By Charlotte A. Smith and Gregory Gicewicz
The Healthcare Laundry Accreditation Council (HLAC) requires that a laundry facility meet specific standards related to its handling of pharmaceutical waste to pass inspection. These wastes are highly regulated. The regulations can oftentimes be challenging to understand, even for the expert. Recently, HLAC and the American Reusable Textile Association (ARTA) co-sponsored a webinar, “Managing Pharmaceutical Waste: What Healthcare Laundry Facilities Need to Know.” This is the first of three articles that are intended to provide a recap of the highlights presented in the webinar. For more information, please refer to the full presentation (available as a PDF) found here. (http://www.hlacnet.org/articles-reports-presentations)
Among the more than 600 standards found in the HLAC Accreditation Standards document are the requirements that:
- The healthcare laundry have policies and procedures in place that address the management of pharmaceutical-contaminated textiles (126.96.36.199)
- The healthcare laundry and the healthcare customer have established a mutually agreeable determination and course of action as to when a pharmaceutical-contaminated textile is to be managed (i.e., discarded) as a pharmaceutical waste or when the textile is to be returned to the customer (188.8.131.52.1).
Meeting these requirements can be a challenge, especially when you consider the complexities involved and the expertise required in the proper handling of pharmaceutical waste. In fact, for the healthcare laundry, there’s only one way to think about pharmaceutical waste: If your healthcare customer generates it, you probably will receive it. This includes drugs remaining in vials, ampules, syringes, used patches, IV bags, inhalers, etc., and the risks they expose.
So, knowing these scenarios, what are your options for handling waste? This can be difficult to answer, especially considering your need to adhere to the multiple agencies involved that oversee pharmaceutical waste management – at the national (EPA, DEA, DOT, OSHA), state (environmental agencies, which can be stricter than federal agencies), and local levels (publicly owned treatment works).
Answering the question begins with understanding some basics about pharmaceutical waste (note: these basics focus primarily on EPA hazardous waste):
“Hazardous” has multiple meanings, especially in healthcare
- Biohazardous refers to what is potentially infectious, like used needles and contaminated linens
- OSHA hazardous refers to what is potentially hazardous to the employee from exposure, like from chemotherapy
- EPA hazardous is defined as what is hazardous to the environment under the Resource Conservation & Recovery Act (RCRA), for example some chemotherapy drugs
- DOT hazardous are those items that pose a hazard during shipping, for example something that is flammable.
There’s a difference between regulated medical waste and hazardous chemical waste
- Regulated medical waste (RMW)
- These are known infection risks, or other potentially infectious materials (OPIM) also known as Red Bag, Red Sharps
- They are heavily regulated and enforced at the state level.
- Hazardous chemical waste
- These are chemicals, including pharmaceuticals, that are defined as hazardous from an environmental perspective
- Hazardous chemical wastes are regulated by the EPA and all state agencies (except Iowa and Alaska).
There are RMW vendors and there are hazardous waste vendors
- RMW vendors:
- May autoclave or microwave all RMW except pathological waste and trace chemotherapy waste
- May incinerate all RMW including pathological and trace chemotherapy waste
- May be authorized to treat non-hazardous pharmaceutical waste at incinerators; not at autoclaves or microwaves
- Permitted by the states; incinerator also permitted by federal government under the Clean Air Act and must meet federal MACT standards (Maximum Allowable Control Technology) for emissions control.
- Hazardous waste vendors (usually a different company):
- Must be authorized at the federal level for hazardous waste receipt and destruction at high temperature
- May also be permitted at the state level for incidental RMW
- Can receive both hazardous and non-hazardous pharmaceutical waste.
The Color-coded Solution
How do you navigate this regulatory jungle? Many healthcare facilities have already created a path for you to follow, and it offers a color-coded solution:
- Red containers: regulated medical waste, potentially infectious, a few drugs, such as plasma
- Yellow containers: “trace” chemotherapy waste – any items that once held chemotherapy drugs but are now empty (you might find these in “chemo” linens)
- White or blue containers: Non-hazardous drug waste – not regulated by EPA but regulated in some states
- Black containers: Hazardous drug waste regulated by EPA and most states
Of course, a color-coded solution raises some questions:
Do you need to carry all these different containers?
Not necessarily. You may decide to manage any drug waste you receive in the black containers, as a hazardous waste. As the most conservative and highly regulated waste stream, this is the most expensive to manage but you won’t need to make a “waste determination” other than to segregate out any pressurized aerosols. These items need to be collected in a separate black container to comply with DOT requirements.
Can you put any drugs down the drain?
The following drugs are what we call the “sewerableseven”:
- Lactated Ringer’s
- Potassium salts
- Calcium salts
- Magnesium salts
You still need to inform your POTW (publicly owned treatment works) of your intention but they should not have a problem with these items that are essentially “body fluids.”
Which vendor takes which containers?
Your regulated medical waste vendor can usually add the yellow containers, which are also regulated medical waste, may contain sharps, and can be managed as “trace” chemotherapy waste at a RMW incinerator. You may need to add this waste stream to your contract.
Your RMW vendor can often take the white/blue non-hazardous pharmaceutical waste container, if you choose to separate these from the hazardous waste pharmaceuticals.
The black hazardous waste containers must be managed by a hazardous waste vendor on a six-part manifest to insure cradle-to-grave tracking of the waste. The waste must be incinerated at a highly permitted hazardous waste facility. Your RMW vendor cannot take this waste but may have a relationship with a hazardous waste vendor that you can access.
Knowing these basics, here are some immediate action steps you can take regarding your handling of pharmaceutical waste:
Review what types of pharmaceutical waste you have been receiving from your healthcare facilities and how often.
Reiterate with your customers the need to reduce/prevent drugs from being placed in the soiled linens.
Check with your regulated medical waste vendor to determine what options they offer in terms of trace chemotherapy waste, non-hazardous pharmaceutical waste, and if they are partnered with a hazardous pharmaceutical waste vendor.
In our next installment, we’ll walk you through some critical decisions regarding managing pharmaceutical waste.
About the Authors:
Charlotte Smith is Senior Regulatory Advisor, PharmEcology Services for WM Sustainability Services, Houston, TX. Gregory Gicewicz is past president of HLAC and owner/operator of the healthcare laundry Sterile Surgical Systems, Tumwater, WA. HLAC Inspector Thomas “Tony” Fitzgerald contributed to the original presentation for the webinar.
Photo credit: (c) Can Stock Photo / mllejules