12 July 2004

FAXed to 202-395-6974

E-mailed: wvogl@samhsa.gov

Federal Register Document Number 04-7984

Public Comment 8400185

**BEFORE THE**

## SUBSTANCE ABUSE & MENTAL HEALTH SERVICES ADMINISTRATION,

#### HEALTH AND HUMAN SERVICES

Docket Management System, 5800 Fishers Lane, Rockwall II, Suite 815,
Rockville, Maryland 20857

**MANDATORY GUIDELINES FOR FEDERAL WORKPLACE DRUG TESTING PROGRAMS**

\[FR Doc 04-7984\]

\* \* \*

## COMMENTS OF

EMPLOYEE SCREENING SERVICES, INC.

(A third-party administrator, MRO, collection site which either may
provide services to federal employees who fall under drug and alcohol
testing regulations.)

## Prepared by IRA JANE HURST-ROMERO, C-SAPA, C-SI -- PRESIDENT & CEO

\* \* \*

## *Comment to SAMHSA in reference to FR Doc 04-7984 Continued* 

## 

## 

## INTRODUCTION

This commentary does not address scientific issues as that is not my
expertise; it does however address the overall issue of implementation
and administration of programs utilizing alternative technology testing
programs. It is an undue burden to expect any one person to specifically
comment on each and every administrative or implementation detail when
the overall concept is in question. My comments include

SPECIFIC COMMENTS IN REFERENCE TO

1.  THE OVERALL ADMINISTRATIVE AND IMPLENTATION CONCEPT PRESENTED IN THE
    PROPOSED REGULATION

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2.  INSUFFICIENT CONSIDERATION OF, AND/OR LACK OF INPUT FROM, IMPACTED
    INDUSTRY (THIRD PARTY ADMINISTRATORS, COLLECTION SITES AND MEDICAL
    REVIEW OFFICERS) AND/OR FEDERALLY REGULATED EMPLOYERS

3.  INSUFFICIENT CONSIDERATION OF INFORMATION REQUIREMENT IMPACT AND
    EXECUTIVE ORDER 12866: ECONOMIC IMPACT ON INDUSTRY

DUE TO REQUIREMENT FOR DEPARTMENT OF TRANSPORTATION (OMNIBUS ACT) TO
INCORPORATE ANY FINAL APPLICABLE HHS RULE IN ITS DRUG & ALCOHOL TESTING
REGULATIONS

[Commentary]{.underline}

Although SAMHSA is responsible for these guidelines, relying on the Drug
Testing Advisory Board (DTAB) \[which meets at least quarterly\] as an
important resource and sounding board appears to be shortsighted. The
members of that board very rarely, if ever, consist of anyone other than
members of SAMHSA and the university or scientific community.

## However the rules involve more than science. This rule imposes logistics and practices on third party administrators, collection sites, medical review officers, as well as the manufacturers of POCTs and laboratories. Yet most of the entities involved with logistics, standard operating procedures (other than those used within laboratories and POCT manufacturers) are not represented. It is my belief that the very industry that provides services to the various federal agencies (and individual federal employees) should be involved in providing logistical information as to the means and methods to be used in implementing alternative technologies. After all, the laboratories analyze results; they don't necessarily collect and interpret hair, sweat or oral fluid specimens. Manufacturers understand their products, but not necessarily those of other manufacturers. It can't be successfully argued that understanding a product, maintaining quality control with a manufacturing process or the logistics of supply and demand provides the proper experience and know-how to integrate that product into a successful drug and alcohol testing effort.

## 

## Various government representatives, when asked about the lack of industry participation, have long held the option that private industry is only interested in "profit" and therefore, could not or would not provide information in a fair and impartial manner. I must differ with that reasoning! The number of persons who are expert in their fields of endeavor and who volunteer their time and efforts to establish such processes as the Certified Substance Abuse Program Administrator designation as an example are well known. There are persons of character within our industry who would serve in an advisory capacity to bring the needed experience to the incorporation of more proper logistics and standard operating procedures for collection sites, TPAs, and MROs than are currently suggested in the NPRM. They should be called upon 

## *Comment to SAMHSA in reference to FR Doc 04-7984 Continued*

## 

## 

## associations, which represent the drug and alcohol testing industry (e.g., Substance Abuse Program Administrators Association), are a great resource. These resources are not being tapped by SAMHSA. Unfortunately, scientists and technicians as well as others who do not deal with these issues day after day are the only source for these current proposed regulations. It would be to the program's benefit to implement a 'gold standard' of administration standards and to maintain the integrity of the current drug testing program. This can only be done if persons recognized as experts in the logistics of program administration are consulted in the same manner as the scientists were consulted in the preparation of this proposed rule. 

