Quality Assurance - Template - Technisch Ontwerp

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1 Introduction

An Information Standard (IS) has both a functional and a technical design, henceforth referred to by their Dutch abbreviations "FO" and "TO", respectively. This template describes both the standard structure and contents of a TO.
The template uses the following annotation:

  • Goal: What the goal of the section is and what information it should include.
  • Standard text: Standard sentences to include if appropriate.
  • Examples: These are taken from multiple Nictiz ISs (BgZ-MSZ 2.0, eOverdracht, etc.).
  • Placeholders: "<" and ">" are used to denote places that should be filled with IS-specific information, like so: <example>.

Goal: The Introduction is used to give the reader general guidance regarding the technical implementation of the IS. It should include general disclaimers.

Standard text: This is the implementation guide (IG) for the information standard (IS) <IS-name>. This IG must be used together with the IS functional specification, see <link to <<IS>> main page>.

Example BgZ-MSZ 2.0 FHIR STU3:
This is the FHIR implementation guide (IG) for the information standard BgZ-MSZ. This IG must be used together with the functional specification: see BgZ main page.

In addition, the guidelines as specified in general FHIR STU3 Implementation Guide apply. The guide defines how to implement FHIR STU3 and what rules apply (e.g. how to handle empty reponses etc.). In particular, the reader should take note of the use case overarching principles and the use of FHIR packages.

1.1 Support

Standard text: For questions, feedback, or change requests, please contact our support team at Nictiz Servicemanagement.

1.2 Known issues

Standard text: The IS described in this document is actively maintained and continuously improved. However, certain limitations may exist due to ongoing development, external dependencies, or the complexity of healthcare interoperability. These known issues are listed in the [<Link-to-FO#known-issues> | FO (in Dutch)].

1.3 Assumed knowledge

Standard text: This TO assumes that the reader is familiar with the following:

  • <your data exchange standard (e.g., FHIR, CDA, XSD, XCA, etc.)>.
  • This TO is accompanied by the <IS> FO.

2 Boundaries & relationships

Goal: This chapter defines how organizations and their relationships are structured and exchanged across systems. It supports interoperability by standardizing hierarchical and functional links. This standard overlaps with others related to identification, roles, and geographic classifications, requiring careful alignment to ensure consistency and avoid duplication.

3 Actors involved

Goal: To give an overview of the actors relevant to the transaction. A table should be used to list the relevant actors, their systems, and, if possible, FHIR CapabilityStatements.

Standard text:

Actors Systems FHIR Capability Statements
Name Description Name Description Name Description
<Actor 1> <Actor description 1> <System role 1> <System role description 1> <CapabilityStatement link 1> <CapabilityStatement description 1>
<Actor 2> <Actor description 2> <System role 2> <System role description 2> <CapabilityStatement link 2> <CapabilityStatement description 2>

Example eOverdracht 4.0.5 STU3:

Actors Systems FHIR Capability Statements
Name Description Name Description Name Description
Sending organization The organization or health care professional(?) at the organization that wants to transfer the care of a patient Sending XIS Healthcare information system of the sending organization CapabilityStatement: Sending XIS FHIR requirements for sending XIS
Receiving organization The organization or health care professional(?) at the organization that the sending organization wants to transfer the care of a patient to Receiving XIS Healthcare information system of the receiving organization CapabilityStatement: Receiving XIS FHIR requirements for receiving XIS

4 Transactions

Goal: In this chapter, the use cases of an IS are elaborated through transactions. A transaction is an HCIM-based dataset (applicable to multiple use cases). A transaction should include information about the (earlier specified) involved actors. It should also include information regarding the available invocations

{=> A transaction is based upon one transaction-dataset.}

(e.g., FHIR queries).

