250 R.I. Code R. 250-RICR-140-15-1.15

Current through October 15, 2024

Section 250-RICR-140-15-1.15 - Treatment, Destruction and Destination Facilities

A. Applicability

The provisions of this Section apply to owners and operators of facilities that treat, destroy, and/or dispose of regulated medical waste as follows:

1. Destination facilities;

2. Intermediate handlers;

3. Generators that receive regulated medical waste accompanied by a tracking form.

4. Persons that treat and/or destroy regulated medical waste that has been generated on-site, and do not treat and/or destroy regulated medical waste that has been generated off-site, shall only be exempt from the provisions of §§ 1.15(B)(1) and (2), 1.15(C), (D) and (F) of this Part.

B. Requirements for Treatment, Destruction, and Destination Facilities

1. A treatment, destruction, or destination facility shall not accept regulated medical waste which is not packaged, labeled, and marked in accordance with §§ 1.7 and 1.11 of this Part.

2. A treatment, destruction or destination facility shall not accept regulated medical waste that is not accompanied by a tracking form that complies with §§ 1.13 and 1.14 of this Part.

3. No person shall operate a treatment, destruction, or destination facility at which regulated medical waste is burned or otherwise treated and/or destroyed unless such treatment, destruction, or destination facility complies with all applicable laws and regulations.

4. All treatment, destruction, or destination facilities shall keep a spill containment and cleanup kit in or near any storage area, loading and unloading area, decontamination area, and treatment area where regulated medical waste is managed. The location of the kits shall provide for rapid and efficient cleanup of spills anywhere within these areas. The kit shall consist of at least the following items:

a. Absorbent material for spilled liquids. The absorbent material shall have a rated capacity of one gallon of liquid for every cubic foot of regulated medical waste that is normally managed in the area for which the kit is provided or ten (10) gallons, whichever is less.

b. One gallon of disinfectant in a sprayer capable of dispersing its charge in a mist and in a stream. The disinfectant shall be of hospital grade and of a formulation described in § 1.14(G)(3) of this Part and be effective against mycobacteria.

c. Fifty (50) red plastic infectious waste bags that meet the requirements of § 1.7(E)(3) of this Part, accompanied by sealing tape (or devices), and appropriate labels as required by § 1.11 of this Part. These bags shall be large enough to overpack any box or other container normally used for regulated medical waste handling by the facility.

d. Two (2) sets of overalls, gloves, boots, caps and protective eye covering, all of which shall be disposable and be impermeable to liquids. Overalls, boots and caps shall be oversized or fitted to medical wastes workers and be made of a moisture resistant or moisture proof material. Gloves for handling regulated medical waste where sharps are not present shall be durable and of moisture resistant or moisture proof material. Gloves for handling sharps shall be puncture resistant or puncture proof in addition to liquid resistant. Boots shall be of durable moisture resistant or moisture proof material which will not tear under the stress of walking. Minimum protective breathing devices shall be surgical masks. Tape for sealing wrists and ankles shall also be provided in the kit.

e. A first aid kit (unless emergency medical care is available on the premises), fire extinguisher, and other appropriate safety equipment.

5. The disinfectants used in cleaning up a spill shall be registered with the U.S. EPA as hospital disinfectants that are also tuberculocidal, fungicidal, virucidal and effective against HIV 1. Also approved as a disinfectant is one-to-ten (1:10) dilution of five percent (5%) sodium hypochlorite solution.

6. All regulated medical waste treatment, destruction, or destination facilities shall, at a minimum, implement the following procedures subsequent to a spill of regulated medical waste upon its discovery:

a. The cleanup crew shall utilize the protective equipment described in § 1.14(G) of this Part during the spill cleanup operation;

b. Limit access to the spill area only to authorized personnel;

c. Place broken containers and spillage inside overpack bags in the kit;

d. Disinfect the area and take other cleanup steps deemed necessary. Any absorbent materials used to disinfect the area shall be considered regulated medical waste;

e. Clean and disinfect non-disposable items;

f. Remove protective equipment and manage disposal items as regulated medical waste;

g. Take necessary steps to replenish containment and cleanup kit;

h. Call for emergency assistance if necessary;

i. Report to the Director immediately all regulated medical waste spills or accidents, unless the quantity of such spills is less than one cubic foot of waste;

j. Submit a medical waste spill report to the Director within forty-eight hours, using the spill or accident report form prescribed by the Director. Any regulated medical waste spill outside the limited access areas shall be reported to the Director. A copy of the report shall be on file at the treatment facility for a minimum of three (3) years. The report form shall include, but not be limited to:

(1) Name of facility;

(2) Name of employee(s) involved;

(3) Address of facility;

(4) Date of spill or accident;

(5) Date of report;

(6) Short detailed summary of events; and,

(7) Procedure(s) used to clean the spill or accident.

k. All spills shall be recorded in a log that is maintained for a minimum of three (3) years from the date of the last entry in the log.

