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. The Clinical Laboratory Improvement Amendments (CLIA) program defines a clinical (medical) laboratory as "a facility that performs testing on 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 assessment of the health of, human beings."
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, concerns the regulations governing the management of patient data. This creates a significant challenge not generally experienced by other types of laboratories.
Government regulatory bodies
In the United States, clinical laboratories are primarily regulated by the Department of Health and Human Services. Inside that infrastructure are sub-entities like the Centers for Disease Control and Prevention (CDC) and the Centers for Medicare and Medicaid Services (CMS) to apply standards and regulations through their respective Laboratory Quality Assurance and Standardization Programs and Clinical Laboratory Improvement Amendments (CLIA). 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.
Internationally, regulatory bodies vary from country to country. However, organizations like the not-for-profit Clinical and Laboratory Standards Institute (CLSI) and associations like the Research Quality Association (RQA) exist to promote a more global approach to regulations and guidance affecting clinical laboratories. Additionally, a set of Good Clinical Laboratory Practice standards — originally developed in 2002 and since adopted by the World Health Organisation (WHO), non-governmental organisations (NGOs), and research institutions worldwide — provide guidance on implementing laboratory practices that are critical for laboratory operations around the world.
Other certifying bodies
For certifications and guidelines that affect laboratory safety, please see the standards and guidance section of the laboratory entry.
Many laboratories, especially pathology laboratories, will seek accreditation from the College of American Pathologists. This organization has a more extensive set of laboratory certification requirements than those 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.
The U.S. Food and Drug Administration (FDA) regulates the "reagents, instruments, and systems intended for use in diagnosis of disease or other conditions, including a determination of the state of health, in order to cure, mitigate, treat, or prevent disease or its sequelae." This type of test equipment is referred to by the FDA as an in vitro diagnostic product (IVD), "intended for use in the collection, preparation, and examination of specimens taken from the human body." These testing products are classified into three different levels: Class I, II, and III. These classifications reflect 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; they are usually performed by only a small number of laboratories. While these developed tests don't currently require 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 they may have more limited market penetration compared to an FDA-approved test.
The Health Insurance Portability and Accountability 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, though interestingly enough, one major part 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 acting as an "out of the box" solution.
- Sood, Ramnik (2006). "Chapter 1: Laboratory". Textbook of Medical Laboratory Technology. Jaypee Brothers Publishers. pp. 01–28. ISBN 818061591X. http://books.google.com/books?id=NJNYKeftqYQC.
- Ezzelle, J; Rodriguez-Chavez, IR; Darden, JM; Stirewalt, M; Kunwar, N; Hitchcock, R; Walter, T; D'Souza, MP (2008). "Guidelines on Good Clinical Laboratory Practice - Bridging Operations between Research and Clinical Research Laboratories". Journal of Pharmaceutical and Biomedical Analysis 46 (1): 18–29. doi:10.1016/j.jpba.2007.10.010. http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2213906/.
An element or two of this article is reused from the Wikipedia article.
- ↑ Sood, Ramnik (2006). "Chapter 1: Laboratory". Textbook of Medical Laboratory Technology. Jaypee Brothers Publishers. pp. 01–28. ISBN 818061591X. http://books.google.com/books?id=NJNYKeftqYQC.
- ↑ "CLIA - How to Obtain a CLIA Certificate of Waiver" (PDF). Centers for Disease Control and Prevention. March 2006. http://wwwn.cdc.gov/cliac/pdf/Addenda/cliac0210/Addendum%20F.pdf. Retrieved 10 September 2013.
- ↑ Chen, Bin; Gagnon, MariBeth; Shahangian, Shahram; Anderson, Nancy L.; Howerton, Devery A., Boone, D. Joe (12 June 2009). "Good Laboratory Practices for Molecular Genetic Testing for Heritable Diseases and Conditions". Morbidity and Mortality Weekly Report 58 (RR06): 1–29. http://www.cdc.gov/mmwr/preview/mmwrhtml/rr5806a1.htm. Retrieved 11 September 2013.
