N.J. Stat. tit. 26, ch. 2A

in effect

N.J. Stat. § 26:2A-1 Program to collect, process, store and distribute; educational and research activities; rules; cooperation

The Department of Health is hereby authorized to establish, equip, maintain and conduct a suitable program to collect, process, store and distribute human blood, and the various human blood derivatives including special therapeutic and diagnostic serums, which are deemed of value in the treatment of sick and injured persons, and the prevention of certain diseases; to carry out such educational and research activities as it may deem necessary in connection with said program; and to establish necessary rules and regulations to effect the purpose of this act. The Department of Health may conduct such program solely as a State activity, or in co-operation with such private institutions, hospitals or municipal or county corporations as the department may select, on such terms as may be agreed upon. L.1945, c. 301, p. 881, s. 1.

N.J. Stat. § 26:2A-2 Public policy

The public policy of this State is to safeguard the health and well-being of the citizens of this State with reference to the use of blood in the treatment of many human diseases, as well as its use in treatment of injuries as a result of casualties or disasters. Use of blood in this manner has increased to such proportions that, in the public interest there is need for establishing minimum standards for the control and licensing of the activities of "blood banks." L.1963, c. 33, s. 1.

N.J. Stat. § 26:2A-3 Definitions

For the purposes of this act, unless otherwise required by the context: (a) "Act" means this act and any rule or regulation adopted hereunder: (b) "Person" means a natural person, partnership, association, corporation, institution, agency, or other similar type entity; (c) "Blood" means human blood or human plasma. (d) "Blood bank" means any commercial or noncommercial activity involving the handling of blood or plasma, intended to be used for therapeutic or prophylactic purposes, which participates in any of the following operations: collection, processing, storage or distribution of blood; (e) "Collection" means the obtaining of blood by the bleeding of donors; (f) "Processing" means the technical stages required to prepare and identify the blood as to its suitability. (g) "Storage" means the holding of blood in connection with collection or processing prior to distribution or transfusion; (h) "Distribution" means the removal of blood from a blood bank to any other location for processing or storage or for the purpose of providing the blood for therapeutic or prophylactic purposes. (i) "Licensee" means a person holding a license under the provisions of this act. (j) "Commissioner" means the Commissioner of the State Department of Health or his duly authorized agent. (k) "Department" means the State Department of Health. L.1963, c. 33, s. 2.

N.J. Stat. § 26:2A-4 License required, expiration, fees, display of license

3. a. No person shall hereafter operate or conduct a blood bank in this State unless duly licensed by the commissioner under the provisions of this act. The licenses required by this act shall be in addition to any other license or permit required by any local board of health or other body exercising the powers of such a board in any municipality in this State. All such licenses shall expire on December 31 in each calendar year and application for renewal therefor shall be made on or before November 10 on forms provided by the department. A fee necessary to conduct blood bank licensure operations, as provided in subsection b. of this section, shall accompany the original application for a license and each renewal thereof. The original or a certified copy of the license shall be conspicuously displayed by the licensee at the premises occupied as a blood bank. b. (1) The fee for transfusion services shall be based on the number of transfusions performed at a facility and shall range from a minimum fee of $200 for a facility which performs up to 1,000 transfusions to a maximum fee of $700 for a facility which performs more than 5,000 transfusions a year; (2) The fee for collection centers shall be based on the number of collections made by a facility and shall range from a minimum fee of $250 for a facility which makes up to 200 collections to a maximum fee of $1,900 for a facility which makes more than 50,000 collections a year; (3) The fee for other blood bank services shall be as follows: Collection Site - $100 Broker - $200 Industrial Blood Bank - $200 Home Transfusion Service - $200. The commissioner may, pursuant to the "Administrative Procedure Act," P.L.1968, c.410 (C.52:14B-1 et seq.), periodically increase the fees to reflect increased State costs in blood bank licensure operations. c. The income received from licensure and renewal fees pursuant to this section shall be appropriated to the department to effectuate the purposes of P.L.1963, c.33 (C.26:2A-2 et seq.). L.1963,c.33,s.3; amended 1991,c.461.

