This guest essay by Dr. Janine Cook details the obligations of Good Laboratory Practice and the government requirements of CLIA. Find out where the two mesh and where they conflict.
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Department of Medical and Research Technology
School of Medicine
University of Maryland
Those of us involved in clinical laboratory medicine must comply with the Clinical Improvement Act (CLIA) of 1988. Those laboratories testing nonclinical specimens in support of FDA and EPA applications or permits must comply with Good Laboratory Practice (GLP). With FDA exerting increasing influence over certain areas in healthcare laboratories, such as Transfusion Medicine, GLP will also increase in importance in clinical laboratory medicine. Fortunately, GLP and CLIA are more similar than different. It is through my study and experience with GLP that I have acquired a better appreciation of CLIA. I am struck by the parallels between the two sets of regulations and their histories.
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Lessons from history
There are two lessons I've learned from the study of history. First, history repeats itself and second, those who do not learn from history are doomed to repeat it. In many ways the CLIA legislation closely parallels the course previously transversed by GLP. The food and drug industry, because of mistakes, required federal regulations to ensure safe consumer products. Our industry, because of such incidents as Pap smear mills producing erroneous results, needed strict federal intervention to ensure quality and accurate patient specimen results.
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I would like to review the GLP story. An understanding of the history of GLP and its regulations may hopefully help us avoid further CLIA legislation.
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Both regulations driven by harm to the public
Like CLIA, GLP has its roots in a history of mistakes by food producers and drug manufacturers that resulted in harm to the general public. Because of these mistakes, the federal government, under the auspices of the Food and Drug Administration (FDA), stepped in to regulate the food and drug industry. The FDA, the federal agency whose mission is to protect consumers from harmful foods, drugs and cosmetics, was created with the enactment of the Food and Drug Act of 1906. This law gave the FDA the power to ban the manufacture and interstate sale of misbranded or impure food and drugs. Food and drug alteration, the mixing of harmful substances with food and drugs, was defined under the inaugural act.
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The powers given to the FDA increased with the Food and Drug Act of 1938, which was passed in response to the 1937 incident when the incorrectly labeled elixir sulfanilamide containing diethylene glycol killed 100 people in 2 months. This new act authorized injunction and seizure, set specific standards, required ingredient listing, established acceptable pesticide residue levels in foods, required drug screening by the FDA, regulated cosmetics and medical devices and increased FDA's enforcement power.
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In response to the European drug market approval of thalidomide, a sedative that caused severe birth defects, the New Drugs Amendments of 1962 was approved. This act gave the FDA more time to review new drug applications, required more safety and efficacy testing and authorized records inspections. Between 1962 and 1976 the FDA acquired even more power, including the requirements for the manufacturer to prove drug effectiveness and to present to the FDA post-approval reporting. Also, the FDA was charged with the responsibility of determining if the benefits from a drug outweigh its risks.
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In the 1950's, 1960's and 1970's, Industrial Bio-Test Laboratories (IBT) performed about 35-40% of all U.S. toxicology testing. Of the 867 audits of IBT performed by the FDA under the 1962 law, 618 were found to be invalid because of numerous discrepancies between the study conduct and data. FDA flexed its muscles and found four IBT managers guilty of fraud.
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As a result of the IBT incident, the FDA decided to regulate laboratory testing. In 1976, the FDA GLP guidelines were proposed; they were finalized in 1978 and became effective in 1979. The GLP guidelines continue to evolve with additional changes made in 1987 and the hope of international GLP in the new millennium.
Why did the FDA feel the need for GLP guidelines? The agency found that not all scientific work was good scientific work. FDA created GLP with the intent that the guidelines will assure the quality and integrity of safety data, allow for the accurate reconstruction of all experiments and support the approval and manufacture of safe, regulated products. To effect compliance with these regulations, FDA was given absolute power over testing laboratories with the threat of such penalties as steep fines and criminal prosecution.
Overview of GLP guidelines
Reading of the GLP guidelines, like most federal regulations, is best reserved for those nights when insomnia threatens you and you need a good defense to ward it off. Lucky for you I have read the guidelines and will provide a brief synopsis. The GLP guidelines are divided into nine subparts, dealing with general provisions, organization and personnel, facilities, equipment, testing facility operations, test and control articles, protocol for and conduct of a nonclinical laboratory study, records and reports and disqualification of testing facilities. Notice the similarities to CLIA as you read the following summary of GLP requirements.
An authorized FDA employee can inspect a laboratory's facility, records and specimens at any time and without warning.
Personnel must possess appropriate education, training and experience to perform the assigned tasks; the education, training and experience must be documented. Job descriptions must be available and current for each individual. The laboratory must have available the appropriate number of personnel required to perform each task as stated in the standard operating procedure (SOP). Personnel must take all necessary precautions to avoid contamination of any testing materials.
The management of the laboratory testing facility must designate a study director; create a quality assurance unit; assure that test materials are assayed as required; make available personnel, resources, facilities, equipment, materials and methodologies as scheduled; assure that the testing personnel clearly understand their duties and assure that any deviations from protocols and SOPs are communicated, corrected and documented.
