Patient Safety Advisory Reprinted from the PA-PSRS Patient Safety Advisory—Vol. 1, No. 3 (September 2004) Produced by ECRI & ISMP under contract to the Pennsylvania Patient Safety Authority Two Takes on the “Time Out” staff responses during the “time out.”1 T he practice of holding a “time out”—pausing for final verification of a patient’s identity, proce- dure, and operative site—has been widely cited as JCAHO is not the only organization to advocate the one strategy to prevent wrong patient, wrong site, use of the time out practice. The American College and wrong procedure errors in surgery and other of Surgeons (ACS) suggests that members of the- invasive interventions. The time out can be a useful surgical team conduct a final verification process to defense against these types of errors, as illustrated ensure that the patient, procedure, and site are cor- in several reports submitted to PA-PSRS in which rectly identified. Further, ACS suggests that all ac- time outs highlighted potential patient identification tivities be halted until verification is accurate.2 The problems. These reports represent success stories Association of periOperative Registered Nurses for the time out practice. (AORN) also advocates the time out procedure in its position statement on correct-site surgery.3 VHA, Other reports we have received document problems a national alliance of not-for-profit hospitals and in implementation that may limit the theoretical health systems, incorporates the time out practice benefits of this safety practice. However, these sto- in its safety program “7 Absolutes to Avoid Surgical ries, too, hold lessons that may help other facilities Site Errors.”4 promote and execute this practice more effectively. The Success Stories The Joint Commission on Accreditation of Health- Case #1: An elderly patient undergoing repair of a care Organizations (JCAHO) includes the use of a hip fracture was prepped for a right-sided proce- time out immediately prior to surgeries and “other dure, consistent with the consent, history and physi- invasive procedures that expose patients to harm” in cal, and a consultation report. During the time out, its Universal Protocol for Preventing Wrong Site, the surgical team determined [method unspecified] Wrong Procedure, Wrong Person Surgery™. [Ed. that the patient had a left hip fracture, which was Note: The JCAHO Universal Protocol was previ- then confirmed by x-ray. The procedure was per- ously addressed in the June 2004 PA-PSRS Patient formed on the correct side. Safety Advisory, under the headline “Patient Safety News.”] This protocol, which became mandatory for Case #2: Prior to performing an angiography, the all JCAHO-accredited facilities on July 1, 2004, re- team conducted a time out and found an unspeci- quires that the time out: fied error on the patient’s wrist band. A nurse famil- iar with the patient was called to the radiology de- [B]e conducted in the location where the pro- partment to positively identify the patient. A new, cedure will be done, just before starting the corrected wrist band was placed on the patient be- procedure. It must involve the entire operative fore the procedure began. team, use active communication, be briefly documented…and must, at the least, include: • Correct patient identity • Correct site and side This article is reprinted from the PA-PSRS Patient Safety Advisory, Vol. 1, No. • Agreement on the procedure to be done 3—September 2004. The Advisory is a publication of the Pennsylvania Patient Safety Authority, produced by ECRI & ISMP under contract to the Authority as • Correct patient position part of the Pennsylvania Patient Safety Reporting System (PA-PSRS). • Availability of correct implants and any Copyright 2004 by the Patient Safety Authority. This publication may be re- special equipment or special requirements printed and distributed without restriction, provided it is printed or distributed in its entirety and without alteration. Individual articles may be reprinted in their entirety and without alteration provided the source is clearly attributed. The organization should have processes and systems in place for reconciling differences in To see other articles or issues of the Advisory, visit our web site at www.psa.state.pa.us. Click on “Advisories” in the left-hand menu bar. ©2004 Pennsylvania Patient Safety Authority Page 1 Reprinted from the PA-PSRS Patient Safety Advisory—Vol. 1, No. 3 (September 2004) Two Takes on the “Time Out” (Continued) failure to obtain or document consent, and failure to Case #3: An adolescent patient was brought to mark the operative site. interventional radiology for a lumbar puncture. Dur- ing a time out, the team discovered that the birth Tips for Performing the “Time Out” date on the patient’s wrist band was incorrect. The procedure was halted while the correct birth date • Performing immediately before the procedure begins was confirmed with the patient’s parents. The error • Performing in