Pa Patient Saf Advis 2011 Dec;8(4):144-9.
Quarterly Update: What Might Be the Impact of Using Evidence-Based Best Practices for Preventing Wrong-Site Surgery? Results of Objective Assessments of Facilities’ Error Analyses
Anesthesiology; Nursing; Surgery
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Author

John R. Clarke, MD
Editor, Pennsylvania Patient Safety Advisory
Clinical Director, Pennsylvania Patient Safety Authority
Professor of Surgery, Drexel University
 

Introduction

Pennsylvania healthcare facilities reported 11 wrong-site surgeries to the Pennsylvania Patient Safety Authority during the most recent reporting quarter, which is an increase from the previous quarter, but matches the third lowest quarterly number of event reports (see Figure). This update includes any belated additions and corrections from previous reporting quarters; specifically, the identification and deletion of a second, duplicate event report of a wrong-site surgery in the first quarter of 2006, resulting in minor adjustments to previous totals for the seven reporting years (June 2004 through September 2011).

Figure. Pennsylvania Patient Safety Authority Wrong-Site Surgery Reports by Quarter

Figure. Pennsylvania Patient Safety Authority Wrong-Site Surgery Reports by Quarter
Successful efforts to decrease wrong-site surgeries—reported previously by the Health Care Improvement Foundation Partnership for Patient Care wrong-site surgery collaboration (73%),1 by the Veterans Health Administration medical team training program (25%),2 and by a recent, unpublished, wrong-site surgery collaboration of facilities in a second region of Pennsylvania (0 events during operating room (OR) procedures in more than 1 year)—continue with an article in this issue of the Pennsylvania Patient Safety Advisory about the Minnesota Time Out.5

Near-Miss Reports

Some recent reports of wrong-site near misses illustrate the value of assessing near-miss events.

Incorrect Specimen Labeling

Two near-miss reports of incorrect labeling of specimens illustrate the importance of following good practices to prevent mislabeled pathology specimens.

The specimen requisition sheet and the specimen container were incorrectly labeled with another patient’s name and number. The physician was notified and correctly identified and labeled the specimen requisition sheet and the specimen container for this patient.

A pathologist, while reading slides on the case, discovered that the wrong laterality was put on both the specimen container and slip (left/right)—[laterality was] right on both, and it should have been left.

All paperwork, especially preprinted labels, from the previous patient should be cleared before bringing another patient into the OR. The site of the specimen should be verified by the surgeon before the specimen leaves the room.

Critical Near Misses

The Authority received a report of a patient scheduled for removal of a ureteral stent from the wrong-side. As it turned out for the patient, there was only one stent and the correct stent was removed.

The World Health Organization High 5s project has identified three near-miss situations as critical near misses that necessitate root-cause analyses:4

  1. Procedures that are done correctly despite incorrect information, such as described in the event report above. However, the Authority would not include doing the correct procedure on the wrong patient as a critical near miss; the Authority would consider operating on the wrong patient as a wrong-site procedure, even if the patient received a medically appropriate procedure.
  2. Errors caught by the last step of the Universal Protocol, the time-out, such as described in the September 2011 Advisory.5 At least three earlier reports have been found in the reporting system since July 2004:

The left knee was prepped for surgery. The OR schedule, patient consent, patient verification, and physician marking all listed the right knee. Theerror was discovered during the time-out. The right knee was prepped and draped, and the procedure was performed.

A patient was intubated, prepped and draped; the time-out was performed and team realized wrong leg. The patient was reprepped and redraped. [Staff] continued with the correct-site surgery.

The OR staff initially draped the wrong leg before a knee arthroscopy procedure. The error was caught during the time-out process. The correct leg was draped, and the procedure completed by the surgeon.

  1. Near-miss situations resulting in cancellation of the procedure. These events have been reported approximately once per year. They occurred when the patient’s understanding was different than the documented information, when drops were put in the wrong eye, and when an incorrect consent could not be corrected because the patient had been sedated. The Authority would not include cancellation of a procedure based on identification that the patient was the wrong patient as a near miss that fell into this critical category, just any cancellation affecting the patient who was supposed to get the procedure, based on identification of the wrong patient, wrong procedure, or wrong site.

Treating critical near misses as seriously as wrong-site events should help maintain awareness of the constant risk of wrong-site events.

Objective Assessments of the Impact of Evidence-Based Best Practices to Prevent Wrong-Site Surgery

The best practice principles for preventing wrong-site surgery have been identified,6 updated, and supported by their evidence base.5,7 Collaborative efforts with the Health Care Improvement Foundation Partnership for Patient Care to upgrade compliance with the best practice principles were effective in reducing wrong-site surgeries in 30 facilities in the Philadelphia area.1 A similar, unpublished collaborative effort in facilities in a second region of Pennsylvania resulted in 0 wrong-site surgeries in facility ORs during OR procedures in more than 1 year. A subjective analysis of the narratives of all wrong-site surgery reports from June 28, 2004, through June 30, 2011, to determine the potential impact of each evidence-based best practice principle was published in the September 2011 Advisory.5 The following is an objective assessment of the impact of each evidence-based best practice principle, based on the error analysis forms completed by facilities’ patient safety officers (PSOs).

