(a) Persons operating blood banks in this State shall meet the qualifications and conduct blood banks in conformity with N.J.S.A. 26:2A all regulations of this Chapter.
(b) Failure to comply with these regulations shall be cause for revocation of license and imposition of penalties by law.
8:8-1.2 Definitions
For the purpose of this chapter, the terms listed below shall be defined and interpreted as follows:
"Additive solution system" means blood preservative systems designed primarily for the extended storage of red blood cells. These systems utilize a second preservative solution for red cell storage in addition to anticoagulant solution necessary for whole blood collection.
"Autologous donation/transfusion" means the collection of blood a blood components from a donor/recipient for subsequent reinfusion in the same individual.
"Blood bank" means any facility involved in the handling of hum blood, blood components or products and which participates in any of the following operations: collection, processing, donor and recipient testing, the storage and distribution of blood and blood components.
"Blood bank director" means a physician licensed in the State with general responsibility for all procedures and policies relating to the donor and recipient, as well as, the collection, processing, storage and distribution of all blood and blood components.
"Blood components" means those preparations that are separate from whole blood and are intended for use as final products for transfusion for further manufacturing, or as products used for in vitro testing.
"Brokerage" means procuring, selling and distributing of whole blood components and blood products without engaging in processing, alteration or other manipulation of the blood component.
"Closed system" means a system in which the blood container is not entered or air introduced.
"Code of Federal Regulations" means the current Code of Federal Regulations, Title 21.
"Collection" means the procedure for obtaining blood by donor phlebotomy.
"Commissioner" means the commissioner of the New Jersey State Department of Health or his duly authorized agent.
"Crossing over" means the transfusion of blood and/or blood components, originally collected for autologous transfusion, to a recipient other than the original donor/recipient.
"Cytapheresis" means the procedure in which blood is removed from the donor, certain cellular elements are separated, and the remaining formed elements and residual plasma are returned to the donor.
"Department" means the New Jersey State Department of Health.
"Designated donor" means a donor that is selected by a recipient for transfusion to this recipient at a later date.
"Directed donation" means the collection of blood or blood components from a designated donor.
"Distribution" means the transfer of blood or blood components from one blood bank facility to any other location for processing or storage or for the purpose of providing the blood for therapeutic, prophylactic or in vitro purposes.
"Donor" means and includes any individual from whom blood or components are collected by a blood bank.
"Health system" means a multidivisional hospital with a blood bank and no more than three satellite blood bank facilities.
"Hemapheresis" means the process of separating freshly drawn whole blood into various components, some of which are retained while the remainder is reinfused into the donor.
"Homologous donation" means the collection of blood or blood components for subsequent transfusion to a recipient other than the donor.
"HIV" means the Human Immunodeficiency Virus, formerly known as the Human T-Lymphotropic Virus Type Ill/Lymphodenopathy-Associated Virus (HTLV-III/LAV) and currently known as HIV-l.
"Key person" means individuals designated by the blood bank director.
"Mobile unit" means a moveable unit that is used to collect blood from donors not at the blood bank site.
"Office of Biologics" means the Federal Office of Biologics, Department of Health and Human Services.
"Phlebotomist" means a person who obtains blood from donors by venipuncture.
"Plasmapheresis" means the procedure in which blood is removed from the donor, the plasma is separated from the formed elements and at least the red blood cells are returned to the donor.
"Preparation" means the method used to manufacture blood and blood components.
"Processing" means all tests and procedures required to prepare and identify the blood and blood products as to their suitability for therapeutic, prophylactic or other in vivo or in vitro purposes.
"Pyrogen-free" means a system free from any material capable of causing a febrile response.
"Reagent" means a substance used for any in vitro purpose.
"Recipient" means any person who receives a transfusion of whole blood or blood components.
"Satellite blood bank" means a facility which is part of a health system which does emergency or limited blood banking activities.
"Service" means any of the functions outlined in the Blood Bank License Application form supplied by the Department.
"Significant step" means any step that would be necessary to reconstruct, from the record alone, the procedures performed and who performed them.
"Stationary collection site" means a site for a blood bank that is permanently located at another facility and performs no function other than collection.
"Storage" means the physical environment of blood or blood components during collection, storage, distribution, transportation or processing.
"Subsidiary blood bank" means a blood bank that is owned or controlled by a parent blood bank.
"Surrogate testing" means the use of alanine-amino transferase (ALT) and Hepatitis B Core Antibody tests to determine the possible presence of non-A, non-B hepatitis.
"Therapeutic phlebotomy" means the removal of whole blood from a donor for the purpose of medical treatment.
8:8-1.3 Licensure
(a) Application for an initial license to conduct a blood bank, as required under the provisions of N.J.S.A. 26:2A-1 et seq. commonly known as the Blood Bank Licensing Act and this chapter, shall be made on forms provided for that purpose by the State of New Jersey.
(b) A blood bank license shall be obtained for each subsidiary blood bank.
(c) Renewal of the license will be on an annual basis on or before November 10th of each year on forms provided for that purpose by the State of New Jersey.
