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RFID in Surgery: Applications of Technology for Inventory Control, Patient Safety and Personnel Management Susan Seidensticker UMUC ITEC 610 April 22, 2010

RFID IN SURGERY Abstract Radio frequency identification (RFID) has the potential to do several things in an operating room. This paper focuses on how RFID would fit into the standard practices found in the perioperative process to improve the inventory control process, promote patient safety and help better determine actual staffing patterns. Keywords: RFID, Operating Room, Surgery, Inventory Control, Materials Management, Sterile Processing, Circulating Nurse, Patient Safety, Retained Foreign Objects

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RFID IN SURGERY RFID in Surgery: Applications of Technology for Inventory Control, Patient Safety and Personnel Management O¶Brien and Marakas (2009) defined radio frequency identification (RFID) as a ³system for tagging and identifying mobile objects´ (p.112). Revere, Black and Zalila (2010) described

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the history of RFID, which dates back to World War II and its applications for identifying Allied aircraft by the British; Dinh (2009) believed that the birth of the technology was actually in the 1920s. Revere et al. (2010) noted that the healthcare industry is growing in its use of RFID technology, with the primary drivers identified as inventory management and patient safety. Kumar, Swanson and Tran (2009) noted that while the implementation costs remain high, there are many applications that have proven cost effective within the supply chain process. Wal-Mart has announced its commitment to having all of its suppliers have an RFID tag on every item before shipping it to the company (³Retailers: RFID still has great potential´, 2009), though the realization of that goal has not fully been met as of yet. Zhou (2009) discussed the pallet level RFID tagging currently in place, with the conclusion that the technology is capable of supporting a supply chain at the individual unit level. Napolitano (2010) identified error reduction in shipping and receiving, increased productivity, ability to track items throughout their life cycle and accurate inventory control as the prime reasons to utilize RFID. A logical place within a healthcare service organization (HSO) to look at RFID is in the perioperative services, which would specifically be in support of the operating room (OR). By expanding the technology to the surgical setting, the safety and efficiency of the care provided by the OR should have a positive long-term impact to the bottom line of the HSO. Figure 1 shows a typical structure for departments that are part of the perioperative services.

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Analysis RFID is the term applied to the type of technology that utilizes radio waves to determine the location of tagged items. There are two (2) types of tags: passive and active. Tags are typically between the size of a United States dime and nickel. Passive tags are powered via the device used to read them, but do not feature the specific detail of what the item in question is: they just note that a tagged item has been found. Active tags are powered by an internal battery, so they do not have an infinite lifespan but do feature the ability to track specific items with much more detail (Kumar, Livermont & McKewan, 2009). RFID has been identified as a

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technology that supply chains can use to reduce labor and inventory costs, reduce errors, increase revenue and improve productivity (Mehrjerdi, 2010). Studies have been conducted regarding the potential of RFID causing interference with medical equipment. In an article by van der Togt et al. (2008), the researchers were able to induce a hazardous situation in a controlled environment; no patients were involved, and the researchers concluded that a HSO should always assess its environment before implementing any new technology to understand what impact it may have on the efficacy of the existing system. A separate study was able to reproduce van der Togt¶s findings, and additionally identified the potential for error in the re-setting of the equipment after the RFID interference occurred (Houliston, Parry, Webster & Merry, 2009). A.F. Ashar & Ferriter (2007) advocated tight controls from HSO management on the types of wireless technologies purchased to ensure that they are easily maintainable while also putting in safeguards to prevent improper interactions. Shoemaker (2007) estimated that passive tags cost $1 each, while active tags cost range from $30-$40. That article also discussed existing RFID applications in healthcare related to patient tracking, medication reconciliation and electronic medical record interfaces. Christe et al. (2008) studied the possibility of RFID technology interfering with other medical equipment commonly used in hospital settings, including monitors and pumps; their findings of a lack of interference should empower an OR to consider adding RFID to their process. Bar coding has some similarities to RFID in terms of tracking key items and individuals. The requirement for line of sight access to read the bar code, however, makes bar coding a more labor intensive mode of monitoring people and things (Booth, Frisch & Miodownik, 2006). There are three areas within the surgical setting where RFID has the potential to become part of

