New Jersey § 26:2h-12

§ 26:2h-12.

a. As used in this act: “ Adverse event ” means an event that is a negative consequence of care that results in unintended

injury or illness, which may or may not have been preventable. “ Anonymous ” means that information is presented in a form and manner that prevents the identification

of the person filing the report. “ Commissioner ” means the Commissioner of Health . “ Department ” means the Department of Health . “ Event ” means a discrete, auditable , and clearly defined occurrence. “Health care facility” or “ facility ” means a health care facility licensed pursuant to P.L.1971, c. 136 ( C.26:2H-1 et seq. ) and a State psychiatric hospital operated by the Department of Human Services and

listed in R.S.30:1-7 . “ Health care professional ” means an individual who, acting within the scope of the individual's licensure or certification, provides health care services, and includes, but is not

limited to, a physician, dentist, nurse, pharmacist , or other health care professional whose professional practice is regulated pursuant

to Title 45 of the Revised Statutes. “ Near-miss ” means an occurrence that could have resulted in an averse event but the adverse

event was prevented. “ Preventable event ” means an event that could have been anticipated and prepared against, but occurs

because of an error or other system failure. “ Serious preventable adverse event ” means an adverse event that is a preventable event and results in death or loss

of a body part, or disability or loss of bodily function lasting more than seven days

or still present at the time of discharge from a health care facility. b. In accordance with the requirements established by the commissioner by regulation,

pursuant to this act, a health care facility shall develop and implement a patient

safety plan for the purpose of improving the health and safety of patients at the

facility. The patient safety plan shall, at a minimum, include: (1) a patient safety committee, as prescribed by regulation; (2) a process for teams of facility staff, which teams are comprised of personnel

who are representative of the facility's various disciplines and have appropriate

competencies, to conduct ongoing 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; (3) a process for teams of facility staff, which teams are comprised of personnel

who are representative of the facility's various disciplines and have appropriate

competencies, to conduct analyses of near-misses, with particular attention to serious

preventable adverse events and adverse events; and (4) a process for the provision of ongoing patient safety training for facility personnel. The provisions of this subsection shall not be construed to eliminate or lessen a

hospital's obligation under current law or regulation to have a continuous quality

improvement program. c. A health care facility shall report to the department or, in the case of a State

psychiatric hospital, to the Department of Human Services, in a form and manner established

by the commissioner, every serious preventable adverse event that occurs in that facility. d. A health care facility shall assure that the patient affected by a serious preventable

adverse event or an adverse event specifically related to an allergic reaction, or,

in the case of a minor or a patient who is incapacitated, the patient's parent or

guardian or other family member, as appropriate, is informed of the 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 as established by the commissioner by regulation. The time, date, participants , and content of the notification shall be documented in the patient's medical record

in accordance with rules and regulations adopted by the commissioner. The content of the documentation shall be determined in accordance with the rules

and regulations of the commissioner. If the patient's physician determines that the disclosure would seriously and adversely

affect the patient's health, then the facility shall assure that the family member,

if available, is notified in accordance with rules and regulations adopted by the

commissioner. In the event that an adult patient is not informed of the serious preventable adverse

event or adverse event specifically related to an allergic reaction, the facility

shall assure that the physician includes a statement in the patient's medical record

that provides the reason for not informing the patient pursuant to this section. e. (1) A health care professional or other employee of a health care facility is encouraged

to make anonymous reports to the department or, in the case of a State psychiatric

hospital, to the Department of Human Services, in a form and manner established by

the commissioner, regarding near-misses, preventable events , and adverse events that are otherwise not subject to mandatory reporting pursuant

to subsection c. of this section. (2) The commissioner shall establish procedures for and a system to collect, store , and analyze information voluntarily reported to the department pursuant to this subsection. The repository shall function as a clearinghouse for trend analysis of the information

collected pursuant to this subsection. f. Any documents, materials , or information received by the department, or the Department of Human Services, as

applicable, pursuant to the provisions of subsections c. and e. of this section 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 under P.L.1963, c. 73 ( C.47:1A-1 et seq. ) or P.L.2001, c. 404 ( C.47:1A-5 et al.); 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

this section. The provisions of this paragraph shall not be construed to limit a health care facility

from taking disciplinary action against a health care professional in a case in which

the professional has displayed 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. The information received by the department, or the Department of Human Services, as

applicable, shall be shared with the Attorney General in accordance with rules and

regulations adopted pursuant to subsection j. of this section, and may be used by

the department, the Department of Human Services , and the Attorney General for the purposes of this act and for oversight of facilities

and health care professionals; however, the departments and the Attorney General

shall not use the information for any other purpose. In using the information to exercise oversight, the department, Department of Human

