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Medical Waste Regulations Tennessee

Medical Waste in the State of Tennessee

Medical Waste Regulations Tennessee

The State of Tennessee has very specific guidelines for both non-hazardous and hazardous medical waste handling and disposal and falls under their established rules for hazardous waste. Hazardous waste is considered to be any item or material that has come into contact with potentially infectious or toxic agents that could cause harm to humans, the community or the environment.

Tennessee requires that all organizations or businesses involved with medical waste must in addition to state and local laws, must also comply with federal guidelines set by the Department of Transportation (DOT) and EPA (Environmental Protection Agency).

Tennessee defines hazardous medical waste as:

“Hazardous Medical Wastes are those medical wastes which contain chemicals (such as Nicotine, Epinephrine, Nitroglycerine, Warfarin, chemotheraphy drugs, etc) that the EPA has determined must be managed under the strict criteria established by federal regulations.”

Under the rules and regulations of the state of Tennessee 0400-11-01-.01 the state specifies:

“Medical wastes” means the following solid wastes: (a) Wastes generated by hospitalized patients who are isolated to protect others from communicable diseases (see the U. S. Centers for Disease Control “Guidelines for Isolation Precautions in Hospitals”, July, 1983 for definition of diseases requiring such isolation). (b) Cultures and stocks of infectious agents, including specimen cultures from medical and pathological laboratories, cultures and stocks of infectious agents from 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. (c) Waste human blood and blood products such as serum, plasma, and other blood components. (d) Pathological wastes (i.e., tissues, organs, body parts, and body fluids) that are removed during surgery and autopsy (e) All discarded sharps (e.g., hypodermic needles, syringes, pasteur 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. (f) Contaminated carcasses, body parts, and bedding of animals that were intentionally exposed to pathogens in research, in the production of biologicals, or in the in vivo testing of pharmaceuticals. (g) The following wastes from patients known to be infected with blood-borne disease: Contaminated wastes from surgery and autopsy (e.g., soiled dressings, sponges, drapes, lavage tubes, drainage sets, underpads, surgical gloves). Wastes from medical, pathological, pharmaceutical, or other research, commercial, or industrial laboratories that were in contact with infectious agents (e.g., specimen containers, slides and cover slips, disposable gloves, lab coats, aprons). Wastes that were in contact with the blood of patients undergoing hemodialysis, including contaminated disposal equipment and supplies such as tubing, filters, disposable sheets, towels, gloves, aprons, and lab coats. Discarded equipment and parts that were used in patient care, medical and industrial laboratories, research, and in the production and testing of certain pharmaceuticals and that may be contaminated with infectious agents.”

The State lists hazardous medical waste in the following categories:

P-Listed chemicals:

“A small quantity — one kilogram — of a P-listed waste can cause a facility to be classified as a “large quantity generator,” and to have to comply with more stringent rules as a consequence. If you are interested in reducing the hazardous waste generated in your facility, eliminating or finding substitutes for P-listed chemicals is a good place to start. 

The P-list includes about 239 different “acutely toxic” substances, listed under about 135 different waste codes. (Some codes cover several substances.) HERC has identified 15 of these that you might expect to find in a healthcare facility. They are listed below, along with their waste codes and typical uses associated with each. The CAS numbers for these compounds can be found in the official list at 40 CFR 216.33. The equivalent Tennessee regulation is foundin Tennessee Rule 0400-12-01-.02(4)(d).”

U-Listed chemicals/materials:

“The U-list includes about 472 distinct materials, listed under about 247 different waste codes. (As with the P-list, the same code can refer to several different materials.) HERC has identified 66 of them that you might expect to find in a healthcare setting. They are listed below along with their waste codes and typical uses. The CAS numbers for these compounds can be found in the official list at 40 CFR 216.33.”

Chemotherapy Agents

“Some chemicals used to treat cancer patients during chemotherapy fall on either the U or P lists. These are often referred to by their brand names rather than the chemical designations appearing on the lists. HERC has compiled a list of some common brand names, together with their chemical names and RCRA waste codes. Please note that since new products may be introduced at any time, the list may not include all brand names composed of RCRA listed chemicals.”

Tennessee makes use of the EPA guidelines for Hazardous Waste Pharmaceuticals:

EPA finalized regulations for the management of hazardous waste pharmaceuticals by healthcare facilities and reverse distributors in a rule published in the Federal Register on February 22, 2019

The Final Rule applies to healthcare facilities that generate, accumulate, or otherwise handle hazardous waste pharmaceuticals and reverse distributors engaged in the management of prescription hazardous waste pharmaceuticals. However, the Final Rule does not apply to non-pharmaceutical hazardous waste or to hazardous waste pharmaceuticals by facilities other than healthcare facilities and reverse distributors.

