Right People in Right Roles - How to Ensure Your Blood Gas Laboratory is Compliant

• CAP Accreditation Resources
• Call CAP Technical Specialists at 800-323-4040

Julie McDowell:

Blood gas laboratories, like all laboratories operating under CLIA, need to ensure that they have qualified personnel in the CLIA defined role. For example, many respiratory therapists only have an associate's degree, so they are not qualified to fulfill the technical consultant role as defined by CLIA because it requires a four-year degree. Recently, the CAP observed that CMS is citing blood gas labs for not having appropriate personnel during their validation inspection, as Dr. Earle Collum outlines in this CAPcast interview. Dr. Collum, why is the CAP clarifying CLIA roles specifically for blood gas laboratory?

Dr. Earle Collum:

Well, one of the reasons is that CMS is citing blood gas laboratories for this, as you just stated, and it was because of appropriate personnel not being in place to perform competency assessments. The CAP is therefore providing guidance on the personnel qualifications and the records needed to demonstrate and maintain compliance. Blood gas testing is classified by the FDA as moderate complex testing. Personnel who assess competency of blood gas testing must qualify for the CLIA defined role of a technical consultant.

Julie McDowell:

Now, who is qualified to be a technical consultant in a blood gas laboratory?

Dr. Earle Collum:

Well, that's a great question. The individual fulfilling the role of a technical consultant must be qualified by both education and experience. The minimum qualifications of a technical consultant include a bachelor's degree in clinical lab science or medical technology. Also for educational purposes, a bachelor's degree in a chemical, physical, or biologic science from an accredited institution is acceptable. In addition, at least two years of training and/or experience in the designated specialty or subspecialty area is required.

For blood gas laboratories, an individual with a bachelor's degree in an appropriate science such as biology, chemistry, respiratory therapy, or pulmonary science, and two years of experience, qualifies as a technical consultant, except in the state of California. In California, a technical consultant must be licensed by the state to perform high complexity testing or be a California licensed physician.

If the laboratory does not have an individual who meets the qualifications, the laboratory director may qualify as the technical consultant. If the director assumes the role of the technical consultant, he or she must perform all six elements of the competency assessment and cannot delegate these functions. The blood gas laboratory may also have a technologist from the chemistry department serve as the technical consultant if he or she meets the qualifications and have appropriate experience in the specialty of chemistry.

Julie McDowell:

Now, Dr. Collum, what records is the laboratory required to maintain for technical consultants in the laboratory?

Dr. Earle Collum:

Well, the laboratory must confirm the individual's credentials by retaining a copy of the diploma with the field of study noted, transcript or primary source verification. A copy of the resume may serve as documentation of years of experience. The CAP does not accept state licensure for respiratory therapists as evidence of education and experience. In addition, a certificate from a respiratory therapy program is not adequate to meet the educational requirements.

The CAP commonly receives questions asking if blood gas personnel who have an associate's degree in respiratory therapy with a bachelor's degree in a non-science field, can qualify as a technical consultant based on the number of science credits earned. CLIA regulations, however, do not have a grandfather clause and do not allow counting of college course credits to allow an individual who's not completed a bachelor's degree program in an appropriate science to qualify as the technical consultant.

Records showing completion of the bachelor's degree program in an appropriate science must be provided as evidence to meet the qualifications. The technical consultant must be listed on the laboratories personnel roster as fulfilling that role.

Julie McDowell:

Finally, Dr. Collum, if laboratories have specific questions on personnel, what's the best way to get clarification?

Dr. Earle Collum:

There are actually a couple of great resources that are CAP related. One is the 1-800 number, and that is the technical specialist option, and that 1-800 number is 800-323-4040. Also, the CAP website at www.cap.org. Choose the laboratory improvement option and the accreditation resources subgroup with the laboratory personnel evaluation roster frequently asked questions can address that issue.

Julie McDowell:

Great. Thank you, Dr. Collum, very much. As mentioned, for more information, please visit cap.org and search under accreditation resources, or as Dr. Collum mentioned, please call CAP technical specialist at 1-800-323-4040.

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