model: 6 nycrr 365-1.2 rmw waste management plan · web viewcontainers holding rmw that cannot be...

Model: 6 NYCRR 365-1.2 RMW Waste Management Plan

Purpose:

This plan is intended to serve as the waste management plan as required by 6 NYCRR Part 365-1.2 (a) of 6 NYCRR, Regulated Medical Waste and Other Infectious Wastes at ______________________________________.

General sections:1. Responsibility, Recordkeeping, and Reporting2. Applicability3. Presumptions4. Definitions5. Points of Generation and Initial management6. Storage Areas7. Personnel Training8. General9. Contingency Plans and Spill Response10.Preparation for Transport11.Transfer of RMW for Off-site TreatmentAppendix A Sample Waste InventoryAppendix B Sample Medical waste Tracking Form

1. Responsibility, Recordkeeping, and Reporting:

The campus is a generator of RMW and is responsible for properly identifying and segregating the waste. The campus has developed, documented, and implemented policies and procedures specific to the management of RMW generated on-site, and for labeling RMW based on the planned method of treatment (e.g., autoclave, incineration, etc.) off-site.

All employees are responsible for compliance with this management plan.

The person with overall responsibility for monitoring compliance with the campus waste management plan is:

NameTitleOffice LocationPhoneEmail

SUNY Office for Capital Facilities December 2018


The following records are maintained on-site for a minimum of three years and will be available for inspection and copying by the department.

(i) A record of RMW managed by estimated quantity and category. Categories include cultures and stocks, human pathological waste, human blood and blood products, sharps, animal waste, and other (specify characteristics).

(ii) A record of how all RMW was managed, including treatment, if applicable. For treatment, copies of certificates of treatment will be retained. For shipment off-site for treatment, copies of tracking documents will be retained.

A report of the RMW generated annually, by estimated quantity and category, will be submitted to the department upon request.

Records and reports are maintained by the party identified in this part.

2. Applicability: Unless otherwise noted, this plan applies to all campus activities that generate regulated medical waste or other infectious waste, including student health centers, athletic training facilities, custodial activities, laboratories, veterinary practices, animal research facilities, radiopharmacies, and waste management facilities.

[Note: The 6 NYCRR Part 365 regulations do not apply to hospitals, residential health care facilities, diagnostic and treatment centers (defined in section 2801 of the Public Health Law) and clinical laboratories (defined in section 571 of the Public Health Law) except to the extent hospitals use bulk packaging or accept RMW from off-site.]

3. Presumptions: The campus does not generate BSL-3 or BSL-4 wastes; it does not handle any

select agents or toxins. The campus does not treat any regulated medical waste (RMW). (See definition

for treatment below.) Any campus autoclave use will not constitute treatment under these regulations.

Use of autoclave may reflect pedagogical needs, convenience, or an effort to slow progression to putrescence. Waste that has been subjected to campus autoclave use will continue to be handled as regulated medical waste.

The campus does not compress or compact RMW. The campus does not use bulk packaging. The campus does not accept RMW from other parties. The campus will employ a third party to remove and treat Regulated Medical

Waste from the campus. This firm will comply with all applicable regulations



including obtaining transport permits from the NYS Department of Conservation and will comply with all applicable local, state and federal regulations.

The campus has a compliance plan to meet the requirements of OSHA’s Bloodborne Pathogens rule, 29 CFR 1910.1030, as adopted by PESH.

4. Definitions: Definitions from 6 NYCRR Part 360.2 are provided here for reference. Additional definitions may be applicable (e.g. the definition of solid waste). Regulations from the Department of Environmental Conservation may be consulted at: https://www.dec.ny.gov/regulations/regulations.html

(122) Generator means any person whose act or process produces a waste or whose act first causes waste to be subject to regulation under this Title.

(202) Primary container means the inner packaging or containment system that is in direct contact with, holding and securing regulated medical waste (e.g., a red bag or sharps container, etc.).

(228) Regulated medical waste (RMW) for the purpose of this Title, means waste generated in diagnosis, treatment or immunization of humans, or animals, in research pertaining thereto, or in production and testing of biologicals; provided, however, that regulated medical waste must not include hazardous waste and household medical waste, except as prescribed in subparagraph (ii) of this paragraph.