Since August 2007, the Authority has asked each PSO who submits a report of a wrong-site surgery to use a standardized error analysis form when doing the root-cause analysis.8,9 These standardized error analysis forms provide a structure for a complete assessment of all evidence-based best practice principles that might be deficient, rather than just focus on the specific causes of the reported event. The forms include yes/no questions relating to the evidence-based best practice principles to prevent wrong-site procedures. Questions did not relate to three evidence-based best practice principles: (1) the correct operation and site is recorded on the history and physical examination (principle 2), (2) all information is verified by the circulating nurse upon taking the patient to the OR (principle 12), and (3) the surgeon specifically empowers team members to speak up if concerned (principle 18). Each deficiency in best practice principles that is identified may be causal, incidental, or contributory to the reported event. This impact analysis focuses on the deficiencies identified by the questions in the systematic review of evidence-based best practice principles.

As of the end of June 2011, the Authority has received 129 completed error analysis forms assessing deficiencies of evidence-based best practice principles associated with wrong-site OR procedures. These error analysis forms represented 51% of all 254 wrong-site procedures during that time. All questions were answered in all forms.

The results (see Table) are presented in the numerical order of the evidence-based best practice principles and grouped according to the four key groups of best practice principles identified by the subjective analysis of the narrative of all wrong-site surgery reports:5,10

Table. Deficiencies of Evidence-Based Best Practice Principles in Error Analyses of Wrong-Site Operative Procedures ​ ​ ​ ​ ​ ​ ​ ​

Assessment*

Yes

No
Un-
Known

Na
% Yes
Or No
% Yes Of Yes/No% No Of Yes/N0Evidence-Based Best Practice Principle
The correct site was specified on the schedule.80%9%2%9%89%90%10%1. The correct site of the operation should be specified when the procedure is scheduled.
The name of procedure(s) was stated correctly on the consent. The correct site/side/level/digit was clearly
stated on the consent.
80%13%6%1%93%86%14%3. The correct operation and site should be specified on the informed consent.
The person obtaining the scheduling information verified the information provided from the surgeon's office.61%5%15%19%67%94%6%4. Anyone reviewing the schedule, consent, history and physical ex-amination, or reports documenting the diagnosis, should check for dis-crepancies among all those parts of
the patient's record and reconcile
any discrepancies with the surgeon when noted.
All information from the surgeon's records was available in the operating suite for verification against primary sources of information.78%5%6%11%83%93%7%5. The surgeon should have supporting information uniquely found in the office records at the surgical facility on the day of surgery.
A member of the operating room (OR) staff performed the preoperative reconciliation.83%8%6%3%91%91%9%

6. All information that should be used to support the correct patient, operation, and site, including the patient's or family's verbal understanding, should be verified by the nurse and surgeon before the patient enters the OR.

6A. RN should verify preoperatively.

Preoperative verification against
the consent and patient records was done by the surgeon prior to the time-out.
67%17%6%9%84%80%20%6B. Surgeon should verify preoperatively.
Verification of patient's information about full name, date of birth, procedure, and correct site or side, if any, was done with identification (ID) band, consent, schedule, and surgeon's documents in the
patient's record.
91%8%2%0%98%92%8%6C. All information, including patient's information, should be verified preoperatively.
All information was verified by the registered nurse (RN) preoperatively.78%16%6%0%94%83%17%6A, 6C. RN should verify all information.
All information was verified by the RN and the surgeon preoperatively.63%29%9%0%91%69%31%6A, 6B, 6C. The RN and the surgeon should verify all information.
The patient was asked to state his or her full name, date of birth, procedure, and correct site or side, if any.78%13%6%2%91%86%14%7. All verbal verification should be done using questions that require an active response of specific information, rather than a passive agreement.
The patient identified by stating full name and date of birth was verified by preoperative RN using patient name and date of birth on ID band.95%2%3%0%97%98%2%8. Patient identification should always require two unique patient identifiers.

