Skip to Main Content
<< Back | Return to Main COMAR Search Page

14 records match your request.

FileAbstract
10.50.01.00.htm 10.50.01.00. Title 10 DEPARTMENT OF HEALTH AND MENTAL HYGIENE Subtitle 50 TISSUE BANKS Chapter 01 Tissue Banks. Authority: Health-General Article, Annotated Code of Maryland. Regulations. Sections. 01. 17-302. 02. 03. 17-301, 17-302. 04. 05. 17-302, 17-304, 17-307. 06. 17-305, 17-310, 17-313. 07. 08. 09. 17-302, 17-303. 11. 12.
10.50.01.01.htm 10.50.01.01. 01 Purpose.. The intent of this chapter is to protect the public and individual health by requiring that all tissue banks operating or providing services in Maryland operate under qualified supervision, reliable procedures, and appropriate quality assurance.
10.50.01.02.htm 10.50.01.02. 02 Scope.. This chapter does not apply to a tissue bank operated:. A. By the federal government; or. B. Solely for research and teaching purposes, if human tissue and tissue products from the research or teaching are not transplanted, transfused, or used within or upon a human.
10.50.01.03.htm 10.50.01.03. 03 Definitions.. A. In this chapter, the following terms have the meanings indicated.. B. Terms Defined.. 1) "Adverse outcome" means an undesirable effect or untoward complication in a recipient as a result of or reasonably related to a transfusion or transplantation of cells, tissue, or both.2) "Allogeneic tissue" means tissue from a human donor intended for use within or upon the body of an individual other than the donor.3) "Allograft" means cells, tissue, or both intend
10.50.01.04.htm 10.50.01.04. 04 Incorporation by Reference.. A. In this chapter, the following documents are incorporated by reference.. B. Documents Incorporated.. 1) Standards for Tissue Banking (American Association of Tissue Banks, 13th Edition) Sections C, D, E, F, G, H, J, K, L, and M1-8 only;2) Standards for Blood Banks and Transfusion Services (American Association of Blood Banks, 29th Edition)3) 42 U.S.C. §1320d et seq. as amended;. 4) 42 U.S.C. §17921 et seq. as amended; and.
10.50.01.05.htm 10.50.01.05. 05 Responsibilities of the OHCQ.. The OHCQ, acting as the Secretary's designee, shall:. A. Inspect or have an inspection conducted for each tissue bank:. 1) When an initial Maryland permit to operate is sought; and. 2) Annually after a Maryland permit has been issued;. B. Issue a permit to an applicant who meets the requirements of this chapter to:. 1) Operate a tissue bank in this State; or. 2) Represent or service in this State a tissue bank that is:. a) In this State; or.
10.50.01.06.htm 10.50.01.06. 06 Permits.. A. General.. 1) Permit Requirement. A person shall hold a permit issued by the Secretary before the person may:. a) Operate a tissue bank in this State; or. b) Represent or service in this State a tissue bank that is:. i) In this State; or. ii) Outside this State.. 2) Operating Without a Permit.. a) Unless a person has a permit issued by the Secretary to operate, represent, or service a tissue bank in this State, a persi) Operate a tissue bank in this State; or.
10.50.01.07.htm 10.50.01.07. 07 Accredited Tissue Bank and Accrediting Organization.. A. Accredited Tissue Bank ― Determination. The Secretary may accept as compliance with the inspection requirements of this chapter a tissue bank accredited by an organization approved by the Secretary, as set forth in §C of this regulation, if the OHCQ determines that the standards of the tissue bank accrediting organization are equivalent to those under this chapter.B. Accredited Tissue Bank ― Requirements. In addit
10.50.01.08.htm 10.50.01.08. 08 Tissue Bank Standards ― General.. A. Applicable Laws. A tissue bank shall comply with all requirements and standards in this chapter as well as with other applicable federal, State, and local laws, regulations, and rules.B. Governing Body. Unless provided by the institution of which it is a part, a tissue bank shall have a governing body consisting of individuals from various professions, that determines the scope of activities to be pursued by the tissue bank and is
10.50.01.09.htm 10.50.01.09. 09 Tissue Bank Standards ― Inspection.. A. General.. 1) A permittee shall allow an on-site inspection by the OHCQ, at any time during the tissue bank's regular hours of operation, to evaluate the tissue bank's compliance with the applicable requirements, conditions, and standards of this chapter.2) An inspection may include, but is not limited to, observation and examination of:. a) Tissue bank facilities and physical security;. b) Equipment;.
10.50.01.10.htm 10.50.01.10. 10 Tissue Bank Standards ― Personnel.. A. General Requirements. A tissue bank shall employ a technical director, medical director, and sufficient staff to:1) Provide accurate and reliable services;. 2) Meet all operational needs; and. 3) Meet all statutory and regulatory requirements and standards.. B. Medical Director.. 1) Qualifications. The medical director:. a) Shall be a physician licensed to practice medicine by the:. i) Maryland Board of Physicians; or.
10.50.01.11.htm 10.50.01.11. 11 Tissue Bank Standards ― Testing to Minimize Disease Transmission.. A. Required Testing.. 1) General ― All Donors. A permittee shall ensure that a prospective donor of tissue, including both leukocyte-rich and leukocyte-poor cell and tissue, intended to be used as an allograft is tested for biochemical, immunological, or serological evidence of:a) Hepatitis B virus (HBV). b) Hepatitis C virus (HCV). c) Human immunodeficiency virus type 1 (HIV-1).
10.50.01.12.htm 10.50.01.12. 12 Tissue Bank Standards ― Technical.. In addition to the requirements and standards in this chapter, a tissue bank shall meet and comply, where applicable, with the following technical requirements and standards:A. Records management, in the manner prescribed in Section C of Standards for Tissue Banking;. B. Tissue acquisition, in the manner prescribed in Section D of Standards for Tissue Banking;. C. Processing, preservation, quarantine, and storage, in the manner prescri
10.50.01.9999.htm 10.50.01.9999. Administrative History Effective date: July 1, 1970. Regulations .01―12 repealed and new Regulations .01―06 adopted effective May 5, 1986 (13:9 Md. R. 1030)Regulation .03 amended effective March 20, 1989 (16:5 Md. R. 629). Regulation .06B amended effective June 11, 1990 (17:11 Md. R. 1343). Regulation .06D amended effective March 20, 1989 (16:5 Md. R. 629) amended and recodified to Regulation .07 effective June 11, 1990 (17:11 Md. R. 1343)Regulation .06E adopted e
<< Back | Return to Main COMAR Search Page