TE_CYS-15_AR40_562_Immunnizations.pdf

Army Regulation 40–562

BUMEDINST 6230.15A

AFJI 48–110

CG COMDTINST M6230.4F

Medical Services

Immunizations and Chemoprophylaxis

Headquarters Departments of the Army, the Navy, the Air Force, and the Coast Guard Washington, DC 29 September 2006

UNCLASSIFIED

SUMMARY of CHANGE

AR 40–562/BUMEDINST 6230.15A/AFJI 48–110/CG COMDTINST M6230.4F

Immunizations and Chemoprophylaxis

This major revision dated 29 September 2006--o Describes role for the Military Vaccine Office (para 1-4d).

o Describes standards for military immunization delivery, including quality improvement mechanisms (para 2-1 and app B).

o Establishes that electronic immunization tracking systems are the preferred record for immunization data (para 2-7).

o Provides guidance on managing Service personnel who lose immunization records (para 2-7c).

o Describes a procedure for dispersing immunization during initial military training into 2 clusters, the first to reduce imminent risk of contagious disease in settings of intimate or household contact and the second for other vaccine-preventable diseases (para 3-1).

o Describes a procedure for giving credit for immunization documented before military Service (para 3-1b).

o Describes procedure for abiding by regulations for vaccines and other products administered in investigational new drug status or under emergency use authorization (chaps 7 and 8).

Headquarters Departments of the Army, the Navy, the Air Force, and the Coast Guard Washington, DC 29 September 2006

Medical Services

Immunizations and Chemoprophylaxis

*Army Regulation 40–562

*BUMEDINST 6230.15A

*AFJI 48–110

*CG COMDTINST M6230.4F

Effective 29 October 2006

H i s t o r y . T h i s p u b l i c a t i o n i s a m a j o r revision.

Summary. This regulation for immuni-z a t i o n a n d c h e m o p r o p h y l a x i s u p d a t e s quality standards for immunization deliv-e r y ; e s t a b l i s h e s e l e c t r o n i c i m m u n i z a t i o n tracking systems as the preferred immuni-zation record; provides guidance for lost i m m u n i z a t i o n r e c o r d s , i m m u n i z a t i o n c r e d i t f o r p r e – e s i s t i n g i m m u n i t y , a n d complying with regulations for vaccines and other products administered in inves-tigation new drug status or in accordance w i t h e m e r g e n c y u s e a u t h o r i z a t i o n ; d e -scribes dividing initial entry immunization into 2 clusters; and describes the role of the Military Vaccine Office.

Applicability. This regulation applies to t h e A c t i v e A r m y , t h e A r m y N a t i o n a l Guard/Army National Guard of the United States, and the U.S. Army Reserve unless otherwise stated. It also applies to the fol-l o w i n g : U n i f o r m e d D e p a r t m e n t s o f t h e Navy, Air Force, and Coast Guard (in-cluding the active and reserve components o f e a c h S e r v i c e ) ; n o n m i l i t a r y p e r s o n s under military jurisdiction; selected Fed-e r a l e m p l o y e e s ; s e l e c t e d e m p l o y e e s o f D O D c o n t r a c t o r s ; a n d f a m i l y m e m b e r s and other health care beneficiaries eligible for care within the military health care system. This regulation is applicable dur-ing mobilization.

Proponent and exception authority.

The proponent of this regulation is The Surgeon General. The proponent has the authority to approve exceptions or waivers to this regulation that are consistent with controlling law and regulations. The pro-ponent may delegate this approval author-ity, in writing, to a division chief within the proponent agency or its direct report-ing unit or field operating agency, in the grade of colonel or the civilian equivalent.

Activities may request a waiver to this regulation by providing justification that includes a full analysis of the expected benefits and must include formal review by the activity’s senior legal officer. All waiver requests will be endorsed by the commander or senior leader of the requ-e s t i n g a c t i v i t y a n d f o r w a r d e d t h r o u g h t h e i r h i g h e r h e a d q u a r t e r s t o t h e p o l i c y proponent. Refer to AR 25–30 for specific guidance.

Army management control process.

This regulation contains management con-trol provisions and identifies key manage-ment controls that must be evaluated.

S u p p l e m e n t a t i o n . S u p p l e m e n t a t i o n o f this regulation and establishment of com-mand and local forms are prohibited with-o u t p r i o r a p p r o v a l f r o m H Q D A , T h e

S u r g e o n G e n e r a l , A T T N : D A S G – Z A , Skyline Place Building 6, Falls Church, VA 22041–3258.

Suggested improvements. Users are invited to send comments and suggested improvements on DA Form 2028 (Recom-m e n d e d C h a n g e s t o P u b l i c a t i o n s a n d Blank Forms) directly to HQDA, The Sur-geon General (DASG–ZA), Skyline Place B u i l d i n g 6 , F a l l s C h u r c h , V A 22041–3258. Air Force users are invited to send comments and suggested improve-ments on AF Form 847 (Recommenda-tions for Change of Publication) through channels to Headquarters, AFMSA/SGOP, 1 1 0 L u k e A v e n u e , S u i t e 4 0 0 , B o l l i n g AFB, Washington, DC 20332–7050.

Distribution. This publication is availa-ble in electronic media only and is in-tended for command levels A, B, C, D, and E for the Active Army, the Army National Guard/Army National Guard of t h e U n i t e d S t a t e s , a n d t h e U . S . A r m y Reserve.

Navy: Ships and stations having medical department personnel.

