Warning: All talk and no action could land a lab in hot water. Don't Just Say; Do For example, a lab is cited for not running two levels of control each day. Deficiencies Should Not Pile Up While one problem is not the end of the world for a lab, a large cluster or pattern of deficiencies could possibly shut it down, Hines cautions.
A deficiency doesn't have to shut down a lab; if the office has a deficiency plan, it can easily address and resolve problems without causing a major upset.
But that doesn't mean labs can brush off obligations to remedy any deficiencies a surveyor uncovers. Labs can follow these suggestions to keep their certifications
blemish-free.
"Don't respond to a deficiency by telling surveyors what you think they want to hear," cautions James Parsons, a consultant with Clinical Laboratory Solutions in Albany, NY. Rather, be very specific about how the lab will fix the problem.
Poor response: Reporting that the lab will be sure to run both controls.
Great response: The lab will rework monitoring procedures to ensure that the proper controls are run each day. Also, the lab director will check the values of those controls weekly.
Remember, a lab cannot set out a plan to follow a program or procedure that's outside of its own financial or personnel scope, counsels Nancy Hines, surveyor with the Rhode Island Department of Health in Providence.
For example, a lab shouldn't tell the agency that it will hire a technical consultant if the lab cannot afford to do so, she stresses.
"You must tell your surveyor who in your lab will be responsible for monitoring your corrections," Hines says. That way, the surveyor knows someone is ensuring that the problem area is under control - which guarantees better, more accurate test results.
After a lab knows who will monitor its corrections - and how they'll do it - the lab director must sign, date and submit the correction plan to the surveyor to make
it official.
Bottom line: Failure to take a citation seriously could jeopardize a lab, Hines warns. But more importantly, shrugging off compliance deficiencies could be disastrous for clients.