Purpose

In April 2004 the New Jersey Legislature enacted the Patient Safety Act, N.J.S.A. 26:2H-12.23-25, in response to their finding that “health care literature demonstrates that the great majority of medical errors result from system problems, not individual incompetence” and that preventable errors were “inherent in all systems”. The Legislature’s goal was to create a system that would allow for the detection and analysis of medical errors while creating a “non-punitive culture that focuses on improving health care, not assigning blame.” While finding that health care facilities and professionals must be held accountable for “serious preventable adverse events” the Legislature also recognized that “punitive environments … may be a deterrent to the exchange of information required to reduce the opportunity for errors to occur in the complex systems of health care delivery.”

Therefore by mandating the “confidential disclosure of the most serious, preventable adverse events” and also encouraging the “voluntary, anonymous and confidential disclosure of less serious adverse events, as well as preventable events and near misses the State seeks to increase the amount of information on system failures, analyze the sources of these failures and disseminate information on effective practices for reducing system failures and improving the safety of patients.” Sec. 12.24.

Patient Safety Plan

The Act requires health care facilities to create a “patient safety plan” which includes the formation of a committee and teams of facility staff, “comprised of personnel who are representative of the facility’s various disciplines” and who are competent “to conduct analysis and application of evidence based patient safety practices in order to reduce the probability of adverse events resulting from exposure to the health care system across a range of diseases and procedures, and … to conduct analyses of near-misses, with particular attention to serious preventable adverse events and adverse events.” Sec. 12.25 (b) (3). The law requires health care facilities to report “every serious preventable adverse event that occurs in that facility” to the N.J. Dept. of Health and also to assure that the patient is informed. Sec. 12.25 (c,d). The law also requires the health care facility to create a process for ongoing patient safety training for facility personnel.

Definitions
An event means a “discrete, auditable and clearly defined occurrence.”

A near miss is an “occurrence that could have resulted in an adverse event but the adverse event was prevented.”

An adverse event is “an event that is a negative consequence of care that results in unintended injury or illness, which may or may not have been preventable.” 

A preventable event is “an event that could have been anticipated and prepared against but occurs because of an error or other system failure.”

A serious preventable adverse event is defined as “an adverse event that is a preventable event and results in death of loss of a body part, or disability or loss or bodily function lasting more than seven days or still present at the time of discharge from the health care facility.”

Health care facility is one licensed by the State of New Jersey. Sec. 12.25 (a).

Duty to tell the patient

Of even greater concern to health care providers is the 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.” 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. Sec.12.25(d). As of May 2006 final regulations had not been issued.

Limited use in other settings

The Act 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.”

Sec. 12. 25 (f) (3).

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

What events must be reported to the patient?

Any “serious preventable adverse event” or “adverse event related to an allergic reaction” as defined above. These must also be reported to the health care facility.

Who must be told?

Generally, the adult patient must be informed. However, in the case of a minor or incapacitated patient the patient’s 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. 

When must the patient be told?

During the episode of care, or if discovered after the episode, in a “timely fashion.”

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. Therefore, if the healthcare provider(s) involved in the event does not inform the patient or their family then a hospital administrator will have to do so.

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.

Moreover, the patient and/or their family may expect you to accept responsibility. 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 answer questions from the patient or family directly, to the extent possible, and to explain any steps taken to prevent a reoccurrence of the event.   

What must the patient or their family be told?

The final regulations to be issued by the Dept. of Health have not yet been completed.  However, it is anticipated that informing the patient will involve disclosure of the event, the cause(s) to the extent known at the time the event is discovered, the identity of the person(s) involved and the health consequences which resulted, or are likely to result, from the reportable event. Consult your facility’s procedure regarding its own requirements. Most hospitals have already created procedures for this situation.   

What must I document in the chart?

The same information provided to the patient verbally. In addition, the date, time, persons present for the notification and the contents of the notification should be documented. 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.

Will telling the patient about such an event increase the chances of a lawsuit?

It may. However, failing to tell them may well increase the chances of a lawsuit even more. In most “serious preventable adverse events” or “adverse events related to an allergic reaction”, the patient and their family members are already aware that something serious has occurred and will understandably have questions about it. Studies have shown that patients who feel their healthcare providers are hiding information from them, or worse yet misleading them, are highly motivated to seek counsel and use the court system to try to find the answers they feel their health care provider failed to give them.