Assessment*

Yes

No
Un-
Known

Na
% Yes
Or No
% Yes Of Yes/No% No Of Yes/N0Evidence-Based Best Practice Principle
The surgeon reconciled any discrepancies using original documents.1%5%4%91%5%95%5%9. Any discrepancies in the information should be resolved by the surgeon, based on primary sources of information, before the patient enters the OR.
Marked properly with verification.34%41%7%18%75%56%44%10. The site should be marked by a healthcare professional familiar with the facility's marking policy, with the accuracy confirmed both by all the relevant information and by an alert patient or patient surrogate if the patient is a minor or mentally incapacitated.
The operative site was marked with the physician's initials.31%40%5%24%71%43%57%11. The site should be marked by the provider's initials.
The time-out was done in the OR.81%16%2%0%98%83%17%13. Separate formal time-outs should be done for separate procedures, including anesthetic blocks, with the person performing that procedure.
The incision was made after the
time-out.
61%6%2%31%67%91%9%14. All noncritical activities should stop during the time-out.
The operative site marking was visible
during the time-out.
53%22%2%23%74%71%29%15. The site mark should be visible and referenced in the prepped and draped field during the time-out.
Verification in the time-out included verification of correct patient, with identification with ID wristband and chart, and verification of procedure and site.50%21%24%5%71%70%30%16. Verification of information during the time-out should require an active communication of specific information, rather than a passive agreement, and be verified against the relevant documents.
The time-out involved the surgeon, anesthesia provider, nursing staff, and surgical technician.70%19%5%6%88%79%21%17. All members of the operating team should verbally verify that their understanding matches the information in the relevant documents.
A member of the operating team raised a specific concern about possible wrong-site surgery at any point before the incision, when the time-out verification or site mark were questionable.8%50%2%41%57%50%50%19. Operating team members who have concerns should not agree to the information given in the time-out if their concerns have not been addressed.
The surgeon responded to a specific
concern a member of the operating team voiced about possible wrong-site surgery.
10%3%2%84%13%97%3%20. Any concerns should be resolved by the surgeon, based on primary sources of information, to the satisfaction of all members of the operating team before proceeding.
Written interpretation of intraoperative images relevant to the case were available in the OR within the time needed to make intraoperative decisions.27%14%6%53%41%85%15%21. Verification of spinal level, rib resection level, or ureter stented should require radiological confirmation, using a stable marker and readings by both a radiologist and the surgeon.
* Total number of responses is 129 for each assessment.
† Best practice principles 2, 12, and 18 were not assessed.
‡ "Yes" responses, when compared to "No" responses, include "NA" responses. ​ ​ ​ ​ ​ ​

 

A. Preoperative verification of the completeness and accuracy of all the information relevant to the operation (principles 1 through 5). At minimum, this information includes the following:

  • Schedule
  • Consent
  • History and physical examination, including office notes if relevant
  • Laboratory results
  • Imaging studies
  • Pathology reports, if relevant

Optimally, this information is all verified to be complete and accurate before the day of elective surgery. Ideally, it would be known to be complete and accurate before leaving the surgeon’s office.

B. Verification and reconciliation of the relevant information and marking of the site by the person doing the procedure on the day of surgery before the patient enters the OR (principles 6 through 11).

C. A properly done time-out, meaning one that actively engages all members of the operating team, references the site mark in the prepped and draped field, and empowers all members of the team to speak up if concerned (principles 12 through 20).

D. When appropriate, intraoperative verification of the anatomic site, specifically for spinal surgery, rib resections, and ureteral stenting. Such verification requires proper localization of the site by imaging studies, ideally with independent confirmation by both the surgeon and an imaging specialist (principle 21).

A. Preoperative verification of the completeness and accuracy of all the information relevant to the operation (principles 1 through 5).

The completeness and accuracy of the information on the consent, regarding the exact procedure and the exact site of the procedure, were deficient in 14% of the analyses of 129 wrong-site events. The correct site was not specified on the schedule according to 10% of the analyses. Information from the surgeons’ records that might have been useful for verification was not available in 7%. Early reconciliation, before the day of surgery, was not done for 6%, not including patients for whom early reconciliation was not possible. The completeness and accuracy of information on the history and physical examination was not assessed.

B. Verification and reconciliation of the relevant information and marking of the site by the person doing the procedure on the day of surgery before the patient enters the OR (principles 6 through 11).

The error analyses revealed that the surgeons did not do preoperative verification with comparison against relevant written information in 20% of wrong-site procedures, whereas the preoperative nurse did not perform verification in 9%. This difference in deficiencies of preoperative verification between surgeons and nurses was statistically significant by chi-square test (X2 = 6.29, p < 0.05). The verification failed to include all relevant patient information in 8% of procedures and did not require the patient to verbalize the information in an active voice (“My name is . . . .”) in 14%. The net effect was that the preoperative nurse failed to do verification, against all relevant information, according to 17% of analyses; and verification by two providers, the nurse and physician, using all relevant information, was deficient in 31% of analyses. Best practice principles with good compliance and minimal deficiencies included the surgeon reconciling discrepancies when they were identified, deficient in only 5% of analyses, and using two identifiers, the least common deficiency, at 2%.

