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Topic Reference

Vaccine Exemptions and Deferrals

A Topic Reference for community discussion

DRAFT Version v0.1.1

Status and Scope

Status: Working draft for community discussion. Nothing in this document is a published standard, an HL7 ballot, or a final decision. Working decisions are recorded so the community can see, question, and improve them, and any of them may change.

In brief

Many jurisdictions let a parent or guardian claim a formal exemption from vaccines that a school or childcare program requires. Immunization information systems (IIS) increasingly hold those exemptions, and schools, providers, and other systems want to exchange them through the HL7 v2 interfaces they already use. National HL7 v2 immunization guidance does not say how, and does not distinguish an exemption from a refusal or a clinical contraindication.

This document sets out a technical template for communicating exemptions, parts of which are implemented in at least one IIS, and frames the rest of the topic: submitting exemptions in unsolicited updates (VXU), defining deferrals, and moving toward formal standards.

What this project covers

  • Definitions that separate exemptions, deferrals, refusals, contraindications, and other reasons a vaccine is not given.
  • The use cases and actors that need exemption or deferral information exchanged.
  • A transport-independent information model for exemption state.
  • A query and response pattern for exemptions.
  • The questions a VXU design must answer, and a path to formal standards.

What this project does not cover

This document defines how exemption information is communicated. It does not define:

  • who qualifies for an exemption, which exemption types a jurisdiction recognizes, or which vaccines a school requires;
  • how an exemption is collected, validated, deduplicated, expired, or revoked;
  • who may send or receive exemption information, or how exchanged information is used, disclosed, or protected, which are matters of IIS and jurisdictional policy; or
  • any effect on immunization evaluation or forecasting, which belongs to a separate clinical decision support proposal.

A jurisdiction’s exemption process can therefore change without changing the message design, as long as its exemption types map to the shared vocabulary. This document is not an HL7 implementation guide or conformance profile.

Concepts and Use Cases

Concepts

An IIS can hold several kinds of statement about a vaccine that was not given. In HL7 v2 they share the non-administration form, but they mean different things and must not be used to carry one another.

Concept Working definition Affects evaluation and forecast Developed here
Formal exemption An official, administrative status that excuses a person from a vaccination requirement under jurisdictional law or policy. It applies to one or more vaccine categories, has a type (such as medical, religious, or philosophical), and has a filing date. No Yes
Refusal A patient’s or parent’s decision to decline a vaccine, usually at a point of care. Not an official status; a person may refuse without holding an exemption. Not by this topic No; existing guidance applies
Contraindication or precaution A clinical assessment that a vaccine is inadvisable or calls for caution. May No; existing guidance applies
Evidence of immunity A history of disease or laboratory result showing a vaccine is not needed. May No; existing guidance applies
Deferral Not yet defined. See Deferrals. Not yet defined Questions only

Terminology cautions

  • A medical exemption is a formal exemption with a medical basis. It is still an administrative status, separate from any clinical contraindication record, even when the same condition underlies both. Its LOINC answer is labeled “Medical contraindication”; prose and displays should say “medical exemption.”
  • For personal-belief exemptions, “Philosophical objection” is preferred over “Parent/patient refusal” so the exemption is not read as a refusal.
  • Jurisdictions use different names for the same exemption types, so display names should be agreed separately from codes.

Deferrals

“Deferrals” are in this topic’s name, but no one has yet said what a deferral is or which use cases need one exchanged. This document does not fit deferrals into the exemption structure until these are answered (OQ-1):

  • Is a deferral a temporary clinical delay, an administrative delay (such as a grace period for school entry), a forecast recommendation, or something else?
  • Does it apply to a vaccine category, a dose, a series, or a period of time?
  • What creates, updates, ends, or supersedes one?
  • How does it differ from a contraindication, precaution, refusal, or forecast status?
  • Which use cases need an IIS to receive a deferral, return one, or both?

Actors

Actor Role in the exchange
IIS Holds the current exemption state and returns or receives it.
School or childcare system Checks whether a student lacking required vaccines holds an exemption.
Provider system (EHR or pharmacy) May query for exemptions or submit them.
Jurisdiction exemption program Issues or records exemptions through its own process, outside the exchange.
Other systems Any other system that exchanges exemptions, such as a state education agency.

Parents and guardians claim exemptions but do not take part in the HL7 exchange.

