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ONC State HIE Cooperative Agreement Technical Assistance Program Laboratory Interoperability: Requirements, Challenges & Strategies May 13, 2011
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ONC State HIE Cooperative Agreement Technical Assistance Program Laboratory Interoperability: Requirements, Challenges & Strategies May 13, 2011.

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Page 1: ONC State HIE Cooperative Agreement Technical Assistance Program Laboratory Interoperability: Requirements, Challenges & Strategies May 13, 2011.

ONC State HIE Cooperative Agreement Technical Assistance Program

Laboratory Interoperability: Requirements, Challenges & Strategies

May 13, 2011

Page 2: ONC State HIE Cooperative Agreement Technical Assistance Program Laboratory Interoperability: Requirements, Challenges & Strategies May 13, 2011.

Agenda

• Introduction– Importance of Lab Interoperability– Actions for States

• Eligible Professionals (Structured Labs into EHR)– Meaningful Use Requirements– Challenges and Strategies– CLIA Regulations– State Innovations

• Eligible Hospital (Electronic Lab Report (ELR))– Meaningful Use Requirements– Challenges and Strategies– State Innovations

• Resources and Tools for Eligible Professionals and Eligible Hospitals

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Page 3: ONC State HIE Cooperative Agreement Technical Assistance Program Laboratory Interoperability: Requirements, Challenges & Strategies May 13, 2011.

INTRODUCTION

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Page 4: ONC State HIE Cooperative Agreement Technical Assistance Program Laboratory Interoperability: Requirements, Challenges & Strategies May 13, 2011.

Why is Lab Interoperability Important?

• Clinical decisions are often made or influenced significantly by lab results. • Lab results can represent up to 70-80% of all health care information for patients

and providers. • Key component of longitudinal Electronic Health Record.• Lab information needs to be shared among providers who may not be directly

linked or related for smooth healthcare delivery (Public/Pop Health-CM).• Over 200,000 Certified Clinical Labs in the US.• Effective exchange of laboratory information will help reduce redundancy of effort

and its associated costs.

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Page 5: ONC State HIE Cooperative Agreement Technical Assistance Program Laboratory Interoperability: Requirements, Challenges & Strategies May 13, 2011.

ACTIONS FOR STATES

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Page 6: ONC State HIE Cooperative Agreement Technical Assistance Program Laboratory Interoperability: Requirements, Challenges & Strategies May 13, 2011.

Initiate a Transparent Multi-Stakeholder Process

• Convene a representative group of stakeholders with a specific interest in lab interoperability, including providers, labs and lab organizations, payors and consumers to participate in the following activities:– Conduct a scan of the environment to determine number and type of labs in

the state, as well as the percentage of laboratories sending results electronically and using LOINC® standards.

– Perform a gap analysis. – Determine how to address gaps to ensure that one or more options are

available to eligible providers to meet Stage 1 MU by focusing on delivery of structured lab results.

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Page 7: ONC State HIE Cooperative Agreement Technical Assistance Program Laboratory Interoperability: Requirements, Challenges & Strategies May 13, 2011.

Monitor and Track MU HIE Capabilities in the State and Set Strategy to Meet Gaps

• Set the baseline, monitor and report on the following measures:– % of clinical laboratories sending results electronically.– % of health departments receiving notifiable lab results electronically.

• Develop and implement a strategy and work plan to address gaps in the delivery of structured lab results, as identified in the environmental scan:– States and providers should expect to address gaps in an incremental manner.– Consider that the size and type of lab can impact their ability and willingness

to participate in information exchange and facilitate interoperability.– Smaller and independent labs may need help from state agencies and/or RECs.

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Page 8: ONC State HIE Cooperative Agreement Technical Assistance Program Laboratory Interoperability: Requirements, Challenges & Strategies May 13, 2011.

Ensure Consistency with National Policies and Standards

• Ensure consistency with national standards, NW-HIN specifications, federal policies and guidelines:– Identify state regulations and statutes affecting lab interoperability.– Work with CLIA administrators.– Advocate for changes to local laws and regulations (see KY).– RECs should encourage adoption of EHRs that support the NW-HIN Direct

Specifications and/or offer lab interfaces with their systems.• Utilize technologies that are adaptable and flexible for future requirements,

including cross-border information exchange:– Some states, such as: New York, Maryland, Virginia and the District of

Columbia, where patients often live in one jurisdiction and seek treatment in another will benefit from studying the regulations of neighboring states to foster consistency where patients’ lab records cross state lines. Cross-border HIE will become more important, prevalent and complex as full interoperability is implemented.

