reglab/statecodes huggingface dataset:
New Jersey Administrative Code › Title 8 - HEALTH › Chapter 7 - LICENSURE OF PERSONS FOR PUBLIC HEALTH POSITIONS › Subchapter 1 - GENERAL PROVISIONS › Section 8:7-1.10 - Qualifications of candidates for licensure

Current through Register Vol. 56, No. 14, July 15, 2024
(a) Regarding the
				qualifications of health officer candidates, applicants shall meet one of the
				following qualifications:
1. Diplomate of the
				American Board of Preventive Medicine or complete eligibility therefor;
2. Degree of doctor or master from an accredited
				college or university program in a health-related field recognized as such by the
				Department of Education such as medicine, osteopathy, veterinary medicine, public
				health, environmental science, health administration, social work, nursing or health
				education. The core course work for the degree shall include or be supplemented by
				at least three credits in each of the following: planning, administration,
				environmental science, social science, biostatistics and epidemiology at the
				undergraduate, junior or senior level; and
i.
				Unless otherwise exempted by statute, satisfactory completion of two years full-time
				employment in a position providing administrative experience in at least three of
				the five existing recognized public health activities as specified in N.J.A.C. 8:52.
3. What a candidate for
				health officer license should know:
i. The health
				officer is expected to provide leadership in the field of public health in his or
				her community. In addition to being the chief executive officer of a local health
				department, he or she is responsible for evaluating the health problems of his
				community, planning appropriate activities to meet their health problems, developing
				necessary budget procedures to cover these activities, and directing the
				department's staff, so as to carry out the activities efficiently, economically and
				in accordance with accepted policies and practices as defined at N.J.A.C. 8:52,
				Public Health Practice Standards of Performance for Local Boards of Health in New
				Jersey. Applicants are examined relative to these essential activities.
New Jersey Administrative Code › Title 8 - HEALTH › Chapter 7 - LICENSURE OF PERSONS FOR PUBLIC HEALTH POSITIONS › Subchapter 1 - GENERAL PROVISIONS › Section 8:7-1.11 - License issuance, renewal, and fees for licenses

Current through Register Vol. 56, No. 14, July 15, 2024
(a) All initial licenses
				granted by the Commissioner in accordance with
				N.J.A.C.
				8:7-1.3shall not fall under the requirements of
				this section.
(b) All licenses shall
				expire on December 31 of each year and may be renewed upon payment of a fee as
				authorized by N.J.S.A. 26:1A-42. The annual license
				renewal fee of $ 50.00 shall be submitted to the Department with the application
				sent to all licensees by the Department and shall include evidence of completed
				continuing education in accordance with
				N.J.A.C.
				8:7-1.13(c) for health officers
				and registered environmental health specialists.
1. License renewal applications shall be completed
				and submitted to the Department by December 1 for the subsequent licensing year.
				Applications received after December 1 shall be assessed a $ 25.00 late fee in
				addition to the license fee.
New Jersey Administrative Code › Title 8 - HEALTH › Chapter 7 - LICENSURE OF PERSONS FOR PUBLIC HEALTH POSITIONS › Subchapter 1 - GENERAL PROVISIONS › Section 8:7-1.12 - Active and inactive licenses

Current through Register Vol. 56, No. 14, July 15, 2024
(a) The requirements set
				forth under 8:7-1.12 through 1.17 shall apply to all individuals eligible to serve
				as a health officer or registered environmental health specialist in the State of
				New Jersey, except where the rule provides for exemption or waiver.
1. An active license shall be issued to applicants
				who have successfully acquired 15 contact hours of approved continuing education in
				accordance with the continuing education requirements set forth in this
				chapter.
2. An inactive license shall be
				issued to applicants without fulfillment of the requirements set forth in this
				chapter for an active license, or without a waiver granted in accordance with
				8:7-1.14.
New Jersey Administrative Code › Title 8 - HEALTH › Chapter 7 - LICENSURE OF PERSONS FOR PUBLIC HEALTH POSITIONS › Subchapter 1 - GENERAL PROVISIONS › Section 8:7-1.13 - License renewal and continuing education requirements

Current through Register Vol. 56, No. 14, July 15, 2024
(a) By the end
				of each annual licensing period, each person employed as a health officer or
				registered environmental health specialist shall meet the requirements for an active
				license. Persons failing to meet the requirements of an active license will be
				issued written notice, which may be served upon the licensee personally, or by
				registered mail, a copy of which shall be filed with the employer with further
				notice to advise the Department of its intent and the means by which it shall
				resolve the matter.
1. As part of the requirement
				for an active health officer license, licensees shall successfully acquire at least
				eight contact hours of continuing education from courses approved in accordance with
				N.J.A.C.
				8:7-1.16 and among the subject areas listed in
				N.J.A.C.
				8:7-1.15(a)9.
New Jersey Administrative Code › Title 8 - HEALTH › Chapter 7 - LICENSURE OF PERSONS FOR PUBLIC HEALTH POSITIONS › Subchapter 1 - GENERAL PROVISIONS › Section 8:7-1.14 - Waiver of continuing education contact hours