Another example of mis-interpretation is the statement "As the
Guidelines received both public and judicial support, the private sector
chose to incorporate the requirement to use only a laboratory that has
HHS certification under the Guidelines, for employee drug testing." In
actuality, it was because so much of the workforce came under DOT
regulation (12,135,000 employees) and DOT regulations incorporated HHS
guidelines, that private industry undertook to follow a "DOT look-alike"
program. Employers who had to test some employees under DOT guidelines,
chose to use DOT look-alike programs for the remainder of their
workforce in order to forestall accusations of discrimination and to
ease the load of day-to-day operations. This then spread to other
non-regulated industries. However, it can not be said that all drug
testing programs utilize SAMHSA certified laboratories. There is much
non-regulated testing which utilizes local, non-certified labs as well
as on-site testing devices. While DOT has made a

tremendous impact on private industry's drug testing programs, it is not
the only version in the public realm. It is critical to understand that
only because of the DOT incorporation of SAMHSA laboratory guidelines
has HHS had impact on the public sector drug testing programs.

I agree that some information needs collection, however I believe that
SAMHSA has once again underestimated the impact. For instance, SAMHSA
has based the burden estimates "on the following number of respondents:
38,000 donors who apply for employment in testing designated positions,
100 collectors, 50 urine testing laboratories, 10 hair testing
laboratories,10 oral fluid testing laboratories, 2 sweat testing
laboratories, 25 IITFs, 30 POCT manufacturers, 50 POCT testers, and 100
MROs."

-   Federal employees or applicants live in all corners of the United
    States and work in many areas of the world. With an estimated 38,000
    donors who are applicants, it would be unreasonable to assume that
    only 100 collection sites would be used. Our firm, in the year 2002,
    performed 16,121 pre-employment tests utilizing 5,426 collection
    sites. (I assure you that we are a standard, medium-size TPA.)
    That's an average of only 3 tests per collection site. Using that
    same average, it is reasonable that 38,000 federal applicants could
    use as many as 15,000 collection sites. A 15,000% increase in
    SAMHSA's estimate of number of collectors or testers would increase
    to the numbers shown in bold in the table below.

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-   While this rule only cites a requirement to respond in the effect on
    federal employees, the NPRM itself states that this rule will affect
    private industry through the Department of Transportation's
    congressional mandate to utilize DHHS regulations where possible. It
    is impractical to suggest that a rule which is likely to affect
    millions of workers not be commented upon in that light. It would
    also seem to be prudent for HHS to take such comments under
    consideration as it could be argued that it is critical, when a
    regulation will affect any other regulation due to a requirement of
    law (in this case, the Omnibus Act requiring DOT to utilize

*Comment to SAMHSA in reference to FR Doc 04-7984 Continued*

> HHS/SAMHSA standards), that the disclosure for satisfaction of the
> Paperwork Reduction Act should also include estimates for any rule
> that will be affected. It is too late to object, change or make
> comments after the affecting rule forces changes as required by law.
> The latest estimate of number of employees affected by the DOT
> regulation is 12, 135,000 which converts to a minimum of a ten
> thousand (10,000 %) percent increase in the amount of time or cost
> estimated by HHS. In fact HHS did not estimate a major economic burden
> to this rule. But if you consider the DOT affect (required by law to
> adopt) then there is a major cost impact if employers must visit and
> monitor collection or POCT site compliance especially in light of the
> fact that DOT regulations affect a minimum of 674,900 employers. And
> conversely, if the proposed program does not require monitoring, then
> the integrity of the DOT program comes into question. After all, it is
> an accepted fact that the collection process (and therefore, the POCT
> and collection process under this proposed rule) is the main problem
> area within the current DOT program. Again, expertise from the very
> industry that this rule will impact would be more than just
> beneficial. It can make the difference between an unwieldy, litigation
> promoting, costly regulation and one that carries forward the
> standards that have evolved within the current federal and DOT
> programs. Surely it is not the intent of HHS (SAMSHA) to promote one
> standard for federal employees and another for private industry.

