(1) Condition: The laboratory must have facilities, space and environmental conditions necessary for conducting the services offered, must provide a reasonably safe, working environment, and must properly dispose of infectious and hazardous wastes.
(a) Standard: Facilities. The laboratory must be constructed, arranged, and maintained to ensure the space, ventilation, utilities necessary for conducting all phases of testing, including the testing process, as appropriate.
(b) Standard: Safety. Safety precautions must be established, posted, and observed to ensure protection from physical hazards and biohazards materials. Adequate fire precautions shall be observed; volatile chemicals and flammable reagents must be properly stored.
(c) Infectious and Hazardous Waste Disposal. Each facility must develop, maintain, and implement written policies and procedures for the definition and handling of its infectious and hazardous wastes which must comply with the requirements of the Occupational Safety and Health Act, 29 U.S.C.A. §§ 651, et seq.
(d) The following waste shall be considered to be infectious waste:
1. Waste contaminated by patients who are isolated due to communicable disease, as provided in the U.S. Centers for Disease Control "Guidelines for Isolation Precautions in Hospitals";
2. Cultures and stocks of infectious agents including specimen cultures collected from medical and pathological laboratories, cultures and stocks of infectious agents form research and industrial laboratories, wastes from the production of biologicals, discarded live and attenuated vaccines, and culture dishes and devices used to transfer, inoculate, and mix cultures;
3. Waste human blood and blood products such as serum, plasma, and other blood components;
4. Pathological waste, such as tissues, organs, body parts, and body fluids that are removed during surgery and autopsy;
5. All discarded sharps (e.g., hypodermic needles, syringes, pasture pipettes, broken glass, scalpel blades) used in patient care or which have come into contact with infectious agents during use in medical, research, or industrial laboratories;
6. Contaminated carcasses, body parts, and bedding of animals that were exposed to pathogens in research, in the production of biologicals, or in the in vivo testing of pharmaceuticals;
7. Other waste determined to be infectious by the facility in its written policy.
(2) Infectious and hazardous waste must be segregated from other waste at the point of generation (i.e., the point at which the material becomes a waste) within the facility.
(3) Waste must be packaged in a manner that will protect waste handlers and the public from possible injury and disease that may result from exposure to the waste. Such packaging must provide for containment of the waste from the point of generation up to the point of proper treatment or disposal. Packaging must be selected and utilized for the type of waste the packaging will contain, how the waste will be treated and disposed, and how it will be handled and transported, prior to treatment and disposal.
(a) Contaminated sharps must be directly placed in leakproof, rigid, and puncture-resistant containers which must then be tightly sealed.
(b) Whether disposable or reusable, all containers, bags, and boxes used for containment and disposal of infectious waste must be conspicuously identified. Packages containing infectious waste which pose additional hazards (e.g., chemical, radiological) must also be conspicuously identified to clearly indicate those additional hazards.
(c) Reusable containers for infectious waste must be thoroughly sanitized each time they are emptied, unless the surfaces of the containers have been completely protected from contamination by disposable liners or other devices removed with the waste.
(d) Opaque packaging must be used for pathological waste.
(4) After packaging, waste must be handled and transported by methods ensuring containment and preservation of the integrity of the packaging, including the use of secondary containment where necessary. Plastic bags of infections waste must be transported by hand.
(5) After packaging, waste must be handled and transported by methods ensuring containment and preserving the integrity of the packaging, including the use of secondary containment where necessary.
(a) Waste must not be compacted or ground (i.e., in a mechanical grinder) prior to treatment, except that pathological waste may be ground prior to disposal.
(b) Plastic bags of infectious waste must be transported by hand.


Tenn. Comp. R. & Regs. 1200-06-03-.11
Original rule filed October 26, 1979; effective December 10, 1979. Repeal filed May 3, 1995; effective July 17,1995. New rule filed January 7, 1997; effective March 23, 1997. Amendment filed March 22, 2001; effective June 5, 2001. Repeal and new rule filed June 18, 2002; effective September 1, 2002.

Authority: T.C.A. §§ 4-5-202, 4-5-204, and 68-29-105.

State regulations are updated quarterly; we currently have two versions available. Below is a comparison between our most recent version and the prior quarterly release. More comparison features will be added as we have more versions to compare.

No prior version found.