*This regulation supersedes AR 40–562/BUMEDINST 6230.15/AFJI 48–110/CG COMDTINST M6230.4E, dated 1 November 1995.

AR 40–562/BUMEDINST 6230.15A/AFJI 48–110/CG COMDTINST M6230.4F • 29 September 2006 i

UNCLASSIFIED

Contents (Listed by paragraph and page number)

Chapter 1 Introduction, page 1 Purpose • 1–1, page 1 References • 1–2, page 1 Explanation of abbreviations and terms • 1–3, page 1 Responsibilities • 1–4, page 1

Chapter 2 Program Elements and Clinical Considerations, page 2 Standards • 2–1, page 2 Logistics • 2–2, page 2 Storage and handling • 2–3, page 3 Hypersensitivity or allergy • 2–4, page 3 Immunizing women of childbearing potential • 2–5, page 3 Exemptions • 2–6, page 3 Immunization and chemoprophylaxis records • 2–7, page 5 Jet–injection immunization devices • 2–8, page 6 Emergency response requirements • 2–9, page 7 Adverse events • 2–10, page 7 Program evaluation • 2–11, page 8 Blood donation • 2–12, page 8

Chapter 3 Personnel Subject to Immunization, page 8 Military personnel • 3–1, page 8 Civilian employees and contracted workers • 3–2, page 10 Other populations • 3–3, page 11

Chapter 4 Specific Immunization Requirements for Department of Defense and Coast Guard Personnel, page 12 Civilian applicability • 4–1, page 12 Adenovirus types 4 and 7 • 4–2, page 12 Anthrax • 4–3, page 12 Cholera • 4–4, page 12 Haemophilus influenzae type b (Hib) • 4–5, page 12 Hepatitis A • 4–6, page 12 Hepatitis B • 4–7, page 12 Influenza A and B • 4–8, page 13 Japanese encephalitis • 4–9, page 13 Measles, mumps, and rubella • 4–10, page 13 Meningococcal disease • 4–11, page 14 Pertussis • 4–12, page 14 Plague • 4–13, page 14 Pneumococcal disease • 4–14, page 14 Poliomyelitis • 4–15, page 14 Rabies • 4–16, page 15 Smallpox • 4–17, page 15 Tetanus, diphtheria, and pertussis • 4–18, page 15 Typhoid fever • 4–19, page 16 Varicella • 4–20, page 16 Yellow fever • 4–21, page 16 ii AR 40–562/BUMEDINST 6230.15A/AFJI 48–110/CG COMDTINST M6230.4F • 29 September 2006

Contents—Continued

Chapter 5 Chemoprophylaxis, page 16 General • 5–1, page 16 Anthrax • 5–2, page 17 Group A streptococcal disease • 5–3, page 17 Influenza A and B • 5–4, page 17 Leptospirosis • 5–5, page 17 Malaria • 5–6, page 17 Meningococcal disease • 5–7, page 18 Plague • 5–8, page 18 Scrub typhus • 5–9, page 18 Traveler’s diarrhea • 5–10, page 18 Tuberculosis • 5–11, page 18

Chapter 6 Biological Warfare Defense, page 18 Responsibilities • 6–1, page 18 Procedures • 6–2, page 18

Chapter 7 Vaccines and Other Products in Investigational New Drug Status, page 19 Purpose • 7–1, page 19 General guidance on IND products • 7–2, page 19 Health recordkeeping requirements for IND products • 7–3, page 19 Information requirements for investigational new drug products • 7–4, page 19 Coordination • 7–5, page 19

Chapter 8 Vaccines and Other Products Used Under Emergency Use Authorization, page 19 General • 8–1, page 19 Criteria • 8–2, page 20 Refusal options • 8–3, page 20 Health recordkeeping requirements for emergency use authorization products • 8–4, page 20 Information requirements for emergency use authorization products • 8–5, page 20 Department of Defense requests for emergency use authorizations • 8–6, page 20 Coordination • 8–7, page 20

Appendixes

A. References, page 21

B. Standards for Military Immunization, page 23

C. Medical and Administrative Exemption Codes, page 24

D. Immunizations for Military Personnel, page 26

E. Management Control Evaluation Checklist, page 28

Table List

Table C–1: Medical exemption codes, page 25 Table C–2: Administrative exemption codes, page 26 Table D–1: Immunizations for military personnel, page 26

Glossary iiiAR 40–562/BUMEDINST 6230.15A/AFJI 48–110/CG COMDTINST M6230.4F • 29 September 2006

Chapter 1 Introduction

1–1. Purpose This publication provides the directive requirements for the Military Vaccination Program; establishes general princi-ples, procedures, policies, and responsibilities for the immunization program; and implements military and international health regulations and requirements.

1–2. References Required and related publications and prescribed and referenced forms are listed in appendix A.

1–3. Explanation of abbreviations and terms Abbreviations and special terms used in this regulation are explained in the glossary.

1–4. Responsibilities a . C o m m a n d m e d i c a l a u t h o r i t y . T h e c o m m a n d m e d i c a l a u t h o r i t y w i l l p r e s c r i b e s p e c i f i c i m m u n i z a t i o n a n d chemoprophylactic requirements for their units per requirements established by this publication and additional guidance provided by the appropriate surgeon general or United States Coast Guard (USCG), Coast Guard, Director of Health and Safety (CG–11).

b. Combatant commanders, major command commanders, unit commanding officers, and officers–in–charge. Com-batant commanders, commanders, commanding officers, and officers–in–charge will—

( 1 ) E n s u r e m i l i t a r y a n d n o n m i l i t a r y p e r s o n n e l u n d e r t h e i r j u r i s d i c t i o n r e c e i v e r e q u i r e d i m m u n i z a t i o n s a n d chemoprophylaxis.

