Pentla - OT World Leipzig

Organisation

36 ready 20 blocked 0 not started 56 total

#1 New Custom Manufacturer Onboarding End-to-End 33/48 69%

Step 1 — Platform Admin opens organisation management and starts creating a new organisation

READY BE FE AC-ORG-001 [CPO] Required fields enforced: organisation type, legal name, country, primary contact email

READY BE FE AC-ORG-002 [CPO] All 4 in-scope organisation types are selectable: Custom Manufacturer, Central Fab, Integrated Clinic-Fab, Clinic

READY BE FE AC-ORG-003 [CPO] Select "Custom-Made Device Manufacturer" as the type

Step 2 — Platform Admin creates the first unit (Production Facility)

READY BE AC-ORG-004 [CPO] Unit requires: name, type, country, address, data residency region, and applicable regulations

READY BE FE AC-ORG-005 [CPO] All 4 unit types are available: Clinic, Production Facility, Office, Warehouse

READY FE AC-ORG-006 [CO] Regulatory configuration and data residency region are auto-suggested based on unit country — e.g., Germany suggests MDR and GDPR with EU data residency

READY FE AC-ORG-007 [CPO] Data residency region is set at the unit level, not the organisation level. The org admin can adjust the auto-suggested region

READY BE AC-ORG-008 [CPO] Creating this first unit satisfies the requirement that an organisation must have at least one active unit

Step 3 — Platform Admin creates the first Org Admin user using the primary contact email

READY BE FE AC-ORG-009 [CPO] The first user is automatically assigned the Org Admin role

READY BE AC-ORG-010 [CPO] Invitation email is sent to the primary contact email

BLOCKED INFRA AC-ORG-011 [CPO] Invitation email includes or links to a privacy notice informing the staff user about data processing, lawful basis, retention, and their GDPR rights (Articles 13 and 15-22)

Step 4 — Platform Admin sets verification status and activates the organisation

READY BE FE AC-ORG-012 [CPO] Verification is a platform admin attribute on the organisation record — not a gate to access

READY BE FE AC-ORG-013 [CPO] Organisation transitions from Setup to Active

READY BE AC-ORG-014 [CPO] Org Admin cannot self-verify

Step 5 — Org Admin accepts the invitation, sets password, and logs in

BLOCKED INFRA AC-ORG-015 [CPO] Org Admin can set their password and access the platform once the organisation is Active

BLOCKED BE AC-ORG-016 [CPO] Platform loads with the Org Admin's primary unit as default context

BLOCKED FE AC-ORG-017 [CPO] On first login, Org Admin sees a welcome state with prompts to complete optional profile fields (trading name, addresses, logo) and invite team members. Incomplete fields are surfaced prominently but do not block platform use

Step 6 — Org Admin completes the organisation profile

READY BE FE AC-ORG-018 [CPO] Optional fields are editable: trading name, tax identifier, registration number, addresses, phone, website, logo

READY FE AC-ORG-019 [CPO] Organisation type is displayed but not editable by the Org Admin. A "Contact Support" action is available, pre-filled with the current type and reason for change request

BLOCKED BE AC-ORG-020 [CPO] Enabled areas are visible but changes require contacting sales

READY BE FE AC-ORG-021 [CPO] Changing the legal name saves immediately (no pending state). Org Admin sees confirmation that the change was saved and a note that Pentla may follow up. The platform admin is notified for potential re-verification. No access interruption

Step 7 — Org Admin configures organisation-wide preferences

READY BE FE AC-ORG-022 [CPO] All preferences configurable: measurement system, date format, time format, timezone, currency, language, locale

READY BE FE AC-ORG-023 [CO] Measurement system selection (metric vs imperial) is present and clearly labelled — this setting will propagate to all clinical measurement capture

Step 8 — Org Admin opens settings and sees sections appropriate for Custom Manufacturer

READY FE AC-ORG-024 [CPO] Visible sections: Organisation Profile, Units, Users and Roles, Preferences, Patient Settings, Production Settings, Notifications, Subscription and Billing

READY AC-ORG-025 [CPO] No sections are shown that do not apply to this organisation type

Step 9 — Org Admin invites team members: a CPO, a Production Manager, and a Technician

READY BE FE AC-ORG-026 [CPO] Role picker shows only roles available for Custom Manufacturer

READY BE FE AC-ORG-027 [CO] Clinician (CPO) role is available at Custom Manufacturer — correct, as CPOs at custom manufacturers assess patients and configure devices

READY BE FE AC-ORG-028 [CO] Physician role is NOT available at Custom Manufacturer — correct, as custom manufacturers receive prescriptions from external prescribers, they do not employ them

BLOCKED BE AC-ORG-029 [CPO] Each invited user must have at least one role assigned

BLOCKED INFRA AC-ORG-030 [CPO] Each invited user must be assigned to at least one unit

BLOCKED INFRA AC-ORG-031 [CPO] Each invited user must have exactly one primary unit

READY BE AC-ORG-032 [CPO] Org Admin can assign all unit-role pairs in a single invitation flow

READY BE FE AC-ORG-033 [CPO] Platform Admin role is not available in the role picker

Step 10 — Org Admin enables notification preferences

BLOCKED FE INFRA AC-ORG-034 [CPO] Notification categories are visible: Orders, Production, Compliance, Billing, System

BLOCKED FE INFRA AC-ORG-035 [CPO] Notification preferences are per-user, not org-wide

BLOCKED FE INFRA AC-ORG-036 [CPO] Notification preferences are accessible from the user's own profile/account settings, not from the organisation settings area

BLOCKED INFRA AC-ORG-037 [CPO] Notification category defaults are role-aware — categories outside the user's area access default to OFF

Edge Cases

READY BE FE AC-ORG-038 [CPO] Attempting to create an organisation with a primary contact email already in use on the platform is rejected

READY BE FE AC-ORG-039 [CPO] Inviting a user with an email already in use on the platform is rejected with a clear error

READY AC-ORG-040 [CO] Technician logs in and sees no patient PII anywhere — only pseudonymised references and fabrication data from the first moment they access the platform

READY BE AC-ORG-041 [CPO] Data retention minimum cannot be set below 10 years for organisations with MDR-applicable units

READY BE AC-ORG-042 [CPO] While the organisation is in Setup state (before activation), no patients or orders can be created — full platform access begins at Active

READY BE AC-ORG-043 [CPO] A user clicks an invitation link after 7 days. They see a clear error explaining the invitation has expired and should contact their Org Admin

READY BE AC-ORG-044 [CPO] Org Admin resends an invitation from user management — resending invalidates any previous invitation link

READY AC-ORG-045 [CPO] Attempting to submit the first order for a manufacturer org that has no registered or business address on file is blocked with a clear error citing Annex XIII requirements

BLOCKED FE AC-ORG-046 [CPO] When a manufacturer organisation has no registered or business address on file, the dashboard and order creation surface a prominent prompt explaining the Annex XIII address requirement and linking to the organisation profile

BLOCKED DEP AC-ORG-047 [CO] If a CPO reaches order submission without an address on file, the order can be saved as a draft — configuration work is not lost

BLOCKED BE AC-ORG-048 [CPO] If a user accepts an invitation while the organisation is still in Setup state, they can set their password but see a message explaining that the organisation is being set up and full platform access will begin once the Platform Admin activates it

#7 CPO Clinical Workflow — Cross-Area Role Verification 3/8 38%

Step 1 — CPO opens the Patients area

READY FE AC-ORG-180 [CO] CPO can view patient records and open a specific patient

Step 2 — CPO opens an assessment for that patient

BLOCKED DEP AC-ORG-181 [CO] CPO can view and create clinical assessments — measurements, contraindications, clinical reasoning