(d) Amendments to the license shall be as follows:
1. A license renewal shall be obtained within 14 days whenever the name or the location of a blood bank is changed.
2. The Department shall be notified in writing within 14 days whenever the ownership, corporate structure, director, and/or services of a blood bank change.
(e) The blood bank shall perform only those services, related to this chapter, for which they specifically request and receive licensure. In the case of new services, written approval shall be received from the Department.
(f) Pursuant to N.J.S.A. 26:2A-4, the following blood bank licensure fees shall be effective November 1, 1992:
1. Transfusion Services:
Number of Transfusions Fee
0-1,000 $200.00
1,001-2,000 300.00
2,001-3,000 400.00
3,001-4,000 500.00
4,001-5,000 600.00
5,001-+ 700.00
2. Collection Centers:
Number of Collections Fee
0- 200 $ 250.00
201- 1,500 500.00
1,501- 3,000 750.00
3,001- 5,000 1,000.00
5,001-10,000 1,250.00
10,001-15,000 1,500.00
15,001-25,000 1,600.00
25,001-35,000 1,700.00
35,001-50,000 1,800.00
50,001- + 1,900.00
3. Other Blood Bank Services:
type Fee
Collection Site $100.00
Broker 200.00
Industrial Blood Bank 200.00
Home Transfusion Service 200.00
8:8-1.4 Inspection
(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 Office of biologics or any private national accrediting agency approved by the Department may be accepted for purposes of approving and issuing renewal of licenses.
8:8-1.5 Proficiency testing
(a) Blood banks must successfully participate in a proficiency testing program approved by the Department.
(b) Records in all proficiency testing results must be maintained, including results and interpretations, and a periodic review by the blood bank director.
8:8-1.6 Brokers
Brokers shall maintain records, applicable to the Department, of all applicable standards and procedures set forth in this chapter.
8:8-1.7 Exemptions
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.
8:8-1.8 Waivers
The Public Health Council on the advise 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 advise and recommendations of an advisory committee.
SUBCHAPTER 2. PERSONNEL
8:8-2.1 Blood bank director
(a) The blood bank director shall administer the blood bank as follows:
1. The director shall be responsible 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.
2. The director shall not individually serve as director or co-director of more than three blood banks, laboratories or one health system.
3. If the blood bank is an integral part of the clinical laboratory, this will be considered one facility.
4. The director shall spend an adequate amount of time in the blood bank to direct and supervise the technical performance of the staff. He shall be readily available for personal or telephone consultation.
5. The director is responsible for the employment of qualified blood bank personnel and their in-service training.
6. If the director is to be absent, the director must arrange for a qualified substitute director.
(b) Qualifications:
1. The blood bank director must have four years of full time clinical experience, of which at least two years were spent acquiring proficiency in blood banking.
2. This experience must include all phases of blood banking including but not limited to:
i. Donor and recipient testing;
ii. The collection, preparation, storage, processing and distribution; and where applicable;
iii. Transfusion of whole blood and blood components.
8:8-2.2 Donor related personnel
(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 of blood and blood components, and in the absence of the blood bank director are responsible for the proper performance of these procedures.
(b) General provisions for donor related personnel are:
1. Each blood bank during the collection of blood shall have a responsible individual on the premises who according to N.J.A.C. 8:8-2.2(c), is qualified to provide emergency care.
2. An adequate number of phlebotomists shall be available.
3. All other personnel associated with donor related functions must be suitably trained and supervised in the performance of their prescribed tasks.
(c) Donor emergency care personnel qualifications are as follows:
1. A physician licensed in the State or a registered nurse (R.N.) holding a current certificate of registration who has fulfilled the following requirements:
i. Has demonstrated his or her familiarity with donor eligibility standards to the satisfaction of the director of the blood bank;
ii. Has taken an eight hour course in cardiopulmonary resuscitation within three years and successfully passed a practical and written exam on the subject matter.
(d) A phlebotomist shall be properly trained or supervised for six months and be proficient in the collection of blood from a donor.
(e) All other personnel associated with donor related functions must be suitably trained and supervised in the performance of their prescribed tasks.
8:8-2.3 Laboratory personnel
(a) The laboratory shall have one or more supervisors who under the general direction of the blood bank director supervise technical personnel, perform tests requiring special skills, and in the absence of the director are responsible for proper performance of all laboratory procedures.
(b) There shall be a sufficient number of properly qualified technical personnel to meet volume and complexity of technical procedures performed by the laboratory.
(c) The laboratory supervisor and laboratory personnel must meet the requirements of N.J.A.C. 8:44 under Regulations for Supervision and Technical Personnel.
SUBCHAPTER 3. FACILITIES, EQUIPMENT AND CONTAMINATED MATERIAL
8:8-3.1 Facilities and equipment
(a) Quarters, environment, and equipment acceptable to the Department 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, 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.
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, must be referred to a laboratory or blood bank licensed by the Department or possess a Federal interstate license.
8:8-3.2 Contaminated material
Contaminated material shall be disposed in a manner consistent with current standards of the New Jersey Department of Health, Health Facilities Evaluation Division and the New Jersey Department of Environmental Protection.
