Certification / Adoption Workgroup

Larry Wolf, chairMarc Probst, co-chair

Certification / Adoption Workgroup

January 10, 2014

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Agenda

• Review of Agenda• HITPC Charge: Step Two

– Presentation on ONC Certification Process– Discussion of Potential LTPAC health IT Certification Criteria

• Next Steps• Public Comment

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Updated Call Schedule

Date Call Schedule 10/25/2013 Overview of new charge11/4/2013, 11/18/2013 Develop a framework for certification12/2/2013, 12/12/20131/10/2014, 1/17/2014

LTPAC EHR background presentation, virtual hearing, draft recommendations

1/21/2013, 1/28/2014,2/7/2014, 2/14/2014

BH EHR background presentation, virtual hearing, draft recommendations

2/21/2014, TBD Workgroup review and finalization of recommendations

3/11/2014 Recommendations to HITPC3/26/2014 Recommendations to HITSC

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CERTIFICATION PROCESS OVERVIEW

Scott Purnell-SaundersONC Office of Certification

CERTIFICATION PROCESS OVERVIEW

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ONC HIT Certification Program – Participants

ONCOffice of the National Coordinator (ONC), Office of Certification manages the ONC HIT Certification Program.

NVLAPNational Voluntary Laboratory Accreditation Program (NVLAP), administered by the National Institute of Standards and Technology (NIST), accredits Accredited Testing Laboratories (ATLs).

ONC–AA ONC-Approved Accreditor (ONC-AA) accredits and oversees ONC-Authorized Certification Bodies (ONC-ACBs). Note: There is only one ONC-AA at a time.

ATLNVLAP Accredited Testing Laboratory (ATL) tests Health IT (HIT), including Complete EHRs and/or EHR Modules. Note: There can be multiple ATLs.

ONC-ACB ONC-Authorized Certification Body (ONC-ACB) certifies HIT, including Complete EHRs and/or EHR Modules. Note: There can be multiple ACBs.

Developer/Vendor Creator(s) of HIT, including Complete EHRs and/or EHR Modules.

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ONC HIT Certification Program – Structure

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ONC reviews and posts certified

product to CHPL

ONCapproves

ONC-AAApproved Accreditor

accredits

NVLAPNational Voluntary Laboratory

Accreditation Program

accredits

Developer/ Vendor

performs testing against criteria

ACBAuthorized

Certification Body*

ACBAuthorized

Certification Body*

ONC-ACBONC-Authorized

Certification Body

certifies tested products

Authorized Testing Body*

Authorized Testing Body*

ATLAccredited Testing

Laboratory

performs testing against criteria

ISO/IEC 17011

ISO/IEC Guide 65

ISO/IEC 17025

NIST 150

NIST 150-31

auth

oriz

es

Product successfully passes testing

Product successfully achieves certification

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Test Method – 2011 and 2014 Edition Comparison

2011 Edition

• Aligned to Stage 1 MU

• 42 certification criteria

• 20 criteria require standards (48%)

• 14 criteria have test data (33%)

• 2 test tools

2014 Edition

• Aligned to Stage 2 MU

• 49 certification criteria

• 28 criteria require standards (57%)

• 29 criteria have test data (59%)

• 9 test tools

On December 14, 2012, the approved 2014 Edition Test Method was posted and is being updated as necessary.

2014 Edition Testing and Certification began on January 2, 2013.

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ONC HIT Certification Program – ATLs and ACBs: Overview

NVLAP – Accredits Testing Laboratories (ATLs)• Certification Commission for HIT (CCHIT)• Drummond Group, Inc.• ICSA Laboratories, Inc.• InfoGard Laboratories, Inc.• SLI Global Solutions• Wyle Laboratories

ANSI – Accredits Certification Bodies (ACBs)• Certification Commission for HIT (CCHIT)• Drummond Group, Inc.• ICSA Laboratories, Inc.• InfoGard Laboratories, Inc.

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ONC-Authorized Certification Body(ONC-ACB)

Certification Based on a Standardized Accreditation Process:• Prior to being authorized by ONC, certification bodies

must be accredited by an ONC-approved Accreditor (ANSI).