(2) Maintain appropriate international, Federal, State, and local records of all immunizations and chemoprophylaxis.

(3) Ensure personnel transferred to another command receive proper screening for and administration of appropriate immunizations and chemoprophylaxis for the area assigned, timed to provide immunity before deployment or exposure.

(4) Ensure deviations from specified immunizations are cleared or authorized by the appropriate combatant com-mander; surgeon general; or CG–11, USCG.

(5) Observe International Military Standardization Agreements (STANAGs), including STANAG 2037, STANAG

2491, and STANAG 3474.

c. Medical commanders, commanding officers, and command surgeons. Medical commanders, commanding officers, and command surgeons will—

(1) Ensure individuals administering immunizations are properly trained in accordance with Department of Defense

(DOD), Service, USCG, and Centers for Disease Control and Prevention (CDC) guidelines and act within their scope of practice as determined by each Service. These training standards will include baseline and annual refresher training.

(2) Appoint, in writing, a privileged physician as medical director of any clinic or activity that administers immunizations. These physicians—

(a) Will complete appropriate training in immunization science in residence or via distance learning.

(b) Be available to address immunization issues, although it is not required that a physician be present for administration of vaccines.

(c) Approve all standard operating procedures for immunization administration in clinics or other locations where immunizations are administered.

(3) Ensure current national standards for adult and pediatric immunizations and chemoprophylactic practices are followed and local practices incorporate requirements of policies contained in references listed at appendix A.

(4) Ensure patients are evaluated for preexisting immunity or need for medical exemptions to immunization, and that granted exemptions are documented as discussed in paragraph 2–6.

(5) Ensure patients needing evaluation of adverse events after immunization are referred to appropriate medical providers, such as the medical subspecialists, including specialists in immunization health care for evaluation, consulta-tion, or indicated intervention.

(6) Ensure compliance with policies and procedures for creating and maintaining immunization records.

(7) Ensure emergency medical response is available; that personnel who administer immunizations are trained at a minimum in basic cardiopulmonary resuscitation and the administration of epinephrine; that medical personnel practice emergency responses; and that health care providers are available to respond to adverse events resulting from immunization.

d. The Army, as Executive Agent for the Military Immunization Program. The Army, as Executive Agent for the Military Immunization Program and in cooperation with the military Services, will—

(1) Operate a Military Vaccine Office to provide the military Services with a coordinated source for information and education of vaccine–related activities needed in order to implement DODD 6205.3 and DODI 6205.2.

1AR 40–562/BUMEDINST 6230.15A/AFJI 48–110/CG COMDTINST M6230.4F • 29 September 2006

( 2 ) M e a s u r e a n d a n a l y z e i m p l e m e n t a t i o n o f i m m u n i z a t i o n p o l i c i e s a s i n d i c a t o r s o f r e a d i n e s s , s a f e t y , a n d effectiveness.

(3) Support quality of standardized automated immunization tracking systems (ITS).

(4) Establish joint clinical quality standards for vaccine administration and for the education and training of personnel in vaccine health care.

(5) Review these standards annually and revise them as necessary.

e. Each of the military Services. Each of the military Services will provide an immunization health care capability to deliver medical specialty consultation, case management, and clinical investigation.

Chapter 2 Program Elements and Clinical Considerations

2–1. Standards

a. Department of Defense policy. The DOD policy concerning immunizations follows the recommendations of the

CDC and the Advisory Committee on Immunization Practices (ACIP), unless there is a militarily relevant reason to do otherwise. Any immunizing agent licensed by the Food and Drug Administration (FDA) or the Department of Health and Human Services (DHHS) may be used, as well as immunizing agents compliant with applicable DOD investiga-tional new drug (IND) or emergency use authorization (EUA) process. Privileged health care providers may make clinical decisions for individual beneficiaries to customize medical care or to respond to an individual clinical situation.

b. Standards for delivery of military vaccines. Standards for delivery of military vaccines are provided in appendix B. Military Services will abide by these standards in routine immunization delivery.

c. Expiration date. Immunizing agents will not be used beyond the manufacturer’s potency expiration date, unless the appropriate surgeon general or CG–11, USCG authorizes extension in exceptional circumstances.

d. Immunization intervals.

(1) Recommended immunization schedules will not be compressed. Immunizations given at an interval shorter than the recommended interval may not provide adequate immune response and should not be counted as part of a primary series, unless part of “catchup” schedules accepted by the CDC. Once an immunization series has been started, complete it, unless a medical contraindication exists or the person is no longer susceptible or likely to be exposed to pathogen in question.

(2) Restarting an immunization series or adding extra doses is not necessary when an initial series of a vaccine or toxoid is interrupted because increasing the interval between doses in a series does not diminish the ultimate immunity obtained. Instead, give delayed doses as soon as feasible.

e. Simultaneous immunizations. National norms regarding simultaneous administration of vaccines will be observed.

(1) In general, to minimize injection–site discomfort, not more than 5 vaccine injections will be given on the same day. Apply this guidance in light of subparagraphs (2), (3), and (4), below.

(2) Additional immunizations are then given at an appropriate later date. A week will often suffice for inactivated vaccines. Live–virus immunizations typically are given simultaneously or at an interval of 4 or more weeks.