the same location where the procedure will was corrected and a new wrist band applied prior to be performed beginning the procedure. • Performing with the patient and clinical team in the same positions as during the procedure These reports are “success stories” because the • Performing after marking the operative site healthcare providers seem to have executed the • Involving all members of the clinical team time out procedure very well. The time out in the • Using active communication (i.e., not assuming silence first case clearly prevented a wrong-side surgery. In means assent) neither case 2 nor 3 had they been about to perform • Using all available documentation (e.g., patient wrist band, a procedure on the wrong patient; the only aspect of history and physical, OR schedule, patient consent, results the verification process noted as problematic is the of imaging or other diagnostic studies) wrist band. Yet, in both cases the clinical team took • Holding the procedure until all forms of verification are in the safe course in halting the procedure until all in- agreement formation used in the verification process was in • Documenting the results of the time out, including how any agreement. discrepancies were resolved It is also interesting to note that the facility in the third case performed a time out before a lumbar puncture, which is not universally viewed as an in- Sources: JCAHO5, 6 and ECRI vasive procedure. While the time out is typically per- formed prior to surgeries and other invasive proce- The Cautionary Tales dures to prevent patient identification errors, these are not the only clinical situations where patient Case #1: A patient presented for cystoscopy and identification is a problem. For example, during one replacement of a stent in the left ureter. The OR month, PA-PSRS received twice as many reports team completed a final time out before beginning involving the wrong patient, side, site, or procedure the procedure. During the procedure, an unspeci- in relation to radiology/imaging as in relation to sur- fied feature of the patient’s anatomy caused the geries/invasive procedures. surgeon to assume the patient’s consent (and pre- sumably other documentation) had been in error, One might ask why something as common as wrist and she inserted the stent in the right ureter. With band errors would bring to a halt procedures where the patient in recovery, the surgeon contacted her all other sources of verification—including presuma- office and confirmed that the left had been the cor- bly the members of the clinical teams themselves— rect side. The patient was brought back to the OR, were in agreement. While on its face this question the stent placed earlier was removed, and a stent seems reasonable, consider the counter-argument. was placed correctly in the left ureter. How many opportunities would there have been to check these patients’ identities before they reached The problem in implementing the time out proce- the sites of their procedures? How many times must dure in this case is that the surgeon ignored the someone have failed to look at their wrist bands, or results of the time out, which presumably ended looked but failed to notice the errors, or noticed the with all members of the surgical team concurring errors but failed to correct them? The fact that these with the available documentation that this was a errors were not caught earlier during medication left-sided procedure. When the surgeon encoun- administration and/or diagnostic testing appropri- tered contradictory evidence about the correct side ately made these clinical teams confirm their pa- for this procedure in the form of some anatomical tients’ identities and correct the errors. feature of the patient, she weighed the evidence of the pre-operative documentation and the surgical A number of other reports recount the time out pro- team’s time out against the evidence provided by cedure successfully identifying errors or omissions the patient’s anatomy. Presumably, the latter evi- in documentation used in the verification process, dence seemed the more compelling at the time, and the procedure proceeded incorrectly. Page 2 ©2004 Pennsylvania Patient Safety Authority Reprinted from the PA-PSRS Patient Safety Advisory—Vol. 1, No. 3 (September 2004) Two Takes on the “Time Out” (Continued) During a time out, if any single element of the team, that same clinician may have felt too in- verification process is inconsistent with the oth- timidated to correct the surgeon’s mistake. ers, some clinical teams will halt the procedure until the error is corrected. Though the time out Notes had been completed and the procedure was in 1. Joint Commission on Accreditation of Healthcare Or- progress when the surgeon encountered the ganizations. Universal protocol for the prevention of wrong contradictory evidence, it may have been possi- site, wrong procedure, and wrong patient surgery [online]. ble for the surgeon to pause long enough to 2003 Jul 18 [Cited 16 Aug 2004]. Available from Internet: contact her office from the OR during the proce- http://www.jcaho.org/ accred- ited+organizations/patient+safety/universal+protocol/ dure rather than after it. Further, the fact that the wss_universal+protocol.htm. surgeon implicitly discounted the evidence re- 2. American College of Surgeons. Statement on ensuring viewed during the time out may indicate that correct patient, correct site, and correct procedure surgery. documentation errors are so frequent that clini- Bull Am Coll Surg 2002 Dec;87(12). cians are predisposed to doubt their veracity. 