Common Clinical Registry Framework meeting, November 16, 2016 – 8 to 9 am CST

Participant / Attendance
Anita Walden - Mtg. Facilitator/Project Co-Facilitator / X
Karen Ritchey - Note taker / X
Susan Matney / X
Peter Goldschmidt
Ed Hammond
Laura Heerman
Sarah Ryan
Tom Kuhn
Seth Blumenthal / X
Rachel Richesson
Frank Minyon
AbdulMalikShakir / X
Maryam Garza / X
Elise Berliner / X
JaspreetBirk
Amy Nordo
Chrystal Price / X
John Roberts / X

X = in attendance

Next Meeting Agenda

  • Interview Template DRAFT discussion continues
  • Meeting, San Antonio, TX, January 2017

ACTION ITEMS:

  • Anita will follow up with HL7 to find out if a brief mention of the Registry Project can be placed in the January Newsletter with plans of an article for the May newsletter
  • Karen will post the White Paper to the CIC Website and the Wiki
  • Anita will send the White Paper to the co-chairs of the co-sponsoring working groups
  • Seth will add page numbers and 1.5 line spacing to the White Paper

oSeth volunteers to refine initial 7 categories/Typesof Registries (from previous minutes).

  • Finalize White Paper (Seth and Rachel)

Previous Weeks Action Items

o Get word out – Newsletters, etc. (Seth, Amy, Chrystal and Anita)- Will wait until White Paper is final

Anita: HL7 newsletter

Seth: PCPI announcements & health care constituencies

Amy: Health care group, NEHQ newsletter, blogs

Chrystal: Trauma groups, WHO

o Registry Types – Seth will refine (clinical, maturation, etc.)- draft document was provided

AGENDA:

Attendance - Karen

Approval of Meeting Summary – Anita

Posted:

Review of Agenda – Anita

Hot Topics-Group

White Paper Status – Seth and Rachel

Storyboard Template Review

Interview Template Concept DRAFT

oRegistry Category <Electronic Processing Only>

oPurpose of Registry _ several functions see Seth’s Registry Function in the box.

oActors in Registry-dropdown list of Stakeholders- (hospitals, clinics, specialty units, legislators, regulators...)

oNational, International State, Federated

oData Sources – Where does data come from? Direct entered, Extracted from medical record, Filling out web forms. Extracted from data systems, Data warehouse, PAC system, Device, Patient Source

oData Collection Mechanism –Direct Data Entry, Electronic Extraction, Secure Web Portal, Applications

oProcess Data – (What is the work flow from data collection to storage)-Data Quality Assurance process, Feedback loop.

oWhat Registry does with data (Process once data is in Registry Custody, analytics

oConsent Requirements (Electronic Consent, Paper Consent, Verbal…)

oList of Data Elements

oFollow-up Required

oUse of Registry or 3rd party Vendors for Data Processing

oData Exchange mechanisms

oData Exchange Partners (Clinics, Government, Other Registries….)

oHow various Registries handle data (??)

oFrequency of Data Collection

oStandard Data Elements

oName of Common Data Model

Approval of Meeting Minutes (November 2, 2016)

Motion made by Anita Walden to approve November 2 minutes, 2ndAbdulMalikShakir

Abstentions – 0

Nay – 0

Yea – 6

Minutes Approved.

Hot Topic – Other meetings attended regarding registries

No news

Agenda Item

Status of White Paper

  • Seth sent updated version on 11/5 to Anita and Rachel. Ready to go out for comment process.

Decision: Sharing the White Paper- get feedback first. Anita to send to CIC, Patient care, CQI and co-sponsor working group. Seth to also share.

HL7 Website discussed.

  • ACTION: Document will be forwarded to Anita/Karen Ritchey for posting on the sites. Replace documents on sites, versus keeping visible history of documents.
  • Discussed: per John Roberts – PHERis an option. He is personally interested - document will go to PHER
  • ACTION: Seth and Rachel will be contacts for feedback of the paper
  • Suggestion: Add page & line numbers to document. Seth will add page numbers and 1.5 line spacing.

Hot Topic (Last meeting Action Item): Get the word out

  • We will wait until the White Paper is final before sending information out about the Registry Initiative

Anita:HL7 Article/Newsletter – will f/u with HL7 on the process for News Letter articles.

Seth: Will place in PCPI Announcements/Newsletter

Amy: Not Present

Chrystal: Understood the paper would be finalized first, then will submit to WHO Committee Newsletter and place on committee’s next agenda

  • Question: How much time need for working groups to review white paper?

Decision: Two weeks. Post by tomorrow and comment deadline of 12/1.

  • Question: Send to broad group or inform people of paper – which first?

Contact for Feedback on White Paper Suggestions:

  • Contact Andrea Ribick, HL7 Director of Communications ()

Publishes three times per year – long lead time to make it into the publication. Maybe have note added to next issue, followed by lengthy article in May.

  • Office of National Coordinators, per John
  • Julia ______. Seth can reach out to contact.
  • CMS – work with sister agency to put in registry (link to CMS effort to collect info. on registries below)

AGENDA ITEM

Storyboard Approach

Interview Template DRAFT (as discussed last meeting)

  • Registry Category <Electronic Processing Only>

Clinical Focus Domain

Cardiology

Surgery

Cancer

Etc.