(i) Regulated medical waste includes:(a) cultures and stocks of infectious agents, culture dishes and devices used to transfer, inoculate or mix cultures that have come into contact with or are known to be contaminated with biological agents infectious to humans, or agents of economic concern (e.g., foreign animal diseases);(b) human pathological waste, including tissue, organs, body parts, excluding teeth and contiguous structures of bone and gum, body fluids removed during surgery, autopsy or other medical procedures, specimens of body fluids and their containers, and discarded materials saturated with body fluids other than urine. Human pathological waste must not include urine or fecal material submitted for purposes other than diagnosis of infectious diseases;(c) human blood and blood products, including their components (e.g., serum and plasma), containers with free-flowing blood, discarded blood products as defined in 10 NYCRR Subpart 58-2, and materials saturated with flowing blood (except feminine hygiene products);(d) sharps, whether used or unused, including residential sharps accepted by a facility regulated under article 28 of the Public Health Law pursuant to section 1389-dd(4) of the Public Health Law;(e) animal waste, including animal carcasses, body parts, body fluids, blood or bedding originating from animals known to be contaminated with infectious agents (e.g., zoonotic or potentially zoonotic organisms) or from animals


https://www.dec.ny.gov/regulations/regulations.html


inoculated with infectious agents for purposes including, but not limited to, research, production of biologicals, or drug testing. Body fluids include urine and feces when infectious agents are known to be shed in the urine and feces; and(f) any other waste materials containing infectious agents designated by the Commissioner of Health as regulated medical waste.

(ii) Regulated medical waste does not include:(a) human cadavers managed in accordance with article 42 of the Public Health Law and the New York State Department of State rules for cemeteries and crematories;(b) discarded and essentially empty urine collection bags and tubing, urine specimen cups, urinary catheters, bedpans contaminated with feces, and urine bottles, unless the item was submitted as a clinical specimen for laboratory tests or the patient was found to have a disease transmitted through urine or feces;(c) tissue blocks of organs or tissues which have been fixed in paraffin or similar embedding materials for cytological or histological examination;(d) organs, tissue or recognizable body parts that have been removed during surgery or child birth, except a fetus, and retained by the patient for religious or other purposes provided that the organs, tissue or body parts are not provided to another person in any form, and are not a potential source of disease transmission, as determined by a health care professional;(e) bandages, gauze, or cotton swabs or other similar absorbent materials unless they are saturated or would otherwise release blood or human body fluids, other than urine, if compressed;(f) housekeeping waste from hotels, except medical waste generated from the provision of healthcare at a hotel;(g) cleaned soiled bedding from commercial laundry facilities that is intended for reuse;(h) veterinary medical waste, if generated by the owner of a companion animal;(i) medical waste, including sharps, generated through the self-administration of medicine in a household, excluding waste containing cultures;(j) pharmaceutical waste generated in a household;(k) contaminated foodstuffs;(l) genetically modified or attenuated infectious agents and their products used in the diagnosis, treatment or immunization of human beings or animals or for research or production of biologicals, including attenuated vaccines, antigens and antitoxins provided genetic modification or attenuation has been conducted to render the infectious agent non-infectious;(m) bandages, gauze, or cotton swabs or other similar absorbent materials that are saturated or would otherwise release blood or human body fluids if compressed and that are generated from cosmetology, ear piercing or tattooing;(n) materials containing an infectious agent at a concentration naturally occurring in the environment, including samples for routine laboratory analyses of foodstuffs, environmental samples, quality control samples, etc.;



(o) medical equipment that is not mixed with RMW and is intended for reuse in a medical setting or equipment used for testing where the components within which the equipment is contained, essentially function as packaging; and(p) used health care products not conforming to the requirements in 29 CFR 1910.1030 and being returned to the manufacturer or the manufacturer’s designee if transported in accordance with 49 CFR 173.134(b)(12). This does not apply to used health care products being transported for treatment as RMW.

(242) Secondary container means the non-bulk outer packaging or containment system used to hold and secure a primary container. A secondary container is a disposable or reusable rigid pail, carton, drum or portable bin that is, under normal conditions of use, leak-resistant, strong enough to prevent tearing or bursting, puncture resistant, impervious to moisture, has leak-proof sides and bottom, has a tight-fitting cover or is otherwise closeable, and is in good repair.