CHAPTER 4. MANAGEMENT
8:8-4.1 Quality control
(a) All blood banks shall have a quality control program which is acceptable to the Department, assures compliance with these rules, and is sufficiently comprehensive to ensure that blood and blood components, reagents and equipment perform as expected.
(b) The quality control program shall include at least the following:
1. Written quality control policies;
2. Evidence of validation of methods;
3. Periodic evaluation of reagents and equipment including the date of performance;
4. 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 appropriate corrective action; and
6. Review by the supervisor or the director.
8:8-4.2 Procedures
(a) All policies and procedures developed for use in the blood bank and required by this chapter shall be detailed in a written procedure manual.
(b) Each procedure shall have a current pertinent literature reference.
(c) The actual test procedures used shall coincide with the manufacturers' product insert unless data to support modifications or written documentation from the manufacturer are available.
(d) The procedure manual shall be reviewed by the blood bank director annually and this review shall be documented by date and the blood bank director's signature.
(e) All significant changes to procedures shall be reviewed, dated and signed by the blood bank director.
8:8-4.3 Documented review
(a) When blood or blood components are collected and/or prepared, a key person in the operation of the blood bank shall conduct a documented review prior to the release and final labelling of blood and blood components to ensure that blood from unsuitable donors will not be distributed for transfusion or further manufacture. If this function is performed by computer, validation of the computer program, as outlined in N.J.A.C.
8:8-5.1(d), 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 N.J.A.C. 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;
3. Blood or blood components with positive or questionable test results are not released for homologous or directed transfusion;
4. Blood or blood components collected from donors that shall be deferred are not released for homologous or directed 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 workrecord;
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;
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; and
8. Autologous donations that are "crossed over" meet all criteria of a homologous donation before they are released into the general blood supply.
(b) Final disposition/destruction of records shall be completed at the time of disposition/destruction and documented review shall verify that records accurately reflect that disposition/destruction.
8:8-4.4 Errors and accidents
(a) If any component prepared from a unit improperly tested, not tested, or tested properly but improperly interpreted for ABO or infectious diseases is accidentally 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 a whole blood unit or any blood component has been transfused prior to recognition of the error, 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 has resulted in the transfusion f blood or blood components that could result in infectious disease or their 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 and advised that it is his or her responsibility to notify the patient/recipient, or his/her representative, of the error. Thorough and complete documentation shall be made as to these actions.
SUBCHAPTER 5. RECORDS AND REPORTING REQUIREMENTS
8:8-5.1 Records
(a) Suitable legible records prepared with indelible material shall be maintained for a period of not less than five years. Records needed to trace unit of blood or blood component from its source to final disposition hall 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.
(b) All corrections to errors made in the records shall:
1. Not conceal the original entry;
2. Document the reason for the correction; and
3. Include the date the change was made and the initials of the person making the change.
(c) Workrecords of tests shall be maintained and these records shall indicate final results together with all corresponding instrument reading; and calculations. Where instrumentation produces tracings or printouts or results, these tracings or printouts shall be retained in a readily traceable manner and may serve as the workrecord.
(d) If records are maintained on computer systems, the following apply:
1. Prior to use or when modifications are made to the program, validation of all computer programs, including, but not limited to, those dealing with processing, labeling, and distribution of blood and blood components, shall be required as follows:
i. To determine if software consistently performs as required and within pre-established limits; and
ii. To include review of confidentiality of donor information, security of data and system documentation.
2. Adequate provisions shall be made to safeguard against the eventuality of unexpected electronic loss of data from the computer storage medium. A system shall be in existence which maintains duplicate records on electronic storage media, updates these duplicates continuously and/or transfers electronically stored data periodically to hard copy such as prints or microfiche.
4. Written procedures shall be available for describing each of the blood bank's methods for performing requirements in (d) 1 through 3 above.
(e) The records shall:
1. Include all data secured and developed by blood banks concerning donor and/or recipient testing, donor identification, medical qualifications, registration as well as the processing, storage and distribution and final disposition of blood and blood components;
2. Make it possible to trace a unit of any blood or blood component from source (for example, donor or shipping facility) to final disposition; (for example, transfused, shipped, autoclaved);
3. Be readily available for review;
4. Be made available on forms provided by the Department for the purpose of preparing the State's Statistical Summary of Blood Use report annually by January 31, of each year, and biannually for the State's HIV Statistical Summary; and
5. Include the actual result of each test observed, recorded immediately, and the final interpretation recorded upon completion of testing.
(f) Before blood is issued for transfusion, test results for each recipient sample shall be compared with the following:
1. Past records of previous ABO and Rh typing results for the past 12 months; and
2. Past records of all patients known to have significant unexpected antibodies; severe adverse reactions to transfusion, and/or difficulty in blood typing.
(g) If computers are used, hard copies of the test results shall be available and used in the case of a computer failure.
