What
Employers Hear From The Drug Test Manufacturers
You
Need to Know What the Testers are Being Told!
The following information is published to provide the reader a perspective of the information commonly available to companies and individuals considering implementing a Drug Testing program within their organizations. This is considered Public Information.
Background
Drug-Free Workplace programs, and particularly their drug testing provisions, have been the subject of numerous lawsuits over the past decade. In the public sector, these have involved questions of the right to privacy, the Constitutional freedom from unreasonable searches by the government when an agency acts as an employer, and due process. All employers, even those with well-intentioned programs, can face court challenges to their Drug-Free Workplace policy based on questions of negligence (negligent hiring, supervision, libel, and slander), contract law, and discrimination (racial, sexual, and disability).
Consulting with an attorney experienced with labor and employment matters in your State is always the best course of action to take before implementing a Drug-Free Workplace program. There are, however, some general "rules of the road" that can help you avoid mistakes and lessons learned the hard way by others.
The following suggestions about minimizing legal risks and exposures are summarized from The Drug Enforcement Administration's Guidelines for a Drug-Free Workplace.
Do:
-Become familiar with common symptoms of drug use.
-Assume that no one in your organization is immune to the problem of drug and alcohol abuse.
-Know your employees. Become familiar with each one's skills, abilities, and normal performance.
-Document job performance regularly, objectively, and consistently for all employees.
-Keep written records that objectively document the performance of troubled employees. These can be used as a basis for referral for to the employee assistance program and/or for testing.
-Take action whenever job performance fails, regardless of whether drug or alcohol use is suspected.
-Know the exact steps to be taken when an employee has a problem and is ready to seek help.
-Obtain appropriate advice when a problem is identified or suspected, and have a witness to any actions when confronting an employee.
Don't:
-Misuse the Drug-Free Workplace program to discipline employees for unrelated problems.
-Single out any employee or group of employees for scrutiny under the policy. Be consistent in your actions with all employee groups or classes.
-Confront a suspected drug dealer [or user] alone. Always have a witness.
-Implement a verbal policy. An effective policy must be written, circulated, and acknowledged in writing by employees in order to have strong legal standing.
-Treat employees who test positive differently. All employees who test positive must be treated consistently to maintain the integrity of the program.
-Take action against employees based on the results of a drug screen only.
-Always obtain the results of a gas chromatography/mass spectrometry (GC/MS) confirmation test before taking action.
-Offer rehabilitation selectively.
-Address drug abuse without including alcohol abuse in the policy.
-Implement a policy and program unilaterally if the workforce is represented by a union. The National Labor Relations Act requires that terms and conditions be included in your bargaining agreement and a drug program falls into that requirement.
What Employers Hear From The Drug Test Manufacturers
1
- Why do companies use urine screening?
Answer:
The evaluation of employees to determine fitness for duty has long been
performed in industry. Within the context of occupational medicine programs,
physical examinations were initially performed to ensure the selection of
personnel free of medical conditions which would be likely to interfere with
their ability to work safely and efficiently. In recent years, within the
context of health promotion and wellness programs, an additional purpose of the
medical evaluation has evolved; that is, to address risk factors that may impair
employee health (e.g., poor nutrition, substance abuse, hypertension). As the
incidence and prevalence of drug abuse in the United States have risen, many
companies have developed pre-employment and in-service drug screening programs.
The primary purpose of these programs is to protect the health and safety of all
employees throughout the early identification and referral for treatment of
employees with drug - and alcohol - abuse problems. The integration of drug
screening with programs of treatment, prevention, and drug education is proving
to be an effective way of managing substance abuse problems in industry.
2
- How many companies are using pre-employment screening?
Answer:
Urinalysis for drug use is being used to screen job applicants by many of the
Nation's largest employers, including major corporations, manufacturers, public
utilities, and transportation, and many small businesses. In general, most
companies have an established policy that they will not hire individuals who
present positive urines indicating current use of illicit substances. However,
many of these companies also counsel applicants who fail the drug screen to seek
treatment and to reapply.
Several surveys have collected information on drug testing in industry. These surveys have varied in size, target populations, and focus, but together give a picture of the status of testing in business and industry. Overall, 6 surveys have found that from 20-33% of companies surveyed have a drug testing program, with significant differences between companies of different types.