+-------+-----------------+------------+-----------+---------+-------+
| Se    | Purpose         | No. of     | Re        | Hours/  | Total |
| ction |                 | R          | sponses/R | R       | Hours |
|       |                 | espondents | espondent | esponse |       |
+-------+-----------------+------------+-----------+---------+-------+
| 4     | Collector is    | 100        | 1         | 0.05 (3 | 5     |
| .4(c) | given name and  |            |           |         |       |
|       |                 | 15,000     |           | min)    | 750   |
|       | phone of        |            |           |         |       |
|       | Federal agency  |            |           |         |       |
|       | point           |            |           |         |       |
|       |                 |            |           |         |       |
|       | of contact      |            |           |         |       |
+-------+-----------------+------------+-----------+---------+-------+
| 8.2 - | Collector       | 100        | 380       | 0.07 (4 | 2,660 |
| 8.5   | completes       |            |           |         |       |
|       | Federal         | 15,000     |           | min)    | 33    |
|       |                 |            |           |         | 9,000 |
|       | CCF for each    |            |           |         |       |
|       | type of         |            |           |         |       |
|       | specimen        |            |           |         |       |
|       |                 |            |           |         |       |
|       | Collected       |            |           |         |       |
+-------+-----------------+------------+-----------+---------+-------+
| 12.24 | Information     | 50         | 10        | 1       | 500   |
|       | related to drug |            |           |         |       |
|       | test            | 7,500      |           |         | 7     |
|       |                 |            |           |         | 5,000 |
|       | that POCT       |            |           |         |       |
|       | tester must     |            |           |         |       |
|       | provide         |            |           |         |       |
|       |                 |            |           |         |       |
|       | to donor        |            |           |         |       |
|       | through MRO     |            |           |         |       |
+-------+-----------------+------------+-----------+---------+-------+
| 12.   | POCT tester     | 50         | 100       | 0.05 (3 | 250   |
| 18(c) | completes       |            |           |         |       |
|       | Federal         | 7,500      |           | min)    | 3     |
|       |                 |            |           |         | 7,500 |
|       | CCF for primary |            |           |         |       |
|       | specimen and    |            |           |         |       |
|       | documents chain |            |           |         |       |
|       | of custody      |            |           |         |       |
|       |                 |            |           |         |       |
|       | for aliquot     |            |           |         |       |
|       | used for the    |            |           |         |       |
|       | POCT            |            |           |         |       |
+-------+-----------------+------------+-----------+---------+-------+

*Comment to SAMHSA in reference to FR Doc 04-7984 Continued*

> SAMHSA indicates that only 25 Instrument Initial Testing Facilities
> (IITFs) will "spring up". Again it is underestimated. In your own
> words "..it was believed that fewer than 10 laboratories would apply
> for HHS certification under the Guidelines to conduct Federal employee
> drug testing, and that the Department would not require even that many
> to test the urine specimens from all Federal agencies. This situation
> changed very quickly when the Department of Transportation (DOT)
> published a final drug testing rule (54 FR 49854) in December 1989 for
> its regulated transportation industries. DOT required its regulated
> industries to use drug testing laboratories that were certified by
> HHS. This requirement began a close relationship between HHS and DOT.
> Additionally, the Nuclear Regulatory Commission (NRC) in its Fitness
> for Duty program contained in 10 CFR Part 26 requires its licensees to
> use drug testing laboratories certified by HHS....... Between July
> 1988 and early 1990, 50 laboratories had received HHS certification
> under the Guidelines, while another 100 laboratories were awaiting
> certification."
>
> So when HHS states " Thus the total annual response burden associated
> with the testing of these alternative specimens by the new
> laboratories and Instrumented Initial Test Facilities (IITFs) and
> Point of Collection Test sites is estimated to be 13,888 hours (that
> is, the sum of the total hours from the above tables). ", it could be
> underestimating the paperwork impact by 1,826,900 hours. This is more
> than double the 1,788,089 hours currently approved by OMB under
> control number 0930-0158 for urine testing under the existing
> Mandatory Guidelines.

