Certification / Adoption Workgroup

1. Certification / Adoption Workgroup Larry Wolf, chair Marc Probst, co-chair January 10, 2014

2. 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

3. Updated Call Schedule

4. CERTIFICATION PROCESS OVERVIEW Scott Purnell-Saunders ONC Office of Certification Certification Process Overview

5. ONC HIT Certification Program – Participants ONC Office of the National Coordinator (ONC), Office of Certification manages the ONC HIT Certification Program. NVLAP National 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. ATL NVLAP 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.

6. ONC HIT Certification Program – Structure ONC approves NVLAPNational Voluntary Laboratory Accreditation Program ISO/IEC 17011 ONC-AAApproved Accreditor authorizes ISO/IEC 17025 accredits ONC reviews and posts certified product to CHPL accredits NIST 150 Authorized Testing Body* ACBAuthorized Certification Body* ACBAuthorized Certification Body* Authorized Testing Body* ATL Accredited Testing Laboratory ONC-ACBONC-Authorized Certification Body NIST 150-31 ISO/IEC Guide 65 performs testing against criteria performs testing against criteria certifies tested products Developer/ Vendor 5 Product successfully passes testing Product successfully achieves certification

7. Test Method – 2011 and 2014 Edition Comparison On December 14, 2012, the approved 2014 Edition Test Method was posted and is being updated as necessary. 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 2014 Edition Testing and Certification began on January 2, 2013.

8. 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.

9. 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

10. 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

11. Summary ONC HIT Certification Program • Launched on October 4, 2012 • Includes new name and structure • Separate entities for testing and certification CHPL • 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 Test Method • 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

12. LTPAC HEARING: Summary of Testimony Received LTPAC Hearing

13. LTPAC Hearing Agenda: December 12, 2013

14. 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.

15. 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

16. PROPOSED LTPAC EHR CERTIFICATION RECOMMENDATIONS Proposed LTPAC EHR

17. Focus of Recommendations: Guiding Principles Guiding Principle: Address the needs of the LTPAC settings; Build on and align with existing criteria/standards (MU, HL7 & CCHIT) to achieve interoperability through: • Transitions of care • Privacy and security • Interoperability • Leveraging existing capabilities • LTPAC setting specific efforts (patient assessments and survey and certification)

18. 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)

19. 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

20. Building on existing criteria and standards

21. Building on existing criteria and standards

22. Recommendation on Privacy and Security Prior LTPAC Certification Efforts (HL7 LTC FP / CCHIT LTPAC) LTPAC Hearing Recommended Areas for Certification • Previous certification efforts have supported privacy, security and integrity criteria • “there should be an overarching 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

23. Recommendation on Summary Care Record at TOC/Referral Recommended Areas for Certification Prior LTPAC Certification Efforts (HL7 LTC FP / CCHIT LTPAC) LTPAC Hearing • Previous certification efforts have supported TOC/referral summaries • The LTC FP and CCHIT LTPAC program pre-date the ONC 2014 transport standards. • The LTC FP and CCHIT LTPAC program pre-date the HL7 Consolidated CDA standard. • “electronic exchange of standardized, interoperable clinical information between different IT platforms becomes the essential tool for care integration between and among acute and LTPAC providers” • “As the patient experiences care transitions, interoperability will lead to efficiencies…” • Support the ability to receive, 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 inclusion of emerging TOC  and care planning standards being reconciled as part of Aug. HL7 CCDA ballot  [MUWG-identified MU 3 criteria]

24. Recommendation on Data Portability Prior LTPAC Certification Efforts (HL7 LTC FP / CCHIT LTPAC) LTPAC Hearing Recommended Areas for Certification • Previous certification efforts have supported the creation of a clinical summary 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 reaterparity 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]

25. View, Download, and Transmit to 3rd Party Prior LTPAC Certification Efforts (HL7 LTC FP / CCHIT LTPAC) LTPAC Hearing Recommended Areas for Certification • Neither the LTC FP nor the 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: Patient portals are available across all LTPAC provider types. However, frequency and breadth of use is unknown. • “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

26. Clinical Summary Prior LTPAC Certification Efforts (HL7 LTC FP / CCHIT LTPAC) LTPAC Hearing Recommended Areas for Certification • Previous certification efforts have supported the Creation of a clinical summary • “…are pressured by receiving 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 in meaningful 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. ]

27. Patient-Specific Educational Resources Prior LTPAC Certification Efforts (HL7 LTC FP / CCHIT LTPAC) LTPAC Hearing Recommended Areas for Certification • Previous certification efforts have supported the process for patient educational resources • 12/2 C/A WG call: Patient portals are available across all LTPAC provider types. However, frequency and breadth of use is unknown. • “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 figure out 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.

28. Recommendation on Incorporating Laboratory Tests & Values/Results Prior LTPAC Certification Efforts (HL7 LTC FP / CCHIT LTPAC) LTPAC Hearing Recommended Areas for Certification • 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 certification efforts have supported receiving and incorporating, displaying lab results • Neither the LTC FP nor the CCHIT LTPAC criteria explicitly identify the ONC specified lab data components, for a test report “The [CDS] systems that we'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 recent certification 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.”

