July 22, 2022 Protect Patient Privacy with a HIPAA-Compliant Shredding Service Patient privacy and confidentiality are huge issues in healthcare. Cybercrime is a growing concern, particularly as more providers adopt electronic health records. For example, there were twice as many reported data breaches during the first five months of 2022 than in the same period in 2021. Although cybercrime gets a lot of attention, patient privacy is often compromised the old-fashioned way by improper disposal of paper documents containing patients’ protected health information (PHI). Any documents that have PHI should be stored securely before shredding/destruction and never mixed in with regular trash or recycling. Sharps Compliance offers secure, HIPAA-compliant document shredding and destruction services in select markets to help ensure providers comply with HIPAA regulations and protect patients’ health data and privacy. HIPAA Regulations and Healthcare Providers In 1996, Congress passed HIPAA, the Health Insurance Portability and Accountability Act, and the rules went into effect in 2003. The law was designed to “improve the efficiency and effectiveness of the health care system” and enact “federal privacy protections for individually identifiable health information.” The HIPAA Privacy Rule “requires appropriate safeguards to protect the privacy of protected health information and sets limits and conditions on the uses and disclosures that may be made of such information without an ‘individual’s authorization.” All healthcare providers and clearinghouses, health plans, and other covered entities must dispose of patients’ health information in a HIPAA-compliant manner. HHS suggested disposal/destruction methods include: For PHI in paper records, shredding, burning, pulping, or pulverizing the records so that PHI is rendered essentially unreadable, indecipherable, and otherwise cannot be reconstructed. Maintaining labeled prescription bottles and other PHI in opaque bags in a secure area and using a disposal vendor, who is considered a business associate and held to the same confidentiality standards, to pick up and shred or otherwise destroy the PHI in a way meeting the required standard. HIPAA Violations Can Be Costly HIPAA-compliant document management and disposal protect your patients’ privacy and your organization’s financial bottom line. Failure to comply with HIPAA can result in both civil and criminal penalties. The fines escalate quickly for repeat violators. Fines can range from $100-$50,000 (per record) based on the level of negligence. The maximum penalty is $1.5 million annually for violations of identical provision. Violations can also result in jail time if the entity has been cited but did nothing to correct the issues (willful neglect). Fines increase with the number of patients and amount of neglect. In addition to the regulatory costs, bad publicity for the hospital or practice may erode patient trust and confidence. For example, in 2019, New York City reporters found boxes containing hundreds of medical files piled on the street outside an office building. The files included “patient names, social security numbers and sensitive medical diagnoses.” The medical practice responsible said the documents were “waiting to be picked up by the shredding company” and that the records had been “thrown out inadvertently.” In 2018, HHS fined a medical records maintenance, storage, and delivery services provider $100,000 after an anonymous tip led investigators to a parking lot where they found over 2,000 medical records in an unsecured company truck. Know the Rules and Train Your Employees An HHS fact sheet is clear about the generator’s responsibility to provide proper employee training: “Covered entities must ensure that their workforce members receive training on and follow the disposal policies and procedures of the covered entity, as necessary and appropriate for each workforce member.” Many organizations have specific disposal containers for different waste streams: Secure containers for sharps and regulated medical wastes Pharmaceutical waste collection containers Cans for regular trash Recycling bins Secure containers for sensitive documentation that require shredding However, employees must understand the system and use it properly. In a 2018 study published in the Journal of the American Medical Association, researchers found that “documents containing medium- and high-sensitivity items were being disposed of in the recycling” at hospitals and other medical care facilities. Employees naturally want to recycle as much as possible but may not consider the privacy and regulatory consequences of mixing PHI documents with regular recycling. Proper employee training is a must! Sharps customers have access to our ComplianceTrac online training and audit platform. It’s available 24/7 and offers convenient, accessible HIPAA training tools. Your staff can access required training on their schedule. Stay Compliant with Sharps Compliance Shredding Services At Sharps Compliance, we offer everything your facility needs to securely collect and store documents with PHI at your facility before pickup and disposal. Our document shredding service includes: Secure containers provided for the collection of materials We accept all paper products containing PHI Pickup available at scheduled frequencies Flat-fee pricing per cabinet – no hidden fees or surcharges Documents destroyed at an NAID-approved facility Document tracking and Certificate of Destruction that should be retained in case of a HIPAA audit or other legal need We offer this HIPAA-compliant waste management service in selected markets. Contact us at 800.772.5657 for more information about our shredding and secure document destruction services. Read More
July 6, 2022 Regulated Medical Waste Disposal in Urgent Care Centers Urgent care clinics bridge the gap between emergency departments (ED) and primary care providers. They’re an alternative for patients who need immediate medical care for conditions that aren’t life-threatening. Patients may present with symptoms as diverse as sore throats, minor cuts and puncture wounds, broken bones, or serious conditions that require emergency transport to an ED. Depending on their services, urgent care centers may generate regulated medical and pharmaceutical wastes. Sharps Compliance is a trusted partner to many urgent care providers nationwide. We provide a variety of medical waste mailback and pickup services customized to each clinic’s needs. What Is Urgent Care? Urgent care clinics carry a variety of names: Acute care clinics Minor emergency centers Quick care clinics Urgent care clinics are changing the healthcare landscape in the US, according to Insider Intelligence. Consumer expectations for healthcare access are changing, and urgent care centers can help fill the gaps. “Consumer demand for hyper-convenient care has reached a fever pitch, especially among younger cohorts. Nearly one-quarter of Millenials haven’t visited a primary care physician (PCP) in five years or more, with about one-third saying that going to get a physical isn’t convenient, per a 2019 Harmony Healthcare IT survey. That’s why we’re seeing more younger patients opt for medical care as well as walk-in appointments for real-time needs such as covid testing.” They provide walk-in treatment of acute injuries and illnesses that aren’t life-threatening but still require professional medical treatment within 24 hours. Because the clinics often offer extended hours outside the regular M-F/9-5 office hours provided by many primary care providers, urgent care clinics provide more immediate patient care. They can be more cost-effective, convenient alternatives to emergency room care. Urgent Care Is a Rapidly Growing Industry in the US The shortage of primary care physicians in the US is getting worse. A 2019 Association of American Medical Colleges report predicted a shortfall of between 21,100 