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The Culture of Patient Safety Practice: Systematic Review
Author's Accepted Manuscript The Culture of Patient Safety Practice: Systematic Review Kevin A. Van, Leticia Nogueira, Diedra Gustafson, Wenda Tieu, Timothy D. Averch, Fernando J. Kim
PII: DOI: Reference:
S2352-0779(16)30215-1 10.1016/j.urpr.2016.08.003 URPR 233
To appear in: Urology Practice Accepted Date: 4 August 2016 Please cite this article as: Van KA, Nogueira L, Gustafson D, Tieu W, Averch TD, Kim FJ, The Culture of Patient Safety Practice: Systematic Review, Urology Practice (2016), doi: 10.1016/j.urpr.2016.08.003. DISCLAIMER: This is a PDF file of an unedited manuscript that has been accepted for publication. As a service to our subscribers we are providing this early version of the article. The paper will be copy edited and typeset, and proof will be reviewed before it is published in its final form. Please note that during the production process errors may be discovered which could affect the content, and all legal disclaimers that apply to The Journal pertain. All press releases and the articles they feature are under strict embargo until uncorrected proof of the article becomes available online. We will provide journalists and editors with full-text copies of the articles in question prior to the embargo date so that stories can be adequately researched and written. The standard embargo time is 12:01 AM ET on that date.
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The Culture of Patient Safety Practice: Systematic Review
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Kevin A. Van, Leticia Nogueira, Diedra Gustafson, Wenda Tieu, Timothy D. Averch, Fernando J. Kim
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Safety Culture, Safety Practice, Safety Standards ABSTRACT
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INTRODUCTION
Regulations and guidelines are essential components for maintaining the safety
throughout multiple industries. Within healthcare, these processes exist to help distinguish
SC
weaknesses in patient care and identify adverse events. The purpose of this manuscript is to review the processes that have been established in healthcare to promote the culture of patient
M AN U
safety. METHODS
Sources were acquired through the National Center for Biotechnology Information database using the keywords “safety”, “World Health Organization”, and “Joint Commission on
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Accreditation of Healthcare Organizations”. Other sources were obtained through research into specific safety processing topics of both industrial and non-industrial institutions. RESULTS/DISCUSSION
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The organizational properties of patient care expand beyond the number of incidents an institution experiences and include having standardized safety values of specific patient care
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procedures. Tools such as SBAR, Reason’s Swiss Cheese model, and the general guidelines established by the World Health Organization have been employed in order to detect and reduce the likelihood of errors in patient practice. These tools also demonstrate the importance of adapting regulated checklists and protocols that are essential in every stage of patient care. CONCLUSION
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While various systems have been implemented throughout the healthcare industry to overcome processing weaknesses, a continued display of effectiveness and improvement upon current subspecialty-specific guidelines are necessary for the assurance of safety in
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EP
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contemporary patient care.
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INTRODUCTION The idea of safety has been a primary objective in all industrial and non-industrial organizations and has influenced countless guidelines and protocols which ensure that safety is
RI PT
maintained (1-3). In the manufacturing industry, Toyota developed protocols to ensure the safety of both workers and customers (2). Other companies such as Motorola have also adapted similar techniques as a means to promote and regulate safety culture (3). In healthcare, protocols are
SC
continually being developed and improved in patient processing in order to assure safety
measures (4, 5). Standards in the quality of healthcare facilities began in the United States with
M AN U
the “Minimum Standards for Hospitals”, which was later followed by necessary accreditation in all healthcare organizations from the Joint Commission on Accreditation of Healthcare Organizations (JCAHO) (6, 7).
The idea of safe practice in patient safety culture (PSC) has been an important aspect for
TE D
advancement in healthcare since its introduction in the Institute of Medicine (IOM) report To Err is Human (5, 8, 9). PSC embodies properties in patient care guidelines and processes that are crucial for preventing adverse events in healthcare. Organizational properties for PSC extend
EP
beyond the number of incidents in patient processing and include established safety values and knowledge of specific patient care protocols (10). Insufficient patient safety guidelines and poor
AC C
communication in the work environment all impede patient safety practices (4, 11). Therefore, the healthcare industry has implemented tools such as SBAR (Situation, Background, Assessment, and Recommendation), Reason’s Swiss Cheese model (Figure 1), general guidelines established by the World Health Organization (WHO), and the National Surgical Quality Improvement Program® (NSQIP) (11-14).
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Patient safety processes are constantly evolving to ensure that harm toward all patients is prevented and general ideals in patient care throughout the healthcare industry are improved and
established in healthcare to promote the culture of patient safety.
