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© 2011 Cal eCONNECT. All rights reserved. 1

California’s Medical Laboratory Assessment and Planning Project

Robert DieterleTechnical ArchitectCal eConnect, Inc.

June 14, 2011Washington DC

Presentation to S&I Framework LRI Group

2© 2011 Cal eCONNECT. All rights reserved.

A California-based nonprofit

Created by the State of California

Purpose: to guide the private and secure delivery of electronic health information – when and where it is needed.

BACKGROUND


Our Mission

To collaboratively establish policies, services, and innovations that make possible the appropriate, secure, and efficient exchange of electronic health information for the purpose of improving health and health care safety, quality, access, and efficiency for all Californians.


Primary Objectives


Core or Foundational Activities


History of the Laboratory Assessment Projectand the S&I Framework LRI Workgroup


“Conduct a comprehensive assessment of the laboratory and provider landscape related to electronic laboratory ordering and results delivery between ambulatory providers and California’s laboratories.

Scope of the California Project

• Purpose: − To understand current state of lab to ambulatory EHR data exchange,

including readiness to adopt a highly constrained implementation guide− To develop a roadmap for how Cal eConnect can help labs and ambulatory

providers adopt a standard for electronic lab reporting

• Focus: electronic reporting of lab results to ambulatory EHR− Readiness of labs (interfaces, current version of HL7, etc.)− Barriers to adoption− Policy and regulatory levers− Best practices− Support needed to adopt an electronic messaging standard for structured

results reporting


HospitalLab

HospitalEHR

IndependentLab

CID = Center for Infectious Disease

CSRB = Cancer Surveillance Reporting Branch

CLPPB = Childhood Lead Poisoning Prevention Branch

GDB = Genetic Disease Branch

CLPPBCSRBCID GDB

CA Dept. of Public Health

AmbulatoryEHR

ImplementationGuide

Cal eConnect /CambriaProject

A. Meaningful Use – Stage 1/2/3 – to EHR

B-1. Meaningful Use – Stage 1/2/3 – to PH

B-2. Meaningful Use – Stage 2/3 – to PH

A

A. “Incorporate clinical lab test results into EHR as structured data” B. “Capability to submit electronic data on reportable (as required by state or local law) lab

results to public health agencies (directly from EP/EH or through performing lab)’’

Scope of the Project -- Electronic Lab Result Reporting and Meaningful Use Criteria


Background -- What is the relationship between Implementation Guides and HL7?

HL7 v2.x

HL7 v2.5.1 -ORU^R01 Message

HL7

HL7 v3.0

HITSP-C36 ELINCS ELR2PH

HL7 v2.3, v2.3.1, etc.HL7 v2.5.1HL7Standard

HL7ImplementationGuides

HL7 v2.5.1 -ADT, OML, etc. Messages


Appendix B: Background -- What are the intended uses of the various implementation guides?

Implementation Guide

Intended Use for Lab Result Reporting

Developed by

HL7 Approved?

HITSP – C36 • Hospital Lab to Hospital EHR• Hospital/Independent Lab to

Ambulatory EHR• Hospital/independent Lab to Public

Health Agency

HITSP WG Yes (2007)

ELINCS • Hospital/Independent Lab to Ambulatory EHR

Industry WG Yes (2008)

ELR2PH • Hospital/independent Lab to Public Health Agency

HL7 WG Yes (2010)


Appendix B: Background -- Do the implementation guides have similar specifications?

Implementation Guide

# of Optional/Total Data Elements

Required Terminologies

Other Requirements

Live Sites

HITSP – C36 1,429 optional / 3,609 total

• LOINC for common lab codes

• SNOMED-CT for results/specimens

• UCUM for units of measures

• Structured med-micro reporting

• Unique objective IDs (OIDs)

• Unique order IDs

• None known

ELINCS 227 optional / 416 total

• LOINC for common lab codes

• HL7 codes for units of measure


• 11 lab-to-EHR interfaces

• All Quest Labs in CA

ELR2PH Not available • LOINC for common lab codes

• SNOMED-CT for results/specimens

• UCUM for units of measures


• Unique objective IDs (OIDs)

• Unique order IDs

• None known


Background -- Who has already implemented ELINCS in California?