(h) Records shall include at least the following:
1. Donor records:
i. An annual record of each unit of blood and blood component, listed by donor unit number, as to its source bank and destination (this may be final disposition);
ii. Donor history, examination, consent, deferral, reactions and also the result of required laboratory tests performed on plasmapheresis and cytapheresis donors;
iii. An annual alphabetical file of donor registration cards or a cross index system;
iv. Blood and component labelling, including initials of person responsible for such labelling;
v. Storage temperatures of components, including dated and initialled temperature recording charts;
vi. Results of visual inspection of blood;
vii. Results of blood processing, including results and interpretation of all tests and retests;
viii. Component preparation, including all relevant dates and times;
ix. Documentation of separation and pooling of recovered plasma;
x. Documentation of units included in pooling of source plasma;
xi. Reissue records, including records of proper temperature maintenance.
2. Recipient records shall include:
i. An alphabetical file on the recipient and all units administered (transfusion services only);
ii. Each recipient's ABO and Rh type available for immediate reference at least for the duration of the current hospitalization;
iii. Patients known to have significant unexpected antibodies, adverse reactions to transfusion and/or difficulty in blood grouping and typing available for immediate reference for at least five years;
iv. Transfusion request records;
v. Test results, interpretations and release (issue) date for compatibility testing;
vi. Emergency release of blood including signature of requesting physician, type of blood and blood component.
3. List of therapeutic bleedings, including signed request by physician, donor's disease and disposition of units;
4. Detailed procedure manual including all policies and procedures developed for use in the blood bank and required by this chapter;
5. Evidence of annual review of the procedure manual by the blood bank director;
6. A data sheet for each cytapheresis procedure and the following information recorded: volume of blood processed; anticoagulants given; duration of procedure; volume of product; drugs given; identity of the donor; any reactions which occurred and how they were treated;
7. Quality control records, including but not limited to: periodic evaluation of personnel, blood and blood components, reagents, equipment, including dates of performance; test performed; observed results; interpretations; identification of personnel performing the test; any appropriate corrective action taken; and review by supervisor and/or director.
8. Antibody identification records;
9. Reports of adverse reactions and laboratory investigation of suspect transfusion reactions;
10. Lot numbers of supplies and reagents.
(i) There shall be a means to identify persons performing each significant step in collecting, processing, compatibility testing and distributing blood or blood components.
8:8-5.2 Reporting requirements
(a) Transfusion reactions shall be reported as follows:
1. Any hemolytic or life threatening transfusion reaction must reported on forms provided by the Department within 10 days of occurrence.
2. Each blood bank and transfusion service shall have a system detecting, reporting and evaluating suspected adverse reactions to transfusion in accordance with current acceptable standards approved by the Department.
(b) Transfusion associated hepatitis and AIDS shall be reported as follows:
1. Any known or presumed case of transfusion associated hepatitis or AIDS brought to the attention of a blood bank shall be reported to the Department within 10 days on forms provided for this purpose.
2. All prospective donors found to test positive for hepatitis B surface antigen shall be reported to the Department within 10 days on forms provided for this purpose and shall be considered ineligible for transfusion purposes as long as they continue to be identified on current lists of interdicted donors supplied by the Department.
(c) Errors and/or accidents, that result in shipment of unsuitable blood and blood components, shall be reported to the Department within 10 days of recognition of the error.
8:8-5.3 (Reserved)
3:8-5.4 (Reserved)
8:8-5.5 (Reserved)
SUBCHAPTER 6. CRITERIA FOR DONOR SELECTION
8:8-6.1 Donor identification
(a) Blood donors shall be identified by a comparison of their signature at the time of donation with an identification card.
(b) The type of identification used shall be written on the donor registration card at the time of each blood donation.
8:8-6.2 Medical history; physical examinations; bleeding limitations
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 Standards of the American Association of Blood Banks. If necessary, these documents may be reviewed at the Department of Health, Clinical Laboratory Improvement Services, Princess South, Princess Road, Bldg. l7F, Lawrenceville, New Jersey.
8:8-6.3 Donor selection
(a) On the day of donation the prospective donor's history shall be evaluated and the donor examined by qualified blood bank personnel trained to follow guidelines acceptable to the Department in order to determine that blood donation will not be detrimental to the donor and to determine that the donor has no evidence of disease transmissible by blood transfusion.
(b) Donors shall be excluded from donating blood for transfusion while their names appear in the latest revision of publications supplied to the blood bank by the Department which prohibit them from serving as a donor.
(c) Before blood or blood components are issued for distribution, permanent deferral records, which include donor past medical history and test results shall be reviewed to determine if the blood and blood components meet all the requirements for homologous use. Blood and blood components which do not meet these requirements can not be used for homologous transfusion.
8:8-6.4 Information provided to the donor
(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.
(b) The donor must 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 identifying the donors of the cause of rejection.
8:8-6.5 AIDS screening requirements
(a) All blood and blood components collected in New Jersey are subject to the requirements of this section.
(b) Educational material must 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, must 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 from hemapheresis, be screened for HIV as specified in N.J.A.C. 8:8-8.3(b)3. Laboratory tests not performed by the collecting facility shall be referred to a blood bank or laboratory approved to perform HIV testing by the Department or which possesses a Federal interstate license to perform HIV testing. It shall be the responsibility of the receiving blood bank to assure that any blood brought in from out-of-state sources is tested for HIV. If the blood is used for homologous transfusion, it must be tested as all other blood and blood components.
