reglab/statecodes huggingface dataset:
New Jersey Administrative Code › Title 8 - HEALTH › Chapter 8 - COLLECTION, PROCESSING, STORAGE AND DISTRIBUTION OF BLOOD › Subchapter 8 - COLLECTION OF BLOOD › Section 8:8-8.5 - Method of blood and blood component collection

Current through Register Vol. 56, No. 14, July 15, 2024
(a) Immediately prior to
				collection of the blood or blood component, a unique sequential numeric or
				alphanumeric identification shall be placed on all material related to that
				donation, such as the blood component label, the donor medical history record and
				pilot tubes. This number shall identify all material related to the particular blood
				donation.
(b) The method employed for
				the removal of blood from the donor shall conform to accepted standards of
				asepsis.
(c) Blood containers and donor
				sets shall be sterile and pyrogen-free.
(d) A closed system shall be used except for blood
				cell separation instruments that use an open system.
(e) If more than one venipuncture is needed,
				another set and container shall be used.
(f) The container into which the blood is
				collected at one venipuncture shall be the final container.
(g) During bleeding, the anticoagulant solution
				and the blood shall be thoroughly mixed.
(h) The outside of the container shall be kept
				clean.
(i) Immediately after bleeding,
				the blood shall be placed in temporary storage having sufficient refrigeration
				capacity to cool the blood continuously toward a range between one to six degrees
				Centigrade unless platelets are to be harvested.
(j) The volume of blood collected from the donor
				shall be in accordance with FDA regulations and AABB Standards.
New Jersey Administrative Code › Title 8 - HEALTH › Chapter 8 - COLLECTION, PROCESSING, STORAGE AND DISTRIBUTION OF BLOOD › Subchapter 8 - COLLECTION OF BLOOD › Section 8:8-8.6 - Pilot samples

Current through Register Vol. 56, No. 14, July 15, 2024
(a) At the time of
				collection, the integral donor tubing shall be filled with anticoagulated blood and
				sealed in such a manner that it will be available for subsequent tests for serologic
				compatibility.
(b) The integral donor
				tubing segments shall be separable from the container without breaking the sterility
				of the container.
(c) At the time of
				collection, additional blood may be collected for laboratory tests provided
				containers are properly labeled before or at the time of collection, accompany the
				blood container, and are re-identified with the blood container immediately after
				filling.
New Jersey Administrative Code › Title 8 - HEALTH › Chapter 8 - COLLECTION, PROCESSING, STORAGE AND DISTRIBUTION OF BLOOD › Subchapter 8 - COLLECTION OF BLOOD › Section 8:8-8.7 - Blood containers

Current through Register Vol. 56, No. 14, July 15, 2024
(a) Containers for whole
				blood and blood components used by licensed establishments, shall be identified by
				recording the manufacturer's lot numbers and shall be sterile and
				pyrogen-free.
(b) The containers shall
				be sufficiently colorless and transparent to permit visual inspection of
				blood.
(c) The blood containers shall be
				provided with closures which maintain a hermetic seal and prevent contamination of
				the contents.
(d) The container and the
				closure shall not interact with the contents under customary conditions of storage
				and use.
(e) The anticoagulant solution
				and additive solution systems shall be sterile, pyrogen-free in the amount
				prescribed for the volume of blood collected, and prepared according to the Code of
				Federal Regulations.
New Jersey Administrative Code › Title 8 - HEALTH › Chapter 8 - COLLECTION, PROCESSING, STORAGE AND DISTRIBUTION OF BLOOD › Subchapter 8 - COLLECTION OF BLOOD › Section 8:8-8.8 - Labeling

Current through Register Vol. 56, No. 14, July 15, 2024
(a) Labeling shall be
				consistent with the most recent Code of Federal Regulations.
(b) Blood and blood components shall be labelled
				to include conspicuous notation of incomplete testing and when applicable positive
				or abnormal test results.
(c) Untested
				autologous blood collected from a donor/recipient, who has been tested in the last
				30 days, shall not be labeled according to standards for uniform labeling of
				allogeneic blood. It shall be labeled as follows:
1. With a statement that the blood was collected
				from a donor known to be tested for FDA-required tests; and
2. The date that the donor recipient was
				tested.
New Jersey Administrative Code › Title 8 - HEALTH › Chapter 8 - COLLECTION, PROCESSING, STORAGE AND DISTRIBUTION OF BLOOD › Subchapter 8 - COLLECTION OF BLOOD › Section 8:8-8.9 - Sterility testing

Current through Register Vol. 56, No. 14, July 15, 2024
(a) Sterility testing
				shall be performed at regular intervals and not less than once monthly, where blood
				is collected or prepared in an open system. Such tests shall not be done on blood
				intended for transfusion.
(b) Culture
				techniques shall be in accordance with the most recent Code of Federal
				Regulations.
(c) Permanent records of
				sterility tests, with evidence that the tests have been performed according to the
				most recent Code of Federal Regulations, and the results shall be kept.
New Jersey Administrative Code › Title 8 - HEALTH › Chapter 8 - COLLECTION, PROCESSING, STORAGE AND DISTRIBUTION OF BLOOD › Subchapter 8 - COLLECTION OF BLOOD › Section 8:8-8.10 - Autologous collection/transfusion

