Md. Code Regs. 10.06.06.02

Current through Register Vol. 51, No. 22, November 1, 2024

Section 10.06.06.02 - Definitions

A. In this chapter, the following terms have the meanings indicated.

B. Terms Defined.

(1) "Anatomical material" means human or animal body parts, including tissues and organs.

(2) "Autoclaving" means a process by which an article is subjected to steam under pressure for documented periods of time, temperature, and pressure that render the article incapable of transmitting disease to humans.

(3) "Blood" means human blood, human blood components, and products made from human blood.

(4) Bloodborne Pathogens.

(a) "Bloodborne pathogens" means pathogenic microorganisms that:

(i) Are present in human blood; and

(ii) Can cause disease in humans.

(b) "Bloodborne pathogens" includes, but is not limited to:

(i) Human immunodeficiency virus;

(ii) Hepatitis B virus; and

(iii) Hepatitis C virus.

(5) "Chemical disinfection" means the application of a chemical agent to an article, so that the article is rendered incapable of transmitting disease to humans.

(6) "Contaminated" means the presence or the reasonably anticipated presence of blood or other potentially infectious materials on an item or surface.

(7) "Cremation" means the incineration of human or animal remains.

(8) "Decontamination" means the use of physical or chemical means to remove, inactivate, or destroy bloodborne pathogens on an article to render the article incapable of transmitting disease to humans.

(9) "Department" means the Department of Health and Mental Hygiene.

(10) "Disinfection" means a method that inactivates:

(a) Vegetative bacteria, fungi, lipophilic/hydrophilic viruses, parasites, and mycobacteria at a 6 log reduction or greater; and

(b) Bacillus stearothermophilus spores and Bacillus subtilis spores at a 4 log reduction or greater.

(11) "Encapsulation" means a process by which:

(a) An article is sealed in a material that renders the article no longer recognizable or capable of transmitting disease to humans; and

(b) The sealed material:

(i) Is decontaminated or disinfected during the encapsulation process; and

(ii) Remains sealed under physical stress.

(12) "Incineration" means a process during which an article is burned:

(a) In an incinerator that meets the requirements of the Department of the Environment as set forth in COMAR 26.11.08;

(b) To carbonized or mineralized ash that is capable of disposal as solid waste; and

(c) So the article is rendered incapable of transmitting disease to humans.

(13) "Infectious agent" means an organism, including viral, rickettsial, bacterial, fungal, protozoal, or helminthic, that is capable of producing infection or infectious disease in humans.

(14) "Interment" means burial in a location, other than a landfill, that is approved for that purpose under applicable law.

(15) "Mechanical destruction" means a physical process that renders an article no longer recognizable as the original article.

(16) "Microbiological laboratory waste" means waste from a microbiological laboratory that:

(a) Contains an infectious agent; and

(b) Includes cultures and stocks of infectious agents and associated biologicals.

(17) "Occupational exposure" means skin, eye, mucous membrane, or parenteral contact with blood or other potentially infectious materials, that results from the performance of an employee's duties.

(18) "Other potentially infectious material" means:

(a) The following human body fluids:

(i) Amniotic fluid;

(ii) A body fluid that is visibly contaminated with blood;

(iii) A body fluid that cannot be readily identified;

(iv) Cerebrospinal fluid;

(v) Pericardial fluid;

(vi) Peritoneal fluid;

(vii) Pleural fluid;

(viii) Saliva only when dental procedures are performed;

(ix) Semen;

(x) Synovial fluid; and

(xi) Vaginal secretions;

(b) A tissue or organ from a living or dead human, not including intact skin, that has not been preserved by a chemical additive or preservative;

(c) The following human immunodeficiency virus, hepatitis B virus, or hepatitis C virus related items:

(i) HIV containing cell, tissue, or organ cultures;

(ii) HIV, Hepatitis B, or Hepatitis C containing media or other solutions; and

(iii) Blood, organs, or other tissues; and

(d) Microbiological laboratory waste.

(19) "Person" means an individual, receiver, trustee, guardian, personal representative, fiduciary, or representative of any kind and any partnership, firm, association, corporation, or other entity.

(20) "Sanitary sewer" means:

(a) A liquid waste piping network leading to a sewerage system permitted under Environment Article, §9-204, Annotated Code of Maryland; or

(b) An on-site sewerage system permitted under Environment Article, §9-204, Annotated Code of Maryland.

(21) "Sharps" means an object contaminated by blood or other potentially infectious material that can cut or penetrate the skin, including but not limited to:

(a) A broken capillary tube;

(b) Broken glass;

(c) An exposed end of dental wire;

(d) A needle;

(e) A surgical instrument; and

(f) A syringe with an attached sharp.

(22) "Special medical waste" means:

(a) Liquid or semiliquid blood or another potentially infectious material;

(b) A contaminated article that releases liquid or semiliquid blood or another potentially infectious material if compressed;

(c) An article that contains dried blood or another potentially infectious material and is capable of releasing the blood or material during handling;

(d) Pathological and microbiological waste containing blood or another potentially infectious material;

(e) Contaminated sharps; and

(f) Anatomical material.

Md. Code Regs. 10.06.06.02

Regulations .02 adopted as an emergency provision effective September 30, 1988 (15:22 Md. R. 2547); emergency status expired March 29, 1989; adopted permanently effective May 1, 1989 (16:8 Md. R. 909)
Regulation .02B amended effective December 20, 1993 (20:25 Md. R. 1947)
Regulations .02 adopted effective September 1, 2004 (31:16 Md. R. 1254)
Regulation .02B amended effective November 6, 2006 (33:22 Md. R. 1732)