1. Summary of Session I Bill Becker, DO MPH Ohio Department of Health Tandem Mass Spectrometry in Newborn Screening

2. Getting Started Planning – space, equipment, training Planning – space, equipment, training Importance of a clinical perspective Importance of a clinical perspective State’s Advisory Committee/Council State’s Advisory Committee/Council Educational materials Educational materials Parents & providers Parents & providers Good Communication Good Communication

3. Instrument Performance Training, Training, & More Training Training, Training, & More Training Understand instrument performance Understand instrument performance “soup to nuts” “soup to nuts” Optimize variables Optimize variables Understand the things that impact “run time” Understand the things that impact “run time” Internal Standards Internal Standards

4. Method Validation Linearity Linearity Precision – inter and intra-assay Precision – inter and intra-assay Accuracy/Precision Accuracy/Precision Target CV’s suggested Target CV’s suggested

5. Other Considerations Interferences & Sources of Contamination Interferences & Sources of Contamination Establishing Analyte Cutoffs Establishing Analyte Cutoffs Quality Control & Quality Assurance Plans Quality Control & Quality Assurance Plans Document, Document, Document Document, Document, Document

6. Routine Operations Maintenance Maintenance Tuning Solution Tuning Solution Reagent & I.S. Preparation Reagent & I.S. Preparation Preparation of Samples & Controls Preparation of Samples & Controls Analysis & Data Handling Analysis & Data Handling

7. Summary Plan Ahead Plan Ahead Train & Educate Train & Educate Rigorous Method Validation Rigorous Method Validation Establish a Quality Assurance Plan Establish a Quality Assurance Plan Communicate Well with Community Communicate Well with Community

8. Tandem Mass Spectrometry in Newborn Screening - Resources CDC NBS QA Program CDC NBS QA Program Association of Public Health Laboratories Association of Public Health Laboratories National Newborn Screening & Genetics Resource Center National Newborn Screening & Genetics Resource Center Training – Laboratory & Follow up Training – Laboratory & Follow up Listserv’s – general NBS, also MS Users Group Listserv’s – general NBS, also MS Users Group Dr Brad Therrell, 512-454-6419, therrell@uthscsa.edu Dr Brad Therrell, 512-454-6419, therrell@uthscsa.edu

9. Questions?