(e) Blood and blood components that are positive, as currently defined by the Department, to a serologic test for HIV or collected from a donor known to be positive to a serologic test for HIV 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.
(g) A blood bank shall use a self deferral system that allows the donation to be drawn and documents that:
1. Each donor has been given the opportunity to confidentially and voluntarily defer their blood donation for use in homologous transfusion before they leave the donation site;
2. The donor has been informed that their blood will be tested for HIV antibody even if they defer their blood for transfusion use, and
3. Blood and blood components from donors that defer their blood for transfusion use shall not be used.
(h) All blood banks must notify the donor of results when there is serologic evidence of the probable causative agent of AIDS as currently outlined by the Department.
(i) Relative donors must be notified and counseled in person. Every effort shall be made to accomplish face to face notification and counseling.
(j) Blood banks must maintain records pertaining to all HIV requirements and test results. These records must be kept in a confidential manner.
(k) Testing facilities shall participate in a proficiency program acceptable to the Department.
(l) Statistical summaries of HIV test results, which do not include the identity of the donor, shall be made available on forms provided by the Department for the purpose of preparing a statistical summary report.
SUBCHAPTER 7. BLOOD AND BLOOD COMPONENTS
8:8-7.1 General criteria
(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 HB5Ag 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.
(e) At the time of collection of the blood or blood component the label shall have a unique numeric or alphanumeric identification.
8:8-7.2 Testing
(a) The preparation of all blood and blood components shall be consistent with, whichever is more stringent, the most recent Code of Federal Regulations or Standards of the American Association of Blood Banks. If necessary these documents may be reviewed at the Department of Health, Clinical Laboratory Improvement Services, Princess South, Princess Road, Bldg. l7F, Lawrenceville, New Jersey.
(b) All laboratory tests shall be made on specimens of blood taken from the donor at the time of phlebotomy in properly identified tubes.
1. Syphilis: Current Code of Federal Regulations referring to approved syphilis testing must be observed.
2. Hepatitis:
i. A sample of blood from each donation shall have a serological test for HB5Ag which is acceptable to the Department.
ii. The blood or blood components shall not be used for transfusion purposes unless results of test(s) are clearly negative, except when delay occasioned by testing may result in a serious threat to the health and well-being of the recipient.
iii. 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 must be notified.
3. Human immunodeficiency virus:
i. Each donation of blood or blood component shall be tested by serologic tests(s) for HIV approved for such use by the Department
ii. The blood or blood components shall not be used for transfusion purpose unless results of test(s) are clearly negative, except where delay occasioned by testing may result in a serious threat to the health and well-being of the recipient.
iii. In instances where untested blood or components are transfused, the attending physician shall attest in writing to the existence of a: emergency and if the test is subsequently positive, the recipient's physician must be notified.
4. Surrogate testing for non-A, non-B Hepatitis:
i. Each donation of blood or blood components shall be tested for alanine-amino transferase (ALT) and Hepatitis B Core Antibody testing by test procedures that are acceptable to the Department.
ii. The blood or blood components shall not be used for transfusion purposes unless results of test(s) are considered normal except where delay occasioned by testing may result in a serious threat to the health and well-being of the recipient.
iii. In instances where untested blood and blood components art transfused, the attending physician shall attest in writing to the existence of the emergency and if the test is subsequently considered to be abnormal the recipient's physician shall be notified.
5. Determination of ABO group:
i. Each container of blood shall be properly identified and labeled as to its blood group.
ii. The ABO type of each blood donation shall be determined b> testing the red cells of the donor using known Anti-A and Anti-B sera, and by testing the serum or plasma for expected antibodies using known A1 and B red blood cells.
(1) 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.
(2) All Anti-A and Anti-B sera shall meet the Code of Federal Regulations minimum requirements, and the procedures used shall follow the manufacturer's directions.
iii. Previous records of ABO type shall not serve as identification of units subsequently given by the same donor.
(1) New determinations shall be made for each collection.
6. Determination of D type:
i. The D type of each container of donor blood shall be determined with Anti-D reagent.
ii. If the blood is D negative, it shall be tested using a technique designed to detect D~.
iii. Only anti-sera meeting the Code of Federal Regulations minimum requirements for the products shall be used and the technique of typing shall be that recommended by the manufacturer.
7. Determination of antibodies:
i. Each container of blood shall be tested for unexpected antibodies using a screening cell suspension which meets the Code of Federal Regulations minimum requirements.
ii. The techniques employed shall be those which will detect clinically significant antibodies and shall include the anti-human globulin test.
iii. Screening procedures must employ fresh serum not older than 48 hours.
iv. Blood in which antibodies are found shall be used in a manner not detrimental to the recipient.
8. Repeat testing: The facility at which the transfusion is administered must confirm the ABO type, on a sample obtained from the integral attached segment, of all units of whole blood and red blood cells, and the D type of all D negative units of whole blood and red blood cells.