METHODS
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advanced (8). The purpose of this manuscript is to review the processes that have been
SC
Sources were initially found by searching the keyword “safety” in the National Center for Biotechnology Information (NCBI) database. After selecting articles using the keyword
M AN U
“safety”, articles that were similar in content were also acquired from the PubMed suggestions that were provided by the NCBI database. Other key terms that were used for research in the NCBI database were “medical error” and “WHO”. The same process was used to acquire articles from the keyword search in the NCBI database. PubMed recommendations were also reviewed.
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Other sources were also acquired through the NCBI database by searching “Joint Commission on Accreditation of Healthcare Organizations”. Research outside of the NCBI database included the search of “Lean Manufacturing” and “Toyota Production” on the Art of Lean website, “Six
EP
Sigma”, “SBAR”, the history of the WHO, and SURPASS (SURgical PAtient Safety System).
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RESULTS/DISCUSSION
Regulations in safety are pervasive in both industrial and non-industrial corporations (1-
3, 5, 8). Initially established by machine shop owner Taiichi Ohno between 1945 and 1955, Toyota developed models such as the Toyota Production System (TPS) and lean manufacturing in order to improve operational efficiency and ensure the safety of both workers and customers (2). The primary objective of both systems is to combine the management and production aspects
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of the company to provide high quality products for its customers while maximizing profit (1, 2). TPS and lean also emphasize the significance of safety over productivity and how the need for continual improvement benefits any organization (2). Motorola also adapted a similar system
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called the Six Sigma technique that promotes and regulates safety culture through five phases: Define, Measure, Analyze, Improve, and Control (DMAIC) (3). Since its introduction in 1987, these phases have helped reduce the number of manufacturing accidents from unsafe behavior
SC
and evaluate work hazards (3). Regulations regarding the quality of healthcare facilities in the United States began with the “Minimum Standards for Hospitals” of 1917 from the American
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College of Surgeons. This consisted of five fundamental requirements for hospital organizations that were considered essential for patient processing, and if a hospital did not meet this criterion, they were not deemed a ‘first-class institution’ (6, 7). The Minimum Standards were later followed by mandated accreditation of healthcare organizations in the United States from
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JCAHO in 1951 (6). Accreditation of medical services through JCAHO provides certification for all healthcare providers and incorporated standards for proper patient care in safety (6). Today, these standards focus on the fundamental guidelines of both patient and organizational processes
EP
that are necessary in providing safe and improved performance in patient care. In any medical setting, the primary concern for all healthcare providers revolves around
AC C
the welfare and safety of patients (4, 5, 11, 15). Principles of patient safety have significantly improved and have received much more attention in the past two decades since the concept was established, but continual improvement to the practice of safety still remains a challenge (5, 9). While the potential for patient harm is unavoidable in any healthcare system, inefficiencies within patient processing steps are more frequently related to adverse events than technical mistakes made during operations (11). The 1991 Harvard Medical Practice Study analyzed
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medical records of patients admitted to 51 acute care hospitals in New York State and examined the proportion of cases with adverse events from pre-operational and post-operational issues. Of the 30,121 records reviewed, adverse events transpired in 3.7% of admissions with 58% of those
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occurrences deemed preventable (15, 16). These findings emphasized the significance of patient safety practice and illuminated the errors within the practices of providers and policy-makers in healthcare.
SC
Errors that remain undetected throughout several levels of patient processing (Figure 2) contribute to the development of adverse events (4, 11). Without proper group-specific processes
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and guidelines within patient care processing, risk to the patient’s well-being is greatly amplified (11). One issue that arises from errors includes the “culture of blame” which prevents healthcare personnel from admitting a mistake or fault due to the fear of being penalized (11, 17). In an analysis of the “culture of blame” from The Hastings Center Report, only 22% of physicians,
TE D
nurses, and administrators surveyed believed that the responsibilities surrounding patient safety were shared equally (17). Systems like SBAR have been established to accommodate these issues in pre-, peri-, and post-operative patient safety regulations. Since its introduction to the
EP
healthcare industry in the late 1900’s, SBAR has been an effective standardizing tool used to convey important information among different healthcare personnel (11, 18). This mode of
AC C
communication helps regulate shared expectations in any healthcare situation and allows staff to efficiently and accurately pass along patient information (18). Kim et al. mentions that SBAR also allows all parties to proactively seek recommendations and necessary information to resolve the issues presented (11).