and 55,200 primary care physicians by 2030. This shortage makes it harder for many Americans to access primary care, particularly in rural and other underserved areas. Emergency departments have long acted as the nation’s health safety net. Even before the COVID-19 pandemic, ED overcrowding was a problem at many hospitals. It can result in worse patient outcomes and higher medical costs. A 2009 study found that serious complications rose three- to five-fold in acute coronary syndrome patients who presented at EDs during times of overcrowding. Long ED wait times are associated with increases in the number of patients who leave against medical advice before treatment is complete. As the number of clinics increases (as well as the expanded services available), so does the need for affordable, regulatory-compliant medical waste disposal solutions for urgent care clinics. Sharps Compliance is here to help. Regulated Medical Waste and Urgent Care We offer mailback collection systems with everything urgent care clinics need to collect, package, and compliantly ship the waste for treatment. Sharps Shipback Systems are ideal for safely collecting and properly treating sharps waste and other used healthcare products. The sizes range from 1-quart to 20 and 30-gallon Covidien sharps shipback containers` with wall enclosures help urgent care centers keep counter space clear. The convenient wall mounts help prevent access to contents in high-traffic areas. We also offer route-based medical waste pickup services for urgent care clinics that generate more red bag waste, like rapid infectious disease testing materials and soiled wound dressings. We provide everything needed to package and label regulated medical wastes for transport. Our fully-permitted vehicles and treatment facilities comply with all state and federal regulations. Urgent Care Centers and Pharmaceutical Waste Disposal Many urgent care clinics may need to dispose of unused, recalled, or expired non-controlled and non-hazardous medications. Our MedSafe Basic is an affordable, easy-to-use disposal solution for the compliant treatment of unwanted and expired medications. Sharps Compliance Offers Solutions State medical waste regulations differ, and we can help urgent care centers comply with all applicable laws. Employee training: Our online training and compliance system, ComplianceTrac, helps clinics provide required employee training, maintain safety data sheets, manage OSHA documentation, and more. Custom medical waste solutions: Our sales and support teams work with each urgent care center to determine their individual needs and develop a custom waste management and disposal solution. Call us at 800.772.5657 to learn more about our medical waste management and disposal solutions for urgent care clinics. We’re here to help you solve problems and comply with all regulatory requirements. Read More
June 29, 2022 Can You Tell the Difference Between Hazardous and Biohazardous Waste? Hazardous and biohazardous wastes can potentially harm human, animal, and environmental health and wellbeing. These two types of wastes differ in composition, origin, dangers, and disposal methods. Waste generators need to understand the difference between biohazardous and hazardous wastes to protect the staff and the public, comply with all applicable regulations, and avoid fines and penalties. Hazardous Waste Examples Hazardous waste is any waste that contains dangerous chemicals, including heavy metals, flammable liquids, corrosive material, and other contaminants that can directly harm living creatures and the environment. Per the EPA, “hazardous waste may come in many forms, including liquids, solids, gases, and sludges.” Healthcare facilities and veterinary clinics may generate small quantities of hazardous wastes and hazardous wastes pharmaceuticals (HWP). The vast majority of hazardous waste is generated from large quantity generators in the industrial sector, including semiconductors, automobiles, and allied chemical industries. Common hazardous waste streams in healthcare include: Flammable liquid mixtures Hazardous Waste Pharmaceuticals, including warfarin/coumadin, insulin, and medical aerosols/inhalers X-ray Process Waste (fixer/developer solutions, film, and lead aprons) Some pharmaceuticals (including their containers) must be managed as hazardous waste. Visit the EPA website for more information about P-list, U-list, or characteristic wastes that must be handled according to guidelines for HWP. Note that these drugs are not the same as the hazardous drug list maintained by the CDC’s National Institute for Occupational Safety and Health (NIOSH). Learn more about the difference between hazardous drugs and hazardous waste pharmaceuticals. Households can also generate hazardous waste. Our infographic lists items you should never put in your household trash, and the accompanying article discusses safe disposal options. Biohazardous Waste Examples Biohazardous waste is medical waste that has the potential to spread disease or pathogens to humans. It’s usually generated at healthcare facilities, including hospitals, dental offices, veterinary clinics, and laboratories, but tattoo studios, medspas, and funeral homes also generate biohazardous regulated medical wastes (RMW). Biohazardous medical waste types include: Sharps waste (needles, scalpels, etc.) Pathological and anatomical waste Microbiological waste Blood, blood products, and other potentially infectious materials (OPIM) Zoonotic waste Contaminated items that would release blood or blood products or OPIM in a liquid or semi-liquid state if compressed Isolation waste Households and individuals also generate biohazardous waste – mostly used sharps. This waste can be a danger to others when improperly disposed of in recycling bins, regular trash, or in public places. Technically, there is no material difference between the terms biohazardous waste and regulated medical waste, but regulatory terminology varies by state: “For example, Arizona state regulations refer to the disposal and management of “biohazardous medical waste” instead of the more commonly used term “regulated medical waste.” In contrast, Mississippi uses the terms “infectious medical waste” and “medical waste” to differentiate between potentially infectious RMW and non-infectious medical waste.” Hazardous Waste and Biohazardous Waste Disposal Federal and state agencies strictly regulate both hazardous and biohazardous waste disposal. Hazardous waste is defined at the federal level by the Resource Conservation and Recovery Act (RCRA). The EPA maintains a list of applicable RCRA hazardous waste regulations. Federal agencies, such as the EPA, OSHA, and DOT, have regulations regarding hazardous and biohazardous medical waste handling, storage, transportation, and treatment. For example: EPA “has jurisdiction over medical waste treatment technologies, which claim to reduce the infectiousness of the waste using chemicals.” DOT “regulates the transportation of wastes it deems capable of posing an unreasonable risk to safety, health, and property when transported.” It does this through mandatory employee training as well as requirements for waste classification, packaging, and paperwork. OSHA medical waste regulations focus on workplace safety issues, such as needlestick prevention, red bag waste classification and management, and employee safety training. However, most regulation is at the state and local level. State medical waste regulations differ, and states are free to impose stricter regulations than federal requirements. Some state hazardous waste classifications are more stringent than federal requirements. Generators must be aware of their state requirements and hazardous waste generator category to ensure that they follow all storage and reporting requirements. Mistakes cost money: a non-conforming hazardous waste stream sent to a treatment facility may incur extra costs for remediation, or worse, be rejected and returned to the generator. Do You Need Help Managing Your Hazardous and Medical Wastes? Sharps Compliance can help answer your questions about your RCRA generator status and other waste disposal issues, including state and federal regulations, employee training, cradle-to-grave waste tracking, and more. We offer comprehensive solutions for managing biohazardous regulated medical waste, unused pharmaceuticals, and hazardous waste. Contact us at 800.772.5857 or request a service quote online. Read More