Current through Register Vol. 56, No. 14, July 15, 2024
(a) Blood banks wishing
				to employ the techniques set forth in this section shall file their protocol and a
				request in writing to the Department, prior to initiation of the service.
(b) The techniques set forth in this section can
				be employed upon receipt of written approval from the Department.
(c) Autologous collection/transfusion shall be
				done only at the written request of the physician or clinical practitioner,
				whichever is more consistent with the AABB Standards. A telephone request shall be
				followed by written confirmation within seven calendar days.
(d) Testing and labelling requirements for
				autologous donations shall be consistent with, whichever is more stringent, this
				chapter or the Code of Federal Regulations.
(e) Donor processing for autologous transfusion
				shall be as follows:
1. Donor qualifications for
				autologous transfusion may vary from standard donor criteria but this entire
				procedure shall be arranged by consultation between the blood bank director and the
				donor-patient's physician or clinical practitioner, whichever is more consistent
				with the AABB Standards.
2. If the
				patient-donor and/or donated unit do not meet the criteria for donor selection
				listed in this chapter to protect the recipient, the unit shall be labeled "For
				Autologous Use Only", segregated, and used solely for this purpose.
3. "Crossing over" shall not be allowed.
4. Blood and blood components that test positive
				or abnormal and are transfused to the donor/recipient shall be labelled with a
				Biohazard label.
New Jersey Administrative Code › Title 8 - HEALTH › Chapter 8 - COLLECTION, PROCESSING, STORAGE AND DISTRIBUTION OF BLOOD › Subchapter 8 - COLLECTION OF BLOOD › Section 8:8-8.11 - Directed donation

Current through Register Vol. 56, No. 14, July 15, 2024
(a) Blood banks wishing
				to employ the techniques set forth in this section shall file their protocol and a
				request in writing to the Department, prior to initiating the procedure.
(b) Such techniques can not be employed until
				written approval is received from the Department.
(c) All requirements of this chapter related to
				allogeneic donations shall be followed.
(d) Directed donations shall be initiated only at
				the written request of the intended recipient's clinical practitioner or a
				transfusion facility. A telephone request shall be followed by written confirmation
				within seven calendar days.
New Jersey Administrative Code › Title 8 - HEALTH › Chapter 8 - COLLECTION, PROCESSING, STORAGE AND DISTRIBUTION OF BLOOD › Subchapter 8 - COLLECTION OF BLOOD › Section 8:8-8.12 - Perioperative autologous blood collection and administration

Current through Register Vol. 56, No. 14, July 15, 2024
(a) Facilities that
				perform perioperative autologous blood collection and administration shall obtain a
				blood bank license to operate in New Jersey.
(b) Facilities shall submit SOP to the Department
				and receive written approval prior to initiation of the service.
(c) Standards of the American Association of Blood
				Banks related to perioperative procedures, as amended or supplemented, shall be
				followed when performing perioperative autologous transfusion procedures.
New Jersey Administrative Code › Title 8 - HEALTH › Chapter 8 - COLLECTION, PROCESSING, STORAGE AND DISTRIBUTION OF BLOOD › Subchapter 8 - COLLECTION OF BLOOD › Section 8:8-8.13 - Therapeutic phlebotomy

Current through Register Vol. 56, No. 14, July 15, 2024
(a) Any person who
				performs a therapeutic phlebotomy shall obtain a blood bank license before offering
				the service.
(b) Therapeutic phlebotomy
				shall be done only at the written request of the patient's physician or clinical
				practitioner, whichever is more consistent with AABB Standards.
(c) There shall be a written procedure describing
				the technique used.
(d) Records shall be
				maintained which include patient identification, diagnosis, therapeutic procedure,
				volume of plasma and cells removed, volume replaced, nature of the replacement
				fluids, any adverse actions, and a record of the administered medications.
(e) Informed consent of the patient shall be
				obtained.
(f) There shall be provisions
				for the management of reactions.
(g) If
				therapeutic phlebotomy procedures and recordkeeping are not entirely performed by
				blood bank personnel, there shall be a written agreement that specifies the division
				of responsibilities for assuring compliance with this chapter.
(h) Any blood or blood component withdrawn from a
				patient for therapeutic purposes shall be clearly indicated as such on the blood
				label.
(i) Blood or blood components
				obtained from therapeutic phlebotomy may be used for allogeneic transfusion using
				the following criteria:
1. Waiver approval from
				the FDA shall be received and the approved procedures and protocols shall be
				followed;
2. It shall be performed at no
				expense to the donor;
3. The donor
				diagnosis shall be hereditary hemochromatosis; and
4. The donor shall meet all the allogeneic
				donation criteria except for donation interval and hematocrit.
New Jersey Administrative Code › Title 8 - HEALTH › Chapter 8 - COLLECTION, PROCESSING, STORAGE AND DISTRIBUTION OF BLOOD › Subchapter 8 - COLLECTION OF BLOOD › Section 8:8-8.14 - Plasmapheresis

