U P DAT E Quarterly Update on Preventing Wrong-Site Surgery John R. Clarke, MD This quarterly update will discuss five issues: Editor, Pennsylvania Patient Safety Advisory Clinical Director, Pennsylvania Patient Safety Authority 1. The direction of the Patient Safety Authority project to prevent wrong-site surgery Professor of Surgery, Drexel University and considerations of its recommendations to prevent wrong-site surgery 2. Estimates of the incidence of wrong-site anesthetic blocks and ureteral stent insertions 3. Informative near-miss reports 4. Preventing misinformation from the surgeon’s office 5. The relationship between wrong-site surgery and the operating room (OR) culture of safety DIRECTION OF THE AUTHORITY’S PROJECT TO PREVENT WRONG- SITE SURGERY AND CONSIDERATIONS OF RECOMMENDATIONS TO PREVENT WRONG-SITE SURGERY There were another 15 wrong-site surgeries this quarter, bringing the total since report- ing began in July 2004 to 469, in a seemingly inevitable weekly march to an unenviable 500. However, the project to prevent wrong-site surgery, starting with the initial identi- fication of evidence-based best-practice principles in September 2007,1 shows progress. The Authority previously reported on the commitments of eight (now nine) facilities to implement wrong-site surgery prevention programs on their own.2 It has also described the results of two collaborations totaling 49 facilities to implement evidence-based best practices to prevent wrong-site surgery. The first collaboration of 30 facilities resulted in a 73% reduction of wrong-site surgery.3 The second collaboration resulted in no wrong-site surgeries in any of the facilities’ ORs for more than one year.4 Extensive analysis has shown no difference in recidivism rates between facilities exhibiting a com- mitment to self-improvement and facilities participating in collaborations, suggesting that both can be equally successful. All of the progress in preventing wrong-site surgery has occurred in the 58 facilities that made a serious effort to prevent wrong-site surgery. The remaining facilities in Figure. Wrong-Site Surgery Trends by Intervention NUMBER OF REPORTS 18 16 14 12 10 8 6 4 Scan this code with your mobile 2 MS12042 device’s QR 0 reader to access Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 the Authority's 2004 2005 2006 2007 2008 2009 2010 2011 wrong-site surgery REPORTS BY QUARTER prevention toolkit. Noted self improvement by outliers (n=9) Neither All collaborations (n=49) Page 28 Pennsylvania Patient Safety Advisory Vol. 9, No. 1—March 2012 ©2012 Pennsylvania Patient Safety Authority Pennsylvania have actually shown an potential barriers to implementation of Wrong-Site Ureteral Stent increase in wrong-site surgeries (see Figure). the recommendations from facilities that Insertions These opposite trends support the notion provide surgical services. The Authority There were three wrong-site procedures that institutional commitment is critical to specifically encourages the OR managers involving ureteral stents reported this preventing this “never” event. The Author- of all facilities in Pennsylvania to indicate quarter, bringing the total number for ity encourages the remaining facilities in facility-specific barriers to possible imple- these wrong-site procedures to 25. As Pennsylvania to make the institutional mentation, as well as provide stories about mentioned in an earlier update, proce- commitment to join in the collaborations successful implementation for each of the dures involving stenting of the ureters to prevent wrong-site surgery. draft recommendations. To solicit this account for about 80% of all wrong-site The variation—or volatility—of the information, the Authority has circulated a urological procedures.6 reported number of events per quarter (or survey to all of the Pennsylvania OR man- gers through their patient safety officers. The Authority obtained the number of of the time between events) has an inverse insertions of ureteral stents from the relationship to the degree of standardiza- Pennsylvania Health Care Cost Contain- tion or consistency of processes within ESTIMATES OF THE INCIDENCE ment Council to calculate an incidence of the groups: the more the volatility, the OF SOME FREQUENT TYPES OF insertion of ureteral stents, as a primary less the consistency in the processes. Vola- WRONG-SITE PROCEDURES procedure, on the wrong side. The tech- tility can be measured by the standard niques for estimating the number of single deviation of the time between events: Wrong-Site Anesthetic Blocks ureteral stent insertions as primary proce- the higher the standard deviation, as a There were another three wrong-site anes- dures was not straightforward. The method percentage of the mean, the greater the thetic blocks reported this quarter, despite for obtaining a point estimate is explained volatility and the less likely that the pro- the attention given to this problem in in the “Calculation of the Number of cesses to prevent wrong-site surgery are recent issues of the Advisory.5,6 A report Ureteral Stents Inserted as a Primary Pro- consistently followed. The Authority exam- by Stanton et al.7 allows one to infer an cedure.” The median point estimate was ined the time between events from July incidence of wrong-site anesthetic blocks. 