July 8, 2004

Department of Health and Human Services, SAMHSA

Attn: Walter F. Vogl, Ph. D.

*wvogl@samhsa.gov*

5600 Fishers Lane

Rockwall II, Suite 815

Rockville, Maryland 20857

# Re: Comments regarding Proposed Revisions to Mandatory Guidelines for

> **Federal Workplace Drug Testing Program**

# Docket Number 04-7984

Dear Dr. Vogl,

[]{.mark}

Please accept these comments prepared by Concentra Inc. (Concentra) in
response to the Notice of Proposed Rulemaking (NPRM) published by the
Department of Health and Human Services' (Department). We applaud the
Department's efforts to expand the Federal Workplace Drug Testing
Program (Program). We believe a good faith effort has been made to
provide for a more stringent drug testing program and we appreciate the
Department's commitment to providing a safe work environment. We agree
with the Department's assessment that there have been significant
advances in scientific technology relative to alternative specimen
testing. However, we do not believe that sufficient research exists at
the present time to proceed with the guidelines presented in the
proposed revisions relative to alternative specimen testing.

Concentra currently operates two hundred fifty-six (256) occupational
health clinics, and one hundred seventy-two (172) on-site medical
clinics throughout the United States. All of our clinics perform DOT
drug testing and all Federal Agencies are represented. As an
organization that is both directly and indirectly impacted by the
proposed revisions, we respectfully submit the following comments for
your consideration. The comments are organized consistent with the
layout and the order of the Proposed Revisions.

**Preamble Commentary**

**GENERAL COMMENTS**

As an entity for whom Department of Transportation (DOT) drug screens
represent twenty-nine percent (29%) of all drug screens, Concentra
highly recommends that the Department collaborate with the DOT where
possible in drafting its final notice of proposed rulemaking.
Collaboration on behalf of these two agencies will result in a uniform
drug testing procedure that will significantly reduce confusion in the
drug testing industry and uphold the Program's "gold standard"
reputation. The production of a uniform drug testing procedure will also
eliminate the conflicting standards that arise when drug testing
facilities develop their own policies and procedures.

**SUPPLEMENTARY INFORMATION**

**The Added Specimens -- Major Change**

Concentra believes that alternative specimen testing has the potential
to greatly enhance the Program. At this time, however, incorporating
alternative specimen testing into the Program is grossly premature and
will severely compromise the "gold standard" reputation that has been
achieved.

Absent from the proposed revisions is an explanation of the
relationships between the various specimens. The absence of this type of
information is cause alone to delay the incorporation of alternative
specimen testing into the Program. For example, what happens when a
donor receives a negative drug result on a hair test but a positive
urine drug test result? As it stands currently, an employee who receives
a positive drug test result on his urine specimen cannot refute this
drug test result in court by evidencing a negative drug test result on a
hair specimen because the Federal government does not recognize hair
specimen testing. In this circumstance, the court will ignore the hair
test result. If, however, alternative specimen testing is incorporated
into the Program and recognized by the Federal government, then a table
of specimen interrelationships will need to be developed. This type of
data exists presently for both the Breath Alcohol Test (BAT) and the
blood alcohol drug test and should also be established for the
alternative specimens prior to incorporating them into the Program.
Until these relationships can be explained to the public, Concentra
recommends that the Department postpone the implementation of
alternative specimen testing.

**Alternative Specimens, *Hair***

The Department is proposing to add hair as an optional specimen
selection for the Program. One rationale for the addition is that "hair
is easily collected, transported and stored." Concentra disagrees with
this statement. There are a number of hair types that would prohibit
collection altogether (e.g. donors that are bald, have military cuts, or
wear their hair in weaves or dreadlocks). If these donors are held to a
different standard (an alternate specimen), there is a potential bias in
their favor as their specimen will only show drug ingestion for a 3-5
day interval preceding the collection, rather than a 30-90 day interval.
Accordingly, there is a potential bias against donors for whom a hair
specimen may be successfully collected. As donors become aware of the
advantages to certain hair styles, they may intentionally alter their
style when they apply for a new job or are selected for a random test.

We also think it is fair to say that our current society is relatively
appearance-conscious and to many, hair plays an important role in
appearance. Donors may not readily accept the loss of 100 mg of hair,
even if it is cut close to the scalp in an area that is not visible. The
collector will likely encounter angry donors resulting in a collection
process that is far from easy.

In addition, Concentra harbors some concerns regarding the ability of
hair to potentially show drug use extending back ninety (90) days.
First, if the proposed revisions are adopted and hair testing is
incorporated as an optional specimen selection, we request that guidance
be added to address how an MRO can determine whether a prescription drug
reasonably justifies the presence of the drug. For example, if the
presence of drugs is indicated in the half inch of hair closest to the
scalp, can a two-week old prescription be used to justify that presence?

Our second concern involves legal ramifications stemming from the
Americans with Disabilities Act (ADA). A "recovering addict" is
protected under the ADA; thus, if a recovering addict is denied a job
because of a positive drug screen, he/she can seek protection by filing
suit under the ADA. As such, Concentra recommends that the Department
incorporate provisions into its proposed guidelines that advise an MRO
when a recovering addict presents for a drug screen. Fore example, these
provisions should address the process for receiving documentation to
confirm the enrollment of a donor in a recovery program, defining a
"recovery program," and follow-up testing for recovering addict.

Concentra also has some questions and concerns regarding the statement
that "sweat can be responsible for drug incorporation at distal segments
of hair which does not correspond to the time of drug ingestion." We
believe that this property can result in misinformation and ambiguity.
For example, if a donor has been taking a prescription drug for two
weeks, and the donor's sweat causes drug incorporation in the segment of
the hair that represents 60 -- 90 days, how will an MRO be able to
confirm whether the prescription drug, or some other non-prescription
drug, is responsible for that incorporation? In addition, the very fact
that some people sweat more than others potentially creates a bias
against donors that are prone to sweating.

Concentra appreciates the fact that you have noted in the preamble that
there is particular concern relative to the role of hair color. Although
we have not conducted, nor are aware of any additional studies on this
topic, we do believe that the potential for bias is a significant
concern and should not be dismissed lightly.

And, finally, although the Department does not address the impact of
chemical treatments on hair, Concentra has some real concerns that such
treatments may invalidate a drug test result. Chemical treatments
(coloring, perms, etc.) alter the composition of the hair strand. A drug
ingesting donor who recently chemically treated his/her hair will
potentially receive a false-negative test result. Concentra requests
that the Department strongly consider the role of chemical treatments in
relative to their effect on the validity of the test.

**Alternative Specimens, *Oral Fluid***

The Department is also proposing to add oral fluid as an optional
specimen selection. Although Concentra agrees that oral fluid
collections can be easily observed and are therefore less likely to be
adulterated, we disagree with the statement that "oral fluid is readily
accessible," particularly since the guidelines require an unstimulated
specimen. "Dry mouth" is not an uncommon condition and should not be
disregarded. If the proposed revisions are passed and oral fluid testing
is incorporated as an optional specimen selection, we recommend that the
Department adopt a specific procedure for "dry mouth" as it has for "shy
bladder" under urine. In addition, it is inevitable that adulterants
will be developed and will affect the validity of oral specimens as they
have with urine.

Concentra agrees with the Department's conclusion relative to marijuana
that "further scientific study is needed to be able to differentiate
between whether the parent drug was present in the oral cavity due to
drug use or environmental contamination." Marijuana is the most common
gateway drug ingested by the average drug user. Concentra believes that
this limitation is sufficient to altogether prevent the incorporation of
oral fluid as an optional specimen selection in the Program. The
potential for a false positive is a significant issue and should be
carefully considered. If it is determined that an oral fluid specimen is
not a reliable test for marijuana, then it should not be incorporated as
an optional specimen selection, particularly since marijuana is the most
common gateway drug ingested by the average drug user.

Concentra strongly disagrees with the recommendation that a urine
specimen be collected every time an oral fluid specimen is collected.
First and foremost, requiring a urine specimen each and every time an
oral fluid specimen is provided will ultimately cause many Federal
agencies to question the cost-effectiveness and timeliness of even
collecting an oral fluid specimen. Furthermore, if each donor is
required to produce an oral fluid specimen and a urine specimen, overall
wait times at collection sites will drastically increase and ultimately
patient satisfaction will decrease. As an example, a typical oral fluid
collection takes approximately ten (10) minutes for the collection, and
potentially, an additional ten (10) minutes if the donor had anything in
his mouth. It then takes approximately fifteen (15) minutes to collect a
urine specimen. The paperwork for both tests takes about fifteen (15)
minutes to process. This results in a potential total time of 50 minutes
to complete the required process for a single donor.