RFID IN SURGERY the routine practice: supplies, instrumentation and personnel. Supply chain processes in the OR setting can vary not only from hospital to hospital, but between OR suites at the same location. Bilyk (2008) discussed the benefits of standardizing methodology and consistently tracking supply usage in the surgical setting, as that allows the OR administration to better plan for its supply needs and have actual usage data that can be used for budgetary planning. Sutherland, van den Heuvel, Ganous, Burton, & Kumar (2005) discussed the ³Operating Room of the Future´, and how standardization workflow and data capture can support both patient safety and the quality of patient care. RFID was viewed as a method of enhancing the capabilities of the perioperative system, not as a solution to all of its issues. The analysis of workflow in an OR can be seen as a continuous process, as any change (new equipment, new procedure, new surgeon, etc.) can have multiple upstream and downstream effects; RFID would be a method to help quantify those impacts. The supply chain function within the OR is typically the responsibility of OR Materials Management (ORMM); this department may report to OR Administration, OR Nursing or the hospital¶s Material Management department. ORMM is not always physically connected to the OR, so the delay in access to inventory at the point of use factors into many layers of decision making regarding supplies. It is the responsibility of ORMM to ensure that all of the single-use or disposable supply items that each surgical case needs are available. There are five major categories of responsibility that ORMM must meet to provide the level of service that an OR requires. The first category is par level management within the OR itself. ORMM staff are responsible for checking the par levels of all supply items that are stored in the hallways and

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RFID IN SURGERY individual suites within the OR, and restocking them as needed; this is a function that would greatly benefit from technology like RFID. The items stored within an OR are typically also kept in the main ORMM location, so the staff is responsible for tracking multiple locations on the same items, and the same item may be found stored within multiple OR suites as well (³Can OR inventory be like a grocery store?´, 2007). As noted in James (2005), RFID technology is already well established in the pharmacy side of healthcare and has demonstrated the ability to

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track at the lot and serial number level of detail. Pharmacy operations are a good comparison for healthcare, as the documentation requirements for each individual surgery is very similar to that of medication. The specific details of what was used or issued are needed in order to track inventory usage as well as generate billing to the patient and/or their insurer (Lahtela & Saranto, 2009). The current normal practice of visual inspection of these items would be able to be augmented through RFID, which would help the ORMM staff obtain more accurate data on what is still on the shelf at the point of use. ORMM would be able to locate misplaced or misfiled items more easily, as well as track data on the actual inventory turn figures of specific items. Items that had been deliberately hidden away by a circulating nurse (CN) would be locatable, and ORMM could avoid ordering items that the HSO does not need (Gamble, 2009). Shelf space in an OR can be very scarce, so the items stored there are intended to be high criticality items, so slow moving items that do not match back up to an urgent (crash cart) type of need would be able to be identified as candidates for storage in an alternate location. The second category is par level management in the main ORMM location. As noted by Barlow (2008), space limitations impact the ability to have every possible item available in large quantities at all times. Setting up organized and easily accessible storage systems and being able to know what is on-site is key for any ORMM in its support of the surgical schedule. This is

RFID IN SURGERY very similar to retail, as the need for accuracy on what is in stock is key while the ability to generate data on fast-moving or slow-moving products will allow for better budgetary planning (³Gerry Weber to roll out RFID for inventory management and loss prevention´, 2010). In both types of par level management, ORMM is responsible for pulling any items that have past the expiration date off of the shelves. This is another way by which an organization can easily lose track of what items are really needed; OR Nursing and ORMM ideally should work together to determine if the expired items really need to be stocked at all. Endicott (2007) discussed how RFID could also support efforts to locate recalled items so that they could be removed from the shelves as soon as possible.

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The third category is the pulling of supplies for surgical cases. Before each surgical case, ORMM pulls the supply items on the preference card, which is printed out in the form of a pick list: this process is the same as that of a warehouse filling an order (Park & Dickerson, 2009). Figure A1 in the Appendix demonstrates how this aspect of ORMM contributes to the start of a surgery. The ORMM staff fills the order for the supplies requested by a surgeon for a specific surgical procedure; in most hospitals, the instrumentation is added to the supplies prior to transport to the OR suite. The OR schedule depends on the ability of ORMM to deliver in a timely fashion. This has similarity with RFID applications in tourism, as luggage tracking (getting the right bag to the right airplane at the right time) would be a similar analogy to what ORMM does with case carts (Oztaysi, Baysan & Akpinar, 2009). If they don¶t the surgeries can run past their scheduled time, causing potential overtime needs for OR nursing and its supporting areas, as well as creating dissatisfaction for the surgeons, as well as for the patients and their families. Case carts are expected to be delivered complete; the perioperative system should be able to alert ORMM and SPD of potential conflicts over scarce resources (Akridge, 2007). If it

RFID IN SURGERY is discovered during the build of the case cart, ORMM and/or SPD should alert the OR Nurse Manager or designee that there is a scheduling problem looming. A function that crosses the second and third categories of ORMM responsibility is the requirement for restocking those items sent to the OR in the case cart that are not used, so they are returned to ORMM unopened. Hiatt (2007) noted that from the OR¶s perspective, it can be beneficial to have multiple sizes or quantities on the case cart, but that there is a tremendous amount of labor involved on items that are pulled and then re-shelved. ORMM runs the risk of over-ordering items that ride the case carts if the assessment of the par levels captures the

