July 12, 2000
Mr. Walt Vogl
Division of Workplace Programs
5600 Fishers Lane
Rockwall II, Suite 815
Rockville, MD 20857
Dear Mr. Vogl:
Following are the comments of the Drug and Alcohol Testing Industry Association (DATIA) on the Draft Mandatory Guidelines for Federal Workplace Drug Testing Programs. DATIA is a 1,000+ member non profit national trade association representing the entire spectrum of service providers in the drug and alcohol testing industry, including consortia, third party administrators, specimen collectors, medical review officers, laboratories, and testing equipment/product manufacturers. DATIA's comments on behalf of its constituency are based upon input from DATIA's members, Legislative & Regulatory Committee, and Board of Directors.
DATIA wishes to commend the SAMHSA/CSAP Division of Workplace Programs
and the Drug Testing Advisory Board (DTAB) on their efforts to update the guidelines
for use in the 21st Century. The inclusion of alternative testing methods is much
needed and appreciated by professionals in the drug and alcohol testing industry.
DATIA is concerned, however, that requirements appropriately applied to laboratories
are inappropriately applied to Point of Collection Tests (POCT) Providers in the
draft guidelines.
We thank you for this opportunity to participate in the formulation of
these revised guidelines at this stage in their development. We look forward to
working with you as you continue to revise the Mandatory Guidelines and DATIA
is available to assist you in any way that you may need. Please feel free to contact
me if you would like to further discuss any of the following comments.
Sincerely,
Laura E. Norfolk
Executive Director
Subpart B, §2.2 Under what conditions can the different types of specimens
be collected?
Although this section lists recommendations, and not requirements for
specimen testing, DATIA feels that Oral Fluid testing should also be recommended
for pre-employment, random, return to duty, and follow-up testing.
Subpart D, §4.1 Who may collect a specimen?
(a) An individual trained or certified to collect specimens.
In keeping the guidelines consistent, DATIA recommends removing "trained or"
as the guidelines continually refer to the fact that collectors are required to
be certified.
Subpart D, §4.3 Who can train and certify collectors?
When determining who can train and certify collectors, DATIA recommends that
the approved programs consist of face-to-face training for collectors, as well
as a comprehensive exam to determine their proficiency. DATIA would like to offer
its current training program, which has been successfully administered since 1997
and has certified over 1,000 Certified Professional Collectors™ (CPC™) and Certified
Professional Collector Trainers (CPCT™), as a model, as well as the Department
of Transportation's BAT Training model program.
The key is to require that training be conducted in person where the trainer
(not computer or video screen) can effectively monitor and gauge the collector's
grasp of the fundamentals. This allows the trainer to tailor the training to target
those areas where the collector is the weakest. In addition, it is important that
the trainer has completed a formal training program and has substantial experience
in performing specimen collections and handling various "what if" issues. The
trainer's training should include not only training on the collection aspects,
but also how to administer an effective training program for their collectors
and how to monitor their collectors to determine when and in which areas additional
training is needed.
Subpart K, §11.21 What summary reports must a laboratory provide to
a Federal Agency?
DATIA recommends that semi-annual summary reports be eliminated. Many employers
continue to receive reports indicating that too few tests were performed to receive
a report. In addition, those that do receive the reports do know what to do with
them since the laboratory results are often different from the results after being
reviewed by a Medical Review Officer. The industry has not seen a benefit from
the statistical reports to support their additional financial and administrative
burdens.
Subpart L, §12.3 What are the requirements for a POCT?
Under this section, it states that a POCT device must be cleared by FDA and
must be included on the SAMHSA/HHS Conforming Products List. What additional criteria
will SAMHSA/HHS use to determine that a FDA approved device is eligible to be
placed on the Conforming Products List? What will be the process for manufacturers
interested in having their product on the Conforming Products List? Will this
information be readily available to manufacturers so as to streamline their approval
process with both FDA and SAMHSA/HHS?
Regarding the validation studies that must be completed prior to placing a
new lot in service, does this refer to studies done at the manufacturing level
or at the POCT provider level? What requirements are there for the validation
studies? Does SAMHSA/HHS plan to verify that these validation studies are done
on each lot and if so how?