**Alternative Specimens, *Sweat***

Relative to incorporating sweat as an optional specimen selection,
Concentra agrees that privacy during collection (application of the
sweat patch) does not appear to be a concern. However, we do believe
there is a significant privacy concern relative to actually wearing the
sweat patch for an extended period of time. Although many companies
require random drug testing, the fact still remains that there is a
negative connotation around being required to have a drug screen, as the
Department noted in its statement that "there could be a stigmatizing
effect on the wearer." Since the upper arm is the recommended location
for the patch, wearers may be uncomfortable dressing in short sleeves,
which may present an issue in warm weather months or in climates where
the weather is predominantly warm. Privacy has been a rapidly growing
concern for at least the past decade, particularly in the health care
industry, with the adoption and implementation of the Health Insurance
Portability and Accountability Act of 1996 (HIPAA). As such, Concentra
recommends that the Department strongly consider the privacy
implications inherent in sweat testing.

Concentra also has some concerns and questions relative to possible
allergic reactions to the sweat patch. As the Department noted, "skin
sensitivity and rash are factors that can only be known after the patch
is applied for the first time." We recommend that the Department
establish a process whereby any potential allergic reactions on behalf
of a donor would be uncovered. This would be, for example, in the form
of a series of questions to be asked of the donor when he/she presents
for a drug screen. If it is discovered that a donor has an allergic
reaction to sweat patches or sweat patch material, then an alternate
specimen should be collected. This will not only reduce the occurrence
of an allergic reaction but it will also reduce the possibility that an
allergic reaction will occur during non-business or weekend hours, as
discussed below.

The guidelines also require that a wearer return to the collection site
to have the patch removed if an allergic reaction occurs. What should
the wearer do if the reaction develops during non-business hours, for
example on the weekend? If the wearer removes the patch, should this be
considered a "refusal to test"? Potentially, if the wearer removes the
patch on Friday evening the rash may subside by Monday morning and it
will be impossible to determine if the wearer did indeed experience an
allergic reaction. This allows for the opportunity to manipulate the
drug test program relative to sweat collections. If the proposed
revisions are passed and sweat testing is incorporated as an optional
specimen selection, we would request that specific procedures be adopted
to address the concerns above.

Concentra agrees with the Department's statement that "sweat patch
contamination issues continue to be a concern." These concerns should
not be taken lightly, as authorizing the use of sweat as an optional
specimen selection without further investigation and research could
result in a plethora of inaccurate test results which would compromise
the integrity of the Program.

As noted in the Preamble, currently sweat testing is used in the private
sector for monitoring drug use during substance abuse treatment and is
also used in the criminal justice system. We believe that these are the
only appropriate uses given the nature of how the sweat is collected
(through sweat patches) and the inherent problems associated with
wearing the patches.

**SUPPLEMENTARY INFORMATION - SUBPARTS**

**Subpart B -- Specimens -- Major Change**

If the proposed revisions are passed and hair, oral fluids, and sweat
testing are incorporated as optional specimen selections, Concentra
agrees that the reasons for defining and limiting the selection of
specimens for the different types of testing are appropriate. However,
we disagree with the appropriateness of using hair for return to duty or
follow-up, and with using oral fluid for random or pre-employment.

Concentra agrees that routinely collecting more than one type of
specimen from a donor should be prohibited except when an oral fluid
specimen is collected. Cost, timeliness, and the potential for
conflicting results are all considerations when multiple types of
specimens are collected.

With regard to the process when a problem occurs during the collection
of one type of specimen (e.g. "dry mouth" or "shy bladder") Concentra
recommends that either the Department or the Federal agency be required
to list an acceptable alternative specimen, rather than have the
collector contact the Federal agency. This should be specifically noted
either in the Guidelines or in the Federal agency's initial request for
testing. An appropriate contact at the Federal Agency may not be readily
available and may cause extended wait times for the donor and the
collector. In addition, as noted previously, if a different specimen is
collected than originally requested, the potential for bias exists, for
or against the donor depending on which specimen is ultimately
collected. This should not be dismissed lightly.

**Subpart D -- Collectors**

Concentra applauds the Department's efforts at creating a more
formalized training process for collectors. We ask that the Department
recognize the burden that additional training will place on drug testing
facilities; and, we recommend that the Department give drug testing
facilities one (1) year from the publication date of the final
guidelines to train and certify all collectors.

**Subpart E -- Collection Sites**

If the proposed revisions are passed and hair testing is incorporated as
an optional specimen selection, Concentra strongly agrees with the
Department that head hair is the only type of hair to collect for a hair
sample.

Concentra disagrees with the requirement that the collector and the
donor are the only individuals present while the specimen is being
collected. Collection areas may be designed to accommodate more than one
collection at a time by multiple collectors. The Department has noted on
several occasions that privacy does not appear to be a concern (other
than for urine) and as such should not be a factor here. We agree that
potential cross-contamination or specimen mix-ups may be an issue, but
we request that the revisions be amended to require that a collector may
only collect a specimen from one donor at a time. This would address the
above noted concern, but will still allow multiple collections by
different collectors in the same area. Many medical facilities are
likely to experience significant operational costs if collection areas
have to be redesigned or additional areas built. This requirement also
appears to conflict with Subpart E, Section 5.4 of the Guidelines which
only prohibits unauthorized personnel to enter the collection site
during the collection.

**Subpart F -- Federal Drug Testing Custody and Control Forms**

The Department has requested comments regarding the use of a single
Federal CCF versus a multiplicity of forms. Concentra strongly agrees
with this proposal. We suggest establishing a uniform and comprehensive
form with check boxes reflecting the different specimens (e.g. head
hair, urine, oral fluid w/urine, etc.). Having one form would be
consistent with the provisions of the OMB Paperwork Reduction Act. It
would also assist in the reduction of potential errors made on the CCF
and drastically lower the amount of paperwork inherent in creating a
multiplicity of forms for each specimen.

Concentra suggests that any new or revised Federal CCF be developed in
collaboration with the DOT. Because a significant portion of the drug
screening industry is dominated by DOT drug screens, it is only
reasonable to collaborate with them prior to developing a new CCF.

We'd also like to recommend that the Department publish the first draft
of the revised Federal CCF for review. In doing so, drug testing
facilities and industry leaders will be given the opportunity to comment
on and recommend changes prior to its adoption. It is important to
involve the aforementioned groups in this process as they will be the
end users of this form.

The Department has also solicited comments regarding whether it would be
useful to add a requirement that the form cannot be altered by the
employee or others. Concentra strongly disagrees with this proposal. The
urine collection guidelines specifically state that "the collector shall
note any unusual behavior or appearance on the Federal CCF." We believe
that comments are a vital form of information for the MRO in making
decisions as to what questions he or she may ask the donor. Relative to
hair collections, a good example would be a case in which the collector
can visually determine that the donor has chemically treated hair
(colored or permed) or that the donor may be wearing a wig but did not
disclose that fact. As such, Concentra strongly recommends that the
Department increase the size of the comment box, rather than eliminate
it. Because the collection process represents the weakest link in the
drug testing process, the size of the comment box/opportunity for
commentary should be enhanced, not eliminated.

And, finally, Concentra asks that the Department consider the
implementation of a paperless CCF process. From the perspective of the
health care industry, electronic transmission or submission of data is
becoming a commonplace practice. Allowing the transmission of the
Federal CCF from the collection site to the laboratory, for example,
will reduce paperwork issues and increase the overall efficiency of the
drug testing process.

**Subpart G -- Collection Device**

In this Subpart, the Department proposes the types of collection devices
to be used by the Federal agency during the collection process. The
Department distinguishes between devices that have been cleared by the
Food and Drug Administration (FDA) and those that have not been cleared.
For non-FDA approved devices, the Department proposes that Federal
agencies must only use a collection device that does not affect the
specimen collected. Concentra requests clarification as to how/what
standards a Federal agency will use in determining whether or not a
collection device affects the specimen collected.

**Subpart H -- Specimen Collection Procedure**

Here the Department establishes the collection procedure for each
specimen. In this Subpart, the Department proposes that a Federal agency
conduct an annual inspection of each collection site it utilizes for
employee drug screens. As mentioned previously, Concentra owns and
operates two hundred fifty-six (256) occupational health clinics across
the United States and is a fairly large provider of drug screening
services. In 2003, Concentra conducted a little over two (2) million
drug screens with only six hundred forty-seven (647) of these
representing Federal agencies (not including DOT drug screens). The 647
drug screens represent approximately seventeen (17) Federal agencies. On
the average, this represents only three (3) drug screens per center on
behalf of Federal agencies over the course of the entire year.
Considering that these 3 drug screens may come from different Federal
agencies, does this number justify the time, effort, and money that each
of these Federal agencies would need to invest to meet this requirement?

**Subpart L -- Point of Collection Test (POCT)**

In this Subpart, the Department proposes to add POCT testing to the
Program. The rationale behind this is that it will yield immediate test
results for those agency employees located in remote areas of the
country.

