NVLAP Healthcare Information Technology LAP

Announcements

Updates to the 2014 Edition Test Method

The Office of the National Coordinator for Health Information Technology (ONC) has begun posting updates to the 2014 Edition Test Method (Test Procedures, Test Data, and Test Tools). Please visit the following website for more information: http://www.healthit.gov/policy-researchers-implementers/2014-edition-final-test-method.

Amendments to NIST Handbook 150-31, NVLAP Healthcare Information Technology Testing

The NVLAP HIT LAP program-specific handbook has been revised to reflect the addition of the 2014 certification criteria for EHR technology to the accreditation program. NVLAP is now accrediting testing applicants to the 2014 Edition test method.

For a description of these revisions, please view NVLAP Lab Bulletin, LB-71-2013, issued on January 2, 2013.

Approval and Publication of the 2014 Edition Test Method

The 2014 Edition Test Method was formally approved on December 14, 2012 by the National Coordinator and is now effective for use in ONC HIT Certification Program (formerly known as the Permanent Certification Program). Notice of the approval appears in the December 14, 2012 Federal Register.

For more information, please refer to the ONC 2014 Edition Test Method webpage.

Addition of the 2014 Certification Criteria for EHR Technology to the HIT LAP

NVLAP has updated its Healthcare Information Technology (HIT) Laboratory Accreditation Program (LAP) to include the new 2014 criteria testing for EHR technology. For laboratories currently accredited by NVLAP, addition of these methods to their scopes of accreditation must be requested in writing. See NVLAP Lab Bulletin LB-70-2012 for more information.

Links to NVLAP DocumentsNIST Handbook 150:2006, NVLAP Procedures and General Requirements NIST Handbook 150-31:2011, NVLAP Healthcare IT Testing NIST Handbook 150 Checklist (Word version)NIST Handbook 150-31 Checklist (Word version)NVLAP Lab Bulletin LB-71-2013, Amendments to NIST Handbook 150-31, NVLAP Healthcare Information Technology Testing NVLAP Lab Bulletin LB-70-2012, Addition of the 2014 Certification Criteria for EHR Technology to the HIT LAP NVLAP General Application Form ITST: HIT Program-Specific Selection List

Welcome

This site has been established to convey information regarding the ongoing development of the NVLAP Healthcare Information Technology (HIT) Laboratory Accreditation Program (LAP). On this site you will find important program development information. It is expected that in the future this site will include links to documents required for successful participation in the program.

Program Description

In response to the Health Information Technology for Economic and Clinical Health (HITECH) Act of 2009, the U.S. Department of Health and Human Services along with the Office of the National Coordinator for Health Information Technology requested establishment of the Healthcare Information Technology Testing Laboratory Accreditation Program by NVLAP to accredit laboratories that perform functional and conformance testing of electronic health record (EHR) technology products to meaningful use requirements as defined in the nationally recognized EHR products testing standards.

Proficiency Testing Requirements

No additional requirements at this time.

Frequently Asked Questions (FAQs)

Q: What is the process for accreditation?

A: The process for laboratory accreditation is as follows:

1) The laboratory applies for accreditation with submission of the application and the appropriate supporting documents and pays the appropriate fees.

2) Upon a complete review of the application and supporting documentation, a determination of application completeness is made. If not deemed complete, the applicant is contacted with a request for additional information.

If complete, a written exam is provided to the laboratory for completion. This exam is utilized to evaluate the laboratory's technical expertise and knowledge of the standards and test procedures/criteria applicable to the scope of accreditation for which the laboratory is applying.

3) The laboratory has an on-site assessment to demonstrate that the lab conforms to ISO/IEC 17025 and NVLAP requirements and the lab demonstrates technical competence for the test criteria for which the lab seeks accreditation.

4) The laboratory resolves nonconformities (if any) documented at the on-site assessment.

5) When all nonconformities are resolved, the laboratory receives accreditation.

The length of the accreditation period is one year. To continue accreditation, the lab will have to submit a renewal application each year with the appropriate fees.

After the initial on-site assessment to establish accreditation, the laboratory will have another on-site assessment during the next accreditation cycle, and then every two accreditation cycles (every two years) thereafter.

References & Information2014 Edition Test Method Approved Test Procedures version 1.1 Final Rule - "Establishment of the Permanent Certification Program for Health Information Technology"Final Rule - “Health Information Technology: Standards, Implementation Specifications, and Certification Criteria for Electronic Health Record Technology, 2014 Edition

Contact

Dana S. Leaman, Program Manager

Phone: 301-975-4679

E-mail: dana.leaman@nist.gov