13.7.2 Engineering Design and Operations Plan- Commercial medical waste storage and treatment facilities shall provide an Engineering Design and Operations Plan for review and approval to the Department and local governing body having jurisdiction prior to the acceptance of any untreated medical waste. The plan shall describe in detail how the facility will comply with all applicable requirements in these regulations. All engineered features of the facility design shall be reviewed and sealed by a registered Colorado Professional Engineer.
(A) The Engineering Design and Operations Plan shall contain the following general facility data:
(1) The names, mailing addresses, telephone numbers and e-mail addresses of the facility owners and operators.
(2) The names, addresses, telephone numbers and e-mail addresses of one or more persons having authority to take actions at the facility in the event of an emergency.
(3) The mailing address and physical address of the facility, including the county and legal description as well as the quarter-section, section, township and range.
(4) A general description of the medical waste storage or treatment facility.
(5) A listing of all permits or construction approvals received by or applied for, including air quality, water quality, local wastewater treatment, and other State or local permits.
(B) The Engineering Design and Operations Plan shall contain, at a minimum, the following maps:
(1) A vicinity map, drawn at a recognized engineering scale, that has been certified by a registered Colorado Professional Engineer showing access and service roads to the facility; zoning and land use; present land owners; property boundaries; easements; rights of way; residences; wells; location of floodplain boundaries; locations of all springs, lakes, streams, wetlands, constructed or natural drainages, and irrigation ditches; and all man-made or natural features relating to the facility within a 1/2-mile radius.
(2) A site map, drawn at a recognized engineering scale, that has been certified by a registered Colorado Professional Engineer showing facility boundaries; location, size, and use of existing or proposed structures or other storage units; areas to be used for unloading, storage, and loading of wastes; general process flow; existing or proposed water diversion, collection, conveyance, treatment, storage and discharge facilities; and any other information requested if necessary to complete review of the plan.
(C) The Engineering Design and Operations Plan shall contain the following operational information.
(1) A narrative description of the general operating plan for the facility, including hours of operation, daily operations methodology, and expected facility capacity.
(2) Descriptions of the job titles, duties, responsibilities and training requirements of all employees who manage medical waste at the site.
(3) For sites where medical waste treatment is to be conducted, the plan shall also include:
(i) Technology validation process- A detailed description of the technology validation process steps and the waste treatment process including capacity of the unit, composition and volume of waste the technology is designed to treat and the composition and volume of waste representing the worst case scenario for this technology. For infectious waste treatment processes, this shall also include a description of the time intervals and locations for biological indicator samples that were placed in the load, and the procedures for testing the biological indicator samples to determine final concentrations after treatment. This information should be provided by the technology manufacturer.
(ii) Technology verification process- A detailed description of the verification testing procedures to be used on a routine basis by the waste treater to verify for the Department that the technology remains effective onsite under actual operating conditions.
(a) Onsite verification testing must be completed on representative test loads before production startup of a newly installed treatment system at the waste treater's facility. The waste treater must maintain documentation of onsite verification testing and monitoring results for each test load, including any deviations from the critical limits and corrective actions taken.
(b) For infectious waste treatment processes, verification procedures shall use biological monitoring. Parametric monitoring may be allowed if the technology manufacturer has successfully demonstrated to the Department that appropriate critical limits are met to achieve adequate biological inactivation and that the parameters to be monitored are directly correlated to biological inactivation.
(c) A description of the treatment technology including manufacturer's name and equipment model number or description, standard operating procedures which have been proven to be effective, and a description of preventive maintenance procedures. For infectious waste treatment processes, a description of the required residence time for waste in the treatment zone and a description of the type and frequency of biologic and/or parametric verification monitoring, including calibration of parametric controls, should also be included.
(d) The waste treater must provide a detailed written operations and maintenance plan that includes the technology manufacturer's specifications and instructions.
(e) The waste treater must follow the written operations and maintenance procedures provided by the technology manufacturer and maintain documentation of onsite treatment and monitoring results for each waste load, including any deviations from the critical limits and corrective actions taken in the event of a deviation.
(iii) A detailed engineering description of the facility with a flow chart showing the components of the treatment system.
(iv) A description of annual operator training requirements including loading and unloading of the treatment system to minimize occupational exposure and physical injury, emergency procedures for handling malfunctioning systems, and documentation requirements for system failure during operation.
(v) A description of waste loads that can be processed, waste feed capacity and rate, and limitations on waste composition and types.
