HRM Reference Site Phase Guidelines

HRM Reference Site PhaseDate: August 12, 2013

OntarioMD Inc.

EMR Specification v4.1

HRMReference Site Phase

Guidelines

Date: Aug 12, 2013

Version: 1.1

1.Validation of HRM Requirements at the Reference Site

1.1Background

EMR Vendors are required to receive approval of all HRM requirements in EMR Spec v4.1, which includes the 4.1A (amendment) published on March 8, 2013 by OntarioMD as a prerequisite to funded physicians participating in the provincial rollout of HRM.

OntarioMD will conduct validation of the HRM requirementsat a Reference Site with live access to the HRM Production environment. The HRM Reference Site Validation will be conducted by the OntarioMD Validation Authority (OMDVA).

This information package is intended to inform and prepare the EMR Vendor and the Reference Site to participate in the HRM Reference Site Validation activities.

In an effort to provide complete information, a summary of obligations and activities that occur once approval of HRM functionality in your Funding Eligible Offering has been received is included.

1.2HRM Reference Site Validation Activities

The HRM Reference Site will be involved in activities that have been defined in two distinct phases; determined by the type of environment (Test and Production). OntarioMD recognizes not all Reference Sites may have a Test environment. In this case, all activities will be conducted in the Production environment.

The EMR Vendor must receive Conditional Approval from OntarioMD for the Funding Eligible Offering for the HRM EMR Spec 4.1 (including EMR Spec 4.1A) requirements prior to the Reference Site Test Environment being upgraded with the HRM code. The Reference Site Test Environment can be prepared in advance of the vendor receiving Conditional Approval to reduce the time it takes to prepare the Reference Site.

Validation of the Funding Eligible Offering against the HRM requirements will occur in the Production environment at the Reference Site and is referred to as the HRM Reference Site Validation Session.

The HRM Reference Site Validation Sessioncan occur once the following conditions are met:

HRM Technical Conformance & Validation is achieved
HRM Reference Site Check Point is passed

The activities to be conducted in each of the Reference Site Phases are captured in Diagram 1 below.

1.3HRM Reference Site Validation Approach

OntarioMD will conduct the HRM Reference Site Validation Session (Validation Session) remotely.

The Validation Session will be conducted by the OntarioMD Validation Authority (OMDVA).

This section describes all the activities and deliverables that the EMR Vendor is required to accomplish prior to and during the Validation Session.

Prior to the Validation Session the EMR Vendor will work with the Reference Site to complete Pre-Validation SessionActivities and will coordinate required clinical and administrative resources for the Validation Session.

Due to the nature of HRM Reference Site Validation occurring in live clinical environment, a test patient cannot be utilized therefore all demonstrations will be conducted with real patient information. As per the EMR Funding Eligibility Approval Process, the OMD VA will provide a privacy declaration that outlines the actions OntarioMD will take to protect any Personal Health Information (PHI) the Validation Authorities are exposed to.

The EMR Vendor must successfully demonstrate the HRM requirements during the Validation Session and complete any corrective actions prior to receiving a final decision.

The validation activities during the Validation Sessionmay include both a clinical user (Clinician) and an admin user (Admin) in addition to the EMR Vendor.

Please note, live clinical use of automated polling of HRM reportsis required to validate HRM at the Reference Site.

1.3.1Pre-Validation Session Activities

In preparing for the HRM Reference Site Validation Session the following Pre-Validation Session Activitiesare required.

The Pre-Validation Session Activities will be initiated during the HRM Site End User Testing Phase and are required to pass the HRM Reference Site Validation Checkpoint.

The EMR Vendor must provide to the OMD VA:

Release Notes that include the HRM functionality
EMR Vendors training plan and materials for HRM end user training
Reference Site specific training schedule
Mapping table of the site specific HRM reports categorization

During the HRM Production Validation Phase the EMR Vendor will work with the Reference Site to achieve the following:

Prepare the Reference Site for the Validation Session:

Upgrade the Offering at the Reference Site to the EMR Spec v4.1 (includes requirements under EMR 4.1A) once approval is received from OntarioMD
Configure the EMR Offering to support all the HRM functionalities as per EMR Spec v4.1 (includes requirements under EMR 4.1A)
Connect the EMR Offering to the HRM Production environment
Complete training to the clinical and admin users at the Reference Site

The EMR Vendor will work with the physician/clinician participating in the Validation Session in order to identify the appropriate patients for which the scenarios can be demonstrated.