Current through Register Vol. 56, No. 14, July 15, 2024
(a) Facilities that
				perform plasmapheresis procedures shall obtain a blood bank license before offering
				the service.
(b) Facilities shall submit
				SOP to the Department and receive written approval prior to initiation of the
				service.
(c) The procedures used shall
				include as a minimum the following requirements:
1. Within one week prior to the first
				plasmapheresis, the donor shall be examined and certified to be in good health by a
				clinical practitioner.
2. A licensed
				physician on the premises shall supervise the performance of manual plasmapheresis
				collection. This requirement shall not be applicable to automated plasmapheresis
				collection which meets the following conditions:
i.
											8:8-8.2, Donor's emergency care, shall
				be strictly followed;
ii. Donor
				emergency care personnel, as required under
				8:8-2.3(d), shall be on
				the premises; and
iii. A contingency
				plan to assure that a physician is available for emergency purposes during the
				procedure shall be in use. The physician response time shall be no longer than 15
				minutes.
3. Prior to each
				procedure, records shall be made and maintained of the major pertinent elements of
				each donor's physical condition and shall also include a determination of the
				donor's total protein.
4. A donor shall
				not serve as a source of plasma unless his or her total protein is within normal
				limits.
5. Quality control records of
				the total protein determinations shall be maintained.
6. If a second plasmapheresis is to be performed
				within 30 days of the first procedure, laboratory tests shall be done on samples of
				the donor's serum to determine that the protein level and ratio of the various
				protein components, as shown by electrophoresis, fall within normal
				limits.
7. A donor shall not serve as a
				source of plasma while there is any significant change in his health, or in the
				values of these initial determinations.
8. Periodic determinations shall be made as
				frequently as necessary and at least every four months to monitor these
				evaluations.
9. The amount of plasma
				withdrawn shall be consistent with the current Code of Federal
				Regulations.
10. A plasmapheresis donor
				may donate a unit of whole blood if 48 hours have lapsed since the last
				plasmapheresis, but at least eight weeks shall elapse after a regular whole blood
				donation before starting a donor in a plasmapheresis program.
11. Plasmapheresis donors shall, on each occasion
				of plasmapheresis satisfy all requirements of whole blood donors outlined in
				N.J.A.C. 8:8-6, Criteria for Donor Selection.
New Jersey Administrative Code › Title 8 - HEALTH › Chapter 8 - COLLECTION, PROCESSING, STORAGE AND DISTRIBUTION OF BLOOD › Subchapter 8 - COLLECTION OF BLOOD › Section 8:8-8.15 - Cytapheresis

Current through Register Vol. 56, No. 14, July 15, 2024
(a) Facilities that
				perform cytapheresis procedures shall obtain a blood bank license before offering
				the service.
(b) Facilities shall submit
				SOP to the Department and receive written approval prior to initiation of the
				service.
(c) A licensed physician on the
				premises shall supervise the performance of manual cytapheresis collection. This
				requirement shall not be applicable to automated cytapheresis collection which meets
				the following conditions:
1.
										8:8-8.2, Donor's emergency care, shall
				be strictly followed;
2. Donor emergency
				care personnel, as required under
				8:8-2.3(d), shall be on
				the premises; and
3. A contingency plan
				to assure that a physician is available for emergency purposes during the procedure
				shall be in use. The physician response time shall be no longer than 15
				minutes.
New Jersey Administrative Code › Title 8 - HEALTH › Chapter 8 - COLLECTION, PROCESSING, STORAGE AND DISTRIBUTION OF BLOOD › Subchapter 8 - COLLECTION OF BLOOD › Section 8:8-8.16 - Immunized donor

Current through Register Vol. 56, No. 14, July 15, 2024
(a) If specific
				immunization of a donor is to be performed, the selection and scheduling of the
				injection of the antigen, and the evaluation of each donor's clinical response,
				shall be by a qualified physician.
(b)
				Any material used for immunization shall be either a product licensed under Section
				351 of the Public Health Service Act for such purpose or one specifically approved
				by the Director, Center for Biologics Evaluation and Research.
(c) Immunization procedures shall be on file at
				each plasmapheresis center where immunizations are performed.
(d) Each donor to be immunized shall be instructed
				regarding possible hazards associated with use of his blood at other blood banks and
				each shall agree that he will not donate blood elsewhere without first divulging his
				immunization status.
(e) Informed
				consent of the donor shall be obtained.
New Jersey Administrative Code › Title 8 - HEALTH › Chapter 8 - COLLECTION, PROCESSING, STORAGE AND DISTRIBUTION OF BLOOD › Subchapter 9 - RECIPIENT BLOOD TESTING › Section 8:8-9.1 - General provisions

Current through Register Vol. 56, No. 14, July 15, 2024
(a) The requirements in
				this section shall apply to both hospital and out-of-hospital transfusion of blood
				for therapeutic purposes.
(b) Forms and
				request for blood and blood components and forms accompanying recipient blood
				samples shall have sufficient information for the positive identification of the
				recipient.
(c) The recipient's full
				name, as it appears on the identification band, and a traceable identification
				number are required. If more than one identification number is needed to establish
				the positive identification of the recipient, all the numbers shall be documented on
				all blood bank documents used for recipient testing.
(d) Incomplete or illegible forms shall not be
				accepted.
(e) The intended recipient and
				the blood sample shall be identified at the time of collection by a mechanism which
				positively identifies the recipient. Use of an armband is considered the method of
				preference. The Department shall approve any other method prior to use.
(f) The sample for compatibility testing shall be:
1. Identified by a label firmly attached to the
				sample before leaving the side of the recipient;
2. Labeled at the time of the collection with at
				least the recipient's full name, as it appears on the identification band, traceable
				identification number, the identity of the person drawing the sample and the date
				the sample was drawn;
3. Obtained within
				three days of the scheduled transfusion when the recipient has been transfused or
				pregnant in the preceding three months or this information is not known;
4. Examined by a qualified person, before a
				specimen is used for typing or compatibility testing, to confirm that all
				information on the request form is in agreement with that on the specimen label. In
				the case of a discrepancy or doubt, another specimen shall be obtained and used for
				these procedures; and
5. Labeled so that
				if it is necessary for the blood bank to affix a second label, the second label
				could be peeled off so that personnel performing the compatibility testing can
				verify that the information on the original and secondary labels match. The second
				label shall be affixed in a manner that it does not obscure the full name of the
				recipient and the traceable identification number.
New Jersey Administrative Code › Title 8 - HEALTH › Chapter 8 - COLLECTION, PROCESSING, STORAGE AND DISTRIBUTION OF BLOOD › Subchapter 9 - RECIPIENT BLOOD TESTING › Section 8:8-9.2 - Suspected transfusion reactions

