JON S. CORZINE Governor DEPARTMENT OF HEALTH AND SENIOR SERVICES PO BOX 360 TRENTON, N.J. 08625-0360 www.nj.gov/health HEATHER HOWARD Commissioner TO: FROM: Public Health Council Heather Howard Commissioner SUBJECT: Proposed Amendments to N.J.A.C. 8:8 Attached for your review and approval is a proposal from the Department s Clinical Laboratory Improvement Service to amend N.J.A.C. 8:8-5.2 and 8.2 and to repeal and propose new rules at N.J.A.C. 8:8-6.3 for the Collection, Processing, Storage and Distribution of Blood which include the following: Delete the requirements to report donors testing positive for Hepatitis B and/or C to the Department s blood bank program for inclusion on the Hepatitis Registry and to defer donors from donating blood whose names appear in the latest revision of the Hepatitis Registry as updated by the Department; Change the expiration date of the provision that allows alternative donor emergency care personnel at certain blood drives as an alternative to Registered Nurses in N.J.A.C. 8:8-8.2(b)-(f) from March 31, 2008 to February 1, 2011 to allow the Department to continue its collection of data in the evaluation of the use of alternative donor emergency care personnel; Reference other Department rules at N.J.A.C. 8:57-1 and 8:57-2 which require reporting of reportable diseases including Hepatitis B and C to the Department s Communicable Disease Service and of HIV-1 and HIV-2 to the Division of HIV/AIDS Services; Clarify that donors testing positive for Hepatitis B and C, HIV-1 and 2 or meeting other deferral criteria established by the FDA, the blood bank rules and the blood bank for permanent or temporary deferral shall be listed on the blood bank s internal deferral lists and that they shall be notified in writing if they are permanently deferred from donating blood; Clarify the language in the existing rule to ensure that deferral records are reviewed prior to the release of blood for distribution and for transfusion; and Establish new Appendix A and Appendix B forms to be used for reporting error, accident and transfusion reaction incidents and the telephone number blood banks will use to report fatal transfusion reaction.
Department staff, in conjunction with the Blood Bank Task Force of New Jersey, has determined that the rules concerning the Hepatitis Registry are no longer necessary and no longer serve their intended purpose. Current Hepatitis B and Hepatitis C testing is much more reliable and specific than earlier tests, financial incentives to donate blood are no longer permitted, and donor screening is more comprehensive, uniform and effective at screening out ineligible donors. In addition, donors testing positive for Hepatitis B and C are notified in writing of the positive test results by the collecting blood center or hospital and are listed on the blood center or hospital s internal donor deferral list. It is unlikely that donors who have been notified that they are not eligible to donate blood will attempt to donate at another blood center. The Department proposes to amend N.J.A.C. 8:8-8.2(j) by extending the effective period of existing N.J.A.C. 8:8-8.2(b) through (f) from March 31, 2008 to February 1, 2011 in order to continue to allow alternative donor emergency care personnel under certain conditions when a physician or RN is not available beyond March 31, 2008 and to enable the Department to continue its collection of data in the evaluation of the use of the alternative donor emergency care personnel. Based on initial data for the period April, 2006 June, 2007, the Department has determined that the alternative donor emergency care personnel provisions have helped to ensure that blood drives are not cancelled due to the unavailability of an RN to staff the drive. Blood collections were increased in 2006 for only the second time in the last 14 years. Without the alternative donor emergency care provisions, the state s annual blood collection deficit would have increased from 75,000 to 95,000 units. It is crucial that New Jersey reduce its reliance on other states to meet our need for blood for transfusions for burn, cancer, trauma and other patients. These new rules do not impose additional regulatory requirements but are intended to clarify and reinforce existing Department and FDA reporting requirements for blood banks to maintain donor deferral lists. These proposed rule changes have been discussed with the Blood Bank Task Force of New Jersey which has expressed its support of the proposed changes. Please let me know if you have any questions. Thank you. 2
HEALTH AND SENIOR SERVICES PUBLIC HEALTH SERVICES BRANCH DIVISION OF PUBLIC HEALTH AND ENVIRONMENTAL LABORATORIES CLINICAL LABORATORY IMPROVEMENT SERVICE Chapter 8 of the State Sanitary Code Collection, Processing, Storage and Distribution of Blood Records and Reporting Requirements Criteria for Donor Selection: Donor Selection; Deferral Records; Deferral Notice to Donor Collection of Blood: Donor Emergency Care Proposed Amendments: N.J.A.C. 8:8-5.2 and 8.2 Proposed Repeal and New Rule: N.J.A.C. 8:8-6.3 Authorized By: Heather Howard, J.D., Commissioner, Department of Health and Senior Services, in consultation with the Public Health Council, Herbert Yardley, M.A., Chair. Authority: N.J.S.A. 26:1A-7 and N.J.S.A. 26:2A-7; and Reorganization Plan No. 003-2005 (June 27, 2005), 37 N.J.R. 2735 (a) (August 1, 2005). Calendar Reference: See summary below for explanation of exception to calendar requirement. Proposal Number: PRN 2008-.
