A topic frequently overheard discussed at the American Society of Clinical Pathologists (ASCP) recent 2022 annual meeting in Chicago was the CMS proposal to allow nurses to perform high-complexity testing. The proposal by the arm of the federal government responsible for healthcare is one of many seeking to address the severe shortage of laboratory personnel across the nation. The unofficial majority opinion of convention attendees was that it would be short-sighted and simply a bad idea to allow these already over-burdened healthcare workers to be responsible for performing high-complexity testing. The focus of nurse education isn't lab testing.
The performance of laboratory testing on human samples is a critical part of quality healthcare delivery service. It has been documented that over 70% of medical decisions are based on laboratory testing results. Therefore it is not surprising there are specific education and training requirements for anyone considering a career in laboratory testing. This two-part article will discuss the basic qualifications necessary to become laboratory testing personnel and the competency requirements mandated to ensure an individual maintains their knowledge and skill in performing lab tests.
Federal regulations were created to mandate the minimum qualifications of laboratory testing personnel. The Clinical Laboratory Improvement Amendments '88 (CLIA) specifically detail the education and experience required for a person to perform non-waived laboratory testing.
The FDA has defined waived and non-waived as the two categories of test systems allowed to analyze human specimens. The primary qualification for a test to be designated waived is that the FDA has approved the test for home use. Waived tests are tests anyone can perform, like home pregnancy tests or glucose testing. Tests not deemed waived fall into the category of non-waived testing.
(There is also a category called provider-performed microscopy (PPM), but those tests are performed primarily by the healthcare provider.)
Non-waived testing is further broken down into two groups: moderate complexity and high-complexity testing. Each type of non-waived testing has its own minimum requirements for education and experience that laboratory testing personnel must have to perform testing.
Moderate-complexity tests are composed of primarily automated clinical laboratory equipment. This includes instruments performing the bulk of chemistry, hematology, and urine analysis. Point-of-Care (POCT) instrumentation is designated mainly as moderate complexity testing.
POCT device manufacturers develop their devices to be easy to use, so they may be designated as moderate-complexity to ensure the device can be used at the bedside by most healthcare workers. The minimum CLIA educational qualification necessary to be allowed to perform moderate-complexity non-waived testing is a high school diploma or equivalent.
CLIA does not require an individual to have any specific experience to perform moderate-complexity testing. Still, the regulations dictate that each individual must have the degree of skill, training, knowledge, and technical abilities to perform testing. In addition, the person performing testing must follow the laboratory procedure, perform quality control and proficiency testing, follow established corrective actions, and be capable of identifying problems that may affect test performance or results.
Laboratorians should be aware that though most automated instrumentation used for patient testing in the clinical lab is designated moderate-complexity, there is a caveat involved. If some type of sample manipulation is required (dilution, saline replacement, manual differential), the sample testing will become highly complex. This is one reason most clinical laboratories ensure they hire individuals meeting high-complexity testing personnel qualifications.
The requirements to perform high-complexity testing are much more involved than moderate-complexity testing.
A bachelor's degree in a chemical, physical, biological, or clinical laboratory science, or medical technology from an accredited institution allows an individual to perform high-complexity testing. Also, an associate's degree in a laboratory science or medical laboratory technology qualifies an individual to perform high-complexity testing. If an individual lacks either of these degrees, the requirements are a bit more nuanced.
(Lab managers and administrators need to be aware that individuals with bachelor's or associate degrees in a chemical, physical, or biological science can be qualified to perform high-complexity laboratory testing if training is well documented. This route can be utilized for science graduates who lack clinical laboratory training. Documentation of training is critical in qualifying these types of employees to work in the laboratory.)
Individuals who lack an associate or bachelor's degree in a chemical, physical or biological science must have a minimum number of college courses from an accredited institution in biology, chemistry, and laboratory technology.
CLIA requires an individual seeking to perform high-complexity testing to have obtained (at a minimum) 60 semester hours. Twenty-four hours of the 60 must be semester science hours that include at least 6 hours of chemistry, 6 hours of biology, and another 12 hours of biology, chemistry, or medical laboratory technology courses in any combination.
In addition to the science courses, there is a requirement that the individual must have completed an accredited laboratory training program or have at least three months of documented training in each specialty the individual is performing high-complexity patient testing.
Veterans also qualify to perform high-complexity testing if they have completed the official military procedures training of at least 50 weeks and held the occupational specialty of Medical Laboratory Specialist. The caveat with military training is that it had to occur on or before April 24, 1995.
There is some grandfathering of individuals who were performing high-complexity laboratory testing before September 1, 1997. These individuals must have a high school diploma and a number of specific laboratory skills, including those required for following procedures, preventative maintenance, and verification of patient test results, to name a few.
Though not often discussed, CLIA also spells out the requirements for cytotechnologists. These lab workers, responsible for examining cytology slide preparations, must either have graduated from an accredited school of cytotechnology or be certified in cytotechnology by an approved certifying agency.
There is also some grandfathering for cytotechnologists without a degree. Before September 1, 1992, an individual must have completed two years at an accredited institution with a minimum of 12 semester science hours. Eight hours of the science course must be in biology. Some other conditions (detailed here) need to be met by individuals who did not graduate from an accredited school of cytotechnology.
CLIA does not require laboratory personnel to be certified by a certification organization such as ASCP, AMT, or AAB BOR. However, many large healthcare systems, especially those located in urban and suburban population centers, ask their lab employees to be certified. Independent and rural labs also have a preference for certification, but often lab applicants just need to meet the minimum testing personnel requirements dictated by CLIA to begin working.
Currently, 11 states and one territory require laboratory personnel to be licensed. Several of these states only require certification and payment of fees to obtain a license. However, individuals seeking to obtain a California license will need to take an examination if they were certified before 2002.
The CLIA regulations regarding laboratory testing personnel are specific and cover all levels of patient testing. The inability to confirm personnel qualifications is one of the three things that will immediately concern inspectors. (The other two are competency and proficiency testing). Laboratory staffing is at a critical low throughout the nation. However, lab managers and supervisors must ensure the people they hire to work meet the minimum education and experience requirements for moderate and high-complexity testing.
The second part of this series will discuss the most frequently cited deficiency in laboratories across the nation--competency. We will talk about why it's difficult, where the problems arise, and what to do when all six competency elements don't apply.
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