Resources

• Agency for Healthcare Research & Quality (AHRQ): National Resource Center for Health Information Technology
• U.S. Food & Administration (FDA): Mobile Medical Applications
•  National Institute of Standards and Technology (NIST):
  • EHR / Health IT Certification Test Methods
  • Health Information Technology Usability Home Page
• National Library of Medicine (NLM): Tools for EHR Certification and Meaningful Use Home Page
• ONC: The Office of the National Coordinator for Health Information Technology (ONC)

Clinical Laboratory Improvement Advisory Committee (CLIAC)

• 2012 Letter from CLIAC to HHS Secretary regarding EHRs, patient safety and usability
• 2013 Letter from ONC in response to CLIAC’s 2012 health IT recommendations
• 2015 Letter from CLIAC to HHS Secretary regarding laboratory interoperability
• 2015 Letter from HHS in response to CLIAC’s 2015 health IT recommendations

• Health IT Policy Committee (HITPC)
• Health IT Standards Committee (HITSC)

APHL-CDC Informatics Self-Assessment for Laboratories
Measures overall informatics capabilities of a laboratory. Can be used for both public health and clinical laboratories.

API Laboratory Information System Assessment Toolkit
Developed by the Association for Pathology Informatics (API) to help laboratory leaders place value on LIS functionality to facilitate discussions with organizational executive leaders

NIST HL7 Validation Tools
Online certification test tools for EHRs based on ONC requirements and associated HL7 Implementation Guides. Current tools include:

• Laboratory Orders Interface (LOI)
• Laboratory Results Interface (LRI)
• electronic Directory of Service (eDOS) (Order test menus in EHR for ambulatory providers)
• Electronic Laboratory Reporting (ELR) (Reporting to state public health agencies)
• Clinical Document Architecture (CDA) Guideline Validation (HL7 v3 exchange model for clinical documents)

ONC SAFER Guides for EHR Assessment
The following four SAFER Guides are specifically noted for review of laboratory data; however elements in all SAFER Guides may have relevance to laboratory testing:

• Test Results Reporting and Follow-up
• Computerized Provider Order Entry with Clinical Decision Support
• Patient Identification (relates to blood product administration, laboratory test ordering, and laboratory results retrieval and display)
• High Priority Practices (relates to order sets, order status, use of SNOMED and LOINC, interface testing, and decision support recommending or relying on laboratory tests)

ONC Security Risk Assessment
Tools to help you conduct a security risk assessment, based on the Health Insurance Portability and Accountability Act (HIPAA) Security Rule. A risk assessment helps your organization ensure it is compliant with HIPAA’s administrative, physical, and technical safeguards. A risk assessment also helps reveal areas where your organization’s protected health information (PHI) could be at risk. Developed by ONC, in collaboration with the HHS Office for Civil Rights (OCR) and the HHS Office of the General Counsel (OGC).

Format Standards

• Health Level 7 International – Standards supporting EHR certification requirements, licensed at no cost.
• HL7 Implementation Guides – Scroll down the page to see guides designated for “Laboratory” on the left side of the table.

Vocabulary Standards

• LOINC® (Logical Observation Identifiers Names and Codes)
  • LOINC® Mapping tool (free): Regenstrief LOINC Mapping Assistant (RELMA) Comprehensive LOINC® mapping resource. Users should consider using a tiered implementation approach. Focus initially on top 80-90% of tests by volume for the laboratory, particularly those with numerical or positive/negative results. These results are the target of CMS incentive payments for EHR adopters. Also give priority to tests for notifiable conditions to public health, which are also targeted. (See the Laboratory Interoperability Collaborative for public health reporting resources below.)

• SNOMED® (Systematized Nomenclature of Medicine–Clinical Terms)
  Hosted at the U.S. National Library of Medicine.

• UCUM (Unified Code for Units of Measure)

Implementation Support

• Laboratory Interoperability Collaborative (LIC)
  Online resource initially developed through a CDC grant, to help connect clinical laboratories to public health laboratories for electronic laboratory reporting of notifiable conditions (aka “ELR”). The resources are helpful in understanding and implementing interoperable vocabulary standards.