(c) Performance of any additional testing for product quality and patient safety is permitted under this chapter. This testing shall comply with all applicable requirements of this chapter.
8:8-7.3 (Reserved)
8:52-4.5 Sexually transmitted diseases
(a) The local board of health shall control sexually transmitted diseases and shall:
1. Provide for medical services for all persons seeking medical care for Sexually Transmitted Disease (STD);
2. Secure prompt reporting of any case of STD and forward reports immediately to the Department of Health, Communicable Disease Field Program, as required by Chapter Two of the State Sanitary Code (N.J.A.C. 8:57-1.2);
in accordance with the policy established by the Department of Health and report results of these services on appropriate forms provided by the Department;
4. Provide counseling to all patients infected with STDs and treated at public health department STD clinics, to include, but not be limited to, disease prevention, sex partner referral, need for follow-up testing, and appropriate action to take when symptoms appear;
5. Provide public education services to the community or target population; and,
6. Analyze reported data and provide a basis upon which to plan and evaluate an effective program for the prevention and control of sexually transmitted diseases.
8:52-4.6 Human Immunodeficiency Virus (HIV infection
(a) The local board of health shall administer a planned program to prevent and control HIV infection and shall:
1. Utilizing seroprevalence and case reporting data provided by the Department of Health, identify ways to reach persons at high risk within the community and develop and implement a strategy to disseminate HIV prevention and control information to these groups;
2. Maintain supplies of educational material to meet information requests on the transmission, prevention and control of HIV;
3. Provide or arrange for other suitable local health education resources (for example, Planned Parenthood, Red Cross) to conduct education programs addressing the epidemiology, prevention and control of HIV to civic and community organizations and occupationally at risk groups utilizing state prepared or equivalent curricula;
4. Provide or arrange for in-service training addressing the epidemiology, prevention and control of HIV to all local health department personnel;
5. Develop and implement a protocol to refer individuals concerned about their HIV status to counseling and testing sites and other health care providers;
6. Refer HIV infected persons and their families seeking services to appropriate provider agencies such as mental health, drug treatment and other social service agencies; and
7. Participate in the planning, development and implementation of a county or regional program to control HIV infection and the progression to AIDS.
SUBCHAPTER 2. REPORTING OF ACQUIRED IMMUNODEFICIENCY SYNDROME AND INFECTION WITH HUMAN IMMUNODEFICIENCY VIRUS
8:57-2.1 Applicability; definition of AIDS, HIV infection and CD4 count
(a) The provisions of this subchapter are applicable to cases of Acquired Immunodeficiency Syndrome (AIDS) and infection with human immunodeficiency virus (HIV). The provisions of N.J.A.C. 8:57-1 shall not apply to any case of AIDS or infection with HIV.
(b) Laboratory results indicative of infection with HIV shall mean laboratory results showing the presence of HIV or components of HIV, or of laboratory results showing the presence of antibodies to HIV. The State Commissioner of Health shall determine the laboratory test results which indicate infection with HIV for the purpose of these rules.
(c) Acquired immunodeficiency syndrome (AIDS) means a condition affecting a person who has a reliably diagnosed disease that meets the criteria for AIDS specified by the Centers for Disease Control of the United States Public Health Services.
(d) A CD4 count means a count of lymphocytes containing the CD4 epitope as determined by the results of lymphocyte phenotyping. An absolute CD4 count means the number of lymphocytes containing the CD4 epitope per cubic millimeter. A relative CD4 count means the number of such cells expressed as a percentage of total lymphocytes.
8:57-2.2 Reporting HIV infection
(a) Every physician attending a person found to be infected with HIV shall, within 24 hours of receipt of a laboratory report indicating such a condition, report in writing such condition directly to the State Department of Health on forms supplied by the State Department of Health. The report shall include the name and address of the reporting physician, the name, address, gender, race and birth date of the person found to be infected with HIV, the date the specimen tested for was obtained, and such other information as may be required by the State Department of Health. A physician shall not report a person infected with HIV if the physician is aware that the person having control or supervision of an institution named in (b) below is reporting that person being infected with HIV, or if the physician is aware that the person has previously been reported to the State Department of Health as being infected with HIV.
(b) The person having control or supervision over any institution, such as a hospital, sanitarium, nursing home, penal institution, clinic, blood bank, or facility for HIV counseling and testing in which any person is determined to be infected with HIV shall, within 24 hours of receipt of a laboratory report indicating such a condition, report in writing such condition directly to the State Department of Health on forms supplied by the State Department of Health. The report shall state the name, address, gender, race, and birth date of the person found to be infected with HIV, the date the specimen tested for HIV was obtained, the name of the attending physician, the name and address of the institution, and such other information as may be required by the State Department of Health. The person having control or supervision of the institution shall not report a person infected with HIV if it is known that a physician is reporting the person or that the person has previously been reported to the State Department of Health as being infected with HIV. The person having control or supervision of the institution may delegate this reporting activity to a member of the staff, but this delegation does not relieve the controlling or supervising person of the ultimate report responsibility.