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information at the wrong time of day. Data from RFID packaging would be able to better inform all involved in the supply chain process as well as the clinical side of surgery as to whether or not those just in case items are ever used. The fourth category of ORMM responsibility involves the management of supply items, instruments and equipment that the hospital has on consignment. These items, which reside in the hospital but aren¶t charged for by the vendor until they are used, are typically high dollar items that require detailed tracking so that the hospital can in turn bill the patient and/or their insurer for their use. Bertrand & Schlatter (2009) theorized that the vendors may soon take it upon themselves to tag the instrumentation and equipment themselves, in an effort to better manage the usage documentation and billing. These items could be seen as similar in nature to blood for transfusion; some supply items have environmental (time and temperature) concerns that resemble the monitoring required of blood products (Davis, Geiger, Gutierrez, Heaser & Veeramani, 2009). RFID is now viewed as a way to eliminate error and provide tracking to ensure that the right unit of blood gets to the right patient at the right time (Briggs et al., 2009).

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The fifth and final category of responsibility is the re-order process for supplies. DeJohn (2008) reported that thirty (30) percent of all health care costs are attributed to supplies, and that 38% of that figure is directly related to the logistical side of the supply chain. ORMM is responsible for ensuring that the items identified during the par level assessments are ordered and re-stocked. DeJohn (2008) also noted that if an overnight shipment is required to bring supplies into the hospital, the freight costs alone may be close to $250 per package. The process of ordering supplies for replenishment allows ORMM to document the usage within the OR. The re-ordering process, in conjunction with the par level assessments, can also support any value analysis efforts regarding new or upgraded product lines (Greene, 2006). Depending on the individual item, ORMM may be ordering at quantities higher than needed to replenish the par level; the vendor units (boxes, cartons, etc.) are broken down to the unit (each) level upon receipt. For a HSO that is committed to RFID at the point of use, vendors that can provide the accountability at the unit level may receive more business (Deitz, Hansen & Richey, 2009). ORMM serves as the control point of not only day to day operations, but as the guardians of new items coming in to the OR and other items being retired from inventory. Hiatt (2008) discussed how ORMM can interact with OR Administration, OR Nursing and the individual surgeons to evaluate new and upgraded products to determine what should be available for use. This also would provide the structure to assist in tracking the impact to clinical outcomes that various types of supplies may have. Shumaker (2006) discussed the benefit of having data to allow for supply standardization and monitoring of contract compliance as additional elements of a strong ORMM. Mateka (2009) stressed the need for surgeon involvement on any changes to the supply products maintained by a hospital. Data from RFID tags on actual usage would make some discussions on whether or not to make a large purchase easier on all parties.

RFID IN SURGERY The CN is the owner of many processes during each surgical case. Schmock (2009) stated that the ³science of nursing and practice of technological competencies can be seen as

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caring, ontological nursing practices´. As described by Thomas (2008), the responsibilities of a CN can be divided into three (3) areas: pre-operative (before the patient enters the OR suite), intra-operative (the arrival of the patient in the OR suite until the surgery is completed) and postoperative (the waking of the patient until the OR suite is cleared out). RFID has the opportunity to impact all three areas of a CN¶s workflow. Pre-operatively, the CN is responsible for: development of the plan of care that meets the needs of the specific patient; preparation of the OR suite before the patient arrives, including the verification of counts of items brought on to the sterile field; and ensuring that equipment is functional (Thomas, 2008). RFID has the potential to reduce the possibility of discrepancies in the counting process, as it is one of the most user-friendly methods of information technology available in the efforts to prevent medical errors (Chao, Jen, Chi & Lin, 2007). In ³Recommended practices for sponge, sharps, and instrument counts´ (2006), the processes by which the nursing team in the OR is to account for items that can be placed onto the sterile field of an OR set-up was detailed. The sixteen (16) elements of sponge counts have many aspects that would be supported through the use of RFID technology, though the recommendations do stress that all members of a surgical team may be held liable if a retained foreign object (RFO) event occurs; no amount of technology would change that liability. HsiehHong & Cheng-Yuan (2009) emphasized that RFID should be used as a confirmation; the technology does not have enough history to remove the human element just yet. RFOs have been identified as one of the eight (8) hospital-acquired complications that the Centers for Medicare & Medicaid Services (CMS) will not (as of October 2008) reimburse a HSO for