Identify up to five (5) patients for which:

HRM reports (text and/or binary)have been received since GO LIVE
HRM reports with annotations (to demo HRM 3.3-c)
HRM reports have been signed-off by more than one provider (to demo 2.1.9-p)
HRM reports have been changed/amended (to demo HRM 3.5-a)
HRM reports have been changed/amended and have annotations (to demo HRM 3.1-c and 3.1-d)
Confidentiality statement for text HRM reports and/or binary HRM Reports (if available)

Be prepared to respond to the sample list of questions available in Attachment A.

1.3.2Reference Site Validation - Check Point

One week prior the scheduled Validation Session, a Check Point meeting with the EMR Vendor, Reference Site, HRM Team and EMR VA Team will be conducted to verify all Pre-Validation Session Activities are completed and the Validation Session can proceed as planned.

The following is a list of items to be discussed and reviewed.

Order / Reference Site Check Point Items
1 / The Reference Site has completed their review of HRM functionalities.
2 / Confirm that no issues or bugs are outstanding.
Verify HRM automated polling is running successfully
Review documented problems HRM during the monitoring phase
3 / Clinical use period has been conducted
4 / Verify whether the Pre-Validation Session Activities has been completed in advance of Validation Session as per Section 3.1

The EMR Vendor worked with the Reference Site and prepared the following:

Prepared the Reference Site for the Validation Session
Identified up to five (5) patients that meet the required criteria
Prepared to respond to the sample list a question available in Attachment A

The EMR Vendor submitted the required documentation to the OMD VA as per section 3.1

5 / Discuss how the export files will be validated against the CDS XSD Schema v 1.1.1 and will be compared with the EMR data.

1.3.3Reference Site Validation Session

The Validation Session will be conducted remotely by the OMD VA.

The Validation Session will be scheduled to occur 4 weeks after the Offering has been upgraded in the Production environment and the Reference Site has begun using HRM.

Note: The Clinician appointed for the Validation Session is asked to not process HRM reports received on the date of the Validation Session. This should only occur if there is norisk of impacting patient care or introducing other risks.

The EMR Vendor is required to have installed all the additional hardware and/or software required to:

Demonstrate the confidentiality statement on the printed HRM reports as per Section 3.1B of this document (i.e., printer).

Validate the export of the HRM report against schema CDS-XSD Schema (eg. XML Spy, Eclipse, etc.)

The following is a representative list of functionality to be demonstrated at the Reference Site. Refer to Attachment B for additional detailsabout the scenarios and requirements:

HRM configuration and administration
Matching HRM reports to report recipient
Matching HRM reports to patient
Signing-off and writing annotations to HRM reports
Version management of HRM reports
HRM reports categorization
Exporting HRM reports

Validation Session Plan

Step / Description of Activity: / Resources
1 / Introduction of all participants and review approach

Clinical use and feedback on HRM
OMD VA will accommodate Clinician’s availability

OMDVA

Clinician
Admin
Vendor

3 / Conduct HRM validation activities and scenarios (refer to Attachment B)

Configuration and administration
Filing and matching HRM reports
Version management of HRM reports
HRM reports categorization
OMD VA identifies corrective actions (if applicable)

OMDVA
Clinician
Admin
Vendor

4 / Conduct Core Data Set (CDS) export activities:

EMR Vendor produces export file
EMR Vendor validate the export file against CSD-XSD Schema (v1.1.1)
OMD VA review compare the “Reports Received” category within the xml file against the HRM reports within the EMR System

OMDVA
Vendor

5 /

OMD VA identifies corrective actions (when applicable)
OMD VA identify next steps
Questions

OMDVA
Vendor

2.Approval of HRM Functionality in the Funding Eligible Offering

2.1Background

The EMR Vendor must successfully demonstrate the HRM requirements during the Validation Session. As per the standard Reference Site Phase, OntarioMD will provide a summary report that includes any corrective actions required.

