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10.10.13.00.htm 10.10.13.00. Title 10 DEPARTMENT OF HEALTH AND MENTAL HYGIENE Subtitle 10 LABORATORIES Chapter 13 Medical Laboratories ― Testing for Hereditary and Congenital Disorders in Newborn Infants Authority: Health-General Article, §13-101―13-103, 13-108―13-112, 13-601―13-605, 17-201―17-206, 17-210, 17-211, 17-215, and 17-216, Annotated Code of Maryland
10.10.13.01.htm 10.10.13.01. 01 Purpose.. A. This chapter, together with COMAR 10.52.12, establishes a coordinated Statewide system for the screening of newborn infants in the State for certain hereditary and congenital disorders associated with severe problems of health or development.B. This chapter also protects the public health by ensuring that accurate and reliable newborn screening and diagnostic test results are provided to a newborn infant's health care providers by requiring a medical laboratory p
10.10.13.02.htm 10.10.13.02. 02 Scope.. This chapter:. A. Identifies standards and requirements for a medical laboratory performing screening tests, diagnostic tests, or both, for hereditary and congenital disorders on blood-spot specimens from newborn infants; andB. Addresses the following newborn screening and diagnostic tests:. 1) Screening tests, which are:. a) First-tier tests; and. b) Supplemental tests; and. 2) Diagnostic tests, which are:. a) Second-tier tests; and. b) Supplemental tests..
10.10.13.03.htm 10.10.13.03. 03 Definitions.. A. In this chapter, the following terms have the meanings indicated.. B. Terms Defined.. 1) "Abnormal test result" means a first-tier, supplemental, or second-tier test result that:. a) Falls outside the normal range for the analyte measured; and. b) Triggers a request for additional testing or is diagnostic for a disorder.. 2) Allele.. a) "Allele" means any one of a series of two or more different forms of a gene or DNA sequence that can exist at a single loc
10.10.13.04.htm 10.10.13.04. 04 Permit.. A. Eligibility.. 1) Except as set forth in a Departmental mutual aid agreement, the Department's public health laboratory is the sole laboratory that may hold a State permit to perform and that may perform a first-tier newborn screening test on a newborn infant.2) A medical laboratory other than the State's public health laboratory may obtain a permit to perform:a) A supplemental test;. b) A second-tier test; or. c) Supplemental and second-tier tests..
10.10.13.05.htm 10.10.13.05. 05 Inspection Requirements.. A. Inspection Authority. The Department may conduct on-site inspections of a permittee or applicant for a permit to perform supplemental or second-tier tests to screen for or diagnose congenital and hereditary disorders in newborn infants.B. Inspection Types. The Department may conduct the following types of inspections to assess compliance with the requirements of this subtitle and COMAR 10.52.12:1) An initial inspection before issuing a permit;.
10.10.13.06.htm 10.10.13.06. 06 Fees.. A. Permit Fees. A permittee or applicant for a permit that is not exempt under COMAR 10.10.04.01C, or that is not another state's public health laboratory approved to provide newborn screening tests under a Departmental mutual aid agreement, shall pay to the Department the applicable fees as required by COMAR 10.10.04 and this regulation.B. Screening and Follow-up Fee Requirement. A birthing center or person responsible for having newborn screening carried out
10.10.13.07.htm 10.10.13.07. 07 Director Requirement, Qualifications, and Responsibilities.. A. Director Requirement. A permittee that offers to perform or performs a first-tier, supplemental, or second-tier test shall employ a director.B. Director Qualifications. The director shall:. 1) Meet the qualifications for a medical laboratory director set forth at COMAR 10.10.07.04; and. 2) Possess a current license as a laboratory director issued by the state in which the laboratory is located if:
10.10.13.08.htm 10.10.13.08. 08 Technical Supervisor Requirement, Qualifications, and Responsibilities.. A. Technical Supervisor Requirement. A permittee that offers to perform or performs a first-tier, supplemental, or second-tier test shall employ a technical supervisor.B. Director as Technical Supervisor. The director may function as the technical supervisor if the director meets the technical supervisor qualifications specified in this regulation.C. Technical Supervisor Qualifications. The techni
10.10.13.09.htm 10.10.13.09. 09 Clinical Consultant Requirement, Qualifications, and Responsibilities.. A. Clinical Consultant Requirement. A permittee that offers to perform or performs first-tier, supplemental, or second-tier tests shall employ a clinical consultant.B. Director as Clinical Consultant. The director may function as the clinical consultant if the director meets the qualifications set forth under §C of this regulation.C. Clinical Consultant Qualifications. The clinical consultant shall be:.
