fbpx
Select Page

Industry Insights

CMS Approves New Certification for High-Complexity Lab Directors

By: Patty Hess, Account Manager, Lighthouse Lab Director Services

On July 24, 2023, CMS sent out a memorandum to all State Survey Agency Directors with the approval of a new board certification for high-complexity laboratory directors. (See the full CMS memo here.)

The new board certification is the American Society of Clinical Pathology (ASCP) Board of Certification (BOC) Diplomate in Medical Laboratory Immunology (DMLI). ASCP is already well known for its certification of medical laboratory professionals. They have over 600,000 individuals credentialed to date.

ASCP BOC DMLI will take the place of the Medical Laboratory Immunology (ABMLI) Certification that was discontinued; although the ABMLI board continues to recertify its Diplomates, it discontinued certifying new individuals in 2016. State Agencies will accept the ASCP BOC DMLI board certification from individuals who recently passed the exam on or after April 1, 2023.

 

How do you get your ASCP BOC DMLI?

There is an online application, submission of documents, and an application fee. The ASCP Procedure guide can be found here.

  1. Application process:
    • Verify they meet all requirements, education, and training. There are 3 routes (listed below), and applicants must meet the minimum requirements to be eligible to take the examination. Applicants can utilize the eligibility assistant here to determine which category and route fits the best.
    • Create an ASCP account login.
      • The applicant’s first and last name in your ASCP account must match a valid form of ID.
      • Select the category and route of the application.
      • Verify contact information.
  1. Submission of Documents to include:
    • Verification of experience or training to include:
      • Download specific training documentation forms corresponding to the applicant’s category and route that the applicant’s immediate supervisor or laboratory management will complete and sign.
      • Must obtain a Letter of Authenticity that must be printed on institutional letterhead.
      • All training and experience documentation must be submitted with a Letter of Authenticity. Documents must be in PDF format. The same person must complete and sign in original handwritten signatures.
    • Verification of academic education.
      • Official transcripts from high school or university, and/or university degree must be requested and sent to ASCP BOC. Please note: Transcripts must not be submitted until after paying the application fee.
  1. Application fee:
    • Must be submitted online and received within 90 days from the start of the application.
    • Fees are non-refundable.
      • Route 1 initial application fee $450
      • Route 2 initial application fee $575
      • Route 3 initial application fee of $575
      • Examination fee $500

After the applicant has completed and submitted the above information, they should monitor their application status and correct any deficiencies with their application. Once the applicant receives an Eligible Admission notification, it will contain instructions on scheduling an appointment to take the exam within the eligibility period.

 

Eligibility Routes for Diplomate in Medical Laboratory Immunology, DMLI(ASCP)

 

  • Route 1
    • Doctorate in immunology, biology, chemistry, immunohematology, microbiology, or equivalent from accredited colleges and universities OR
    • DrPH, MD, or DO if special training and experience is approved by the DMLI Exam Committee OR
    • Foreign degrees must be equivalent to a U.S. degree which will be determined by an acceptable transcript evaluation AND
    • Successful completion of a CPEP approved program in medical laboratory immunology.

 

  • Route 2
    • Doctorate in immunology, biology, chemistry, immunohematology, microbiology, or equivalent from accredited colleges and universities OR
    • DrPH, MD, or DO if special training and experience is approved by the DMLI Exam Committee OR
    • Foreign degrees must be equivalent to a U.S. degree which will be determined by an acceptable transcript evaluation AND
    • Three years of full-time acceptable post-doctoral training, research experience, and/or supervisory experience relevant to medical laboratory immunology in an acceptable clinical laboratory within the last six years. All experience must be completed post-doctorate.
      • Acceptable Clinical Laboratory:
        • CMS CLIA certificate of registration, compliance, accreditation
        • DOD CLIP certificate of registration, compliance, accreditation
        • JCI accreditation
        • Accreditation under ISO 15189, CAP, ASHI
        • Other laboratory accreditation approved by the DMLI Examination Committee

 

  • Route 3
    • Doctorate in immunology, biology, chemistry, immunohematology, microbiology, or equivalent from accredited colleges and universities OR
    • DrPH, MD, or DO if special training and experience is approved by the DMLI Exam Committee OR
    • Foreign degrees must be equivalent to a U.S. degree which will be determined by an acceptable transcript evaluation AND
    • Two years of full-time acceptable pre-doctoral supervisory experience relevant to medical laboratory immunology in an acceptable clinical laboratory AND
    • Two years of full-time acceptable post-doctoral training, research experience, and/or supervisory experience relevant to medical laboratory immunology in an acceptable clinical laboratory within the last five years.
      • Acceptable Clinical Laboratory:
        • CMS CLIA certificate of registration, compliance, accreditation
        • DOD CLIP certificate of registration, compliance, accreditation
        • JCI accreditation
        • Accreditation under ISO 15189, CAP, ASHI
        • Other laboratory accreditation approved by the DMLI Examination Committee

 

  • Laboratory Experience to fulfill the experience requirement in Route 2 and 3:
          • Immunologic Techniques- must have experience in 3 of the 5 areas:
            • Cell function assays
            • Electrophoresis techniques
            • Flow cytometry
            • Immunoassays
            • Molecular techniques
          • Immunodiagnosis and Clinical Correlations- must have experience in 5 of the 7 areas:
            • Allergic diseases
            • Autoimmune diseases
            • Histocompatibility/immunogenetic and transplant immunology
            • Immunodeficiency disorders (primary and secondary)
            • Infectious disease
            • Inflammation
            • Tumor immunology/hematologic disorders
          • Clinical Laboratory Management and Operations- must have experience in all areas.
            • Laboratory administration
            • Quality control and quality assurance
            • Test development, validation, and implementation

 

Looking ahead

If you need assistance understanding this new certification, or are seeking to hire a full- or part-time lab director to oversee your laboratory, don’t hesitate to reach out directly to our Lab Director Services Team for a free consultation.

 

Sharing is caring!