VantagePoint. - patient selection - patient identification - informed consent - anesthesia safety - equipment readiness - site/procedure validation

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VantagePoint

®

2011

VP

Even the most common surgeries present significant risk exposure and require scrupulous attention to every detail. the following process stages are especially susceptible to error and must be managed in a consistent, methodical and team-oriented manner:

Audit Tool for Measuring Compliance with the Universal Surgery Safety Protocol…6 Resources…8 issue 2

Surgical Safety:

Twelve Strategies to Reduce Error and Complication Rates

this edition of Vantage Point®_{is designed to help surgical teams focus on critical areas, evaluate current safety practices and introduce}

necessary enhancements. By implementing simple protocols designed to improve communication and documentation during all phases of surgical care, healthcare organizations can protect patients and reduce exposure to liability claims associated with life-threatening injuries, delayed recovery times, and unnecessary pain and suffering.

PRe-PROCeDuRe DuRing PROCeDuRe POst-PROCeDuRe

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patient selection

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patient identification

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informed consent

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anesthesia safety

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equipment readiness

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site/procedure validation

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team interaction

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body positioning

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equipment sterility

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incision technique

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surgical counts

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oxygenation/airway management

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hemodyamic monitoring

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thermal control

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handoff communication

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clotting prophylaxis

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infection control

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protocol compliance

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discharge readiness

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1. institute a wROng PeRsOn/ PROCeDuRe/site PROtOCOl.

the Joint Commission’s “Universal Protocol for Preventing Wrong Site, Wrong Procedure, Wrong Person Surgery” requires the sur-gical team to implement essential safety initiatives – including patient identification and site marking – at key junctures, from when the decision is made to operate through all preparatory and sur-gical activities.1

initially designed for operating room (oR) use, the Universal Pro- tocol is becoming common practice wherever invasive procedures are performed, including endoscopy suites, interventional radiol-ogy settings, catheterization laboratories, emergency departments, and intensive care and special procedure units. implementation of the protocol varies somewhat by setting. However, in any clinical environment, verification of correct person, procedure and site should occur

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when the procedure is first scheduled at the facility

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at the time of admission or entry into the oR, clinical unit or procedure suite

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while the patient is awake and fully coherent, if possible

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whenever the patient is transferred to another caregiver or location

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before the patient leaves the pre-operative area and enters the surgical room

By adopting an easy-to-follow safety checklist, surgical teams can help ensure that problems in the pre-operative stage are identified and resolved. For a sample surgical safety checklist and implementation strategies, visit the World Health organization Web site at http://www.who.int/patientsafety/safesurgery/en/.

1 For more on the Universal Protocol, visit http://www.jointcommission.org/facts_about_the_universal_ protocol/; for information about recent revisions, see http://www.jointcommission.org/assets/1/18/

2. enhanCe anD exPanD infORmeD COnsent DOCumentatiOn.

A careful, detailed and unambiguous informed consent process helps protect the patient, surgeon and organization. Prior to the procedure, verify that all relevant facts have been made known to the patient and documented in the record. Consent documen-tation should include

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traditional patient identifiers, such as full name, record number and mandatory signatures

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name and description of the surgery or procedure,

with correct site/side, level and digit noted, as necessary

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fully spelled out words, with abbreviations used only for spinal level designations (i.e., C for cervical, t for thoracic and L for lumbar)

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notation of specific implant to be inserted or device to be removed, if applicable

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donor site and harvest information (if applicable), such as source of harvest, retrieval date and recipient data if a signed consent form is found incomplete, altered, illegible, or outdated and no longer considered valid, it should be re-executed and signed by all relevant parties before surgery commences. to prevent documentation discrepancies, carefully review consent forms before obtaining the patient’s signature.

By adopting an easy-to-follow

safety checklist, surgical teams

can help ensure that problems

in the pre-operative stage are

identified and resolved.

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3. CleaRly maRk suRgiCal sites.

the intended incision or insertion site always should be marked clearly and checked against the patient record. inconsistent or ambiguous markings can lead to confusion among surgical staff, potentially resulting in operations on the wrong site.

Basic safety requirements include using an FDA-approved marker, ascertaining the visibility of marks after draping, and requesting that the patient and/or family members confirm the correct site. Staff should refrain from marking non-operative sites and employ- ing adhesive site markers as the sole indicator.

the following additional guidelines promote accurate and thorough surgical marking:

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The surgeon/physician of record preferably completes the marking, with others participating only as permitted by state regulation.