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Page 9: ONC State HIE Cooperative Agreement Technical Assistance Program Laboratory Interoperability: Requirements, Challenges & Strategies May 13, 2011.

Align with Medicaid and Public Health Programs

• Establish an integrated approach that represents Medicaid and public health programs.

• Work with Medicaid and private payors to include interfaces as part of their contractual agreements with labs.

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Page 10: ONC State HIE Cooperative Agreement Technical Assistance Program Laboratory Interoperability: Requirements, Challenges & Strategies May 13, 2011.

ELIGIBLE PROFESSIONALS (STRUCTURED LABS INTO

EHR)

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Page 11: ONC State HIE Cooperative Agreement Technical Assistance Program Laboratory Interoperability: Requirements, Challenges & Strategies May 13, 2011.

Eligible Professionals - MU Requirements • Meaningful Use (MU) requires that at least 40% of test results ordered by eligible

or authorized professionals must be recorded as structured results in the provider EHR:– Applies to results that are either in a positive/negative or numerical format. – Must be incorporated into EHR as structured data.

• Methodology should be in place prior to MU stage 1 deadlines:– End of 2011 should be adequate to meet 2012 goals.

• Results must be in both machine and human-readable format.• Codes must be electronically displayed in human-readable format; if tests have

been received with LOINC® codes.• Patient records must be updated in a timely manner, based on received lab results.• Eligible Hospitals must comply with all Eligible Professional Requirements for

structured labs into certified EHRs.

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Page 12: ONC State HIE Cooperative Agreement Technical Assistance Program Laboratory Interoperability: Requirements, Challenges & Strategies May 13, 2011.

Workflow and HIE Options

Internet(May utilize HIE)

Transport of Specimen

LabEHR System LIMS

Order

ResultLIMS

Hospital, Clinic or Provider Office

In-houseLab

Order

Result

External/Reference Laboratory

1

4

1

2

3 3

4

Workflow:1. Lab order entered in EHR and

transmitted to LIMS2. Specimen transported to lab3. Lab runs test(s) and enters result in

LIMS4. LIMS sends lab result back to EHR

Lab Order

LIMS With or W/o

Custom Message

Mapping and Translation

Process

HIE System(Routing to EP, with or

w/o message trans lation

and mapping)

HL7 Interface or Direct

Structured Result

Certifi ed EHR

HIE/HUB

EligibleProfessional

HIE options for delivering structured labs into an EHR

Lab Result

Lab

Dir

ect

to

E

P

Sp

ecim

enTra

nsp

orte

d to

Lab

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Page 13: ONC State HIE Cooperative Agreement Technical Assistance Program Laboratory Interoperability: Requirements, Challenges & Strategies May 13, 2011.

ELIGIBLE PROFESSIONALS

CHALLENGES AND STRATEGIES

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Page 14: ONC State HIE Cooperative Agreement Technical Assistance Program Laboratory Interoperability: Requirements, Challenges & Strategies May 13, 2011.

Challenges and Strategies: Policy

Challenges Strategies• Lack of standardized contract language for EHR

contractors and lab IT procurements to support interface development strategies

• Develop standardized contract language that includes recommend requirements for:

− Messaging - HL7 2.5 preferred (or 2.3)− Transport – HIE services or Direct− Vocabulary - Adoption of LOINC®

• Weak business case for low volume practices • Little coordination among small, independent lab

partners

• Work with RECs to help smaller providers and laboratories move to interoperability

• Target gaps in infrastructure via strategies such as shared services or grants to small or independent laboratories

• Develop core services to reduce cost and complexity of information exchange:

− Code mapping services− Other message transformation services

• Enable state-wide directories and/or merge current disparate compendia

• Utilize Direct-enabled technology to assist smaller labs and providers

14Indicates strategies highlighted in “State Innovations” section

Page 15: ONC State HIE Cooperative Agreement Technical Assistance Program Laboratory Interoperability: Requirements, Challenges & Strategies May 13, 2011.

