This simple question has fueled a bitter fight ever since The Association of periOperative Registered Nurses officially recommended that bouffant hats be worn in the OR by all surgical team members. Since then, there's been a back-and-forth of testy statements and unsatisfying studies.
After participating with other healthcare heavy-hitters this winter in a task force that met to discuss recommendations for OR attire, specifically ear and hair covering, AORN expects to make changes to its Guideline for Surgical Attire in 2019.
Lisa Spruce, DNP, RN, CNS-CP, CNOR, ACNS, ACNP, FAAN, director of evidence-based perioperative practice for AORN, says the organization will still recommend complete hair coverage in that revised guideline, but "there's not going to be a recommendation on which head covering."
All Ears for Evidence
As for the coverage of ears, AORN is "probably going to come out in our new guideline and say the ears don't need to be covered," notes Spruce, because the task force feels the research focusing on its necessity has been inconclusive. "However," she says, "our guideline stands as is until it's revised."
It is significant that AORN will likely be changing its stance. While the organization is the world's largest professional association for perioperative nurses, it is a tone-setter for issues affecting all healthcare workers who enter the OR. CMS and subsequently The Joint Commission followed AORN's lead on headwear and has cited healthcare organizations accordingly.
The study that seems to have ended this battle was led by Troy Markel, MD, assistant professor of surgery at Indiana University, who examined the effectiveness of disposable bouffant hats and skull caps as well as newly laundered cloth skull caps in preventing airborne contamination.
Not only did Markel and his peers observe no significant differences between the disposable bouffant hats and the disposable skull caps "with regard to particle or actively sampled microbial contamination," they also determined that the disposable bouffant hats had greater permeability, penetration, and greater microbial shed compared to both disposable and cloth skull caps.
Thus, the researchers concluded last October that disposable bouffant hats "should not be considered superior to skull caps in preventing airborne contamination in the operating room."
That study made the strongest case to date in the contentious debate over OR headwear.
Bouffant Hat Vs. Skull Cap Debate
Several years ago, AORN began, depending on who you ask, either promoting the use of bouffant hats among surgical staff or advocating for skull caps to be banned. The organization encouraged full coverage of the ears in the OR, one of the reasons why AORN favored bouffant hats.
In 2016, the American College of Surgeons, who see the skull cap as "symbolic of the surgical profession," came out and said skull caps "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." Executive director David Hoyt, MD, FACS, stated that ACS' new guideline for appropriate attire was "based on professionalism, common sense, decorum, and the available evidence."
As Priya Nori, MD, medical director of the antibiotic stewardship program at the Montefiore Health System and associate professor at Einstein School of Medicine, puts it, people were ticked.
"Surgeons said, 'Where's the evidence? We've been doing this for generations,' " says Nori.
Last year, surgeons from the University of Buffalo and Kaleida Health also challenged AORN's stance with a study published in Neurosurgery, arguing that according to research, wearing bouffant hats in the OR didn't influence surgical site infection rates for Class 1 cases.
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, said last year, "This interpretation resulted in hospitals around the country being cited by outside reviewers for poor infection-control practice if anyone in the OR was seen wearing a surgical cap."
That included Kaleida Health, which had previously received a letter placing the organization in immediate jeopardy because CMS considered the skull cap to be inadequate OR headwear.
AORN fired back, saying "there were too many assumptions in that study." But the organization also claimed the researchers "repeatedly misrepresented the AORN recommendation throughout the article" and later issued a statement to correct "misrepresentation" and "misinformation" of its position, noting that "there is no recommendation that bouffant caps should be worn."
By doing the latter, AORN appeared to be softening its stance, though the organization notes that its current Guideline for Surgical Attire, revised in 2014, does not explicitly recommend bouffant caps. AORN will revise its guideline again in 2019 following the study from Markel and his peers that found that the requirement for ear coverage is not supported by sufficient evidence.
"It was the first, if only, [study] that I have seen that looked at the effectiveness of those types of hats as far as whether they were doing what they were designed to do," says Spruce, speaking on behalf of AORN. "I think it just sparked everybody's interest and opened up this discussion."
