1. Page 0 10/19/201510/19/2015 Meaningful Use of Health IT: Laboratory Data Capturing and Reporting Nikolay Lipskiy, MD, DrPH, MBA CDC, PHITPO

2. Page 1 10/19/2015 Speakers 10/19/2015 E-mail: dgz1@CDC.GOVdgz1@CDC.GOV

3. Page 2 10/19/201510/19/2015 Background Process Payment incentives are available for Medicare and Medicaid eligible providers and hospitals that purchase, implement, and meaningfully use certified EHR systems. EHRs certified by a recognized body must meet a set of Stage 1 objectives, and be able to report to CMS or states on a set of clinical quality measures that will be set forth by CMS in 2011. Additional objectives will be required for Stage 2 to receive incentives in 2013 and for Stage 3 in 2015. Timelines July13, 2010 CMS / ONC Final Rules Displayed July 28, 2010 CMS / ONC Final Rules Published in the Federal Register Effective Date : 60 days after CMS / ONC Final Rules Published Jan. 1, 2011: Registration Process to receive incentive payments begins May, 2011: EHR incentive payments begin Five Stage 1 Objectives Improve quality, safety, efficiency, and reduce health disparities Engage patients and families in their own health care Improve care coordination Improve population and public health Ensure adequate privacy and security protections for personal health information

4. Page 3 10/19/201510/19/2015 Composition of Measures at Stage 1 CORE SET (15 Objectives)− Eligible Professionals, Eligible Hospital, or CAH required to satisfy all core set of objectives Meaningful Use MENU SET (10 Objectives) − Select 5 Measures that includes one from Population Health − The other 5 Measures defer to Stage 2 Core Objectives

5. Page 4 10/19/201510/19/2015 Core Objectives (cont.)* Composition of Measures at Stage 1 * D. Blumenthal and M. Tavenner. The “Meaningful Use” regulations for Electronic health Records. The New England Journal of Medicine, 2010, 07/13/2010

6. Page 5 10/19/201510/19/2015 Core Objectives: Capturing of Laboratory Data In EHRs 1) §170.302(g) - Incorporate laboratory test results* Final Rule Text: (1) Receive results. Electronically receive clinical laboratory test results in a structured format and display such results in human readable format. ( 2) Display test report information. Electronically display all the information for a test report specified at 42 CFR 493.1291(c)(1) through (7). ( 3) Incorporate results. Electronically attribute, associate, or link a laboratory test result to a laboratory order or patient record. The 42 C.F.R. § 493.1291 Standard: Test report. States: “(c) The test report must indicate the following: (1) For positive patient identification, either the patient's name and identification number, or a unique patient identifier and identification number. (2) The name and address of the laboratory location where the test was performed. (3) The test report date. (4) The test performed. (5) Specimen source, when appropriate. (6) The test result and, if applicable, the units of measurement or interpretation, or both. (7) Any information regarding the condition and disposition of specimens that do not meet the laboratory's criteria for acceptability. This measure does not specify a standard by which laboratories must transmit test results * 45 Part 170, Health Information Technology: Initial Set of Standards, Implementation Specifications, and Certification Criteria for Electronic Health Record Technology, Final rule

7. Page 6 10/19/201510/19/2015 §170.302(h) - Generate patient lists Generate lists of patients by specific conditions to use for quality improvement, reduction of disparities, research* Core Objectives: Capturing of Laboratory Data in EHRs Final Rule text, §170.302(i): Generate patient lists. Enable a user to electronically select, sort, retrieve, and generate lists of patients according to, at a minimum, the data elements included in: (1) Problem list; (2) Medication list; (3) Demographics; and (4) Laboratory test results. * 45 Part 170, Health Information Technology: Initial Set of Standards, Implementation Specifications, and Certification Criteria for Electronic Health Record Technology, Final rule

8. Page 7 10/19/2015 Final Rule – Standards & Certification (1) 10/19/2015 Federal Register / Vol. 75, No. 144 / Wednesday, July 28, 2010 / Rules and Regulations (page – 52) - LinkLink

