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Patient safety is a serious public health issue. Like obesity and motor vehicle crashes, harms caused during care have significant mortality, morbidity, quality-of-life implications, and adversely affect patients in every care setting.[1][2] 

In 1999, the Institute of Medicine published a landmark in Patient Safety: a report titled “To Err is Human: Building a Safer Health System.” This report found that at least 44,000 people, and perhaps as many as 98,000 die each year in hospitals as the result of medical errors.[3]

In the report's wake, organizations across the globe created several initiatives to improve Patient Safety. In the U.S., Congress passed legislation to reduce medical errors by 50 percent in five years. Money was spent to hire quality and safety officers. The public focused on errors. The Centers for Medicare and Medicaid (CMS) began to adjust payments based on quality measures, and published star ratings on its website for patients to compare hospitals. Healthcare professionals and the public became aware of the need to reduce harms in hospitals, including adverse drug events, preventable deaths, and pressure ulcers/injuries.[1]

Although Patient Safety has advanced in important ways since the report by the Institute of Medicine, work to make care safer for patients has progressed at a rate much slower than anticipated.[1][2] 

How safe are patients these days? 

Table 1 below illustrates a snapshot of recent facts that underscore the need for clinicians, patients, healthcare organizations and government to continue to focus on Patient Safety.

Table 1. Recent Facts in Patient Safety
  • It is estimated that there is a 1 in 3 million risk of dying while traveling by airplane. In comparison, the risk of patient death occurring due to a preventable medical accident, while receiving health care, is estimated to be 1 in 300 in the world (WHO, 2019).[2] 
  • Estimated hospital-related death due to medical error in the U.S. vary from 163,156 deaths/year [4] to 440,000 deaths/year [5]
  • The most common Medicare hospital-acquired conditions (HACs) are adverse drug events, pressure ulcers/injuries, falls, and catheter-associated urinary tract infections (AHRQ).[4]
  • Globally, as many as 4 out of 10 patients are harmed while receiving health care in primary and outpatient settings. The most detrimental errors are related to diagnosis, prescription and the use of medicines. (WHO, 2019).[2]    
  • Inaccurate or delayed diagnosis is one of the most common causes of patient harm and affects millions of patients.[2]  

Understanding definitions in Patient Safety - not everything is a medical error

The relatively new field of Patient Safety has its own jargons and definitions. Understanding these definitions is the first step for clinicians and Wound Care and/or Hyperbaric Oxygen Therapy Services to create safer practice environments. 

Table 2. Important Definitions in Patient Safety (National Patient Safety Foundation) [1]
  • Adverse drug event: An adverse event involving medication use. 
  • Adverse event: Any injury caused by medical care. Examples include pneumothorax from central venous catheter placement, anaphylaxis to penicillin, and postoperative wound infection. Identifying something as an adverse event does not imply “error,” “negligence,” or poor quality care. It simply indicates that an undesirable clinical outcome resulted from some aspect of diagnosis or therapy, not an underlying disease process. Preventable adverse events are the subset that are caused by error.
  • Error: An act of commission (doing something wrong) or omission (failing to do the right thing) that leads to an undesirable outcome or significant  potential for such an outcome. For instance, ordering a medication for a patient with a documented allergy to that medication would be an act of commission. Failing to prescribe a proven medication with major  benefits for an eligible patient (e.g., low-dose unfractionated heparin as venous thromboembolism prophylaxis for a patient after hip replacement surgery) would represent an error of omission.
  • Near-miss: “Near-miss” event is an unplanned occurrence that does not result in injury, illness, or damage, but had the potential to do so. 
  • Harm: An impairment of structure or function of the body and/or any deleterious effect arising therefrom, including disease, injury, suffering, disability and death, and may be physical, social, or psychological.
  • Just culture: A culture that recognizes that individual practitioners should not be held accountable for system failings over which they have no  control. A just culture also recognizes many individual or “active” errors  represent predictable interactions between human operators and the  systems in which they work. However, in contrast to a culture that touts  “no blame” as its governing principle, a just culture does not tolerate  conscious disregard of clear risks to patients or gross misconduct (e.g.,  falsifying a record, performing professional duties while intoxicated).
  • Patient safety: Patient safety refers to freedom from accidental or preventable injuries produced by medical care. Thus, practices or interventions that improve patient safety are those that reduce the occurrence  of preventable adverse events.
  • Safety culture: The safety culture of an organization is the product of individual and group values, attitudes, perceptions, competencies,  and patterns of behavior that determine the commitment to, and the  style and proficiency of, an organization’s health and safety management. Organizations with a positive safety culture are characterized by communications founded on mutual trust, by shared perceptions of the  importance of safety, and by confidence in the efficacy of preventive  measures (Health and Safety Commission 1993). Safety culture refers to both (a) the intangible sharing of the safety value  among organization members and (b) the tangible results of this shared  value in the forms of behavior and structure (Groves 2014).
  • Total systems safety: Safety that is systematic and uniformly applied (across the total process) (Pronovost et al. 2015).