Current through Register Vol. 56, No. 14, July 15, 2024
(a) The Public Health
				Council for good cause, such as serious illness or accident involving self or family
				and determined by the Council to have prevented a health officer's or registered
				environmental health specialist's completion of continuing education, may waive all
				or part of the requirement for the licensing period. All such requests to the Public
				Health Council by the health officer or registered environmental health specialist
				shall be in writing and shall be accompanied by written documentation supporting the
				reasons for the request.
(b) Waivers
				shall be granted for one licensure period at a time. If the situation for which the
				waiver is granted continues, the health officer or registered environmental health
				specialist shall reapply in writing to the Public Health Council.
New Jersey Administrative Code › Title 8 - HEALTH › Chapter 7 - LICENSURE OF PERSONS FOR PUBLIC HEALTH POSITIONS › Subchapter 1 - GENERAL PROVISIONS › Section 8:7-1.15 - Continuing education course criteria

Current through Register Vol. 56, No. 14, July 15, 2024
(a) Continuing education
				courses eligible for contact hours under this subchapter shall include:
1. Courses, seminars, or programs focusing on
				professional competency and ethics, as well as legal aspects relating to the
				practice of public health, environmental health, and sanitation;
2. Courses, seminars, or programs in public
				health, health care, health education, environmental science, health planning,
				epidemiology;
3. Courses, seminars, or
				programs in public health administration, environmental health, communicable
				diseases, maternal and child health, and chronic diseases;
4. Courses, seminars, or programs designed to
				acquaint health officers and registered environmental health specialists with the
				utilization and application of new techniques, policy, and developments relating to
				public health, environmental health, and sanitation;
5. Courses, seminars, or programs in home and
				community based alternatives to nursing facilities, the health problems of older
				adults and disabled persons, and the promotion of wellness and health in older
				adults;
6. Courses, seminars or programs
				in environmental and occupational health hazard evaluations, risk communications,
				remediation and public health issues concerning air, water, pesticides, public
				health pest control, soil, wastes, food, radiation, noise, chemicals, particulates,
				microbiology and microbiological agents;
7. Courses, seminars or programs in emergency
				response, crisis management and disaster control with respect to public health
				issues;
8. Courses, seminars or programs
				concerning historical, current or future perspectives on the structure, function and
				roles of national, state and local boards, councils, departments and public health
				professionals such as health officers, public health nurses, registered
				environmental health specialists and public health educators; and
9. Courses, seminars or programs in public health
				leadership and management development; community partnerships, organizing and
				coalition building; the use of data and information technologies in policy
				development and decision making; continuous quality improvement; cultural diversity;
				the integration of health delivery systems; and outcomes measurement and
				evaluation.
New Jersey Administrative Code › Title 8 - HEALTH › Chapter 7 - LICENSURE OF PERSONS FOR PUBLIC HEALTH POSITIONS › Subchapter 1 - GENERAL PROVISIONS › Section 8:7-1.16 - Course, seminar, or program approval; application fee

Current through Register Vol. 56, No. 14, July 15, 2024
(a) Any course of study
				that addresses the content areas specified at
				N.J.A.C.
				8:7-1.15(a)  of fered by an
				educational institution, association, professional society, person, or organization
				and used by applicants for the purpose of continuing education and licensure in this
				State as health officers or registered environmental health specialists may be
				approved by the Public Health Council, in accordance with this chapter.
1. Any course, seminar, or program that is
				sponsored by the Department , the New Jersey Department of Environmental Protection,
				or a school or program accredited by the Council on Education for Public Health or
				the National Environmental Health, Science and Protection Accreditation Council,
				which fulfills the requirements set forth at
				N.J.A.C.
				8:7-1.15is exempt from securing approval from the
				Public Health Council. The Public Health Council shall determine the number of
				continuing education contact hours that will be assigned to the course, seminar, or
				program.
2. The annual meetings of the
				New Jersey Association of City and County Health Officials, New Jersey Environmental
				Health Association, South Jersey's Sanitarians' Association, New Jersey Public
				Health Association, American Public Health Association, and National Environmental
				Health Association, upon approval of the Public Health Council and in accordance
				with this section, may be used in partial fulfillment of the requirement for
				continuing education.
New Jersey Administrative Code › Title 8 - HEALTH › Chapter 7 - LICENSURE OF PERSONS FOR PUBLIC HEALTH POSITIONS › Subchapter 1 - GENERAL PROVISIONS › Section 8:7-1.17 - Record of continuing education contact hours

Current through Register Vol. 56, No. 14, July 15, 2024
(a) A licensee shall
				maintain documentation of course, seminar, or program continuing education
				completion.
(b) A licensee shall submit
				to the Public Health Council verification of accumulated continuing education
				contact hours. Verification material shall include evidence of the successful
				completion through attendance at or faculty-level instruction of an approved course,
				seminar, or program, in the form of a copy of the certificate or similar formal
				record certified by the sponsor.
1. The contact
				hour certificate(s) of attendance may be used for either the health officer or the
				registered environmental health specialist license application(s); for those
				individuals who apply for both licenses, the same contact hours acquired may be
				applied to the renewal of both licenses.
New Jersey Administrative Code › Title 8 - HEALTH › Chapter 7 - LICENSURE OF PERSONS FOR PUBLIC HEALTH POSITIONS › Subchapter 1 - GENERAL PROVISIONS › Section 8:7-1.18 - Continuing education advisory committee