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(Pronovost, Goeschel & Wachter, 2008), so those avoidable costs (additional surgery, inpatient stay and legal) would be part of the return on investment (ROI) calculations of any preventive technology. A retrospective review of malpractice claims noted that the majority of RFO occurrences were in patients who had undergone either abdominal or gynecological procedures (Kaiser, Friedman, Spurling, Slowick & Kaiser, 1996). The current standard involves a radiopaque strip imbedded in the sponge, thus allowing it to be visible on an x-ray; however, there are many concerns about the ability of the reviewer to properly identify these items when interpreting the image (Rogers, Jones & Oleynikov). Macario, Morris & Morris (2006) reported that their study of RFID sponge detection technology had a perfect accuracy rate, but that fact alone did not preclude the need for diligence by the nursing and surgical teams. A review of current sponge detection technology will be presented in the Methods section of this paper. The twelve (12) elements for sharps and other countable items are also described; some of these items are too physically small to be considered for RFID at this time. The instrument counting process also has sixteen (16) elements. Instrumentation with RFID tags affixed to them is not yet widely available, though the German manufacturer Aris (2007) advertised that this is now available. The American manufacturer RF Surgical (2010) stated that they have a RFIDbased instrument tracking plan in development. Every OR depends on its SPD to ensure that their surgical instruments are properly cleaned, packaged and sterilized for every case that they perform. Figures A2, A3 and A4 in the Appendix describe the process flow within the SPD of a large academic medical center. It is the responsibility of the OR staff to ensure that every instrument delivered to them is accounted for

RFID IN SURGERY at the end of each surgical case. RFID-tagged instrumentation would provide both ends of the

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process with a view of where its inventory is, and provide assurances that the items aren¶t being left in the patient or tossed in the trash. Carver (2007) reported that anecdotal information from large hospitals placed the estimate between twenty (20) to thirty (30) labor hours per day can be lost just looking for misplaced instrumentation. RFID-tagged instruments may also reduce the risk of injury to the nursing staff. In the event of a mismatched count, the potential for a sharp (countable) object breaking the skin is higher, as the nursing team will be actively trying to resolve the discrepancy and the items may be handled in a less than optimal fashion (³Injuries in the OR´, 1997). Tu, Zhou & Piramuthu (2009) have studied the potentials for false positive readings of RFID tagged items in healthcare, and identified concerns about the impact of fluids and tag orientation on accuracy. The potential would still exist that members of the nursing and surgical teams would still have to manipulate the reader, the instrumentation and/or the patient in order to accurately capture the location of tagged items. RFID-tagged instrument technology has to be able to survive extreme conditions in order to fulfill the safety and efficiency goals of a HSO. As directed by the Association for the Advancement of Medical Instrumentation ST79 (2006), instrumentation must be able to handle the cleaning process, which involves enzymatic cleaners, soaps and hot water. As Spry (2008) described, the RFID-embedded instruments must also survive the rigors of steam sterilization, which requires the items reach temperatures of at least 270 degrees Fahrenheit to ensure that the conditions for sterility are met. In an ideal world these would be active RFID tags, which would allow the OR staff to know exactly what items they are using; this would provide for much more detail than a passive RFID tag, which would just indicate the presence of an instrument in the

RFID IN SURGERY area being scanned. Nagy et al. (2006) expressed concern that the expected battery life for the active RFID tag is 3 to 5 years, though advances in the technology have increased that

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expectation since that article was published. In ³RFID for 2,500 sterilizations´ (2009), the Swiss company MBBS states that they had developed a process to marry an RFID tag to individual instruments and were able to promise that it would survive 2,500 sterilization cycles without failing. Jacobs (2009) also discussed RFID survivability through the sterilization process, though the battery for the tag discussed in that article could only be counted on for 500 sterilization cycles. RFID capability would allow the surgical team to reduce the amount of time the patient is in the OR. For example, if there are 200 surgical instruments, 100 sponges and 20 other sharps for a single surgical case, it may take several minutes to account for all of them at each of the designated counting points. All other work being done by the CN and scrub nurse/technician should come to a complete halt during each count to reduce the risk of error, thus delaying the departure of the patient to Recovery. The ability to confirm the location of all instruments, sponges and sharps brought to the OR may also allow HSOs to greatly reduce the number of intra-operative and post-operative x-rays. The nursing staff would also be able to reduce the amount of time it takes to break down the sterile field set-up and return the instrumentation to the sterile processing team for reprocessing and sterilization when they are assured that everything that came in to the room has been accounted for. Mathias (2006) noted that the counts are necessary, but must occur at some of the busiest times of a surgical case. The implementation of RFID-tagged items will allow the OR nurses to reduce the amount of time they spend counting and recounting during a surgical case (³System One recommends RFID for the healthcare industry´, 2007). Per the ³Recommended practices