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All marks are legible and unambiguous, and include three initials of the physician/surgeon.

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Special precautions are taken for potentially confusing procedures, including those that involve laterality, paired organs, multiple structures or multiple levels.

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Hands and feet are clearly marked, including the surface of the digit on which the surgical procedure will be per-formed (i.e., anterior, posterior or both).

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In orthopedic cases, the site is marked immediately after the cast or splint is removed.

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When the site is not visually identifiable (such as a vertebra in spinal surgery), the surgeon/physician confirms the exact level/site by checking an intra-operative image with secure markers indicating scale and/or orientation.

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Whenever more than one surgeon is operating, all relevant surgical sites are marked prior to the first procedure.

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If a patient refuses marking, or where marking may cause a permanent tattoo, a special-purpose wristband may be used containing the patient’s full name, a second identifier, the anatomical site and the name of the procedure.

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Surgical sites remain unmarked only in a limited number of situations – e.g., single-organ procedures such as hysterec- tomy or appendectomy, spinal blocks for pain management involving fluoroscopy, incisions through a midline orifice, and cardiac catheterization or other interventional cases where the insertion site is not predetermined.

For additional information and resources supporting correct-site surgery initiatives, visit the Web site of the Association of

peri-operative Registered nurses (AoRn) at http://www.aorn.org/

PracticeResources/ToolKits/CorrectSiteSurgeryToolKit.

4. COnDuCt anD DOCument a thOROugh anesthesia safety CheCk.

Anesthesiologists and certified registered nurse anesthetists should conduct an anesthesia checkout procedure to confirm patient readiness. Such a safety check can help prevent nerve damage, cardiac and respiratory arrest, overdosing of inhalation agents and other serious injuries. A pre-anesthesia checkout pro-cedure should verify that

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patient suction is available and adequate to clear an airway

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required monitors are on and alarms properly set

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vaporizers are adequately filled and filler ports are tightly closed, if applicable

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the carbon dioxide absorption system is functioning and absorbent is not exhausted

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the breathing system pressure is confirmed and leak testing completed

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gas flow is present through the breathing circuit during both inspiration and exhalation

For additional recommendations and a series of checklists, visit the Web site of the American Society of Anesthesiologists at

http://www.asahq.org/For-Members/Practice-Management/ Practice-Parameters/2008-Sample-ASA-Recommendations-for-PreAnesthesia-Checkout-Procedures.aspx.

5. keeP suRgiCal teams intaCt.

to the extent possible, surgical team composition should remain stable. Familiarity strengthens team cohesiveness and communi-cation, which in turn promotes consistency of approach and over- all efficiency. Whenever new team members are present, time should be set aside prior to the procedure for all participants to introduce themselves.

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7. halt the PROCeDuRe in the eVent Of any inCOnsistenCies.

if a time-out reveals data discrepancies or disagreement among team members, surgery should be suspended and no instruments or equipment offered until the issue is resolved – provided the delay does not compromise the patient’s safety or result in clinical deterioration. the measures taken to address apparent inconsis-tencies or interpersonal conflicts should be documented in the patient care record before proceeding.

8. aDheRe tO eViDenCe-baseD infeCtiOn COntROl guiDelines.

Surgical site infections (SSis) are a leading cause of illness in post-operative patients and a major source of professional liability claims. nearly a decade ago, the Centers for Disease Control and Prevention (CDC) promulgated recommendations for the prevention of SSis due to procedural lapses, such as failure to confirm instrument sterility, inappropriate antibiotic administration and substandard disinfection practices.

infection control procedures should be regularly reviewed to ensure continuing compliance with these recommendations. A summary of the CDC guidelines is available at http://www.facs.org/ about/committees/cpc/ssiguide0700.pdf.

9. Remain aleRt tO POssible eRRORs in suRgiCal COunts.

Although infrequent, instances of retained foreign objects still occur, especially when additional surgical instruments or pads are placed on the field and not recorded. Risk factors for inaccurate counts include surgeries involving multiple openings or stages, patient obesity, emergency procedures and poor visualization of the surgical site. in all cases, surgical teams must remain vigilant regarding the number of items placed on the field. Additionally, teams need to carefully document any item intentionally left within a cavity and, if necessary, the rationale for not performing a count. Counts should be witnessed and verified by the team as a whole – never by one staff member acting alone – and carefully docu-mented in the patient care record. organizational policy should mandate the taking of X-rays following an incorrect or disputed sponge or instrument count, even if the surgeon or physician ad- vises against it.

