Clinical laboratory

A clinical laboratory (sometimes referred to as a medical laboratory) is a laboratory where tests are done on clinical specimens in order to get information about the health of a patient as pertaining to the diagnosis, treatment, and prevention of disease.

Basics of operations

The clinical laboratory at one level, whether chemistry or pathology, operates like many other testing laboratories. However, there are a number of operational differences between the clinical laboratory and the many other laboratories.

One of these differences is the need to have a specific unidirectional workflow. This is intended to both minimize the risk of biohazard contamination, and to establish assurance that samples cross contamination is minimized.

Another difference, addressed below, are the privacy regulations that govern the management of patient data. This creates a significant challenge not generally experienced by other types of laboratories.

Government regulatory bodies

Clinical laboratories within the United States are primarily regulated by the Department of Health and Human Services. Although generally not as strict as the regulations regarding pharmaceutical and diagnostic manufacturers, they nonetheless establish a significant hurdle to managing the overall operations of the laboratory, from acquiring customers to acquiring samples, to testing, reporting results, and handling billing for the completed tests.

Other certifying bodies

Many laboratories, especially pathology laboratories, will seek accreditation from the College of American Pathologists. This organization has a more extensive set of requirements that a laboratory must comply with in order to be certified, than are contained within the CLIA regulations.

Classification of tests performed by Clinical Laboratories

Clinical laboratories perform basically two classes of tests, FDA approved and laboratory developed. FDA defines three classifications of tests, Class I, II, and III. The classification reflects the risk associated with erroneous results as well as the complexity of the test.

Class I tests are frequently exempt from FDA review and approval, while Class II and III tests are not. Class III tests tend to require extensive review and approval, including extensive evaluation of clinical data associated with the test.

Laboratory developed tests, are not generally marketed, but are usually performed by only a small number of laboratories. While not currently requiring FDA review and approval, there is increasing pressure on the FDA to maintain oversight of these tests. In addition, laboratory developed tests may not be covered by insurance programs, such as Medicare, and thus may have more limited market penetration than an FDA approved test.

HIPAA regulations

The Health Insurance Portability and Affordability Act was passed in 1996, with the initial objective to address problems associated with benefits upon retirement, as well as other legal issues around the delivery of healthcare.

In 2003, the privacy rule came into effect. The privacy rule has become the best known provision of HIPAA, and has significant impact on the operations of the clinical laboratory, in particular the data handling/records management aspect of the laboratory operations.

The general principal that the HIPAA privacy regulations establish is that personal data needs to be protected. The general requirement is that data that can be used to identify an individual has to be handled in such a way that it is only connected with healthcare related information for the minimum necessary number of individuals required to execute the required healthcare related activities for the patient.

Medicare regulations (CLIA)

In 1988, in response to fatalities due to improper reading of PAP smears, Congress passed the Clinical Laboratory Improvement Amendments, which established quality standards for clinical laboratories. Although the faulty PAP smears were performed by Federal laboratories, the new law applied to all clinical laboratories (and interestingly enough, one major category of Federal laboratories, the Veteran’s Administration, received an exemption from the new CLIA regulations.

The CLIA regulations are not particularly complex, largely focusing on proficiency verification requirements for individuals performing tests, and the classification of tests according to complexity. It is this classification which, in turn, affects the licensing requirements of laboratories and individuals performing those tests.

Laboratory information systems

A significant component of most clinical laboratories is their Laboratory Information System(LIS). These systems vary significantly in complexity, with systems for Anatomical Pathology laboratories often requiring significant customization, while smaller systems for supporting basic clinical chemistry laboratories can often be a more “out of the box” solution.