July 2010 - Operating Room

INSIDE THE CURRENT ISSUE

July 2010

Operating Room

Outpatient Connection

Study finds lapses in infection control practices at ambulatory surgical centers

An assessment of nearly 70 ambulatory surgical centers in three states found that lapses in infection control were common, including for practices such as hand hygiene, injection and medication safety and equipment reprocessing, according to a study in JAMA. Between 2001 and 2008 there was a greater than 50 percent increase in the number of Medicare-certified ASCs in the United States; currently more than 5,000 ASCs participate in the Medicare program. "In 2007, these facilities performed more than 6 million procedures with services extending beyond what is traditionally considered surgery to include endoscopy, pain injections, and dental procedures among others," the authors write. "Little is known about infection control practices in ASCs."

The study included the inspection of ASCs in three states, selected based on geographic dispersion, number of ASCs each state committed to inspect, and relative cost per inspection. Sample size was based on the number of inspections each state estimated it could complete between June and October 2008. Sixty-eight ASCs were assessed; 32 in Maryland, 16 in North Carolina, and 20 in Oklahoma. Surveyors from CMS, trained in use of an audit tool, assessed compliance with specific infection control practices, focusing on five areas of infection control: hand hygiene, injection safety and medication handling, equipment reprocessing, environmental cleaning, and handling of blood glucose monitoring equipment.

Overall, 46 of 68 pilot ASCs (67.6 percent) had at least 1 lapse in infection control noted by surveyors and 17.6 percent of the facilities had lapses identified in 3 or more of the 5 infection control categories. Twelve of 62 facilities (19.4 percent) were noted to have a lapse in adherence to hand hygiene or appropriate use of personal protective equipment (i.e., gloves); 28.4 percent of 67 facilities had deficiencies related to injection practices or medication handling, primarily through use of single-dose vials for more than 1 patient.

Nineteen of 67 facilities (28.4 percent) failed to adhere to recommended practices regarding reprocessing of surgical equipment; 12 (18.8 percent) of 64 facilities did not appropriately clean high-touch surfaces in patient care areas; and 25 (46.3 percent) of 54 facilities had lapses in appropriate handling of equipment used for blood glucose monitoring.

The researchers also found that 39 (57.4 percent) of 68 pilot ASCs were ultimately cited for deficiencies in infection control and 20 of 68 ASCs (29.4 percent) were cited for deficiencies related to medication administration, including use of single-dose medications for multiple patients. To assist that effort, CMS has made the ASC infection control audit tool available online.

Developing a culture of safety in the surgical suite

by Susan Cantrell, ELS

AORN Perioperative Standards and Recommended Practices

We are so fortunate to live in an era where surgical suites exist. They are lifesavers, literally; yet, there is the potential for so many things to go so very wrong in the surgical suite. Studies show the majority of adverse events are surgical-related. What’s needed is the "culture of safety" that we hear so much about, particularly since the 1999 Institute of Medicine report "To Err Is Human: Building a Safer Health System," which estimated there are up to 98,000 deaths due to medical errors annually.

Culture of safety

Culture of safety focuses less on blaming individuals and more on understanding what makes conditions ripe for adverse events and how those findings can be used to improve the situation in a facility by changing processes, promoting cross-disciplinary participation, and motivating healthcare organizations to adopt new safety practices.

Linda Groah, RN, MSN, CNOR, NEA-BC, FAAN, executive director and CEO, Association of periOperative Registered Nurses (AORN), Denver, CO, explained what culture of safety means for the surgical suite. "A culture of safety provides an atmosphere where the perioperative team members can openly discuss errors and identify areas for process or system improvements without fear of reprisal. The organization has a commitment to safety, and it is articulated at all levels of the organization. Resources are allocated and incentives or rewards that promote a healthy patient-safety culture are communicated to the staff. Safety is valued as a top priority, even at the expense of productivity. Errors and mistakes are evaluated in a manner that contributing factors are reviewed first, and then accountability is established and appropriate actions are taken."