The Department has stated that Federal agencies that choose to
participate in POCT testing will bear some of the same responsibilities
for ensuring compliance as they do for the laboratory-based drug testing
program. As such, the Department proposes that these Federal agencies
must meet the following requirements:

1.  Use only POCTs that are on the list of SAMHSA-certified devices;

2.  Ensure that only trained testers are used and provide them with a
    standard operating procedures manual;

3.  Ensure that the requirements of the regulation are fulfilled;

4.  Accomplish the inspection of the POCT test sites;

5.  Accomplish proficiency testing;

6.  Maintain records on the trainers as well as inspections;

7.  Investigate failures;

8.  Make available all Federal agency records for the POCT-related
    activities for periodic inspections by the Secretary; and

9.  Other responsibilities.

Relative to requirements 2 and 4 -- 6, Concentra harbors some grave
concerns regarding both the feasibility and practicality of these
requirements. For example, a Federal agency utilizes our Houston, Texas
medical center two or three times a year for employee POCT drug screens.
Requiring that they conduct an annual inspection of this center is
overly burdensome as the volume of drug screens we receive from them
does not reasonably justify an inspection. Concentra recommends that the
Department consider strongly consider modifying these provisions to
reflect these types of circumstances.

Additionally, requirement #2 mandates that Federal agencies ensure that
only trained testers are used and that each Federal agency (e.g.
Department of Justice, Department of Labor, etc.) provide them with a
standard operating procedures manual. Concentra requests clarification
regarding who will be performing the training and whether trainers will
be required to know and abide by all the procedures outlined in
different agency manuals, which may conflict with one another.
Specifically, Concentra requests clarification as to whether each
Federal agency will be developing a uniform procedure manual, or may be
developing individual manuals. Concentra believes that requiring POCT
testers to operate under a number of separate manuals is extremely
burdensome; and, we encourage the Department to collaborate with
impacted Federal agencies (e.g. DOT, NRC) to develop a uniform drug
testing manual.

Relative to requirement #6, the Department requests that the Federal
agency would be required to retain a record(s) of the collector(s)
training. Concentra recommends that this be amended to coincide with the
DOT's current policy that requires each collector to retain his/her own
training records.

Also in this subpart, the Department discusses the requirement that one
of every ten (10) negative samples must be sent to an HHS-certified
laboratory for confirmation. Concentra believes this is an unnecessarily
burdensome requirement. Concentra would also like the Department to
elaborate on the procedure for the selection process and for the
logging/tracking of which samples were selected. For example, over the
course of a month, Concentra may perform one hundred and six (106)
POCTs, only two (2) which are for Federal agency employees. Should
Concentra send approximately ten (10) of these samples to an HHS
certified lab, or wait until we have conducted ten (10) POCTs for
Federal agency employees, which may not occur at any given site over the
course of an entire year? In other words, does the one-out-of-ten
requirement only apply to Federal agency employee samples or does it
apply to all POCT samples? Another significant question is which party
incurs the additional cost of the quality control test -- the Federal
agency whose employee's sample was chosen or the POCT collection site?
Concentra requests that the Department address these concerns.

**Subpart N -- Medical Review Officer -- Major Change**

Relative to Sections 14.4 -- 14.7, the Department has requested comments
regarding whether the same type of specimen or one of the other types of
specimens should be collected when a specimen is reported as invalid by
the lab. First and foremost, Concentra strongly disagrees with the
designation of an "invalid" specimen. We believe that designating a
specimen as "invalid" will create a loophole in the Program particularly
with respect to "random," "return to duty," and "reasonable
suspicion/cause" drug tests. If a specimen conducted during one of these
tests is designated "invalid" by the laboratory, then the whole
objective of this test will have been negated. For example, a "random"
drug screen is performed to encourage a drug-free workplace. If the
specimen is reported invalid, then the reason for conducting the test in
the first place has been voided. Collecting a different or subsequent
specimen will not have the same effect because the test can no longer be
deemed a "random" drug screen. This is just one instance in which
"invalid" specimens will compromise the integrity and force of the
Program. As such, Concentra recommends that the Department withdraw the
"invalid" drug screen from the proposal; and, for specimens that the
laboratory cannot determine the adulterating substance, we suggest that
the Department continue to designate these specimens as dilute,
adulterated, or substituted.

If the Department proceeds with designation of an "invalid" specimen,
MROs utilized by Concentra suggest changes to the procedure. One
suggestion is that an observed urine specimen be collected in every
instance that a test is reported as invalid. Another recommendation is
to collect the same type of specimen be tested in addition to one of the
alternative specimens. For example, for an invalid urine test, repeat
the urine test and add a hair, saliva, or sweat test. It is important to
recognize however, that debate would likely ensue if one specimen came
back positive and the other negative. In general, MROs utilized by
Concentra did not support the use of alternative specimens.

Concentra would also like to recommend that the Department use DOT's 49
CFR Part 40 as a model for developing provisions governing MROs. Because
such provisions already exist, we recommend that the Department use them
as a starting point to build from, if necessary. Also, many drug testing
facilities have aligned their drug testing policies to the DOT
Guidelines, and using them will encourage uniformity throughout the drug
testing industry.

[]{.mark}

**Subpart P -- Criteria for Rejecting a Specimen for Testing -- Major
Change**

Section 16.3 describes the types of omissions and discrepancies that
occasionally occur on the Federal CCF. The Department has requested
comments as to whether the MRO should be responsible for tracking these
types of errors. MROs used by Concentra recommend that the guidelines
permit the MRO to designate a qualified individual to perform this
function by including the terminology "or designee".

Relative to Section 16.4, the Department has requested comments on any
other errors that must be corrected before the MRO can report a test
results or discrepancies that may occur and must be corrected when the
collector transfers the specimen to a POCT tester. MROs servicing
Concentra do not believe they have enough experience with alternative
specimens to comment.

## Electronic Technology Applications

The Department has requested comments as to whether electronic
technology and capabilities should be addressed in the Guidelines. Over
the past decade, the health care industry has led both the private and
public sectors in incorporating electronic technology into its
operational structure. Concentra strongly recommends that the Department
contemplate developing policies/guidelines that would facilitate the use
of electronic technology in the drug testing industry. As mentioned in
our Subpart F discussion, collectors can easily and more efficiently
complete and submit an electronic Federal CCF to laboratories. The drug
screening industry is eagerly awaiting the Department's permission to
implement electronic technology applications into the drug testing
process.

**SUPPLEMENTARY INFORMATION**

**Impact of These Guidelines on Government Regulated Industries**

Concentra fervently believes that these proposed changes to the
Guidelines will impact the DOT and NRC regulated industries. The Omnibus
Transportation Employee Testing Act of 1991 (OTETA) requires that the
DOT absorb any revisions or guidelines developed by the Department of
Health and Human Services. As such, these guidelines will likely be
absorbed into 49 CFR Part 40 if adopted.

In addition, Concentra is confident that private industries will be
impacted as well, as non-regulated tests tend to be held to a "gold
standard" which is typically based on the regulated industries'/Federal
guidelines. As a result, these guidelines will likely be applied to
millions of donors/tests rather than thousands as considered in the
Department's burden analysis. In 2003, Concentra conducted six hundred
forty-seven (647) drugs screens for employees of Federal agencies,
585,205 DOT drug screens, and 1,426,452 drug screens on behalf of the
private sector -- a ratio of approximately 1: 900 : 2200. It is likely
that other entities who offer drug screening services experience the
same or similar ratios, and if the guidelines become the "gold
standard," the Department's burden analysis will have
[grossly]{.underline} underestimated the potential impact on the drug
screening industry. In order to more realistically project the burden
associated with the proposed revisions, projected man hours and all
costs should be considered for both regulated and non-regulated testing.
Potential bias, discrimination, and privacy concerns should also be
considered for both regulated and non-regulated testing. And finally,
training requirements should be considered relative to every collection
site and every staff member who collects specimens for employees across
all industries.

**Guideline Commentary**

**[Subpart B -- Specimens]{.underline}**

*[Section 2.1 What Types of Specimens May Be Collected?]{.underline}*

As mentioned in the Preamble, Concentra strongly recommends against the
use of head hair, oral fluid and sweat as alternative specimens in the
Program until further research is conducted, greater justification is
provided, and the current technology is updated to ensure greater
efficiency and accuracy.

We also feel that, if the primary motivation for introducing these
alternative specimens is the potential for adulteration of a urine
specimen, the Department must take into consideration the fact that
adulterants will almost certainly be developed for these alternative
specimens as well. It is only a matter of time before some entrepreneur
begins to replicate the sweat patch or that a creative method for
adulterating an oral fluid specimen is developed.