What factors adversely affect Patient Safety and lead to errors? 

It is interesting, if not alarming that some 20 years after the Report was published that many of the same problems are occurring, without significant improvement. If we dissect the various errors, adverse events, and harms, we may come across the following underlying factors leading to gaps in Patient Safety:  

  • Weak Safety Culture: The Joint Commissions Sentinel Event Database identified “leaderships failure to create an effective safety culture” as a contributing factor to adverse events. In essence, a leader who is committed to prioritizing and making patient safety visible through every day actions is a critical part of creating a true culture of safety.[6]  Maintaining a safety culture requires leaders to consistently and visibly support and promote everyday safety measures.[7] The report states that Inadequate Leadership contributes to the occurrence of Adverse Events in many ways, for example:
    • Insufficient support of patient safety event reporting [8]
    • Lack of feedback or response to staff and others who report safety vulnerabilities [8]
    • Allowing intimidation of staff who report events [1]
    • Refusing to consistently prioritize and implement safety recommendations
    • Not addressing staff burnout [9][10]
  • Poor system designs and organizational factors, delays in care [11]
  • Inappropriate/ insufficient/ outdated education and training  [12]
  • Gaps in transition of care, absence of multidisciplinary approach [12]
  • Inadequate/ insufficient communication among the personnel directly involved in wound treatment and with patients and caregivers  [12]
  • Inadequate/ incomplete medical records documentation: proper documentation is essential for continuity of care. Also, providers depend on documented medical history in order to provide accurate diagnoses and care plans.[13]

Patient Safety, errors and liability in Wound and Hyperbaric Oxygen Therapy Programs

Factors that adversely affect Patient Safety such as the ones stated above can lead to errors and subsequent lawsuits. In analyzing the profile of recent insurance claims, a provider of liability insurance coverage for nurses found that the majority of lawsuits had allegations related to treatment and care. Those were followed by allegations related to assessment, monitoring, patients’ rights/professional conduct, and medication administration.[11] 

Specific examples of common allegations against wound care providers are listed below [13]

  • Failure to diagnose wounds appropriately. For instance:
    • Failure to making a timely, proper diagnosis of infection or peripheral artery disease, leading to foot amputation
    • Failure to diagnose malignancy manifesting as a non-healing ulcer
    • Failure to detect expanding hematoma caused by puncture wound in a patient who returns to the clinic with excruciating pain, gets discharged with pain medication only, and returns with abscess 
  • Failure to administer appropriate care. For instance: 
    • Maintaining the same initial care plan despite worse response to initial treatment, leading to infection and leg amputation
    • Use of antibiotic cream to treat blisters on leg despite allergy history, leading to severe allergic reaction and leg amputation 
    • Failure to treat an infected surgical leg, leading to disfigurement and impaired gait
  • Failure to keep adequate documentation. For instance: 
    • Allegation of negligence by the healthcare professional that cannot be defended due to lack of complete documentation of care provided to patient. 
    • In some states in the U.S. clinicians may be directly liable for breach of his/her duty to maintain records 
  • Failure to communicate (and document) care instructions, risks and potential outcomes, or obtain consent from patient. For instance: 
    •  Failure to provide (or document) post discharge care instructions to a patient who presented to the emergency department with an animal bite that subsequently evolved to gangrene and required partial amputation of finger.

