A long-standing adage in the healthcare industry is "first, do no harm." When it comes to prot
ecting the environment, this industry must take this challenge to heart. As a group, the healthcare industry generates over two million tons of waste annually. This amount of waste, along with many other aspects associated with healthcare facility operation, gives the industry a very large "environmental footprint" and attracts heavy environmental regulatory, accreditation and ethics scrutiny. This article presents some "food for thought" regarding several major issues surrounding a few primary environmental laws affecting healthcare providers.
First, who exactly should be concerned about these different types of environmental issues? These would include any of the following:
• Ambulatory surgical centers
• Birthing centers
• Blood banks
• Clinics (medical, dental and veterinary)
• Dialysis centers
• Educational/research centers
• Emergency centers
• Hospices
• Hospitals
• Pharmacies
• Pharma manufacturers
• Laboratories (clinical and diagnostic)
• Long-term care facilities
• Research facilities
The history of general environmental standards in the healthcare industry hit the headlines in the late 1980s when medical waste began washing up on east coast shorelines. This spawned the 1990 Federal Pollution Prevention Act. In 1998, when public officials realized the healthcare industry was the fourth largest source of mercury in waste streams, the Environment Protection Agency and American Hospital Association entered into a Memorandum of Understanding that set the framework for the "Hospitals for a Healthy Environment" program. This program addressed a number of issues including elimination of mercury waste, minimization of other chemical waste and a focus on pollution prevention.
The memorandum jumpstarted serious discussions of a number of far-reaching implications in hopes of decreasing the industry's environmental footprint. The concept of "Practice Green Health" was started as a result.
Eventually, the Joint Commission on Accredited Hospital Organization's certification process evolved to include that institutions demonstrate compliance with environmental control/compliance. JCAHO also manages safety risks, promotes safe working environments and performs inspections of facilities, hazardous materials, waste management plans, permits and licensing. Some states accept JCAHO certification as evidence of facility compliance with certain laws; however, the Joint Commission certification does not preclude inspections by state or federal agencies.
Healthcare facilities are a microcosm of almost every aspect of environmental law affecting air, water, waste, nuclear material and toxic substances — all regulated media.
Healthcare facilities, particularly hospitals and research facilities, are some of the largest waste generators in the United States. All types of waste — solid, hazardous, pharmaceutical, medical and low-level radioactive — are generated by healthcare facilities daily.
Exacerbating this situation even more is the use of "disposable" medical products. It is estimated by the EPA that 1 percent of all solid waste in the U.S. originates at healthcare facilities.
One of the most common violations cited by the EPA is the commingling of various types of medical waste with common garbage, which does not have a special regulatory program related to disposal and handling. These two types of waste must be separated.
A unique category of solid waste encountered frequently by healthcare facilities is construction/demolition waste. C&D wastes, such as asbestos, lead-based paint and lead shielding, often require special handling and disposal. Any facility considering refitting or demolition must be sensitive to properly disposing of materials used decades before, but now considered hazardous.
At first glance, discarding old medical records would seem to be a simple matter. But, If you treat them as simple waste, you are in violation of the Health Information Portability and Accountability Act. Any protected health information, including electronic and paper medical records, must be handled, disposed and/or recycled in such a way that protects patient confidentiality.
Biohazardous materials, which washed up on the east coast beaches in the 1980s, include blood and blood products, body fluids, tissues and organs, used bandages, used surgical instruments, discarded "sharps," cultures and surgical gloves and gowns. These are often referred to as "Red Bag Wastes." Though not regulated as a "hazardous waste" in most jurisdictions, this category must now be handled separately and may be incinerated at facilities specifically permitted under the Clean Air Act.
Worker safety laws also govern the handling of biohazardous material and other "environmental" issues such as exposure to toxic substances, noise and equipment operation. When it comes to occupational safety and health programs, half the states have their own federally approved programs. These are more commonly administered by state labor regulators.
Additionally, some waste from facilities is regulated under the Atomic Energy Act. The Nuclear Regulatory Commission licenses and regulated nuclear devices and radioactive waste including solids, liquids and gasses contaminated by radioactive substances used in the diagnosis and treatment of diseases. The NRC does differentiate between low levels and high levels of radioactivity in waste. As a rule, healthcare facilities produce low level waste. However, check the regulations closely. Violation of the NRC regulations can result in violations being deemed criminal.
The highest percentage of healthcare industry violations relates to the improper handling of hazardous waste. The waste is generated throughout the facilities in any number of ways. Maintenance materials, cleaning fluids, solvents, laboratory chemicals and pharmaceuticals fall into this category. These materials are highly regulated under federal rules and mandate a cradle-to-grave framework for their handling and disposal.