A public hearing on the proposed amendments will be held on the following date at the following location:, 2008 New Jersey Department of Health and Senior Services First Floor Auditorium Health and Agriculture Building 369 South Warren Street Trenton, NJ 08608 Submit written comments by, 2008 to: Ruth Charbonneau, Director Office of Legal and Regulatory Affairs NJ Department of Health and Senior Services PO Box 360 Trenton, NJ 08625-0360 The agency proposal follows: Summary N.J.A.C. 8:8, Collection, Processing, Storage and Distribution of Blood, establishes the requirements for the operation of blood banks in New Jersey. It sets the minimum standards for the collection, processing, storage, and distribution of blood for therapeutic or prophylactic purposes to protect the health and safety of blood donors and recipients. 2
N.J.A.C. 8:8-5.2 addresses reporting requirements. The Department is proposing technical amendments throughout this section to eliminate the passive voice and to improve readability. The Department proposes to amend N.J.A.C. 8:8-5.2(a) to establish, as new Appendix A, the form blood banks are to use to report transfusion reactions, and to establish the telephone number blood banks are to use to report fatal transfusion reactions. The Department proposes to amend N.J.A.C. 8:8-5.2(b) to require blood banks to report to the Department, in writing, cases of HIV infection and/or AIDS presumed to be associated with a transfusion. Existing N.J.A.C. 8:8-5.2(c) requires blood banks to report to the Department blood test results of prospective donors that are positive for hepatitis B surface antigen and antibody to hepatitis C virus, and requires blood banks to treat these prospective donors as ineligible for allogeneic donation as long as their names continue to appear on a list the Department supplies of persons who have tested positive for hepatitis. The Clinical Laboratory Improvement Service of the Department has conferred with members of the Blood Bank Task Force of New Jersey, which is comprised of representatives of the eight blood centers serving New Jersey and hospital blood banks. These consultations have resulted in a consensus that the list of persons who have tested positive for hepatitis and who are ineligible for allogeneic donation no longer serves 3
the purpose for which the Department originally intended its establishment, for the following reasons: 1. In the past, screening tests for hepatitis blood banks performed were less reliable and more frequently yielded falsely positive results. Currently, blood banks conduct Hepatitis B and Hepatitis C testing of donated blood using tests that are more reliable and specific than earlier tests. As a result, blood banks do not need to rely on a Departmentprovided list. 2. In the past, blood banks could use financial incentives to encourage blood donation, resulting in a higher risk of their accepting the blood of ineligible donors. The Code of Federal Regulations now prohibits this practice, and authorizes only voluntary donors, thus enhancing the safety of the blood supply and lessening the risk of donations from persons with hepatitis. Moreover, donor screening is generally more comprehensive, uniform, and effective at screening out persons who are ineligible to donate than it was in the past. 3. Distribution of the list of persons with hepatitis who are ineligible to donate poses an unnecessary risk of identity theft for the approximately 20,000 persons listed therein in that it contains Social Security numbers. 4. The State does not distribute a list of persons who have other infectious diseases that require deferral from donating blood. This results in the incongruous or disparate focus on the exclusion of persons with 4
hepatitis from the blood donation system when other diseases may be of equal or greater concern to the blood supply. Moreover, the list of persons with hepatitis who are ineligible to donate is not a comprehensive listing of all individuals in New Jersey who have tested positive for Hepatitis B and C. Rather, it lists only persons who were prospective blood donors and who have tested positive for hepatitis. Thus, a blood bank s reliance on the list to the exclusion of other means of predistribution testing and screening measures could result in the acceptance of ineligible donors blood into the blood supply. For these reasons, the Department proposes to delete the requirement that it distribute the list of persons with hepatitis who are ineligible to donate. The Department proposes new N.J.A.C. 8:8-5.2(c) to provide a cross-reference to the existing requirement that blood banks report to the Communicable Disease Service of the Department donor s positive test results of reportable diseases, in accordance with procedures that program establishes. The Department proposes new N.J.A.C. 8:8-5.2(d) to provide a cross-reference to the existing requirement that blood banks report to the Division of HIV/AIDS Services of the Department donor s positive HIV test results, in accordance with procedures that program establishes. 5
