PDMP & Health IT Integration All-Hands Meeting January 7th, 2014.

PDMP & Health IT Integration

All-Hands Meeting January 7th, 2014

Meeting Etiquette

• Remember: If you are not speaking keep your phone on mute

• Do not put your phone on hold – if you need to take a call, hang up and dial in again when finished with your other call– Hold = Elevator Music = very frustrated speakers and

participants

• This meeting, like all of our meeting is being recorded– Another reason to keep your phone on mute when not

speaking

• Feel free to use the “Chat” feature for questions, comments or any items you would like the moderator or participants to know.

NOTE: This meeting is being recorded and will be posted on the Meeting Artifacts Wiki page after

the meeting

From S&I Framework to Participants:Hi everyone: remember to keep your phone on mute

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Agenda

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Topic Time Allotted

General Announcements 5 minutes

Overview of S&I Framework 5 minutes

S&I Use Case Development Process 20 minutes

PDMP & HITI Use Case Development Timeline 5 minutes

Winter Concert Series: Bill Lockwood of ASAP 15 minutes

Next Steps/Questions 5 minutes

General Announcements

• The PDMP & Health IT Integration Initiative meets weekly on Tuesdays from 12-1pm. – For the most up-to-date schedule check the “Weekly

Meetings” Section of the PDMP & Health IT Integration Wiki Homepage:http://http://wiki.siframework.org/PDMP+%26+Health+IT+Integration+Homepage

Note: Please check the meeting schedule weekly to get the most up-to-date meeting information

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Join the Initiative

• We encourage all members to “sign up” or join the initiative. By joining this ensures you stay up-to-date with the work being done, communications and any initiative activities.

• Simply complete the Join Form on the Join Wiki Page: http://wiki.siframework.org/PDMP+%26+Health+IT+Integration+Join+the+Initiative 5

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• Creates a collaborative, coordinated, incremental standards process.

• Is guided by the ONC (with input from Federal Advisory Committees).

• Is enabled and led by the an open community of industry participants who are interested in solving real-world problems.

Each S&I Initiative focuses on narrowly-defined, broadly applicable challenge, tackled through a rigorous development cycle, and provides input to Federal Advisory Committees for consideration.

The Standards & Interoperability (S&I) Framework:

Phase Planned Activities Pre-Discovery Development of Initiative Background

Development of Initiative Charter Definition of Goals & Initiative Outcomes

Discovery Creation/Validation of Use Cases, User Stories & Functional Requirements Identification of interoperability gaps, barriers, obstacles and costs Review of Vocabulary

Implementation Creation of aligned specification Documentation of relevant specifications and reference implementations such as

guides, design documents, etc. Validation of Vocabulary Development of testing tools and reference implementation tools

Pilot Validation of aligned specifications, testing tools, and reference implementation tools Revision of documentation and tools

Evaluation Measurement of initiative success against goals and outcomes Identification of best practices and lessons learned from pilots for wider scale

deployment Identification of hard and soft policy tools that could be considered for wider scale

deployments

S&I Framework Phases & PDMP & Health IT Integration Activities

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We are Here

PDMP Project Timeline

Kick-off (11/14)

Pre-Discovery, Call for Participation

Jan 14June 14

Discovery

Initiative End

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Nov 13 July 14Mar 14

Implementation Pilot

User Stories, Use Cases, Functional Requirements

Standards Gap Analysis

Harmonized Specifications

Technology Evaluations Reference Model Implementation

& Validation

Use Case Kick Off

Use Case Consensus

Standards and Harmonization Kick Off

Pilot Kick Off

S&I FrameworkPrescription Drug Monitoring Program &

Health IT Integration Initiative

Use Case & Functional Requirements Kickoff Meeting

January 7, 2014

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Agenda

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Topic Time Allotted

General Announcements 5 minutes

Overview of S&I Framework 5 minutes

S&I Use Case Development Process•Use Case Development Objectives•Use Case Structure and Outline•Section-by-Section Overview

20 minutes

PDMP & HITI Use Case Development Timeline•Use Case Timeline•Draft In/Out of Scope, Assumptions, Scenarios•Use Case Next Steps

5 minutes

Winter Concert Series: Bill Lockwood of ASAP 15 minutes

Next Steps/Questions 5 minutes

Use Case Development Objectives

• Engage Stakeholders as Committed Members, Invite Experts, or Interested Parties in the creation of a Use Case This is you all!