Unused pharmaceuticals are gaining increasing attention from federal regulators since scientists have identified numerous pharmaceutical compounds which have found their way into the nation's waterways in discernible levels. In the past, facilities have disposed of large quantities of unused drugs by flushing them down the drain. There is now evidence of endocrine disruptors in the nation's waterways, forcing healthcare facilities to address this waste disposal in a controlled manner.
The second most common citation for healthcare facilities is violation of the Clean Air Act. Boilers, incinerators, sterilizers and generators are stationery sources requiring permits under the Clean Air Act. Permitting is very complicated and depends on the locality and technology proposed.
Indoor air quality can also be an issue. There must be proper air handling systems in place. Failure to do so can result in problems that exacerbate exposure and possible allergic reactions to dust and airborne vapors. Water intrusion, from any number of possible sources, may foster the growth of microorganisms, including mold. These could be dangerous to individuals with immature or compromised immune systems.
Waste water is the final area we will deal with in this article. Most facilities simply discharge their waste water into a sewage system operated by local government. These public facilities must comply with the federal Clean Air Act and will establish water quality standards for the facility. An industrial user permit is required. Substances from the healthcare facility wastewater can complicate the discharge system. These particular substances, such as detergents, maintenance chemicals, lab waste and pharmaceutical flushing must be pre-treated.
In conclusion, when addressing environmental issues at an operating facility or conducting due diligence in an acquisition, healthcare facility administrators must work with their environmental, health and safety professionals and environmental counsel to conduct detailed environmental audits of their facilities. The EPA and states have protocols supporting the concept of "internal compliance audits." When followed and violations are corrected and self-reported, the facility will mitigate the possibility of those violations causing harm and/or being found in an inspection and being subject to civil penalties or worse. The healthcare industry must meet its environmental obligations, duties and the oath that sets the standards of the medical community: "First, do no harm."
Bill Gorton is chair of the Environmental, Natural Resources & Energy Service Group at Stites & Harbison. He is national counsel to numerous clients related to environmental, regulatory and land/water resources matters. He advises clients in transactions involving the sale or acquisition of highly regulated businesses, facilities and real estate including environmental due diligence and addressing associated liabilities. Mr. Gorton also assesses and advises risks associated with operational aspects and facility site conditions for corporate America. Prior to his law career, he managed many projects throughout the U.S. as an environmental consultant.
ecting the environment, this industry must take this challenge to heart. As a group, the healthcare industry generates over two million tons of waste annually. This amount of waste, along with many other aspects associated with healthcare facility operation, gives the industry a very large "environmental footprint" and attracts heavy environmental regulatory, accreditation and ethics scrutiny. This article presents some "food for thought" regarding several major issues surrounding a few primary environmental laws affecting healthcare providers. First, who exactly should be concerned about these different types of environmental issues? These would include any of the following:
• Ambulatory surgical centers
• Birthing centers
• Blood banks
• Clinics (medical, dental and veterinary)
• Dialysis centers
• Educational/research centers
• Emergency centers
• Hospices
• Hospitals
• Pharmacies
• Pharma manufacturers
• Laboratories (clinical and diagnostic)
• Long-term care facilities
• Research facilities
The history of general environmental standards in the healthcare industry hit the headlines in the late 1980s when medical waste began washing up on east coast shorelines. This spawned the 1990 Federal Pollution Prevention Act. In 1998, when public officials realized the healthcare industry was the fourth largest source of mercury in waste streams, the Environment Protection Agency and American Hospital Association entered into a Memorandum of Understanding that set the framework for the "Hospitals for a Healthy Environment" program. This program addressed a number of issues including elimination of mercury waste, minimization of other chemical waste and a focus on pollution prevention.
The memorandum jumpstarted serious discussions of a number of far-reaching implications in hopes of decreasing the industry's environmental footprint. The concept of "Practice Green Health" was started as a result.
Eventually, the Joint Commission on Accredited Hospital Organization's certification process evolved to include that institutions demonstrate compliance with environmental control/compliance. JCAHO also manages safety risks, promotes safe working environments and performs inspections of facilities, hazardous materials, waste management plans, permits and licensing. Some states accept JCAHO certification as evidence of facility compliance with certain laws; however, the Joint Commission certification does not preclude inspections by state or federal agencies.
Healthcare facilities are a microcosm of almost every aspect of environmental law affecting air, water, waste, nuclear material and toxic substances — all regulated media.
Healthcare facilities, particularly hospitals and research facilities, are some of the largest waste generators in the United States. All types of waste — solid, hazardous, pharmaceutical, medical and low-level radioactive — are generated by healthcare facilities daily.
