LabOratory on Personnel Requirements

LabOratory on Personnel Requirements

By Teresa A Scott, MT(ASCP)

COLA Education Division Medical Technologist

Subpart M of the Clinical Laboratory Improvement Amendments (CLIA) “consists of the personnel requirements that must be met by laboratories performing moderate complexity testing, PPM procedures, high complexity testing, or any combination of these tests. … The moderate complexity procedures specified as PPM procedures are considered such only when personally performed by a health care provider during a patient visit in the context of a physical examination.” [1] 

If the PPM (Physician Performed Microscopy) procedures are not performed by the health care provider, the laboratory must meet the personnel requirements for labs performing moderate complexity testing.  CLIA defines four personnel positions for moderate complexity and five positions for high complexity.  (See Table 1.)  There are no personnel requirements for waived testing. 

Table 1 

There must be at least one person who meets the qualifications and can fulfill the duties and responsibilities for each of the CLIA defined positions, regardless of the actual title used in the laboratory.  For instance, the individual designated as the “Laboratory Specialist” may meet the requirements and fulfill the duties of the CLIA defined position of “General Supervisor.” 

It is also possible for one person to fill multiple positions as long as they are qualified for each.  For example, if qualified for all positions, the Laboratory Director may also act as the Technical Supervisor and the Clinical Consultant.

Personnel must meet the most stringent qualifications for the testing performed in the laboratory.  That is, if both high and moderate complexity testing are performed, the Laboratory Director must meet the qualifications defined under high complexity.  The high complexity testing must be done only by staff who meet the qualifications for high complexity Testing Personnel, and staff performing only moderate complexity testing must meet the qualifications for moderate complexity Testing Personnel.

Some states have additional personnel requirements which then become applicable for CLIA purposes.  As a specific example, if the state requires personnel to be licensed to hold a medical laboratory position, CLIA would require licensure as well.

There are different eligibility pathways for individuals to qualify for each CLIA-defined position.  These pathways consider the individual’s educational level, and varying amounts of work experience and/or laboratory training, and other considerations to determine if the individual is eligible to fill each position.  The remainder of this article will focus on these various eligibility pathways.

Moderate Complexity

Each laboratory performing moderate complexity testing must fill the positions of Laboratory Director (LD), Clinical Consultant (CC), Technical Consultant (TC) and Testing Personnel (TP).

Laboratory Director

All candidates for LD “must be qualified to manage and direct the laboratory personnel and the performance of [laboratory] tests and … must possess a current license as a laboratory director issued by the State in which the laboratory is located, if such licensing is required.”[2]  If the candidates are physicians, they must also be licensed to practice in the State in which the laboratory is located.

See Table 2 for a summary of the moderate complexity eligibility pathways.  A licensed MD or DO who is Board certified in Anatomic and/or Clinical Pathology qualifies as a Lab Director of a moderate complexity lab without additional training or experience.  If the licensed MD or DO is not a Board certified pathologist, or if the physician is a licensed DPM, there are two possible eligibility pathways. 

1. The licensed physician can have at least one year of training and/or experience directing or supervising non-waived testing. 
2. In lieu of this experience, the licensed physician can take 20 Continuing Medical Education (CME) credits in laboratory practice.  These credits must address the responsibilities of the Laboratory Director.  The equivalent of these 20 CME credits could also have been obtained via laboratory training during medical residency. 

Additional eligibility pathways include:

–   Individuals with Doctoral degrees in a chemical, physical, biological, or clinical laboratory science must be Board certified in their specific field or have at least one year experience directing or supervising non-waived testing.

–   Individuals possessing Master’s degrees in a chemical, physical, biological, or clinical laboratory science need to have at least one year of laboratory training or experience and an additional year of supervisory experience in a laboratory performing non-waived testing. 

–   If individuals hold eligible Bachelor’s degrees (in a chemical, physical, biological, or clinical laboratory science), the amount of lab training or experience, and supervisory experience is increased to at least two years of each.

Individuals with less formal education do not qualify to be directors of laboratories performing moderate complexity testing.

Clinical Consultant

According to CLIA, “the Clinical Consultant must be qualified to consult with and render opinions to the laboratory’s clients concerning the diagnosis, treatment and management of patient care.”[3]  Therefore, this individual must be a licensed MD, DO or DPM.  An individual with a Doctoral degree and Board certification who qualifies as a Laboratory Director is also eligible to be a clinical consultant. 

Individuals possessing Master’s, Bachelor’s or Associate’s degrees are not eligible to become CCs.

