
As secure information destruction providers look to ancillary services in an effort to diversify their businesses, they may find themselves considering the transportation and disposal of regulated medical waste, particularly if they have a strong client base in the health care industry.
The broad term “regulated medical waste” includes biohazardous, pharmaceutical and hazardous wastes that are controlled by federal, state and local laws and regulations. Additionally, some facilities have accreditation and certification standards that must be met to maintain licensing. Some of these standards overlap with the best practices used in the secure information destruction industry, and this article will identify those relationships as well as what’s involved in serving the medical waste disposal needs of the customers you may already have.
Requirements for medical waste management include storage containers, transportation, treatment and disposal. Several national firms (Stericycle, Daniels Sharpsmart and Waste Management Healthcare Solutions) provide comprehensive transportation and treatment services nationwide. Additionally, hundreds of firms coast to coast provide transportation services, bringing the waste from the generator to a third-party treatment site. Some companies have expanded into medical waste transportation services from other parts of their businesses, including medical device sales and recycling and document destruction service providers. Conversely, some of the medical waste companies offer secure document destruction as a part of their overall spectrum of services.
If you are considering expanding from document destruction into the medical waste business, here are a few things to consider.
Leveraging existing relationships
A trusted relationship with a vendor is valuable to a health care facility. Whether a hospital or small office practice, the ease and comfort these health care providers have with an existing vendor can aid in expanding services. Some secure document destruction providers have expanded solely because their customers have requested that they do so. In that case, moving into a new area of business with a prearranged revenue stream is worthy of consideration.
There also is the synergy associated with confidential patient waste that is part of secure document destruction services and that which is part of medical waste, such as IV bags, vials and other patient-identified waste items. Virtually any partially delivered medication has some form of patient identifier and, therefore, must be handled according to federal HIPAA (Health Insurance Portability and Accountability Act) standards.
Varying regulations
Medical waste is regulated by individual states or local agencies, meaning these regulations vary somewhat depending on location. (California and New York have the most stringent and specific requirements.) The first place to look for specific information on medical waste regulations is to your state Department of Public Health or Environment. Anyone transporting, treating or disposing of medical waste requires various permits issued by state or local authorities.
Federal DOT (Department of Transportation) registration is required to transport medical waste. Additionally, each hauler must have an EPA (Environmental Protection Agency) ID number, which is issued by the state a company operates in. You must first contact your state Department of Health or Environment that regulates the transportation of hazardous waste to secure an EPA ID number. These state agencies also can tell you if a specific permit to transport medical waste is required.
Bags or sharps containers must be placed in labeled, sealed containers inside the generator’s location and on the truck. Rubbermaid containers of varying sizes are often used for this purpose. When a full container is picked up at the health care facility, it is generally replaced with one that has been cleaned or disinfected. Regardless, any visibly soiled container must be cleaned before being returned to the health care facility.
Vehicles must be fully enclosed and leak resistant or leak proof. The cargo area must be separate from the cab, and the back must be secured so containers do not topple or spill. Some states may require the truck be labeled as to its contents.
To treat or not?
All medical waste must be treated to render it noninfectious prior to disposal. This is usually done in an autoclave (steam sterilizer), though a variety of alternative methods have been approved at the state level. Human anatomical, pathological, pharmaceutical and trace chemotherapy wastes must be incinerated. Should these waste items be part of your service offering, you must have access to a suitable disposal site that provides incineration.
While the process of autoclaving is not complicated, permitting, installing and operating a treatment facility is expensive and adds additional requirements beyond the scope of this article. However, with autoclave sites spread throughout the country, many haulers have made arrangements with these sites to provide disposal for red bags and sharps containers.
If a hauler elects to go directly to the permitted treatment facility at the conclusion of each route, typically the only permits required are for the transportation outlined above. However, if the truck will be parked prior to proceeding to the treatment site, it must go to a permitted transfer station where the load can either be stored or consolidated onto a different truck.
Transfer station permits are not nearly as complex as treatment facility permits are, and many haulers with other businesses can modify their existing trucking sites for such transfer permits. However, no storage, unloading or transfer of waste can take place except at a permitted transfer station.