Step 3 — CPO navigates to Orders and opens the device configurator

BLOCKED DEP AC-ORG-182 [CO] CPO can configure a device by selecting components from the component catalog

READY FE AC-ORG-183 [CO] CPO can submit the order

Step 4 — CPO navigates to Production to check an order at a quality checkpoint

BLOCKED DEP AC-ORG-184 [CO] CPO can view production status for orders they submitted

BLOCKED DEP AC-ORG-185 [CO] CPO can approve or reject at a quality gate checkpoint (e.g., test socket approval)

READY FE AC-ORG-186 [CO] CPO cannot assign work, reorder the queue, or perform production management actions

Step 5 — CPO navigates back to Orders to perform a fitting

BLOCKED DEP AC-ORG-187 [CO] CPO can record fitting notes and delivery

Patients

55 ready 32 blocked 79 not started 166 total

#0 Patient Creation Scenarios 4/30 13%

Prerequisites

BLOCKED BE AC-PAT-016 [CPO] Patient creation requires the organisation to be in Active state — blocked with explanatory message when organisation is in Setup or Terminated state

NOT STARTED AC-PAT-321 [CPO] Patient creation requires assignment to an active unit — blocked if no active units exist

NOT STARTED AC-PAT-322 [CPO] New patient's primary unit is auto-assigned from the user's active unit context *(AC-ORG-072, AC-ORG-073)* — no manual unit selection in the creation form. If a CPO needs to create a patient for a different unit, they switch unit context first (one action in the persistent header control), then create the patient

Mandatory and progressive fields

READY BE AC-PAT-001 [CPO] Patient record can be created with minimum fields: first name, last name, date of birth, phone number, email address

NOT STARTED AC-PAT-323 [CPO] Insurance information (health insurance card number and insurance provider — e.g., KZZ number and ZZZS in Slovenia) is required when a Reimbursement Prescription (naročilnica) is created for the order — the system checks payer validity before the CPO invests in fabrication. For self-paying patients (Path D), no Reimbursement Prescription is needed — self-pay is marked explicitly

NOT STARTED AC-PAT-324 [CPO] Shipping address is required before device delivery — prompted at delivery, not at creation

Draft orders without Clinical Prescription

NOT STARTED AC-PAT-325 [CPO] A CPO can proceed from assessment to device configuration before the Clinical Prescription (izvid) is in the system. The order is created silently — the CPO begins clinical work without an explicit "create order" step

NOT STARTED AC-PAT-326 [CPO] The draft order collects assessment data, measurements, scans, and device configuration — all before the Clinical Prescription arrives

NOT STARTED AC-PAT-327 [CPO] The order cannot be confirmed/submitted for production until a valid Clinical Prescription (izvid) is linked (for MDR-regulated orders). The Clinical Prescription is a submission gate, not a creation prerequisite. For insured patients, a Reimbursement Prescription (naročilnica) is additionally required before fabrication can begin

NOT STARTED AC-PAT-328 [CPO] When an order is cancelled, the linked Clinical Prescription (izvid) is released and can be linked to a different order for the same patient. The Reimbursement Prescription (naročilnica), if any, is voided and must be reissued for a new order

NOT STARTED AC-PAT-206 [BOTH] When a Clinical Prescription is uploaded for a patient with a draft order, the system auto-matches the prescription to the draft order if the match is unambiguous (one draft per patient and device type). If multiple drafts exist, the system prompts the admin or CPO to select which order the prescription covers — one click

NOT STARTED AC-PAT-207 [BOTH] When a prescription is auto-matched to a draft order, the CPO who owns the draft is notified that the prescription has arrived and the order is ready to submit. The CPO re-enters the draft via the notification — not by browsing the Orders area

READY AC-PAT-002 [CPO] Patient reference number (e.g., `JoSm-00142`) is generated once per patient at first order creation — not at patient creation. It is a stable, human-readable identifier that serves as the production pseudonym, allowing the fabrication team to identify the patient's devices without seeing their full name. Consultation-only patients do not receive one. The format is configurable per organisation. For cross-org orders, the patient reference serves as the pseudonymised identifier visible to the receiving organisation (see GLOSSARY.md — Patient Reference Number, Pseudonym)

READY AC-PAT-003 [CPO] Duplicate detection fires on name + DOB match — shows potential matches but does not block creation

READY BE AC-PAT-004 [CPO] Patient status starts as Active when the record is created

Path A and B — CPO in the field

NOT STARTED AC-PAT-329 [CO] CPO can create a patient record and capture preliminary clinical notes, measurements, and photos in the field

NOT STARTED AC-PAT-330 [CPO] When the patient later visits the clinic, admin can add insurance and other administrative data to the existing record

Path C and D — Admin creates, CPO continues

NOT STARTED AC-PAT-331 [CPO] Admin can create a patient record with demographics and contact details. The CPO later opens the same record to add clinical data

NOT STARTED AC-PAT-332 [CPO] Admin can enter the Clinical Prescription (izvid) and/or Reimbursement Prescription (naročilnica) at reception if the patient brings them

Path E and F — CPO creates directly in clinic

NOT STARTED AC-PAT-333 [CO] CPO can create the patient record and proceed directly to clinical work without admin involvement

Transparency and consent per path

NOT STARTED AC-PAT-334 [CPO] Both Admin and CPO roles can record the patient information acknowledgment. The record captures WHO informed the patient

NOT STARTED AC-PAT-335 [CPO] The signed patient information form (patient information acknowledgment + non-clinical consents) must be scanned and uploaded to the patient record as a classified attachment type (distinct from clinical images and scans — aids audit retrieval and is excluded from cross-org sharing)

NOT STARTED AC-PAT-336 [CPO] Patient information is a soft prompt, not a hard block — clinical work can proceed if the patient information record hasn't been completed yet, but the system shows a persistent reminder

NOT STARTED AC-PAT-337 [CPO] If a patient refuses to sign the form, the CPO records "patient was verbally informed, declined to sign" — the GDPR transparency obligation is met by informing the patient, not by obtaining their signature. Clinical work proceeds regardless

NOT STARTED AC-PAT-338 [CPO] Non-clinical consent checkboxes on the form must default to unchecked — pre-ticked boxes are not valid consent under GDPR (Recital 32, CJEU Planet49)

NOT STARTED AC-PAT-339 [CPO] Non-clinical consent (marketing, research) can be captured at any point — reception, during assessment, or at a later visit. It never blocks clinical actions

NOT STARTED AC-PAT-340 [CPO] When a patient arrives at reception, the admin can check in Pentla whether the patient information and consent form was signed digitally before the appointment. If signed → proceed to appointment. If not → admin gives paper form at reception

NOT STARTED AC-PAT-341 [CPO] The patient information record distinguishes how it was signed: pre-appointment (digital), at reception (paper), or during visit (paper or verbal). All three satisfy GDPR transparency equally

Edge Cases

NOT STARTED AC-PAT-013 [CPO] Concurrent edit: if admin and CPO are both editing the same patient record, the second to save is informed and must refresh

NOT STARTED AC-PAT-342 [CPO] Duplicate detection works the same regardless of who creates the record (admin or CPO) and where (field or clinic)

#1 New AFO Patient — End-to-End 23/47 49%

Step 2 — Verify patient information and consent

BLOCKED BE AC-PAT-025 [CPO] Outstanding patient information items are visible on the patient record summary — none should remain before clinical work begins

READY BE AC-PAT-020 [CPO] Patient information record present with: timestamp, method, staff member identity

BLOCKED BE AC-PAT-021 [CO] Patient information record is informational — not a consent gate. Clinical processing continues under the treatment lawful basis (Article 9(2)(h))

