Healthcare Best Practices Blog

Chemotherapy – What you don’t know might hurt you

Written By Matt Bauer, Marketing Intern

Chemotherapy treatment has been responsible for saving the lives of millions of cancer patients, but this same treatment may be killing those that administer it.  By design, chemo drugs are deadly.  Chemotherapy drugs are used to exterminate fast-dividing cancer cells in the body, in order to return the body to its normal state.  Also, chemicals similar to chemo drugs were used in World War I as deadly mustard gas against soldiers. 

Studies from as far back as the 1970’s linked chemo agent exposure with increased rates of cancer, but it wasn’t until the mid-1980’s that Occupational Safety and Health Specialists (OSHA) deemed chemotherapy agents “hazardous.” Thousands of healthcare workers were chronically exposed to these agents on the job before voluntary regulations were put into place. 

Although the drugs and byproducts of chemotherapy are considered toxic, recent findings from the Pacific Northwest based investigative journal, InvestigateWest, show that OSHA does not regulate exposure in the workplace.  A new study done by the U.S. Centers for Disease Control (CDC) confirms that chemo continues to contaminate these facilities, despite knowledge of the dangers and the safety precautions necessary to avoid them.

 In regards to these findings, OSHA claims to have no regulatory authority over the matter other than under their “General Duty” clause – a clause that allows inspectors to warn institutions if they see a concern.  InvestigateWest documents that OSHA has only used the General Duty clause once in the last 10 years to warn a healthcare facility of their handling of hazardous material. 

There are several chemotherapy drugs that are regulated under RCRA hazardous wastes standards, but many others are not.  Due to this disconnect in the OSHA and RCRA regulation, most hospitals and other healthcare facilities have customized procedures for employee handling of chemo agents.  This confusion about regulation and hazardous material determination is a common problem in the healthcare industry. 

Workers in the Healthcare field come into more contact with known human carcinogens than workers from any other occupation.  For this reason, most occupational health specialists advocate for stricter regulation of chemotherapy drugs and chemo waste.  In order to reduce confusion, changes must be made on a federal level.  More needs to be done to protect the people that help save so many lives.

If you have any questions please contact Steve Todisco, Senior Healthcare Account Manager Triumvirate Environmental Cell: 339-226-0524, stodisco@triumvirate.com

Keeping costs down in the Healthcare EH&S Arena

Steve Todisco, Senior Healthcare Account Manager

When it’s time to get something done what is your typical method of making it happen if you can’t get it done internally? Whether you work for a living, purchase goods and services as a private consumer, own your own business, work for yourself, or work for someone else, when you need something you go out and research your best overall value; right? Maybe you go out and get a few “bids” so that you can accurately compare costs from multiple organizations. People do it when they buy homes, shoes, and when they purchase professional services.

There is a commercial floating around right now that speaks to cutting costs and there is a group of office folks sitting around a conference room table trying to figure what else to “cut” from their budgets. I know you have seen it. One of them has an epiphany and says to everyone. “What about all of this stuff?” Referring to paper, pens, folders, supplies, software, people, time, effort, etc. Then the finance guy says it could cost us millions. Millions?

The point that I am trying to make is when purchasing anything there are certain costs that we usually don’t track. These costs are typically referred to as soft costs. Soft costs can include:

• Your time spent: (Your time is valuable right? How much have you wasted so far?)
• The cost of doing your due diligence
• Hiring a consultant to help you make a decision
• Wasted office supplies
• Insurance on existing
• Benefits for existing employees
• Pulling existing resources away to make them do something else, at a lower quality
• Many, Many more

I recently was involved in bidding on a hazardous waste pharmaceutical program and then won the contract, and some of the individuals involved kept telling me that they were going to “do that internally”. They were referring to completing their own waste pickups, doing their own training, inspections, purchasing their own containers, etc. In the midst of the whole process I kept trying to inform them that the individuals who you will be tasking to complete these new jobs already have many tasks to do day to day, and I kept asking them - have you considered the cost (internally) to having these folks work the extra hours, etc. Of course they thought that they didn’t have to worry about those things because it wasn’t their job to. The largest cost to this particular institution was to complete their own training of about 1200 nurses. Now I don’t know about you but I’ve trained a lot of nursing staff over the past 5 years; and I don’t care what anyone says, it takes some time to get that done. If you plan on doing it yourself plan on making sure that you consider the internal “cost “ to your organization of about 150 hours of actual training time. That’s no small cost. And when you add in the fact that they have to be trained also it adds even further soft costs to the overall concept.