The transfer station requirements usually involve a secured building or yard, containment to prevent spillage and items necessary to clean up any spills that occur. Here, again, the requirements are state specific; therefore, the state Department of Health or the Environment should be contacted to secure specific requirements. Additionally, local laws concerning zoning and plan check may affect whether a site may be suitable for permitting as a transfer station. By contacting the local planning department, you will be able to determine whether a building will qualify for such an operation.
Opting for treatment
Offering full-service disposal of medical waste (containers, transportation, treatment and disposal) requires product inventory (bags and containers), permits and insurances. In this case, the capital investment is much higher than that for transportation alone. However, the benefits associated with operating your own treatment facility offer security both to you and your customer; you’re not at risk of losing your disposal site because of third-party issues beyond your control. These issues can include equipment downtime, labor strikes, ownership changes or capacity. The choice requires thought and evaluation, including equipment considerations.
Treatment can be via an autoclave, chemical sanitizer or alternative heat treatment. Autoclaves have the benefit of being universally accepted by each state without a specific technology permit. Other technologies must first be permitted by the respective state agency before being installed and used. Such permits are the responsibility of the technology manufacturer and not of the user.
Autoclaves vary by size and type and should be evaluated based on the volume and composition of the waste treated and whether material handling components are incorporated. Without material handling components, you’ll be dumping containers and carts manually.
The larger the autoclave, the more you’ll want to look at units that have pretreatment and post-treatment vacuum functions. These vacuums essentially remove air from the vessel, which increases the efficiency of the unit.
Other technologies, such as concurrent shredding of the waste while being treated, leaving the waste nonrecognizable as well as noninfectious, offer different benefits. In some locales this may be preferred.
Once a choice has been made, a comprehensive efficacy study using surrogate waste (unless otherwise authorized) will establish the required operating parameters of the technology selected.
Choosing to treat waste yourself does have a myriad of benefits, and you do have options regarding the technology that will work best for you. Treating waste is not difficult as long as care is taken to establish the operating parameters (time and temperature profiles for autoclaves, for example) that will ensure efficacious treatment of the waste.
Reporting and recordkeeping
Each load of waste requires a “chain of custody” document. This document may be called a manifest or tracking document. It is a paper trail that lists the generator, transporter or transporters, treatment entity and disposal site. First and foremost, this is the most important document of record and typically must be retained for viewing by any authorized regulatory agency at any time for a period of three years.
Additional documents may include employee training, such as the Hazard Communication and Blood Borne Pathogen training programs required by OSHA (Occupational Safety and Health Administration) as well as others on a case-by-case basis. IIPP (illness and injury prevention programs) must be established in writing and available to regulators and employees at any time. Such training programs must be available to employees upon hiring and must include annual or other periodic updates. Experience shows that the better the training program, the fewer the injuries and violations of law and regulation.
Additional considerations
Your customer also will drive what is required. Many hospitals, for example, require 10-year background checks on all employees of the medical waste disposal firm; however, because hospitals are subject to licensing, certification and accreditation standards, their policies and procedures for vendors can vary widely. Small-quantity generators, such as practitioner’s offices, outpatient centers, clinical laboratories and dental offices, may have fewer vendor requirements and be easier to serve.
Knowing the market you wish to serve, its size and the customer base you wish to target will help define the requirements you need to establish this segment of your business. You also can discuss what’s required with your existing customers to ensure your service program targets their specific issues. Local and state regulatory agencies often are helpful in this area as well. They like the business base and the advantages that competition affords the health care sector and, in most instances, will encourage the effort.
Choosing to expand into medical waste can make sense on many levels for secure document destruction companies already providing services to the health care sector. A comprehensive market and regulatory analysis will help determine the viability and scope of the effort.
Bob Spurgin is president of Spurgin & Associates, an environmental consulting firm in Irvine, Calif., established in 1989. He is a nationally recognized expert in health care waste management practices and has assisted more than 200 hospitals and health systems in addressing waste management and environmental issues. He also heads a Medical Waste Advisory Group on LinkedIn and has appeared on television and spoken at many national conferences concerning medical waste. More information can be found at www.spurginassociates.com.