Every stage involved in patient processing has the potential for errors (9, 11). While SBAR presents an established protocol of communication in healthcare organizations, re-
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examination of patient information in subsequent levels of processing is also necessary to prevent adverse events (4, 9, 11). James T. Reason and Dante Orlandella proposed the “Swiss Cheese Model” to illustrate this idea in patient safety practice (11, 19). The model theorizes that
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patient processing is similar to a stack of Swiss cheese slices; the holes are opportunities for a mistake to pass through and the cheese is the “defensive layers” that guard from failure (11, 19). Errors in one of the defensive layers can result in the problem passing on to the next level of
SC
processing which would either be caught by the subsequent layer or pass through to the next defensive stage. If the problem continues unnoticed through all defensive layers, the mistake can
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result in an adverse event (11, 19). The “Swiss Cheese Model” modulates how failures can arise in patient practice if accidents and errors are aligned and are not caught by successive layers of defense (11, 19). It also demonstrates the importance of regulated checklists and protocols that are necessary in all stages of patient care (11) .
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WHO was formed in 1948 after the initial United Nations meeting in 1945 (20). WHO is responsible for the coordination and establishment of international health regulations throughout the United Nations (20). In 2007, WHO launched the Safe Surgery Saves Lives Campaign in
EP
order to improve the safety regulations surrounding surgical procedures. The WHO Surgical Safety Checklist and WHO Guidelines for Safe Surgery of 2009 helped introduce perioperational
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checklists and improved operational teamwork (21, 22). The full implementation of these protocols from WHO have been linked to improved outcomes in patient care through its method of identifying and correcting potential processing errors during surgical procedures (11, 20, 21, 23). Even though the WHO checklist applies primarily to operating procedures, other guidelines and checklists have been established to address events involved with patient processing before and after the surgical procedure (24). The SURPASS checklist involves other areas for regulated
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safety protocols and is not catered to any specific level of processing (24). SURPASS is the original evidence-based checklist that addresses patient safety coordination during admission and discharge (24). In 2004, the Joint Commission also developed the Universal Protocol (UP) for
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Preventing Wrong Site, Wrong Procedure, and Wrong Person Surgery which established
regulations for preoperative verifications and a “time out” immediately before procedures for patient corroboration (24). Preoperative verifications from the UP of Joint Commission in patient
SC
processing are quintessential in the practice of patient safety (24). UP for Preventing Wrong Site, Wrong Procedure, and Wrong Person Surgery is necessary not only in the operating room,
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but also during appointment scheduling and whenever patients enter the healthcare facility (24).
CONCLUSION
The endeavors and undertakings of the healthcare industry have all contributed to the
TE D
development of safety processes in both preceding and contemporary patient care regulations. While protocols such as SBAR and those developed by WHO have contributed immensely to current patient safety practices, continual improvement to present-day guidelines
EP
is still imperative throughout patient safety processing. Recurrent ideals that have been mentioned for improvement include enhanced team-based modes of patient care and checklists
AC C
that can be adaptable to serve a any hospital setting or system of operation. The development and adoption of refined protocols in patient processing requires not only a continued display of effectiveness in current guidelines, but also the ongoing modification of organization-specific regulations of error prevention in patient safety practice.
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REFERENCES
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1. Mathis T. What Can Safety Learn from Lean? 2012. Available from: http://ehstoday.com/safety/what-can-safety-learn-lean 2. Toyota. Toyota Production System Basic Handbook. Art of Lean, Inc. Available from: http://www.artoflean.com/files/Basic_TPS_Handbook_v1.pdf 3. Ateekh-ur-Rehman L. Safety Management in a Manufacturing Company: Six Sigma Approach. Engineering [Internet]. 2012; 4(7):[400-7 pp.]. Available from: http://www.scirp.org/journal/PaperInformation.aspx?PaperID=20540. 4. ABC of Patient Safety. Sandars J, Cook G, editors. Walden, MA: BMJ Books; 2007. 5. Graham S, Brookey J, Steadman C. Patient Safety Executive Walkarounds. Advances in Patient Safety: From Research to Implementation (Volume 4: Programs, Tools, and Products). 4. Rockville, MD: Agency for Healthcare Research and Quality (US); 2005. 6. Alkhenizan A, Shaw C. Impact of accreditation on the quality of healthcare services: a systematic review of the literature. Ann Saudi Med. 2011;31(4):407-16. 7. Melo S, Beck M. Quality management and managerialism in healthcare : a critical historical survey. Houndmills, Basingstoke, Hampshire ; New York, NY: Palgrave Macmillan; 2014. viii, 217 pages p. 8. Kohn LT, Corrigan JM, Donaldson MS. To Err Is Human: Building a Safer Health System. Institute of Medicine; 1999. 9. Emanuel L, Berwick D, Conway J, et al. What Exactly is Patient Safety? In: Henriksen K, Battles J, Keyes M, editors. Advances in Patient Safety: New Directions and Alternative Approaches (Vol 1: Assessment). 1. Rockville, MD: Agency for Healthcare Research and Quality; 2008. 10. Reiman T, Pietikäinen E, Oedewald P. Multilayered approach to patient safety culture. Qual Saf Health Care. 2010;19(5):e20. 