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for sponge, sharps, and instrument counts´ (2006), full instrument counts should be conducted at least three times per surgical case: during the initial set-up of the sterile field, before the surgical team starts to close the incision site(s), and at end of the surgery but before the patient leaves the room. Additional counts are recommended for every time there is a change in personnel, whether it is the CN or the scrub nurse/technician. The scrub function is responsible for the actual management of the instrumentation during the surgery, while the CN ensures that the materials and equipment needed for the surgery are available; the CN is also responsible for the documentation of the nursing actions during each case. To conduct a count, both the CN and scrub nurse/technician must work together to verify what they have. Intra-operatively, the CN has many different roles that often must be managed simultaneously. The CN performs clinical activities, such as assisting Anesthesia in putting the patient to sleep and working with the surgical team in the positioning of the patient on the OR table. The CN participates in the surgical time out, where the entire team in the OR suite doublechecks that they have the right patient and right procedure planned. The CN also assesses the patient before placing the grounding pads, which allow the surgeon(s) to use the cautery to stem bleeding. The CN is also responsible for the connection and powering on of all required equipment. Once the surgery is underway, the CN also prepares any specimens and blood samples for transport to pathology and lab; and assists with wound and drain management for the patient (Thomas, 2008). Meyer, Fairbrother, Egan, Chueh & Sandberg (2006) discussed the applications of active RFID for locating equipment. A CN is frequently asked in the intraoperative period to have additional equipment brought into the OR suite; an example of this would be video towers for support of endoscopy. If the equipment were also RFID-enabled, the CN would be able to easily locate the equipment and not have to go searching through the OR

RFID IN SURGERY looking for the item(s); this would allow the CN to spend more time focused on the care of the patient (Grey, 2007). Tagging equipment would also provide information for budgetary

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planning, as the utilization data required to justify additional purchases would be easily captured (Fisher & Monahan, 2007). The CN issues additional supplies and fluids to the sterile field as they are needed (Thomas, 2008). Some of these items are brought in to the room via the case cart, while others are stored in the OR suite or the OR hallways. If the item(s) requested are not immediately available, the CN will call to the appropriate department (ORMM or SPD) to request the item(s) be delivered to them as soon as possible. ORMM and SPD personnel would benefit from RFID tracking if the requested item(s) have already been issued off of their shelves; they would be able to track the items to the OR suite(s) that they are in and allow the clinical teams to decide which surgical case gets to have that scarce item and thus maintain the highest level of patient safety (³Is it time to add instrument tracking?´, 2007). If the CN notes that they always have to request the same items, they should look at persuading the surgeon to agree to modify the preference card for that particular procedure. RFID tracking of supplies would provide quantifiable data on how often items that are not on the preference list are used, and thus could make the case for changing the cards that much clearer. Schwaitzberg (2006) discussed how RFID could assist the perioperative team when there is a product failure, and allow for the specific lot and serial number in question to be tracked until the issue was resolved. The CN serves as a traffic cop in the OR suite to ensure that the flow within the room is not putting the patient at risk, as well as monitoring the sterile field, and is responsible for and

RFID IN SURGERY coordinates with ORMM and Sterile Processing department (SPD) to bring in any additional items requested during the surgery (Thomas, 2008). Surgeons frequently change the posted

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procedure and/or decide that they need additional items to complete the case, but do not always remember to tell anyone before they arrive in the OR (Sayers, 2009). For those items that would be considered countable, the CN is also responsible for initiating the count of the new item(s), as well as updating whatever counting documentation the team is using so that the next counting cycle knows to look for the item(s). The final major intra-operative responsibility for a CN is documentation. There are legal requirements regarding documentation of key data points related to the surgical case; they include what procedure was done; what supply items were utilized; the capturing of key time points during the surgical case; and a record of exactly who was in the OR suite and for how long (Thomas, 2008). RFID would be able to eliminate the manual portion of personnel documentation, as all members of the surgical, nursing, anesthesia and support services teams are required to have their identification badge on their person. If the badge was RFID enabled the OR record to automatically document each individual that comes and goes from the room, as well as how long they stay there. This type of information would be very valuable in planning for staff allocation based on the type of surgery scheduled. Katz & Rice (2009) discussed some of the concerns that clinicians may have about being monitored at that level, referencing several other studies that demonstrated some fear of increased workloads and/or excessive managerial oversight if the clinicians are continuously tracked. In any hospital area where radiation is given, the staff is issued monitors to wear to detect exposure; RFID tracking of the personnel would also support any efforts regarding headcount in the event of a leak (Huang, Shih, Lee, Chao & Wang, 2010).

RFID IN SURGERY The data on supply usage is used as the basis for generating a patient¶s bill for surgery; OR times, as recorded by the CN, are also used to calculate the technical (hospital) charges.

