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Code of Maryland Regulations (Last Updated: April 6, 2021) |
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Title 10. Maryland Department of Health |
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Part 3. |
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Subtitle 10. LABORATORIES |
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Chapter 10.10.13. Medical Laboratories—Testing for Hereditary and Congenital Disorders in Newborn Infants |
Chapter 10.10.13. Medical Laboratories—Testing for Hereditary and Congenital Disorders in Newborn Infants
| Sec. 10.10.13.00. Notations |
| Sec. 10.10.13.01. Purpose |
| Sec. 10.10.13.02. Scope |
| Sec. 10.10.13.03. Definitions |
| Sec. 10.10.13.04. Permit |
| Sec. 10.10.13.05. Inspection Requirements |
| Sec. 10.10.13.06. Fees |
| Sec. 10.10.13.07. Director Requirement, Qualifications, and Responsibilities |
| Sec. 10.10.13.08. Technical Supervisor Requirement, Qualifications, and Responsibilities |
| Sec. 10.10.13.09. Clinical Consultant Requirement, Qualifications, and Responsibilities |
| Sec. 10.10.13.10. General Supervisor Requirement, Qualifications, and Responsibilities |
| Sec. 10.10.13.11. Testing Personnel Requirement and Qualifications |
| Sec. 10.10.13.12. First-Tier, Supplemental, and Second-Tier Tests |
| Sec. 10.10.13.13. Screening Test Blood-Spot Specimens — Collection and Test Requisition |
| Sec. 10.10.13.14. Screening Test Blood-Spot Specimens — Procedures, Submission, and Delivery Requirements |
| Sec. 10.10.13.15. Test Blood-Spot Specimens — Use, Research, Storage, and Retention |
| Sec. 10.10.13.16. Test Records — Retention |
| Sec. 10.10.13.17. Testing — First-Tier |
| Sec. 10.10.13.18. Testing — Second-Tier and Supplemental |
| Sec. 10.10.13.19. Proficiency and Competency Testing for Newborn Screening Tests |
| Sec. 10.10.13.20. Quality Control |
| Sec. 10.10.13.21. Quality Assessment and Quality Assurance |
| Sec. 10.10.13.22. Quality Assurance — Continuity of Operations and Disaster Recovery Plan |
| Sec. 10.10.13.23. Reporting Test Results |
| Sec. 10.10.13.24. Reporting Abnormal Test Results to the Follow-Up Unit |
| Sec. 10.10.13.25. Reporting System and Communication Software |
| Sec. 10.10.13.26. Availability of Statistical and Scientific Data |
| Sec. 10.10.13.27. Sanctions |
| Sec. 10.10.13.9999. Administrative History |