N.J. Admin. Code § 8:43E-10.9

Current through Register Vol. 56, No. 21, November 4, 2024

Section 8:43E-10.9 - Confidentiality protections and restrictions on disclosure and use

(a) Documents, materials, and information received by the Department or the Department of Human Services, as applicable, in accordance with 8:43E-10.6 and 10.8 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 under P.L. 1963, c. 73 (47:1A-1 et seq.), or P.L. 2001, c. 404 (47:1A-5 et seq.); or

3. Used in an adverse employment action or in the evaluation of decisions made in relation to accreditation, certification, credentialing, or licensing of an individual, which is based on the individual's participation in the development, collection, reporting or storage of information in accordance with P.L. 2004, c. 9 (26:2H-12.2 3 through 12.25).

(b) Documents, materials, and information (including RCAs and minutes of meetings) developed by a health care facility exclusively during the process of self-critical analysis, in accordance with 8:43E-10.4, 10.5 or 10.6 concerning preventable events, near-misses and adverse events, including serious preventable adverse events, and any document or oral statement that constitutes the disclosure provided to a patient or resident or the patient or resident's family member or guardian, in accordance with 8:43E-10.7, as well as the entry in the medical record related to such disclosure, shall not be:

1. Subject to discovery or admissible as evidence or otherwise disclosed in any civil, criminal or administrative action or proceeding; or

2. Used in an adverse employment action or in the evaluation of decisions made in relation to accreditation, certification, credentialing or licensing of an individual, which is based on the individual's participation in the development, collection or reporting or storage of information in accordance with P.L. 2004, c. 9 (26:2H-12.2 3 through 12.25).

(c) The confidentiality protection and protection from discovery or introduction into evidence provided in this section shall also apply to any person who performs responsibilities for or participates in meetings of the patient or resident safety committee.

1. These persons shall not be required to testify as to any matters within the knowledge gained by the person as a result of responsibility for or participation on the patient or resident safety committee.

2. These persons shall be allowed to testify as to any matters within their knowledge that was gained outside of their responsibility for or participation on the patient or resident safety committee.

(d) Subsections (a) through (c) above shall not be construed to limit the ability of a health care facility to take disciplinary action against a health care professional in a case in which the professional has displayed recklessness, gross negligence or willful misconduct or where there is evidence, based on similar cases known to the facility, of a pattern of significant substandard performance that resulted in serious preventable adverse events.

(e) Subsections (a) through (c) above shall not be construed to increase or decrease, in any way, the availability, discoverability, admissibility or use of any documents, materials or information otherwise available from other sources merely because the documents, materials or information were presented during proceedings of the patient or resident safety committee.

(f) Notwithstanding (a) through (c) above, if information submitted to or developed by the patient or resident safety committee provides a reasonable basis to suspect criminal behavior on the part of anyone employed by, on the medical staff of, or acting as an agent of, a health care facility, the facility shall report such information to the appropriate police authorities and, as applicable, to the Department in accordance with 8:43E-10.11(b).

(g) Notwithstanding (b) above, the patient or resident safety committee may release de-identified aggregate trend data on preventable adverse events and near-misses, and a facility may file reports, analyses or plans required pursuant to this subchapter without violating this section or compromising the protections afforded by this section to the reporter of such information, the patient or resident safety committee and the underlying data.

(h) Notwithstanding (a) through (c) above, the Department, or, in the case of a State psychiatric hospital, the Department of Human Services, may use information derived from confidential reports in order to promote increased patient or resident safety, or to develop recommendations to facilities on "best practices" and other modalities for improving safety in the delivery of health care services.

(i) To accomplish the purposes of (h) above, the Department or the Department of Human Services may:

1. Use the root cause analysis process for oversight purposes to require corrective action by a facility to avoid or reduce the likelihood of similar serious preventable adverse events in the future.

i. The Department or the Department of Human Services, as applicable, shall reserve punitive enforcement action for those cases in which a facility has displayed recklessness, gross negligence or willful misconduct, or in which evidence exists of a pattern of significant substandard performance that has the potential for or actually results in harm to patients or residents.

ii. Information derived from confidential reporting that is used for oversight of facilities shall continue to be maintained as confidential and shall not be subject to discovery, admissible as evidence, or otherwise disclosed in any civil, criminal or administrative action or proceeding, and shall not be considered a public record;

2. Use de-identified information to alert other health care facilities of potentially harmful practices that should be avoided or amended; and

3. Use aggregated, de-identified data to determine Statewide averages and trends in reported preventable adverse events and near-misses within New Jersey heath care facilities, based on the type of facility.

i. Any report produced using this data shall not include information reflecting specific facilities or health care professionals, but shall merely constitute a trend analysis.

N.J. Admin. Code § 8:43E-10.9