Overall, Concentra requests that the Department recognize that certain
interest groups or organizations have a financial incentive to see these
proposals adopted. The truth is that we all have financial incentives to
see these proposals adopted as it will expand our line of services and
result in an increase in the number of employers who use us for drug
testing, among other services. However, by introducing these alternative
specimens at the present time, we all take the risk of jeopardizing the
integrity of drug testing as a whole by introducing specimens that can
both potentially bias and stigmatize certain ethnic groups and produce
an increase in non-negative results because the necessary technology has
not been refined. Concentra suggests that the Department strongly
consider the potential devastating impact that alternative specimen
testing will have on the integrity and "gold standard" reputation of the
Program, if adopted.

*[Section 2.2 Under What Circumstances Can the Different Types of
Specimens Be Collected?]{.underline}*

In this section, the Department includes a table listing the situations
for which the collection of a specific specimen is most appropriate.
Concentra questions the appropriateness of using head hair specimens for
"return to duty" and "follow up" testing. In light of the fact that head
hair captures drug use extending back ninety (90) days, it is possible
that drug use extending prior to rehabilitation might be captured;
therefore, a recovering addict/donor who has been clean or rehabilitated
for the length of his/her absence could be wrongly accused of ingesting
drugs. As "recovering addicts" are protected under the ADA, it is
possible that a wrongly accused employee/donor will file suit. In light
of this, we highly recommend that the Department seriously contemplate
the legal ramifications inherent in using head hair as an alternative
specimen. We also suggest removing "return to duty" and "follow up"
tests from the table as reasons for collecting a head hair specimen.

We also question the suitableness of collecting an oral fluid specimen
for a "pre-employment" or "random" drug tests. Because of the
short-detection window for oral fluid, this specimen would not be
appropriate or useful in capturing recent or previous drug use. As such,
Concentra suggests removing "pre-employment" and "random" drug tests
from the table as reasons for collecting an oral fluid specimen.

Concentra requests guidance as to the potential situation where a
collector inadvertently collects the wrong or incorrect specimen (e.g.
collecting a head hair specimen for a post-accident test). Is this
specimen still acceptable for testing or must the specimen be discarded
and the appropriate one collected?

*[Section 2.3 Can More Than One Type of Specimen Be Collected at the
Same Time from the Same Donor?]{.underline}*

Concentra feels that the Department has developed this subsection in a
clear and organized fashion; however, to avoid confusion, we feel that
title of this Section needs to be revised. To avoid confusion, we
suggest that the Department replace the term "Time" with "Test." The
term "test" is more specific and will reduce any ambiguity. Another
provision that may cause confusion is the phrase "Yes, more than one
type of specimen may be collected..." Concentra feels that this
statement can be replaced satisfactorily with "Only in the following
circumstances can more than one type of specimen be collected:....." or
"The collection of more than one type of specimen is permitted only
under the following circumstances.." This will eliminate or circumvent
most uncertainty on behalf of those who might read the lead-in as
authorizing them to collect more than one specimen in all circumstances.

Subsection (a) requires that a urine specimen be collected each and
every time when an oral fluid specimen is collected. As mentioned
previously, if each donor is required to produce an oral fluid specimen
and a urine specimen, overall wait times at collection sites will
drastically increase and ultimately, patient satisfaction will decrease.
As an example, a typical oral fluid collection takes approximately ten
(10) minutes for the collection, and potentially, an additional ten (10)
minutes if the donor had anything in his mouth. It then takes
approximately fifteen (15) minutes to collect a urine specimen. The
paperwork for both tests takes about fifteen (15) minutes to process.
This results in a potential total time of 50 minutes to complete the
required process for a single donor. This requirement eliminates any
incentive for an employer to request that an oral fluid specimen be
collected. If a urine specimen must be collected anyway, it would be
much easier, more efficient, and less expensive for a Federal agency to
request the collection of a urine specimen in the first place, and,
thereby, avoid any unnecessary and redundant collections.

Subsection (b) prompts the collector to contact the Federal agency when
a problem occurs during the specimen collection process (e.g. "shy
bladder"). As it is often difficult to reach a Federal agency
representative, Concentra recommends that the Department establish
protocol to deal with these types of situations by mirroring the DOT's
procedure relative to "shy bladder."

*[Section 2.4 How is Each Type of Specimen To Be
Collected?]{.underline}*

In this section, the Department proposes that each type of specimen be
collected as a split specimen.

Concentra requests that the Department consider the increased costs of
containers and postage that will be incurred with the collection of a
split specimen for all specimens collected. As the HHS standards for
drug testing represent the "gold standard" for drug testing in the
private industry, the likelihood that testing centers will adopt these
procedures industry-wide (to include non-Federal/private drug testing as
well) is extremely high.

**[Subpart C -- DRUG AND VALIDITY TESTS]{.underline}**

Subsections 3.19 through 3.22 establish the criteria that must be used
to report specimen samples as an invalid result. Concentra strongly
advises the Department to reconsider designating a test result as
"invalid." As mentioned in the Preamble, "invalid" test results will
create a large loophole in the Guidelines that will likely threaten the
integrity of the Program. Accordingly, Concentra advises the Department
to withdraw the "invalid" drug screen from the proposal; and, for
specimens that the laboratory cannot determine the adulterating
substance, we suggest that the Department continue to designate these
specimens as dilute, adulterated, or substituted.

**[Subpart D -- Collectors]{.underline}**

*[Section 4.1 Who May Collect a Specimen?]{.underline}*

In Subsection (c) of this section, the Department proposes that an
employee working for a testing facility not serve as the collector if
he/she could link the identity of the donor to the donor's drug test.
Concentra applauds the Department's efforts in providing for and
maintaining the confidentiality of the donor's test results; however, we
feel that this requirement would be extremely difficult to enforce. If
adopted, additional guidance will need to be provided as to how testing
facilities are expected to ensure compliance with this requirement,
simply because it will be very difficult to know or determine in advance
whether or not a given collector will remember enough information about
a donor that will enable him to link the test result to the donor's
identity. For example, who will determine in advance whether or not a
link between the donor and test result might occur -- the employee
himself, the testing facility administrator, the donor, etc.

Relative to POCTs, the current process is that the collector and the
test are the same individual and that individual would clearly be able
to link the results back to the donor, particularly since the test must
be done within a certain period time following the collection. If
adopted, this requirement would necessitate significant process change.

*[Section 4.2 What are the Requirements to Be a Trained Collector for a
Federal Agency?]{.underline}*

Concentra applauds the Department's attempts to create a more formalized
training process for collectors. We do however, have some concerns
relative to the training requirements and respectfully request that the
Department recognize the tremendous impact that the training
requirements would impose on collectors. As such, we recommend that the
Department allow time to implement training and certification for all
collectors and suggest a "phase in" period of 1 year.

As mentioned previously, Concentra operates two hundred and fifty-six
(256) occupational health clinics in thirty-six (36) states and
eighty-five (85) markets. Concentra also currently operates one hundred
seventy-two (172) on-site clinics. Concentra occupational health clinics
alone employ approximately three thousand six-hundred (3,600) employees
and all of these employees are cross-trained to serve as collectors. If
the proposed revisions were adopted, we would need to provide training
for each of our 3,600 employees, with each one performing five (5)
consecutive error-free mock collections for four (4) devices (for each
type of specimen). We anticipate that we will need at least fifty (50)
market trainers to facilitate the training. Considering the costs of
travel and training time for both the trainers and the 3,600 collectors,
one only has to imagine the concerns that Concentra has significant
concerns surrounding these requirements. These concerns will be
addressed below by subpart.

Subsection (a) requires that a trained collector have read and
understood these Guidelines. Concentra suggests that the Department
reword this section to state that collectors only be required to read
and understand the Guidelines relevant to their job responsibilities.

The Department states, in subsection (b), that a trained collector will
have, among other things, read and understood any "guidance provided by
the Federal agency which is consistent with these Guidelines." Concentra
requests clarification as to whether all agencies will be developing
guidance pertaining to the collection process. If so, this means that
testing facilities like Concentra will be inundated with a number of
different drug testing standards and policies. As such, Concentra
recommends collaboration by all Federal agencies in developing uniform
guidance.

Subsection (c) states that collection proficiency is demonstrated by
completing five consecutive error-free mock collections for a particular
specimen. For reasons mentioned above, we believe that this requirement
would be unduly burdensome to collection sites both financially and from
a resource perspective. Taking into account the various alternative
specimens, this means that collection sites will incur an additional
financial burden to obtain the training supplies, which would be in
excess of our standard orders.

[]{.mark}

A second consideration pertaining to the requirement set forth in
subsection (c) is the amount of training time that would be necessitated
by this requirement. The amount of time needed to perform this training
would significantly interfere with the day-to-day operations of
collection sites. In order not to disrupt operations, collection sites
might be required to conduct training on weekends, and, as such, would
need to compensate employees for overtime.

