Top 5 Things to Know About The 2014 Edition ONC HIT Certification Program. Rylla Riverman, RN, CISM, GEIT, CHCQM-Fellow Gorylla Inc.

Transcription

1 Top 5 Things to Know About The 2014 Edition ONC HIT Certification Program Rylla Riverman, RN, CISM, GEIT, CHCQM-Fellow Gorylla Inc.

2 Today s Agenda Understanding the Major Differences Between the 2011 Program and the 2014 Program Base EHR vs. Complete EHR Gap Certification Price Transparency Safety Enhanced Design Quality Management System

3 2011 to 2014 ONC HIT Certification What has to be certified has changed. Definition of the EHR has expanded for attestation (Base EHR vs. Complete EHR) Criteria to be certified is changed. More accountability and depth in the program

4 Types of EHRs Edition ONC HIT certification Hospital (Inpatient) or Eligible Provider (Ambulatory) Modular or Complete 2011 Modular = Security +/- other criteria (but not all) 2011 Complete = Security + all other criteria 2014 Modular = at least one criteria (security optional) 2014 Complete = All criteria 2014 Base EHR = Minimum standard required for attestation, Base EHR + Menu Measures selected by EPs or HOS

5 Base EHR + Menu Measures Selected by EPs or HOS Base EHR Includes These Certification Criteria Requirements: Demographics (a)(3) Problem List (a)(5) Medication List (a)(6) Medication Allergy List (a)(7) Clinical Decision Support (a)(8) Computerized Provider Order Entry (a)(1) Clinical Quality Measures (c)(1) through (3) Transitions of Care (b)(1) Data Portability (b)(7) Privacy and Security (d)(1) through (8)

6 Stage 1, Stage 2, When, Where? 2011 Edition - Used for Stage 1 Expires 12/31/ Edition - May be used for Stage 1 or 2 Expires 12/31/2015

7 What is Gap Criteria Certification Criteria categorized as unchanged are considered Eligible under the 2014 Edition EHR certification criteria If eligible, you may not have to retest this criteria. Your criteria must be up to date with Product Updates with your ACB You still have other responsibilities with that criteria in seeking certification.

8 Gap Certification Criteria 2014 Edition 2011 Edition Regulation section Title of regulation paragraph Regulation section Title of regulation paragraph (a)(6) Medication list (d) Maintain active medication list (a)(7) Medication allergy list (e) Maintain active medication allergy list (b)(5) Incorporate laboratory tests and (h) Incorporate laboratory test results values/results (inpatient setting only) (f)(1) Immunization information (k) Submission to immunization registries (d)(1) Authentication, access control, and (o) Access control authorization (d)(6) Emergency access (p) Emergency access (d)(5) Automatic log-off (q) Automatic log-off (d)(8) Integrity (s) Integrity (d)(1) Authentication, access control, and (t) Authentication authorization (d)(9) Optional accounting of disclosures (w) Accounting of disclosures (a)(1) Computerized provider order entry (a) Computerized provider order entry (a) (a)(17) Inpatient setting only advance directives (h) Advance directives.

9 Gap Criteria Do Require Self Attestation Gap Criteria that a Self- Attestation document is required. For Gap eligible criteria requiring Safety-Enhanced Design, you also must apply for and certify to (g)(3) (a)(1) Computerized provider order entry (a)(6) Medication list (a)(7) Medication allergy list All of the gap-eligible criteria require (g)(4) Quality Management System To certify any criteria through the Gap Certification Policy, you must apply for and certify to (g)(4) Quality Management System.

10 Gap Certification With No Inspection Day Testing Gap Certification that does not require any inspection testing includes: (d)(1) Authentication, access control, and authorization (d)(5) Automatic Log-off (d)(6) Emergency Access (d)(8) Integrity (d)(9) Optional - Accounting of Disclosures (f)(1) Immunization Information

11 Gap Criteria Requiring Percentage Based ( (g)(1 or 2) Testing Unchanged 2011 Edition criteria that requires (g)(1) or (g)(2) testing - This gap-eligible criteria has a percentage-based measure to be tested and passed. This includes: (a)(1) Computerized provider order entry (a)(6) Medication list (a)(7) Medication allergy list Inpatient Only (a)(17) Inpatient setting only advance directives (b)(5) Incorporate laboratory tests and values/results

12 4 Steps to Gap Certification Step 1: Determine Which Criteria Apply for Gap Certification Step 2: Determine if any of the gap-eligible criteria you are applying for have a percentage-based measure to be tested and pass. To Qualify, Pass the Percentage Base Measures of (g)(1 or 2) in your inspection. Step 3: Determine if the gap-eligible criteria you are applying requires Safety-Enhanced Design. To Qualify: Pass The Self Attestation Step 4: All of the gap-eligible criteria require (g)(4) Quality Management System. To Qualify: Pass The Self Attestation 2013 CCHIT Slide 12 March 12, 2013

13 Price Transparency Any additional types of costs that a customer is required to incur to implement a certified product to enable it to support Meaningful Use. These may include such fees as monthly service fees, interface development or configuration fees, 3 rd party database software and more.

14 Safety Enhanced Design (g)(3) SED incorporates all the data elements defined in the Customized Common Industry Format Template for EHR Usability Testing (NISTIR 7742). GAP criteria must also adhere to the standard(s) or defined processes. Examples of UCD industry standards include: ISO , ISO , ISO 13407, ISO 16982, and ISO/IEC If you have not considered an industry standard during development, you may provide an outline and short description of the process used in the design.

15 Quality Management System QMS testing will be performed using attestation. You must specify which QMS system(s) was used in the development of the product. You may use an industry standard system, an internally developed system, or none.

16 QMS Specifics The use of a QMS in the development, testing, implementation and maintenance for each capability of an EHR technology to be certified must be identified. To Qualify: Pass The Self Attestation Where the whole development organization uses the same QMS (or not at all) across all teams, then this certification criterion may be met with one report. Where there is variability across teams, the applicant will need to indicate the individual QMS followed for the applicable certification criteria for which the EHR technology is submitted for certification.

17 QMS Specifics From the Final Rule There are no established unacceptable methods, thus any method is appropriate. It is encouraged that applicants select an established QMS, but they are not required to do so. A modified version of an established QMS or an entirely home grown QMS is acceptable. Documentation of the current status of QMS in an EHR technology development organization is sufficient.

18 Summary Work with your ONC Certified Accredited Certified Body or Authorized Testing Body for details ONC Website HIT Certification Program Testing Methods