Doctorate of Clinical Laboratory Science (DCLS)

• Applicants typically must hold a bachelor’s or master’s degree in clinical laboratory science or a related field, along with national certification (e.g., ASCP) and relevant professional experience.
• The didactic portion of a DCLS program is typically online with varying residency requirements by program. Flexible online or hybrid formats are commonly available to accommodate working professionals while completing required clinical experiences.
• Typical degree completion time for full-time students is 3 years and 4-6 years for part-time students.
• The common requirements for acceptance are 3 years of experience as an MLS, ASCP MLS board certification, current ASCP certification maintenance, and a minimum GPA requirement.
• The residency or clinical requirements vary by program. The DCLS residency is typically in person and can vary from weeks to a year, depending on the DCLS program.

DCLS professionals practice laboratory medicine within a defined scope of practice using a specific knowledge set. The DCLS is recognized by many professional institutions as a terminal degree in the profession.

In a clinical setting, DCLS professionals function as "front-line" members of the healthcare team alongside physicians, nurses, and pharmacists. Their practice includes:

• Clinical consultation: they provide patient-centered consultation to healthcare teams and patients regarding the appropriate selection and interpretation of laboratory tests.
• Interprofessional collaboration: Practitioners participate in clinical rounding and patient care conferences alongside members of the health care team, such as physicians, pharmacists, and nurses, to improve clinical diagnoses.
• Clinical rounding: they participate in patient care rounds and interprofessional collaboration to improve clinical diagnoses.
• Patient advocacy: they consult directly with patients to help them understand their lab results.
• Diagnostic efficiency: they develop patient-centered test algorithms and reflex testing protocols to streamline care.

Resources

The DCLS Scope of Practice was drafted by the American Society of Clinical Laboratory Scientists (ASCLS). This keystone document defines the professional role, responsibilities, and competencies of a DCLS graduate, emphasizing their integration into interprofessional patient care teams to improve diagnostic accuracy, efficiency, and patient outcomes.

The DCLS Position Paper was drafted by the American Society of Clinical Laboratory Scientists (ASCLS), which was the first to formally recognize the DCLS as the terminal advanced practice degree in the profession of medical laboratory sciences. This designation reflects more than a decade of collaborative work among professional organizations, accrediting bodies, and stakeholders to define the role, responsibilities, and educational requirements for the degree.

The DCLS Body of Knowledge was drafted by the American Society of Clinical Laboratory Scientists (ASCLS) to serve as a comprehensive framework outlining the competencies and skills necessary for professionals in the DCLS program, guiding education, certification, and practice standards.

Having a DCLS degree alone does not qualify an individual as a high complexity laboratory director (HCLD). Management experience, continuing education, and board certification approved by the Department of Health and Human Services (HHS) are required. States requiring lab licensure may have stricter requirements.

Under 42 CFR §493.1443(b)(3)(i), a laboratory director of high complexity testing must hold an earned doctoral degree in a chemical, physical, biological, or clinical laboratory science from an accredited institution and be certified by a board approved by the U.S. Department of Health and Human Services (HHS). The Centers for Medicare & Medicaid Services (CMS) lists the following boards as approved for HCLD (High Complexity Clinical Laboratory Director) certification.

Certifying organizations

• The American Board of Bioanalysis (ABB) is a certifying board that evaluates and certifies individuals in the clinical laboratory profession, ensuring they meet the necessary qualifications and standards. The ABB certifies clinical laboratory directors, consultants, and supervisor based on their education, experience, and knowledge in the laboratory field.
• The National Registry of Certified Chemists (NRCC) is an American certification agency that provides professional certifications for chemists in various fields, ensuring excellence in the chemistry profession.
• The American College of Histocompatibility and Immunogenetics (ACHI) is a certifying board that provides voluntary credentialing examinations for professionals in the field of histocompatibility and immunogenetics. It is sponsored by the American Society for Histocompatibility and Immunogenetics (ASHI) and approved as a certification board by the U.S. Department of Health and Human Services (DHHS).
• The ASCP Diplomate in Medical Laboratory Immunology (DMLI) is a doctoral-level certification offered by the American Society for Clinical Pathology Board of Certification (ASCP BOC) for professionals specializing in clinical immunology.

Lab licensure by state

These states require licensure for laboratory personnel. Check state requirements for laboratory directorship.

• California Laboratory Field Services 
• Florida Department of Health 
• Hawaii Department of Health 
• Louisiana State Board of Medical Examiners 
• Montana Board of Clinical Laboratory Science Practitioners 
• Nevada Division of Pubic and Behavioral Health Medical Laboratory Services 
• North Dakota Board of Clinical Laboratory Practice 
• New York State Office of the Professions 
• Tennessee State Licensure Board 
• West Virginia Office of Laboratory Science 

Explore primary source information for current laboratory regulations.

• The Guide to Lab Test Utilization is a resource geared toward medical professionals to recommend better tests and diagnostic practices. Use it for the latest recommendations in laboratory test ordering and interpretations. It is approved by the Academy of Diagnostics & Laboratory Medicine and ADLM’s Science and Practice Core Committee
• The Clinical Laboratory Improvement Amendments (CLIA) of 1988 establishes federal quality standards for all U.S. laboratories testing human specimens to ensure accurate and reliable results for diagnosis, prevention, or treatment of disease.
• The Federal Register: Clinical Laboratory Improvement Amendments of 1988 (CLIA) Fees; Histocompatibility, Personnel, and Alternative Sanctions for Certificate of Waiver Laboratories
• The CLIA lab lookup contains information about all U.S. laboratories. A search can be performed using the laboratory’s information such as a facility’s name, CLIA number, and medical director. A list of CLIA laboratories can be generated by demographic or geographic filters.
• The FDA test complexity database categorizes laboratory tests as waived, moderate, or high complexity based on CLIA criteria and is publicly accessible for reference.