healthcare
Environmental solutionsnews Covering infection prevention, medical waste management & sustainable practices
VOL. XII XV NO. NO. 41 VOL.
www.HealthcareEnvironmentalSolutions.com
spring 2019 WINTER 2016
EPA Finalizes Rule Addressing Management of Hazardous Waste Pharmaceuticals But is it Helpful?
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he U.S. Environmental Protection Agency (“EPA”) recently finalized a longawaited rule specifically addressing the management and disposal of hazardous waste pharmaceuticals by “healthcare facilities” and “pharmaceutical reverse distributors.” The rule, “Management Standards for Hazardous Waste Pharmaceuticals and Amendment to the P075 Listing for Nicotine,” which EPA Acting Administrator Andrew Wheeler signed on December 11, 2018 (the “Final Rule”), aims to streamline the federal requirements for managing hazardous waste pharmaceuticals in a way that is more in line with the operations of hospitals, pharmacies and other healthcare providers (as opposed to the industrial manufacturing sector) while balancing EPA’s mission to protect human health and the environment.[1] Although the Final Rule is focused only on those pharmaceuticals that qualify as “hazardous waste” under the Resource Conservation and Recovery Act (“RCRA”), the rule has implications for all “healthcare facilities,” including: pharmacies, hospitals, ambulatory surgical centers, health clinics, physicians’ offices,
optical and dental providers, chiropractors, long term care facilities, and veterinary clinics. The Final Rule also specifically addresses “reverse distributors,” i.e., third-party logistics providers that assist healthcare facilities with managing and returning their unused and expired pharmaceuticals to pharmaceutical manufacturers in exchange for a manufacturer credit.
Highlights of the Final Rule
zz Confirms EPA’s prior policy and stated regulatory interpretation that: � prescription pharmaceuticals moving through reverse distribution are considered “waste” at the healthcare facility level (as opposed to when they
arrive at the reverse distributor, pharmaceutical manufacturer or hazardous waste disposal site); and, � nonprescription pharmaceuticals and other unsold retail items moving through reverse distribution are not considered solid wastes when the healthcare facility transfers materials to a reverse distributor as long as there is a “reasonable expectation” the product(s) will be used/reused or reclaimed; zz Specifically prohibits healthcare facilities from disposing of hazardous waste pharmaceuticals “down the drain”; zz Exempts healthcare facilities from becoming “large quantity generators” (“LQGs”) under RCRA when generating more than one (1) kilogram of acutely hazardous waste pharmaceuticals in a single month, thereby alleviating the need to comply with otherwise onerous RCRA requirements applicable to LQGs (e.g., reporting and record keeping); zz Allows healthcare facilities to accumulate hazardous waste pharmaceuticals on site without a RCRA permit for up to one (1) year; and zz Exempts FDA-approved over-the-counter nicotine replacement therapies from regulation as RCRA hazardous wastes.
Continued on page 3
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EPA Finalizes Rule Addressing Management of Hazardous Waste Pharmaceuticals Continued from page 1
Impacts of the Rule to Healthcare Facilities
he Final Rule is intended to provide greater Tfacilities flexibility and clarification for healthcare and reverse distributors handling pharmaceuticals, however it also imposes new restrictions and requirements concerning notification, training, labeling, reporting and record-keeping requirements that will affect the day-to-day operations of many companies in the healthcare and pharmaceutical industries. In addition, failure to comply with EPA’s regulations can lead to enforcement and the imposition of penalties and other sanctions, so it is important that potentially affected entities become familiar with the requirements of the Final Rule, evaluate if and how the Final Rule may impact their business and operations (e.g., by reviewing their pharmacies’ formularies and confirming what pharmaceuticals would be considered hazardous waste when discarded or processed through reverse distribution), and revise/update (or if necessary, develop) their hazardous waste (and pharmaceutical waste) management and compliance programs. As a best management practice, potentially
healthcare
Environmental solutionsnews Covering Infection prevention, medical waste management & sustainable practices
