Section 410IAC3-3-4. Designated laboratories; requirements to perform screening tests for disorders

   An approved laboratory must meet the following requirements in order to perform screening tests for disorders on dried blood samples from newborns or infants:

(1) Complies with Public Law 90-174, the Federal Clinical Laboratory Improvement Act of 1988, and is accredited by the College of American Pathologists, or is accredited by the Joint Commission on Accreditation of Hospitals.

(2) Performs or makes reasonable assurances that it will perform each one of the above screening tests on all newborns or infants born in the state of Indiana.

(3) Performs repeat newborn screening on blood specimens annually as a follow-up to abnormal screens or screens that are not legally valid as described above.

(4) Uses laboratory procedures and values for normal and abnormal test results that have been submitted to and approved by the department.

(5) Initiates the approved tests within twenty-four (24) hours of receipt of the specimen and completes all approved tests within seventy-two (72) hours of receipt of the specimen.

(6) Reports findings in a timely manner and maintains records of the results of all screening and follow-up testing in accordance with the requirements of the department.

(7) Provides reports of its screening activities to the department in the format and time frame specified by the department.

(8) Maintains a written quality assurance program covering all aspects of its newborn screening activity, which is approved yearly by the department.

(9) Cooperates with other relevant agencies concerned with newborn or infant health care.

(10) Participates in a laboratory quality assurance program, including proficiency testing, approved by the department.

(Indiana State Department of Health; 410 IAC 3-3-4; filed Nov 7, 1986, 3:30 p.m.: 10 IR 417; filed Feb 25, 1988, 4:30 p.m.: 11 IR 2579; readopted filed Jul 11, 2001, 2:23 p.m.: 24 IR 4234; readopted filed May 22, 2007, 1:44 p.m.: 20070613-IR-410070141RFA; filed Apr 25, 2012, 3:46 p.m.: 20120523-IR-410100504FRA)