4.1 <Transaction 1>

4.1.1 Involved actors

Standard text:

Transaction group Transaction Actor Role
<Transaction group name> <Transaction 1> <System role 1> <Role explanation 1>
<Transaction 2> <System role 2> <Role explanation 2>


Example MedMij LaboratoryResults 2.0.42 FHIR STU3:

Transaction group Transaction Actor Role
Retrieve Laboratory Results(PULL) Retrieve laboratory results request Patient (using a PHR) Request laboratory results from the XIS
Retrieve laboratory results response Healthcare professional (using a XIS) Serves laboratory results to the PHR

4.1.2 Invocations

Goal: To give an overview of the invocations used to query FHIR servers in the use case.

Standard text:

Query Description
<sorting variable 1 (e.g., FHIR resource or FO chapter)>
<HCIM 1> 
 <HTTP Method> [base]/<FHIR resource>?_include=<FHIR resource>:<Search parameters>
<Description of queried data>
<HCIM 2> 
 see Patient.maritalStatus
<Description of queried data>
<sorting variable 2 (e.g., FHIR resource or FO chapter)>
<HCIM 3> 
 <HTTP Method> [base]/<FHIR resource>?_include=<FHIR resource>:<Search parameters>
<Description of queried data>

Example BgZ-MSZ 2.0 STU3: [expand/collapse]:

4.1.2.1 FHIR Query Specification

The table below provides an overview of the FHIR queries to exchange all BgZ-MSZ sections.

Query Description
1 Demographics and identification
1.1 Patient 
GET [base]/Patient?
_include=Patient:general-practitioner

The patient information available in the source system is exchanged as a FHIR patient instance that conforms to the nl-core-patient profile.

  • The last known marital status available in the source system is exchanged using the patient.maritalStatus field.
  • If available in the source system, the general practitioner (GP) is exchanged (a) as a FHIR Practitioner instance conforming to the nl-core-practitioner profile, where the Practitioner.identifier indicates a GP, and/or (b) as a FHIR Organization instance conforming to the nl-core-organization profile. The specified referenced resources are returned in full.
  • Information regarding the primary partner/contact available in the source system is exchanged using elements of the patient instance. It is not exchanged using the RelatedPerson resource.
1.2 Marital status 
see Patient.maritalStatus

Marital status data are exchanged via the patient resource (see 1.1).

2 Financial information
2.1 Payer 
GET [base]/Coverage?
_include=Coverage:payor

The payer data available in the source system is exchanged as a FHIR coverage instance that conforms to the zib-Payer profile.

  • The specified referenced payor resource instances, that may be of type nl-core-organization, nl-core-patient, or nl-core-relatedperson, are returned in full.
3 Treatment restrictions
3.1 Treatment instructions 
GET [base]/Consent?
category=http://snomed.info/sct|11291000146105

All treatmentDirectives available in the source system are exchanged as FHIR consent instances, which conform to the zib-TreatmentDirective profile.

  • The consent.category is fixed to ‘treatment instructions’ (code = '11291000146105' in codeSystem 'SNOMED CT').
3.2 Advance directive 
GET [base]/Consent?
category=http://snomed.info/sct|11341000146107

All AdvanceDirectives available in the source system are exchanged as FHIR consent instances, which conform to the zib-AdvanceDirective profile.

  • The consent.category is fixed to ‘levenstestament en wilsverklaring in dossier’ (code = '11341000146107' in codeSystem 'SNOMED CT').
  • the document is only exchanged via a pdf.
4 Contact persons
4.1 Contact 
Patient.contact

Primary partner/contact data are exchanged via the patient resource (see 1.1).

5 Functional/mental status
5.1 Functional or mental status 
GET [base]/Observation?
category=http://snomed.info/sct|118228005,
http://snomed.info/sct|384821006

All functional or mental status information available in the source system is exchanged as FHIR observation data that conforms to the zib-FunctionalOrMentalStatus profile.

