RESEARCH
Perioperative Safety in Plastic Surgery Is the World Health Organization Checklist Useful in a Broad Practice? Nataliya Biskup, MD,* Adrienne D. Workman, MD,* Emily Kutzner, BS,* Oluwaseun A. Adetayo, MD,† and Subhas C. Gupta, MD, CM, PhD, FRCSC, FACS* Introduction: In October 2007, the World Health Organization (WHO) introduced the Safe Surgery Saves Lives Program, the cornerstone of which was a 19-item safe-surgery checklist (SSC), in 8 selected hospitals around the world. After implementation, death rates decreased significantly from 1.5% to 0.8% (P = 0.003), inpatient complications reduced from 11% to 7% (P < 0.001), as did rates of surgical site infection (P < 0.001) and wrong-sided surgery (P < 0.47), across all sites. On the basis of these impressive reductions in complications and mortality, our institution adopted the WHO SSC in April 2009, with a few additional measures included, such as assuring presence of appropriate implants and administration of preoperative antibiotics and thromboembolic prophylaxis. Our purpose was to evaluate the efficacy and applicability of the surgical safety checklist in a multisurgeon plastic surgery hospital-based practice, by analyzing its effect on morbidity and outcomes. Methods: A retrospective review of the morbidity and mortality data from the Department of Plastic Surgery at Loma Linda University Medical Center was conducted from January 2006 to July 2012. Data on morbidity and mortality before and after implementation of the surgical safety checklist were analyzed. Results: The most common complications were wound related, including infection, seroma and/or hematoma, dehiscence, and flap-related complications. No significant decrease in the measured complications, neither total nor each specific complication, occurred after the implementation of the SSC. Although verifying appropriate administration of antibiotic, presence of appropriate equipment and materials, performing a preoperative formal pause, and verifying the execution of the other measures included in the SSC is critical, untoward outcomes after implementation of the checklist did not measurably decrease. In its current form as this time, the checklist does not seem to be efficacious in Plastic Surgery. Conclusions: Although certain elements of the WHO SSC checklist are universal and should be adopted, certain specific aspects require modification to improve applicability in a plastic surgery–specific practice. This necessitates the creation of a surgical safety checklist specifically for plastic surgery as other surgical specialties have proposed. Key Words: surgical safety, WHO checklist, surgical safety plastic surgery, applicability of surgical safety checklist (Ann Plast Surg 2016;76: 550–555)
I
n January 2009, the New England Journal of Medicine published a landmark study detailing the World Health Organization's (WHO) implementation of Safe Surgery Saves Lives Program, the cornerstone of which included a Surgical Safety Checklist (Fig. 1).1 The 3-phase 19-item checklist comprised of various perioperative items, directly targeted to assure the execution of specific safety measures. Conducted
Received October 21, 2014, and accepted for publication, after revision, November 22, 2014. From the *Department of Plastic Surgery, Loma Linda University School of Medicine, Loma Linda, CA and †Division of Plastic Surgery, Pediatric Plastic Surgery, Albany Medical Center, Albany, NY. Conflicts of interest and sources of funding: none declared. Reprints: Nataliya Biskup, MD, Department of Plastic Surgery, Loma Linda University School of Medicine, 11175 Campus St, Suite 21126 Loma Linda, CA92354. E-mail: [email protected]. Copyright © 2015 Wolters Kluwer Health, Inc. All rights reserved. ISSN: 0148-7043/16/7605–0550 DOI: 10.1097/SAP.0000000000000427
550
www.annalsplasticsurgery.com
in 8 worldwide hospitals from October 2007 through September of 2008, this prospective study compared a cohort of 3733 surgical patients before and 3955 surgical patients after implementation of the WHO checklist.1 The implementation of the checklist led to impressive, significant decreases in death rates from 1.5% to 0.8% (P = 0.003), inpatient complications from 11% to 7% (P < 0.001), rates of surgical site infection (P < 0.001), and wrong-sided surgery (P < 0.47). Since this publication, the capacity of a checklist to reduce complications and improve outcomes has been confirmed repeatedly in broad surgical practice.1–9 By April of 2009, Loma Linda University Medical Center (LLUMC) adopted an institution-specific surgical safety checklist. The checklist integrated the WHO surgical safety checklist with the Joint Commission's Universal Protocol and the National Quality Foundation Patient Safety Goals (Fig. 2). The Department of Plastic Surgery at LLUMC, a multisurgeon plastic surgery hospital–based practice, sought to evaluate the checklist's effect on complication rates and outcomes of core surgical safety measures.