Current through Register Vol. 56, No. 14, July 15, 2024
(a) The Department shall
				convene a continuing education advisory committee, which shall provide advice;
				examine trends, policies, and innovations; review needs assessment; and assist in
				the development of other pertinent activities regarding continuing education for
				public health professionals.
(b) The
				committee shall provide specific advice to the Board on issues regarding the ongoing
				process of the development of the continuing education rules and programs for health
				officers and registered environmental health specialists, as needed.
New Jersey Administrative Code › Title 8 - HEALTH › Chapter 8 - COLLECTION, PROCESSING, STORAGE AND DISTRIBUTION OF BLOOD › Subchapter 1 - GENERAL PROVISIONS › Section 8:8-1.1 - Compliance

Current through Register Vol. 56, No. 14, July 15, 2024
(a) Persons, known as
				licensees, for the purpose of this chapter, shall operate blood banks in this State
				and shall meet the qualifications and conduct blood banks in accordance with
				26:2A-2 et seq. and all rules in this
				chapter.
(b) Failure to comply with
				26:2A-2 et seq. and with this chapter
				shall be cause for revocation of license and imposition of penalties as prescribed
				by 26:2A-2 et seq.
New Jersey Administrative Code › Title 8 - HEALTH › Chapter 8 - COLLECTION, PROCESSING, STORAGE AND DISTRIBUTION OF BLOOD › Subchapter 1 - GENERAL PROVISIONS › Section 8:8-1.3 - Licensure

Current through Register Vol. 56, No. 14, July 15, 2024
(a) Application for an
				initial license to conduct a blood bank, as required under the provisions of
				26:2A-2 et seq., commonly known as the
				Blood Bank Licensing Act and this chapter, shall be made on forms provided for that
				purpose by the Department.
(b) A blood
				bank license shall be obtained whenever any function related to the collection,
				processing, storage, distribution or the administration of blood and blood
				components is performed.
(c) A separate
				blood bank license shall be obtained for each permanent location of a blood bank
				even if the location is owned and operated by the same licensee. No more than one
				blood bank license shall be issued for each location. However, a licensed blood bank
				may permit representatives of another licensed blood bank to provide services within
				its facility that are within the scope and consistent with the provisions of this
				chapter provided that the licensed blood bank director has reviewed and approved the
				SOP for that service.
(d) Renewal of the
				license shall be on an annual basis on or before November 10th of each year on forms
				provided for that purpose by the Department.
(e) Amendments to the license shall be as follows:
1. A license renewal shall be obtained 30 days
				prior to a change in the location or the name of the blood bank.
2. The Department shall be notified in writing, 30
				days prior to a change, whenever the ownership, corporate structure, director,
				and/or services of a blood bank change.
New Jersey Administrative Code › Title 8 - HEALTH › Chapter 8 - COLLECTION, PROCESSING, STORAGE AND DISTRIBUTION OF BLOOD › Subchapter 1 - GENERAL PROVISIONS › Section 8:8-1.4 - Inspection

Current through Register Vol. 56, No. 14, July 15, 2024
(a) Blood bank
				facilities and operations shall be made available for inspection upon request by any
				authorized representative of the Department during normal working hours.
(b) Reports of inspections of blood banks made by
				the Center for Biologics Evaluation and Research may be accepted for purposes of
				approving and issuing renewal of licenses.
New Jersey Administrative Code › Title 8 - HEALTH › Chapter 8 - COLLECTION, PROCESSING, STORAGE AND DISTRIBUTION OF BLOOD › Subchapter 1 - GENERAL PROVISIONS › Section 8:8-1.5 - Proficiency testing

Current through Register Vol. 56, No. 14, July 15, 2024
(a) Blood banks shall
				successfully participate in Department approved proficiency testing
				surveys.
(b) Records of all proficiency
				testing results shall be maintained, including results and
				interpretations.
(c) Proficiency test
				results shall be periodically reviewed and evaluated by the blood bank
				director.
(d) Proficiency testing shall
				be performed in accordance with the proficiency testing requirements specified in
				N.J.A.C. 8:44.
New Jersey Administrative Code › Title 8 - HEALTH › Chapter 8 - COLLECTION, PROCESSING, STORAGE AND DISTRIBUTION OF BLOOD › Subchapter 1 - GENERAL PROVISIONS › Section 8:8-1.6 - Brokers

Current through Register Vol. 56, No. 14, July 15, 2024
(a) Brokers shall obtain
				a blood bank license.
(b) Brokers shall
				maintain records in accordance with all applicable standards and procedures set
				forth in this chapter.
New Jersey Administrative Code › Title 8 - HEALTH › Chapter 8 - COLLECTION, PROCESSING, STORAGE AND DISTRIBUTION OF BLOOD › Subchapter 1 - GENERAL PROVISIONS › Section 8:8-1.7 - Waivers

Current through Register Vol. 56, No. 14, July 15, 2024
The Department is empowered to waive such of these regulations as
				  may be necessary for purposes of research, experimentation and new methodologies in
				  blood banking activities, provided requests for such activities, are received in
				  writing and approved by the Department prior to initiation of the activity.
New Jersey Administrative Code › Title 8 - HEALTH › Chapter 8 - COLLECTION, PROCESSING, STORAGE AND DISTRIBUTION OF BLOOD › Subchapter 1 - GENERAL PROVISIONS › Section 8:8-1.8 - Public Health Council