December 1, 2021 System Development of the Hazardous Waste e-Manifest System Hazardous waste generators get invoiced for an “EPA Electronic Manifest Program Fee.” Why? What is this fee used for? Let’s see if we can answer that for you. The EPA regulates all types of hazardous waste (HW) generated in healthcare, from spent solvent (such as alcohols and ketones) and pharmaceuticals to diagnostic testing procedure residuals. Much of the HW that these businesses generate must be shipped long distances to treatment, storage, and disposal facilities (TSDFs) where it can be properly disposed of or recycled. Hazardous waste must be tracked throughout its entire life cycle (cradle-to-grave) so that the EPA and other regulatory authorities can determine its origin and destination and know it was properly managed. Following waste from start to finish reduces the risk of fines from improper dumping and harmful environmental consequences. What Is the EPA e-Manifest? On June 30, 2018, the EPA launched a national system for tracking hazardous waste shipments electronically. This system, known as the “e-Manifest system,” modernizes the nation’s cradle-to-grave hazardous waste tracking process while saving valuable time, resources, and dollars for industry and states. The EPA established e-Manifest per the Hazardous Waste Electronic Manifest Establishment Act, which Congress enacted into law on October 5, 2012. e-Manifest is a multi-faceted program that includes the following: System development Regulation and policy Implementation and communication Consultation with the e-Manifest federal advisory committee The e-Manifest system offers generators, transporters, and receiving facilities a digital one-stop shop for manifest tracking and recordkeeping to meet their regulatory requirements. Receiving facilities upload manifest copies at the end of their lifecycle, and generators can log in to view their completed manifest copies. Hazardous Waste Paper Manifests The EPA set June 30, 2021 as the deadline to ensure all TSDFs report manifest information to RCRAInfo (the program which hosts e-Manifests) electronically. Now, the EPA will no longer accept paper manifest submissions from TSDFs, but paper manifests may still be used from the HW generator location for shipments to the TSDF. Paper manifests are still used for over-the-road shipments because the larger HW service providers have not yet aligned their software tracking systems to the EPA’s digital architecture. It is all still a work in progress, funded by the e-Manifest program fees. Improving the e-Manifest System The EPA is committed to ensuring that the e-Manifest system must meet its users’ needs. To accomplish this goal, they are: Conducting user-centered design Developing and utilizing agile software development methodologies This approach enables continuous improvement through pilots and testing, using iterative processes, and regular engagement with users and stakeholders throughout the process. The EPA will continue to provide ongoing opportunities for input until a full-scale system is complete and thoroughly tested by all entities. e-Manifest Fees: Who’s Paying for This Program? The development of this program is costly to the EPA, so money is collected to defray these costs. The EPA publishes user fees by July 1 of each odd-numbered calendar year on their website. These published user fees will then cover the two fiscal years beginning on October 1 and ending on September 30 of the next odd-numbered calendar year. These fees are updated to reflect actual program costs and manifest usage. The user fee is charged to receiving waste facilities (TSDFs) for each manifest they submit to the EPA. Generators, transporters, and brokers are not directly charged. Thus, the TSDF will pass along this cost from the EPA to their customers who deliver the waste for management. If you have questions about the e-Manifest program and the fee structure, call Sharps Compliance at 800.772.5657 to learn more. Read More
November 10, 2021 Is Your PPE Regulated Medical Waste? OSHA requires employers to “provide appropriate PPE for workers who could be exposed to blood or other infectious materials (such as internal bodily fluids).” Commonly used Personal Protective Equipment (PPE) for healthcare workers include gloves, gowns, goggles, masks, and face shields. While some of those items may be reusable, the majority are single-use items requiring disposal after use. Though OSHA defines what level of contamination requires disposal as regulated medical waste, state regulations may have more strict definitions of what PPE must be disposed of as regulated medical waste (RMW). Do your employees know how to tell the difference? Proper training on waste segregation – for PPE and other medical-related wastes – can help you create a safer workplace, keep you regulatory compliant, and save on medical waste disposal costs. Many Facilities Face Rising Costs for PPE Procurement & Disposal The COVID-19 pandemic put healthcare providers in a double bind: as demand for PPE increased, so did the cost to purchase it. However, medical waste disposal costs also increased for many medical facilities due to the over-classification of COVID-related PPE as RMW. Initial uncertainty about modes of disease transmission led many to err on the side of caution and treat all PPE as RMW. Later guidance from OSHA and the CDC indicated that most COVID-related PPE could be disposed of in regular trash. “The Occupational Safety and Health Administration and the CDC released guidance specific to COVID-19 waste, which determined that the virus is a Category B infectious substance. This means PPE and other medical waste generated in the treatment of patients with COVID-19 can be managed in the same way as other waste related to Category B infectious substances, in contrast to the more hazardous Category A infectious waste generated in the management of diseases such as Ebola.” In most states, this means that only PPE that is grossly contaminated with blood or other potentially infectious materials to the extent that such substances could be released upon handling should be treated as RMW. The rest can be disposed of in regular trash. However, remember that several states and industries have more stringent guidelines for the management of PPE waste during the COVID-19 pandemic. Always check with your appropriate regulatory agencies for handling and disposal guidelines. Read our September 2021 updated guide to COVID medical waste to learn more about waste disposal requirements for healthcare settings and other industries. Strategies to Lower PPE and RMW Disposal Costs Because PPE may have been in contact with bloodborne pathogens or other potentially infectious materials (OPIM), some waste generators place all of it in red biohazard bags to be disposed of as regulated medical waste “just in case.” This is an expensive mistake! RMW disposal costs are as much as ten times higher than for municipal trash. Even small reductions in quantities can result in big savings. Make waste segregation easy: Use color to provide visual cues. For example, RMW waste goes in red containers, recycling in green, regular trash in brown, etc. Place them conveniently for staffers, but separate them so that red bag containers aren’t side-by-side with regular trash. Use posters and visual aids: Place informational posters or other visual aids above waste containers. Employees