Current through Register Vol. 56, No. 14, July 15, 2024
(a) Each blood bank and
				transfusion service shall have a system for detecting and evaluating suspected
				adverse reactions to transfusion.
(b)
				All suspected transfusion reactions shall be evaluated promptly.
(c) In the event of a suspected transfusion
				reaction, the staff attending the patient shall:
1.
				Immediately notify the blood bank and the responsible clinical practitioner. All
				instructions for the evaluation of the suspected reaction shall be documented;
				and
2. Note the reaction in the
				patient's medical record and on the blood transfusion documentation.
New Jersey Administrative Code › Title 8 - HEALTH › Chapter 8 - COLLECTION, PROCESSING, STORAGE AND DISTRIBUTION OF BLOOD › Subchapter 9 - RECIPIENT BLOOD TESTING › Section 8:8-9.3 - Operative blood order schedules

Current through Register Vol. 56, No. 14, July 15, 2024
(a) If type and screen
				procedure is used, there shall be prompt availability of ABO compatible blood to
				meet unexpected transfusion requirements.
(b) If this blood is needed before compatibility
				testing is completed, an immediate spin crossmatch shall be performed before the
				blood can be released.
1. Testing shall be
				completed promptly and the results documented.
New Jersey Administrative Code › Title 8 - HEALTH › Chapter 8 - COLLECTION, PROCESSING, STORAGE AND DISTRIBUTION OF BLOOD › Subchapter 9 - RECIPIENT BLOOD TESTING › Section 8:8-9.4 - Urgent requirement for blood and blood components

Current through Register Vol. 56, No. 14, July 15, 2024
(a) Urgent requirements
				for blood are situations in which delay in provision of blood may unduly jeopardize
				the patient, therefore, blood may be issued before completion of routine
				tests.
(b) The following standards shall
				apply to urgent situations:
1. Recipients whose
				ABO group and Rh type have been determined by the transfusing facility without
				reliance on previous records may receive type-specific blood before required tests
				have been completed.
2. Recipients whose
				ABO group is not known shall receive type O red blood cells.
3. The record shall contain a statement of the
				requesting physician indicating that the clinical situation was sufficiently urgent
				to require release of blood before completion of required testing and shall include
				the written or validated electronic signature of the requesting physician.
4. The tag or label shall indicate in a
				conspicuous fashion that required testing had not been completed at the time of
				issue.
5. Required tests shall be
				completed promptly.
6. The
				identification number required in
				8:8-9.1 and
				8:8-10.1 shall be traceable.
New Jersey Administrative Code › Title 8 - HEALTH › Chapter 8 - COLLECTION, PROCESSING, STORAGE AND DISTRIBUTION OF BLOOD › Subchapter 10 - ISSUE AND ADMINISTRATION OF BLOOD AND BLOOD COMPONENTS FOR TRANSFUSION › Section 8:8-10.1 - Issue of blood

Current through Register Vol. 56, No. 14, July 15, 2024
(a) Issue and
				administration of blood and blood components shall be at the request of a clinical
				practitioner.
(b) A blood transfusion
				request form indicating the recipient's full name, as it appears on the
				identification band, traceable identification number and the type and quantity of
				component shall be completed.
(c) A
				label or tag with the appropriate information to identify the unit with the intended
				recipient shall be attached to the blood container before its release from the
				laboratory for transfusion.
(d) At the
				time the blood or blood component is released from the blood bank for transfusion,
				the person receiving the blood shall present a written request with sufficient
				information for the positive identification of the recipient.
(e) The technologist who issues the blood shall
				perform an identification check along with the person picking up the blood. This
				identification check shall involve active participation by both individuals in a
				review of the identifying information on the blood bag and the requisition slip. At
				a minimum, this review shall include the recipient's full name, as it appears on the
				identification band, traceable identification number, the type of component
				requested, and the date of transfusion.
(f) The blood bank shall record the unit number
				and the type of component issued.
(g)
				Retention of blood samples shall be as follows:
1.
				A stoppered or sealed sample of each donor blood, and a similar sample of the
				recipient's blood, shall be stored at 1 to 6 [degrees] C for at least seven days
				after transfusion.
New Jersey Administrative Code › Title 8 - HEALTH › Chapter 8 - COLLECTION, PROCESSING, STORAGE AND DISTRIBUTION OF BLOOD › Subchapter 10 - ISSUE AND ADMINISTRATION OF BLOOD AND BLOOD COMPONENTS FOR TRANSFUSION › Section 8:8-10.2 - Administration of blood and blood components

Current through Register Vol. 56, No. 14, July 15, 2024
(a) Blood or blood
				components for transfusion shall be prescribed by a clinical practitioner.
(b) Identification of the recipient and the blood
				container shall be as follows:
1. Each transfusion
				service shall have a written procedure for the positive identification of the
				recipient and the blood container.
2. At
				the bedside, immediately prior to transfusion, two qualified individuals (whose
				qualifications are determined and verified by the medical institution or the
				transfusing facility in consultation with the blood bank director) shall
				simultaneously check and match all information identifying the container with the
				identifying information on the person of the intended recipient and the
				compatibility testing request slip. If the information does not match, the
				initiation of transfusion shall be suspended until the discrepancy is adequately
				investigated and resolved.
3. At the
				bedside, immediately after the identifying information in (b)2 above is matched, and
				before the transfusion is initiated, the two qualified individuals that checked this
				information shall sign the transfusion form to attest that this information was
				checked and that it matched.
4. All
				identification attached to the container shall remain attached at least until the
				transfusion has been completed.
New Jersey Administrative Code › Title 8 - HEALTH › Chapter 8 - COLLECTION, PROCESSING, STORAGE AND DISTRIBUTION OF BLOOD › Subchapter 10 - ISSUE AND ADMINISTRATION OF BLOOD AND BLOOD COMPONENTS FOR TRANSFUSION › Section 8:8-10.3 - Reissue of blood and blood components

