# PRD: VigilCare Records — Paper Chart Digitization & Approval Platform ## Overview A clinical records intake system that converts paper-based patient charts into structured, human-verified digital records before they enter the VigilCareClinical alerting pipeline. Designed for small hospitals, district clinics, and island health systems where the majority of historical and day-to-day records still exist on paper. The workflow is deliberately manual at every extraction step: **Scan / upload → Human data entry → Human verification → Approved patient record** There is **no OCR** in scope. Every structured field is typed by a human who reads the scan. A second human compares the entry against the original image before the record becomes clinically authoritative. Unapproved drafts never trigger alerts, scoring, or surveillance. VigilCareClinical ([vigilcare-clinical-api-prd.md](vigilcare-clinical-api-prd.md)) remains the downstream intelligence layer: threshold alerting, NEWS2, sepsis detection, ward dashboard, and long-term archival. VigilCare Records is the **precursor** that creates the fuel — patient identity, encounters, and observations — in a governed, auditable way. This project maps to `sd-mid-009` (Outbox Pattern for approval promotion events), `sd-mid-013` (CQRS — draft vs live read models), `sd-junior-004` (RBAC), and senior trade-off conversations around **data quality gates vs time-to-value** in resource-constrained health systems. **Stack:** .NET 8 Web API, PostgreSQL, MinIO (scanned document storage), Redis (work-queue assignment locks), Serilog → Seq, Prometheus → Grafana, xUnit, Docker Compose. Vue 3 digitization workstation UI (separate repo or `VigilCare.Records.Web` project). **Prerequisite / companion:** VigilCareClinicalAPI Phases 1–2 minimum (patient, encounter, observation ingest). Full VigilCare value unlocks as approved observations flow into the existing Kafka alert pipeline. --- ## Goals - Provide a complete scan-to-approved workflow for paper chart conversion without OCR or machine extraction - Enforce **separation of duties**: the person who enters data cannot verify their own entry - Promote approved structured data into VigilCareClinical's live domain model (Patient, Encounter, Observation) atomically - Maintain a full audit trail linking every approved field to its source scan, entry clerk, verifier, and approver - Support two operational modes: **Track A** (historical backfill with full dual-human gate) and **Track B** (live bedside capture with clinician attestation, lighter gate) - Produce a deployable precursor that makes VigilCareClinical credible in paper-only facilities — not as a standalone EMR replacement ## Non-Goals - **OCR or automated field extraction** — explicitly out of scope for v1; may be evaluated in a future phase after human-verified baseline quality is established - HL7/FHIR compliance or LIS instrument integration - Full EMR functionality (billing, pharmacy inventory, scheduling beyond basic encounter open) - Replacing VigilCareClinical's alert engine, scoring, or ward dashboard - HIPAA-certified or jurisdiction-specific medical device registration (model the patterns; certification scoped per deployment) - Multi-facility federated identity across islands (single-tenant deployment per site in v1) --- ## Problem Statement VigilCareClinical assumes structured, timestamped clinical data already exists. In paper-based facilities: 1. Patient identity lives in folders, ward books, or duplicate index cards — no stable MRN workflow 2. Vitals and lab results are handwritten — illegible, untimestamped at minute precision, or lost between visits 3. There is no encounter boundary — "the patient" is not the same as "this admission" or "this clinic visit" 4. Clinicians cannot trust machine-generated alerts if the underlying values were guessed from poor handwriting Without a digitization and approval layer, VigilCare has nothing to observe. With it, even a 20-bed district hospital can convert charts incrementally and activate real-time alerting as live capture replaces paper forms. --- ## Relationship to VigilCareClinical ``` ┌─────────────────────────────────────────────────────────────────────┐ │ VigilCare Records (this PRD) │ │ │ │ Scan → Entry → Verify → Approve │ │ ↓ │ │ Draft tables (never alert) │ │ ↓ on approval │ │ Promotion service ──────────────────────────────────────────────┐ │ └──────────────────────────────────────────────────────────────────│──┘ │ ┌──────────────────────────────────────────────────────────────────▼──┐ │ VigilCareClinicalAPI │ │ │ │ Patient → Encounter → Observation → Outbox → Kafka → Alerts │ └─────────────────────────────────────────────────────────────────────┘ ``` **Invariant:** Draft observations are invisible to VigilCareClinical's alert engine, Elasticsearch ward projection, and scoring consumers. Only batches that have passed approval are promoted to live tables. Promotion is idempotent — re-running an approval job for the same batch produces no duplicate live rows. **Track A (backfill):** Full pipeline — scan, entry, verification, approval. Historical vitals and labs enter as observations with `recordedAt` taken from the chart (not scan time). Alerts on backfilled critical values are **suppressed by default** unless the facility explicitly opts in per batch (`enableRetroactiveAlerts: false` default). **Track B (live capture):** Credentialed clinician enters vitals at bedside. Skips verification queue; requires `clinicianAttestation: true` on submit. Observations promote immediately to VigilCareClinical with `source: live_capture`. Every live-capture submission still creates a `DigitizationBatch` (audit unit) with draft observations, `DigitizationEvent` entries, and live rows in a single transaction — see [Track B audit model](#track-b-audit-model). **Deployment model (v1):** Integrated PostgreSQL — Records draft tables and VigilCareClinical live tables (`patients`, `encounters`, `observations`, `outbox_events`) share one database instance (separate schemas). Promotion runs in a single local transaction. Split deployment with HTTP + saga retry is documented as a future deployment option, not the portfolio default. --- ## API Conventions Same response envelope as VigilCareClinical and other portfolio projects. Prefix: `/api/v1`. **Success:** ```json { "success": true, "statusCode": 200, "data": {}, "error": null } ``` **Error:** ```json { "success": false, "statusCode": 422, "data": null, "error": { "message": "Verifier cannot approve a batch they entered.", "code": "SEPARATION_OF_DUTIES_VIOLATION" } } ``` **Pagination:** Work queues and batch lists use offset pagination (`?page=1&pageSize=20`). Audit event history uses cursor pagination on `(occurred_at DESC, id DESC)`. **Idempotency:** `POST /api/v1/digitization-batches/:id/approve` accepts an `Idempotency-Key` header. Duplicate approval requests return the same promotion result without creating duplicate live observations in VigilCareClinical. --- ## Roles and Permissions | Role | Permissions | |---|---| | **Intake clerk** | Upload scans, create batches, assign patient (existing MRN or new registration draft) | | **Data entry clerk** | Edit draft fields on batches in `uploaded` or `rejected` state; submit for verification | | **Verifier** | Review batches in `pending_verification`; field-level pass/fail; reject with reason; cannot verify batches they entered | | **Clinical approver** | Final promotion trigger via `POST .../approve` for batches in `verified` or `awaiting_clinical_approval`; cannot approve batches they entered | | **Clinician** | Track B live capture; attestation on own entries (attestation satisfies verify + approve for that batch only) | | **Administrator** | User management, batch type config, retroactive alert policy, work-queue reassignment | ### Verification vs approval (Track A) Track A uses **two distinct human gates** before promotion: 1. **Verifier** — compares structured draft fields against the scan (`POST .../verify` or `POST .../reject`). This is the dual-human data-quality check. 2. **Clinical approver** — authorizes promotion (`POST .../approve`), which creates live clinical records. Every Track A batch requires this step regardless of batch type. **Optional third gate:** For high-stakes `batchType` values, site configuration routes verify-pass batches to `awaiting_clinical_approval` instead of `verified`. The clinical approver then reviews after the verifier before promotion. See [Site configuration](#site-configuration) below. | After verifier pass | Next status | Who calls `approve` | |---|---|---| | Site config: clinical sign-off **not** required for this `batchType` | `verified` | Clinical approver (or administrator) | | Site config: clinical sign-off **required** for this `batchType` | `awaiting_clinical_approval` | Clinical approver (or administrator) | Separation of duties is enforced at the service layer, not only in the UI. `enteredByUserId === currentUserId` blocks verify and approve actions with `409 SEPARATION_OF_DUTIES_VIOLATION`. Verifiers never call `approve`; clinical approvers never call `verify`. ### Site configuration Per-site `ClinicalApprovalRequired` maps `batchType` to whether verify-pass routes to `awaiting_clinical_approval` (physician queue) vs `verified` (ready for immediate approver sign-off). Default portfolio configuration: | batchType | Clinical sign-off after verify? | |---|---| | `patient_registration` | No | | `allergy_update` | No | | `encounter_summary` | Yes | | `vitals_sheet` | Yes | | `lab_results` | Yes | | `medication_list` | Yes | | `mixed` | Yes | Administrators may override this map per deployment in `appsettings.json` (`SiteConfig.ClinicalApprovalRequired`). --- ## Domain Model ### DigitizationBatch The unit of work for one digitization effort — typically one scanned document or one logical chart section (vitals sheet, lab report, admission face sheet). | Field | Description | |---|---| | `id` | UUID | | `status` | See state machine below | | `batchType` | `patient_registration`, `encounter_summary`, `vitals_sheet`, `lab_results`, `medication_list`, `allergy_update`, `mixed` | | `patientId` | Nullable until linked; may reference draft or live patient | | `encounterDraftId` | Nullable; encounter context for vitals/labs | | `documentRef` | MinIO object key for the scanned PDF/image | | `documentSha256` | Content hash for integrity verification | | `track` | `backfill` (Track A) or `live_capture` (Track B) | | `enableRetroactiveAlerts` | Default `false`; if `true` on approval, promoted observations participate in alerting | | `enteredByUserId` | Set on first draft save | | `verifiedByUserId` | Set on verification pass | | `approvedByUserId` | Set on final approval | | `rejectionReason` | Nullable; required when status → `rejected` | | `promotedAt` | Nullable; timestamp when live records created | | `promotionEncounterId` | VigilCareClinical encounter ID after promotion | | `supersedesBatchId` | Nullable; links a correction batch to the batch it replaces | | `clinicianAttestation` | `true` for Track B batches attested at bedside | ### DraftPatient / DraftPatientUpdate Structured patient fields extracted from paper — demographics, allergies, blood type, emergency contact, medications (for `medication_list` batches). On approval of a `patient_registration` or `allergy_update` batch, merges into VigilCareClinical `Patient` (create or patch). `medicationsJson` is stored on the digitization audit record in v1; medication rows are not promoted to a pharmacy module (out of scope). ### DraftEncounter A clinical episode extracted from the chart: admission date, department, room/bed, admission reason, discharge diagnosis (if applicable). Promotes to VigilCareClinical `Encounter`. ### DraftObservation A single measurable value: observation code, numeric value, unit, `recordedAt` (from chart, required), optional note. Subject to the same plausibility ranges as VigilCareClinical ingest. Never written to live `observations` until batch approval. ### DigitizationEvent Append-only audit log entry for every state transition and field-level correction. ```json { "id": "uuid", "batchId": "uuid", "eventType": "uploaded | entry_started | submitted_for_verification | rejected | verified | awaiting_clinical_approval | approved | promoted | live_capture_attested | correction_requested", "actorUserId": "uuid", "occurredAt": "2026-06-22T14:30:00Z", "metadata": { "rejectionReason": "SpO2 value unclear on scan — decimal ambiguous", "fieldsChanged": ["observations[2].value"] } } ``` ### ScannedDocument Stored in MinIO. Original paper is the legal source; the scan is the working reference for entry and verification. Retention: minimum 7 years (configurable per jurisdiction). Scanned documents are **never deleted** when a batch is rejected — only the draft is returned for correction. --- ## Batch Status State Machine ``` ┌──────────────┐ │ uploaded │ └──────┬───────┘ │ assign / first save ▼ ┌──────────────┐ ┌──────────│ in_entry │◄─────────┐ │ └──────┬───────┘ │ │ │ submit │ reject │ ▼ │ │ ┌──────────────┐ │ │ │ pending │─────────┘ │ │ verification │ │ └──────┬───────┘ │ │ │ verify fail │ verify pass │ ─────────┤ │ │ │ site config │ site config │ = false │ = true │ ┌────────┴────────┐ │ ▼ ▼ │ ┌──────────────┐ ┌──────────────────────┐ │ │ verified │ │ awaiting_clinical │ │ └──────┬───────┘ │ _approval │ │ │ └──────────┬─────────────┘ │ └──────────┬──────────┘ │ │ clinical approver: approve │ ▼ │ ┌──────────────┐ └────────────►│ approved │ └──────┬───────┘ │ promotion (sync or retry job) ▼ ┌──────────────┐ │ promoted │ (terminal — live records exist) └──────────────┘ Track B shortcut: live_capture creates a batch already in promoted — see Track B audit