Challenges and Strategies: Policy

Challenges Strategies• No long-term economic model for sustainability • Encourage lab participation by:

− Offering interoperability to clinical providers may give specific labs a competitive advantage

• Investigate models for fee exchange service fees• Explore long-term funding opportunities

• Need for coordination between Medicaid, private payers and other health plans to require lab partners to support standards

• Establish policy, purchasing or regulatory requirements for electronic sharing of laboratory results in State or Medicaid contracts

• Lack of alignment (due in part to time constraints) of various initiatives promoting structured lab results

• Participate in S&I framework lab initiative and adopt final recommendations that reduce optionality

• Align disparate initiatives by working with certified EHR systems to meet Stage 1 MU requirements

• New standards and/or certification may require new or updated systems

• Work with vendors to determine if systems have been certified or can be upgraded to meet new certification criteria

• Implementation of laboratory orders into the HIE infrastructure

• Implementing orders will take significant resources. It may be better to delay this until lab reporting systems are firmly in place

15Indicates strategies highlighted in “State Innovations” section

Page 16: ONC State HIE Cooperative Agreement Technical Assistance Program Laboratory Interoperability: Requirements, Challenges & Strategies May 13, 2011.

Challenges and Strategies: Policy

Challenges Strategies• Differences in interpretation of CLIA regulations

from state to state• Lack of clear definition of CLIA regulations relating

to interoperability

• Define variance in interpretation from state to state• CMS has recently released specific guidance on

aspects of the CLIA regulations which relate to Stage 1 MU guidelines (see following slides for more information)

• State CLIA administrators may be able to help this process by providing guidance on CLIA language as it relates to interoperability and health information exchange

16Indicates strategies highlighted in “State Innovations” section

Page 17: ONC State HIE Cooperative Agreement Technical Assistance Program Laboratory Interoperability: Requirements, Challenges & Strategies May 13, 2011.

Challenges and Strategies: Standards

Challenges Strategies• Most states lack a central listing of all labs, making

it difficult to identify all potential participating labs− CMS has a central database, but it is not

electronic

• Accrediting organizations, such as the College of American Pathologists (CAP), may have accessible databases

• Lack of defined standards and certification models for LIS-EHR interfaces

• ELINCS provides some help with this process, mapping proprietary codes to standardized codes

• Participate in S&I framework lab initiative and adopt final recommendations that reduce optionality

• No standard compendium exists for lab test orders− This includes variations of the definition of

“normal” and “abnormal” ranges depending on the system in use

• Work to define normal and abnormal ranges

17Indicates strategies highlighted in “State Innovations” section

Page 18: ONC State HIE Cooperative Agreement Technical Assistance Program Laboratory Interoperability: Requirements, Challenges & Strategies May 13, 2011.

Challenges and Strategies: Standards

Challenges Strategies• Lack of uniform standards for laboratory

vocabulary:− Codes may need to be translated to a

standardized form− Semantic interoperability is required for

data transmissions to be understood

• Adopt LOINC® codes as a standard vocabulary for lab test results and orders, in accordance with the ONC Final Rule identifying LOINC® version 2.27 as the standard for laboratory coding that certified EHRs must support

• If LOINC® is not in place, there may be a need for code translation services

• Rely on certified technology wherever possible

• Multiple standards exist for representing lab results, making it difficult for the receiving system to process the incoming transmission properly

• Use commonly-adopted standards and implementation guides for lab results

• Adopt S&I framework lab recommendations due out fall of 2011

18Indicates strategies highlighted in “State Innovations” section

Page 19: ONC State HIE Cooperative Agreement Technical Assistance Program Laboratory Interoperability: Requirements, Challenges & Strategies May 13, 2011.

Challenges and Strategies: Transport

Challenges Strategies• Lab results must be transported reliably from the

lab to the provider• Lab result suppliers and/or HIE vendors should

provide secure encrypted transport services• These requirements should be spelled out in

standardized contractual language• Direct may be a useful option, providing a simple,

SMTP-based “push” transport useful with or without an EHR

• Challenges with bi-directional exchange:− Important for aggregation and business

intelligence tools− Bi-directional exchange not yet developed in

most systems

• Work with LIMS vendors to develop bi-directionality in their products.

• If an HIE is in place, work with the HIE vendor to assure bi-directionality of data

19Indicates strategies highlighted in “State Innovations” section

Page 20: ONC State HIE Cooperative Agreement Technical Assistance Program Laboratory Interoperability: Requirements, Challenges & Strategies May 13, 2011.

CLIA REGULATIONS FOR ELIGIBLE PROFESSIONALS

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Page 21: ONC State HIE Cooperative Agreement Technical Assistance Program Laboratory Interoperability: Requirements, Challenges & Strategies May 13, 2011.