What is the kicker is that this person making the decisions wasn’t aware that an independent consultant was hired by senior management and was in the process to “dig in” to where the spending was occurring in their department. When they uncovered the internal costs to the organization for all the wasted time, untrained resources, lack of knowledge on the topic, and many other factors they came up with the department had actually costed internally $146,000 (These are actual numbers folks) dollars to this specific program in soft, internal costs. In my world that is a lot of money, and lo and behold guess what happened next? Yup – you guessed it. The individual that was responsible for this department was let go due to overspending, and not truly understanding what it was really costing them. (Now I guess getting rid of a position is a cost savings).

Senior management then asked me to provide what would have been the cost if we had completed all of the items that they wanted to do “internally”, and I was sad to say that the number came up to a measly $38,000 dollars when all was said and done. This means I am probably not charging enough. That’s a story for another day.

The overall and underlying point I am trying to get across is that there are many costs that we don’t think of as “hard costs”. The costs that don’t show up on the budget sheets in those senior management meetings, the ones that come up to organizations each and every day.  The really great organizations, which balance the budget sheets well, and can, stay in the black, are those that have all the facts, and make decisions that best fit their particular organizations. These need to be considered all the time, and especially when you hire a vendor, contractor, company who provides supplies, etc. We can usually provide a better, more customer intimate service that gets the job done for an overall less cost (both hard and soft) to an organization.

If you have any questions on how to manage and or define your soft costs please don’t hesitate to contact me.

Steve Todisco, HEM, CHMM Senior Healthcare Account Manager Triumvirate Environmental Inc. stodisco@triumvirate.com

Similarities and differences between Pharmaceutical and Chemotherapy waste

By Steve Todisco, Senior Healthcare Account Manager

Some of you out there have been asking questions about the differences and similarities between chemotherapy waste and the newly coined term, "pharmaceutical" waste. By definition, pharmaceutical waste includes all expired, unused, contaminated or discontinued drugs (also known as medicines or chemicals) that can no longer be used for humans or animals. Chemotherapy waste, once no longer intended for human or animal use, is really just a sub-set of pharmaceutical waste.

In the broader scale, Pharmacy waste falls in to one of several categories; it is either hazardous or non-hazardous (as defined by the EPA). Thus, it stands to reason that chemotherapy waste, also, may be either hazardous or non-hazardous. There are currently nine (9) chemotherapy drugs whose waste is listed by the EPA as hazardous since 1976. Ironically, this list has not been updated and there are today many more chemotherapy drugs whose waste is much more dangerous to the environment than the original list of nine (9)...more to follow on this issue.

Typically, chemotherapy waste no longer intended for human or animal use comes in three flavors for those who are managing, collecting and disposing of it; namely, "product", "trace" or "bulk". The following rules apply: 1) If the chemotherapy waste is a packaged drug and eligible for reverse distribution (a topic for another day), then it may be managed as a "product" and returned for credit. 2) If the chemotherapy waste is EPA "listed" or "characteristic" within a container and less than 3% of its therapeutic dose remains intact (including gowns, glove, masks used in the administration of the chemotherapy waste for which there are no spills or leaks on them), then it may be managed as non-hazardous "trace" chemotherapy waste. It is usually collected in a "yellow bucket" and may be disposed of by a medical waste incinerator. 3) If the chemotherapy waste is EPA "listed" or "characteristic" within a container and more than 3% of its therapeutic dose remains intact (including contaminated gowns, gloves or other disposable items upon which chemotherapy has spilled or leaked-out upon them), then it must be managed as hazardous waste. It is then typically placed in the "black bucket" and disposed of by a hazardous waste incinerator. And finally, 4) if the chemotherapy waste is not identified as either "listed" or "characteristic", it may be managed as non-hazardous waste and disposed of as trace chemotherapy per above.

