Delta’s drug-testing problems raise questions about validity testing

Airline drops a major lab, leading to investigation

A controversy over drug testing for airline pilots that led Delta Air Lines to pull its business from a major laboratory was followed quickly by a government investigation of all certified drug testing labs, raising questions about the validity testing that is used across the country.

The Atlanta-based Delta Air Lines previously used LabOne, based in Lenexa, KS, for the pilot testing required by the Department of Transportation. The airline recently announced that it was pulling its testing work from the lab because of a dispute with the pilots’ union over the accuracy of validity testing, and specifically regarding the testing of one particular pilot. LabOne reported that the pilot’s urine sample had been substituted.

The dispute caught the attention of federal regulators, who quickly launched a survey of all DOT-certified laboratories to determine whether they are using the most current procedures and standards for validity testing.

That investigation called into question the accuracy of the laboratories used by employers and occupational health providers across the country, but an executive at LabOne says there’s no need to worry.

Michael Peat, MD, president of the substance abuse testing division at LabOne, tells Occupational Health Management that the company’s validity testing is reliable and complies with federal regu-lations. He says there is no reason to fear that employees will be falsely accused of substituting or adulterating urine samples.

"We are following all the correct policies and procedures and there is no reason for me to think that there is any widespread problem," Peat says. "This situation may have raised fears that are unfounded."

Delta says it doubts substitution charge

Peat says the whole controversy with Delta is a product of the difficulties the airline is having with the pilots’ union. Along with the flight attendants’ union, the pilots’ union has fought the airlines for years regarding substance abuse testing requirements and specifically the validity testing that can reveal when a subject attempted to cheat by substituting someone else’s urine or adulterating the urine sample.

Airlines in the United States have randomly tested flight crews for drug use since 1989. The airlines began using the validity tests in 1998 even though the DOT does not require them.

The issue came to a boil recently when the unions challenged Delta’s decision to dismiss one pilot and four flight attendants based on LabOne’s reports that they had substituted urine samples in an effort to pass the test. The unions alleged that LabOne used improper testing procedures and even falsified documents. After some debate, the airline gave in and decided to reinstate the pilot and flight attendants.

At the same time, Delta announced that it was pulling its business from LabOne because of concerns about the reliability of its testing. In addition, the Delta announcement said the company would require that samples thought to be substituted be sent to an independent lab for confirmation.

Soon after that announcement, Peat confirmed that Delta had informed the lab of its decision to pull its business, but the airline still was using the lab while it searched for a new one.

In a memo distributed to Delta employees, executive vice president of human resources Bob Colman said the company’s investigation raised "some questions about the lab’s processing of samples found to have been substituted." The memo did not explain the details of what was wrong with the testing, but the pilots’ union contended that LabOne’s window of accuracy for creatinine was too wide.

In response to the Delta controversy, federal investigators at two agencies launched investigations into LabOne and all other DOT-certified drug-testing laboratories. The DOT and the U.S. Department of Health and Human Services (HHS) looked into the specific allegations against LabOne but also surveyed all 65 laboratories certified by the government.

Lab stands by original report

Four inspectors from the HHS visited the LabOne headquarters to determine whether the company is complying with federal standards for validity testing.

"We haven’t heard anything from them to indicate that they didn’t like what they found," Peat says. "As far as we know, they were satisfied with their visit."

The DOT and the HHS did not return calls seeking comment on the findings of their inspections.

Peat says the controversy centers on the updating of a federal standard that outlines how validity testing must be conducted in DOT-certified labs. On Sep. 28, 1998, HHS issued National Laboratory Certification Program Directive 35, known as PD 35, which outlined the specific requirements for certified labs. And then on July 28, 1999, the HHS updated those requirements by issuing PD 37. The newer version changed some directions for validity testing in an effort to ensure accuracy.

The Delta pilot in question produced the specimen in July 1999. The LabOne facility received the updated federal standard on July 29, 1999 — one day after it was issued. Peat says it took several months to update its policies and procedures to comply with PD 37, but the new standards were in place at LabOne by January 2000. The survey of DOT-certified labs focused on whether they were in compliance with PD 37, Peat says, and he suspects most labs are.

Peat says occupational health providers may wish to confirm with their testing labs that they are in compliance with PD 37, but he suggests that few will report they still use PD 35.

"The government apparently was concerned that the labs had not implemented the directive, but that was partly because they issued it without any implementation date," Peat says. "For this case, the directive didn’t change anything anyway. We received PD 37 on July 29 and the specimen came in on July 31. We obviously had not implemented the document in just two days."

But more importantly, Peat says the disputed sample would not have tested differently under the new directive. PD 37 changes the manner in which some test results are reported, but the cutoffs for creatinine and specific gravity are not changed.

"The pilot in question produced a specimen with creatinine of 0 and specific gravity of 1.000. We defined it as substituted according to PD 35," he says. "There is no reason to think that the sample would test differently, and we would still declare that it was substituted under PD 37. We stand by our results that the specimen was substituted."