(3) Priority of immunization is based on relative likelihood of the various microbial threats and the existence of any vaccine–vaccine, vaccine–antibody, or vaccine–drug interactions. A starting point for prioritizing immunizations for an individual would consider microbes most likely to be encountered (for example, typhoid, hepatitis A, influenza), of greatest severity if encountered (for example, anthrax, smallpox, meningococcal, yellow fever, Japanese encephalitis, rabies), or of long–standing risk (for example, hepatitis B, tetanus–diphtheria–pertussis, poliovirus, varicella, meas-les–mumps–rubella (MMR)). In military training centers, contagious diseases would typically represent the most imminent threats.

(4) Prioritization (see para (3), above) is best performed by an experienced health care provider. The 5–injection threshold should only be exceeded in cases where the vaccine recipient is deploying beyond the reach of deployable medical resources, where exceptional personal exposure to infectious diseases exists, or when authorized by the physician responsible for the immunization service.

f. Screening for immunity. For some vaccine–preventable diseases, serologic or other tests can be used to identify preexisting immunity from prior infection or immunization that may eliminate the need for unnecessary immunization.

Such testing may be adopted where it offers advantages in terms of improved care or medical economics.

2–2. Logistics

a. Immunizing and chemoprophylaxis agents are requisitioned in accordance with medical supply procedures.

b. All personnel involved with medical supply will expend sufficient resources to maintain the cold chain in vaccine delivery, ensuring appropriate storage temperatures during shipment and avoiding inappropriately low or elevated temperatures. Shipping and storage advice is available from Service medical logistics centers (for example, Class VIII Service Item Control Center).

2 AR 40–562/BUMEDINST 6230.15A/AFJI 48–110/CG COMDTINST M6230.4F • 29 September 2006

c. To minimize the shipment of vaccines that must be stored at frozen temperatures, small stations and ships may requisition these items from a nearby military medical activity stocking the items. Requisitioning procedures and reimbursement are prescribed by the supplying activity.

2–3. Storage and handling Immunizing and chemoprophylaxis agents are stored, shipped, and handled in accordance with the pharmaceutical manufacturers’ instructions as outlined in the product’s package insert or other guidance.

2–4. Hypersensitivity or allergy

a. Before administration of any medication, including vaccines, determine if the individual has previously shown any unusual degree of adverse reaction or allergy to it or any specific component of the vaccine or its packaging (for example, eggs, gelatin, preservatives, latex). Review the manufacturers’ package inserts and reference materials for product–specific information.

b. Individuals with reported hypersensitivity are deferred from immunization or chemoprophylaxis.

(1) Refer the patient to an appropriate medical specialist for evaluation, unless the health record documents prior consultation or a specialist’s recommendations (see paragraph 2–6 for discussion of medical exemptions).

( 2 ) D o c u m e n t h y p e r s e n s i t i v i t y t o a n y v a c c i n e , v a c c i n e c o m p o n e n t , o r m e d i c a t i o n o n t h e S F 6 0 0 ( H e a l t h

Record–Chronological Record of Medical Care) and on the problem list. Exemptions from further immunization are entered in DOD– or USCG–approved electronic ITS, on the PHS Form 731 (International Certificate of Vaccination), the deployable health record (that is, DD Form 2766 (Adult Preventive and Chronic Care Flowsheet)), and/or in other relevant paper–based immunization records.

2–5. Immunizing women of childbearing potential A pregnancy screening test for women of childbearing potential is not routinely required before administering vaccines, including live–virus vaccines. Take the following precautions to avoid unintentional immunization with contraindicated products during pregnancy:

a. Display signs asking pregnant women to identify themselves. Discreetly ask the woman if she is or might be pregnant. If the answer is a certain “no”, document this in the health record and immunize her. If the answer is “yes”, defer her from immunization until her pregnancy ends, unless benefits of immunization outweigh risks in pregnancy (see para d, below and ACIP guidelines regarding immunizations indicated during pregnancy). If pregnancy status is uncertain, defer immunization until after a negative pregnancy evaluation (for example, urine or serologic test).

b. With regard to smallpox (vaccinia) vaccine, a specific pre–immunization screening form (available at http:// www.smallpox.mil/resource/forms.asp) that assesses the date of the last menstrual period is required. For women whose last menstrual period was more than 28 days ago, a pregnancy test is recommended.

c. If a live–virus vaccine is administered, counsel the woman to avoid becoming pregnant for an appropriate interval (for example, as recommended by CDC or the vaccine manufacturer) and document that counseling in the health record.

d. If a woman is pregnant and immunization is indicated for her while she is pregnant, immunize in consultation with the woman’s obstetric health care provider.

e. Breastfeeding women may be immunized in accordance with the current ACIP guidelines. At present, no immunization products are medically contraindicated in breastfeeding women. Smallpox vaccine is withheld from breastfeeding women, except in an outbreak, primarily due to the potential for contact transmission of vaccinia virus to the child.

f. If a contraindicated vaccine is inadvertently administered to a pregnant woman, report the event upon discovery to local preventive medicine and obstetric services and complete appropriate quality assurance documents. Report such cases to any applicable case registry such as the National Smallpox Vaccine in Pregnancy Registry. Contact the preventive medicine service or the Military Vaccine Office for reporting procedures.

2–6. Exemptions There are 2 types of exemptions from immunization: medical and administrative. Granting medical exemptions is a medical function that can only be validated by a health care professional. Granting administrative exemptions is a non–medical function, usually controlled by the individual’s unit commander.

a. Medical exemptions. A medical exemption includes any medical contraindication relevant to a specific vaccine or other medication. Medical exemptions will be customized to the health of the vaccine candidate and the nature of the immunization considered. Medical exemptions may be temporary (up to 365 days) or permanent. General examples of medical exemptions include those in (1), (2), and (3), below. Standard exemption codes appear in appendix C.

