What is Laboratory Law?
Laboratory law has developed significantly in the past 50 years. According to Malcolm H. Merrill and W. Max Chapman’s “Laboratory Technicians: The Clinical Laboratory Law and Its Meaning to Private Physicians”, clinical laboratory law was originally introduced in 1938, and laboratories were at first monitored on only a voluntary basis. While a number of amendments have been made to laboratory law since then, perhaps the most important development came about in 1988, when Congress passed the Clinical Laboratory Improvement Act. The act was written and passed into law after medical misconduct resulted in “a number of deaths from false-negative Pap smear readings.”
What Regulations are Laboratories Subjected To?
Laboratory law varies from state to state. California State Laboratory Law requires that most laboratories be licensed or registered with the state. In addition to holding Clinical Laboratory Improvement Amendments Certification (CLIA), labs require that complex testing cases be handled by chemists or scientists with a more advanced degree or certification. Calibrated lab equipment of the highest quality is used to produce the most exact measurements. These labs are inspected every 2 years to ensure that regulations are being met. Labs are also given tests—a process called “proficiency testing—in which their results help to determine the quality and accuracy of their testing practices.
Different types of laboratories are subject to regulation from different government entities. This is most oftentimes the state’s Department of Health, The U.S. Department of Health and Human Services, the Food and Drug Administration and the Center for Disease Control and Prevention, among others.
Implications of Improper Regulation
Scientific, or research, misconduct carries with it serious legal and ethical implications; as a result, the consequences for carrying out research misconduct are severe.
One case of research misconduct has been plaguing U.S. headlines as of late: A chemist in a state lab in Massachusetts has come under fire recently for allegedly “lying about drug samples she tested”. The chemist, Annie Dookhan, confessed to lying about the number of samples she tested, admitting that at times she would test only a fraction of a group of samples and record the same results for all untested samples. A local news station reported that Dookhan’s lab practices were often questioned by her colleagues. According to the Wall Street Journal , there are “nearly 1,100 inmates currently serving time in cases in which Ms. Dookhan was the primary or secondary chemist.”
There are many more negative consequences of improper, or absent, regulation of laboratories. This can include the improper handling and disposal of laboratory waste and hazardous substances, risking the safety of laboratory personnel and inaccurate results from contamination or lax clinical testing.
Is There Enough Regulation?
The lab scandal in Massachusetts highlights lingering inefficiencies in laboratory law. While Dookhan was charged with obstruction of justice, her misconduct affected the outcome of thousands of drug-related cases.
To prevent serious cases of scientific misconduct, some scientists are calling for increased regulation and supervision—a move that would include setting up cameras in laboratories. Some of those involved with Dookhan’s case claim that this added level of supervision may be unnecessary, and that an in-lab quality manager provides an adequate level of supervision.
It is possible that laboratories could avoid serious cases of misconduct like this by discouraging competition based on the number of samples tested. Dookhan reportedly came under suspicion of her colleagues after outperforming them significantly by turning in suspiciously high numbers of tested samples. After all, some of the most significant changes to laboratory law came about after medical misconduct was directly attributed to human injury or death. Whether it be an incorrect medical test that results in the death of a patient after treatment is not sought, or the contamination of evidence for criminal cases that results in jail time for thousands, laboratory results often have a serious impact in peoples’ lives. Focusing on the importance and potential implications of results—undoubtedly a goal of most regulated laboratories—may be the best solution for self-supervision in chemists, researchers and lab technicians.