11. Kim FJ, da Silva RD, Gustafson D, et al. Current issues in patient safety in surgery: a review. Patient Saf Surg. 2015;9:26. 12. Borgmann H, Helbig S, Reiter MA, et al. Utilization of surgical safety checklists by urological surgeons in Germany: a nationwide prospective survey. Patient Saf Surg. 2015;9:37. 13. Hill MR, Roberts MJ, Alderson ML, et al. Safety culture and the 5 steps to safer surgery: an intervention study. Br J Anaesth. 2015;114(6):958-62. 14. de Vries AH, Boute MC, Kuppen MC, et al. Patient Safety Risks of Basic Urological Procedures Performed by Junior and Senior Residents. J Surg Educ. 2015;72(5):918-26. 15. Weingart SN, Wilson RM, Gibberd RW, et al. Epidemiology of medical error. BMJ. 2000;320(7237):774-7. 16. Brennan TA, Leape LL. Adverse events, negligence in hospitalized patients: results from the Harvard Medical Practice Study. Perspect Healthc Risk Manage. 1991;11(2):2-8. 17. Ramsey G. Nurses, medical errors, and the culture of blame. Hastings Cent Rep. 2005;35(2):20-1. 18. SBAR Overview and Introduction Available from: SaferHealthCare.com 19. Reason J. Human error: models and management. BMJ. 2000;320(7237):768-70. 20. World Health Organization. Patient Safety Curriculum Guide: Multi-professional Edition. World Health Organization 2011. 21. Nishiwaki K, Ichikawa T. WHO Surgical Safety Checklist and guideline for safe surgery 2009. Masui. 2014;63(3):246-54.
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LEGEND
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22. World Health Organization. WHO Surgical Safety Checklist (First Edition). 2008. 23. Braham DL, Richardson AL, Malik IS. Application of the WHO surgical safety checklist outside the operating theatre: medicine can learn from surgery. Clin Med (Lond). 2014;14(5):468-74. 24. Shekelle PG, Wachter RM, Pronovost PJ, et al. Making health care safer II: an updated critical analysis of the evidence for patient safety practices. Evid Rep Technol Assess (Full Rep). 2013(211):1-945.
Figure 1. Swiss Cheese Model A) The potential for error at each stage is aligned and lack
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successive barriers, so an adverse event can occur. B) The potential for error at each stage is not aligned and include successive barriers, so an adverse event is not as likely to occur.
Figure 2. Step Model A) A surgical safety checklist viewed as a staircase-step model. B) An adverse event visualized in the staircase-step model.
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Lack in verification of site for surgical procedure
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Lack in verification of site for surgical procedure
B.
Patient received procedure on the wrong surgical site
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A.
Pre-operative team checked, re-confirmed, and prevented surgery on the wrong side
Patient received procedure on the correct surgical site
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Before Skin Incision
Before Leaving OR
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Before Anesthesia
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7
6
5 Confirm Team Intro
3 2 1
Verify
Check
A.
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Identity Site Procedure Consent Site Mark
8 Imaging Check
Verbal Nurse Confirm
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Patient Confirm
Verbal Team Confirm
9
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4
Review Critical Events
Confirm Antibiotic
10
Anesthesia Airway
Allergy Blood-loss Risk
Anesthesia Surgical team
Patient Site Procedure
Bleeding Instability Organ injury
Allergy Reaction Administration
Site Side Organ
Procedure Instrument Specimen Equipment
Handoff
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Before Skin Incision
Before Leaving OR
Shortcut/ Lack of verification of Allergy Blood-loss Risk
7
5
Verbal Team Confirm
4 2
Confirm Team Intro
Check
B.
Anesthesia Airway
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Patient is allergic to Penicillin
Allergy Blood-loss Risk
Anesthesia Surgical team
Patient Site Procedure
Confirm Antibiotic
10 9 Imaging Check
Verbal Nurse Confirm
Site Side Organ
Procedure Instrument Specimen Equipment
8
Adverse Event due to the lack of verification of Penicillin allergy
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Patient Confirm
Identity Site Procedure Consent Site Mark
Review Critical Events
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1
Verify
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6
3
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Before Anesthesia
Bleeding Instability Organ injury
Allergy Reaction Administration
Handoff
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Key of Definition for Abbreviations
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WHO- World Health Organization JCAHO- Joint Commission on Accreditation of Healthcare Organizations PSC- Patient Safety Culture SBAR- Situation, Background, Assessment, Recommendation NCBI- National Center for Biotechnology Information TPS- Toyota Production System SURPASS- Surgical Patient Safety System UP- Universal Protocol for Preventing Wrong Site, Wrong Procedure, and Wrong Person Surgery
PII: DOI: Reference:
S2352-0779(16)30215-1 10.1016/j.urpr.2016.08.003 URPR 233
To appear in: Urology Practice Accepted Date: 4 August 2016 Please cite this article as: Van KA, Nogueira L, Gustafson D, Tieu W, Averch TD, Kim FJ, The Culture of Patient Safety Practice: Systematic Review, Urology Practice (2016), doi: 10.1016/j.urpr.2016.08.003. DISCLAIMER: This is a PDF file of an unedited manuscript that has been accepted for publication. As a service to our subscribers we are providing this early version of the article. The paper will be copy edited and typeset, and proof will be reviewed before it is published in its final form. Please note that during the production process errors may be discovered which could affect the content, and all legal disclaimers that apply to The Journal pertain. All press releases and the articles they feature are under strict embargo until uncorrected proof of the article becomes available online. We will provide journalists and editors with full-text copies of the articles in question prior to the embargo date so that stories can be adequately researched and written. The standard embargo time is 12:01 AM ET on that date.