AORN and others felt the evidence was enough to revisit the controversy and, according to Spruce, ACS assembled the task force, which included the Council on Surgical and Perioperative Safety, the American Society of Anesthesiologists, the Association for Professionals in Infection Control and Epidemiology, the Association of Surgical Technologists, and The Joint Commission.
Reassess Policies
The task force met in February and the organizations released, in early May, a joint statement that read: "Over the past two years, as recommendations were implemented, it became increasingly apparent that in practice, covering the ears is not practical for surgeons and anesthesiologists and in many cases counterproductive to their ability to perform optimally in the OR."
The group determined that "available scientific evidence does not demonstrate any association between the type of hat or extent of hair coverage and [surgical site infection] rates."
The statement added that "in reassessing the strength of the evidence for this narrowly defined recommendation," the task force concluded that "evidence-based recommendations on surgical attire developed for perioperative policies and procedures are best created collaboratively, with a multi-disciplinary team representing surgery, anesthesia, nursing, and infection prevention."
Spruce says AORN had already decided "that it was time to revise that guideline" but "it was valuable" to hear the thoughts among that multidisciplinary group. She adds, "The perioperative setting has always been a team environment and we've always promoted that, so we want the teams to come together and agree on issues that are important to patient safety."
AORN's Guideline for Surgical Attire will be reviewed by AORN's advisory board, which includes representatives from organizations that formed the task force, plus the Society for Healthcare Epidemiology of America (SHEA), the International Association of Healthcare Central Service Material Management, and the American Association of Nurse Anesthetists. That revised guideline will be available for public comment early next year and will be ready for publication in April 2019.
In the meantime, Spruce recommends that healthcare organizations "convene all of the relevant stakeholders"—an all-inclusive, interdisciplinary team—"to discuss their current facility policy and either confirm that it's going to stay the same until the guideline comes out or go ahead and institute changes based on the consensus of [the task force]."
She notes that The Joint Commission was part of the consensus, so allowing the use of skull caps "should be fine."
However, Steven A. MacArthur, a senior consultant with The Greeley Company in Danvers, Massachusetts, believes that healthcare organizations should proceed with caution.
"Until CMS provides some relief or guidance or recapitulation relative to the skullcap issue, you have to go by what has been documented in the process, which is in this case, 'Thou shalt not wear skull caps as the only protection,' " says MacArthur. "Until CMS tells their surveyors not to chase this, then … they are increasing their vulnerability relative to the survey process."
Regardless of whether CMS again follows AORN's lead on OR headwear, Nori, who in April at SHEA's spring conference discussed this topic and other controversies in OR equipment and attire, doesn't anticipate widespread policy changes among U.S. healthcare organizations.
"Even if AORN dials things back, for us to implement another cultural change, it's a big undertaking to then change all of our equipment and share new information," says Nori. "It's engrained in people to do it a certain way. The most important thing is just standardization to avoid errors in the OR. So even if they make a 180-degree change in their recommendation, I don't think my hospital system … would tell all of our surgeons, 'Hey, you don't have to do that anymore.' "
Asked which headwear she recommends, Nori says that "based on what we know about the mechanics of shedding the bacteria and skin cells and hair and all that, I think as much of that stuff you can cover as possible, that's great. I think whatever is comfortable, whatever breathes, and whatever doesn't alienate people by forcing people to wear one thing. I think you have to have different options for different types of people. And it just kind of has to make sense scientifically."
Adds Nori, "I think it would be good for [AORN] to finally put a statement out assuaging people's previous objections, because that part in particular was pretty controversial. … There shouldn't be any kind of very strong national recommendation unless there's good evidence behind it."
The Department of Justice (DOJ) charged Olympus Corp. this month with paying millions of dollars in kickbacks to hospitals and doctors to buy its products.
The company, which owns 85% of the U.S. endoscope market, has agreed to pay $646 million to resolve the criminal charges and civil charges brought against it. The sum is the largest total amount paid in U.S. history for violations involving the Anti-Kickback Statute by a medical device company.
“Olympus Corp. of the Americas’ and its subsidiaries’ greed-fueled kickback scheme threatened the impartiality of medical decision-making and the financial integrity of Medicare and Medicaid,” said Special Agent in Charge Scott J. Lampert of the U.S. Department of Health and Human Services in a statement.
