The statistics are staggering – and the potential fallout from the incidents even more so. In the cases of medication errors alone, the Institute of Medicine reports that an estimated 1.5 million Americans are injured or killed by drug mix-ups each year, and a Joint Commission safety notice — which came on the heels of the highly publicized incident last year where actor Dennis Quaid’s newborn twins were accidentally administered a near-fatal dose of blood thinner — warns that roughly one in 15 hospitalized children is harmed by drug mix-ups.

"Medication errors continue to be one of the most frequent causes of preventable harms in healthcare," the Joint Commission reports, adding that such mistakes continue to occur despite dedicated efforts, such as the development of the National Patient Safety Goal on medication reconciliation, which was instituted in 2005. "Many organizations have struggled to develop and implement effective and efficient processes to meet the intent of that goal," the agency acknowledged. Given the challenges that many organizations appear to be having in meeting the complex requirements of the NPSG 8, the Joint Commission is evaluating and refining its expectations. Still, during this time, the accrediting agency expects organizations to continue to address medication reconciliation within their facilities. During the onsite survey, the Joint Commission will evaluate the organization’s medication reconciliation processes, discuss opportunities for improvement and collect information on the progress organizations are making in meeting NPSG 8.

Indeed, the potential impact of medication reconciliation is significant. The Institute of Safe Medication Practice estimates that 50% of medication errors and 20% of adverse medical events could be eliminated with proper medication reconciliation.

Healthcare organizations have a wealth of resources at their disposal to drive medication administration best practices. In addition to information provided by the Joint Commission, the Institute for Healthcare Improvement offers a wide range of strategies to minimize risks for drug-related errors. Several of the IHI’s recommendations include labeling drugs specifically for each dose and immediately removing discontinued medications to eliminating or reducing the availability of multiple medication strengths and the number of medications available on units. [Editor’s note: For a more comprehensive list of recommended changes, see the Institute for Healthcare Improvement’s Improved Care Processes for Administering Medications at www.ihi.org/IHI/Topics/PatientSafety/MedicationSystems/
Changes/Improve+Core+Processes+for+Administering+Medications.htm.] The Association of periOperative Registered Nurses also offers drug-safety resources, including its guidance document "Safe medication practices in perioperative practice settings." AORN also introduced a Safe Medication Administration Toolkit that includes medication administration competencies; common medication conversion calculations; an herbal interactions poster; a pocket reference of common perioperative medications; and contact hour modules that address medication errors, perioperative pharmaceutical considerations and medications common to perioperative patient care.

Vendors are also doing their part to help healthcare organizations meet the regulatory requirements regarding safe medication administration. The Correct Medication Labeling System by Sandel Medical Industries, for example, includes everything needed to mark and label medication on and off the sterile field, including labels preprinted with the most commonly used medications for seven departments in the hospital (the labels are compliant with the most current Joint Commission requirements and AORN recommendations to include drug name, strength, amount, expiration date, and time); markers with a dual tip and dual ink that eliminates the need for two markers in the sterile field (one side is used for marking labels, the other for marking skin); proprietary ID flags that make labels more visible to the entire surgical team and can be applied to stainless steel basins, med cups and glass cups (a peel-off syringe strip of the same color is included to use along with medication labels); and a syringe label to ensure proper color coordination (each med cup flag incorporates a peel-off syringe label of the same color to use along with the medication labels).

"The preprinted labels reduce set-up time and help eliminate the potential for illegible writing," noted Dan Sandel, founder of Sandel Medical Industries LLC, Chatsworth, CA, adding that the company’s unique ID flags make medication labels more visible to the entire surgical team, thereby further helping to reduce medication errors.

When a patient undergoes a surgical procedure, the last thing they want to imagine is a subsequent operation to remove a retained sponge, instrument, needle or other surgical device. Unfortunately, for approximately one surgical patient in 7,000, that’s the unfortunate outcome, according to a study published in the Annals of Surgery last year.

The study, which examined 153,263 surgical procedures, revealed that discrepancies in the final count of devices (one mitigating factor in retained device incidents) increased with longer surgeries, late procedures and changes in staff during the surgery. Another study, published in the New England Journal of Medicine in 2003, showed that the risk of retained objects was significantly higher in emergency cases, procedures where unplanned changes occurred, and in patients with higher body mass indexes. Aside from requiring another surgery to remove left-behind objects, retained devices pose other problems as well – from visceral perforation and bowel obstruction to sepsis or infection and, in rare cases, death.