Use cases

ID Use case Exchange Status
UC-1 A school asks the IIS only for a student’s exemptions. QBP/RSP Implemented in at least one IIS
UC-2 A school asks for immunization history and exemptions together. QBP/RSP Implemented in at least one IIS
UC-3 A school asks for evaluated history and forecast with exemptions. QBP/RSP Implemented in at least one IIS
UC-4 A provider asks for exemptions. QBP/RSP Same pattern
UC-5 A system submits a new or changed exemption to the IIS. VXU Not yet designed; see Unsolicited updates
UC-6 A system exchanges a deferral. Not determined Not defined (OQ-1)

The first use cases are kindergarten through grade 12 school requirements, where a school reviewing compliance needs to know whether a student holds an exemption, its type, and the vaccine categories it covers.

Information Model

This chapter describes exemption information independently of any message. Query and Response shows how it is carried in HL7 v2; a VXU or FHIR design should carry the same information.

Structure

A person has zero or more exemption items. Each item states that one vaccine category is exempted, with a type and a filing date. One exemption form usually produces several items. The type may differ from item to item, even where a jurisdiction’s own process applies one type to every vaccine selected.

A response may instead state that no exemptions are documented as of a date. That statement is itself exemption information.

Data elements

Element Meaning Status
Exemption type The basis of the exemption Required
Exempted vaccine category The vaccine or vaccine-preventable disease covered Required
Date filed When the exemption was filed with the jurisdiction Required
As-of date When a “no exemptions documented” statement is true Required for that statement
Who completed or issued the exemption The person or organization behind it Not required; optional if a need is shown (OQ-2)
Status, expiration, revocation, school year Whether and when the exemption is in force Not required for a snapshot (OQ-2)
Exemption identifier Stable identifier for updating or revoking an item Not needed for a snapshot; open for VXU (OQ-12)
Source and provenance Which system or program asserted it Open for VXU (OQ-14)

Every element should have an operational reason to exist. Elements were left out of the query design because no consumer needed them, not because they were judged unimportant.

Current-state semantics

A query response is a snapshot of the IIS’s current exemption state, with no history or lifecycle events. An exemption that has ended is simply absent from later responses, and consumers query again to see changes. The IIS manages expiration and revocation in its own process, for example through grade-based rules or later vaccination. Unsolicited updates need more; see Unsolicited updates.

Vocabulary

Exemption type uses answers from LL4353-0, the example answer list for LOINC 100282-3. The list covers reasons a vaccine was not given generally; only these are used:

Code LOINC display Use
LA27164-5 Medical contraindication Medical exemption
LA27171-0 Religious exemption Religious exemption
LA27170-2 Philosophical objection Philosophical or personal-belief exemption
LA137-2 None No exemptions documented; not in LL4353-0

LA27167-8 (Parent/Patient refusal) is in the list but is not used for exemptions. Whether these LOINC codes are the best fit is open (OQ-4).

Exempted vaccine category uses CVX, preferring “unspecified formulation” codes or the code that represents a CDC vaccine group, because an exemption covers a category, not a product. CVX is not a disease-group vocabulary: MMR and varicella, for example, have no “unspecified” code. A disease-group vocabulary could replace this later without changing the rest of the model (OQ-3).

Query and Response

This chapter sets out the QBP/RSP pattern for exemptions. Parts of it are implemented in at least one IIS. Profile identifiers shown here are local choices, not national assignments.

Requested explicitly

Exemption content is returned only when the query explicitly asks for it. Whether the IIS returns it to a particular requester is IIS policy, outside this document; the exchange only signals that exemptions were requested and whether they are included (OQ-8).

Existing querying systems do not expect exemptions, and most people have none, so adding exemption content (or “none” statements) to every response would add size and processing for no benefit. Returning exemptions based only on the requester’s settings in the IIS was considered and set aside, so that a querying system always knows exemptions may be present.

Requesting exemptions

The request adds an exemption profile in repeating MSH-21, alone or with an existing query profile:

MSH-21 in the query Meaning Valid
Z34 Immunization history Yes, existing
Z44 Evaluated history and forecast Yes, existing
Exemption profile alone Exemptions only Yes
Z34 and exemption profile History plus exemptions Yes
Z44 and exemption profile Evaluated history and forecast plus exemptions Yes
Z34 and Z44 Conflicting intents No; return an error with ERR

Order of the repeated values carries no meaning. Only listed combinations are valid (OQ-7). Z34 and Z44 keep their current meanings.