~40 sites currently utilize a version of ELINCS

11 sites in California currently using ELINCS HL7-R1 for lab reporting


Our approach was to gather and analyze data, develop initial findings, and then refine our conclusions to build a roadmap


The assessment focused on labs’ readiness to adopt a lab data exchange implementation guide

Key Research Questions Initial Hypotheses

1. What types of laboratories are more ready to adopt an implementation guide for electronic messaging?

• Large, high-volume labs are more likely to have a higher degree of readiness due to their technology and financial resources

2. What barriers do laboratories face in adopting a data exchange standard for laboratory messaging?

• Lack of financial resources, technical maturity, and staff knowledge are all significant implementation barriers

3. What are other State’s doing to facilitate the adoption of electronic data exchange by laboratories?

• Mandates, regulatory oversight, lab licensing processes, and incentive/disincentive programs are critical for encouraging adoption

• Centralized translation services will help smaller labs bear the financial and technical burdens

4. What policy and regulatory levers are available to facilitate adoption of electronic laboratory messaging?

• Medi-Cal provider agreements and CDPH laboratory licensing can provide the enforcement vehicles

5. What types of support do laboratories need from Cal eConnect to aid in lab adoption of data exchange standards for lab messaging?

• Centralized hub/translation services are critical for Cal eConnect to provide

• Awareness, information, and technical assistance are valuable services which Cal eConnect can provide


Our study revolved around the following 5 areas and resulted in 22 key findings


Market Findings:1. While there are ~20,000 CLIA

certified labs in California, we estimate the target lab population to be ~9,000.

2. Physician Office Labs are the majority of California labs (50-60% of labs), but their estimated test volume is only ~10%.

3. Hospital Labs only represent ~5% of California labs, but they appear to account for the largest % of test volume.

4. Independent Labs only represent ~4% of California labs, but likely account for ~33% of test volume.

5. Rural labs make up 20% of the lab population; yet their volume is unknown.

Key Take-Away:•The lab population is too large for Cal eConnect to significantly support all labs in their adoption – need to focus on segmenting and prioritizing the population.•Addressing hospitals and large, independent commercial labs first, will yield a high % of the overall tests being transmitted electronically.


Lab Readiness Findings:

6. Several labs are unaware of existing standards, definitions, available resources, and California’s overall direction.

7. Many small labs do not have the existing infrastructure to exchange data electronically.

8. Labs will adopt a new standard or implementation guide only if their trading partners are ready for the standard.

9. Some labs appear to be reliant on their LIS vendors for guidance with adoption of an HL7 standard or implementation guide.

10. Since a variety of LIS and EHR systems are being used in California, many labs must build their own interface(s).


Lab Readiness Findings (continued):

11.The majority of labs who are transmitting data electronically today appear to be able to transmit in HL7 2.3.1.

12.The larger the lab (volume), the higher the likelihood that it is ready to transmit in HL7 2.5.1.

13. Many labs need to support multiple HL7 versions based on the interfaces with their trading partners.

14. Labs are not motivated to adopt a HL7 messaging standard due to the high cost, without an incentive or mandate.

15. Volume of Medi-Cal tests is not a determining factor of readiness to adopt a HL7-compliant messaging standard.

Key Take-Aways:•A coordinated communication plan and program is needed by Cal eConnect, CDPH, and DHCS to raise awareness among labs•Designation of a specific implementation guide would be welcomed by labs, especially if the guide supports a bi-directional (order and results) interface•To capture the greatest volume of lab results in a compliant format, focus on the large independent labs and large hospital labs•A centralized translation service may reduce the complexity of interfacing with multiple trading partners

HL7/ELINCS Readiness

CDPH’s Survey indicated:• ~50% of the respondents send electronic lab results

outside of their organization• ~67% of the respondents are able to transmit HL7

messages, either through their software or a conversion/translation engine

o ~97% of these labs are able to transmit results in HL7 2.3.1

o ~47% of these labs are able to transmit results in HL7 2.5.1

o ~43% of these labs are able to transmit results in both HL7 2.3.1 and 2.5.1


Barriers to Adoption:

16. Based on lab type, size, and other factors, each lab faces its own unique challenges and barriers to adoption.

Key Take-Away:•A key strategy is developing a tiered incentive and support approach


Policy and Regulatory Levers:17. Encouraging Implementation Guide adoption among Medi-Cal FFS labs

would require significant changes to the Medicaid Program Administration (MCPA).