• Accreditation is granted to a certification body based on the assessment of the body's competence in accordance with ONC and ANSI requirements, including demonstrated compliance with:

– ISO/IEC Guide 65 - General requirements for bodies operating product certification systems

– IAF Guidance on the application of ISO/IEC Guide 65 – 45 CFR PART 170 – Health Information Technology Standards,

Implementation Specifications, and Certification Criteria and Certification Programs for Health Information Technology

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ONC-Authorized Certification Body(ONC-ACB)

The certification process reassures health care providers that technology they adopt has been evaluated by an independent third party for conformance to federally approved criteria.

Some of the key activities of the certification body include:• Reviewing test results submitted by Accredited Test Labs (ATLs) for products

being considered for certification

• Rendering a decision on certification and communicating results to ONC for

publishing on the CHPL

• Maintaining a directory of certified products, including results of testing used to

render certification decisions for 2014 Edition certified products

• Providing an official certificate, certification mark, and working with the vendors to

maintain up to date certifications through product updates

• Conducting post-market surveillance of certified products

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Summary

ONC HIT Certification

Program

CHPL

Test Method

• Launched on October 4, 2012

• Includes new name and structure

• Separate entities for testing and certification

• Launched CHPL 3.0 in January 2013

• Includes 2011 Ed., 2014 Ed., and combination of 2011 and 2014 Ed.

• Offers downloadable “CHPL Product Information” report

• 2014 Ed. Test Method posted on December 14, 2012 (updates on-going)

• Testing and Certification began on January 2, 2013

• Unit-based testing currently implemeneted (required)

Scenario-Based Testing

• Scenario-based testing for future implementaiton (optional)

• Make testing clinically plausible

• First scenario, EHR Interoperability: Intake, available for public input

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LTPAC HEARING:Summary of Testimony Received

LTPAC HEARING

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LTPAC Hearing Agenda: December 12, 2013

Panel 1: Clinical Perspective— Shelly Spiro, Pharmacy HIT Collaborative — Steve Handler, University of Pittsburgh — Brian Yeaman, NRHS Findlay Family Medicine — Nimalie Stone, CDC

Panel 4: Vendor Perspective — John Damgaard, MDI Achieve — Doc DeVore, Answers on Demand — Karen Utterback, McKesson — Cheryl Hertel, Cerner

Panel 2: Clinical Perspective— Terry O’Malley, Partners HealthCare — Laura Tubbs, Southwest LTC Management Services — Lauri Harris, Avalon Healthcare

Panel 5: Regulatory / Quality Improvement Perspective — Karen Tritz, CMS — Stella Mandl, CMS— Crystal Kallem, Lantana Group — Darrell Shreve, Aging Services of Minnesota

Panel 3: Provider Perspective— Lisa Harvey McPherson, Eastern Maine Homecare — Steve Chies, Benedictine Health System — Scott Ranson, Brookdale Living — Terry Leonard, Life Care Centers of America

Panel 6:Patient and Caregiver Perspective — Leslie Kelly Hall, Healthwise — Sandy Atkins, Partners in Care Foundation — Joanne Lynn, Altarum

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Summary

Interoperable Systems Needed:– Need a consistent core capability; does not need to be tied to MU– Should be limited to areas of importance for LTPAC settings and EHR-focused– Must have consistent standards for sending/receiving of information and the contents of

messages– EH/EP are just beginning to exchange health information and certification criteria should further

such efforts– Must include transitions of care and care plans, including patient input

Concerns:– Transport (still occurs point to point)– Message content – will the information be relevant to the receiver (e.g. help with the mandated

assessments)? – Message standards – will the messages be able to be imported? ( Will the codes line up?)– Correct use of the technology pipeline– Dichotomy between vendor/provider comments: vendors cautioning restraint, providers noting

need for more robust systems– Broad concern about unfunded mandates. Emphasis on voluntary. Value in certification as a

roadmap.

