Federal Register Document Number 04-7984

Public Comment 8400123

July 12, 2004

Walter F. Vogl, Ph.D.

Drug Testing Section, Division of Workplace Programs, CSAP

5600 Fishers Lane

Rockwall II

Suite 815

Rockville, Maryland 20857.

RE: FR DOC 04-7984

Dear Dr. Vogl,

In response to the proposal by the U.S. Health and Human Services to
establish guidelines for using alternative testing methodologies for
federal workplace drug testing programs, Kroll Laboratory Specialists
offers the following correspondence outlining our opposition on all
counts and respectfully recommends that the proposal be withdrawn.

Since 1989, Kroll Laboratory Specialists has participated in the
National Laboratory Certification Program (NLCP) that regulates the
laboratories certified to test specimens as part of the federal drugfree
workplace program. Our experience with federal testing, and drug testing
as a whole, enables us to comment on the proposed changes with a
definitive understanding of procedures, protocols, and methodologies.
This proposed modification of the Mandatory Guidelines for Federal
Workplace Drug Testing Programs to allow alternative testing methods
causes us concern. Our apprehension is not a result of our business
stake in the drug testing industry but is a result of our clients' stake
in a program that must remain universally uniform and reliable. HHS's
proposal will modify the federal guidelines in such a way that they no
longer resemble the steadfast methods that our clients have depended on
to ensure their drug testing programs are consistent and, thereby,
accurate and legally defensible.

Consistency is the ability to maintain a particular standard with
minimal variation. This is what the federal guidelines have been
striving for since their inception; however, several areas within the
alternative testing matrix are inconsistent and perforate what has been
established as a singularly coherent program for companies to follow.

The first consistency issue lies in the fact that no single alternative
testing methodology is recommended for all testing situations. For
example, hair testing is not recommended for post accident or reasonable
suspicion testing. Drug testing with hair specimens may provide evidence
of long term use; however, it cannot detect recent use, i.e. the day or
few days before. Companies are attempting to uncover recent use when the
analysis is being performed under post accident or reasonable suspicion
circumstances. Hair testing cannot provide definitive proof of recent
use and, therefore, requires that another testing methodology be used in
post accident and reasonable suspicion circumstances. Using two separate
methodologies to test in two separate employment situations could be
difficult for company representatives and collectors to coordinate. In
relation to testing for all drugs of abuse, the potential for testing
positive for marijuana due to passive inhalation is too great with
saliva testing. Marijuana is America's most abused drug, and, as such,
companies need to know if their employees or potential employees are
marijuana users to have an effective program. Saliva testing cannot
provide definitive proof of marijuana use and, therefore, requires that
another testing methodology be used to test for marijuana. Collecting a
urine specimen along with a saliva specimen could be neglected, and,
thus, the test performed would not be complete. Finally, regarding
separate screening and confirmation requirements, point of collection
testing only provides initial test results indicating the qualitative
presence of a drug or drug metabolite. Suspect positive specimens from
POCT devices must be confirmed with a separate, distinct testing
methodology; therefore, companies that utilize POCT devices would have
to send all suspect positive specimens to a laboratory for confirmation.
Point of collection testing cannot provide definitive proof of the
presence of any drug or drug metabolite and, therefore, requires that
another testing methodology be used to confirm initial test results.
Transporting suspect positive specimens to a separate location for
confirmation adds to the complexity of ensuring chain of custody and
specimen integrity.

In all of these cases, the companies that elect to use an alternative
specimen must combine methodologies to fully meet federal requirements
for all testing situations, which would inevitably complicate their
testing programs, create inconsistencies, and incur additional costs.
The only universally accepted method, which is both convenient and cost
effective and meets all requirements, is traditional, laboratory-based
urine testing.

In addition to the aforementioned issues, several others fragment the
overall coherence that a single methodology drug testing program
provides. For the end user -- the company required to perform drug
testing -- opening up the program to other methods, produces sweeping
irregularity and unpredictability with regards to employment practices,
statistical reporting, and training.

First of all, enabling companies to choose from several "approved"
testing methodologies creates inconsistencies in the universal hiring
practices employed by federally-regulated companies. Because each
testing methodology has a different drug detection period, a potential
employee that may be hired by a company using one testing methodology
could be denied employment by another that uses a different one. These
two companies should be equal, utilizing the same employment practices
and hiring from the same applicant pool..

Secondly, various companies using various testing methodologies also
leads to a lack of consistency in program monitoring. Positivity rates
may vary among the testing methodologies. These variations in positivity
rates would complicate the interpretation of industry statistics and
would have to be accounted for when performing statistical analyses.
Within that, companies that have to use multiple testing methodologies,
i.e. those that normally use hair testing and would have to use urine
for a post accident test, would have disparate statistics because of the
disparate methods. Again, performing a statistical analysis on the
company and comparing it to industry-wide statistics would be imprecise
without accounting for the varied positivity rates.