N.J. Stat. § 26:2A-5 Issuance; application; renewal

A license shall be issued to any person who has been conducting a blood bank prior to the effective date of this act upon submission of a properly completed application form and payment of an application fee of $25.00. Said license shall be renewable as provided in this act and shall be subject to all the provisions of this act. L.1963, c. 33, s. 4.

N.J. Stat. § 26:2A-6 Donor registration statement

No licensee shall collect blood hereafter unless he has first obtained from the prospective donor a completed registration statement which shall set forth the name and address of the donor and shall contain such other information as the rules and regulations adopted hereunder shall require. L.1963, c. 33, s. 5.

N.J. Stat. § 26:2A-7 Standards; rules and regulations; contents

(a) The standards of operation for blood banks, including standards for the collection, processing, storage, and distribution of blood for therapeutic or prophylactic purposes shall be established by rules and regulations adopted and promulgated by the Public Health Council of the department. Such rules and regulations shall be incorporated in and made a part of the State Sanitary Code. (b) The rules and regulations so promulgated shall include but not be limited to provision for: (1) Qualifications for personnel employed in a blood bank. (2) Restrictions upon the use of blood donors. (3) Standards for collection, processing, storage, and distribution of blood. (4) Evaluation of performance of blood banks. L.1963, c. 33, s. 6.

N.J. Stat. § 26:2A-8 Suspension or revocation of license

Any license issued in accordance with the provisions of this act may be suspended or revoked by the commissioner for a violation of any of the provisions of this act. L.1963, c. 33, s. 7.

N.J. Stat. § 26:2A-9 Notice and hearing

The commissioner, before refusing to grant a license, or before suspending or revoking a license previously granted, except as hereinafter provided in section 10 of this act, shall give notice to the applicant or licensee personally, or by mail addressed to him at his last known address, and afford him an opportunity to be heard with respect thereto at a time and place specified in such notice. Such applicant or licensee shall have the right to be heard in person or by attorney, and to offer evidence pertinent to the subject of the hearing. A duly certified copy of the order of the commissioner issued as a result of such hearing shall be served on the applicant or the licensee by mail personally addressed to him at his last known address, except if such applicant or licensee be a corporation then the order shall be served in the same manner upon any officer or registered agent of the corporation. L.1963, c. 33, s. 8.

N.J. Stat. § 26:2A-10 Enforcement by commissioner; authority; obstruction of performance

The commissioner shall enforce the provisions of this act and may make complaints against persons violating its provisions or the rules or regulations issued thereunder and prosecute violations of same. The commissioner shall have the power and authority to enter and inspect any blood bank and to make such investigation of the premises and the books and records as is reasonably necessary to carry out the provisions of this act. It shall be a violation of this act for any person to obstruct, hinder, delay or interfere, by force or otherwise, with the performance by the commissioner of any duty under the provisions of this act. L.1963, c. 33, s. 9.

N.J. Stat. § 26:2A-11 Existence of violations at blood bank dangerous to public health; order of commissioner; hearing; injunctive relief

If the commissioner shall have reason to believe that a condition exists or has occurred at a blood bank, in violation of the provisions of this act, which is dangerous to the public health, he may order such blood bank to correct such violation and may suspend the license of the blood bank until such correction is completed. If a licensee shall deny that a violation exists or has occurred, he shall have the right to apply to the commissioner for a hearing. Such hearing shall be held and a decision rendered within 48 hours of the receipt of said request. If the commissioner shall rule against the licensee, the licensee shall have the right to apply for injunctive relief against the commissioner's order. Jurisdiction for such injunctive relief shall be in the Superior Court of New Jersey. L.1963, c. 33, s. 10.

