Glucometry Waiver is Necessary
by Jim Chandler
The federal government requires that all laboratories testing human specimens, such as blood, for the purposes of diagnosis and treatment, must be certified by the Health Care Finance Administration (HCFA), Department of Health and Human Services. This applies to EMS agencies that perform glucometry tests. These requirements are set forth in Clinical Laboratory Improvement Amendments (CLIA) of 1988. Fortunately, the government also allows for a CLIA waiver when certain conditions are met. The bad news is there is the waiver application and fee, and biannual renewal process and fee. The good news is that EMS agencies are eligible for the waiver. The better news is that the Tidewater EMS Council maintains a regional CLIA waiver for all of its EMS agencies.
HCFA first began to notify laboratories in 1991 of the CLIA requirements, and final regulations were not adopted for another year. The EMS community became aware of the regulations about a year later, and began to investigate the necessity for compliance. By 1994 it became clear that EMS was expected to comply, and efforts were begun to seek cost effective, multiagency waivers. One state was able to obtain a statewide waiver; Virginia attempted but failed on a statewide basis. The Old Dominion EMS Council applied for a regional waiver and was successful. Tidewater essentially copied the Old Dominion waiver application and procedures, and was awarded a regional waiver in January of 1996. The waiver was valid for two years. At present, the Tidewater region has obtained its second waiver, valid until January, 2000. A number of other EMS regions have also obtained waivers.
Some 40 of the region’s licensed EMS agencies have fulfilled the requirements to fall under the council’s umbrella waiver. The agency requirements are simple: advise the council that you want to fall under the regional waiver, provide a list of glucometry equipment (make and model) that you use and agree to use and maintain the equipment according to manufacturer’s specifications. A standard one page agreement form is available from the council for that purpose. (Coming soon: downloadable form.) Of course, if your agency does not use glucometry, the waiver is not necessary. If you are in doubt whether your agency falls under the regional CLIA waiver, please feel free to contact the TEMS office, (757) 446-5179.
Whether your agency falls under a state, regional or local waiver, be aware that federal regulations require laboratory certification, or a waiver, for any EMS agency performing tests on human specimens.
Contact the author: Jim Chandler
The author is the executive director of the Tidewater EMS Council and is responsible for maintaining the council's regional CLIA waiver.