(vi) A description of control systems including air flow, waste moving/mixing systems, procedures to be used for facility startup and scheduled and/or unscheduled shutdown, warning systems and waste feed cutoff, if applicable.
(4) A waste characterization and acceptance plan, including waste screening methods to be used, radioactive material scanning, waste exclusion procedures and rejection of prohibited wastes, handling methods for wastes that require special or non-standard handling, and a contingency plan for handling prohibited wastes.
(5) A detailed description of the on- and offsite controls to be used to prevent nuisance conditions, including dust, noise, mud, odors, and control of disease vectors including the attraction, breeding and emergence of insects, birds or rodents.
(6) A waste handling and storage plan, including a detailed description of the unloading, monitoring, handling and storage practices to be used and information on methods to secure access and set up barriers to prevent unauthorized entry to areas where waste is stored.
(i) All exterior doors, gates or lids to medical waste storage areas shall be marked with the biohazard symbol, if applicable, and the words "Caution- Medical Waste Storage Area- Unauthorized Persons Keep Out". Letters on signs shall be at least two inches in height and legible.
(ii) Medical waste shall be stored in a manner and location that maintains the integrity of the packaging and provides protection from water, precipitation and wind. Storage units shall be constructed of easily cleanable materials that are impervious to liquids and resistant to corrosion from disinfectants, have adequate drainage, and are free of standing water.
(iii) Medical waste shall be stored for no more than fourteen (14) calendar days from the date of receipt at the storage facility before being transported to an approved treatment or disposal facility.
(iv) If odors or other nuisance conditions develop, the waste shall immediately be placed in an enclosed unit maintained at or below 45 degrees Fahrenheit or transported to an approved treatment or disposal facility.
(7) A description of the tracking system to be used to maintain control of waste flow. The system shall include: the source, volume, and types of waste received; the date the waste was received; for storage facilities, the date the waste was shipped to the treatment or disposal facility; for treatment facilities, the date the waste was treated and sent for disposal. Documentation, including copies of waste tracking logs, shipping papers and/or manifests, shall be retained for a minimum of three (3) years from the date the waste was shipped from the facility.
(8) An operational safety, fire prevention and contingency plan to minimize hazards. The plan shall include:
(i) A plan for the alternate management of wastes in the event the facility is not in operation due to equipment failure or closure due to unforeseen circumstances, or if the permitted capacity of the facility will be exceeded.
(ii) Cleanup procedures to be implemented in the event of a loss of containment, spill or release.
(iii) The location and use of all spill response supplies and personal protective equipment and the methods to be used to manage recovered waste and contaminated spill response supplies and personal protective equipment.
(iv) The designated person or persons responsible for implementing the plan.
(v) Spill reporting provisions.
(vi) A fire protection plan in compliance with local fire codes.
(9) A personnel training plan identifying training to be received by each employee based on the responsibilities associated with their job duties. Training shall be conducted, at a minimum:
(i) When the employee starts a new position or receives additional duties related to medical waste management.
(ii) When new medical waste management procedures are implemented.
(iii) On an annual basis.
Employee training shall include, but not be limited to: medical waste identification, bloodborne pathogens, waste containment and labeling; storage requirements; equipment operations including equipment startup, shutdown, maintenance, and associated procedures to assure safe operation; and roles and responsibilities when implementing the facility contingency plan. Training for employees that prepare waste for shipment shall be consistent with US DOT requirements.
(10) A closure plan providing information on the actions to be taken at the time of final facility closure, including:
(i) The Department, the local governing body having jurisdiction, and customers serviced by the facility shall be notified in writing at least sixty (60) calendar days in advance of the proposed closure date. If applicable, signs of a suitable size notifying drop-off customers of the site closure shall be placed in a conspicuous area at the entrances to the facility at least sixty (60) calendar days in advance of the proposed closure date.
(ii) The facility shall not accept new or additional waste shipments for storage and/or treatment fourteen (14) calendar days prior to the date of anticipated closure. All wastes shall be transported offsite to an approved solid waste site or facility within fourteen (14) calendar days of receipt of the final waste load.
(iii) Waste storage units and waste management areas shall be cleaned to disinfect and/or remove visible traces of medical waste.
(iv) Wthin thirty (30) calendar days of completing closure activities, the owner and operator shall provide written notification to the Department and the local governing body having jurisdiction to document that proper treatment and disposal of all wastes has taken place in accordance with the approved closure plan and that facility closure standards have been achieved.