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Krupka & Sandberg (2006) described the ORs as the ³financial locomotives of many hospitals´, so ensuring that all charges are captured are key to the fiscal health of the organization. The supply portion would also be supported by RFID, as the tracking elements described earlier for ORMM¶s management of items would apply here as well: the OR record would be able to document what was used during each case as well as what was returned (unused) after the surgery was completed. The increased automation of the process may allow for reduction of after-the-fact labor required to generate a patient¶s bill (Cangialosi, Monaly & Yang, 2007). RFID would also support the documentation and proper disposal of wasted supplies, as some single use items might be treated as reusable otherwise. Unless a hospital has approval from the Food and Drug Administration, all items designated single use are to be disposed of once they are opened (³FDA wants to know more about reuse of opened-but-unused items´, 2002). The RFID tagged items would provide the information needed for an accurate perpetual inventory, which would allow the HSO administration to know exactly what instruments and supplies they have, how long it has been in service and/or on the shelf, when it was repaired (for instrumentation), lot numbers for monitoring supplies for recall, and how much items cost to replace. The technology would help the materials management staff locate sterile supplies faster, and keep a better accounting of the various par levels at all locations where supplies are stored. RFID would also aid sterile processing employees in locating requested instrumentation more quickly, which would in turn support the quality control function when there is concern about the sterilization process working properly. This would eliminate the occurrences of instruments

RFID IN SURGERY being lost in the laundry or trash, and would also reduce the amount of money the HSO would need to budget for replacement items.

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In order for the full benefit of RFID in the OR to be felt, there will need to be cooperation from the supply manufacturers and vendors. The vendors are not uniformly putting the singleuse items in packaging that can support an RFID tag. The actual size of the tag may make some items difficult to add a tag to; it is unlikely that one would expect to have every individual bandage tagged with an RFID chip on its wrapper. The vendors may be more amenable to tagging the larger box that the item comes in, but for tracking and accounting purposes the CN would have to be able to scan something to document that items usage: if not, expense costs are not documented and the goal of complete activity based costing is impaired. The data available from the RFID tags would provide real time usage information to the HSO, which would allow for detailed analyses to be conducted in determining what additional supplies and instrumentation are needed to support the surgical volumes. The data will also help the OR nursing team with the maintenance of the preference cards. Reducing inaccuracies in preference cards will also reduce the amount of nursing time needed to get a surgical case started, as the team would always have an accurate record of what the surgeon likes to use when they perform that type of procedure. Catalano (2007) discussed the concepts behind allowing the intra-operative documentation to be done while mobile; in a traditional OR, the CN would retreat to a desk (or other flat surface) to record key pieces of information. Documentation done at the point and time of use is more likely to be accurate than if it is done in a retrospective fashion. A CN may

RFID IN SURGERY also be asked to support various data collection efforts, as some surgeons are conducting research based on specific supply usage (such as orthopedic implants) or on practice aspects.

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Post-operatively, the CN: assists Anesthesia in waking the patient; participates in the tear down and clean up of the OR suite, including the final confirmation that all items that were counted in to the surgery are accounted for; and providing report to the nurses in the recovery room on the status of the patient. The element of teamwork contributes to the efficient use of resources, the consistency of care provided to the patient, and to the overall structure for patient safety (Sexton et al., 2006). The communication requirements within an OR have frequently been compared to those of aviation. Crew Resource Management (CRM), which was described by Sax et al. (2009) as a practice that combines human and system issues together to ensure that the lines of communication are open, that the process of error management is well-defined, and that the overall work environment is strong. Helmreich (2000) discussed organizational culture as it related to aviation, and noted that it ³reflects its (the organization¶s) attitudes and policies regarding punishment of those who commit errors, the openness of communication between management and the flight crew, and the level of trust between individuals and senior management´ (p. A135). The culture of healthcare can be described in the same manner. Gore et al. (2010) presented a study done to assess the culture within an OR once the CRM training had been provided to the physicians and nurses which showed that the CRM had a positive impact to the perception of patient safety; Haynes et al. (2009) noted a reduction in patient deaths when checklists similar to those associated with the CRM structure were used. In a separate study it was noted that even after CRM training, the compliance by OR staff with all

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patient safety practices was relatively low (France, Leming-Lee, Jackson, Feistritzer & Higgins, 2008). RFID could work in support of a CRM environment within the OR; if an initial scan for countable items came up short, the ability of the nursing staff to be able to put everyone in the room either on alert or have them stop what they are doing would reduce the risk that a patient would leave the OR with a RFO. Cima et al. (2008) found that in 38.2% (13/34) of the RFO events they surveyed, the count had been reported correct at the end of the surgical case. Egorova et al. (2008) discussed the issue of counting discrepancies and the time the nursing team has to spend trying to resolve them. Potential labor savings can be calculated based on the nursing time that is spent on counting. As an example, if a 20 room OR averages 2 cases per room per day, a 10-minute reduction in each counting cycle would be 20 hours of OR time; this figure would be higher if additional counts were needed due to personnel changes. The counting process requires the CN and the scrub nurse/technician, 20 hours of OR time would be 40 hours of nursing time each day. A typical OR may be scheduled for 5 days a week and 50 weeks a year, so the 40 hours of nursing time equates to 10,000 nursing hours per year. If the time allocated to counting could be reduced by half, and if the average nursing labor rate is $40 (wage plus fringe benefits), the HSO may realize $200,000 of nursing labor that can either be put towards other tasks or used to support a reduction in overtime. This would be an annual savings for every year that a HSO used RFID-tagged countable items. Cima et al. (2008) noted that the standard practice for surgeries where there are incorrect counts is to perform an x-ray at the end of the case. Lincourt et al. (2006) found that the x-rays are not always interpreted correctly, as radiologists do not always properly identify the items left inside a patient even if they are visible on the x-ray. With the ability to easily locate the RFID-

