SubPart 70-2 - Management of Regulated Medical Waste

Effective Date: 
Wednesday, March 15, 2006
Doc Status: 
Complete

Section 70-2.1 - Waste management plan

70-2.1 Waste management plan. Each facility shall develop, document and implement policies and procedures specific to the management of regulated medical waste generated on-site and/or treated at the facility. Such policies and procedures shall minimally include, but not be limited to: a description of the types, and method(s) for treatment and disposal, of regulated medical waste; procedures for safe handling and transport of the waste within the facility from the point of generation or intake to the point of storage and/or treatment; a description of storage areas, including, as applicable, patient care areas, which details the location, ventilation and capacity of each storage area, and the length of time waste is to be retained in each area; and the titles and contact information for persons responsible for monitoring compliance. Facilities that treat regulated medical waste on-site shall include in their regulated medical waste management plan an operation plan for each treatment system employed.

Effective Date: 
Wednesday, March 15, 2006
Doc Status: 
Complete

Section 70-2.2 - Containment and storage

70-2.2 Containment and storage.

(a) Regulated medical waste shall be separated from other waste as soon as practicable at the point of generation prior to storage, treatment or disposal. Containers holding regulated medical waste containing or mixed with hazardous waste, radioisotopes and/or toxic drug waste shall be so labeled to identify waste types contained therein and so as to provide other information, including but not limited to isotope and level of radioactivity pertinent to determining whether specific procedures for management and/or disposal are applicable. Radiological medical waste shall be stored until decayed to a background radiation level prior to transport off-site of the generating facility and/or treatment.

(b) Containment of regulated medical waste for handling, storage, and treatment shall be accomplished with a primary container for protection from the elements and limiting exposure to employees and the public. Each primary container holding regulated medical waste shall be:

(1) marked prominently with the universal warning sign or the word “biohazard”; and

(2) impervious to moisture, be secured and situated so as to prevent leakage or preclude loss of contents during handling, storage and/or transport.

(3) be located away from pedestrian traffic, be vermin and insect free, and shall be maintained in a sanitary condition.

(c) Whenever regulated medical waste is transported off-site for treatment elsewhere, the primary container shall have affixed a label or imprint indicating the name and address of the generation facility and shall comply with the transport requirements of subdivision (h).

(d) (1) In addition to the requirements of subdivisions (b) and (c) of this section, the primary container for regulated medical waste, with the exception of sharps, shall be a plastic bag; red in color; and of a strength sufficient to resist ripping, tearing, or bursting under normal conditions of use and handling.

(2)

In addition to the requirements of subdivisions (b) and (c) of this section, the primary container for discarded sharps shall be rigid, leakproof, puncture-resistant and closable, and may serve as a secondary container for purposes of transport, provided it meets the definition of a secondary container.

(e)(1) Under no circumstances shall a sharps container be filled beyond the fill line indicated on the container.

(2) Sharps containers shall be removed from patient care areas to a room or area designated for regulated medical waste storage, whenever the container has reached the fill line indicated on the container. Sharps containers shall be removed from patient care areas within thirty (30) days or upon the generation of odors or other evidence of putrification, whichever occurs first, without regard to fill level.

(f) Regulated medical waste, with the exception of sharps as provided in subdivision (e) of this section, may be held in patient care areas for a period not to exceed twenty-four (24) hours and at a clinical laboratory for a period not to exceed seventy-two (72) hours, at which time the waste shall be moved to a storage area.

(g)(1) Each storage area shall be adequate for the volume of regulated medical waste generated between scheduled waste pick-ups by a transporter, or, for facilities treating the waste on-site, the volume of waste that can be treated on-site within a twenty-four (24) hour period.

(2) Each storage area shall:

(i) display prominent signage indicating the space is used to store regulated medical waste;

(ii) be designed or equipped to prevent unauthorized access;

(iii) be designed or located to protect waste from the elements, and prevent access by vermin;

(iv) hold the waste at a temperature that prevents rapid decomposition and resultant odor generation;

(v) be appropriately ventilated; and

(vi) be of sufficient size to allow clear separation of regulated medical waste from any other waste, whenever waste other than regulated medical waste is stored in the same area.