The Department proposes to amend existing N.J.A.C. 8:8-5.2(d), to be recodified as new N.J.A.C. 8:8-5.2(e), to require blood banks to report errors and accidents described at N.J.A.C. 8:8-4.4, regardless of whether they result in the availability of unsuitable blood and blood components for transfusion or distribution, and to establish as new Appendix B the form to be used to make such reports. The Department proposes to amend existing N.J.A.C. 8:8-5.2(e), to be recodified as new N.J.A.C. 8:8-5.2(f), to require blood banks to report errors and accidents that result in no harm to the recipient using the form at new Appendix B. Proposed new N.J.A.C. 8:8-5.2(g) would establish that the forms at appendices A and B are available on request from the Blood Bank Program of the Clinical Laboratory Improvement Service and are available for download from the Department s forms web page on the internet. The Department proposes to repeal existing N.J.A.C. 8:8-6.3, Donor selection, and to establish new N.J.A.C. 8:8-6.3, Donor selection; deferral records; deferral notice to donor. Proposed new N.J.A.C. 8:8-6.3(a) would require trained blood bank staff to screen prospective donors on the date of donation, and to defer those who do not meet the eligibility criteria the AABB Standards and the Code of Federal Regulations establish. 6
Proposed new N.J.A.C. 8:8-6.3(b) would require blood banks to adhere to the recordkeeping requirements the Code of Federal Regulations establishes with respect to the deferral of persons from blood donation. Proposed new N.J.A.C. 8:8-6.3(c) would require blood banks to notify in writing prospective donors that the blood bank determines to permanently defer from donating blood for allogeneic use. Existing N.J.A.C. 8:8-2.3(d) and 8.8(a) require the presence of a physician or a registered nurse to be present on the premises during blood collection for donor emergency care. The industry commonly refers to this personnel requirement as the RN requirement because physicians rarely staff blood drives, and it has been the practice to staff blood drives using RNs for donor emergency care. In 2006, the Department, in consultation with the Public Health Council, amended N.J.A.C. 8:8-8.2 to allow the use of alternative donor emergency care personnel when blood centers have made a reasonable effort to staff blood drives with a physician or a registered nurse and neither is available, during blood drives that do not involve predominantly high school-aged students or the performance of autologous or maternal/fetal collections. 37 N.J.R. 3765(a) (October 3, 2005), 38 N.J.R. 1732(a) (April 17, 2006). The purpose of this exception is to avoid blood drive cancellations and other missed blood collection opportunities due to the unavailability of physicians or registered nurses. 7
N.J.A.C. 8:8-8.2(f) establishes March 31, 2008, as the expiration date for the use of alternative donor emergency care personnel. The purpose of this expiration date is to permit the Department to evaluate the effectiveness of this exception in increasing blood collections and maintaining donor safety, and to require the Department to conduct rulemaking if the exception proved effective. The Department proposes to amend N.J.A.C. 8:8-8.2(j) to extend the effective period of existing N.J.A.C. 8:8-8.2(b) through (f) to February 1, 2011, to enable the Department to continue its collection of data in the evaluation of the use of alternative donor emergency care personnel. Pursuant to N.J.A.C. 1:30-3.3(5), because a 60-day comment period has been provided for this notice of proposal, this notice is excepted from the rulemaking calendar requirement. Social Impact The proposed amendments at N.J.A.C. 8:8-5.2 would ensure that blood banks report transfusion reactions and errors and accidents to the Blood Bank Program of the Clinical Laboratory Improvement Service in a uniform manner using forms the Department establishes. As discussed in the Summary, above, the proposed deletion of existing N.J.A.C. 8:8-5.2(c) would eliminate an unnecessary requirement while enhancing the safety of the blood supply and eliminating a potential 8