CLIA Regulations – CMS Guidance Review

• Visual inspection:– Routine checks should be conducted to verify accurate, timely and reliably

conveyed results. – CLIA does not specify the method or frequency. Laboratories should establish

protocols that are reasonable based on the transmission mechanisms they use.

• Transmission of lab data through an HIE is acceptable under CLIA:– The key CLIA attribute is accuracy of information.– Electronic transmission of data need not be a barrier. Information transmitted

from laboratories should be accurately, timely and reliably sent to the final report destination.

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Page 22: ONC State HIE Cooperative Agreement Technical Assistance Program Laboratory Interoperability: Requirements, Challenges & Strategies May 13, 2011.

CLIA Regulations – CMS Guidance Review

• Encourages use of standards:– Does not require a particular standard.– CMS encourages the use of recognized standards such as HL7 as a data

transmission standard and LOINC® for laboratory test vocabulary.• Retention requirements unchanged:

– Laboratory records must be retained for at least two years.– CLIA does not specify the form in which records are to be retained, rather, CLIA

specifies that reports must be retrievable upon request for defined periods of time.

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Page 23: ONC State HIE Cooperative Agreement Technical Assistance Program Laboratory Interoperability: Requirements, Challenges & Strategies May 13, 2011.

CLIA Regulations – Differences Among States

• 20 states have incorporated language in their statutes referencing CLIA, including NH, AZ, and GA. Many other states are considering changes to state laws that were originally designed to mirror CLIA and need to be adjusted to reflect new approaches.

• Certain states, including NY, set their own state-level standards for certain kinds of laboratories. These standards are adjunctive or more stringent than the CLIA regulations.

• Laboratory records have been converted to electronic formats in many locations across the nation.

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Page 24: ONC State HIE Cooperative Agreement Technical Assistance Program Laboratory Interoperability: Requirements, Challenges & Strategies May 13, 2011.

CLIA Regulations – Differences Among States

• Release of results to provider:– Laboratory results must be released to an “authorized individual”.– The definition by statute varies from state to state.

• Release of results to patients:– Subject to the laws in each state. – The statutes vary widely by state.

• Release of results directly to EHR:– If one of the following conditions is met, it is permissible to release lab results

directly to an EHR, which can then be accessed directly by authorized providers or patients:

– The regulations in that state allow for release of lab records directly from the lab to a patient.

– Consent for patient or secondary provider access has been obtained prior to release of the lab records.

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Page 25: ONC State HIE Cooperative Agreement Technical Assistance Program Laboratory Interoperability: Requirements, Challenges & Strategies May 13, 2011.

STATE INNOVATIONS FOR ELIGIBLE PROFESSIONALS

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Page 26: ONC State HIE Cooperative Agreement Technical Assistance Program Laboratory Interoperability: Requirements, Challenges & Strategies May 13, 2011.

Delaware – Encouraging Lab Participation• Overview:

– An early implementer of HIE in 2007. – 75% of all Delaware hospitals and providers participating.– Most major national, regional and hospital-based laboratories are

participating.– 80-90% of all lab tests flow though a single system.

• Encouraging lab participation:– Interfaces:

– Standardized lab result data to ensure smooth exchange of information.– Negotiated standard/maximum rates with vendors.– Currently a maximum of $1,500 which includes bidirectional interface,

upgrades and services.– State HIE team certifies vendors.– REC supports providers to validate the DHIN EHR interface to ensure data

integrity of all DHIN data displayed in the EHR.

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Page 27: ONC State HIE Cooperative Agreement Technical Assistance Program Laboratory Interoperability: Requirements, Challenges & Strategies May 13, 2011.

Delaware – Encouraging Lab Participation

• Building consensus - a key attribute for success:– Convened multiple stakeholders and did not act without consensus; “all for

one and one for all”.– No initial “go-live” until everyone was on board.– Public-private multi-stakeholder groups, including a Board of Directors.– Project managers from all organizations contributing data meet weekly to

support technical/functional enhancements.– Avoided the use of “policy levers” and all participation is voluntary.

• Challenges:– Sustainability is evolutionary and coincides with value-added services.– Private sector funds are match by State funds.– EHR vendor willingness to load and maintain orders compendium for each

DHIN participating lab.

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Page 28: ONC State HIE Cooperative Agreement Technical Assistance Program Laboratory Interoperability: Requirements, Challenges & Strategies May 13, 2011.

