MU Stage1 Final Rule - Electronic Copy of Health Information (EH/CAH)

SECTION # Section 170.306(d)—Electronic Copy of Health Information

MU OBJECTIVE Provide patients with an electronic copy of their health information (including diagnostic test results, problem list, medication lists, medication allergies, discharge summary, procedures), upon request.

MU STAGE 1 MEASURE More than 50% of all patients of the EP or the inpatient or emergency departments of the eligible hospital or CAH (POS 21 or 23) who request an electronic copy of their health information are provided it within 3 business days.

CERTIFICATION CRITERION Final Rule Text: §170.306(d). (1) Enable a user to create an electronic copy of a patient’s clinical information, including, at a minimum, diagnostic test results, problem list, medication list, medication allergy list, and procedures: (i) In human readable format; and (ii) On electronic media or through some other electronic means in accordance with: (A) The standard (and applicable implementation specifications) specified in §170.205(a)(1) or §170.205(a)(2); and (B) For the following data elements the applicable standard must be used: (1) Problems. The standard specified in §170.207(a)(1) or, at a minimum, the version of the standard specified in §170.207(a)(2); (2) Procedures. The standard specified in §170.207(b)(1) or §170.207(b)(2); (3) Laboratory test results. At a minimum, the version of the standard specified in §170.207(c); and (4) Medications. The standard specified in §170.207(d). (2) Enable a user to create an electronic copy of a patient’s discharge summary in human readable format and on electronic media or through some other electronic means.

STANDARDS §170.205(a)(1) §170.205(a)(2) §170.207(a)(1) §170.207(a)(2) §170.207(b)(1) §170.207(b)(2) §170.207(c) §170.207(d)

TEST CRITERIA # §170.306(d)
http://healthcare.nist.gov/docs/170.306.d.1_ElectronicCopyOfHealthInformation_v1.1.pdf
http://healthcare.nist.gov/docs/170.306.d.2_ElectronicCopyOfHealthInformation_v1.1.pdf

USERS	CORE / MENU	SOLUTION DEVELOPERS	STATUS
EH/CAH	CORE	TBD	TBD

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GAP ANALYSIS

12/11/2010 1:28 PM (EDT)