Step 3 — Enter Clinical Prescription (izvid) and Reimbursement Prescription (naročilnica)

READY BE AC-PAT-030 [CPO] Clinical Prescription (izvid) requires: prescriber name, qualification, licence number, institution, diagnosis (with ICD code), device authorised, laterality (left/right/bilateral — shown for lateralised devices; hidden for midline devices such as cranial helmets and spinal braces), prescription date, expiration date, uploaded document. Prescriptions can be created by users with prescribing authority: Physician role (always), or Clinician role where the unit's jurisdiction authorises CPO prescribing *(BR-ORG-029)*. Admin can record prescriber details and upload prescription documents from paper prescriptions — this is data entry of an external prescription, not the clinical act of prescribing

NOT STARTED AC-PAT-343 [CPO] Reimbursement Prescription (naročilnica) requires: health insurance card number, insurance provider, cost estimate, reference to Clinical Prescription, uploaded document. Only needed for insured patients (Paths A, B, C)

READY BE AC-PAT-033 [CPO] Previously entered prescribers are suggested on name entry

BLOCKED FE AC-PAT-035 [CO] K-level field does NOT appear for an AFO Clinical Prescription — K-level is prosthetic-specific

READY BE AC-PAT-032 [CPO] Clinical Prescriptions are immutable after creation — corrections supersede the original, which is preserved in the audit trail

Step 4 — Conduct Initial Assessment

READY AC-PAT-040 [CPO] System verifies the patient record is in Active state before an assessment can be started — if the patient is Inactive, reactivation is prompted

READY BE AC-PAT-042 [CPO] Assessment starts in Draft status

READY AC-PAT-045 [CO] For returning patients, medical history is pre-populated from the patient record and editable

NOT STARTED AC-PAT-344 [CO] Each measurement records: type, anatomical location, laterality (left/right/N/A), value, unit (per org settings), and condition (weight-bearing/non-weight-bearing/supine)

NOT STARTED AC-PAT-345 [CO] For returning patients, previous measurements are visible alongside new measurements

READY AC-PAT-050 [CO] Clinical reasoning fields present: assessment summary, treatment goals, device recommendation, special instructions

NOT STARTED AC-PAT-346 [CO] Empty clinical reasoning triggers a warning but does NOT block completion

Step 5 — Mark a required field as clinically unavailable

READY AC-PAT-049 [CO] CPO can mark a required field as "clinically unavailable" with mandatory free-text justification

NOT STARTED AC-PAT-347 [CO] The justification becomes part of the assessment record

NOT STARTED AC-PAT-348 [CPO] Assessment with documented field unavailability is valid for order creation

Step 6 — Upload scan files and clinical images

BLOCKED FE AC-PAT-102 [CPO] Scan files (STL, OBJ, PLY, STEP) can be uploaded with metadata: body region, laterality, description

BLOCKED FE AC-PAT-103 [CPO] Clinical images (JPG, PNG, HEIC) can be uploaded

READY AC-PAT-104 [CPO] File integrity verified via checksum on upload

READY AC-PAT-105 [CPO] File size limits enforced per type (500 MB scan, 50 MB image)

BLOCKED BE AC-PAT-109 [CPO] If no patient information record exists, the system prompts — but does not block upload

Step 7 — Complete assessment and create order

READY BE AC-PAT-041 [CO] Minimum fields enforced for Initial Assessment completion: weight, height, at least one measurement, contraindication review completed (either individual category review or a single 'no contraindications identified' confirmation covering all categories)

READY BE AC-PAT-043 [CPO] On completion, system records: CPO identity and completion timestamp

READY BE AC-PAT-034 [CPO] Clinical Prescription (izvid) validity checked at order submission (not draft creation) — must be active, non-expired. For insured patients, Reimbursement Prescription (naročilnica) must also be approved before fabrication begins. Draft orders can exist without either document per AC-PAT-325

READY AC-PAT-100 [CPO] Attachments linked to the order as references, not copies

Step 8 — Trial Fitting after fabrication

READY BE AC-PAT-063 [CO] Trial Fitting assessment can be created linked to the order

NOT STARTED AC-PAT-349 [CO] Clinical Prescription is inherited from the order — not re-verified at each visit

NOT STARTED AC-PAT-350 [CO] Iteration outcome field present with device-appropriate labels: Proceed to finishing / Rebuild / Adjust and refit / Discontinue (device approach not viable — requires clinical justification, cancels the order)

READY BE AC-PAT-051 [CO] Any device adjustments recorded as distinct structured entries

READY BE AC-PAT-052 [CPO] Adjustment records cannot be edited after creation — append-only. Soft delete for errors, original preserved

Step 9 — Device Delivery

READY AC-PAT-064 [CPO] Device Delivery assessment created with delivery confirmation

NOT STARTED AC-PAT-351 [CO] CPO performs delivery examination: fit verification, alignment check, skin check, functional test, patient/caregiver education (donning/doffing, wear schedule, skin care), delivery checklist (all components present, device matches configuration)

BLOCKED BE AC-PAT-055 [CO] Clinician-rated device outcomes captured:

BLOCKED BE AC-PAT-120 [BOTH] Annex XIII Section 1 statement generated at fitting/delivery — frozen after generation

Step 10 — Post-delivery Follow-Up (2–4 weeks later)

READY AC-PAT-069 [CO] Follow-Up assessment can be created linked to the order (Slovenian: Kontrola po prevzemu)

NOT STARTED AC-PAT-352 [CO] Follow-Up does not require a prescription

NOT STARTED AC-PAT-353 [CO] Follow-Ups are numbered sequentially (Follow-Up 1, 2, 3...)

NOT STARTED AC-PAT-354 [CO] CPO performs follow-up examination: device fit, skin condition under device, wear pattern (pressure marks, redness), functional performance, alignment

READY BE AC-PAT-051 [CO] Device adjustments can be recorded at follow-up visits (using IN-PAT-008 fields)

BLOCKED BE AC-PAT-055 [CO] Clinician-rated device outcomes captured at follow-up

BLOCKED BE AC-PAT-054 [CO] CPO indicates next steps after the visit

Edge Cases

READY AC-PAT-070 [CO] Bilateral AFO: single assessment with laterality-specific measurements → single bilateral order

NOT STARTED AC-PAT-355 [CPO] Clinical Prescription near expiration: system warns during assessment if it expires within 30 days

NOT STARTED AC-PAT-356 [CPO] Clinical Prescription expires while assessment is in Draft: completion OK, but order submission blocked. Prescription validity is checked at the time the system processes the Gate 3 check — if the prescription expires on the submission date, submission succeeds if the expiration date is today (expiry means "before today," not "before this moment")

READY AC-PAT-071 [CPO] Full visit history visible for the order: Initial Assessment, Trial Fitting(s), Device Delivery, Follow-Up(s), Service visits

#2 Corrective Helmet Treatment — Infant with Guardian 13/39 33%

Step 1 — Create infant patient record

READY AC-PAT-110 [CPO] Entering a DOB indicating a minor triggers a prompt for guardian information

READY AC-PAT-111 [CPO] Minor detection is calculated from DOB, not a manual flag

READY AC-PAT-112 [CPO] Multiple guardians can be entered (both parents), one marked as primary contact

Step 2 — Patient information and guardian consent

READY BE AC-PAT-024 [CPO] Consent record identifies the guardian as the consenting party, not the infant

READY AC-PAT-114 [CPO] Communication preferences default to the guardian's contact details

Step 3 — Consultation and cranial scan (most patients arrive without prescription)

READY AC-PAT-060 [CO] CPO creates a Consultation (no prescription required). Scans the infant, captures cranial measurements, evaluates severity