Finally, relevant to the five error-free mock collections required by
subsection (c), Concentra requests clarification as to how these mock
collections should be conducted for the alternative specimens. Will our
medical center employees be required to produce oral fluid specimens for
each other until they have each completed their five error-free mock
collections. For hair, will the use of a wig be required or must our
medical center employees continue to cut each other's hair until they
have met this requirement?

Subsection (d) requires that all trained collectors successfully
complete a training course by an established organization for the
particular type(s) of specimen(s) for which the individual is being
trained. Concentra requests clarification of the term "established
organization" (e.g. who or what is an established organization and what
does an organization have to do to become established?). We also request
guidance as to what or whose standards or materials should be used to
develop the training course (e.g. Federal agency guidance, these
Guidelines, protocol established by industry leaders, etc). We also have
some serious concerns about the impact of the requirement that all
collectors complete a training course for each of the alternative
specimens. Because we cross-train all of our medical center employees so
that everyone can perform collections if the situation calls for it,
this requirement would necessitate that all 3,600 employees take a
course for each of the four specimens. We request that the Department
recognize this burden by approving a one (1) year "phase in" to fulfill
this and other aforementioned training requirements.

*[Section 4.3 How is a Collector's Training Documented?]{.underline}*

In Subsection (b)(2), the trainer is given the option of completing a
"train the trainer" course to become qualified. Again, Concentra
requests clarification as to both the guidelines and standards that must
be used to develop this type of course and the definition of
"established organization."

In addition to the individual subsections discussed above, Concentra
would like to request clarification pertaining to retraining of
employees. Absent from the proposed regulation is how a collector
remains proficient in the collection process and how often or frequently
retraining must occur. Concentra requests that the Department establish
a five (5) year retraining cycle to coincide with the "refresher
training" schedule established by the DOT in 49 CFR 40.33 (e). Because a
refresher training cycle has already been established by the DOT,
Concentra believes it would be reasonable and practicable to adopt this
standard.

Concentra would also like to suggest the probability that testing
facilities conducting Federal employee drug testing will be prompted to
adopt these provisions across the board to include
private-sector/non-Federal employee drug testing for two reasons. First,
because the HHS Guidelines represent the "gold standard" for drug
testing, it is likely that testing facilities will implement the
requirements set forth in the Mandatory Guidelines for all drug testing.
Second, adopting the Guidelines for all drug testing will also result in
the simplification of the collection process for those facilities that
perform drug testing for both Federal and private/non-Federal employees.

Concentra believes that the title of this subsection is misleading as it
does not actually address how a collector's training is documented. It
actually appears to address the responsibilities and qualifications that
must be met by the trainer. As such, we recommend that Section 4.3 be
entitled, "What Are the Qualifications and Responsibilities of an
Approved Trainer?" This revision will more appropriately address the
provisions set forth in this section and it will naturally flow from the
previous section entitled "What are the Requirements to Be a Trained
Collector for a Federal Agency?"

**[Subpart E -- Collection Sites]{.underline}**

*[Section 5.1 Where Can a Collection for a Drug Test Take
Place?]{.underline}*

Subsection (b) establishes some examples of an appropriate collection
site. These examples do not go far enough, specifically with respect to
sweat patches and oral fluid specimens. Concentra requests that the
Department clarify appropriate collection sites for these specimens.

*[Section 5.2 What Are the Requirements for a Collection
Site?]{.underline}*

In subsections (b) and (f), the Department utilizes the term "secure" to
refer to storage conditions. Concentra requests clarification regarding
this term and what conditions constitute secure record storage.
Specifically, does the Department require that the temporary storage
area have a lock or is it sufficient that the storage area be located in
an area where other patients would not normally have reasonable access
to it?

Absent from this section is a requirement restricting donor access to
potential adulterants (e.g. chemicals, contaminants). Concentra
recommends that the Department includes provisions to this effect.

*[Section 5.3 How Long Must Collection Site Records Be
Stored?]{.underline}*

In this section, the Department establishes a two (2) year retention
period for collection site records. Concentra requests that the
Department distinguish between original collection site records and the
MRO's copy of these records. We are amenable to maintaining original
collection site records for two (2) years. We strongly advise, however,
that the Department conform to the thirty (30) day retention period set
forth in 49 CFR Part 40 for the MRO's copy of these records. It is
sufficient that we maintain the original records and not keep two (2)
copies of the same document.

*[Section 5.4 How Does the Collector Ensure the Security of a Specimen
at the Collection Site?]{.underline}*

In subsection (a)(1), the Department states that no "unauthorized
personnel" should be allowed to enter the collection site during the
collection. Concentra requests that the Department clarify this term to
specify who would be considered authorized personnel -- other staff
members, other staff members who have been trained to collect specimens,
supervisors, etc.? In the preamble, it states that "the collector and
the donor are the only individuals present while the specimen is being
collected." This statement conflicts with (a)(1) of this section and
needs clarification. Concentra recommends revising the Preamble to
coincide with this subsection.

Concentra is concerned that subsection (b) makes the assumption that all
specimen packaging is tamper-evident. Because the Department has not
established this requirement, we feel that the tamper-evident packaging
will not always be provided for each specimen. Instead of requiring
tamper-evident packaging, Concentra recommends that the Department
propose the development of standard kits, similar to those developed by
the DOT in 49 CFR Part 40.

*[Section 5.5 -- 5.7 Privacy Requirements]{.underline}*

Concentra requests clarification as to specifically what type of privacy
is to be afforded to the donor for each type of specimen. Different
interpretations as to what constitutes privacy may lead to conflicting
collection site standards and consequently a multitude of claims
regarding violation of donors' privacy.

*[Section 5.8 What are the Privacy Requirements When Collecting a Urine
Specimen?]{.underline}*

Subsection (c) provides that mere suspicion that the donor may tamper
with or substitute the specimen is enough to warrant an observed
collection. Concentra believes that this section leaves the Department
open to a barrage of complaints regarding violation of privacy rights.
To avoid potential legal complications, Concentra suggests that the
Department develop a list of circumstances or situations that would
support a decision to conduct an observed collection.

**[Subpart F -- Federal Drug Testing Custody and Control
Forms]{.underline}**

The Department requested comments on whether or not it would "be
preferable, and practical, to have a single Federal CCF that could be
used for all the various specimens, rather than a multiplicity of
forms." Concentra strongly agrees with this proposal. We suggest
establishing a uniform and comprehensive form with check boxes
reflecting the different specimens (e.g. head hair, urine, oral fluid
w/urine, etc.). Having one form would be consistent with the provisions
of the OMB Paperwork Reduction Act. It would also assist in the
reduction of potential errors made on the CCF and will drastically lower
the amount of paperwork inherent in creating a multiplicity of forms for
each specimen.

Concentra suggests that any new or revised Federal CCF be developed in
collaboration with the DOT. Because a significant portion of the drug
screening industry is dominated by DOT drug screens, it is only
reasonable to collaborate with them prior to developing a new CCF.

We'd also like to recommend that the Department publish the first draft
of the revised Federal CCF for review. In doing so, drug testing
facilities and industry leaders will be given the opportunity to comment
on, recommend changes, and bless the form prior to its adoption. It is
important to involve the aforementioned groups in this process as they
will be the end users of this form.

The Department has also solicited comments regarding whether it would be
useful to add a requirement that the form cannot be altered by the
employee or others. Concentra strongly disagrees with this proposal. The
urine collection guidelines specifically state that "the collector shall
note any unusual behavior or appearance on the Federal CCF." We believe
that comments are a vital form of information for the MRO in making
decisions as to what questions he or she may ask the donor. Relative to
hair collections, a good example would be a case in which the collector
can visually determine that the donor has chemically treated hair
(colored or permed) or that the donor may be wearing a wig but did not
disclose that fact. As such, Concentra strongly recommends that the
Department increase the size of the comment box, rather than eliminate
it. Because the collection process represents the weakest link in the
drug testing process, the size of the comment box/opportunity for
commentary should be enhanced, not eliminated.

And, finally, Concentra asks that the Department consider the
implementation of a paperless CCF process. From the perspective of the
health care industry, electronic transmission or submission of data is
becoming a commonplace practice. Allowing the transmission of the
Federal CCF from the collection site to the laboratory, for example,
will reduce paperwork issues and increase the overall efficiency of the
drug testing process.

**[Subpart G -- Collection Device]{.underline}**

*[Section 7.2 Which Collection Devices May Be Used?]{.underline}*

The Department requested comments on the proposed requirement that a
Federal agency must only use a collection device that does not affect
the specimen collected. Concentra feels that this is an appropriate
requirement however we believe the Department needs to elaborate on the
subsection (b) which states for non-FDA cleared devices, a "Federal
agency must only use a device that does not affect the specimen
collected." If the Department is asking Federal agencies to clear
non-FDA approved devices, Concentra advocates the development of
criteria to assist them in clearing a collection device.

