Validation of Surgical Sponge Counts Using Technology

Transcription

1 CME ONLINE Validation of Surgical Sponge Counts Using Technology An Online Continuing Medical Education Activity Sponsored By Grant Funds Provided By

2 Welcome to Validation of Surgical Sponge Counts Using Technology (An Online Continuing Medical Education Activity) CONTINUING MEDICAL EDUCATION INSTRUCTIONS This educational activity is being offered online and may be completed at any time. Steps for Successful Course Completion: To earn continuing education credit, the participant must complete the following steps: 1. Read the overview and objectives to ensure consistency with your own learning needs and objectives. 2. Review the content of the activity, paying particular attention to those areas that reflect the objectives. 3. Complete the Test Questions and compare your responses with the answers provided. 4. For additional information on an issue or topic, consult the references. 5. To receive credit for this activity complete the evaluation and registration form. 6. A certificate of completion will be available for you to print at the conclusion. Pfiedler Enterprises will maintain a record of your continuing education credits and provide verification, if necessary, for 7 years. If you have any questions, please call: CONTACT INFORMATION: 2014 All rights reserved Pfiedler Enterprises, 2101 S. Blackhawk Street, Suite 220, Aurora, Colorado Phone: Fax:

3 INTRODUCTION Despite advances in the delivery of health care, retained surgical items (RSI) continue to occur with serious implications for patients, providers, and health care costs. Even with strict counting protocols, surgical sponges are the most common retained surgical item. A consistent finding in the limited available research literature indicates a majority of retained surgical sponges occurred where the count had been reported as correct. The fact that counts may be erroneous shows the importance of human factors in such instances that are preventable medical errors. While most facilities establish their counting protocols according to the guidelines and recommendations from the Association of perioperative Nurses (AORN), many other professional organizations including The Joint Commission, the American College of Surgeons, and Agency for Healthcare Research and Quality (AHRQ) have published standards and best practices for patient safety improvements. In addition, NoThing Left Behind policy originated in 2004 as a National Surgical Patient Project to Prevent Retained Surgical items. This comprehensive policy represents a culmination of the best, safest, rational and most reasonable set of current practices from surgeons and nurses around the country and is designed to be flexible for individual site use. Although surgeons use various methods to track sponges during operations, manual counts remain important and are still key to avoiding retained sponges. Radiography is one approach employed in cases with incorrect counts but is not a standardized approach throughout most institutions. While manual sponge counts with radiograph support are more accurate than manual counts alone, this approach is not infallible. Ideally, a system independent of human error that validates the manual count is the goal of achieving zero retained surgical sponges. Relying on counting as the primary mechanism to avoid RSIs is unreliable and new technologies are being incorporated as an adjunct to manual counting protocols. One technological approach utilizes two-dimensional (2D) bar coding designed to eliminate false correct counts. The process entails sponges or towels each labeled with a unique code and arranged in a pack with a master tag that contains all of the codes of the sponges within the pack. The bar code reader recognizes each code and will not allow for duplicate counting. Currently there is no perfect system that can count and detect sponges, instruments and sharps, however, this data-matrix or bar code system is capable of validating the manual sponge count Radio frequency detection is another technological process available today. This is a sponge detection system employing a low energy, low radio frequency beacon sewn into sponges, towels, and laps. A disposable radio frequency detection wand emits a beep when an RF signal is detected. This is an adjunct to manual counting protocols and is not capable of counting or distinguishing between types of sponges. RFID technology is similar to RF but adds identifying information to each tag. The system, which combines sponge counting, detection, and electronic records, consists of a receptacle with scanner, RFID-tagged sponges, and scanning wand. If there is a count discrepancy, the reusable wand is used to scan the patient to detect any remaining sponges. 3

4 Systems that help prevent counting errors while not disrupting work flow or increase case duration will be added to the standard of care in the near future as the focus on patient safety and procedural accuracies continue to draw more attention. OBJECTIVES Upon completion of this online continuing medical education activity, participants should be able to: 1. Discuss the guidelines and recommended practices provided by regulating agencies related to safe surgical sponge counting procedures. 2. Describe the current practices for the sponge ACCOUNTing system outlined by the NoThing Left Behind patient safety project. 3. Evaluate the problems with the current counting process. 4. Examine the advantages and disadvantages of intraoperative radiographic examinations. 5. Analyze the radiofrequency detection systems related to miscounts of sponges. 6. Discuss the RFID counting and detection technology related to the IN-count and the OUT-count process. 7. Explain how the data-matrix coded sponge system validates the manual count. 8. Identify the medicolegal aspects in terms of malpractice claims for retained surgical items. INTENDED AUDIENCE This continuing medical education activity is intended for use by surgeons who are interested in learning more about implementing technological adjuncts to validate manual surgical sponge counts when performing open surgical or minimally invasive procedures. STATEMENT OF NEED This continuing medical education activity provides an opportunity for surgeons to gain awareness of the safety hazards of surgical sponge count errors to their patients; improved results of technological adjuncts to manual surgical sponge counts; human error risks associated with manual sponge counting procedures; clinical considerations related to radiographic screening techniques; and knowledge of new technologies for counting surgical sponges that augment manual sponge counting. PROFESSIONAL PRACTICE GAPS Physicians need to understand the patient harm resulting from retained surgical items; the improved results of implementing technological adjuncts to manual sponge counts; the human error risks associated with manual surgical sponge counting; key clinical considerations related to radiographic screening techniques; and factors involved in the selection and use of new technologies for counting surgical sponges. 4