Minnesota – Preparing for Laboratory Interoperability

• The MN e-Health Initiative and Public Health Laboratory provide leadership by:– Fostering the development of a state-wide laboratory network.– Using a robust database to identify participating labs.– Facilitating communication with all labs.– Bringing together stakeholders to raise awareness and create understanding

through communication channels.

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Page 29: ONC State HIE Cooperative Agreement Technical Assistance Program Laboratory Interoperability: Requirements, Challenges & Strategies May 13, 2011.

Minnesota – Preparing for Laboratory Interoperability

• To foster laboratory interoperability, MN is: – Identifying the status, barriers, and gaps for lab interoperability through

various survey tools.– Minnesota Clinical E-Laboratory Assessment for HIT Adoption and use

(statewide survey of 180 labs developed by Public Health Laboratory and Office of Health Information Technology).

– AHA Annual Survey Information Technology Supplement with Minnesota Specific Questions.

– MN Health Information Technology (HIT) Ambulatory Clinic Survey.– Providing oversight of Minnesota Health Information Exchange Service

Providers as required by MN Statute (62J.498-62J.4982) including monitoring volume and type of HIE transactions conducted.

– Identifying ways to leverage HITECH resources to provide technical assistance to labs and exchange partners.

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Page 30: ONC State HIE Cooperative Agreement Technical Assistance Program Laboratory Interoperability: Requirements, Challenges & Strategies May 13, 2011.

Minnesota – Preparing for Laboratory Interoperability

• Future Issues:– Continuing to develop a standard-based interface for messaging.– Developing tools and methods to provide technical assistance.– Identifying/providing incentives to achieve interoperability.– Incorporating the recommendations and activities from the MN.

e-health Initiative, including the Standards & Interoperability Workgroup, as well as the Adoption and Meaningful Use Workgroup relating to laboratory interoperability.

• To learn more about the MN e-Health Initiative go to: www.health.state.mn.us/e-health/index.html

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Page 31: ONC State HIE Cooperative Agreement Technical Assistance Program Laboratory Interoperability: Requirements, Challenges & Strategies May 13, 2011.

California – Multi-Pronged, Incremental Approach

• Medi-Cal:– Currently assessing the feasibility of contracting/requirements for electronic lab results.– Analyze claims and assess and prioritize labs by volume and market.

• Interoperability standards:– Ensure adoption and use of uniform lab interoperability reporting standards and

implementation guides.• Cal eConnect- State-Level Governance Entity:

– The implementation plan prioritizes the development of lab services as its most important value-added service (outside of Meaningful Use).

– Aids labs in routing lab results.– Potential to provide translation services for lab data.

» Outgoing messages must match incoming messages highlighting importance of translation services.

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Page 32: ONC State HIE Cooperative Agreement Technical Assistance Program Laboratory Interoperability: Requirements, Challenges & Strategies May 13, 2011.

Kentucky – Standardizing Semantic Interoperability• Developed detailed use cases first.• Milestones and lessons:

– Regulations: A group of stakeholders successfully lobbied the KY legislature to ease the consent restrictions for secondary providers seeking to obtain lab results from the HIE.

– Standards: Transformation of lab results to conform to required coding and transport standards was quite a challenge for labs not already using LOINC® coding.

– Successfully negotiated lab contract with lab supplier LabCorp.– Initially attempted to have the HIE convert EHR data to CCD.– May be problematic in that many EHRs are not capable of parsing the lab data

back out properly.– It may make more sense to use the HIE as a simple conduit of data using HL7

messages.• Current status:

– Routing lab results from state lab to physician – in testing.– Delivering electronic lab results to physicians who order electronically –

though still in early phases.

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Page 33: ONC State HIE Cooperative Agreement Technical Assistance Program Laboratory Interoperability: Requirements, Challenges & Strategies May 13, 2011.

North Carolina – Beginning a Direct Pilot

• NC is a Direct Pilot Implementation Geography:– Decision was made in December 2010 during a meeting with LabCorp, the

REC, the HIE, and HIT Coordinator.– Noted in the Operational Plan.

• Two phases to accommodate NC’s Operational Plan, which calls for more web-based exchange of results, and the use of Direct so that results can be exchanged quickly:– Direct – LabCorp already has the interfaces so this work can begin now.– XDR for "web-based" push of lab results – Cannot start until the HIE is

operational (by end of 2011).• Created two groups to tackle issues:

– Steering Committee that addresses policy issues.– Technical group, which has developed a work plan.