The DOJ says that by using kickbacks, Olympus’ U.S. division (OCA) made over $600 million in sales and $230 million in profits. The company admits to the charges, which include the folling:
Holding up a $50,000 research grant until a hospital signed a deal to purchase Olympus equipment
Giving a doctor with a major role in a New York medical center’s buying decisions free use of $400,000 in equipment for his private practice.
Paying off doctors with hot air balloon rides, winery tours, spa treatments, lavish meals and rounds of golf at an Olympus sponsored forum.
Paying for a trip for three doctors to travel to Japan in 2007 as a quid pro quo for their hospital’s decision to switch from a competitor to Olympus.
Giving a hospital a $5,000 grant to facilitate a $750,000 sale.
Giving a week-long, paid vacation in Japan to the physician president of a professional organization and his spouse for three years in a row. The president was also paid a $10,000 honorarium to give a single lecture during each trip.
“The Department of Justice has longstanding concerns about improper financial relationships between medical device manufacturers and the health care providers who prescribe or use their products,” said Principal Deputy Assistant Attorney General Mizer. “Such relationships can improperly influence a provider’s judgment about a patient’s health care needs, result in the use of inferior or overpriced equipment, and drive up health care costs for everybody.”
The OCA division’s settlement is split between $312.4 million for criminal penalties and an additional $310.8 million to settle civil claims under the federal and various state False Claims Acts. Mizer said in addition to yielding a substantial recovery for taxpayers, the settlement will send a clear message that these types of abusive arrangements will not be tolerated.
Charges for Olympus’ Latin American Division
In addition, The DOJ is charging Olympus’ Latin American (OLA) division $22.8 million over a separate criminal charges involving the Foreign Corrupt Practices Act (FCPA).
Between 2006 and 2011, OLA spent nearly $3 million in cash, money transfers, personal grants, personal travel and free or heavily discounted equipment to get providers at government-owned facilities to buy Olympus products. OLA admits it delivered this illicit kickbacks benefits to pre-selected practitioners at “training centers,” nominally set up to educate and train doctors. In total, OLA actions earned them $7.5 million in profits.
Olympus has come under fire in recent months by the Food and Drug Administration and the Senate after it was revealed that their duodenoscopes were linked to dozens of infection outbreaks and 21 deaths since 2012. A report by The Washington Post found that the company knew its scopes had a flaw that prevented them from being disinfected properly, but concealed the dangers from hospitals for two years.
“OLA’s illegal tactics in Central and South America mirrored Olympus’s conduct in the United States. The FCPA resolution announced today demonstrates the department’s commitment to ensuring the integrity of the health-care equipment market, regardless whether the illegal bribes occur in the U.S. or abroad,” said Principal Deputy Assistant Attorney General Bitkower.
As part of the settlement Olympus has signed a new corporate integrity agreement with the Department of Health and Human Services. The program requirements include:
Compliance responsibilities for OCA management and the board of directors
A health care compliance code of conduct that includes certain standards
Training and education that includes specified standards
Requirements for consulting arrangements, grants and charitable contributions, management of field assets and review of travel expenses
A risk assessment and mitigation process
New review procedures for testing the compliance program
“For years, Olympus Corporation of the Americas (OCA) and Olympus Latin America (OLA) dropped the compliance ball and failed to have in place policies and practices that would have prevented the substantial kickbacks and bribes they paid,” said U.S. Attorney Paul Fishman. “It is appropriate that they be punished for that. At the same time, the deferred prosecution agreement takes into account the companies’ cooperation and commitment to fully functional corporate compliance.”
Hosptials are expected to work harder at stopping waterborne illnesses.
On June 2, CMS issued a new memo to surveyors on the importance of reducing cases of Legionella infections. Accredited facilities should double check their waterborne pathogens compliance, as surveyors will likely pay more attention to it in upcoming surveys.
Legionellosis is comprised of a sometimes fatal form of pneumonia called LD as well as Pontiac fever. The bacterium grows in the parts of hospital water systems that are continually wet and is spread through inhalation of aerosolized droplets of contaminated water.
Legionellosis poses a particular risk to patients older than 50, who smoke or have chronic lung or immunosuppression conditions. Approximately 9% of reported legionellosis cases are fatal.