can quickly see what type of waste is permitted in each container. Sharps Compliance provides posters and training materials to all our customers to help them properly segregate wastes. Use the proper size collection containers: Small RMW containers in exam and patient rooms make it harder for patients and workers to treat them as regular trash containers. We can help you determine the most appropriate size of medical waste recovery systems for your facility. Employee training: No healthcare worker wants to make a mistake and unintentionally spread disease or injure someone. Without proper training, employees may err on the side of caution: if they’re not absolutely sure it’s safe, it goes in the red bag. That means your biohazardous medical waste containers may be full of used gloves and gowns instead of actual regulated medical waste products. Those bloated red bags can break your RMW disposal budget, but simple staff training can fix this, using resources like the complementary segregation posters provided to Sharps customers. State training requirements differ, but OSHA requires orientation training and annual refresher training for employees who have regular or occasional potential for exposure to bloodborne pathogens or OPIM. Additionally, facilities that have direct pickup of RMW must also provide DOT training. Sharps Compliance Can Help Sharps Compliance is a leading single-source provider of regulatory-compliant services for healthcare professionals. We offer comprehensive waste management services for sharps, medical waste, and pharmaceutical wastes. With our service, there are no contracts or hidden fees. Contact us to request a service quote or call 1.800.772.5657 for more information about how we can help you stay compliant and save money on disposal costs. Read More
October 13, 2021 Part 2: Federal vs. State Hazardous Waste Generator Categories In Part 1 of this series, we discussed the differences between federal and state RCRA programs. In Part 2, we will talk about the different hazardous waste (HW) generator categories and why they are important. Except for Alaska and Iowa, which operate under federal jurisdiction, each state runs an approved Resource Conservation and Recovery Act (RCRA) program for managing hazardous waste. Each state’s program must be at least as stringent as the federal RCRA regulations, but they are not required to be identical. Differences between state hazardous waste programs range from small (but important) to significant. One area where variations are quite common is RCRA generator categories. What Are the Three Categories of Hazardous Waste Generators? The federal regulations have three hazardous waste generator categories. The category assignment is based upon the quantity of hazardous waste a facility generates within a calendar month. The quantities of HW listed per generator category below are per a 30-day period. Large Quantity Generator (LQG) LQGs generate: 1,000 kg (2,200 pounds) of non-acute hazardous waste 1 kg (2.2 pounds) of acute hazardous waste 100 kg (220 pounds) of acute hazardous waste mixed with debris Notes: LQGs must have an EPA identification number. There are no accumulation limits for LQGs. Small Quantity Generator (SQGs) SQGs generate: >100 kg and < 1,000 kg of non-acute hazardous waste < 1 kg of acute hazardous waste < 100 kg of acute hazardous waste mixed with debris SQGs can accumulate on-site, at any one time: < 6,000 kg (13,200 pounds) of non-acute hazardous waste < 1 kg of acute hazardous waste < 100 kg of acute hazardous waste mixed with debris Note: SQGs must have an EPA identification number. Very Small Quantity Generator (VSQG)* VSQGs generate: < 100 kg (220 pounds) of non-acute hazardous waste < 1 kg (2.2 pounds) of acute hazardous waste < 100 kg of acute hazardous waste mixed with debris VSQGs can accumulate on-site, at any one time: < 1,000 kg (2,200 pounds) of non-acute hazardous waste < 1 kg of acute hazardous waste < 100 kg of acute hazardous waste mixed with debris *Formerly known as Conditionally Exempt Small Quantity Generators or CESQGs. More on this below. Why Your Hazardous Waste Generator Status Matters Under RCRA, not all hazardous waste generators are treated equally. Large Quantity Generators (LQGs) are subject to the most stringent standards. LQG facilities must do all the following: Provide annual hazardous waste training for personnel Accumulate waste on-site for no more than 90 days Comply with RCRA air standards Store ignitable and reactive wastes at least 50 feet from the property line Submit biennial reports Develop a comprehensive written contingency plan SQGs and VSQGs are subject to fewer and may be exempt from many hazardous waste management requirements. VSQG vs. CESQG Often called the most significant hazardous waste rulemaking in decades, the RCRA Generator Improvements Rule (GIR) made major changes to the federal hazardous waste management regulations. One of those changes was to re-name Conditionally Exempt Small Quantity Generators or CESQGs. These generators are now referred to as Very Small Quantity Generators or VSQGs. In states that have not yet adopted the GIR, VSQGs may still be referred to by their “old” name – Conditionally Exempt Small Quantity Generators. As of May 1, 2021, 34 states had adopted the GIR, even though the final rule was published on November 28, 2016. By law, individual states have up to 24 months to adopt the rule. In states that have not yet adopted the GIR, regulatory authorities are discussing their options internally, drafting rules, and collecting public input. If you have questions about managing your hazardous waste, contact us for a free consultation. Read More
September 29, 2021 Part 1: Federal vs. State Hazardous Waste Classifications Last updated on October 13, 2021 In the United States, enforcing laws and regulations involves a balancing act between the federal government and individual state governments. When it comes to hazardous waste management, states can impose standards stricter than the federal governments. As a result, certain materials not regulated as solid or hazardous waste under the federal Resource Conservation and Recovery Act (RCRA) may be regulated materials/wastes under a specific state’s program. Under RCRA, Congress and the US EPA encourage each state to implement and oversee its own hazardous waste program. With the exception of Alaska and Iowa, each US state (and several territories) maintains its own RCRA program that it operates, incorporating, at a minimum, the federal rules. For the US EPA to authorize a state’s RCRA program to operate instead of federal standards, the state program must be: Consistent with the federal RCRA standards Comprehensively at least as stringent as the RCRA An individual state’s hazardous waste program may be more stringent than the federal regulations. However, a state’s program cannot be less stringent than the federal regulations. Without getting into the minutia, different federal regulations deal with the authorization and implementation of individual state programs, e.g.: US Code: Title 42 6926: Authorized State Hazardous Waste Programs Code of Federal Regulations: Title 40: Protection of Environment §271.1 In the end, some states have a broader scope of hazardous waste rules that generators within a said state must follow. Common State Differences in Hazardous Waste Classification While the federal regulations generally provide a strong foundation for state RCRA programs, a state’s hazardous waste definition commonly varies in these (and other) ways: Additional listed wastes: Industry-specific listed waste codes are typical in states where a unique industry is prevalent Polychlorinated Biphenyl (PCB) wastes Unique military wastes in states with military installations handling sensitive materials Expanded characteristic wastes: Additional characteristics such as a “lethality” or “severe” toxicity as part of the definition of hazardous waste