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Briefings on Hospital Safety, October 2017

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September 28, 2017

NIOSH: How safe is peracetic acid for healthcare workers?

The substance is an increasingly common ingredient in high-level disinfectants, but there’s still a lot we don’t know about its health effects for workers.

Prior to the 2000s, glutaraldehyde was the preferred high-level disinfectant (HLD) in healthcare settings. The chemical was estimated to account for 84% to 89% of applications. Its dominance has been softening, however, in recent decades as an increasing number of organizations have turned to other active ingredients, including peracetic acid, to sterilize equipment and facilities, according to the results of a 2011 survey published three years later in Infection Control & Hospital Epidemiology.

The survey, which asked more than 4,600 healthcare workers about the chemicals they use, determined that glutaraldehyde remains the most popular (59% of HLDs), followed by peracetic acid (16%), then ortho-phthalaldehyde (15%). While these substances are used in similar applications, there are differences in the ways they are regulated—and that can impact perceptions of their relative safety.

Several factors could be driving the rising popularity of alternatives to glutaraldehyde, says study coauthor James M. Boiano, MS, CIH, a senior industrial hygienist and assistant coordinator of the NIOSH Healthcare and Social Assistance Sector Program. Notably, there is an enforceable occupational exposure limit for glutaraldehyde but not for peracetic acid. That can lead users to believe the alternatives are safer or otherwise less toxic, Boiano says.

“It should be noted, however, that [ortho-phthalaldehyde] has been shown to cause similar health effects as glutaraldehyde,” he says.

Switching to one of the alternatives could also be attractive for other reasons: to reduce disinfection time, lessen the risk of exposure by inhalation (due to lower vapor pressure), or accommodate other needs specific to the user, Boiano adds.

When healthcare workers fail to appreciate the hazards posed by a given chemical, they run the risk of making matters worse by failing to protect themselves. The same survey that found rising use of peracetic acid also found significant rates of potentially dangerous handling practices: 5% of respondents reported having experienced an HLD spill or leak, 9% failed to wear gloves, 17% lacked training in safe handling, 19% lacked standard procedures to minimize exposure, and 44% failed to wear water-resistant gowns.

“This survey indicates that the use of recommended PPE, particularly gowns/outer garments, is not universal among workers who use HLDs to disinfect medical instruments,” Boiano and his coauthors wrote in their survey report. “Best practices for handling HLDs, including wearing protective gloves, water-resistant gowns, and eye/face protection to minimize skin and eye exposure, are not always followed. The most commonly reported reason for the underutilization of gloves, gowns, and eye/face protection suggests a perception that exposures are negligible or so infrequent that they do not warrant their use. Lack of training on safe handling practices and lack of employer standard procedures suggest that employers may not fully recognize the hazards and potential adverse health effects of HLDs.”

Input sought

Currently, NIOSH has neither a recommended exposure limit nor an immediately dangerous to life or health (IDLH) value for peracetic acid. Similarly, OSHA has no permissible exposure limit for the substance. But that could change. In 2015, NIOSH had proposed establishing an IDLH value for peracetic acid at 1.7 mg/m3, but public feedback persuaded the agency to put those plans on hold.

“The public comments indicated that (1) the proposed IDLH value was overprotective, (2) the data available for peracetic acid are of low quality, and (3) issues exist with sampling and analysis of air samples for peracetic acid in the workplace,” the agency explained earlier this year in a request for information. “Based on these comments, NIOSH is reevaluating the proposed IDLH value for peracetic acid.”

Now NIOSH is seeking public comments to inform the agency’s evaluation, including epidemiological and field studies, quantitative risk assessments, evaluations of workplace controls, and other information. Among those who have responded thus far is Rick Huston, senior director of plant operations and safety officer for HealthPartners Regions Hospital in St. Paul, Minnesota.