7. Treatment, destruction, and destination facilities shall:

a. Store regulated medical waste in a manner and location that maintains the integrity of the packaging;

b. Maintain regulated medical wastes in a non-putrescent state, using refrigeration or freezing when necessary;

c. Lock outside storage areas containing regulated medical wastes to prevent unauthorized access;

d. Designate and label regulated medical waste storage areas not limited to authorized personnel by posting a sign stating "warning: regulated medical waste" and/or displaying the international biohazard symbol at all points of access; and,

e. Store regulated medical waste in a manner and location that is not accessible to animals and does not provide a breeding place or a food source for insects or rodents.

8. Treatment, destruction, and destination facilities shall adhere to the following storage regulations:

a. No regulated medical waste shall be stored more than fourteen (14) days;

b. No facility shall store more than seven (7) times its total maximum daily capacity for treatment and/or destruction of regulated medical waste;

c. All facilities shall formulate a plan and submit a copy to the Director for approval. At a minimum the plan shall:

(1) Address compliance with the requirements set forth in §§ 1.15(B)(4), (6), (7), (8) of this Part, and shall provide for the removal of regulated medical waste to an alternate facility in the event that the facility is not in compliance with §§ 1.15(B) (8)(a) through (b) of this Part;

(2) Be maintained at the treatment facility; and,

(3) Designate an emergency coordinator and an alternate emergency coordinator.

d. The facility shall implement the appropriate section(s) of its plan under the following conditions:

(1) Its maximum storage capacity for regulated medical waste (as determined by § 1.15(B)(8)(b) of this Part) has been exceeded; or,

(2) The storage time for regulated medical waste has exceeded fourteen (14) days; or,

(3) The facility operator anticipates exceeding the maximum storage capacity and/or the fourteen (14) day storage time limit for regulated medical waste.

e. A generator that also treats or destroys regulated medical waste generated on premises owned or operated by the generator shall be subject to the requirements of § 1.15(B)(8) of this Part when the untreated regulated medical waste is stored in a centralized storage area prior to treatment or destruction.

9. Training/Notification Requirement: The owner of a treatment, destruction or destination facility shall notify in writing all employees involved with the treatment and destruction of regulated medical wastes of the provisions in § 1.15 of this Part. This training/notification shall be accomplished through the use of a medical waste procedure manual and/or through appropriate training materials.

C. Use of the Tracking Form

1. Destination Facility: When a destination facility receives regulated medical waste accompanied by a tracking form, the owner or operator shall:

a. Sign and date each copy of the tracking form to certify that the regulated medical waste listed on the tracking form was received;

b. Note any discrepancies as defined in § 1.15(D) of this Part on the tracking form;

c. Immediately give the transporter at least one copy of the signed tracking form;

d. Retain a copy of each tracking form in accordance with § 1.15(E)(1) of this Part.

2. Intermediate Handlers: When an intermediate handler receives regulated medical waste accompanied by a tracking form, the owner or operator shall meet the following requirements:

a. The owner or operator shall initiate a new tracking form for each shipment of regulated medical waste that has either been treated or destroyed. The owner or operator shall also meet all the requirements for generators under §§ 1.6 through 1.13(H) of this Part including signing the tracking form, indicating the acceptance of the waste as specified in box 20, and entering the new tracking form number in box 21.

b. The owner or operator shall maintain a log matching the original generator's tracking forms to the tracking form that the owner/operator shall initiate. This log shall include:

(1) Name(s) of generator(s);

(2) Generator's address;

(3) The date the regulated medical waste was originally shipped by the generator or the generator's unique tracking form number;

(4) The new tracking form number to which the waste is assigned.

c. Within fifteen (15) days of receipt of the tracking form that was initiated by the owner/operator and that was signed by the destination facility, the intermediate handler shall:

(1) Attach a copy of the tracking form, signed by the destination facility, to the original tracking form initiated by the generator according to § 1.13(C) of this Part;

(2) Send a copy of each tracking form to the generator that initiated the tracking form; and,

(3) Retain a copy of each tracking form in accordance with the requirements of § 1.14(L) of this Part.