**[Subpart H -- Specimen Collection Procedure]{.underline}**

To promote consistency and uniformity in the drug testing industry,
Concentra request that the Department conform as much as possible to DOT
guidelines set forth in 49 CFR Part 40. Also in this Subpart, Concentra
has suggested the development of a pre-screening policy prior to
collecting each alternative specimen.

*[Section 8.2 What Procedure is Used to Collect a Head Hair
Sample?]{.underline}*

Please refer to previous comments in the Preamble relative to using head
hair as an alternative specimen. Additionally, following please find
commentary relative to specific provisions included in this section.

First and foremost, Concentra requests that the Department recognize
safety concerns inherent in introducing scissors into the collection
process. A belligerent donor or one who is under the influence of an
illicit drug(s) may react harshly to the specimen collection. It is not
difficult to imagine a donor seizing the scissors from a collector and
creating an emergency situation -- one that the drug testing facilities
may not be equipped to handle. On the other hand, an inept collector
could injury a donor during the collection process which could result in
a personal injury lawsuit.

In general, this section does not address religious traditions or
customs that might interfere with the collection of a head hair
specimen. Concentra requests that the Department address this situation.
For example, should an alternate specimen be collected or does the
refusal to provide a specimen constitute a "refusal to test" in this
situation?

Subsection (a)(7) instructs collectors regarding how to collect or cut
the head hair specimen. The Department establishes the weight of hair
needed for testing at one hundred (100) mg and states that the sample
collected must meet that requirement. The proposed guidelines do not
instruct the collector as to whether they should cut extremely long hair
down to approximately 1.5 inches before they weigh the hair. Our concern
is that the difference in the amount of long hair versus the amount of
short required to equal 100 mg is significant and will cause confusion
when the collector is cutting the hair (i.e. it takes significantly
fewer strands of long hair to meet the requirement than it does for
short hair.)

Concentra also requests clarification concerning when the specimen
collected does not meet the 100 mg requirement. For example, must the
collector dispose of the first specimen and start again or can they cut
an additional piece from the same region? If the collector must dispose
of the first specimen, must they collect the second specimen from the
same location or a different one?

Also pertaining to (a)(7), Concentra has some concerns regarding the
textural differences of hair (e.g. fine hair, coarse hair). We believe
that the amount of hair or number of strands that must be collected to
meet the 100 mg requirement will vary depending upon the texture of the
donor's hair. A greater sample will need to be collected from a donor
with thin/fine hair as opposed to one with thick/coarse hair.

In subsection (a)(8), the process for splitting a head hair specimen is
outlined. The process of obtaining a split specimen for head hair is an
extremely subjective, time-consuming and intricate process. Furthermore,
the likelihood that strands from the specimen will be lost and/or
contaminated is extremely high.

Generally speaking, Concentra requests that the Department consider
developing a questionnaire to be added the collection procedure. To
reveal any contamination concerns, collectors should be instructed to
ask, for example, whether or not the donor has chemically treated their
hair in the past 60 days. Questions of this nature would occur prior to
specimen collection and should be asked to reduce the occurrence of
false negative test results. Concentra also requests guidance as to the
development of a "next best specimen" policy that would be implemented
when an invalidating circumstance (e.g. chemical treatment) is
discovered. For example, when it is discovered that the donor has
chemically treated her hair, what is the next best specimen for
conducting the drug test?

*[Section 8.3 What Procedure is Used to Collect an Oral Fluid
Specimen?]{.underline}*

Please refer to previous comments in the Preamble relative to using oral
fluid as an alternative specimen. Additionally, following please find
commentary relative to specific provisions included in this section.

In subsection (a)(4), the Department requests that "the collector
confirm that the donor has not had anything in his or her mouth for ten
(10) minutes prior to providing the oral fluid specimen." Concentra
requests that the Department elaborate on exactly how a collector is to
ensure that a donor has not had anything in his mouth for the past 10
minutes. Even if asked, it is possible that a donor will lie to the
collector. Does the Department then propose to develop some type of test
to confirm this?

If the donor has had something in his mouth in the past 10 minutes, the
Department proposes that the collector "wait 10 minutes prior to
beginning the collection process." Concentra requests clarification as
to how a collector should ensure that the employee does not put anything
into his or her mouth. Also, who should be monitoring the donor during
this 10 minute timeframe?

Although not discussed, Concentra believes that certain types of
prescription and over-the-counter drugs might invalidate the oral fluid
specimen. As such, we recommend that the Department develop a
questionnaire to be asked prior to the oral fluid collection (e.g. "Have
you taken a prescription drug tablet today?"). These questions will help
to uncover any factors that could potentially invalidate the specimen
and, ultimately, the drug test result. Concentra also requests guidance
as to the development of a "next best specimen" policy that would be
implemented when an invalidating circumstance (e.g. prescription drug
tablet or cough syrup) is discovered. For example, when it is discovered
that the donor has recently ingested a prescription drug tablet, what is
the next best specimen for conducting the drug test?

Subsection (a)(6) requires that 2 mL of oral fluid be collected over a
fifteen (15) minute period of time or "until the appropriate volume of
specimen is collected." Concentra requests that the Department develop a
maximum timeframe for collecting an oral fluid specimen, much like the
three (3) hour timeframe for "shy bladder" adopted by the DOT in 49 CFR
40.193. This will enhance the efficiency of the collection process and
foster productivity in the testing facilities. It is also unreasonable
to retain a donor for an inordinate length of time.

Subsection (a)(8) specifies how the oral fluid specimen needs to be
split. Concentra requests that the Department elaborate on the
requirement to mix the specimen prior to splitting the specimen. Why
must the specimen be mixed and with what is it being mixed? Generally
speaking, splitting an oral fluid specimen can be an exceedingly
unpleasant and complicated process. Furthermore, the splitting process
for an oral fluid specimen is in its infancy and, as such, needs to be
refined.

In subsection (a)(16), the Department requires that the collection of an
oral fluid specimen be accompanied by the collection of a urine
specimen. Concentra strongly disagrees with the recommendation that a
urine specimen be collected every time an oral fluid specimen is
collected. This requirement will inherently reduce an agency or
employer's desire to collect an oral fluid specimen. If a urine specimen
has to be collected whenever an oral fluid specimen is collected, it
makes sense that employers will simply elect to collect a urine, sweat,
or head hair specimen. Furthermore, if each donor is required to produce
an oral fluid specimen and a urine specimen, the collection process
could take up to fifty (50) minutes (as mentioned previously). This will
drastically increase and ultimately patient satisfaction and employer
satisfaction will decrease.

*[Section 8.4 What Procedure is Used to Collect a Sweat Patch
Sample?]{.underline}*

Please refer to previous comments in the Preamble relative to the use of
sweat as an alternative specimen. Additionally, following please find
commentary relative to specific provisions included in this section.

Consistent with recommendations for the other two alternative specimens,
Concentra request that the Department develop a questionnaire to be
asked prior to the sweat patch application (e.g. "Do you have an
allergic reaction to Band-aids or latex?"). These questions will help to
uncover any factors (including allergies) that could potentially
invalidate the specimen and, ultimately, the drug test result. Concentra
also requests guidance as to the development of a "next best specimen"
policy that would be implemented when an invalidating circumstance (e.g.
history of allergic reaction) is discovered. For example, when it is
discovered that the donor has an allergy that could result in the
removal of a sweat patch, what is the next best specimen for conducting
the drug test?

In (a)(7), the Department states that the sweat patch should be worn for
no less than three (3) days and no more than seven (7) days before
returning to the collection site. To avoid confusion, Concentra requests
that the Department develop a schedule outlining sweat patch application
and removal timeframes. By doing this, the Department will have set
definitive timeframes for the application and removal of the sweat
patch. Please see sample table below.

  -------------------------------------- --------------------------------
  **Patch Application**                  **Patch Removal**

  Monday                                 Thursday

  Tuesday                                Friday

  Wednesday                              Monday

  Thursday                               Monday

  Friday                                 Tuesday
  -------------------------------------- --------------------------------

The Department states in (a)(8) that the collector will remove the sweat
patches from the donor "within several minutes." Concentra requests
clarification as to whether this means the two patches should be removed
with several minutes of each other or within several minutes of
returning to the collection site. If it is intended to mean within
several minutes of returning to the collection site, Concentra asks that
the Department recognize that, depending upon the time of day, the
volume of drug screens or urgent medical care business might prevent the
sweat patches from being collected within that timeframe.

