Army Regulation 40-562
Medical Services
Immunizations and Chemoprophylaxis
Distribution Restriction Statement.
Destruction Notice.
Department of the Army
Bureau of Medicine
Air Force
Coast Guard
This publication
supersedes Army Regulation 40-562/BUMEDINST 6230.15/Air Force Instruction
48-110(1)/CG COMDTINST M6230.4F dated 20 Jan 1995.
Unclassified
Summary of Change
This revision--
· Describes standards for military immunization delivery, including quality-improvement mechanisms (para 2-1 and app B).
· Describes roles for the Military
Vaccine Agency and the Vaccine Healthcare Centers Network (paras
2-6, 2-7, and 3-1).
· States that electronic immunization
tracking systems are the preferred record for immunization data (para 2-7).
· Provides guidance on managing
Service members who lose immunization records (para
2-7).
· Describes a procedure for dispersing
immunization during initial military training into two clusters, the first to
reduce imminent risk of contagious disease in settings of close contact and the
second for other vaccine-preventable diseases (para
3-1).
· Describes a procedure for giving
credit for immunizations documented before military Service (para 3-1).
· Describes procedures for abiding by
regulations for vaccines and other products administered in investigational new
drug status or under emergency use authorization (ch
7 and ch 8).
History. This issue publishes a major revision.
Summary. This publication provides the directive
requirements for the Military Vaccination Program; establishes general
principles, procedures, policies and responsibilities for the immunization program;
and implements military and international health regulations and requirements.
Applicability. This regulation applies to uniformed
departments of the Army, Marine Corps, Navy, Air Force, and Coast Guard
(including the Active and Reserve Components of each Service), nonmilitary
persons under military jurisdiction, selected Federal employees, selected
employees of Department of Defense contractors, and family members and other
healthcare beneficiaries eligible for care within the military health care
system. Each form affected by the
Privacy Act that is required by this regulation either contains a Privacy Act
Statement incorporated in the body of the document or is covered by DD Form
2005, Privacy Act Statement-Healthcare Records.
Army Management Control Process. This
regulation contains management control provisions and identifies key management
controls that must be evaluated.
Supplementation. Army:
Supplementing this publication is prohibited without prior approval from
The Surgeon General (DASG-HCA), 5111 Leesburg Pike,
Interim
Changes.
Suggested Improvements. Army:
Users are invited to send comments and suggested improvements on DA Form
2028 (Recommended Changes to Publications and Blank Forms) or similar format
directly to HQDA (DASG-HCA), 5111 Leesburg Pike,
Committee Continuance Approval.
Distribution. This publication is available in electronic
media only and can be accessed according to instructions from each Service.
Table of Contents (listed by
paragraph number)
Chapter 1
Introduction
Purpose - 1-1
References - 1-2
Abbreviations and terms - 1-3
Responsibilities - 1-4
Chapter 2
Program Elements and Clinical
Considerations
Standards - 2-1
Logistics - 2-2
Storage and handling - 2-3
Hypersensitivity or allergy - 2-4
Immunizing women of childbearing
potential - 2-5
Exemptions - 2-6
Immunization records - 2-7
Jet-injection immunization devices -
2-8
Emergency response requirements -
2-9
Adverse events - 2-10
Program evaluation - 2-11
Blood donation - 2-12
Chapter 3
Personnel Subject to Immunization
Military personnel - 3-1
Other populations - 3-2
Chapter 4
Specific Immunization Requirements
for DoD and USCG Personnel
Adenovirus types 4 and 7 - 4-1
Anthrax - 4-2
Cholera - 4-3
Haemophilus influenzae
type b (Hib) - 4-4
Hepatitis A - 4-5
Hepatitis B - 4-6
Influenza A and B - 4-7
Japanese encephalitis - 4-8
Measles, mumps, and rubella - 4-9
Meningococcal disease - 4-10
Pertussis - 4-11
Plague - 4-12
Pneumococcal disease - 4-13
Poliomyelitis - 4-14
Rabies - 4-15
Smallpox - 4-16
Tetanus and diphtheria - 4-17
Typhoid fever - 4-18
Varicella - 4-19
Yellow fever - 4-20
Chapter 5
Chemoprophylaxis
General - 5-1
Anthrax - 5-2
Group A
streptococcal disease - 5-3
Influenza A&B - 5-4
Leptospirosis - 5-5
Malaria - 5-6
Meningococcal disease - 5-7
Plague - 5-8
Scrub typhus - 5-9
Traveler’s diarrhea - 5-10
Tuberculosis - 5-11
Chapter 6
Biological Warfare Defense
Purpose - 6-1
Responsibilities - 6-2
Procedures - 6-3
Chapter 7
Vaccines and Other Products in
Investigational New Drug Status
Purpose - 7-1
General guidance on
Health record-keeping requirements
for
Informational requirements for
Chapter 8
Emergency Use Authorization
General - 8-1
Criteria - 8-2
Refusal options - 8-3
DoD requests for EUAs
- 8-4
Appendixes
A. References
B.
