Sec. 10.10.13.09. Clinical Consultant Requirement, Qualifications, and Responsibilities

A. Clinical Consultant Requirement. A permittee that offers to perform or performs first-tier, supplemental, or second-tier tests shall employ a clinical consultant.

B. Director as Clinical Consultant. The director may function as the clinical consultant if the director meets the qualifications set forth under §C of this regulation.

C. Clinical Consultant Qualifications. The clinical consultant shall be:

(1) A doctor of medicine or a doctor of osteopathy licensed to practice medicine or osteopathy; and

(2) Board certified by the American Board of Medical Genetics as a:

(a) Clinical geneticist;

(b) Medical geneticist; or

(c) Biochemical geneticist.

D. Clinical Consultant Responsibilities. A clinical consultant shall provide clinical consultation related to:

(1) Inquiries concerning specific newborn screening tests;

(2) Interpretation of specific test results;

(3) Possible diagnostic or supplemental testing; and

(4) Assistance in ensuring that appropriate tests are ordered to meet clinical expectations.