“Regions Hospital considered using peracetic acid as part of our general routine cleaning of two patient care areas which encompassed patient rooms,” Huston wrote in a comment. “These rooms included patient rooms, restrooms, utility rooms, work spaces, and all other ancillary spaces within the patient care units.”

The hospital had already used peracetic acid in its sterile processing department for certain applications, such as surgical equipment. Then, last year, the hospital conducted a trial on a peracetic acid product. About 10 employees were exposed to the chemical.

“Some staff reported irritated respiratory systems, but others felt no effects from working with the chemicals. We decided not to move forward with the chemical for housekeeping cleaning purposes due to employee and patient safety concerns,” Huston wrote.

“In our findings,” he added, “the level of staff training and education, concentration of the cleaning agent, and the environment of care are all factors worth studying when determining the applicability of using peracetic acid.”

The stated end goal of NIOSH’s current comment-collection process is to develop “appropriate communication products that convey the potential health risks, recommended measures for safe handling, and establish exposure recommendations.” Comments had been due in June, but the collection period was extended four months to October 1, 2017. To review the latest comments or submit your own, view the online docket

For the time being

While the powers that be continue to consider how best to communicate hazards associated with peracetic acid (and other HLDs, for that matter), employers should continue referring to safety data sheets (SDS) for guidance, Boiano says. The OSHA Hazard Communication standard requires that these sheets be available in the workplace to ensure that workers have access to information on the hazards each chemical poses and the proper techniques for handling, storage, and transportation. Study this information carefully, then proceed with caution.

“The health effects of peracetic acid (PAA) exposure include irritation of the skin, eyes, and mucous membranes of the nose and throat following acute exposure via direct contact or inhalation, and bronchitis and chemical pneumonitis following repeated or prolonged inhalation exposure,” Boiano says. “Because the long-term health effects of exposure (e.g., cancer, adverse reproductive outcomes) are unknown, prudence dictates that a precautionary approach be taken to minimize the likelihood of exposure.”

Employers should also cut their chances of exposure through the use of solid industrial practices, Boiano adds.

“This would include implementing the hierarchy of controls in the following decreasing order of efficacy: substitution, engineering controls, following administrative controls, work practice controls, and personal protective equipment,” he says. “Should workers experience symptoms related to exposure to PAA, they should notify their employer’s health and safety department, occupational health unit, or their doctor so that the work environment is evaluated and corrective actions can be taken.”

 

Peracetic acid facts

What is it? Peracetic acid is a peroxide-based molecule used extensively as an antimicrobial agent in many commercial applications. 

When is it used? It is routinely used as a sterilant during the cleaning of endoscopes and other medical devices, as a disinfectant in food processing, as a bleaching agent, and in the synthesis of other chemicals. 

How is it diluted? Technical and commercial peracetic acid products contain peracetic acid, acetic acid, and hydrogen peroxide in solution. Concentrations of peracetic acid in these products vary but do not exceed 40%.

How might it affect workers? Acute exposure to peracetic acid is irritating to the eyes, respiratory tract, and skin. Peracetic acid is a strong sensory irritant considered to be more potent than acetic acid or hydrogen peroxide.

(This information was adapted from a document published by the CDC: www.regulations.gov/document?D=CDC-2017-0015-0001.)


 

Bouffant vs. skull caps: Debate over surgeon headwear rages on

Research casting new light as surgeons grapple with OR attire guidelines

If you thought the debate over what surgeons and their staff should be required to wear on their heads in the OR had been settled, think again. A study published by the journal Neurosurgery has refueled the quarrel. The researchers argue there is insufficient evidence to support an outright ban on skull caps, which some surgeons prefer over puffy bouffant caps. Others contend the researchers’ conclusions miss the mark.

