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PO Box 360
Trenton, NJ 08625-0360

For Release:
August 16, 2010

Poonam Alaigh, MD, MSHCPM, FACP
Commissioner

For Further Information Contact:
Office of Communications
(609) 984-7160


 
Department of Health and Senior Services proposes the readoption without change of N.J.A.C. 8:8, Collection, Processing, Storage and Distribution of Blood


 

The Division of Public Health and Environmental Laboratories, Clinical Laboratory Improvement Service, of the Department of Health and Senior Services is proposing the readoption without change of N.J.A.C. 8:8, which governs the collection, processing, storage and distribution of blood. 

 

         N.J.A.C. 8:8 prescribes standards for the operation of blood banks in New Jersey.  N.J.A.C. 8:8 protects New Jersey’s blood supply by regulating the storage and testing of blood, the management and maintenance of blood banks, blood bank personnel, recordkeeping and reporting, donor selection, blood collection, and transfusions.

 

          The Department plans to propose amendments, repeals and new rules to N.J.A.C. 8:8 in the near future to modernize the blood bank rules.  The Department convened a blood bank rule advisory committee composed of blood bank administrators, physician directors, blood bank supervisors and technologists, a representative of the Health Professionals and Allied Employees union, a representative of the New Jersey State Nurses Association and Department staff to review and revise the blood bank rules.  The Department held a series of meetings with the advisory committee from December 2009 through February 2010 at which the existing blood bank rules were reviewed to determine the technical accuracy of the rules with regard to changes in the blood banking technology, U.S. Food and Drug Administration (FDA) regulations and American Association of Blood Banks (AABB) accreditation standards and whether the existing rules adequately protect the health and safety of the estimated 400,000 New Jersey residents who donate blood or receive blood transfusions each year.

 

         The committee recommended moving forward with rule changes.  Many of the upcoming proposed rule changes would update the existing rules or standardize language and references throughout the chapter and ensure consistency with the FDA regulations and AABB standards without imposing significant additional regulatory requirements.

 

         The proposal appears in the August 16, 2010 issue of the New Jersey Register.  LexisNexis® provides free on-line public access to the New Jersey Administrative Code and the New Jersey Register at http://lexisnexis.com/njoal.

 

         A public hearing on the proposed new rules will be held on September 13, 2010, between 2:00 P.M. and 4:00 P.M. at the New Jersey Department of Health and Senior Services, First Floor Auditorium, Health and Agriculture Building, 369 South Warren Street (at Market Street), Trenton, New Jersey 08608.  Persons wishing to comment on the proposal at the public hearing who wish to be placed on the list of speakers are requested to telephone Ms. Mary Marks at (609) 984-7923 by September 7, 2009, and bring a written copy of their remarks for submission to the public record.

 

         The public has until October 15, 2010 to comment on the proposal.  Persons wishing to comment on the proposal must submit their comments in writing to Ruth Charbonneau, Director, Office of Legal and Regulatory Affairs, New Jersey Department of Health and Senior Services, PO Box 360, Trenton, NJ 08625-0360.  Written comments on the proposal must be postmarked on or before October 15, 2010, which is the close of the 60-day public comment period.

 
 
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