METHODS After obtaining appropriate approval from the institutional review board at LLUMC, a retrospective review of all intradepartmental, plastic surgery–specific complications over the period of January 2006 through July 2012 was conducted. Data were obtained from the following 2 sources: (1) intradepartmental morbidity and mortality reporting of postsurgical complications and (2) a search of the department's entire patient database for patients with International Classification of Diseases, Ninth Revision (ICD-9) diagnoses consistent with postsurgical complications, detailed in Table 1. By verifying and combining the data from morbidity and mortality reporting with the data obtained from the ICD-9 query, we were able to obtain a comprehensive and accurate list of all postsurgical complications. Additional data for each complication included date and type of the complication; patient's age, sex, and diagnosis; date and name of index operation; and date of any returns to operating room or hospital. Our institution implemented the surgical safety checklist on April 1, 2009. Thus, we divided our complications based on the date of initial/index operation which led to the complication. If the index operations occurred before April 1, 2009, the associated complication was designated as one occurring before checklist implementation. If the index operation occurred on/after April 1, 2009, the associated complication was designated as one occurring after checklist implementation (Tables 2 and 3). Complications were further subdivided into those occurring within 30 days of the index operation, as defined in the study of the surgical safety checklist of Haynes et al,1 and those occurring beyond 30 days. All patient data were stored and accessed on password-protected institutional computers in a departmental office accessible only to authorized individuals.
Statistics Given the categorical nature of our data, bivariate analysis was performed using Fisher exact test. All tests were 2-sided, with statistical Annals of Plastic Surgery • Volume 76, Number 5, May 2016
Copyright © 2016 Wolters Kluwer Health, Inc. All rights reserved.
Annals of Plastic Surgery • Volume 76, Number 5, May 2016
Perioperative Safety in Plastic Surgery
FIGURE 1. World Health Organization surgical safety checklist.
FIGURE 2. Loma Linda University Medical Center surgical safety checklist. © 2015 Wolters Kluwer Health, Inc. All rights reserved.
www.annalsplasticsurgery.com
Copyright © 2016 Wolters Kluwer Health, Inc. All rights reserved.
551
Annals of Plastic Surgery • Volume 76, Number 5, May 2016
Biskup et al
TABLE 1. ICD-9 Complication Codes Quarried Cardiac complications
997.1, 410.0-410.9, 998.0 Cardiac complications, acute myocardial infarction 997.3 Respiratory complications from a procedure 415.1 Respiratory complications, pulmonary embolism 997.2 Peripheral vascular complications (includes phlebitis, thrombophlebitis) 997.0 Nervous system complications 997.00 Nervous system complications, unspecified 997.01 Central nervous system complication: anoxic brain damage or cerebral hypoxia (not stroke or infarction 997.02) 997.09 Other nervous system complications 998.1 Complications of hematoma, etc 998.11 Hemorrhage complicating a procedure 998.12 Hematoma complicating a procedure 998.13 Seroma complicating a procedure 998.2 Accidental puncture or laceration during a procedure E870.0 Accidental puncture or laceration during a surgical operation 998.3 Disruption of operative wound 998.31 Disruption of internal operation wound 998.32 Disruption of external operation wound 998.83 Non-healing surgical wound 998.5, 999.3 Postoperative infections 998.51 Infected postoperative seroma 998.59 Other postoperative infection (abscess) 998.8 Other specified complications of procedures, NEC 998.89 Other specified complications 998.9 Unspecified complication of procedure, not elsewhere classified 999.9 Unspecified or unclassified complications of medical care,
Respiratory complications Peripheral vascular complications CNS complications
Complications of hematomas
Complication of accidental cut, puncture, or hemorrhage during a procedure Complication of operative wound
Postoperative infection
Other complications
significance set at a probability value of 0.05 or less. Analyses were performed using MedCalc Statistical Software, version 14.8.1.0.
