-The New Jersey Department of Health and Senior Services today ordered
Medical Laboratory of Ironbound - a small laboratory in Newark with
a limited number of physician clients - to immediately stop all
were further ordered to give the department a list of their physician
clients and patient clients so that the patients can be notified
of possible erroneous results of tests performed and reported by
department recommends that potentially affected patients contact
their physician for further guidance. The Department is also operating
a toll-free number at 800-792-9770. The number will be operational
today until 10:00 p.m. for special assistance and on Saturday and
Sunday from 9:00 a.m. to 4:00 p.m. During the week, assistance for
the public will be available from 9:00 a.m. until 5:00 p.m.
department recommends that affected doctors use their clinical judgment
to determine which patients should be retested. Physicians should
consider retesting any patient whose tests were performed by the
laboratory since January 9, 2001. The department estimates about
4,000 patients may have had tests performed at the laboratory since
department takes very seriously its responsibility to safeguard
the health of patients in New Jersey," said acting Health and
Senior Services Commissioner Clifton R. Lacy, M.D. "An essential
part of that responsibility is taking appropriate action, as we
are today, in cases that do not meet the safety and quality standards
our regulations demand and our residents deserve."
order to cease and desist testing was issued as a result of an intensive,
three-month investigation of the facility launched in late December
by department staff. The inspectors found serious deficiencies that
may have compromised the integrity of laboratory testing performed
by Medical Laboratory of Ironbound.
department's investigation was performed in close coordination with
the federal Centers for Medicare and Medicaid Services (CMS), which
is taking separate regulatory action.