Added criteria to an existing characteristic code definition For example, states may broaden the federal definition of corrosivity stated in 40 CFR 222 to include more than aqueous (high water) liquids and add physically solid or non-aqueous materials. They may also do any of the following: Add constituents to the table of contaminants under the toxicity characteristic Change maximum concentration levels Create a table of non-RCRA/state-regulated contaminants (e.g., for persistent and bioaccumulative toxic substances) The mixture rule: Under the federal rules, mixing solid waste with a listed hazardous waste causes the entire mixture to be regulated as that listed hazardous waste. However, federal regulations have exceptions that exclude this mixture as a hazardous waste if the hazardous waste was only listed for ignitability, corrosivity, or reactivity and the resultant mixture no longer exhibits a characteristic. A state may not allow for this exception. Universal Wastes There are five types of hazardous wastes that are regulated less stringently as universal wastes: Batteries Pesticides Mercury-containing equipment (e.g., thermometers, thermostats, and other items containing elemental mercury) Lamps (e.g., fluorescent bulbs) Aerosols Many states have added to their lists of universal wastes to include things like paint, e-waste, CRTs, and antifreeze. In some cases, there are additional requirements for state-only universal waste (e.g., paint in Texas and CRTs in California). Know Your State Rules for Hazardous Waste Management Hazardous waste generators nationwide must comply with all applicable hazardous waste regulations — both federal and state-specific ones. Because the state program may include additional, more stringent, or different requirements, generators must be aware of the requirements in their state and how they differ from the US EPA rules. In Part 2 of this series, we will review some of the more stringent rules in specific states. If you have questions about managing your hazardous waste, contact us for a free consultation. Read More
September 15, 2021 How and Why Your RCRA Generator Status Can Change The RCRA hazardous waste management regulations require every generator to determine their generator status monthly (40 CFR 262.13). When determining your generator status, you must count all your hazardous waste at the “point of generation” unless it is specifically excluded. It’s not unusual for your generator status to change from month to month, depending on exactly what you generate. The RCRA regulations list separate generator status thresholds for Hazardous waste Acutely hazardous waste Spill cleanup materials from acutely hazardous waste Under RCRA, generator status is based on the amount of hazardous waste generated per month. Large Quantity Generators or LQGs are subject to the most stringent hazardous waste management requirements. RCRA Generator Status Amount Generated Per Month Large Quantity Generator (LQG) 1,000 kg or more; or >1 kg acute HW (2,200 pounds or more; or > 2.2 pounds acute HW) Small Quantity Generator (SQG) >100 kg but <1,000 kg (>220 pounds but <2,200 pounds) Very Small Quantity Generator (VSQG) (Formerly known as Conditionally Exempt Small Quantity Generators or CESQG) 100 kg or less (220 pounds or less) What Could Change My Generator Status? The volume of hazardous waste your site produces in a given month can vary for many reasons. You may have had an extra productive month, for example, or a change in operations may lead to increased production. A spill or accident may generate additional waste that vaults you to a higher generator status. Regardless of the reason, the EPA requires you to do a monthly count of these wastes as described under 40 CFR 262.13. It is helpful to keep a running log of your wastes as you produce them to know how much you have so that you’re not surprised by a status change at the end of the month. What if I Go Up a Generator Status? Let’s start by looking at the first month in which you would be required to change your status. To keep things simple, we will assume your wastes are not somehow excluded from counting (e.g., by the new episodic generation exclusion introduced in the Generator Improvements Rule – more on this below). Example: If you generated 600 kg of hazardous waste in June, you would be a small quantity generator (SQG) of hazardous waste. If you exceed the LQG threshold of 1,000 kg per month or the 1 kg threshold for acute hazardous waste in July, all of July’s waste would have to be managed under the requirements for LQGs at 40 CFR 262.17. The requirements for LQGs include, among other things, RCRA training for personnel and a 90-day time limit on storage on-site. Again, the LQG requirements would apply to all the waste you generated in the month, not just the amount that’s “over” the threshold. Once you have been required to change your status, it is possible to lower your generator status if it were not a permanent operational change. If you reduce your waste production sufficiently, you could manage the waste in the subsequent months under the reduced regulation. However, some states may require you to prove that you have changed generator status. If you would be an LQG for multiple non-consecutive months, they likely will not allow you to change your status continually. Do I Have to Formally Change My Generator Status? According to the EPA, Form 8700-12 is the form that you use to notify the EPA and your state’s environmental regulatory agency of your hazardous waste activities through which you are given an EPA Identification Number for your site that you must resubmit for a change in generator status The form’s instructions clearly state: “You must use this form to submit a subsequent notification if your site already has an EPA Identification Number and you wish to change information (e.g., generator status, new site, contact person, new owner, new mailing address, new regulated waste activity, etc.).” While this is not a regulatory requirement, per se, based on these directions, you would use Form 8700-12 to update your status whether you went up (e.g., from SQG to LGQ) or down a status (e.g., from LQG to SQG). Some states use a state-specific form in place of EPA’s Form 8700-12, as well as their own deadlines for submitting or revising their form. Check with your state to determine if there are state-specific requirements. Relief for Episodic Events In its Generator Improvements Rule, the US EPA added a provision to provide relief for “episodic events” that would otherwise impact a facility’s generator status. EPA defines “episodic event” as “an activity that does not normally occur during generator operations and results in the generation of hazardous wastes that exceeds the calendar month quantity limits for the generator’s usual category” (40 CFR 262.231). Episodic events may be planned or unplanned. Examples of planned episodic events include lab or tank cleanouts, short-term maintenance projects, and the removal of excess inventory. Examples of unplanned episodic events include a spill, damaged equipment, or a product recall. While every state is required to adopt the Generator Improvements Rule, at least in part, not every state has done so. States must maintain a hazardous waste program that is at least as stringent as the Federal RCRA regulations. Because the new relief for episodic events makes the regulations less stringent, states can choose to adopt the relief or not. Check to see if your state provides some relief for episodic events. In states that have adopted the new relief, a VSQG or SQG can experience an episodic event without resubmitting Form 8700-12. There are, however, notification requirements that go along with claiming this relief. Once again, you will want to check your state regulations to see what reliefs are available and how best to submit the required information. Permanent Changes to Generator Status For permanent status changes, the Form 8700-12 would have to be revised. If your site is a VSQG subject to the RCRA rules in 40 CFR 262.14, you may have to use Form 8700-12 to obtain an EPA ID number if you do not already have one. Without obtaining an EPA ID number, you would not be able to properly ship your wastes for treatment, among other issues. Sharps Compliance can help answer questions about your RCRA Generator Status and hazardous waste. We offer comprehensive solutions for the management of regulated medical waste, hazardous waste, and unused medication. Read More