The study reviewed more than two years’ worth of surgical site infection (SSI) data from Kaleida Health’s Buffalo General Medical Center, which operates 25 ORs. During the first 13 months, OR personnel were permitted to choose between a bouffant or skull cap. During the second 13-month period, the hospital re-quired OR personnel to wear bouffant caps. The results showed that the mandatory head-worn PPE didn’t influence SSI rates for Class 1 cases, the researchers noted. Their work, published in May, has been held up as evidence that surgeons should be permitted to keep their iconic headwear—despite others worrying the caps could pose an avoidable infection risk by sometimes leaving sideburns and hair along the nape of the neck exposed.

“The authors reasonably conclude that operating room staff should cover their hair with the headwear of their choice,” wrote Michael Schulder, MD, FAANS, a member of the journal’s editorial board and neurosurgeon based in Manhasset, New York, in a comment published with the article. That conclusion, however, has been challenged by the Association of periOperative Registered Nurses (AORN), which submitted a letter to the journal’s editor-in-chief to rebut several claims.

“There were too many assumptions in that study,” says Lisa Spruce, DNP, RN, CNS-CP, CNOR, ACNS, ACNP, FAAN, director of evidence-based perioperative practice for AORN. “If they had designed it a little bit differently, then this would have been a valuable study, but you’ve got to look at your design.”

Spruce says the researchers added a layer of value to the body of research on this topic. But the implications of their findings are limited by several factors, including the number of participants in the study, the length of observation, and the ill-advised expectation that any improvement in the SSI rate would be immediate, she says.

Furthermore, the AORN letter complained that the researchers had misrepresented AORN’s position on prop-er headwear. The study claimed AORN’s surgical attire guidelines “specifically state that surgical skull caps should not be worn.” But that is simply untrue, AORN says.

“Regrettably, the authors have repeatedly misrepresented the AORN recommendation throughout the article,” Spruce and three colleagues wrote in their letter to the Neurosurgery editor.

“The guideline does not mention skull caps nor is there any mention of bouffant caps,” the letter continued, noting that AORN does not specify which type of head covering to wear, only that hair should not be ex-posed.

“The AORN Guideline for Surgical Attire simply recommends that ‘A clean surgical head cover or hood that confines all hair and completely covers the ears, scalp skin, sideburns, and nape of the neck should be worn,’ ” the letter adds. “This recommendation is supported by a number of studies showing that hair can be a source of bacterial organisms and potential SSI.”

That letter prompted a response from the study’s six-member team, says lead researcher Kevin Gibbons, MD, senior associate dean for clinical affairs with the Jacobs School of Medicine and Biomedical Sciences at the University at Buffalo, State University of New York. While the researchers acknowledge certain limita-tions in their study, they argue that it is sound and large enough to be useful. (Neither AORN’s letter nor the research team’s response had been published as of Neurosurgery’s July 2017 edition.)

Furthermore, the researchers defended their characterization of AORN’s stance on skull caps. Regardless of the precise way its formal guidelines are worded, AORN’s own literature on the topic has stated clearly that skull caps should not be worn in the OR, Gibbons says.

“So their position that they did not take a position on skull caps I don’t quite find to be credible,” Gibbons says. “And I think most people familiar with the argument would agree with that.”

At the very least, AORN has muddied the waters with its public statements on the topic. In a column for Outpatient Surgery magazine in April, Spruce explained “why AORN recommends wearing a bouffant cap.” The following month, AORN issued a statement to correct “misrepresentation” and “misinformation” of its posi-tion, noting, “There is no recommendation that bouffant caps should be worn.”

After seeing a previous version of this story in August, AORN said the statement published in Outpatient Surgery was incorrect. A magazine staffer had ghostwritten Spruce’s column and secured AORN’s approval of the language prior to publication, but an error was introduced during the editing process after AORN had signed off on a draft, AORN says. So, at AORN’s urging, the magazine updated the language in Spruce’s column in August, about four months after the piece was published. The updated column explains “why AORN recommends wearing a ‘clean, low-lint surgical head cover or hood that confines all hair and covers scalp skin [and is] designed to minimize microbial dispersal.’”