Additionally, it is important to note that the integrity of the specimen
collection is primarily dependent on the donor. Although subsection
(a)(9) instructs the collector to inspect the sweat patch, we feel that
stricter measures must be in place to ensure that the donor has not
tampered with or replaced the sweat patch. Unfortunately, the technology
is such that few safeguards currently exist. As such, we recommend that
the use of sweat as an alternative specimen either be postponed until
the appropriate technology can be developed or limited to substance
abuse programs and the criminal justice system where it is currently
being used.

*[Section 8.5 What Procedure is Used to Collect a Urine
Specimen]{.underline}*

Subsection (a)(1) requires that there be no other source of water (e.g.
no shower or sink) in the enclosure where urination occurs. In the event
that drug screens are being conducted on-site, this requirement would
likely be impossible to meet. Concentra requests that the requirement be
amended to conform with DOT's 49 CFR Part 40 which require that any
other source of water be disabled and/or secured before the sample is
collected.

Subsection (a)(9) requires that the collector "instruct" the donor to
not flush the toilet until the specimen is delivered to the collector.
Many facilities have installed sensor-driven toilets that flush
automatically. This could represent a complication for onsite drug
screens if the facility has installed such toilets. Concentra requests
clarification as to whether premature flushing constitutes a refusal to
test or if the collector should revert to an observed collection at that
point.

Subsection (a)(10)(ii) states that if the donor is unable to provide the
required amount of urine, he/she is allowed to have one 8-ounce glass of
water every 30 minutes up to a maximum of 24 ounces. Concentra requests
that this be revised to coincide with the DOT standard set forth in 49
CFR 40.193 (b)(2). This standard permits a maximum of forty (40) ounces
of fluid evenly distributed over a three (3) hour period of time. Also,
in this subsection, it states that if the donor drinks the water and
then fails to provide 30ml of urine, the collector must contact the
appropriate authority to obtain guidance. Concentra recommends that this
be amended to state that "if the donor fails for any reason to provide
45ml of urine ....." for consistency purposes. We are concerned that
only provided 30ml will not allow for a split specimen.

Subsection (a)(13) instructs the Federal agency to select the observer
if there is no collector of the same gender available. Subsection
(a)(16) also reiterates this requirement. Concentra has three concerns
relative to this obligation. First, it is often difficult to contact the
appropriate representative of the Federal agency. Second, how can the
Federal agency possibly select the observer without being present at the
collection site -- can a non-collector be an observer? What if the
observer chosen is uncomfortable observing as this is probably not their
typical role? And, finally, there are legal ramifications inherent in
this requirement. Having a male collector perform an observed urine
collection for a female employee and vice versa will leave the testing
facility open to sexual harassment claims. Concentra advises the
Department to strongly consider both the feasibility and legal
ramifications of this requirement.

Generally speaking, we also request that the Department clearly discuss
and outline the qualifications and expectations of an observer. For
instance, is this a role that will require training or can anyone be an
observer?

Subsection (a)(19) requires that Bottle A be sent for testing even if
there was not enough urine to split into Bottle B. Concentra disagrees
with this requirement. If the donor only provides 30 mL of urine, then a
split specimen cannot be created. If there is not enough urine for a
split, then none of the urine should be tested (if a split specimen is
always required as proposed in these guidelines).

Relative to subsection (a)(24), Concentra disagrees with the requirement
that a high level supervisor must review and concur that an observed
specimen is needed. Concentra requests that this subsection be amended
to coincide with DOT 49 CFR Part 40 which empowers the collector to make
the decision to order an observed collection.

*[Section 8.6 What are the Responsibilities of a Federal Agency That
Uses a Collection Site?]{.underline}*

Subsection (b) requires that Federal agencies must conduct an annual
inspection of each collection site used to collect agency specimens. It
also states that these Federal agencies must respond to reports of
collector and collection site deficiencies reported to them and must
take appropriate action to preclude the recurrence of such deficiencies.
While Concentra applauds the Department's efforts in enforcing and
ensuring compliance, we question the feasibility of this requirement.

Conducting an annual inspection of each collection site is a significant
burden on both the Federal agency and the testing facility. Additional
employees may be required depending on the number of collection sites
that the Federal agency uses for employee drug testing. It will also
drastically increase the amount of paperwork and records needed to
document such inspections. Altogether, the burden in terms of man-hours
and money required to conduct annual inspections is tremendous. As such,
Concentra recommends that a qualifier be added to this requirement. For
instance, testing facilities for which an individual Federal agency
accounts for greater than twenty-five percent (25%) of its annual drug
testing volume will need to be inspected by a Federal agency.

**[Subpart L -- Point of Collection Test (POCT)]{.underline}**

This subpart establishes the criteria for POCT devices that may be used
as part of the Program. It also establishes the criteria for when
Federal agencies may use a POCT, what the responsibilities are of a
Federal agency that chooses to use a POCT, and the procedures that must
be followed when using a POCT.

*[Section 12.16 What are the Requirements to be a POCT
Tester?]{.underline}*

Concentra would like to reiterate here comments relative to this section
that reflect similar provisions outlined in Subpart D -- Collectors.
Please refer to Subpart D for our comments and concerns.

*[Section 12.18 What are the Requirements for Conducting a
POCT?]{.underline}*

Concentra would like to have the opportunity to comment on the
OMB-approved CCF (referenced in Subsections (a) and (e)) for POCT and
alternative specimen testing prior to approval. This opportunity is not
provided in the Notice of Proposed Rulemaking (NPRM) and we strongly
recommend that you make this opportunity available.

Relative to subsection (e), Concentra requests that the Department amend
this section to require that all specimens, including the urine
specimen, be submitted for analysis. Requiring that the urine split
specimen only be sent when an oral fluid specimen is "presumptive
positive" for marijuana is unclear and worrisome. If the Department
plans to require a urine specimen collection in the first place, then
Concentra recommends that the primary specimen be sent along with the
split to the lab. Why impose that burden on the collection site if the
specimen is not going to be used at all? Second, for validity and
assurance purposes, it is highly recommended that the Department send
the urine specimen. With the inconsistencies and weaknesses inherent in
oral fluid testing, it makes sense that a urine specimen would be tested
to validate the result yielded by the oral fluid specimen.

*[Section 12.19 What are the Quality Control Requirements when
Conducting POCTs?]{.underline}*

Subsection (a)(1) requires that the collection site test POCT kits each
day before donor specimens are tested. Concentra believes that quality
control requirements should rest primarily with the manufacturer. We
suggest that the Department include provisions to this effect requiring
that the manufacturer perform ongoing quality control checks and
implementing recalls of POCT devices when necessary. Furthermore, since
kits are tested by the manufacturer, are FDA-approved, and have an
expiration date, Concentra feels that additional quality control by the
collection site is unnecessarily burdensome and redundant. The
collection site's responsibility should be limited to checking the
expiration date before proceeding with the collection.

Subsection (a)(2) requires that the collection site test POCT devices
with machine-read endpoints each day. Again, Concentra believes that
this responsibility primarily rests with the manufacturer. Concentra
recommends that the collection site only be required to perform quality
control testing once a month unless the manufacturer specifies
otherwise.

Subsection (c) requires that at least one of every ten negative samples
must be sent to an HHS-certified laboratory for confirmation. Concentra
believes this is an unnecessarily burdensome requirement. Concentra
would also like the Department to elaborate on the procedure for the
selection process and for the logging/tracking of which samples were
selected. For example, over the course of a month, Concentra may perform
106 POCTs, only 2 of which are for Federal agency employees. Should
Concentra send approximately 10 of these samples to an HHS certified
lab, or wait until we have conducted 10 POCTs for Federal agency
employees, which may not occur at any given site over the course of an
entire year? In other words, does the one-out-of-ten requirement only
apply to Federal agency employee samples or does it apply to all POCT
samples? Another significant question is which party incurs the
additional cost of the quality control test -- the Federal agency whose
employee's sample was chosen or the POCT collection site?

*[Section 12.21 What Does a POCT Tester Do With a Specimen After
Conducting a POCT?]{.underline}*

Subsection (a) states that "each presumptive positive, adulterated, or
substituted specimen together with its split is sent to an HHS-certified
laboratory for additional testing." Concentra requests clarification
regarding the perceived down-time this requirement creates. For example,
if a DOT employee's POCT yields a "perceived, positive adulterated or
substituted specimen," does a testing facility need to wait for MRO
confirmation to contact the employer; or does the testing facility
contact the employer and place the employee on a probationary status
until the MRO can confirm the results. If waiting for clarification is
required, this poses a potential safety risk from the standpoint of
placing an at-risk driver on the road who may injure not only himself
but others as well. This requirement will also elicit legal
ramifications and donor stigmatization if a donor is unjustifiably
"stood down" or placed on probationary status. As such the down-time
created by this requirement causes concern for legal, operational and
safety reasons and should not be dismissed lightly.

Also in this section, Concentra would like to reiterate its concerns
with the one tenth requirement that was highlighted in subsection (c) of
Section 12.19.