Standards
for Military Immunization
C.
Medical and
Administrative Exemption Codes
D. Immunizations for Military Personnel
Chapter 1
Introduction
1-1. Purpose
This publication provides the directive requirements for the Military Vaccination Program, establishes general principles, procedures, policies, and responsibilities for the immunization program, and implements military and international health regulations and requirements.
1-2. References
References are provided in appendix A.
1-3. Explanation of abbreviations and
terms.
Abbreviations and terms used in this publication are defined in the glossary.
1-4. Responsibilities.
a. The command medical authority will prescribe
specific immunization and chemoprophylactic
requirements for their units per requirements established by this publication
and additional guidance provided by the appropriate surgeon general or United
States (U.S.) Coast Guard (USCG) Director of Health and Safety (G-WK).
b. Combatant commanders, commanders,
commanding officers, and officers-in-charge will–
(1) Ensure military and nonmilitary
personnel under their jurisdiction receive required immunizations and
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 commander;
surgeon general; or Commandant G-WK, USCG.
(5) Observe International Military
Standardization Agreements (STANAGs), including
STANAG 2037, STANAG 2491, and STANAG 3474.
c. Medical commanders, commanding officers,
and command surgeons will–
(1) Ensure individuals administering
immunizations are properly trained IAW 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 officer-in-charge of any clinic or activity that administers
immunizations. It is not required that a physician be present for
administration of vaccines. However, a physician must be available to address
immunization issues. The responsible physician must approve all standard
operating procedures for immunization administration in clinics or locations
where immunizations are administered.
(3) Ensure current national
standards for adult and pediatric immunizations and chemoprophylactic
practices are followed and references listed appendix A of this publication are
reflected in local practice.
(4) Ensure patients are evaluated
for preexisting immunity or need for medical exemptions to immunization, and
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 clinical resources of the Vaccine Healthcare
Centers (VHC) Network (see para d (2) below), for
evaluation, consultation, 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 personnel practice emergency responses, and that healthcare providers are available
to respond to adverse events resulting from immunization.
d. Support elements. Inclusion of Section 1.4
is contingent on approval of revised DoDI 6205.2. If DoDI 6205.2 is not approved by the
time this regulation/instruction is approved, drop section 1.4.
(1) The Army, in cooperation with
the military Services, will operate a Military Vaccine Agency, to provide the
military Services with a single source for information, education, and
coordination of vaccine-related activities, to fulfill DoD Instruction 6205.2.
This agency will measure and analyze implementation of immunization policies as
indicators of readiness, safety, and effectiveness. This agency will also
support expansion and quality of standardized automated immunization tracking
systems.
(2) The Army, in cooperation with
the other military Services, will coordinate clinical centers of excellence for
vaccine health care. These centers of excellence shall be known as the VHC
Network. The VHC Network shall establish and update as necessary joint clinical
quality standards for vaccine administration and for the education and training
of personnel in vaccine health care.