5 CONTINUING MEDICAL EDUCATION CREDIT INFORMATION Instructions This booklet is intended as an online activity. Please take the following steps to complete this activity: 1. Read the overview and objectives for this educational activity and compare them with your own learning objectives. 2. Read the booklet, paying particular attention to those areas that reflect the objectives. 3. Consult the glossary or a dictionary for definitions of unfamiliar words. 4. Complete the post-test. If some areas are unclear, review those sections of the booklet. 5. For further information, consult the References/Suggested Readings/Bibliography. CREDIT INFORMATION Accreditation This activity was planned and implemented in accordance with the Essential Areas and Policies of the Accreditation Council for Continuing Medical Education (ACCME). Pfiedler Enterprises is accredited by the Accreditation Council for Continuing Education (ACCME) to provide continuing medical education for physicians. Credit Designation Pfiedler Enterprises designates this enduring activity for a maximum of 2.0 AMA PRA Category 1 Credit(s). Physicians should claim only the credit commensurate with the extent of their participation in the activity. DISCLAIMER Pfiedler Enterprises does not endorse or promote any commercial product that may be discussed in this activity. RELEASE AND EXPIRATION DATE This continuing medical education activity was planned and provided in accordance with accreditation criteria. This material was originally produced in December, 2013 and revised in August It can no longer be used after August 2016 without being updated; therefore, this continuing education activity expires in August SUPPORT Grant funds for the development of this activity were provided by Stryker. 5

6 PLANNING COMMITTEE/AUTHORS/REVIEWERS Julia A. Kneedler, RN, MS, EdD Chief Executive Officer Pfiedler Enterprises Steven X. Cabrales, MD, FACS, CPE Chief Medical Officer/VP of Quality & Safety/Surgeon Previous: PeaceHealth St. John Medical Center Kern Singh, MD Associate Professor Department of Orthopaedic Surgery Rush University Medical Center Carol J. Wilcox, MT (ASCP), MA, BS Consultant Pfiedler Enterprises Aurora, CO Longview, WA Chicago, Illinois Aurora, CO DISCLOSURE OF RELATIONSHIPS WITH COMMERCIAL ENTITIES FOR THOSE IN A POSITION TO CONTROL CONTENT FOR THIS ACTIVITY Pfiedler Enterprises has a policy in place for identifying and resolving conflicts of interest for individuals who control content for a CME activity. Information below is provided to participants, so that a determination can be made if identified external interests or influences pose potential bias in content, recommendations or conclusions. The intent is full disclosure of those in a position to control content, with a goal of objectivity, balance and scientific rigor in the activity. For additional information regarding Pfiedler Enterprises disclosure process and our CME Advisory Committee members, visit our website at: Disclosure includes relevant financial relationships with commercial interests related to the subject matter that may be presented in this CME activity. Relevant financial relationships are those in any amount, occurring within the past 12 months that create a conflict of interest. A commercial interest is any entity producing, marketing, reselling, or distributing health care goods or services consumed by, or used on, patients. Activity Planning Committee/Authors/Reviewers: Julia A. Kneedler, RN, MS, EdD Co-owner of company that receives grant funds from commercial entities Steven X. Cabrales, MD, FACS, CPE Consultant for Patient Safety Technologies, Inc.: Education, Product Promotion Kern Singh, MD Consultant for DePuy, A Johnson & Johnson Company; Stryker, Zimmer Royalties from Pioneer; Zimmer 6

7 Carol J. Wilcox, MT (ASCP), MA, BS No conflicts of interest PRIVACY AND CONFIDENTIALITY POLICY Pfiedler Enterprises is committed to protecting your privacy and following industry best practices and regulations regarding continuing education. The information we collect is never shared for commercial purposes with any other organization. Our privacy and confidentiality policy is covered at our website, and is effective on March 27, To directly access more information on our Privacy and Confidentiality Policy, type the following URL address into your browser: In addition to this privacy statement, this Website is compliant with the guidelines for internet-based continuing education programs. The privacy policy of this website is strictly enforced. CONTACT INFORMATION If site users have any questions or suggestions regarding our privacy policy, please contact us at: Phone: Postal Address: 2101 S. Blackhawk Street, Suite 220, Aurora, CO Website URL: 7

