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Code of Maryland Regulations

Chapter 13

Md. Code Regs. 10.10.13

Medical Laboratories — Testing for Hereditary and Congenital Disorders in Newborn Infants

Effective May 25, 2026

.01Purpose..02Scope..03Definitions..04Permit..05Inspection Requirements..06Fees..07Director Requirement, Qualifications, and Responsibilities..08Technical Supervisor Requirement, Qualifications, and Responsibilities..09Clinical Consultant Requirement, Qualifications, and Responsibilities..10General Supervisor Requirement, Qualifications, and Responsibilities..11Testing Personnel Requirement and Qualifications..12First-Tier, Supplemental, and Second-Tier Tests..13Screening Test Blood-Spot Specimens — Collection and Test Requisition..14Screening Test Blood-Spot Specimens — Procedures, Submission, and Delivery Requirements..15Test Blood-Spot Specimens — Use, Research, Storage, and Retention..16Test Records — Retention..17Testing — First-Tier..18Testing — Second-Tier and Supplemental..19Proficiency and Competency Testing for Newborn Screening Tests..20Quality Control..21Quality Assessment and Quality Assurance..22Quality Assurance — Continuity of Operations and Disaster Recovery Plan..23Reporting Test Results..24Reporting Abnormal Test Results to the Follow-Up Unit..25Reporting System and Communication Software..26Availability of Statistical and Scientific Data..27Sanctions.