(1) Underlying health condition of the vaccine candidate (for example, based on immune competence, phar-macologic or radiation therapy, pregnancy, previous response to immunization).

(2) Evidence of immunity based on serologic tests, documented infection, or similar circumstances.

(3) An individual’s clinical case is complex or not readily definable. In such cases, consult appropriate medical

3AR 40–562/BUMEDINST 6230.15A/AFJI 48–110/CG COMDTINST M6230.4F • 29 September 2006 specialists; additional clinical support is available from medical subspecialists including specialists in immunization health care.

(4) The primary care provider or a physician specialist may grant temporary or permanent medical exemptions. If additional clinical consultation is needed to assess a patient’s condition, the primary care provider will perform the initial clinical workup appropriate to the presenting symptoms and grant a temporary medical exemption pending the results of a referral to a medical specialist appropriate to the individual’s clinical condition (for example, dermatology, neurology, rheumatology, allergy–immunology). Specialists in immunization health care can facilitate these referrals.

Multidisciplinary consultations may be appropriate. A follow–up visit by the patient to his or her primary care provider is not required if the specialist grants a permanent medical exemption. Cases warranting permanent medical exemption due to a vaccine–related adverse event will be reported to the Vaccine Adverse Events Reporting System (VAERS).

Electronic and paper health records will be annotated regarding temporary and permanent medical exemptions and the vaccines to which they apply. When no longer clinically warranted, medical exemptions will be revoked. Air Force:

military members with permanent medical exemptions require a medical evaluation board and/or a flying waiver in accordance with AFI 48–123.

(5) Individuals who disagree with a provider’s/consultant’s exemption recommendations may be referred for a second opinion to a provider experienced in vaccine adverse–event management, such as specialists in immunization health care at a medical center.

(6) Personnel will appropriately annotate electronic ITS and paper–based health records with exemption codes denoting evidence of immunity, severe adverse event after immunization, other temporary or permanent reasons for medical exemption, and other appropriate categories.

b. Administrative exemptions. Standard exemption codes appear in appendix C.

(1) Separation or retirement. Within 180 days before separation or retirement, Service personnel may be exempt from deployment (mobility) immunizations (see app D) if the following conditions are met:

(a) They are not currently assigned, deployed, or scheduled to perform duties in a geographical area where an immunization is indicated.

(b) The commander has not directed immunization because of overriding mission requirements. Personnel meeting these requirements and desiring an immunization exemption must identify themselves to their commander. The member must have approved retirement or separation orders. Active duty personnel continuing duty in the Reserve Component (RC) are not exempted on this basis.

(2) Thirty days or less of Service remaining. Exemptions apply to civilian employees and contractor personnel who will leave a position subject to immunization with 30 days or less.

(3) Religious.

(a) For Service personnel, immunization exemptions for religious reasons may be granted according to Ser-vice–specific policies to accommodate doctrinal religious beliefs. This is a command decision made with medical and chaplain advice.

1. Requests for religious exemption must include name, rank, social security number (SSN), occupational specialty code or branch, and a description of the religious tenet or belief contrary to immunization. Army: (see AR 600–20, para 5–6). Air Force: Permanent exemptions for religious reasons will not be granted. The major command (MAJ- COM) commander is the designated approval and revocation authority for temporary immunization exemptions. Coast Guard: CG–122 is the designated approval and revocation authority for temporary immunization exemptions.

2. A military physician must counsel the applicant. The physician should ensure that the Service personnel is making an informed decision and should address, at a minimum, specific information about the diseases concerned;

specific vaccine information including product constituents, benefits, and risks; and potential risks of infection incurred by unimmunized individuals.

3. The commander must counsel the individual and recommend approval or denial of the exemption request, by endorsement. The commander must counsel that noncompliance with immunization requirements may adversely impact deployability, assignment, or international travel, and that the exemption may be revoked under imminent risk conditions. The commander, in making his or her recommendation, should consider the potential impact on the individual, the unit, and the mission.

4. Forward exemption requests through command channels to the respective Service approval authority for decision.

Individuals with active requests for religious exemption are temporarily deferred from immunizations pending outcome of their request. For USCG, forward through appropriate chain to G–WPM, via CG–1121.

(b) Civilian employees submit religious–exemption requests to their supervisors. Such requests will be processed in accordance with 29 CFR 1605 and component and local policies.

c. Bargaining units. Civilian personnel affected by this document who are members of bargaining units will be considered for exemption consistent with applicable personnel management policies.

d. Other categories. Administrative or medical personnel will appropriately annotate electronic ITS with exemption codes denoting separation, permanent change of station, emergency leave, missing or prisoner of war, deceased, and other appropriate categories.

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2–7. Immunization and chemoprophylaxis records

a. Electronic immunization tracking systems.

(1) For military personnel, civilian employees, and other health care beneficiaries, the DOD–approved electronic

ITS are the preferred record for immunization data, including date, immunization given, dose, and identification of the person administering. Clinics and other activities administering immunizations will transmit electronic records and exemption information to (and receive updates from) a DOD–centralized repository at least weekly. Transcription of historical data from official records will occur concurrently with the implementation of electronic tracking.

(2) Electronic ITS must—

(a) Comply with the requirements of the National Vaccine Injury Compensation (NVIC) Program outlined in paragraph d, below.