Technical Consultant

CLIA requires labs to employ one or more individuals who are qualified to provide technical consultation for each of the specialties and subspecialties (hematology, chemistry, microbiology, etc.) for which the lab performs moderate complexity testing.

As with the Director, a licensed MD or DO who is Board certified in Anatomic and/or Clinical Pathology does not need additional training or experience to qualify as a Technical Consultant.  At least one year of laboratory training and/or experience is needed by individuals with the following licenses and/or degrees:

–   Licensed MD/DO – not Board certified in Anatomic and/or Clinical Pathology

–   Licensed DPM

–   Doctoral degree

–   Master’s degree

An individual with a Bachelor’s degree must have at least two years of laboratory training and/or experience. 

It is permissible for the laboratory to have a separate TC for each of the specialties and/or subspecialties for which testing is performed.  When this is the case and the TC provides consultation in only one specialty, the laboratory training/experience must be in that specialty.

Testing Personnel

As the name implies, Testing Personnel are the individuals who actually perform the laboratory testing.  Any licensed physician (whether MD, DO or DPM) can perform laboratory testing.  Any individual with a college degree (Doctoral, Master’s, Bachelor’s or Associate’s) in a chemical, physical, biological or clinical laboratory science can perform laboratory testing.  These pathways assume that these individuals obtained appropriate laboratory experience while they earned their degrees. 

Individuals with a high school diploma or GED may also perform laboratory testing, but they require specific laboratory training in addition to their education.  If they served in the military as a Medical Laboratory Specialist, the 50 week course of medical training they took fulfills the training requirements.  If they do not have military experience, they must have “documentation of training appropriate for the testing performed, prior to analyzing patient specimens.”[4]  Refer to the CLIA regulations for specific details that must be included in this training. 

High Complexity

Each laboratory performing high complexity testing must fill the positions of Laboratory Director (LD), Clinical Consultant (CC), Technical Supervisor (TS), General Supervisor (GS), and Testing Personnel (TP). 

Laboratory Director

As stated earlier, all candidates for LD “must be qualified to manage and direct the laboratory personnel and the performance of [laboratory] tests and … must possess a current license as a laboratory director issued by the State in which the laboratory is located, if such licensing is required.”[5]  If the candidates are physicians, they must also be licensed to practice in the State in which the laboratory is located.

Individuals who wish to become directors of high complexity laboratories must either be physicians or have Doctoral degrees.  There are no pathways to qualify as a director for individuals with other levels of education. 

The eligibility pathways for directors of high complexity laboratories are summarized in Table 3.  When comparing the requirements for moderate and high complexity LDs, note these key differences:

–   The amount of experience needed is different.

–   Directors of labs performing high complexity testing need experience in high complexity laboratories while directors of labs performing moderate complexity testing can obtain experience in either moderate or high complexity labs.

–   Physicians cannot qualify to become directors of labs performing high complexity testing by taking CME courses.

The eligibility pathways for Laboratory Directors of labs performing high complexity testing include: 

1. A licensed MD or DO who is Board certified in Anatomic and/or Clinical Pathology qualifies as a director of a high complexity laboratory without any further training or experience. 
2. A licensed MD, DO, or DPM who is not Board certified in Anatomic and/or Clinical Pathology requires additional experience to qualify as a Laboratory Director.  This “additional experience” can be met in two ways: 

–   At least one year of laboratory training during medical residency or

–   At least two years experience directing or supervising high complexity testing. 

1. An individual with a Doctoral degree must also meet additional requirements to qualify as a director of a laboratory performing High Complexity testing: 

–   The degree must be in a chemical, physical, biological or clinical laboratory science.

–   The individual must be certified in that science by a Board approved by the Department of Health and Human Services. 

For a PhD doctor who is not Board certified to qualify, the individual had to already be serving as a Laboratory Director prior to February 24, 2003.  This doctor can continue to serve as LD if he or she has two years of laboratory training and/or experience plus two years of experience directing or supervising high complexity testing. 

Clinical Consultant

The Clinical Consultant for a high complexity lab is defined the same way as a CC for a moderate complexity lab.  To qualify as a CC for high complexity labs, the individual must be a licensed MD, DO or DPM or must hold a doctoral degree and qualify as a Lab Director for high complexity laboratories.

Technical Supervisor

According to the CLIA regulations, “the laboratory must employ one or more individuals who are qualified by education and either training or experience to provide technical supervision, for each of the specialties and subspecialties of service in which the laboratory performs high complexity tests or procedures.”[6]   An individual is qualified to act as a Technical Supervisor in a particular specialty only if that person has experience or training in that specialty.  Thus, it is possible for an individual to be a TS in one specialty and not another, which means that it may be necessary for the laboratory to have a different TS for each specialty.  If the individual qualifies as a TS in more than one specialty, the experience needed in each specialty can be obtained concurrently.