  • Functional status data are exchanged with the observation.category fixed to ‘Functional finding’ (code = '118228005' in codeSystem 'SNOMED CT').
  • Mental status data are exchanged with the observation.category fixed to ‘Mental state, behavior and/or psychosocial function finding’ (code = '384821006 ' in codeSystem 'SNOMED CT').
  • please note that as defined in the BgZ dataset, the category may be both a functional and a mental status.
  • The target system may be configured to optimize the use of this information. For example, it may be configured to group and categorize according to StatusName regarding mental, hearing, vision, mobility and language skills.
6 Complaints and diagnoses
6.1 Problem 
GET [base]/Condition

All problems available in the source system are returned as zib-Problem instances.

  • The condition.ProblemStatus must be populated when exchanging data. In cases where for legacy data there is no Problem.ProblemStatus recorded in the source system then the Condition.clinicalStatus field must be populated with an assumed state such as “active” if there is no problemEndDate defined. It is a known problem that the data-absent-reason cannot be used. This aspect is under investigation.
  • Note that no Condition.category (e.g. diagnosis or symptom) may be assumed while exchanging data if the condition.category is not known.
  • Note that the condition.code can exchange multiple encodings for the same problem. In the transaction it is defined that a problem may contain an additional more specific problemName that is exchanged using a second condition.code.coding.
7 Social history
7.1 Living Situation 
GET [base]/Observation?
code=http://snomed.info/sct|365508006

All living situations available in the source system are exchanged as FHIR Observation instances that conform to the zib-LivingSituation profile.

  • The Observation.category is fixed to ‘Residence and accommodation circumstances - finding’ (code = ' 365508006' in codeSystem 'SNOMED CT').
  • The HouseType cardinality is 1..1R and must be exchanged accordingly.
7.2 Drug Use 
GET [base]/Observation?
code=http://snomed.info/sct|228366006

All drug use available in the source system is exchanged as a FHIR Observation instances that conform to the zib-DrugUse profile.

  • The Observation.category is fixed to ‘Finding relating to drug misuse behavior’ (code = '228366006' in codeSystem 'SNOMED CT').
  • The target system may be configured to optimize the use of this information. For example, grouping data according to a specific DrugOrMedicationType.
7.3 Alcohol Use 
GET [base]/Observation?
code=http://snomed.info/sct|228273003

All known alcohol use, available in the source system, is exchanged as FHIR Observations that conform to the zib-AlcoholUse profile.

  • The Observation.category is fixed to ‘Finding relating to alcohol drinking behavior’ (code = '228273003' in codeSystem 'SNOMED CT').
7.4 Tobacco Use 
GET [base]/Observation?
code=http://snomed.info/sct|365980008

All known Tobacco Use, available in the source system, is exchanged as FHIR Observation instances that conform to the zib-TobaccoUse profile.

  • The Observation.category is fixed to ‘Finding of tobacco use and exposure’ (code = ' 365980008' in codeSystem 'SNOMED CT').
7.5 Nutrition Advice 
GET [base]/NutritionOrder

All Nutrition Advice available in the source system is exchanged as a FHIR NutritionOrder instances that conform to the zib-NutritionAdvice profile.

  • The target system may be configured to optimize the use of this information. For example, grouping data according to a specific NutritionOrder.oralDiet.type.
8 Alerts
8.1 Alert 
GET [base]/Flag

All alerts available in the source system are exchanged as a FHIR Flag instances that conform to the zib-Alert profile.

9 Allergies
9.1 Allergy Intolerance 
GET [base]/AllergyIntolerance

All allergies and intolerances available in the source system are exchanged as a FHIR AllergyIntolerance instances that conform to the zib-AllergyIntolerance profile.

  • According to the BgZ-MSZ transactions, the AllergyIntolerance.Reaction.Symptom must be exchanged if available. In cases where for legacy data there is no Symptom recorded, then the Reaction.manifestation field MUST be populated with a value from the Valueset-data-absent-reason.
"manifestation":{
   "extension": [{
      "url": "http://hl7.org/fhir/StructureDefinition/data-absent-reason",
      "valueCode": "unknown"
    }]
  },
10 Medication
10.1 Medication Agreement 
GET [base]/MedicationRequest?
category=http://snomed.info/sct|16076005&
_include=MedicationRequest:medication

All medication agreements available in the source system are exchanged FHIR MedicationRequest instances that conform to the zib-MedicationAgreement profile.