(b) Incorporate DOD–directed levels of security, certification, and redundancy, and the requirements of the Health

Insurance Portability and Privacy Act of 1986 to preclude unauthorized access to personal medical information and to survive hardware or software malfunction.

(c) Incorporate appropriate redundancy characteristics to survive hardware or software malfunction.

(d) Be capable of generating printed reports of immunization status and exemption information on both an individ-ual and unit basis.

(3) A printed report from the electronic ITS, in PHS Form 731, SF 601 (Health Record–Immunization Record), or

DD Form 2766C (Adult Preventive and Chronic Care Flowsheet) (Continuation Sheet) format, accompanied by an official clinic stamp and the authorized signature and printed name of an authenticating official, will qualify as an official paper immunization record.

(4) A printed report as identified in paragraph (3), above will suffice as a valid certificate of vaccination for international travel for active duty members of the Armed Forces as outlined in Article 36 (Ann 6) of the World Health Organization (WHO) international health regulations.

b. Non–electronic immunization and chemoprophylaxis records.

(1) Deployment records. Transfer information regarding immunizations and chemoprophylaxis including date, prod-uct given, dose, and initials of person administering to the deployable health record (that is, DD Form 2766) or comparable approved form, either by computer–generated report or by hand. Upon return from deployment, transfer entries on the deployment record into the appropriate ITS or other electronic record system

(2) PHS Form 731. Prepared upon request for each member of the Armed Forces and for nonmilitary personnel receiving immunizations, including date, immunization given, dose, and initials of person administering. The form contains valid certificates of immunization for international travel and quarantine purposes in accordance with WHO international health regulations. PHS Form 731 remains in the custody of the individual who is responsible for its safekeeping and for keeping it in his/her possession when traveling internationally. Data is entered by hand, rubber stamp, typewriter, or by printout from a DOD–approved electronic immunization tracking system.

(a) Abbreviations. Use abbreviations for vaccines and their manufacturers conforming to the nomenclature adopted by the CDC Vaccine Identification Standards Initiative (VISI) (http://www.cdc.gov/nip/visi/prototypes.htm#abbrev-iations). When writing, the day, month, and year are listed in that order. The day is expressed in Arabic numerals, the month spelled out or abbreviated using the first 3 letters of the word, and the year expressed in Arabic numerals either by 4 digits or by the last 2 digits (for example, 14 June 1994 or 14 Jun 94).

(b) Transcribed records. Entries based on prior official records will include the following statement: “Transcribed from official records.” Alternately, the statement may cite the specific source (for example, “Transcribed from SF 601.”

When entries are transcribed onto paper records, the initials of the transcriber will be included on each entry.

(c) Supply. PHS Form 731 is obtained through normal publication supply channels.

(d) Stamps. Use in accordance with instructions received from the Foreign Quarantine Division of the CDC; the appropriate surgeon general; Chief, Bureau of Medicine and Surgery; or CG–11. The USCG authorizes the use of a standard address for military members which may be stamped on the face of the PHS Form 731. Stamps are procured by local purchase as necessary.

1. Army. Army officers: HQDA (DAPC–PSR–R), Hoffman II, 200 Stovall Street, Alexandria, VA 22332–0400;

Army enlisted: Commander, U.S. Army Enlisted Records and Evaluation Center, ATTN: PCRE–FS, 8899 East 56th

Street, Indianapolis, IN 46249–5301.

2. Navy. Bureau of Naval Personnel, Washington, DC 20370.

3. Air Force. HQ AFPC/DPMDB, Randolph AFB, TX 78148.

4. Marine Corps. Headquarters, U.S. Marine Corps, Washington, DC 20380.

5 . C o a s t G u a r d . C o m m a n d a n t , C G – 1 1 , U S C G H e a d q u a r t e r s , 2 1 0 0 S e c o n d S t r e e t S W , W a s h i n g t o n , D C

20593–0001.

(e) Written signatures. Written signatures must appear in appropriate spaces on each certificate; signature stamps are not valid.

(3) SF 601 (Navy, Marine Corps, and USCG). Prepare SF 601 in accordance with Chapter 16, NAVMED P–107, 5AR 40–562/BUMEDINST 6230.15A/AFJI 48–110/CG COMDTINST M6230.4F • 29 September 2006

U.S. Navy, or CG COMDTINST M6000.1 series. When prepared, SF 601 and PHS Form 731 contain the SSN as identifying data.

(4) DD Form 2766C. Air Force. Initiate DD Form 2766C for all personnel at the time of entry into military service.

(5) Paper–based immunization and chemoprophylaxis records. Individuals preparing paper–based immunization and chemoprophylaxis records will ensure that paper records match the electronic ITS.

c. Lost immunization records. If an individual’s immunization records are lost, assume the individual received standard immunizations administered at entry into military service by the individual’s accession source (for example, enlisted, Service academy, direct commission) unless there is an objective reason to believe otherwise. Do not repeat such immunizations. Base decisions for future immunizations on assumed date of last immunization (for example, individual assumed to have received tetanus–diphtheria toxoid in July 1995 would next be immunized in July 2005).

d. National Vaccine Injury Compensation Program.