N.J. Stat. § 26:2A-12 Violations; penalties

Any person who violates the provisions of this act or an order of the commissioner shall be liable for the first offense to a penalty, to be established by the commissioner, of not less than $100.00 nor more than $1,000.00 and for the second and each succeeding offense for a penalty of not less than $500.00 nor more than $5,000.00. The penalties herein provided shall be enforced by the department as plaintiff in a summary proceeding in accordance with the penalty enforcement law (N.J.S. 2A:58-1, et seq.). L.1963, c. 33, s. 11.

N.J. Stat. § 26:2A-13 Short title

This act shall be known and may be cited as the "Blood Safety Act of 1991." L.1991,c.131,s.1.

N.J. Stat. § 26:2A-14 Patient to be informed of blood transfusion options

a. Whenever a blood transfusion may be necessary during a surgical procedure, a physician or surgeon shall inform the surgery patient, prior to performing the surgical procedure, of the options of receiving autologous blood transfusions, designated blood transfusions or homologous blood transfusions. b. The physician or surgeon who will perform the surgery shall note on the patient's medical record that the patient was advised of the opportunity to receive an autologous, designated or homologous blood transfusion, if a transfusion becomes necessary. c. The physician or surgeon who will perform the surgery shall not be required to provide his patient with an explanation of the transfusion options pursuant to this section, if medical contraindications exist or the surgery is performed on an emergency basis. d. If there are no medical contraindications or the surgery is not performed on an emergency basis, the physician or surgeon shall allow adequate time, prior to surgery, for predonation to occur. If the patient waives the option to predonate blood, the physician or surgeon shall not incur any liability for his failure to allow the predonation to occur. L.1991,c.131,s.2.

N.J. Stat. § 26:2A-15 Health care facility required to accept autologous, designated blood

a. A health care facility which performs a transfusion shall be required to accept autologous or designated blood for a potential transfusion to a patient, if the blood is received from a blood bank licensed by the Department of Health, and has been tested and prepared in accordance with standards approved by the department. b. A health care facility which accepts autologous or designated blood and similar blood components shall pay a service fee to the blood bank which provides the blood or blood components, equal to the price it is charged for homologous blood or blood components. L.1991,c.131,s.3.

N.J. Stat. § 26:2A-16 Blood bank to inform donor, patient of fees

A blood bank which collects autologous or designated blood shall inform the donor of the blood or the intended recipient of the blood, in the case of a designated blood transfusion, of all fees that the blood bank charges to process, store, transport or otherwise prepare the blood for transfusion. L.1991,c.131,s.4.

N.J. Stat. § 26:2A-17 Definitions relative to human milk banks.

1. For the purposes of this act: "Collection" means the obtaining of donated human breast milk. "Commissioner" means the Commissioner of Health. "Department" means the Department of Health. "Distribution" means the removal of donated human breast milk from a human milk bank to any other location for processing or storage or for the purpose of providing breast milk to a hospital or selling breast milk to a parent. "Human milk bank" means an organized service that provides for the selection of a donor of human breast milk, the collection, processing, storage, and marketing of donated human breast milk, and the distribution of donated human breast milk to a hospital for use by low birth weight babies or new mothers with delayed lactation, or directly to a parent, with a physician's prescription order, who is unable to nurse, or is in need of additional breast milk to feed, the parent's child. "Marketing" means the use of suitable media to advertise the availability of, promote the appropriate use of, and provide information on how to safely procure, donated human breast milk. "Person" means a person, partnership, association, agency, organization, or other similar entity. "Processing" means the technical stages required to prepare and identify donated human breast milk as to its suitability. "Storage" means the holding of donated human breast milk in connection with collection or processing prior to its distribution. L.2017, c.247, s.1.

N.J. Stat. § 26:2A-18 Criteria for operation of a human milk bank.