model. ``` **Allowed transitions (Track A):** | From | To | |---|---| | `uploaded` | `in_entry` | | `in_entry` | `pending_verification` | | `pending_verification` | `verified`, `awaiting_clinical_approval`, `rejected` | | `rejected` | `in_entry` | | `verified` | `approved` | | `awaiting_clinical_approval` | `approved`, `rejected` | | `approved` | `promoted` | | `promoted` | *(none — terminal)* | Illegal transitions return `409` with a stable error code. A `promoted` batch cannot return to any earlier state. Corrections require a **new** batch referencing `supersedesBatchId`. ### Track B audit model Track B is **not** a bypass of the batch model — it is a shortcut through the **workflow states**, not the audit unit. Every live-capture submission: 1. Creates a `DigitizationBatch` with `track: live_capture`, `batchType: vitals_sheet` (or appropriate type), `documentRef: "live-capture"`, and a synthetic `documentSha256` derived from clinician + encounter + timestamp (no scan file). 2. Writes `DraftObservation` rows for every entered value (audit trail). 3. Sets `enteredByUserId`, `verifiedByUserId`, and `approvedByUserId` to the attesting clinician (attestation replaces the dual-human gate for that batch only). 4. Inserts live `Observation` rows and outbox events in the **same transaction**, leaving the batch in `promoted` immediately. 5. Emits `DigitizationEvent` entries: `live_capture_attested`, then `promoted`. This keeps digitization history, patient coverage stats, and Prometheus batch metrics consistent across both tracks. --- ## Features --- ### 1. Document Upload and Batch Creation **Description:** Intake clerk scans or uploads a paper record. System stores the file in MinIO, computes SHA-256, creates a batch in `uploaded` state, and writes a `DigitizationEvent`. **Endpoints:** - `POST /api/v1/digitization-batches` — multipart upload: `file` (PDF, JPEG, PNG; max 25 MB), `batchType`, optional `patientId`, optional `track` (default `backfill`) - `GET /api/v1/digitization-batches/:id` — batch detail with document presigned URL (15-minute expiry) - `GET /api/v1/digitization-batches` — filter by `status`, `batchType`, `assignedTo`, `track`; paginated - `PATCH /api/v1/digitization-batches/:id/assign` — assign to entry clerk (Redis lock prevents double-assignment) **Validation:** - Accepted MIME types: `application/pdf`, `image/jpeg`, `image/png` - Reject empty files - **Duplicate detection (when `patientId` is set):** reject if `documentSha256` matches an existing batch for the **same patient** within 24 hours (`409 DUPLICATE_DOCUMENT`) — prevents accidental double-scan of the same chart page - **Cross-patient duplicates:** the same physical form scanned for two different patients is allowed (distinct patients, distinct batches). Operators may still see a warning in the UI if the SHA matches any batch site-wide (informational only in v1) **Concepts practiced:** Object storage for immutable document artifacts, content-addressed deduplication, presigned URLs for secure document viewing without proxying binary through the API. --- ### 2. Draft Data Entry **Description:** Entry clerk views the scan alongside structured form fields. Saves draft patient updates, encounter context, and observations. Batch moves to `in_entry` on first save. **Endpoints:** - `GET /api/v1/digitization-batches/:id/draft` — full draft payload: patient fields, encounter, observations[] - `PUT /api/v1/digitization-batches/:id/draft/patient` — upsert draft patient demographics or updates - `PUT /api/v1/digitization-batches/:id/draft/encounter` — upsert draft encounter fields - `POST /api/v1/digitization-batches/:id/draft/observations` — add observation row - `PUT /api/v1/digitization-batches/:id/draft/observations/:obsId` — edit observation - `DELETE /api/v1/digitization-batches/:id/draft/observations/:obsId` — remove observation from draft - `POST /api/v1/digitization-batches/:id/submit-for-verification` — validates completeness, transitions to `pending_verification` **Required fields before submit (by batch type):** | batchType | Required draft content | |---|---| | `patient_registration` | Full name, date of birth, sex; MRN generated on approval if new | | `encounter_summary` | Linked patient; encounter with admission date, department, admission reason | | `vitals_sheet` | Linked patient, encounter context, ≥1 observation with `recordedAt` | | `lab_results` | Linked patient, encounter, ≥1 lab observation code, `recordedAt` | | `medication_list` | Linked patient; `medicationsJson` with ≥1 entry **or** explicit `noActiveMedications: true` | | `allergy_update` | Linked