6. imPOse manDatORy time-Outs.

Active communication among surgeons/physicians, scrubbed staff, anesthesia providers and nurses is necessary to minimize confu-sion regarding consent, surgical site marking, site verification, and the availability of equipment and supplies. Scheduling a time-out immediately prior to the start of a procedure enhances safety awareness and affords the surgical team the opportunity to con-firm correctness of

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patient identity, using full name and record number

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procedure to be performed and patient position

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site and side, if applicable

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implants and availability of specialized equipment

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patient wristband, which should be consistent with information on patient care record

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radiological images, in terms of both patient identity and anatomical orientation

note when and why time-outs occur on the surgical/procedure record, and include the names of the team members who partici-pate in them.

the following additional measures may further enhance safety and minimize the potential for miscommunication within the surgical unit:

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Discuss basic safety measures and fire prevention and response protocols prior to commencing the procedure. (See CnA HealthPro AlertBulletin®_{2010 – issue 1, “Surgical}

Flash Fires: Enhanced Awareness Helps Extinguish Risk,” available at www.cna.com.)

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Signal agreement with each instruction by a brief spoken acknowledgement or affirmative gesture.

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Take a time-out at moments of transition, e.g., whenever a new surgeon or physician assumes primary responsibility for the procedure.

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Reconfirm patient identity and site markings whenever the operative site is re-draped.

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Maintain a calm, quiet atmosphere in the operating room or procedure suite, as distractions and interruptions can lead to omissions, mistakes or misunderstandings at a critical moment.

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Recent improvements in clinical practice – including a broader, multidisciplinary approach to counts, as well as the use of radio frequency identification, bar coding and other technological inno- vations – can significantly reduce the risk of erroneous surgical

counts. Visit the AoRn Web site (http://www.aorn.org/News/

August2010News/RSI/) for information about the updated “Recommended Practices for Prevention of Retained Surgical items,” which is available as an electronic document.

10. fOCus On hanDOff COmmuniCatiOn.

Standardized handoff protocols facilitate the accurate transmis-sion of information about a patient’s care and condition whenever personnel changes occur. Consistent use of a set, shared format – such as I-SBAR (Introduction, Situation, Background, Assessment,

Recommendation) or PACE (Patient/Problem, Assessment/Actions,

Continuing treatments/Changes, Evaluation) – helps structure and clarify communication. (For additional strategies to improve handoff communication, see AlertBulletin®_{2006 – issue 1, “new}

Patient Safety Goal targets Hand-off Communication,” available at www.cna.com.)

Hospitals and clinics can help reduce errors in information trans-fer by requiring that all handoffs involve thorough, unhurried and mutual communication between sender and recipient. For more information about improving perioperative handoff procedures, visit

http://www.medlineuniversity.com/DesktopModules/Documents/ ViewDocument.aspx?AddToLog=1&DocumentID=653.

11. DRaft guiDelines tO manage ClOtting DisORDeRs.

Medicare has categorized postoperative deep venous thrombosis (DVt) and pulmonary embolism (PE) as non-reimbursable, hospital- acquired conditions. Preventing these life-threatening clotting disorders requires a clinical framework to evaluate and treat surgical patients at risk for venous thromboembolism (VtE). Detailed recommendations on adult VtE prophylaxis are available from the institute for Clinical Systems improvement at http://www.icsi.org/ venous_thromboembolism_prophylaxis/venous_thromboembo lism_prophylaxis_4.html. (For additional information on prevent-ing embolisms, see Vantage Point®_{2008 – issue 3, “Emergency}

Department Liability: Sound Risk Control Strategies Can Reduce Misdiagnosis,” available at www.cna.com.)