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The Culture of Patient Safety Practice: Systematic Review
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Kevin A. Van, Leticia Nogueira, Diedra Gustafson, Wenda Tieu, Timothy D. Averch, Fernando J. Kim
ACCEPTED MANUSCRIPT
Safety Culture, Safety Practice, Safety Standards ABSTRACT
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INTRODUCTION
Regulations and guidelines are essential components for maintaining the safety
throughout multiple industries. Within healthcare, these processes exist to help distinguish
SC
weaknesses in patient care and identify adverse events. The purpose of this manuscript is to review the processes that have been established in healthcare to promote the culture of patient
M AN U
safety. METHODS
Sources were acquired through the National Center for Biotechnology Information database using the keywords “safety”, “World Health Organization”, and “Joint Commission on
TE D
Accreditation of Healthcare Organizations”. Other sources were obtained through research into specific safety processing topics of both industrial and non-industrial institutions. RESULTS/DISCUSSION
EP
The organizational properties of patient care expand beyond the number of incidents an institution experiences and include having standardized safety values of specific patient care
AC C
procedures. Tools such as SBAR, Reason’s Swiss Cheese model, and the general guidelines established by the World Health Organization have been employed in order to detect and reduce the likelihood of errors in patient practice. These tools also demonstrate the importance of adapting regulated checklists and protocols that are essential in every stage of patient care. CONCLUSION
ACCEPTED MANUSCRIPT
While various systems have been implemented throughout the healthcare industry to overcome processing weaknesses, a continued display of effectiveness and improvement upon current subspecialty-specific guidelines are necessary for the assurance of safety in
AC C
EP
TE D
M AN U
SC
RI PT
contemporary patient care.
ACCEPTED MANUSCRIPT
INTRODUCTION The idea of safety has been a primary objective in all industrial and non-industrial organizations and has influenced countless guidelines and protocols which ensure that safety is
RI PT
maintained (1-3). In the manufacturing industry, Toyota developed protocols to ensure the safety of both workers and customers (2). Other companies such as Motorola have also adapted similar techniques as a means to promote and regulate safety culture (3). In healthcare, protocols are
SC
continually being developed and improved in patient processing in order to assure safety
measures (4, 5). Standards in the quality of healthcare facilities began in the United States with
M AN U
the “Minimum Standards for Hospitals”, which was later followed by necessary accreditation in all healthcare organizations from the Joint Commission on Accreditation of Healthcare Organizations (JCAHO) (6, 7).
The idea of safe practice in patient safety culture (PSC) has been an important aspect for
TE D
advancement in healthcare since its introduction in the Institute of Medicine (IOM) report To Err is Human (5, 8, 9). PSC embodies properties in patient care guidelines and processes that are crucial for preventing adverse events in healthcare. Organizational properties for PSC extend
EP
beyond the number of incidents in patient processing and include established safety values and knowledge of specific patient care protocols (10). Insufficient patient safety guidelines and poor
AC C
communication in the work environment all impede patient safety practices (4, 11). Therefore, the healthcare industry has implemented tools such as SBAR (Situation, Background, Assessment, and Recommendation), Reason’s Swiss Cheese model (Figure 1), general guidelines established by the World Health Organization (WHO), and the National Surgical Quality Improvement Program® (NSQIP) (11-14).
ACCEPTED MANUSCRIPT
Patient safety processes are constantly evolving to ensure that harm toward all patients is prevented and general ideals in patient care throughout the healthcare industry are improved and
established in healthcare to promote the culture of patient safety.