9. Page 8 10/19/2015 Final Rule – Standards & Certification (2) 10/19/2015

10. Page 9 10/19/201510/19/2015 CSTE-CDC ELR Taskforce is focused on nationwide implementation of electronic laboratory reporting. A draft vision of successful nationwide implementation of ELR: “All labs (public and private) conducting clinical testing identify laboratory results that indicate a potential reportable condition for one of the jurisdictions they serve, format the information in a standard manner, and transmit appropriate messages to the responsible jurisdiction; all jurisdictions can and do receive and utilize the data.” Proposed Workgroups to Address the Priorities: Meaningful Use Workgroup: Charged with developing a strategic plan for coordination and communication between states, CDC and ONC. Timeline: August 2010– January 2011 ELR Standards and Management Workgroup: Charged with evaluating and endorsing electronic data standards to reduce variation in what is required for ELR across the nation. Timeline: August 2010- July 2011 Model Law and Policy for ELR: Charged with developing model state law and policy for ELR to be made available to all states for adoption. Timeline: August 2010-December 2010 Resource Needs/Capacity Assessment Workgroup: Charged with articulating exactly what resources are needed to implement local/state ELR through a capacity assessment. Timeline: August 2010-February 2011 LIS Vendors/Large Laboratories Workgroup: Charged with communicating with LIS vendors to include appropriate standards into products prior to certification and to work with large laboratories to ensure full implementation of ELR. Timeline: August 2010-January 2011 National Activities for Supporting Meaningful Use/ELR Objective

11. Page 10 10/19/201510/19/2015 Next Steps

12. Page 11 10/19/201510/19/2015 Next Steps (cont.)* Hurdles: Lack of human and fiscal resources. Expanding the use and maintenance of 3rd party messaging brokers to simplify message building. Issue with maintaining multiple messages for multiple partners (again, see adoption of 3rd party technologies). Standardizing and collaborating at the national level, while maintaining state based priorities. Readiness for HL7 Based on PHLIP readiness assessments (34 respondents) completed by SPHL participating in the project, we have the following statistics: o 75% of respondents were generating 2.3.1 messages.  This data matches data from the 2008 ELR survey that indicated that the national labs were also at 2.3.1 o 14% responded they are producing 2.5.1 messages o 85% of respondents are using a third party broker which will assist in moving to and maintaining new versions of HL7 (as opposed to building that capacity in their LIMS) The extent of or approach to State based/jurisdictional collaborations regarding the advancement of 2.5.1 for ELR. * Information for slides 9 and 10 was adapted from a presentation of Dr. Seth Foldy “Public Health Preparation for Meaningful Use Stage 1 ” at the Summit on Public Health Readiness For meaningful Use, Atlanta, August 9 th, 2010

13. Page 12 10/19/201510/19/2015 Readiness for LOINC From the 2009 ELR survey 88% of jurisdictions had implemented at least a partially operational ELR. Of these only about half were more than 50% operational. From this we can infer that they all have at least some rudimentary capacity to receive, map, and/or store data using LOINC codes, since it is a required coded element in the ELR message. Based on PHLIP readiness assessments, about 60% of state public health laboratories were using LOINC codes in their Laboratory. What is not known is how the jurisdictions are using LOINCs. Although we can assume the LOINC codes are being used to aggregate received data and to map to local codes for transmitted data, these specific questions have not been asked in these surveys. Since the LOINC database is constantly being updated with newer versions, the version of LOINC being used is unknown and may be an earlier or later version. Most jurisdictions find and update map LOINC codes on the own, probably use the most current or most available LOINC data base Hurdles: Staffing, funding and message variation. o Of these staffing is the biggest challenge to adoption of LOINC. Because of LOINC’s complexity and redundancy and the lack of harmonization of ELR vocabularies, the laboratories oftentimes lack the technical skill and knowledge to implement the LOINC standard. Funding for LOINC training. The modification LIMS and workflows in order to incorporate LOINCs The ability to identify appropriate LOINC codes. o Increasing collaboration between Labs and Epis to define the appropriate LOINC codes for use. Next Steps (cont.)

14. Page 13 10/19/201510/19/2015 Thank you