The EMR vendor is obligated to successfully complete the corrective actions and demonstrate at the discretion of the OntarioMD Validation Authority prior to receiving a final decision.

Once OntarioMD has awarded their final decision of Approval of the HRM functionality for the EMR Offering the EMR vendor will schedule all client systems to be upgrades. Refer to the HRM Vendor Planning Guide for information about deploying HRM across the Province.

2.2EMR Vendor Actions & Obligations

As per the EMR Funding Eligibility Agreement EMR vendors are optional and required actions once Approval of the HRM functionality is awarded.

This section describes the one time activities required as part of the Reference Site Phase.

# / ACTIONS & OBLIGATIONS / REFERENCE
1 / Update existing Schedule I - Offerings Pricing and Fees Schedule; if the schedule of fees are changing; install and maintain security keys and certificates.
Submit to
Required only if there are changes to fees; in advance of final decision. / Schedule I of EMR Funding Eligibility Approval Process
2 / Update existing Schedule H - Vendor Offering Profileto include HRM for publication on the OntarioMD website.
Submit to / Schedule H of EMR Funding Eligibility Approval Process
3 / Submit any marketing materials to OntarioMD that make reference to HRM, the EMR Adoption Program or OntarioMD;must be reviewed and approved by OntarioMD in advance of publication.
Submit to
Submit prior to Approval; OntarioMD will require 5 business days to respond. / EMR Funding Eligibility Agreement
4 / Submit the Release Notes which include HRM functionality to OntarioMD.
Note: this activity is identified in section 3.1 of this document / Appendix H
EMR As A Service
5 / Submit your standard training materials for HRM to OntarioMD (e.g. User Manual, Training Materials). Additional guidance is provided in next section.
Note: this activity is identified in section 3.1 of this document / Schedule B of EMR Funding Eligibility Approval Process

2.3EMR Vendor Obligations in Appendix H

Appendix H of EMR Specification 4.1/4.1A outline the following obligations required of EMR vendors to maintain their Funding Eligible Offering.

# / ACTIONS & OBLIGATIONS / REFERENCE
1 / Upgrade EMR Offering at the Clinician Practice with the approved HRM functionality (as per EMR Spec v4.1/4.1A). / Appendix H
EMR As A Service
2 / When the Clinician Practice requires the Vendor’s support to install and maintain the security keys and certificates and other related software to support functionality and access to a PEHRA;

Vendor must have the written consent of Client/Customer as a condition of doing so.
Vendor must ensure the Clinician Practice is aware of any costs or changes to their EMR support agreement associated with this service.
Vendor must ensure the Clinician Practice understands their responsibility for installing and maintaining of the security keys, certificates and other related software.
In this situation, supporting installation and on-going maintenance may include acquisition and installation of updated security keys, certificates and other related software, and associated testing and verification.
To the extent that Vendor comes into possession of security keys, certificates and other related software, Vendor shall keep such information confidential and will take reasonable and secure steps to prevent any loss, disclosure, or unauthorized use or compromise of same.
Vendor agrees to install technical and administrative controls over the use of security keys, certificates and other related software.

/ Appendix H
EMR As A Service
(section 7.1 (g))
3 / When the Clinician Practice declines the Vendor’s support for installing and maintaining the security keys, certificates and other related software.

Vendor must ensure that Client/Customer understands their responsibility.
Client/Customer must decline (this support) in writing to Vendor.

/ Appendix H
EMR As A Service
(section 7.1 (g))

2.4Development of HRM Training Materials

To assist all EMR vendors as they prepare training materials about the HRM functionality, OntarioMD has provided a list of recommended (but not limited to) topics to be covered as part of the HRM product training and supported in training/end user materials.