Currently, out of all the certified laboratories in the U.S., two labs
that are conglomerates have over two thousand (2,000 patient centers)
collection sites between them. It is inconceivable that anyone could be
so remiss as to not consider it a possibility those two conglomerates
may certify each of these sites as IITFs. After all it could be
beneficial to their market share. What number of my estimate of an
approximate 15,000 collection sites which may be utilized for the
federal program will apply for IITF certification in order to keep their
market share? And what number of the over one hundred thousand (100,000)
known collection sites currently used by regulated employers will apply
for IITF certification in order to perform regulated initial testing via
instrumentation. While before HHS only missed the number of certified
labs by ninety (90%) percent, you could easily miss the number of IITFs
by ten thousand (10,000%) percent

-   The idea of having federal agencies inspects and keep records for
    collection sites is expensive, cumbersome and duplicative. If DOT
    were to take up these regulations, it boggles the imagination to
    consider over 674,000 private employers inspecting 100,000
    collection sites. And how do you consider 674,000 private employers
    inspecting 15,000 or more IILF's. Who do they report their
    inspections to? For that matter, how does SAMHSA handle the reports
    of multiple federal agencies that have inspected the IILF's that
    they might utilize?

*IN SUMMARY,* it is not only science that builds a better program, it is
the proper [implementation]{.underline} of that science and common
sense. There are representatives from TPAs, collection sites, MROs and
employers who are widely recognized as expert in their various areas of
endeavor. This part of the industry which services the federal employee
testing programs has not been queried BEFORE THE FACT OF NPRM;
therefore, 1) the proposed rule affects a up to 10,000plus percent more
people and employers than indicated. 2) the proposed rule does not take
into consideration the effect it will have on non-federal employees
(through a

*Comment to SAMHSA in reference to FR Doc 04-7984 Continued*

requirement of law) even though it will have a massive effect on the DOT
(and possibly the NRC, NASA rules that affect their contractors' safety
sensitive employees).; 3) the proposed rule does not effect an
information gathering or IITF site monitoring program that can be
reasonably implemented yet maintain current standards without undue
economic and paperwork burdens; 4) the proposed rule was prepared
without industry expertise from the collection site, employer or
third-party administrator areas of endeavor (and which is readily
available); 5)the proposed rule underestimates the possibility of a new
area of industry and its attendant cost to federal employers as well as
private employers -- the IITF Site Consultant (as happened with the
original DOT rule and the appearance of TPAs to administer required
programs); 6) the proposed rule more than doubles the impact of
additional paperwork and cost when DOT's incorporation of the rule is
considered; 7) the proposed rule underestimates the number of
respondents; and finally, 8) the proposed rule in unwieldy in the
extreme and does not provide an adequate, common sense administrative or
administrative system.

While SAMHSA is to be commended for its efforts as well as the thorough
scientific investigations that are behind this proposed regulation, it
is my opinion that this proposed rule be withdrawn and a new advisory
board be convened, not to review scientific issues, but to review and
suggest solutions to the methodology used in the operating practices and
implementation of alternative testing technologies. This board or panel
should also review whether specifying types of occasions when each
technology may be used because of detection time limits or whether
employers should be allowed to select the one or more technologies they
wish to use and accept liability for. After all, for 15 years urine
technology has been used effectively with its detection time limits and
employers have successfully accepted the liability of those limits. It
is my opinion that private industry has found ways to effectively
utilize these new technologies. This is experience that needs to be
incorporated into these regulations. Inclusion of alternative
technologies should go forward and the sooner the better. But it must go
forward in a less cumbersome, costly way.

![](media/image3.png){width="2.888888888888889in"
height="0.6333333333333333in"} Sincerely,

Ira Jane Hurst-Romero, C-SAPA, C-SI

President and Chief Executive Officer

IJHR:s