Current through Register Vol. 56, No. 14, July 15, 2024
The Public Health Council on the advice of the Commissioner may
				  promulgate, enforce and may amend or repeal these regulations that at any given time
				  shall be no less stringent than the complete interim or revised Code of Federal
				  Regulations in effect at that time. In administering the Blood Bank Licensing Act,
				  the Department can seek the advice and recommendations of an advisory
				  committee.
New Jersey Administrative Code › Title 8 - HEALTH › Chapter 8 - COLLECTION, PROCESSING, STORAGE AND DISTRIBUTION OF BLOOD › Subchapter 2 - PERSONNEL › Section 8:8-2.2 - Blood bank director

Current through Register Vol. 56, No. 14, July 15, 2024
(a) The blood bank
				director and the licensee shall be responsible for compliance with
				26:2A-2 et seq. and the rules set forth
				in this chapter.
(b) The blood bank
				director shall administer the licensed activities of the blood bank as follows:
1. The director shall be responsible and shall
				have authority for all procedures and policies relating to all phases of donor and
				recipient testing as well as the collection, processing, storage, and distribution
				of all blood and blood components. Procedures and policies for the administration of
				blood and blood components shall be established in consultation with the blood bank
				director.
2. The director shall not
				individually serve as director or co-director of more than three blood banks,
				laboratories or one health system. If the blood bank is an integral part of the
				clinical laboratory, this shall be considered one facility.
3. The director shall spend an adequate amount of
				time in the blood bank to direct and supervise the technical performance of the
				staff. The director shall be readily available for personal or telephone
				consultation.
4. The director shall be
				responsible for the blood bank personnel's in-service training and their adherence
				to established policies and procedures.
5. If the director is to be absent, the director
				must arrange for a qualified substitute director.
6. The director may delegate his or her
				responsibilities for administering the licensed activities of the blood bank to a
				properly qualified and trained designee. If the director appoints a designee, the
				director shall be responsible for the proper performance of all the designee's
				duties and these duties shall be outlined in the SOP.
New Jersey Administrative Code › Title 8 - HEALTH › Chapter 8 - COLLECTION, PROCESSING, STORAGE AND DISTRIBUTION OF BLOOD › Subchapter 2 - PERSONNEL › Section 8:8-2.3 - Blood bank personnel

Current through Register Vol. 56, No. 14, July 15, 2024
(a) The blood bank shall
				have one or more supervisors who under the general direction of the blood bank
				director supervise all functions related to the collection, processing, testing,
				storage and distribution of blood and blood components, and in the absence of the
				blood bank director are responsible for proper performance of these
				procedures.
(b) General provisions for
				donor/transfusion related personnel are:
1. Each
				blood bank during the collection or transfusion of blood shall have a responsible
				individual on the premises who, according to
				8:8-2.3(d), shall be
				qualified to provide emergency care and in out-of-hospital transfusion situations
				performs the transfusion.
2. An adequate
				number of personnel shall be available.
3. Personnel associated with donor or transfusion
				related functions shall be suitably trained through a formal training program and
				supervised in the performance of their prescribed tasks. Personnel shall demonstrate
				their competency to the satisfaction of the director of the blood bank.
New Jersey Administrative Code › Title 8 - HEALTH › Chapter 8 - COLLECTION, PROCESSING, STORAGE AND DISTRIBUTION OF BLOOD › Subchapter 3 - FACILITIES, EQUIPMENT AND CONTAMINATED MATERIAL › Section 8:8-3.1 - Facilities and equipment

Current through Register Vol. 56, No. 14, July 15, 2024
(a) Quarters,
				environment, and equipment shall be provided to maintain safe and acceptable
				standards for handling of human blood and blood components.
(b) Blood donor facilities shall consist of at
				least a waiting room, private screening area for donor questioning, bleeding area,
				donor recovery area, lavatory facilities and the proper equipment for collection and
				immediate storage of blood.
(c) The
				blood bank shall also provide a processing laboratory as follows:
1. The laboratory shall have appropriate equipment
				for donor and/or recipient testing, component preparation, record keeping, storage
				and distribution of blood and blood components.
2. All laboratory tests required for proper donor
				blood processing, not performed by the collecting facility, shall be referred to a
				laboratory or blood bank licensed in New Jersey or hold an applicable Federal
				certificate or license.
3. The blood
				bank shall identify all equipment that is critical to the provision of blood and
				blood components with unique identification and shall provide a schedule to ensure
				that all critical equipment is monitored and maintained as required by the
				manufacturer and in accordance with this chapter.
New Jersey Administrative Code › Title 8 - HEALTH › Chapter 8 - COLLECTION, PROCESSING, STORAGE AND DISTRIBUTION OF BLOOD › Subchapter 3 - FACILITIES, EQUIPMENT AND CONTAMINATED MATERIAL › Section 8:8-3.2 - Contaminated material

Current through Register Vol. 56, No. 14, July 15, 2024
Contaminated material shall be disposed in a manner consistent
				  with the rules of the New Jersey Department of Health and Senior Services and the
				  New Jersey Department of Environmental Protection at N.J.A.C. 7:26-3A.
New Jersey Administrative Code › Title 8 - HEALTH › Chapter 8 - COLLECTION, PROCESSING, STORAGE AND DISTRIBUTION OF BLOOD › Subchapter 4 - MANAGEMENT › Section 8:8-4.1 - Quality control and quality assurance