patient, allergies list (may be empty with explicit `noKnownAllergies: true`) | | `mixed` | Linked patient, encounter context, and **at least one** of: ≥1 observation with `recordedAt`, or complete encounter summary (admission date + department + admission reason) | **Concurrent draft editing:** Redis assignment lock prevents double-assignment at intake (`PATCH .../assign`). Draft saves require the acting user to match `enteredByUserId` (or hold the `Administrator` role); otherwise `409 BATCH_NOT_ASSIGNED`. v1 does not use field-level optimistic locking — within an assigned session, last write wins. Administrators may reassign via work-queue tools, which clears the Redis lock and updates `enteredByUserId`. **Plausibility validation:** Reuse VigilCareClinical observation plausibility ranges at draft save time. Out-of-range values return `422 OBSERVATION_OUT_OF_PLAUSIBLE_RANGE` with the same error shape — catch decimal errors (5.2 vs 52) before verification. **UI requirement (digitization workstation):** Side-by-side layout — scan viewer (zoom, pan, rotate) on the left; structured entry form on the right. Field-level "verified" checkbox for verifier pass (stored in draft metadata, not live record). **Concepts practiced:** Draft vs live data separation, optimistic UI with server validation, batch-type-driven validation rules. --- ### 3. Verification and Rejection **Description:** Verifier reviews entry against the scan. Can approve field-by-field or reject the entire batch with a mandatory reason. Verifier cannot be the entry clerk. On verify pass: status → `verified` or `awaiting_clinical_approval` per [site configuration](#site-configuration). On verify fail: status → `rejected` (returns to entry queue). **Endpoints:** - `GET /api/v1/work-queue/verification` — batches in `pending_verification`, sorted by `submittedAt ASC` - `GET /api/v1/work-queue/clinical-approval` — batches in `awaiting_clinical_approval`, sorted by `submittedAt ASC` - `POST /api/v1/digitization-batches/:id/verify` — body: `{ "fieldChecks": [{ "fieldPath": "observations[0].value", "passed": true }], "passed": true }` - `POST /api/v1/digitization-batches/:id/reject` — body: `{ "reason": "..." }` → status `rejected`, notifies entry clerk Reject is allowed from `pending_verification` (verifier; separation of duties applies) or `awaiting_clinical_approval` (clinical approver; separation of duties does **not** apply — approver may not have been the entry clerk by role design). **Concepts practiced:** Separation of duties enforcement, work-queue patterns, structured rejection loops. --- ### 4. Approval and Promotion to VigilCareClinical **Description:** Final approval triggers an atomic promotion: draft records become live Patient / Encounter / Observation rows in VigilCareClinical (same database in integrated deployment, or HTTP calls to VigilCareClinical API in split deployment). Batch status → `promoted`. **Endpoints:** - `POST /api/v1/digitization-batches/:id/approve` — requires `verified` or `awaiting_clinical_approval`; restricted to `ClinicalApprover` or `Administrator`; Idempotency-Key supported - `GET /api/v1/digitization-batches/:id/promotion-result` — live IDs created: `patientId`, `encounterId`, `observationIds[]` **Promotion transaction sequence:** 1. Begin database transaction (or saga with compensating actions in split deployment) 2. Create or update `Patient` in VigilCareClinical (assign MRN if new) 3. Create or match `Encounter` (open as `active` or `discharged` based on draft) 4. Insert each `DraftObservation` as live `Observation` with `source: digitization_backfill` or `source: live_capture` 5. Write outbox events for each observation (Kafka pipeline activates **only if** `enableRetroactiveAlerts` or `track: live_capture`) 6. Update batch status → `promoted`, set `promotedAt`, write `DigitizationEvent` 7. Commit **Default alert behavior:** | track | enableRetroactiveAlerts | Alert pipeline | |---|---|---| | `backfill` | `false` (default) | Observations stored; no alert evaluation | | `backfill` | `true` | Full VigilCareClinical alert path | | `live_capture` | n/a | Full alert path immediately | **Concepts practiced:** Outbox pattern for promotion side effects, idempotent promotion, configurable clinical safety policy for historical data. --- ### 5. Corrections and Supersession **Description:** Approved records are not silently edited. A correction creates a new batch with `supersedesBatchId` pointing to the original. Correction goes through the full entry → verify → approve cycle. On promotion, erroneous live