81,317 insertions of a single ureteral stent 2004 through September 2011 (to avoid The authors reported on their experience as a primary procedure from the beginning open-ended reporting at the end of the with a verification protocol to prevent of the third quarter of 2004 through the current quarter). The results confirm that wrong-site blocks. Despite their preven- end of the first quarter of 2011. During demonstrated efforts to prevent wrong-site tion protocol, they experienced two events that period, the Authority received 19 re- surgery are associated not only with better over three years in a hospital practice in ports of a ureteral stent being inserted in results, but also with less volatility, imply- which peripheral nerve blocks accounted the incorrect ureter as a primary procedure ing that the improvements are not due to for 44% of approximately 19,500 anes- without realization and reinsertion in random variation, but to more consistency thetics per year. These estimates produce the correct ureter before the end of the in following procedures (see Table 1). an incidence of approximately one wrong- procedure, for an incidence of one wrong- The Authority is circulating draft recom- site block for every 12,870 peripheral site procedure for every 4,280 procedures. mendations for preventing wrong-site nerve blocks. Assuming the upper range of the estimates surgery. It invites comments about the for the number of unilateral procedures, the incidence is at least one wrong-site pro- cedure for every 4,765 procedures. Table 1. Volatility of the Time between Wrong-Site Surgery Events for Different Initiatives to Prevent Wrong-Site Surgery, Pre- and Post-Intervention INFORMATIVE NEAR-MISS DAYS DAYS REPORTS GROUP PRE SD % POST SD % Self-improvement 27 27 101% 44 32 71% A Proposed Addition to Critical First collaboration 39 40 103 55 23 42 Near-Miss Reports In the December 2011 update,4 the Second collaboration 54 42 78 116 45 39 Authority listed three types of wrong-site No known initiative 10 7 69 9 5 61 near-miss events identified by the World SD = standard deviation Health Organization’s High 5s project as % = standard deviation as a percentage of the mean critical near misses worthy of root-cause Vol. 9, No. 1—March 2012 Pennsylvania Patient Safety Advisory Page 29 ©2012 Pennsylvania Patient Safety Authority U P DAT E CALCULATION OF THE NUMBER OF URETERAL STENTS INSERTED AS A PRIMARY PROCEDURE The Authority obtained the number of insertions of ureteral and then extrapolate the subsequent percentages over stents between the beginning of the third quarter of 2004 and time using linear regression. the end of the first quarter of 2011 from the Pennsylvania Health Care Cost Containment Council in order to calculate an 4. Use the correlation of the number of stents as primary incidence of insertion of ureteral stents, as a primary procedure, procedures from ICD-9 codes compared to all stents from on the wrong side. CPT codes for each quarter (until mid-2007) when both were available and then extrapolate the subsequent In-patient procedures were determined from International number of stents as primary procedures over time using Classification of Diseases-Ninth Revision (ICD-9) codes for linear regression. insertion of ureteral stents as primary procedures. The number of patients who received bilateral stents, with no Outpatient procedures were determined from the same ICD-9 potential for right-left confusion, was estimated by calculat- codes from the third quarter of 2004 through the second quar- ing the difference between the counts of primary ureteral stent ter of 2007. Subsequently, only Current Procedural Terminology procedures on all the records and the number of records with (CPT) codes for ureteral stents were available for outpatient primary ureteral stent procedures. This difference was then sub- procedures through the first quarter of 2011. The Authority tracted from the number of records with primary ureteral stent extrapolated the number of outpatient stents done as primary procedures to estimate the lower limit on the number of uni- procedures by four methods: lateral stents. The