At least one implementation uses Z99^CDCPHINVS, assigned locally, as its request profile. A complete design needs a pair: a query profile meaning “exemption content is requested” and a response profile meaning “exemption content is included,” so the response’s MSH-21 repeats as well (for example Z42 with the exemption response profile). No national pair has been agreed (OQ-5). Whether QPD-1 also carries the combined intent is open (OQ-6).

Example: evaluated history and forecast plus exemptions, with QPD-1 carrying the primary intent only. Identifiers and demographics are illustrative.

MSH|^~\&|SCHOOLSYS|SCHOOL01|IIS|IIS01|20260115093000-0700||QBP^Q11^QBP_Q11|Q0001|T|2.5.1|||ER|AL|||||Z44^CDCPHINVS~Z99^CDCPHINVS
QPD|Z44^Request Evaluated History and Forecast^CDCPHINVS|Q0001|STU1001^^^SCHOOL01^MR|Example^Pat^^^^^L||20190601|F
RCP|I|1^RD&records&HL70126

Response order group

Exemptions go in one dedicated ORC/RXA[/RXR]/OBX... order group, however many vaccine categories are exempted, as long as all items share the same administrative context. In an evaluated-history response it sits with the other non-administration groups, after immunization history and before forecast.

The ORC and RXA follow the pattern already used for contraindications and history of disease:

Field Value Note
ORC-3 9999^IIS Established placeholder
RXA-3 Date the message was built Required by structure; no exemption meaning
RXA-5 998^No Vaccination Administered^CVX
RXA-20 NA Not administered

RXR may appear where the structure calls for it and adds no meaning. NK1 may be returned under the underlying query profile to help confirm a match. NTE is optional; omit it without a defined need.

Paired observations

Each exemption item is two OBX segments sharing an OBX-4 sub-ID:

Field Exemption type observation Vaccine category observation
OBX-2 CE CE
OBX-3 100282-3^Vaccine exemption certificate^LN (LOINC) 30956-7^Vaccine type^LN (LOINC)
OBX-4 Pair identifier Same pair identifier
OBX-5 Exemption type (vocabulary) Vaccine category (vocabulary)
OBX-11 F F
OBX-14 Date filed Not used

Example: two religious exemption items, for hepatitis A and DTaP. In a complete response, OBX-1 continues the numbering of earlier groups.

ORC|RE||9999^IIS
RXA|0|1|20260115||998^No Vaccination Administered^CVX|999||||||||||||||NA
OBX|1|CE|100282-3^Vaccine exemption certificate^LN|1|LA27171-0^Religious exemption^LN||||||F|||20250901
OBX|2|CE|30956-7^Vaccine type^LN|1|85^HepA Unspecified^CVX||||||F
OBX|3|CE|100282-3^Vaccine exemption certificate^LN|2|LA27171-0^Religious exemption^LN||||||F|||20250901
OBX|4|CE|30956-7^Vaccine type^LN|2|107^DTaP Unspecified^CVX||||||F

No exemptions documented

When exemptions were requested and are being returned but none are on file, the IIS may send the order group with a single exemption-type observation whose value is LA137-2^None^LN and whose OBX-14 is the response date. The ORC and RXA are still required. When exemption content is not being returned, send no exemption group at all.

OBX|1|CE|100282-3^Vaccine exemption certificate^LN|1|LA137-2^None^LN||||||F|||20260115

Path Forward

Unsolicited updates

Exemptions could also be submitted to an IIS in VXU messages. A VXU should carry the same payload as a response: the order group and paired observations.

The query mechanism does not transfer. A response is a snapshot the IIS builds from its own data; a VXU tells a receiver about something it may already hold. A VXU design must therefore decide:

  • whether a message reports one event or the sender’s complete current set (OQ-11);
  • what identifies an exemption so it can be replaced, revoked, or deleted (OQ-12);
  • whether a sender may assert “none,” which could erase exemptions from another source (OQ-13); and
  • provenance and acknowledgement behavior (OQ-14).

Candidate artifacts

This Topic Reference is the shared starting point. Formal artifacts will be separate and will cite it.

Artifact Purpose Resolves
Exemption query and response profile proposal Assign and define the profile pair and response behavior OQ-3 to OQ-10
Exemption submission (VXU) proposal Define unsolicited exemption updates OQ-11 to OQ-14
Deferral concept paper Define deferrals and their use cases OQ-1
Conformance test cases Let implementers test queries, responses, and errors Follows the profile proposal

The sponsoring body and publication path are open (OQ-15).