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tagged items, HSOs should be able to drastically reduce the number of intra-operative and postoperative x-rays they perform solely for patient safety; those x-rays done as part of a clinical pathway would not be affected. Costs attributed to the reduction in intra-operative imaging could then be factored in to any ROI calculation the HSO does on the RFID technology. Dossett, Dittus, Speroff, May & Cotton (2008) estimated that the actual costs for intra-operative x-rays, including technician and physician-interpretation labor, were $705 per surgical case. Gawande, Studdert, Orav, Brennan & Zimmer (2003) noted that the likelihood of a RFO occurrence was higher when the surgery was urgent (unscheduled), the procedure(s) performed were different than what was originally scheduled, and/or the patient had a high body mass index. This study found that most hospitals have at least one RFO annually, with an average cost per occurrence for compensation and legal fees of $52,581 (in 2003 dollars); Shah & Lander (2009) found that cost to be $42,077 (in 2008 dollars). Korcok (2009) reported on a RFO occurrence that went to court in Georgia where a sponge was left in the patient during an operation on the colon; the settlement awarded was $10 million. These preventable costs could also be factored into a HSO¶s decision making regarding investment in RFID technology. A challenge faced by every OR is to determine how to measure what the actual costs of doing business really are. Berkey (2007) reviewed the concept of utilizing the case mix index and average supply expenses per case to come up with a dollar figure that could be used for benchmarking with other institutions. In ³How ORs track, manage supply costs´ (2006), several existing metrics were reviewed that centered on average costs per case or per minute of OR time. Activity based costing (ABC) evaluates costs at the individual process or activity level (Krug, Van Zanten, Pirson, Crott & Borght, 2009), while also factoring in the proportionate

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amount of overhead costs (Demeere, Stouthuysen & Roodhooft, 2009). Ramsey (1994) outlined how the variables would apply in a perioperative example: the activity would be the specific surgical procedure, while the input variable would be labor (surgeons, nurses, anesthesiologist, etc.), technology (equipment, monitors, etc.) and supplies. RFID would support data collection on all of those elements. Baker & Boyd (1997) presented an evaluation of one hospital¶s OR and how ABC was implemented. RFID could have eased that implementation, as it would have allowed for simultaneous data collection on all cases, rather than having to stage the implementation to start with the highest volume procedures. As noted by Lawson (2005), reimbursement for healthcare services has become much less generous since the early 1980s, so a HSO has a strong motivation to make all of its processes as accurate and efficient as possible: to put it simply, you can¶t bill for what you don¶t document. Siegmueller & Herden-Kirchhoff (2010) acknowledged that implementing ABC in the perioperative setting would be difficult, but would benefit any HSO that chose to do so. Methods As discussed previously, RFID tagged surgical instruments are not yet widely available, and many of the supplies used within an OR are not yet tagged at the unit level. Personnel tracking is well established technology (Huang et al, 2010), but a HSO would typically roll this out throughout the organization and not just in one area so that a standard is maintained for all employees. The area where the traceability would make an immediate impact to the flow of work and patient safety within the OR is surgical sponge tracking. To test the effectiveness of the technology, a comparison (pilot) of three competing vendors would be held. Specific procedures would be chosen for the pilot and the same groups

RFID IN SURGERY of surgeons and nurses would be utilized, in an effort to reduce as much external variation as

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possible; as mentioned earlier, abdominal and gynecological cases have been found to have the highest occurrences of RFOs (Kaiser et al., 1996). A defined number of surgical cases would be set before the pilot began, and the vendors would be assessed sequentially (e.g., collect all data on Vendor A before moving to Vendor B and then Vendor C). A simulation lab could be made available to train the CNs on the proper use of the technologies: the µcan you find the hidden sponge¶ practice would allow the CNs to have some familiarity with the equipment prior to taking it into an OR suite with a patient. The first step for any new process analysis requires an understanding of the existing process. The OR would have to define all of the existing steps of sponge counting; this as-is assessment serves as the baseline data by which the vendor products are to be compared. Data on time, labor and cost are part of the as-is assessment, as well as an understanding of what process flow variations exist based on which OR suite is used (proximity to additional sponge supplies during the intra-operative period). Variations in the practice of documentation by the CN for tracking counts would also be captured. The as-is assessment would include time study data on how long it takes to count utilizing the current standard of radiopaque sponges, and the CN and surgical technician labor dollars associated with that. The as-is assessment would also develop a benchmark on the time and costs associated with unscheduled intra-operative x-rays. The actual cost of the x-ray would include the all labor associated (x-ray technician, CN, surgical technician, surgeon, anesthesiologist and radiologist) as well as the fixed cost of the x-ray and the overhead costs associated with OR suite time. As referenced previously, Dossett et al. (2008) put an actual cost

RFID IN SURGERY of intra-operative x-rays at $705 per surgical case, but each HSO would want to verify that number internally.

