Agenda Item: Welcome
MR. STEPHENSON (Chair): Good morning. This is the open
session of the Drug Testing Advisory Board meeting. This is going to be a
fairly abbreviated meeting. I apologize to any of the folks who had to come in
from out of town for this, but we tried to make sure that everything that we
could put together here would be available for you today. We are going to have
an added treat. We are going to talk a little bit about a new product and a
resource that is going to be available right now, and this might be kind of a
coming out party for it. We will save that for just a little later.
I ask that everybody sign in so we know who is here. If
there is anyone who would like to make a public comment, please notify one of
our representatives so we can account for time before the end of the public
session.
Agenda Item: HHS UPDATE
MR. STEPHENSON: For this session, the HHS update is
going to be fairly abbreviated, and it's not because we don't have a lot to
talk about. It's because we are not in a position yet to be able to discuss
revisions to our Mandatory Guidelines. I can tell you that the documentation
has been prepared, it has been submitted at our Department level for internal
review, and is in the process of incorporating final comments that have come
back from all the operating divisions within the Department. We are not in a
position to share the document in public session at this time and we do not
have an exact time for its release for public comment, but it is definitely
getting closer. We have a new or a pending replacement contract for the
national laboratory certification contract. We anticipate that this will -- I
do not know how many of you saw a copy of the statement of work and anything
that was written down or understand what's out there - but there is a huge
increase in the types and complexity of tasks that are contemplated under this
new contract and that there will be funding for. An award is pending. There
will be negotiations and a process of review that still is pending, but we
certainly expect to have a contract negotiated and awarded some time between
mid-July and mid-August. Any better than that I can't tell you. Wishfully, I'd
like to see it in mid-July. Realistically, it will probably happen some time
after the 1st of August. But that means that there will be resources available
to do expanded performance testing (PT) work and a number of other tasks
associated, everything from MRO-related issues to collection site issues and so
forth. I do not believe the people that are going to have to do the work are
necessarily looking forward to it because it is going to be a lot of tough
work. But it is going to be something that is going to give us some new
resources that we have not had available in the past. We just have not had the
funds to do everything that needed to be done or necessarily all of the
flexibility in our contracting process to do it, but that is due to change very
soon.
Agenda Item: DOT UPDATE
MR. SHATINSKY (DOT): We have two issues that we just
wanted to present to the Board. First, the issue of the Health Insurance
Portability and Accountability Act (HIPAA). We received many phone calls
regarding HIPAA and its impact on the drug testing program within the
Department of Transportation, as well of course as the non-regulated sector. We
spent quite some time taking a look at the regulations.
We dealt with the HHS point of contacts to develop the
regulations, and basically the bottom line on the HIPAA issue is that this does
not affect DOT transportation federal drug testing. Two main reasons. One is,
although in the preamble I believe in the HIPAA regulations it did mention drug
testing as being a test which they accepted as a medical test, our feeling
basically was that it's not a diagnostic test; it's a test that's designed for
in a sense pre-employment or employment qualification and safety-related. It's
not for diagnostic purposes. The second issue had to do with the fact that in
the rule it did say that if something is required, release of information is
required by regulation or by law, then it's exempt from having to have a
release signed by the individual. And, of course, most of the processes that we
have set up under DOT are mandated by regulation.
Specifically, for example, the release by a laboratory
of the results to the MRO, the release of the information by the MRO to the
employer or to another physician, and so on. Substance abuse professionals is
another group that basically comes up and asks this question, and we require
them to release certain information to the employer.
Basically we decided that these are mandatory
requirements and are not covered by the HIPAA rule. We did develop a question
and answer document that was published on May 3rd, and it is on our web site. I
do have about 15 or 20 copies here if anybody's interested.
The interesting thing that I just want to leave with
the Board is that we are getting calls from the industry asking what's the
impact of HIPAA on the non-regulated testing. Of course, we cannot really tell
them that. We have no idea. It's outside of our purview. But that's going to be
something that's going to be probably driving the industry to a certain degree
in the very near future.
Second issue that we had -- and again, most of you are
aware of this problem -- is that last week on May 28th we published an interim
final rule related to how to treat substituted specimens in a certain category.
Most of you know that there was some controversy regarding the cutoff levels
for creatinine that identified substituted specimens. We tried to work
something out with HHS and we were in the process of doing something together.
We wanted to do something as two agencies in concert.
Unfortunately, we felt pressure to get something out
right away, so we did publish an interim final rule. It did not affect actually
anything at the laboratory level other than requesting the laboratories report
quantitation on those specimens that fell below the 5 creatinine level, report
the quantitations to the MRO. We have tasked the MRO's with taking those
specimens that fall between 2 and 5, identifying them as dilute specimens to
the employer, but also requesting that those individuals have an immediate
recollection under direct observation.