Subpart L, §12.4 Who may conduct a POCT?
Subpart L, §12.5 What are the qualifications for the person who performs
a POCT?
DATIA suggests that §12.4 be changed to read "A certified collector trained
and proficient in the use of the specific device/system used to perform the POCT",
and eliminate §12.4 (b) which requires a trained tester to perform the test.
This is due to the fact that §12.4 and §12.5 contradict each other.
According to §12.4 (b) a trained tester must perform the test under the supervision
of the Responsible Technician, and under §12.5 (a) a certified collector
must perform the POCT. Since in the majority of cases the collector will also
be performing the test, we suggest that this single reference to a "trained tester"
be eliminated.
Subpart L, §12.6 What are the qualifications of a Responsible Technician?
It appears that a POCT Provider is considered to be a laboratory under these
new guidelines. Many of the responsibilities in this section do not appear to
apply to a POCT Provider. For example:
(a)…even where another individual has overall responsibility for an entire
multi-specialty laboratory
(d)...monitor analytical performance of all controls and standards; document
the validity, reliability, accuracy, precision, and performance characteristics
of each device/system used at that testing facility
These responsibilities are identical to the responsibilities listed for a laboratory's
Responsible Person. Since their responsibilities are identical, will a Responsible
Technician also be required to adhere to the qualifications for a Responsible
Person (Ph.D., experience in analytical forensic toxicology, etc.)?
DATIA cannot emphasize enough that a POCT provider is not a laboratory. The
toxicology and science behind the POCTs is developed by the manufacturer and approved
by the FDA and SAMHSA/HHS. The certified collectors who perform the POCT do not
have a laboratory/toxicology background, nor do they need to. They simply need
to understand and be proficient in specimen collection and how to operate/read
the POCT device. No quantitative results are obtained at the POCT Provider, nor
does the POCT Provider report any positive results. This is information that is
provided by the laboratory once a non-negative is sent to the laboratory for confirmation.
DATIA does understand the need/desire for a supervisory person at the POCT
Provider to ensure that the certified collectors are properly reading the tests.
This goal can be accomplished through the training process. Since training and
certification is required for collectors, the Responsible Technician could be
the POCT Provider's certified collector trainer. This will in fact satisfy two
requirements of the guidelines at once. The responsibilities of the certified
collector trainer would be to administer quality control on each new lot of POCT
devices before putting them into use, monitoring the proficiency of the provider's
collectors, offering refresher training as needed, and being available to answer
questions as they arise.
Subpart L, §12.10 What are the requirements for conducting a POCT?
DATIA suggests that information be included on procedures for non-negative
results. In addition, it should be clarified that only negative results are forwarded
to the MRO from the POCT Provider. Non-negative results will be reported as positive
or negative from the laboratory after confirmation testing.
Subpart L, §12.11 What are the quality control requirements when conducting
a POCT?
DATIA does not agree that quality control testing should be performed each
day. Rather each lot should be tested by the manufacturer before shipment and
by the POCT Provider before placing the POCTs into use. If there is a problem
with a device, there will most likely be a problem with that whole lot. By requiring
daily testing rather than lot testing, you risk the possibility of not testing
a damaged lot. Since each test device is separate from one another, there is no
added benefit in requiring daily quality control testing in addition to testing
each lot. In addition, each device comes with an expiration date and storage instructions.
POCT Providers should be held responsible for ensuring these storage guidelines
are adhered to and that no devices are past their expiration date.
Subpart L, §12.12 What are the application requirements for a POCT
Provider?
These requirements are again identical to those required for laboratories.
DATIA does not see the reason for or positive effects of requiring POCT Providers
to be certified by SAMHSA/HHS. Both FDA and SAMHSA/HHS have approved the test
devices that POCT Providers use, and a SAMHSA/HHS approved program has certified
the persons performing the screens. Why then must a facility that utilizes these
approved products and employs these approved collectors be required to be certified
as well? This seems like an extra burden, for both the POCT Provider and SAMHSA/HHS,
that is not necessary.