METHODS
RI PT
advanced (8). The purpose of this manuscript is to review the processes that have been
SC
Sources were initially found by searching the keyword “safety” in the National Center for Biotechnology Information (NCBI) database. After selecting articles using the keyword
M AN U
“safety”, articles that were similar in content were also acquired from the PubMed suggestions that were provided by the NCBI database. Other key terms that were used for research in the NCBI database were “medical error” and “WHO”. The same process was used to acquire articles from the keyword search in the NCBI database. PubMed recommendations were also reviewed.
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Other sources were also acquired through the NCBI database by searching “Joint Commission on Accreditation of Healthcare Organizations”. Research outside of the NCBI database included the search of “Lean Manufacturing” and “Toyota Production” on the Art of Lean website, “Six
EP
Sigma”, “SBAR”, the history of the WHO, and SURPASS (SURgical PAtient Safety System).
AC C
RESULTS/DISCUSSION
Regulations in safety are pervasive in both industrial and non-industrial corporations (1-
3, 5, 8). Initially established by machine shop owner Taiichi Ohno between 1945 and 1955, Toyota developed models such as the Toyota Production System (TPS) and lean manufacturing in order to improve operational efficiency and ensure the safety of both workers and customers (2). The primary objective of both systems is to combine the management and production aspects
ACCEPTED MANUSCRIPT
of the company to provide high quality products for its customers while maximizing profit (1, 2). TPS and lean also emphasize the significance of safety over productivity and how the need for continual improvement benefits any organization (2). Motorola also adapted a similar system
RI PT
called the Six Sigma technique that promotes and regulates safety culture through five phases: Define, Measure, Analyze, Improve, and Control (DMAIC) (3). Since its introduction in 1987, these phases have helped reduce the number of manufacturing accidents from unsafe behavior
SC
and evaluate work hazards (3). Regulations regarding the quality of healthcare facilities in the United States began with the “Minimum Standards for Hospitals” of 1917 from the American
M AN U
College of Surgeons. This consisted of five fundamental requirements for hospital organizations that were considered essential for patient processing, and if a hospital did not meet this criterion, they were not deemed a ‘first-class institution’ (6, 7). The Minimum Standards were later followed by mandated accreditation of healthcare organizations in the United States from
TE D
JCAHO in 1951 (6). Accreditation of medical services through JCAHO provides certification for all healthcare providers and incorporated standards for proper patient care in safety (6). Today, these standards focus on the fundamental guidelines of both patient and organizational processes
EP
that are necessary in providing safe and improved performance in patient care. In any medical setting, the primary concern for all healthcare providers revolves around
AC C
the welfare and safety of patients (4, 5, 11, 15). Principles of patient safety have significantly improved and have received much more attention in the past two decades since the concept was established, but continual improvement to the practice of safety still remains a challenge (5, 9). While the potential for patient harm is unavoidable in any healthcare system, inefficiencies within patient processing steps are more frequently related to adverse events than technical mistakes made during operations (11). The 1991 Harvard Medical Practice Study analyzed
ACCEPTED MANUSCRIPT
medical records of patients admitted to 51 acute care hospitals in New York State and examined the proportion of cases with adverse events from pre-operational and post-operational issues. Of the 30,121 records reviewed, adverse events transpired in 3.7% of admissions with 58% of those
RI PT
occurrences deemed preventable (15, 16). These findings emphasized the significance of patient safety practice and illuminated the errors within the practices of providers and policy-makers in healthcare.
SC
Errors that remain undetected throughout several levels of patient processing (Figure 2) contribute to the development of adverse events (4, 11). Without proper group-specific processes
M AN U
and guidelines within patient care processing, risk to the patient’s well-being is greatly amplified (11). One issue that arises from errors includes the “culture of blame” which prevents healthcare personnel from admitting a mistake or fault due to the fear of being penalized (11, 17). In an analysis of the “culture of blame” from The Hastings Center Report, only 22% of physicians,
TE D
nurses, and administrators surveyed believed that the responsibilities surrounding patient safety were shared equally (17). Systems like SBAR have been established to accommodate these issues in pre-, peri-, and post-operative patient safety regulations. Since its introduction to the
EP
healthcare industry in the late 1900’s, SBAR has been an effective standardizing tool used to convey important information among different healthcare personnel (11, 18). This mode of
AC C
communication helps regulate shared expectations in any healthcare situation and allows staff to efficiently and accurately pass along patient information (18). Kim et al. mentions that SBAR also allows all parties to proactively seek recommendations and necessary information to resolve the issues presented (11).
