Applicant Guide to EMR Certification

Transcription

1 Applicant Guide to EMR Certification Updated December 2015 Contact us at: Phone: (204)

2 Table of Contents Introduction... 2 About this guide Manitoba s agent Certification Levels... 2 Standard Integrated Expression of Interest Initial EMR Product Certification... 3 Overview... 3 Apply... 4 Self-Assessment Agreement Application form Assess... 4 Certification environment Assessment methods Applicant role in product assessment Certify... 5 Certification term Maintaining certification Certified EMR Product Lifecycle... 6 Issue Standard... 6 Enhance... 7 Reassess... 7 Re-certify... 7 Report and Monitor... 7 Certification Levels Three Key Stages Certified EMR Product Lifecycle 2 3 5

3 Introduction The Government of Manitoba s EMR Certification is focused on electronic medical record systems or EMRs. The goal of this process is to certify EMR products that have the ability to support the strategic and operational objectives of the Government of Manitoba (Manitoba) and end-users of Manitoba Certified EMR Products over time. ABOUT THIS GUIDE Manitoba is pleased to provide this Applicant Guide to EMR Certification to potential Applicants. This guide is intended to provide Applicants with an overview of how to apply for EMR Certification and participate in the product assessment process. In addition to this Guide, Applicants will need the following to complete their application: the EMR Certification Application form the EMR specifications against which each EMR product will be assessed a copy of the Applicant Agreement for EMR Certification A copy of the Applicant Agreement is available to applicants who submit an Expression of Interest to Manitoba. Certification Levels Before you apply for EMR Certification in Manitoba, you must determine which certification level you wish to request for your EMR product. Applicants may choose from two different EMR Certifications based on what is appropriate for their organization, product, and target customer market. STANDARD This entry-level certification may be appropriate for Applicants whose target customers include specialists and/or clinicians whose needs may be met with a basic level of EMR integration. This certification level requires EMR products to certify against Manitoba s baseline clinical and administrative requirements and the echart Manitoba Context-Sensitive Launch Interface. Additional specifications are available to those applying for Standard Certification, on an optional basis. As such, this certification level may also be appropriate for Applicants who want to enter the Manitoba market with a lower initial investment, and enhance the EMR s functionality over time to achieve the full Integrated EMR Certification. MANITOBA S AGENT Manitoba has designated the Primary Care/ Community Information Systems (PCIS) Office at Manitoba ehealth to act on its behalf to manage the EMR Certification process. INTEGRATED The Integrated EMR Certification may be appropriate for Applicants whose target customer includes primary-care or community specialty clinics of all sizes who are seeking an interoperable EMR system that enables connections to other healthcare systems. Other target customers include those participating in key provincial initiatives such as My Health Teams. Refer to the Primary Care website for more information. To apply for Integrated EMR Certification, Applicants must have achieved ISO 13485:2003 Certification. EMR products requesting Integrated EMR Certification are required to certify against a number of interoperability specifications. Page 2

4 To help with your decision, the following table provides a side-by-side comparison of the components of each certification level. ASSESSMENT CRITERIA STANDARD EMR INTEGRATED EMR ISO 13485:2003 Certification Not required Prerequisite Baseline EMR Requirements Mandatory Mandatory echart Manitoba Context-Sensitive Launch Interface Mandatory Mandatory ehealth_hub Optional* Mandatory Primary Care Quality Indicator Reminders and Data Extract Optional Mandatory Interprofessional Team Data Extract Optional Mandatory Comprehensive Care Management Billing Support Optional** Mandatory Access, Capacity and Workload Reporting Optional Mandatory *ISO 13485:2003 certification is a prerequisite for this component. **Primary Care Quality Indicator Reminders and Data Extract specification is a prerequisite. Summary descriptions, specifications and assessment guides related to each component are available on the Manitoba ehealth website. The EMR product must meet all mandatory requirements before the end of the product assessment in order to achieve certified product status. Therefore, it is critical that your team review all relevant documentation. This will help you to determine your EMR product readiness. Those considering requesting Integrated EMR Certification must also be aware of the additional mandatory requirements that the EMR product must meet in the future. Known requirements are described within the Planned EMR Enhancements schedule of the Applicant Agreement for EMR Certification. It is expected that additional requirements will be issued over time. EXPRESSION OF INTEREST Get started by submitting your Expression of Interest to Manitoba. This is easily done using the convenient online form. Once your Expression of Interest is received, Manitoba ehealth will coordinate a discussion with you and key members of your organization. This will provide you and your team with an opportunity to ask questions and gain clarification on any aspect of the process, ensuring that everyone has a common understanding. We re available to help you understand the requirements. Contact us at: [email protected] Initial EMR Product Certification OVERVIEW There are three key stages within EMR Certification as illustrated below. P P P P CERTIFICATE 1. APPLY 2. ASSESS 3. CERTIFY Assess product readiness Review and sign Agreement Complete and submit application package Applicant to establish certification environment Collaborative effort to complete assessment within 180 days Manitoba will finalize and communicate certification decision Page 3