Which, of course, leaves us some final, parting thoughts; such as:

1. Given that the chemotherapy drugs developed and manufactured after 1976 are far often more dangerous to ourselves and to our environment than those identified in 1976 (albeit currently not regulated), should we, as good and responsible stewards of the earth, collect all chemotherapy waste, regardless of their properties, and,

2.  If we do, should all chemotherapy waste then be disposed of only by hazardous waste incineration?

Where does the line blur between "cost" and "conscience"?

For your opinions, or for a free consultation for building an EPA compliant pharmaceutical program, please contact per the information below.

Steve Todisco, Senior Healthcare Practice Manager, HEM, CHEM
Triumvirate Environmental, Inc.
Cell Phone: 339-226-0524 or Email: stodisco@triumvirate.com

An Intro to Rad Waste for New York State Hospitals

By Courtney Drayer, Technical Services Representative

Radioactive waste is divided into 3 categories; high level, mill tailings, and low level. High level radioactive waste is spent nuclear reactor fuel. Mill tailings are contaminated soils and debris remaining after an area has been mined for Uranium Ores. Commercial waste that is neither high level nor mill tailings is low level radioactive waste. Low level radioactive waste (LLRW) can consist of any material that has become contaminated with radioactive material or has become radioactive via exposure to neutron radiation.

LLRW are generated at commercial facilities such as hospitals, universities, and some industrial facilities. Some common examples of LLRW include PPE used in areas where radioactive material is present, animal carcasses containing radioactive pharmaceuticals, scintillation fluids, and equipment used to process radioactive materials. Low level radioactive waste is then further divided into 4 subcategories in 10 CFR 61.55-56 (http://www.nrc.gov/reading-rm/doc-collections/cfr/part061/part061-0055.html). These subdivisions are, in order of increasing radioactivity; Class A, Class B, Class C, and Greater than Class C. Class A-C is regulated by the Nuclear Regulatory Commission while the "Greater than Class C" group is generally regulated by the Department of Energy. Most radioactive materials used in Hospitals can be stored on site until the material has decayed to a point where the radiation level of the waste matches that of the background level. At that point, the waste can either be disposed of as regulated medical waste or hazardous waste, as appropriate. When decay does not occur within a reasonable time frame (half lives > 90 days), this waste must be sent to a low level radioactive waste disposal facility for proper disposal.

In order to obtain any radioactive material or engage in research or clinical activities with radioactive materials in NYS a license must be obtained. The licenses for radioactive waste generators in New York State fall under the jurisdictions of the New York State Department of Health (NYS DOH), the New York City Department of Health (NYC DOH), or the Federal Nuclear Regulatory Commission (NRC). Most sites will fall under the NYS DOH jurisdiction. Institutions in NYC will fall under NYC DOH while Nuclear power plants will fall under NRC. All licensees that generate or plan to generate LLRW within the next 5 years, regardless of jurisdiction, are required by 21 NYCRR Part 502 (http://www.nyserda.org/about/nyserda.regulations.pdf) to file an annual low-level radioactive waste report with the New York State Energy Research and Development Authority. If any of the waste disposed of is mixed radioactive and hazardous waste, that waste will also need to be included on the annual report for hazardous waste for NYS and included in waste weights for the NYS TP550 quarterly hazardous waste tax.

DAB Disposal in NYC

By Courtney Drayer, Technical Services Representative

3,3'-Daminobenzadine tetrahydrochloride (DAB) is an organic molecule that is oxidized by hydrogen peroxide in the presence of hemoglobin to produce a dark brown color that histologists can used to stain nucleic acids and proteins. Although DAB waste is not specifically regulated by the Environmental Protection Agency (EPA) or the New York State Department of Environmental Conservation (NYS DEC), DAB comes from a class of molecules (benzadines) which are known carcinogens. In fact, all benzadines that have been studied have been determined to have mutagenic properties by the US National Toxicology Program. Since DAB is not regulated, specifically, by EPA or NYS DEC, lab personnel may be tempted to "detoxify" and/or dispose of DAB through the sewers. It should be noted, however, that most methods of treatment result in either a hazardous solid or chlorinated byproducts that are also mutagenic. So what's an EH&S manager to do?