PUBLICATION STAFF Publisher / Editor Rick Downing Contributing Editors / Writers Sandy Woodthorpe Shipman & Goodwin LLP Production & Layout Barb Fontanelle • Christine Mantush Advertising Sales Rick Downing Subscription / Circulation Donna Downing Editorial, Circulation & Advertising Office 6075 Hopkins Road, Mentor, OH 44060 Ph: 440-257-6453 • Fax: 440-257-6459 Email: downassoc2@oh.rr.com Subscription information, call 440-257-6453. Healthcare Environmental Solutions news (ISSN #1557‑6388) is published quarterly by Downing & Associates. Reproductions or transmission in whole or in part, without written permission of the publisher, is prohibited. Annual subscription rate U.S. is $19.95. Outside of the U.S. add $10.00 ($29.95). Contact our main office, or mail-in the subscription form with payment. ©
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affected entities should continue to ensure they have appropriate internal and external support with respect to environmental, health and safety compliance issues generally, and confirm that appropriate contractual protections are in place in their agreements with vendors and service providers. Lastly, certain states may have different and, in some cases, stricter requirements than those imposed at the federal level. Accordingly, healthcare facilities (like all regulated entities) should ensure their operations not only comply with the Final Rule, but any additional applicable state regulatory programs as well. Ultimately, while the Final Rule is a step in the right direction to ease the regulatory burden on healthcare facilities, understanding and confirming what practices and procedures need to be implemented, revised or confirmed at the facility level to ensure compliance going forward will be critical to answer the question of whether the rule is helpful to the regulated community. [1] The Final Rule will be effective at the federal level six months after it is published in the Federal Register, which has not yet occurred, and will be codified at 40 CFR Parts 261, 262, 264, 265, 266, 268, 270, and 273. Reprinted with permission by Shipman & Goodwin LLP.
CDC Calls on Employers to be More Vigilant About Infection Risks
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andscapers and animal tenders join lab workers and health care workers as most at risk for infectious diseases, according to a Centers for Disease Control article published in Emerging Infectious Diseases. The CDC article, a review of existing literature about infectious diseases in the workplace, examined 66 investigations of workplace infection cases between the years 2006 and 2015. The authors stress that the types of threats to employees is evolving from respiratory viruses and zoonotic pathogens, which are the remain primary risks to worker safety, to new threats, such as Ebola virus, lymphocytic choriomeningitis virus, norovirus, Bacillus anthracis, and Yersinia pestis, that caused several workplace disease clusters. Identifying disease carriers is a challenge in any situation, but employers unfamiliar with infectious disease and those who have no monitoring in place can unknowingly increases risk to employees, the authors say. The study authors urge more research to increase understanding of where risks exist as a way to make these workplaces as safe as possible. spring 2019
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News Briefs
Innovation is an Answer to Reducing Plastic Packaging in Healthcare
State and Federal Reporting Laws: Do They Limit HAI Prevention?
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o reduce high volumes of non-infectious health care plastic waste, innovative partnerships in the U.S. are yielding new fit-for-purpose and highly sustainable packaging, according to a Med-Tech News
article. The industry-wide trend is being driven by trade groups, contract bid requirements, manufacturing process optimization and coordinated sustainability effort between packaging producers and end users to reduce waste. While Group Purchasing Organizations (GPOs) are influencing purchasing behavior through responsible sourcing initiatives, health care organizations are requiring medical OEMs to show they can meet device and packaging recyclability, removal of Polystyrene from packaging and potential use of recycled content in primary packaging. Packaging manufacturers are looking to reduce packaging size, eliminate unnecessary components, and streamline shipments whenever possible. Some are even working with the end-user hospitals to increase education around proper recycling and reuse. New developments that are emerging from this trend include sealed trays instead of pouches for medical devices, and fewer components required in the overall package, including laser-etched instructions on the tray. Medical device manufacturers are working with CMOs (contract manufacturing organizations) that provide end-to-end services, as well as working with hospitable groups and recyclers to recover more plastic. Research is turning up new applications for recycled health care plastics. For example, low-melt HDPE can be recycled into drainage pipe and lawn edging. The Healthcare Plastics Recycling Council (HPRC) estimates that one million tons of this waste is generated every year.