Services , and Attorney General, as applicable, shall place primary emphasis on assuring effective

corrective action by the facility or health care professional, reserving punitive

enforcement or disciplinary action for those cases in which the facility or the professional

has displayed recklessness, gross negligence , or willful misconduct, or in which there is evidence, based on other similar cases

known to the department, Department of Human Services or the Attorney General, of

a pattern of significant substandard performance that has the potential for or actually

results in harm to patients. g. Any documents, materials , or information developed by a health care facility as part of a process of self-critical

analysis conducted pursuant to subsection b. of this section 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 the patient's

family member or guardian pursuant to subsection d. 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; 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, reporting , or storage of information in accordance with subsection b. of this section. The provisions of this paragraph shall not be construed to limit a health care facility

from taking disciplinary action against a health care professional in a case in which

the professional has displayed 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. h. Notwithstanding the fact that documents, materials , or information may have been considered in the process of self-critical analysis

conducted pursuant to subsection b. of this section, or received by the department

or the Department of Human Services pursuant to the provisions of subsection c. or

e. of this section, the provisions of this act shall not be construed to increase

or decrease, in any way, the availability, discoverability, admissibility , or use of any such documents, materials , or information if obtained from any source or context other than those specified

in this act. i. The investigative and disciplinary powers conferred on the boards and commissions

established pursuant to Title 45 of the Revised Statutes, the Director of the Division

of Consumer Affairs in the Department of Law and Public Safety and the Attorney General

under the provisions of P.L.1978, c. 73 ( C.45:1-14 et seq. ) or any other law, rule , or regulation, as well as the investigative and enforcement powers conferred on the

department and the commissioner under the provisions of Title 26 of the Revised Statutes

or any other law, rule or regulation, shall not be exercised in such a manner so as

to unduly interfere with a health care facility's implementation of its patient safety

plan established pursuant to this section. However, this act shall not be construed to otherwise affect, in any way, the exercise

of such investigative, disciplinary , and enforcement powers. j. The commissioner shall, pursuant to the “Administrative Procedure Act,” P.L.1968,

c. 410 ( C.52:14B-1 et seq. ), adopt such rules and regulations necessary to carry out the provisions of this

act. The regulations shall establish: criteria for a health care facility's patient

safety plan and patient safety committee; the time frame and format for mandatory

reporting of serious preventable adverse events at a health care facility; the types

of events that qualify as serious preventable adverse events and adverse events specifically

related to an allergic reaction; the circumstances under which a health care facility

is not required to inform a patient or the patient's family about a serious preventable

adverse event or adverse event specifically related to an allergic reaction; and

a system for the sharing of information received by the department and the Department

of Human Services pursuant to subsections c. and e. of this section with the Attorney

General. In establishing the criteria for reporting serious preventable adverse events, the

commissioner shall, to the extent feasible, use criteria for these events that have

been or are developed by organizations engaged in the development of nationally recognized

standards. The commissioner shall consult with the Commissioner of Human Services with respect

to rules and regulations affecting the State psychiatric hospitals and with the Attorney

General with respect to rules and regulations regarding the establishment of a system

for the sharing of information received by the department and the Department of Human

Services pursuant to subsections c. and e. of this section with the Attorney General. k. Nothing in this act shall be construed to increase or decrease the discoverability,

in accordance with Christy v. Salem, No. A-6448-02T3 (Superior Court of New Jersey,

Appellate Division, February 17, 2004)(2004 WL291160), 1 of any documents, materials or information if obtained from any source or context

other than those specified in this act. 1

See 841 A.2d 937.