September 1, 2021 Drug Decomposition/Deactivation Products: Compliance, Safety, & Cost Issues Although several drug deactivation products are marketed for pharmaceutical waste disposal in home and clinical settings, none have been reviewed or approved by the Drug Enforcement Agency (DEA) or Environmental Protection Agency (EPA). Disposing of drugs in the trash (even after treatment with a drug decomposition product) may violate state and/or local regulations. Federal guidelines from the DEA, EPA, and FDA for consumer disposal of household medicines recommend take-back programs as the best disposal option. Unlike ultimate users, regulated generators of pharmaceutical waste – including hospitals, veterinarians, and long-term care facilities, to name a few – must comply with strict regulatory requirements for collecting, transporting, tracking, and treating regulated medical wastes, pharmaceutical wastes, and hazardous wastes. Regulatory Compliance Issues with Drug Decomposition Products Regulated medical, pharmaceutical, and hazardous waste disposal regulations are complex and detailed, but facilities that use drug deactivation products for medication disposal face additional training and compliance difficulties. Many states impose restrictions on methods of drug disposal. For example – Colorado prohibits the trash disposal of activated carbon-based decomposition products, and California requires the incineration of all Rx wastes (including used charcoal-based products). Other concerns include: State prohibitions on trash disposal: Although the main selling point for drug decomposition products is the ease of trash disposal, businesses’ use of such products results in a regulated business waste. This waste would be prohibited from trash disposal in most states unless extensive waste characterizations are performed to prove the mixtures are not hazardous. DEA irretrievable standard: Most drug decomposition products rely on activated carbon or charcoal to deactivate the medications. Users must follow the directions exactly for the processes to work correctly. In addition, many such products include a disclaimer that they are incapable of entirely dissolving capsule shells and patches. The DEA’s non-retrievable standard requires destruction methods to render all controlled substances non-retrievable, even mixtures where any controlled substance is likely to be present. Product limitations: Generators using these products must perform waste characterization on each bottle/batch and exercise care when combining different medications for treatment. If any individual medicine added to the disposal product has a federal hazardous waste designation, then all the resulting product-drug mixture must be managed as hazardous waste, according to the EPA’s Final Rule. Mixing of medications for treatment can raise disposal costs and/or incur regulatory penalties. Safety and shipping issues: Businesses generating both hazardous and non-hazardous pharmaceutical waste would need to implement separate disposal solutions for hazardous waste pharmaceuticals and multiple other drug categories prohibited by the product itself. For instance: Bio-based drugs, which can lead to mold growth in the bottle “Gas-causing” items or antacids, which can result in off-gassing All drug decomposition/deactivation products require the user to mix medications with a chemical solution. This raises the possibility of accidental exposure in case of spills or overfilling. Additionally, the following restrictions also apply: Bottles must be kept in controlled and secure locations and cannot necessarily be distributed throughout a facility for convenient access. Most products should be used within one year – or sooner if additives are bio-based. Mailback systems require the use of liquid hardeners to make them compliant for shipping by common carrier. However, some medications may not be compatible with the hardener. Some mailback systems are labeled using the expired DOT classification of ORM-D, as well issues with hardeners could lead to fines from UPS or DOT if spills result. Costs Associated with Drug Decomposition/Deactivation Products Waste generators can face high costs from using these products. Waste segregation: Salaried staff must spend time identifying and segregating wastes to determine what can and can’t be mixed with decomposition products. Training: The FDA approved seven new drugs in July 2021 and 12 in June 2021. Generators who use drug decomposition/deactivation products must ensure that staffers responsible for using the products receive updated information and training whenever any new drugs are used in the facility. Labor: Many medications are stored in blister packs as both a safety precaution and medication compliance aid. Many children can easily open a “child-proof” cap, but even many adults have difficulty removing a pill from a blister package. Consider how much time it will take for staff to empty vials, remove pills from packaging, and mix the medications with the product’s chemicals. A 2019 survey conducted by Sharps Compliance among a large U.S.-based long-term care (LTC) provider found that nurses spent an average of 12 hours a month removing pills from their containers for disposal. Implementing drug disposal programs utilizing collection receptacles or mailback packages allows staffers to spend more time on patient care. These programs potentially save up to $10,000 annually for the time it takes two RNs to prepare medications for disposal via a multi-step process compared to placing wastes in a collection receptacle. Regulatory Compliant Alternatives to Deactivation Products Consolidation of medication disposal options – both hazardous and non-hazardous pharmaceuticals – into a single solution can help waste generators control costs and more easily comply with federal, state, and local regulations. Our DEA-compliant MedSafe collection kiosk streamlines the disposal of unwanted, unused, and expired medications. It’s a full-service medication collection and disposal solution that meets the DEA Controlled Substances Act requirements. Comingled collection of controlled and non-controlled pharmaceuticals Inner liners returned prepaid via common carrier Online shipment tracking Proof of destruction using incineration to meet the DEA’s non-retrievable standard for controlled drugs MedSafe medication collection kiosks help generators control costs. Reduce the time required for waste segregation and training Spend less time preparing medications for disposal No additional costs or extra fees for compliant handling and treatment of hazardous waste pharmaceuticals Many LTC communities have found that MedSafe is a better alternative to decomposition products. Use of the collection kiosks offers savings of up to $12,000 a year per community and easier regulatory compliance. Contact us to learn more about how Sharps Compliance can help your facility manage your regulated medical, pharmaceutical, and hazardous waste compliance and training. There are never any hidden fees, and we work with you to develop a custom regulated waste disposal solution that meets your needs and budget. Read More