• Identified practices volunteering as test cases, and gained support of their EHR vendors to participate in the pilot.

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Page 34: ONC State HIE Cooperative Agreement Technical Assistance Program Laboratory Interoperability: Requirements, Challenges & Strategies May 13, 2011.

New Jersey – Developing Regulations

• NJ plans to implement regulation to compel all labs to send results electronically as a requirement for payment of claims.

• Working with Quest to implement this plan:– Quest believes it can comply with such a regulation and advised NJ to include

the standard processing of orders in the regulation.– NJ is awaiting sample language from Quest.– The Department of Banking and Insurance, a key stakeholder, is in full support.

• NJ plans to follow S&I framework (lab initiative) recommendations on specifications when addressing the interoperability issues around labs.

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Page 35: ONC State HIE Cooperative Agreement Technical Assistance Program Laboratory Interoperability: Requirements, Challenges & Strategies May 13, 2011.

Wisconsin – Providing Technical Assistance for Lab Interoperability• WI conducted a survey to identify HIE “white space” and found:

– Of 739 reference labs in Wisconsin, about 168 don’t deliver any results electronically and about 350 only deliver results electronically to providers within their legal entity.

• WI plans to target outreach efforts and HIE technical assistance (TA) for implementing Direct secure messaging to reference labs, including labs in critical access hospitals, who are not presently delivering electronic results to the providers they serve in their community.

• Used lab tests volume (from claims data) and the number of providers served by a lab to help prioritize labs receiving subsidized TA.

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Page 36: ONC State HIE Cooperative Agreement Technical Assistance Program Laboratory Interoperability: Requirements, Challenges & Strategies May 13, 2011.

Wisconsin – Providing Technical Assistance for Lab Interoperability

• There are several stakeholders involved in this activity:– The WI Statewide Health Information Network (WISHIN) is the state-level

governing body and maintains all programmatic responsibilities (though it is not the recipient of the Cooperative Agreement).

– The REC is collaborating with WISHIN by identifying critical access hospitals with reference labs that need HIE assistance.

– The state-level HISP is a sub-recipient to WISHIN and serves as the resource center for HIE TA and for Direct services.

• TA includes access to website resources, telephone consultations, and potentially an initial site visit. Beyond that, WI plans to subsidize HIE TA with Cooperative Agreement Program funding, where the labs will have to pay a fee for onsite TA received.

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Page 37: ONC State HIE Cooperative Agreement Technical Assistance Program Laboratory Interoperability: Requirements, Challenges & Strategies May 13, 2011.

ELIGIBLE HOSPITALS

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Page 38: ONC State HIE Cooperative Agreement Technical Assistance Program Laboratory Interoperability: Requirements, Challenges & Strategies May 13, 2011.

Eligible Hospitals: MU Requirements

• Eligible Hospitals must comply with all Eligible Professional Requirements for structured result into their EHR.

In addition Eligible Hospitals must:

• Select one of three public health measures.• Electronically record, retrieve, and transmit reportable clinical lab results to public

health agencies:– Stage 1 requirement is for a single test, and then submission, if tested

successfully and if agency can receive.– Must use HL7 v2.5 and appropriate implementation guide which requires

LOINC® and SNOMED.• EHR/HIE vendors should provide secure, encrypted and auditable transport

services (e.g., Direct).• Must use certified option for sending labs to public health. In many cases, this

requires a separate certification process for the eligible hospital if sending directly from LIMS.

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Page 39: ONC State HIE Cooperative Agreement Technical Assistance Program Laboratory Interoperability: Requirements, Challenges & Strategies May 13, 2011.

Workflow and Meaningful Use ELR Certification Scenarios

39

EHR And/Or LIMS And

Custom Message

Mapping and Translation

Process

EHR And/Or LIMS EHR

HIE System(Routing to

PH, No message

trans lation or mapping)

HIE System(Routing

or message trans latio

n or mapping

HIE System(Routing

or message trans latio

n or mapping

Scenario 2 * (multi -component)

Hospital

Scenario 3Meaningful Use EHR Certification Scenarios for ELR

Scenario 1 * (multi -component)

* A How-To document for the hospi ta ls should be created to expla in the process of certifying multiple components us ing certifi cation authorities

Public Health

HIE/HUB

= Hospi ta l s must certify a l l modules , s ince the EHR i s not performing a l l the MU functions

Complaint 2.5.1 message Non-complaint 2.5.1 message Complaint 2.5.1 message

Complaint 2.5.1 message

Publ ic Heal th Data Stores / Appl ications

Publ ic Heal th Message Receiver Publ ic Heal th Message Receiver

Publ ic Heal th Data Stores / Appl ications

Publ ic Heal th Message Receiver

Publ ic Heal th Data Stores / Appl ications

Dire

ct to

PH

Dire

ct to

PH

=

=

Page 40: ONC State HIE Cooperative Agreement Technical Assistance Program Laboratory Interoperability: Requirements, Challenges & Strategies May 13, 2011.