"AORN annually publishes Perioperative Standards and Recommended Practices, which can serve as guidelines in establishing department policy and procedures that will provide a safe culture for patient care," noted Groah. "In addition, there is a CD with a template that allows facilities to customize a policy or procedure, thus eliminating the time-consuming task of creating a document for the facility. We also partner with Advanced Practice Strategies to provide the ‘OR Safety Series,’ education on high-risk issues that occur in operating rooms."

Sandel’s TIME OUT products help reduce the incidence of surgical errors by reminding the surgical team to take a "time out," as recommended by The Joint Commission’s Universal Protocol, to ensure that the correct procedure is performed on the correct site, on the correct patient, every time.

"Healthcare workers must continually be on the alert for the unexpected," urged Groah. "It means being vigilant, being informed, and being aware that, at any given moment, an untoward event can occur."

Something as simple as a checklist can make the difference between an operation that turns out well and one that turns out tragically. Groah continued: "Utilization of critical-event checklists, such as the Comprehensive Surgical Checklist developed by AORN that includes the World Health Organization (WHO) and the Joint Commission requirements can be utilized to prevent wrong-side, wrong-site, wrong-patient surgery."

Groah also commented on how processes, products, equipment, and technology play a part in creating a safe environment for patients. "Teams that include materials managers, sterile-processing managers, surgeons, anesthesia providers, nurses, surgical technologists, biomedical engineers, and infection preventionists are being utilized to select products and equipment for use in the perioperative areas. Focuses of the selection process include the safe use of the equipment and the education of members of the staff prior to implementation in the clinical setting. Technology is very important in the care of the surgical patient, but it must always be accompanied by establishing clinical competencies and then educating and training the clinician to meet the competencies prior to implementation in the clinical environment."

Industry’s role in patient safety

Industry has answered the need for a culture of safety in the surgical suite with a variety of products and devices to meet a variety of potential situations and problems. Healthcare Purchasing News (HPN) asked vendors what their companies are doing to make the surgical suite a safer place.

The time to ensure safety in the surgical suite begins well before the cut. The motto at Sandel Medical Industries, LLC, Chatsworth, CA, is "Safety Means Never Having to Say You’re Sorry," and their products help to ensure just that. They have a very simple system that can be very effective in preventing medical error in the surgical suite. Lucy B. Reday, product manager, described how their TIME OUT products work for safety in the surgical suite. "Sandel Medical’s TIME OUT products help healthcare facilities enforce compliance with visual reminders to take the required ‘time out,’ as required by the Joint Commission, and support WHO’s ‘Surgical Safety Checklist.’ The bright orange safety color makes TIME OUT products difficult to ignore on the sterile field."

Baxa DoseEdge Pharmacy Workflow Management System

The TIME OUT system is comprised of four products: The TIME OUT Beacon is an orange towel, available in disposable non-woven and disposable cotton, that can be placed over the surgical site, over the Mayo Stand, or on the back table, where it remains until personnel required to be in the room are present, at which time the "time out" procedure can be performed. The orange TIME OUT Hood, which is reusable, can be placed over the surgical scalpel or other sharps within the sterile field. The orange disposable TIME OUT Sleeve can be placed on the surgical scalpel, the Mayo Stand, or the back table to serve as a reminder to implement the "time out" protocol. Sandel’s Correct Medication Labeling System, Reday noted, "offers the users everything needed to mark and label medication on the sterile field, as required by regulatory agencies. With its proprietary flag system and preprinted labels, a facility has the option to customize a kit to meet their specific needs and provide the products in one convenient package. The healthcare facility saves time and reduces cost."

Reday explained further how use of the TIME OUT products are advantageous in the areas of cost, ease of use, and use of time. "Any time you can prevent avoidable medical errors it saves the hospital thousands of dollars in lawsuits, settlement cost, additional medical treatment costs, Occupational Safety and Health Administration (OSHA) fines, and the impact on the workforce. Sandel Medical Industries recognizes the need to help healthcare facilities by providing easy-to-use, economical products. The TIME OUT products can be purchased economically, some for less than $1 each, and can also be purchased to be included in the facility procedural kits, which save time and money. The Correct Medication Labeling System includes preprinted labels, which help to reduce set-up time and help to eliminate the potential of illegible writing. Our proprietary, unique ID flags make our medication labels more visible to the entire surgical team, therefore helping to avoid medication errors. Our 4-in-1 Marker eliminates the need for two markers on the sterile field; one side is used for marking labels, the other side for marking skin. Our Petite Skin or Permanent markers are smaller in size. Either markers help reduce cost and waste."