In general, the larger the company, the more likely it is to have a drug testing program. One survey by the American Management Association found that 15% of companies doing under $15 million do testing, while 36% of companies doing over $1 billion do some testing. Of Fortune 500 companies, over 50% report testing. Other surveys have also documented this relationship. In a college placement Council survey, while overall 28% of companies did testing, 58% of those with over 5,000 employees have testing programs. Larger companies are leading in the adoption of drug testing programs.
There are also significant differences by industry. Federally regulated industries are most likely to test -- utilities (91%) and transportation (81%); followed by manufacturing (44%), communications (34.5%), mining/construction (15.3%), and with the lowest rates in retail (13.0%), services (12.6%) and finance and insurance (8.7%) industries.
3
- If in service testing is used, how often should employees
be screened?
Answer: Company
policy regarding the frequency of drug screening is usually determined with
consideration of risk factors associated with safety, security, and health.
Over the last 5 years, a continuum of drug screening policies has evolved,
ranging from post accident evaluation to random, unannounced testing. The
least intrusive is an incident-driven policy wherein screening occurs only after
an accident or "incident" (e.g., a fight) or other "probable cause" event.
High-risk or safety sensitive occupations where public safety is of special
concern may require routine scheduled screening. In these cases, screening is
often tied to evaluation of fitness for duty or to annual physical
examinations. In extremely hazardous and high-risk occupations, periodic
unannounced or random testing to assure the health and safety of employees may
be warranted.
4
- What about individual rights, privacy, and
confidentiality?
Answer: How best
to deal with the problems associated with employee drug use is a complex issue.
Principles of public safety, efficient performance, and optimal productivity
must be balanced against individuals' reasonable expectations of privacy and
confidentiality. Job situations where there is a substantial risk to the public
safety will surely justify greater permissible intrusions than would be
acceptable where risks to the employee or community are perceived as minimal.
On the one hand, an employer has the right to demand a drug-free workplace; on
the other, an employee has reasonable rights to privacy and confidentiality.
Since substance abuse is a diagnosable and treatable illness, policies and
procedures should be written to ensure the confidentiality of employee medical
records, as in any other medical or health-related condition. Urinalysis test
results, which could be part of such a diagnosis, should be treated with the
same confidentiality.
5a
- Who should set up a drug screening program?
5b -
How does one develop a policy?
Answer: The
first priority should be to establish whether there is a need for a screening
program. Is drug use present and significant? Can a drug use deterrent be
established by means other than urine screening? The decision of whether or
not to establish a drug-testing program will also depend to a large extent on
the work setting. The initial question that management should consider is,
"What is the purpose for testing?" The key concerns must be for the health and
safety of all employees (i.e., early identification and referral for treatment)
and to assure that any drug detection or screening procedure would be carried
out with reasonable regard for the personal privacy and dignity of the worker.
The second critical question to consider is what you will do when employees are identified as drug users. Once these issues are clarified, experts should be consulted to assist in drafting a policy.
6
- What level of drug in the urine indicates and
individual is impaired?
Answer: Although
urine screening technology is extremely effective in determining previous drug
use, the positive results of a urine screen cannot be used to improve
intoxication or impaired performance. Inert drug metabolites may appear in
urine for several days, even weeks (depending upon the drug), without related
impairment. However, positive urine screen do provide evidence of prior drug
use.
7
- How reliable are urinalysis methods?
Answer: A
variety of methods are available to laboratories for drug screening through
urinalysis. Most of these are suitable for determining the presence or absence
of a drug in a urine sample. Accuracy and reliability of the methods must be
assessed in the context of the total laboratory system. If the laboratory uses
well-trained and certified personnel who follow acceptable procedures, then the
accuracy of the results should be very high. Laboratories should maintain good
quality control procedures, follow manufacturer's protocols, and perform a
confirmation assay on all positives by a different chemical method from that
used for the initial screening. The Department of Health and Human Services (DHHS)
has published Mandatory Guidelines for Federal Workplace Drug Testing Programs
(Guidelines), as well as Standards for Laboratory Certification. All Federal
agencies are required to follow these Guidelines and may only purchase services
from laboratories that have been certified through the DHHS-sponsored National
Laboratory Certification Programs. Drug testing guidelines for Federal agencies
specify use of Immunoassays for initial screenings and gas chromatography/mass
spectrometry for the confirmation tests.
Equally important are the procedures that are followed to document how and by whom the sample is handled from the time it is taken from the individual, through the laboratory, until the final assay result is tabulated. This record is referred to as the "chain of custody" for the sample.
8
- What does laboratory quality assurance mean?