  • The MedicationRequest.category is fixed to ‘Prescription’ (code = '16076005' in codeSystem 'SNOMED CT')
  • The PharmaceuticalProduct agreed upon to be used is returned in full as FHIR Medication instance according to the zib-Product profile.
10.2 Administration Agreement 
GET [base]/MedicationDispense?
category=http://snomed.info/sct|422037009&
_include=MedicationDispense:medication

All administration agreements available in the source system are exchanged FHIR MedicationDispense instances that conform to the zib-AdministrationAgreement profile.

  • The MedicationDispense.category is fixed to ‘Provider medication administration instructions’ (code = '422037009' in codeSystem 'SNOMED CT')
  • The PharmaceuticalProduct in the agreement is returned in full as FHIR Medication instance according to the zib-Product profile.
10.3 Medication Use 
GET [base]/MedicationStatement?
category=
urn:oid:2.16.840.1.113883.2.4.3.11.60.20.77.5.3|6&
_include=MedicationStatement:medication

All medication use available in the source system are exchanged FHIR MedicationStatement instances that conform to the zib-MedicationUse profile.

  • The MedicationStatement.category is fixed to ‘Medicatiegebruik’ (code = '6' in codeSystem ' 2.16.840.1.113883.2.4.3.11.60.20.77.5.3')
  • The PharmaceuticalProduct that is used is returned in full as FHIR Medication instance according to the zib-Product profile.
11 Medical devices
11.1 Medical device 
GET [base]/DeviceUseStatement?
_include=DeviceUseStatement:device

All device use statements available in the source system are exchanged as FHIR DeviceUseStatement instances that conform to the zib-MedicalDevice profile.

  • The actual medical device products are returned in full as FHIR Device instances that conform to the zib-MedicalDevice profile.
12 Vaccinations
12.1 Vaccination 
GET [base]/Immunization?
status=completed

All administered vaccinations available in the source system are exchanged as FHIR Immunization instances conforming to the zib-Vaccination profile.

  • Only vaccinations that have been administered are exchanged. Effectively, the Immunization.status is always fixed to ‘completed’.
13 vital signs and measurements
13.1 Blood pressure 
GET [base]/Observation/$lastn?
code=http://loinc.org|85354-9

The last known Blood pressure available in the source system is exchanged as a FHIR Observation instance that conforms to the zib-BloodPressure profile.

  • The Observation.category is fixed to ‘Blood pressure panel with all children optional’ (code = '85354-9' in codeSystem 'LOINC').
  • The Observation.effectiveDateTime is used to determine the last known Observation.
13.2 Body weight 
GET [base]/Observation/$lastn?
code=http://loinc.org|29463-7

The last known Body Weight available in the source system is exchanged as a FHIR Observation instance that conforms to the zib-BodyWeight profile.

  • The Observation.category is fixed to ‘Body weight’ (code = ' 29463-7' in codeSystem 'LOINC').
  • The Observation.effectiveDateTime is used to determine the last known Observation.
13.3 Body height 
GET [base]/Observation/$lastn?
code=http://loinc.org|8302-2, 
http://loinc.org|8306-3, 
http://loinc.org|8308-9

The last known Body Height available in the source system is exchanged as a FHIR Observation instance that conforms to the zib-BodyHeight profile.

