Surgeons: CMS survey won't lower SSI rates
More minimally invasive procedures needed
Memo to the Centers from Medicare & Medicaid Services (CMS) from two leading surgeons on the literal cutting edge of infection prevention in the OR: Hospitals and federal regulators should encourage the use of newer and safer types of surgery and more transparency with patients on procedure options and possible outcomes. That would do more to reduce surgical site infection (SSI) rates than inspections by CMS and other government regulators.
"My prediction is that most hospitals will be found compliant with these measures that CMS is going to check, yet wide variations in surgical site infections will continue," says Martin A. Makary, MD, MPH, an associate professor of surgery and health policy at the Johns Hopkins Hospital in Baltimore, MD. "Unfortunately, these metrics, while important, don't capture the variation and complexity in care, and they don't capture the variation in surgical practice."
While conceding that much of its effort is to emphasize "the basics," the CMS has developed a draft hospital survey that includes a surgical procedure tracer to monitor infection control elements in the OR. The CMS survey, which is currently in a pilot testing phase, advises inspectors to assess essential infection control measures in the surgical area, including:
- Healthcare personnel perform a surgical scrub before donning sterile gloves for surgical procedures (in OR) using either an antimicrobial surgical scrub or an FDA-approved alcohol-based antiseptic surgical hand rub;
- Surgical masks are worn (and properly tied, fully covering mouth and nose) by all personnel in restricted areas where open sterile supplies or scrubbed persons are located;
- Traffic in and out of OR is kept to minimum and limited to essential staff;
- Cleaners and EPA-registered disinfectants, when in use, are labeled, diluted according to manufacturer's instructions, and are dated;
- Anesthesia equipment is cleaned and disinfected between patients; and
- All surfaces, including but not limited to floor, walls, and ceilings have cleanable surfaces, are visibly clean, and there is evidence that all surfaces are cleaned regularly in accordance with hospital policies and procedures.
Too rudimentary to have impact?
The proposed guidelines outline strategies that have been around for at least the last 10 years, says Ramon Berguer, MD, general surgeon at Contra Costa Regional Medical Center in Martinez, CA.
"I can't say I was impressed at how far-reaching the CMS guidelines were," he says after reviewing the survey for Hospital Infection Control & Prevention. "I was not impressed they were pushing the envelope at all."
Makary concurs, saying, "It doesn't push to any new ground like antibiotic sutures, skin closure devices, minimally-invasive surgery. It's pretty much run-of-the-mill, and it won't make any difference in infection rates."
Another omission in the CMS surveyor guidelines involves scalpel safety and sharps handling, though that may be beyond the agency's regulatory reach.
"Sharps safety items have been considered to be out of the scope of Medicare," Makary notes.
The Occupational Safety and Health Administration generally takes responsibility for that area. While a rare risk to patients, sharps injuries exposed OR personnel to the risk of infection by HIV, viral hepatitis B and C, and bacterial infections in as many as 15% of operations, according to a 2007 report by the American College of Surgeons.1
Hospital ORs have considerable room for improvement in how they handle sharps safety, particularly with regard to newer recommended practices, such as double gloving, blunt tip suture needles, and the hands-free technique, Berguer says.
While the CMS surgical procedure tracer standards are silent on sharps safety, they pay considerable attention to documentation compliance, Berguer says. Any hospital with an infectious diseases nurse and that complies with existing IC standards will have no difficulty passing the CMS inspection, he says.
One change CMS could encourage that would result in much better outcomes involves requiring transparency and improved methods of informed consent, suggests Makary, author of a book in press for publication, "Unaccountable: What Hospitals Won't Tell You and How Transparency Can Revolutionize Health Care."
Patients who are considering surgery need to be fully informed and educated about the most realistic benefits and risks they face and learn about all available options — including not having surgery at all, he says.
"In my career and training, I've seen unnecessary operations that result in infections," Makary says. "Those preventable harms or infections are not at the level of hand washing or sterile technique; they're at the level of choice to do the procedure and informed consent that overstates benefits and understates risks."
When health authorities quote infection and mortality rate statistics they often use data that comes from some of the largest health centers, and these rates could be significantly lower than what patients might find at their own local hospital.
For instance, pancreas surgery may be listed as having a 1% mortality rate, while in the real world the mortality rate is in the 7% to 9% range, Makary says. Other infection rates may be similarly downplayed, he adds.
"We are doing a research study now and are finding providers at a hospital are not aware of their hospitals' infection or complication rates, so how can they be providing patients with accurate information?" he says. "This is the basis for a new movement — a shared decision-making movement."
Shared decision-making would be possible only with transparency and publicly-available data, such as having hospitals publish their local complication and infection rates online, he adds.
"What's going to work better?" Makary says. "A regulation where you send in government inspectors to check the things most people are doing, or empowering consumers to go to hospitals where there is good information on their performance?"
Few hospitals will lead this effort without some government requirement or incentive, he adds.
"Right now, the only things reported publicly are what Medicare is requiring, and that includes very few outcomes," he says. "In fact, surgical site infections are one of the only outcomes that Medicare requires in public reporting, and that will start this summer."
Maximize minimal invasive surgery
Another change that Medicare has not promoted but which would make a huge difference in surgical infection rates is the move to minimally invasive surgery (MIS) whenever possible and clinically indicated, he adds.
"There's a vast underutilization of minimally invasive surgery in the United States," Makary says. "MIS is associated with infection rates of approximately 1%, which is remarkable."
The overall surgical site infection rate in the United States is 1.9%, according to Centers for Disease Prevention and Control data from 2006-2008. However, this rate can range as high as 10% to 40% depending on the hospital and type of procedure, Makary says.
MIS incisions are small, allowing little space for infections to set in. A number of studies have shown great results from the use of MIS, yet it's underused because of culture, finances, lack of peer review, and understating options to patients, he says. MIS also results in decreased pain and shorter hospitalization rates, but patients are instead told they should have the traditional surgical procedure because that's what many surgeons prefer, Makary says.
Health systems could improve their own surgical site infection rates by changing the culture to encourage MIS and by making several other changes, such as making it easier for doctors and staff to do the right thing, Berguer says.
"Often you go into a hospital and they can't get the surgeon to wear eye protection," he says. "This is because the eye protection equipment is in a closet down the hall."
The solution is to make it easier for doctors to pick up the gear by simply putting the equipment where they can more easily reach it.
Another strategy would be to place video cameras next to the sinks so doctors are observed while washing their hands. This has been shown to improve compliance and lengthen the time spent washing hands, Makary suggests.
One institution that installed cameras noticed dramatic improvements in hand washing rates, like a speed-trap camera at an intersection, he adds.
Reference
- ST-58 – Statement on sharps safety. Bullet Amer Col Surg 2007;92(10): http://bit.ly/L1fHzW
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