risk of identity theft to persons on the list of those prospective donors who have tested positive for hepatitis. The proposed repeal and new rule at N.J.A.C. 8:8-6.3 would ensure that blood banks adhere to uniform standards in the selection of donors, the maintenance of deferral records, and the notification of permanently deferred donors, thus contributing to public confidence in the safety of the blood supply. The proposed amendment at N.J.A.C. 8:8-8.2 would authorize the blood banks continued use of alternative donor emergency care personnel while extending the period during which the Department is collecting data on the practice toward the development of a final recommendation. Following is a summary of the Department s efforts to date with respect to the collection of data on this issue. The Department has collected data from the State s eight blood centers with respect to the numbers of units collected and donor reactions for blood drives staffed by registered nurses as compared to those staffed by alternative donor emergency care personnel for the periods of January 1, 2006 through December 31, 2006 and January 1, 2007 through June 30, 2007. The blood centers reported collecting 22,587 units of blood from January 1, 2006 through December 31, 2006 and 23,655 units of blood from January 1, 2007 through June 30, 2007 during blood drives using alternative donor 9
emergency care personnel, for a total of 46,242 units. Blood collections in 2006 increased by nearly 7,000 units over 2005. This was only the second time in the past 14 years that blood collections increased over the previous year s collections. Upon the Department s preliminary review, the data show no significant difference in donor reactions on blood drives staffed by alternative donor emergency care personnel as compared to those staffed by registered nurses or physicians. Thus, the Department believes it would be safe and efficient to continue to authorize this practice while the Department finalizes its recommendations. Economic Impact The Department does not believe the proposed amendments at N.J.A.C. 8:8-5.2 would have an economic impact on the public or the regulated community. The proposed amendments would restate existing requirements to report to the Clinical Laboratory Improvement Service while establishing uniform forms for that report. Existing rules of the Communicable Disease Service require blood banks to report certain illnesses and conditions. The Department does not believe that the proposed repeal and new rule at N.J.A.C. 8:8-6.3 would have an economic impact on the public or the regulated community. Under the existing rules and under Federal law, blood banks currently adhere to the Code of Federal Regulations, and, to 10
maintain accreditation, the AABB Standards in donor selection and in recordkeeping. As stated above, other existing requirements establish the obligation to report certain diseases and conditions to the Department. The elimination of the requirement that the Department distribute a list of persons who have attempted to donate and who have tested positive for hepatitis would save Department staff resources with no decrease in safety to the blood supply. The proposed amendment at N.J.A.C. 8:8-8.2(j) extending the authorization period for the use of alternative donor emergency care personnel, during an additional period of Department data collection and analysis of the practice, would benefit New Jersey s blood banks and the public by providing a mechanism to prevent the cancellation of blood drives due to the unavailability of physicians or registered nurses. Failure to collect blood due to the cancellation of blood drives can result in reduced revenues to blood banks, and blood shortages. Blood shortages can result in the postponement of scheduled elective surgeries resulting in lost revenues to health care facilities. Federal Standards Analysis 21 CFR Parts 600 through 640, defined at N.J.A.C. 8:8-1.2 as the Code of Federal Regulations, address blood banking. The proposed 11
amendments and new rule meet but do not exceed these applicable Federal standards. The Code of Federal Regulations addresses electronic data, quality management, reporting, and recordkeeping issues. The Federal standards cited above do not establish qualifications for donor emergency care personnel or other blood bank personnel other than to require that personnel have appropriate education, training, and experience necessary to perform their job duties and responsibilities. The Federal standards do not address communicable disease and HIV/AIDS reporting requirements. These requirements vary from state to state. Jobs Impact The Department does not anticipate that the proposed amendments and the proposed repeal and new rule would result in the generation or loss of jobs. Regulatory Flexibility Analysis Facilities licensed as blood banks in the State include free-standing blood centers, hospitals, brokers, industrial manufacturers, dialysis centers, home infusion companies, ambulatory surgery centers and oncology clinics. Approximately 142 of the blood banks affected by these 12
