U.S. HealthWorks Expects to Have Initial Public Offering
Specimen Validity Testing Guidelines
CDC and Smallpox Immunization
FDA Approves New Rapid HIV Test Kit
Non-Evidential Alcohol Screening Devices

U.S. HealthWorks Expects to Have Initial Public Offering

U.S. HealthWorks, the second largest for-profit chain of occupational medicine programs, is likely to have an initial public offering (IPO) of its stock in early 2003, according to comments made during a September 20, 2002 panel discussion at the 16th Annual National Conference of RYAN Associates and the National Association of Occupational Health Providers.

The panel discussion, entitled, “Future Shock—Where are We Headed and What Do We Need to Do Now?” included representatives of the three largest for-profit chains of clinics: Robert Allday, Vice President, Corporate Development, Concentra Health Services, Addison, TX; Nicholas Kirby, Senior Vice President, Development, Occupational Health + Rehabilitation (OH+R), South Portland, ME; and Douglas Ziegeler, National Senior Vice President for Mergers, Acquisitions and Development, U.S. HealthWorks, Van Nuys, CA.

Of the other two corporations, OH+R is already a public company. Concentra was previously a public company, but following a steep stock price decline, it was acquired by Yankee Acquisition Corporation in 1999.

Concentra is also considering returning to a publicly-held status, but such a move is likely to occur after U.S. HealthWorks.

According to panel participants, a primary reason for the U.S. HealthWorks’ IPO is that the capital markets are currently the best means of raising capital to fund further acquisitions. In 2001 U.S. HealthWorks acquired HealthSouth’s occupational medicine clinics.

[Comment: For-profit chains represents about 25% of the occupational medicine clinic market. U.S. HealthWorks’ IPO is likely to increase that percentage by providing them with additional capital for expansion. One target, interestingly, might be OH+R. Look for Concentra to move in the third or fourth quarter of 2003. These events will further alter the occupational medicine landscape. Be prepared. – William L. Newkirk, MD, FACPM (wln)]

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Specimen Validity Testing Guidelines

The Drug and Alcohol Testing Industry Association (DATIA) recently informed the Department of Health and Human Services (HHS) about its concerns regarding the number of challenges to drug test results in regard to specimen validity testing guidelines. The challenges were made by persons who appear to have naturally provided a specimen that meets the “substituted” criteria (creatinine <5mg/dl and specific gravity <1.002 or >1.020). DATIA believes there is need for further studies to establish the criteria for a substituted specimen.

DATIA believes the substituted criteria need to be evaluated for the following reasons:

1. The clinically accepted reference ranges for normal urine referenced in HHS’ basis for the “substituted” criteria were disproved by the studies referenced by HHS and by a study performed by the Department of Transportation (DOT).
2. Studies exist, but were not evaluated by HHS, on the effects of factors such as altitude, menstrual cycle, etc. on the body’s fluid balance and urine output.
3. It has been shown that the variance in creatinine and specific gravity measurements by HHS certified laboratories can vary as much as 0.001 for specific gravity and 2.2 for creatinine—a variance that could have caused specimens in the HHS-referenced studies to be reported as “substituted.”

Due to the fact it has been shown that a normal person can submit a specimen that is on the threshold of the “substituted” criteria, and that with the documented laboratory coefficient of variation such a specimen could be incorrectly categorized as “substituted,” DATIA urged HHS to conduct further research on the issue before proceeding with publishing the final Validity Testing Guidelines. For more information, see www.datia.org.

CDC and Smallpox Immunization

The Centers for Disease Control (CDC) have released The Smallpox Vaccination Clinic Guide as part of its Smallpox Response Plan and Guidelines. The guide is designed to facilitate and strengthen the ability of state and local officials to quickly and effectively implement voluntary large-scale vaccination clinics in response to a smallpox outbreak. The CDC also provides a Smallpox Vaccination and Adverse Effect Training Module for health professionals on its web site. Both guides are available at www.bt.cdc.gov/agent/smallpox.

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FDA Approves New Rapid HIV Test Kit

On November 7, 2002 HHS Secretary Tommy G. Thompson announced that the U.S. Food and Drug Administration had approved a rapid HIV diagnostic test kit that provides accurate results (99.6%) in twenty minutes.

The test uses less than a drop of blood, can be stored at room temperature, requires no specialized equipment and may be considered for use outside of traditional laboratory or clinical settings. The test can quickly detect antibodies to HIV-1, the HIV virus that causes infection in most cases in the U.S. Secretary Thompson said that each year 8,000 people who never return for their results come to public clinics for HIV testing. With this test they can receive results in less than half an hour, allowing them to get the care they need and begin to take precautions to prevent spread of this disease.

FDA currently categorizes the OraQuick test as “moderate complexity” under the Clinical Improvements Amendments of 1988 (CLIA). This designation means that the OraQuick test can only be given in CLIA-approved labs by CLIA-certified laboratory technicians or medical staff. Should the manufacturer apply for a CLIA waiver, the FDA can evaluate it for use under less stringent conditions. Secretary Thompson urged the OraSure company to apply for the CLIA waiver.

FDA Deputy Commissioner Dr. Lester M Crawford pointed out that this test will help in identifying HIV-positive pregnant women going into labor without pre-natal testing. It is also a critical resource for healthcare and emergency workers who suffer accidental exposures to HIV infected blood.

[Comments: This could be an important new tool in effectively dealing with bloodborne pathogen exposures. It should significantly speed up the source classification as positive or negative for HIV. And, consequently, improve the efficiency of accurately providing HIV post-exposure prophylaxis. – wln]

Non-Evidential Alcohol Screening Devices

The Department of Transportation established procedures for the use of non-evidential alcohol screening devices that became effective October 31, 2002. The procedures are contained in the Federal Register, Vol. 67, No 190, Tuesday, October 1, 2002, Rules and Regulations. The devices had been previously approved, but no procedures had been developed for their use. Therefore, they couldn’t be used for the workplace alcohol testing under 49 CFR Part 40.

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