• Identify Scenarios and User Stories that address real-world problems

• Keep it simple

• Focus on the business and functional requirements: Focus on “what” the requirements should be rather than “how”

• Create a finalized Use Case that demonstrates value and supports the proposed goals and success criteria for the Initiative

• Publish a finalized Use Case that contains necessary content, supported by artifacts, to enable Harmonization and subsequent S&I Framework efforts to occur

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•1.0 Preface and Introduction

•2.0 Initiative Overview– 2.1 Initiative Challenge Statement**

•3.0 Use Case Scope– 3.1 Background**– 3.2 In Scope– 3.2 Out of Scope– 3.3 Communities of Interest

(Stakeholders)**

•4.0 Value Statement**

•5.0 Use Case Assumptions

•6.0 Pre-Conditions

•7.0 Post Conditions

•8.0 Actors and Roles

•9.0 Use Case Diagram

Use Case OutlineTailored for each Initiative

• 10.0 Scenario: Workflow– 10.1 User Story 1, 2, x, …– 10.2 Activity Diagram

o 10.2.1 Base Flowo 10.2.2 Alternate Flow (if needed)

– 10.3 Functional Requirementso 10.3.1 Information Interchange Requirementso 10.3.2 System Requirements

– 10.4 Sequence Diagram

• 11.0 Dataset Requirements

• 12.0 Risks, Issues and Obstacles

• Appendices

– Privacy and Security Considerations– Related Use Cases– Previous Work Efforts– References

** Leverage content from Charter

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Assumptions• Outlines what needs to be in place to meet or realize the requirements of the Use

Case • These points are more functional in nature and state the broad overarching

concepts related to the Initiative. • The Use Case assumptions will serve as a starting point for subsequent

harmonization activities

Pre Conditions• Describes the state of the system, from a technical perspective, that must be true

before an operation, process, activity or task can be executed. • It lists what needs to be in place before executing the information exchange as

described by the Functional Requirements and Dataset requirements.

Post Conditions• Describes the state of the system, from a technical perspective, that will result

after the execution of the operation, process activity or task.

Review of Key Use Case SectionsAssumptions, Pre-conditions and Post-conditions

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Review of Key Use Case SectionsUse Case Diagrams

• Conceptually represents the Business Actors interacting with the Use Case and the User Stories

• Provides a pictorial representation of the environment where the exchange takes place

• Characterizes the types of interactions that an actor has with a specific system

• Shows the association and interaction between the business actors and the Use Case

• It provides an overview of the actors (users or external systems) and the interactions between them

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Example: Transitions of Care

Review of Key Use Case SectionsDefining the Actors

• This section of the Use Case outlines the business actors that are participants in the information exchange requirements for each scenario. A business actor is a person or organization that directly participates in a scenario.

• The business actor must use a system to perform the functions and to participate in the information interchange. The system or system actor has roles (send, receive, publish, subscribe or in some cases display) and actions which involve exchanging content. Please see the table below for an example of these designations.

Actor System Role

PCP EHR System Sender

Specialist EHR System Receiver

Patient PHR System Receiver

Example

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Review of Key Use Case SectionsScenarios

• The scenario is a comprehensive description of the actors, interactions, activities, and requirements associated with the information exchange

• Scenarios pertain to supporting the health information exchange and describing key flows, and they are supplemented by User Stories

• Example: Specialist requests a patient’s Clinical Care Summary from Primary Care Provider (PCP)

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Scenario 1

User Story 1 User Story 2

Scenario 2

User Story 1 User Story 2

Review of Key Use Case SectionsUser Story• User Stories describe the real world application as an example or instantiation of the

Scenario

• User Stories summarize the interaction between the actors of the Use Case, and specify what information is exchanged from a contextual perspective

• These interactions are further described in subsequent sections. Historically, user stories have been utilized to provide clinical context

• Example Scenario (from previous slide): Specialist requests a patient’s Clinical Care Summary from Primary Care Provider (PCP)

• Example User Story: A Specialist receives a referral and requires more information to treat the patient properly at the point of care. Using an EHR System, the Specialist sends a request to the PCP for the patient’s Clinical Care Summary. The PCP successfully receives the requests, understands the requests, and sends the patient’s Clinical Care Summary back to the Specialist via the EHR System. The Specialist successfully receives the patient information, understands it, and makes an informed decision that can provide better quality of care to the patient.