Exacerbating this situation even more is the use of "disposable" medical products. It is estimated by the EPA that 1 percent of all solid waste in the U.S. originates at healthcare facilities.
One of the most common violations cited by the EPA is the commingling of various types of medical waste with common garbage, which does not have a special regulatory program related to disposal and handling. These two types of waste must be separated.
A unique category of solid waste encountered frequently by healthcare facilities is construction/demolition waste. C&D wastes, such as asbestos, lead-based paint and lead shielding, often require special handling and disposal. Any facility considering refitting or demolition must be sensitive to properly disposing of materials used decades before, but now considered hazardous.
At first glance, discarding old medical records would seem to be a simple matter. But, If you treat them as simple waste, you are in violation of the Health Information Portability and Accountability Act. Any protected health information, including electronic and paper medical records, must be handled, disposed and/or recycled in such a way that protects patient confidentiality.
Biohazardous materials, which washed up on the east coast beaches in the 1980s, include blood and blood products, body fluids, tissues and organs, used bandages, used surgical instruments, discarded "sharps," cultures and surgical gloves and gowns. These are often referred to as "Red Bag Wastes." Though not regulated as a "hazardous waste" in most jurisdictions, this category must now be handled separately and may be incinerated at facilities specifically permitted under the Clean Air Act.
Worker safety laws also govern the handling of biohazardous material and other "environmental" issues such as exposure to toxic substances, noise and equipment operation. When it comes to occupational safety and health programs, half the states have their own federally approved programs. These are more commonly administered by state labor regulators.
Additionally, some waste from facilities is regulated under the Atomic Energy Act. The Nuclear Regulatory Commission licenses and regulated nuclear devices and radioactive waste including solids, liquids and gasses contaminated by radioactive substances used in the diagnosis and treatment of diseases. The NRC does differentiate between low levels and high levels of radioactivity in waste. As a rule, healthcare facilities produce low level waste. However, check the regulations closely. Violation of the NRC regulations can result in violations being deemed criminal.
The highest percentage of healthcare industry violations relates to the improper handling of hazardous waste. The waste is generated throughout the facilities in any number of ways. Maintenance materials, cleaning fluids, solvents, laboratory chemicals and pharmaceuticals fall into this category. These materials are highly regulated under federal rules and mandate a cradle-to-grave framework for their handling and disposal.
Unused pharmaceuticals are gaining increasing attention from federal regulators since scientists have identified numerous pharmaceutical compounds which have found their way into the nation's waterways in discernible levels. In the past, facilities have disposed of large quantities of unused drugs by flushing them down the drain. There is now evidence of endocrine disruptors in the nation's waterways, forcing healthcare facilities to address this waste disposal in a controlled manner.
The second most common citation for healthcare facilities is violation of the Clean Air Act. Boilers, incinerators, sterilizers and generators are stationery sources requiring permits under the Clean Air Act. Permitting is very complicated and depends on the locality and technology proposed.
Indoor air quality can also be an issue. There must be proper air handling systems in place. Failure to do so can result in problems that exacerbate exposure and possible allergic reactions to dust and airborne vapors. Water intrusion, from any number of possible sources, may foster the growth of microorganisms, including mold. These could be dangerous to individuals with immature or compromised immune systems.
Waste water is the final area we will deal with in this article. Most facilities simply discharge their waste water into a sewage system operated by local government. These public facilities must comply with the federal Clean Air Act and will establish water quality standards for the facility. An industrial user permit is required. Substances from the healthcare facility wastewater can complicate the discharge system. These particular substances, such as detergents, maintenance chemicals, lab waste and pharmaceutical flushing must be pre-treated.
In conclusion, when addressing environmental issues at an operating facility or conducting due diligence in an acquisition, healthcare facility administrators must work with their environmental, health and safety professionals and environmental counsel to conduct detailed environmental audits of their facilities. The EPA and states have protocols supporting the concept of "internal compliance audits." When followed and violations are corrected and self-reported, the facility will mitigate the possibility of those violations causing harm and/or being found in an inspection and being subject to civil penalties or worse. The healthcare industry must meet its environmental obligations, duties and the oath that sets the standards of the medical community: "First, do no harm."
Bill Gorton is chair of the Environmental, Natural Resources & Energy Service Group at Stites & Harbison. He is national counsel to numerous clients related to environmental, regulatory and land/water resources matters. He advises clients in transactions involving the sale or acquisition of highly regulated businesses, facilities and real estate including environmental due diligence and addressing associated liabilities. Mr. Gorton also assesses and advises risks associated with operational aspects and facility site conditions for corporate America. Prior to his law career, he managed many projects throughout the U.S. as an environmental consultant.