On July 26, 2022 the CMS opened up comments regarding the docket CMS-2022-0119-0001. This CMS proposal discusses adding a definition for “doctoral degree” in 493.2 for the purposes of high complexity laboratory director (HCLD) qualifications. Board certification by a Department of Health and Human Services (HHS) approved certifying body is a requirement for HCLD qualification. The American Association of Clinical Chemistry (AACC) is one of the nine board certifying bodies listed by the HHS.1 The AACC voiced opposition to including the Doctor of Clinical Laboratory Science (DCLS) in the definition.
The AACC is a reputable certifying body that shares the common goal with the ASCLS to maintain the highest standards for quality laboratory testing. It is tragic the AACC remains confused about the types of doctoral degrees, and thus does not support the inclusion of the DCLS in the definition of “doctoral degree” as stated in the comment to the CMS and on their website. Furthermore, the AACC comment states,
“Historically CMS, along with the CLIA approved certifying agencies, have not recognized DCLS as an acceptable degree for taking an exam to serve as a HCLD.”2
This statement is false. DCLS graduates have attained board certification from the National Registry of Certified Chemists (NRCC) and are currently HCLDs of laboratories with certification from CLIA approved certifying agencies. Currently the NRCC certified DCLS is being recognized as an HCLD by the CMS.
There are three broad categories of doctoral degrees as defined by the National Center for Educational Statistics (NCES):
- Doctor’s degree-research/scholarship: These individuals have emphasis on research with no required clinical component. This doctorate is defined by the NCES as not intended for the purposes of professional practice.
- Doctor’s degree-professional practice: This is completed to achieve recognition, credential, or license, for practice in a profession such as a medical doctor (MD). These have more emphasis on the clinical component and no research is required for the majority of these degrees. Since the MD student is working towards credentialing, the MD is categorized by the NCES as a first professional level doctorate. The DCLS is also in this category as an advanced practice doctorate, not as a 1st professional level doctorate such as the PharmD and DPT The DCLS is a credentialed, practicing professional with both the research and clinical components.
- Doctor’s degree-other: these doctorates do not fit in either of the categories listed above but are considered doctor’s degrees such as honorary doctorates.3
The AACC states,
“AACC agrees with CMS’ previous position—stated as recently as 2018--that the DCLS is not an acceptable PhD under CLIA.2
This statement demonstrates the AACC’s confusion about the types of doctorates: the DCLS is not a Ph.D. as described above.
The AACC makes assumptions about the DCLS coursework:
“The DCLS is a coursework driven program, which focuses primarily on laboratory management.”2
While laboratory management experience is a requirement for the HCLD, this is not the focus of DCLS coursework. The DCLS completes advanced coursework in the many disciplines of the clinical laboratory as well as clinical rotations. The DCLS is trained to meet the Institute of Medicine (IOM) Core Competencies for Health Professionals:
- Provide patient-centered care,
- Work in interdisciplinary teams,
- Employ evidence-based practice,
- Apply quality improvement,
- Utilize informatics.4
The AACC supports the Ph.D. as an HCLD where the above listed competencies are not a focus of Ph.D. research. The AACC regards research as an important component of an HCLD qualification but regards the MD as a qualifying HCLD even though it that lacks the research component. The DCLS has the greatest relevancy to the clinical laboratory of all three doctorates since it meets both of these components.
The Centers for Medicare and Medicaid Services (CMS) regulates all laboratories in the U.S. that perform testing on human specimens through CLIA.5 The CMS does not regulate research laboratories. The purpose of CLIA is to ensure quality lab testing of human specimens as specified above. The DCLS has the experience and advanced training necessary for an HCLD. The AACC regards the DCLS as an MLS seeking to expand their knowledge and their role is commensurate to a technical section lead:
“Although AACC applauds the desire of any individual to expand their knowledge and improve their skills, the DCLS falls short of meeting the requirements necessary for a person to serve as HCLD.”2
AACC acknowledges that the research Ph.D. must achieve experience performing high complexity laboratory testing before serving as a HCLD, which the DCLS already has upon doctoral completion. The AACC is a respected, certifying body with abundant subject matter experts among AACC membership. However, the misconceptions listed in the AACC communication are tragically misleading. The ASCLS-IN supports the DCLS as being fully qualified to serve as a HCLD.
Article Written By:
Biz Fisher MHA-HI, MLS(ASCP)CM, PBTCM
ASCLS-IN Past President
1Certification Boards for Laboratory Directors of High Complexity Testing. December 31, 2020. Department of Health and Human Services (HHS). Accessed from: Certification Boards for Laboratory Directors of High Complexity Testing | Guidance Portal (hhs.gov)
2AACC Comments to CMS Proposed Rule Regarding CLIA Updates. August 24, 2022. American Association of Clinical Chemistry (AACC). Accessed from: AACC Comments to CMS Proposed Rule Regarding CLIA Updates | AACC.org
3Structure of U.S. Education. U.S. Department of Education. Accessed from: Structure of U.S. Education
4Institute of Medicine. (2003). Health professions education: A bridge to quality. Washington, DC: National Academies Press.
5Clinical Laboratory Improvement Amendments (CLIA). Centers for Medicare and Medicaid Services. Accessed from: Clinical Laboratory Improvement Amendments (CLIA) | CMS