18. Encouraging Implementation Guide adoption via the Managed Care contracts would have a high cost and low impact.

19. Standardization would help but is difficult to enforce and monitor.

Key Take-Away:•To facilitate adoption of a HL7 compliant lab messaging implementation guide (for lab to ambulatory EHR and lab to Public Health report), a specific authority to mandate and enforce a standard is likely needed

Best Practices:20. Some states have adopted and communicated a statewide

standard/specification (and implementation guide).

21. In addition to standards and specific implementation guides, states have implemented translation services to support labs who cannot meet the standard.

22. Other states have implemented financial and technical assistance programs to facilitate adoption.

Key Take-Away:•There are precedents for state HIE agencies to provide financial and/or technical assistance to help labs adopt standards and integrate with data-exchange hubs•However, we are unaware of any state as large and varied as California that has attempted such a program


High-level recommendations

Recommendations

1.Designate and promote a single highly constrained implementation guide, such as ELINCS as the preferred implementation guide for reporting lab results to ambulatory EHRs

2.Develop a customer-segment focused strategy to enable prioritization of incentives and support

3.Create targeted incentive and technical assistance programs based on customer-segments

4.Deploy HIE core services and lab data exchange services

5.Support California labs by coordinating and engaging with LIS and EHR vendors

6.Build CeC’s organizational capabilities to support client-focused services and necessary internal processes

7.Coordinate activities with related agencies and projects (e.g., with Public Health and Medi-Cal M.U. incentive program)

22© 2011 Cal eCONNECT. All rights reserved. 22

Lab Characteristics Low volume, few customers

Low volume, many customers

High volume, few customers

High volume, many customers

Examples • Physician group• Small independent lab

• Rural hospitals• Hospital lab, no

outreach• Labcorp

Barriers/reasons for not using electronic reporting

Manual processes are sufficient for their organization and business needs (n) / /

No demand from customers, providers or hospital who order lab results (n) / /

Existing infrastructure and/or technology cannot easily support electronic reporting (a)

Financially difficult to implement (a) Barriers/reasons for not adopting lab messaging standards

No incentive if already transmitting in another compliant format (e.g. meeting MU w/o ELINCS) (n)

No demand from customers, providers or hospitals the lab is sending electronic results for (n)

Existing infrastructure and/or technology cannot easily support or be modified to adopt standard message (a)

Financially difficult to implement (a)

KEY = High Applicability/Probability of barrier = Medium Applicability/Probability of barrier= Low Applicability/Probability of barrier(n) = a need barrier (driver/reason to implement )(a) = an ability barrier (ability to implement)

Key Takeaways:• Generally, smaller labs have more reasons/barriers not to adopt electronic lab reporting

• For low volume, few customer labs – they have less reason to adopt electronic reporting, but if they did, have a relatively higher capability of adopting electronic reporting

• For low volume, many customer labs – they have more reason to adopt electronic reporting, but they have a higher financial burden to do so

• Generally, for labs already sending compliant electronic results, the need or reason to adopt a specific standard can be a barrier while heir technology and financial burden to begin

sending standard messages is not

Barriers to electronic lab reporting and standard messaging - Summary


Implementation options/strategies for electronic lab reporting and standard messaging – Summary

Lab Characteristics Low volume, few customers

Low volume, many customers

High volume, few customers

High volume, many customers

Examples • Physician group• Small independent lab

• Rural hospitals• Hospital lab, no

outreach• Labcorp

Options and strategies for adopting electronic reporting

Manual processes are sufficient for their organization and business needs (n)

• Create mandate that all labs need to report electronically

• Create incentives

• Naturally incentivized by benefits of electronic reporting

• Demand by customers wanting to meet MU and can benefit by receiving electronic reports will drive laboratory adoption

No demand from customers, providers or hospital who order lab results (n)

Existing infrastructure and/or technology cannot easily support electronic reporting (a)