While preventing incidents of retained devices requires a multi-pronged approach that includes ongoing, targeted staff education and systematic due diligence (for specifics, see sidebar, AORN recommendations for improving count accuracy), some innovative counting and detection solutions have surfaced recently to help surgical services professionals further cut the risks. The SmartSponge System from ClearCount Medical and the RF Surgical Detection System from RF Surgical, for example, are radio frequency-enabled sponge detection systems that allow surgical sponges to be detected via small RF tags. The SmartSponge System is a radio frequency identification-enabled sponge counting and detection system that allows surgical staff to count and scan for sponges that have the RFID tags sewn into them. With the SmartSponge System, used sponges are automatically scanned – via an onboard counting scanner – as they are discarded into the SmartBucket. "The scanning wand can also be used at the end of the procedure to scan the patient to identify if there are any sponges left inside the patient," noted Kari Cashmore, director of marketing and product management for Cardinal Health Inc. Cardinal Health is the exclusive distributor of both the SmartSponge System and the Safety-Sponge System by SurgiCount Medical.

The RF Surgical Detection System is an RF-enabled detection system that consists of three main components: a handheld scanning wand connected to a console and a radio frequency tag which is sewn into surgical sponges. When the system is activated and the wand is passed over a patient, an audible and visual alert signals the presence of any retained sponges fitted with a RF Detect tag. When using this system, the operating room staff follows their standard/manual protocols for counting sponges and then uses the RF Surgical wand at the end of the procedure to scan the patient.

Bar coding and computer-assisted documentation is at the heart of SurgiCount Medical’s Safety-Sponge System. Also exclusively distributed by Cardinal Health, the Safety-Sponge System consists of handheld scanning devices (SurgiCounters), surgical sponges that have uniquely identified 2-D data matrix bar code tags affixed to them, and a networked application that allows for the complete review, management and analysis of the count reports generated. The scanning device is used to scan and record the bar codes during the initial and final counts. The data captured during the procedure can then be managed using the SurgiCount Citadel file manager which then provides electronic count reports, measured outcomes, customizable search capabilities, among other surgical data. "We believe that the use of computer assisted counting is the most cost effective solution available today and also best complements the current AORN recommended practices relative to sponge counts," Cashmore said, citing two recently published studies that highlighted the effectiveness of computer-assisted counting to prevent retained foreign objects. One, a Mayo Clinic study published in 2008 in the Journal of the American College of Surgeons, confirmed that relying on manual counting is unreliable and supported investigation of computer-assisted technologies. Another study, from Harvard Brigham and Women’s Hospital System, published last year in the Annals of Surgery, concluded that use of automated counting using bar coded surgical sponges improved detection of miscounted and misplaced sponges, and was well tolerated and accepted by surgical staff.

"We believe that the solution a customer chooses should support the current AORN recommended counting practices and also be adopted across all their surgical procedures in order to create a universal standard of enhanced patient care to ensure the prevention of retained foreign sponges," Cashmore continued.

Even manual counting can be improved with the help of easy-to-use, supportive solutions. The surgical sponge counter introduced by Medline Industries Inc. in 2008, for example, was designed to help staff conduct counts at the end of the procedure. A plastic bag with ten small or five large pockets — and a clear front with a blue backing to improve visibility — the surgical sponge counter allows nurses to fill the pockets as they are removed from the patient. While the product does not do the counting for them, it decreases the time it takes to count, so the patient is not under anesthesia longer, "and can decrease risk of human error," pointed out John Marks, Medline’s vice president of marketing. The bags hang from a rack for easy nurse access, with the rack connected to an IV pole or a wall in the OR; Medline provides the rack for free with purchase of the sponge counter bags.

Although wrong-site, wrong procedure and wrong person surgery are sentinel events tracked through the Joint Commission, actual incidence of such surgical errors across all surgical settings has been difficult to track and measure. What is known is such errors are quite rare; however, the incidents are alarming and eye-opening, nonetheless.