RESULTS The Department of Plastic and Reconstructive Surgery at Loma Linda University is an academic plastic surgery practice consisting of 8 board-certified plastic surgeons who operate in both inpatient and outpatient settings. More specific details of our practice are provided in Table 4, including percentage of inpatient versus outpatient surgery and percentage of surgical procedure types. A total of 2166 patients were operated on before list implementation (January 1, 2006–March 31, 2009) and a total of 2310 patients after checklist implementation (April 1, 2009–June 30, 2012). On the basis of analysis of complications acquired before and after checklist implementation, the surgical safety checklist did not seem to contribute to a significant decrease in complications; neither early (30 days) complications were reduced (Table 2). Neither could a decrease in complication
rates be demonstrated when the total complications were subdivided based on specific complication type (Table 3). Surprisingly, even the incidence of surgical site infection, both total and infection within 30 days of index surgery, was not reduced by checklist implementation. No wrong-sided surgery or retention of foreign body occurred before or after implementation.
DISCUSSION In light of these findings, the surgical safety checklist in its current form does not seem to be effective in reducing complications in plastic surgery. The broad application of a preoperative formal pause seems to help improve staff awareness and communication between team members. Namely, it has been shown to increase awareness of the patient's medical history, medication, and allergies; roles among the team members; and possible critical events.10,11 Undoubtedly, the checklist promotes a culture of safety within the operating room.
TABLE 2. Total Late and Early Complications Before and After Checklist Implementation
Complications
Less than 30 d of operation More than 30 d of operation Total
552
Before List Implementation (June 2006-March 31, 2009), n = 2166
Complications per Year
After List Implementation (April 1, 2009-June 2012), n = 2310
Complications per Year
P
101
37.9
104
32.8
0.830
28
10.5
29
9.2
129
48.4
133
42.0
www.annalsplasticsurgery.com
1 0.799
© 2015 Wolters Kluwer Health, Inc. All rights reserved.
Copyright © 2016 Wolters Kluwer Health, Inc. All rights reserved.
Annals of Plastic Surgery • Volume 76, Number 5, May 2016
Perioperative Safety in Plastic Surgery
TABLE 3. Specific Complications Before and After Checklist Implementation Total Complications
Dehiscence Infection
Perioperative Safety in Plastic Surgery Is the World Health Organization Checklist Useful in a Broad Practice? Nataliya Biskup, MD,* Adrienne D. Workman, MD,* Emily Kutzner, BS,* Oluwaseun A. Adetayo, MD,† and Subhas C. Gupta, MD, CM, PhD, FRCSC, FACS* Introduction: In October 2007, the World Health Organization (WHO) introduced the Safe Surgery Saves Lives Program, the cornerstone of which was a 19-item safe-surgery checklist (SSC), in 8 selected hospitals around the world. After implementation, death rates decreased significantly from 1.5% to 0.8% (P = 0.003), inpatient complications reduced from 11% to 7% (P < 0.001), as did rates of surgical site infection (P < 0.001) and wrong-sided surgery (P < 0.47), across all sites. On the basis of these impressive reductions in complications and mortality, our institution adopted the WHO SSC in April 2009, with a few additional measures included, such as assuring presence of appropriate implants and administration of preoperative antibiotics and thromboembolic prophylaxis. Our purpose was to evaluate the efficacy and applicability of the surgical safety checklist in a multisurgeon plastic surgery hospital-based practice, by analyzing its effect on morbidity and outcomes. Methods: A retrospective review of the morbidity and mortality data from the Department of Plastic Surgery at Loma Linda University Medical Center was conducted from January 2006 to July 2012. Data on morbidity and mortality before and after implementation of the surgical safety checklist were analyzed. Results: The most common complications were wound related, including infection, seroma and/or hematoma, dehiscence, and flap-related complications. No significant decrease in the measured complications, neither total nor each specific complication, occurred after the implementation of the SSC. Although verifying appropriate administration of antibiotic, presence of appropriate equipment and materials, performing a preoperative formal pause, and verifying the execution of the other measures included in the SSC is critical, untoward outcomes after implementation of the checklist did not measurably decrease. In its current form as this time, the checklist does not seem to be efficacious in Plastic Surgery. Conclusions: Although certain elements of the WHO SSC checklist are universal and should be adopted, certain specific aspects require modification to improve applicability in a plastic surgery–specific practice. This necessitates the creation of a surgical safety checklist specifically for plastic surgery as other surgical specialties have proposed. Key Words: surgical safety, WHO checklist, surgical safety plastic surgery, applicability of surgical safety checklist (Ann Plast Surg 2016;76: 550–555)