HRM Administrator Training

Enabling HRM (if done by the HRM Administrator)
Installing the required keys to configure HRM (if done by the HRM Administrator).
Resolve HRM report matching errors (i.e. match HRM reports to the proper patient chart, clinician recipient or the proper category, etc).
Report Categorization

HRM End User Training

Where to find reports received through HRM?
How to review/sign off reports?
Where are HRM reports stored in the patient chart?
How to add comments to HRM reports?
How to print a confidentiality statement on the HRM report
Handle HRM reports delivered to a wrong clinician inbox
Report Categorization

Attachment A: Reference Site Question Outline

The following is a list of the types of questions that may be covered during the Validation Session. This is not considered a comprehensive list.

# / HRM Functionality / Questions / Resource
1 / Configuration & Administration /

What training was provided to EMR users?
Have you experienced HRM connectivity problems? How do you resolve them?
Have you attempted manual polling?
Are you notified whether the manual polling is successful or not?

Clinician/Admin
Admin/Vendor
Clinician
Clinician/Admin

2 / Filing &Matching HRM reports /

How are you informed about new HRM reports in your inbox/work queue or patient chart?
How is indicated in the inbox/work queue that one HRM reports has been reviewed?
Have you encountered HRM reports that have not been delivered to the intended recipient?
Have you been trained about matching the HRM reports to the proper recipient?
Have you encountered HRM reports that have not been matched to the proper patient?
Have you been trained to match HRM reports to the proper patient?

Clinician
Clinician
Clinician/Admin
Clinician/Admin
Clinician/Admin
Clinician/Admin

3 / Version management of HRM reports /

Is there an indication of the author and the date/time when the annotation was entered?
Are the all instances/versions of the same HRM report grouped together with the most recent version displayed in the provider inbox/work queue and patient chart?
Are the comments/annotations kept separately for each instance?

Clinician
Clinician

Clinician

4 / HRM reports categorization /

Have you encountered HRM reports that have not been automatically categorized?
Have you been trained to match an un-matched HRM report to the proper category?
Who receives notification for uncategorized reports?

Clinician/Admin
Admin

Admin

HRM Reference Site PhaseDate: August 12, 2013

Attachment B: Reference Site Scenarios

This section contains the HRM requirements and the associated scenarios to be demonstrated at the reference site and validated by the OMD VA during the Validation Session.

The OMD VA may, at any time, request that a validation script be repeated and/or items related to the validation script execution be clarified.

In addition, if the OMD VAis unsure whether a requirement is met, they may request that the functionality related to that requirement be demonstrated in a manner different than that shown in the validation script.

It is preferred that both, a clinical user (Clinician) and an admin user (Admin) be available and prepared to demonstrate the HRM functionalities, however the Reference Site can designate the EMR Vendor to conduct the demonstration.

HRM Req
# / HRM Requirement /Functionality / To Be Validated / Resource
HRM Conformance. Testing
3.1 (a) / Allow the automated submission of a request to the HRM for transmission of qualified reports. / 1.The default polling interval has been setup for the Reference Site
2.Functionality for changing the polling interval is available.
3.HRM reports are automatically downloaded.
Optional:
4.Check auto polling attempts in the audit trail. / Admin
Vendor
3.1 (b) / Allow for the manual ad hoc retrieval of hospital reports. /

Clinician has access to manual polling.
Clinician attempts a manual polling.

Optional:

Check manual polling attempts in the audit trail.

/ Clinician
3.1 (c)
3.1 (d) / Alerts or messages EMR administrator if automatic polling is down or unsuccessful.
Alert or message to the user and the EMR Administrator is provided if manual retrieval is unsuccessful / Refer to any connectivity notifications experienced.
1.What notification is provided when the HRM connection is down?
2.What is the process in place for resolving HRM connectivity problems?
Optional:
3.Review historic notifications for HRM connection problems including the identification of a time stamp in the message / Admin
Clinician
Vendor
3.2 (a,d)
3.2 (b,e) / Match the retrieved reports to the recipient physician/nurse practitioner within the EMR using:
- the College of Physicians & Surgeons of Ontario (CPSO) 5 digit unique identifier number with a prefix of ‘D’ provided by the HRM.
-the College of Nurses of Ontario (CNO) 7 digit unique identifier number with a prefix of ‘N’ provided by the HRM
Each physician/nurse practitioner recipient of a report will have their own copy of the report delivered by the HRM and made available in the physician/nurse recipient recipient’s “in-box”
Note: The match of the HRM reports to the physician/nurse practitioner within EMR must be performed on the CPSO or CNO number regardless the length of the CPSO (5 or 7 digits) or CNO number (7 digits). /