One 1999 mail survey of hand surgeons revealed that 21% reported performing wrong-site surgery at least once during their career, with wrong-finger surgery accounting for 63% of the 242 incidents reported. The Joint Commission performed a root cause analysis of 126 wrong-site surgery cases reported to the agency. The Joint Commission reported that surgery on the wrong patient occurred in 13% of cases, wrong procedures occurred in 11%, and surgeries on the wrong body part or site occurred in 76%. The incidents spurred the convening of a national summit by the Joint Commission in 2003, with the summit’s recommendations promulgating the Universal Protocol for Preventing Wrong Site, Wrong Procedure, Wrong Person Surgery. The Universal Protocol, which was updated in July 2008 and took effect January 1, 2009, emphasized three principal components: conducting a pre-procedure verification process; marking the procedure site; and performing a ‘time out’ immediately prior to starting the procedure. The Universal Protocol remains applicable to all non-surgical invasive procedures and all surgical procedures.

Possible contributing factors for wrong-site surgery include emergency operations, unusual time pressures to start or complete the procedure, and involvement of multiple surgeons or multiple procedures in a single surgical visit. The root causes identified by hospitals most often related to communication, preoperative assessment of the patient, and the procedures used to verify the operative site. Communication issues fall into two categories: failure to engage the patient (or family, when appropriate) in the process of identifying the correct surgical site, either during the informed consent process or by the physical act of marking the intended surgical site, and incomplete or inaccurate communication among members of the surgical team, often through exclusion of certain members of the team (e.g. surgical technicians) from participation in the site verification process, or through reliance solely on the surgeon for determining the correct operative site. The thoroughness of the preoperative assessment of the patient was also a frequent contributing factor, often through failure to review the medical record or imaging studies in the immediate preoperative period, according to the Joint Commission. The procedures for verifying the correct operative site were found to be flawed in many cases due to no formal procedure; no final check in the operating room; the absence of any oral communication in the verification procedure; all relevant information sources not available in the operating room; no checklist to ensure all relevant information sources were checked; some members of surgical team being excluded from the verification process and felt they were not permitted to point out a possible error; and total reliance on the surgeon for verifying the surgical site, coupled with the attitude that the surgeon should never be questioned.

The Joint Commission suggests the following strategies for reducing the risk of wrong-site surgery:

• Clearly marking the operative site and involve the patient in the marking process to enhance the reliability of the process.

• Requiring an oral verification of the correct site in the operating room by each member of the surgical team.

• Developing a verification checklist that includes all documents referencing the intended operative procedure and site, including the medical record, X-rays and other imaging studies and their reports, the informed consent document, the operating room record, and the anesthesia record; and

• Directly observing the marked operative site on the patient.

Other strategies that may be helpful, according to the Joint Commission, include personal involvement of the surgeon in obtaining informed consent; and ensuring through ongoing monitoring that verification procedures are followed for high-risk procedures.

"Nurses have been looking for new ways to help enforce compliance with the Joint Commission’s Universal Protocol for Preventing Wrong Site, Wrong Procedure and Wrong Person Surgery to ensure patient safety," Sandel explained. Founded in March 2002, Sandel Medical Industries attended its first AORN Congress one month later with the sole purpose of listening to nurses’ concerns and soliciting their suggestions on how to address patient and staff safety issues. By March 2003, Sandel had developed more than 100 patient and staff safety products with the help of perioperative nurses and hospital personnel who helped guide product development efforts. Sandel’s TIME OUT products were developed to help drive compliance with Joint Commission requirements via prominent visual reminders. The Time Out products include a Time Out Beacon, which is a reminder to pause and implement the Time Out Protocol; a disposable Time Out Sleeve, which can be placed on the scalpel during set-up or placed on the Mayo stand or back table to serve as a reminder to implement the Time Out Protocol; and the reusable Time Out Hood, which can be placed over the scalpel or any sharps device within the sterile field.

The ongoing nursing shortage is also paving the way for new product development. The latest wave in staff safety, according to Sandel is Engineered Sharps Injury Prevention, which is being driven by regulatory requirements, legislation and the medical community. To address these concerns, the company has added a line of staff patient safety product, such as safety scalpels and handles, and a neutral zone and hands-free passing tray – all in the same bright orange safety color.

"Working with perioperative nurses and hospital personnel enables Sandel to utilize its expertise in product development efforts, ensuring that we consistently address issues facing the healthcare industry today," said Sandel.