August 18, 2021 DUMP Opioids Act Will Increase Community Options for Safe Opioid Disposal On July 29, 2021, President Biden signed the Dispose Unused Medications and Prescription (DUMP) Opioids Act into law. Beginning in 2022, it will give community residents access to medication disposal collection receptacles, including Sharps Compliance’s MedSafe kiosks, located at certain VA medical centers. Instead of waiting for semi-annual Drug Take Back Day events, this additional disposal option will help unused/unwanted opioids and other harmful medications from being misused or diverted into the environment. The COVID Pandemic Affected Addiction Treatment and Overdose Rates in 2020 During the pandemic lockdowns, patients with Opioid Use Disorder (OUD) faced many problems, including difficulty accessing treatment, isolation, and financial worries. In addition, the economic downturn forced some states to cut budgets for drug treatment and education programs. The consequences were heartbreaking. Overdose deaths soared in 2020, with a nationwide increase of almost 30%, with some states experiencing increases of at least 40% over 2019. “This is the highest number of overdose deaths ever recorded in a 12-month period, and the largest increase since at least 1999,” Dr. Nora Volkow, director of the National Institute on Drug Abuse, told NPR. DUMP Opioids Act: “A smart way to save lives.“ Even before the pandemic, officials were concerned about rising OUD rates among veterans. Between 2010 and 2016, opioid overdose death rates among veterans increased by 65%. Two recent federal laws aim to make safe drug disposal easier for veterans and others. The Johnny Isakson and David P. Roe, M.D. Veterans Health Care and Benefits Improvement Act of 2020, became law in January 2021. One provision (Section 3009) directs “certain Department of Veterans Affairs medical facilities to have physical location for the disposal of controlled substances medications.” It takes effect on January 1, 2022. The Dispose Unused Medications and Prescription Opioids Actamends Section 3009 of the previous bill. It expands the law to give community residents access to medication disposal kiosks at covered VA medical facilities. It also authorizes the VA Secretary to implement public information campaigns about available facilities and drop-off dates/times. The DUMP Opioids Act’s Senate sponsor, John Kennedy of Louisiana, expressed hope that his bill will help families and communities keep opioid painkillers out of the wrong hands: “Many opioid users rely on unused prescription medications that belong to family and friends, and Americans can help fight opioid addiction simply by clearing out their medicine cabinets. We can reduce access to addictive and dangerous substances by making it easy for every American to get rid of unused medicine at drop boxes that sit on VA medical centers. The DUMP Opioids Act is a smart way to save lives, and you don’t have to wait until Take Back Day.” Federal agencies recommend take-back options as the preferred method for disposing of opioids and other medications to protect the public and the environment. Sharps Compliance ContinuesOur Public/Private Partnership with the VA Sharps Compliance began working with the Department of Veterans Affairs in 2010 when the VA launched a 5-year pilot program to provide disposal options for medical waste and unused dispensed medications generated outside healthcare settings: The pilot, initiated in collaboration with the Houston-based Sharps Compliance Corp., allows each medical center in the VA Capitol Health Care Network (VISN 5) region, both inpatient and outpatient, to provide the Sharps Disposal By Mail System and the RxTakeAway solutions to patients. After a successful trial period, the VA expanded the program nationwide in 2015 to supply Takeaway Medication Recovery System Envelopes to VA healthcare facilities as part of the VA’s Consolidated Mail Outpatient Program. Ultimate users can use the envelopes to dispose of both controlled and non-controlled medication waste right from the privacy of their own homes. All mailback systems are pre-addressed and affixed with prepaid postage. The partnership is ongoing. The VA Center for Medication Safety prescription safety page includes information about how veterans can Receive postage-paid TakeAway Medication Recovery System Envelopes at no charge Dispose of medications in MedSafe medication disposal receptacles located at certain VA healthcare facilities Passage of the DUMP Opioids Act will make it easier for communities with participating VA medical facilities to safely dispose of unused medications, including controlled substances, while also protecting their families, communities, and the environment. Read More
August 4, 2021 The Benefits of Sharps Mailback Systems: Safe, Affordable, & Regulatory Compliant Used needles and other sharps can cause needlestick injuries and spread infections if they aren’t disposed of properly. As the opioid epidemic continues and the number of patients who self-inject medications increases, so does the need for secure disposal options in public spaces and for those who self-inject medications at home. Sharps Compliance can help. Our TakeAway Recovery Systems are all-inclusive mailback solutions that offer an affordable, safe, and convenient way to collect, package, and ship small quantities of sharps wastes. Safely Manage Sharps Waste with Mailback Systems Use the TakeAway Recovery Systems to pack your used sharps, complete the necessary paperwork, and ship the package directly to our disposal facility. They’re ideal for small quantity waste generators like veterinarians, tattoo parlors, dentists, med spas, pharmacies, and physician offices because you return them based on your needs, not a waste hauler’s schedule. Other benefits of TakeAway Recovery systems include: Cost: You pay for only what you need. When a container is full, place it in the provided mailback box, complete the paperwork, and return using the prepaid, pre-addressed mailing label. Scalability: Many facilities find that their need for sharps disposal fluctuates – for example, pharmacies during flu shot season. The TakeAway systems provide flexibility and affordability. You can easily scale up during high usage times without changing providers or signing a new contract. Liability: Businesses can be held liable if employees or customers are injured by discarded sharps. Our Sharps Secure Needle Disposal System is a lockable collection cabinet designed specifically for public restrooms. Return it for disposal and treatment using a TakeAway Recovery System mailback box. Regulatory compliant: Both state and federal regulations govern the handling, transport, and treatment of regulated waste disposal. The TakeAway Recovery Systems supply everything you need to comply with applicable state and local regulations, including tracking and proof of destruction. Sharps Mailback Options for Individuals The global injectable drug market is projected to grow at a compound annual growth rate of 11.8% between 2016-2021. For example, advances in veterinary medicine make it possible to treat chronic illnesses, like diabetes, at home, with many pet owners giving regular injections to their pets. It’s very important for individuals who self-inject, whether themselves or their pets, to dispose of their used sharps safely. Needlestick injuries are all too common in trash and recycling facilities and are expensive to treat. A 2016 study of needlestick injuries to workers in materials recycling facilities found that workplace injuries could total as much as $2.25 million in direct medical care costs. Many states have specific regulations regarding home sharps collection and disposal to reduce the risk of needlestick injuries. Some specifically prohibit the mixing of home-generated sharps with regular trash or recycling. We can help you safely manage your sharps waste at home. TakeAway Recovery Systems are comprehensive, prepaid mailback systems that come in a variety of sizes. Choose the one that fits your personal needs. Travel-Size Sharps Tubes are designed for on-the-go use. These containers easily fit into a purse, pocket, or