ClearCount SmartSponge, "Out" Bucket & SmartWand-DTX system

Medline Industries Inc., Mundelein, IL, has a system that addresses a too-common problem in the operating room (OR): sponges that get left behind in the patient. John J. Marks, corporate marketing, talked to HPN about Medline’s solution, which he said "gives surgeons and OR teams a new tool to prevent the anxiety of a potentially devastating OR error."

"Medline is the exclusive distributor for the SmartWand-DTX and SmartSponge System, the only FDA-cleared systems using radio-frequency identification (RFID) to both count and locate surgical sponges," said Marks. "The systems, created by ClearCount Medical Solutions (Pittsburgh, PA), use a technology featuring chip-embedded sponges to count and locate sponges during surgery. Retained surgical sponges can hurt and even kill affected patients and cost hospitals an average of $63,000 in follow-up operation expenses, according to Federal Register and Medicare statistics, per incident, not including legal fees and potentially large settlements. Human counting error is the most common cause of unaccounted-for sponges being left behind."

Marks explained further how the SmartSponge and SmartWand work. "The process is a little like finding a coin on the beach with a metal detector but much more high-tech and precise. Each sponge has its own ID number coded in its RFID tag. The SmartSponge System can read and record the unique ID number of each sponge as it comes out of its packaging in the OR, as it is used in the patient, and as it is removed and disposed of. Both the SmartSponge and SmartWand-DTX count multiple sponges and read through blood and tissue, and they can locate a missing tagged sponge using radio waves to signal the RFID tag to identify itself. Both systems also use the same RFID-tagged consumables, providing hospitals, for the first time, with a choice of devices to best address the unique conditions of each OR."

Baxter’s V-Link Luer-activated device with VitalShield protective coating

Needlesticks continue to be a common injury in healthcare, unfortunately. The surgical suite is a prime place to get one. David T. Young, public relations manager, Surgical Devices Group, Covidien, North Haven, CT, said: "More than 600,000 needle punctures are reported every year, according to OSHA. Needlestick injuries are associated with the increased risk of disease from infectious agents. In response to the serious health, safety, and economic concerns arising from needlestick and other sharps-related injuries, Congress passed the Needlestick Safety and Prevention Act in 2000. To help minimize this hazard in the surgical suite, Covidien offers an exclusive family of blunt suture needles called Protect Point, designed to reduce the risk of needlestick injuries. Protect Point needles are available in three types of blunt tips for different tissue types, ranging from tougher tissue, such as muscle and fascia, to soft and highly vascular tissue, such as liver and kidney. The needles are coated with NuCoat, which allows for consistent and easy tissue penetration pass after pass. The American College of Surgeons endorses the use of blunt suture needles for fascial suturing, and both OSHA and the National Institute for Occupational Safety and Health support their use wherever feasible and appropriate to help reduce injuries to surgical personnel."

Surgeries usually involve catheters. Catheters are associated with bloodstream infections (BSIs). BSIs can be devastating, even lethal, to the patient’s health and doesn’t help the hospital’s pocketbook any either. John P. O’Malley, Baxter spokesman, Baxter, Deerfield, IL, talked to HPN about a device they have that can help prevent BSI. "Healthcare-associated BSIs can be both costly and life-threatening. Baxter’s V-Link Luer-activated device (LAD) with VitalShield protective coating is an antimicrobial needleless intravenous (IV) connector that has been shown to kill at least 99.99% of 6 common pathogens known to cause catheter-related (CR) BSIs, including the highly treatment-resistant bacteria methicillin-resistant Staphylococcus aureus, vancomycin-resistant Enterococcus faecalis (VRE), Escherichia coli, Staphylococcus epidermidis, Pseudomonas aeruginosa, and Enterobacter cloacae. V-Link is coated on both inner and outer surfaces with a proprietary silver-based antimicrobial technology, which is key to its helping to prevent contamination and growth of some pathogens within the device. It is a key addition to a broad line of needleless IV-access products and is based on a well-known design with a flat, swabable surface, translucent housing, and double-seal protection."

