Compliance with Standards

Compliance with Standards 1. Any laboratory which offers this testing must meet the standards outlined in this section and, if requested, provide the agency with a written statement that they will comply with these standards. All specimens must be tested in an approved laboratory located in the United States. 2. The results of hemoglobinopathies, galactosemia, and congenital adrenal hyperplasia screening are not always clear cut and this type of screening requires extensive input from a recognized reference laboratory. Screening by tandem mass spectrometry requires extensive expertise and experience in this testing methodology. 3. A single control laboratory is required for screening. The laboratory should be proficient in all required testing methodologies.