Understanding CLIA y88 Provisions
What policy has the Clinical Laboratory Improvement
Advisory Committee (CLIAC) recommended regarding three-year medical technologists? If these people have completed a one-year program accredited
by the American Medical Association and are certified by the American Society of Clinical Pathologists,
will they be considered equivalent to professionals
with a bachelor's degree?
CLIAC has made no specific recommendation
regarding three-year medical technologists. CLIAC
did, however, recommend at its May 26-27, 1993,
meeting that a bachelor's degree in a science, or
equivalent, plus one year of clinical laboratory
training/experience for general supervisors and an
associate degree for testing personnel become the
prospective requirements for high-complexity
testing. Additional CLIAC recommendations provide alternative pathways for individuals who are
working as supervisors to qualify as general supervisors, which includes those who have graduated
from an accredited laboratory training program
and have two years' experience supervising highcomplexity testing. CLIAC also recommended that
equivalency for an associate degree (a minimum
number of semester hours of education in appropriate sciences) with certain experience and training be defined. These recommendations are not
official until published in a regulation. When the
bachelor's degree becomes the minimum requirement, individuals must meet either the requirement or its equivalent.
Will the Department of Health and Human Services
add a grandfather provision to the Clinical
Laboratory Improvement Amendments of 1988 (CLIA
'88) allowing certified laboratory assistants to perform high-complexity testing without the 24-hour
supervisory review restriction?
CLIAC recommended additional grandfather
provisions for high-complexity personnel, which
will be published in an impending regulation.
Other grandfathering provisions may be considered as a result of comment to all CLIA regulations and will be addressed in the final, final
CLIA regulations.
During its on-site, biennial laboratory surveys, is
the Health Care Financing Administration (HCFA)
enforcing the high-complexity testing qualifications for testing personnel and general supervisors? Will currently employed individuals be
disenfranchised even though grandfather clauses
for these positions may soon be published?
As part of the survey process, HCFA is reviewing
the qualifications of individuals in these positions
against existing regulations. We have notified our
regional offices and state agencies conducting the
surveys that they must cite any noncompliance
with the published regulations as deficiencies.
The laboratory can, however, submit a plan of
correction that indicates that the individual may
qualify under a grandfather clause in an impending regulation for the survey in review.
If medical technologists have concerns about
CLIAC recommendations, to whom should they
write?
Edward L. Baker, MD
Executive Secretary, CLIAC
Director, Public Health Practice
Program Office
Centers for Disease Control and Prevention
1600 Clifton Rd, NE, MS E20
Atlanta, GA 30333
Carlyn Collins, MD, MPH
Director, Division of Laboratory Systems
Centers for Disease Control and Prevention
4770 Buford Hwy, MS G25
Atlanta, GA 30341-3724
Questions, Anyone?
If you have questions
about the laboratory
or your career that
may be shared by
other laboratorians,
please send them to:
Laboratory
Medicine,
2100 W Harrison St,
Chicago, IL 60612;
or send them
electronically to:
72262.520@
CompuServe.Com.
The first line of
your message
should read: Attn:
Terri Yablonsky.
People with questions about whether they meet
the requirements may write to their state health
agencies or to Judith Yost, MA, MT(ASCP), at
1849 Gwynn Oak Ave, Baltimore, MD 21207.®
This month's expert is Judith A. Yost, MA,
MT(ASCP), director, Division of Laboratory
Standards and Performance, Office of Survey and
Certification, Meadowwood East Building, Health
Care Financing Administration, Baltimore, Md.
FEBRUARY 1995
VOLUME 26, NUMBER 2
LABORATORY MEDICINE
105