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HEALTHCARE ENVIRONMENTAL SOLUTIONS news
spring 2019
n an article published on Contagion Live, hospital epidemiologist and infection preventionist, Saskia v. Popescu, MPH, MA, CIC, notes how government reporting requirements can adversely impact the effectiveness of hospital-acquired infection (HAI) control programs. Popescu says that while “reporting is critical to maintain an awareness of the overall burden and changes in HAIs throughout the United States, it can also hinder frontline efforts, which runs counter to HAI prevention strategies.” The time-consuming HAI reporting required for Medicare reimbursement is a considerable burden to hospitals, taking up as much as five hours of a preventionist’s work day, she continues. Add reporting responsibility and most of the day is spent on recordkeeping, not routine infection prevention duties, such as rounding, isolation monitoring, and staff and patient education, among others. A 2011 study published in American Journal of Infection Control looked at 1036 hospital infection prevention departments in the Northeast U.S. For states with HAI reporting requirements, the survey found higher numbers of epidemiologists employed, but also correspondingly higher admissions and patient days than states without the HAI reporting laws. The study results pointed to the importance of addressing infection prevention staffing in the face of increasing regulatory requirements, Popescu noted. HAI has remained a leading cause of death in US acute-care hospitals despite concerted efforts by government and healthcare providers. The high costs of hospital-acquired infections (estimated to be between $28 billion to $45 billion per year according to an NIH study published in 2009) are well-known.
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News Briefs
EU Data on Antimicrobial Resistance Heightens Global Concerns
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arma, Italy – Data released in late February by the European Centre for Disease Prevention and Control (ECDC) and European Food Safety Authority (EFSA) reveal that antimicrobials used to treat diseases transmitted between animals and humans are becoming less effective, according to a statement released by the EFSA. The data was submitted by 28 EU Member States (MSs) and jointly analyzed by EFSA and ECDC and focused on four antibiotic resistant bacteria: zoonotic Salmonella, Campylobacter, Escherichia coli (E. coli) and methicillin2019 resistant Staphylococcus HES 1/2 Page Island aureus (MRSA). Scientists looked at incidences of Salmonella 5-7/16” x 7-1/8” and Campylobacter bacteria found in food and young humans and animals and incidences of E. coli and MRSA found in animals and food only.
According to the report, which refers to 2017 data, resistance to fluoroquinolones (such as ciprofloxacin) is so high in Campylobacter bacteria in some countries that these antimicrobials no longer work for the treatment of severe campylobacteriosis cases. Most countries reported that Salmonella in humans is increasingly resistant to fluoroquinolones. Multidrug resistance (resistance to three or more antimicrobials) is high in Salmonella found in humans (28.3 percent) and animals, particularly in S. Typhimurium. In Campylobacter, high to extremely high proportions of bacteria were found to be resistant to ciprofloxacin and tetracyclines. However, combined resistance to critically important antimicrobials was very low to
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low in Salmonella and Campylobacter from humans and animals and in indicator E. coli from animals. “Carbapenemase-producing E. coli were detected in the mandatory, specific monitoring for ESBL/AmpC/carbapenemaseproducing E. coli in fattening pigs in Germany. The detection of carbapenemase-producing Enterobacteriaceae in the environment of a swine farrow-to-finish operation in the United States was also recently reported (Mollenkopf et al., 2017). These findings are important, because carbapenems are critically important in human medicine, the authors said in the report summary. Pigs are the main animal reservoir for monophasic S. Typhimurium while S. Typhimurium is commonly found in most food-production animals, though most common in pigs and cattle (EFSA and ECDC, 2018b), they noted. The EU Commissioner for Health and Food Safety noted that national policies in some countries limiting antimicrobial use have led to a decrease of antimicrobial resistance. In June 2017, the European Commission adopted the EU One Health Action Plan against Antimicrobial Resistance, calling for effective action against this threat and recognizing that it needs to be tackled in both human health, animal health and the environment. The prudent use of antimicrobials is essential to limiting the emergence and spread of antibiotic-resistant bacteria in humans and animals.
Americore Facility Cited for Biohazards
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HEALTHCARE ENVIRONMENTAL SOLUTIONS news
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llwood City, PA – Amid financial difficulties, Ellwood City Medical Center faces citations from the Pennsylvania Department of Health for biohazard storage violations, according to the LeeDaily.com website and Ellwood City Ledger. In January, state inspectors allegedly found large amounts of biohazardous waste stored improperly in a shed on the hospital grounds. Another report (unconfirmed) said the hospital’s medical waste contractor had not been paid and refused pick up for two weeks. Meantime, the Lawrence County (PA) District Attorney’s Office is conducting a criminal investigation into hospital leaders’ financial practices. Lee County Hospital Authority entered into a contract with Americore Health to reopen Lee County’s only hospital late in 2017. Based on a revisit to the Relicensure Survey completed on May 2, 2018, the state Department of Health determined that Ellwood City Medical Center was in compliance with the requirements of the Life Safety Code for an existing health care occupancy.
