Federal Register Document Number 04-7984
Public Comment 8400170

From:  Doctors Review Service

7/12/04

POCT For Drugs

Given that the devices being considered show an 80% ratio of accuracy as per
your documentation, this would leave a 20% margin of error, which could
result in both false negatives and false positives.

Maintaining the integrity of the collection site with the use of POCT drug
testing devices could become very burdensome and expensive.

Given that POCT testing is most suited for Post-Accident and Random
purposes, those facilities that choose to use POCT will be forced to choose
additional forms of testing to maintain a complete testing program.

With regard to Section 2.3: Where the department proposes to prohibit
routine collections of more than one type of specimen per donor, we believe
that if there is an immediate cause to collect an additional or alternative
specimen i.e. shy bladder, that such collection should be able to be
collected using one of the approved alternative methods, as long as the
collector is trained in the additional device without having to seek prior
approval for such action.

With respect to requiring oral fluid testing to include the testing of a
urine specimen simultaneously, this provision would increase the cost of the
collection substantially enough for the end user to be prohibited from using
the new technology. Oral fluid testing affords the end user the ability to
have observed collections that can eliminate issues involving adulteration
and privacy. We believe that the technology supports the use of oral fluid
testing as an independent methodology.

Section 3.1 required test for marijuana and cocaine only: The Federal
Department of Transportation has been testing for five drugs since it's
program inception in 1989. We are in favor of including the same five panel
testing for all federal workplaces.

With respect to 3.2a, MDMA testing: Given the prevalence of MDMA we believe
that testing for this should be included in all federally mandated testing
programs.

Regarding cutoff levels for cocaine and amphetamine, we agree with your
decision to reduce these levels, identifying 10% to 20% more specimens
containing cocaine metabolites and 5% to 24% containing amphetamine will
increase the effectiveness of the drug testing programs and increase the
safety benefit created by these programs.

Subpart E Sections 5.5, 5.6, 5.7 and 5.8: We agree that head hair should be
the only type collected for a hair sample. We additionally agree with the
Departments belief that it would be more appropriate to conduct a drug test
using a different specimen rather than attempting to collect hair from
another body site.

Subpart F, Federal Custody and Control Forms: This is a difficult comment,
although we believe that a single federal CCF should be used for all of the
various specimens, it would be imperative that the CCF be created in a
manner that would not add confusion to the testing process. We agree that
multiplicity of forms to identify each specific testing product could be
problematic and difficult to maintain for organizations that chose to
incorporate multiple testing products. A single CCF for each individual
product would simplify the testing for companies who would chose to select
only one product and would have a specific form to use for that product.

With respect to it being useful to add a requirement employees and others
could not alter the Federal CCF in any way e.g. comments. Certain comments
are essential for communication between the MRO and the collection facility.
We do agree however, that changes that effect account numbers, client names,
test panels and other various changes should not be permitted on chain of
custody forms.

Section 7.2 Subpart G collection device: We believe that if the FDA has
not cleared a collection device, these devices should not be used for
Federal employee testing.

Subpart J Blind samples: We believe that the reduction in blind specimen
submissions is warranted and that the recommended percentage will
effectively provide the protections required.

Sections 11.26, 11.27, 11.28 and 11.29: We believe that levels should be
automatically reported to the MRO. This will increase the effectiveness of
the MRO to provide a conclusion to a testing process in a more timely and
effective manner.

With respect to POCT's we again believe that only devices approved by the
FDA should be allowed when the result of these tests will impact a persons
livelihood and reputation.

We believe that the criteria outlined in Section 12.7 will be a good basis
for the maintenance of the POCT program.

We are glad that the inclusion of required tests that are negative are
being sent to a laboratory for confirmation which is an essential and most
important requirement.

Section 14.3, proposal that an individual who works under the direct
supervision of an MRO may conduct the review and report of a negative
result, we agree with this provision.

For specimens reported as invalid by the laboratory, the Department proposes
to allow the MRO to direct the agency to have another specimen collected, we
agree with this provision.

Subpart P criteria for rejecting a specimen for testing, we believe that the
inclusion of a fatal error on all chain of custody forms regardless of the methodology of testing should be no printed or written signature of the donor, which establishes the inability to connect the donor to the specimen.
We feel that this error should result in the donor returning to continue the collection process until a completed specimen can be tested.

Section 16.3 omissions and discrepancies: The MRO would find tracking discrepancies which are considered by the agency as insignificant and contacting the collector, laboratory of IITF with recommendations of corrections when these discrepancies occur more than once a month would be an undue hardship on the MRO and staff. Instead we propose that anytime the
MRO finds a problem, that they immediately contact the collector, laboratory or IITF in order to remedy these situations.

Issues of special interest: With respect to oral fluid and dry mouth we do not believe that adapting specific procedures are necessary. Again, we additionally would like to comment on the fact that oral fluid is a good
alternative methodology for the test types as recommended, but we suggest revisiting needing an additional specimen to complete the testing process.

Diane F. Schwimmer
Director of Medical Services
Doctors Review Service