Laura Kehler, RN, BSN, MS, CIC, infection prevention coordinator, Garden City (MI) Hospital, related her facility’s experience with Baxter’s V-Link LAD with VitalShield: "Garden City Hospital, a 325-bed community hospital outside Detroit, Michigan, launched an effort to reduce all peripheral and central catheter-associated BSIs to a target rate of zero by developing and implementing its ‘Infection Prevention Bloodstream Initiative,’ a customized bundle approach of which V-Link was one element. During a baseline period, September 2007 to May 2008, Baxter’s Clearlink IV connector was used on all peripheral and centrally placed IV catheters throughout its facility. During this baseline period, the hospital saw 18 BSIs per 37,860 patient-days, yielding a rate of 0.047 per 100 patient-days. During the evaluation period, September 2008 to May 2009, Baxter’s V-Link device replaced Clearlink as the intravenous connector as part of the bundled approach. BSI rates decreased to 0.019 per 100 patient-days, or 7 BSIs per 32,295 patient-days, during the evaluation period. BSI rate reduction was roughly 60% and resulted in cost avoidance of $365,511 for the hospital. Since May 2009, Garden City’s BSI rate has dropped even further to 0.011 per 100 patient-days."

InVisionPlus connector from RyMed Technologies
with cut-away illustration.

RyMed Technologies, Franklin, TN, also has device designed to thwart BSI. Dana Ryan, CEO, explained that "CR-BSI can be caused by bacteria that enter through the connector and adhere to biofilm within the catheter. Connectors are the gateway to the catheter’s fluid pathway. The InVision-Plus is designed to protect the catheter’s fluid pathway by preventing bacterial entry and minimizing biofilm. InVision-Plus has several design features that help defeat fibrin build-up and bacterial adhesion." Features include a smooth, tight surface that is easy to disinfect; a straight fluid pathway that can be fully flushed, which helps to prevent bacterial adhesion; and no clamping sequence, which prevents blood reflux, a precursor to CR-BSI, and which makes it easier to use.

John Schultz, MD, anesthesiologist at Duke University Medical Center, has had a good experience with InVision-Plus at his facility. "Open ports and uncapped stopcocks have been documented risks to our patients. The InVision-Plus provides a ‘closed’ intravenous system for open ports or stopcocks. These IV connectors can be added to existing systems or be permanently fused. The InVision-Plus, I believe, significantly promotes compliance with Centers for Disease Control and Prevention guidelines in regard to ‘capping stopcocks at all times’."

Medegen MaxGuard advanced luer-activated device
with Agion antimicrobial technology

Ryan related two other experiences: "MD Anderson Cancer Center [Texas] conducted a 15-week trial with InVision-Plus that resulted in a 10-fold decrease in CR-BSI for their intensive-care–unit patients. Based on these results, MD Anderson implemented InVision-Plus throughout the entire hospital." In another facility in California, said Ryan, "InVision-Plus is part of the hospital’s central-line bundle that has eliminated CR-BSI for more than 4 years."

Another plus, noted Ryan, is costs saved. "Hospitals, home infusion, and long-term–care facilities across the country that have implemented the InVision-Plus system have found it to be a significant cost savings for their institutions by reducing CR-BSI and thrombotic occlusions."

Another company offering needle-free IV connectors designed to help reduce CR-BSI is Medegen, recently acquired by CareFusion (San Diego, CA). Medegen’s MaxPlus Clear is a clear positive displacement connector engineered to assist facilities in enhancing the clinical best practices of priming, swabbing and flushing due to its unique design. The clear housing provides visual confirmation of priming and flushing of the device, while the smooth top makes disinfection easier. Positive displacement helps prevent reflux of blood into the catheter at disconnect reducing the occurrence of catheter occlusions.

Medegen’s MaxGuard has all the same features as the MaxPlus Clear with the addition of antimicrobial technology to provide an extra level of protection for those patients who need it most. The antimicrobial guards against the most common pathogens known to cause CR-BSI. Laboratory testing demonstrated greater than 99.999% reduction on six leading pathogens known to cause bloodstream infections.

