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Federal
Register Document Number 04-7984 Public
Comment 8400159 From: Mary McPhee July
12, 2004 Department
of Health and Human Services 5600
Fishers Lane Rockwall,
II Suite 815 Rockville,
MD 20857 RE: Docket # 04-7984 While
it is evident that much work and collaboration were involved in the drafting of
the new, proposed guidelines, Whole Health Management Inc. respectfully submits
the following comments regarding the Proposed Revisions to Mandatory Guidelines
for Federal Workplace Drug Testing Programs.
WHM supports and appreciates the Department of Health and Human Services
commitment to maintaining the integrity of the entire Drug-Free Federal
Workplace Program. WHM
serves as a TPA and as such, provides numerous urine drug screen collectors for
private companies as well as DOT covered companies including Federal Workplace
employees. We would like to express
some concerns and request clarification regarding several points concerning the
new proposed changes to the rules. As
collectors, we primarily focused on Subpart D-Collectors and subsequent parts
as it relates to our organization and role in performing collections with the
various testing modes. WHM will
certainly be forced to incur increased costs in obtaining certified collectors
and testers due to increased donor privacy not to mention the additional costs
associated with the increased training necessary to perform additional
alternative specimen collections. We
are concerned with the increased costs as related to purchasing and storage of
additional supplies as well as the increase costs for each collector to perform
the volume of quality controls tests (as written, 3 for each mode of
collection) that would be incurred. In
addition, there would be substantial costs to maintain urine collection when
saliva testing is done. We
have need for clarification of what is “donor privacy that is appropriate for
the specimen being collected” in section 5.2 of Subpart E, is it only the need
for oral and visual privacy or for physical privacy? In
section 5.6 Subpart E Clarification: What is an appropriate container for
collecting spit?. To “expectorate” is
to bring forth phlegm from the bronchial passages and is certainly not
considered saliva. There needs to be
clarification as to what is required for collection: saliva or expectorant. We
believe that a standardized list for the containers and devices used for
testing will greatly enhance the program and reduce the liability for collector
errors as well as increase the accuracy of the collection and test. In
Subpart H Specimen
Collection Procedures: we believe a
switch should occur in the order of procedures allowing Section 8.2 to be
before Section 8.1. Clarification: Is there scientific documentation to support
Section 8.2 (5)? Does cleaning scissors
with alcohol actually kill lice? What
is the probability of adulteration from a previous donor? Is there any possible adulteration to a
test where alcohol has been used on the scissors prior to obtaining the
specimen?? Do we now need to train the
collectors in identifying lice on a head? In
Section 8.2 (7) Clarification: Will we need a scale that measures 100 mg of
hair or are there other guide lines for determining how much is 100 mg? In
Section 8.3 (2) Will
agency and authority be the same personage? In
Section 8.3 (4) Point of
Concern: There will be an
increase in testing time to allow for the collector to actually observe the
donor for 10 minutes to confirm that the donor has not had anything in his/her
mouth for the past 10 minutes prior to obtaining an oral fluid specimen. This will significantly reduce the number of
collections that can be done in an 8 hour work shift and impose a major burden
to the collection process. In
Section 8.3 (5) Clarification: the clean specimen tube, will this be
specified as an appropriate container and be federally regulated? This tube is not sealed prior to use? In
Section 8.3 (6) Clarification: Spit/saliva (not expectorate) collection----
if this takes more than 15 minutes, how long should you give the donor, an
hour, all day? In
Section 8.3 (8) Clarification: Mixes what with what? We are unclear as to the focus of this. In
Section 8.3 (9) If
there is not an enough for a split specimen, will there be provisions to
accommodate the donor if he requests a split later? In
Section 8.4 – (3) Clarification: Is it necessary for the donor to empty
his/her pockets for a “sweat test”? If
the donor refuses to empty his/her pockets and it is a refusal to test, should
the employee than be terminated? In
Section 8.4 (5) Clarification:
To wash an area to prepare it for the
application of a sweat patch, will it be determined which soap to use as to not
interfere with the collection or testing of the patch after removal and what if
the donor is allergic to soap, what shall be used then to cleanse the
skin? Does the growth of hair over that
body part and the use of adhesive for the patch cause any harm to the donor
that may be of concern later? In
Section 8.4 (6) Clarification: Should the collector placing the patch be of
the same gender as the donor? What if
in placing the patch, the donor would have to remove a shirt or blouse? There
is a real possibility that donors will have privately exposed areas for
cleansing and patch placement. In
Section 8.4 (7) Clarification: Define 3 days. Is it based on 24 hours after patch placement or is it considered
day to day? Who decides on which of the
3-7 days the patch should be removed?
