Lab Extra Credit Case Study

The Clinical Laboratory
Marcus stepped out of his car and into the sunshine, ready to head into the hospital for another day of work in the molecular diagnostics laboratory. Having graduated six months ago from college, he felt very fortunate to have found a great job that would give him valuable experience until he was ready to apply to medical school. Marcus had majored in biology and spent his senior year working in a research lab studying the genes that control early embryonic development in zebrafish. In his current job, he was studying genes again, but this time for a completely different purpose: to find genetic changes in patient DNA that could be contributing to their disease. Entering the laboratory wing of the hospital, Marcus thought, Working in the molecular diagnostics lab sure is different from when I was doing experiments in the research lab!

What made Marcus think that? What exactly is a molecular diagnostics lab, and how does it differ from a research lab? A molecular diagnostics laboratory is just one of several types of laboratories that exist in hospitals. These laboratories are also referred to as medical laboratories, or clinical laboratories. The term “clinical” refers to the actual diagnosis and
treatment of patients.

The following resources may help you to answer the questions below.

• Food and Drug Administration (FDA). Tests used in clinical care.
<https://www.fda.gov/medical-devices/vitro-diagnostics/tests-used-clinical-care>

• American Association for Clinical Chemistry (AACC). Where lab tests are performed.
<https://labtestsonline.org/articles/where-lab-tests-are-performed>

• American Association for Clinical Chemistry (AACC). Collecting samples for laboratory testing.
<https://labtestsonline.org/articles/collecting-samples-laboratory-testing>

Questions
1. What types of samples might be collected from patients to use for laboratory testing?
2. What are some examples of situations where a doctor might order a lab test to aid in the diagnosis and treatment of a patient?

There are many rules and regulations in place in order for a clinical laboratory to conduct testing. All clinical laboratories are regulated by the government, through the Clinical Laboratory Improvement Amendments, or CLIA. All clinical laboratories must be CLIA-certified. To obtain certification, a laboratory needs to provide evidence that the tests that they perform meet quality control standards, that the personnel performing the tests are adequately trained, and that the equipment being used for the test is functioning correctly and is properly calibrated.
The following resources may help you to answer the questions below.

• American Academy of Family Physicians (AAFP). Clinical Laboratory Improvement Amendments (CLIA).
<https://www.aafp.org/practice-management/regulatory/clia.html>

• Food and Drug Administration (FDA). Clinical Laboratory Improvement Amendments (CLIA).
<https://www.fda.gov/medical-devices/ivd-regulatory-assistance/clinical-laboratory-improvement-amendments-clia>

• Centers for Medicare and Medicaid Services (CMS). How to obtain a CLIA certificate.
<https://www.cms.gov/Regulations-and-Guidance/Legislation/CLIA/Downloads/HowObtainCLIACertificate.pdf>

Questions
3. Why does the government regulate clinical laboratories? Why is CLIA certification required?
4. How does the work of a clinical laboratory differ from the experiments being conducted in a research laboratory? Why don’t research laboratories have to comply with CLIA regulations?