CHALLENGES AND STRATEGIES FOR

ELIGIBLE HOSPITALS

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Page 41: ONC State HIE Cooperative Agreement Technical Assistance Program Laboratory Interoperability: Requirements, Challenges & Strategies May 13, 2011.

Challenges and Strategies: Policy

Challenges Strategies

• Lack of Public Health Readiness • Ensure better communication and cooperation between public health agency and Medicaid/SDE where ties are weaker

• Leverage activities of CDC and appropriate professional organizations (ASTHO, AIRA, ISDS, CSTE, APHL)

• Apply for additional public health readiness funds when available (ARRA, other)

• Work with PH to develop a comprehensive MU assessment and plan

• Clinical work flow for disease reporting is more complex than lab result reporting alone

• Most using translation services

• Inconsistent documentation of reportable conditions by state

• Work with CDC and CSTE to keep state-by-state listing up-to-date

41Indicates strategies highlighted in “State Innovations” section

Page 42: ONC State HIE Cooperative Agreement Technical Assistance Program Laboratory Interoperability: Requirements, Challenges & Strategies May 13, 2011.

Challenges and Strategies: Technical

Challenges Strategies• Multiple, inconsistent transport protocols • Work with public health agency to educate about

Direct and other options• Encourage development of agency-wide transport

for PH submissions• Work with state NEDSS project to ensure reporting

is compliant with MU

• Lab reports submitted directly from LIMS may not be a certified EHR solution

• Work with EP/EH to ensure proper certification of multiple component system leverage existing electronic lab reporting systems

• Lack of uniform use of standards for laboratory vocabulary:

• Codes may need to be translated to a standardized form

• Semantic interoperability is required for data transmissions to be understood

• Adopt LOINC® codes as a standard vocabulary for lab test results, in accordance with the ONC Final Rule identifying LOINC® version 2.27 as the standard for laboratory coding

• If LOINC® 2.27 is not in place, there may be a need for code translation services

• Rely on certified technology wherever possible

42Indicates strategies highlighted in “State Innovations” section

Page 43: ONC State HIE Cooperative Agreement Technical Assistance Program Laboratory Interoperability: Requirements, Challenges & Strategies May 13, 2011.

STATE INNOVATIONS FOR ELIGIBLE HOSPITALS

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Page 44: ONC State HIE Cooperative Agreement Technical Assistance Program Laboratory Interoperability: Requirements, Challenges & Strategies May 13, 2011.

CDC Cooperative Agreement Surescripts

• Overview:– Collaboration with American Hospital Association and College of American

Pathologists.– Technical Assistance directly with hospitals.– Enable 500 Hospitals to achieve Meaningful Use for ELR:

– Includes 100 Critical Access Hospitals.

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Page 45: ONC State HIE Cooperative Agreement Technical Assistance Program Laboratory Interoperability: Requirements, Challenges & Strategies May 13, 2011.

Massachusetts ELR Reporting

• Overview:– MA ELR reporting went into production with June 2004.– Web service end point to send SOAP messages.– Plan to migrate to centralized Statewide HL7 Gateway.– 40 of 76 of hospitals laboratories send HL7 2.3.1 messages with local codes.– Upgrades to accept HL7 2.5.1 message by June 2011.– HL7 messages directly consumed by MAVEN (Statewide disease surveillance

system).• ELR transformation services:

– Local codes for laboratory tests and results translated to standard LOINC® and SNOMED.

– Other local codes (race, sex, etc.) translated to standard HL7 vocabularies.– HL7 2.3.1 messages for hospitals already transmitting to be transformed to

HL7 2.5.1 (certification process to be determined).

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Page 46: ONC State HIE Cooperative Agreement Technical Assistance Program Laboratory Interoperability: Requirements, Challenges & Strategies May 13, 2011.