8 Validation of Surgical Sponge Counts Using Technology INTRODUCTION Retained surgical items (RSIs) are considered a preventable error and one of the major issues at the forefront of the surgical patient safety movement. The Joint Commission categorizes RSI as a sentinel event.. The National Quality Forum considers retention of a foreign object a serious preventable event and reports that surgical items left behind during surgery are a never event since such things are never suppose to happen. The Centers for Medicare & Medicaid (CMS) includes the retention of a foreign object in its list of hospital-acquired conditions for which reimbursement will not be provided. 1 Gossypiboma is the technical term for a retained surgical sponge, pad, or towel (gossypium is Latin for cotton and piboma is Swahili for place of concealment). Incorrect sponge counts occur despite adherence to recommended standards of practice for correct counting procedures. Each year in the U.S. there are 3000 to 5000 retained surgical items (RSIs), including sponges, towels, laparotomy pads, instruments, sharps and needles, left inside patients after surgery resulting in sepsis, fistula or small bowel obstruction and visceral perforation, multi-million dollar lawsuits, and even fatal patient outcomes. The incidence of RSIs is difficult to estimate since an RSI can remain undetected for years and data relying on paid malpractice claims certainly represents an under reported number of RSIs. A 2003 study by Gawande et al 2 found the incidence of RSIs to be 1 in 8,801 to 1 in 18,760 inpatient operations per year. Two later studies estimated that RSIs occur more frequently. The author s analysis of administrative and event reporting data found that of 153,263 operations, the RSI rate was 1 in 7,000 surgeries 3. The second study involving 191,168 surgical procedures at a facility that routinely performed post operative radiographs reported the incidence of RSIs was 1 in 5, Greenberg and colleagues 5 demonstrated that a count discrepancy occurred in 1 of every 8 operations. A consistent finding in nearly all the published reports of RSIs was that the instrument and sponge counts were reported as correct prior to closure in the majority of cases. 6, 7 This data illustrates the need to evaluate the surgical environment and unintended human error. The costs of surgical never events to the health care system in the United States was described by Mehtsun et al 8. Malpractice settlements and judgments of 9,744 surgical never events including retained surgical items, wrong-site, wrong-patient, and wrong-procedure surgery totaled $1.3 billion between 1990 and Increased payments were associated with severe patient outcomes and claims involving a physician with multiple malpractice reports. The most common type of event was retention of a surgical item. The mean malpractice payment per retained surgical item for the 4,857 incidents studied was $86,247. This figure does not include associated huge legal fees, additional inpatient and disability care, lost work days, and harm to provider and hospital reputation. The annual liability settlements and other costs related to retained sponges amount to an estimated $500 million to $750 million. 8

9 The most commonly retained items are surgical sponges, which account for 72% to 88% of all objects left behind. 9, 10, 11, 12 Many factors contribute to the difficulty accounting for sponges: sponges are used in very high numbers during a case; many members of the operating team use sponges and may be inserting them into the patient s body; sponges can easily move from one place to another inside a body cavity as the result of manipulating the patient s position or organs; sponge color and size change drastically as they absorb blood and body fluids blending them into the patient s internal cavity. In addition, sponges may inadvertently be left because surgical staff changes during breaks/shifts so accurate counts are not relayed to the next team (nurses/pa s etc). In a multicenter case-match study of RSI risk factors, Stawicki et al 13 concluded that longer duration of surgery, safety variances, incorrect counts during the procedure, unexpected intraoperative events, and the patient s body mass index result in elevated RSI risk. Cima et al 14 studied the incidence and characteristics of potential and actual retained surgical items in surgical patients. Routine use of high-resolution postoperative x-rays was standard procedure during this study which disturbingly accounted for finding 59% of unexpected retained surgical items all of which had reported correct counts. One conclusion drawn by the researchers was that breakdown in communication was the most common contributing factor including failure to communicate placement of items within a body cavity to other team members and failure to communicate the purpose of the film to the radiologist. Of concern in the study was the failure of portable x-ray equipment to detect 6 of 18 retained surgical items leading the author to the belief that ideally the survey x-ray should be performed with dedicated high-resolution radiographic equipment in dedicated imaging areas. The fact that cotton sponge products are the most common RSIs and given the reliance on counting sponge products by operating room personnel, serious evaluation of new technologies to improve counting accuracy is warranted. The usefulness of radiofrequency detection, radiofrequency identification (RFID), and data-matrix coded sponge (DMS) systems are being implemented in hospitals across the country as technological adjuncts used in conjunction with standard counting practices. The DMS system has been used as a reliable technology that validates manual counts and improves patient safety. GUIDANCE FOR PREVENTION OF RSIs The manual sponge counting process has been in place for decades. Surgeons and operating teams routinely rely on the practice of a sponge count to reduce the risk of a retained surgical sponge that cause serious patient harm including the potential for another surgical procedure to remove the sponge and exposure to more anesthesia. In an effort to reduce the incidence of retained sponges and instruments and in concert with national patient safety initiatives, several professional organizations have issued recommendations and guidance on the prevention of retained items after surgery. The term retained surgical items is now more common than retained foreign objects to differentiate them from foreign objects that are not surgically related such as bullets, shrapnel, swallowed pennies, pins and other objects. 9

10 American College of Surgeons (ACS) The ACS is a professional association of surgeons dedicated to improving the quality of care for the surgical patient by setting high standards for surgical education and practice. In support of ACS patient safety priorities, they strongly urge individual hospitals and healthcare organizations to take all reasonable measures to prevent the retention of foreign bodies in the surgical wound. The ACS Statement on the Prevention of Retained Foreign Bodies after Surgery provides guidelines that may be adapted to a variety of practice settings including ambulatory surgery, traditional operating rooms, surgeons offices, or other areas where invasive and operative procedures are performed. 15 The ACS guidelines to minimize the risk of retained foreign objects are summarized as follows: Consistent application of a standardized counting process. Performance of a methodical exploration before closing of the surgical site Use of x-ray detectable items in the surgical wound Maintenance of an OR environment optimal for focused performance Clear communication Careful documentation Use of x-ray or other electronic devices as needed Documentation should include, but not be limited to: results of surgical item counts, notification of the surgical team members, instruments or items intentionally left as packing, and actions taken if count discrepancies occur. Surgical facilities must provide resources to ensure that necessary equipment and personnel are available to support these perioperative surgical safety measures. Policies and procedures for the prevention of retained foreign bodies should be developed, reviewed periodically, revised as necessary, and available in the practice setting. Agency for Healthcare Research and Quality (AHRQ) Patient Safety Indicator Specifications The AHRQ provides a detailed description, which is briefly presented below, of evidencebased best practices derived from professional association guidelines, research literature, and experience lessons learned from hospitals work on previous AHRQ Quality Indicator implementation efforts