briefcase for easy access. After use, place the sharp item into the tube, secure the lid, and retain it until you safely dispose of it in a sharps collection kiosk, disposal container at an airport or other public restroom, or in your home TakeAway Recovery container. How Sharps Mailback Systems Work The packaging, labeling, and transportation of sharps mailbacks are subject to USPS packaging requirements. Manufacturers must utilize only FDA-cleared sharps containers as part of their sharps mailback systems. Additionally, all systems must pass rigorous independent testing to gain USPS approval for the transport through the mail. Fortunately, the mailback process is much less complicated for the end-user. Our TakeAway Recovery Systems provide everything you need to safely contain, store, package, label, and return your used sharps. Our mailback systems include: A primary collection container Prepaid postage, pre-addressed return shipping box Components to package full sharps container for transport Waste manifest tracking form Instructions for use, proper treatment, and online documentation of treated waste Contact us to learn more about how we can help you comply with existing regulations and safely dispose of sharps and other regulated wastes. Read More
July 21, 2021 Safe Opioid Storage & Disposal Helps Protect Kids & Pets from Accidental Poisoning In 2019, an estimated 9.7 million people misused prescription painkillers, and 70.6 % of drug overdose deaths involved opioids. Not all of those deaths were the result of intentional misuse. Prescription opioids and opioid use disorder treatment medications kept in the home pose a danger to children and pets if they aren’t stored in secure containers and disposed of safely. Learn more about how to protect your family members (including the furry ones) from accidental medication poisoning. Dogs Are Also Victims of the Opioid Crisis Although most pet owners consider their companion animals to be full-fledged family members, some people with substance abuse problems are willing to abuse their own pets to obtain opioid prescriptions from veterinarians. Fortunately, only a tiny minority of pet owners use or abuse their animals to gain access to opioids! Yet, even the most loving families may accidentally put their pets at risk. In 2020, the journal Plos One published a study that analyzed calls to the ASPCA’s poison control hotline for pets between 2006 and 2014. Researchers found 5,162 cases of accidental pet opioid poisonings during that time. In general, smaller, younger dogs were most likely to be the subject of the calls. Other common human medications, including over-the-counter painkillers, heart medications, antidepressants, and other drugs, are also dangerous for dogs. Cats are especially sensitive to acetaminophen but can also be poisoned by cold medicines, antidepressants, and other human medications. It’s important to keep any type of medication in secure containers where pets can’t access them. Dogs are notorious for digging through garbage cans, so avoid disposing of household medications in regular trash containers. According to the FDA, securely locking, storing, and disposing of unwanted opioids should be a priority for pet owners. Proper disposal also helps protect the environment. Opioid Poisoning Cases of Young Children Are Increasing In 2018, the journal Pediatrics published a study of “Trends in Pediatric Deaths from Prescription and Illicit Opioids.” It highlighted an often-overlooked aspect of the national opioid crisis. Unsecured opioid medications pose a danger to children in the home – particularly young children and teens. “Across the United States, nearly 5000 children younger than 6 years are evaluated annually in emergency departments for opioid exposures. In addition, hospitalizations for opioid poisonings increased nearly 2-fold across all pediatric age groups between 1997 and 2012. Rates more than doubled among children aged 1 to 4 years, and in adolescents aged 15 to 19 years, poisonings attributed to suicidal and unintentional intent increased 2- and 3-fold, respectively.” Dr. Megan Land of Emory University in Atlanta presented a study to the 2020 Society of Critical Care Medicine congress. The result showed that opioid poisonings in children are becoming more deadly. In an interview, Land noted that the most common causes were “standard opiate pills likely to be in medicine cabinets, such as oxycodone, codeine, and tramadol. These are medications that someone might get for a sprained ankle or [after] surgery.” Small children spend a lot of time on the floor and at play. They’re particularly curious about unfamiliar objects and try to put everything in their mouths. That tendency can be deadly. Thirteen-month-old Edwin Perocier Jr. died after his parents gave him a pill bottle containing Suboxone tablets to use as a rattle. Edwin managed to open the bottle and ingest one or more tablets. Nine-month-old Maisie Gillan died after she and her parents visited the home of a neighboring family. The previous week, a visiting relative had dropped a single Methadone tablet on the floor. Maisie found it while crawling and swallowed it. Tips to Keep Kids and Pets Safe from Medication Poisoning Both of these examples were terrible accidents that ended in tragedy. Fortunately, there are ways to make medication safety part of your child- and pet-proofing plan. Store medications out of sight and out of reach. A locked box or cabinet is safest for medications always kept in the home. Wall hooks for purses keep the contents out of reach of curious babies and toddlers. Avoid storing medicines in purses, nightstands, kitchen or bathroom counters, and other accessible locations. Keep medications in their original packaging. Many people find the blister packs containing pills hard, even frustrating, to open. But that’s an important safety feature! They’re difficult for children and pets to open. Never call medicine “candy” or treat pill bottles as toys. Children’s vitamins are designed to be both tasty and visually appealing, but thousands of children are treated in emergency rooms each year because of supplement overdose. Safely dispose of unused/unwanted medications. If you don’t need it, don’t keep it around! Many people keep unused opioids “just in case” they may need them later, but leftover pills contribute to misuse. They may be stolen, misused by friends or family members, or consumed by curious children or pets. Federal agencies recommend take-back options as the preferred method for opioid disposal. These options include: Semi-annual drug take-back events sponsored by local governments and community organizations. Secure medication collection receptacles located at pharmacies and law enforcement offices. TakeAway Medication Recovery System envelopes are the most convenient solution for many people. Simply place your unused/unwanted medications in the postage-paid envelope and send it to Sharps Compliance for safe, compliant disposal. Medications within their entire packaging can be placed directly in the envelope. You don’t have to store them at home while waiting for a special drug take-back event or travel to a drop-off location. Suspect Poisoning? Get Help Quickly If you think your child may have been poisoned by medication or any other toxic substance, call the Poison Control Center at 1.800.222.1222. If you suspect your pet has been poisoned, call the ASPCA’s Animal Poison Control Center at 1.888.426.4435. Sharps Compliance works with health care providers, state and federal regulators, and community organizations to educate the public about the importance of safe medication disposal. We also provide disposal options for community collection and in-home medication disposal. Our pharmaceutical waste disposal solutions help you keep your family and community safe from accidental poisoning and drug diversion. Contact us by email or call 1.800.772.5267 to learn more. Read More