Answer: Quality
assurance procedures (QA) are documented programs which the laboratory follows
to ensure the highest possible reliability by controlling the way samples for
analysis are handled and instruments are checked to be sure they are functioning
correctly, and by minimizing human error. Standard and blank samples are
analyzed along with the unknown samples to ensure that the total laboratory
system is producing the expected results. These known samples are referred to
as quality control samples. Quality assurance is described in detail in NIDA's
Standards for Certification of Laboratories engaged in Urine Drug Testing, and
in the NIDA Research Monograph 73 entitled Urine Testing for Drugs of Abuse.
9a
- Many reports have appeared in the news media about legal
cases in which experts have questioned the validity of a urine assay result.
9b -
Does this indicate that the assay methods are not
sufficiently reliable for broad application?
Answer: There is
little controversy among experts in those cases where appropriate methods were
used, good laboratory procedures where followed in the context of a good quality
assurance program, and adequately trained personnel carried out the analysis and
interpretation.
10
- What are the primary methods being used for initial
testing (screening) of urine specimens?
Answer: Most
urine screening today is done by immunoassay methods such as radioimmunoassay (RIA),
enzyme immunoassay (EIA), and fluorescence polarization immunoassay (FPIA).
11
- What are "confirmation assays"?
Answer: If an
initial screening assay shows a sample as being positive, a second assay should
be employed to confirm the initial result. Two different assays operating on
different chemical principles having both given a positive result greatly
decreases the possibility that a methodological problem or a "cross reacting"
substance could have created the positive.
A confirmation assay usually should be carried out by a method which is of comparable sensitivity and which is more specific (or selective) than a screening assay. Examples of confirmation methods currently in use include gas chromatography (GC), gas chromatography/mass spectrometry (GC/MS), and high performance liquid chromatography (HPLC). These are sophisticated instrumental methods requiring highly trained technicians to operate them. Properly run, they are capable of providing highly selective assays for a variety of drugs.
12
- What is the preferred method for confirmation of
presumptive positives from initial urine screens?
Answer: Gas
chromatography coupled with mass spectrometry (GC/MS) has evolved as the
preferred method for confirmation of a positive urine screening test, primarily
because it provides the greatest level of specificity and therefore the greatest
margin of certainty and legal defensibility. Additionally, it is the only
method which provides a documented data record suitable for review and
interpretation by an outside expert. This method of confirmation is required of
laboratories which are certified for urine drug testing for Federal employee
programs.
13
- What do assay "sensitivity" and assay "cutoff" mean?
Answer: The
ability of any assay to detect low levels of drugs has an inherent limit. The
concentration of drug in the urine sample below which the assay can no longer be
considered reliable is the "sensitivity" limit. The "cutoff" point is the
concentration limit that will actually be used to assay samples. Any sample
which assays below this level is considered a negative. Manufacturers of
commercial urine screening systems set cutoff limits to their assays well above
the sensitivity limits of the assay to assure accuracy and reliability and to
minimize the possibility of a sample which is truly negative giving a (false)
positive result.
For example, standards for testing of Federal employees require all initial immunoassay screens for detection of marijuana use to be set at 100 ng/ml, although virtually all commercial immunoassays are "sensitive: enough to be run at cutoffs far below this level. Setting the cutoff at 100 ng/ml not only decreases the possibility of a false positive resulting from operating the assay too close to its limit of sensitivity, but also significantly decreases the possibility of a positive test resulting from passive inhalation.
14
- How can false positive results occur?
Answer: It is
theoretically possible for substances other than the drug in question to give a
positive result in a screening assay. This is sometimes referred to as "cross
reactivity." However, most substances which could possibly cause such a cross
reaction have been evaluated by the assay manufacturers and found not to
interfere. These companies can supply brochures for all their drug screens
which detail the extent to which other drugs or substances cross react with the
assay.
False positive results can occur due to human error. This is directly dependent on the experience of the laboratory personnel conducting the test and on the laboratory quality assurance procedures any good laboratory imposes to recognize such errors.
15
- How frequently do false positives occur?
Answer: While
there have been some reports of the occurrence of false positives, these can
usually be traced to poor quality control procedures at the laboratory site or
to the fact that appropriate confirmation procedures were not used to verify the
"presumptive positive." Typically the samples which were the subject of these
reports were specimens which tested positive by an initial screen but could not
be confirmed by the confirmation assay. Such "unconfirmed positives" should
always be reported as negatives.
16
- What substances have caused false positives with drug
screening assays?