Chapter 2
Program Elements and Clinical Considerations
2-1. Standards
a. DoD policy. It is the DoD policy to follow recommendations of the CDC and the Advisory Committee on Immunization Practices (ACIP) concerning immunizations, unless there is a militarily relevant reason to do otherwise. Immunizing agents used in the DoD will meet the requirements of the Department of Health and Human Services (DHHS) for the production and distribution of such materials and meet standards acceptable to the Food and Drug Administration (FDA) and any applicable DoD investigational drug review process. Privileged healthcare 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
are not used beyond the stated potency expiration date, unless the appropriate
surgeon general or Commandant (G-WK), USCG authorizes extension in exceptional
circumstances.
d. Immunization intervals.
(1) 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 “catch-up”
schedules accepted by the CDC.
(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 in Service members, not more than five vaccine
injections will be given on the same day.
(2) Additional vaccinations are then
given at an appropriate later date. A week will often suffice for inactivated
vaccines. Live-virus vaccinations 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 take into
account 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,
poliomyelitis, varicella, measles-mumps-rubella).
This sequence would not apply in military training centers, where contagious
diseases would typically represent the most imminent threats.
(4) Prioritization (see para (3) above) is best performed by an experienced
healthcare provider. The five-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 infection or disease which may
remove the need for superfluous immunization. Such testing will be adopted where
it offers advantages in terms of improved care or medical economics.
2-2. Logistics
a. Immunizing agents are requisitioned IAW medical supply procedures.
b. 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 advice is available from
Service medical logistics centers.
c. To minimize the shipment of vaccines
that must be stored at frozen temperatures, small stations and ships may
requisition these items from a military medical activity stocking the items.
Requisitioning procedures and reimbursement are prescribed by the supplying
activity.
2-3. Storage and handling
Immunizing agents are stored, shipped, and handled IAW 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 it (for example, eggs, gelatin, preservatives) or latex packaging, if applicable. 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 specialist for evaluation, unless the medical record documents
prior consultation or specialist’s recommendations.
See paragraph 2-6 for discussion of medical exemptions.
(2) Document hypersensitivity to any
vaccine, vaccine component, or medication on the Standard Form (SF) 600 (Health
Record-Chronological Record of Medical Care) and on the problem list.
Exemptions from further immunization are entered in DoD-
or USCG-approved electronic immunization tracking systems (ITSs), on the Public Health
Service (PHS) Form 731 (International Certificate of Vaccination), and 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. Discretely ask the woman if
she is or might be pregnant. If the answer is a certain ‘no,’
document this in the healthcare 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 (e.g., urine or
serologic test).
b. With regard to
smallpox (vaccinia) vaccine, a specific
pre-immunization screening form (available at 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, 1 month) and document that counseling in the health record.
d. If a woman is pregnant and immunization is indicated for her while
pregnant, immunize under direction of the woman’s
obstetric healthcare provider.
e. Breastfeeding women may be
vaccinated IAW 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.
When a
contraindicated vaccine is inadvertently administered to a pregnant woman,
report the event upon discovery to local preventive medicine and obstetric
services and complete quality-assurance documents. In some cases, special
registries for such cases have been established, such as the National Smallpox
Vaccine in Pregnancy Registry.
2-6. Exemptions
There are two types of immunization exemptions: medical and administrative. Granting medical exemptions is a medical function that can only be validated by healthcare personnel. 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 planned. Medical
exemptions may be temporary (up to 365 days) or permanent. General examples of
medical exemptions include those in (1)-(3) below. Standard exemption codes
appear in appendix c.
(1) Underlying health condition of
the vaccine candidate (for example, based on immune competence, pharmacologic
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 specialist(s); additional clinical support is available
from the DoD VHC Network.
(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 work-up
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). The VHC Network can facilitate
these referrals. Multidisciplinary consultations may be appropriate. Return of
the patient to his or her primary care provider is not required if the
referring 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). Medical
records will be annotated regarding temporary and permanent medical exemptions.
When no longer clinically warranted, medical exemptions will
be revoked. For Air Force (AF) personnel, military members with permanent
medical exemptions will require a medical evaluation board and/or a flying
waiver IAW AF Instruction 48-123.
(5) Service members who disagree
with a given provider’s/consultant’s recommendations
regarding exemption may be referred for a second opinion to a provider
experienced in vaccine adverse-event management (e.g,
VHC Network).