The detailed analytical procedures would be best provided to SAMHSA/HHS by
the manufacturer as part of their process in applying to be on the Conforming
Products list. The administrative procedures seem to be self-evident, but could
be enumerated in the guidelines to ensure that POCT Providers are aware of the
paperwork that must be completed in association with conducting a POCT.
Subpart L, §12.13 What are the performance test requirements for a
POCT Provider?
With the use of FDA and SAMHSA/HHS approved POCT devices that are quality control
tested both at the lab and at the POCT provider, these requirements (which are
identical to those for a lab, with the exception of the concentration of drugs
in the sample) seem unnecessary and inappropriate for the POCT provider.
Subpart L, §12.14 What are the inspection requirements for a POCT Provider?
DATIA does not see the value or feasibility in inspecting the thousands of
potential POCT Providers. What will the inspection consist of? Storage of the
POCTs? Paperwork? How does SAMHSA/HHS plan to inspect mobile POCT Providers who
collect the specimens at the employer's place of business? Again, this is a requirement
appropriate for laboratories that is being inappropriately applied to POCT Providers.
If monitoring of the facilities and their protocols is deemed necessary, this
could be done in other ways including submission of Standard Operating Procedures
and Collector Certifications to SAMHSA/HHS.
Subpart L, §12.15 Who may inspect a POCT Provider?
See §12.14 comments. In addition, there will need to be a large number
of inspectors. There are many more POCT Providers than laboratories. This will
place a larger burden on SAMHSA/HHS than the POCT Provider.
Subpart L, §12.16 What happens if a POCT Provider does not meet the
minimum inspection requirements?
See §12.12 and §12.14 comments&endash; DATIA does not see the benefit
of certifying or "recognizing" POCT Providers.
Subpart L, §12.17 Where is a list of "recognized" POCT providers published?
See §12.12 and §12.14 comments &endash; DATIA does not see the benefit
of certifying or "recognizing" POCT Providers. In addition, we believe that this
list will top over a thousand in contrast to the list of laboratories, which remains
under one hundred.
Subpart L, §12.22 What summary report must a Federal Agency receive
from a POCT Provider?
See Subpart K, §11.21 comments
Subpart L, §12.23 What type of relationship is prohibited between a
POCT Provider and a Medical Review Officer?
See Subpart N, §14.3 comments
Subpart N, §14.1 Who may serve as an MRO?
Any professional in the drug and alcohol testing industry should be as current
on technique, technology, and regulations as possible. As such, DATIA believes
MROs should be certified by an outside or independent entity through a face-to-face
educational session using an HHS approved or reviewed curriculum and passing a
proficiency exam covering the MRO's role and responsibilities in the testing process.
There are currently long standing and successful MRO Certification programs that
are well respected within the industry. As an important and integral part of all
drug testing programs, MROs should not be the one link in the drug testing process
that is exempt from certifying that they meet industry standards.
DATIA believes that in an effort to maintain the quality and integrity of the
services provided and ultimately the safety of the public, all service professionals
in the drug and alcohol testing industry should be certified as to their proficiency.
A HHS approved or reviewed training, testing, and certification procedure should
be instituted by a variety of non-profit and for profit programs. In addition
to maintaining each provider's proficiency as the industry evolves, it also provides
the employer with a benchmark to determine quality of service and products.
Subpart N, §14.3 What type of relationship is prohibited between an
MRO and a laboratory, POCT provider, or an instrumented initial test facility?
POCT Providers should not be included in this prohibition. Many occupational
medicine clinics, wellness centers, consortia, third party administrators, etc.,
provide specimen collections, point of collection testing, and medical review
officer services. Under these new guidelines, these businesses will be forced
out of drug testing for federal workplace programs. DATIA does not see any valid
reasons or positive effects for prohibiting medical review officers from being
an employee of or having a financial interest in a POCT Provider. No positive
tests are reported from the POCT Provider to the MRO since all non-negatives must
go through traditional laboratory testing. Once a specimen has been found to be
non-negative, the procedures follow those for traditional urine specimen lab-based
drug testing, which do not prohibit an MRO from being an employee of or having
a financial interest in a collection facility. Point of Collection Testing should
not be regarded as laboratory testing, but rather as a form of screening out negative
specimens at the collection facility from those being sent to the laboratory.