(244) Select agent or toxin means a biological agent or toxin determined to have the potential to pose a severe threat to public health or safety, to animal or plant health, or to animal or plant products as outlined in 7 CFR part 331, 9 CFR part 121, and 42 CFR part 73, as incorporated by reference in section 360.3 of this Title.

(262) Storage means the temporary holding or containment of waste in a manner which does not constitute disposal. However, any waste retained on-site for a period in excess of 12 months constitutes disposal, unless otherwise specified in this Part or Parts 361 through 365 of this Title.

(263) Storage area for the purposes of Part 365 of this Title means a room, delineated area or designated space designed for storage of regulated medical waste or other infectious waste, within a building, or within or on any permanent structure attached or unattached to a building, including a loading dock, situated on property owned by or under management of the facility operator. Storage area does not include a trailer, bulk outer container, and other transportable container or vehicle not owned by the facility but situated on a facility property.

(279) Transporter means a person engaged in the off-site transportation of waste by means of air, rail, highway, or water conveyance.

(282) Treatment for the purposes of Part 365 of this Title means any method, technology or process designed to change the character or composition of any regulated medical waste or other infectious waste so that it no longer constitutes a threat to public health and the environment. Treatment does not include compaction or disinfection.



5. Points of Generation and Initial Management: Appendix A details the types of waste, location of generation, and method(s) for treatment of disposal of RMW generated on-site. It includes:

o Type/category of waste generatedo Location of generationo Primary contact persono Location of storage areao Method of transport from point of generation to storage areao Methods of disposal

6. Storage Areas: The following areas are used for storage of RMW when they are removed from the immediate area of generation:

Location Size/Estimated Capacity Notes

A RMW storage area is adequately sized for the volume of RMW generated between scheduled waste pick-ups by a transporter. If the area is used for other wastes, there must be sufficient capacity to allow segregation.

The storage area has adequate ventilation and temperature control to prevent rapid decomposition and odor generation. The storage area protects the waste from the elements and vermin. The storage area is prominently signed and designed to prevent unauthorized access.

RMW is not stored in a storage area for a period exceeding 30 days. (Note for a generator of less than 50 pounds of RMW per month that does not accept RMW for treatment from other facilities, storage may be allowed to extend to not more than 60 days.)

For radiological RMW, the RMW may be stored for a period of time necessary to allow decay to a background radiation level, or if long lived must be managed as a prohibited radioactive material (including waste disposal).



7. Personnel Training: Employees are trained on their responsibilities under this plan as well as protective actions. This training often overlaps with the training required under OSHA’s Bloodborne Pathogens (BBP) standard and may be provided at the same time as BBP training.

Training is provided at the time of initial assignment to activities involving potential exposure to RMW or other bloodborne pathogens. It is repeated at least annually. Additional training may be provided to reflect workplace changes or identification or programmatic deficiencies.

Employees are instructed to report all potential exposures to bloodborne pathogens per the OSHA Bloodborne Pathogens compliance program.

Training records are maintained by the office listed in Part 1.

8. General:

a. RMW is separated from other waste as soon as practicable at the point of generation prior to storage, treatment or disposal.

b. Sharps and other RMW containers must be removed from patient care or use areas, or from a laboratory or other generation area to an RMW storage area when the container has reached the fill line indicated on the container, is otherwise filled, or the container generates odors or other evidence of putrefaction, whichever occurs first.

c. Containers holding RMW that cannot be treated by an autoclave or other approved treatment technology is labeled accordingly. Note: On-site treatment of waste may require a NYS DEC permit to operate. Consult 6 NYCRR Part 365 to determine whether a permit is required. The label identifies the waste types and acceptable treatment method (e.g., incinerate only, etc.).

d. RMW that contains radioactive isotopes must be stored until decayed to a background radiation level prior to transport off-site, unless returned to the dispensing radiopharmacy or managed as a prohibited radioactive material.

e. RMW is contained in a primary container.

f. Fluids contained in leak-proof containers are placed in a primary container, oriented in an upright position and secured to prevent leakage, and then placed in a secondary container prior to off-site transport.



g. RMW cannot be transferred from one container to another in a manner that compromises health and safety of the persons handling the RMW. RMW being moved from one container to another, or one location to another within a facility is, at a minimum, secured in a primary container.