NOT STARTED AC-PAT-116 [CPO] The scan report (produced by scanner software, e.g., Qwadra) is uploaded to Pentla. Pentla parses the PDF and extracts measurement data (CVAI, Cephalic Index, circumference, diagonals, severity) into the assessment fields — CPO reviews and confirms, no manual re-entry. Parents take a copy of the report to the prescriber

BLOCKED BE AC-PAT-053 [CO] Assessment form adapts for the cranial helmet device type (both Consultation and Initial Assessment)

READY BE AC-PAT-062 [CO] CPO creates an Initial Assessment. Consultation data (measurements, scan, clinical reasoning) carries forward into a reference panel — CPO reviews and copies relevant data

BLOCKED BE AC-PAT-085 [CO] All cranial measurement fields are present and functional

NOT STARTED AC-PAT-131 [CO] Clinical flag checkboxes are available during the helmet assessment (Consultation, Initial Assessment, and Progress Review). Multiple flags can be selected

NOT STARTED AC-PAT-132 [CO] Selected clinical flags are visible to the technician alongside the device configuration — the technician does not need to search the patient record

NOT STARTED AC-PAT-133 [CO] When atopic dermatitis is flagged, the configurator shows a soft warning recommending moisture-wicking liner and breathable padding material

BLOCKED BE AC-PAT-113 [CO] Guardian-reported outcomes replace clinician-rated device outcomes for the infant

NOT STARTED AC-PAT-116 [CPO] The scan report produced by the scanner software can be uploaded to the patient record as a Document attachment. For Consultation patients (no prescription yet), this is the evidence the parents take to the prescriber

Step 4 — Helmet order, fabrication, and initial fitting (Device Delivery)

NOT STARTED AC-PAT-357 [CPO] Device Delivery does NOT close the order — this is the start of treatment, not the end

BLOCKED BE AC-PAT-120 [BOTH] Annex XIII Section 1 statement generated at device delivery — frozen after generation

BLOCKED BE AC-PAT-121 [BOTH] Post-delivery adjustments are part of Annex XIII Section 2 documentation (living document), NOT the Section 1 statement

Step 5 — Monthly Progress Review (checkup 1)

READY AC-PAT-080 [CPO] Progress Review can be created linked to the existing helmet order

READY AC-PAT-081 [CO] Baseline (Initial Assessment) automatically linked for comparison

BLOCKED BE AC-PAT-086 [CO] Cranial measurements captured and comparable to baseline for tracking progress

READY AC-PAT-065 [CO] Visit outcome required before finalisation: Continue treatment / Treatment complete / Refer out / Device replacement

READY BE AC-PAT-051 [CO] Multiple structured device adjustments recordable per visit (using IN-PAT-008 fields)

READY BE AC-PAT-052 [CPO] Adjustment records immutable after creation — append-only

BLOCKED BE AC-PAT-087 [CO] Treatment timeline indicates which visits have scan data attached

Step 6 — Progress Reviews 2 through N

NOT STARTED AC-PAT-358 [CPO] Progress Reviews numbered sequentially per order (1, 2, 3...)

READY AC-PAT-082 [CO] Treatment timeline shows all visits chronologically: date, type, scan indicator, adjustment count, visit outcome

Step 7 — Treatment complete

BLOCKED BE AC-PAT-083 [CPO] Only one Progress Review per order can be marked "treatment complete"

NOT STARTED AC-PAT-359 [CPO] Treatment completion signals the Orders module to close the order. If Gate 4 passes, the order moves to COMPLETE and the CPO sees confirmation. If Gate 4 fails, the CPO sees the gate failure results with actionable items — they do not need to navigate to the Orders area separately to trigger the gate

BLOCKED BE AC-PAT-122 [BOTH] Gate 4 at order completion verifies: Section 1 was already generated at delivery, Section 2 documentation is complete (all Progress Reviews, adjustments, treatment completion)

Edge Cases

BLOCKED BE AC-PAT-084 [CPO] Treatment completion is final for v1. [post-WHX] Reversal with approval

NOT STARTED AC-PAT-360 [CPO] Attempting treatment complete on a second Progress Review for the same order is blocked

NOT STARTED AC-PAT-127 [CO] "Device replacement" outcome: CPO takes a new scan at this visit. A new order is created for the replacement device, linked to the original for treatment continuity

NOT STARTED AC-PAT-128 [CO] The original order stays in IN_TREATMENT while the replacement is being fabricated — the patient continues wearing the old device. The original closes when the replacement is fitted, with the reason that the device was replaced (not treatment complete)

NOT STARTED AC-PAT-129 [CO] The replacement requires its own Clinical Prescription and Reimbursement Prescription — it is a separate custom-made device under MDR. The AWAITING_PRESCRIPTION path can be used

NOT STARTED AC-PAT-130 [CO] The full treatment timeline (all Progress Reviews from both orders) is visible to the CPO. The treatment baseline from the original Initial Assessment persists as the reference for the full treatment arc

BLOCKED BE AC-PAT-115 [CPO] Guardian change during treatment: new guardian added, previous preserved in history

NOT STARTED AC-PAT-361 [CO] Assessment saved as Draft if infant is uncooperative — CPO completes later

NOT STARTED AC-PAT-362 [CO] No maximum limit on number of Progress Reviews or treatment duration

#3 Prosthetic Test Socket Iterations — Returning Patient 15/33 45%

Step 1 — Open returning patient and start Initial Assessment

READY AC-PAT-045 [CO] Medical history pre-populated from patient record, editable

NOT STARTED AC-PAT-345 [CO] Previous measurements visible alongside new measurements

READY AC-PAT-095 [CO] Previous prosthesis configurations visible with full bill of materials

BLOCKED BE AC-PAT-053 [CO] Assessment form adapts for prosthetic device type

READY AC-PAT-090 [CO] All prosthetic-specific fields present and functional

Step 2 — Complete assessment and create order

NOT STARTED AC-PAT-363 [CO] Prosthetic Initial Assessment minimum fields include amputation level and K-level in addition to standard minimums

Step 3 — Test Socket 1: Creation and Trial Fitting

READY AC-PAT-091 [CPO] Test socket iteration auto-numbered: "Test Socket 1"

READY BE AC-PAT-063 [CO] Trial Fitting assessment created linked to the order for Test Socket 1

NOT STARTED AC-PAT-349 [CO] Clinical Prescription inherited from the order — not re-verified at each fitting

NOT STARTED AC-PAT-350 [CO] Iteration outcome field present with prosthetic-specific labels: Proceed to definitive fabrication / Rebuild socket / Adjust and retest / Discontinue (device approach not viable — requires clinical justification, cancels the order)

NOT STARTED AC-PAT-364 [CO] CO documents socket fit findings: pressure distribution, alignment, suspension adequacy, gait observation, patient-reported comfort

READY BE AC-PAT-051 [CO] Structured adjustment records for socket modifications made during fitting (using IN-PAT-008 fields)

BLOCKED BE AC-PAT-055 [CO] Clinician-rated device outcomes captured at Trial Fitting

Step 4 — CPO selects "Rebuild socket" — iteration loop

NOT STARTED AC-PAT-365 [CPO] New test socket fabrication cycle begins within the same order — iteration increments to "Test Socket 2"

NOT STARTED AC-PAT-366 [CO] CO documents the clinical reasoning for the rebuild decision — what was wrong with the previous socket and what needs to change

READY AC-PAT-094 [CO] Full iteration history visible: all previous fittings with outcomes, adjustments, and clinical reasoning at each

Step 5 — Test Socket 2: Trial Fitting — CPO selects "Proceed to definitive"

READY BE AC-PAT-063 [CO] Trial Fitting assessment created for Test Socket 2

NOT STARTED AC-PAT-350 [CO] Iteration outcome: CO selects "Proceed to definitive fabrication"

