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Md. Code Regs. 10.10.13 – Medical Laboratories — Testing for Hereditary and Congenital Disorders in Newborn Infants | Midpage
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Code of Maryland Regulations
Title 10
§ 10
Chapter 13
Md. Code Regs. 10.10.13
Medical Laboratories — Testing for Hereditary and Congenital Disorders in Newborn Infants
Effective May 25, 2026
.01
Purpose.
.02
Scope.
.03
Definitions.
.04
Permit.
.05
Inspection Requirements.
.06
Fees.
.07
Director Requirement, Qualifications, and Responsibilities.
.08
Technical Supervisor Requirement, Qualifications, and Responsibilities.
.09
Clinical Consultant Requirement, Qualifications, and Responsibilities.
.10
General Supervisor Requirement, Qualifications, and Responsibilities.
.11
Testing Personnel Requirement and Qualifications.
.12
First-Tier, Supplemental, and Second-Tier Tests.
.13
Screening Test Blood-Spot Specimens — Collection and Test Requisition.
.14
Screening Test Blood-Spot Specimens — Procedures, Submission, and Delivery Requirements.
.15
Test Blood-Spot Specimens — Use, Research, Storage, and Retention.
.16
Test Records — Retention.
.17
Testing — First-Tier.
.18
Testing — Second-Tier and Supplemental.
.19
Proficiency and Competency Testing for Newborn Screening Tests.
.20
Quality Control.
.21
Quality Assessment and Quality Assurance.
.22
Quality Assurance — Continuity of Operations and Disaster Recovery Plan.
.23
Reporting Test Results.
.24
Reporting Abnormal Test Results to the Follow-Up Unit.
.25
Reporting System and Communication Software.
.26
Availability of Statistical and Scientific Data.
.27
Sanctions.