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Review of Key Use Case SectionsActivity Diagram

• An Activity Diagram is a special form of a state transition diagram in which all or most of the states are activity states or action states

• The Activity Diagram illustrates the Use Case flows graphically, and represents the flow of events and information between the actors

– It also displays the main events/actions that are required for the data exchange and the role of each system in supporting the change

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Review of Key Use Case SectionsFunctional Requirements

• Functional Requirements identify the capabilities a system in a role must have in order to enable interoperable exchange of the healthcare data of interest

– They provide a detailed breakdown of the requirements in terms of the intended functional behaviors of the application

• The Functional Requirements include:– Information Interchange Requirements– System Requirements

• The Information Interchange Requirements define the system’s name and role. They also specify the actions associated with the actual transport of content from the sending system to the receiving system

• System Requirements include the requirements internal to the system necessary to participate successfully in the transaction. System requirements may also detail a required workflow that is essential to the Use Case

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• A Sequence Diagram is primarily used to show the interactions between objects in the sequential order that they occur

– This representation can make it easy to communicate how the exchange works by displaying how the different components interact

– The primary use of the diagram is in the transition from requirements expressed as use cases to the next and more formal level of refinement

• Note: Horizontal lines are used to identify the specific activity between the systems

Review of Key Use Case SectionsSequence Diagram

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Dataset Requirements• Include the data elements and data element sets that will be available within the

message or document. Each data element included is necessary for some aspect of the Use Case; however, the requirements do not specify exactly how they may be used together. All data element sets may contain multiple data elements unless otherwise stated.

• The identification of data elements forms the foundation for harmonization activities. The data elements identified in the Use Case set constraints on the contents of documents and messages.

Issues Risks and Obstacles• Lists the concerns that might interfere with meeting the requirements of the Use

Case. • Note: This list takes into consideration risks outlined in the Charter

Review of Key Use Case SectionsDataset Requirements & Issues, Risks & Obstacles

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S&I Community Enabling Toolkit (CET)Use Case Overview

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Prescription Drug Monitoring Program & Health IT Integration

Use Case Discussion

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Agenda

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Topic Time Allotted

General Announcements 5 minutes

Overview of S&I Framework 5 minutes

S&I Use Case Development Process•Use Case Development Objectives•Use Case Structure and Outline•Section-by-Section Overview

20 minutes

PDMP & HITI Use Case Development Timeline•Use Case Timeline•Draft In/Out of Scope, Assumptions, Scenarios•Use Case Next Steps

5 minutes

Winter Concert Series: Bill Lockwood of ASAP 15 minutes

Next Steps/Questions 5 minutes

PDMP & HIT Integration InitiativeProposed Use Case & Functional Requirements Development Timeline

Week Target Date (2014) All Hands WG Meeting Tasks Review & Comments from Community via Wiki page

due following Monday @ 12 noon

1 1/7Use Case Kick-Off & UC Process Overview

Introduce: In/Out of Scope, Context Diagram and ScenarioConcert Series Presentation: ASAP

Review: In/Out of Scope, Scenario and Assumptions sections

2 1/14Review: In/Out of Scope, Context Diagram, Assumptions , ScenarioIntroduce: User Stories

Review: User Stories, Context Diagram, Assumptions, Pre/Post Conditions

3 1/21 Review: User StoriesIntroduce: Pre/Post Conditions, Actor and Roles

Review: User Stories, Pre/Post Conditions, Base Flow and Activity Diagram

4 1/28Review: Finalize User Stories, Pre/Post conditionsIntroduce: Activity Diagram and Base FlowConcert Series Presentation: OnePort Health

Review: Activity Diagram, Base Flow and Functional Requirements

5 2/4 Review Activity Diagram and Base FlowIntroduce: Functional Requirements & Sequence Diagram

Review: Functional Requirements, Sequence Diagram, Data Requirements

6 2/11 Review Functional RequirementsIntroduce: Data Requirements Review: Data Requirements

7 2/18 (To be rescheduled)

Review: Data Requirements and Risks & IssuesBegin End-to-End Review End-to-End Review by community

2/25 HIMSS Meeting

8 3/4 End-to-End Comments Review & disposition End-to-End Review ends

9 3/11 Finalize End-to-End Review Comments & Begin Consensus Begin casting consensus vote

10 3/18 Consensus Vote* Conclude consensus voting

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PDMP & HIT Integration – Use Case Assumptions

1. Health IT system is capable of querying a PDMP

2. All Healthcare Professionals have appropriate legal authority based on state regulations to request and receive information from state PDMP

3. Healthcare Professionals accessing the PDMP follow state guidelines as appropriate, including any privacy and security requirements as required by each individual state PDMP authority

4. The PDMP returns high positive matches to the Healthcare Professional1

5. The Healthcare Professional accesses information that already exists within the PDMP at the time of querying

Definitions

Healthcare Professional- A medical practitioner or provider of care who has legal authorization to access prescription drug data for patients at the point of care to make informed clinical decisions and appropriate treatment recommendationsThis may include: Prescribers, dispensers, nurses, etc.