3. Rail Shipments: If a destination facility or intermediate handler receives regulated medical waste from a rail transporter that is accompanied by shipping papers containing the information required on the medical waste tracking form, with the exception of the generator's certification and chain of custody signatures, the owner or operator or his agent, shall:

a. Sign and date each copy of the tracking form or the shipping papers (if the tracking form has not been received);

b. Note any discrepancies, as defined in § 1.15(D) of this Part, on each copy of the tracking form or shipping papers (if the tracking form has not been received);

c. Immediately give the rail transporter at least one copy of the tracking form or shipping papers (if the tracking form has not been received);

d. If the facility is a destination facility, send a copy of the signed and dated tracking form to the generator within fifteen (15) days after the delivery. If the owner or operator has not received the tracking form within fifteen (15) days of delivery, a copy of the signed and dated shipping papers shall be sent to the party initiating the tracking form;

e. If the facility is an intermediate handler, retain a copy of the tracking form (or the shipping papers if the tracking form has not been received), until a copy of the tracking form signed by the owner or operator of the destination facility. The destination facility or intermediate handler shall then:

(1) Attach a copy of the tracking form (signed by the destination facility) to the original tracking form (or the shipping papers if the tracking form has not been received) initiated by another party;

(2) The intermediate handler and destination facility shall send a copy of each tracking form (or each set of shipping papers) to the party who initiated the tracking form; and,

(3) The intermediate handler and destination facility shall retain a copy of each tracking form in accordance with the requirements of § 1.15(E) of this Part.

f. The intermediate handler and destination facility shall retain a copy of the tracking form (or shipping papers if signed in lieu of the tracking form) for at least three hundred and seventy-five (375) days from the date of acceptance of the regulated medical waste.

D. Tracking Form Discrepancies

1. Tracking form discrepancies required for:

a. Any variation in piece count such as a discrepancy of one box, pail, or drum in a truckload; or,

b. Any variation in the actual weight of any single container of regulated medical waste that differs from its listed weight by more than ten percent (10%); or,

c. Any variation in the actual weight of all containers in a shipment of regulated medical waste that differs from the total weight listed on the medical waste tracking form by more than five percent (5%).

d. Discrepancies in number of containers for each category of regulated medical waste as described on the label imprinted or affixed to the outer surface of the package;

e. For packaging that is broken, torn, or leaking; and,

f. Regulated medical waste that arrives at an intermediate handler or a destination facility unaccompanied by a tracking form, where the owner or operator knows such form is required, or for which the tracking form is incomplete or not signed.

2. Upon discovering a discrepancy, the owner or operator of the treatment, destruction, or destination facility shall attempt to resolve the discrepancy with the waste generator, the transporter and/or the intermediate handler. If the discrepancy is not resolved, the owner or operator shall submit a letter, within fifteen (15) days of receiving the waste, to the Director. The letter shall describe the nature of the discrepancy and the attempts the owner or operator has undertaken to reconcile it. The owner or operator shall include a legible copy of the tracking form or shipping papers in question with the letter. If the discrepancy is the type specified in § 1.15(D)(1)(d) of this Part, the report shall specify the quantity of waste received, the transporter, and the generator(s).

E. Recordkeeping

1. The owner or operator of a destination facility or an intermediate handler receiving regulated medical waste shall maintain records for a minimum of three (3) years from the date the waste was accepted. These records shall contain the following information:

a. Copies of all tracking forms and logs required by these regulations; and,

b. The name and address of each generator that delivered waste to the destination facility or intermediate handler under § 1.13(B)(2) of this Part, and the generator's address; and,

c. Copies of all discrepancy reports required by § 1.15(D) of this Part.

2. The owner or operator of a destination facility or an intermediate handler that accepts regulated medical waste from generator(s) subject to § 1.13(B)(2) of this Part shall maintain the following information for each shipment of regulated medical waste accepted:

a. The date the waste was accepted;

b. The name and address of the generator who originated shipment;

c. The total weight of the regulated medical waste accepted from the originating generator; and,

d. The signature of the individual accepting the waste.