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Summary Continued

Testimony on Setting –Specific Criteria:• Should be limited to regulatory minimum• Should focus on the potential to reduce regulatory reporting

burden (driven in part by different regulatory requirements across settings)

• Should consider workflow differences that are distinct from EP/EH settings

• Should enable increased clarity and consistency regarding standards

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PROPOSED LTPAC EHRCERTIFICATION RECOMMENDATIONS

PROPOSED LTPAC EHR

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Focus of Recommendations: Guiding Principles

– Transitions of care– Privacy and security – Interoperability– Leveraging existing capabilities– LTPAC setting specific efforts (patient assessments

and survey and certification)

Guiding Principle: Address the needs of the LTPAC settings; Build on and align with existing criteria/standards (MU, HL7 & CCHIT) to achieve interoperability through:

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Basis for Recommendations

• HIE RFI• LTPAC Hearing Testimony & Submitted Letters• Mapped comparison of prior, industry-led certification efforts,

including HL7 LTC Functional Profile (FP) and CCHIT (sponsored by ASPE) – Note: these efforts pre-date the MU certification program– However, these efforts demonstrate areas of importance for criteria

development (as identified by the industry)– Mapping also linked testimony from the LTPAC EHR hearing

• Analysis of ONC 2011/2014 certification modules adopted by LTPAC vendors (sponsored by ASPE)

• New, emerging health IT standards that could support LTPAC HIE (e.g. HL7 TOC and Care plan standards)

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Recommendation

ONC should consider LTPAC EHR certification criteria which addresses the following domains:• Privacy and Security• Interoperability, including:

– Transitions of care– Clinical Summary– Data Portability– View, Download, Transmit – Patient-Specific Education Resources – Incorporation of Laboratory Tests & Values/Results – Clinical Decision Support – Clinical Quality Measures

• Advance Care Planning • Patient Demographics • Clinical Health Information • Medication Related Criteria • Public Health (Immunizations)• Federally Required Patient Assessments • Survey and Certification Requirements

Building on existing criteria and standards

Recommendations MU MU 2 Base MU 2 Interoperability CriteriaPrivacy and Security MU2 x

Summary Care Record atTOC/Referral MU2, MU3* x x

Data Portability MU3* x x

View, Download, and Transmit to3rd Party

MU2 x

Clinical Summaries MU, M3* x

Patient-Specific EducationalResources MU2 x

Incorporating Laboratory Tests &Values/Results MU2 x

Clinical Decision Support MU2 x x

Advance Care Planning MU2, MU3*

Patient Demographics MU2 x

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Building on existing criteria and standards

Recommendations MU MU 2 Base MU 2 Interoperability CriteriaClinical Health Information:•Problem list•Medication list•Medication allergy list

MU2 x

•Clinical Information Reconciliation MU2 x

•Electronic Notes MU2

Medication Related: •e-MAR•Drug-formulary checks

MU2

•Electronic prescribing x

CPOE MU2 x

Public Health (Immunizations) MU2 x

LTPAC Setting Specific: PatientAssessment

LTPAC Setting Specific: Survey andCertification

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Recommendation on Privacy and Security

• “there should be anoverarching standard around security and privacy” • “.. if my IT department had not evaluated the [EHR]software—I would've implemented a piece of software that, on a daily basis, would have been a HIPAA data breach violation”

• Authentication, Access Control, and Authorization

• Auditable Events and Tamper-Resistance

• Audit Report(s) • Amendments• Automatic Log-Off• Emergency Access • End-User Device Encryption • Integrity • Optional – Accounting of

Disclosures

• Previous certificationefforts have supportedprivacy, security andintegrity criteria

LTPAC Hearing Recommended Areas for Certification

Prior LTPAC Certification Efforts (HL7 LTC FP /

CCHIT LTPAC)

Recommendation on Summary Care Record at TOC/Referral

• “electronic exchange ofstandardized, interoperable clinical information between different IT platforms becomes the essential tool for care integration between and among acute and LTPAC providers”

• “As the patientexperiences care transitions, interoperability will lead to efficiencies…”

• Support the ability toreceive, display, incorporate, create and transmit summary care records with a common data set in accordance with the Consolidated Clinical Document Architecture (CCDA) standard and using ONC specified transport specifications

• Support the inclusionof emerging TOC and care planning standards being reconciled as part of Aug. HL7 CCDA ballot [MUWG-identified MU 3 criteria]

• Previous certificationefforts have supportedTOC/referral summaries

• The LTC FP and CCHITLTPAC program pre-datethe ONC 2014 transportstandards.

• The LTC FP and CCHIT LTPAC program pre-datethe HL7 Consolidated CDA standard.