READY AC-PAT-092 [CPO] "Proceed to definitive" can only be set once per order

READY AC-PAT-094 [CO] Full iteration history visible: 2 fittings, outcomes at each, what changed between iterations

NOT STARTED AC-PAT-364 [CO] Socket fit findings documented — the definitive socket will be fabricated based on the accepted test socket

Step 6 — Definitive prosthesis delivery

READY AC-PAT-064 [CPO] Device Delivery with delivery confirmation and clinician-rated device outcomes

NOT STARTED AC-PAT-351 [CO] CO performs delivery examination: fit verification, alignment check, skin check, functional test, patient/caregiver education

BLOCKED BE AC-PAT-120 [BOTH] Annex XIII Section 1 statement generated at fitting/delivery — frozen after generation

Step 7 — Same patient returns 5 years later

NOT STARTED AC-PAT-005 [CPO] Patient can be reactivated — prompts verification of demographics and consent status

READY AC-PAT-095 [CO] Previous prosthesis orders visible with full component detail

READY AC-PAT-045 [CO] Medical history pre-populated but editable (weight, medications change over years)

NOT STARTED AC-PAT-345 [CO] Previous measurements visible alongside new measurements

Edge Cases

READY AC-PAT-049 [CO] K0 patient: CPO can mark assessment fields as "clinically unavailable" with justification and proceed

READY AC-PAT-049 [CO] Open wound: measurements marked "clinically unavailable" with justification

NOT STARTED AC-PAT-367 [CPO] Attempting "Proceed to definitive" after it was already set is blocked

BLOCKED BE AC-PAT-093 [CPO] "Proceed to definitive" is final for v1. [post-WHX] Reversal with approval and documented clinical justification

NOT STARTED AC-PAT-368 [CO] No hard limit on test socket iterations

#15 Patient-to-Order Seamless Flow (Cross-Module) 0/6 0%

BLOCKED DEP AC-PAT-200 [BOTH] When the CPO proceeds from an assessment to device configuration, patient data (measurements, contraindications, prescriber details, linked scans/images) is already populated — no re-entry. The order is created silently

BLOCKED FE AC-PAT-201 [BOTH] The CPO can navigate back to the patient record from the order context and return to the order without losing work

BLOCKED BE AC-PAT-202 [BOTH] Device type selection reflects the assessment context — if the CPO assessed for an AFO, the device type is pre-suggested (but changeable)

BLOCKED BE AC-PAT-203 [BOTH] Component pre-fill (per the CPO's clinical assessment and the device type's default component tree) happens automatically — the CPO reviews and adjusts, not builds from scratch

BLOCKED BE AC-PAT-204 [BOTH] The CPO can complete the full flow (patient creation → assessment → device selection → component configuration → offer → order confirmation) without leaving the workflow or re-entering data at any step

BLOCKED DEP AC-PAT-205 [BOTH] Clinical Prescription verification and Reimbursement Prescription validation happen at the appropriate moments (per AC-PAT-327 and AC-PAT-323) without interrupting the flow — the system guides, not blocks

#17 Lower Limb Orthotic Assessment 0/11 0%

Step 1 — Initial Assessment with pathology classification

NOT STARTED AC-PAT-448 [CO] The 12 orthotic SubCategory values (DROP_FOOT, SPASTIC_EQUINUS, SPASTIC_EQUINOVARUS, CROUCH_GAIT, KNEE_RECURVATUM, KNEE_INSTABILITY, KNEE_VALGUS_VARUS, HIP_INSTABILITY, ANKLE_INSTABILITY, FOOT_DEFORMITY, IMMOBILISATION, GAIT_DEVIATION_COMPLEX) are available when the device type is a lower limb orthotic

NOT STARTED AC-PAT-449 [CO] Type values are filtered to the selected SubCategory — e.g., selecting DROP_FOOT shows only COMPLETE_PARALYSIS, PARTIAL_WEAKNESS, PROGRESSIVE, RECOVERING

NOT STARTED AC-PAT-450 [CO] The selected SubCategory and Type populate the order's `pathologySubCategory` and `pathologyType` respectively

NOT STARTED AC-PAT-451 [CO] Functional Grade (FG-1 through FG-4) is used for orthotic patients. K-level field is hidden

Step 2 — Functional assessment fields

NOT STARTED AC-PAT-452 [CO] Lower limb orthotic Initial Assessment captures all required fields: Functional Grade, primary functional presentation, clinical specification, range of motion per relevant joint, muscle strength (MMT), weight-bearing status, and skin condition

NOT STARTED AC-PAT-453 [CO] When the SubCategory is neurological (DROP_FOOT, SPASTIC_EQUINUS, SPASTIC_EQUINOVARUS, CROUCH_GAIT, KNEE_RECURVATUM, GAIT_DEVIATION_COMPLEX), muscle tone assessment (Modified Ashworth Scale) is required in addition to muscle strength

NOT STARTED AC-PAT-454 [CO] Gait observation with structured prompts per deviation type is captured

Step 3 — Fabrication measurements

NOT STARTED AC-PAT-455 [CO] Fabrication measurements are captured at Initial Assessment: circumference measurements at multiple levels per device type, length measurements, joint axis locations, foot length and width, and impression method (scan/cast/foam box)

Step 4 — Proceed to device configuration

NOT STARTED AC-PAT-456 [CO] The selected pathology SubCategory and Type pre-fill the configurator's conditional rules — e.g., DROP_FOOT pre-fills a dorsiflexion assist hinge, SPASTIC_EQUINUS pre-fills a plantarflexion stop

Edge Cases

NOT STARTED AC-PAT-457 [CO] When a patient has multiple functional deficits (e.g., spasticity + drop foot), the CO classifies by the dominant biomechanical problem. The full clinical picture is captured in the assessment narrative

NOT STARTED AC-PAT-458 [CO] Orthotic-specific fields (Functional Grade, gait observation, muscle tone, pathology SubCategory/Type) are hidden when assessing for a non-orthotic device

Orders & Configuration

42 ready 38 blocked 14 not started 94 total

#1 New AFO Order — End-to-End 16/44 36%

Step 1 — Proceed from assessment to device configuration

NOT STARTED AC-ORD-001 [CPO] When a CPO proceeds from a completed assessment to device configuration, the order is created silently with seamless transition — no explicit "Create Order" action

NOT STARTED AC-ORD-135 [BOTH] The Orders area does not contain a "Create Order" button or any order initiation action. Orders can only be initiated from within a clinical event context (assessment, service visit, warranty evaluation). The Orders area is a monitoring dashboard showing in-progress orders and awaiting-action items

NOT STARTED AC-ORD-136 [BOTH] The system pre-fills the device type based on assessment data (diagnosis, pathology, clinical context). The CPO confirms the suggestion or selects a different type. No blank dropdown requiring the CPO to pick from scratch

NOT STARTED AC-ORD-002 [CPO] The order record contains explicit links to patient, assessment, and prescription

NOT STARTED AC-ORD-003 [BOTH] The clinical context snapshot is captured at creation and cannot be modified afterward

BLOCKED BE AC-ORD-138 [CPO] Proceeding to configuration from an assessment is blocked if the assessment is currently being edited by another user — the CPO sees a message indicating the assessment has unsaved changes. Proceeding is permitted only from a saved (Draft or Complete) assessment

BLOCKED FE AC-ORD-139 [CPO] CPO can initiate a snapshot correction on a DRAFT or SUBMITTED order. The correction records the original value, new value, clinical justification, and correcting user (per the snapshot correction record). Attempting a correction on an order in any other status is blocked with a message directing the CPO to cancel and recreate