Every stage involved in patient processing has the potential for errors (9, 11). While SBAR presents an established protocol of communication in healthcare organizations, re-
ACCEPTED MANUSCRIPT
examination of patient information in subsequent levels of processing is also necessary to prevent adverse events (4, 9, 11). James T. Reason and Dante Orlandella proposed the “Swiss Cheese Model” to illustrate this idea in patient safety practice (11, 19). The model theorizes that
RI PT
patient processing is similar to a stack of Swiss cheese slices; the holes are opportunities for a mistake to pass through and the cheese is the “defensive layers” that guard from failure (11, 19). Errors in one of the defensive layers can result in the problem passing on to the next level of
SC
processing which would either be caught by the subsequent layer or pass through to the next defensive stage. If the problem continues unnoticed through all defensive layers, the mistake can
M AN U
result in an adverse event (11, 19). The “Swiss Cheese Model” modulates how failures can arise in patient practice if accidents and errors are aligned and are not caught by successive layers of defense (11, 19). It also demonstrates the importance of regulated checklists and protocols that are necessary in all stages of patient care (11) .
TE D
WHO was formed in 1948 after the initial United Nations meeting in 1945 (20). WHO is responsible for the coordination and establishment of international health regulations throughout the United Nations (20). In 2007, WHO launched the Safe Surgery Saves Lives Campaign in
EP
order to improve the safety regulations surrounding surgical procedures. The WHO Surgical Safety Checklist and WHO Guidelines for Safe Surgery of 2009 helped introduce perioperational
AC C
checklists and improved operational teamwork (21, 22). The full implementation of these protocols from WHO have been linked to improved outcomes in patient care through its method of identifying and correcting potential processing errors during surgical procedures (11, 20, 21, 23). Even though the WHO checklist applies primarily to operating procedures, other guidelines and checklists have been established to address events involved with patient processing before and after the surgical procedure (24). The SURPASS checklist involves other areas for regulated
ACCEPTED MANUSCRIPT
safety protocols and is not catered to any specific level of processing (24). SURPASS is the original evidence-based checklist that addresses patient safety coordination during admission and discharge (24). In 2004, the Joint Commission also developed the Universal Protocol (UP) for
RI PT
Preventing Wrong Site, Wrong Procedure, and Wrong Person Surgery which established
regulations for preoperative verifications and a “time out” immediately before procedures for patient corroboration (24). Preoperative verifications from the UP of Joint Commission in patient
SC
processing are quintessential in the practice of patient safety (24). UP for Preventing Wrong Site, Wrong Procedure, and Wrong Person Surgery is necessary not only in the operating room,
M AN U
but also during appointment scheduling and whenever patients enter the healthcare facility (24).
CONCLUSION
The endeavors and undertakings of the healthcare industry have all contributed to the
TE D
development of safety processes in both preceding and contemporary patient care regulations. While protocols such as SBAR and those developed by WHO have contributed immensely to current patient safety practices, continual improvement to present-day guidelines
EP
is still imperative throughout patient safety processing. Recurrent ideals that have been mentioned for improvement include enhanced team-based modes of patient care and checklists
AC C
that can be adaptable to serve a any hospital setting or system of operation. The development and adoption of refined protocols in patient processing requires not only a continued display of effectiveness in current guidelines, but also the ongoing modification of organization-specific regulations of error prevention in patient safety practice.
ACCEPTED MANUSCRIPT
REFERENCES
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1. Mathis T. What Can Safety Learn from Lean? 2012. Available from: http://ehstoday.com/safety/what-can-safety-learn-lean 2. Toyota. Toyota Production System Basic Handbook. Art of Lean, Inc. Available from: http://www.artoflean.com/files/Basic_TPS_Handbook_v1.pdf 3. Ateekh-ur-Rehman L. Safety Management in a Manufacturing Company: Six Sigma Approach. Engineering [Internet]. 2012; 4(7):[400-7 pp.]. Available from: http://www.scirp.org/journal/PaperInformation.aspx?PaperID=20540. 4. ABC of Patient Safety. Sandars J, Cook G, editors. Walden, MA: BMJ Books; 2007. 5. Graham S, Brookey J, Steadman C. Patient Safety Executive Walkarounds. Advances in Patient Safety: From Research to Implementation (Volume 4: Programs, Tools, and Products). 4. Rockville, MD: Agency for Healthcare Research and Quality (US); 2005. 6. Alkhenizan A, Shaw C. Impact of accreditation on the quality of healthcare services: a systematic review of the literature. Ann Saudi Med. 2011;31(4):407-16. 7. Melo S, Beck M. Quality management and managerialism in healthcare : a critical historical survey. Houndmills, Basingstoke, Hampshire ; New York, NY: Palgrave Macmillan; 2014. viii, 217 pages p. 8. Kohn LT, Corrigan JM, Donaldson MS. To Err Is Human: Building a Safer Health System. Institute of Medicine; 1999. 