CCHIT LTPAC)

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Recommendation on Data Portability

LTPAC providers:

• “are pressured by receiving EHs for better information”

• “getting pressure from EHs to be part of the system”

• “The focus of [LTPAC EHR] certification should be to support transitions of care”

• “standards used in meaningful use, such as CDA, SNOMED, LOINC, and RxNorm, can be and are supported within the EHR products to help obtain reater parity in the exchange of information regardless of formal certification”

• Support the ability to create a set of export summaries for all patients, formatted in accordance with the CCDA.

• Support the ability to enable patients who switch providers to have their care continue seamlessly (no repeat tests, missing key clinical information, etc). [MU 3 goal from IE WG]

• Support the ability to enable providers switching EHR systems to continue providing seamless care to patients (coded data in old system is consumable by the new system so clinical decision support still works). [MU 3 goal from IE WG]

• Previous certificationefforts have supported the creation of a clinical summary



CCHIT LTPAC)

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View, Download, and Transmit to 3rd Party

• “As we view, download, and transfer, the provider should protect … information, but the patient should continue…to direct it, so the work being done in Blue Button would have a great application in transitions of care and [LTPAC]”

• Support the ability to provide secure online access to health information for patients and authorized representatives to electronically view, download their health information in accordance with the CCDA standard

• Support the ability to transmit such information using ONC specified transport specifications

• Neither the LTC FP northe CCHIT LTPAC program include requirements providing patients with an online means to view, download, and transmit specified data to a 3rd party.

• 12/2 C/A WG call: Patientportals are available across all LTPAC provider types. However, frequency and breadth of use is unknown.



CCHIT LTPAC)

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Clinical Summary

• “…are pressured byreceiving EHs for better information and getting pressure from EHs to be part of the system”

• “The focus of [LTPAC EHR]certification should be to support transitions of care”

• “standards used inmeaningful use, such as CCDA, SNOMED, LOINC, and RxNorm, can be and are supported within the EHR products to help obtain greater parity in the exchange of information regardless of formal certification”

• Support the ability to create a clinical summary in accordance with the CCDA standard in order to provide it to a patient.

[Recommendation: Consistent with MUWG-identified criteria for MU3; update forthcoming. ]

• Previous certificationefforts have supported theCreation of a clinical summary



CCHIT LTPAC)

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Patient-Specific Educational Resources

• “75 percent of [long term care] provided by families in the home, and by non-licensed personnel and agencies going into the home.”• “we need to figureout the presentation layer that appeals to patients and families, … have one record that all parties can tap into, upload to, download from, right through to the end of the person’s life…”

• Support the ability to use ONC specified standards to electronically retrieve patient-specific education from content/knowledge resources.

• Previous certificationefforts have supported the process for patient educational resources

• 12/2 C/A WG call: Patientportals are available across all LTPAC provider types. However, frequency and breadth of use is unknown.



CCHIT LTPAC)

Recommendation on Incorporating Laboratory Tests & Values/Results

“The [CDS] systems thatwe've developed use signals that require the presence of admission, discharge, transfer, lab, and medication data…there are existing standards for lab, including LOINC and medications, NCPDP, and are widely available to support [AD detection and management].” “Due to our recentcertification process, we've built in some key capabilities. We can now import lab results…”

“Indeed, we find that sharing…lab results and just the exchange of demographics … have been the primary interest.”

• Support the ability to electronically receive, incorporate, and display clinical laboratory tests and values/results in accordance with the HL7 Version 2.5.1 Implementation Guide and with laboratory tests represented in LOINC

• Previous certificationefforts have supported receiving and incorporating, displaying lab results

• Neither the LTC FP northe CCHIT LTPAC criteria explicitly identify the ONC specified lab data components, for a test report



CCHIT LTPAC)

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Recommendation on Clinical Decision Support

• “CDS can greatly improvethe detection and management of [adverse consequences] and improve [regulatory compliance] and inclusion of medication specific CDS should provide alignment with and support existing federal and state programs...” • “the level ofopportunity for using [CDS] at the time of prescribing can be quite significant. For example, …clear opportunity to optimize the way antibiotics are being used and other antimicrobials”

• “we should try and link[CDS rules] to those harm related events to try and reduce that ”

Support the ability:• Evidence-based decision

support interventions. • Linked referential clinical

decision support. • Clinical decision support

configuration.• Automatically and

electronically interact• Source attributes• Drug-drug, drug-allergy interaction checks.