  • Purpose of Registry

Functions/Capabilities/Purpose/Use

Cardiology

Quality Improvement

Research

Guideline of Development

Etc.

Seth’s document relative to the above is shared with group via email (and is attached at the end of this meeting summary).

  • Suggestion:Per Anita, Proposed Template Question – Function of Registry should offer drop down answer menu - select all that apply.
  • Storyboard idea: What does a Registry do with the data?
  • Suggestion for Template – “Device surveillance”. Good list. Add to template and circulate.
  • Actors in Registry-dropdown list of (nurses, study coordinators, physicians….)

Chrystal: Ask Registries who are the actors.

Consider: (1)Who interacts with the data, or (2) who are the stakeholders?

  • Stakeholders
  • Hospital
  • Clinics
  • Specialty Units
  • Legislators/Regulators
  • Scope
  • National
  • State
  • Federal
  • Data Sources
  • Discussion: Historical data entered from patient chart, health systems, data warehouse to registries. Also directly from patients via portals.

AbdulMalik: Consider Source types (Mechanism).

  • Process Data – (What is the work flow from data collection to storage)
  • Data quality assurance: get it correct before entry in registry.

Interview Template DRAFT – topics not covered will be discussed next meeting

oRegistry Category <Electronic Processing Only>

  • Purpose of Registry _ several functions (see Seth’s Registry Function in the box on the page.
  • Actors in Registry-dropdown list of Stakeholders- (hospitals, clinics, specialty units, legislators, regulators...)
  • National, International State, Federated
  • Data Sources – Where does data come from? Direct entered, Extracted from medical record, Filling out web forms. Extracted from data systems, Data warehouse, PAC system, Device, Patient Source
  • Data Collection Mechanism –Direct Data Entry, Electronic Extraction, Secure Web Portal, Applications
  • Process Data – (What is the work flow from data collection to storage)-Data Quality Assurance process, Feedback loop.

What we will cover next meeting…

What Registry does with data (Process once data is in Registry Custody, analytics

oConsent Requirements (Electronic Consent, Paper Consent, Verbal…)

oList of Data Elements

oFollow-up Required

oUse of Registry or 3rd party Vendors for Data Processing

oData Exchange mechanisms

oData Exchange Partners (Clinics, Government, Other Registries….)

oHow various Registries handle data

oFrequency of Data Collection

oStandard Data Elements

oName of Common Data Model

ACTION:

Finalize White Paper (Seth and Rachel)

Document will be forwarded to Anita/Karen Ritchey for posting on Web.

Seth and Rachel will be contacts for feedback. Deadline December 1.

Get word out – Anita, HL7 newsletter / Seth, PCPI Announcements/Newsletter

Next Meeting Agenda

  • Interview Template continued
  • Meeting, San Antonio, TX, January 2017 (who should we invite and what topics to cover?)

Next meeting – Wednesday November 30 @ 9 AM (EST)

Submitted by: Karen Ritchey

Attachment:

Notes from November 2016 calls discussion on registry types for the DAM

Seth Blumenthal / PCPI & NQRN

HL7 Common Clinical Registry Framework project

Notes from November 2016 calls discussion on registry types for the DAM

Seth Blumenthal / PCPI & NQRN

The NQRN advocates for “collect once and re-use” health data infrastructure. We prefer generalized clinical information systems including registries, that collect data that can be used for multiple purposes.

Although it is common to refer to registries by their primary purpose, such as medical device postmarketing surveillance, NQRN prefers that registries by categorized by the clinical domain(s) they focus their data collection on. We then recommend that registry functions be added to that list.

Example:

Registry inventory

Name / Domain / Registry function(s)
Registry A / Cardiology / Quality improvement
Research
Guideline development
Performance reporting i.e., to CMS as a QCDR
CDS
Public reporting
Device surveillance
Registry B / Surgery / …
Registry C / Orthopedics / Device surveillance
Registry D / Immunization / Public health surveillance
Registry E / Cancer / Quality improvement
Research
Guideline development
Performance reporting
Public health surveillance
…
Registry X / … / …

The NQRN national clinical registry inventory (available here) lists registries across the clinical domains. It is not a comprehensive list but it has most of the major registry programs in the United States.

The NQRN registry maturational framework (Framework) describes the functions of a registry, along with the underlying capability necessary to support those functions. A public preview version of the framework is available here. The Framework lists the following high-level functions a registry could potentially have at various maturity phases in its lifecycle:

  • Quality improvement
  • Research
  • Guideline development
  • Shared decision-making tools development
  • Performance measurement reporting; facilitating the submission of data/results to evaluating organizations such as the federal government, health plans and ratings organizations
  • Measure development and testing
  • Public reporting
  • Clinical decision support
  • Cost effectiveness evaluation

In addition to more detailed specific functions or uses within these categories, the Framework then categorizes registries according to various registry domains such as participation size and scope, data type, measure type, reporting, etc.

NQRN has not published the full detailed Framework, but NQRN is currently submitting a paper on the Framework to peer-review journals.