The experience requirement for the Microbiology specialty has a further stipulation that at least six months of the experience or training must be within the applicable subspecialty.  As an example, an individual with a PhD in Microbiology may be a Technical Supervisor in Parasitology, only if he or she has at least one year of Microbiology laboratory experience that includes six months experience in a Parasitology laboratory.  

These are the eligibility pathways for Technical Supervisor: 

–   As with other positions, a licensed MD or DO who is Board certified in Anatomic and/or Clinical Pathology is qualified to be a Technical Supervisor without additional training or experience. 

–   A licensed MD, DO or DPM who is not Board certified in Anatomic and/or Clinical Pathology, or an individual with a Doctoral degree in a chemical, physical, biological or clinical laboratory science qualifies with at least one year of laboratory training and/or experience in the specialty or subspecialty which he or she will supervise.  Remember that if the specialty is Microbiology, the doctor must have at least six months of training and/or experience within the applicable subspecialty.

–   Individuals with Master’s degrees in a chemical, physical, biological or clinical laboratory science will qualify as Technical Supervisors if they have at least two years training or experience within the specialty or subspecialty.

–   Individual with Bachelor’s degrees in a chemical, physical, biological or clinical laboratory science will qualify as Technical Supervisors if they have at least four years training or experience within the specialty or subspecialty.

There is an exception to these requirements.  An individual must be an appropriately qualified medical doctor to fill the position of Technical Supervisor in a laboratory performing Blood Bank testing.  In the specialty of Immunohematology, the Technical Supervisor must be a licensed MD, DO or DPM who is Board certified in Anatomic and/or Clinical Pathology or who has the appropriate training or experience.  The other degree pathways are not available. 

The additional experience requirements for Technical Supervisor are summarized in Table 4.

General Supervisor

The General Supervisor provides the day-to-day supervision of testing personnel and reporting of test results.

A qualified high complexity LD or a qualified TS is also qualified to fill the General Supervisor position.

Additional pathways allow licensed physicians or individuals with Doctoral, Master’s or Bachelor’s degrees in an eligible science to become General Supervisors.  These individuals must also have one year of laboratory training and/or experience in the high complexity specialty or subspecialty they will supervise.

Most individuals who qualify as Testing Personnel for high complexity testing will qualify as General Supervisors once they have achieved two years of laboratory training and/or experience. 

Testing Personnel

To perform High Complexity testing, individuals must have a college degree.  An individual with a medical degree is qualified to perform high complexity testing.  If the degree is a Doctoral, Master’s or Bachelor’s degree, it must be in a chemical, physical, biological or clinical laboratory science.  If the degree is at the Associate’s level, it must be in clinical laboratory science or its equivalent. 

The CLIA regulations also allow education equivalent to an Associate’s degree, but they specify the minimum number of semester hours of particular classes that must be taken by individuals for them to qualify as high complexity Testing Personnel.   There are also requirements for approved training programs and for experience in each specialty.  Refer to the CLIA regulations for details.

Additional Considerations

The CLIA regulations list additional pathways and “grandfather” exceptions not mentioned in this article.  Subpart M also states the specific responsibilities and duties of each of the CLIA-defined positions, as well as requirements for personnel training and competency assessment.  There are also directives for appropriate and acceptable documentation of qualifications, training and assessment.  If you have questions about specific personnel, refer to the federal regulations, or the appropriate State or accrediting agency.

Table 2 

Table 3

Table 4

[1] Department of Health and Human Services, Centers for Disease Control and Prevention (CDC),  Current CLIA Regulations (including all changes through 01/24/2004); http://wwwn.cdc.gov/clia/regs/subpart_m.aspx

[2] Ibid, §§493.1403, 493.1443

[3] Ibid., §493.1417

[4] Ibid., §493.1423

[5] Ibid, §§493.1403, 493.1443

[6] Ibid., §493.1449

About COLA

COLA accredits almost 8,000 medical laboratories and provides the clinical laboratory with a program of education, consultation, and accreditation. The organization is an independent, non-profit accreditor whose education program and standards enable clinical laboratories and staff to meet U.S. CLIA and other regulatory requirements. For more information about COLA accreditation services and educational products, and online educational opportunities, please call 800-981-9883 or visit COLA's web site at www.cola.org or www.colainsider.com.