11 Recommended Practice Counts at appropriate points during surgery Appropriate staff education Team collaboration Use of equipment and instruments Standardized practices Details of Recommended Practice Perform a sponge, sharp, and instrument count when instruments/ sponges are opened, as surgery begins, as closure begins, and during subcuticular or skin closure in the same sequence Create an education model that promotes development of knowledge and research for perioperative staff consistent with national criteria. 25 Promote and maintain a collaborative and ethical work environment that facilitates trust and confidence to allow all members of the interdisciplinary team the opportunity speaks up if patient safety is compromised Integrate new instruments or equipment into practice that prevents retention of foreign bodies, including incorporating modern technology as a safety practice Integrate use of innovative surgical techniques, radiographic technology, and standardized practices and protocols for all procedures The Joint Commission (JC) and National Quality Forum (NQF) The Joint Commission is committed to improve health care for the public by evaluating and inspiring health care organizations to provide the safe and effective care of the highest quality and value. The Joint Commission categorizes RSI as a sentinel event that requires defect analysis. 37 In 1996, the Joint Commission implemented a Sentinel Event Policy designed to help health care organizations identify sentinel events and take action to prevent their recurrence. When a sentinel event occurs, the health care organization is required to complete a root cause analysis, make improvements to reduce risk, and monitor the effectiveness of those improvements. The root cause analysis is expected to include examination of the organizations systems and processes that can be altered to reduce the likelihood of a sentinel event recurrence and to protect patients from harm when a sentinel event does occur. Sentinel Event Alert 38 (2013) The Joint Commission published a Sentinel Event Alert on October 17, 2013 for Preventing unintended retained foreign objects (URFOs). According to the sentinel event data reported to The Joint Commission, the most common root causes of URFOs are: Lack of policies and procedures Noncompliance with existing policies and procedures Problems with hierarchy and intimidation of surgical staff Failure with physician communication Failure of staff to communicate relevant patient information Inadequate of incomplete education of staff Potential strategies for improvement include consistent adherence to available guidelines, processes, and tools that improve multi-stakeholder perioperative processes, 11

12 enhance team communication, and the use of assistive technology. Continuous education and training of appropriate staff on new and existing policies and procedures to prevent URFOs should be provided. The Sentinel Event Alert further elaborates on: Effective processes and procedures Develop a highly reliable and standardized counting system using a multidisciplinary approach (involving all surgical team specialists) with support from organizational leaders Use published resources, including but not limited to, The Joint Commission, American College of Surgeons, AORN, NoThing Left Behind to guide the development and implementation of effective evidence-based organizationwide standardized policy and procedures that promote consistency in practice. The policy should address all invasive procedures and include the following: DDA counting procedure DDWound opening and closing procedures DDIntraoperative radiographs Effective communication Promote open communication and reduce hierarchical barriers among surgical team members through briefings and debriefings as a standard part of surgical procedures. Ensure verbal verification of the results of the counting procedure by the surgeon. Appropriate documentation Document the results of counts of all surgical items or items intentionally left inside a patient and the actions taken if count discrepancies occur. Safe technology Explore the use of assistive technology to supplement manual counting procedures and methodical wound exploration including bar-coding, radiofrequency (RF) tags to detect soft goods, and radio frequency identification systems (RFID). Related Joint Commission requirements Compliance with response to sentinel events as part of a patient safety program according to standards and elements of performance (EP) for hospitals, ambulatory and office-based surgery facilities. 12