Does the patch need to be removed at the location/facility of placement
(for traveling employees that may be difficult)? Does the patch need to be removed only by the patch placer in
order to determine if there are signs of tampering? We believe that the MRO
should be the one to cancel tests and not the collector. In
Section 8.4 (8 & 9) Clarification:
What are the signs of tampering to a sweat
patch? In
section 8.4 (11) Clarification: Will the date
of placement as well as the date of removal be recorded somewhere on the form? In
Section 8.5 (4) Point of
Concern: We believe the written procedures should be
shared with the donor prior to collection just as in the DOT guidelines. In
Section 8.5 (9) Point of
Concern: We feel strongly that thee donor should not
be the one flushing the toilet before the collector has a chance to inspect the
bathroom for signs of specimen substitution or adulteration. In
Section 8.5 (11) Point of
Concern: We feel strongly that the donor should not
be turning their back on the collector or their specimen to wash their hands
until after the specimen is sealed in the transport containers. In
Section 8.5 (24) Point of
Concern: We question stipulating who can be a direct
observer if a same gender observer is not available. Can the agency then acquire an opposite gender observer thus
inviting sexual harassment claims and possibly raising privacy concerns? Should the observer be documented on the
CCF? In
Subpart L – Point of Collection Test: We
agree, establishing a list of approved devices and requirements for using these
devices is paramount. In
Section 12.8 (b) Point of
Concern: A standardized set of operational procedures
from DHHS to maintain uniformity and consistency using the testing devices
should exist. Each testing agency may
develop its own manual would lead to possible misinterpretations and legal
loopholes. In
Section 12.8 (g) Point of
Concern: There will certainly be an increased cost
for record keeping incurred. How do we
document the training of collectors?
Who trains the trainers? Will a
model course for training be developed? In
Section 12.18 Clarification: Does this section say that a POCT tester can
be the same as the collector as long as the donor has left the building? Point of
Concern: We strongly believe that developing a CCF
that will contain all the necessary steps for documentation is paramount. An OMB form that will contain the internal
COC as well as additional seals for resealing specimens so tracking can exist
is also paramount. Would it be a fatal
flaw if seals are not numerically matched? In
Section12.19 (a & b) Point of
Concern: There will be the increased cost associated
with the Quality Control aspect of testing in that the collector must perform
one negative, one positive and one valid normal test on each testing device
that that collector will be using during their day. With more than one collector on any given day, the cost of
testing devices will be exorbitant.
Will the testing devices contain a quality control to determine whether
or not it is accurate? If a device is approaching its expiration
date, is there scientific data that test is still reliable? In
Section 12.19 (2)(c) Clarification: How will collectors count the one out of the
every 10 specimens collected? Will it
be the actual tenth specimen collected, then the twentieth and so on? Or can it be any one of the specimens as
long as more than two are performed in that day? As a TPA, we would like clarification on the reasoning for this
process in addition to performing blind specimens processing. Would a separate QC lab need to be utilized
for processing these specimens in addition to the lab used for confirmation
testing and blind specimen testing? In
Section 12.20 Clarification: How many
devices should be QC tested and failed before the collector gets a new lot
numbered box? With no number
established, it is left wide open to anyone’s interpretation. In
Section 12.22 (a) Point of
Concern: A three day delay in reporting results to an
agency with POCT testing seems to defeat the purpose of POCT. In
Section 12.24 (b) Point of
Concern: With regard to giving the donor a copy of
the collectors resume (with the personal address, phone number & other
personal information) of the collector would seemingly violate the collectors’
right to privacy. Why would the donors
right to know supercede & therefore violate the collectors’ right to
privacy? In
Section 12.26 (a) Clarification: Will there
be a Federal List of Free Lance MRO’s that can
be used by testing facilities to review drug test results if, as now
proposed, the MRO cannot be an employee of the company doing the collections? WHM
strongly feels the new proposed guidelines (as currently written)
significantly increase time utilized in
performing collections thereby significantly decreasing the quantity of tests
that can be performed. Impacting the
quantity of tests performed directly impacts agents’ volume/numbers of
employees that can be tested as required.
Additionally, the increased cost for the quality controls for each
testing device and the increased audit responsibility place an undue burden on
the agencies. As collectors, we are
always looking to improve our processes so as not to earn the “weakest link”
reputation, the new proposed guide lines will certainly limit our ability to
achieve this. We
support any recommendations that have the ability to scientifically improve the
drug free workplace for the employees and employers as well as promote the
imperative state of “public safety”.
Respectfully, we request clarification of many of the proposed
guidelines and we ask that our points of concern be given serious
consideration. We look forward to a
collaborative future with meaningful guideline revisions. Whole
Health Management Inc. 20600
Chagrin BLVD, Suite 1000 Cleveland,
Ohio 44122 216-921-8601
X18 Mary
McPhee Evelyn
Jackson Mariana
Cardosa |