Current through Register Vol. 56, No. 14, July 15, 2024
(a) All blood banks
				shall have quality control and quality assurance programs which shall be in
				compliance with these rules, and shall be sufficiently comprehensive to ensure that
				blood and blood components, reagents and equipment perform as expected.
(b) The quality control and the quality assurance
				programs shall include at least the following:
1.
				Written procedures that include all policies and procedures developed for
				use;
2. Evidence of validation of
				methods;
3. Evidence of periodic
				evaluation of reagents and equipment including the date of performance;
4. Evidence of periodic evaluation of blood and
				blood components in accordance with, whichever is more stringent, the current Code
				of Federal Regulations and/or the current Standards of the American Association of
				Blood Banks;
5. Evidence of periodic
				evaluation to determine that policies and procedures are appropriate and are
				followed;
6. Evidence of daily review of
				computer maintained error correction records by the blood bank director or
				supervisor.
7. Evidence of appropriate
				and timely corrective action;
8. Review
				by the supervisor or the director;
9.
				Evidence of self-evaluation of the clinical appropriateness of licensed activities;
				and
10. Documented evidence of
				monitoring of the transfusion which shall include:
i. The type of the component;
ii. The blood unit identification
				number;
iii. The pre-transfusion,
				15-minute and post-transfusion vital signs;
iv. The volume transfused;
v. The identities of the transfusionist and the
				reviewing staff; and
vi. Notation of any
				suspected transfusion reaction.
New Jersey Administrative Code › Title 8 - HEALTH › Chapter 8 - COLLECTION, PROCESSING, STORAGE AND DISTRIBUTION OF BLOOD › Subchapter 4 - MANAGEMENT › Section 8:8-4.2 - Standard operating procedures

Current through Register Vol. 56, No. 14, July 15, 2024
(a) All policies and
				procedures developed for use in the blood bank and required by this chapter shall be
				detailed in a manual(s) of SOP.
(b) Each
				procedure shall have a current pertinent literature reference.
(c) The actual test procedures used shall coincide
				with the manufacturers' current product insert or written documentation from the
				manufacturer.
(d) The most current
				edition of the manufacturer's product inserts shall be available.
(e) The manual(s) of SOP shall be reviewed by the
				blood bank director annually and this review shall be documented by date and the
				blood bank director's signature.
(f) All
				significant changes to procedures shall be reviewed, dated and signed by the blood
				bank director.
New Jersey Administrative Code › Title 8 - HEALTH › Chapter 8 - COLLECTION, PROCESSING, STORAGE AND DISTRIBUTION OF BLOOD › Subchapter 4 - MANAGEMENT › Section 8:8-4.3 - Documented review

Current through Register Vol. 56, No. 14, July 15, 2024
(a) When blood or blood
				components are collected and/or prepared, a key individual in the operation of the
				blood bank shall conduct a documented review prior to the release and final labeling
				of blood and blood components to ensure that blood from unsuitable donors shall not
				be distributed for transfusion or further manufacture. If this function is performed
				by computer, validation of the computer programs, as outlined in
				8:8-5.1(e)  shall be
				performed. This review procedure shall be in writing and the procedure shall include
				tracking of all collected and/or prepared blood and blood components, to assure
				that:
1. The sequence of the numbers of the blood
				and blood components drawn are verified and donor numbers for which no donations are
				available are accounted for;
2. All
				required testing, as outlined in
				8:8-7.2, Testing, is performed on all
				blood and blood components, with specimens drawn from the donor at the time of
				collection, before release for transfusion. For granulocytes, the specimen may be
				drawn up to 10 days prior to collection;
3. Blood or blood components with positive or
				questionable test results are not released for allogeneic transfusions;
4. Blood or blood components collected from donors
				that shall be deferred are not released for allogeneic transfusion or for further
				manufacture;
5. If required tests are
				performed by the blood bank, the testing is performed correctly and properly
				interpreted as determined by at least the following criteria:
i. Personnel are following the blood bank's
				established procedures for the test;
ii.
				Equipment is correctly set-up for test method specific adjustments;
iii. Test results on the machine printout can be
				traced to the worklist;
iv. Test runs,
				that are unacceptable by the criteria specified in the manufacturers' product
				insert, are repeated;
v. Appropriate
				repeat testing is performed; and
vi.
				Review of the interpretation of all final test results to assure that the
				interpretation complies with state requirements, when applicable, or the
				manufacturers' product insert;
6. If required tests are performed by personnel
				outside the blood bank, the criteria used to determine a final reactive or
				nonreactive result coincides with the blood bank's own policy of interpreting
				results used to discard blood and blood components for transfusion; and
7. That all blood and blood components from
				donations that have positive or questionable test results are quarantined until
				their final disposition is determined or they are destroyed.
New Jersey Administrative Code › Title 8 - HEALTH › Chapter 8 - COLLECTION, PROCESSING, STORAGE AND DISTRIBUTION OF BLOOD › Subchapter 4 - MANAGEMENT › Section 8:8-4.4 - Errors and accidents

Current through Register Vol. 56, No. 14, July 15, 2024
(a) If an error occurs
				and any component prepared from a unit improperly tested, not tested, or tested
				properly but improperly interpreted for ABO or infectious diseases is labeled and
				released for transfusion, fractionation, reagent production, research or other use,
				immediate effort shall be made to locate and quarantine all components until
				satisfactory resolution occurs.
(b) If
				an accident occurs and any component is released, which is not suitable for
				transfusion, fractionation, reagent production, research or other use, immediate
				effort shall be made to locate and destroy all components.
(c) If a whole blood unit or any blood component
				has been transfused prior to recognition of the error or accident, the medical
				director of the blood collection facility shall be immediately notified and shall
				take immediate appropriate action to resolve the problem. If the error or accident
				has resulted in the transfusion of blood or blood components that could result in
				infectious disease or other harmful consequences, appropriate medical staff from the
				collection facility shall notify the patient/recipient's hospital blood bank
				director who shall document that the patient/recipient's physician is notified of
				the error or accident and advised that it is his or her responsibility to notify the
				patient/recipient or his or her representative. Thorough and complete documentation
				shall be made as to these actions.
New Jersey Administrative Code › Title 8 - HEALTH › Chapter 8 - COLLECTION, PROCESSING, STORAGE AND DISTRIBUTION OF BLOOD › Subchapter 5 - RECORDS AND REPORTING REQUIREMENTS › Section 8:8-5.1 - Records