13 The Joint Commission works with the National Quality Forum (NQF) to create consensus around nationally agreed-upon measures for quality and safety. The NQF has identified a list of serious reportable events 39 which includes RSI on the list and is one of the Center for Medicare & Medicaid Services never events, one of the hospital-acquired conditions that is preventable. 40 In 2011, NQF updated the definition of when surgery ends. The June 2009 Advisory defined when surgery ends as after counts have concluded, the surgical incision has been closed, and/or operative devices such as probes have been removed, regardless of the setting. 41 The definition for the end of surgery was revised to after all incisions or procedural access routes have been closed in their entirety, and, if relevant, final surgical counts confirming accuracy of counts and resolving any discrepancies have concluded and the patient has been taken from the operating/ procedure room. 42 This revised definition has implications for the perioperative team because it encourages OR staff to take measures to prevent RSIs after the incision is closed while the patient is still under anesthesia and in the OR. AAOS Information Statement According to the unified information statement on orthopedic surgical safety, orthopaedic surgeons and organizations recognize the national safety goals of the JC, National Quality Forum (NQF) and Agency for Healthcare Research and Quality (AHRQ) designed to minimize preventable harms and improve surgical outcomes. 43 The Institute of Medicine (IOM) As one of its six goals to improve healthcare systems, the Institute of Medicine includes prevention of RSI in the goal for preventing injuries resulting from care. The IOM supports the latest AORN standards and recommendations stating Healthcare organizations are responsible for employing standardized, transparent, verifiable, reliable practices to account for all surgical items used during a procedure to lessen the potential for patient harm as a result of retention. 44 The Council on Surgical and Perioperative Safety s (CSPS) Safe Principle 6 The CSPS endorses standardized processes of care to prevent the retention of foreign bodies during surgery. 45 The specific standardized processes referenced by the CSPS include: the American College of Surgeons statement on the Prevention of Retained Foreign Bodies after Surgery; Veteran s Health Administration (VHA) directive on Prevention of Retained Surgical Items; Institute for Clinical Systems Improvements (ICSI): Health Care Protocol: Retention of Unintentionally Retained Foreign Objects in Surgery; Association of Surgical Technologists (AST) Recommended Standard of Practice for Counts; Association of perioperative Registered Nurses (AORN) Recommended Practices for Prevention of Retained Surgical Items. The Veterans Health Administration (VHA) According to the VHA Directive , the Chief of Surgery is responsible for ensuring that the surgical team performing an operative procedure in which there is any possibility for retention of a surgical item adheres to the VHA directive standards. The VHA directive policies for standardization of processes include: 46 Sponges. All surgical sponges placed in the surgical field must be in their original configuration and must not be cut or used for dressings. 13

14 Radiopaque Surgical Items. Non-radiopaque surgical items used in the OR, such as IV line insertion sponges, must be disposed of in separate, designated waste receptacles and never mixed with counted surgical items. Methodical Wound Exploration. The surgeon must visually and manually conduct a methodical exploration of the operative field to remove all surgical items from the body cavity. This wound exploration must be performed before closing the surgical wound. Count of Surgical Items. All surgical items must be counted in every case and must occur: Before the procedure has begun to establish a baseline count; Before the closure of a cavity within a cavity (uterus); Before wound closure begins; At skin closure or end of procedure; and At the time of permanent relief of either scrub person or circulating nurse Use of Intraoperative Radiograph. An intraoperative radiograph of the surgical field is not required if a methodical wound exploration is performed and there is a correct count of surgical items at the completion of the procedure. However, a radiograph of the entire surgical field must be performed and interpreted by a physician at the completion of a surgical procedure, prior to the patient s transfer from the OR. A radiograph is required under the following circumstances: When there is an incorrect count and the surgical item in question is not recovered; (a radiologist must interpret the radiograph and provide verbal or written communication to the surgical team when the item in question is not found. The radiologists report must be available to the surgical team in a timely fashion recommended to be less than 30 minutes.) When the surgeon, scrub technician or nurse, and circulating nurse unanimously agree the number of surgical instruments used prohibits an expeditious and timely count. When the clinical condition of the patient requires emergency care to the extent the counting processes may not be in the best interest of the patient. Any time a member of the surgical team expresses concern about the accuracy of the count process, even though the methodical wound exploration has been performed and the surgical item count is correct. In addition to implementing standardized procedures and adherence to strict counting procedures (manual and adjunct), multidisciplinary teamwork and communication, documentation, policy and procedure development, and measures for investigation of count discrepancies should be considered. 14

15 Institute for Clinical Systems Improvement (ICSI) The Institute for Clinical Systems Improvement (ICSI) promotes the use of evidence-based practices using clinicians to review current scientific literature and develop evidence-based guidelines and policies on numerous health conditions. The number of unintentional retained surgical sponges following vaginal deliveries prompted ICSI to establish guidelines for retained foreign objects after vaginal deliveries. Clinical highlights include: Counting of sponges/soft goods, sharps and miscellaneous items for vaginal deliveries. Only sponges/soft goods with radiopaque markers will be present on the delivery field. Establishing accurate count processes for the baseline and final counts are critical during vaginal deliveries. If the baseline count is not accurately performed before using countable items, all subsequent counts should be considered compromised. Radiographs should be obtained for compromised and unreconciled counts to ensure that a foreign object has not been unintentionally retained. Good communication is necessary before and during the procedure, when staff changes and/or at handoffs. The Association of perioperative Registered Nurses (AORN) Most facilities have probably modeled their policies on AORN guidelines. 47 AORN has recently revised and updated the Recommended Practice: Prevention of Retained Surgical Items. 48 AORN provides a number of specific recommendations for the surgical sponge count. In addition to sponge count practices for open surgical procedures, AORN recommends counts should be performed during minimally invasive procedures such as laparoscopy and thoracoscopy. The following are best practices related to how to count: Separate sponges completely for initial count and all counts. Two perioperative team members should view and count the sponges concurrently. Every count should performed using the same logical standardized sequence. The surgeon should announce closure and perform a methodical wound exploration before surgical site closure. There should be no distractions, interruptions or staff changes during the count process. Use only radiopaque soft goods in the wound, including towels. Adjunct technologies may be used to supplement manual count procedures. (Bar code, radio-frequency, and RFID technology will be explored later in the course.) No sponges, needles or instruments should be removed from the OR before wound closure is complete. 15