9. Contingency Plans and Spill Response:

If there is a significant spill of RMW, it will be addressed immediately:

The spill area will be cordoned off. OSHA Bloodborne Pathogens trained personnel will contain and collect the spill,

and then disinfect the impacted area. Special care will be taken to avoid contact with sharps (e.g. use of

brooms/shovels and dustpans or forceps to avoid manual contact). The spilled waste and the material generated during the clean-up will be

managed as regulated medical waste. The final phase of the clean-up will include disinfection of the impacted areas

using an acceptable disinfecting solution.

Significant spills will be promptly reported to the person identified in Part 1, and that person or the senior manager of the area will determine if sufficient clean-up has occurred.

Records will be kept of all significant spill events, including dates and time, location, cause, corrective action and personnel involved in the clean-up. These records will be maintained by the person identified in Part 1.

Incidental spill of potentially infectious materials (in routine work areas in routine working quantities), will be cleaned and disinfected immediately per work area protocols and by the personnel immediately involved. Records need not be kept of these incidental spills.

If there is failure of the disposal vendor firm to remove waste in an acceptably timely manner, it will be addressed promptly. This plan has been predicated on the use of a third party to appropriately remove RMW from the campus on a regular basis. Should the third party be unable to reasonably adhere to its regular removal schedule, the person in Part 1 or the senior manager of the generating area will make alternate arrangements or determine that the delay can be accommodated. The nature of the alternate arrangements may reflect the causal factor for the third party’s non-compliance, and may include termination of any contractual arrangements and establishment of new contracts with other parties.



10.Preparation for Transport:

Prior to transport of RMW off-site for treatment, the primary containers, except sharps containers, are placed in a secondary container, and marked prominently with the universal biohazard symbol or the word Biohazard; and, if applicable, with an affixed label indicating that the contents require special handling (e.g., incinerate only, etc.); and

The secondary container must be commercially manufactured disposable (e.g., fiberboard boxes that meet USDOT HMR specifications or reusable secondary containers.

Primary Containers:

Primary containers are labeled with the name and address of the generating facility when placed in a secondary container that is a bulk container used by multiple generators.

Primary containers, with the exception of sharps containers, must be a plastic bag that complies with the standards prescribed by 49 CFR 173.196, 173.197 and 173.199, and is certified by the bag manufacturer to meet Federal requirements.

The primary container for discarded sharps must be rigid, leak-proof on the sides and bottom, puncture-resistant and closable, and may serve as a secondary container for purposes of transport, provided it meets the definition of a secondary container.

Primary containers must not be filled in a manner that results in the breakage of the container.

Primary containers in laboratory and clinical settings are kept in secure locations (e.g., access restricted rooms) when in use and must be properly closed when moved to other locations. In other settings, primary containers must be properly closed at all times when not being filled.

Sharps or other secondary containers must not be opened for consolidation or other purposes unless the container is routinely reopened to add waste.

Only primary containers that have been approved for reuse by the United States Food and Drug Administration (FDA), may be reused.



Secondary containers:

Secondary containers must comply with the standards prescribed by the USDOT found at 49 CFR 173.134, 173.196, 173.197, and 173.199. Reusable secondary containers can include wheeled carts or roll-off bulk containers.

All internal surfaces of a reusable secondary container, except for reusable sharps containers, must be completely protected by a disposable liner, which may also function as the primary container provided it meets the criteria for a primary container, or the secondary container serves as both a primary and secondary container. The liner must be removed as a secured unit with the contained RMW and treated as RMW.

Reusable secondary containers must be inspected prior to return to use to verify that the containers are not defective and are cleaned and disinfected, have no cracks or other defects, and that the lid closes and, if available, the locking mechanism works. Reusable containers must be immediately cleaned and disinfected upon emptying if the liner is compromised, visual inspection yields evidence that the container's surface has come in contact with RMW prior to treatment, the contained waste includes cultures and/or stocks, or the contained waste has a highly infectious bioload.

Disposable single-use secondary containers, broken reusable containers or containers no longer in service are treated as RMW unless decontaminated for recycling.

Movement of RMW:

Movement of RMW within a facility from the point of generation to the point of storage or treatment must be by covered cart or other appropriately covered conveyance system marked prominently with labeling indicating that the contents are infectious or are RMW.