Again, there were two reasons for our action. One, we
felt that there were a few people out there -- and again, you were all involved
in some of these discussions -- that seemed to be able to produce a specimen
with a very, very low creatinine level. In order to give due process and
protect these individuals until there is a specific set of criteria that's
developed by HHS and us eventually, we felt that we should give these
individuals some, quote unquote, "break" in that area. At the same time, we
were very concerned about the safety issue and the fact that some individuals
might use that to try to circumvent the system. Our best solution was to say
those specimens that fell between that range of 2 and 5 would be called dilute
specimens also, but would require direct observation recollection.
It seems -- it was just published. There are copies of
the rule itself at the front desk and I also have some copies here if anybody
wants it. We have not had any MRO's call us yet, but of course it has been only
a few days.
Other than that, the only question that has come up, as
I said, in this area, a couple of federal agencies have called us and said,
well, we have both federal agency testing and we have DOT-mandated testing. And
they were a little concerned about how to handle that because in essence there
are two groups of people now that are going to be treated differently. The
Federal agency individual who has a creatinine of 4 is going to be maybe tagged
with a substituted specimen, whereas somebody who is a driver for a Federal
agency under DOT will have that as a dilute specimen.
We of course do not have an answer to that point, but
we have had a couple of Federal agencies come in and ask us. So that will be an
issue that we will have to take a look at.
Are there any questions?
MR. STEPHENSON: What is interesting is when we went
back and reviewed the percentage of Federal agency employees that also had some
kind of dual accountability we found, out of about 1.6 million federal
employees, there were probably around 10,000 that had this dual
accountability issue.
I think we can say that in the luck of the draw to date
we have never had a federal employee below a 5 on the creatinine issue, so it's
never become a problem in the Federal agencies to date. That doesn't mean that
this afternoon or tomorrow it won't happen, but to date it hasn't.
You're probably going to be lucky on both sides. As
long as these are federal employees, you are probably not going to have it come
up even with the lower reporting level for your standards. So that's good.
MR. SHATINSKY: Are you saying that for some reason
federal employees, because they are federal employees, can urinate differently
than the general population?
MR. STEPHENSON: I do not think it's that. I think the
issue is that there's a lot of other issues that come into play. When you hire
and look at a federal employee, that preselects individuals. Second, there's
not as much testing in terms of the percentage of the total population that is
out there and so the total numbers are there. You are not going to see those
extreme tails in terms of the range of possibilities. We do not also have a lot
of airline attendants as federal employees, the people that have that very
specific work environment and so forth. Those are all issues that are out
there, but we understand and we are doing everything in our power to make sure
that we are able to become a single standard as soon as that is legally
possible.
Is there anything else that anyone wants to talk about on DOT, any questions?
(No response)
Agenda Item: NRC UPDATE<
DR. WEST (NRC): Good morning to everyone. I'll just
give a brief update of our rulemaking activities, specifically to update you on
the proposed rule for fitness for duty, 10 CFR Part 26. We are continuing to
move forward in this area and our current schedule would dictate that we are
expecting to have a proposed rule to the Office of the Executive Director of
Operations, which is one step removed from the Commission, February 27, 2004.
We do have somewhat of a revised schedule.
The principal reason for a revised schedule is that we
have had other competing work that the staff has been responsible for that is
of a high priority for the Commission in the area of issuing orders of one kind
or another. That's had an impact on having to redirect resources to accommodate
this additional work.
That is our current schedule and, generally speaking,
the rulemaking package is moving through the internal process. We are wrapping
up the regulatory analysis, basically how much is the rulemaking effort, how
much is it going to cost or how much is it going to save? That's the general
topic, and of course that gets into some backfit considerations and so on.
This is roughly where we are and we are about to move
the package through our internal review process as it heads toward the
Commission.
Closing Comments
MR. STEPHENSON: I am going to offer the opportunity to
folks that had come here with the "Get Fit, SAMHSA." This is a new web site
that's been developed as a resource. Do we have the opportunity to demonstrate
any of this? Has that been set up? Has anybody arrived yet with that
information? (No response)
All right, we may have to do that at a later time. In
fact, we will because I can't describe all the things that are on the web site
nor can I animate it without having it directly linked to the Internet. That's
one of the things we need to do. They are supposed to be bringing some
material, so if they arrive with the materials before time for us to break then
we'll do it at a different time.
At this time, I would like to ask if anyone has any
public comments that they would like to make, any issues that they want to
present to the group?
(No response)
All right, I think we are going for a record here of
the shortest open session of the Drug Testing Advisory Board. But what I will
do is, I am going to provide an extended coffee break in an opportunity for
folks to talk and to have some discussions.
At this point, I would like to close the open session
of the Drug Testing Advisory Board.
Whereupon, at 8:52 a.m., the open session was adjourned
and the Board recessed to reconvene the same day in closed session.