16 AORN recommended best practices for count discrepancies include: The RN circulator has the ethical responsibility to notify the perioperative team of the number and type of item discrepancy. Once notified the surgeon and team members should acknowledge the discrepancy notice verbally. All sterile and non-sterile team members should initiate a search of the surgery area and that surrounding the sterile area for the missing item. Wound closure should be suspended until the discrepancy is resolved, if the patient can safely tolerate the closure delay. If the item is not found, a radiograph will be ordered. Effective communication with the x-ray technician and radiologist should include the item they are looking for and the location in the body they will image. The radiograph results should be by direct report in a timely manner with read-back verbal confirmation. Radiographs may be waived in cases where the patient is unstable (or if a small needle would not be visible radiographically). Repeat and verify the count. AORN recommends that documentation should include results of the surgical item count, notification of the team members, any surgical items intentionally left in the patient, and actions taken if a count discrepancy occurred. NoThing Left Behind : Prevention of Retained Surgical Items Multistakeholder Policy 49 No Thing Left Behind is a National Surgical Patient Safety Project to Prevent Retained Surgical Items that originated by a practicing surgeon in 2004.The No Thing Left Behind : Prevention of Retained Surgical Items Multistakeholder Policy represents the best and safest set of current practices that every hospital operating room, ambulatory surgery center, labor and delivery room and procedural area can adopt to make it safer for patients that receive care in their facilities. Within the 50 page NoThing Left Behind Policy there are a number of safety rules clearly presented for nurses and surgical technologists, surgeons, radiologists and radiology technologists, and anesthesiologists. The sponge accounting practices and surgeon procedures from the policy will be discussed now in more detail. 16

17 The general rules of sponge management include: Use only clear plastic bags to line kick buckets and sponge receptacles. Bloody sponges in red biohazard bags are difficult to see as are unused sponges in white bags. All surgical sponges or radiopaque towels placed in the patient should be white cotton gauze disposables. These disposables may contain a separate identifiable label or tag. Surgical sponges may not be altered or cut for use. The number of different types of sponges used during a procedure should be minimized. Small sponges should be passed to the surgical field on an instrument. Accounting for small surgical sponges should be done according to a standardized practice. A sponge unattached to an instrument that is passed between the surgical technologist and the surgeon is considered a free surgical sponge. These sponges include, but are not limited to; 4 x 4 s, 4 x 8 s, lap pads, mini laps or baby laps. Free surgical sponges should be managed using an accounting system consisting of plastic hanging blue-backed sponge holders and a wall mounted dry-erase board. Surgical sponges should not be used as dressings. This practice can cause incorrect final sponge counts and may be mistaken as sponges within the wound on x-ray. Vaginal packs and gauze dressings should remain unopened on the back table until needed. These sponges may get mixed with the surgical sponges and invalidate the count. The No Thing Left Behind Policy identifies the procedures and safety rules for surgeons as follows: Determination of an extreme emergency condition: The surgeon must consult with the anesthesia personnel when determining a case is an extreme emergency condition. The emergency determination must be verbally declared. Standard counting practices may be aborted under emergency circumstances. X-rays of the operative site must be ordered by the surgeon and reviewed by the radiologist as soon as possible after completion of the surgery to ensure there are no retained surgical items. Performance of a methodical wound examination: Prior to closure in every operation or if informed of a missing item, the surgeon must perform a methodical exploration of the operative wound. 17

18 The space to be closed must be carefully examined using two sensory modalities (seeing and touching) whenever possible with special attention given to closure of a cavity within a cavity (i.e. heart, major vessel, stomach, bladder, uterus, and vagina). The surgeon must make every effort to make sure no unintended items have been left in body cavities. The general process is to look and feel in the recesses of the wound and examine under fatty protuberances and soft tissue appendages. In cases of abdomen and pelvis surgery, unless clinically contraindicated, all four quadrants of the abdomen should be explored. In chest and mediastinal procedures specific spaces and cavities should be examined: Mediastinal procedures examine the ipsilateral pleural cavity Cardiac procedures examine the retrocardiac space and transverse sinus to the left and right of the aorta and pulmonary artery Thoracic procedures examine the thoracic cavity, and more specifically the thoracic apex and base of the lungs, paravertebral sulcus, and inferior recesses of the diaphragm. Palpate from apex to base with a hand or finger behind the lung Actions to reconcile an incorrect count: The surgeon should stop closing the wound and repeat the methodical wound examination when informed of a missing object. The circulating nurse must tell the surgeon what specific item is missing. If a radiopaque item is not found, an x-ray must be obtained. The wound should be covered with a sterile non-opaque towel and the radiologist should be told specifically what item is missing. Obtain both AP and oblique views. The surgeon should wait for the radiologist results before completely closing the wound. If the item is not found, the incorrect final count will be documented in the medical record by the circulating nurse and an Incorrect Count Report completed. Notify administration, risk manager, and disclose the missing item to the patient. Clinical decision to leave a surgical item in the patient When there is an incorrect final count of a radiopaque item, the surgeon makes the clinical decision whether a radiopaque item will or can be removed. 18