Finally, ensuring consistency in the training of all participants in the
drug testing program is a monumental task. As currently available for
traditional, laboratory-based urine testing, training programs for each
methodology must be outlined for collectors, medical review officers,
and company representatives. Collectors will need to be provided with
the appropriate collection protocols for each method. Additionally, they
will need to be trained on the various points of deviation for each
methodology. For example, collectors must be trained to ensure a urine
specimen is collected with a saliva specimen so that testing for
marijuana can be conducted. Further, they would need to be trained to
ensure that urine is collected for those clients that normally use hair
testing so that a post accident or reasonable suspicion test can be
performed. These exceptions must be clear to the collector, and their
collection methods must be agreed upon by all laboratories and deemed
legally defensible for companies. Assuming that collecting for
alternative testing methods will follow along with the collection
requirement for traditional, laboratory-based urine testing, the
collectors will need to be certified to perform collections for each
methodology. Along with the need to design and implement consistent
collector protocols, training and certification programs will need to be
developed and enforced. Certification for collectors has been recently
implemented to correct the inconsistencies in collection protocols,
ensuring the integrity of the collection process and reducing the number
of rejected specimens due to collector error. This commitment to
consistency must continue with the alternative testing methodologies
and, as such, will expand the already overwhelming task of ensuring
certification. With the potential for millions of collectors out there,
enforcement will be difficult. Add this to the need to educate MROs and
company representatives on interpreting results and managing programs,
and not enough resources currently exist to design and implement
training and certifications programs.

As final commentary on the proposed guidelines for alternative testing
methodologies, Kroll would like to address the complicated nature of
point of collection testing. Our experience indicates that specific
attention should be paid to point of collection testing and the
logistical issues that surround implementing this method for the federal
drugfree workplace program.

If a company chooses to perform its own collections for a point of
collection testing program, an employee of the company will participate
in every step of the process -- collecting the specimen, testing the
specimen, and interpreting the results of the test. Having each
individual involved in the testing process employed by the same company
conducting the testing will eliminate the checks and balances currently
in place to maintain the integrity of the specimen, preserve the donor's
privacy, ensure the accuracy of test results, and guarantee the
defensibility of test results in a court of law. A step in the process
may be inadvertently neglected or the results of the test intentionally
misread to the benefit or detriment of the donor. Too many opportunities
for errors, omissions, or corruption exist when placing all of these
steps in a single location, exposing a company utilizing point of
collection testing to be held liable in unfair hiring practices, unfair
dismal, or negligent hiring lawsuits.

Point of collection testing also exposes the donor's right to privacy.
Confidentiality has always been a large part of the federal drug testing
program. Special care was taken to design a chain of custody form to
conceal the donor's name from the laboratory, ensuring that donors are
only identifiable by their social security numbers and assuring results
are not influenced by an employee knowing the individual on whom he/she
is performing analysis. Where a laboratory is an objective entity with
no history with or knowledge of the donor, in point of collection
testing, the donor will encounter with the collector and/or tester.
These two individuals may be related, friends, or enemies. In any
scenario, the results are subject to falsification to the benefit or
detriment of the donor. Even if the donor and collector/tester are not
known to each other prior to the point of collection testing process,
donor confidentiality and test integrity are still breached. First of
all, corruption of the testing process is possible. The donor may
attempt to bribe the collector/tester or the collector/tester may
attempt to extort money from the donor in exchange for a negative test
result. Secondly, potential confrontation issues exist. The donor may be
insistent on knowing his/her results immediately or agitated and irate
at the prospect of having to be confirmed, putting the collector/tester
in awkward and potentially harmful situations. Finally, an individual's
positive initial test result could damage his/her reputation within a
company, even though that result does not confirm positive in a
laboratory setting. Results not yet confirmed by laboratory testing are
known to the collector/tester. The collector/tester may tell other
employees or form his/her own negative opinion of an employee. The
slightest question about breach of confidentiality, specimen integrity,
or result falsification can lead to a legal dispute about employment
action taken on results of a point of collection test.

Finally, while point of collection testing may appear like an
inexpensive alternative to traditional laboratory urine testing,
implementing a POCT program under federal guidelines will eventually
become a burden on a company. If companies or collection facilities
performing point of collection testing are held to the same security
standards as laboratories, the areas where the testing is performed,
devices are stored, and records are maintained must be secure. Many
companies or collection facilities would find meeting these stringent
requirements cumbersome. A similar burden would be on companies or
collection facilities to ensure that collectors are certified and
appropriate procedures are followed. Additionally, ensuring Medical
Review Officers are informed of on-site negative test results and
maintaining meticulous records would be challenging. Non-regulated
clients, who are not held to the high standards of federal testing
programs, have difficulty implementing point of collection testing
programs, training collectors, managing this training, interpreting
results, and addressing issues like shy bladder and adulterant testing.
These difficulties will only be magnified when attempting to meet the
strict requirements of performing federally-regulated testing.

Thus far, Kroll Laboratory Specialists' response has focused on the
"real world" issues created by accepting alternative methodologies for
drug testing in the workplace. We have chosen to focus on this area
because scientific acceptance of alternative testing is still being
debated. Issues of environmental contamination remain, and specimen
validity testing and quality control procedures have yet to be
determined. With these technical and logistical issues unresolved, Kroll
Laboratory Specialists asserts that modifying federal guidelines to
include alternative testing methodologies is simply premature, and we
recommend that the HHS's proposal be withdrawn. While we understand the
need to "advance" and keep up with "new technology," these technologies
must be researched more thoroughly to determine impact on real world
scenarios, and the straightforward consistency that has been created
through years of evolution in traditional, laboratory urine testing
programs must be evenly applied. Let us remember that the initial
purpose of the federal drug testing program was to ensure a drugfree
workforce nationwide. Accepting other methodologies would expand the
program to an unrecognizable, unpredictable state, and this lack of
consistency would be in direct opposition to the original mission.

Sincerely,

Kroll Laboratory Specialists