The magazine’s editorial team declined to comment on the edit, referring questions about its own internal processes to AORN. In a phone call, Outpatient Surgery Editor-in-Chief Dan O’Connor declined to comment on his team’s decision to make the edit without including an editor’s note to acknowledge the consequential change. Even the updated version argues that one specific type of headwear is superior to the other, implying that this specific preference is based on AORN guidelines.

“Surgeons might resist covering their skullcap with a bouffant,” Spruce’s column in Outpatient Surgery states. “But should we sit idly by while people refuse to follow AORN recommendations based on personal preference and not on the evidence? Making surgeons happy shouldn’t trump keeping patients safe. Wearing proper head coverings isn’t hard or harmful. Based on everything we know, it’s just common sense.”

Spruce made similar statements in material published by the AORN Journal in 2014 and 2015, but AORN notes that those statements were correct at the time because they were made prior to the 2015 release of AORN’s revised Guideline for Surgical Attire. A systematic review process prompted the change to the rec-ommendation regarding hair covering, AORN says.

Real-world impact

The disagreement over what AORN’s guidelines say and mean matters because those guidelines are used by CMS and accrediting organizations as a yardstick of sorts for healthcare organizations. If a facility fails to measure up, it can suffer swift real-world consequences—that was the case for Buffalo General Medical Cen-ter, anyway.

Gibbons says an outside reviewer with the New York State Department of Health, on behalf of CMS, visited the hospital and noted a surgeon’s skull cap as inadequate OR headwear. Because that cap’s presence was re-garded as a failure to implement standards to minimize SSIs, it resulted in a letter from CMS placing the or-ganization in immediate jeopardy. That meant Kaleida Health would either have to quickly take steps to bring Buffalo General’s ORs into compliance with the standards or risk losing a major source of funding.

“When we’re threatened with loss of government Medicare and Medicaid funding, we have to pay attention,” Gibbons says, noting that Kaleida Health is the largest non-governmental employer in western New York.

“This is sort of a heavy-handed top-down response, which does get a lot of people upset for a variety of rea-sons,” Gibbons says, adding that similar events have played out at a number of other institutions. “We’re not the only ones,” he says.

Kaleida responded to CMS by imposing a skull cap ban in early 2015. That ban inspired the study. Gibbons and his team compared SSI rates from before and after the ban and found no benefit in the change.

Schulder, from the Neurosurgery editorial board, praised the researchers for having “decided to strike back” against the citation with their own medical research.

“Across the United States, draconian dress codes have been imposed on surgeons and other operating room personnel. Many years of accepted customs have been upended,” Schulder wrote in his comment. “These reg-ulations are not based on evidence but now have the backing of state regulatory agencies. If surgeons find these new rules disruptive, the most effective way to counter them is by—yes—evidence-based medicine.”

Gibbons acknowledged that Schulder’s comment takes on a “somewhat militaristic tone” that casts the re-search in a vengeful light, but he argued that’s not how the study should be seen.

“This is an experiment that has been imposed upon us, so let’s learn from it,” Gibbons says. “If, for whatever reason, there is a mandatory change in practice and you have the ability to measure an outcome before that change and after that change, I think that’s what you should do. It’s the hallmark of science.”

Prior clashes

In staking out its position on this topic, AORN has found itself at odds with the American College of Sur-geons (ACS), an association that claims more than 80,000 members worldwide. The ACS Board of Regents last year approved a statement on OR attire that took a more lax approach to headwear, basing its guidelines on “professionalism, common sense, decorum, and the available evidence.” The statement described skull caps as part of OR tradition.

“The skull cap is symbolic of the surgical profession,” the ACS statement said. “The skull cap may be worn when close to the totality of hair is covered by it and when only a limited amount of hair on the nape of the neck or modest sideburns remains uncovered.”

Spruce says that statement of express permission is too vague. What qualifies as “close to the totality” of hair? What is a “limited amount” of nape-of-the-neck hair? What are “modest sideburns”?

“That’s very hard to be able to enforce something like that with your perioperative team,” she says.