19 Documentation of the decision to leave a surgical item in the patient must be included in the medical record and an Incorrect Final Count Report must be completed. Operative Report Dictation: It is a recommended practice for the surgeon to include the status of the final surgical counts and any actions taken to prevent the retained item in the operative dictation of the case. 19

20 COMMON SPONGES COUNTED Every medical specialty has specific surgical sponges that best accommodate the amount of blood and body fluids to absorb and the size of the wound for surgical procedures the clinicians perform. Table 1 is a brief comparison of the common sponges counted and the general use for each sponge type. 50, 51 Table 1 Type/Class of Sponge Detection Count Sequence Uses Radiopaque sponges Non-radiopaque sponges Detectable on x-ray Not detectable on x-ray Varies by type Not part of IN/OUT manual sponge count Used inside the body; NOT used as dressing sponge Used outside the body (i.e. in the eye) Radiopaque 4 in x 4 in/4 in x 8 in Detectable on x-ray Count by tens Used to absorb blood and body fluids in small wounds; Not used in peritoneum Laparotomy sponges Detectable on x-ray Counted by fives Used to absorb blood and body in large wounds; Used to keep viscera moist and out of the way (packing); Used for padding under retractors; retractors; Used in peritoneum Stick sponges Detectable on x-ray Counted by fives and tens; Made by folding 4 x 8 sponge and grasping with sponge forceps Always used on sponge forceps Uses: blunt dissections; blot or retract deep Kitners/kitner dissectors/ peanut/ pusher Detectable on x-ray Counted by fives Always clamped in some forceps for use Use: blunt dissection or blotting Cottonoids/ patties/ neuropledgets Come in a variety of sizes, usually with an X-ray detectable string Counted by tens Used to blot and protect delicate tissue, especially in neurosurgery (brain and spinal cord Tonsil sponges Detectable on x-ray Counted by fives Three sizes: small, medium, and large; Used on a forcep for tonsillectomy 20

21 52, 53, 54 CURRENT SPONGE COUNTING PRACTICES When to Count: An IN count of surgical sponges must occur: 1. Before the procedure begins to establish a baseline count. This IN count can detect packaging errors and provides information about the number of items that will be used during the case. When possible, this IN count will be performed before the patient enters the OR. An OUT count of surgical sponges must occur: 1. Before the closure of a cavity within a cavity This OUT count is a CAVITY count for cases involving an open cavity such as the uterus, bladder, stomach, or peritoneum. 2. Before wound closure begins This OUT count is a CLOSURE count when closure of fascia is initiated or layer before subcutaneous closure. 3. At the time of permanent relief of either the scrub person, surgical technologist, or the circulating nurse This OUT count is a RELIEF count conducted at the time of a personnel change. 4. When any OR team member requests a count This OUT count is an ANYTIME count performed at the discretion of any OR team member who needs to verify the count. 5. At subcuticular or skin closure or end of the procedure This OUT count is the FINAL count performed when sponges are no longer in use and are all removed from the field. The final count can only be recorded as CORRECT or INCORRECT. How to Count: Sponge counts should be performed in the same sequence each time and the sequence should be defined in the health care facility policy. A typical sequence for OUT counts should be conducted in the following order: 1. Surgical site 2. Sterile field 3. Mayo stand 4. Back table 5. Kick buckets or containers holding discarded sponges 6. Holders or counter boxes 7. Safe repository where dropped or contaminated items are placed 21

22 According to the NoThing Left Behind Policy, all the sponges collected throughout the case should be put in hanging blue-backed plastic sponge holders; one sponge in each pocket of a holder that can hold 10 sponges. Both used and unused sponges must be in the sponge holders at the end of the case in order to perform the final count. This ensures visual verification of the free surgical sponges used in a procedure. In addition, the policy employs a permanently mounted dry erase board in each OR where the counts for all surgical items are visible to personnel in the room. The procedure for counting sponges should include the following guidelines: Initial count and all counts require separation of the sponges to confirm all sponges are separated and not sticking together, and the correct number of sponges are packaged by the manufacturer. All sponges used during the procedure must be radiopaque to facilitate detection by x-ray in the case of a retained sponge. Radiopaque surgical sponges and soft goods should not be cut or altered in any way or used for dressing. The binding strips of packages should only be broken when the sponges are to be counted. Two nurses are required for each count: the circulating nurse and the scrub person will count out loud and concurrently view the sponges being counted. Counts should be performed according to the logical sequence defined in the health care facility policy. Allow sufficient time for the standardized method counts. Before closure of the surgical site, the surgeon should announce closure and perform a methodical wound exploration for any RSIs. No staff changes, interruptions, or distractions should occur during the counting process. No sponges should be removed from the operating room before completion of the procedure. No trash receptacle should be removed from the operating room before the completion of the procedure. Adjunct technologies may be used to supplement the manual count procedures. It is apparent that relying solely on human counting ability and visual detection inherently leaves the process open to a wide degree of human error. Count Discrepancies A MISCOUNT is when there is a discrepancy in one of the OUT counts and then the discrepancy is reconciled. An RSI is 100 times more likely to occur when a miscount is present