(c) Every clinical laboratory shall, within five working days of completion of a laboratory test which has results indicative of infection with HIV, report in writing such results to the State Department of Health. The report shall include the name and address of the clinical laboratory, the name and address of the submitter of the laboratory specimen, any identifying information the laboratory may have on the person from whom the laboratory specimen was obtained, including the unique code if a code is the only information identifying the person from whom the laboratory specimen was obtained, and other epidemiological information as may be required by the State Department of Health on a general or a case-by-case basis. Only specimens sent to the laboratory from physicians' offices in New Jersey or from institutions in New Jersey should be reported.
8:57-2.3 Reporting AIDS
(a) Every physician attending any person ill with AIDS shall, within 24 hours of the time AIDS is diagnosed, report in writing such condition directly to the State Department of Health on forms supplied by the State Department of Health. The report shall include the name and address of the reporting physician, the name, address, gender, race, and birth date of the person ill with AIDS, the date of onset of the illness meeting the criteria for the diagnosis of AIDS, and such other information as may be required by the State Department of Health. Such report should be made whether or not the patient previously had been reported as having HIV infection. The report of AIDS will be deemed to also be a report of HIV infection.
(b) The person having control or supervision over any institution, such as a hospital, sanitarium, nursing home, penal institution, or clinic, in which a person is ill with AIDS shall, within 24 hours of the time AIDS is diagnosed, report such condition in writing directly to the State Department of Health on forms provided by the State Department of Health. The report shall state the name, address, gender, race and birth date of the person ill with AIDS, the date of onset of the illness meeting the criteria for the diagnosis of AIDS, the name of the attending physician, the name and address of the institution, and such other information as may be required by the State Department of Health. Such report should be made whether or not the patient previously had been reported as having HIV infection. The report of AIDS will be deemed to also be a report of HIV infection. The person having control or supervision of the institution may delegate this reporting responsibility to a member of the staff, but this delegation does not relieve the controlling or supervising person of the ultimate reporting responsibility.
(c) Every clinical laboratory shall, within five working days of completion of a CD4 count which has absolute or relative results below a level specified by the Centers for Disease Control as criteria for defining AIDS, report in writing such results to the State Department of Health. The report shall include the name and address of the clinical laboratory, the name and address of the submitter of the laboratory specimen, identifying information the laboratory may have on the person from whom the laboratory specimen was obtained, including the unique code if a code is the only information identifying the person from whom the laboratory specimen was obtained, and other epidemiological information as may be required by the State Department of Health on a general or a case-by-case basis. Only specimens sent to the laboratory from physicians' offices in New Jersey or from institutions in New Jersey should be reported.
8:57-2.4 Testing procedures
No physician or institution may direct a person be tested for HIV, a component of HIV, or antibodies to HIV, unless the name and address of the person whose specimen is being tested is known and recorded by the physician or institution, except that the State Commissioner of Health may designate facilities which are permitted to test for antibodies to HIV without obtaining the name and address of the person being tested. The name and address of a person requesting testing without giving his or her name and address at such a designated facility are not required to be reported to the State Department of Health.
8:57-2.5 Exceptions to communicable disease classification of AIDS and HIV
(a) AIDS or HIV infection shall not be considered a communicable disease for purposes of admission to, attendance in, or transportation in any of the following:
1. Nursing homes and other health care facilities;
2. Rooming and boarding homes, and shelters for the homeless;
3. Ambulances and other public conveyances; and
4. Educational facilities.
8:57-2.6 Access to information
As provided by N.J.S.A. 26:4-2 and 26:5C-5 through 14, the information reported to the Department shall not be subject to public inspection, but shall be subject to access only by the State Department of Health for public health purposes.
8:57-2.7 Failure to comply with reporting requirements
(a) Physicians failing to fulfill the reporting requirements of this subchapter may receive written notification of this failure. Physicians failing to meet these reporting requirements, despite warning, shall be subject to a fine, as allowed by N.J.S.A. 26:4-129. In addition, those whose failure to report is determined by the State Department of Health to have significantly hindered public health control measures shall be subject to other actions, including notification of the Board of Medical Examiners of the State Department of Law and Public Safety, and appropriate hospital medical directors or administrators.
(b) The person having control or supervision over any institution, who fails to fulfill the aforementioned reporting obligations, may receive written notification of this failure. Superintendents failing to meet these reporting requirements, despite warning, shall be subject to a fine, as allowed by N.J.S.A. 26:4-129. In addition, those whose failure to report is determined by the State Department of Health to have significantly hindered public health control measures, shall be subject to other actions, including notification of the State Department of Health, Division of Health Facilities Evaluation, other appropriate licensing review organizations, and other appropriate agencies.
(c) Laboratory supervisors failing to fulfill the aforementioned reporting obligations may receive written notification of this failure. Supervisors failing to meet these requirements, despite warning, shall be subject to fines as allowed by N.J.S.A. 26:4-129. In addition, those whose failure to report is determined by the State Department of Health to have significantly hindered public health control measures, shall be subject to other actions, including notification to the State Clinical Laboratory Improvement Services.