Answer:
Ibuprofen, a nonsteroidal anti-inflammatory agent used for pain relief found in
Advil, Nuprin, and similar over-the-counter (OTC) drugs was found to interfere
with the Syva EMIT test and cause apparent false positives for the marijuana
metabolite. Syva has corrected the problem by altering the formulation of the
EMIT kit. These substances no longer cause false positives in initial screening
assays. This potential error was never a problem for other immunoassays, nor
for EMIT if a confirmation assay was used.
Phenylpropanolamine (PPA) and ephedrine, found in OTC diet pills and cold remedies, are similar in chemical structure to amphetamines and can produce an apparent (false) positive for amphetamines in immunoassay screens.
Neither ibuprofen, PPA, nor ephedrine preparations will lead to a false positive error, however, if an appropriate GC/MS confirmation assay is carried out, because the GC/MS technique can specifically identify the illicit drug.
17
- Do poppy seeds cause false positives for opiates?
Answer: Poppy
seeds commonly used on bagels or other baked goods frequently do contain
sufficient amounts of morphine to produce detectable concentrations of morphine
in urine, even though the amount of ingested morphine is insufficient to cause
any behavioral effect in the individual. It has been reported in the literature
that ingestion of three poppy seed bagels can lead to urine morphine levels in
excess of 2,500 ng/ml and codeine levels greater than 200 ng/ml.
Therefore a positive urine resulting from poppy seeds is not a false positive, since the drug is actually present in detectable levels. Obviously, a caution must be exercised in interpreting such a positive result as an indicator of heroin use.
One method to distinguish true heroin use is to analyze the urine specimen for 6-monoaccttylmorphine, a heroin metabolite which cannot come from poppy seeds. Recently testing programs have begun routine screening for this metabolite in urines tested opiate positive by an immunoassay screen. The assay requires use of GC/MS methods at very low concentrations and is therefore a highly sophisticated procedure
18
- How can false positives be eliminated?
Answer: Probably
the two most important reasons for the occurrence of false positives are poor
quality assurance (QA) procedures in the laboratory and the absence of an
appropriate confirmation assay to confirm presumptive positives arising from an
initial screening procedure.
A good laboratory will impose a stringent and well-documented QA system and will also use a well-validated confirmation assay for all samples that test positive in a first screen.
19
- How can safeguards be provided to ensure an employee
will not be accused wrongfully?
Answer: One
essential part of any drug-testing program is the medical review of laboratory
results. A positive drug test result does not automatically identify an
employee/applicant as a user of illegal drugs. Confirmed positive test results
for amphetamines, barbiturates, opiates, and even cocaine can result from
legitimate medical treatment.
The DHHS Guidelines for drug testing by Federal agencies require that a licensed physician, with knowledge of substance-abuse disorders, be contracted to review and interpret any positive test results. The guidelines specify:
-In
carrying out this responsibility, the Medical Review Officer shall examine
alternate medical explanations for any positive test result.
-This action could include conducting a medical interview with the individual,
review of the individual's medical history, or review of any other relevant
biomedical factors.
-The Medical Review Officer shall review all medical records made available by
the tested individual when a confirmed positive test could have resulted from
legally prescribed medication.
If procedures such as those prescribed for the Federal drug testing program are followed, the chances of an individual being wrongfully accused of using illicit substances will be virtually eliminated.
20
- Are rigorous and costly laboratory procedures always
necessary?
Answer: The need
to use assay systems which are based on state-of-the-art methods and rigorously
controlled procedures should be mandatory in situations where the consequences
of a positive result to the individual are great. In a case where the
consequences are less severe, such as a counseling situation, it might be
acceptable to use less rigorous systems. For instance, pediatricians sometimes
use portable screening systems in their practices to assist in the diagnosis and
treatment of drug problems in adolescents. Deterrence screening programs might
employ screening assays alone when warnings are the only consequence of a
positive assay. Such programs should however use more rigorous procedures when
more severe actions are to be taken.
21
- Can passive inhalation of marijuana smoke lead to a
positive urine even if the person did not smoke a joint?
Answer:
Inadvertent exposure to marijuana is frequently claimed as the basis for a
positive urine. Passive inhalation of marijuana smoke does occur and can result
in detectable body fluid levels of THC (tetrahydrocannabinol, the primary
pharmacological component of marijuana) in blood and of it's metabolites in
urine. Clinical studies have shown, however, that it is highly unlikely that a
nonsmoking individual could unknowingly inhale sufficient smoke by passive
inhalation to result in a high enough drug concentration in urine for detection
at the cutoff of currently use urinalysis methods.