2. a. A person shall not operate a human milk bank that is located in this State or distributes donated human milk in this State unless the human milk bank is accredited by, and registered with, the department pursuant to this act. b. Any person desiring to operate a human milk bank shall: (1) adhere to the guidelines for the establishment and operation of a donor human milk bank as required by the department; (2) adhere to the best practices for expressing, storing, and handling human milk in hospitals, homes, and child care settings as required by the department; (3) undergo a yearly assessment by the department, to provide evidence of adherence to the most recent edition of guidelines for the establishment and operation of a human milk bank; (4) comply with any other provisions required by the department; (5) register with the department in a form and manner prescribed by the department; and (6) pay to the department an annual registration fee established by the department in order to offset the department's administrative costs incurred in executing its responsibilities under this act. L.2017, c.247, s.2.

N.J. Stat. § 26:2A-19 On-site facility inspections.

3. The department shall conduct an on-site facility inspection of each registered human milk bank at least once every five years, and shall inspect documents, records, files, or other data maintained by a human milk bank during normal operating hours and without prior notice. If the department's inspection finds that a human milk bank is not in compliance with the department's requirements and guidelines for the accreditation of human milk banks, the department shall revoke the human milk bank's accreditation. L.2017, c.247, s.3.

N.J. Stat. § 26:2A-20 Civil actions authorized under certain circumstances; additional relief; appeal.

4. a. The commissioner is authorized to institute a civil action in a court of competent jurisdiction for injunctive relief to enjoin the operation of a human milk bank whenever the commissioner determines that: (1) a condition exists or has occurred at the human milk bank that is dangerous to the public health; (2) the human milk bank has repeatedly violated the provisions of this act; or (3) a human milk bank has opened or is operating without complying with the provisions of this act. b. The commissioner may, in addition, request such other relief as is deemed necessary. In any such action the court may proceed in a summary manner. c. Any person aggrieved by a final decision of the commissioner shall be entitled to seek judicial review in the Appellate Division of the Superior Court. All petitions for review shall be filed in accordance with the Rules of the Court. L.2017, c.247, s.4.

N.J. Stat. § 26:2A-21 Violations, penalties.

5. a. Any person who operates a human milk bank that is not accredited and registered pursuant to this act, or who has used fraud or misrepresentation in obtaining accreditation or registration or in the subsequent operation of a human milk bank, or who violates any other provision of this act shall be subject to a penalty of not less than $100 or more than $1,000 for the first offense and not less than $500 or more than $5,000 for the second or any subsequent offense. b. The department shall have the jurisdiction to enforce and collect any penalty imposed because of a violation of this act in a summary proceeding in accordance with the "Penalty Enforcement Law of 1999," P.L.1999, c.274 (C.2A:58-10 et seq.). Process shall be in the nature of a summons or warrant and shall issue only at the suit of the commissioner as plaintiff. c. A penalty recovered pursuant to the provisions of this section shall be recovered by the commissioner and paid into the State treasury. L.2017, c.247, s.5.

N.J. Stat. § 26:2A-22 Rules, regulations.

6. The commissioner, pursuant to the "Administrative Procedure Act," P.L.1968, c.410 (C.52:14B-1 et seq.), shall adopt rules and regulations necessary to effectuate the purposes of this act. L.2017, c.247, s.6.

N.J. Stat. § 26:2A-23 Findings, declarations relative to embryo storage facilities.