observations are marked `superseded` (append-only — not deleted). **Endpoints:** - `POST /api/v1/digitization-batches` — body includes optional `supersedesBatchId` - `GET /api/v1/patients/:id/digitization-history` — all batches for a patient with promotion status **Concepts practiced:** Immutable clinical audit trail, correction-as-new-batch pattern (same as national digital services land registry approach). --- ### 6. Live Capture (Track B) **Description:** Credentialed clinician enters vitals or labs at point of care on a tablet. No verification queue. Each submission creates an audit `DigitizationBatch` (see [Track B audit model](#track-b-audit-model)), writes draft observations for traceability, and promotes live observations synchronously with full alert evaluation. **Endpoints:** - `POST /api/v1/live-capture/encounters/:encounterId/observations` — body: observation fields + `clinicianAttestation: true` + password re-confirm or PIN - `POST /api/v1/live-capture/encounters` — open encounter + initial vitals in one request (outpatient workflow) **Validation:** Requires `Role: Clinician`. Creates batch + draft observations + live observations in one transaction; batch lands in `promoted` immediately. Returns VigilCareClinical observation IDs and any synchronous critical alerts generated. **Concepts practiced:** Lighter gate for real-time care vs heavy gate for backfill; same underlying observation schema. --- ### 7. Patient Registry (Draft and Live) **Description:** Search and link batches to patients. Support new patient registration through the draft pipeline. **Endpoints:** - `GET /api/v1/patients/search?q=` — search live VigilCareClinical patients by MRN or name - `POST /api/v1/patients/draft` — create draft-only patient (no MRN until approval) - `GET /api/v1/patients/:id/summary` — live patient + pending draft batches + digitization coverage stats **Digitization coverage stat:** `approvedBatchCount / estimatedTotalBatches` — optional manual `estimatedChartSections` per patient for progress tracking. --- ### 8. Work Queues and Operational Dashboard **Description:** Supervisors monitor backlog, assignment, and throughput. **Endpoints:** - `GET /api/v1/work-queue/entry` — batches awaiting or in entry - `GET /api/v1/work-queue/clinical-approval` — batches awaiting physician sign-off after verification - `GET /api/v1/work-queue/overview` — counts by status, average time-in-queue, reject rate - `GET /api/v1/digitization-batches/:id/events` — cursor-paginated audit trail **Metrics (Prometheus):** - `digitization_batches_by_status` (gauge) - `digitization_promotion_duration_seconds` (histogram) - `digitization_rejection_total` (counter) - `digitization_queue_age_seconds` (gauge — oldest pending verification) --- ### 9. Authentication and Audit **Description:** JWT auth with role claims. Every state transition writes a `DigitizationEvent`. Document access logged. **Endpoints:** - `POST /api/v1/auth/login` - `GET /api/v1/auth/me` **Audit requirements:** - Who viewed a scan and when - Who changed which draft field (field-level diff in event metadata on save) - Who approved promotion and which live record IDs were created --- ## Digitization Workstation UI Separate Vue 3 SPA or Razor-hosted frontend. Four primary views: | View | User | Purpose | |---|---|---| | **Intake** | Intake clerk | Upload, assign patient, print MRN label | | **Entry** | Data entry clerk | Side-by-side scan + form | | **Verification** | Verifier | Side-by-side with field checkboxes, approve/reject | | **Queue dashboard** | Supervisor | Backlog, reject rate, clerk throughput | Not a full EMR UI. No clinical alerting views — those remain in VigilCareClinical's ward dashboard. --- ## Data Storage | Store | Purpose | |---|---| | **PostgreSQL** | Draft tables, batch metadata, digitization events, user/role data. Shares database with VigilCareClinical in integrated deployment. | | **MinIO** | Scanned PDFs and images; content-addressed keys `scans/{year}/{month}/{batchId}/{sha256}.pdf` | | **Redis** | Batch assignment locks (`SET batch:assign:{id} NX EX 3600`). Work-queue counters are derived from PostgreSQL queries in v1 (no Redis counter cache required) | --- ## Integration Contract with VigilCareClinical **v1 deployment:** integrated PostgreSQL — promotion writes directly to VigilCareClinical tables in a single transaction. Split deployment (Records service calling VigilCareClinical REST + `PromotionRetryService`) remains supported as an alternate topology; see Phase 8. On promotion, VigilCare Records writes to the same tables VigilCareClinical owns: | Draft entity | Live entity | Notes | |---|---|---| | `DraftPatient` | `patients` | MRN generated via existing `GenerateMrnAsync` logic | | `DraftEncounter` | `encounters` | Status from draft; `roomBed`, `admissionReason` mapped | | `DraftObservation` | `observations` | Same `observationCode`, `value`, `unit`, `recordedAt`; adds `metadata.source` | Observation codes must match VigilCareClinical's catalog: `HEART_RATE`, `TEMP_C`, `BP_SYSTOLIC`, `BP_DIASTOLIC`, `RESP_RATE`, `SPO2`, `POTASSIUM_MEQ_L`, `GLUCOSE_MG_DL`, `WBC_K_UL`, `LACTATE_MMOL_L`, etc. If VigilCareClinical is unreachable in split deployment, batch remains `approved` and a background promotion retry job runs with exponential backoff. Batch does not revert to draft. --- ## Acceptance Criteria | Criterion | Verification | |---|---| | Separation of duties | Entry clerk cannot verify or approve own batch — `409` | | Draft isolation | Draft observations never appear in VigilCareClinical alert queries or ward dashboard | | Promotion atomicity | Partial promotion (patient created, observations failed) never committed | | Idempotent approval | Duplicate `Idempotency-Key` on approve returns same result, no duplicate observations | | Rejection loop | Rejected batch returns to entry; resubmit reaches verification again | | Backfill alert suppression | Default backfill promotion creates observations with zero alerts | | Live capture alert path | Track B critical potassium triggers synchronous alert in VigilCareClinical | | Audit completeness | Every status transition has a `DigitizationEvent` with actor and timestamp | | Document immutability | Scan object in MinIO not modified or deleted on reject/correct | | Plausibility at draft | Value 520 for potassium rejected at draft save, not at promotion | | Clinical approval routing | `vitals_sheet` verify-pass → `awaiting_clinical_approval` when site config requires it | | Track B audit batch | Live capture creates `DigitizationBatch` in `promoted` with draft observations and events | | Draft assignment guard | Unassigned clerk receives `409 BATCH_NOT_ASSIGNED` on draft save | | Cross-patient duplicate scan | Same SHA for two different patients allowed; same patient within 24h rejected | --- ## Build Order | Phase | Focus | |---|---| | 1 | Schema, auth, roles, batch CRUD, MinIO upload, status machine | | 2 | Draft entry API (patient, encounter, observations), submit-for-verification | | 3 | Verification, rejection, separation of duties, work queues | | 4 | Promotion service → VigilCareClinical live tables, outbox integration, idempotency | | 5 | Corrections / supersession, patient digitization history | | 6 | Track B live capture with clinician attestation | | 7 | Digitization workstation UI (entry + verification side-by-side) | | 8 | Prometheus metrics, supervisor dashboard, promotion retry job | | 9 | Seed data, E2E verification script, clinical scenario documentation | --- ## Step-by-Step Guide Complete phases in order. Promotion (Phase 4) must not be built until the draft state machine and separation of duties are correct — debugging promotion bugs alongside workflow bugs is painful. --- ### Phase 1 — Schema, Upload, and Status Machine **What to do:** 1. Create `digitization_batches`, `draft_patients`, `draft_encounters`, `draft_observations`, `digitization_events` tables. 2. Implement batch status machine with explicit transition matrix; illegal transitions → `409`. 3. Wire MinIO upload with SHA-256 computation and presigned GET URLs. 4. Seed two users per role (entry, verifier, clinician) for separation-of-duties testing. 5. Implement JWT auth with role claims. **Why:** The status machine is the backbone. Getting transitions wrong means drafts leak into live data or approved batches get re-edited. Test every illegal transition before building entry forms. --- ### Phase 2 — Draft Entry **What to do:** 1. Implement draft CRUD endpoints and batch-type validation on submit. 2. Port plausibility validator from VigilCareClinical (shared library or duplicated with comment linking source). 3. Write integration tests: incomplete vitals batch cannot submit; plausible observations save; implausible rejected. **Why:** Plausibility at draft save prevents the most common digitization error — decimal misplacement — from ever reaching verification. --- ### Phase 3 — Verification and Rejection **What to do:** 1. Implement verification and rejection endpoints with separation-of-duties checks. 2. Build work-queue endpoints sorted by `submittedAt`. 