Marking the site properly, including verifying the location against relevant patient information as well as the patient’s understanding, was deficient in 44% of the analyses of wrong-site events in which marking the site was applicable. When marking the site was applicable, the surgeon’s initials were used in only 43% of the analyses, the word “yes” in 41%, and other, unspecified notations, if any, in the remainder of the analyses.

C. A properly-done time-out, meaning one that actively engages all members of the operating team, references the site mark in the prepped and draped field, and empowers all members of the team to speak up if concerned (principles 12 through 20).

Failure to do a time-out in the OR was reported in 17% of the analyses of wrong-site events. The surgeon apparently did not wait for the time-out before making the incision in 9%.

The site marking was not visible in the prepped and draped field during the time-out according to 29% of the analyses. Verification did not include checking information about the patient (identity, procedure, and site) against the written information in 30% of the analyses. The time-out did not involve all members of the operating team in 21%.

As a result, information was not correct or the site mark was not visible during the time-out and team members failed to raise concerns according to 50% of the analyses. However, a concern was raised and the surgeon failed to respond in only 3% of analyses. Specific empowerment by the surgeon, encouraging team members to speak up if concerned, was not assessed.

D. When appropriate, intraoperative verification of the anatomic site, specifically for spinal surgery, rib resections, and ureteral stenting. Such verification requires proper localization of the site by imaging studies, ideally with independent confirmation by both the surgeon and an imaging specialist (principle 21).

Deficiencies of intraoperative verification of the anatomic site, when appropriate, were reported in 15% of analyses.

The objective assessment of the impact of following evidence-based best practice principles to prevent wrong-site surgery, using information from uniform error analyses of 129 wrong-site operative procedures, supports the previously reported subjective analysis of the report narratives.5 All four groups of best practice principles would address deficiencies commonly found in the error analyses of wrong-site operative procedures:

  1. Preoperative verification
  2. Verification and marking of the site by the person doing the procedure on the day of surgery before the patient enters the OR
  3. Properly done time-outs, engaging all members of the operating team, referencing the site mark in the prepped and draped field, and the surgeon empowering all members of the team to speak up if concerned
  4. Intraoperative verification of the anatomic site, when indicated, by imaging studies

Notes

  1. Pelczarski KM, Braun PA, Young E. Hospitals collaborate to prevent wrong-site surgery. Patient Saf Qual Health 2010 Sep-Oct:20-6.
  2. Neily J, Mills PD, Eldridge N et al. Incorrect surgical procedures within and outside of the operating room: a follow-up report. Arch Surg 2011 Jul 18. [epub ahead of print].
  3. Rydrych D. Success in preventing wrong-site procedures in Minnesota with the Minnesota Time Out [online]. Pa Patient Saf Advis 2011 Dec [cited 2011 Dec 1]. Available from Internet: http://patientsafetyauthority.org/ADVISORIES/AdvisoryLibrary/2011/dec8(4)/Pages/home.aspx.
  4. Croteau, Rick (Joint Commission International). Personal communication with: John R. Clarke. 2011 Nov 4.
  5. Clarke JR. Quarterly update: what might be the impact of using evidence-based best practices for preventing wrong-site surgery? [online]. Pa Patient Saf Advis 2011 Sep [cited 2011 Nov 4]. Available from Internet: http://patientsafetyauthority.org/ADVISORIES/AdvisoryLibrary/2011/sep8(3)/Pages/109.aspx.
  6. Pennsylvania Patient Safety Authority. Principles for reliable performance of correct-site surgery [online]. 2010 Dec [cited 2011 Nov 4]. Available from Internet: http://patientsafetyauthority.org/EducationalTools/PatientSafetyTools/PWSS/Pages/principles.aspx.
  7. Quarterly update: the evidence base for best practices for preventing wrong-site surgery [online]. Pa Patient Saf Advis 2010 Dec [cited 2011 Nov 4]. Available from Internet: http://patientsafetyauthority.org/ADVISORIES/AdvisoryLibrary/2010/dec7(4)/Pages/151.aspx.
  8. Blanco M, Clarke JR, Martindell DP. Wrong site surgery near misses and actual occurrences. AORN J 2009 Aug; 90(2):215-8, 221-2.
  9. Pennsylvania Patient Safety Authority. Wrong-site surgery error analysis form [online]. 2010 Aug [cited 2011 Nov 4]. Available from Internet: http://patientsafetyauthority.
    org/EducationalTools/PatientSafetyTools/PWSS/Pages/wss_error_analysis.aspx
    .
  10. Pennsylvania Patient Safety Authority. Associations for key best practice principles in a potential impact analysis of 431 wrong-site procedures [online]. 2011 Sep [cited 2011 Nov 10]. Available from Internet: http://patientsafetyauthority.org/EducationalTools/PatientSafetyTools/PWSS/Pages/p_associations.aspx.
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