All wheeled carts used as secondary containers are kept in a sanitary condition, disinfected before reuse, and are not allowed to become putrescent. They must be used exclusively for RMW.

However, waste held in containers meeting the definition of secondary container may be transported within a facility from point of generation to the point of storage or treatment using an open conveyance system (e.g., laboratory cart, dolly, etc.) provided each container is labeled and appropriately closed.

RMW must not be moved within a facility by gravity alone (e.g., trash chutes, slides, etc.) without control of impact.



11. Transfer of RMW for off-site treatment.

Generators of RMW transfer the waste for off-site treatment only to a transporter authorized to transport RMW under 6 NYCRR Part 364.

Radiological RMW must be returned to the dispensing radiopharmacy, stored at the generator’s location until the RMW has decayed to a background radiation level, or if long lived must be managed as a prohibited radioactive material (including waste disposal).

A hard copy of a medical waste tracking form must accompany each load of RMW leaving the generator. The instructions on the tracking form must be followed. A copy of the required tracking form is included in Appendix B.

All municipal solid waste transported in a load containing RMW must also be treated as RMW, unless the RMW is separately contained in a secondary container or is otherwise kept separate from the MSW by leak-proof barriers.

Any pharmaceutical waste that is unable to be separated at the site of generation must include a label that reads “Incinerate Only” on the secondary container and must be incinerated at an authorized facility. Pharmaceutical waste may not be disposed in sanitary sewers, septic systems or waste water treatment systems.

Secondary containers must be labeled in accordance with the definitions and applicable classification criteria (e.g., RMW, Infectious Substances or Used Healthcare Products) required by 49 CFR 173.134. Each label must be printed on or affixed to a surface (other than the bottom) of the container and be located on the same surface of the container near the proper shipping name marking. Each label, whether printed on or affixed to a container, must be durable and weather resistant.

If an infectious substance, secondary containers, except sharps containers, must be affixed with an “INFECTIOUS SUBSTANCE” label or marked with the fluorescent orange Universal “BIOHAZARD” symbol meeting the specification under 29 CFR 1910.1030(g)(1)(i) in accordance with 49 CFR 173.134, date of transport, and if applicable, that the contents (if containing pharmaceutical, chemical or pathological waste) require incineration. An “INFECTIOUS SUBSTANCE” label is not required on a non-bulk secondary container with a “BIOHAZARD” marking.



Appendix A Sample Waste Inventory Type of Waste Location of

GenerationLocation of Storage

Primary Contact Person

Method of transport to Storage

Method(s) of Disposal

1 Outpatient medical care practice – non sharps

Collected in red bags in marked bins in Student Health Center patient care rooms.

Closet in SHC Heather Healthful

Double bagged and hand delivery of closed primary containers each evening.

Collection at Student Health Center and then disposal though a licensed, contracted RMW disposal firm.

2 Outpatient medical care practice - sharps

Collected in marked sharps containers in patient care areas

Closet of SHC Heather Healthful

Hand delivery of primary containers when the container reaches the fill line.

Collection at Student Health Center and then disposal though a licensed, contracted RMW disposal firm.

3 Laboratory – sharps Collected in marked sharps containers in laboratory.

Transported to RMW storage area.

Albertus Einsteinium

Lab worker contacts ___ to transport the waste in closed sharp container via covered wheeled cart.

Collection at RMW storage area and then disposal through a licensed contracted RMW disposal firm.

Athletic Training – non sharps

Collected in red bags in marked bins in the AT medical room closet.

AT Closet Jane Jocque Double bagged and hand delivery of closed primary containers each evening.

Collection at Athletic Training and then disposal though a licensed, contracted RMW disposal firm.

Athletic Training - sharps

Collected in marked sharps containers in patient care areas

AT Closet Jane Jocque Hand delivery of primary containers when the container reaches the fill line.

Collection at Athletic Training and then disposal though a licensed, contracted RMW disposal firm.



Appendix B Medical Waste Tracking Form

https://www.dec.ny.gov/docs/materials_minerals_pdf/medwste.pdf


https://www.dec.ny.gov/docs/materials_minerals_pdf/medwste.pdf

model: 6 nycrr 365-1.2 rmw waste management plan · web viewcontainers holding rmw that cannot be...

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