Photo of John NoblittWith the New Year of 2015 now upon us, this may be a good time for you to commit to the process of becoming certified by the end of the year. Whether you have aspirations to obtain certification as a laboratory equipment specialist, a radiology equipment specialist, or a biomedical equipment specialist, the process begins with the same action: You must commit to the time and effort it will take to obtain this professional milestone in your career. Once again this year, I will share insights and information about the certification exams and try to anticipate the types of questions you may find on the ICC examinations.

The Clinical Laboratory

To begin the new year, I have reviewed many of the topics that have been written about in this column over the years. One area stands out as needing attention in my estimation: the clinical laboratory. In my opinion, the requirements and best practices for working with clinical laboratory equipment should be explored in more depth than has previously been done here. So let us begin the New Year with some basic information about the clinical laboratory, such as regulatory agencies involved in this area, the different departments operating in this environment, and some of the tests being performed by these various departments within the hospital laboratory.

Regulatory agencies you should be aware of, besides The Joint Commission (JC), which pertain to the clinical laboratory in the hospital are as follows:

The College of American Pathologists, better known as CAP. This organization offers accreditation services and standards to clinical labs in the United States and abroad. CAP accredits laboratories and helps ensure that they are meeting federal regulations on testing.

The Clinical Laboratory Improvement Amendments of 1988, also known as CLIA. CLIA is a federal act that specifies minimum performance standards in clinical laboratory testing.

The Centers for Medicare & Medicaid Services, better known as CMS or CMMS. This agency is part of the federal government under the Department of Health and Human Services and is responsible for implementing CLIA.

American Association of Blood Banks, referred to as AABB. This organization specializes in advancing the practice and standards of transfusion medicine and cellular therapies to optimize patient and donor care and safety, as stated in the organization’s mission statement.

There are a number of other agencies that are concerned with clinical laboratory environments, such as the FDA, COLA, and the National Accrediting Agency for Clinical Laboratory Sciences (NAACLS), to mention just a few. However, CAP, CLIA, CMS, and AABB are the four most important sources of key standards that have found their way onto ICC accreditation exams, such as centrifuge speed and time testing, blood bank temperatures for safe handling, and storage procedures for blood products.


Clinical labs and their departments will differ from facility to facility, usually in accordance to the size of the lab. Most all hospital labs will have the following departments (and possibly more), which perform different types of analyses:

Hematology. This department tests different cellular components of blood. Common quantitative tests involve various blood components, such as erythrocytes, leukocytes, platelets, hemoglobin, and hematocrit. Qualitative tests for this department may be looking at cell size, shape, and maturity. These types of tests can assist in diagnosing anemia and other anomalies.

Clinical Chemistry. This department performs different tests on plasma, serum, spinal fluid, and urine. Common tests in this area of the lab are blood coagulation tests, blood glucose, cholesterol, electrolytes, and heart and liver enzyme testing. Equipment used in this area of the lab can involve types of photometry or even electrophoresis.

Immunology. Once referred to as serology, this can be a separate department or part of the blood bank or microbiology, depending on the size of the lab. This department will typically test for pregnancy, HIV, hepatitis, STDs, and other infectious diseases. The blood bank, which may sometimes be called immunohematology, performs ABO group and Rh typing before blood transfusions are performed.

Microbiology. This department is responsible for culturing and identifying different microorganisms. Bacteriology, a subset of microbiology, performs tests by inoculating different specimen types to culture media. Organisms that grow in the culture are identified to determine which type of antibiotic may be most beneficial for the patient. Virology (the study of viruses) mycology (the study of fungi), and parasitology (the study of parasites) are also part of microbiology. However, many of these types of tests are sent out to reference laboratories, since special care must be observed when handling these specimens.

This is a very brief overview of some of the most notable laboratory departments, types of testing, and key agencies that you should be familiar with in working with the clinical laboratory in your facility. I will be bringing you more information about the equipment used to perform many of these tests in a future ICC Prep column.

I hope you find this information useful in your quest to become certified.

Review Questions

1) Which act specifies minimum performance standards for all clinical laboratories?
b) FDA

2) Which organization is responsible for procedures of transfusion services?
a) FDA
c) Joint Commission
d) CAP

3) Virology testing would most likely be found in which laboratory department?
a) Phlebotomy
b) Microbiology
c) Hematology
d) Blood Bank

4) Which government agency has the responsibility for implementing CLIA standards?
a) CMS
b) FDA
d) Joint Commission

John Noblitt, MAEd, CBET, is the BMET program director at Caldwell Community College and Technical Institute, Hudson, NC. For more information, contact editorial director John Bethune at [email protected].
Answers: 1—D, 2—B, 3—B, 4—A