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A project manager would review the surgical schedule and coordinate the deployment of the equipment and supplies for the pilot. Many ORs list bundled procedure packs on their preference cards that come with the radiopaque sponges; the project manager would have to ensure that those sponges don¶t get intermingled with those of the piloted technologies. The project manager would coordinate the capture of data on the time spent counting with each technology, the number of times an unscheduled x-ray was requested during each technology¶s pilot, and the satisfaction level of the team with the different technologies. The OR leadership would also conduct the financial analysis on each technology to develop ROIs for each one. Vendor A in this scenario represents ClearCount Medical Solutions. The SmartSponge System would be brought into the OR for trial in cases; the equipment platform is on wheels, and has the potential to be moved out of the room and brought back in if there are space concerns in the OR suite. The sponges contain a small imbedded active RFID tag in the corner, and can be read in to the case in large quantities simultaneously. Once sponges are used, they can be placed in the scanning bucket, where the tags will be read and the count updated accordingly (ClearCount Medical Solutions, 2010). If the counts indicate that there is something missing, the CN would use a reader (wand) to run over the trash container, the linen basket and the sponge bucket. If the item(s) remain missing, the CN would alert the surgeon that there is a potential RFO. As noted by Lahtela & Hassinen (2009), the scanner has to be sure to maintain the proper hygiene within a healthcare setting. The CN would have to ensure that they are not

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contaminating a sterile field while conducting the scan. The CN would work with the rest of the surgical team to scan the patient, ensuring that the incision site(s) are not contaminated by the scanning process; if found within the patient, the surgical team would then make sure that removal occurs prior to the completion of the surgical case. If the item(s) remain missing, the CN would contact their manager to request assistance in checking the rest of the OR suite for the missing item. The surgical team would resume their work on the patient. Vendor B represents RF Surgical Solutions. This technology is less specific than ClearCount¶s, as it utilizes passive tags; it is a detection (prevention) system rather a counting mechanism, so the data capture discussed earlier in this article would be limited. A base unit powers the reader (wand), which can be scanned over the patient to ensure that no sponges have been left behind at the end of surgery (RF Surgical, 2010); the CN would have to take the same precautions in the sterile field as described above. The wand would have the capability to be run over/across other parts of the OR suite as well if the sponge(s) were still unaccounted for. Vendor C represents SurgiCount Medical, which markets a bar coding technology. The bar code is visible on each sponge, and the sponges are bundled with a ³master tag´ to allow for large quantities to be scanned in at one time. The bar code reader is handheld, so it takes up much less space than the competing technologies (SurgiCount Medical, 2010). The expected downside is that used sponges would have to be individually manipulated to be held up to the bar code reader in subsequent counts. Conclusion The decision about what technology for surgical sponge detection is the best fit for a HSO is unique to each organization. The best clinical fit may be too costly for some

RFID IN SURGERY organizations, but the next best fit may be affordable and still provide the HSO with a better process than it had previously. If the HSO can afford it, RFID can provide them with the data needed to support many different things. RFID has the potential to provide the level of real-time inventory tracking that an OR would need to ensure that all items are always accounted for. As referenced in ³Arizona UMC succeeds with wireless asset tracking´ (2009), this type of design can be run though the

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lightweight access point protocol (LWAPP), thus easing the initial deployment as well as making the management of the system simpler and allowing it to be expanded more easily. The infrastructure needed to support RFID would also help run other new technologies that are constantly being rolled out to the ORs. The data generated from RFID tags would support a HSO¶s ABC efforts, thus providing a level of awareness on costs that allow for solid financial decision making. RFID would simplify the OR supply chain, as well as reduce overnight freight and/or occurrences of lastminute ordering of supplied. RFID would also provide: real-time personnel tracking, and eliminate that element from the CN¶s documentation process; support efforts to prevent RFOs from occurring; and, in general, increase the available time for CNs to provide direct care to patients in the OR.

RFID IN SURGERY Appendix

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Figure A1: The process for getting ready for surgery. Developed by the author from observation of practice at multiple hospitals, 1996-2010.

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Figure A2: Sterile Processing ± Decontamination process. Developed by the author from observation of practice at an Academic Medical Center, 2005-2007.

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Figure A3: Sterile Processing ± Inspection, Reassembly and Sterilization process. Developed by the author from observation of practice at an Academic Medical Center, 2005-2007.

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Figure A4: Sterile Processing ± Sterile Storage and Case Cart process. Developed by the author from observation of practice at an Academic Medical Center, 2005-2007.

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