29. Recommendation on Clinical Decision Support Prior LTPAC Certification Efforts (HL7 LTC FP / CCHIT LTPAC) LTPAC Hearing Recommended Areas for Certification • Prior certification efforts have supported CDS interventions based on problems, medications, medication allergies, demographics & labs • “CDS can greatly improve the 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 of opportunity 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.

30. Recommendation on Clinical Quality Measures Prior LTPAC Certification Efforts (HL7 LTC FP / CCHIT LTPAC) LTPAC Hearing Recommended Areas for Certification • Neither the LTC FP nor the 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. • “if [EHR]certification requirements 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 data uniformity…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.

31. Recommendation on Clinical Health Information Prior LTPAC Certification Efforts (HL7 LTC FP / CCHIT LTPAC) LTPAC Hearing Recommended Areas for Certification • Prior certification efforts have supported the ability to electronically record, change, and access problem list, medication list , medication history, active medication allergy list and medication allergy history. • Support the ability to record, change, and access the: • Problem list • Medication list • Medication Allergy list using ONC specified standards • Support clinicalinformation reconciliation. • Support Electronic Notes. • “…documents to meet CMS 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.”

32. Recommendation on Advance Care Planning Prior LTPAC Certification Efforts (HL7 LTC FP / CCHIT LTPAC) LTPAC Hearing Recommended Areas for Certification 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 • “We need advanced plans in 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 record whether an advance directive exists for the patient • Support the ability to store an advance 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

33. Recommendation on Patient Demographics Prior LTPAC Certification Efforts (HL7 LTC FP / CCHIT LTPAC) LTPAC Hearing Recommended Areas for Certification • Neither LTC FP nor CCHIT criteria identify explicit demographic data elements to be captured and maintained. • Neither LTC FP nor CCHIT include criteria addressing the ability to record, change, and access preliminary cause of death in the event of a mortality. “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

34. Recommendation on Medication Related Criteria Prior LTPAC Certification Efforts (HL7 LTC FP / CCHIT LTPAC) LTPAC Hearing Recommended Areas for Certification • Previous certification efforts have supported the ability to: • record, change and access each of the order types (i.e., meds, labs, radiology /imaging) • Verify right patient • NCPDP SCRIPT v10.6 • Automatically and electronically check whether a drug formulary exists for patient or drug • “the practice of prescribers entering orders electronically into the EHR will decrease the chance for errors in the interpretation of prescriber orders.” • “a significant number of orders 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.” • “Pharmacists electronically 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

35. Recommendation on Computerized Provider Order Entry (CPOE) Prior LTPAC Certification Efforts (HL7 LTC FP / CCHIT LTPAC) LTPAC Hearing Recommendation • “A subset of the criteria rules, 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” • Previous certification efforts have supported the ability to record, change and access each of the order types (i.e., meds, labs, radiology/imaging) • Support the ability to electronically record, change, and access the following order types: (i) Medications; (ii) Laboratory; and (iii) Radiology/imaging.

36. Recommendation on Public Health Transmission to Immunization Registries Prior LTPAC Certification Efforts (HL7 LTC FP / CCHIT LTPAC) LTPAC Hearing Recommendation • Previous certification efforts have supported the ability to record, change, and access immunization information. • Neither the LTC FP nor the 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. • “defining a health IT standard 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 to electronically generate immunization information for electronic transmission using ONC specified standards.

37. Recommendation on LTPAC Setting-Specific Criteria: Federally Required Patient Assessments Prior LTPAC Certification Efforts (HL7 LTC FP / CCHIT LTPAC) LTPAC Hearing Recommended Areas for Certification • “The handling of the MDS, … 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. • Previous certification efforts have supported the ability to create, maintain, transmit, and reuse assessment content. • 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 accepted vocabulary standards to enable the reuse of assessment data for: • various clinical purposes; and • administrative purposes. • Support the ability of the provider or a designated third party to create and exchange interoperable LTPAC Assessment Summary CDA documents

38. Recommendation on LTPAC Setting-Specific: Federally Required Patient Assessments Prior LTPAC Certification Efforts (HL7 LTC FP / CCHIT LTPAC) LTPAC Hearing Recommended Areas for Certification • “LTPAC reporting requirements should be harmonized with clinical data required for patient care.” • CMS believes that data uniformity…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... “ • Previous certification efforts have supported the ability to create, maintain, transmit, and reuse assessment content. Future work: • Harmonization of federal content and format for patient assessments with ONC specified EHR standards (e.g. consistent standards on demographics). • Make the data element library publically available and link content to nationally accepted standards.

39. Recommendation on LTPAC Setting-Specific Criteria: Survey and Certification Prior LTPAC Certification Efforts (HL7 LTC FP / CCHIT LTPAC) LTPAC Hearing Recommended Areas for Certification • Prior certification has supported surveyor access to the complete EHR, consistent with federal requirements. • “Surveyors need prompt and complete access to the EHR to complete surveys as required.” • “It would be interesting to 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 to promptly provide surveyors with access to the complete EHR, consistent with federal requirements.” Future work: • Support  surveyor navigation 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.

40. 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.