Validation

  • Experience from existing implementations is the first test of the query design and is recorded as review input.
  • Other IIS should review the design before profiles are assigned, so the identifiers do not collide with local profiles.
  • Message examples should be validated against national conformance tools once profiles exist.

Steps

  1. Review definitions, scope, and use cases with the community.
  2. Confirm the explicit request and payload as the common design, or record objections.
  3. Gather requirements from IIS and submitters interested in VXU.
  4. Agree on a definition of deferral, or narrow the topic.
  5. Choose a sponsoring body and prepare the first formal proposal.

Appendix: Working Decisions and Open Questions

This appendix consolidates the working decisions on the topic and the questions still open. A working decision is the current position for discussion, not a final or approved decision. Each records where it came from so it can be revisited. Details are in the linked sections.

Working decisions

ID Working decision Basis
WD-1 A formal exemption is distinct from a refusal and a clinical contraindication (Concepts). Implementation experience; national guidance does not separate them
WD-2 Exemptions do not change evaluation or forecasting (scope). Implementation experience
WD-3 The information model is transport-independent; QBP/RSP and VXU carry the same payload (Information Model). Implementation experience; VXU use case
WD-4 This document defines how exemption information is communicated, not intake, lifecycle, eligibility, or who may send, receive, or use it (scope). Implementation experience
WD-5 Exemption content is returned only when explicitly requested; whether a requester receives it is IIS policy (requested explicitly). Implementation experience
WD-6 The paired-observation order group is the leading worked example for exemption payloads (paired observations). Implementation experience
WD-7 A query response is a current-state snapshot (semantics). Implementation experience
WD-8 “No exemptions documented” is sent only when exemptions were requested and are being returned (no exemptions). Implementation experience
WD-9 Exemption requests are post-coordinated in repeating MSH-21 (requesting). Implementation experience
WD-10 Locally assigned identifiers such as Z99 are implementation experience, not national assignments (requesting). Implementation experience
WD-11 The topic covers QBP/RSP and VXU without assuming they share an exchange contract (unsolicited updates). Project plan
WD-12 The wire representation is jurisdiction-neutral and permits a different type per vaccine category (structure). Implementation experience
WD-13 Deferrals stay in scope but are not fitted into the exemption structure until defined (Deferrals). Project plan

Open questions

Each question needs discussion before the affected text is settled. Questions that belong to a related topic are referred there rather than answered here.

ID Question Sources in tension Status
OQ-1 What is a deferral in this topic, and which use cases need it exchanged? Topic name includes deferrals; no use case described Open
OQ-2 Should issuer, status, expiration, or school year be optional elements? Query design found no need; VXU and other jurisdictions may Open
OQ-3 What vocabulary identifies exempted categories where CVX is not enough? CVX is product-oriented; requirements are disease-oriented Open; CVX used for now
OQ-4 Are these LOINC codes the best fit? 100282-3 is a document code whose description says the exemption reason is typically carried by 85714-4; LL4353-0 is an example list of general non-vaccination reasons; and LA137-2 (None) is not in that list. Implemented use of 100282-3; LOINC term descriptions Open
OQ-5 What national request and response profiles should be assigned, and should the first be labeled experimental to leave room for immunities or deferrals? Z99 used locally; a Z70 to Z73 range discussed; local collisions Open
OQ-6 Does combined intent appear only in MSH-21, or also in QPD-1? Design discussion kept QPD-1 to the primary intent; implementation test queries repeat it Open
OQ-7 What is the complete table of valid combinations, and which ERR codes apply? Mechanism agreed; codes not defined Open
OQ-8 How does a response distinguish “no exemptions on file” from “exemptions not returned” or “not supported”? “None” covers only the first case Open
OQ-9 Do legacy senders and receivers tolerate repeating MSH-21, and should an IIS ignore or reject an unrecognized profile? Backward compatibility not tested broadly Open
OQ-10 With several or replaced exemptions for one category, does a response return only the active one? Snapshot semantics; intake rules vary Open
OQ-11 Does a VXU report exemption events or a complete snapshot? Snapshot design; update needs Open
OQ-12 What identifiers and matching rules support replacement, revocation, and deletion in VXU? Not needed for a snapshot Open
OQ-13 Is a “none” assertion safe or meaningful in a VXU? Safe in an IIS-built response; may erase other sources’ data in a submission Open
OQ-14 What provenance and acknowledgement rules apply to VXU? No VXU requirements gathered yet Open
OQ-15 What sponsoring body and publication path should take formal artifacts forward? Not decided publicly Open