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. 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 last 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)
In the two previous articles, Handling Pharmaceutical Waste in Healthcare Laundry Part I and Part II, we discussed the basics of handling pharmaceutical waste received in the healthcare laundry, critical decisions you need to make in managing this complex waste stream, and containment and storage of pharmaceutical waste. Here, we’ll wrap up by discussing which waste vendors to use, how to manage DEA controlled substances safely and in compliance, and how to protect your employees from harm and your organization from OSHA violations.
Which Vendors for Which Waste Stream
Here’s a look at which waste vendors should you use for each waste stream.
Yellow trace chemotherapy waste containers/hamper bags:
- Your current regulated medical waste vendor should be able to manage trace chemotherapy waste for you through incineration at a regulated medical waste facility
- This waste stream is considered to be biohazardous,which means you can also place needles and other trace contaminated sharps into the hard plastic yellow container
- You will need an addendum to your regulated medical waste contract, which should specify that only EMPTY vials, ampules, IVs, etc. of chemotherapy can be accepted.
Black hazardous waste containers:
- A hazardous waste transporter must be used to manage this waste stream
- Your regulated medical waste management company may have a contracted vendor they work with and there are a number of local hazardous waste brokers whocan pick up your hazardous waste; they will generate the following required forms:
- Initialhazardous waste profile based on information you provide to them or their experience in the industry. This must be re-certified annually.
- The six-part hazardous waste manifest whichis created each time you ship hazardous waste and provides cradle-to-grave tracking.
- The shipping labels based on the hazardous waste profile and manifest.
- The Land Disposal Restriction Form (LDR) whichalso accompanies each shipment.
Choosing a Vendor
It’s important to choose a hazardous waste vendor that has experience managing pharmaceutical waste, as it is very different from typical industrial hazardous waste streams. Brokers will consolidate your hazardous waste and usually ship it to one of three companies in the US that routinely provide incineration at their TSDF (treatment, storage and disposal facility) – Clean Harbors, Veolia, and Heritage. These companies also provide direct pick-up services in various part of the country.
Regardless of which company does the pick up, require them to provide the EPA ID numbers for their company and the names, addresses, and EP ID numbers of all companies handling the waste including the final incineration firm.
There are some additional facilities that can manage this waste stream but you must have their ID numbers on file for your protection.
DEA Controlled Substances
The Drug Enforcement Administration (DEA) has published a list (schedule) of drugs that it considers to be “drugs of abuse.”
That is, they are drugs used inappropriately and illegally and are most often addictive. Those drugs that have no recognized medical use are listed in Schedule I of the five schedules. Heroin is a good example. Schedule II drugs are those that are recognized as being medically useful, but have very high addiction and abuse potential, such as morphine and oxycodone. Schedules III through V are drugs that have descending abuse potential, but still enough to be listed by DEA.
It’s extremely important that you have a program to identify and properly manage these drugs, both for your employees’ protection and your business liability.
Identifying a controlled substance
- Vials and ampules from the manufacturer will have the distinctive upper caseC with the appropriate Roman numeral such as CII, CIII, etc. on the label
- IV bags will have patient information and some indication that it is a controlled substance
- The manager receiving these drugs from the employee who is receiving soiled linen should be trained to recognize these markings.
How to manage controlled substance wastage
- The DEA’s Drug Disposal Rule of 2014 considers drugs that have been charged out to a patient and unused to be “wastage” and out of the DEA’sclosed loop regulatory system
- Your primary responsibility is to prevent diversion of these drugs and to manage them in compliance with all EPA, state, tribal and local environmental regulations
- The most conservative method is to purchase one of the “sequestering” devices on the market that render the drugs “non-divertible” by either adsorbing them onto an activated carbon material or chemically altering them in such away as to be unusable.
How to dispose of the sequestering devices
- Since the great majority of controlled substances are non-hazardous drugs, the used cartridges or devices can be disposed in the non-hazardous waste container when discarded, if you have chosen to segregate; otherwise, dispose of them in the hazardous waste container.
Discarding controlled substances down the drain to prevent diversion
- While this is allowed by some states, you must alsocheck with your local publicly owned treatment works (POTW) and obtain permission to do drain disposal
- This is not a best practice environmentally and may not be permitted.
- You will need to document the name, strength and quantity of the drug and double witness the sequestration
- You should also inform the healthcare facility that sent it of their breach of security in the handling of controlled substances, as this is a serious operational failure within their organization.
When managing pharmaceutical waste
- Assume all incoming items, including any drug vials, ampules, are considered to be potentially infectious waste
- Provide and documentrequired Blood Borne Pathogen training to all employees
- Provide appropriate personal protective equipment to potentially exposed employees
- Include specific procedures for sharps, scalpels, devices, etc.
- Provide appropriate Hazardous Materials Training with respect to potential exposure to trace chemotherapy, chemotherapy, and other hazardous drugs.
When managing Other Potentially Infectious Medical Waste (OPIM)
- Assume all linens are OPIM and wear appropriate PPE
- Pre-wash all linens labeled as “chemotherapy,” then re-wash with regular laundry
- Manage non-chemotherapy sharps of all kinds in a red sharps container labeled as “biohazardous”
- Manage TRACE chemotherapy waste in a yellow sharps container labeled as “tracechemotherapy” and biohazardous
- Contract with an appropriate regulated medical waste transporter for treatment at a permitted autoclave, microwave, or RMW incinerator for red sharps containers; trace chemotherapy waste should be sent onlyto an RMW incinerator.
- Manage manifests based on state regulated medical waste regulations.
Among the more than 600 standards found in the HLAC Accreditation Standards document are two requirements that focus on the need for the laundry to have policies, procedures and a course of action regarding the handling of pharmaceutical waste. But policies and procedures alone are meaningless without a proper understanding of the many different aspects involved in the management of these wastes – e.g., the multiple meanings of “hazardous,” the difference between regulated medical waste and hazardous chemical waste, how to store pharmaceutical waste, etc.
Pharmaceutical waste is a complex waste stream involving EPA, state hazardous waste authorities, the DEA, OSHA and DOT. The laundry has to know what it is doing in all of these interrelated areas or risk failing HLAC inspection. In fact, failure in any of these areas could add up to failing as many as 20 HLAC standards.
Know the basics, understand the critical decisions involved, and keep your employees safe: have a plan, identify and contract with appropriate waste vendors, provide appropriate PPE and training to relevant employees.
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.