3. Test: entry clerk A submits → verifier A attempts verify → `409`; verifier B succeeds. **Why:** Separation of duties is a clinical trust requirement, not a nice-to-have. Enforce in the service layer from day one. --- ### Phase 4 — Promotion **What to do:** 1. Implement approval endpoint and promotion transaction against VigilCareClinical tables. 2. Wire outbox events for observations where alerting is enabled. 3. Implement `enableRetroactiveAlerts` flag — default `false`. 4. Test full path: upload → entry → verify → approve → observations in live table → zero alerts for backfill default. 5. Test idempotency: approve twice with same key → one set of live rows. **Why:** This phase connects Records to Clinical. Run against a VigilCareClinical Phase 2 environment where synchronous critical alerting exists, and verify Track B vs Track A behavior explicitly. --- ### Phase 5 — Corrections **What to do:** 1. Add `supersedesBatchId` and supersession logic on promotion. 2. Mark superseded live observations inactive (soft flag, not delete). 3. Test: wrong potassium promoted → correction batch → new value live, old value superseded in audit. --- ### Phase 6 — Live Capture (Track B) **What to do:** 1. Implement clinician attestation endpoint bypassing verification. 2. Test critical value entered via live capture → alert fires before response returns. --- ### Phases 7–9 — UI, Observability, Documentation Build the side-by-side workstation UI. Add Prometheus metrics and a supervisor queue view. Write `docs/digitization-workstation-guide.md` and an E2E script `./scripts/run-vigilcare-records-verification.sh`. --- ## Deployment Notes (Small Island Context) - **Single-site tenant:** One hospital or health district per deployment. No cross-island federation in v1. - **Offline intake (optional extension):** Scan and draft entry on a local server; promotion queued until uplink to central VigilCareClinical returns. Aligns with VigilCareClinical climate-resilience Phases 20–24 — Records gateway can share the same ward-first sync pattern. - **Staffing reality:** Same person may hold entry and intake roles, but **never** entry and verifier on the same batch. System enforces this even when staff roster is small. - **Paper originals:** Scanned document is the working copy; physical chart remains legal original until jurisdiction defines otherwise. README must state this explicitly. --- ## Success Metrics (Operational) | Metric | Target (6 months post go-live) | |---|---| | Charts with ≥1 approved batch | 80% of active patients | | Average verification turnaround | < 24 hours | | Rejection rate | < 15% (indicates entry quality or scan quality issues if higher) | | Live capture share of new observations | Trending up month-over-month | | VigilCareClinical alerts from live capture | ≥1 demonstrated critical-value workflow per site | --- ## Architecture Decisions | Decision | Choice (v1) | Rationale | |---|---|---| | **Integrated DB vs split API** | Integrated PostgreSQL, shared instance, separate schemas | Atomic promotion in one transaction; simpler to build and demo; split path documented for production hardening | | **Clinical approver routing** | Site config map (see [Site configuration](#site-configuration)); default requires physician queue for encounter/vitals/labs/medications/mixed | High-stakes chart sections get an extra gate; registration and allergy-only updates stay verifier → approver | | **Retroactive alerts** | `enableRetroactiveAlerts: false` default on backfill | Prevents alert storms from historical critical values; opt-in per batch for facilities that accept the risk | | **MRN issuance** | Locally generated MRN via VigilCareClinical `GenerateMrnAsync` | National health ID integration deferred per deployment | ## Open Questions (per deployment) 1. **Retroactive alerts policy:** Will the Ministry of Health allow backfilled critical values to trigger pages, or is storage-only the mandated default? 2. **MRN issuance:** National health ID integration vs locally generated MRN when a national registry becomes available? 3. **Split deployment:** When does the site require Records and Clinical in separate services (saga + retry) vs integrated database? --- ## References - [vigilcare-clinical-api-prd.md](vigilcare-clinical-api-prd.md) — downstream alerting and observation ingest - [Completed/VigilCareClinicalAPI/VigilCare-Partner-Brief.md](Completed/VigilCareClinicalAPI/VigilCare-Partner-Brief.md) — clinical positioning and scope boundaries - [Completed/national-digital-services-architecture.md](Completed/national-digital-services-architecture.md) — scan-and-verify pattern for paper-to-digital government services