• Prior certification effortshave supported CDS interventions based on problems, medications, medication allergies, demographics & labs



CCHIT LTPAC)

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Recommendation on Clinical Quality Measures

• “if [EHR]certificationrequirements for LTPAC… were to include… the ability to exchange…interoperable data elements required for good transitions and …longitudinal coordination of care… this could be a quality metric that could drive some of the adoption of the EHR, [and] fundamentally improve the process of care.”

• “CMS believes that datauniformity…across settings, is critical to facilitate … transfer of information…and ….implement measures that can be harmonized across settings...”

• C/A Workgroup requests that HITPC Quality Measures WG discuss clinical quality measures further and provide recommendations to C/A WG on potential LTPAC CQM opportunities for LTPAC EHR certification.

• Neither the LTC FP northe CCHIT criteria require the ability to capture the data required by the specified Data Element Catalogs, use the HL7 QRDA standard, or require the ability to calculate quality measures as specified in the ONC 2014 edition.



CCHIT LTPAC)

Recommendation on Clinical Health Information

• “…documents to meetCMS documentation requirements of an annual comprehensive med review. This structured document contains the pharmacist provided reconciled active med list, allergy list, indications for each active medication, and special instructions for the patient…can be used by pharmacists and other health care providers in all practice settings including LTPAC and behavioral health.”

• Support the ability to record, change, and access the:o Problem listo Medication listo Medication Allergy listusing ONC specified standards

• Support clinical information reconciliation.

• Support Electronic Notes.

• Prior certification effortshave supported the ability to electronically record, change, and access problem list, medication list , medication history, active medication allergy list and medication allergy history.



CCHIT LTPAC)

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Recommendation on Advance Care Planning

• “We need advanced plansin all records, we need to know who the surrogate is, and not just a yes/no. We need to be able to code the major decisions…We need to make the core elements available to the patient, family, and caregiver. “

“…it is becoming actually harmful and dangerous to have in the electronic record only a yes/no on an advanced directive. Now, a majority of states accept the POLST—we could readily digitize most of the POLST entries, and we could readily scan and attach to the record a real document”

• Support the ability to recordwhether an advance directive exists for the patient

• Support the ability to store anadvance directive document in the record or provide a link to the advance directive in a repository or other location. [MUWG-identified MU3 Criteria]

• Support the ability to retain versions of the advance

directive document in the record or enable links to earlier versions of the advance directive document. [MUWG-identified MU3 Criteria]

•Future work: Standards for content of the advance directive

Prior certification has indicated:

• the type of advance directives completed

• when last reviewed, time stamp entry of information

• name and relationship of party completing the advance directive

• location and or source of legal documentation

*More info in supplemental mapping materials



CCHIT LTPAC)

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Recommendation on Patient Demographics

“exchange of demographics and using some of the older ADT standards have been the primary interest…”

• Support the ability to record, change, and access patient demographic data

using ONC specified standards

• Neither LTC FP nor CCHITcriteria identify explicit demographic data elements to be captured and maintained.

• Neither LTC FP nor CCHITinclude criteria addressing the ability to record, change, and access preliminary cause of death in the event of a mortality.



CCHIT LTPAC)

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Recommendation on Medication Related Criteria

• “the practice ofprescribers entering orders electronically into the EHR will decrease the chance for errors in the interpretation of prescriber orders.”

• “a significant number oforders are changed today verbally or via telephone, …..keystroke errors are frequently identified in our business as contributors to adverse events that result in patient harm.”

• “Pharmacistselectronically accessing and exchanging clinical information in these settings are vital to meeting institutional quality and safety medication management processes.”

Support for: • e-MAR• Electronic prescribing• Drug-formulary checks

• Previous certificationefforts have supported the ability to:

o record, change and access each of the order types (i.e., meds, labs, radiology /imaging)

• Verify right patient• NCPDP SCRIPT v10.6• Automatically andelectronically check whether a drug formulary exists for patient or drug



CCHIT LTPAC)

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Recommendation on Computerized Provider Order Entry (CPOE)

• “A subset of the criteriarules, such as e-prescribing, labs and other diagnostic data, and activities of daily living [from the ONC 2014 certification criteria would support TOC], could apply”

• Support the ability to electronically record, change, and access the following order types: (i) Medications; (ii) Laboratory; and (iii) Radiology/imaging.