rules are small businesses as defined by Regulatory Flexibility Act, N.J.S.A. 54:14B-16 et seq. The requirements applicable to blood banks that are small businesses are the same as the requirements applicable to all blood banks generally, and are described in the Summary, above. The costs of compliance to blood banks that are small businesses are the same as the costs applicable to all blood banks generally, and are described in the Economic Impact, above. The Department has determined that the proposed amendments and the proposed repeal and new rule are the minimum standards necessary to ensure compliance with applicable Federal standards and to ensure the safety of the blood supply and the collection process, and to ensure public confidence in the system with respect to the issues of reportable events and illnesses, donor selection and deferral, and the provision of donor emergency care. Agriculture Industry Impact The proposed amendments and the proposed repeal and new rule would have no impact on the agriculture industry. Smart Growth Impact 13
The Department does not anticipate that the proposed amendments and the proposed repeal and new rule would have any impact on smart growth in New Jersey or on the implementation of the New Jersey Development and Redevelopment Plan. Full text of the proposed repeal may be found in the New Jersey Administrative Code at N.J.A.C. 8:8-6.3. Full text of the proposed amendments and new rule follows (additions indicated in boldface thus; deletions indicated in brackets [thus]): 14
8:8-5.2 Reporting requirements (a) [Transfusion] Blood banks shall report the following transfusion reactions [be reported] to the Department as follows: 1. [Any hemolytic] Hemolytic and/or delayed hemolytic and other known or suspected life-threatening transfusion reactions [shall be reported on forms provided by the Department] within 10 days of the occurrence[.], using the form at Appendix A, incorporated herein by reference; and 2. [Any known] Known and/or suspected fatal transfusion reactions [shall be reported] by telephone call to (609) 292-0522 by the next working day [of] after the day the event occurs, with written follow-up [on forms provided by the Department] within 10 days of the occurrence, using the form at Appendix A, incorporated herein by reference. (b) [Transfusion] Blood banks shall report in writing to the Blood Bank Program, Clinical Laboratory Improvement Service, of the Department, at P O Box 361, Trenton, NJ 08625-0361, known and/or presumed cases of HIV infection and/or AIDS associated [AIDS shall be reported as follows: 1. Any known or presumed case of transfusion associated AIDS brought to the attention of a blood bank] with a transfusion within 10 days [on forms provided for this purpose] of the date on which the case is brought to the attention of the blood bank. 15
[(c) All prospective donors found to test positive for hepatitis B surface antigen and antibody to hepatitis C virus 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) Blood banks shall report prospective donors testing positive for Hepatitis B, Hepatitis C, syphilis and infectious diseases that are reportable pursuant to N.J.A.C. 8:57-1 to the Communicable Disease Service of the Department or the local health agency in accordance with N.J.A.C. 8:57-1. (d) Blood banks shall report prospective donors testing positive for HIV-1 and/or HIV-2 to the Division of HIV/AIDS Services of the Department in accordance with N.J.A.C. 8:57-2. [(d) Errors, as outlined in] (e) Blood banks shall report to the Department the occurrence of errors and accidents described at N.J.A.C. 8:8-4.4[(a), that result in the availability of unsuitable blood and blood components for transfusion or distribution, shall be reported on forms provided by the Department] within 15 working days of the recognition of the error, using the form at Appendix B, incorporated herein by reference. [(e) Errors] (f) Blood banks shall report to the Department the occurrence of errors and accidents that result in the wrong blood or blood 16