Current through Register Vol. 56, No. 14, July 15, 2024
(a) Suitable legible
				records prepared with indelible material shall be maintained for a period of not
				less than five years. Records needed to trace a unit of blood or blood component
				from its source to final disposition shall be kept for at least 10 years after
				transfusion or five years after the latest expiration date for the individual
				product, but in no case for less than 10 years.
1.
				The blood bank shall have a policy addressing the confidentiality of donor and
				recipient records.
New Jersey Administrative Code › Title 8 - HEALTH › Chapter 8 - COLLECTION, PROCESSING, STORAGE AND DISTRIBUTION OF BLOOD › Subchapter 5 - RECORDS AND REPORTING REQUIREMENTS › Section 8:8-5.2 - Reporting requirements

Current through Register Vol. 56, No. 14, July 15, 2024
(a) Blood banks shall
				report transfusion reactions to the Department as follows:
1. Hemolytic and/or delayed hemolytic and other
				known or suspected life-threatening transfusion reactions within 10 days of the
				occurrence, using the form at chapter Appendix A, incorporated herein by reference;
				and
2. Known and/or suspected fatal
				transfusion reactions by telephone call to (609) 292-0522 by the next working day
				after the day the event occurs, with written follow-up within 10 days of the
				occurrence, using the form at chapter Appendix A, incorporated herein by
				reference.
New Jersey Administrative Code › Title 8 - HEALTH › Chapter 8 - COLLECTION, PROCESSING, STORAGE AND DISTRIBUTION OF BLOOD › Subchapter 6 - CRITERIA FOR DONOR SELECTION › Section 8:8-6.1 - Donor identification

Current through Register Vol. 56, No. 14, July 15, 2024
(a) Blood donors shall
				be identified by an identification card or another form of authorized
				identification.
(b) The type of
				identification used shall be written on the donor registration card at the time of
				each blood donation.
New Jersey Administrative Code › Title 8 - HEALTH › Chapter 8 - COLLECTION, PROCESSING, STORAGE AND DISTRIBUTION OF BLOOD › Subchapter 6 - CRITERIA FOR DONOR SELECTION › Section 8:8-6.2 - Medical history; physical examinations; bleeding limitations

Current through Register Vol. 56, No. 14, July 15, 2024
Medical history, physical examinations, and bleeding limitations
				  of the donor shall be consistent with, whichever is more stringent, the most recent
				  Code of Federal Regulations or the most recent Standards of the American Association
				  of Blood Banks. If necessary, these documents may be reviewed at the Department of
				  Health and Senior Services, Clinical Laboratory Improvement Services, Health and
				  Agriculture Building, Room 401, Trenton, New Jersey 08625-0361. In addition, for
				  emerging issues, the most recent FDA guidelines shall be followed. These documents
				  are available at
www.fda.gov/cber/guidelines.htm
.
New Jersey Administrative Code › Title 8 - HEALTH › Chapter 8 - COLLECTION, PROCESSING, STORAGE AND DISTRIBUTION OF BLOOD › Subchapter 6 - CRITERIA FOR DONOR SELECTION › Section 8:8-6.3 - Donor selection; deferral records; deferral notice to donor

Current through Register Vol. 56, No. 14, July 15, 2024
(a) Blood bank personnel
				trained to conduct donor eligibility screening in accordance with AABB Standards,
				the Code of Federal Regulations, and the blood bank's policies and procedures shall
				evaluate each prospective donor's history on the day of donation to ensure that the
				prospective donor meets the criteria for blood donation contained in the AABB
				Standards and the Code of Federal Regulations, and shall defer any person who does
				not meet these criteria.
(b) Blood banks
				shall adhere to the Code of Federal Regulations in the maintenance of records with
				respect to the temporary and permanent deferral of persons from donating
				blood.
(c) If, as a result of laboratory
				testing of donated blood, a blood bank determines that a donor meets criteria for
				permanent deferral, the blood bank shall transmit written notice to the donor
				informing the donor that he or she is permanently deferred and cannot donate blood
				for allogeneic use and that the blood bank will maintain his or her name in the
				blood bank's record of persons permanently deferred from donating blood.
New Jersey Administrative Code › Title 8 - HEALTH › Chapter 8 - COLLECTION, PROCESSING, STORAGE AND DISTRIBUTION OF BLOOD › Subchapter 6 - CRITERIA FOR DONOR SELECTION › Section 8:8-6.4 - Information provided to the donor