Current through Register Vol. 56, No. 14, July 15, 2024
(a) Blood or blood
				components which have been returned to the blood bank shall not be reissued for use
				unless the following conditions have been met:
1.
				The container closure or seal has not been punctured or tampered with;
2. The blood has been continuously stored and
				shipped under controlled conditions, which maintain acceptable temperatures for the
				product, or it is returned to the blood bank within a pre-determined time, set by
				the blood bank, which is acceptable to the Department;
3. Whole blood and red blood cells have not been
				allowed to warm above 10 degrees Centigrade or cool below one degree
				Centigrade;
4. Original identification
				labels and tags are attached and unaltered;
5. The original pilot sample has not been removed
				or tampered with and at least one sealed segment of the integral donor tubing
				remains attached to the container;
6. If
				applicable, the blood has been allowed to settle long enough to permit reinspection
				of the plasma; and
7. The records
				indicate the blood was reissued with documentation of the time it was returned and
				reissued.
New Jersey Administrative Code › Title 8 - HEALTH › Chapter 8 - COLLECTION, PROCESSING, STORAGE AND DISTRIBUTION OF BLOOD › Subchapter 11 - STORAGE OF BLOOD › Section 8:8-11.1 - General provisions

Current through Register Vol. 56, No. 14, July 15, 2024
(a) The equipment used
				for the storage of blood or blood components shall be kept clean and individual
				compartments used only for the storage of blood and blood components, blood bank
				reagents, pilot and patient samples.
(b)
				No food or potentially contaminated material shall be stored in the equipment used
				for storage of blood or blood components.
(c) Written procedures shall be readily available
				containing directions on how to maintain blood and blood components within
				permissible temperatures and including instructions to be followed in the event of
				power failure or other disruption of refrigeration.
New Jersey Administrative Code › Title 8 - HEALTH › Chapter 8 - COLLECTION, PROCESSING, STORAGE AND DISTRIBUTION OF BLOOD › Subchapter 11 - STORAGE OF BLOOD › Section 8:8-11.2 - Refrigerators for the storage of blood and blood components

Current through Register Vol. 56, No. 14, July 15, 2024
(a) The refrigerator for
				the storage of blood shall maintain the blood at a temperature between 1-6 [degrees]
				C.
(b) Refrigerators for blood or blood
				component storage shall be provided with a fan for circulating air or be of a design
				to ensure that the proper temperature is maintained throughout.
(c) Liquid temperature shall be
				monitored.
(d) The liquid medium used
				shall reflect the actual temperature of blood in storage.
New Jersey Administrative Code › Title 8 - HEALTH › Chapter 8 - COLLECTION, PROCESSING, STORAGE AND DISTRIBUTION OF BLOOD › Subchapter 11 - STORAGE OF BLOOD › Section 8:8-11.3 - Freezers for the storage of blood and blood components

Current through Register Vol. 56, No. 14, July 15, 2024
(a) Freezers for blood
				and blood components stored frozen shall maintain the blood and blood components at
				a temperature below -18 degrees Centigrade.
(b) Liquid nitrogen freezers used to store blood
				and blood components shall maintain them at a gas phase temperature below -120
				degrees Centigrade.
New Jersey Administrative Code › Title 8 - HEALTH › Chapter 8 - COLLECTION, PROCESSING, STORAGE AND DISTRIBUTION OF BLOOD › Subchapter 11 - STORAGE OF BLOOD › Section 8:8-11.4 - Room temperature storage

Current through Register Vol. 56, No. 14, July 15, 2024
(a) Components for room
				temperature storage shall be maintained at a temperature of 20 to 24 degrees
				Centigrade.
(b) If components are stored
				in an open storage area, the ambient temperature shall be recorded every four hours
				during storage.
New Jersey Administrative Code › Title 8 - HEALTH › Chapter 8 - COLLECTION, PROCESSING, STORAGE AND DISTRIBUTION OF BLOOD › Subchapter 11 - STORAGE OF BLOOD › Section 8:8-11.5 - Temperature monitoring systems

Current through Register Vol. 56, No. 14, July 15, 2024
(a) All equipment used
				to store blood and blood components shall have a system to record temperature
				continuously. In the event of equipment failure, the blood and blood component
				storage temperature shall be recorded at least every four hours.
(b) The temperature recording device shall be
				calibrated periodically, inspected at least daily and written records of the
				temperatures shall be kept on file.
(c)
				Alarms shall be attached to the blood and blood component storage equipment and
				shall be subject to the following:
1. Visual and
				audible alarm systems shall be attached to the equipment to indicate whenever the
				temperature is outside acceptable ranges.
2. Alarms shall be installed in locations to
				provide 24 hour coverage by night personnel or switchboard operators.
3. The alarms shall be set to activate at a
				temperature which shall allow proper action to be taken before the blood or blood
				components reach undesirable temperatures.
4. When the alarm is activated, the licensee shall
				initiate a process for immediate investigation and appropriate corrective action
				shall be documented.
New Jersey Administrative Code › Title 8 - HEALTH › Chapter 8 - COLLECTION, PROCESSING, STORAGE AND DISTRIBUTION OF BLOOD › Subchapter 11 - STORAGE OF BLOOD › Section 8:8-11.6 - Inspection of stored blood and blood components