5 APPLY As with any certification process, the number of respondents is unknown. Manitoba is preparing to manage multiple EMR product assessments concurrently. However, there are limitations to the organization s capacity. To ensure high-quality assessments are conducted in an equitable manner, Manitoba will: accept and process certification applications on a first-come, first-served basis prioritize products requesting Integrated EMR Certification, as this best aligns with provincial healthcare strategies SELF-ASSESSMENT Applicants are required to complete a self-assessment of the Baseline EMR Requirements. Any requirement for which the assessment method is marked as Assertion, requires that you declare whether or not your product currently meets this requirement. The Applicant Assertion document is available on the EMR Certification Specifications page of the website. The completed assessment must be included with your submitted application. Scope of Manitoba s Baseline Requirements Manitoba s baseline requirements (functional and non-functional) include the fundamental clinical and administrative features and data elements considered the must-haves to support a primary care or community specialty practice. Baseline requirements are organized into distinct categories listed below. Categories with an asterisk also include a list of required data elements. Patient Demographics* Provider Demographics* Organization Demographics* Schedule Management* Clinical Encounters Medical Record Management* Lab and Diagnostic Test Management* Medications Management* Immunization Management* Clinical Decision Support Referral Management* Documentation and Document Management Workflow and Communications* Billing Queries Privacy Security User Interface Technical AGREEMENT Manitoba will provide you with a copy of the Applicant Agreement for your review. You should review it carefully as it outlines terms and conditions for the Assessment Period and for the Certification Term, should your EMR product be certified by Manitoba. APPLICATION FORM The Application Form requires you to provide basic information regarding your organization and the EMR product to be assessed. You must also indicate which certification you are requesting, as well as any optional components. Once complete, the Application Form must be accompanied by: 1. the supporting documentation listed in the Application Checklist 2. a completed self-assessment of your product against Manitoba s Baseline requirements 3. two signed copies of the Applicant Agreement for EMR Certification Submit the application to EMR@manitoba-ehealth. ca. We recommend that you submit an application for EMR certification only if you are confident that the EMR product will be able to meet all of the requirements within the Assessment Period. ASSESS CERTIFICATION ENVIRONMENT Prior to initiating the assessment, Applicants are responsible for establishing a Certification Environment for their EMR product. As described in the Applicant Agreement, Manitoba ehealth will support Applicants in connecting to components of the Manitoba ehealth communications infrastructure that are required to assess the EMR product. Applicants must also ensure that the environment be configured and contain a comprehensive sample data set to appropriately support assessment activities. Refer to the Applicant Agreement for more details regarding this environment. Manitoba will leverage the Certification Environment to complete the assessment process. There is no fee for Manitoba s EMR Certification. Page 4

