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300 BCE
Beginnings of Specimen Testing
Hippocrates, who is known as the “Father of Medicine”, initiated diagnostic protocols which included testing patient body fluids. Testing fluids was done by visually inspecting and tasting urine. The presence of bubbles on the surface of urine was indicative of kidney disease. The presence of sediment, pus, or blood in urine was a sign of disease. Physicians would also test urine by pouring it on the ground. If it attracted ants, then the patient was suffering from boils. (Bereger, 1999). -
The First Clinical Laboratory
The first clinical laboratory was opened at Johns Hopkins Hospital in 1896. It was a twelve-by-twelve room with $50 worth of equipment. Previously, physicians performed laboratory testing in their own homes and offices. But, typically, laboratory testing was something that was viewed as unnecessary. Laboratory testing took up a lot of time and space. However, with epidemics of cholera and tuberculosis, laboratory testing proved to be a valuable diagnostic tool to clinicians (Delwiche, 2003). -
Karl Landsteiner Discovers Difference in Blood Types
Karl Landsteiner, a Viennese pathologist, discovered the different human blood types and described them as the ABO blood group. Landsteiner studied the unsuccessful blood transfusions between human to human. He noticed that people with incompatible blood groups had adverse reactions during transfusions such as shock, jaundice, and hemoglobinuria. Testing was developed to determine blood type which helped the patients receive compatible blood of the same blood group (Berger, 1999). -
ASCP Formed
The American Society of Clinical Pathology (ASCP) was formed to support and educate doctors wanting to specialize in pathology. Pathology is the study of disease and pathologists are physicians who specialized in that study. Pathologists would then train assistants, who were primarily female, to conduct routine clinical laboratory testing. The training of laboratory assistants allowed the pathologists to perform more advanced or technical testing in the laboratory (Delwiche, 2003). -
American College of Surgeons' Mandates Clinical Laboatories
During hospital inspections, the American College of Surgeons (ACS) found that 14% of all U.S. clinical laboratories were either commercial or reference labs which means they may or may not have been under the guidance of a physician (Berger, 1999). To combat this issue, ACS decreed that all hospitals have a clinical laboratory that runs under the guidance of a physician, preferably a pathologist (Dewiche, 2003). -
Sir Alexander Fleming discovers Penicillin
Alexander Fleming, a Scottish scientist, was testing different antibacterial substances on animals, in hopes that he would find a non-toxic antibacterial agent. One of his plates of staphylococcus grew a mold which was a contaminant, but Fleming noticed that there was a zone of inhibition, which is an area of no bacterial growth, around the mold colony. He tested the effects of this mold diluted out to 800 times and it still had the same desired effect on the bacterial growth (Berger, 1999). -
ASCP Creates Board of Registry
The ASCP accredited education programs and, in order to prove their education and be certified in clinical laboratory practices, students would have to challenge the Board of Registry (BOR), which is a certification exam. This certification process helped standardize the education of laboratory workers. To be board eligible, a person had to have a high school diploma, completed one year of didactic work, and have six months of experience from an ASCP accredited laboratory (Delwiche, 2003). -
The Coulter Principle Developed
Wallace Coulter developed a new technology to count and size of particles using electrical impedance. This methodology could measure particles as small as 0.4 micrometers and up to 1600 micrometers. This allowed blood cells to be counted more quickly than by manual means. Over 98% of automated cell counters incorporate the Coulter Principle counting method. -
New Categories of Laboratory Workers
With the increasing workload of clinical laboratories, the positions laboratory assistants and medical lab technicians were created to aid the pathologist and pathology assistants. Additionally, specialties were developed for laboratory technicians. A laboratory technician could specialize in chemistry, microbiology, hematology, and blood banking. Master's and doctoral programs were created in order to train future laboratory technicians and assistants (Delwiche, 2003). -
CLIA '88
President Ronald Regan signed the Clinical Laboratory Amendments of 1988 (CLIA '88) into law. Under this law, all labs were required to have a certificated issued by the Department of Health and Human Services (HHS). HHS certifies that the lab has adequate quality assurance and quality control programs to ensure the accuracy and validity of all test results generated by the lab. Proficiency testing was also mandated by this amendment to compare peer groups in the same regions (Berger, 1999).