BLOCKED BE AC-ORD-140 [CPO] When the source assessment linked to an order has been amended (per AC-PAT-299), the order detail view displays a notice: "Source assessment updated." The snapshot remains unchanged — the CPO reviews the amendment and decides whether to correct the snapshot or take no action

NOT STARTED AC-ORD-007 [CPO] Only CPOs can create new device orders; Production Managers can create repair and maintenance orders

BLOCKED FE AC-ORD-008 [CPO] Orders are scoped to the organisation — users in Organisation A cannot see Organisation B's orders

BLOCKED BE AC-ORD-141 [CPO] Within a multi-unit organisation, orders are assigned to the unit where they were created. When a CPO switches unit context *(AC-ORG-073)*, the order list filters to orders for the selected unit. Orders from other units are accessible via search but not shown in the default list. Org-level roles (Org Admin) see all orders across all units regardless of unit context

Step 2 — Configure device in the visual configurator

READY BE AC-ORD-030 [BOTH] The configurator displays a visual representation of the device — not a form with dropdowns

BLOCKED DEP AC-ORD-031 [CO] Pre-filled mode loads all components per the device type's component tree

BLOCKED DEP AC-ORD-032 [CO] Every pre-filled component can be changed, removed, or swapped

BLOCKED DEP AC-ORD-033 [CO] Build-from-scratch mode starts with an empty canvas and allows manual component addition

BLOCKED DEP AC-ORD-034 [CPO] Switching between modes preserves existing component selections

BLOCKED BE AC-ORD-036 [CPO] All component actions are logged with timestamp and user

BLOCKED DEP AC-ORD-037 [CO] Device categories and types are supported per the defined table

BLOCKED DEP AC-ORD-048 [CPO] Reimbursement codes are visible on each component

Step 3 — Link attachments

NOT STARTED AC-ORD-137 [BOTH] Attachments captured during the assessment are auto-linked to the order when the CPO proceeds from assessment to configuration — no manual browse-and-select step for assessment files

READY AC-ORD-060 [CPO] Additional patient attachments can be linked to an order manually

BLOCKED FE AC-ORD-061 [CPO] New uploads are added to the patient record and linked to the order in one action

READY BE AC-ORD-062 [CPO] Required attachments by device type block submission if not linked — hard block

BLOCKED BE AC-ORD-063 [CPO] One attachment can be linked to multiple orders

Step 4 — Set payment path (Path A)

BLOCKED FE AC-ORD-080 [CPO] Four payment paths (A, B, C, D) are supported and documented on the order

BLOCKED BE AC-ORD-086 [CPO] Order total is calculated from component unit prices — not manually entered

BLOCKED BE AC-ORD-087 [CPO] Insurance budget is displayed alongside the order total for comparison

READY AC-ORD-088 [CPO] Payment path is required before order submission (part of quality gate 3)

Step 5 — Submit order (DRAFT → SUBMITTED)

READY BE AC-ORD-092 [BOTH] Gate 3 verifies required components, no hard-block errors, required attachments, documented overrides, prescriber details, and payment path before submission

READY BE AC-ORD-017 [CPO] Every status transition is logged with timestamp, user, and notes

READY BE AC-ORD-010 [CPO] All 17 statuses are supported with the defined transitions

Step 6 — Production through delivery (RECEIVED → IN_PRODUCTION → SHIPPED → DELIVERED)

READY BE AC-ORD-006 [CPO] The order reference number is assigned at RECEIVED status, not at creation

NOT STARTED AC-ORD-065 [CPO] Production staff see attachment files without patient PII

Step 7 — Fitting

READY BE AC-ORD-100 [BOTH] Every device passes through FITTING before COMPLETE — no shortcut exists

READY AC-ORD-101 [CO] Fitting assessment can be recorded with fit evaluation, adjustments, and clinical notes

BLOCKED BE AC-ORD-102 [CO] Clinician-rated device outcomes are captured at fitting per the Patients area model (AC-PAT-055): comfort, function, satisfaction, pain, cosmetic acceptability, wear time, issues reported

READY AC-ORD-103 [CPO] Adjustments are append-only and cannot be deleted

NOT STARTED AC-ORD-104 [CO] Base workflow: FITTING → COMPLETE after acceptance

Step 8 — Complete order (Gate 4)

READY BE AC-ORD-093 [BOTH] Gate 4 verifies fitting documentation, PROs, serial numbers, traceability chain, and Annex XIII readiness before completion

NOT STARTED AC-ORD-076 [CPO] All Annex XIII required fields are present in the order data model

Edge Cases

READY BE AC-ORD-035 [CO] Bilateral flag creates L/R pair with mirror or independent configuration per AC-CTE-022 through AC-CTE-025; each side is independently editable when in independent mode. Bilateral handling applies to orthotic devices — prosthetic bilateral patients create two separate orders (one per side) per BR-PROS-006, because each residual limb has independent test socket iterations and completion timelines

READY AC-ORD-004 [CPO] Draft orders can be saved and resumed later

READY BE AC-ORD-005 [CPO] Draft orders without a prescription link can be deleted; submitted orders cannot

READY BE AC-ORD-012 [CPO] FITTING is required between DELIVERED and COMPLETE — no shortcut exists

#2 Prosthetic Order with Test Socket 9/12 75%

Step 1 — Create order and configure prosthesis

BLOCKED BE AC-ORD-046 [CO] Pre-fill logic populates components based on assessment data and patient context

BLOCKED BE AC-ORD-047 [CO] K-level pre-fill is scoped to prosthetics — not applied to all device types

READY BE AC-ORD-014 [CO] `TEST_DEVICE_*` statuses are only available for orders whose device type includes the test device phase

READY AC-ORD-015 [CPO] The test device phase and treatment phase are independent — a device type may include either, both, or neither

Step 2 — Submit and fabricate test socket

READY AC-ORD-011 [CPO] The unified status flow applies to all orders, with optional phases determined by device type

Step 3 — Test socket fitting and iteration

READY BE AC-ORD-106 [CO] Test device phase: test socket fitting allows approve, rebuild, or adjust-and-retest decisions

READY BE AC-ORD-108 [CO] Test socket iterations are numbered and each evaluation is a distinct record

READY BE AC-ORD-016 [CO] Test socket approve/rebuild decisions can only be made by a CPO

Step 4 — Rebuild iteration

READY BE AC-ORD-009 [CPO] Component modifications during `TEST_DEVICE_FITTING` and FITTING are logged with what changed, clinical reasoning, timestamp, and user

BLOCKED DEP AC-ORD-039 [CO] The configurator can be reopened during `TEST_DEVICE_FITTING` and FITTING to swap components

Edge Cases

READY BE AC-ORD-106 [CO] Unlimited test socket iterations — no system-imposed maximum

READY BE AC-ORD-100 [CPO] Gate 4 serial number check applies to definitive device components only — test socket components are exempt

#3 Treatment Phase Devices (Cranial Helmets, Scoliosis Braces) 4/12 33%

Step 1 — Create order and configure helmet

READY BE AC-ORD-013 [CO] IN_TREATMENT is only available for orders whose device type includes the treatment phase

BLOCKED DEP AC-ORD-037 [CO] Device categories and types are supported per the defined table

Step 3 — Enter treatment phase (FITTING → IN_TREATMENT)

READY BE AC-ORD-105 [CO] Treatment monitoring phase: FITTING → IN_TREATMENT → COMPLETE after treatment completion signal

Step 4 — Treatment completion

BLOCKED BE AC-ORD-098 [BOTH] Orders with treatment phase require treatment completion signal at gate 4

Edge Cases

READY AC-ORD-103 [CO] Gate 4 displays a soft warning for orders with treatment phase when treatment duration is below a configurable minimum. The default minimum is device-type-aware (e.g., 14 days for cranial helmets, 6 months for scoliosis braces) — not a single organisation-level default

