PDMP & Health IT Integration
All-Hands Meeting
January 7th, 2014
Meeting Etiquette
• Remember: If you are not speaking keep your phone
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– Hold = Elevator Music = very frustrated speakers and participants
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• Feel free to use the “Chat” feature for questions, comments
or any items you would like the moderator or participants to
know.
From S&I Framework to
NOTE: This meeting is being recorded and
will be posted on the Meeting Artifacts Wiki
page after the meeting
Participants:
Hi everyone: remember to keep your
phone on mute 
2
Agenda
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
3
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+Integrat
ion+Homepage
Note: Please check the
meeting schedule weekly
to get the most up-to-date
meeting information
4
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+t
he+Initiative
5
The Standards &
Interoperability (S&I) Framework:
•
•
•
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.
6
S&I Framework Phases &
PDMP & Health IT Integration Activities
Phase
Pre-Discovery
We are Here
Discovery
Implementation
Pilot
Evaluation
Planned Activities
 Development of Initiative Background
 Development of Initiative Charter
 Definition of Goals & Initiative Outcomes
 Creation/Validation of Use Cases, User Stories & Functional Requirements
 Identification of interoperability gaps, barriers, obstacles and costs
 Review of Vocabulary
 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
 Validation of aligned specifications, testing tools, and reference implementation tools
 Revision of documentation and tools



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
7
PDMP Project Timeline
Nov 13
Jan 14
Mar 14
July 14
June 14
Kick-off (11/14)
Use Case Kick Off
Initiative End
Use Case Consensus
Standards and Harmonization Kick
Off
Pre-Discovery, Call for
Participation
Discovery
Pilot Kick Off
Pilot
Implementation
User Stories, Use Cases,
Functional Requirements
Standards Gap
Analysis
Harmonized
Specifications
Technology Evaluations
8
Reference Model
Implementation
& Validation
S&I Framework
Prescription Drug Monitoring
Program & Health IT Integration
Initiative
Use Case & Functional Requirements
Kickoff Meeting
January 7, 2014
9
Agenda
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
10
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
11
Use Case Outline
Tailored for each Initiative
• 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)**
• 10.0 Scenario: Workflow
– 10.1 User Story 1, 2, x, …
– 10.2 Activity Diagram
o 10.2.1 Base Flow
o 10.2.2 Alternate Flow (if needed)
– 10.3 Functional Requirements
o 10.3.1 Information Interchange Requirements
o 10.3.2 System Requirements
– 10.4 Sequence Diagram
• 4.0 Value Statement**
• 11.0 Dataset Requirements
• 5.0 Use Case Assumptions
• 12.0 Risks, Issues and Obstacles
• 6.0 Pre-Conditions
• Appendices
• 7.0 Post Conditions
• 8.0 Actors and Roles
• 9.0 Use Case Diagram
–
–
–
–
Privacy and Security Considerations
Related Use Cases
Previous Work Efforts
References
** Leverage content from Charter
12
Review of Key Use Case Sections
Assumptions, Pre-conditions and Post-conditions
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.
13
Review of Key Use Case Sections
Use 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
Example: Transitions of Care
14
Review of Key Use Case Sections
Defining 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.
Example
Actor
System
Role
PCP
EHR System
Sender
Specialist
EHR System
Receiver
Patient
PHR System
Receiver
15
Review of Key Use Case Sections
Scenarios
•
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)
Scenario 1
User Story 1
User Story 2
Scenario 2
User Story 1 User Story 2
16
Review of Key Use Case Sections
User 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.