3. Association of periOperative Registered Nurses. AORN position statement on correct site surgery [position state- Case #2: A 45-year-old female patient pre- ment]. 2003 Feb [Cited 2004 Aug 16]. Available from Inter- sented for surgery for release of “trigger thumb.” net: http://www.aorn.org/about/positions/correctsite.htm. Prior to conducting a time out, the surgeon 4. Mathias JM. VHA’s program to curb wrong-site surgery. made an incision at the site for a carpal tunnel OR Manager 2002 Mar;18(3):7-9. release. Another clinician alerted the surgeon to 5. Joint Commission on Accreditation of Healthcare Or- the error. After suturing the incorrect incision, ganizations. Guidelines for implementing the universal the team stopped to perform a time out, and protocol for the prevention of wrong site, wrong procedure, then proceeded to perform the scheduled opera- and wrong patient surgery [online]. 2003 Jul 18 [Cited 2004 Aug 16]. Available from Internet: tion. http://www.jcaho.org/accredited+organizations/ pa- tient+safety/universal+protocol/up+guidelines.pdf. Clearly, the problem in implementing the time 6. Joint Commission on Accreditation of Healthcare Or- out in this case is that the surgeon made an inci- ganizations. Frequently asked questions about the univer- sion before performing the time out. It is not sal protocol for preventing wrong site, wrong procedure, clear whether this was a lapse or an intentional wrong person surgery [online]. 2003 Jul 18 [Cited 2004 Aug 16]. Available from Internet: http://www.jcaho.org/ violation. The systems lesson in this case is less accredited+organizations/patient+safety/ about the technical details of the time out than it universal+protocol/faq_up.htm. is about teamwork and a culture of safety. If the surgeon was impatient and skipped the time out intentionally, this sends a message to the rest of the OR team that safety measures are unimpor- tant and can be ignored. However, if this was an unintentional lapse, the team might consider whether a change in group dynamics surrounding the time out might de- crease the probability of omitting it. For exam- ple, if it is not clear who is responsible for calling the time out, no one may feel responsible. On the other hand, if the surgeon feels that he or she alone bears all the responsibility for patient identification, he/she may feel that “it’s their call” whether to ignore verification-related safety practices. We cannot leave this case, of course, without noting that another member of the team did stop the surgeon when witnessing the wrong incision. A fundamental attribute of a culture of safety is the recognition that safety is everyone’s respon- sibility. In another facility or in another surgical ©2004 Pennsylvania Patient Safety Authority Page 3 Reprinted from the PA-PSRS Patient Safety Advisory—Vol. 1, No. 3 (September 2004) An Independent Agency of the Commonwealth of Pennsylvania The Patient Safety Authority is an independent state agency created by Act 13 of 2002, the Medical Care Availability and Reduction of Error (“Mcare”) Act. Consistent with Act 13, ECRI, as contractor for the PA-PSRS program, is issuing this newsletter to advise medical facilities of immediate changes that can be instituted to reduce serious events and incidents. For more information about the PA- PSRS program or the Patient Safety Authority, see the Authority’s website at www.psa.state.pa.us. ECRI is an independent, nonprofit health services research agency dedicated to improving the safety, efficacy and cost-effectiveness of healthcare. ECRI’s focus is healthcare technology, healthcare risk and quality management and healthcare environmental management. ECRI provides information services and technical assistance to more than 5,000 hospitals, healthcare organizations, ministries of health, government and planning agencies, and other organizations worldwide. The Institute for Safe Medication Practices (ISMP) is an independent, nonprofit organization dedicated solely to medication error prevention and safe medication use. ISMP provides recommendations for the safe use of medications to the healthcare community including healthcare professionals, government agencies, accrediting organizations, and consumers. ISMP's efforts are built on a non-punitive approach and systems-based solutions. Page 4 ©2004 Pennsylvania Patient Safety Authority