NOT STARTED AC-ORD-077 [CPO] Pediatric orders inherit guardian patient information acknowledgment from the patient record

Pre-prescription production path (clinical urgency — cranial helmets)

BLOCKED FE AC-ORD-110 [CPO] When the CPO determines clinical urgency for a patient, they can move an order from DRAFT to AWAITING_PRESCRIPTION with a documented justification. Available for any device type. Gate 2 (production readiness) must pass

READY AC-ORD-111 [CPO] A prepayment (deposit) can be recorded on the order in AWAITING_PRESCRIPTION status — amount, timestamp, user captured

BLOCKED BE AC-ORD-112 [CPO] Production can begin from AWAITING_PRESCRIPTION (AWAITING_PRESCRIPTION → RECEIVED → IN_PRODUCTION) without a prescription

BLOCKED BE AC-ORD-113 [CPO] When the Clinical Prescription and Reimbursement Prescription arrive, they are linked to the order. A prescription-configuration consistency check fires automatically

BLOCKED BE AC-ORD-114 [CPO] The payment path transitions from D (self-pay) to A (insurance covers). The prepayment is returned to the patient/guardian — amount, timestamp, user, and reason recorded

BLOCKED BE AC-ORD-115 [BOTH] The device cannot be fitted to the patient (FITTING blocked) until the prescription is linked and verified

#10 Quality Gates Verification 6/15 40%

Gate 1 — Assessment to configuration

READY BE AC-ORD-091 [BOTH] Gate 1 verifies assessment completion, patient information record, prescription, prescriber details, and clinical context before order creation

BLOCKED BE AC-ORD-099 [CO] Gate 1 clinical context check is device-type-aware — only fields required for the selected device type are verified

Gate 3 — Order submission

READY BE AC-ORD-092 [BOTH] Gate 3 verifies required components, no hard-block errors, required attachments, documented overrides, prescriber details, and payment path before submission

READY AC-ORD-101 [CPO] Gate 3 verifies that Path B/C `patientInformed` confirmation is current (timestamp later than most recent self-pay amount change)

BLOCKED BE AC-ORD-102 [CPO] Gate 3 treats expired Path C approval (`approvalValidUntil`) as a soft warning, not a hard block

Gate 4 — Order completion

READY BE AC-ORD-093 [BOTH] Gate 4 verifies fitting documentation, PROs, serial numbers, traceability chain, and Annex XIII readiness before completion

BLOCKED BE AC-ORD-098 [CPO] Orders with treatment phase require treatment completion signal at gate 4

READY BE AC-ORD-100 [CPO] Gate 4 serial number check applies to definitive device components only — test socket components are exempt

READY AC-ORD-103 [CPO] Gate 4 displays a soft warning for orders with treatment phase when treatment duration is below a configurable minimum

Cross-cutting gate behaviour

BLOCKED BE AC-ORD-094 [CPO] A broken traceability chain link blocks progression at any gate

BLOCKED BE AC-ORD-095 [CPO] Clear feedback is provided when a gate check fails, identifying the specific issue

NOT STARTED AC-ORD-142 [CPO] When a gate check fails due to data owned by another area (e.g., incomplete assessment, missing patient information record, expired prescription), the failure message identifies the specific gap and provides a direct link to the source record in the Patients area (e.g., "Assessment incomplete: missing weight, height. Open assessment")

BLOCKED BE AC-ORD-096 [CPO] Gate evidence is recorded with timestamp, user, and check results

BLOCKED BE AC-ORD-097 [CPO] Gate evidence is append-only and cannot be modified

NOT STARTED AC-ORD-076 [CPO] All Annex XIII required fields are present in the order data model

#11 Device Rejection at Fitting 7/11 64%

Step 1 — Device arrives at fitting

READY BE AC-ORD-100 [BOTH] Every device passes through FITTING before COMPLETE — no shortcut exists

READY AC-ORD-101 [CO] Fitting assessment can be recorded with fit evaluation, adjustments, and clinical notes

Step 2 — CPO rejects the device

NOT STARTED AC-ORD-107 [CO] Device rejection at fitting sends the order back to IN_PRODUCTION with a documented reason

READY BE AC-ORD-027 [CPO] A device rejected at fitting returns to IN_PRODUCTION with a documented rejection reason

Step 3 — Component modifications during rework

BLOCKED DEP AC-ORD-039 [CO] The configurator can be reopened during FITTING to swap components

READY BE AC-ORD-009 [CPO] Component modifications during FITTING are logged with what changed, clinical reasoning, timestamp, and user

BLOCKED BE AC-ORD-036 [CPO] All component actions are logged with timestamp and user

Step 4 — Rework and return to fitting

READY AC-ORD-101 [CO] A new fitting assessment is recorded for the reworked device

BLOCKED BE AC-ORD-102 [CO] PROs are captured again at the second fitting

Edge Cases

READY BE AC-ORD-017 [CPO] Every status transition (FITTING → IN_PRODUCTION → FITTING) is logged

READY BE AC-ORD-020 [CPO] Cancelled and rejected orders retain all data

Component Trees

42 ready 1 blocked 7 not started 50 total

#1 CPO Configures a New AFO — Tree Evaluation End-to-End 29/30 97%

Step 1 — CPO selects device type

READY AC-CTE-001 [BOTH] Device hierarchy presents category → type → subtype navigation

READY BE AC-CTE-003 [CPO] Selecting a subtype loads the published tree version for that subtype

READY AC-CTE-004 [CPO] If only one subtype exists for a type, subtype selection is skipped

Step 2 — Bilateral handling (if bilateral device)

READY BE AC-CTE-022 [CO] Bilateral device creates paired configurations — left and right — with the default bilateral mode (mirror or independent) coming from the tree definition per position, not from user choice

READY BE AC-CTE-023 [CO] Mirror behaviour copies selections from primary side to secondary side — default for orthotic positions where both sides typically use the same components

READY BE AC-CTE-024 [CO] Independent behaviour allows different selections per side — default for prosthetic positions where residual limbs differ. Note: bilateral prosthetic devices use separate orders (one per side) per BR-PROS-006, not paired configurations within one order. The bilateral handling in AC-CTE-022 through AC-CTE-025 applies to orthotic bilateral configurations

READY BE AC-CTE-025 [CO] CPO can switch between mirror and independent at any point — switching from independent to mirror warns that the secondary side's selections will be replaced by the primary side's, and requires confirmation before proceeding

Step 3 — Tree loads and pre-fill fires

READY BE AC-CTE-005 [BOTH] The configurator displays all component positions for the selected device type, each clearly indicating whether it is required, optional, or conditionally dependent on another selection

READY AC-CTE-006 [CO] Pre-fill recommendations populate based on patient clinical data from the linked assessment — weight, height, activity level, pathology

READY AC-CTE-007 [CPO] Pre-fill sources layer in priority order: assessment data overrides previous device history, which overrides organisation preferences, which overrides Pentla defaults — when sources conflict, the higher-priority source wins

READY BE AC-CTE-008 [CO] Previous device manufacturer ranks higher in suggestions but does not lock the selection

READY BE AC-CTE-009 [CPO] Pre-fill populates all positions before the CPO begins interacting with the configurator — there is no visible loading state for pre-fill results after the tree appears

Step 4 — CPO reviews and modifies components

READY BE AC-CTE-010 [BOTH] Every pre-filled value can be changed, removed, or swapped by the CPO — pre-fill is recommendation, never constraint

READY AC-CTE-011 [CO] Available products for each position come from the organisation's component catalog, filtered by component category

READY AC-CTE-012 [CPO] Preferred catalog entries rank higher in the selection list