Current through Register Vol. 56, No. 14, July 15, 2024
(a) Stored blood and/or
				blood components shall be inspected daily and records maintained during the entire
				period of storage and immediately prior to issue or use.
(b) If the color or physical appearance is
				abnormal or there is any indication or suspicion of contamination, the unit of blood
				or blood components shall not be issued for transfusion purposes.
(c) There shall be methods to limit and detect
				bacterial contamination in all platelet components in accordance with AABB
				Standards.
New Jersey Administrative Code › Title 8 - HEALTH › Chapter 8 - COLLECTION, PROCESSING, STORAGE AND DISTRIBUTION OF BLOOD › Subchapter 11 - STORAGE OF BLOOD › Section 8:8-11.7 - Expiration dates of blood and blood components

Current through Register Vol. 56, No. 14, July 15, 2024
(a) The expiration date
				shall be the last day on which the blood and blood components are considered
				suitable for transfusion purposes.
(b)
				Expiration dates shall be in accord with the Code of Federal Regulations, as amended
				or supplemented.
New Jersey Administrative Code › Title 8 - HEALTH › Chapter 8 - COLLECTION, PROCESSING, STORAGE AND DISTRIBUTION OF BLOOD › Subchapter 11 - STORAGE OF BLOOD › Section 8:8-11.8 - Packaging and transportation

Current through Register Vol. 56, No. 14, July 15, 2024
(a) Processed whole
				blood, modified whole blood and all liquid red blood cell components shall be
				transported in a manner that will maintain temperatures of one to 10 degrees
				Centigrade.
(b) Components ordinarily
				stored at 20 to 24 degrees Centigrade shall be transported at this
				temperature.
(c) Components ordinarily
				stored frozen shall be transported in a manner designed to keep them
				frozen.
(d) Immediately upon arrival,
				the receiving facility shall transfer the blood to temperature controlled equipment
				for further storage.
New Jersey Administrative Code › Title 8 - HEALTH › Chapter 8 - COLLECTION, PROCESSING, STORAGE AND DISTRIBUTION OF BLOOD › Subchapter 12 - OUT-OF-HOSPITAL TRANSFUSIONS › Section 8:8-12.1 - General provisions

Current through Register Vol. 56, No. 14, July 15, 2024
(a) A facility that
				intends to perform out-of-hospital transfusion shall obtain a blood bank license to
				offer the service in New Jersey.
(b) Any
				facility that issues blood and blood components to an Out-of-Hospital Transfusion
				(OOHT) service shall be a blood bank licensed in accordance with this chapter to
				perform "Transfusion Services" and "Processing (Routine)".
(c) The OOHT service and the New Jersey licensed
				"Transfusion Service" shall have a written agreement that specifies the division of
				responsibilities for assuring compliance with this chapter. If the OOHT service
				performs no function other than transfusion of the blood, the New Jersey licensed
				transfusion service shall agree in this written document to perform recipient
				testing required in
				8:8-9.1 and
				8:8-9.2, and to provide technical
				consultation when necessary.
(d) Blood
				banks wishing to employ the techniques set forth in this subchapter shall file their
				protocol and a request in writing with the Department, prior to initiation of the
				procedure.
(e) Such techniques shall
				only be employed upon receipt of written approval from the Department.
(f) The procedures used shall be acceptable to the
				Department and ensure that there is compliance with this Chapter.
New Jersey Administrative Code › Title 8 - HEALTH › Chapter 8 - COLLECTION, PROCESSING, STORAGE AND DISTRIBUTION OF BLOOD › Subchapter 12 - OUT-OF-HOSPITAL TRANSFUSIONS › Section 8:8-12.2 - Out-of-hospital transfusions (OOHT)

Current through Register Vol. 56, No. 14, July 15, 2024
(a) Out-of-hospital
				transfusions (OOHT) shall be done under medical supervision, and the patient shall
				be observed during the transfusion and for an appropriate time thereafter for
				suspected adverse reactions. Specific instructions concerning possible adverse
				reactions shall be provided in writing for the patient.
(b) Blood or blood components for transfusion
				shall be prescribed by a clinical practitioner.
(c) OOHT services shall be licensed to transfuse
				blood and blood components, in accordance with this chapter.
(d) Recipient safety shall be assured by at least
				the following:
1. If a physician is not present,
				the transfusionist shall be a person able to administer emergency care and shall be
				a registered nurse (R.N.) holding a current certificate of registration who has
				fulfilled the following requirements:
i. Has taken
				an eight hour course in cardiopulmonary resuscitation within three years and
				successfully passed a practical and written exam on the subject matter.
New Jersey Administrative Code › Title 8 - HEALTH › Chapter 8 - COLLECTION, PROCESSING, STORAGE AND DISTRIBUTION OF BLOOD › Subchapter 12 - OUT-OF-HOSPITAL TRANSFUSIONS › Section 8:8-12.3 - Out-of-hospital transfusions (OOHT) in emergency situations