HRM reports received (not reviewed) are delivered to the inbox of the correct HRM report recipient.
HRM reportsintended for Nurse Practitioner recipients (if any) are delivered in the proper clinician inbox.

Optional:

Check transaction in the audit trail.

/ Clinician
Vendor
3.3 (a)
3.3 (c) / Automatically match retrieved reports to the patient’s chart within the EMR using the demographic fields provided.
The EMR files one copy of the hospital report in the patient’s chart / 1.HRM report is saved in the correct patient chart.
Optional:
2.Check transaction in the audit trail. / Clinician
Vendor
3.3 (c) / Any associated comments and annotations are retained separately and visually accessible along with the corresponding report copy in the patient chart. / 1.Clinician’s annotation/noteadded to downloaded HRM reportsis stored with the report. / Clinician
3.5(a) / The most current report instance should be presented in the patient’s chart with prior versions accessible when required. / Assumption: the Reference Site received at least one changed/amended HRM report.
1.Verify that for different instances/versions of the same downloaded HRM report the EMR Offering displays the most current instance with prior instances available.
2.Verify that annotations are associated to correct instance.
Optional:
3.Check the audit trail for downloaded HRM reports that are changed. / Clinician
3.4 (a) / The EMR must automatically categorize report’s Class, Sub-Class for Medical Record report types and Class and Accompanying Sub-Class according to the existing EMR categorization/report organization criteria. / Note: refer to site specific mapping table

Using appropriate examples, check categorization of downloaded HRM reports

/ Admin
Clinician
3.4 (d) / The EMR has the capability to resolve the following situations pertaining to reports retrieved from the HRM:
1)Unmatched patient
2)Unmatched physician
3)Unmatched categories (class and sub-class for MR reports; class and accompanying sub-class for DI / CRT reports) / Assumption: the Reference Site received HRM report that didn’t match to a patient, to a clinician, to a category.

Review functionality to manually match the un-matched HRM reports

/ Clinician
As per HRM XSD Schema / The downloaded HRM reports containing embedded human readable text are accessible from within the EMR Offering /

Open a downloaded HRM report containing embedded human readable text.

/ Clinician
As per HRM XSD Schema / The downloaded HRM reports containing binary files (e.g. pdf, etc) are accessible from within the EMR Offering /

Open a downloaded HRM report containing a binary file (if applicable).

/ Clinician
3.6 (a) / Supports addition of Medical Practice confidentiality statement on printed text reports.. /

Verify that confidentiality statement can be inserted on the text HRM reports.

/ Clinician
3.6 (b) / Supports addition of Medical Practice confidentiality statement on printed binary reports. /

Verify that confidentiality statement can be inserted on the binary HRM reports (if applicable).

/ Clinician
Baseline Requirements (Appendix A / Appendix B)
2.1.9 (n)
AppA / Verify that the patient chart indicates the sign-off date and reviewer identity for all HRM reports that are signed off. /

Observe how system indicates sign off date and reviewer identity in patient chart

/ Clinician
2.1.9 (p)
AppA / Verify that one and the same HRM report can be signed off by multiple clinicians, i.e. ordering and copied-to clinicians. /

Observe patient record with HRM report that has been reviewed by more than one clinician.

/ Clinician
2.1 (d)
AppB / Produce a CDS export and verify that all downloaded HRM reports are properly exported in the “Attached Files” section. /

Export the Reports Received section for all the reviewed patient(s)
Validate the export file against the most recent version of the CDS XSD Schema using an XML tool
Compare HRM reports information in the patient chart with the exported data

/ Vendor