Laboratory tests classified as waived may be approved for professional use, home use (sold over-the-counter), or both. Tests approved for "home use only" are not appropriate for use by healthcare professionals in a Joint Commission accredited organization.
To determine if a test is approved for professional use, the information can sometimes be found in the manufacturer's package insert or by calling the manufacturer directly. You may also check the 510(k) summary that was submitted to the FDA by the manufacturer for approval. Many of these are available electronically through the following website: http://www.accessdata.fda.gov/scripts/cdrh/devicesatfda/
Follow the following steps to determine if the test is intended for professional use:
Enter the name of the device in the search field.
Locate the device in the list produced by the search.
Click on the "Summary" for the device to open the 510(k) document.
Read the 510(k) summary, particularly the section titled "Intended Use".
If there is language indicating the instrument may be used in professional settings or by healthcare professionals, it meets the standards requirement.
Manual:
Critical Access Hospital
Chapter:
Waived Testing WT
First published date: April 11, 2016
This Standards FAQ was first published on this date.
Browse our gallery of books and e-books to find trusted prep and readiness resources, practical checklists and toolkits, and resources on specialized health care topics.
Online education is the most convenient and cost-effective way to educate your staff and minimize expenses without the need to leave your organization.
Assessing and sustaining compliance with accreditation standards or CMS CoPs can be a challenge, but it doesn’t have to be. Rely on our proven software solutions developed by our team of industry experts.
Note: To provide adequate support to those organizations that are either accredited/certified or seeking accreditation/certification, we will only answer those questions submitted by those organizations seeking accreditation/certification or currently accredited/certified by the Joint Commission. The Joint Commission no longer answers questions submitted by students or vendors. Thank you for your understanding.