1. The Legislature finds and declares that: a. In vitro fertilization, commonly known as IVF, is an accepted and widely used method of assisted reproductive technology (ART). ART has helped an estimated six million couples in the United States who have trouble getting or maintaining a pregnancy start families. b. In 2016, the federal Centers for Disease Control and Prevention reported that there were approximately 267,000 IVF cycles performed in the United States, with more than five percent of those cycles occurring in New Jersey. By the end of the century, more than a million American patients who suffer from infertility will undergo IVF procedures. c. The use of ART in the United States is not as prevalent as its use in other developed countries. In Japan, one in 20 children are born as a result of ART. In Norway the number is one in 10. As more women rise to executive positions in America's board rooms, and IVF becomes a more financially viable option because of increased health insurance coverage, ART will provide more of an opportunity for couples to preserve their fertility until they are ready to start a family. d. IVF provides a pathway to motherhood for women who have experienced life threatening diseases, such as cancer, and the reproductive damage that is often a consequence of the treatments associated with these illnesses. e. While technological advances in, and success rates of, IVF have increased since its inception 40 years ago, there is currently little state or federal regulation concerning the storage of embryos in embryo storage facilities . f. In March of 2018, the failure of a storage tank at an Ohio fertility clinic caused the apparent loss of more than 4,000 frozen embryos and eggs, affecting 950 patients. Days after the storage tank failure in Ohio, a liquid nitrogen tank at an unrelated fertility clinic in California, containing thousands of eggs and embryos, malfunctioned, affecting another 400 patients. g. It is in the best interest of the State to require that the Department of Health promulgate regulations governing the storage of human eggs, pre-embryos, and embryos in embryo storage facilities to guard against catastrophic storage system failure, such as those that occurred in California and Ohio, and the potential loss of such specimens that may result from long-term power outages during storms and other natural disasters. L.2019, c.268, s.1.

N.J. Stat. § 26:2A-24 Definitions relative to embryo storage facilities.

2. As used in this act: "Commissioner" means the Commissioner of Health. "Department" means the Department of Health. "Embryo storage facility" means a facility which cryopreserves and stores human eggs, pre-embryos, and embryos for later use in in vitro fertilization, embryo transfer, gamete transfer, pronuclear stage transfer and zygote transfer, and other procedures performed to achieve a pregnancy or pregnancies. Embryo storage facility shall also include the office of a licensed health care provider which stores human eggs, pre-embryos, or embryos. "Person" means any individual, corporation, company, association, organization, society, firm, partnership, joint stock company, or the State or any political subdivision thereof. L.2019, c.268, s.2.

N.J. Stat. § 26:2A-25 Licensure for embryo storage facility.

3. a. No person shall conduct, maintain, or operate an embryo storage facility in this State unless licensed by the department pursuant to the provisions of this act. A separate license shall be required for each embryo storage facility location. The license shall be posted and displayed at all times in a prominent location within the facility. No license issued pursuant to this act shall be transferable. A change in the ownership of the facility shall require notification to the department within 14 calendar days and reapplication for licensure. b. The department shall not license a person to conduct, maintain, or operate an embryo storage facility pursuant to this act unless the department is satisfied that the person has demonstrated good character, competency, and integrity, and has furnished such information to the commissioner as the commissioner may require for this purpose. c. Within 90 days after the effective date of P.L.2022, c.106 (C.26:2A-25), as a condition of continued or new licensure, an embryo storage facility that is required to record or report the health information of a patient, shall record and report the patient's health information using a program that is compliant with the "Health Insurance Portability and Accountability Act of 1996," Pub.L.104-191 and requirements adopted by the U.S. Department of Health and Human Services regarding functions, technological capabilities, and security features within the program. L.2019, c.268, s.3; amended 2022, c.106.

N.J. Stat. § 26:2A-26 Rules, regulations.

