Don’t Let CLIA Regs Put a Halt on Sales

Edition: August 2003 - Vol 11 Number 08
Article#: 1624
Author: Sheila Dunn

Just when you’d gotten the hang of selling lab equipment, Uncle Sam adds one more obstacle: the final Clinical Laboratory Improvement Amendments (CLIA) regulation. (Federal Register. Vol. 68, No. 16. Friday, Jan. 24, 2003.)

Thankfully, the new regulation affects only labs that decided to bring on new moderate-complexity tests after Apr. 24, 2003; other POLs need not worry about it. In addition, manufacturers are stepping up to the plate to provide easy, turnkey programs for POL customers.

As you know, the CLIA regulation divides all testing into two categories – waived and non-waived. Anyone who can fog a mirror and pay $150 every other year can do waived testing. Moderate- and high-complexity testing are both classified as non-waived.

The most recent statistics from the Centers for Medicare and Medicaid Services (CMS, formerly called HCFA) show a total of about 97,000 POLs, of which about 22 percent perform moderate- or high-complexity testing. Here’s how they break down:

• Waived POLs: 44,111 (46 percent);

• PPM POLs: 31,376 (32 percent);

• Mod/High POLs: 21,435 (22 percent);

• Total POLs: 96,922.



The final CLIA regulation eases restrictions in some areas but, for the most part, it adds technical requirements that will put the onus for performing them squarely on your customer – unless manufacturers step up to the plate to address them.

Essentially, the regulation subjects moderately complex labs to high-complexity quality requirements and imposes “method validation,” a process of conducting an experiment to verify that the test is as reliable in the customer setting as manufacturers claim. Most POLs have no earthly idea how to calculate accuracy, precision and reportable range. Telling them they have to go through this painful process can bring the selling process to an abrupt halt.



Remove the Hassle Factor

To avoid losing the sale before placement (or having the instrument bounce shortly after placement), be sure that the manufacturer provides your POL customer with the tools necessary to painlessly comply with CLIA, such as prewritten policies and procedures. Another tool is to perform most of the method validation procedure during installation of the equipment.

Beckman Coulter has provided a CLIA program, called “CLIA Without Complications,” to customers for the last four years. The company recently updated the program to reflect today’s current CLIA requirements. According to Tom Warren, hematology sales manager, “Beckman Coulter is committed to our POL customers’ success with regard to regulations and reimbursement. We provide several kinds of assistance, ranging from a fill-in-the-blanks CLIA manual to a full year of consultation for new customers.

“It’s a real selling point, and in exchange for our CLIA compliance programs, we have happy, committed customers who pass their CLIA inspections with flying colors.”

By removing the CLIA hassle factor, customers are more satisfied with the equipment, opening the door to additional, higher volume testing.

Several other companies that service this market have also made a serious commitment to helping their customers painlessly comply with CLIA, especially since the final regulation became effective. “POLs should be provided with everything they need, so that CLIA compliance becomes a non-issue in the selling process,” says Lisa Wickstrom, director of distributor relations for Biosite Corp., which recently introduced its BNP test to the POL market.

Helping customers comply with the regulation helps distributor reps keep the reagent business after placing the units. Too often, customers feel as if equipment installers do the old “knock, drop and run” routine, leaving the customer to deal with CLIA. When that happens, distributors can lose the reagent stream they worked so hard to acquire.

The bottom line for distributors: Be sure the manufacturers you work with provide what your customers need to be in compliance. If they don’t, either sell waived tests only, or sell moderate- and high-complexity tests only to those accounts with med techs on board.

Typical POLs lacking a lab tech will need help performing method validation before they can begin testing. They’ll also need to write policies for proficiency testing, quality assessment, quality control, equipment maintenance, personnel training, personnel evaluation and several other areas. Either the manufacturer has to provide this information, or you can find a local lab consultant to do it. Lab consultants typically charge about $1,500 to $2,000 for this service.

The upside: With the right systems in place or the right manufacturer partners, you can make the final CLIA regulation virtually invisible for your customers.

Resources: Commission on

Office Laboratory Accreditation (COLA)

Hotline: 1-800-981-9883. www.cola.org