Amid concerns about the reliability of PAP smear testing and false negative results leading to patient deaths, Congress passed the Clinical Laboratory Improvement Amendments of 1988 (CLIA ’88). The CLIA regulations govern every laboratory, including small physician offices.
The definition of a laboratory, according to CLIA regulations, is: “a facility for the biological, microbiological, serological, chemical, immunohematological, hematological, biophysical, cytological, pathological, or other examination of materials derived from the human body for the purpose of providing information for the diagnosis, prevention, or treatment of any disease or impairment of, or the assessment of the health of, human beings. These examinations also include procedures to determine, measure, or otherwise describe the presence or absence of various substances or organisms in the body.” This means any laboratory performing tests on a sample from the human body (i.e. blood, saliva, urine, tissue, etc.) to diagnose or treat an illness or to improve the health of a person is regulated by CLIA.
The CLIA regulations consist of the following general categories:
- Quality Assurance
The main focus of CLIA is the quality of laboratory testing. Quality Assurance makes up most of the CLIA regulations and is divided into four categories: General Laboratory Systems; Pre-analytic Systems (before testing); Analytic Systems (during testing); and Post-analytic Systems (after testing). Within the Quality Assurance categories, CLIA requirements include: quality control; procedure manuals; complaint investigations; instrument maintenance; and many other items.
CLIA regulations were intended to govern all types of laboratories, from the small physician office laboratory performing only CBC testing, to the large reference laboratories with pathology departments. This makes the CLIA regulations confusing, as some regulations don’t seem to apply to every laboratory.
At ProLab Consulting, LLC, our consultants have been trained, by CLIA, to interpret CLIA regulations. Let our consultants assist your laboratory in meeting the confusing, CLIA regulations. Our consultants are friendly, knowledgeable, and understand your needs.