More importantly, Spruce asks, what benefit is derived from exposing patients to skin and hair? What poten-tial harm does it bring? Those questions should inform a surgeon’s thinking, she says. AORN published a de-tailed critique of the ACS statement.

Gibbons says the ACS “took a misstep” with its statement. “The skull cap should neither be defended nor at-tacked as a symbol of the surgical profession,” he says. “In part, I think that’s very dated thinking.”

David B. Hoyt, MD, FACS, executive director of ACS, says everyone involved in this conversation agrees that recommendations must be evidence-based.

“Everybody is in agreement that they want to do the right thing; they want to do the safest thing,” he says. “The issue is, what is that?”

Hoyt says the ACS has sponsored a forthcoming study that, like the recent Neurosurgery paper, will show the error in thinking the evidence supports a skull cap ban.

“We’re trying to get an objective assessment of the data that people agree upon and not have this turn into a disagreement that serves no one,” he says.

“We’re trying to deemphasize the controversy over this,” Hoyt adds. “This is a difference of opinion about certain things, and we’re trying to get more evidence to inform it so that everybody can come to a statement of agreement, rather than turn this into a controversy. We’ve got more important things to do in medicine right now.”

Established evidence

In a second comment published with the article, neurosurgeon Peter Nakaji, MD, who practices at the Bar-row Neurological Institute in Phoenix, echoed the paper’s central message, drawing a parallel between the present debate and past disputes over hand hygiene.

“Medicine looks back with some chagrin now on the story of Ignaz Semmelweis and the difficulty he had spreading the practice of handwashing in the 1800s. Yet one recalls that the real lesson of that story is that he had evidence to back him up that was not understood or was ignored at the time,” Nakaji wrote. By contrast, he added, “there is very little evidence for one form of headwear over another, or any headwear at all.”

The researchers themselves stopped short of suggesting there’s insufficient evidence to require head-worn PPE, in one form or another, to minimize SSI risk. Human bodies are constantly shedding bacteria, they not-ed. Although this gradual desquamation of the skin is perfectly normal, it can be a major source of OR conta-gion.

“Human hair of the scalp is a common reservoir of pathogens including Staphylococcus aureus and Gram-negative bacilli,” the researchers wrote. “The shedding of these microorganisms from hair has been recog-nized as a potential source of bacteria in the OR, hence a cause of postoperative infection. Covering the hair of the surgical staff and patients for major and minor surgical procedures and sometimes even for re-dressing of wounds is recommended.”

Spruce contends that this well-established evidence is sufficient to warrant an expectation that OR personnel keep all hair covered, including sideburns and hair on the nape of the neck.

“Once you prove the sky is blue, there’s no reason to prove it again,” she says.

Gibbons argues, however, that establishing that hair and skin are known infection risks to OR patients doesn’t automatically establish that bouffant caps are superior barriers. Gibbons says he prefers a skull cap precisely because it works better with his other head-worn equipment—not because of any purported symbolic signifi-cance that some have suggested it carries.

“I do think that a lot of the surgical community resents some of the implications that those who prefer skull caps do so because they think it makes them look macho or sexy,” he adds.

Both AORN and ACS say they will follow the evidence wherever it leads and make recommendations accord-ingly. For the time being, AORN advises healthcare professionals to take initiative on the local level and find head coverings that will satisfy the expectations of all stakeholders.

“Change never works if it’s a top-down approach and you’ve got a leader saying, ‘Everybody, you’re going to have to do this, period, no discussion,’ ” Spruce says. “It works better when you have a multidisciplinary team come together and talk about our goals to cover our hair and ears."


 

Physical features can help prevent suicide, patient self-harm

Consider using roll-down doors on emergency department exam rooms, breakaway clothes hooks on walls, and cone-shaped or push-pull handles for doors to decrease the physical risk of patient harm while also protecting your facility from costly Requirements for Improvement (RFI). 