6 Assessment Timeframe Unless otherwise agreed with Manitoba, Applicants have 180 days (from the date of application approval) to ensure their EMR product meets Manitoba s assessment criteria for the certification level requested. ASSESSMENT METHODS Each requirement will be assessed using one of four methods, which is indicated within each of the published specifications and assessment guides: Assertion Within their application package, Applicants will make an assertion (Yes or No) based on their self-assessment of the product s ability to meet the requirement. Manitoba may choose to audit Applicant assertions as part of the certification process, as authorized within the Applicant Agreement. Verification Leveraging the Certification Environment, Manitoba will verify the product s ability to meet the requirement. Clinical and administrative resources may be involved in the verification process. Demonstration Applicants will demonstrate key functions within their EMR product. Demonstrations may be conducted in person, by remote means (e.g. teleconference and Internet) or through recorded video. System Integration Testing This most comprehensive assessment method requires an end-to-end test of key functions such as interoperability between the EMR product and other systems (e.g. echart Manitoba Launch or ehealth_hub). Manitoba will provide Applicants with a confidential report of deficiencies at various stages of product assessment. Any deficiencies identified by Manitoba or within your self-assessment will be tracked and must be remedied before the end of the product Assessment Period. APPLICANT ROLE IN PRODUCT ASSESSMENT Applicants play a key role in the assessment process. To ensure that steady progress continues throughout the Assessment Period, you may want to consider designating a resource within your team to lead your efforts. Key responsibilities include: reviewing the Applicant Agreement to ensure a full understanding of the role and responsibilities of all parties completing a self-assessment of the EMR product against Baseline EMR Requirements, including provision of additional documentation required to support your assertions submitting a completed Application to Manitoba, ensuring all required documentation is included establishing and maintaining a Certification Environment for your EMR product coordinating product demonstrations and fully participating in System Integration Testing activities working to remedy any deficiencies identified during the product assessment process CERTIFY Manitoba will examine assessment results, determine the product s certification status, and formally communicate this to the Applicant. If successful, certification will be effective on the date of the Notice of EMR Certification. Subsequently, Applicants may begin to market their product as a Manitoba Certified EMR, and the Certified EMR Product will be listed on the Manitoba ehealth website. CERTIFICATION TERM The Certification Term begins on the date of the Notice of EMR Certification, and continues until such time as one party terminates the Agreement. Termination options relevant to all parties are described in the Applicant Agreement. MAINTAINING CERTIFICATION EMR Certification is just the beginning of what Manitoba hopes will be a long-term, mutually beneficial relationship. Collaboration between Manitoba and vendors of Certified EMR Products will be essential. Manitoba will look to you for innovative and practical solutions that ensure EMR enhancements bring value to healthcare providers and patients across the province and advance Manitoba s healthcare strategies. Assessment must be completed within 180 calendar days, unless otherwise agreed by Manitoba. Page 5

7 Certified EMR Product Lifecycle This section describes the lifecycle of activities for EMR products after successful certification. ISSUE STANDARD Throughout the Certification Term, Manitoba will issue provincial standards to support enhancement of Manitoba s Certified EMR Products, as defined within the Applicant Agreement Requirements and Change Management. Specifications will be posted to the Manitoba ehealth website, along with information indicating how EMR products will be assessed against these specifications. Provincial standards will be issued as either a Change Order or a Change Proposal. Change Orders are mandatory, and must be completed successfully in order to maintain the product s certified EMR status. The Change Order process is described in the Applicant Agreement. Change Proposals are optional, and Applicants may choose to implement those that best meet their customers needs. If you choose to respond to a Change Proposal, you must submit an application to Manitoba ehealth indicating your intention. This will help Manitoba to plan assessment activities to certify the EMR product against these optional requirements. Change Orders are mandatory, and must be met to maintain Certified EMR status. Change Proposals are optional; choose which meets your customers needs. Page 6

8 ENHANCE The Certified EMR Product will be enhanced to meet the requirements described within the provincial specification. It is important that you communicate with Manitoba on a regular basis to share information regarding any issues and/or progress. REASSESS The Certification Environment must be updated to include the new enhancements prior to product assessment. Once updated, Manitoba will schedule assessment activities. Ongoing product assessment will be completed using one or more of the assessment methods described in the Assess section of this document. RE-CERTIFY If the EMR product successfully completes the assessment process, the EMR will be re-certified. Certification status will be updated on the Manitoba ehealth website based on the results of the assessment process. Certification statuses are described in more detail in the Applicant Agreement. REPORT AND MONITOR During the Certification Term, you will have a number of obligations to Manitoba and purchasers of the Certified EMR Product. These are all described in detail within the Applicant Agreement. This section highlights only a few of the obligations and you must review the Applicant Agreement to ensure complete familiarity and understanding. Quarterly reporting to Manitoba: You are required to regularly provide information to Manitoba ehealth regarding, for example, any incident trends or issues associated with the Certified EMR Product. Material Change Notification: You are required to notify Manitoba ehealth if you make any Material Change to the Certified EMR Product. At Manitoba s discretion, any such change may require assessment. Manitoba may choose to: Perform regression testing on the Certified EMR Product on an annual basis to ensure its continued alignment with Manitoba s requirements. Any questions? Contact us at: [email protected] Phone: (204) Page 7