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TPDN 1989, Vol. 49, No. 34 Page 3
a. Only adequately trained personnel, con-
sistent with the complexity of test pro-
cedures, should be permitted to conduct
the laboratory testing.
b. A quality assurance program designed to
assure the reliability and medical useful-
ness of the laboratory data must be a
component of laboratory testing. It should
include a quality control program to
monitor precision of laboratory perform-
ance, an instrument maintenance pro-
gram, a procedures manual, a continuing
education program for laboratory staff,
and written documentation of all these
activities. As part of an external quality
assurance program, the laboratory must
participate in an approved proficiency
testing program.
c. The POL must have adequate facilities
and equipment to perform its scope of
testing in a safe and reliable manner.
5. Annual on-site inspection of the estimated
100,000 physician office laboratories in the
US is not economically feasible. It is recom-
mended that on-site inspection of a minimum
of 5% of randomly selected POLs be con-
ducted annually. In addition, unannounced
inspections should be conducted as a result of
complaints, poor performance in profi-
ciency testing, questions raised by the survey
questionnaire submitted by the POL, or sus-
picion of fraud.
State and territorial public health laboratories
have an important public health responsibility to
ensure that clinical laboratory services provided
to its residents are performed in an accurate and
reliable. manner. When the quality of laboratory
services declines, the failure of preventive health
services and patient care may occur, as evidenced
by the problem with PAP smear screening for
cervical cancer. Compliance with good labora-
tory practices can no longer be left to voluntary
initiatives.
In the POL, inadequate training, lack of knowl-
edge concerning internal quality control/quality
assurance processes, and the use of incorrect
laboratory procedures are the most common
causes of erroneous laboratory results. There-
fore, in addition to mandatory compliance with
regulations, state and territorial public health
laboratories have a major responsibility to pro-
vide training and guidance to physician office
lab personnel, as there are few reliable sources
of such assistance.
* * *
MEFLOQUINE APPROVED FOR MALARIA*
Mefloquine (Lariam) has been approved for the
treatment and prevention of infection with two.
malaria parasites, Plasmodium falciparum and
Plasmodium vivax, including those strains of
P. falciparum resistant to other anti-malaria
drugs.
Mefloquine, which is a designated orphan drug,
was developed and tested by the Walter Reed
Army Institute of Research, Hoffmann-La Ro-
che, and the World Health Organization.
In many areas of the world, including southeast
Asia, Africa, and South and Central America,
many strains of P. falciparum parasites have
become resistant to chloroquine, the mainstay
of treatment .and prevention of malaria.
*DHHS. FDA Drug Bulletin 1989;19(2):17.
Mefloquine has been shown to kill P. falcipa-
rum and P. vivax parasites in red blood cells. In
clinical trials carried out in South America and
southeast Asia involving more than 1,000
patients, the drug was found to be highly effec-
tive in destroying the parasites in infected
individuals with mild to moderate illness.
Patients with severe malaria should be treated
initially with an intravenous antimalarial drug.
In patients with P. vivax infection, after initial
treatment with mefloquine, primaquine must be
used to clear the liver phase infection and
prevent relapse.
In addition to these studies demonstrating effec-
tiveness in treatment of malaria, separate studies
showed mefloquine to be effective in preventing
malarial infections. It is recommended for
travelers to areas where malaria is endemic,
TPDN 1989, vol. 49, No. 34
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