(3) Regulated medical waste shall not be stored for a period exceeding thirty (30) days, except that a site generating under fifty (50) pounds of regulated medical waste per month and not accepting regulated medical waste for treatment from other facilities, may store waste for a period not exceeding sixty (60) days.

(h) Prior to transport off-site of the generating facility for treatment elsewhere:

(1) primary containers shall have affixed a label or imprint indicating the name and address of the generating facility; and

(2) primary containers, except as provided in (c)(2) of this section, shall be placed in a secondary container with an affixed label or imprint, indicating the name and address of the generating facility, and such container marked prominently with signage indicating that the contents are infectious or regulated medical waste; and, if applicable, with an affixed label indicating that the contents contain or are mixed with hazardous waste, and/or toxic drug waste.

(i) All internal surfaces of a reusable secondary container used to hold regulated medical waste shall be completely protected by a disposable liner, which may also function as the primary container provided it meets the criteria for a primary container provided in subdivisions (b) and (c) of this section. The liner shall be removed as a secured unit with the waste and treated as regulated medical waste. A reusable secondary container shall undergo washing and decontamination upon emptying whenever the liner is compromised; visual inspection yields evidence that the container’s surface has come in contact with the contained waste prior to treatment; the contained waste includes cultures and/or stocks; or the contained waste has a highly infectious bioload.

(j) Under no circumstances shall regulated medical waste be transferred from one container

to another (e.g., for consolidation or loading of a treatment system) in a manner that compromises health and safety of the persons handling the waste. Regulated medical waste being moved from one container to another, or one location to another within a facility shall as a minimum be secured in a primary container.

(k) Reusable sharps containers shall not be opened for consolidation or other purposes unless such procedure has been approved as part of the facility’s treatment system operation plan.

(l) Disposable secondary containers for storing and handling regulated medical waste shall be treated as regulated medical waste.

(m) Transport of regulated medical waste within a facility from the point of generation to the point of storage or treatment shall be by covered cart or other appropriately covered conveyance system marked prominently with signage indicating that the contents are infectious or are regulated medical waste; provided, 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 or dolly) provided each container is labeled and appropriately closed. Regulated medical waste shall not be moved within a facility by gravity alone without control of impact, i.e., trash chutes or slides.

(n) Regulated medical waste shall not be compacted unless it has undergone treatment as provided in section 70-2.3 of this Subpart.

Effective Date: 
Wednesday, March 15, 2006
Doc Status: 
Complete

Section 70-2.3 - Treatment and disposal

70-2.3 Treatment and disposal. (a) Except as provided in subdivisions (b) and (c) of this section, treatment of regulated medical waste shall be by:

(1) discharge into a sanitary sewerage system connected to a secondary treatment facility, if the waste is liquid or semi-liquid, except as specifically prohibited by the Commissioner of Health, or by local law or ordinance;

(2) incineration in a regulated medical waste incineration facility under permit pursuant to Article 19 of the Environmental Conservation Law;

(3) decontamination by autoclaving in conformance with the requirements of Subpart 70-3 of this Part; or

(4) an alternative regulated medical waste treatment system approved by the Commissioner of Health.

(b) Restrictions on autoclave use.

(1) no autoclave shall be used for treatment of regulated medical waste containing or mixed with hazardous waste and/or toxic drug waste;

(2) no autoclave shall be used for treatment of radiological medical waste;

(3) no autoclave shall be used for treatment of recognizable human body parts; and

(4) an autoclave may be used for the treatment of human tissue(s), human organs; animal carcasses or animal body parts provided the Department has expressly approved the autoclave model as an alternative treatment technology for such use pursuant to Subpart 70-5 of this Part.

(c) Cultures and stocks.