(6) Personnel will appropriately
annotate electronic ITSs and paper-based medical
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 members 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 geographic 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 within 30 days or less.
(3) Religious. Immunization
exemptions for religious reasons may be granted according to Service-specific
policies to accommodate doctrinal religious beliefs of a Service member. This
is a command decision made with medical and chaplain input.
(a) Requests for religious exemption must include name, rank, social
security number (SSN), occupational specialty code or branch, name of
recognized religious group, date of applicant’s
affiliation, a description of the religious tenet or belief contrary to
immunization, and supporting certification signed by an authorized personal
religious counselor. The counselor attests that the applicant is an active
member in good standing of the espoused religious group, adheres to tenets
consistent with the espoused religious beliefs, and the religious group has a
tenet or belief opposing immunizations. AF: Permanent exemptions for religious
reasons will not be granted. The major command (MAJCOM)/ commander is the designated approval and revocation authority for
temporary immunization exemptions. USCG: G-WPM is the designated approval and
revocation authority for temporary immunization exemptions.
(b) A military chaplain must counsel the applicant and recommend approval or
denial of the exemption request, by endorsement. The chaplain should attempt to
ascertain the validity of the Service member’s
request. The chaplain’s endorsement should address
the above issues to the greatest extent possible, based on his/her counseling
and knowledge of the individual and the individual’s
religion.
(c) A military physician must counsel the applicant and recommend approval
or denial of the exemption request, by endorsement. The physician should ensure
that the Service member is making an informed decision, and should address, at
a minimum, the following:
1. Specific information about the
diseases concerned,
2. Specific vaccine information
including benefits and risks, and
3. Potential risk of infection
incurred by unvaccinated individuals.
(d) 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/her recommendation, should consider the potential
impact on the individual, the unit, and the mission.
(e) Forward exemption requests through command channels to the respective
Service personnel command for decision. Individuals with active requests for
religious exemption are temporarily deferred from immunizations, pending
outcome of their request. USCG: Forward through appropriate chain to G-WPM, via
G-WKH-1.
(f) Religious exemptions may be revoked if the individual and/or
his or her unit’s mission are at imminent risk of
exposure to a disease for which an immunization is available. This is in
keeping with the authority concerning involuntary therapeutic care when
military mission accomplishment may be compromised.
(4) Civilian personnel affected
by this document who
are members of bargaining units will be considered for exemption consistent
with applicable personnel management policies.
(5) Administrative or medical personnel
will appropriately annotate electronic ITSs with
exemption codes denoting separation, permanent-change-of-station, emergency leave, missing/prisoner of war, deceased, and other
appropriate categories.
2-7. Immunization records
a. Electronic immunization tracking systems.
(1) For military personnel, civilian
employees, and other healthcare beneficiaries, DoD-approved electronic ITSs are the preferred record for immunization data.
Electronic immunization records and exemption information will be transmitted
to and received from a DoD-centralized immunization repository at least weekly.
Transcription of historical immunization data from official immunization
records will occur concurrently with the implementation of electronic
immunization tracking.
(2) Electronic ITSs
must–
(a) Comply with the requirements of the National Vaccine Injury Compensation
(NVIC) Program outlined in paragraph d below.
(b) Incorporate appropriate levels of security to preclude unauthorized
access to personal medical information.
(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 individual and unit basis.
(3) A printed report from an
electronic ITS, in PHS Form 731, SF 601, or DD Form 2766C (Vaccine
Administration Record (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 80 (Part VI) of the World Health Organization (WHO) international
health regulations.
b. Non-electronic immunization records.
(1) PHS Form 731. Prepared
upon request for each member of the Armed Forces and for nonmilitary personnel
receiving immunizations. The form contains valid certificates of
immunization for international travel and quarantine purposes IAW 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 ITS.
(a) Abbreviations. Use only abbreviations for vaccines and their
manufacturers conforming to the nomenclature adopted by the CDC Vaccine
Identification Standards Initiative (VISI) (www.cdc.gov/nip/visi/prototypes.htm#abbreviations).