CHAPTER 61
ACQUIRED IMMUNODEFICIENCY SYNDROME
Executive Order No. 66 (1978) Expiration Date
Chapter 61, Acquired Immunodeficiency Syndrome, expires on October 4, 1996.
CHAPTER TABLE OF CONTENTS
SUBCHAPTER 1. PARTICIPATION AND ATTENDANCE AT SCHOOL BY INDIVIDUALS WITH HIV INFECTION
8:61-1.1 Attendance at school by pupils or adults infected by Human Immunodeficiency Virus (HIV)
SUBCHAPTER 2. ELIGIBILITY CRITERIA TO PARTICIPATE IN THE AIDS DRUG DISTRIBUTION PROGRAM
8:61-2.1 Purpose; scope
8:61-2.2 Definitions
8:61-2.3 Clinical eligibility
8:61-2.4 Income eligibility
8:61-2.5 Residence
8:61-2.6 Third party coverage
8:61-2.7 Application process
8:61-1.1 Attendance at school by pupils or adults infected by Human Immunodeficiency Virus (HIV), also known as HTLV-III or LAV
(a) For purposes of this section, the following words shall have the following meanings:
"Adult" means a teacher, administrator, food service employee or other school staff member.
"Pupil" means an individual who is entitled to attendance at school in grades K-12, as well as a pre-kindergarten child who is entitled to attendance at school.
(b) Pupils with HIV infection shall not be excluded from attending school for reason of the HIV infection. Exclusion of HIV-infected pupils can only be for reasons that would lead to exclusion of any other pupil.
(c) Adults with HIV infection in all school settings shall not be restricted from their normal employment for reason of the HIV infection unless they have another illness which would restrict that employment.
(d) No pupil or adult shall be excluded from school, solely by virtue of the fact of living with or being related to an HIV-infected individual.
(e) Any pupil or adult, with or without HIV infection, shall be removed from school if and when the individual has weeping skin lesions that cannot be covered.
(f) All schools and day care facilities, regardless of whether pupils or adults with HIV are present, shall adopt routine procedures for handling blood and body fluids. District boards of education shall develop written policies and procedures for sanitation and hygiene when handling body fluids and shall make available training and appropriate supplies to all school personnel, in conformance with N.J.C. 6:29-2.5.
(g) It is not necessary that anyone in the school be specially notified that an HIV-infected individual is registered to attend school or is an employee of the school. Should school officials receive notification of the presence of an HIV-infected individual, records containing identifying information regarding the HIV status of the individual must be kept confidential as required by N.J.S.A. 26:5C-5 et seq. Such information can be shared, only with the written consent of the pupil's parent or guardian, with those who need to know the status to determine the educational program for the pupil.
SUBCHAPTER 2. ELIGIBILITY CRITERIA TO PARTICIPATE IN THE AIDS DRUG DISTRIBUTION PROGRAM
8:61-2.1 Purpose; scope
The purpose of this subchapter is to describe the clinical and financial criteria which individuals must meet in order to become enrolled in the AIDS Drug Distribution Program.
8:61-2.2 Definitions
The following term, as used in this subchapter, shall have the following meaning:
"AIDS Drug Distribution Program" means the program by which eligible individuals will receive designated medications approved by the Federal Food and Drug Administration which have been recognized as either prolonging or enhancing the life of individuals with HIV infection from funds appropriated to the State from the Federal government.
1. The medications designated for coverage will be determined administratively within the Division of AIDS Prevention and Control based on considerations of cost, efficacy and frequency of use.
8:61-2.3 Clinical eligibility
To be considered clinically eligible to participate in the AIDS Drug Distribution Program, an individual must meet the clinical criteria established by the manufacturer of the drug, as determined by a physician.
8:61-2.4 Income eligibility
(a) In order to be eligible for this program, the individual(s) shall be a permanent resident of New Jersey and must have an annual income in accord with the following standards:
Number of Persons Annual
in household Income
One $30,000
Two $40,000
Three $50,000
Four $60,000
Five or more $70,000
1. An applicant and spouse shall be considered separated when each maintains a separate residence and the applicant does not have access to or receive support from the spouse's income.
2. An applicant and spouse shall be considered separated when the spouse has been institutionalized in a long-term facility, either skilled or intermediate, or in a state or county psychiatric hospital at least 30 consecutive days prior to application.
(b) Income shall be determined in accordance with the standards delineated at N.J.A.C. 10:69A-6.2.
8:61-2.5 Residence
Residence shall be determined in accordance with the standards delineated at N.J.A.C. 10:69A-6.4.
8:61-2.6 Third party coverage
Individuals who are eligible to receive the covered medications from entitlement programs or third party payors are not eligible to receive benefits under this program.
8:61-2.7 Application process
(a) Applications to enroll in the program can be obtained by calling the Department of Health AIDS HOTLINE, at 1-800-624-2377.
(b) Once the application is received by an interested individual, the form should be completed and returned to the address indicated on the application.
(c) If approved for participation in the Program, the Department or its designee will notify the individual, his or her physician, and the pharmacy from which the prescription will be filled.
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