12. RequiRe anD mOnitOR COmPlianCe with PROtOCOls.

Consistent application of surgical protocols and checklists is associated with a significant reduction in major postoperative compli-cations.2_{Surgical teams should be observed on a regular basis to}

assess compliance with established safety initiatives, such as site marking, verification and time-out periods. Retrospective review of surgical documentation – as facilitated by the worksheet included on pages 6-7 – is another important risk management technique. noncompliant actions should be classified as surgical errors and reported through appropriate quality improvement channels. Any invasive procedure contains an inherent measure of risk. By avoiding shortcuts, communicating thoroughly and continuously, and operating in a deliberate and safety-conscious manner, sur-gical teams can help protect patients from harm while minimizing personal and organizational exposure.

2 Semel, M. et al. “Adopting a Surgical Safety Checklist Could Save Money and Improve the Quality Of Care in U.S. Hospitals.” Health Affairs, September 2010, Volume 29:9, pp.1593-1599. The article can be purchased at http://content.healthaffairs.org/content/29/9/1593. A summary of the findings is available at http://journalistsresource.org/studies/society/health/adopting-a-surgical-safety-checklist-could-save-money-and-improve-the-quality-of-care-in-u-s-hospitals/.

To reduce errors, all handoffs should

involve thorough, unhurried and

mutual communication between

sender and recipient.

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Audit Tool for Measuring Compliance with the Universal Surgery Safety Protocol

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The following checklist, based on the Universal Protocol, is intended to aid in assessing written patient safety policies and enhancing surgical teams’ consistency, safety awareness and documentation practices.

yes nO

inDiCatOR One

VeRifiCatiOn: Correct person, procedure and site were confirmed and documented…

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when the surgery/procedure was scheduled

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upon admission to the hospital or surgical facility

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with the patient awake and coherent, or by a family member

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before the patient left the pre-operative area or entered the procedure room

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when responsibility for care was transferred to another surgeon or caregiver

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when the patient was transferred to another location after the surgery/procedure

inDiCatOR twO

CheCklist DOCumentatiOn: Vital information was reviewed prior to the start of the surgery/procedure, including…

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medical history and physical exam

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consent form, which specified the procedure and the site, side, level and digit, as necessary, without use of unauthorized acronyms or abbreviations

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notation of specific system or device to be implanted or removed, if applicable

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harvest and donor site facts, such as source of harvest, retrieval date and recipient data

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all radiological images germane to the case

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special equipment requirements for the surgery/procedure

inDiCatOR thRee

site maRking: incision or insertion site was marked…

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by the individual performing the surgery/procedure

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in a clear and unambiguous manner, consistent with organizational policy

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with three legible initials, rather than an X

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at operative sites only

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in areas visible after patient prepping and draping

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with an FDA-approved “permanent” marker

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for laterality, multiple structures and levels, as appropriate

Patient: ______________________________________ Patient care record number: ______________________________ Date of surgery/procedure: _____________________ Surgery/procedure type: _________________________________ Surgeon/physician: ____________________________ team members: _________________________________________ Date of audit: _________________________________ Auditor: ________________________________________________

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yes nO

inDiCatOR fOuR

site maRking COnfiRmatiOn: Recommended precautions were taken, including…

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use of radiographic techniques for marking vertebral levels

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confirmation of site marking by fully awake patient and/or family member, if possible

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final verification of the site during the time-out before incision or insertion

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adherence to approved alternative measures for patients who refuse site marking

inDiCatOR fiVe

time-Out PROCeDuRe: immediately prior to the initial incision, the entire team paused to audibly confirm the correct…

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patient

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side and site

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procedure

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body position

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implants and special equipment, if relevant

inDiCatOR six

DisCRePanCies anD DisagReements: if inconsistencies or other issues arose, the patient care record reflects that team members…

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suspended all activity until the inconsistency or problem was resolved

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followed organizational policy and parameters for conflict management

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Published by CNA. For additional information, please contact CNA HealthPro at 1-888-600-4776. The information, examples and suggestions presented in this material have been developed from sources believed to be reliable, but they should not be construed as legal or other professional advice. CNA accepts no responsibility for the accuracy or completeness of this material and recommends the consultation with competent legal counsel and/or other professional advisors before applying this material in any particular factual situation. Please note that Internet hyperlinks cited herein are active as of the date of publication, but may be sub- ResOuRCes

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American College of Surgeons (ACS), at www.facs.org

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American Society of Anesthesiologists (ASA), at www.asahq.org

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Association of perioperative Registered nurses (AoRn), at www.aorn.org

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the Joint Commission, at www.jointcommission.org