CALLING ALL LABS:
CLIA HELP ON CAMPUS

Many of NIH’s 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.

The Clinical Center Clinical Pathology Department has established a centralized CLIA Resource 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 patient’s 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 government’s regulatory oversight of laboratory testing performed in the United States.

Neither test volume nor the presence or absence of charges affects a laboratory’s status–only 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 regulated—but regulated nonetheless—are tests generally performed in clinics, including those at NIH, that fall under the "moderately complex" category of Physician Performed Microscopy Procedures.

Labs that perform highly and moderately complex tests are subject to standards in proficiency testing, patient test management, quality control, quality assurance, and personnel qualifications.

CLIA certification 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 $400.

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).

The purpose of the group is to promote interactions between NIH laboratories pursuing diverse approaches to the study of the nervous system. The format—an introductory overview by the section or lab PI, followed by a presentation by a postdoctoral fellow—is meant to encourage lab-meeting–style discussions and collaborations among fellows.

Co-chairs (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.