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

It may. However, failing to tell them may also increase the chances of a lawsuit. In most “serious preventable adverse events” or other mishaps the patient and their family members are already aware something has gone wrong 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.[21]

In contrast, some patients who get 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 occur and they continue to trust health care providers who are honest with them. There is evidence to suggest an honest explanation and apology may decrease the likelihood of a lawsuit. However, pre-suit settlements may also be an important part of the statistical decrease in the number of lawsuits filed. See www.SorryWorks.net for further information.

Should I say “I’m sorry”?

In the past four years 27 states have passed laws which allow physicians to apologize when things go wrong without fear that their words will be used against them. Nine other states are considering such measures.[24] The PSA attempts to protect statements made to the patient when disclosing an adverse event.[25] However, no court has yet decided that the PSA overrides the general rule that one’s statements may be used against them.[26] Patients and jurors may well interpret “I’m sorry” as an admission of fault. Again, caution is advised when communicating any mishap. In any event, efforts to prevent future adverse events are important to patients.[21] Evidence of remedial measures taken after an event to prevent recurrences is generally not admissible in court to prove negligence, though it may be used for other purposes.[23]

Can any of my statements or documentation be used against me?

The PSA indicates that the written and verbal information given by the provider/facility to the patient and/or State are not subject to disclosure, nor admissible in a civil, criminal or administrative action.[27] Generally, patients’ attorneys are not allowed to obtain a facility’s internal 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 confidential evaluations necessary to improve health care systems.[28]

However, the statements or documents may be used if a facility, professional board or the Attorney General seeks to discipline, terminate or suspend a provider who displayed “recklessness, gross negligence or willful misconduct” or a “pattern of significant substandard performance resulting in serious preventable adverse events.”[29] The PSA also provides that the date, time, participants and content of the notification of the patient regarding a serious preventable adverse event or allergic reaction is to be documented in the patient’s chart.[30] Patients have a right to obtain a copy of their chart.[31] Final regulations to be issued under N.J. Admin. Code 8:43E-10 may protect notification documents from disclosure; if not, patients will certainly share them with their attorney. The documents may also be available through “any source… other than those specified in this Act”.[32] No court has yet ruled on these potential “loopholes” in the law. Therefore caution is advised when communicating any mishap.

Moreover, if a doctor 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 the original explanation should be put before the jury to discredit the explanation the doctor is now giving the jury. No court has yet ruled on such arguments. Therefore, doctors 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 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.

Can the facility or Board punish me for not disclosing required information?

Yes. The health care facility is subject to fines and other sanctions for violations of the PSA.[33] Even if the patient somehow does not know about the event, the JCAHO reviews charts and may 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 is subject to State fines. This could cause the health care facility or a professional board to initiate some form of disciplinary action against the “silent” provider.

Must I also report less serious incidents to the facility, patient or State?

The PSA encourages voluntary reporting of “preventable events”, “adverse events” and “near misses” to the facility for the purpose of discovering and repairing defects in the health care system. Voluntary reports by the provider to the facility, patient or State are subject to the same provisions on discovery and adverse use as the more serious events for which the PSA requires notice to the facility, patient and State.[34] However, informed consent/refusal requires disclosure of information which a reasonable patient would deem “material” in making health care choices, including choice of provider, even though the PSA may not require disclosure. Patient attorneys may claim silence suggests a doctor was hiding negligence, not an explainable “complication”.

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

The American Society for Healthcare Risk Management suggests documenting:

1) Clinical details. A complete, accurate factual description of the 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;
• Contents of the discussion;
• Questions asked and responses given;
• Patient reaction and level of understanding exhibited by the patient/family;
• Treatment alternatives, the risks and benefits of each as discussed with patient;
• Plan for further care or monitoring, reasons for it, and any follow up discussions;
• Any offer of assistance and the patient’s response to it;
• Note that additional information will be provided as it becomes available;
• Avoid derisive comments about other providers and self serving statements.[35]

One may consider asking a competent patient or family member to read and sign the notification documentation. This may increase the chances of the patient seeking counsel and a copy of the document, but may also help prevent or defend later claims that appropriate disclosure was not made to the patient or family and that additional harm was suffered as a result.

Adverse Events, page 6