9. Emanuel L, Berwick D, Conway J, et al. What Exactly is Patient Safety? In: Henriksen K, Battles J, Keyes M, editors. Advances in Patient Safety: New Directions and Alternative Approaches (Vol 1: Assessment). 1. Rockville, MD: Agency for Healthcare Research and Quality; 2008. 10. Reiman T, Pietikäinen E, Oedewald P. Multilayered approach to patient safety culture. Qual Saf Health Care. 2010;19(5):e20. 11. Kim FJ, da Silva RD, Gustafson D, et al. Current issues in patient safety in surgery: a review. Patient Saf Surg. 2015;9:26. 12. Borgmann H, Helbig S, Reiter MA, et al. Utilization of surgical safety checklists by urological surgeons in Germany: a nationwide prospective survey. Patient Saf Surg. 2015;9:37. 13. Hill MR, Roberts MJ, Alderson ML, et al. Safety culture and the 5 steps to safer surgery: an intervention study. Br J Anaesth. 2015;114(6):958-62. 14. de Vries AH, Boute MC, Kuppen MC, et al. Patient Safety Risks of Basic Urological Procedures Performed by Junior and Senior Residents. J Surg Educ. 2015;72(5):918-26. 15. Weingart SN, Wilson RM, Gibberd RW, et al. Epidemiology of medical error. BMJ. 2000;320(7237):774-7. 16. Brennan TA, Leape LL. Adverse events, negligence in hospitalized patients: results from the Harvard Medical Practice Study. Perspect Healthc Risk Manage. 1991;11(2):2-8. 17. Ramsey G. Nurses, medical errors, and the culture of blame. Hastings Cent Rep. 2005;35(2):20-1. 18. SBAR Overview and Introduction Available from: SaferHealthCare.com 19. Reason J. Human error: models and management. BMJ. 2000;320(7237):768-70. 20. World Health Organization. Patient Safety Curriculum Guide: Multi-professional Edition. World Health Organization 2011. 21. Nishiwaki K, Ichikawa T. WHO Surgical Safety Checklist and guideline for safe surgery 2009. Masui. 2014;63(3):246-54.
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22. World Health Organization. WHO Surgical Safety Checklist (First Edition). 2008. 23. Braham DL, Richardson AL, Malik IS. Application of the WHO surgical safety checklist outside the operating theatre: medicine can learn from surgery. Clin Med (Lond). 2014;14(5):468-74. 24. Shekelle PG, Wachter RM, Pronovost PJ, et al. Making health care safer II: an updated critical analysis of the evidence for patient safety practices. Evid Rep Technol Assess (Full Rep). 2013(211):1-945.
Figure 1. Swiss Cheese Model A) The potential for error at each stage is aligned and lack
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successive barriers, so an adverse event can occur. B) The potential for error at each stage is not aligned and include successive barriers, so an adverse event is not as likely to occur.
Figure 2. Step Model A) A surgical safety checklist viewed as a staircase-step model. B) An adverse event visualized in the staircase-step model.
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Lack in verification of site for surgical procedure
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Lack in verification of site for surgical procedure
B.
Patient received procedure on the wrong surgical site
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Pre-operative team checked, re-confirmed, and prevented surgery on the wrong side
Patient received procedure on the correct surgical site
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Before Skin Incision
Before Leaving OR
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Before Anesthesia
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5 Confirm Team Intro
3 2 1
Verify
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Identity Site Procedure Consent Site Mark
8 Imaging Check
Verbal Nurse Confirm
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Patient Confirm
Verbal Team Confirm
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Review Critical Events
Confirm Antibiotic
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Anesthesia Airway
Allergy Blood-loss Risk
Anesthesia Surgical team
Patient Site Procedure
Bleeding Instability Organ injury
Allergy Reaction Administration
Site Side Organ
Procedure Instrument Specimen Equipment
Handoff
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Before Skin Incision
Before Leaving OR
Shortcut/ Lack of verification of Allergy Blood-loss Risk
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Verbal Team Confirm
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Confirm Team Intro
Check
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Anesthesia Airway
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Patient is allergic to Penicillin
Allergy Blood-loss Risk
Anesthesia Surgical team
Patient Site Procedure
Confirm Antibiotic
10 9 Imaging Check
Verbal Nurse Confirm
Site Side Organ
Procedure Instrument Specimen Equipment
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Adverse Event due to the lack of verification of Penicillin allergy
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Identity Site Procedure Consent Site Mark
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Before Anesthesia
Bleeding Instability Organ injury
Allergy Reaction Administration
Handoff
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Key of Definition for Abbreviations
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WHO- World Health Organization JCAHO- Joint Commission on Accreditation of Healthcare Organizations PSC- Patient Safety Culture SBAR- Situation, Background, Assessment, Recommendation NCBI- National Center for Biotechnology Information TPS- Toyota Production System SURPASS- Surgical Patient Safety System UP- Universal Protocol for Preventing Wrong Site, Wrong Procedure, and Wrong Person Surgery