*[Section 12.22 How is a POCT Negative Result?]{.underline}*

Subsection (a) states that a negative result should be reported directly
to an MRO within three (on average) working days. Concentra disagrees
with the timeframe of three (3) working days. We recommend that the
Department conform to the twenty-four (24) hour or next business day
timeframe established by the DOT within 49 CFR Part 40 as the downtime
created by the 3 working day requirement will create .

Concentra also recommends that the Department require that all results
be sent to the MRO and not only the negative results.

*[Section 12.23 How Long Must Records Generated at the POCT Site be
Retained?]{.underline}*

Concentra requests clarification as to whether the records must be
stored on site or may be archived at a storage facility. Furthermore, we
request that the Department provide a timeframe for retrieving any
records that are archived at a storage facility.

*[Section 12.24 What POCT Information is Available to the
Donor?]{.underline}*

This Section outlines the types of information that an employee can
obtain relevant to his/her POCT test. This information can be attained
only upon the written request by the employee through the MRO or Federal
agency. Along with other records, subsection (b) states the POCT tester
is required to provide a copy of his/her resume or curriculum vitae.
Concentra believes this requirement is unnecessarily burdensome and
should be removed from this subsection. We believe it is sufficient to
provide the employee with proof of POCT training. We also recommend that
the documentation package include a copy of the CCF and both the
employees test and test result.

*[Section 12.25 What Statistical Summary Report Must a Federal Agency
Provide to the Secretary?]{.underline}*

Subpart (d) states that the Federal agency must make available the POCT
tester to testify in a proceeding against a Federal employee when that
proceeding is based on a test result that begins with a POCT. Concentra
requests clarification as to which party will bear the expense of travel
to the proceeding, the Federal agency or the POCT tester. Concentra
recommends that the Federal agency be responsible for the expense, and,
as such, recommends adding the verbiage "at its own expense."

*[Section 12.26 What Type of Relationship is Prohibited Between a
Manufacturer of a POCT Device or a POCT Site Operation and an
MRO?]{.underline}*

Concentra requests clarification as to what relationship constitutes a
conflict of interest.

**[Subpart N -- Medical Review Officer (MRO)]{.underline}**

Where possible, Concentra reiterates its desire to see this section
aligned with the provisions established for MROs in 49 CFR Part 40/DOT
guidelines.

Relative to Sections 14.4 -- 14.7, the Department has requested comments
regarding whether the same type of specimen or one of the other types of
specimens should be collected when a specimen is reported as invalid by
the lab. Generally speaking, Concentra strongly disagrees with the
designation of an "invalid" specimen. We believe that designating a
specimen as "invalid" will create a loophole in the Program particularly
with respect to "random," "return to duty," and "reasonable
suspicion/cause" drug tests. If a specimen conducted during one of these
tests is designated "invalid" by the laboratory, then the whole
objective of this test will have been negated. For example, a "random"
drug screen is performed to encourage a drug-free workplace. If the
specimen is reported invalid, then the reason for conducting the test in
the first place has been voided. Collecting a different or subsequent
specimen will not have the same effect because the test can no longer be
deemed a "random" drug screen. This is just one instance in which
"invalid" specimens will compromise the integrity and force of the
Program. As such, Concentra recommends that the Department withdraw the
"invalid" drug screen from the proposal; and, for specimens that the
laboratory cannot determine the adulterating substance, we suggest that
the Department continue to designate these specimens as dilute,
adulterated, or substituted.

If the Department proceeds with designation of an "invalid" specimen,
MROs utilized by Concentra suggest changes to the procedure. One
suggestion is that an observed urine specimen be collected in every
instance that a test is reported as invalid. Another recommendation is
to collect the same type of specimen be tested in addition to one of the
alternative specimens. For example, for an invalid urine test, repeat
the urine test and add a hair, saliva, or sweat test. It is important to
recognize however, that debate would likely ensue if one specimen came
back positive and the other negative. In general, MROs servicing
Concentra did not support the use of alternative specimens.

*[Section 14.4 What Must an MRO Do When Reviewing a Hair Test
Result?]{.underline}*

Throughout this section, the Department requires that the MRO contact
the donor whenever a positive, adulterated or invalid result is
reported. The donor is then asked to provide a valid medical explanation
for the result. If a valid explanation is not provided, then appropriate
action is taken. Concentra requests that the Department recognize
potential difficulties for the donor in providing a valid medical
explanation. It may be unreasonable asking them to remember what
happened months ago. Furthermore, an MRO may have difficulty determining
whether or not, for example, a prescription obtained forty-five (45)
days ago accounts for detected drug use.

*[Section 14.7 What Must an MRO Do When Reviewing a Urine Test
Result?]{.underline}*

Subsection (g) would require that a second specimen be collected under
direct observation even when the donor is able to provide a valid
medical explanation/prescription for the invalid test result. Concentra
requests that the Department elaborate upon its rationale for this
requirement.

*[Section 14.9 How Does the MRO Report a Primary Specimen Test Result to
an Agency?]{.underline}*

Subsection (c) requires that an MRO send a hard copy of either the
completed MRO copy of the Federal CCF or the separate letter/memorandum
report for all non-negative results. Concentra requests clarification as
to whether this copy must be an original copy with an original signature
or whether it can be a stamped signature. This requirement also appears
in Subsection 15.14(c) and should be clarified there as well.

**[Subpart O -- Split Specimen Tests]{.underline}**

*[Section 15.1 When May a Split Specimen Be Tested?]{.underline}*

Subsection (b) states that the donor must make a written request to have
the split specimen tested. Concentra feels that this is an unreasonable
burden and a verbal request is sufficient.

Concentra disagrees with subsection (c) which requires that a donor
provide a new sample if the second portion of a split specimen cannot be
tested (e.g. lost in transit). This seems to be an undue punishment for
the donor. The donor has already met his or her responsibility in
providing the first specimen and should not be subjected to a second
test. Concentra requests that this subsection be revised to coincide
with DOT guidelines/49 CFR Part 40 that state that if the split specimen
cannot be tested, then the test is simply cancelled. The donor is not
required to provide a new specimen.

**[Subpart P -- Criteria for Rejecting a Specimen for
Testing]{.underline}**

Relative to Sections 16.1 and 16.2, Concentra requests that the
Department acknowledge the potential for identifying future additional
fatal and correctable errors.

*[Section 16.3 What Discrepancies are Not Sufficient to Require a
Laboratory or IITF to Reject a Hair, Oral Fluid, Sweat or Urine Specimen
for Testing or for an MRO to Cancel a Test?]{.underline}*

This section describes the types of omissions and discrepancies that
occasionally occur on the Federal CCF. Concentra recommends that the
types of errors identified in Subsection (b) should be corrected in all
instances by adding a Memorandum for Record (MFR) or an Affidavit of
Correction.

In addition, Concentra recommends that the Department allow for
attaching an MFR or an Affidavit of Correction to all copies of the CCF
at any point during the collection or testing process when a correctable
error is discovered.

The Department has also requested comments as to whether or not the MRO
should be responsible for tracking these types of errors. MROs utilized
by Concentra recommend that the guidelines permit the MRO to designate a
qualified individual to perform this function by including the phrase
"or designee".

Relative to Section 16.4, the Department has requested comments on any
other errors that must be corrected before the MRO can report a test
results or discrepancies that may occur and must be corrected when the
collector transfers the specimen to a POCT tester. MROs providing
services for Concentra do not believe they have enough experience with
alternative specimens to comment.

### Request for Information 

There has been much debate as to whether drug screen results are
considered protected health information (PHI) as defined by HIPAA.
Specifically, does a donor have a right to access (get a copy of) drug
screen results and/or the MRO report? Is a HIPAA authorization required
in order to release the results back to the employer? If a laboratory is
sending results directly to the employer, can the laboratory rely on the
fact that the provider secured an authorization? Do drug screen results
need to be kept for a minimum of six years? Do disclosures of drug
screen results to the employer have to be accounted for if a patient
requests an accounting of disclosures? As the addition of alternative
specimens is likely to add to the debate, Concentra requests
clarification relative to how, if at all, HIPAA applies to drug screen
results.

**Closing Remarks**

In summation, Concentra believes adopting these proposals at the present
time would compromise the integrity and threaten the "gold" standard
reputation of the Program. We applaud the Department's efforts to point
out particular concerns throughout the proposal. However, Concentra
believes that until the Department conducts additional research and is
able to sufficiently address these concerns, the proposed revisions to
the Guidelines should be tabled.

Sincerely,

**Concentra Inc.**

**720 Cool Springs Boulevard**

**Suite 300**

**Franklin, Tennessee 37067**

**Phone: (615) 778.4000**

**Fax: (615) 224.9103**

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Rebecca Berthiaume Rebecca Hellman

Director of Regulatory Compliance Regulatory/Legislative Specialist