Current through Register Vol. 56, No. 14, July 15, 2024
(a) Facilities not
				routinely using blood and blood components for therapeutic purposes that can
				anticipate that they may use them on an emergency basis to treat a life-threatening
				situation, shall be licensed as outlined in
				8:8-1.3, Licensure. This licensure
				requirement shall not be applicable to ambulatory surgery centers that are not
				required to be licensed by the Department.
(b) The facilities described in (a) above shall
				comply with N.J.A.C. 8:8-5, Records and Reporting Requirements, N.J.A.C. 8:8-9,
				Recipient Blood Testing and
				8:8-10.1, Administration of blood and
				blood components.
(c) If a nonsurgical
				situation exists, which could not be anticipated and blood or blood components for
				therapeutic purposes are necessary on an emergency basis to treat a life-threatening
				situation, a licensed blood bank shall be permitted to release blood and blood
				components to an entity not licensed as a blood bank provided that:
1. The attending physician shall attest in writing
				to the existence of the emergency and the licensed blood bank shall maintain this
				documentation as required in 8:8-5.1, Records.
2. N.J.A.C. 8:8-9, Recipient Blood Testing and
				8:8-10.1, Administration of blood and
				blood components are followed.
New Jersey Administrative Code › Title 8 - HEALTH › Chapter 8 - COLLECTION, PROCESSING, STORAGE AND DISTRIBUTION OF BLOOD › Subchapter 13 - HEMATOPOIETIC PROGENITOR CELLS › Section 8:8-13.1 - Compliance

Current through Register Vol. 56, No. 14, July 15, 2024
(a) Persons, known as
				licensees, for the purpose of this chapter, operating blood banks involved in the
				collection, processing, storage, distribution and/or transplantation of
				hematopoietic progenitor cells (HPC), shall meet the qualifications and conduct
				blood banks in accordance with
				26:2A-2 et seq., the rules in this
				subchapter and the provisions of N.J.A.C. 8:8-1 and 3.
New Jersey Administrative Code › Title 8 - HEALTH › Chapter 8 - COLLECTION, PROCESSING, STORAGE AND DISTRIBUTION OF BLOOD › Subchapter 13 - HEMATOPOIETIC PROGENITOR CELLS › Section 8:8-13.2 - Definitions

Current through Register Vol. 56, No. 14, July 15, 2024
For the purpose of this subchapter, the terms listed below shall
				  be defined and interpreted as follows:
"Allogeneic" means the collection of HPC for subsequent
				  transplantation to a recipient other than the donor. The term "allogeneic" is also
				  known as homologous.
"Autologous" means the removal and storage of HPC from a donor
				  for subsequent reinfusion into the same person. The term "autologous" is also known
				  as autogeneic.
"Collection and processing service" means an organizational
				  entity that collects or processes HPC or performs both functions.
"Cord blood" means blood in the placenta and umbilical cord that
				  may be rich in HPC.
"Designee" means an individual designated by the medical and/or
				  laboratory director in writing, who is qualified by education, training and/or
				  experience to assume his/her duties for specific aspects of the
				  collection/processing service.
"First degree blood relative" means a parent, child, or
				  sibling.
"Hematopoietic progenitor cells (HPC)" means pluripotential cells
				  that may be capable of self-renewal and differentiation into any mature blood cells,
				  which are present in peripheral blood and placental/cord blood.
"Hematopoietic progenitor cell blood bank" means an operation
				  engaged in HPC collection, processing, storage, distribution and/or transplantation
				  that shall be referred to as blood banks or HPC blood banks in N.J.A.C.
				  8:8-13.
"Human leukocyte antigens (HLA)" are proteins located on the
				  surface of the white blood cells and other tissues of the body that are used for
				  typing in allogeneic transplants to determine histocompatibility between donor and
				  intended recipient.
"Manipulated HPC" means HPC obtained after one or more processes
				  have been performed to intentionally purge or enrich the starting material.
"Processing" means all tests and procedures required in preparing
				  and identifying the HPC products as to their suitability for therapeutic,
				  prophylactic or other in vivo or in vitro purposes.
"Recipient" means any person who receives a transplantation of
				  HPC.
"System" means the organizational structure, responsibilities,
				  policies, processes, procedures, and resources established by the licensee to
				  achieve the requirements of these rules.
New Jersey Administrative Code › Title 8 - HEALTH › Chapter 8 - COLLECTION, PROCESSING, STORAGE AND DISTRIBUTION OF BLOOD › Subchapter 13 - HEMATOPOIETIC PROGENITOR CELLS › Section 8:8-13.3 - Personnel

Current through Register Vol. 56, No. 14, July 15, 2024
(a) The licensee shall
				be responsible for obtaining a qualified HPC blood bank medical director, laboratory
				director and qualified technical staff.
(b) The medical director shall:
1. Be a physician who is appropriately licensed to
				practice medicine in New Jersey and is board certified in one or more of the
				following specialties: Hematology; Oncology; Pediatric Hematology/Oncology;
				Immunology and/or Pathology;
2. Have at
				least two years of documented experience or training in the relevant field, and have
				supervised at least 10 HPC collection and/or transplantation procedures for which
				they have direct authority;
3. Acquire
				proficiency in new procedures as they are developed with appropriate study,
				training, supervision, and/or certification;
4. Be responsible and have the authority for
				providing oversight of the entire HPC process, and shall specifically assure that
				each portion of the collection, processing, administration and storage comply with
				this subchapter;
5. Be responsible for
				adherence with 26:2A-2 et seq. and this
				subchapter;
6. Be responsible for the
				employment of qualified HPC personnel, their in-service training and their adherence
				to established policies and procedures.
7. A qualified medical director may serve in the
				dual capacity of medical director and laboratory director with full responsibility
				for all HPC services and duties listed in this subchapter and (c) below.
New Jersey Administrative Code › Title 8 - HEALTH › Chapter 8 - COLLECTION, PROCESSING, STORAGE AND DISTRIBUTION OF BLOOD › Subchapter 13 - HEMATOPOIETIC PROGENITOR CELLS › Section 8:8-13.4 - Quality management