17
Review of Key Use Case Sections
Activity 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
18
Review of Key Use Case Sections
Functional 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
19
Review of Key Use Case Sections
Sequence Diagram
•
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
20
Review of Key Use Case Sections
Dataset Requirements & Issues, Risks & Obstacles
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
21
S&I Community Enabling Toolkit (CET)
Use Case Overview
22
Prescription Drug Monitoring
Program & Health IT Integration
Use Case Discussion
23
Agenda
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
24
PDMP & HIT Integration Initiative
Proposed Use Case & Functional Requirements Development Timeline
Week
Target Date
(2014)
All Hands WG Meeting Tasks
1
1/7
Use Case Kick-Off & UC Process Overview
Introduce: In/Out of Scope, Context Diagram and Scenario
Concert Series Presentation: ASAP
Review: In/Out of Scope, Scenario and Assumptions
sections
2
1/14
Review: In/Out of Scope, Context Diagram, Assumptions ,
Scenario
Introduce: User Stories
Review: User Stories, Context Diagram, Assumptions,
Pre/Post Conditions
3
1/21
Review: User Stories
Introduce: Pre/Post Conditions, Actor and Roles
Review: User Stories, Pre/Post Conditions, Base Flow and
Activity Diagram
4
1/28
Review: Finalize User Stories, Pre/Post conditions
Introduce: Activity Diagram and Base Flow
Concert Series Presentation: OnePort Health
Review: Activity Diagram, Base Flow and Functional
Requirements
5
2/4
Review Activity Diagram and Base Flow
Introduce: Functional Requirements & Sequence Diagram
Review: Functional Requirements, Sequence Diagram, Data
Requirements
6
2/11
Review Functional Requirements
Introduce: Data Requirements
Review: Data Requirements
7
2/18 (To be
rescheduled)
Review: Data Requirements and Risks & Issues
Begin End-to-End Review
End-to-End Review by community
2/25
Review & Comments from Community via Wiki page
due following Monday @ 12 noon
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
25
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 recommendations
This 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
Out of Scope
In Scope
1.
2.
3.
4.
5.
6.
7.
8.
Connecting PDMPs to Health IT systems using existing
standards; (technical mechanism for actual exchange of
data)**
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)
Improving effective and efficient access to PDMP data by
Healthcare Professionals**
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
Safety notifications/ automated alerts from PDMP
Define standard set of data elements used to submit
queries each time
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
Define system/technical requirements that allow
applications to access data in a consistent manner across
the local Health IT system
1.
Method of extraction
**Leveraged from Charter
1.
2.
3.
4.
5.
6.
7.
8.
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.)**
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)**
Third party access - (this is an implementation specific decision
and may vary by implementation, pilot sites and state statues
and law)**
Reporting patient prescription information from dispensers to
state PDMP
Policy-based decisions on how PDMPs are managed,
accessed, and updated that vary from state to state
Timeliness of PDMP: Currency of Data
Storing query response from PDMP
Health IT system’s structure of display for the query response
27
Generic Scenario &
Context Diagram
Pre-Step: Healthcare
Professional logs into
Health IT System
PDMP & HIT Integration
Use Case Scope
1. Sends query to state PDMP
Interstate
Hub
Healthcare Professional
receives requested
information
2. PDMP sends query response
AND/OR
Pre-Step: Healthcare
Professional logs into
Health IT System
PDMP & HIT Integration
Use Case Scope
1. Sends query to state PDMP
Healthcare Professional
receives requested
information
2. PDMP sends query response
28
Agenda
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
29
ASAP
ASAP
A History of Working
with PDMPs
American Society for Automation in Pharmacy
492 Norristown Road • Suite 160 • Blue Bell, PA 19422
610/825-7783 • 610/825-7641 (fax) • www.asapnet.org
A History of Working with PDMPs
• First ASAP standard developed in 1995
Standard 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 lengths
for 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
37
Preparing for 2014- Proposed
January Meeting Schedule
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
38
Contact Information
•
For questions, please feel free to contact your support leads:
–
Initiative Coordinators:
•
•
–
Johnathan Coleman jc@securityrs.com
Sherry Green sgreen@namsdl.org
ONC Leads:
•
•
•
Mera Choi mera.choi@hhs.gov
Jennifer Frazier Jennifer.Frazier@hhs.gov
Helen Caton-Peters Helen.Caton-Peters@hhs.gov
– SAMHSA Leads
•
•
–
Jinhee Lee Jinhee.Lee@samhsa.hhs.gov
Kate Tipping Kate.Tipping@samhsa.hhs.gov
Support Team:
•
•
•
Project Management:
– Jamie Parker jamie.parker@esacinc.com
– Ali Khan Ali.Khan@esacinc.com (Support)
Use Case Development:
– Ahsin Azim Ahsin.Azim@accenturefederal.com
– Presha Patel presha.patel@accenture.com
Vocabulary and Terminology Subject Matter Expert:
– Mark Roche mrochemd@gmail.com
39
Questions
40
PDMP & Health IT Integration
Resources
•
•
•
•
•
Initiative Wiki Homepage
– http://wiki.siframework.org/PDMP+%26+Health+IT+Integration+Home
page
Become a Community Member
– http://wiki.siframework.org/PDMP+%26+Health+IT+Integration+Join+t
he+Initiative
Project Charter
– http://wiki.siframework.org/PDMP+%26+Health+IT+Integration+Charte
r+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
41