News Briefs
Stericycle Will Truck Utah Medical Waste to Kansas
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alt Lake City, UT – Stericycle has rescinded its plan to move its North Salt Lake medical waste processing operations to a remote area of Utah because of costly water supply issues, according to a Deseret News article. A company spokesperson explained that the project, which consisted of constructing twin incinerators on a 40-acre parcel in Tooele County, was not feasible. The new facility was part of a negotiated settlement in which the Utah Division of Air Quality agreed to waive half of a $2.3 million fine on Stericycle for violations. The settlement was reached in 2015. The company had agreed to locate its North Salt Lake incineration operations to a more remote section of the state away from residential populations within three years. The company says it will now truck Utah medical waste to Kansas. Stericycle incinerates medical waste that includes pathological streams, trace chemotherapy and nonhazardous pharmaceutical waste it collects from clients such as hospitals and nursing homes.
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New Sanitation System Halves Healthcare Associated Infections and Cuts Costs by 75 Percent
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he spread of antimicrobial resistance in hospitals can be limited by sanitation methods that remodulate the hospital microbiota, leading to lower antimicrobial consumption and costs, according to a paper in Infection and Drug Resistance co-authored by two Bocconi University scholars (for the part related to costs) with University of Ferrara and colleagues from University of Udine. In particular, an experiment conducted in five Italian hospitals using the probiotic Cleaning Hygiene System (PCHS), a trademarked probioticbased sanitation method, coordinated by the CIAS research centre of the University of Ferrara, led to a 52% decrease in healthcare associated infections (HAI, a kind of infection that tend to exhibit higher resistance to antibiotics than community-acquired infections), a 60.3% reduction in associated drug consumption and a 75.4% decrease in the related costs. The results, Bocconi University’s Rosanna Tarricone, co-author of the study, says, suggest that the introduction of probiotic-based sanitation methods can be considered as a useful component of infection prevention strategies. Money saving are only a part of the story, as HAIs affect 3.2 million people in Europe every year, resulting in 37,000 deaths. The Internal Medicine wards of the hospitals enrolled in the study were surveyed for six months while using the conventional chemical-based sanitation method and, then, for a further six months using ecologically sustainable detergents containing spores of three Bacillus species. Overall 12,000 patients were included in the study and over 30,000 environmental samples from hospital surfaces were analyzed. The new sanitation system was associated with a mean 83% decrease of the detected pathogens on hospital surfaces and a significant reduction (70-99.9%) of antimicrobial resistant genes. In the case of Staphylococcus aureus (Staphylococcus spp. represented up to 90% of the total surface microbiota detected and S. aureus, in particular, plays an important role in HAIs), the isolates from the post-intervention phase were 63.9-93.5% less resistant to antibiotics, depending on the antibiotic type, and those resistant to three or more antibiotics decreased by 72.4%. The number of healthcare associated infections diminished by 52%, as detailed in another co-authored paper (PLOS ONE 13(7): e0199616), and the cost per HAI episode diminished by 45.6%, translating into the aforementioned 60.3% reduction in associated drug consumption and 75.4% decrease in related costs. Since the analysis focused only on drug costs, taking into account other variables, such as the length of stay in hospital, our estimates of the savings are likely to be conservative, concludes Carla Rognoni, the other Bocconi University co-author of the paper.
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News Briefs
Vermont Hospital Fined for Hazmat Violations
Joint Commission Has Zero Tolerance for Hand Hygiene Non-Compliance
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ridgeport, CT – Embracing and reinforcing safety culture is one of the most important ways an ambulance service can ensure compliance, according to an interview with Bridgeport Hospital’s vice president of Ambulatory Services published on BeckersASC.com. Factors that contribute to a successful program include: • Having team members crosscheck one another if they are not following expected hand-washing practices. • Monthly reviews of hand-hygiene performance data help to address any areas performing below target. • An anonymous observation program to educate and engage colleagues from around the health system, including students. Hand hygiene compliance is mandatory in ambulatory care settings. Starting in 2018, ambulatory care surveyors from The Joint Commission began issuing citations if they saw staff not following hand hygiene guidelines. According to an Outpatient Surgery article, surveyors will cite facilities if they observe a single caregiver failing to wash her hands appropriately during direct patient contact. “Any observation by surveyors of individual failure to perform hand hygiene in the process of direct patient care will be cited as a deficiency resulting in a Requirement for Improvement (RFI) under Infection Prevention and Control (IC) Standard IC.02.01.01, EP 2,” reads the Joint Commission update on hand hygiene noncompliance. Since 2004, the Joint Commission has required facilities to implement — and improve compliance with — a hand hygiene program. The accreditation organization points out that its handwashing standard hasn’t changed — only how surveyors are now evaluating the standard. The Joint Commission’s rationale is that facilities have had more than a decade to create and monitor the effectiveness of their hand hygiene programs.
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erlin, VT – Central Vermont Medical Center (CVMC) has been fined $20,250 for multiple hazardous waste violations, according to a Vermont Digger story. Vermont Department of Environmental Conservation fined the hospital for storage, labeling and management violations, as well as hazardous waste stored outside the hospital’s designated waste collection stations. The issues were found during a routine inspection of the hospital in July. In addition, DEC found that the facility lacked arrangements with emergency response personnel about the locations and types of hazardous materials on site, and certain areas lacked emergency information postings. A follow-up visit in September found several continuing storage and waste management violations. Following negotiations, CVMC, which is part of the UVM Health Network, agreed to pay the fine and submit a plan to correct its violations and return to compliance. The hazardous materials were largely found in the hospital’s laboratory and pharmaceutical departments, where chemicals like barium and xylene were not being properly managed as hazardous waste, according to the court docket, Vermont Digger reports. An Agency of Natural Resources enforcement and litigation representative noted that although small infractions, there were enough violations, observed on multiple occasions, that warranted the citations and fine. The fine demonstrated DEC’s seriousness about labeling, storing, and managing hazardous waste – even in small quantities – at a facility, as well as preparedness in handling a hazardous waste emergency. The settlement agreement was incorporated into a court order on Feb. 4 by the Vermont Superior Court, Environmental Division. The Berlin facility is registered as a “Small Quantity Generator,” meaning it generates between 220 and 2,200 pounds of hazardous waste a month.
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News Briefs
New Bleach Spray Proves Effective Against C diff and MRSA Contamination
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leveland, OH – A bleach-based spray tested at Louis Stokes Cleveland Veterans Affairs Medical Center, a 215-bed acute care facility, was found to effectively reduce Clostridium difficile (C diff) Using the sporicidal disinfectant showed a decrease from 24 percent to 5 percent in non-c diff rooms postdischarge, according to study findings published in the American Journal of Infection Control. The study was designed to test whether non-C diff rooms were contaminated with spores before and after a switch from quaternary ammonium disinfectant to Clorox Healthcare Fuzion Cleaner. The study focused on 51 non-C diff rooms tested after the postdischarge cleaning and prior to the switch to the bleach spray, and 39 non-C diff rooms cultured after switching to the bleach product. Prior to switching products, 24 percent (12/51) of the rooms had contamination of at least one site (room and/or bathroom) and 10 percent had MRSA contamination. When cleaning practices were switched to using the bleach spray, the rate of contamination dropped to 2 of 39 rooms. This trend was statistically significant for both C diff and MRSA contamination. The US Centers for Disease Control and Prevention (CDC) estimates that, in the United States, half a million cases of C diff occur every year, and roughly 15,000 people die due to the infection. As a result of the severity of these infections and the challenges for infection control, surveillance and reporting is required not only by many state laws, but also reimbursement regulations through the Centers for Medicare and Medicaid Services (CMS).
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Estonian Scientists Develop Method of Removing Antibiotic Residue from Waste Water
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allinn, Estonia – According to study findings published in the Chemical Engineering Journal, a waste-free chemistry method using aerogel has been shown to be effective in removing antibiotic residue from waste water. It has been well-documented for some time by researchers that antibiotic residues have been getting into rivers, lakes and streams. The impact on water ecosystems is significant, but antibiotic residues in water supplies contribute to the alarming problem of antibiotic resistance that affects humans. Only about half of the prescription drugs and other newly emerging contaminants in sewage are removed by treatment plants, according to a 2013 report by the International Joint Commission, a consortium of officials from the United States and Canada who study the Great Lakes. In Estonia, researchers at Tallinn University of Technology have been developing and studying applications for organic aerogels, including filtering antibiotics from waste water. Organic aerogels are light, porous materials produced from phenolic compounds resulting from processing oil shale, in this case, Estonian oil shale. A carbon dioxide extraction method is used. The reaction takes place quickly and at room temperature (earlier the production of aerogel required heating at a temperature as high as 100°C for a longer period of time). By doping these aerogels with metals, an excellent catalyst carrier is produced that can be used for waste water treatment. Photocatalytic activity of organic aerogels doped with metals (iron, copper, cobalt and nickel) showed novel and surprising results. The best results were obtained by using nickel. Since aerogel is a highly porous material with large specific surface area, it is well-known for its excellent adsorbent properties, which is particularly important when acting as a catalyst. Applying photocatalytic degradation, the researchers were able remove the antibiotic trimethoprim, which is used to treat kidney infections, from waste water. Until now, cleaning water from pharmaceutical waste has been extremely complicated and not very effective, they wrote.
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News Briefs
Decolonization Protocol Can Prevent Dangerous Infections Among Discharged Hospital Patients
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ntiseptic soap, mouthwash, and nose ointment after hospital discharge reduced infections and infection-associated hospitalizations due to MRSA in high-risk patients Hospital patients who have methicillin-resistant Staphylococcus aureus (MRSA) can prevent future infections by following a standard bathing protocol after discharge, according to research results published in the Feb. 14 issue of the New England Journal of Medicine. The Changing Lives by Eradicating Antibiotic Resistance, or CLEAR, trial divided 2,121 adult patients at random into one of two groups. All patients in both groups were “colonized” with MRSA; that is, they carried MRSA silently on their bodies. One group received education in infection prevention measures related to personal hygiene, laundry and cleaning in the home, and the other group received the same education along with instruction in decolonization — that is, a treatment regimen to remove MRSA bacteria from their bodies. The decolonization regimen included bathing or showering with an over-thecounter antiseptic soap, rinsing the mouth and throat with a prescription mouthwash, and applying an antibiotic ointment to the nose. The patients were taught to self-administer the decolonization regimen daily for five days, twice a month, for six months. “Our goal was to understand whether removing MRSA from the skin, nose and throat was better than hygiene education alone in reducing MRSA or other infections and associated hospitalizations,” said Dr. Mary Hayden, professor of internal medicine and pathology, chief of the Division of Infectious Diseases, and director of the Division of Clinical Microbiology at Rush University Medical Center. In the group that received education alone, one out of every 11 (9.2 percent) participants developed a MRSA infection and one in four (23.7 percent) developed a serious infection from any pathogen, with most infections (85 percent) leading to hospitalization. The decolonization plus education regimen reduced MRSA infections by 30 percent, compared to the group that only received education, and reduced all types of infections by 17 percent. Patients who did not miss any doses of decolonization had 44 percent fewer MRSA infections and 40 percent fewer infections overall. Participants in the study were recruited from 17 hospitals and seven nursing homes in Southern California (Orange County and Los Angeles County). The participants were adults who were able to bathe or shower (either by themselves or with caregiver assistance), had been hospitalized in the previous 30 days, and tested positive for MRSA while in the hospital or 30 days before or afterward. (California mandates MRSA screening at hospital admission in high-risk patients.) The researchers followed the patients for 12 months after they were discharged from the hospital, meeting with them in their homes or in a research clinic four times and conducting an exit interview at the end of the year. They also contacted the participants monthly, asked them to report any hospitalizations or clinic visits for infection and reviewed their medical records from the study period. National data from the Centers for Disease Control has shown that MRSA carriers who are discharged from hospitals are at high risk of serious disease due to MRSA in the year following discharge. Approximately 5 to 10 percent of hospitalized patients are MRSA carriers. “With an issue this large, we wanted to find best practice strategies to prevent these infections and associated hospitalizations,” said Hayden. “This large clinical trial helped determine that there is a way to help prevent infections after patients go home and it can prevent readmission.” The study was conducted through longstanding collaborations between the University of California Irvine, Los Angeles Biomedical Research Institute at Harbor-UCLA, and Rush University.
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