California – Multi-Pronged, Incremental Approach

• Public health: – Assess public health capability to accept electronic lab results under ONC’s

standards and specifications for EHR.– California Department of Public Health developing an implementation guide to

assist hospitals (and laboratories) submit lab results to public health in order to meet Meaningful Use.

– Align public health lab reporting requirements with ambulatory and hospital lab reporting requirements wherever possible.

– Work with state laboratory field services to ensure licensing and certification of labs in California do not hamper interoperability.

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Page 47: ONC State HIE Cooperative Agreement Technical Assistance Program Laboratory Interoperability: Requirements, Challenges & Strategies May 13, 2011.

New Mexico HIE – ELR Reporting

• Overview:– NMHIC was created in 2004, and is operated by LCF Research. – NMHIC is New Mexico’s State Designated Entity (SDE), and designated by NM

Department of Health as the official agent for ELR reporting.– ELR reporting went into production with NM-DOH in June 2010.– 33 % of all New Mexico hospitals laboratories are participating, including the three

largest healthcare delivery systems in the state.– 66 % major national and regional laboratories are participating, including the two largest

independent reference laboratories in the state. – As NMHIC adds hospitals and labs to the HIE, ELR reporting to NM-DOH will increase.

• ELR transformation services:– Filtering, Coding, Message Transformation and Forwarding:

– NMHIC HIE inbound lab interfaces are customized to filter out reportable labs.– NMHIC performs appropriate LOINC® and SNOMED code mapping.– NMHIC transforms message type from v. 2.x to 2.3.1 for NM-DOH.– NMHIC forwards all reportable labs to the NM-Electronic Disease Surveillance.

System (NM-EDSS), which is connected to CDC-NEDSS.

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RESOURCES AND TOOLS FOR

ELIGIBLE PROVIDERS AND ELIGIBLE HOSPITALS

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State HIE Lab Interoperability CoP

• The State HIE Lab Interoperability Community of Practice (CoP) is comprised of approximately 70 members, including State HIT Coordinators and other key state stakeholders working to advance lab interoperability in their state.

• Short-term objectives focus on lab results delivery, including:– Developing standardized contract language for EHR contractors and lab IT

procurements, specifically for lab-to-EHR exchange requirements and vendor selection.

– Identifying common levers for Medicaid, private payers and others.– Defining CLIA and other regulations that relate to or may potentially hinder

laboratory participation in HIE.– Standardizing content specifications for results reporting, including HL7, LOINC®,

ELINCS (content, and vocabulary) as well as policy levers to encourage use of standardized laboratory codes.

• Long-term objectives focus on lab orders.• Contact Greg Farnum ([email protected]), ONC Facilitator for the Lab

Interoperability CoP, for more information.

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Regional Extension Center (REC) Functional Interoperability Community of Practice• The REC Program supports a Community of Practice (CoP) focused on functional

interoperability and HIE. • The Lab Workgroup within this CoP is tasked with aligning the REC program tasks

with Lab/Meaningful Use Stage 1 requirements: – This work group will collaborate with the other groups working on lab

interoperability and will report back to the CoP on a bi-weekly basis. 

 

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Standards and Interoperability Framework Lab Results Interface (LRI) Initiative• The LRI initiative was launched to incorporate lab results into EHR as structured

data. This aligns with the goals of MU to:– Achieve cost savings of up to 90% due to lab interface development

improvements by 2015. – Reduce total lab interface implementation time by up to 20% by 2013.

• The initiative is focused on:– Addressing this challenge for the subset of lab reporting to primary care

(internal medicine, family practice, pediatrics). – Optionally: Enable pilots that demonstrate electronic results delivery through

the agreed-upon standard, including linkages with directories and transport. • The group held its first meeting on February 1, 2011.• To stay informed, access deliverables and see outputs of the Use Case and

Requirements (UCR) Workgroup visit: S&I LRI Initiative

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Resources and Tools

• State HIE Program Website: – http://www.statehieresources.org

• CLIA Laws:– https://www.amia.org/files/shared/290-05-

0015_Final_508_State_CLIA_Law_Report.pdf– http://www.chcf.org/~/media/Files/PDF/E/

ElectronicLabResultsExchangePolicy.pdf– http://www1.cms.gov/SurveyCertificationGenInfo/downloads/SCLetter10-

12.pdf • Releasing Clinical Laboratory Test Results: Preliminary Report on Survey of State

Laws:– https://www.amia.org/files/shared/290-05-

0015_Final_508_State_CLIA_Law_Report.pdf

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