I
n January 2009, the New England Journal of Medicine published a landmark study detailing the World Health Organization's (WHO) implementation of Safe Surgery Saves Lives Program, the cornerstone of which included a Surgical Safety Checklist (Fig. 1).1 The 3-phase 19-item checklist comprised of various perioperative items, directly targeted to assure the execution of specific safety measures. Conducted
Received October 21, 2014, and accepted for publication, after revision, November 22, 2014. From the *Department of Plastic Surgery, Loma Linda University School of Medicine, Loma Linda, CA and †Division of Plastic Surgery, Pediatric Plastic Surgery, Albany Medical Center, Albany, NY. Conflicts of interest and sources of funding: none declared. Reprints: Nataliya Biskup, MD, Department of Plastic Surgery, Loma Linda University School of Medicine, 11175 Campus St, Suite 21126 Loma Linda, CA92354. E-mail: [email protected]. Copyright © 2015 Wolters Kluwer Health, Inc. All rights reserved. ISSN: 0148-7043/16/7605–0550 DOI: 10.1097/SAP.0000000000000427
550
www.annalsplasticsurgery.com
in 8 worldwide hospitals from October 2007 through September of 2008, this prospective study compared a cohort of 3733 surgical patients before and 3955 surgical patients after implementation of the WHO checklist.1 The implementation of the checklist led to impressive, significant decreases in death rates from 1.5% to 0.8% (P = 0.003), inpatient complications from 11% to 7% (P < 0.001), rates of surgical site infection (P < 0.001), and wrong-sided surgery (P < 0.47). Since this publication, the capacity of a checklist to reduce complications and improve outcomes has been confirmed repeatedly in broad surgical practice.1–9 By April of 2009, Loma Linda University Medical Center (LLUMC) adopted an institution-specific surgical safety checklist. The checklist integrated the WHO surgical safety checklist with the Joint Commission's Universal Protocol and the National Quality Foundation Patient Safety Goals (Fig. 2). The Department of Plastic Surgery at LLUMC, a multisurgeon plastic surgery hospital–based practice, sought to evaluate the checklist's effect on complication rates and outcomes of core surgical safety measures.
METHODS After obtaining appropriate approval from the institutional review board at LLUMC, a retrospective review of all intradepartmental, plastic surgery–specific complications over the period of January 2006 through July 2012 was conducted. Data were obtained from the following 2 sources: (1) intradepartmental morbidity and mortality reporting of postsurgical complications and (2) a search of the department's entire patient database for patients with International Classification of Diseases, Ninth Revision (ICD-9) diagnoses consistent with postsurgical complications, detailed in Table 1. By verifying and combining the data from morbidity and mortality reporting with the data obtained from the ICD-9 query, we were able to obtain a comprehensive and accurate list of all postsurgical complications. Additional data for each complication included date and type of the complication; patient's age, sex, and diagnosis; date and name of index operation; and date of any returns to operating room or hospital. Our institution implemented the surgical safety checklist on April 1, 2009. Thus, we divided our complications based on the date of initial/index operation which led to the complication. If the index operations occurred before April 1, 2009, the associated complication was designated as one occurring before checklist implementation. If the index operation occurred on/after April 1, 2009, the associated complication was designated as one occurring after checklist implementation (Tables 2 and 3). Complications were further subdivided into those occurring within 30 days of the index operation, as defined in the study of the surgical safety checklist of Haynes et al,1 and those occurring beyond 30 days. All patient data were stored and accessed on password-protected institutional computers in a departmental office accessible only to authorized individuals.
Statistics Given the categorical nature of our data, bivariate analysis was performed using Fisher exact test. All tests were 2-sided, with statistical Annals of Plastic Surgery • Volume 76, Number 5, May 2016
Copyright © 2016 Wolters Kluwer Health, Inc. All rights reserved.
Annals of Plastic Surgery • Volume 76, Number 5, May 2016
Perioperative Safety in Plastic Surgery
FIGURE 1. World Health Organization surgical safety checklist.