Current through Register Vol. 56, No. 14, July 15, 2024
(a) Consent shall be
				obtained in writing from the prospective donor after the procedure has been
				explained in terms the donor can understand and after the donor has had an
				opportunity to ask questions and refuse consent. Consent shall include information
				on significant risks of the procedure and tests performed to reduce the risks of
				infectious disease to the recipient.
(b)
				The donor shall be instructed in post phlebotomy care and cautioned as to possible
				adverse reactions.
(c) The blood bank
				director shall be responsible for a mechanism for notifying the donors of the cause
				of rejection.
New Jersey Administrative Code › Title 8 - HEALTH › Chapter 8 - COLLECTION, PROCESSING, STORAGE AND DISTRIBUTION OF BLOOD › Subchapter 6 - CRITERIA FOR DONOR SELECTION › Section 8:8-6.5 - AIDS screening requirements

Current through Register Vol. 56, No. 14, July 15, 2024
(a) All blood and blood
				components collected in New Jersey are subject to the requirements of this
				section.
(b) Educational material shall
				be given to the blood donors prior to the collection of blood which will allow
				donors to determine whether or not they have engaged in high risk
				behavior.
(c) All donors including those
				utilized in hemapheresis, shall be screened by history for the early signs and
				symptoms of AIDS.
(d) The collecting
				agency shall ensure that all blood and blood components collected in New Jersey,
				including those obtained by hemapheresis, be tested for HIV-1 and HIV-2 as specified
				in 8:8-7.2. Laboratory tests not performed
				by the collecting facility shall be referred to a blood bank or laboratory licensed
				to perform HIV testing by the Department as specified in
				8:8-3.1(c)2. It shall
				be the responsibility of the receiving blood bank to assure that any blood brought
				in from out-of-state sources shall be tested for HIV types 1 and 2 in accordance
				with testing methods specified in AABB Standards and FDA regulations. If the blood
				is used for allogeneic transfusion, it shall be tested as all other blood and blood
				components.
(e) Blood and blood
				components that are positive, as defined by Centers for Disease Control (CDC) in the
				"Morbidity and Mortality Weekly Report" of August 14, 1987, in "Laboratory Evidence
				for or Against HIV Infection," as amended and supplemented, incorporated herein by
				reference, to serologic tests for HIV types 1 and 2 or collected from a donor known
				to be positive to serologic tests for HIV types 1 and 2 shall either be discarded or
				used for research purposes only.
(f)
				Prior to a donation of blood or blood component each donor shall be notified in
				writing and shall have signed a written statement confirming that:
1. The blood or blood components shall be tested
				for evidence of the probable causative agent of acquired immune deficiency
				syndrome.
2. Donors found to have
				serologic evidence of HIV shall be placed on a confidential internal deferral list
				and may, if deemed appropriate by the Department, a confidential statewide deferral
				list.
3. The donor shall be notified of
				the test results in accordance with requirements described in (i) below.
4. Blood or blood components shall not be donated
				for transfusion purposes by a person if the person has reason to believe that he or
				she has engaged in high risk behavior.
New Jersey Administrative Code › Title 8 - HEALTH › Chapter 8 - COLLECTION, PROCESSING, STORAGE AND DISTRIBUTION OF BLOOD › Subchapter 7 - BLOOD AND BLOOD COMPONENTS › Section 8:8-7.1 - General criteria

Current through Register Vol. 56, No. 14, July 15, 2024
(a) The procedure for
				the collection, processing, storage, and distribution of blood and blood components
				shall meet the requirements of this chapter.
(b) Blood banks shall establish criteria for
				collection, processing, storage, and distribution, according to current standards,
				acceptable to the Department.
(c) Sale
				or exchange of blood and/or blood products positive for HIV and/or HBsAg shall not
				be made without the express permission, in writing, of the Department.
(d) Blood banks distributing blood and blood
				components shall:
1. Have available an information
				circular with each product explaining its proper indications and usage (thawing,
				dosage, stability, side effects, adverse reactions, hazards, etc.);
2. Provide accurate expiration dates and hours on
				the container label for all blood and blood components; and
3. Meet licensed expiration dates for the
				product.
New Jersey Administrative Code › Title 8 - HEALTH › Chapter 8 - COLLECTION, PROCESSING, STORAGE AND DISTRIBUTION OF BLOOD › Subchapter 7 - BLOOD AND BLOOD COMPONENTS › Section 8:8-7.2 - Testing

Current through Register Vol. 56, No. 14, July 15, 2024
(a) All laboratory tests
				shall be made on specimens of blood taken from the donor at the time of phlebotomy
				in properly identified tubes. For granulocytes, the specimen may be drawn 10 days
				prior to collection.
(b) When available,
				FDA licensed reagents shall be used for screening tests.
(c) Required infectious disease testing includes a
				serologic test for syphilis (STS), Hepatitis B Surface Antigen (HBsAg), antibody to
				Hepatitis C Virus (HCV), HCV RNA, Hepatitis B Core Antibody (HBcAb), antibody to
				Human Immunodeficiency Virus Type I (HIV-1), HIV-1 RNA, antibody to Human
				Immunodeficiency Virus Type 2 (HIV-2) and antibody to Human T-Lymphotrophic viruses
				I/II (HTLV I/II).
(d) Testing shall be
				performed as required in
				8:8-7.2 and shall adhere to FDA
				regulations.
(e) The blood or blood
				components shall not be used for therapeutic purposes unless results of test(s) are
				clearly negative except where delay occasioned by testing may result in serious
				threat to the health and well-being of the recipient.
(f) In instances where untested units are
				transfused, the attending physician shall attest in writing to the existence of an
				emergency and if the test is subsequently positive, the recipient's physician shall
				be notified.
(g) Determination of ABO
				group shall be as follows:
1. Each container of
				blood shall be properly identified and labeled as to its blood group.
2. The ABO group of each blood donation shall be
				determined by testing the red cells of the donor using known Anti-A and Anti-B
				reagents, and by testing the serum or plasma for expected antibodies using known A1
				and B red blood cells. The two methods of testing shall be recorded and be in
				complete agreement before any label or release can be effected for the unit of
				blood.
3. All Anti-A and Anti-B reagents
				shall meet the Code of Federal Regulations minimum requirements, and the procedures
				used shall follow the manufacturer's directions.
4. Previous records of ABO group shall not serve
				as identification of units subsequently given by the same donor. New determinations
				shall be made for each collection.
New Jersey Administrative Code › Title 8 - HEALTH › Chapter 8 - COLLECTION, PROCESSING, STORAGE AND DISTRIBUTION OF BLOOD › Subchapter 8 - COLLECTION OF BLOOD › Section 8:8-8.1 - General criteria