  • By default, the Observation.category is fixed to ‘Body height’ (code = ' 29463-7' in codeSystem 'LOINC').
  • If it is recorded that a measurement is taken while the patient is lying or standing, ‘Body height --lying’ (code = ‘8306-3’ in CodeSystem ‘LOINC’) or ‘Body height --standing’ (code = ‘8308-9’ in CodeSystem ‘LOINC’) are used.
  • The Observation.effectiveDateTime is used to determine the last known Observation.
14 Results
14.1 Laboratory test result 
GET [base]/Observation/$lastn?
category=http://snomed.info/sct|49581000146104
&_include=Observation:related-target

All last known Laboratory results, with the most recent test result for each PanelOrBattery, are exchanged as FHIR observations conforming to the zib-LaboratoryTestResult-Observation profile.

  • Per PanelOrBattery, all known laboratory tests are exchanged, regardless of their TestDateTime. They are exchanged as related observations with the PanelOrBattery-observation.
  • The optional ResultType is not used when selecting Laboratory results for exchange.
  • The resultStatus cardinality is 1..1R in contract to the zib and must be exchanged accordingly. The LaboratoryTestResult has a DateTime property that is used by the lastn algorithm.
15 Procedures
15.1 Procedure 
GET [base]/Procedure?
category=http://snomed.info/sct|387713003,
http://snomed.info/sct|258174001

All operative and image guided procedures available in the source system are exchanged as FHIR Procedure instances that conform to the zib-Procedure profile.

  • Surgical procedure are exchanged via an instance with the Procedure.category fixed to ‘Surgical procedure’ (code = ‘387713003’ in CodeSystem ‘SNOMED CT’).
  • Image guided procedures are exchanged via an instance where the Procedure category is fixed to ‘Imaging guidance’ (code = ‘258174001’ in CodeSystem ‘SNOMED CT’).

Procedure instances with any other category that the two specified above are not exchanged. The default category for the BgZ MSZ is ‘procedure’ (code = ‘71388002’ in CodeSystem ‘SNOMED CT’).

16 Encounters
16.1 Encounter 
GET [base]/Encounter

All Encounters available in the source system are exchanged as FHIR Encounter instances that conform to the zib-Encounter profile.

17 Planned care activity
17.1 Procedure 
GET [base]/ProcedureRequest?status=active

All planned procedures available in the source system are exchanged as FHIR ProcedureRequest instances according to the zib-ProcedureRequest profile.

18 Care Setting
18.1 Health professional 
GET [base]/CareTeam?status=active&_include=CareTeam:participant

All health professionals available in the source system are exchanged as part of a CareTeam instance according to the nl-core-careteam profile.

  • Practitioners are returned in full as FHIR Practitioner instances according to the nl-core-practitioner profile.
18.2 Healthcare provider 
see Procedure.performer
see Encounter.serviceProvider

Providers, are exchanged as part of the BgZ information elements according to the nl-core-organization profile. There is no specific query to retrieve Health Providers.

Meta data
Meta data 
GET [base]/Provenance

All provenance data available in the source system for a specific BgZ summary is exchanged as FHIR provenance instances according to the BgZ-metadata profile.

Table 4. FHIR queries used to retrieve BgZ MSZ components.

4.1.3 Search parameters

4.2 <Transaction 2>

4.2.1 Involved actors

4.2.2 Search parameters

4.2.3 Invocations

5 NP (if applicable)

[table with terminology mapping so that NP can be applied]

6 Selection criteria

Goal: definition of selection criteria that can be used.


Example of slection criterium

FunctionalOrMentalStatus.category is used to select (a) a function status or (b) a mental status


[tabel]

7 Data exchange standard

Goal: This chapter should show how the data exchange standard was used to accommodate the Dutch Health Care Information Models (HCIMs) used in the IS. The contents of this chapter change based on the chosen data exchange standard. Currently supported is HL7 FHIR. HL7v3(including CDA), HL7v2, IHE XDS, IHE XCA and others are not supported yet.

7.1 HL7 FHIR

Goal: Every implementation of the standard will require the availability of the information presented here.