FIGURE 2. Loma Linda University Medical Center surgical safety checklist. © 2015 Wolters Kluwer Health, Inc. All rights reserved.
www.annalsplasticsurgery.com
Copyright © 2016 Wolters Kluwer Health, Inc. All rights reserved.
551
Annals of Plastic Surgery • Volume 76, Number 5, May 2016
Biskup et al
TABLE 1. ICD-9 Complication Codes Quarried Cardiac complications
997.1, 410.0-410.9, 998.0 Cardiac complications, acute myocardial infarction 997.3 Respiratory complications from a procedure 415.1 Respiratory complications, pulmonary embolism 997.2 Peripheral vascular complications (includes phlebitis, thrombophlebitis) 997.0 Nervous system complications 997.00 Nervous system complications, unspecified 997.01 Central nervous system complication: anoxic brain damage or cerebral hypoxia (not stroke or infarction 997.02) 997.09 Other nervous system complications 998.1 Complications of hematoma, etc 998.11 Hemorrhage complicating a procedure 998.12 Hematoma complicating a procedure 998.13 Seroma complicating a procedure 998.2 Accidental puncture or laceration during a procedure E870.0 Accidental puncture or laceration during a surgical operation 998.3 Disruption of operative wound 998.31 Disruption of internal operation wound 998.32 Disruption of external operation wound 998.83 Non-healing surgical wound 998.5, 999.3 Postoperative infections 998.51 Infected postoperative seroma 998.59 Other postoperative infection (abscess) 998.8 Other specified complications of procedures, NEC 998.89 Other specified complications 998.9 Unspecified complication of procedure, not elsewhere classified 999.9 Unspecified or unclassified complications of medical care,
Respiratory complications Peripheral vascular complications CNS complications
Complications of hematomas
Complication of accidental cut, puncture, or hemorrhage during a procedure Complication of operative wound
Postoperative infection
Other complications
significance set at a probability value of 0.05 or less. Analyses were performed using MedCalc Statistical Software, version 14.8.1.0.
RESULTS The Department of Plastic and Reconstructive Surgery at Loma Linda University is an academic plastic surgery practice consisting of 8 board-certified plastic surgeons who operate in both inpatient and outpatient settings. More specific details of our practice are provided in Table 4, including percentage of inpatient versus outpatient surgery and percentage of surgical procedure types. A total of 2166 patients were operated on before list implementation (January 1, 2006–March 31, 2009) and a total of 2310 patients after checklist implementation (April 1, 2009–June 30, 2012). On the basis of analysis of complications acquired before and after checklist implementation, the surgical safety checklist did not seem to contribute to a significant decrease in complications; neither early (30 days) complications were reduced (Table 2). Neither could a decrease in complication
rates be demonstrated when the total complications were subdivided based on specific complication type (Table 3). Surprisingly, even the incidence of surgical site infection, both total and infection within 30 days of index surgery, was not reduced by checklist implementation. No wrong-sided surgery or retention of foreign body occurred before or after implementation.
DISCUSSION In light of these findings, the surgical safety checklist in its current form does not seem to be effective in reducing complications in plastic surgery. The broad application of a preoperative formal pause seems to help improve staff awareness and communication between team members. Namely, it has been shown to increase awareness of the patient's medical history, medication, and allergies; roles among the team members; and possible critical events.10,11 Undoubtedly, the checklist promotes a culture of safety within the operating room.
TABLE 2. Total Late and Early Complications Before and After Checklist Implementation
Complications
Less than 30 d of operation More than 30 d of operation Total
552
Before List Implementation (June 2006-March 31, 2009), n = 2166
Complications per Year
After List Implementation (April 1, 2009-June 2012), n = 2310
Complications per Year
P
101
37.9
104
32.8
0.830
28
10.5
29
9.2
129
48.4
133
42.0
www.annalsplasticsurgery.com
1 0.799
© 2015 Wolters Kluwer Health, Inc. All rights reserved.
Copyright © 2016 Wolters Kluwer Health, Inc. All rights reserved.
Annals of Plastic Surgery • Volume 76, Number 5, May 2016
Perioperative Safety in Plastic Surgery
TABLE 3. Specific Complications Before and After Checklist Implementation Total Complications
Dehiscence Infection