component being transfused[, regardless of] that results in no harm to the recipient [, shall be reported on forms provided by the Department] within 15 working days of the recognition of the error, using the form at Appendix B, incorporated herein by reference. (g) Appendices A and B are available on request from the Blood Bank Program of the Clinical Laboratory Improvement Service of the Department and are available for download from the Department s forms page at http://nj.gov/health/forms. 8:8-6.3 Donor selection; deferral records; deferral notice to donor (a) Blood bank personnel trained to conduct donor eligibility screening in accordance with AABB Standards, the Code of Federal Regulations, and the blood bank s policies and procedures shall evaluate each prospective donor s history on the day of donation to ensure that the prospective donor meets the criteria for blood donation contained in the AABB Standards and the Code of Federal Regulations, and shall defer any person who does not meet these criteria. (b) Blood banks shall adhere to the Code of Federal Regulations in the maintenance of records with respect to the temporary and permanent deferral of persons from donating blood. (c) If, as a result of laboratory testing of donated blood, a blood bank determines that a donor meets criteria for permanent deferral, the 17
blood bank shall transmit written notice to the donor informing the donor that he or she is permanently deferred and cannot donate blood for allogeneic use and that the blood bank will maintain his or her name in the blood bank s record of persons permanently deferred from donating blood. 8:8-8.2 Donor[ s] emergency care (a) (i) (No change.) (j) Subsections (b) through (f) shall not be effective after [March 31, 2008] *February 1, 2011*. 18
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New Jersey Department of Health and Senior Services Clinical Laboratory Improvement Service PO Box 361 Trenton, NJ 08625-0361 TRANSFUSION REACTION REPORT INSTRUCTIONS: 1. Pursuant to N.J.A.C. 8:8-5.2, blood banks must report Hemolytic and/or delayed hemolytic and other known or suspected life-threatening transfusion reactions within 10 days of the occurrence using this form; and must report known and/or suspected fatal transfusion reactions by telephone call to 609-292-0522 by the next working day after the day the event occurs, with written follow-up within 10 days of the occurrence, using this form. 2. Forward the original copy of the report to the address listed above; retain a copy for your records. 3. If there are any questions, contact the Blood Bank Unit at 609-292-0522. 4. Briefly summarize the events leading to the reaction below. Attach copies of the transfusion reaction work-up performed. 5. Describe corrective action(s) taken to prevent error from recurring. Name of Blood Bank Telephone Number Date of Transfusion Time of Transfusion Day, Date & Time of Reaction Amount of Blood Transfused Patient ABO Group Donor ABO Group Location of Patient at Time of Reaction Patient Name Patient Age Diagnosis Type of Reaction Fatal Non-Fatal Hemolytic Anaphylactic Delayed Hemolytic a. Amount of time after transfusion b. Specify antibody, if applicable Bacterial (List Organism) Describe Events Leading to the Reaction and Corrective Action Taken (If more space is needed attach additional sheets.) Date Reported Name of Blood Bank Director Signature of Blood Bank Director CL-44 JAN 08 Forward completed Report to address listed above; retain a copy for your records.
New Jersey Department of Health and Senior Services Clinical Laboratory Improvement Service PO Box 361 Trenton, NJ 08625-0361 ERROR / ACCIDENT REPORT Instructions: 1. Pursuant to N.J.A.C. 8:8-5.2, blood banks must report to the Department the occurrence of errors and accidents described at N.J.A.C. 8:8-4.4 within 15 working days of the recognition of the error, using this form. 2. Keep a copy for your records and forward the original report to the above address. If more space is needed, attach additional sheets. 3. If there are any questions, contact the Blood Bank unit at (609) 292-0522. Name of Blood Bank Telephone Number Name of Person Completing the Form Telephone Number Date of Error Date Error Detected Type of Error Infectious Disease Testing, Specify Test: Improperly Tested Not Tested Properly Tested but Improperly Interpreted or Labeled ABO, Specify: Permanent Deferral, Specify: Confidential Unit Exclusion Transfusion-Related Septicemia Other, Specify: CL-21 JAN 08 Page 1 of 2 Pages.
ERROR / ACCIDENT REPORT, Continued Name of Blood Bank Donation Number (s) Components Prepared from each Donation Number Components Transfused (List by Number) Successful Recall(s) (List by Number) Describe the Error Describe Corrective Action(s) taken to prevent error from recurring. Name of Blood Bank Director (Print) Signature of Blood Bank Director Date Reported Forward completed Report to address listed above; retain a copy for your records CL-21 JAN 08 Page 2 of 2 Pages.