4. a. The department shall promulgate rules and regulations pursuant to the "Administrative Procedure Act," P.L.1968, c.410 (C.52:14B-1 et seq.) governing the storage and care of human eggs, pre-embryos, and embryos by an embryo storage facility in accordance with: (1) Standards ISO 9001 and ISO 20387 of the International Organization for Standardization; (2) standards for biorepositories established by the College of American Pathologists Biorepository Accreditation Program; and (3) the U.S. Food and Drug Administration guidance on Current Good Tissue Practices. b. The rules and regulations promulgated pursuant to this section shall promote safety and best practices among embryo storage facilities and, at a minimum: prescribe standards governing the operation, maintenance, and administration of embryo storage facilities; the safety and adequacy of the physical plant or the facilities; compliance with State and local fire safety codes; the number of staff and the qualifications of each staff member; the protection and safety of the equipment used by embryo storage facilities to process and store human eggs, pre-embryos, and embryos; the maintenance and confidentiality of records and furnishing of required information; the maintenance of all appropriate accreditations and certifications; the establishment of a quality management program; and the review of the scope of internal audits. c. The department shall conduct an on-site facility inspection and shall evaluate the embryo storage facility to determine whether the facility complies with the provisions of this act. d. The department shall have the authority to inspect and examine the physical plant or facilities of an embryo storage facility and to inspect all documents, records, files, or other data maintained pursuant to this act during normal operating hours and without prior notice. e. The department shall request the appropriate State and local fire, health, and building officials to conduct examinations and inspections to determine compliance with State and local ordinances, codes, and regulations by an embryo storage facility. The inspections shall be conducted and the results reported to the department within 60 days after the request. f. If an embryo storage facility meets the requirements of this act and the rules and regulations promulgated hereunder, the department shall issue a license to the facility. A license shall be valid for a period of one year and may be renewed at the end of that period, subject to continued compliance with the provisions of this act. g. Nothing in this section shall be interpreted to permit the adoption of any code or standard which exceeds the standards established pursuant to the "State Uniform Construction Code Act," P.L.1975, c.217 (C.52:27D-119 et seq.). L.2019, c.268, s.4.

N.J. Stat. § 26:2A-27 Application for licensure.

5. Any person operating an embryo storage facility on or after the effective date of this act or desiring to operate an embryo storage facility shall make application for licensure in a manner and on forms prescribed by the commissioner. The license application form shall include, but shall not be limited to, the following information: a. the name and address of the embryo storage facility b. a description of the facility's premises and facilities and the hours of its operation; and c. any other information the commissioner deems necessary to include on the license application form. L.2019, c.268, s.5.

N.J. Stat. § 26:2A-28 Fees for licensure.

6. a. The commissioner shall establish a minimum fee to be paid by each embryo storage facility at the time of application for a license and at every renewal of a license. b. The income received from licensure and renewal fees pursuant to this section shall be appropriated to the department to effectuate the purposes of this act. L.2019, c.268, s.6.

N.J. Stat. § 26:2A-29 Denial, suspension, revocation, refusal to renew license.

7. The department may deny, suspend, revoke, or refuse to renew a license for good cause, including, but not limited to: a. Failure of an embryo storage facility or its operator to comply with the provisions of this act; b. Violation of the terms and conditions of a license by an embryo storage facility or its operator; c. Use of fraud or misrepresentation by an embryo storage facility or its operator in obtaining a license or in the subsequent operation of the facility; d. Refusal by an embryo storage facility or its operator to furnish the department with required files, reports, or records; or e. Refusal by an embryo storage facility or its operator to permit an inspection by an authorized representative of the department during normal operating hours. L.2019, c.268, s.7.

N.J. Stat. § 26:2A-30 Notice, hearing.

8. a. The department, before denying, suspending, revoking, or refusing to renew a license, shall give notice to the operator personally, or by certified or registered mail to the last known address of the operator with return receipt requested. The notice shall afford the operator with an opportunity to be heard in person or by an attorney, and to offer evidence pertinent to the subject of the hearing. b. The hearing shall take place within 60 days from the issuance or mailing of the notice and shall be conducted in accordance with the "Administrative Procedure Act," P.L. 1968, c.410 (C.52:14B-1 et seq.). L.2019, c.268, s.8.

N.J. Stat. § 26:2A-31 Violations, third degree crime.

9. Any person who operates or assists in the operation of an embryo storage facility which does not have a license, who has used fraud or misrepresentation in obtaining a license or in the subsequent operation of a facility, who offers, advertises, or provides any service not authorized by a valid license, or who violates any other provision of this act, shall be guilty of a crime of the third degree. L.2019, c.268, s.9.

Source: Open US Law by Vaquill AI (CC BY 4.0)URL: https://www.njleg.state.nj.us/legislative-activity/statutesFetched: 10/17/2026