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 three letters of the word, and the year expressed
in Arabic numerals either by four digits or by the last two 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. The DoD immunization stamp (rubber stamp,
fixed type, immunization certification, DoD seal, national stock number: 7520-00-823-8162)
is available through medical supply channels.
(d) Stamps. IAW instructions received from the Foreign Quarantine Division
of the CDC; the appropriate surgeon general; Chief, Bureau of Medicine and
Surgery; or Commandant (G-WK), 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.
2.
3.
4.
5. USCG. Commandant (G-WK), USCG
Headquarters, 2100 Second Street SW, Washington, DC 20593-0001.
(e) Written signatures. In all cases, written signatures must appear in
appropriate spaces on each certificate; signature stamps are not valid.
(2) SF 601 (Marine Corps, Navy, and
USCG). Prepare SF 601 IAW Chapter 16, NAVMED P-107, U.S. Navy, or CG COMDTINST
M6000.1 series. When prepared, SF 601 and PHS Form 731 contain the SSN as
identifying data.
(3) AF. Initiate DD Form 2766C for
all personnel at the time of entry into military service.
(4) Paper-based immunization
records. Individuals preparing paper-based immunization records will ensure
that paper records match the electronic ITS.
(5) Deployment records. Transfer
information regarding immunizations, including date, immunization given, dose,
and initials of person administering to the deployable medical record (that is,
DD Form 2766 (Adult Preventive and Chronic Care Flowsheet)),
or comparable approved form, either by computer-generated report or by hand.
c. Lost immunization records. If an individual’s immunization records are lost, assume the
individual received standard vaccinations 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 vaccinations. Base
decisions for future immunizations on assumed date of last vaccination (for
example, Service member assumed to have received tetanus-diphtheria toxoid in
July 1995 would next be vaccinated 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, measles, mumps, rubella, poliovirus, hepatitis B, Haemophilus influenzae
type b, varicella, rotavirus, pneumococcal-conjugate
antigens, and any new vaccine 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 medical 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. Single camera-ready
copies of VISs are available from State health
departments or through the CDC website (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 the VISs.
However, to ensure the existence of a record that the materials were provided,
healthcare personnel who administer vaccines will make a notation in 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 Service member or beneficiary who requests one. Further, the
Military Vaccine Agency website (www.vaccines.mil) will link to the current
versions of VISs.
(5) The NCVIA requires that the
following events be reported to VAERS:
(a) Any event listed in the NVIC Program’s Vaccine
Injury Table (www.hrsa.gov/osp/vicp/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 healthcare beneficiaries are eligible to file claims with the NVIC
Program, according to the Program’s procedures.
2-8. Jet-Injection immunization devices
a. 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," were withdrawn from DoD and USCG use in 1997 on grounds of safety. Their use of the same unsterile nozzle and fluid pathway to inject consecutive patients could allow transmission of blood-borne pathogens. 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 multi-dose 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 of MUNJIs by their use of a new, disposable,
sterile fluid pathway for each patient. Several are FDA-cleared for sale in the
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 one person present must be trained and current in basic
cardiopulmonary resuscitation, oro-pharyngeal airway
management, and recognition and initial treatment of anaphylaxis with
epinephrine.
c. Anaphylaxis management. Supplies
necessary for emergency medical management of anaphylaxis (that is,
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. ACIP general
recommendations suggest that people be observed for 15 to 20 minutes after
being vaccinated.
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.
f.
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 and other medications.
a. Mandatory information consists of
identification, lot number, and manufacturer of the biological agent; 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 healthcare
providers to report adverse events to VAERS. They may use the VAERS reporting
form (Form VAERS-1) or submit electronic reports via the www.vaers.org website.
VAERS forms and information can be obtained by calling 1-800-822-7967 or by
accessing the VAERS website.
c. Reporting requirements.
(1) Healthcare personnel must report
adverse events resulting in hospitalization, a life-threatening event (for
example, anaphylaxis), time lost from duty more than 24 hours (more than 1 duty
shift), or an event related to suspected contamination of a vaccine vial.
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
(www.hrsa.gov/osp/vicp/table.htm). These are minimum requirements.
(2) Further, healthcare providers are encouraged to report other adver