Chapter 10.10.13 - Medical Laboratories - Testing for Hereditary and Congenital Disorders in Newborn Infants
- Section 10.10.13.01 - Purpose
- Section 10.10.13.02 - Scope
- Section 10.10.13.03 - Definitions
- Section 10.10.13.04 - Permit
- Section 10.10.13.05 - Inspection Requirements
- Section 10.10.13.06 - Fees
- Section 10.10.13.07 - Director Requirement, Qualifications, and Responsibilities
- Section 10.10.13.08 - Technical Supervisor Requirement, Qualifications, and Responsibilities
- Section 10.10.13.09 - Clinical Consultant Requirement, Qualifications, and Responsibilities
- Section 10.10.13.10 - General Supervisor Requirement, Qualifications, and Responsibilities
- Section 10.10.13.11 - Testing Personnel Requirement and Qualifications
- Section 10.10.13.12 - First-Tier, Supplemental, and Second-Tier Tests
- Section 10.10.13.13 - Screening Test Blood-Spot Specimens - Collection and Test Requisition
- Section 10.10.13.14 - Screening Test Blood-Spot Specimens - Procedures, Submission, and Delivery Requirements
- Section 10.10.13.15 - Test Blood-Spot Specimens - Use, Research, Storage, and Retention
- Section 10.10.13.16 - Test Records - Retention
- Section 10.10.13.17 - Testing - First-Tier
- Section 10.10.13.18 - Testing - Second-Tier and Supplemental
- Section 10.10.13.19 - Proficiency and Competency Testing for Newborn Screening Tests
- Section 10.10.13.20 - Quality Control
- Section 10.10.13.21 - Quality Assessment and Quality Assurance
- Section 10.10.13.22 - Quality Assurance - Continuity of Operations and Disaster Recovery Plan
- Section 10.10.13.23 - Reporting Test Results
- Section 10.10.13.24 - Reporting Abnormal Test Results to the Follow-Up Unit
- Section 10.10.13.25 - Reporting System and Communication Software
- Section 10.10.13.26 - Availability of Statistical and Scientific Data
- Section 10.10.13.27 - Sanctions