The Final Rule will affect industries such as pharmacies and drug stores, veterinary clinics, physicians’ and dentists’ offices; health care practitioners such as chiropractors, outpatient care centers, ambulatory surgical centers, hospitals, nursing care facilities, continuing care retirement communities, some medical examiners and coroners’ offices, wholesale distributors, supermarkets, warehouse clubs and supercenters, retailers of pharmaceuticals, and reverse distributors that help healthcare facilities calculate and receive credit from pharmaceutical manufacturers when healthcare facilities have unused pharmaceuticals they no longer need.

Pharmaceuticals are defined as any drug or dietary supplement for use by humans or other animals; any electronic nicotine delivery system; or any liquid nicotine packaged for retail sale for use in electronic nicotine delivery systems. The definition includes dietary supplements, prescription drugs, over-the-counter drugs, homeopathic drugs, compounded drugs, investigational new drugs, pharmaceuticals remaining in non-empty containers, personal protective equipment contaminated with pharmaceuticals, and clean-up material from spills of pharmaceuticals. However, the Final Rule exempts FDA-approved over-the-counter nicotine replacement therapies such as patches, gums, and lozenges from regulation as a RCRA hazardous waste.”

Who Generates Medical/Infectious Waste

Any organization, company, or facility that is involved with or comes into contact with medical and infectious waste is considered to be a generator. These can include but are not limited to hospitals, private physicians, clinics, multiple medical clinics, dentists, veterinarians, coroners, research labs, biopharmaceutical labs, tattoo parlors, and body piercing businesses.

All generators of medical/infectious waste are required to comply with the State of Tennessee:

“Hazardous waste generators in Tennessee are required by regulation to file annual hazardous waste reports with the Division of Solid Waste Management (DSWM).  Small Quantity Generators pay associated fees to DSWM as well.  Large Quantity Generators owe annual fees to both DSWM and the Division of Remediation. The annual report forms are online and will be mailed to the last address on file with TDEC for each facility each winter.”

Medical Waste Storage Requirements

Tennessee requires:

Medical Waste Transport Requirements

Medical waste transporters must follow the state of Tennessee rules for hazardous waste transport:

Each transfer facility shall maintain logs of all shipments of hazardous waste entering and leaving the facility as required by TN Rule Chapter 0400-12-01.04(1)(c)2, either in hard copy and/or in a computer file(s). This must include, at a minimum, the following information for each shipment:

(I) The date the shipment arrived;

(II) The generator’s name and EPA identification number;

(III) The manifest document number associated with the shipment;

(IV) The date the hazardous waste was shipped out of the transfer facility; and

(V) If the transporter mixes hazardous wastes by placing them into a single container at the transfer facility:

  1. The item number(s) and letter(s) from the manifest document number(s) for all separately containerized wastes that are combined in the container; and
  2. If the hazardous wastes mixed in the container have different U.S. DOT shipping descriptions, the new manifest number 

This information must be retained for a period of three years and made available for review by TDEC. 

A transfer facility may maintain the information in an equivalent log form or computer file provided that all the information required is available in an organized manner at the time of an inspection of the transfer facility.

A transfer facility can utilize paper records, computer records, or both methods as long as the forms below are used or an equivalent system is utilized.  All information maintained in a computer file(s) must be able to be printed in hard copy.  Each transfer facility shall maintain the required Log Forms or equivalent records.

The log forms, or equivalent records, shall be maintained for a minimum of three years from the most recent entry. The transporter shall maintain copies of all manifests for three years from the date the first transporter signed for the receipt of materials. These records may be maintained at a central location. In addition, each transfer facility shall maintain copies of all manifests that are referenced on Form Two, or equivalent records for Form Two, for a minimum of three years.

Source Separation

All regulated medical waste, including COVID-19 medical waste, generated from health care agencies are subject to Tennessee medical waste regulations. (see state of Tennessee 0400-11-01-.01 above)

Tennessee uses the CDC guidelines for source separation of medical waste:

“Medical wastes require careful disposal and containment before collection and consolidation for treatment. OSHA has dictated initial measures for discarding regulated medical-waste items. These measures are designed to protect the workers who generate medical wastes and who manage the wastes from point of generation to disposal.967 A single, leak-resistant biohazard bag is usually adequate for containment of regulated medical wastes, provided the bag is sturdy and the waste can be discarded without contaminating the bag’s exterior. The contamination or puncturing of the bag requires placement into a second biohazard bag. All bags should be securely closed for disposal. Puncture-resistant containers located at the point of use (e.g., sharps containers) are used as containment for discarded slides or tubes with small amounts of blood, scalpel blades, needles and syringes, and unused sterile sharps.967 To prevent needlestick injuries, needles and other contaminated sharps should not be recapped, purposefully bent, or broken by hand. CDC has published general guidelines for handling sharps.6, 1415 Health-care facilities may need additional precautions to prevent the production of aerosols during the handling of blood-contaminated items for certain rare diseases or conditions (e.g., Lassa fever and Ebola virus infection).203”

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