READY BE AC-CTE-013 [CPO] Each component shows its reimbursement code

BLOCKED DEP AC-CTE-109 [CPO] Component specifications in the configurator (size, weight class, load rating) display in the organisation's configured measurement system (metric/imperial per AC-ORG-202). Changing the org preference affects display only — stored specifications retain their original units

READY BE AC-CTE-014 [CO] Selecting a component that triggers a conditional dependency immediately updates affected positions — e.g., selecting an articulated shell requires a hinge

READY BE AC-CTE-015 [CO] When a component selection triggers a dependency, the configurator responds correctly: required positions appear, excluded positions are removed, recommended positions show a suggestion, and default-value positions are pre-populated — each response matches clinical expectation for the device type

READY BE AC-CTE-016 [CPO] Changing a component updates only visibly affected positions — unrelated positions remain unchanged

READY AC-CTE-017 [CPO] When the CPO changes a component, dependency and validation updates appear without a visible loading state — affected positions update immediately

READY BE AC-CTE-018 [CO] Compatibility rules check physical constraints between selected products — e.g., adapter type mismatch between knee and pylon

READY AC-CTE-019 [CO] Hard blocks prevent submission for physical impossibilities — the affected positions display the specific incompatibility (e.g., "selected knee requires 4-hole adapter, selected pylon has tube-clamp adapter") and the CPO can continue configuring other positions while the conflict exists

READY BE AC-CTE-020 [CO] Soft warnings allow submission with documented clinical justification — the justification field appears in-context at the warning, not on a separate screen

READY BE AC-CTE-021 [CPO] Positions without a selection do not trigger compatibility warnings — the CPO is not warned about a conflict until both relevant components are selected

Step 5 — Full validation on submission

READY BE AC-CTE-026 [BOTH] Full validation pass runs at submission: all positions checked, all dependencies verified, all compatibility rules evaluated

READY BE AC-CTE-027 [CPO] Every position shows a validation status — including valid ones

READY BE AC-CTE-028 [CPO] Hard blocks prevent submission; soft warnings allow submission with override

Step 6 — Save and resume (edge case)

READY AC-CTE-029 [CPO] Reopening a saved draft re-evaluates the full tree against saved selections using the pinned tree version

READY BE AC-CTE-030 [CPO] Re-evaluation catches catalog changes since the draft was saved — deactivated products flagged

#2 CPO Configures a Transfemoral Prosthesis — Complex Tree 6/12 50%

Step 1 — Device type selection and pre-fill

NOT STARTED AC-CTE-031 [CO] Transfemoral prosthesis tree loads with all expected positions: socket, liner, knee unit (with proximal/distal adapters, charging dock, battery charger), socket adapter, pylon, functional adapter, foot, ankle adapter, suspension (with socket valve, vacuum pump, auxiliary belt), cosmetic cover, stump socks, protective sleeve

READY BE AC-CTE-032 [CO] K-level from assessment pre-fills appropriate knee unit categories — K2 sees fluid-controlled (default), polycentric, and microprocessor; K3 sees microprocessor ranked first and fluid-controlled; K4 sees microprocessor (default) with fluid-controlled and polycentric alternatives

NOT STARTED AC-CTE-033 [CO] Patient weight pre-fills load-rated components within safe range across all eight weight-validated components (socket adapter, knee unit, knee proximal/distal adapters, pylon, functional adapter, ankle adapter, foot)

Step 2 — Knee unit cascade

NOT STARTED AC-CTE-034 [CO] Selecting a specific knee unit triggers adapter compatibility check on pylon and cascade to charging dock and battery charger (microprocessor) or exclusion (mechanical, fluid-controlled)

NOT STARTED AC-CTE-035 [CO] If selected pylon adapter is incompatible with the knee unit, a hard block appears at both affected positions — the CPO can continue configuring other positions and resolve the mismatch before submission

NOT STARTED AC-CTE-036 [CO] Changing the knee unit re-evaluates charging dock, battery charger, and adapter chain dependencies

Step 3 — Free-form entry for unlisted product

READY BE AC-CTE-037 [CPO] CPO can enter an unlisted product for any position using free-form entry

READY BE AC-CTE-038 [CO] Free-form entries are subject to the same compatibility validation as catalog entries

READY BE AC-CTE-039 [CPO] Free-form entries are per-order and do not enter the catalog automatically

Step 4 — Component swap during fitting

READY BE AC-CTE-040 [CO] During `TEST_DEVICE_FITTING` or FITTING status, the same evaluation logic applies — validation rules do not change. Components used during test fitting may be temporary clinic stock (e.g., a demo knee for gait evaluation) and are distinguished from definitive selections in the final BoM

READY BE AC-CTE-041 [CO] Swapping a component during fitting triggers the same dependency re-evaluation

Step 5 — Subtype with multiple activity variants (edge case)

NOT STARTED AC-CTE-045 [CO] Transtibial prosthesis subtypes (everyday, sports, swimming) are separate device configurations, each with its own tree — a patient may have multiple active prostheses for different activities, ordered independently

#8 Device Type Examples — Clinical Accuracy Spot-Check 7/8 88%

Step 1 — AFO tree accuracy

READY BE AC-CTE-102 [CO] Solid AFO tree: shell (with proximal trim as specification), footplate, posterior strap, calf cuff, instep strap (conditional — deep-shell override), padding, liner (conditional on laminated fabrication at DEVICE level), lateral/medial support (per-side valgus/varus, valid across bilateral pairs), T-strap (conditional on tibial torsion), growth margin (conditional on paediatric), rocker bottom, sole insert — positions, per-side alignment rules, and clinical workflow order are clinically accurate

READY BE AC-CTE-103 [CO] Articulated AFO tree: hinge selection triggers appropriate ankle joint dependencies

Step 2 — Prosthetic tree accuracy

READY BE AC-CTE-104 [CO] Transtibial prosthesis: socket assembly (liner, socket shell), socket adapter, suspension (8 types with bidirectional liner-suspension rules), functional adapter, pylon, foot, ankle adapter — positions, dependencies, and clinical workflow order are clinically accurate

READY BE AC-CTE-105 [CO] Transfemoral prosthesis: socket assembly (liner, socket shell, socket valve), socket adapter, suspension (4 primary types + auxiliary belt with bidirectional liner rules), knee unit (4 types with charging dock/battery charger cascade), functional adapter, pylon, foot, ankle adapter — positions, dependencies, and clinical workflow order are clinically accurate

NOT STARTED AC-CTE-112 [CO] Knee disarticulation prosthesis: socket assembly (liner, socket shell, socket windows conditional on condyle prominence at DEVICE level), socket adapter, suspension (5 primary types + auxiliary belt with bidirectional liner rules), knee unit (3 polycentric types with charging dock/battery charger cascade for microprocessor), functional adapter, pylon, foot, ankle adapter — positions, dependencies, condyle prominence as primary structural classifier, and clinical workflow order are clinically accurate

Step 3 — Cranial helmet accuracy

READY BE AC-CTE-106 [CO] Protective helmet: shell, padding, chin strap — simple structure, no reshaping components

READY BE AC-CTE-107 [CO] Corrective helmet: treatment monitoring components present, pathology classification (positional/synostotic with 11 subtypes), shell appearance selection (colour for 3D-printed, design pattern for thermoplastic), padding options (type, material, thickness, colour, perforation), closure system, clinical flags (hemangioma, atopic dermatitis, drainage, scar, birthmarks, glasses), device preview, and forehead window conditional rules reflect clinical practice

Step 4 — Spinal accuracy

READY BE AC-CTE-108 [CO] Cheneau TLSO: pressure zones, curve classification input, pad positioning — reflects scoliosis brace clinical practice