Badly maintained water systems have been linked to the 286% increase in legionellosis between 2000-2014. There were 5,000 cases of it reported to the Centers for Disease Control and Prevention (CDC) in 2014 alone. About 19% of outbreaks were associated with long-term care facilities and 15% with hospitals.
Just a few items that can spread the contamination include:
Decorative fountains
Shower heads and hoses
Electronic and manual faucets
Hot and cold water storage tanks
Water heaters and filters
Pipes, valves, and fittings
Eyewash stations
Ice machines
Cooling towers
Medical devices (e.g., CPAP machines, hydrotherapy equipment, bronchoscopes, heater-cooler units)
“Healthcare facilities are expected to comply with CMS requirements to protect the health and safety of its patients,” the agency writes in its memo. “Those facilities unable to demonstrate measures to minimize the risk of LD are at risk of citation for noncompliance with the CMS Conditions of Participation. Accrediting organizations will be surveying healthcare facilities deemed to participate in Medicare for compliance with the requirements listed in this memorandum, as well, and will cite noncompliance accordingly.”
The memo tells surveyors to review policies, procedures, and reports documenting water management implementation results to ensure facilities:
Conduct a facility risk assessment to identify where Legionella and other waterborne pathogens could grow and spread in the facility water system.
Implement a water management program that considers the ASHRAE industry standard and the CDC toolkit. The program should include control measures such as physical controls, temperature management, disinfectant level control, visual inspections, and environmental testing for pathogens.
Specify testing protocols and acceptable ranges for control measures. Document the results of testing and corrective actions taken when control limits are not maintained.
The contents of this memo go into effect immediately.
Answering the call of healthcare professionals, the CDC has updated the surgical site infection guidelines using a process to condense thousands of studies into 170 high-quality trials.
This article first appeared June 21, 2017 on HCPro.
In May 2017, the CDC released its new guideline for surgical site infection (SSI) prevention, the first such update since the turn of the century.
Between 2006 and 2009, roughly 1.9% of surgical procedures in the United States resulted in SSI complications; however, it's likely that number is much higher since about 50% of SSIs don't become evident until after discharge. Estimated costs of SSIs range from $10,443 to $25,546 per infection, although it can cost more than $90,000 to treat an SSI involving a prosthetic joint implant or an antimicrobial-resistant organism.
"There is increasing demand for evidence-based interventions for the prevention of SSI," wrote lead author Sandra Berríos-Torres, MD, in the guideline. "The last version of the CDC Guideline for Prevention of Surgical Site Infection was published in 1999. While the guideline was evidence informed, most recommendations were based on expert opinion, in the era before evidence-based guideline methods."
Answering the call of healthcare professionals, the CDC updated the guideline using the Grading of Recommendations, Assessment, Development and Evaluation (GRADE) process to condense thousands of studies into 170 high-quality trials. The results were then categorized by the strength of the evidence supporting them.
The news was published in JAMA Surgery and includes an accompanying editorial.
"The [updated] CDC guidelines use a strict process for literature review, development of consensus, public reporting, and refinement of their final recommendations," wrote Pamela A. Lipsett, MD, MHPE, MCCM, in the accompanying editorial. "The article from the CDC by Berríos-Torres et al in this issue of JAMA Surgery is useful to every surgeon because it is brief and summarizes the recommendations, with their level of support. It tells us what we should do and what we do not know. The supplementary material is inclusive and recommended for anyone with a thirst for the evidence supporting these recommendations."
Peggy Prinz Luebbert, MS, CIC, CHSP, CSPT, an infection prevention and healthcare safety professional and consultant, says that having guidance based on expert opinion rather than evidence is par for the course in our society right now. It's difficult and expensive to scientifically validate medical recommendations, which unfortunately means physicians often have to depend on opinions. That's what makes the CDC's update such a breath of fresh air.
"I'd say it's easier for us to present information to our surgeons when the science is there and has been validated," she says. "Unfortunately, that's so difficult to do. It's going to be hard unless time and money are put in by either private parties or the government to be able to [do the research and] get the validation we need. So we're not going to see very many [of these kinds] of updates."
