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Documentation Package Workflow

Last reviewed: 2026-07-23

Package contract

A complete package contains exactly one JSON object for each document type:

• source_fact_manifest
• clinician_authored_intervention_record
• goals_monitoring_checkpoint_record
• informed_preference_shared_decision_record
• transition_reconciliation_record
• intended_use_handoff_record

All six must use schema version 2.0 and the same subject_ref, data_classification, draft status, and notice.

1. Intended-use gate

Complete the intended-use/handoff record first:

• purpose and authorized users;
• local setting and accountable roles;
• prohibited-use list;
• privacy and processing attestations;
• local policy, retention, change-control, and reporting routes;
• local emergency-process reference;
• handoff sender, recipient, and acknowledgment;
• clinician sign-off and documentation-handoff release gate.

Do not remove prohibited uses. The generator restores the complete list in every new package.

2. Source-fact manifest

Every clinical or process statement used elsewhere must have a source fact. A fact records:

• a stable fact ID;
• fact kind;
• the exact bounded statement supplied;
• source type, title, local locator, and version/date;
• verification status, verifier role, and time;
• applicability status when an official source or policy is involved.

Allowed source categories distinguish signed local records, authorized EHR records, current FDA labeling, current REMS materials, current official guidance, and local policy.

The manifest does not decide which source applies. An authorized professional must confirm applicability.

3. Clinician-authored interventions

Each intervention record must:

• state that the decision was supplied and verified by an authorized licensed professional;
• preserve the clinician-authored action without rewriting it into a recommendation;
• link to at least one verified source fact;
• record parameters only as supplied;
• identify the responsible role;
• preserve explicit start/end dates when supplied;
• include verifier role and time.

The validator checks structure and provenance only. It does not parse or judge a medication, procedure, therapy, device, referral, or instruction.

4. Goals, monitoring, and checkpoints

Separate:

• goals — statement, measurement, target, target date, and source facts;
• monitoring items — item, method, supplied frequency text, explicit next due date, owner, and source facts;
• checkpoints — exact supplied date, purpose, owner, linked records, and source facts.

Do not convert a narrative frequency into dates. Do not infer a checkpoint from a target, medication, intervention type, standard interval, or prior appointment.

5. Informed preferences and shared decisions

Record only what the authorized clinician documented:

• decision topic;
• options actually presented;
• whether benefits, harms, and uncertainty were documented;
• the person's stated preference;
• the clinician-documented outcome;
• participant and author roles;
• source facts, time, and acknowledgment status.

Do not generate missing options, risk estimates, benefit claims, alternatives, or consent language.

6. Transition and reconciliation

Record:

• sending and receiving settings and roles;
• exact handoff date;
• medication-reconciliation status;
• source and destination list fact references;
• discrepancy status and authorized reviewer;
• handoff items, owners, recipients, and acknowledgment;
• unresolved items and their local route.

completed_by_authorized_clinician is a declaration to be verified against the local record. The script does not perform reconciliation.

7. Deterministic checks

Run in this order:

python3 scripts/validate_treatment_plan.py PACKAGE_DIRECTORY
python3 scripts/validate_traceability.py PACKAGE_DIRECTORY
python3 scripts/check_completeness.py PACKAGE_DIRECTORY
python3 scripts/privacy_process_check.py PACKAGE_DIRECTORY
python3 scripts/check_consistency.py PACKAGE_DIRECTORY
python3 scripts/timeline_generator.py PACKAGE_DIRECTORY --output SCHEDULE.json

The checks answer different questions:

• structural validator — are document types, fields, types, enums, bounds, and dates valid?
• traceability validator — do all clinical/process records point to existing verified facts?
• completeness checker — are required records, reviews, routes, acknowledgments, sign-off, and release declarations complete?
• privacy/process checker — are local authorization, minimization, external-tool prohibition, qualified review, retention, and direct-identifier safeguards documented?
• consistency checker — do package IDs, statuses, classifications, references, and explicit date order agree?
• timeline generator — what events occur on dates already supplied?

Run every check again after any change.

8. Minimized issue handling

Reports use field paths, not values. For example, a report may identify interventions[0].verification.status without printing the action text.

Resolve each issue in the authoritative local record:

1. Locate the field path.
2. Compare with the signed source.
3. Ask the responsible authorized role to supply or verify the missing value.
4. Update provenance.
5. Re-run all checks.

Never correct clinical content from memory or general guidance.

9. Sign-off and handoff

Before releasing for authorized documentation handoff:

• all source facts are verified;
• source applicability is confirmed where required;
• interventions are verified;
• reconciliation is completed or explicitly not applicable by an authorized reviewer;
• unresolved items are routed and acknowledged;
• privacy/process review is complete;
• local policy and reporting routes are populated;
• the recipient is identified;
• the authorized licensed signer completes the attestation;
• the release gate is set to released_for_authorized_documentation_handoff;
• blocker codes are empty.

The visible draft/not-medical-advice notice remains. Release does not authorize implementation by an agent.

10. Change control

For every revision:

• preserve the prior authorized version according to local records policy;
• update source versions and verification times;
• re-run every check;
• obtain new sign-off when clinical content, recipient, classification, purpose, or governing source changes;
• record disposition of superseded local copies;
• never overwrite a source record or silently reuse an old approval.