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September 22, 2004
Ms. Betty Kusel, Director
Regulatory Affairs Program
New York Department of Health
PO B ox 509
Albany, NY 12201-0509
Re: Response to your inquiry of 8/17/04
Dear Ms. Kusel:
As consultant to D-A-T-A.org,
a trade association of Direct Access testers, I am responding to
your inquiry of 8/17/04 to members Direct Laboratory Services, Inc.
and HealthCheck USA (DLS and HCI). D-A-T-A.org was organized two
years ago to establish the highest standards of excellence for the
delivery of low cost, high-quality, physician assisted, laboratory
screening services directly to consumers.
Although they market directly to the consumer on websites www.directlabs.com
and www.healthcheckusa.com, they provide information on and promote
Wellness for prevention and early detection of disease through laboratory
testing.
Neither DLS nor HCI operate a clinical lab or accept or process
any specimens. They provide discounted pricing on lab services as
a reseller of lab testing only through laboratories licensed in
the state of New York. All tests are ordered by their respective
Medical Directors. The consumer is referred to a New York licensed
laboratory draw site, with the appropriate requisition form to include
the licensed Physician ordering the test, and the draw requirements.
Specimens are collected through that collection site, contracted
by the licensed laboratory, and processed by that laboratory.
Furthermore, DLS and HCI follow a stringent policy of review of
all results by their Physicians, and alert their clients of critical
values and are then referred to their personal physicians for follow-up.
Attached is documentation from 1998, which shows review and approval
of these services and policies by the New York State Department
of Health.
If there are any questions, please do not hesitate to contact me,
John Bell with DLS, or Holt Vaughan with HCI. Thank you for your
time and consideration in this matter.
Sincerely,
John Reilly
President
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