There is at least one more regulatory agency in New York City to consider while deciding how to handle your DAB waste; The Department of Environmental Protection. The DEP governs and enforces the RCNY (Rules of the City of New York) regulatory body which covers "Materials and Substances Excluded from Public Sewers" in Title 15, Chapter 19-03. This chapter describes materials that not permitted to be discharged down the drain and Line 10 (iii) states that:

Toxic substances in such quantities, which the person knows or has reason to know, may when discharged from a single source or in combination with other sources; (iii) be detrimental to the health of human beings, animals, or aquatic life.

Since benzadines are known carcinogens, they are detrimental the health of humans and animals. Within NYC, the RCNY is the regulatory basis for the collection, treatment, and ultimate disposal of DAB as a non regulated but toxic material. Outside of NYC, line 10 (iii) is still regulation with a lot of common sense. If you wouldn't want to drink it and it causes harm to people and the environment, please don't put it down the drain.

EPA INSPECTIONS: Preparing for, and responding to a surprise inspection

By Lawrence Hren, Onsite Support Services Coordinator

In my recent experience with EPA inspections focused toward laboratory and hazardous waste management, it has become apparent that preparation for a surprise inspection is every bit as important as properly responding to an inspection. While this is by no means an all-inclusive guide to successfully handling an EPA inspection, the following should serve as an outline of key points to consider prior to and during an inspection:

• Is your emergency contact information accurate and up to date?
• This may be one of the first things an inspector delves into upon arrival at your facility. Additionally, it is important to test your primary and secondary methods of acquiring an MSDS in the event of an emergency. For example: if you have identified that MSDS's will be obtained via the internet in the event of an emergency, you should also be sure that you are familiar with an alternative method such as calling an emergency MSDS hotline and that an MSDS can be faxed to your facility on short order.
  

• Is your Main Accumulation Area (MAA) well maintained, in compliance, and is your weekly MAA inspection log complete and up to date?
• Proper MAA maintenance is intrinsically linked to running a top notch Haz-Waste management program at your facility. Deficiencies during this portion of an EPA inspection will most likely lead to a higher level of scrutiny during the remainder of the inspection. Be sure that you are completely in compliance with MAA regulations and that the space is as clean and organized as possible. Don't forget to make sure all emergency contact info is conspicuously posted and a phone is located inside of or very close by the MAA
• Weekly MAA inspection logs are to be kept on file for 3 years. It is crucial that there are no gaps in the records. Be sure to take into account long weekends and holiday schedules. If you can present a simple SOP geared towards accommodating for such circumstances, all the better!
  

• How well are your laboratories maintained? Are training records kept on file and readily available?
• Once inside the lab, an inspector will most likely ‘interview' lab staff. Questions will focus on waste management, safety procedures, and chemical compatibility issues in your chemical storage cabinets. 
• RCRA is all about records. Be sure that all laboratory training records and lab SOPs are available. 
• Out of date, unusable, or excessive amounts of chemicals should not be stored in the lab. Chemical storage/labeling issues raise a red flag, and are viewed as an indicator of poor lab practices

The main thing to keep in mind during an inspection is to remain calm and answer all questions honestly and to the best of your ability. Never try to down-play compliance issues as a means to dissuade the inspector from looking into them. Dedication to running an exemplary program goes a long way.

Risks/Rewards for a hospital using one source for all waste-streams.

By Bob Shuman, National Corporate Healthcare Director

Hospital organizations are now being sought after by some Waste Providers to "bundle" all of their waste-streams under one contract. This one-size fits all concept has certain risks and rewards that should be examined closely. This notion is becoming particularly popular with Hospital Senior Management. Let's discuss some of the implications of this concept, now.

Perceived Rewards - One provider, one invoice, one contact person, one culpable party when things go "bang in the night", one-stop shopping. Sounds good on paper...and may be good for the bottom line ("may" being the operative word).

Potential Risks - No one waste provider manages, expertly, all waste-streams. No one waste provider actually services all waste-streams without "brokering" some portion of the business. No one waste provider can deliver technical and regulatory guidance on all waste streams.

So, at the end of the day you have to ask yourself, does convenience outweigh compliance?

It's your call...more to follow.