(1) The National Childhood Vaccine Injury Act (NCVIA) of 1986 and other regulations set standards for certain immunizations. These requirements apply to U.S. vaccines containing diphtheria, tetanus, pertussis, MMR, poliovirus, hepatitis A, hepatitis B, Haemophilus influenzae type b, influenza, varicella, rotavirus, pneumococcal–conjugate antigens, and other vaccines recommended by the CDC for routine administration to children after the Secretary DHHS publishes a notice of coverage. For these vaccines, the patient’s name; identifying number (for example, sponsor’s SSN); type of vaccine; date of administration; manufacturer; lot number; and the name, address, and title of person administering the vaccine must be recorded in a permanent health record or permanent office log or file, in either paper or electronic format. The electronic ITS is the primary method of immunization documentation. Other records and management reports may be generated from the electronic immunization database, as described above. Until electronic systems are fully implemented, continue to record the information on the paper immunization record and in a permanent clinic immunization log.

(2) Personnel who administer any vaccine covered under the NVIC program, to either children or adults, will provide the vaccinee an opportunity to read the most recent relevant vaccine information statements (VISs) provided by the DHHS and an opportunity to ask questions about the vaccine. Camera–ready copies of VISs are available from State health departments or through the CDC Web site (http://www.cdc.gov/nip/). Translations of VISs into languages other than English are available from nongovernmental organizations (for example, Immunization Action Coalition).

(3) Personnel who administer vaccines are not required to obtain the signature of the military member, patient, or legal representative acknowledging receipt of a VIS. However, to create a record that the materials were provided, health care personnel who administer vaccines will annotate each patient’s health record (for example, SF 600, SF 601, DD Form 2766C) that the VISs were provided at the time of immunization.

(4) To comply with the NCVIA of 1986 and other regulations, current versions of the VISs published by the CDC will be posted on readily accessible bulletin boards near immunization clinics and mass immunization sites. Printed copies will be provided to any individual who requests one. Further, the Military Vaccine Office Web site (http:// www.vaccines.mil) will link to the current versions of VISs.

(5) The NCVIA requires that the following events be reported to VAERS:

( a ) A n y e v e n t l i s t e d i n t h e N V I C p r o g r a m ’ s v a c c i n e i n j u r y t a b l e ( h t t p : / / w w w . h r s a . g o v / v a c c i n e c o m p e n s a t i o n / table.htm) that occurs within the time period specified or within 7 days, if that is longer.

(b) Any contraindicating event listed in a vaccine’s package insert (that is, product labeling).

(6) In addition, VAERS accepts all reports by any interested party of real or suspected adverse events occurring after the administration of any vaccine.

(7) All DOD and USCG health care beneficiaries are eligible to file claims with the NVIC program, according to the program’s procedures.

2–8. Jet–injection immunization devices

a. The DOD and USCG withdrew needle–free multi–use nozzle jet injectors (MUNJIs) capable of 600 or more injections per hour, formerly identified within DOD supply systems as “hypodermic injection apparatus jet automatic:

115 volt or foot operated,” in 1997 due to safety concerns. Their use of the same unsterile nozzle and fluid pathway to inject consecutive patients could allow transmission of bloodborne pathogens. The MUNJIs are known by the trade names Ped–O–Jet®, Med–E–Jet®, Hypospray®, and DermoJet®, among other brands, and were usually refilled quickly from attached multidose vaccine vials. These devices remain unapproved and will not be used.

b. A new generation of needle–free disposable–cartridge jet injectors (DCJIs) avoid the safety concerns for MUNJIs by their use of a new, disposable, sterile fluid pathway for each patient. Several are FDA–approved for distribution in the United States and approved for military use (http://www–nehc.med.navy.mil/prevmed/251800z.txt) in accordance with the manufacturer’s current recommendations, especially with regard to infection control. Administration rates with these DCJIs are currently slow because they must be filled and loaded manually. Research and development is underway for automated pre–filling and finger–free loading and ejecting of cartridges that would make future high–speed DCJIs suitable for mass immunization programs.

6 AR 40–562/BUMEDINST 6230.15A/AFJI 48–110/CG COMDTINST M6230.4F • 29 September 2006

2–9. Emergency response requirements

a. Written plan. Clinics or activities administering immunizations will develop and maintain a written plan for emergency response, including management of anaphylaxis and fainting.

b. Training. Whenever vaccines are administered, at least 1 person present must be trained and current in basic c a r d i o p u l m o n a r y r e s u s c i t a t i o n , o r o – p h a r y n g e a l a i r w a y m a n a g e m e n t , a n d r e c o g n i t i o n a n d i n i t i a l t r e a t m e n t o f anaphylaxis with epinephrine.

c . A n a p h y l a x i s m a n a g e m e n t . S u p p l i e s n e c e s s a r y f o r e m e r g e n c y m e d i c a l m a n a g e m e n t o f a n a p h y l a x i s ( t h a t i s , epinephrine, oral airway) and equipment and ability to activate an emergency medical system must be immediately accessible on scene during administration of any vaccine.

d. Observation. The ACIP general recommendations suggest that persons be observed for 15 to 20 minutes after being immunized.

e. Temporary flying restrictions. Aviation personnel typically will be grounded for 12 hours after immunization, or as specified by their flight surgeon. No formal grounding documents are required for uncomplicated immunization.

Personnel who previously experienced urticaria, hypersensitivity phenomena, or other unusual phenomena after an immunization will be exempt from flying duties for an appropriate interval (for example, 72 hours) as determined by the flight surgeon. Further temporary grounding may be necessary until significant side effects resolve. Air Force aircrew: All injectable immunization except Japanese–encephalitis vaccine (JEV); access to medical care on the ground is recommended for all personnel unless operational needs dictate otherwise. Japanese–encephalitis vaccine: Grounding is required for 3 days after first dose, 5 days after second dose, and 3 days after third dose; grounding reduction for critical missions may be granted by MAJCOM according to current Air Force JEV policy.

f. Self–assessment. Personnel experiencing adverse events that could compromise their performance will remove themselves from flying duties and notify their flight surgeon.