upper limit was estimated by assuming all of 1. Calculate the percentage of stents as primary procedures the stents were unilateral, placed sequentially, if there was more from ICD-9 codes compared to all stents from CPT codes than one count per record. for the times (until mid-2007) when both were available and then use that percentage as the conversion factor for These calculations resulted in eight point estimates, ranging each subsequent quarter. from 72,782 to 90,582, for the number of ureteral stents done as primary procedures from July 2004 through March 2. Calculate the percentage of stents as primary procedures 2011. The median point estimate was 81,317 insertions of a from ICD-9 codes compared to all stents from CPT codes single ureteral stent as a primary procedure. In that period, the for each quarter (until mid-2007) when both were avail- Authority received 19 reports of a ureteral stent being inserted able and then take the average of those percentages as in the incorrect ureter as a primary procedure, without timely the conversion factor for each subsequent quarter. realization and reinsertion in the correct ureter, for an incidence 3. Calculate the percentage of stents as primary procedures of 1 every 4,280 procedures. Assuming the upper range of the from ICD-9 codes compared to all stents from CPT codes estimates for the number of unilateral procedures, the incidence for each quarter (until mid-2007) when both were available is at least 1 every 4,765 procedures. analyses, perhaps using the Authority’s from the originally scheduled pro- As previously noted,4 treating critical near standard form: wrong-site near misses cedure because of a near-miss event misses as seriously as wrong-site events resulting in the following: caught during the preparation of should help maintain awareness of the 1. Procedures that are done correctly the patient for surgery. An example constant risk of wrong-site events. on the correct patient despite incor- of a report that would fall into this rect information category is as follows: Reminders from Other Near- 2. Errors caught by the last step of the Left eye was marked with the word Miss Reports This Quarter Universal Protocol, the time-out “right” over it. Drops were put in the All verbal verification should be done 3. Near-miss situations resulting in can- left eye prior to surgery. Error noted using questions that require an active cellation of the procedure prior to patient having procedure. response of specific information rather The patient did require the surgery than a passive agreement, such as in the A report this quarter suggests a fourth on the left side, so the surgeon spoke following example: category: with the patient and his wife, got a The patient was identified in preop- 4. Medically indicated procedures new consent, and proceeded with the done, with prior approval, that differ erative [area]. The patient was asked left eye. if name and physician were correct, Page 30 Pennsylvania Patient Safety Advisory Vol. 9, No. 1—March 2012 ©2012 Pennsylvania Patient Safety Authority and the patient answered yes. The the needle localization on Nov. 8 and A patient was scheduled for L total bracelet was checked for identifica- then was taken to the OR without hip replacement. While setting up, tion and allergies. Upon entering first going to nuclear medicine. It was the doctor heard a [sales] representa- the OR, during bracelet check and then discovered that the patient was tive talking to a technician about correct surgery confirmation, it was not injected in nuclear medicine. instruments for L hip. The doctor determined that it was the incorrect A patient was on the OR schedule stated that it was not L but R hip. patient. The patient was for another for total right-hip arthroplasty. The The office sheet was checked, and physician. The patient was returned consent signed by the patient in the it was verified that it stated L hip. to the preoperative [area], and the physician’s office was for left-shoulder Implants and instrumentation pres- correct patient was taken to the OR. surgery that he had completed in ent were for L hip. The patient [had Even after the completion of the proce- June. A new consent was signed by discussed with surgeon doing] R hip. dure, attention must be paid to proper the patient. The case was cancelled and resched- documentation regarding the pathology uled for a later date. A patient was scheduled for a proce- specimen, postoperative orders, and dicta- dure on the left foot. The surgery was A middle-aged man was scheduled tion of the operative note. This report actually to be done on the right foot. by the surgeon for insertion of a left shows improper documentation in the The