(1) cultures and stocks containing select agents or toxins listed in 42 CFR Part 73 (Vol. 70, March 18, 2005) shall be treated on-site by incineration, autoclaving or use of alternative treatment system approved for such treatment provided, however, whenever a facility without a predictable need for on-site treatment generates such waste incidental to the delivery of medical care, the generating facility shall arrange for transportation of the select agents and toxins to a facility authorized to treat such material and shall comply with Federal regulations regarding possession, use and transfer of select agents and toxins. Such regulation shall include 42 CFR, Part 73 (Vol. 70, March 18, 2005). Federal regulations are published by the Office of the Federal Register, National Archives and Records Administration and may be purchased from the Superintendent of Documents, Government Printing Office, Washington, DC 20402. Copies are available for inspection and copying in the New York State Department of Health, Bureau of Hospital and Primary Care Services, Hedley Park Place, 433 River Street, Troy, NY 12180.

(2) except where on-site treatment is required by local health code, cultures and stocks containing infectious agents other than those referenced in paragraph (1) of this subdivision

may be transported off-site for treatment.

(d) Discarded sharps shall be destroyed prior to disposal. Sharps not coming in contact with infectious agents need not be treated in accordance with subdivision (a) of this section.

(e) Generators of regulated medical waste shall have in place a response plan to be followed in the event the facility is notified that regulated medical waste, known or suspected to be untreated, has been found commingled with solid waste.

Such response plan and any corrective action taken shall be documented.

(f) Radiation detection.

(1) each facility that treats regulated medical waste shall have a radiation detection system to screen waste for radiological medical waste and a contingency plan in the event radiation levels above background are detected in waste loads delivered for treatment. The radiation detection system shall be appropriate for effective screening of the type(s) and volume of waste, and shall be set to alarm whenever ionizing radiation above the local background ionizing radiation level is detected; and

(2) no facility shall treat radiological medical waste by autoclaving; and

(3) no facility shall treat radiological waste using an alternative regulated medical waste treatment system unless the system has been approved by the Department for such treatment pursuant to Section 70-5 of this Part.

(g) Treated regulated medical waste shall be disposed of as solid waste at an incinerator, landfill or other disposal facility authorized by the Department of Environmental Conservation to accept regulated medical waste after treatment.

(h) No facility shall transfer or release treated regulated medical waste that is not accompanied by a Department of Health certificate of treatment.

Effective Date: 
Wednesday, March 15, 2006
Doc Status: 
Complete

Section 70-2.4 - Transfer of regulated medical waste for off-site treatment

70-2.4 Transfer of regulated medical waste for off-site treatment. (a) Generators of regulated medical waste shall transfer such waste for off-site treatment only to a regulated medical waste transporter permitted by the Department of Environmental Conservation; provided, however, that a generator of under fifty (50) pounds of regulated medical waste per month registered with the Department of Environmental Conservation pursuant to 6 NYCRR Part 364 may transport its own waste for off-site treatment.

(b) A facility that generates waste and arranges transport for off-site treatment or disposal, or otherwise participates in the transport of regulated medical waste shall ensure that a regulated medical waste tracking form prescribed by the Department of Environmental Conservation accompanies each load.

(c) All solid waste transported in a load containing regulated medical waste shall be treated as regulated medical waste, unless the regulated medical waste is separately contained in a secondary container meeting the requirements of section 70-2.2(h) of this Subpart or is otherwise kept separate from the solid waste by leak-proof barriers.

Effective Date: 
Wednesday, March 15, 2006
Doc Status: 
Complete

Section 70-2.5 - Record keeping

70-2.5 Record keeping. (a) A record of regulated medical waste by quantity and categories as defined in Public Health Law 1389-aa and for disposition of treated waste on-site shall be maintained and retained on-site by the generator for three

(3) years from the date of disposition of the waste, and shall be available for inspection and copying by the Department. Documentation of corrective action related to a commingling incident shall be retained three (3) years.

(b) A report of the regulated medical waste generated annually, by quantities and categories as defined in Public Health Law 1389-aa shall be submitted to the Commissioner of Environmental Conservation upon request.

Effective Date: 
Wednesday, March 15, 2006
Doc Status: 
Complete