N.J. Admin. Code § 8:43E-10.7

Current through Register Vol. 56, No. 11, June 3, 2024

Section 8:43E-10.7 - Disclosure to patient or resident

(a) A health care facility shall ensure that a patient or resident or, in the case of a minor or incompetent adult, the patient's or resident's personal representative, guardian, parent, or other family member, as appropriate, and provided disclosure is permissible under applicable confidentiality law, is informed of the following:

1. Any serious preventable adverse event that affected the patient or resident; and

2. Any adverse event resulting from an allergic reaction that was not previously documented in the patient's or resident's medical history.

i. In the case of an allergic reaction, a facility shall arrange that the patient or resident be informed of other circumstances, if known, in which the same allergic reaction might occur, and of known preventive measures, if any, and shall arrange that the patient or resident be advised to inform any health care professionals providing future care of the allergic reaction.

(b) The patient's or resident's attending physician, the facility administrator, the facility's medical director or another health care professional authorized in accordance with facility policies shall make the disclosure required pursuant to (a) above within 24 hours of the time the facility discovers the event.

(c) A health care facility shall ensure that a patient or resident or, in the case of a minor or incompetent adult, the patient's or resident's personal representative, guardian, parent, or other family member, as appropriate, is informed of the event or allergic reaction in the following manner:

1. In person, if the patient or resident is still in the facility;

2. By telephone, if the patient or resident has left the facility and the facility is unable to arrange a face-to-face meeting; or

3. By certified mail, if the facility is unable to contact the patient or resident by telephone.

(d) If the patient or resident's attending physician determines that informing the patient or resident of the event would seriously and adversely affect the health of a patient or resident who is a competent adult, then the facility shall ensure that the attending physician, the facility administrator, the facility's medical director, or another health care professional authorized in accordance with facility policies informs a family member of the event, if a family member is available and can be so informed without violating any applicable confidentiality or privacy law.

1. In selecting a family member to whom to make the disclosure required pursuant to this subsection, the facility shall accord first preference to a spouse, a partner in a civil union, or a domestic partner, then to adult children or parents, and then to siblings.

2. The facility shall ensure that the attending physician documents in the patient or resident's medical record the basis of the determination that disclosure of the adverse event to the patient or resident would seriously and adversely affect the patient or resident's health.

(e) Notwithstanding (a) through (d) above, the facility shall ensure that information concerning the serious preventable adverse event or allergic reaction is not disclosed to a family member who is not the guardian or who does not have a medical power of attorney, if the patient has prohibited disclosure of his or her protected health information, in accordance with and subject to 45 CFR § 164.522, to any family members.

(f) In disclosing information in accordance with (b) or (c) above, the facility shall ensure that the following information is recorded in the patient or resident's medical record:

1. The time, date, and individuals present when the disclosure was made, and the person to whom the disclosure was made; and

2. A statement that the occurrence of a serious preventable adverse event or adverse event related to an allergic reaction, as applicable, was disclosed.

(g) The facility may request written acknowledgement from the patient or resident, or the patient or resident's parent, guardian, or family member, as applicable, that the patient or resident or family member received information about the serious preventable adverse event or an allergic reaction.

1. If a facility requests written acknowledgment, the facility shall advise the patient or resident, or the patient or resident's parent, guardian, or family member, as applicable, that signing the acknowledgement is voluntary and in no way constitutes either a release from liability by the patient or resident or an admission of liability on the part of the physician or health care facility.

i. The facility shall provide this advice orally at the time it makes the request, and the acknowledgment form shall state at the beginning, in easily readable print, that signing the acknowledgement is voluntary and in no way constitutes either a release from liability by the patient or resident or an admission of liability on the part of the physician or health care facility.

(h) Notwithstanding 8:43E-10.9, the patient or resident's medical record, excluding the information required in accordance with (f) above, shall be available to the patient or resident upon request, subject to discovery, and admissible as evidence or otherwise disclosed in a civil, criminal, or administrative action or proceeding.

N.J. Admin. Code § 8:43E-10.7