consent was incorrect, as was all ureteral stent. The imaging studies postoperative orders: dictated information on the chart. were performed at another institu- Eye surgery orders were completed The correct consent was obtained by tion. The report was not present in and sent to pharmacy with the wrong the physician in the holding area. patient information received from the eye indicated (written as “right” The handwritten history and physical office. The procedure was performed when it should have been “left”). The from the physician was correct. Most for ureteral calculus. The consent, surgery center called the pharmacy incorrect areas have been corrected by reservation form, and registration and gave a new copy of the orders appropriate personnel. Follow-up with all stated the left ureter. A time-out with the correct eye indicated. involved hospital staff was done. was conducted with the information as stated, with participation of the A patient with back and right-leg surgeon. The pyelogram [showed no PREVENTING MISINFORMATION pain was scheduled for L4-5 discec- irregularities]. After the procedure, FROM THE SURGEON’S OFFICE tomy. No laterality was identified when the surgeon consulted office The two major causes of wrong-site surgery by the physician when scheduling, notes, the surgeon determined that are misinformation and misperception. nor was laterality identified on the it should have been a right ureteral Ensuring the completeness and accuracy consent. In the preoperative holding stent because the stone was present of information from the surgeon’s office [area], the site was marked (lumbar on the right. A right ureteral stent is the first step in preventing misinforma- area of the back). The surgeon per- was inserted [later]. tion from leading to wrong-site surgery. formed a left L4-5 hemilaminotomy and excision of herniated disk. The This year, the Authority had the opportu- Three wrong-site surgeries, one near miss nity to visit a facility that had requested with cancellation of the operation, and next morning, the surgeon saw the patient, and when questioned about a consultation as part of its initiative to three other reports of near misses during prevent wrong-site surgery after experi- the past quarter underline the impor- how his left leg was feeling, the patient stated his left leg was always encing four events within one year. The tance of the surgeon’s office providing facility stated that its preadmission testing accurate information. As usual, all cases fine, the pain was in his right leg. The surgeon realized the procedure (PAT) personnel identified incomplete or have been edited to provide contextual inconsistent information on the schedule, de-identification. was done on the incorrect side; the patient was taken back to the OR consent, and/or history and physical from A patient was scheduled for needle and underwent a right hemilaminot- the surgeon’s office. These deficiencies localization and sentinel node injec- omy and excision of herniated disk. were corrected with calls to the surgeon’s tion, and then surgery to remove office. The PAT staff estimated that they sentinel nodes. The surgeon scheduled The patient information received caught inconsistencies on an average of the surgery for Nov. 8, but scheduled from the physician’s office identified four patients every day. That means the the sentinel node injection in nuclear the wrong side. offices were putting incorrect information medicine for Nov. 9. The patient had (continued on page 33) Vol. 9, No. 1—March 2012 Pennsylvania Patient Safety Advisory Page 31 ©2012 Pennsylvania Patient Safety Authority U P DAT E Table 2. Differences in Agreement with Statements on a Culture of Safety Survey by Operating Room Personnel between Facilities with No History of Wrong-Site Surgery and a History of Wrong-Site Surgery STATEMENT PERCENTAGE P CHI-SQUARE No Wrong- Wrong-Site Site Surgery Surgery Agreement with the Following Statements was Significantly More Likely with No Wrong-Site Surgery than with Wrong-Site Surgery I know the first and last names of all the personnel I worked with 88% 61% 0.000 during my last shift. It is easy for personnel in the operating rooms (OR) here to ask 79 63 0.001 questions when there is something that they do not understand. Working in this hospital is like being part of a large family. 65 51 0.001 There is widespread adherence to clinical guidelines and evidence- 79 59 0.001 based criteria regarding patient safety here. Patient safety is constantly reinforced as the priority in the ORs here. 86 72 0.001 I know the proper channels to direct questions regarding patient 89 81 0.002 safety in the ORs here. Staff/attending physicians in the ORs here take responsibility for 74 58 0.002 patient safety. Medical errors* are handled appropriately in this hospital. 