2–10. Adverse events Describe in the individual’s health record a detailed account of severe adverse events after administering immunizing agents or other medications.

a. Mandatory information consists of identification, lot number, and manufacturer of the vaccine or other medica-tion; date of administration; name and location of the medical facility; the type and severity of the event; treatment provided; and any exemption from additional doses.

b. The NVIC program requires health care providers to report adverse events involving vaccines to VAERS. They may use the VAERS form (Form VAERS–1 (Vaccine Adverse Event Reporting System)) or submit electronic reports via the http://www.vaers.hhs.gov Web site. VAERS forms and information can be obtained by calling 1–800–822–7967 or by accessing the VAERS Web site at http://www.vaers.hhs.gov/.

c. The DOD and USCG require health care providers to report adverse events involving other medications (for example, immune globulins, chemoprophylaxis agents) to MedWatch. They may use the MedWatch reporting form (FDA Form 3500 (MedWatch: The FDA Safety Information and Adverse Event Reporting System)) or submit electronic reports via the http://www.fda.gov/medwatch/index.html Web site. MedWatch forms and information can be obtained by calling 1–888–463–6332 or by accessing the MedWatch Web site.

d. Reporting requirements are as follows:

(1) Health care personnel must report adverse events resulting in hospitalization, a life–threatening event (for example, anaphylaxis), time lost from duty more than 24 hours (that is, more than 1 duty shift), an event related to suspected contamination of a vaccine vial, and an event warranting permanent medical exemption (that is, a contrain-dicating event). Reports are also required for the following events: anaphylaxis, brachial neuritis, encephalopathy, encephalitis, rubella–associated chronic arthritis, thrombocytopenic purpura, vaccine–strain measles infection in an immunodeficient recipient, paralytic poliomyelitis, and any other entry in the vaccine injury table maintained by the NVIC program (http://www.hrsa.gov/osp/vicp/table.htm). These are minimum requirements.

(2) Further, health care providers are encouraged to report other adverse events that the provider considers unex-pected in nature or severity.

(3) Reports of mild expected reactions are not required (for example, low–grade, self–limited fever of less than 24 hours duration; temporary local soreness, redness, or minor swelling at the site of immunization) because they are already expected, but such reports may be submitted if the clinician or patient wishes.

e. Patients may also submit a VAERS or MedWatch report directly. If a patient wishes to submit a VAERS report, health care personnel will assist the patient in completing the form, regardless of professional judgment about causal association to immunization.

f. Attach pertinent information from the recipient’s health record to the VAERS or MedWatch report. Submit copies of the report within 7 days of adverse event recognition as follows:

(1) Send the original report form and any appropriate supporting documents to the VAERS or MedWatch office.

(2) Retain 1 copy for the Clinical Quality Management Program at the reporting medical unit, which will typically involve the unit’s Pharmacy and Therapeutics Committee.

7AR 40–562/BUMEDINST 6230.15A/AFJI 48–110/CG COMDTINST M6230.4F • 29 September 2006

(3) File a copy of the VAERS or MedWatch report in the patient’s individual health record or annotate the relevant information on the report within the health record.

(4) Submit 1 copy to the appropriate disease–control authority according to current contact instructions—

(a) Army. Army Medical Surveillance Activity.

(b) Navy and Marine Corps. Navy Environmental Health Center.

(c) Air Force. Air Force Institute for Operational Health.

(d) Coast Guard. Commandant, CG–1121.

g. Immediately notify the Defense Medical Standardization Board via e–mail message, if contamination or other serious problem with a vaccine vial or lot is suspected. Suspend usage, but quarantine and retain all such opened or unopened vials or lots under appropriate storage conditions pending further investigation and disposition instructions.

h. An adverse reaction to a DOD–directed immunization in Service personnel is a line–of–duty condition. Military treatment facility (MTF) commanders will provide full access to RC members for evaluation and treatment of adverse events potentially related to DOD–directed immunizations. Reserve Component unit commanders will inform their members that they may seek medical care for such adverse events with the unit providing assistance and information related to pay status and compensation issues. Each of the military Services will provide an immunization health care capability to deliver medical specialty consultation, case management, and clinical investigation (also see para 1–4d).

Any necessary documentation, including line–of–duty determinations, will be completed after the Guardsman or Reservist is evaluated and, if required, treated. In no case will such evaluation or treatment be denied or delayed pending line–of–duty determination. If additional health care is required after the initial visit and a line–of–duty determination has established a Service connection, a notice of eligibility must be completed in accordance with

DODD 1241.1.

2–11. Program evaluation

a. General requirements. Each Service will develop appropriate quality improvement mechanisms to ensure immu-nizations and chemoprophylaxis agents are administered in accordance with this publication.

b. Program assessment. Military treatment facilities and commands storing health records will review immunization and chemoprophylaxis practices at least annually to ensure compliance with current standards of care and documenta-tion and as a measure of medical readiness and health promotion. This will include self–assessment of the vaccine coverage level of supported populations (for example, military units, preschool children, influenza immunization of beneficiaries 50 years or older, pneumococcal immunization of patients with diabetes). Commands will track perform-ance over time to progressively improve vaccine coverage.

c. Measure of coverage. Military treatment facilities and commands will conduct a review of the adequacy of immunization coverage among supported populations at least annually.

2–12. Blood donation For timing of immunization with regard to blood donation, clinicians will consider the policies of the Armed Services Blood…