Standard text:

Em.png

<IS> uses the FHIR Packaging mechanism. This conveniently bundles all profiles, terminology, example material and other conformance resources you need into a single archive, which can be downloaded or installed using the appropriate FHIR tooling. This version of the information standard uses the following packages:

  • [<link to package 1>]
  • [<link to package 2>]
  • [<link to package 3>]

Note: packages use Semantic Versioning. Other versions can be used at will as long as they have the same major.minor number or a minor number higher than the stated version.

Example eOverdracht 4.0.5 STU3:

Em.png

eOverdracht uses the FHIR Packaging mechanism. This conveniently bundles all profiles, terminology, example material and other conformance resources you need into a single archive, which can be downloaded or installed using the appropriate FHIR tooling. This version of the information standard uses the following packages:

Note: packages use Semantic Versioning. Other versions can be used at will as long as they have the same major.minor number or a minor number higher than the stated version.

7.1.1 Artifacts

Goal: This section shows the link between HCIM and FHIR resources. The table should follow the structure of the FO and refer to the FO (e.g., see FO).
For example, the link to the BgZ-MSZ 2.0 FO would be: [2.0 Chapter 2.1.1] In the BgZ 2.0 FO the data is sectioned off in chapters and sections. Therefore, the table would use the following headers:

  1. Chapter - The relevant chapter from the FO.
  2. HCIM - The name of the HCIM to be exchanged.
  3. Target - The FHIR resource or data element used to exchange the specified HCIM.
  4. Profile - The FHIR profile used in this information standard. Use Sjabloon Simplifier.


Example BgZ-MSZ 2.0 FHIR STU3:

Tabel 1. Mapping table between a HCIM and a FHIR resource with a link to the profile specified by this information standard
Chapter HCIM Target Profile
1 Patient Patient http://nictiz.nl/fhir/StructureDefinition/BgZ-Patient
MaritalStatus Patient.maritalStatus
2 BloodPressure Observation http://nictiz.nl/fhir/StructureDefinition/zib-BloodPressure
BodyWeight Observation http://nictiz.nl/fhir/StructureDefinition/zib-BodyWeight
BodyHeight Observation http://nictiz.nl/fhir/StructureDefinition/zib-BodyHeight
3 LaboratoryTestResult Observation http://nictiz.nl/fhir/StructureDefinition/zib-LaboratoryTestResult-Observation
Specimen http://nictiz.nl/fhir/StructureDefinition/zib-LaboratoryTestResult-Specimen
4 Procedure Procedure http://nictiz.nl/fhir/StructureDefinition/BgZ-Procedure
5 Encounter Encounter http://nictiz.nl/fhir/StructureDefinition/zib-Encounter

7.1.2 Examples of FHIR instances

Standard text: A link to generated FHIR instances in the information standards' Nictiz-testscripts GitHub folder should be included.

Example BgZ-MSZ 2.0 STU3: Nictiz-testscripts (BgZ-MSZ 2.0)

8 Optional elements (not part of template chapters)

Here we will answer questions you may have about this template:

What if my IS uses workflow with a unique technical implementation?
If absolutely necessary, an additional chapter called "Workflow" may be added after the "Boundries & relationships" chapter.

What if want to add footnotes?
If absolutely necessary, an additional chapter called "Footnotes" may be added after the "Transactions" chapter. In there, a footnotes may be added using <ref> and ‎<references /> tags.

9 Release notes (not part of the template)

Goal: Release notes are not a part of the TO template because this information about the information standard should already be available in the FO. This is described in the | Kwaliteitshandboek Standaardisatie - Stappenplan patchrelease. Moreover, release notes for technical implementation are already published in the | Nictiz Simplifier packages and | GitHub pages.

In onderstaande tabel staan alle wijzigingen met betrekking tot dit Quality Assurance (QA) Proces, vanaf versie 3.0.0.

Versie Datum Release notes
Overgenomen van "https://informatiestandaarden.nictiz.nl/index.php?title=qa:Template_TO&oldid=275472"