Proper Labeling of Chemicals

By Steve Todisco, Senior Healthcare Account Manager

If you work in any field that pertains to hazardous waste management in any region of the United States, and also in any niche; you are bound by a few sets of rules. And by a few I mean a lot more than a few. Some of those rules are simple to follow and some of them are not. In the following paragraphs I am going to give you the keys to giving your hazardous waste program a good old compliance boost! (For those with a weak heart you might want to turn back now).

The proper labeling of chemicals in the form of labeling for hazardous and non-hazardous waste will take you very far in the world when it comes to being subjected to a full force inspection. Each state has it’s own special rules but you can boil it down to a few specific easy to follow items:

• The words hazardous waste

• Full chemical name with no chemical formulas or abbreviations

• Properly checked off hazard classes (Toxic, Ignitable, Corrosive, Reactive)

• A date when the container has been “deemed” full by its owner

Some states won’t require all of the above to be followed, but some states will (for a complete listing of what your state requires – Please go to your state specific website).

When it comes to non-hazardous waste the most important thing is that regulators know and understand visually that the waste in question is actually non-hazardous waste. With the simple creation of a label that states what the waste stream is and the words non-hazardous you can avoid questioning.

These are both state and federal requirements so make sure that your labeling your hazardous and non-hazardous waste appropriately because it accounts for a large percentage of violations that we see on a day to day basis. Simple training on this matter will help you avoid writing a large paycheck to your favorite regulatory institution.

As always if you have any questions, please feel free to call me at 339-226-0524.

Ambulatory Care

By Steve Todisco,  Healthcare Account Manager

How many of you are familiar with pharmaceutical waste management, and also emergency showers in the emergency department?

In the world of pharmaceutical waste there are many locations that usually have waste that needs to be picked up and disposed of properly. Areas like the pharmacy, nursing units, Emergency Room, ICU, etc. Did you know that the ambulances routinely give medication routinely in route to the hospital? They typically generate a small amount of pharmaceutical waste that more often than not get’s mishandled. One simple way to avoid issues with local, state, and federal regulatory agencies is to provide a proper pharmaceutical waste container for the guys and gals that complete your ambulatory care upon the checkout of a particular patient they have cared for (even though it was a short time). The waste you will find could fall into many categories like biomedical waste, hazardous chemical “pharmaceutical waste”, and non – hazardous waste as well. Be sure to include this outlying area usually within the ED as an accumulation area and complete your required inspections and assessments.

The other area typically missed also within the emergency department is known as an emergency shower. Or a decontamination shower “Decon shower”. These showers are used to decontaminate potentially contaminated and contaminated patients as they get admitted to the emergency department. This area is typically drained to an underground storage tank (UST). Now depending on what your wastewater permit allows for discharge you might have to have this tank analyzed and pumped off for disposal prior to allowing for discharge. Another unfortunate use of an area such as this is on occasion in the winter time (if you have snow in your area!) these wheeled gurney’s (hospital beds) which will accumulate sand and salt from the outdoor activities and get cleaned in your Decon shower because it is central to the outside door. Same deal here if your discharge permit has limitations on what you can discharge you might want to look into if this practice is happening at your facility.

As always if you have questions please don’t hesitate to contact me.

Pharmaceuticals Found in the Drinking Water

 Regulatory Compliance and Social Responsibility

By Bob Shuman, National Healthcare Director

Many hospital organizations today are struggling internally with the dilemma of meeting the regulatory standards for the management, collection and disposal of pharmaceutical waste. This predicament is further complicated with both the uncertainty of the direction E.P.A. is headed with its adoption of its proposed universal waste rule, as well as the harsh reality that many pharmaceuticals developed post-RCRA are far more dangerous to human beings, wildlife and the environment than those currently regulated (and enforced).

Given the latter issue related to those post-RCRA pharmaceuticals, the conundrum arises as to "how much" of the pharmaceutical band-width a hospital should be prepared to collect to achieve both compliance with applicable regulations, and, to also adopt the "socially responsible" position that promotes the preservation of our waterways and drinking water.

To be sure, hospitals are faced with the quandary of where they each feel they should place themselves along the pharmaceutical collection continuum. This decision is not a simple one; it brings to bear questions related to cost, training, time and resource allocation, to name just a few considerations. In the end, there is no "one" best solution; however, each hospital must take the plunge into the water soon, no matter how cold it may be, at first.