The study director has the overall responsibility for the conduct of the study and is the single point of study control. The responsibilities of the study director include assuring that the protocol is approved and followed, all data is recorded and verified, unforeseen circumstances are noted and corrective action is taken and documented, test systems are specified in the protocol, GLP is followed and documentation is archived.
GLP regulations mandate that the testing facility has a QA (Quality Assurance) unit that is separate from and independent of the personnel engaged in the conduct and direction of each study. The duties of the QA unit are extensive and include monitoring each study; assuring that the facility, equipment, personnel, methods, practices, records and controls conform to GLP; maintaining a master schedule of duties being performed; maintaining copies of all protocols; periodically completing internal audits and submitting status reports which include descriptions of problems noted and any corrective actions; submitting of written status reports to management and the study director; ensuring no deviations occur from the approved protocols or SOPs without appropriate authorization and documentation; reviewing the final study reports; enclosing the QA report in the final study report; preparing and maintaining QA SOPs and making documentation available for regulatory inspections.
The GLP regulations require that the testing facility be suitable in size and construction. A separate laboratory operations area is needed. Storage space to archive specimens and data must be adequate. To avoid contamination and mix-ups between test and control articles, separate areas are needed for receipt, storage and preparation of materials and the storage of products.
Instrumentation must be of appropriate design and have adequate capacity to function per the protocol and SOP. A detailed written SOP is needed for each instrument. All instrumentation must be adequately operated, inspected, cleaned, maintained, tested, calibrated and standardized. Equipment performance, use and maintenance are documented.
Standard Operating Procedures (SOP)
The GLP SOP states exactly how the procedure is to be done each time, every time. The SOP must be current, clearly written, immediately available to the staff, adhered to and authorized. A historical file of SOPs is maintained. The regulations list those procedures requiring SOPs.
Reagents and Solutions
Reagents and solutions are labeled with their identity, titer or concentration, storage requirements and expiration date. Reagents and solutions must not be used if deteriorated or outdated.
The guidelines governing animal care are quite detailed. The reader should consult the regulations for further information.
Test and Control Materials
For each batch of test and control materials, the identity, strength, purity, composition and stability must be determined and documented. Methods of synthesis for the materials are documented. Each batch is labeled with the material name, CAS number, batch number, expiration date and storage conditions.
Test and control materials are handled in such a way to ensure receipt documentation, proper identification, appropriate storage and adequate distribution processes to avoid contamination, deterioration or damage.
If test or control articles are mixed with carriers, the uniformity, concentration, stability and expiration date of the mixture must be determined.
Since consumer safety decisions are based on laboratory data, the laboratory must ensure the quality and integrity of all the data it produces through appropriate documentation.
All data and observations are recorded in a laboratory notebook. Except for data generated by automated data collection systems, data is recorded directly, promptly and legibly using permanent black ink. Documentation in advanced is prohibited. All data entries are dated on the date of entry and signed and initialed by the analyst entering the data. Any changes to the recorded data are made without obscuring the original entry; the reason for the change is indicated and the change is dated and signed. White Out® is never used. Data entries must include the identification of the project and all equipment used. All statistical and calculation procedures are described. A second person is required to verify all critical calculations and that verification is documented. All raw data is retained. Units are identified as necessary on all numerical results. Any deviations from the protocol or SOP are recorded along with the reason for the deviation. The study director must acknowledge the deviation through appropriate documentation.
The testing laboratory's final report must state the laboratory's name and address, the start and end dates of the study, the objectives and procedures of the protocol, statistical methods used and the identification of test and control articles.
Archiving is an assigned responsibility because access to the archives is restricted to authorized personnel only. Archiving must be timely and all archived data is indexed to permit expedient retrieval.
[If you want to learn more about GLP, consult the Federal Register Part 58 - Good Laboratory Practice for Nonclinical Laboratory Studies.]
The many similarities between GLP and CLIA should help clinical laboratory scientists recognize the opportunities to contribute to quality laboratory testing for public safety, as well as direct testing for healthcare diagnosis and monitoring. Laboratory analysts who are well trained in quality management will find those skills to be transferrable to other fields where the quality of laboratory testing is also important.
Biographical details of Janine Denis Cook, Ph.D., DABCC
Janine is an assistant professor in the Department of Medical and Research Technology, School of Medicine, University of Maryland, Baltimore. She has a B.S. and M.S. degree in Chemistry (organic!) from Creighton University, Omaha, NE. Her Ph.D. in Chemistry (biochemistry) was earned at The University of Iowa, Iowa City, IA. Her postdoctoral training was in The Johns Hopkins University Biochemistry Department and in The University of Maryland Medical Systems Clinical Chemistry postdoctoral training program. She has ten years experience as the Department Head/Technical Director of Chemistry at Maryland Medical Laboratory (now Quest), a regional reference laboratory.