83 72 0.003 I would feel safe being treated here as a patient. 83 72 0.003 Decision making in the OR utilizes input from relevant personnel. 66 46 0.004 Important issues are well communicated at shift changes. 71 56 0.004 Briefings are common in the OR. 67 51 0.005 I receive appropriate feedback about my performance. 73 53 0.005 The culture in the ORs here makes it easy to learn from the errors 66 54 0.007 of others. This hospital does a good job of training new personnel. 69 55 0.011 The levels of staffing in our ORs are sufficient to handle the number 50 36 0.014 of patients. Nurse input about patient care is well received in the OR. 78 63 0.014 I am encouraged by my colleagues to report any patient safety 83 70 0.024 concerns I may have. I have the support I need from other personnel to care for patients. 76 67 0.024 Hospital administration supports my daily efforts. 50 37 0.027 Information obtained through incident reports is used to make 65 58 0.028 patient care safer in the ORs here. Agreement with the Following Statements was Significantly More Likely with Wrong-Site Surgery than with No Wrong-Site Surgery High levels of workload are common in the ORs here. 77% 92% 0.000 I have made errors that had the potential to harm patients. 4 18 0.004 In the ORs here, it is difficult to speak up if I perceive a problem 16 28 0.005 with patient care. I have seen others make errors that had the potential to harm 26 41 0.006 patients. * Medical error is defined as any mistake in the delivery of care by any healthcare professional, regardless of outcome. Page 32 Pennsylvania Patient Safety Advisory Vol. 9, No. 1—March 2012 ©2012 Pennsylvania Patient Safety Authority (continued from page 31) accuracy, and consistency of the informa- abbreviations and with all numbers tion on the schedule, consent, and history written out is consistent with general on the schedules, consents, and/or histo- and physical when the information leaves principles for preventing errors. Pertinent ries and physicians of 1,000 patients per the surgeon’s office, prior to verifica- supporting information uniquely found year. Another approximately 500 patients tion in PAT or the preoperative holding in the office records should be included, per year were operated on without passing area. Achieving this goal would eliminate or copies attached, with the history and through PAT. information errors and require more uni- physical. In contrast, AnMed Health Women’s and formity of processes from surgeon offices. Everyone reviewing the schedule, consent, Children’s Hospital in Anderson, South Surgeon offices and surgical facilities history and physical examination, and/or Carolina, is reported to have never had should establish systems to verify that reports documenting the diagnosis should a wrong-site surgery. Nevertheless, when the following information is complete check for discrepancies among all those staff of the 72-bed hospital looked at their and accurate before leaving the surgeon’s parts of the patient’s record and reconcile system, they found 15 scheduling errors office once the decision to operate is any discrepancies with the surgeon when- per day. A project team created a manual made and the procedure is scheduled, ever noted. for each surgeon’s office and reduced during PAT, and in preoperative admis- A sample checklist and a sample monitor- scheduling errors by approximately 93%.8 sions, as well as before entering the OR. ing tool are available from the Authority Ms. Martha Rush, in a personal commu- At minimum, this information includes to help in achieving that goal (see http:// nication to the Authority, was gracious in the following: patientsafetyauthority.org/Educational- sharing the following critical advice pro- vided to AnMed surgeons’ offices: — Schedule Tools/PatientSafetyTools/PWSS/Pages/ — Consent home.aspx). The schedule must include the patient’s legal name and two — History and physical examination, including office notes if relevant THE RELATIONSHIP BETWEEN other identifiers, the name of the procedure—including laterality if — Laboratory results WRONG-SITE SURGERY AND THE pertinent—without abbreviations OR CULTURE OF SAFETY — Imaging studies and with all numbers written out, — Pathology reports when relevant Eleven facilities in Pennsylvania that hap- and the preoperative diagnosis. pened to use the same culture of safety The information required for scheduling The surgical procedure consent survey instrument have cooperated with the procedure should include the side or should be completed in the sur- the Authority by sharing the results of site, if pertinent. The suggestion that the