Current through Register Vol. 56, No. 14, July 15, 2024
(a) Blood banks wishing
				to employ the techniques set forth in this subchapter shall file their protocol and
				a request in writing to the Department, prior to initiation of this
				service.
(b) The techniques set forth in
				this subchapter can be employed upon receipt of written approval from the
				Department.
New Jersey Administrative Code › Title 8 - HEALTH › Chapter 8 - COLLECTION, PROCESSING, STORAGE AND DISTRIBUTION OF BLOOD › Subchapter 8 - COLLECTION OF BLOOD › Section 8:8-8.2 - Donor emergency care

Current through Register Vol. 56, No. 14, July 15, 2024
(a) Blood shall be drawn
				from donors only when donor emergency care personnel are available on the premises
				in accordance with
				8:8-2.3(d).
(b) The blood bank director may determine on a
				case-by-case basis with each blood collection drive, as a means to increase the
				availability of the State's blood supply, that a particular blood collection drive
				is exempt from the emergency care personnel requirement in (a) above, so long as
				prior to making that determination the blood bank has made a reasonable effort, in
				the manner specified in the blood bank's standard operating procedures which are
				required under (c)1 below, to schedule a physician or nurse for that blood drive and
				has determined that one is not available and so long as the conditions set forth in
				(c) below are met.
(c) Each of the
				following conditions shall be met in order for the blood bank director to authorize
				an exemption under (b) above:
1. The blood bank
				shall draft a standard operating procedure outlining the requirements for granting
				an exemption from the emergency care personnel requirement in (a) above;
2. The blood bank director shall conduct the blood
				collection drive in accordance with the blood bank's standard operating
				procedure;
3. Alternative emergency care
				personnel shall be present at the site of the blood collection drive who meet
				training, education and experience requirements established by the blood bank
				director and who, at a minimum, possess current CPR and standard first aid
				certifications, and have readily available either land line or cell phone
				communications to immediately call 9-1-1 for assistance in the event of a medical
				emergency;
4. The blood bank shall
				maintain accurate records documenting all occurrences when the blood bank director
				has authorized an exemption under (b) above, including the date and location of the
				blood collection drive, the name and signature of the blood bank director who
				authorized the exemption and the rationale for the blood bank director's
				determination that the blood collection drive is exempt from the emergency care
				personnel requirement in (a) above; and
5. Notwithstanding any of the provisions of this
				chapter to the contrary, the blood bank director shall not grant an exemption under
				(b) above under any of the following circumstances:
i. When blood is to be collected from a group
				predominantly made up of high school aged students; or
ii. When blood is to be collected for the express
				purpose of autologous collection or maternal/fetal collection that is not conducted
				in a general hospital.
New Jersey Administrative Code › Title 8 - HEALTH › Chapter 8 - COLLECTION, PROCESSING, STORAGE AND DISTRIBUTION OF BLOOD › Subchapter 8 - COLLECTION OF BLOOD › Section 8:8-8.3 - Medical contingency plan

Current through Register Vol. 56, No. 14, July 15, 2024
(a) Each location for
				collection or the transfusion of blood and blood components shall have a current
				medical contingency plan specific for that location which shall include:
1. Immediate access to an identified land line
				telephone for notification of 9-1-1 or other emergency care services; and
2. A detailed SOP developed by the blood bank
				director outlining the circumstances under which 9-1-1 or other emergency care
				services shall be immediately notified.
New Jersey Administrative Code › Title 8 - HEALTH › Chapter 8 - COLLECTION, PROCESSING, STORAGE AND DISTRIBUTION OF BLOOD › Subchapter 8 - COLLECTION OF BLOOD › Section 8:8-8.4 - Donor protection

Current through Register Vol. 56, No. 14, July 15, 2024
(a) Preparation of the
				donor's skin for phlebotomy shall be adequate to afford protection from infection to
				the donor and to the future recipient.
(b) All equipment used in the collection of blood,
				such as syringes, needles, lancets or other blood letting devices, capable of
				transmitting infection to donor or recipient, shall be sterile and pyrogen
				free.
(c) Disposable thermometers or
				other temperature checking device maintained in a sanitary manner shall be
				used.
(d) All personnel concerned with
				the collection of blood shall be instructed in appropriate first aid procedures in
				the event of donor reaction.
(e)
				Suitable drugs, supplies and instructions for use shall be immediately available at
				all times.