23 For a CORRECT FINAL COUNT there is a team verification that the number of sponges documented on the dry erase board agrees with the number of sponges in the sponge holders. Regardless of the equipment and systems in use, a CORRECT COUNT means the IN count of all sponges (used and unused) agrees with the OUT count of all sponges (used and unused). When an INCORRECT FINAL COUNT occurs, the number of sponges in the sponge holder does not agree with the number on the dry erase board. There is either one or more missing sponge or one or more extra sponges. Again, regardless of the equipment and system in use, the IN count of all sponges does not agree with the OUT count of all sponges used or unused during the surgical procedure. Immediately upon noting a count discrepancy, the RN circulator has the ethical responsibility to notify the perioperative team. The surgeon and team members should verbally acknowledge the notice and take action to methodically inspect the sterile and unsterile areas to locate the missing sponge(s) or other surgical item(s). As previously discussed, if the patient can tolerate delayed wound closure, the surgeon should suspend closure until the discrepancy is resolved. As stated in the guidance policies above, if the item is not found, a radiograph will be ordered and the radiology team should be given a clear understanding of what they are looking for. The radiologist on duty should directly call the OR in a timely manner with the results of the film review and the report should include a read back verbal confirmation. The findings must be documented in the operative record. Repeat and verify the count. Policies, Procedures, and Documentation The availability of clear policies and procedures for the staff to follow reduces the chance for individual interpretation and increases patient safety. Every health care facility must develop policies and procedures for the prevention of RSIs. The policy should be periodically reviewed and revised to reflect current evidence-based best practices. Policies and documentation should include: For reporting purposes, the policy should define the end of the surgical procedure as it relates to the specific state definition. The definition can vary from state-tostate. Documentation should include: Count results Intentionally retained items Actions taken to resolve count discrepancies Surgical count competency with the variety of count practices should be validated as part of orientation for new OR team members, annually and after process revisions. 23

24 Quality audits should be conducted to validate compliance with best-practice policies. Additional RSI Reduction Strategies Multidisciplinary approaches to the prevention of RSIs involve all members of the perioperative team during all surgical and invasive procedures. AORN-recommended practices emphasize that the responsibility for preventing RSIs and the legal responsibility for RSIs is shared among the registered nurse circulator, scrub nurse, surgeon, anesthesia professionals, and others assisting in the procedure. 56 Teamwork and the strategies below are additional strategies to preventing RSIs. Collaboration with all members of the surgical team in the development of effective policies, procedures, and tools related to the counting processes along with team member commitment to preventing RSIs is critical. 57 Buy-in by all team members, surgeons, and collaboration with anesthesia is essential to effective RSI reduction strategies. Use of a dry-erase whiteboard to document to document the number and types of sponges (and other surgical items) allows all personnel in the OR to see the count. This strategy is recommended (as previously mentioned) by the NoThing Left Behind Policy. 58 Use of pocketed sponge bags to place sponges to be counted allowing for visibility and separation of each sponge. 59 This strategy is also recommended (as previously mentioned) by the NoThing Left Behind Policy. Use of a standardized documentation count sheet to prevent reliance on memory alone for counts. Implementation of a time out or surgical pause for counting. 60 Use of assistive technology that can validate the manual count(s); detect RF tagged sponges; or count and detect RFID tagged sponges. Problems with current sponge counting practices The current sponge counting practices have proven unacceptably inaccurate. A vast majority of retained sponge cases occur in the presence of falsely correct counts. Cima et al 61 conducted a review of the incidence and characteristics of retained items over a period of four years ( ) at the Mayo Clinic. Of 191,168 operations performed, there were 34 actual retained foreign objects (now referred to as retained surgical items) for a defect rate of approximately 1:5,500 operations. In the 34 cases with retained objects, there were 23 sponges, 7 miscellaneous items, 3 needles and 1 instrument as represented in Figure 1. The 34 retained objects occurred in incidents where the count had been reported as correct in 21 patients (62%). 24

25 Figure 1: RSIs (Adapted from Cima et al. J Am Coll Surg. 2008; 207:80-87.) Needles 9% Instrument 3% Other 21% Sponges 67% Sponge count discrepancies can be attributed to human factors, communication failures, and the OR environment. Humans make mistakes exacerbated by distractions, fatigue, time pressures, lack of sufficient personnel, and communication failures. The different cultures in the OR can result in communication failure. One cross cultural example between individuals in the OR team is the nurse to surgeon relationship. Each has specific roles, expertise and skills with opinions that may conflict and contribute to communication failures that influence human performance. The OR environment can impact the counting process such as interruptions, equipment noise, conversations, and OR traffic can all distract those involved in the counting process. Transfer of responsibilities between staff during breaks or shift changes can cause distractions that interfere with transfer of information between team members. Communication breakdowns, lack of information transfer, work load and competing tasks pose threats to sponge counting and patient safety in the operating room. RADIOGRAPHIC SCREENING While consideration of human factors that may affect the count and adherence to standardized procedures are important ways to reduce the risk of retained surgical items, most guidance documents also recommend the use of radiographic screening as a risk reduction strategy. Some institutions conduct surveillance using routine postoperative screening radiographs and others selectively include radiographic screening at the end of cases involving incorrect counts, an emergent procedure, and unexpected change in procedure, or in cases with high patient body mass index. One deterrent to using x-rays in all cases is the fact that they are time consuming and costly. Devgan et al 62 calculated the net cost of intraoperative screening as $ per patient or approximately $11.5 million for routine radiographic screening for all surgical patients. Another concern is 25