Waived Testing—The Importance of Performing Proficiency Testing
The Certificate of Waiver (COW) laboratories must only perform waived laboratory tests. Yet the Centers for Medicare and Medicaid Services (CMS) began random inspections of some COW laboratories in 2002. Many laboratories choose to participate in proficiency testing as a quality assurance check. MLE responded to that desire by preparing special modules of two-sample proficiency modules, designed for the waived testing laboratory needs. Our custom selection of waived modules appears in the MLE catalog.
E-notification Service—waived testing information delivered to your e-mail account.
As an MLE participant, you can sign up to receive waived testing information that will be delivered to your e-mail account. MLE will send FREE, timely notifications about changes or additions to the CMS list of waived laboratory tests via e-mail. These notifications will enable you to make decisions affecting the quality of care for your patients and financial health of your laboratory.
MLE offers a wide array of cost-saving Waived Testing Modules for continued quality assurance at a lower cost. In addition, when the notification involves a Microbiology test, you will be prompted to review your PT order to ensure regulatory compliance for any remaining non-waived analytes. This will protect your laboratory from unexpected compliance issues.
To sign up, please send us an e-mail with the subject line “E-notification Service Requested” and don’t forget to give us your MLEID number. Send the e-mail to: mle@acponline.org
Laboratory Inspections
The Centers for Medicare & Medicaid Services (CMS) is initiating on-site visits to facilities enrolled in the Clinical Laboratory Improvement Amendments of 1988 (CLIA'88) program that have a certificate of waiver (COW). The CLIA program conducted an initial pilot study in the States of Colorado and Ohio, where on-site visits of a random sample of 200 CLIA COW and Provider Performed Microscopy Procedures (PPMP) laboratories were performed. As MLE reported to you in the September issue of the Observer, significant quality and certification problems were identified in over 50 percent of these laboratories.
CMS expanded this pilot to include eight additional States to verify the scope and seriousness of the initial study's findings. As a result of this expanded pilot, quality problems were identified that corroborated the initial study findings, which included:
- 32% failed to have current manufacturer's instructions;
- 32% didn't perform quality control as required by manufacturer of Centers for Disease Control and Prevention (CDC)
- 16% failed to follow current manufacturer's instructions;
The Centers for Disease Control and Prevention (CDC), Office of Inspector General (OIG), and New York studies have similar findings.
Due to the significant increase in the number and types of tests waived, the rapidly expanding number of laboratories with no oversight, and the serious findings in COW laboratories, CMS will be visiting two percent of COW laboratories starting early in 2002. The laboratories will be notified in advance, first by letter and then by telephone to confirm the on-site visit. The surveys will focus on the education of testing personnel to ensure quality testing. If quality problems are found, the inspectors will provide assistance to the laboratories to achieve accurate and reliable results. If certificate problems are found, the inspectors will ensure the laboratories operate under the correct certificate. There will be no fee charged to the laboratories at this time for these inspections.
MLE informed ACP members that increased inspections were on their way in September 2001 issue of the Observer. The information contained in the article can help you prepare for an inspection, and offers a number of important quality assurance safeguards that can keep your laboratory's results accurate and reliable: Is your waived lab compliant? Try these four tips (from ACP Observer, September 2001 (Vol. 21, No. 8), page 5. )
MLE has published a number of articles in its continuing education piece, Focus On. These articles address specific issues pertaining to quality assurance and the survey process. They may help you to recognize some deficiencies in your laboratory before the inspector arrives.
Resources
Newly Updated and Expanded
Waived Testing-- Doing It Right!
(formerly titled CLIA: What You Need to Know About the Waived Testing Category)
This Guide Summarizes the CDC’s Recommendations for Good Laboratory Practices for Waived Testing Sites.
Page updated: 3-17-08
MLE Resources
Related Laboratory Websites
- Centers for Medicare and Medicaid Services (CMS)
- CMS Regional Offices Contact List
- Centers for Disease Control and Prevention (CDC)
- COLA
- TJC (formerly Joint Commission on Accreditation of Healthcare Organizations (JCAHO)
- State Agencies Contact List
- American Society of Clinical Pathologists (ASCP)
- National Committee for Clinical Laboratory Standards (NCCLS)
- Occupational Safety and Health Administration (OSHA)
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