Current through Register Vol. 56, No. 14, July 15, 2024
(a) HPC collection,
				processing, and administration service(s) shall establish and maintain a program or
				programs for quality control, quality assurance and quality assessment, which shall
				be in accordance with
				8:8-4.1. The ultimate responsibility for
				the implementation of an adequate quality management program shall reside with the
				medical director.
1. There shall exist a written
				method for evaluating product specifications, specimen collection, storing,
				processing, usage, administration policies, and ability of services to meet patient
				needs.
New Jersey Administrative Code › Title 8 - HEALTH › Chapter 8 - COLLECTION, PROCESSING, STORAGE AND DISTRIBUTION OF BLOOD › Subchapter 13 - HEMATOPOIETIC PROGENITOR CELLS › Section 8:8-13.5 - Records

Current through Register Vol. 56, No. 14, July 15, 2024
(a) Suitable and legible
				records shall be maintained for a period of not less than five years. Records to
				trace a unit of HPC from source to final disposition shall be kept for at least 10
				years after transplantation. Written records shall be prepared with indelible
				material. All records stored off-site shall be retrievable within 24
				hours.
(b) All corrections made in the
				HPC records shall not conceal the original entry; shall document the reason for the
				correction; and shall include the date the change was made and the initials of the
				person making the change.
(c) Complete
				records for all aspects of HPC activities performed shall be maintained. Records
				shall include the identity of the personnel who performed each significant step,
				quality control and when applicable donor history, medical examination, consent,
				deferral, reactions and laboratory test results; storage temperature; labeling,
				issue, and administration of HPC and its final disposition.
(d) Records maintained on computer shall comply
				with all the requirements of this chapter as set forth in
				8:8-5.1(e).
(e) All records of HPC donors that do not meet the
				donor suitability criteria shall be kept for a period of 10 years.
New Jersey Administrative Code › Title 8 - HEALTH › Chapter 8 - COLLECTION, PROCESSING, STORAGE AND DISTRIBUTION OF BLOOD › Subchapter 13 - HEMATOPOIETIC PROGENITOR CELLS › Section 8:8-13.6 - Reporting requirements

Current through Register Vol. 56, No. 14, July 15, 2024
(a) Any error in
				collection, processing, testing or administration of HPC that results in an adverse
				clinical event shall be reported on forms provided by the Department within 15
				working days of occurrence.
(b) All
				prospective donors found to test positive for hepatitis B surface antigen and
				hepatitis C virus antibody shall be reported to the Department within 10 calendar
				days on forms provided for this purpose. These donors shall be considered ineligible
				for transplantation purposes as long as they continue to be identified on current
				lists of interdicted donors supplied by the Department, unless approved by the
				medical director and the recipient's physician.
(c) All prospective donors who test positive for
				communicable diseases shall be reported to the Department in accordance with
				N.J.A.C. 8:57.
(d) Corrective actions
				shall be documented and reviewed promptly by the medical director/laboratory
				director dependent upon whether the corrective action in this case is of medical or
				technical nature.
(e) Any errors, as set
				forth in 8:8-4.4(a), that result
				in the availability of unsuitable HPC products shall be reported to the Department
				on forms provided for that purpose.
New Jersey Administrative Code › Title 8 - HEALTH › Chapter 8 - COLLECTION, PROCESSING, STORAGE AND DISTRIBUTION OF BLOOD › Subchapter 13 - HEMATOPOIETIC PROGENITOR CELLS › Section 8:8-13.7 - Criteria for donor identification

Current through Register Vol. 56, No. 14, July 15, 2024
(a) HPC donor shall be
				identified by an identification card or another form of authorized identification
				that provides a mechanism to positively identify prospective donors.
(b) The type of identification used shall be
				written on the donor registration card at the time of each HPC donation.
New Jersey Administrative Code › Title 8 - HEALTH › Chapter 8 - COLLECTION, PROCESSING, STORAGE AND DISTRIBUTION OF BLOOD › Subchapter 13 - HEMATOPOIETIC PROGENITOR CELLS › Section 8:8-13.8 - Criteria for donor selection

Current through Register Vol. 56, No. 14, July 15, 2024
(a) When establishing
				the suitability of HPC donors for collection, the criteria used for medical history;
				physical examinations; bleeding limitations and the applicable requirements as
				prescribed by 8:8-6.2 shall be followed and shall be
				consistent with FDA regulations.
(b)
				When selecting donors for suitability, the applicable requirements as prescribed by
				8:8-6.3 shall be followed and shall be
				consistent with FDA regulations and AABB Standards.
(c) The recipient's physician shall write a
				request for collection and processing before HPC are collected.
(d) The licensee shall obtain an informed consent
				of the peripheral blood donor prior to collection.
(e) Informed consent for cord blood donors shall:
1. Be obtained from birth mother, preferably both
				parents and if applicable, the legal custodian(s), according to
				8:8-6.4(a)  and the
				AABB Standards;
2. Not be obtained
				during active labor or while the mother is under the influence of
				sedation;
3. Be obtained prior to
				collection in cases of in utero collection; and
4. Begin before collection and be completed within
				48 hours of collection.
New Jersey Administrative Code › Title 8 - HEALTH › Chapter 8 - COLLECTION, PROCESSING, STORAGE AND DISTRIBUTION OF BLOOD › Subchapter 13 - HEMATOPOIETIC PROGENITOR CELLS › Section 8:8-13.9 - Collection of HPC

Current through Register Vol. 56, No. 14, July 15, 2024
Collection of HPC shall be in accordance with N.J.A.C. 8:8-8.