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EuroRec SealPreparing a certification session

Morten Bruun-Rasmussenmbr@mediq.dk

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Vilnius, Lithuania. 26th January, 2012

Guideline for running a test

Introduce a uniform and transparent methodology for the certification of Electronic Health Record systems in Denmark (and Europe)

It is mandatory to follow the guideline by the certification of a system: Result and documentation

of specific certifications can be compared

Can be repeated – with the same results – by more authorised certifiers

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Certification of EHR systems using the EuroRec Seal

Guideline and Procedure

Document name Certification of EHR systems using the EuroRec Seal. Guidelines and Procedures

Date 27.08.2009

Certification of EHR systems using the EuroRec Seal

Guideline and Procedure

Document name Certification of EHR systems using the EuroRec Seal. Guidelines and Procedures

Date 27.08.2009

Compliance and conformance

The certification, documents to what extend the software product is compliant with the conformance criteria being tested

The certification, does not ensure: Stress testing: system performs with expected volumes Execution testing: system achieves desired level of proficiency Recovery testing: system can be returned to an operational status

after a failure Operations testing: system can be executed in a normal operational

status Security testing: system is protected in accordance with importance

to organisation

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Certification methodology

EHR system

EuroRec Seal Guideline

Procedure

Certification documents

Delivery document.• # of tests performed• Approved• Not approved

SelfevaluationTest-log

ValidationTest-log

Test data set

Test criteria

EuroRec Seal Statements

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Each version of a health item has a date and time of registration.

Each version of a health item has a user responsible for the effective data entry identified.

Each update of a health item results in a new version of that health item.

Each version of a health item has a status of activity, e.g. active or current, inactive, history or past, completed, discontinued, archived.

Deletion of a health item results in a new version of that health item with a status "deleted".

Each version of a health item has a person responsible for the content of that version. The person responsible for the content can be a user or a third party.

A complete history of the versions of a health item can be presented.

Each version of a health item has a date of validity.

The system enables the user to designate individual health items as confidential.

Each health item is uniquely and persistently associated with an identified patient.

Each version of a health item is uniquely and persistently identified.

Each user is uniquely and persistently identified.

The system enables to assign different access rights to a health item (read, write,...) considering the degree of confidentiality.

All patient data can be accessed directly from the patient record.

Each patient and its EHR is uniquely and persistently identified within the system.

The system takes the access rights into account when granting access to health items, considering the role of the care provider towards the patient.

The system offers to all the users nationally approved coding lists to assist the structured and coded registration of health items.

The pick lists and reference tables offered by the system are the same for all the users of the same application.

The system does not display deleted health items, audit logs excepted.

The system does not include deleted health items in clinical documentation or export, for audit purposes excepted.

Test scenarios

The objective is to test and ensure that the business process flows are tested from end to end

Scenarios are simple and based on a number of steps, where each step gives precise instruction on what to do

In average a test of a EuroRec Seal statement will include 3-4 steps.

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Test data

Data which have been specifically identified for use by testing the EHR against the EuroRec Seal

Some data may be used in a confirmatory way, typically to verify that a given set of input to a given function produces some expected result

It is mandatory to use the specified test data in the scenarios, unless it is clearly stated the test data only serve as examples

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Conformance criteria

The aim is to test and gain confidence in the correct functioning of the implementation with respect to a specific EuroRec statement

Based on a functional testing (black-box testing) with the emphasis on testing the externally observed functionality against the EuroRec Seal.

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EuroRec Seal #1,GS001537.1

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Each version of a health item has a date and time of registration.

Quoted Statement

1. Search for patient2. Add a health item, eq. a diagnose3. Add a health item, eq. an intervention4. Add a health item, eq. a consultation note

Test scenario

1. Patient #12. Diagnose: Chronic Heart Failure3. Intervention: Electrocardiogram4. Consultation note: Congestive heart failure with severe

LV systolic dysfunction

Test data

Check that the date and time for the diagnose, the intervention and the consultation note are the same as the date and time for the registration. The registration is the date and time, when the decision or process happened (not always the date and time for entering the data).

Criteria

EuroRec Seal #4: GS001579.2Each version of a health item has a status of activity, e.g. active or current, inactive, history or past, completed, discontinued, archived.

Quoted Statement

1. Search for patient2. Search for a health item, eq. diagnose, intervention or

consultation note3. Display the current status of activity4. Update the status of activity5. Repeat step 2-4 minimum 3 times and update status of activity

Test scenario

1. Patient #12. Diagnose: Chronic Heart Failure3. N/A4. Status of activity: State 1, state 2, state 3…5. N/A

Test data

Check that the status of activity for a health item (eq. diagnose, intervention, consultation note) can have different status of activity.

Conformance criteria

Test environment

The vendor will provide minimum two networked computers with printers etc. All necessary components and resources for

running the test shall be available (PCs, laptops, printers, servers etc.)

The system shall be preloaded with necessary test data before the test Number of patients and data descriptions

are specified in the guideline

The EHR system shall be configured as a “live” system running in daily operation

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Start

VendorSelf-evaluation

Week 1 Week 2 Week 3 Week 4 Week 5

Validation

Week 6

Vendor fix errorsif not approved

Validation

Testlog

Testlog

Deliverydocument

Testlog

Deliverydocument

Test log A template which is used

to document the actions and results of the test of the EHR system against the EuroRec Seal

It is mandatory to use the test log at both phase I – self evaluation and phase II – validation

If an error during the test is detected it shall be documented exhaustive

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Delivery document

The objective is to document if the EHR system has passed or not passed the test.

After the end of phase II – validation, the certifier will fill out a delivery document

The delivery document is to be signed by the representative from the vendor and the representative from the certification organization.

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EuroRec certificate

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CSC announces the achievement of the EuroRec certificate world-wide

Thank you

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