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TPDN 1989, Vol. 49, No. 34
6. If a person is symptomatic, he/she should
seek medical care from a qualified health
professional rather than attempt to utilize a
home test for self-diagnosis.
Regardless of the results of a home test kit,
a person with symptoms should be seen by
a physician at which time the test usually
would be repeated in a laboratory if the
clinical impression would so indicate. Noth-
ing is gained by a patient attempting to self-
diagnose his illness by using a home test kit.
In summary, the Association of State and Terri-
torial Public Health Laboratory Directors op-
poses approval of any type of home test kit for
identification and diagnosis of communicable or
infectious diseases. The use of such home test
kits would not significantly reduce the cost of
health care and could lead to a number of adverse
reactions including possible crises or life-threat-
ening situations. Significant harm to the
individual or patient, as well as to the commu-
nity, could result from the spread of drug
resistant communicable disease agents.
PHYSICIAN OFFICE LABORATORY
TESTING
Effective January 1, 1990, the Clinical Labora-
tory Improvement Amendments of 1988 will
require that all laboratories, including physician
office labs (POLs) and local public health depart-
ment clinics which perform laboratory testing,
be certified and adhere to personnel standards,
proficiency testing, and inspection standards.
POLs will have until July 1, 1991, to comply
with these requirements. Certification will be
waived for labs performing only low-risk testing
as defined by regulators.
A provision in the Omnibus Budget Reconcili-
ation Act of 1987 requires POLs performing a
minimum of 5,000 tests annually to be certified
by HHS, beginning on January 1, 1990, in order
to be eligible for Medicare reimbursement. It is
anticipated that this provision will be amended
to exclude the 5,000 minimum.
Regulation of POLs is important because studies
indicate that the quality of laboratory test results
from POLs is not comparable to those from
hospital and independent laboratories. The vol-
ume of testing in POLs is significant and increas-
ing annually by approximately 15%. Currently,
about 25% of all outpatient testing is performed
in POLs. In states which regulate POLs,
performance has been shown to improve.
As POL testing increases, the concern about the
quality of such testing has become a serious
public health issue. Physicians who perform in-
office laboratory tests have a public responsibil-
ity to provide reliable results. Often the physi-
cian is lulled into a false sense of security that
test results are reliable because of the simplicity
of test procedures or instrumentation.
The Association of State and Territorial Public
Health Laboratory Directors recommends the
following guidelines for regulating the physician
office laboratory.
1. Physician office laboratories should be regu-
lated based on the complexity of the tests per-
formed, not on test volume or whether the
physician personally performs the tests on
his own patients.
2. A tiered system of POL testing should be
used to group these laboratories as to the
extent of regulatory compliance required.
For example, those POLs performing only
low-risk tests would be required to register,
meet quality control standards, and partici-
pate in a proficiency testing (PT) program
for those tests where PT is available. All
other POLs would be required to meet
licensure/certification requirements for per-
sonnel, quality assurance, proficiency test-
ing, and physical facilities, and be subject to
inspection.
3. An advisory committee should be established
for the purpose of reviewing tests to deter-
mine which have a low-risk for the patient
if performed incorrectly. This review proc-
ess must be ongoing because of the rapid
changes in test procedures and instrumenta-
tion.
4. Physician office labortories should meet the
basic requirements of performing laboratory
tests with accuracy and precision and provide
reliable reporting of test results. To accom-
plish these objectives, the POLs should com-
ply with the following generally accepted
standards.
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