may send the wrong message to the patient as it may suggest you are more concerned about protecting yourself and the facility than about helping your patient cope with the adverse event. Some facilities require the attending physician to notify the patient.

Moreover, the patient and/or their family may expect their doctor to inform them. Your absence or silence may increase their anger, frustration and desire to seek counsel. Even if you were not involved in the event itself it may be helpful to all concerned to have a trusted doctor or other health care professional present to help explain what happened, the likely impact on the patient’s health, the treatment options available and their prognosis. It is important to patients and families to answer questions directly, to the extent possible, and to explain any steps taken to prevent a reoccurrence of the event.[21]

What must the patient/ family and State be told?

The Dept. of Health and Senior Services creates and updates PSA guidelines for reports to the State. See the DHSS website www.state.nj.us/health and search “Patient Safety Initiative” for more information. Future regulations are anticipated under N.J. Admin. Code 8:43E-10. In Liguori [7], informed consent to continued care of the comatose patient required disclosure to the family about the cause, extent and care of her injury. Other information, such as the availability of treatment and monitoring to minimize risks of harm, may also be important to the patient,[22] and even necessary to meet informed consent/refusal requirements. Consult facility procedures and counsel for guidance on what patients or their families must be told in specific situations.

There are also helpful guidelines on what to say, and how to say it, when informing patients.[22]

What must I document in the chart?

Generally, the same information provided to the patient verbally. The date, time, persons present for the notification and the content of the notification should be documented.[17] If a competent adult patient is not notified then the reason(s) that the health care provider chose to inform the family instead of the patient must also be documented. [22]

Adverse Events, page 5