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To prevent a delay in processing your application please check to make sure all of
the following are included:
Completed application with each section completely filled out
Signature of Laboratory Director must match the name in section II of application
If the status of your CLIA certificate is changing, a completed CMS 116 form must be submitted
Director Qualifications
Copy of CV, Diploma (highest degree), ECFMG (if applicable), board certification for MD or PhD
(if applicable)
Technical Supervisor Qualifications (for the discipline of HISTOLOGY)
Copy of American Pathology Board certification in Anatomical Pathology
Copy of Maryland (Board of Physicians) license to practice medicine
Genetics Testing
Copy of Technical Supervisor’s diploma (must be MD, DO or PhD), board certification from the
American Board of Medical Genetics or 4 years of verified (not self-generated) experience in
clinical genetics and CV
Copy of Test Menu
Copy of a Validation Study of one test (includes a summary and raw data)
Letter from Director documenting that the lab does not perform “Direct to Consumer” testing
Certificate of Accreditation Laboratories
Copy of enrollment verification from the designated accrediting organization
Applicants Located in Maryland Applicants Located Out of State
Completed CLIA application in agreement with State
application
Copy of CLIA certificate and State Laboratory License, if
applicable
Copy of Director’s Maryland (Board of Physicians)
license to practice medicine
Copy of most recent survey, which includes cited deficiencies and
corrective actions
For High Complexity Laboratories: Documentation of training,
education and previous experience that meets CLIA Sec.
493.1443: Standard: Laboratory Director Qualifications
Copy of Director’s State license to practice medicine from the
State where the laboratory is located
For Moderate Complexity Laboratories:
Board Certification or Documentation of 20 CME from
approved programs for Medical Director that meets CLIA
Sec. 493.1405
Documentation of training, education and previous experience
that meets CLIA Sec. 493.1443: Standard: Laboratory Director
Qualifications
Documentation of licensure as a practitioner seeking a Letter
of Exception (midwife, nurse practitioner, etc.
Proof of most recent participation in annual GYN cytology
proficiency testing