CLIA HELP ON CAMPUS
of NIHs research laboratories are also "clinical laboratories"
according to the definitions encompassed in the Clinical Laboratory
Improvement Amendments of 1988 (CLIA 88) and must be certified as
meeting CLIA operational standards.
Center Clinical Pathology Department has established a centralized
Center to help institute laboratories meet these standards.
CLIA 88 covers
all laboratory tests performed on "materials derived from the
human body" for the diagnosis, prevention, treatment, or monitoring
of patients, as well as the assessment of patient health or impairment.
Any NIH laboratory that performs tests on human specimens that have
a patient-linked unique identifier and that generates information
used in the management of the patients condition or results
that are reported to the patient or a physician must conform with
CLIA 88. CLIA 88 is the legal foundation of the federal governments
regulatory oversight of laboratory testing performed in the United
volume nor the presence or absence of charges affects a laboratorys
statusonly the nature of the tests performed. The law requires
that the laboratory define the level of complexity of its testing
within broad categories, and most testing at NIH falls into the
"highly complex" classification. Somewhat less tightly
regulatedbut regulated nonethelessare tests generally
performed in clinics, including those at NIH, that fall under the
"moderately complex" category of Physician Performed Microscopy
perform highly and moderately complex tests are subject to standards
in proficiency testing, patient test management, quality control,
quality assurance, and personnel qualifications.
is for two years and contingent on inspection. Labs must fill out
a CLIA registration form and prepare for inspection by a CLIA inspector
(from the Health Care Financing Administration). The usual fee is
The CLIA Resource
Center will assist lab directors and staff in filing their registration
forms and preparing for inspection. For information about CLIA 88
and the NIH CLIA Resource Center, contact Peggy
Spina or Thomas
Fleisher. The Clinical Pathology Department may be reached at
496-5668 (phone) and 402-1612 (fax).
Neurobiology Interest Group now meets Fridays, twice a month, from
4:30 to 6:30 at the Cloisters rathskellar. Typically, the
formal portion of the meeting will be followed by a social hour
of the group is to promote interactions between NIH laboratories
pursuing diverse approaches to the study of the nervous system.
The formatan introductory overview by the section or lab PI,
followed by a presentation by a postdoctoral fellowis meant
to encourage lab-meetingstyle discussions and collaborations
(and contact persons) are Chip
Gerfen, at 496-4341 and Chris
McBain, at 402-4778. Anyone interested in learning more about
the interest group may visit its website
and subscribe to its mailing list.