• Provide financial incentives and/or implementation support for disadvantaged organizations

• Adopt standard to assist with interface costs

• Generally are able to meet financial and technical needs to adopt electronic reportingFinancially difficult to implement (a)

Options and strategies for adopting lab messaging standards

No incentive if already transmitting in another compliant format (e.g. meeting MU w/o ELINCS) (n)

• Promote a single highly constrained ambulatory implementation guide

• Create demand for standards via adoption and usage of a Health Information Exchange

• Create sales/information campaign on the benefits of adopting lab reporting standards

• Create economic incentives to adopt standard

• Naturally incentivized if a standard would drive costs down with future interfaces

No demand from customers, providers or hospitals the lab is sending electronic results for (n)

Existing infrastructure and/or technology cannot easily support adoption of a standard message (a)

• Ensure technology feasibility by providing vendors incentives or mandating vendors to adopt standards

• Generally, current systems should be able to be configured to new standardsFinancially difficult to implement (a)


Regulatory Inventory – SummaryRegulatory Area

DescriptionCode Section

Summary and highlights

Health Information Exchange Development

Laws and codes dealing with California’s initiative to develop statewide HIE

HSC 130200 – 130205

• Creates OHII under CHHS• Defines powers and enforcement

HSC 130250 – 130255

• California Health Information Technology Act • Establishes need for HIE• Establishes need for governance entity• Gives CHHS power to apply for ARRA funds and subgrant funds to the governance entity• Defines power of the governance entity of HIE• Defines spending power of any grants received

HSC 130275 - 130282

• Defines powers of CHHS to adopt HIE• Establishes use of demonstration projects• Gives CHHS power to adopt regulations during demonstration project evaluations• Defines regulatory process of adopting regulations• Defines responsibilities of creating HIE

Privacy and Security

Laws and codes dealing with the Privacy and Security of patient medical information in California

CCC 56 – 56.16

• Confidentiality of Medical Information Act• Governs use and non-use of patient information

MedicaidLaws and codes governing the Medi-Cal providers

WIC 14000 – 14028.8

• Medi-Cal Act• Governs the relationship of Medi-Cal providers with Medicaid

Public Health Reporting

Laws and codes mandating hospitals and laboratories to report to CDPH

HSC 120130

• Duty to establish list of reportable diseases and conditions• Mandates electronic reporting commencing July 1 2009 or within one year of the establishment of a state electronic laboratory reporting system, whichever is later in a manner specified by the department (CalREDIE system)• List of diseases will be published in CCR Title 17 2505

HSC 121022 • Mandate HIV Reporting from laboratories

CCR Title 17 2505 and

• List and form of lab reports

AB 2658 - established CalREDIE

• Can use CalREDIE to report to Local Health Departments• Public health laboratories affected only???• Must send electronically

Licensing and Certification

Laws and codes governing licensure and registration of clinical laboratories in California

BPC 1200 – 1265 +

• Governs licensing and operations of laboratories• ( 1265 c)The department shall not issue a license or registration until it is satisfied that the clinical laboratory will be operated within the spirit and intent of this chapter, that the owners and laboratory directors are each of good moral character, and that the granting of the license will not be in conflict with the interests of public health.


Recommendations to the S&I LRI Framework Group

High-Level Recommendations

1. Focus on:

• a highly constrained implementation guide – easier to implement• ambulatory – this is the most significant area for improvement• incorporate public health and hospital reporting as alternate segments• Minimizing the number of data elements to be consumed by EHRs

2. Account for:

• the time and effort to implement a new guide• the difficulty of certifying compliance with a complex guide

3. Ensure that the guide can be implemented in parts for each environment

4. To facilitate adoption:

• Awareness needs to be raised among many labs• Need to set and communicate a direction, many labs are waiting • Financial incentives may be needed to address cost of adoption• Technical assistance programs are needed

5. Policy and regulatory levers need to be identified and utilized

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© 2011 Cal eCONNECT. All rights reserved. 26

Cal eConnect is committed to partnering with other states, the federal government, and the industry to facilitate the adoption of a common implementation guide that fills the required gaps that are currently impeding exchange.

For more information about this project or Cal eConnect, visit:

www.caleconnect.org

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