10.10.13.10.htm 10.10.13.10. 10 General Supervisor Requirement, Qualifications, and Responsibilities.. A. General Supervisor Requirement. A permittee that offers to perform or performs first-tier, supplemental, or second-tier tests shall employ a general supervisor.B. General Supervisor Qualifications. The general supervisor shall:. 1) Meet the qualifications for a general supervisor set forth at COMAR 10.10.07.06B(1) and. 2) Have at least 6 months experience supervising the operation of applicabl
10.10.13.11.htm 10.10.13.11. 11 Testing Personnel Requirement and Qualifications.. A. Requirement. A permittee that offers to perform or performs first-tier, supplemental, or second-tier tests shall employ sufficient laboratory testing personnel to perform testing in accordance with the requirements of this chapter.B. Qualifications. Testing personnel shall meet the qualifications set forth at COMAR 10.10.07.07..
10.10.13.12.htm 10.10.13.12. 12 First-Tier, Supplemental, and Second-Tier Tests.. A. First-Tier Tests; Requirement. The Department’s public health laboratory shall perform first-tier tests on all screening blood-spot specimens collected from a newborn infant.B. First-Tier Tests; Testing Limitations.. 1) Only the Department's public health laboratory may screen for the disorders listed in §C of this regulation.2) A permittee may perform a supplemental or a second-tier test only when the test is requested by a
10.10.13.13.htm 10.10.13.13. 13 Screening Test Blood-Spot Specimens ― Collection and Test Requisition.. A. Blood-Spot Specimen Collection.. 1) A person shall collect a newborn infant’s blood-spot specimen for testing under this chapter by using only the special blood-spot specimen collection test requisition card provided by the Department.2) The Department shall provide the special blood-spot specimen collection test requisition card to the:
10.10.13.14.htm 10.10.13.14. 14 Screening Test Blood-Spot Specimens ― Procedures, Submission, and Delivery Requirements.. A. Standard Operating Procedure. The individual in charge of a birthing facility or the individual’s designated representative, or the home birth attendant shall maintain written standard operating procedures for the collection, handling, storage, and transport of newborn infant blood-spot specimen collection test requisition cards, including instructions for staff to:
10.10.13.15.htm 10.10.13.15. 15 Test Blood-Spot Specimens ― Use, Research, Storage, and Retention.. A. Use. A permittee may use a newborn infant blood-spot specimen from a newborn infant to test for only the conditions listed in Regulation .12C of this chapter.B. Research. A researcher may not use a Maryland newborn infant’s blood spot specimen or test results for research purposes unless the:1) Research is approved in writing by the Department's:. a) Newborn Screening Program; and.
10.10.13.16.htm 10.10.13.16. 16 Test Records ― Retention.. The Department’s public health laboratory shall retain and maintain electronically or as a hard copy for 25 years the:A. Top copy of the requisition portion of the blood-spot specimen collection test requisition card;. B. All test results and reports;. C. Electronic data bases; and. D. Supporting documents that show how a reported test result was obtained and verified, including but not limited to:1) Quality control records;.
10.10.13.17.htm 10.10.13.17. 17 Testing ― First-Tier.. A. The Department’s public health laboratory shall test, using first-tier tests, appropriately timed and collected blood-spot specimen of a newborn infant’s blood for the disorders listed in Regulation .12C of this chapter.B. Full-Term Healthy Newborn Infants.. 1) If a newborn infant is born at term and is healthy, the Department’s public health laboratory shall conduct a:a) First screening using first-tier tests to detect the disorders listed in
10.10.13.18.htm 10.10.13.18. 18 Testing ― Second-Tier and Supplemental.. A. When a test request is made by an individual authorized to request a laboratory test, as set out in COMAR 10.10.06.02:1) A permittee other than the Department's public health laboratory may perform a second-tier or supplemental test; and2) The Department's public health laboratory may perform a second-tier test.. B. A permittee:. 1) May not contract out, subcontract, or otherwise transfer supplemental or second-tier testing to a
10.10.13.19.htm 10.10.13.19. 19 Proficiency and Competency Testing for Newborn Screening Tests.. A permittee shall:. A. Meet all requirements set forth in COMAR 10.10.05;. B. Successfully participate in one or more approved proficiency testing programs that cover all first-tier, second-tier, and supplementary tests offered or performed;C. Evaluate and document performance, semiannually during the first year of testing and annually thereafter, of all individuals responsible for testinD. In addition to the pro
10.10.13.20.htm 10.10.13.20. 20 Quality Control.. A. Quality Control Program.. 1) A permittee shall develop, establish, implement, maintain and follow written quality control policies, procedures, and techniques that provide and ensure accurate, reliable, and valid test results and reports.2) A permittee's quality control program shall:. a) Cover all tests, methods, and procedures performed by the laboratory; and. b) Meet the standards and requirements set forth in this chapter and COMAR 10.10.06..