Health IT System – An information system that is used by a Healthcare Professional to collect and store patient information including demographics, medicine, etc. (i.e. EHR, HIE, Pharmacy System)

1 Question for Community: What are the responses you receive when querying a PDMP? 26

PDMP & HIT Integration – In and Out of Scope

In Scope

1. Connecting PDMPs to Health IT systems using existing standards; (technical mechanism for actual exchange of data)**

2. If standards do not exist, identifying the gap in the current standards and working with the Standards Organizations (SDOs) to address the gaps** (Refers to harmonization activity)

3. Improving effective and efficient access to PDMP data by Healthcare Professionals**

4. Health IT system has ability to view query response from PDMP

1. Healthcare Professional querying PDMP for a known patient through a Health IT system

2. Healthcare Professional querying a state PDMP connected to the same hub as the state they are located in

5. Safety notifications/ automated alerts from PDMP

6. Define standard set of data elements used to submit queries each time

7. Define system /technical requirements for Healthcare Professionals to be able to access patient information already stored in a PDMP

1. Accessing a PDMP through a Health IT system (i.e. EHR system) instead of another portal

8. Define system/technical requirements that allow applications to access data in a consistent manner across the local Health IT system

1. Method of extraction

Out of Scope

1. Defining the trigger event for how the PDMP is queried or initiated by the user (e.g., hyperlink while ordering, pressing a button, automatic trigger, etc.)**

2. Addressing delegation of rights to individuals not legally authorized to prescribe medications (this is an implementation specific decision and may vary by implementation and pilot sites)**

3. Third party access - (this is an implementation specific decision and may vary by implementation, pilot sites and state statues and law)**

4. Reporting patient prescription information from dispensers to state PDMP

5. Policy-based decisions on how PDMPs are managed, accessed, and updated that vary from state to state

6. Timeliness of PDMP: Currency of Data

7. Storing query response from PDMP

8. Health IT system’s structure of display for the query response

27**Leveraged from Charter

Generic Scenario & Context Diagram

Pre-Step: Healthcare Professional logs into Health IT System

1. Sends query to state PDMP

Healthcare Professional receives requested information

PDMP & HIT Integration Use Case Scope

2. PDMP sends query response

Pre-Step: Healthcare Professional logs into Health IT System

1. Sends query to state PDMP

Healthcare Professional receives requested information

PDMP & HIT Integration Use Case Scope

2. PDMP sends query response

Interstate Hub

AND/OR

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Agenda

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Topic Time Allotted

General Announcements 5 minutes

Overview of S&I Framework 5 minutes

S&I Use Case Development Process•Use Case Development Objectives•Use Case Structure and Outline•Section-by-Section Overview

20 minutes

PDMP & HITI Use Case Development Timeline•Use Case Timeline•Draft In/Out of Scope, Assumptions, Scenarios•Use Case Next Steps

5 minutes

Winter Concert Series: Bill Lockwood of ASAP 15 minutes

Next Steps/Questions 5 minutes

ASAP A History of Working

with PDMPs

American Society for Automation in Pharmacy492 Norristown Road • Suite 160 • Blue Bell, PA 19422

610/825-7783 • 610/825-7641 (fax) • www.asapnet.org

ASAP

A History of Working with PDMPs

• First ASAP standard developed in 1995Standard has evolved over the years, based on

requests from PDMPs to:– Improve the quality of the information reported to better detect

abuse and diversion.– Expand the data elements for a more complete picture of those

receiving controlled substances.– Refine examples on how to submit data for specific data elements.– ASAP Workgroups average 20 or so participants. Workgroups

include representation from PDMPs, system vendors, drug chains, PDMP hubs and data collection organizations.

– ASAP named as the reporting standard in state PDMP legislation enacted.

– Latest ASAP standard required for SAMHSA grant funding.

A History of Working with PDMPs

4.2, the current version, published in September 2011.Minimal changes to Version 4.1. Example: Increased field lengthsfor a few data elements based on PDMP suggestions.

