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Federal Register Document Number
04-7984 Public Comment 8400135 From: Marty Brady July 12, 2004 The following are comments and
questions we have regarding the proposed new mandatory drug testing guidelines
for alternative matrices. Oral Fluid. Requirement to collect urine along
with oral fluid. It does not seem necessary to
require an agency to collect a urine specimen when they collect an oral fluid
specimen because of concern about passive THC contamination. When a donor has actually smoked marijuana,
it is difficult to detect THC in oral fluid.
The published Lab One study demonstrates that oral fluid drug testing
yields results that are comparable with urine drug testing as long as the
cutoffs are set appropriately. I have
not read any studies that support the potential for an oral fluid THC positive
from passive inhalation. This
requirement will essentially eliminate oral fluid as a testing matrix. It is hard to imagine anyone collecting an
oral fluid specimen if you also have to collect a urine specimen. In addition, with this stipulation in place,
the only time you might want to collect an oral fluid specimen is in a case of
very recent usage. In such a case, the
THCA probably won’t even have shown up in the urine yet, which is why you
wanted oral fluid in the first place.
So the proposed remedy doesn’t fully address the alleged problem. Before this rule is finalized, more
published work is necessary. Oral Fluid collection and
validity. Section 8.3 paragraph 8. How should the oral fluid be mixed and then
transferred? If collection devices were
allowed, the handling of oral fluid specimens would be simplified. Collection devices should measure the amount
of oral fluid collected. If recovery
issues are viewed as “affecting” the collected specimen, some collection
devices may violate section 7.2.
Perhaps 7.2 could be clarified.
If collection devices are allowed, the substituted specimen criteria for
oral fluids may need revision, since you would have to know how much oral fluid
you obtained in order for the IgG concentration to have meaning. Hair testing. Should hair testing be allowed for
follow-up or return to duty. Since you
can detect drugs in hair for a long time, how can you distinguish drugs
detected in the hair from last week’s drug use from drugs detected in the hair
from last month’s drug use? I didn’t
see any guidance in the proposed rule on collection or testing to address this
concern. Should baldness be treated like
dry mouth or shy bladder? Guidelines on
how to handle such situations would be helpful. Is head hair defined?
Does head hair include eyebrows, moustache and beard hair? How is the collector to know when
the hair specimen is 100 mg? Is the
collector supposed to weigh it? Are
there guidelines for rejecting a hair specimen at the laboratory for
insufficient specimen as there are for urine? CCF. On page 19682, it is suggested
that one CCF be used for all types of specimens. This would simplify the whole process. There should be some extra room on the CCF for specimen choice
boxes especially since the “split” specimen box can be removed since all
specimens will be split. Collectors
should be able to write comments on CCF.
Allowing the writing of comments on the CCF was questioned in the
guidelines. Quantitative Reporting. Drug concentrations should be
printed on the report without special MRO request. This is already done for all of our non-regulated clients. The MRO would be responsible for maintaining
objectivity. Electronic Technology. On page 19687, the question is
asked if the new regulations should give guidance on electronic technology
applications. Yes, I think this would
eliminate a lot of the guesswork for laboratories that want to modernize their
operations. Definitions. 1) Should the definition of “Laboratory” be revised to include the
“CT” as a releaser of results? 2) Should the definition of a “negative result” be modified to state
“….MRO when a ‘valid’ specimen contains no drug…..” 6AM Initial Test. Section 3.7 allows for screening
all specimens for 6AM. It makes more
sense to only test specimens for a 6AM test that are positive for opiates (same
aliquot). If it is negative, there is
no need to run a 6AM GC/MS test even if the specimen is positive for morphine
by GC/MS. If the specimen is positive
for 6AM by immunoassay, you have additional supporting data for the 6AM GC/MS
result. This would result in faster
turnaround times and less cost for the laboratories. Specimen Collection. Procedures for collections do not
seem to fully take into account the nature of the different matrices. Having a donor empty his pockets for a urine
collection is pertinent because he is given privacy and an opportunity to
adulterate his specimen. Those
precautions don’t seem pertinent to hair, oral fluid and sweat patch
collections. The certification statement for
the donor in alternative matrices collections should be more pertinent to the
specific matrix. For example, should
the certification statement for a hair collection include language about the
collected specimen being their natural hair and that they do (or do not) dye
their hair, etc. (It is suggested in
the guidelines that hair be digested and tested for dye.) Will digestion detect the use of a human
hair wig. Is dying your hair an attempt
to adulterate a hair test? For oral fluids instead of just
asking the donor if they had anything in their mouth in the last 10 minutes,
have the collector take a look in their mouth or have the donor rinse their
mouth with water 2 minutes before collection.
Some of the validity test requirements for oral fluids could be
eliminated if precautionary procedures were followed. Second Specimen. On page 19686, the question is
asked whether the second specimen collected in an invalid situation be of a
different matrix. I believe that many
of the invalid situations would go away if the donor knew they would be
required to submit to a hair test for the second test. We can expect a lot more invalid specimens
in the future due to the new validity test regulations so a better way to
address the issue seems warranted. The guidelines ask the question
about collecting a second type of specimen should a shy bladder situation
occur. As the current guidelines stand,
oral fluid would be eliminated as a second specimen since you by definition you
are unable to obtain a urine specimen.
If the rule of oral fluid specimens were relaxed, I think agencies
should be allowed to advocate a second type of specimen in such situations.
Section 2.3. POCT testing. To ensure that all non-negative
specimens are detected, the cutoffs for onsite testing could be lower than the
initial test cutoffs. A similar
practice is utilized on colorimetric pH testing to send any potential non-negative
to the pH meter for testing. Typographical error. On page 19697, under oral fluid
and urine confirmation cutoffs, phencyclidine appears to be listed as an
opiate. Sincerely, Martin J. Brady Director of Toxicology S.E.D. Medical Laboratories |