10.10.13.21.htm 10.10.13.21. 21 Quality Assessment and Quality Assurance.. A. A permittee shall:. 1) Establish and follow a written quality assessment plan that covers all phases of the testing process;2) Meet the applicable quality assurance requirements of COMAR 10.10.06; and. 3) Have an accessioning mechanism or system that:. a) Tracks blood-spot specimens and allows first and subsequent blood-spot specimens and test results from the same newborn infant to be linked for testing and analysis; and
10.10.13.22.htm 10.10.13.22. 22 Quality Assurance ― Continuity of Operations and Disaster Recovery Plan.. A permittee shall develop, implement, and maintain written continuity of operations and disaster recovery plans that ensure the continuous performance of essential functions and operations:A. During an emergency; or. B. When the laboratory temporarily can no longer meet the requirements and standards set forth in this chapter.
10.10.13.23.htm 10.10.13.23. 23 Reporting Test Results.. A. All Test Results. For a newborn infant, a permittee shall:. 1) Report all first-tier, supplemental, and second-tier results to:. a) The person who requested the test; and. b) An individual who will use the test results in identifying, tracking, caring for, and treating the newborn infant, including:i) A physician specialist; and. ii) Personnel in the Follow-Up Unit;. 2) Report to the persons listed in §A(1) of this regulation within 3 workin
10.10.13.24.htm 10.10.13.24. 24 Reporting Abnormal Test Results to the Follow-Up Unit.. A. Reporting Requirements. A permittee shall immediately report an abnormal or diagnostic test result to the Follow-Up Unit by:1) Telephoning and personally speaking to an individual in the Follow-Up Unit;. 2) Telephoning and personally speaking to a back-up individual representing the Follow-Up Unit, if an attempt to make in-person contact with an employee of the Follow-Up Unit fails; and3) Following up a telepho
10.10.13.25.htm 10.10.13.25. 25 Reporting System and Communication Software.. A permittee shall:. A. Have available and use a reliable and accurate electronic information system that is capable of collecting, compiling, transferring, and communicating all normal and abnormal test results to the Follow-Up Unit; andB. Provide the Follow-Up Unit, where applicable, with:. 1) The necessary information system and electronic communications software or interface to be used by the Follow-Up Unit to r
10.10.13.26.htm 10.10.13.26. 26 Availability of Statistical and Scientific Data.. A. Statistical Reports. The State’s public health laboratory, the Follow-Up Unit, or both, on request, shall provide Newborn Screening Program statistical data for official State and national reports to:1) The Council;. 2) The Department's Office of Genetics and Children with Special Healthcare Needs; and. 3) State and federal agencies that use test results and statistics for the care and treatment of newB. Research Investigation
10.10.13.27.htm 10.10.13.27. 27 Sanctions.. A. Due to the life-threatening nature and effect of errors in newborn screening testing, the Secretary may order summarily the suspension of a permit if the Secretary finds that the public health, safety, or welfare imperatively requires emergency action, including but not limited to, if a permittee has:1) Failed to report a newborn infant's abnormal test result as required in this chapter;.
10.10.13.9999.htm 10.10.13.9999. Administrative History Effective date:. Regulations .01―27 adopted as an emergency provision effective January 1, 2009 (36:2 Md. R. 97) adopted permanently effective March 23, 2009 (36:6 Md. R. 490)Regulation .02A amended effective April 24, 2017 (44:8 Md. R. 404). Regulation .03B amended effective April 24, 2017 (44:8 Md. R. 404). Regulation .04B amended effective April 24, 2017 (44:8 Md. R. 404). Regulation .06B amended as an emergency provision effective July 1, 2012 (3
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