4.2 not only being used by retail and outpatient pharmacies, but veterinarians and physicians dispensing from stock.

4.2 used by pharmacies to report CS Rxs written by not only physicians but veterinarians and dentists as well.

4.2 can be used for real-time reporting as well as batch reporting.

A History of Working with PDMPs

The required data elements form the minimum data set. These are the data elements states agreed must be reported. Optional data elements can be invoked based on a state’s reporting requirements.

Examples: Some states want the species reported (animal vs. human). Some states want an ID (military ID, driver’s license, tribal ID, green card, etc.) and first and last name of person dropping off or picking up the Rx, if different from the patient, and the relationship to the patient.

Other examples: Method of payment. Date sold vs. date dispensed.

A History of Working with PDMPs

• Zero Report Standard

In 2011 added this standard in response to industry request that we needed one way to report when no controlled substances were dispensed during the reporting period. Workgroup had representation from all the stakeholders.

• Error Report Standard Also added a common data structure and minimum data set to communicate specific errors identified by a PDMP within each batch file received that must be corrected and resent.

A History of Working with PDMPs• ASAP Web Service Standard

1. Published in January 2013, to move ad hoc queries on a person of interest into the workflow of a pharmacy management system and EHR system.

2. XML based.

3. Supports automated polling of PDMP data to see if anyone hit the state’s threshold for triggering an unsolicited report. Would happen as a background task.

4. Ad hoc queries can handle reference numbers and “pick lists” where probable matches are returned to ensure selection of the correct person of interest.

5. Supports all the data elements in the ASAP reporting standard in order to provide states with flexibility for the information provided in a response.

6. Provide sample program to facilitate implementation (tested and works).

7. Low cost for PDMPs to implement (a prime consideration).

8. It is cost neutral — there is no transaction charge involved for a query.

9. Uses NIEM tags.

A History of Working with PDMPs

• General– All ASAP standards are made available to PDMPs and state

and federal agencies at no charge.

– Have established a close working relationship with state programs over the years.

– Have had regular attendance at Annual Harold Rogers National Meetings over the years to stay abreast of the issues facing PDMPs and how ASAP can respond.

Next Steps

• Review In/Out of Scope, Scenario and Assumptions sections

• Next Meeting is Tuesday, January 14 from 12:00pm - 1:00pm EST

• Reminder: All PDMP & HIT Integration Announcements, Meeting Schedules, Agendas, Minutes, Reference Materials, Use Case, Project Charter and general information will be posted on the PDMP Wiki page– http://wiki.siframework.org/PDMP+%

26+Health+IT+Integration+Homepage

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Preparing for 2014- Proposed January Meeting Schedule

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Date Meeting Topics

January 7th, 2014 • S&I Process Overview• Use Case Kick-Off & UC Process Overview• Introduce: In/Out of Scope, Context Diagram and Scenario• ASAP Presentation by Bill Lockwood

January 14th, 2014 • Review: In/Out of Scope• Discuss Context Diagram• Discuss Assumptions • Review Scenarios• Introduce: User Stories

January 21st, 2014 • May be canceled due to HL7 (TBD by the community)

January 28th, 2014 • Review: User Stories• Introduce: Pre/Post Conditions• Introduce Actors • Introduce Roles

Contact Information

• For questions, please feel free to contact your support leads:– Initiative Coordinators:

• Johnathan Coleman [email protected]• Sherry Green [email protected]

– ONC Leads:• Mera Choi [email protected]• Jennifer Frazier [email protected]• Helen Caton-Peters [email protected]

– SAMHSA Leads• Jinhee Lee [email protected]• Kate Tipping [email protected]

– Support Team:• Project Management:

– Jamie Parker [email protected]– Ali Khan [email protected] (Support)

• Use Case Development: – Ahsin Azim [email protected] – Presha Patel [email protected]

• Vocabulary and Terminology Subject Matter Expert: – Mark Roche [email protected]

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Questions

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PDMP & Health IT IntegrationResources• Initiative Wiki Homepage

– http://wiki.siframework.org/PDMP+%26+Health+IT+Integration+Homepage

• Become a Community Member– http://wiki.siframework.org/PDMP+%26+Health+IT+Integratio

n+Join+the+Initiative• Project Charter

– http://wiki.siframework.org/PDMP+%26+Health+IT+Integration+Charter+and+Members

• Standards and Interoperability(S&I) Framework– http://wiki.siframework.org/Introduction+and+Overview

• S & I Calendar of Events– http://wiki.siframework.org/Calendar

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