geon’s office, if possible. It should their culture of safety survey responses procedure be scheduled without abbrevia- include the patient’s legal name for OR personnel to create an aggregate tions and with all numbers written out and the name of the procedure, report; eight of the facilities had expe- is consistent with general principles for including laterality if pertinent, rienced a wrong-site surgery and three preventing errors.9 without abbreviations and with all of the facilities had not. They agreed to The description of the procedure on cooperate on the condition of confiden- numbers written out. The name the consent should also include the side tiality. The eight facilities with wrong-site of the procedure on the consent or site, if pertinent, with the patient’s surgery reported aggregate responses from should match the surgeon’s order signature to indicate verification by the 328 respondents. The three OR facilities and the procedure scheduled. patient. The suggestion that the proce- without wrong-site surgery reported aggre- All spaces should be completed, dure be scheduled without abbreviations gate responses from 105 OR respondents. including date, patient’s signa- and with all numbers written out is again The results revealed statistically significant ture, and witness’s signature. consistent with general principles for relationships between perceptions of the The history and physical should preventing errors. culture of safety by operating room pro- include the preoperative diag- viders and the histories of the facilities The history and physical should include nosis and the planned surgical regarding wrong-site surgery (see Table 2). the preoperative diagnosis and planned procedure. The results reinforce the importance procedure, including the side or site, if The Authority advocates that facilities pertinent. Again, the suggestion that of conducting proper briefings, being make a goal of 100% completeness, the procedure be scheduled without engaged, and expressing concerns. Vol. 9, No. 1—March 2012 Pennsylvania Patient Safety Advisory Page 33 ©2012 Pennsylvania Patient Safety Authority U P DAT E NOTES 1. Clarke JR, Johnston J, Finley ED. Available from Internet: http://patient- 7. Stanton MA, Tong-Ngork S, Liguori GA, Getting surgery right. Ann Surg 2007 safetyauthority.org/ADVISORIES/ et al. A new approach to preanesthetic Sep;246(3):395-403. AdvisoryLibrary/2011/dec8(4)/ site verification after 2 cases of wrong site 2. Quarterly update on the preventing Pages/144.aspx. peripheral nerve blocks. Reg Anesth Pain wrong-site surgery project. Pa Patient 5. Quarterly update on the preventing Med 2008 Mar-Apr;33(2):174-7. Saf Advis [online] 2010 Jun [cited 2012 wrong-site surgery project: improving, but 8. Butcher L. Wrong-site surgery [online]. Jan 25]. Available from Internet: http:// still room for perfection. Pa Patient Saf Hosp Health Netw 2011 Nov [cited 2012 patientsafetyauthority.org/ADVISORIES/ Advis [online] 2009 Dec [cited 2011 Dec Jan 25]. Available from Internet: http:// AdvisoryLibrary/2010/Jun7(2)/Pages/ 9]. Available from Internet: http://patient- www.hhnmag.com/hhnmag_app/jsp/ 65.aspx. safetyauthority.org/ADVISORIES/ articledisplay.jsp?dcrpath=HHNMAG/ 3. Pelczarski KM, Braun PA, Young E. Hos- AdvisoryLibrary/2009/Dec6(4)/ Article/data/11NOV2011/1111HHN_ pitals collaborate to prevent wrong-site Pages/141.aspx. FEA_wrongsite&domain=HHNMAG. surgery. Patient Saf Qual Healthc. Sep/Oct 6. Quarterly update on the preventing 9. Potentially dangerous abbreviation in sur- 2010:20-26. wrong-site surgery project: digging deeper. gery. PA PSRS Patient Saf Advis [online] 4. Clarke, JR. Quarterly update: what might Pa Patient Saf Advis [online] 2010 Mar 2004 Mar [cited 2012 Jan 25]. Available be the impact of using evidence-based best [cited 2012 Jan 25]. Available from Inter- from Internet: http://patientsafetyauthor- practices for preventing wrong-site surgery? net: http://patientsafetyauthority.org/ ity.org/ADVISORIES/AdvisoryLibrary/ Results of objective assessments of facili- ADVISORIES/AdvisoryLibrary/2010/ 2004/Mar1(1)/Pages/02a.aspx. ties’ error analyses. Pa Patient Saf Advis Mar7(1)/Pages/26.aspx. [online] 2011 Dec [cited 2012 Jan 25]. Page 34 Pennsylvania Patient Safety Advisory Vol. 9, No. 1—March 2012 ©2012 Pennsylvania Patient Safety Authority PENNSYLVANIA PATIENT SAFETY ADVISORY This article is reprinted from the Pennsylvania Patient Safety Advisory, Vol. 9, No. 1—March 2012. The Advisory is a publication of the Pennsylvania Patient Safety Authority, produced by ECRI Institute and ISMP under contract to the Authority. Copyright 2012 by the Pennsylvania Patient Safety Authority. 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