No.

In Massachusetts, any statements, writings, or benevolent gestures relating to the suffering of patients involved in an unexpected outcome are inadmissible as evidence of liability. Even so, some types of apologies are better than others. An apology that includes such words as "I am so sorry that my treatment caused you harm" is inappropriate.

A sincere expression of regret following a poor outcome or upsetting experience, such as "I am sorry this happened" coupled with a discussion about future treatment options can demonstrate an empathetic and caring attitude. Apologies can help to mitigate any anger the patient may feel, and communicate that you will work with the patient to improve the outcome.

While information in the medical record should never be deleted, obliterated, or altered after the fact, the judicious use of an addendum in a medical record is reasonable, as long as the addendum is designated as such and dated. Accepted rationale for including an addendum would be for the correction of facts (i.e., persons involved, time of event, sequence of events) and for the addition of facts or clarifying information. Individuals who participated in the care, but were unable to access the record until a later date, may also provide added information. Addenda should not be used to state opinions, perceptions, or defenses.

Arguments Supporting Addenda

Accuracy: The witness to the event may not be the person who documents it. Inaccuracies, even those that appear minor, should be corrected by someone who did witness the event.

Recall: Recording everything that is happening during an emergency situation is often impossible. Witnesses to an event may recall details at a later time, in which case, an addendum is appropriate.

Clarification: Information previously thought irrelevant may be deemed pertinent upon review of the case by an objective clinician. In this case, clarifying comments should be added to the record if they are pertinent to future care.

Arguments Against Addenda

Perception: The major argument against writing addenda is the potential that they may be perceived as attempts to falsify or change the record of fact. Inappropriately phrased, an addendum may appear to be "self-serving" rather than providing information important in the course of a patient's recovery. For example, following an adverse event, individuals may attempt to explain their own particular role (or lack of one) in addenda. This appears defensive, does not contribute to the care of the patient, and should be avoided.

Vulnerability: An addendum will be interpreted by plaintiff counsel as an attempt to alter the medical record and, if at all possible, used to support his or her client's claim. Seemingly insignificant record details are often magnified and used effectively to emphasize a plaintiff's point.

The Safe Medical Devices Act (SMDA) requires that any "device user facility" report certain types of medical device-related events to the Food and Drug Administration (FDA). Besides a hospital, a device user facility includes:

• an ambulatory surgical facility,
• a nursing home, or
• an outpatient diagnostic or treatment facility (such as a mammography unit or home health agency).

The requirements do not apply to a physician's office, which is defined as one used for the primary purpose of examination, evaluation, and treatment/referral of patients.

All qualifying device user facilities have the same reporting responsibilities, regardless of size or complexity. Medical device-related deaths must be reported directly to the FDA and the manufacturer (if known), while events meeting the definition of device-related serious illness and serious injury are reported only to the manufacturer. (In the event a manufacturer is unknown, these reports go to the FDA.)

Device user facilities are also required to have written procedures for identifying and evaluating events that might be reportable. These facilities must also comply with documentation requirements, and provide employees with training and education about their obligations under the institution's program. Programs in all settings are subject to FDA auditing for compliance with the mandatory reporting requirements.

Copies of the mandatory reporting form, instructions, and the coding manual can be obtained from the FDA by calling 1.800.638.2041. Or visit the FDA's website.