Healthcare Information Technology LAP

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

Section 7.7.2 of ISO/IEC 17025:2017 requires a laboratory “monitor its performance by comparison with results of other laboratories, where available and appropriate”. NVLAP is not aware of any widely available interlaboratory comparison for Healthcare IT (HIT) testing. Laboratories may choose to organize interlaboratory comparisons among themselves, however NVLAP does not require participation in interlaboratory comparison in the RDI program. If an appropriate interlaboratory comparison becomes available, NVLAP may require participation and will notify all laboratories of requirements.

Requirements Documents

• NIST Handbook 150:2020, update 1, NVLAP Procedures and General Requirements
• NIST Handbook 150-31:2021, NVLAP Healthcare IT Testing
• Lab Bulletin LB-142-2021: Release of NIST Handbook 150-31, 2021 Edition
• Lab Bulletin LB-131-2020: Addition of the 21st Century Cures Act: Interoperability, Information Blocking and the ONC Health IT Certification Program final rule to the HIT LA
• Lab Bulletin LB-116-2020: Update to NVLAP accreditation documents for laboratories accredited to ISO/IEC 17025:2017 under the ILAC MRA

References and Information

• The ONC Health IT Certification Program 
• The Office of the National Coordinator for Health Information Technology
• NIST Health IT Standards and Testing