• Regional Extension Centers
  ONC-funded technical support centers for EHR implementation.

Implementation Support for Rural Health Setting

• Rural Assistance Center’s Health Information Technology Toolkit
  The Rural Assistance Center (RAC) was established in December 2002 as a rural health and human services “information portal.” RAC helps rural communities and other rural stakeholders access the full range of available programs, funding, and research that can enable them to provide quality health and human services to rural residents. Originally created under by the U.S. Department of Health and Human Services’ Rural Initiative.

• FCC Broadband Connectivity Resources
  Summary of various Federal Communications Commission programs to support access to telecommunications, broadband and internet services in rural settings.

• USDA Health IT Capital Resources
  Links to a variety of funding opportunities from the US Department of Agriculture intended to develop the IT infrastructure for rural and agricultural communities.

• National Rural Health Resource Center
  Nonprofit organization providing a full range of services to support health IT for rural health populations. Originally developed through grants from HRSA’s Office of Rural Health Policy.

• Health IT Buzz – Official ONC Blog
• Health IT Strategist
• HITECH Answers

ONC Federal Advisory Committees and Workgroups
Submit an application for future consideration on a national committee or workgroup.

• Standards & Interoperability Framework (S&I)
  Join a voluntary IT standards setting workgroup. Organized by the ONC, the S&I Framework is an active online community of volunteers developing Health IT standards (HL7 Implementation Guides), such as those that support the Laboratory Order Interface (LOI), Laboratory Results Interface (LRI), and electronic Directory of Service (eDOS). Collaboration occurs online by joining the S&I Wiki
• Measure Applications Partnership
  Provide feedback on proposed healthcare measures to the National Quality forum.
• Regulations.gov
  The official government portal to submit comments for proposed regulations.

EHR Related Acronyms from Fall 2011 Clinical Laboratory Improvement Advisory Committee meeting

• The Essential Role of Laboratory Professionals: Ensuring the Safety and Effectiveness of Laboratory Data in Electronic Health Record Systems, CDC Report, May 2014
• FDASIA Health IT Report – Proposed Strategy and Recommendations for a Risk-Based Framework
  U.S. Food and Drug Administration, Office of the National Coordinator, and Federal Communications Commission, April 2014.
• Laboratory Interoperability Best Practices – Ten Mistakes to Avoid
  College of American Pathologists White Paper, March 2013
• Health Information Technology Patient Safety Action and Surveillance Plan
  Office of the National Coordinator Proposal, December 2012
• How to Identify and Address Unsafe Conditions Associated with Health IT
  Office of the National Coordinator, November 2013
• Comparative User Experiences of Health IT Products: How User Experiences Would Be Reported and Used
  Institute of Medicine Discussion Paper, September 2012
• Health IT and Patient Safety: Building Safer Systems for Better Care
  Institute of Medicine Report, November 2011
• Report to the President – Realizing the Full Potential of Health Information Technology to Improve Healthcare for Americans: The Path Forward
  President’s Council of Advisors on Science and Technology, December 2010

• ONC EHR Standards and Certification: Health Information Technology Standards, Implementation Specifications, and Certification Criteria and Certification Programs for Health Information Technology (45 CFR 170)
  • Stage 1 (2012)
  • Stage 2 (2014)
  • Stage 3 (2017 – Proposed rule expected fall of 2014 per CMS communication.)
• CMS Meaningful Use: Standards for the Electronic Health Record Technology Incentive Program (42 CFR 495)
  • Stage 1 (2012)
  • Stage 2 (2014)
  • Stage 3 (2017 –Proposed rule expected fall of 2014- per CMS communication.)
• HIPAA – 2013 Modifications to the HIPAA Privacy, Security, Enforcement, and Breach Notification Rules
  (HIPAA 45 CFR Parts 160 and 164)