Quick Intro
The following steps will assist Clinical Information System (CIS) software developers with a direct Prescription Delivery Service (PDS), declare software conformance with the Agency’s Electronic Prescribing technical framework. A direct PDS generally provides the capability to prescribe and dispense, without the requirement to dispense from a community pharmacy. Often this model is used within a hospital environment where the hospital pharmacy will dispense the medication.
If your product is not using a closed/direct model, please check the other options available here:
Step 1: Develop Your Product
Review the latest version of the Electronic Prescribing Conformance Profile within the Technical Framework documentation available here:
Identify the applicable requirements/conformance points that apply to your product. Each requirement identifies if it is applicable to a Direct PDS model. Applicable requirements have a “yes” in the “Direct PDS” column. Where “No” appears in the “Direct PDS” column, it means the requirement is not applicable.
Also consider the requirements that apply to direct medication chart PDS. The applicable conformance requirements are marked with “yes” in the “Med charts Direct PDS” column.
Conformance Test Specifications and test data are available to assist your development and testing here:
Commence developing your product.
Note:
Please ensure you check the specific requirements of the states and/or territories in which you intend to release your product. Some states and territories have established approval criteria software developers must meet prior to deployment. Details available here:
Step 2: Conduct Internal Testing
Conduct a self assessment against the applicable requirements/conformance points and your own internal testing.
Note:
If you have previously declared conformance to an older version of the conformance profile, please contact [email protected] for support to identify the delta testing applicable to your product.
Step 3: Complete the Conformance Test Specification
Complete the Electronic Prescribing Conformance Test Specification (CTS) and submit to the Australian Digital Health Agency.
Please ensure the CTS for your product, completed in full, with:
- the relevant test outcomes (pass, fail, N/A) recorded against each test case
- a corresponding reason documented for any test marked as N/A
- completed Test Summary Report (TSR) worksheet
- relevant evidence for each test outcome including screenshots, recordings, documentation or other.
*If you have previously declared conformance to an older version of the conformance profile, please ensure the CTS for your product is complete in full, with:
- delta tests marked and passed in the CTS with evidence provided (please see the note in step 4 to access the delta)
- all other tests marked as passed in the CTS – include a comment no change from previous conformance (if applicable)
- the relevant test outcomes (pass, fail, N/A) recorded against each test case
- a corresponding reason documented for any test marked as N/A
- completed Test Summary Report (TSR) worksheet
- relevant evidence for each test outcome including screenshots, recordings, documentation or other.
Conformance Test Specification – test result and test evidence cells (screenshot below)
Conformance Test Specification – test result and test evidence cells (screenshot below)
Test Summary Report (TSR) worksheet (screenshot below)
Step 4: Conduct Conformance Assessment
The Australian Digital Health Agency will conduct your Conformance Assessment observation session.
The purpose of the observed Conformance Assessment is to verify and confirm the results recorded in your submitted Conformance Test Specification (CTS) and validate any further information requested by the Australian Digital Health Agency.
You will be informed by the Australian Digital Health Agency if you are ready to undergo observation and will schedule the session at a mutually agreeable time.
During and following your observed Conformance Assessment, the Australian Digital Health Agency may request further evidence for specific test cases to ensure the record of the test is full and accurate.
Step 5: Declare Conformance
Upon successful completion of previous steps, you may now declare your product’s conformance to the Australian Digital Health Agency by completing the Electronic Prescribing Conformance Vendor Declaration Form and submit your completed form to [email protected]
When completing the Conformance Vendor Declaration Form, please ensure you have completed all relevant information such as:
Inclusion of companion software details in section 1.3. Companion software may include: PDS adaptor(s), workflow engine(s), mobile gateway(s) etc.
Please ensure that the information in the Conformance Vendor Declaration Form matches that of the Test Summary Report (TSR) tab in the final Conformance Test Specification (CTS).
Note:
The Conformance ID is a text string of no more than 36 printable characters containing a text string representing the Product Name, a single character delimiter (“|”) and an alpha-numeric string representing the Software Product Version. Noting that the Conformance ID may assist with issue identification and is used to manage participation, declaration of accurate version information is strongly advised. It is, however, recognised that some software products update version information on a regular basis and in response to changes which do not impact electronic prescribing functionality. For this reason, software vendors may ascertain for themselves the granularity of version information declared in the Conformance ID and the occasions at which it is declared.
Electronic Prescribing Conformance Vendor Declaration Form
If the Agency identify any errata in your submission, you will be informed directly. Common errata include:
- Invalid conformance ID
- Incorrect “reason for this declaration”
- Failure to include companion software components
- Information mismatch between the final CTS Test Summary Report (TSR) worksheet and the Conformance Vendor Declaration Form
Upon successful processing, you will be notified by the Agency directly.
Your product conformance ID is added to the Register of Conformance. This register is communicated by the Agency to Services Australia and PDS providers for operationalisation.
Step 6: Deploy Updated Product
Once you have received a notification that your product has been included on the list of conformant products you may commence deploying electronic prescribing functionality into production and conduct associated training to your end users.
Conclusion
You should now be able to gain product conformance with the Agency’s Electronic Prescribing Technical Framework for your Direct PDS CIS product/s. If you need any further assistance please contact [email protected].