Test Procedure ID	VistA Functions	Captured	Comments	Questions	Testing Notes
VE170.306.d.1 – 1.01	Create all five sample patients in advance using: - patient demographics (PIMS = JoAnne Brougham) - problem list (CPRS = CAC, Nedi Parks or Patti Henderson) - prescriptions (inpatient or outpatient? = Marv Friedman) - medication allergy (CPRS = Marv Friedman) - - need a Snomed code for the allergy type - - need to link RxNorm code to allergen - lab (enter, accession, verify = Dan Gray) - - need to link Lab tests to LOINC codes - procedures (CPRS, TIU = CAC again)		Tester shall select one test data set from TD170.306.d.1 (Note contradiction with Required vendor information, which claims the vendor gets to pick the patient). - We need to document how to do all of these things and train our lead tester and backup testers to be able to do all of this.
VE170.306.d.1 – 1.01	Have Marv Friedman review drug requirements: - are these inpatient pharmacy or outpatient - if outpatient, can we use non-VA drugs to cover this - if not, then we need to develop the CCR to handle inpatient Rx
TE170.306.d.1 – 1.02	We need package experts to review how to do each of these things We need to document how to do each of these things We need to train the lead tester and backup testers in doing this During the test, the lead tester needs to perform these actions		Vendor shall enter Vendor-supplied test data and/or NIST-supplied test data/examples into the patient record based on the data set selected by the Tester from TD170.306.d.1, including - Diagnostic test results - Problem list - Medication list - Medication allergy list - Procedure list
TE170.306.d.1 – 1.03	need to create UI to generate a CCR for a patient (EWD) (who?) - we'll need an EWD team to develop this - Rob Tweed, plus others to be determined need a CPRS client mod to launch the VISTA Comm EWD app - Steve Shreeve These are almost the same requirements as for core 7 EP - so solving it for one will solve it for both - except core 7 EP has the tester running this code during test		Using the Vendor-supplied test data and/or NIST-supplied test data/examples and the EHR function(s) identified by the Vendor, the Tester shall create a copy of the patient’s clinical information on electronic media or other electronic means in the Vendor-selected HL7 CCD format or ASTM CCR format, including - Diagnostic test results - Problem list - Medication list - Medication allergy list - Procedure list
TE170.306.d.1 – 1.03	We need to confirm whether CCR handles all these data elements Develop CCR further to handle any missing elements: - Snomed code with allergy type - RxNorm code with allergen - LOINC code with lab test result - possibly inpatient pharmacy data, which would be big development
TE170.306.d.1 – 1.03	Given NIST's preference for CCDs and their choice of an unreliable CCR conformance testing tool, it may be essential for us to finish our CCD development so we can test with a CCD if need be. What's left to be done? - we need to resolve the reduced list of errors remaining - it requires XSLT development talent - Ken Miller, Nancy Anthracite, and Dave Mishler can help finish this off - there are several other good people we could add - if we're willing to pay we can finish this off in time - a lot of hacking needs to be done to clean up the details - we need to complete the development we already started
TE170.306.d.1 – 1.04	Ensure that our CCR will pass a visual inspection		Using the NIST-supplied Inspection Test Guide, the Tester shall verify that the copy of the patient’s clinical information has been created correctly and without omission Using the Vendor-supplied test data and/or the NIST-supplied test data/examples in the TD170.306.d.1. data set selected by the Tester, Tester shall verify that all of the patient clinical information data are stored in the patient’s record, including - Diagnostic test results - Problems - Medications - Medication allergies - Procedures
TE170.306.d.1 – 1.04	We need to test our CCR using the standard American Academy of Family Physicians and the CCR Acceleration Task Force CCR style sheet to confirm we can pass this.		Note that NIST's test suite is silent about this, but it follows from the requirement for CCDs.
TE170.306.d.1 – 1.04	If we develop a CCD, we need to test it using the standard HL7 CCD style sheet to confirm we can pass this.		HL7 CCD style sheet – HL7 provides a style sheet to render HL7 CCD structured documents as part of the CCD specifications package. Contact HL7 directly for the specification package.
TE170.306.d.1 – 1.04	We can estimate our CCR with a CCR validator - http://chit.dyndns.org/CCRValidation We then need to ensure that our CCR will pass the CCR conformance testing tool - NIST has selected a broken Java-based CCR conformance testing tool - this endangers the use of a CCR in testing - potentially, we could try to make the SourceForge CCR Java validator work - we would need someone who knows Java - the CCR validator source code is available at SourceForge - but it's not actually running successfully anywhere as a validation service - we would need to set it up online as a validation service so people can test with it		Using the NIST-supplied conformance testing tool identified in the Conformance Test Tools section of this test procedure, Tester shall verify that the copy of the patient’s clinical information has been created in HL7 CCD format or ASTM CCR format, using the specified vocabularies, and in human readable form correctly and without omission, including - Diagnostic test results - Problems - Medications - Medication allergies - Procedures ASTM CCR – Open Health Data provides an ASTM CCR validation tool designed specifically to support this test procedure. The tool is available through the following: - Files can be retrieved from the SourceForge site: http://sourceforge.net/projects/ccrvalidator - Direct link to the file: http://sourceforge.net/projects/ccrvalidator/files/ValidationService/1.0/ValidationServi ce-1.0.war/download - Source code location: http://ccrvalidator.svn.sourceforge.net/viewvc/ccrvalidator/branches/
TE170.306.d.1 – 1.04	We can estimate our CCD with a CCD validator - https://www.solventus.com/aquifer/ccrviewportcontainer.aspx We then need to ensure that our CCD will pass the CCD conformance testing tool - NIST has a CCD conformance testing tool - it is available now at http://xreg2.nist.gov/cda-validation/index.html - practice beforehand to prove our CCD will pass it		HL7 CCD/HITSP C32 – NIST provides an HL7 CCD/HITSP C32 validation tool designed specifically to support this test procedure. The tool is available in two forms: - a downloadable package for local installation available at http://xreg2.nist.gov/cda- validation/mu.html - a web-accessable validator which is hosted by NIST available at http://xreg2.nist.gov/cda-validation/mu.html Support for these tools is available by contacting: - Andrew McCaffrey (andrew.mccaffrey@nist.gov) - Computer Scientist - National Institute of Standards and Technology (NIST) - Information Technology Laboratory