National Voluntary Laboratory Accreditation Program (NVLAP) Workshop for Laboratories Interested in the Testing of Health Information Technology (HIT) Electronic Health Record Technology

AGENCY:

National Institute of Standards and Technology (NIST), Commerce.

ACTION:

Notice of public workshop.

SUMMARY:

The National Voluntary Laboratory Accreditation Program (NVLAP) will hold a public workshop on Tuesday, April 26, 2011 at the Marriott Hotel, Gaithersburg Marriott Washingtonian Center, located at 9751 Washingtonian Boulevard, Gaithersburg, MD 20878. The purpose of the workshop is the exchange of information among NVLAP, the NIST Information Technology Laboratory, the Department of Health and Human Services (HHS), laboratories interested in seeking NVLAP accreditation to perform Testing of Health Information Technology (HIT) electronic health record technology under the permanent certification program administered under the Office of the National Coordinator for Health Information Technology, HHS.

There is no charge for the workshop; however, advanced registration is necessary. There will be no on-site, same-day registration. The deadline is Wednesday, April 20, 2011.

DATES:

The workshop will be held on Tuesday, April 26, 2011 from 9 a.m. to 4:30 p.m. Contact Beth Thomas at beth.thomas@nist.gov or (301) 975-4521 for pre-registration.

ADDRESSES:

The workshop will be held in the Gaithersburg Marriott Washingtonian Center, 9751 Washingtonian Boulevard, Gaithersburg, MD 20878.

FOR FURTHER INFORMATION CONTACT:

Dana Leaman, (301) 975-4679, e-mail: dana.leaman@nist.gov. The mailing address is 100 Bureau Drive, Mail Stop 2140, Gaithersburg, MD 20899-2140. Information regarding NVLAP and the accreditation process can be viewed at http://www.nist.gov/nvlap.

SUPPLEMENTARY INFORMATION:

In response to a request from the U.S. Department of Health and Human Services (HHS), National Coordinator for Health Information Technology, the National Voluntary Laboratory Accreditation Program (NVLAP) is considering establishing an accreditation program for laboratories that test HIT electronic health record technology.

NVLAP accreditation criteria are established in accordance with the Code of Federal Regulations (CFR, title 15, Part 285), NVLAP Procedures and General Requirements. To be accredited by NVLAP, laboratories conducting testing of HIT electronic health record technology will be required to meet ISO/IEC International Standard 17025, general requirements for the competence of testing and calibration laboratories. In addition, for each new LAP, NVLAP works with the affected testing community to develop program-specific technical requirements. These requirements tailor the general accreditation criteria referenced in Sections 4 and 5 of the NIST handbook 150 to the test and services in the new LAP. Program-specific requirements include the details of the scope of accreditation, test and measurement equipment, personnel requirements, validation of test methods, and reporting of test results.

NVLAP accreditation does not imply any guarantee (certification) of laboratory performance or test/calibration data. NVLAP accreditation is a finding of laboratory competence.