F. Treatment, Destruction, and Disposal of Regulated Medical Wastes

1. Regulated medical waste remains subject to the handling and management requirements of these regulations and to any relevant federal regulations until the regulated medical waste is both treated and destroyed.

2. Once regulated medical waste has been both treated and destroyed, its residue may be disposed of as non-regulated medical waste unless that residue meets the definition of hazardous waste as defined by DEM Rules and Regulations for Hazardous Waste Management (Subchapter 10 Part 1 of this Chapter). Untreated regulated medical waste may be transported off-site for treatment and destruction, treated on-site and transported off-site for destruction, or treated and destroyed on-site. Regulated medical waste shall not undergo mechanical destruction before it has been treated, unless the mechanical destruction and treatment are part of a single, self-contained process that does not place employees or the public at risk of exposure to untreated regulated medical waste.

3. Treatment and destruction combinations that fulfill the requirements for proper treatment and destruction of regulated medical wastes include, but are not limited to, the following:

a. For Liquid Regulated Medical Wastes, Including Body Fluids, Human Blood and Blood Products: Acceptable disposal methods include:

(1) Incineration;

(2) With approval from the local sewer authority, discharge into a sanitary sewer system that has a secondary wastewater treatment facility. Methods of discharge shall be limited to: direct discharge into the sanitary sewer system; discharge after steam sterilization; or discharge after chemical disinfection with a one-to-ten (1:10) dilution of five percent (5%) sodium hypochlorite solution or equivalent chemical disinfection.

(3) Discharge into an Individual Sewage Disposal System (ISDS), provided that chemical disinfectants and/or preservatives are not added to the body fluids, human blood and/or blood products prior to discharge and that no more than ten (10) gallons of body fluids, human blood and/or blood products are discharged in an ISDS during a twenty-four (24) hour period;

b. For Human Pathological Wastes (Not Including Body Fluids) and Isolation Wastes: Acceptable technologies include:

(1) Incineration;

(2) In response to the threat posed by certain isolation waste (human or animal) the Director may prescribe alternate treatment standards as described in § 1.2(B) of this Part.

c. For Sharps and Unused Sharps: Acceptable technologies include:

(1) Incineration;

(2) Chemical disinfection, utilizing chemicals specifically approved by EPA/FIFRA for disinfection of medical waste, with or followed by grinding or shredding; and,

(3) Steam sterilization followed by grinding or shredding.

d. For Other Regulated Medical Wastes (including, but not limited to, cultures and stocks, items saturated and/or dripping and/or caked with human blood): Acceptable technologies include:

(1) Incineration;

(2) Chemical disinfection, utilizing chemicals specifically approved by EPA/FIFRA for disinfection of medical waste, with or followed by grinding or shredding;

(3) Steam sterilization followed by grinding or shredding.

4. Alternative Technologies: Any other treatment, destruction and/or disposal technology shall only be utilized if such treatment, destruction and/or disposal technology has been approved in writing by the Director.

5. Approval of Alternative Technologies:

a. The Director shall not grant approval for the use of any other combination of treatment, destruction and/or disposal technologies, unless and until such technologies are proven, on the basis of thorough tests to:

(1) Completely and reliably inactivate Geobacillus stearothermophilus spores or Bacillus atrophaeus spores at a 4 Log₁₀ reduction or greater; and,

(2) Completely and reliably inactivate vegetative bacteria, fungi, viruses, parasites, and mycobacteria at a 6 Log₁₀ reduction or greater [this requirement is applicable to technologies not based on thermal and chemical treatment]; and,

(3) Be protective with respect to total impact on the environment; and,

(4) Ensure the health, safety and welfare of both facility employees and the general public; and,

(5) Ensure that the total weight and/or volume of the end product of the alternative technology does not exceed the total weight and/or volume of the regulated medical waste prior to treatment and/or destruction. Testing must also demonstrate that inactivation is uniformly and within containers reasonably likely to be treated in the system.

b. Notwithstanding the provisions of § 1.15(F)(5)(a) of this Part, the Director may deny any application for just cause within the scope and intent of these regulations.

250 R.I. Code R. 250-RICR-140-15-1.15

Amended effective 4/22/2020