In contrast, some patients who receive an honest explanation of the occurrence from their healthcare provider do not sue, even though they may have a legitimate claim, because they recognize errors can and do occur and they continue to trust health care providers who are honest with them. In fact there is evidence to suggest an honest explanation and apology actually decreases the likelihood of a lawsuit. See www.SorryWorks.net for further information. Patients are also interested in efforts to prevent future such events.

Can my statements and documentation be used against me?

The law specifically states that the information given by the provider/facility to the patient and/or State is not to be admissible in a civil or criminal action. Patients’ attorneys are not allowed to obtain the documents unless a judge finds the patient cannot obtain the facts through the ordinary pre-trial discovery process and that the need for this information outweighs the public interest in the candid, confidential evaluations necessary to improve the health care system.  Disclosure may also be allowed if the facility seeks to terminate, or is sued for failing to supervise or terminate, a provider who displayed “recklessness, gross negligence or willful misconduct” or a “pattern of significant substandard performance resulting in serious preventable adverse events.”

Moreover, if the health care provider gives the patient an explanation at the time of the event, but later gives a different explanation in court, the patient’s attorney may argue that the original explanation should be put before the jury to discredit the explanation the provider is now giving the jury. No court has yet ruled on such arguments. Therefore, providers should be careful when explaining the perceived cause of the event in the hours or days after it occurs. Experience has shown that subsequent detailed analysis, such as that in peer review, root cause analysis or litigation, may reveal a different cause of the event than was perceived when the event occurred. It would be wise to explain and document that the cause stated to the patient is based on a preliminary investigation.

Are there any penalties for failure to disclose this information?

Yes. The health care facility is subject to a $10,000 fine for violations of this law. Even if the patient somehow does not know about the event, the JCAHO reviews charts and may well discover the incident. If there is no documentation that the patient or their family has been informed of a “serious preventable adverse event” or “adverse event related to an allergic reaction” the health care facility will likely be fined. This may provoke the health care facility to fine, suspend or even terminate the employment or privileges of a health care provider who failed to inform the facility of such an event.

Must I also report less serious incidents to my health care facility?

The Act requires the reporting of “serious preventable adverse events” and “adverse events related to an adverse reaction” to the facility. It encourages the voluntary reporting of “near misses” and other “adverse events” to the facility for the purpose of discovering and repairing defects in the health care system. These voluntary reports of less serious events and near misses by the provider/facility to the State are subject to the same limitations on discovery and admissibility in court as the more serious events which must be reported to the facility, patient and State.

What should I document to help defend myself and my colleagues?

The American Society for Healthcare Risk Management suggests:

1) Clinical details. Following an event, a complete, accurate, factual description of the pertinent clinical information related to the event should always be entered in the medical record by the appropriate health care provider:

• Objective details of the event, including date, time and place;
• Patient’s condition immediately prior to the event;
• Medical intervention and response;
• Notification of physician and/or consultants.

2) All communication between the health care provider and the patient/family. Consult your facility’s requirements but this generally should include: 

• Time, date and place of discussion;
• Names and relationships of those present for the discussion;
• The contents of the discussion;
• Questions asked and responses given;
• Patient reaction and level of understanding exhibited by the patient/family;
• Any offer of assistance and the patient’s response to it;
• Note that additional information will be provided as it becomes available;
• Treatment alternatives, the risks and benefits of each as discussed with patient;
• Plan for further care and any follow up discussions;
• Avoid derisive comments about other providers and self serving statements.

Summary

The Patient Safety Act is the law in New Jersey. Health care providers must report to their facilities, and facilities must report to their patients and the State all “serious preventable adverse events” and “adverse events related to an allergic reaction” during the episode of care, or if discovered after the episode of care, in a timely fashion. Notification must be documented in the patient’s chart. Voluntary reporting of “near misses”, adverse events, and preventable events is encouraged to help detect and repair flaws in the health care system. There are limits on access to and use of this information.

Instead of viewing this law as a burden, try to recognize what may be your only opportunity to discuss the event with your patient and “set the record straight.” After a serious preventable adverse event or adverse event related to an allergic reaction the patient may feel wounded both physically and psychologically by their health care provider. A candid discussion may start the patient on the road to recovery and may also begin to repair the relationship between the patient and their health care provider. 

The foregoing is not to be construed as legal advice. Health care providers should familiarize themselves with the policies, procedures and requirements of their health care facilities for reporting and disclosing such events to their facility and patients. Health care providers are advised to consult a qualified attorney on the issues discussed herein.    

Risk Management Article #3 - Credentialing