• Previous certificationefforts have supported the ability to record, change and access each of the order types (i.e., meds, labs, radiology/imaging)

LTPAC Hearing RecommendationPrior LTPAC Certification

Efforts (HL7 LTC FP / CCHIT LTPAC)

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Recommendation on Public Health Transmission to Immunization Registries

• “defining a health ITstandard for… influenza vaccine administration… would enable…information…exchanged between… providers as well as … state vaccination registries. This could reduce duplication of immunization …among different…providers caring for the same person, reduce… individual’s risk of receiving multiple vaccinations…, and provide [PH] with reliable information and vaccine coverage within communities”

• Support the ability toelectronically generate immunization information for electronic transmission using ONC specified standards.

• Previous certificationefforts have supported the ability to record, change, and access immunization information.

• Neither the LTC FP northe CCHIT LTPAC criteria address creating immunization information for transmission using the HL7 v2.51 Immunization Messaging standard or HL7 Standard Code Set CVX – Vaccines Administered.

LTPAC Hearing RecommendationPrior LTPAC Certification

Efforts (HL7 LTC FP / CCHIT LTPAC)

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Recommendation on LTPAC Setting-Specific Criteria: Federally Required Patient Assessments

• “The handling of theMDS, … census data, care planning, quality assurance activities, by and large …are primarily used for internal operations of the SNF. There are a number of SNFs that would like to be able to transmit data… but the interoperability structure in the state is not terribly well developed for communicating between hospitals and SNFs, SNFs and home health or home care, assisted living.

• Support the ability to create,maintain, and transmit (in accordance with CMS requirements) assessment instruments and data sets for LTPAC: MDS 3.0, OASIC-C , IRF-PAI, CARE subset for LTCH, and a Hospice Item Set.

• Support the use of acceptedvocabulary standards to enable the reuse of assessment data for:

o various clinical purposes; and

o administrative purposes.

• Support the ability of the provider or a designated third party to create and exchange interoperable LTPAC Assessment Summary CDA documents

• Previous certificationefforts have supported the ability to create, maintain, transmit, and reuse assessment content.



CCHIT LTPAC)

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Recommendation on LTPAC Setting-Specific: Federally Required Patient Assessments

• “LTPAC reportingrequirements should be harmonized with clinical data required for patient care.”

• CMS believes that datauniformity…across settings, is critical to facilitate … transfer of information. It’s also what’s needed…to develop and implement measures that can be harmonized across settings... “

Future work: • Harmonization of federalcontent and format for patient assessments with ONC specified EHR standards (e.g. consistent standards on demographics).

• Make the dataelement library publically available and link content to nationally accepted standards.

• Previous certificationefforts have supported the ability to create, maintain, transmit, and reuse assessment content.



CCHIT LTPAC)

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Recommendation on LTPAC Setting-Specific Criteria: Survey and Certification

• “Surveyors need promptand complete access to the EHR to complete surveys as required.”

• “It would be interestingto consider if an EMR certification program could also include certain interoperability with this QIS [Quality Indicator Survey] software.”

•“it [is] imperative for the surveyors …to look across modules of the EMR to understand the timeline of how the different care components fit together.”

• Support the ability topromptly provide surveyors with access to the complete EHR, consistent with federal requirements.”

Future work:• Support surveyornavigation of the EHR. (e.g. Implementation guide describing the functions in the EHR that surveyors need). More work is needed in this area. • Support the QIS process.More work is needed in this area.

• Prior certification hassupported surveyor access to the complete EHR, consistent with federal requirements.



CCHIT LTPAC)

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Recommendation on Tracking LTPAC EHR Adoption and Use Trends

• As ONC advances LTPAC certification, ONC should track national trends in LTPAC health IT adoption. Such efforts should include tracking use by functionality and criteria.

• National survey data on LTPAC EHR adoption and use should utilize definitions that are consistent with those in the MU program.

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Certification / Adoption Workgroup

Documents