CDC and CLIA Recommendations Chart

Untitled Document
Recommendations Issues Addressed Calls to Action Suggested Strategies Useful Resources

1.) Engagement: Laboratory professionals can provide laboratory expertise for health information technology (HIT) decision-making in the design, development, and implementation of Electronic Health Record (EHR) systems at both national and local levels

Current HIT Market Factors that increase data exchange and display errors as a result of ineffective communication and a lack of collaboration between labs and other stakeholders:

  • EHR vendors ongoing failure to consult/collaborate with lab professionals continually widens the knowledge gap between clinical practice/workflow and EHR system design and implementation
  • Frequent lab Information System (LIS) variance regarding Logical Observation Identifiers Names and Codes (LOINC) utilization, standardization, and mapping approaches perpetuates EHR-LIS interface semantic interoperability challenges
  • Some labs (i.e. rural labs) have limited access to HIT expertise and infrastructure

Part 1: Determine and communicate opportunities and mechanisms to get involved in collaborative, multi-disciplinary efforts supporting the semantic interoperability of lab data across HIT systems

Part 2: Share clinical expertise with federal agencies to aid in the development of national-level HIT policy, certification criteria, and standards to ensure that lab data is well-managed, CLIA-compliant, and used properly in a clinical context

  1. Provide lab expertise for HIT decision-making at national and local levels
  2. Serve on policy and standards federal advisory committees and the numerous ONC workgroups
  3. Monitor and submit comments on proposed rules and guidelines from all areas of government that impact EHR implementation and future EHR data use
  4. Foster healthcare executive and lab leadership support for staff to participate in national collaborative efforts
  5. Work with policy, certification, and standards development organizations to determine opportunities for collaboration
  6. Institute communication networks for the timely distribution of relevant healthcare information and issues
  7. Improve awareness of and connect providers and labs with resources that support the improvement and use of EHR systems
List of Relevant Federal Agencies:
  • The Centers for Medicare and Medicaid Services (CMS)
  • The Office of the National Coordinator (ONC)
  • The National Institute for Standards and Technology (NIST)
  • The Health Information Management Systems Society  (HIMSS)
  • The Federal Drug Administration (FDA)
  • The National Quality Forum (NQF)
  • The Agency for Healthcare Research and Quality (AHRQ)

Guidance Materials:
Safety Assurance Factors for EHR Resilience (SAFER) Guides, funded by ONC; published January 2014
Regenstrief LOINC Mapping Assistan (RELMA): a free mapping tool for converting local lab coding to LOINC

Collaboration Participation Opportunities:
The Lab Interoperability Collaborative: Provides an array of services to hospital labs to enable submission of reportable lab results to public health agencies as defined in MU final rules

2.) Data Integrity and Usability: Laboratory professionals can guide and maintain data integrity and usability to ensure that laboratory data are accurately presented in the EHR and available at the point of care

Differences in EHR and LIS Systems that often result in the incomplete and/or inaccurate transmission of lab data, thereby hindering semantic interoperability and accurate display of test results:

  • Differing hard-coding and data elements (i.e. reference ranges and/or units of measure)
  • Differing maximum character limits for data fields; may result in the truncation of test/long number strings
  • Differing sequential order of test result display based on date of service (i.e. chronological vs. reverse chronological display)
  • Differing allowable special characters (i.e. #, &, $, etc.)
  • Differing system designs for alerts, flags, and color-coding
  • Different fields and formats between hard copy lab reports and electronic screen display

Part 1: Collaborate with  vendors to ensure the usability, interoperability, and safety of HIT systems storing, exchanging, and incorporating structured lab data

Part 2: Collaborate with vendors to ensure that patient-specific lab information is provided in a timely manner to the intended recipient, not altered in an exchange between systems (interoperability and fidelity), and displayed in a manner assuring accurate interpretation





  1. Engage with EHR developers on the development and design of lab-related EHR system features (i.e. critical results alerts)
    • Assure EHR configuration aligns with clinical workflow patterns by promoting user-centered design features that support clinical practice realities
  2. Provide lab expertise for assessing and improving the interoperability and usability of EHR systems at both organizational and national levels
    • Develop lab data usability guidance, including consensus-based HIE standards
    • Share knowledge on lab data content and context to help shape the development of realistic scenarios for usability testing
    • Collaborate with other stakeholders to develop guides and practice models to improve EHR systems and CDS tools
  3. Facilitate rigorous assessment of the usability of lab test ordering and reporting functions in the EHR for high-risk patient testing
    • Verify that lab data are successfully transmitted and accurately displayed on the EHR user-screens
    • Lead/guide/participate in thorough usability testing throughout the design, configuration, and implementation of EHR systems to assure optimized display behavior

ONC’s Laboratory Report Tiger Team is tasked with making recommendations to ONC that will reduce the cost and burden associated with implementing EHR system interfaces that support lab test ordering and results reporting to physician offices.

The Standards & Interoperability (S&I) Framework: A collaborative community of volunteer participants from public and private sectors who are focused on providing the tools, services and guidance to facilitate functional HIE

Relevant Recently Published White Papers:

3.) Innovation: Laboratory professionals can partner with stakeholders to stimulate innovation in EHR technology and usability to reduce laboratory data-related errors attributed to the use of EHR systems

Legal barriers and the lack of aggregate data on EHR system-related patient safety events limit understanding of the scope and context of errors in EHR systems which, in turn, can limit or delay innovation

More data on real and potential EHR system-related errors are needed from credible, vetted sources to support assessment of EHR systems, identify patterns of safety concerns, and make improvements

Part 1: Advocate for the elimination of barriers to the free-flow of information on EHR system-related errors and patient safety risks, and develop guidelines for improved patient access to lab data

Part 2: Stimulate and drive HIT innovation to improve the usability of EHR systems, prompt identification of emerging conditions, reduce delays in treatment, improve patient safety, and benefit patient outcomes/save lives

  • Sophisticated analytics (i.e. computerized analysis of clinical indicators)
  • Real-time, automated CDS tools
  • Electronic test result management tools (i.e. timely/meaningful alerts)
  1. Champion collaborative efforts and support research agendas to provide more detail on lab data-related patient safety concerns in the EHR
  2. Collaborate with human factors engineers, EHR system interface designers, and others to advance innovation and the usability of lab data displays so that the right information is available at the right time and in the right format
  3. Encourage participation in EHR system assessments and voluntary reporting of EHR-related issues to Patient Safety Organizations (PSOs)
  4. Lead innovation in patient access to lab information
    • Convene experts and develop guidelines for improved patient access to lab data
    • Produce guidelines for the design of patient portals
    • Develop and disseminate education materials based on test results to inform the patient’s healthcare decision-making

CLIA Program and HIPAA Privacy Rule; Patients’ Access to Test Reports, Final Rule

Human Factors Engineering, AHRQ Definition: “A discipline that takes into account human strengths and limitations in the design of interactive systems that involve people, tools and technology, and work environments to ensure safety, effectiveness, and ease of use.”

Relevant Recently Published Literature: