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Jan-Mar 2013

Medical Waste Management

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The Latest Super Bug to Hit Hospitals


By Todd Williams

irst there was MRSA and C-Diff. Now there is a new super bug plaguing the medical community, one that threatens to be even more difficult to control. The bacteria, known as CarbapenemResistant Enterobacteriaceae, or CRE, have the uncanny ability to fight off the powerful carbapenem antibiotics as well as other, often used antibiotics. And although not yet as common as the more well-known hospitalacquired infections (HAI), CRE has been popping up in health care facilities in 42 states according to Alex Kallen, a medical officer with the Centers for Disease Control (CDC). Although CRE is such a widespread problem, the highest proportion of cases have been reported in the northeast area of the country, with the densest outbreaks found in New York City, Kallen notes. He adds that recently more numerous outbreaks of CRE have been logged in Miami, and Chicago. Other, smaller pockets of the bugs have been reported in Oregon, Minnesota, Pennsylvania, Wisconsin, South Carolina, Maryland and Virginia. In addition to the US, CRE strains have produced outbreaks in other countries as well. So-called “medical tourism” to

India, for example, has led to major outbreaks of CRE in Europe. According to Kallen, a coordinated, regional approach is needed to control a CRE outbreak. Because unlike other bugs, CRE transmission specifics are not as well known, the sharing of information is very important. Kallen notes surveillance of the bacteria is conducted and shared through the National Healthcare Safety Network and the Emergency Protection Program. According to the CDC, CRE belongs to an obscure family of drug-resistant bacteria that has been targeting hospitals and nursing homes for over 10 years. Now CRE with death rates as high as 40% in infected patients is emerging as a major problem in the medical community. E-Coli and Klebsiella are the two most common CREs, and both are found in the gut, explains Dr. Frank Esper, an infection disease physician at University Hospitals, Cleveland, Ohio. Other CREs show up as pneumonia, meningitis, abscesses, bloodstream infections and urinary tract infections. “In the gut,” he notes, “These bacteria usually cause no problem. Once they get outside Continued on page 3

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Medical Waste Management  Jan-mar 2013

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Publisher / Editor Rick Downing

Contributing Editors / Writers

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CRE: The Latest Super Bug to Hit Hospitals

Continued from page 1

the gut, then they cause infections.” Lax infection control procedures, nonor misidentification of the bacteria, and indiscriminate overuse of antibiotics have all played a part in the spread of CRE, say disease control experts. According to Dr. Gary Rosell, director for the Department of Veterans Affairs (VA) Infectious Diseases Service, the most commonly found places harboring CRE are the trauma, burn and intensive care units in hospitals.The bug has also been detected in long-term care facilities where the sophistication for detection and prevention is often less than perfect. Although the VA’s 152 medical centers and 1,400 outpatient clinics have experienced fewer cases of CRE than other public and private hospitals, it still is present and actively monitored and controlled. “The VA is trying to get ahead of the spread of CRE through hand hygiene, proper cleaning of the environment, patient isolation when necessary and the proper use of antibiotics,” Dr. Roselle says. Dr. Roselle notes that the VA has infection control practitioners in all its facilities and has “significant expertise in HAI procedures.” Although he says the “vast majority “ of germs in a hospital setting are not CRE, UHs’ Dr. Esper notes he takes the bacteria “very seriously.” “We don’t want any cases here,” he says. Although proper hand washing procedures are extremely important in the control of CRE, Dr. Esper and other experts have additional weapons at their disposal in the battle against infections in the hospital. First and foremost is the correct and rapid identification of the bacteria. Prompt testing helps prevent the spread of CRE within the hospital. A positive test for the bacteria normally places the patient into contact isolation. This requires the patient be kept in a private room. The CDC suggests that inpatient facilities should have an awareness of whether or not CRE have been cultured from patients admitted to their facility and, if so, whether these positive cultures were collected within 48 hours of admission. According to Mike Zambo, an architect and Principal for Health Care Design for Bostwick Design Partners, Cleveland, Ohio, most hospitals are now designed with single rooms making isolation easier than when there were large wards. In fact, he notes, “we are

designing special isolation rooms in the larger hospitals; rooms much like operating rooms in terms of a sterile environment.” Zambo explains that the one component of these more sterile rooms is the design of air handling equipment to keep bacteria at bay through negative and positive air pressure. Negative air pressure keeps bacteria out of an isolation room, while positive air pressure keeps clean air in a room. Air filtration as well as the frequency of air changes in a patient room is being revised upwards by the Federal Guideline Institute from six air changes per hour to 15 per hour, the same as operating rooms. Another design innovation, says Zambo, is the number and location of hand washing sinks. “For many years we designed rooms with one sink for every four beds. Now it is one for every three beds. Also, infection control experts are pushing for caregiver sinks to be separate from patient sinks. We have also been required to design edge and seam-free surfaces that could trap bacteria,” Zambo says. And Dr. Esper adds that no matter what the design of a room is, isolation room procedures are still very important. He specifies these rules require that all visitors, both medical personnel and family, don gowns, masks, gloves and booties that are immediately disposed when the person leaves the room. Of course, hand washing is mandatory when entering and leaving a room. “We set the bar very low for isolation. Even for flu and diarrhea we require isolation,” says Dr. Esper. The CDC’s Kallen explains that the bacteria’s prime mode of spreading is through people-to-people contact, specifically through hand contact and not aspiration. However, IV lines, catheter tubes, endotrachael tubes, and other medical devises also harbor the bugs. When possible, the use of these devices should be restricted and discontinued when not needed. The VA’s Dr. Roselle adds that proper cleaning of the rooms is extremely important in infection control, whether it be for CRE or any other HAI. He specifies that all surfaces, including floors and other flat surfaces need to be cleaned, especially in the isolation rooms as well as ICU rooms. The mantra used when fighting CRE, according to CDC’s Kallen, is “detect and protect.” Continued on page 4

Jan-mar 2013  Medical Waste Management


medical waste management

CRE: The Latest Super Bug to Hit Hospitals Continued from page 3

Since bacteria loves to live and thrive on surfaces in a hospital, surfaces that are frequently touched and handled by patients, visitors and caregivers alike, cleaning is important. But in addition to proper cleaning techniques, infection control specialists, architects and manufacturers are always on the lookout for materials that are unfriendly to the bugs. Over the years surfaces such as handrails, grab bars, door handles, bed rails, over bed tray tables, IV poles, call buttons and other touched surfaces have evolved from wood to steel to plastic to other materials which are more sterile and more easily cleaned. One such material that has shown great promise in controlling the spread of CRE is copper and its various alloys. According to Harold Michaels, PHD, and senior vice president of the Copper Development Association, a trade group representing the copper, brass and bronze industries, when CRE lands on copper surfaces, respiration stops and the bug’s DNA breaks into very small segments, no longer work for some patients, especially the at-risk group of people: effectively killing the CRE bacteria. the elderly, the very young, and those with compromised immune systems. Because the bacteria are quickly eliminated, they do not have the Hospital units like those that specialize in chemotherapy and organ survival time necessary to thrive and mutate. And says Michaels, the transplants; whose patients depend on antibiotics to control infections, higher the copper content of the surface, CRE’s reaction to the material is could be hit hard by the uncontrolled spread of CRE. faster. Also, as the copper tarnishes, the reaction time According to Dr. Roselle, “CRE cases will increases even more. increase nationally, particularly because there are no “Over the years surfaces “We believe that the hydration of copper, or new drugs in the pipeline.” such as handrails, grab the oxidation, releases the ions faster, thus affecting Infectious disease specialists all acknowledge bars, door handles, bed that the major drug companies have little financial the CRE bacteria. Furthermore, our latest studies indicate an 83 percent reduction of bioload on copper rails, over bed tray tables, incentive to develop new antibiotics because these surfaces,” Michaels says. IV poles, call buttons and drugs are taken only until a patient has recovered, Because of strict EPA testing procedures and making them less profitable than drugs taken for other touched surfaces chronic illnesses. requirements, Michaels says Europe has taken the lead in the use of copper in medical settings. Countries have evolved from wood “Unfortunately, because we’ve overused many ahead in the medical use of the material include antibiotics, bacteria has learned the lesson of what to steel to plastic to Greece, England, France, Ireland, India, Japan and doesn’t kill them, makes them stronger,” notes UHs’ other materials which Chile, who just happens to be the world’s largest Dr. Esper. are more sterile and more producer of copper. Dr. Esper explains that some doctors have gone Copper, says Zambo, is showing up in more and back to trying some older, more toxic antibiotics in easily cleaned.” more products specific to the hospital environment. an attempt to defeat CRE, meeting with some limited He says architects are becoming more aware of the CRE problem and are success. And since the big pharmaceutical companies no longer develop considering the built environment increasingly important to the elimination new antibiotics, he feels that role will be taken up by small, independent of the bug. pharmas. However, he says this will be a slow process because of the Due to the fact that studies on the use of copper and other alloys tremendous cost of the research and development. in hospitals are relatively new, there aren’t that many products to choose “Small firms need to make money as well. I think that they will need from, says Zambo. He adds that even though an architect might specify a government help to get these drugs off the ground. I hope a whole lot of particular surface material in a room, that doesn’t mean it is readily available deaths will not be necessary to get the industry to develop a new generation from a reliable manufacturer at a cost effective price. of antibiotics,” Dr. Esper argues. “We at the VA are aware of the contribution of the built environment In the meantime, Dr. Esper and others cite the need to try and reduce in both industrial and clinical settings. We are aware of the effects of the use of “big, umbrella antibiotics” unless absolutely required. He UV light, vapor and surfaces to prevent bio film. Solid research also says there needs to be more studies conducted on the use of on building design and materials by industry and health care antibiotics in domestic animals raised for food. is needed to help us fight CRE and other HAIs,” says Dr. Dr. Roselle prescribes the optimum effective use of Roselle. antibiotics as “using the right drug, the right dosage, the Assuming everything is being done to prevent CRE right patient, the right mode of administration and from showing up in the medical environment, the last the right length of time.” line of defense and the line which has failed to stop “The good news in this whole issue is that CREs CRE and in fact even contributed to its spread, is the have not been found in healthy people. It hasn’t gone use of antibiotics. out into the general public as yet,” notes Kallen. Roselle and other infection experts cite the overuse of And Dr. Roselle concludes although CRE is a problem all antibiotics as one of the major contributing facts to the which he puts at the top of the infectious disease list, because spread of CRE and HAI in general. there is so much attention being drawn to this bacteria, early Because of the rapid growth and mutation of bacteria and the intervention will hopefully halt the spread of CRE and ultimately tendency to overuse certain antibiotics, most commonly-used antibiotics contain it within the medical environment. 4

Medical Waste Management

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news briefs

Low-Tech “Tools” Still Effective


ower-tech approaches have merit in infection control, according to one new study. Checklists and communication protocols have been found to reduce central line-associated bloodstream infections in newborns by 58 percent in less than a year. Using such approaches, the Comprehensive Unit-Based Safety Program saved more than $2 million, according to an Agency for Healthcare Research and Quality report. One study published in BMC Infectious Diseases, looked at the infectious disease risk associated with patient transfers and found that implementing communications tools such as a pre-transfer checklist and a colored cue to highlight patient infectious status on the transfer form helped increase prevention compliance rates by 95 percent. In a period of four months, transfers using the colored cue had a compliance rate of 73 percent and transfers with the pre-transfer checklist had a compliance rate of 71 percent, while the control group had a 38 percent compliance rate. When both interventions were used, the compliance rate reached 74 percent — a 94.7 increase over the control group’s rate. However, while the colored cue was accepted, adherence to the checklist was at 40 percent.  Read more: Read the abstract Read the announcement regenstrief-study-informatics-tools-underutilized-in-prevention-/.

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Medical Waste Management  Jan-mar 2013

Exam Room Recycling and Composting Program Begins in Santa Barbara


ANTA BARBARA, CA—According to an article posted on the Santa Barbara Independent’s website, a clinic here is recycling and composting paper waste from its offices and examining rooms. The program, led by Service Core Group of Sansum Clinic, a multi-specialty clinic, trained staff to deposit paper in small, black hanging baskets with are regularly emptied into a specially-designed dumpster.. The Clinic developed its program in consultation with the city of Santa Barbara. Since January 2011, it has trimmed waste going to landfills from 80 percent to 20 percent and doubled recycling from 20 percent to 40 percent. As of last December, hand towels and exam table paper were added to the program when it was discovered these materials could be composted. This allowed further diversion from the landfill because now 40 percent of the Clinic’s paper waste is being composted. The paper collection began in the administrative offices and nurses stations and was later expanded to include the medical offices. Plans are being developed to add cafeteria food scraps to the Clinic’s recycling program.

Jeff Adix New CEO of Veolia Environmental Services for North America


eolia Environmental Services North America (VESNA) recently announced the appointment of Jeff Adix as President and CEO of the organization. He replaces Richard Burke, who recently left the company to serve as President of Advanced Disposal Services (ADS), which acquired the assets of Veolia ES Solid Waste. As President and CEO of VESNA, Adix will be responsible for the overall performance, growth and operations of the company, which include the collection, treatment and recycling of hazardous wastes and turn-key industrial cleaning and maintenance. Adix previously worked for Veolia from 2000 to 2009. During this time, he served as a member of VESNA’s Executive Committee and held senior management roles of increasing responsibility, including Senior Vice President of Support Services and Chief Financial Officer for the company’s former solid waste business.

news briefs

Researchers Find New Way to Fight MRSA


HAPEL HILL, NC—The results of a genetic study on methicillinresistant Staphylococcus aureus (MRSA) has yielded findings that may lead to effective treatment of a particularly stubborn strain – USA300 — that causes the vast majority of MRSA skin and soft tissue infections seen in emergency rooms. According to the research conducted by a University of North Carolina School of Medicine team of scientists, USA300 is not only persistent in healthcare facilities – it has been found to hitchhike its way to the general public. When the team tested hundreds of MRSA strains, they found that all of them except one – USA300 – were sensitive to polyamines, the anti-bacterial compounds that exist naturally on skin and which normally destroy germs. Polyamines are critical to wound repair because they are anti-inflammatory and promote tissue regeneration. What is so different about USA300? The scientists found that it contains a chunk of 34 genes, called the arginine catabolic mobile element (ACME) not present in other MRSA strains. By mutating each of ACME genes, one by one, the scientists created a MRSA strain that could be killed off by the polyamines. To confirm that they had the right gene, the researchers added a normal, non-mutated version of the gene -- named SpeG – to other strains of MRSA and showed that it could make them resistant to polyamines. It’s not clear how this unique genetic material enables the bacteria to survive and persist in the community, but the University of North Carolina School of Medicine report says the SpeG gene allowed USA300 to remain on the skin for anywhere from a day to a week, giving the infection time

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to spread to the next host. “Previously, the field tried to understand MRSA by focusing on attributes that we already knew were important, such as the amount of toxins or virulence factors a given strain makes. Those elements may explain why the disease is so bad when you get it, but they don’t explain how a particular strain takes over. Our work uncovers the molecular explanation for one strain’s rapid and efficient spread to people outside of a crowded hospital setting,” said senior study author Anthony Richardson, PhD, assistant professor of microbiology and immunology at the UNC School of Medicine. “The problem is by the time you figure out how one strain comes into dominance, it often fades away and a new strain comes in. But because these compounds occur naturally and are so toxic, we still think they can lead to treatments that are effective against all MRSA. We will just have to put in a little extra work to block the gene and make this particular strain of MRSA susceptible to polyamines,” said senior study author Anthony Richardson, PhD, assistant professor of microbiology and immunology at the UNC School of Medicine. The UNC study was published January16, 2013, in the journal Cell Host & Microbe. The research was funded by the National Institute of Allergy and Infectious Diseases. Study co-authors from UNC include Lance R. Thurlow, PhD; Gauri S. Joshi, PhD; Justin R. Clark; Jeffrey S. Spontak; Crystal J. Neeley; and Robert Maile, PhD.

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Jan-mar 2013  Medical Waste Management


news briefs

Businesses Must Prepare for Pandemics and Other Disasters


T. LOUIS, MO—The results of a study which examined how often U.S. businesses, including healthcare and non-healthcare companies, prepare for disasters and biological events found that too many of them are unprepared for disasters, especially pandemics. This news is according to an article posted on Saint Louis University researchers surveyed policies and actual practices in healthcare and non-healthcare companies. What they found was that written policies were one thing, actual practice was another. One glaring issue is that 60 percent of businesses reported they encourage ill staff to stay home, but about 40 percent responded that the business has a culture that encourages staff to work when they are sick. The study’s principal investigator, Terri Rebmann, Ph.D., associate professor at SLU College for Public Health and Social Justice, thinks the study’s findings are particularly timely, given that the U.S. is currently in the midst of an influenza outbreak, one of the worst in the decade. Rebmann said businesses need to improve their disaster plans for biological events so that they are able to minimize the impact of disasters and continue daily operations. “One of the key findings from the study was that about 60 percent of businesses reported they have a policy that encourages their ill staff to stay home,” said Rebmann. “There’s a disconnect between written policies versus what the business culture encourages. This can contribute to disease spread in the business setting, especially among healthcare agencies.”

Company to Repay NY State Millions for Overcharging


TATEN ISLAND, N.Y.—The Statan Island Advance reports that a waste disposal company owes New York taxpayers $2.4 million, due to overcharges for medical waste collection. In a case brought by the New York State Attorney General, Eric T. Schneiderman’s office, the Illinois-based Stericycle was accused of improperly charging nearly 1,000 New York police and fire departments, ambulance companies, hospitals and schools. Starting in 2003, officials found, the company regularly added 18 percent “automated price increases” to bills without telling customers. Investigators who followed up on a 2010 whistleblower tip found overcharges as high as $6,500. The company got away with overcharging by first enticing customers with fixed price agreements and then automatically adding so-called fuel and energy surcharges to every bill at a rate of 18 percent. The charges did not correspond with market prices. In some cases, customers were billed even though they had no pickups for long periods of time. As part of the legal settlement, Stericycle has agreed to refund all of the excessive charges – more than $820,000 – to every impacted government agency in the state. The whistleblower will receive 20 percent of the settlement money as an incentive and reward, officials with the attorney generals’ office said, while the rest of the money goes to the state. The company agreed to discontinue its “automated price increase” system, and to notify customers of an opt-out opportunity whenever it raises rates in the future.

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Medical Waste Management  Jan-mar 2013

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Stericycle Must Double Treat Waste, Says WA State


ENTRALIA, WA—According to an article from Chronicle and McClatchy-Tribune news sources posted on, medical waste treatment and recycling company Stericycle has been ordered to upgrade its Morton, WA facility. Following a review of the company’s waste discharge permit reapplication and data on samples of discharge from the plant, the state Department of Ecology decided to require Stericycle to pretreat its waste. The secondary sterilization will entail design and construction of a new system to treat sewage before discharging it to the municipal treatment plant, an upgrade which Ecology officials say will help protect the nearby Tilton River from pass-through pollution, In making the order, the state is responding to long-time public concerns about mercury, heavy metals and pharmaceuticals pollution, as well as environmental and human health risks related to the data it reviewed for the past five years of Stericycle’s Morton operation. Ecology officials say the company has repeatedly violated pollutant limitations. They also note that the company has increased the strength and volume of its waste product since it began discharging its sewage to the Morton waste treatment plant. Ecology officials say the plant was never meant for treating industrial waste and Stericycle’s pretreatment upgrade will reduce overloading. Varying concentrations of hormones, steroids, PPCP’s and metals have been found in processing tanks at Stericycle’s facility. The monthly sampling data reviewed by Ecology showed that Stericycle violated regulatory limits for total suspended solids, or general water quality, 47 times since 2007. In December 2010, a sampling from the company’s pump vault showed levels of mercury and chromium exceeding limitations by at least 20 times. Polynuclear aromatic hydrocarbons -- powerful pollutants that can be carcinogenic -- and volatile organic compounds also were present in several of Stericycle’s waste streams, Ecology reported. “These solids can be picked up by the sump pump and discharged to the sewer,” Ecology’s hazardous waste unit reported. There’s another benefit of Stericycle pretreating its waste to remove contaminants -- the company may be able send sludge discharge to the Morton facility to produce saleable fertilizer.  Delays have occurred due to the complexities of building the pretreatment system. A tentative schedule suggests Stericycle will submit a final design in April and will install the system by the end of 2013.

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Proposed House Bill Could Make Medical Waste Dumping Illegal


A S H I N G T O N, D. C. — A c c o rd i n g t o a n a r t i c l e o n, a new bill, if passed by Congress, would make dumping medical waste punishable by up to 30 days in jail and a $500 fine. The bill, HB 1208, is intended to keep disposable equipment, instruments, utensils, human tissue, laboratory waste and blood specimens or other substances that could carry pathogenic organisms out of landfills. The bill, recently approved by the House Health and Human Services Committee, would increase safety at single-stream recycling centers, where workers who do the hand-sorting come into contact with contaminated materials from industrial and residential sources. Sponsored by Rep. G. Mark Mickelson (R-Sioux Falls), the bill was supported by Tom Martinec, state deputy secretary of health, and by the South Dakota Association of Healthcare Organizations. Mickelson says state laws already regulate how medical waste should be disposed, but recycling centers aren’t covered. “This needs to be clarified as we become more of a recycling society,” says Rep. Melissa Magstadt (R-Watertown), who believes the bill will ensure better adherence to dumping rules.

Jan-mar 2013  Medical Waste Management


news briefs

New Drug Halts Drug-Resistant Strains of Flu Virus


ccording to a study led by University of British Columbia researchers, a new class of influenza drug has been shown effective against drug-resistant strains of the flu virus. The study, published online February 21 in the journal Science Express, details the development of a new drug candidate that prevents the flu virus from spreading from one cell to the next. The drug is shown to successfully treat mice with lethal strains of the flu virus. In order to spread in the body, the flu virus first uses a protein, called hemagglutinin, to bind to the healthy cell’s receptors. Once it has inserted its RNA and replicated, the virus uses an enzyme, called neuraminidase, to sever the connection and move on to the next healthy cell. “Our drug agent uses the same approach as current flu treatments -- by preventing neuraminidase from cutting its ties with the infected cell,” says UBC Chemistry Prof. Steve Withers, the study’s senior author. “But our agent latches onto this enzyme like a broken key, stuck in a lock, rendering it useless.” The World Health Organization estimates that influenza affects three to five million people globally each year, causing 250,000 to 500,000 deaths. In some pandemic years, the figure rose to millions. “One of the major challenges of the current flu treatments is that new strains of the flu virus are becoming resistant, leaving us vulnerable to the next pandemic,” says Withers, whose team includes researchers from Canada, the UK, and Australia. “By taking advantage of the virus’s own ‘molecular machinery’ to attach itself,” Withers adds. “The new drug could remain effective longer, since resistant virus strains cannot arise without destroying their own mechanism for infection.”

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Recycling of Plastic Bags, Wraps and Film Rises to 1 Billion Pounds Annually


ashington, DC–The recycling o f p l a s t i c f i l m c l i m b e d fo u r percent to reach 1 billion pounds annually in 2011 for the first time, according to a recent national report. The category of “plastic film” includes plastic bags, product wraps and commercial shrink film. The report, developed by Moore Recycling Associates, Inc. on behalf of the American Chemistry Council (ACC), noted that the recycling of plastic film has grown 55 percent since just 2005.  According to the report, approximately 58 percent of U.S.-recovered postconsumer film was consumed domestically in 2011 – up from 53 percent in 2010 – largely due to growth in the plastic and composite lumber industry, the primary market for this material. The composite lumber industry showed a 120-million-pound increase in consumption from 2010 to 2011 to reach 55 percent of the total market for recovered film.  Consumption of postconsumer plastic film by the film and sheet industry, the second largest market for this material, held steady at 100 million pounds, or 16 percent of the total market. Recycled polyethylene film is used to make a range of products, including durable plastic and composite lumber for outdoor decks and fencing, home building products, garden products, crates, pipe, and new film packaging like plastic bags. Recovery data in the report, “2011 National Postconsumer Plastic Bag & Film Recycling Report,” is based on a survey of 19 U.S. and three Canadian processors of postconsumer film along with 37 companies that export this material. Through ACC’s Flexible Film Recycling Group (FFRG), which represents resin producers, film converters, brand owners, and recyclers, the industry is actively working to increase both commercial and consumer participation in the film recycling process. “Reaching the 1-billion-pound mark is an achievement that plastics makers, recyclers and retailers can be proud of,” said Steve Russell, vice president of plastics for ACC, “and we’re continuing to work together to get that number even higher.” There are currently more than 15,000 locations where consumers can bring their used polyethylene bags and wraps to be recycled, primarily at large grocery and retail chains across the United States.  “In-store collection is absolutely critical for recycling plastic bags, wraps and other flexible film packaging,” said Russell.  “The infrastructure is there. The plastic film industry is now working to help grocers and retailers maximize the collection of this valuable material by sharing tools and best practices and through consistent customer education.”

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news briefs

New HIPAA Breach Notification Rule May Prove Costly for HIPAA-Covered Entities By Erin M. Duffy and Lisa W. Clark


n light of this heightened standard, covered entities, business associates and downstream contractors should consider carefully reviewing their breach notification policies and procedures, training materials and contractual arrangements in an effort to avoid potential liability under the Breach Notification Rule. On January 17, 2013, the U.S. Department of Health and Human Services (HHS) announced a final omnibus rule amending the Health Insurance Portability and Accountability Act of 1996 (HIPAA) in accordance with the HITECH Act of 2009. The 2013 amendments, which are effective on March 26, 2013, supplement and modify the HIPAA Privacy, Security, Breach Reporting and Enforcement Rules. The regulations modify the interim final rule (the “Breach Notification Rule”) published in August 2009 that required notice to patients and others of a “breach,” or disclosure of unsecured protected health information (PHI), by covered entities and business associates (collectively referred to as “HIPAA-covered entities”). One of the most significant changes to the Breach Notification Rule modifies and clarifies the definition of “breach” and the risk-assessment approach required for breach notification. In light of this heightened standard, covered entities, business associates and downstream contractors should consider carefully reviewing their breach notification policies and procedures, training materials and contractual arrangements in an effort to avoid potential liability under the Breach Notification Rule.

Things Every Covered Entity and Business Associate Should Be Aware of About the Breach Notification Rule ➤ Unless an exception applies, an impermissible use or disclosure of PHI is presumed to be a “breach,” unless the HIPAA-covered entity can demonstrate that there is a low probability that the PHI has been compromised based upon, at minimum, a four-part risk assessment. ➤ The new risk assessment factors are significant in that they provide a specified structure for the risk assessment that if not adequately performed and documented could provide a basis for imposition of costly penalties. ➤ The Breach Notification Rule extends to business associates and their downstream subcontractors.



n general, the Breach Notification Rule requires a covered entity to notify an individual when unsecured PHI has been improperly disclosed. The entity must also notify HHS regarding confirmed breaches, either through an annual report or sooner, depending on the number of individuals affected. In some instances, media must also be notified. Integral components of the Breach Notification Rule are definitions of “unsecured PHI” and “breach.” In particular, HHS clarified that the impermissible use of disclosure of PHI is 12 Medical Waste Management  Jan-mar 2013

presumed to be a “breach,” unless the HIPAA-covered entity demonstrates there is a low probability that the PHI has been compromised.

Significant Definitions and Analysis “Unsecured PHI”


nsecured PHI” is “protected health information that is not rendered unusable, unreadable, or indecipherable to unauthorized individuals through the use of a technology or methodology specified by the Secretary in guidance.” HIPAA-covered entities that implement the specified technologies and methodologies with respect to PHI are not required to provide notifications in the event of a breach of such information— that is, the information is not considered “unsecured” in such cases. It is important to note that the data-protection standards recognized under the HIPAA Breach Notification Rule (encryption and destruction) are different from the data-protection standards articulated under the HIPAA Security Rule and the HIPAA Privacy Rule. The Security Rule requires covered entities to protect electronic PHI by satisfying a number of general standards. The Privacy Rule requires that covered entities apply reasonable safeguards to all PHI. Thus, even PHI that was protected in accordance with the Privacy and Security Rules, such as by use of firewalls, but was breached under the terms of the new Breach Notification Rule, would have to be reported. In addition, the HIPAA Security Rule requires “security incident reporting.” A “security incident” means the attempted or successful unauthorized access, use, disclosure, modification or destruction of information or interference with system operations in an information system. Therefore, even though a “breach” as defined by the Breach Notification Rule has not occurred, security incident reporting may still be required under the HIPAA Security Rule or by contract.



he most significant change to the Breach Notification Rule is the definition of the term “breach.” HHS defines “breach” as the “acquisition, access, use, or disclosure” of PHI in violation of the Privacy Rule that “compromises the security or privacy” of the PHI. Under the interim rule, HHS defined the phrase “compromises the security or privacy of the PHI” to mean the inappropriate use or disclosure of PHI involving significant risk of financial, reputational or other harm. The final rule changes this definition by stating that, unless an exception applies, an impermissible use or disclosure of PHI is presumed to be a “breach,” unless the HIPAAcovered entity can demonstrate there is a low probability that the PHI has been compromised based upon, at minimum, a four-part risk assessment. HHS also clarified that uses or disclosures that impermissibly involved more than the minimum necessary information may qualify as breaches. Therefore, such incidents should be evaluated as any other impermissible uses or disclosures to determine whether breach notification is not required.

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“Risk of Harm” Analysis Replaced with “Low Probability”


HS has shifted away from the subjective, non-uniform “risk of harm” analysis toward a system that focuses more objectively on the risk that the PHI has been compromised. The “low probability” risk assessment will provide HIPAA-covered entities with less latitude in making internal determinations that exclude certain incidents from the definition of “breach” and from the associated notification requirements. HIPAA-covered entities now have the burden of showing that a breach has not occurred. The risk assessment must be performed following all impermissible uses and disclosures that do not otherwise fall within the other enumerated exceptions to the definition of “breach.” If a risk assessment is not performed and none of the other exceptions apply, the incident is automatically presumed to be a breach. The final rule requires the risk assessment to consider at least the following four factors: 1. The nature and extent of the PHI involved, including the types of identifiers and likelihood of re-identification. To assess this factor, entities should consider the type of PHI involved, such as whether the disclosure involved information of a sensitive nature (e.g., credit cards; Social Security numbers; information that increases the risk of identity fraud; and clinical information, such as diagnosis, treatment plans, medication, medical history and test results). Considering the type of information disclosed will allow the HIPAA-covered entity to assess the probability that the PHI could be used by an unauthorized user in a manner adverse to the individual. Additionally, if there are few, if any, direct identifiers in the PHI impermissibly disclosed or used, the HIPAA-covered entity may want to determine whether there is a likelihood that the PHI released could be re-identified based on the context and the ability to link the information with other available information. 2. The unauthorized person who used the PHI or to whom the disclosure of PHI was made. Entities should consider whether the unauthorized person who received the information has obligations to protect the privacy and security of the information. For example, if PHI is impermissibly disclosed to another entity obligated to abide by the HIPAA Privacy and Security Rules or to a federal agency obligated to comply comparable regulations, then there may be a lower probability that the PHI has been compromised since the recipient of the information is obligated to protect the privacy and security of the information in a similar manner as the disclosing entity. Furthermore, if the information impermissibly used or disclosed is not immediately identifiable, entities may want to determine whether the unauthorized person who received the PHI has the ability to re-identify the information. 3. Whether the PHI was actually viewed or acquired or, alternatively, if only the opportunity existed for the information to be viewed or acquired. For example, if a laptop computer was stolen and later recovered and a forensic analysis shows that the PHI on the computer was never accessed, viewed, acquired, transferred or otherwise compromised, the HIPAA-covered entity could determine that the information was not actually acquired by an unauthorized individual even though the opportunity existed. In contrast, if a HIPAA-covered entity mailed information to the wrong individual who opened the envelope and called the entity to say that she received the information in error, in this case, the unauthorized recipient viewed and acquired the information because she opened and read the information to the extent that she recognized it was mailed to her in error. 4. The extent to which the risk to the PHI has been mitigated. HIPAA-covered entities may want to attempt to mitigate the risks to the PHI following any impermissible use or disclosure, such as by obtaining the recipient’s satisfactory assurances that the information will not be further used or disclosed (through a written confidentiality agreement or similar means) or will be destroyed. They should consider the extent and efficacy of the mitigation when determining the probability that the PHI has been compromised. The federal government clarifies that each factor above must be considered in a HIPAA-covered entity’s risk analysis, and other factors may also be

considered where necessary. HIPAA-covered entities should then evaluate the overall probability that the PHI has been compromised by considering all the factors in combination. These risk assessments should be thorough and completed in good faith, and the conclusions reached have to be reasonable. If an evaluation of the factors discussed above fails to demonstrate there is a low probability that the PHI has been compromised, breach notification is required. With regards to breach notification, the HIPAA-covered entity bears the burden of proof to demonstrate that all notifications were given or that the impermissible use or disclosure did not constitute a breach and to maintain documentation (e.g., the risk assessment) to meet the burden of proof.

Exceptions to the Definition of “Breach”


he final rule also eliminated the exception where the PHI used or disclosed constitutes limited data sets that do not contain any dates of birth and ZIP codes. The other exceptions remain. Specifically, a “breach” does not include: • Any “unintentional” acquisition, access or use of PHI by a workforce member or individual acting under the authority of the covered entity or business associate that is made in good faith, within the course or scope of employment or other professional relationship, and is not further used or disclosed in an unlawful manner under the HIPAA Privacy Rule. • An “inadvertent” disclosure to another authorized person at the same covered entity, business associate or organized healthcare arrangement, and the PHI is not further used or disclosed in an unlawful manner under the HIPAA Privacy Rule. • A disclosure where the covered entity or business associate had a good-faith belief that the unauthorized person to whom the information was disclosed would not reasonably be able to “retain” such information.

New Policies and Procedures Required


h e Breach Notification Rule requires HIPAA-covered entities to develop and document policies and procedures, train workforce members on and have sanctions for failure to comply with these policies and procedures, permit individuals to file complaints regarding these policies and procedures or a failure to comply with them, and require HIPAA-covered entities to refrain from intimidating or retaliatory acts. Thus, a HIPAA-covered entity is required to consider and incorporate the new breach notification requirements with respect to its administrative compliance and other obligations.



very data breach is unique, and any assessment determining the probability that PHI was compromised will be highly fact-dependent and will incorporate a significant degree of subjectivity. However, the new low-probability standard is likely to be hard to meet and strongly indicates that HHS intends for the vast majority of breaches to be disclosed. Thus, with this heightened burden on risk-assessment analysis and notification, it is vital that all covered entities and business associates examine and update their current policies and procedures to ensure that they can detect and respond to potential data breaches in an appropriate and compliant manner. Erin M. Duffy and Lisa W. Clark are associates in Duane Morris’ Health Law Practice Group in the firm’s Philadelphia office. Duane Morris attorneys provide the full range of services to entities that handle healthcare and other personal data, including healthcare providers, data analytic and management companies, software development and storage vendors, health information exchanges, and many others. Attorneys in the Duane Morris Health Law Practice Group have extensive experience with counseling clients on potential data breaches under HIPAA and other privacy and security laws, and in developing and executing a data breach response plan, including reporting to federal, state, local and foreign governmental agencies and responding to formal agency investigations. Jan-mar 2013  Medical Waste Management 13

news briefs

Mail-Back Envelopes Make Pill Recycling Easy, Convenient


HULA VISTA, CA—The San Diego Union Tribute recently reported that the city of Chula Vista launched a new pharmaceuticals collection program late in 2012 and it’s already a winner. Special mail-back envelopes, available at local drugstores and pharmacies, make disposing of old or unused pills easier for residents. The envelopes are available at all the major pharmacies, including Rite Aid, Walgreens and CVS, and some smaller local pharmacies. Though US Drug Enforcement Agency-sanctioned Drug Take-Back Days, have been highly successful, yielding 2,782 pounds in pharmaceuticals, the new program is expected to attract more participation because of the convenience. Since October, the mail-back program has distributed 1,056 medicine disposal pouches to its residents. The city pays between $4 and $5 per pouch from Welldyne RX, the same company that provides medical equipment to pharmacies, and will pay for up to five pouches per resident per year. A disposal receptacle that has been stationed at the Chula Vista Police Department has collected 1,914 pounds of prescription drugs from residents since 2009. Chula Vista’s new pill mail-back program is similar to the city’s disposal program for medical sharps, which launched in 2009. Also coordinated through the major pharmacies, residents can obtain up to three 1-quart sharp disposal containers per year for needles, EpiPens and other hazardous sharps. Through that program, the city has issued 2,315 sharps containers in the last four years, at a cost of about $15 each. The program makes the recycling process safer for both residents and recycling workers. Funding for the city’s mail-back initiative is supported by a percentage of the money residents pay for trash and recycling pickup.

Preventionists Say Informatics Tools Need Improvement


ALTIMORE, MD— reports that a new study shows that although health information exchange (HIE) has proven to be a useful tool in hospital infection control, its effectiveness is being hampered by system limitations. A survey of infection control specialists (known as “preventionists”) indicated that only 10 percent knew they were involved in an HIE, while 49 percent were not aware whether they were. The study, published  in the  American Journal of Infection Control, is based on a poll of 44 IPs. While more than 70 percent reported access to an electronic health record system, less than 20 percent of them were involved in the design, selection or implementation of such systems. The systems in place, many respondents said, generally did not include modules or components that supported infection-control activities, according to an  announcement  from Indiana University School of Medicine, which conducted the study. Preventionists remarked that inadequate or wholly missing data sorting capabilities bogged things down, causing them to make time-consuming searches through individual electronic patient records. Current HIE systems were designed without preventionists input, in some cases, and they say that helpful features, such as alerts and flags, are absent and should have been included in the system design. Meanwhile, a study published in the February issue of the American Journal of Infection Control found that simply having dedicated infectionprevention personnel on staff may  add to evidence-based prevention practices. Also, a 2012 KLAS® report found that dedicated infection-control software is very often used by healthcare professionals to ease the burden of government reporting rather than to monitor their hospital’s acquired infection rates.

14 Medical Waste Management  Jan-mar 2013

More Colorado Health Facilities Meet or Exceed Infection Rate National Standard in 2012


he Colorado Department of Public Health and Environment’s annual Health Facility-Acquired Infections report shows more health facilities in the state met or exceeded (better than) the national standard for infection rates in 2012. There were 528 facilities that met or exceed the standard in 2012, compared to 509 in 2011. The report compares the incidence of health care associated infections (HAI) at Colorado facilities to the national mean, and shows whether each facility was the “same,” “better” or “worse” than the national standard. In 2012, 24 health facility reports scored “worse” than the national mean, compared to 39 in 2011. As part of a comprehensive reform to address HAI, 34 states, including Colorado and the District of Columbia, have mandated public HAI reporting to create greater transparency between health care facilities and the public while supporting greater accountability. Colorado’s legislatively mandated report contains data for surgical site infections in cardiac, orthopedic and abdominal operative procedures; central line-associated bloodstream infections in adult and neonatal critical care units and longterm acute care hospitals; and dialysis related infections in outpatient dialysis treatment centers. Data provided in the report are self-reported by each facility. Dr. Chris Urbina, the department’s executive director and chief medical officer, said, “Since the Health Facility-Acquired Infections Disclosure Act was passed in 2006, the number of reports has increased as new surgical procedures (breast and colon procedures) and new facilities (rehabilitation hospitals) have been added to the report. This increased surveillance of health facility-acquired infections helps to focus efforts on reducing the number of infections at these facilities.” In reviewing facility infection rates, readers must consider that infection rates can be influenced by factors such as better surveillance and reporting compliance, and less healthy populations, rather than poor infection control practices. To assess the validity of reported data, the department’s Patient Safety Program has conducted three validation studies to date on central line associated bloodstream infections, hernia surgical site infections and dialysis infections. All three validation studies provided the opportunity to identify areas of misunderstanding about infection surveillance and reporting and provide focused education to health facility staff about surveillance definitions, rules and practices. A fourth validation study for hip/knee procedures is currently underway.

Higher Indoor Humidity Inactivates Flu Virus Particles


ccording to a recent report on, higher humidity levels indoors can significantly reduce the infectivity of influenza virus particles released by coughing. This conclusion was based on research published February 27, in the open access journal PLOS ONE by John Noti and colleagues from the National Institute for Occupational Safety and Health, Centers for Disease Control and Prevention. The researchers tested the effect of relative humidity on the capacity of flu virus released in a simulated ‘cough’ to re-infect cells. They found that an hour after being released in a room at a relative humidity of 23% or less, 70-77% of viral particles retained their infectious capacity, but when humidity was increased to about 43%, only 14% of the virus particles were capable of infecting cells. Most of this inactivation occurred within the first fifteen minutes of the viral particles being released in the high-humidity condition. The study concludes that maintaining indoor relative humidity at levels greater than 40% can significantly reduce the infectious capacity of aerosolized flu virus.

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New HIPAA Breach Notification Rule May Prove Costly for HIPAA-Covered Entities


Mail-Back Envelopes Make Pill Recycling Easy, Convenient


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