Year after year, suicides continue to be among the top most reviewed sentinel events by The Joint Commission, moving from fourth place in 2013 to third in 2014 and staying there for 2015, according to information released by the accreditor in February. 

In 2015, 95 suicide events were reviewed, up from 82 in 2014 and 90 events the year before that. In addition, the number of self-inflicted injury events reviewed by The Joint Commission has also spiked, going from five in 2014 to 21 in 2015. 

The reporting of sentinel events is voluntary, and The Joint Commission itself notes that those numbers reflect only a small number of actual events. 

But you can be sure that any time the accreditor finds out about a suicide, whether self-reported, through news reports, or other means, commission surveyors will be on-site shortly thereafter, notes Ernest Allen, ARM, CSP, CPHRM, CHFM, a former surveyor and now patient safety account executive with The Doctor’s Company, based in Napa, California.

“Within a month they’re going to be knocking on the door,” Allen warned hospital facility managers, engineers, safety specialists, and others at last fall’s EC Summit. 

CMS surveyors might follow, as could state health department officials and the lawyers of surviving family members, Allen said.

Surveyors have many ways to cite problems 

Suicides can be cited under several requirements, including: 

  • National Patient Safety Goal 15: Hospitals are required to identify safety risks inherent in the patient population. For patients at risk of suicide, NPSG.15.01.01, EP 1, specifically calls for a documented risk assessment that includes environmental features “that may increase or decrease the risk for suicide.” 
  • Environment of Care standard EC.02.01.01: The hospital must manage safety and security risks, including under EP 1 those associated with the environment of care and identified through internal sources such as “ongoing monitoring of the environment,” root cause analysis, and proactive risk assessments and external causes such as Sentinel Event Alerts. EP 3 requires the hospital to take action to minimize or eliminate identified physical risks.
  • EC.02.06.01: The hospital must have and maintain a “safe, functional environment,” which includes under EP 1 the requirement that interior spaces meet the needs of the patients and are “safe and suitable to the care, treat¬ment, and services provided.” Hospitals must also show a measure of success under EP 1. 

Those deficiencies might be found by the life safety surveyor but are just as likely, and perhaps these days more so, to be cited by the nurse or even physician surveyor, Allen warned. “It’s a growing issue.” 

While patients can get very creative when looking for ways to harm themselves, hanging is a frequent choice, often using a bedsheet, said Allen. A review of insurance claims shows such methods as hanging from a towel rack, the side of a bedrail, or a curtain rod; patients have also used a belt in a closet, tied a treadmill cord to the ceiling of an exercise room, or hooked a bedsheet over the top of a bathroom door. 

Physical modifications to rooms and equipment can decrease the risk of self-harm. 

For more information on ways to safeguard your phys¬ical environment, the National Association of Psychiatric Health Systems' “Design Guide for the Built Environment of Behavioral Health Facilities” is now available as a free download at the Facility Guidelines Institute.  


 

Use updated CDC toolkit to improve staff training, vaccine management

Train employees how to take maximum advantage of new technologies while adhering to best practices to improve vaccine management

The CDC’s Vaccine Storage and Handling Toolkit, updated in 2016, offers guidance on a range of issues, including recommendations on staff training. The toolkit and other CDC materials are cited by The Joint Commission as go-to sources on vaccine management. 

“Hospitals do a pretty good job with vaccine storing and handling. But when there is a breakdown, it usually happens in one of three elements: well-trained staff, reliable storage and accurate vaccine inventory,” says Sean Trimble, a public health analyst with the CDC.

“A well-trained staff cannot be emphasized enough, because if you have that, and then you have something fail in another area, the staff knows how to respond and how to fix it.”

Start by designating and training a primary vaccine coordinator, as well as an alternate. Provide extra training to these individuals on proper storage and handling of vaccines, including emergency policies and procedures.

Technology must complement training

There are many technologies that remove or reduce the burden of human maintenance. For example, vaccine refrigeration


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