While medication errors continue to be an important patient safety concern, technology presents a number of attractive opportunities to reduce the incidence of error. For example, the DoseEdge Pharmacy Workflow Management System from Baxa Corp., Englewood, CO, has been upgraded with new features that extend DoseEdge capabilities to include mobile dose tracking, more pharmacist verification options and enhanced dose status monitoring.

Illustration courtesy Nestle Nutrition.
The similarity between an IV spike set and an enteral (tube-feeding) spike set makes it easy to confuse them.

Nestle Nutrition’s SpikeRight Enteral Closed System has an enteral-specific port built into the container to reduce risk of misconnection.

Along with a range of configurable options that add new security parameters to the verification process, DoseEdge users also gain access to extended scanning capabilities. This enables new tracking options for scan-tracking doses outside the pharmacy. An easy-to-read, programmable Status Board displays key dose information to appropriate health-system staff, enabling pharmacists and technicians to spend more time focusing on patient safety and less time chasing lost doses, the company noted.

Sometimes when patients leave the OR, they will not be able to feed themselves orally and so will require a feeding tube. Carol Siegel, MS, RD, LDN, head of medical affairs, Nestlé Nutrition, Florham Park, NJ, talked to HPN about medical error related to tube feeding and what Nestlé Nutrition is doing about it. "In April 2006, the Joint Commission issued a Sentinel Event Alert raising awareness of the issue of tubing misconnections. One of the errors highlighted in this alert was the misconnection of enteral tubing (tube feeding) to an IV port. At the time, all closed tube-feeding systems (prefilled tube-feeding containers) included a universal port that was able to accept an enteral spike set or an IV spike set, as they have a similar design. If a nurse pulls the wrong set, spikes the tube-feeding container with an IV set, and connects it to an IV port, this poses a serious patient-safety risk, which often is fatal."

"As a result, leading healthcare organizations, ie, the Joint Commission, ECRI Institute, and the Institute for Safe Medication Practices, urged manufacturers to redesign their products to reduce the risk of dangerous tubing misconnections. In response, Nestlé HealthCare Nutrition eliminated the universal port from all their closed-system tube-feeding products and introduced SpikeRight, an enteral-specific port that accepts a specially designed spike set to help reduce the risk of tubing misconnections."

Covidien’s PROTECT·POINT Blunt Suture Needles are designed to reduce tissue penetration force in tougher tissue, like muscle and fascia, while still offering glove penetration protection.

"A recent paper from The Joint Commission Journal on Quality and Patient Safety, ‘Enteral Feeding Misconnections: A Consortium Position Statement,’ recommended purchasing strategies that include buying prefilled containers with screw-top design that reduces compatibility with IV equipment and searching all manufacturers’ products for the safest systems. Nestlé HealthCare Nutrition improved communication on packaging and partnered with the American Society of Parenteral and Enteral Nutrition to launch a major safety education campaign called Be ALERT, designed to help clinicians administer tube feedings more safely and reduce the risk of tubing misconnections. The Be ALERT campaign provides bedside caregivers with a reminder of five key practices that should be followed when administering a tube feeding to help reduce the risk of errors: Aseptic technique; Label enteral equipment; Elevate head of bed, when clinically possible; Right patient, right formula, right tube; Trace all lines and tubing back to patient. More than 20,000 posters have been distributed to hospitals and may be downloaded free of charge from www.nutritioncare.org/safety.

Siegel noted that the savings related to SpikeRight is because it reduces the risk of a potentially harmful tubing misconnection and subsequent consequences. "A tubing misconnection can lead to tragic consequences for patients and significant costs for a hospital in patient care and liability. The cost:benefit ratio of this adapted feeding port can be financially monumental to an institution. The potential benefit to patients and families is enormous. In addition, closed tube-feeding systems have been shown to decrease nursing time, decrease the risk of touch contamination, and decrease waste related to longer hang times."

Ensuring safety

The surgical suite definitely can save lives, but it has the potential to take lives, too. No one wants that to happen. Healthcare workers want to do what’s best for their patients. Industry wants to help healthcare workers make it possible to care for their patients in the most fitting and efficient manner. Working together, they can help to ensure that the surgical suite is a safe place for patients.