- ↑ Viana, Raquel V.; Wallis, Carole L.; Isin, Akyar (ed.) (2011). "Chapter 3: Good Clinical Laboratory Practice (GCLP) for Molecular Based Tests Used in Diagnostic Laboratories" (PDF). Wide Spectra of Quality Control. InTech. pp. 29–52. ISBN 9789533076836. http://www.intechopen.com/download/pdf/23728.
- ↑ "HHS Organizational Chart". U.S. Department of Health & Human Services. http://www.hhs.gov/about/orgchart/. Retrieved 11 September 2013.
- ↑ "Laboratory Quality Assurance and Standardization Programs". Centers for Disease Control and Prevention. http://www.cdc.gov/labstandards/. Retrieved 11 September 2013.
- ↑ 7.0 7.1 "Clinical Laboratory Improvement Amendments (CLIA)". Centers for Medicare and Medicaid Services. http://www.cms.gov/Regulations-and-Guidance/Legislation/CLIA/index.html. Retrieved 11 September 2013.
- ↑ "About CLSI". Clinical and Laboratory Standards Institute. http://www.clsi.org/about-clsi/. Retrieved 11 September 2013.
- ↑ "What is RQA?". Research Quality Association. http://www.therqa.com/about-us/. Retrieved 11 September 2013.
- ↑ "Good Clinical Laboratory Practice (GCLP) Version 2". Research Quality Association. http://www.therqa.com/publications/booklets/gclp/. Retrieved 11 September 2013.
- ↑ Ezzelle, J; Rodriguez-Chavez, IR; Darden, JM; Stirewalt, M; Kunwar, N; Hitchcock, R; Walter, T; D'Souza, MP (2008). "Guidelines on Good Clinical Laboratory Practice - Bridging Operations between Research and Clinical Research Laboratories". Journal of Pharmaceutical and Biomedical Analysis 46 (1): 18–29. doi:10.1016/j.jpba.2007.10.010. http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2213906/. Retrieved 11 September 2013.
- ↑ 12.0 12.1 "IVD Regulatory Assistance - Overview of IVD Regulation". Food and Drug Administration. 3 September 2010. http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/IVDRegulatoryAssistance/ucm123682.htm. Retrieved 13 September 2013.
- ↑ 13.0 13.1 Kazon, Peter M.; Danzis, Scott D. (ed.); Flannery, Ellen J. (ed.) (2010). "Chapter 6: Laboratory Developed Tests". In Vitro Diagnostics: The Complete Regulatory Guide. Food and Drug Law Institute. pp. 115–127. ISBN 193506522X. http://www.fdli.org/resources/resources-order-box-detail-view/in-vitro-diagnostics-the-complete-regulatory-guide.
- ↑ "Overview HIPAA - General Information". Centers for Medicare and Medicaid Services. http://www.cms.gov/HIPAAGenInfo/. Retrieved 11 September 2013.
- ↑ "Clinical Laboratory Improvement Act (CLIA)". Association of American Physicians and Surgeons, Inc. http://www.aapsonline.org/msas/clia.php. Retrieved 11 September 2013.
- ↑ "VD Regulatory Assistance - CLIA Categorization Criteria". Food and Drug Administration. http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/IVDRegulatoryAssistance/ucm124208.htm. Retrieved 13 September 2013.
- ↑ Pantanowitz, Liron; Henricks, Walter H.; Beckwith, Bruce A. (December 2007). "Medical Laboratory Informatics". Clinics in Laboratory Medicine 27 (4): 823–43. doi:10.1016/j.cll.2007.07.011. http://www.sciencedirect.com/science/article/pii/S0272271207000893. Retrieved 11 September 2013.
- ↑ "Medical laboratory informatics". ClinfoWiki. 19 November 2011. http://clinfowiki.org/wiki/index.php/Medical_laboratory_informatics. Retrieved 11 September 2013.
- ↑ Henricks, Walter H. (9 October 2012). "LIS Basics: CP and AP LIS Design and Operations" (PDF). Pathology Informatics 2012. Walter H. Henricks, MD. http://www.pathinformatics.pitt.edu/sites/default/files/2012Powerpoints/01HenricksTues.pdf. Retrieved 11 September 2013.