22
- Can time of previous drug use be determined from
analysis of urine?
Answer: Not
specifically. Urine specimens positive for cannabinoids, for instance, signify
that a person has consumed marijuana or marijuana derivatives from within 1 hour
to as much as 3 weeks or more (in extreme cases) before the specimen was
collected. Generally, a single smoking session by a casual user of marijuana
will result in subsequently collected urine samples being positive for 2-4 days,
depending on the screening method employed and on physiological factors which
cause drug concentration to vary. Detection time increases significantly
following a period of chronic use. Determination of a particular time of use is
thus difficult. The same issues would hold for other drugs, although the time
after use during which a positive analysis would be expected might be reduced to
a few days rather than a week or more.
23
- What adverse health effects can be correlated with the
presence of marijuana metabolites in urine?
Answer: No
studies have attempted to correlate metabolites in urine with specific adverse
health effects. The presence of metabolites in urine indicates previous use of
marijuana, and use of marijuana, at least on a chronic basis, is likely to lead
to adverse health effects. Specific effects, however, cannot be correlated with
a single urine concentration of metabolite.
24a
- Can the level of "intoxication" of an individual due to
marijuana use be gauged by urinalysis?
24b -
Can his or her "use patterns" be determined?
Answer:
Impairment, intoxication, or time of last use cannot be determined from a single
urine test. A true-positive urine test indicates only that the person has used
marijuana in the recent past, which could be hours, days, or weeks depending on
the specific use patterns. An infrequent user should be completely negative in
a few days. Repeated positive analyses over a period of more than 2 weeks
probably indicate either continuing use or previous heavy chronic use.
25
- How long after use can cocaine/ heroin/ phencyclidine/
marijuana be detected by urinalysis?
Answer:
Detection times are dependent on the sensitivity of the assay. The more
sensitive the assay, the linger the drug can be detected. Drug concentrations
are initially highest hours after drug use and decrease to undetectable levels
over time. The time it takes to reach the point of nondetectability depends on
the particular drug and other factors such as an individual's metabolism. The
sensitivity of urine assay methods generally available today allows detection of
cocaine use for a period of 1-2 days. These detection times would be somewhat
lengthened in cases of previous chronic drug use but probably to no more than
double these times. Metabolites of the active ingredients of marijuana may be
detectable in urine for up to 10 days after a single smoking session. However,
most individuals cease to excrete detectable drug concentrations in 2-5 days.
Metabolites can sometimes be detected several weeks after a heavy chronic
smoker (several cigarettes a day) has ceased smoking.
26
- If a urine sample is negative a day after a positive
sample, does this mean the first result was wrong?
Answer: No.
Urine concentrations of drugs such as THC, PCP, or cocaine decrease rapidly with
time. Using the Federal cutoff levels, light or occasional use may only be
detectable for 1-3 days. Therefore, samples collected 1 day apart may show
positive on the first sample and negative on the second sample. The negative
second sample cannot be used to draw any conclusions about the accuracy of the
first sample.
Other factors that can change the concentration of the drug in urine are:
Dilution of the drug by consuming large amounts of fluids or by use of diuretics variation of the excretion of drug based on the time of day when the collection takes place.
These factors could result in repeated samples collected over several days alternating between positive and negative.
27
- How are the results of a urine drug assay expressed?
Answer:
Frequently the results of an assay are reported by the laboratory simply as
positive or negative. If a sample is reported as positive, this means that the
laboratory detected the drug in an amount exceeding the cutoff level it has set
for that drug. Different laboratories using different procedures and methods
may have different cutoff levels. For this reason, one laboratory could
determine a sample to be positive and another determine the same sample to be
negative if the actual amount of drug in the sample fell between the cutoff
levels used by the two laboratories.
Analyses may also be reported quantitatively. The actual concentration of the drug is expressed as a certain amount per volume of urine. Depending on the drug or the drug metabolite that is being analyzed, urine concentrations may be expressed either as nanograms per milliliter (ng/ml) or as micrograms per milliliter (mg/ml). (There are 28,000 micrograms in an ounce, and 1,000 nanograms in a microgram.) Cocaine metabolites may be detected in amounts as high as several micrograms in a heavy user, but the levels of metabolites from marijuana use rarely reach one microgram per milliliter and are usually expressed in nanograms per milliliter.
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