As the federal government orders drug tests for millions of public and private sector employees, it may be creating a shortage of laboratories to analyze the tests.
Only 24 laboratories are certified by the National Institute on Drug Abuse, an arm of the Department of Health and Human Services, to analyze drug tests.
At least 100 more laboratories around the nation could conduct the testing demanded by the government, but the institute`s stringent requirements are blocking qualified laboratories from the growing drug-testing market, according to many in the industry.
The fear is that with more companies turning to drug tests, approved laboratories will be overwhelmed and test results delayed. In addition, labs awaiting National Institute on Drug Abuse certification believe the government`s tough standards deny them a new source of profits.
The high standards for the institute`s certification are designed to maintain drug-free workplaces for employers and protection of privacy rights for employees, according to advocates of the process.
But those same standards could make it difficult for private sector employers, who do the most drug testing, to start effective testing programs, critics say.
”If they (the drug abuse institute) stayed where they are, I doubt 100 labs would meet the standards,” said Dr. Thorne Butler, director of accreditation for the Forensic Urine Drug Testing laboratories, a division of the Skokie-based College of American Pathologists.
”Quite frankly, people who contract with (the institute) want to keep it the way it is so they won`t have to compete with others,” Butler said.
”We`re at the mercy of a few labs.”
The College of American Pathologists accredits 48 laboratories in conjunction with the American Association for Clinical Chemistry.
Many laboratories are accredited by the institute and the college. But the institute`s certification is considered the mark of outstanding performance for commercial laboratories.
Certification from the institute also may carry more credibility in court, according to those concerned with the legal aspects of employee drug testing.
”We`re being very strict in getting labs in,” said Navy Cmdr. John Irving, head of the drug testing section for the institute`s office of workplace initiatives.
There are enough laboratories certified by the institute to handle the number of employee drug tests in the government`s current plan, Irving said. That plan covers about 2 million employees who work with or for the government.
Though the institute`s labs can handle 10 million tests each year, the real test for these labs may come early next year. That`s when the Department of Transportation is scheduled to test all truck and bus drivers, pilots and seamen for drugs. At that time, another 4 million tests will enter the laboratories.
”If we have 50 (institute-certified laboratories) by the end of the year, we`ll be in good shape,” said Michael McNulty, general manager of the SmithKline Bio-Science Laboratories facility in Schaumburg. That lab is certified by the institute and the College of American Pathologists.
The SmithKline laboratory was accredited in December, along with nine others. Though more than 100 laboratories have applied for certification, the institute has certified 14 more since the first 10 were accepted.
The institute and the college are discussing making the college`s certification equal to the institute`s.
”(The institute) is being very rigid in its approach,” said Dr. Loyd R. Wagner president-elect of the College of American Pathologists. Wagner said institute officials ”have not made movement” toward granting equal status to his group.
The pathologists` group is attempting to modify a bill in the U.S. House of Representatives that would require all commercial laboratories to follow institute guidelines, Wagner said.
”We want the bill to direct the secretary of Health and Human Services to establish criteria for a acceptance of a private accrediting agency,”
Wagner said.
Many feel price is the main factor that has kept the pool of institute-accredited laboratories low. The institute`s certification process, which takes about three months, costs $17,000 for the initial stages.
Expenses of a laboratory that examines a large volume of drug tests can exceed $1 million due to the costs of state-of-the-art equipment and qualified personnel.
But those expenses mean the employers who use the certified laboratories spend less on legal fees, Irving said. He added that if the laboratory is reliable, the employer will spend less in legal battles with disgruntled employees.
The first tests for certification involve proficiency of a laboratory`s ability to detect drugs in the test sample. The laboratories also receive a followup inspection if they pass the performance test. This includes an evaluation of the equipment and personnel, security given to the urine samples and the procedures used to handle them.
Besides the levels of accuracy that the institute imposes on laboratories as they examine urine samples, the institute also requires long-term refrigeration capacity for the samples and detailed documentation of all aspects of the testing.
”Quality control and expertise are very important for drug testing,”
said Robert King, vice president of marketing for the South Bend Medical Foundation Inc., an institute-certified laboratory in South Bend, Ind.
”Certification is difficult, but on such a sensitive issue, it makes sense.”
In defense of their program, the college of pathologists and its certified laboratories say they follow the same quality-control standards. He added that both programs use three advisers to oversee the certification tests.
The main difference between the two accrediting agencies is the manner in which they respond to the laboratories seeking certification, Butler said.
”If you flunk the inspection, we tell you how to fix it,” he said, explaining the method by which the college grades laboratories. The institute says you ”don`t pass, but they don`t tell you why.”
Most employee drug tests originate from the private sector, Butler said, adding that because the institute took its accreditation program from the Department of Defense, its laboratories don`t properly collect drug test samples from civilian employees.
For example, private employees should not line up to se samples in the manner used to test soldiers, Butler said. He added that the laboratories accredited by the institute are not authorized to test for alcohol, barbiturates or benzodiazepines (which include Valium), drugs that private employers may want a laboratory to detect.
”It`s one thing to run a program for the military, it`s another thing to run it for private businesses,” Butler said. ”It`s not applicable to some private employers. All private industry is asking (of the institute) is make it more applicable and practicable.”
At least one laboratory asks for a quicker response from the institute. The American Institute for Drug Detection, based in Rosemont, is awaiting a decision on its application for institute certification, said Vice President Don Shattuck. The institute told him the laboratory would be informed of its status in late May.
”We should have known by now,” Shattuck said. He said the institute`s delay has put his laboratory at a disadvantage in the marketplace, because potential clients also are awaiting the institute`s approval of his laboratory.
Though the institute is not likely to ease its standards for analysis of the samples, SmithKline`s McNulty says the requirements for security may be compromised to allow hospital laboratories and other commercial facilities that can`t afford the certification to obtain it.
In the meantime, employers who don`t do business with the federal government but do require employee drug tests should be aware that their laboratory doesn`t need the government`s certification, McNulty said.
”We`re starting to see lay people grab on to (the institute) even though they don`t need it,” McNulty said. ”You can have high-quality testing without using (institute) laboratories as long as you use a lab that gives
(institute) quality.”