What actions can be implemented to improve Patient Safety and reduce errors? 

Wound care and/or hyperbaric oxygen therapy (HBOT) clinicians and Wound Care and/or HBOT Services can take actions to provide optimal care and reduce the potential for errors, and thus decrease risks for malpractice lawsuits.[11] Effective leadership and availability of a competent and compassionate workforce is a prerequisite for the provision of safe care.[2] 

For governments, organizations, healthcare institutions and clinicians 

The National Patient Safety Foundation has provided guidance for governments, organizations, healthcare institutions and clinicians for achieving total systems safety (Table 3).  

Table 3. Eight Recommendations for Achieving Total Systems Safety (adapted from National Patient Safety Foundation)[1]
  1. Ensure that leaders establish and sustain a safety culture
    • For instance, develop playbooks, policies and procedures that foster safety
  2. Create centralized and coordinated oversight of patient safety
    • For instance, implement collaborative improvement efforts in patient safety across the care continuum
  3. Create a common set of safety metrics that reflect meaningful outcomes
    • For instance, metrics that reinforce successful transition of care such as percentage of referred patients for whom the primary care clinician gave patient written information on reason for referral or consultation
  4. Increase funding for research in patient safety and implementation science
    • For instance, encourage organizations that have successfully established safety innovations to share with other organizations
  5. Address safety across the entire care continuum
    • For instance, identify and implement best practices for safety improvement across the care continuum
  6. Support the health care workforce
    • For instance, provide tools and training to enhance clinical decision making
  7. Partner with patients and families for the safest care
    • For instance, provide patient education materials
  8. Ensure that technology is safe and optimized to improve patient safety
    • For instance, design health IT to facilitate communication and  coordination with the patient and family

For wound care and HBOT clinicians and services

  • To strengthen education and training to minimize medical errors:
    • Follow evidence-based clinical practice guidelines and current best practices. Keep abreast of the latest advances in medical science, as failing to do so can result in legal liability.[13][11] 
    • Ensure policies and procedures highlighting Patient Safety are in place and followed.  Policies and procedures are essential to Wound Care and/or HBOT Services, as they provide a road map and promote safe practices.[14]
    • Leverage technology to access knowledge on-demand at the point-of-care [2]
  • To enhance and streamline communications among healthcare team, across the continuum of care
    • Provide timely, accurate communication, and document what is being communicated. [11]
  • To enhance communications and engage patients and caregivers:


About the Authors

Elaine Horibe Song, MD, PhD, MBA
Dr. Song is a Co-Founder and Chief Executive Officer of WoundReference, Inc., a clinical and reimbursement decision support & telemedicine platform for wound care and hyperbaric clinicians. With a medical, science and business background, Dr. Song previously served as medical director for a regenerative medicine-focused biotech company in California, and for a Joint Commission International-accredited hospital network. Dr. Song also served as a management consultant for Kaiser Permanente, practiced as a plastic surgeon in private practice and academia, and conducted bench and clinical research in wound healing, microsurgery and transplant immunology. Dr. Song holds a position as Affiliate Professor, Division of Plastic Surgery, Federal University of Sao Paulo, and is a volunteer, Committee Chair of the Association for the Advancement of Wound Care. She has authored more than 100 scientific publications, book chapters, software registrations and patents.
With over four decades of healthcare experience, Jeff currently holds the position of Principal Partner at Midwest Hyperbaric LLC and the Co-founder and Chief Clinical Officer of Wound Reference. Jeff has excelled in critical care throughout his career, devoting almost a decade as a Flight Respiratory Therapist/Paramedic for the Spirit of Kansas City Life Flight. In 1993, Jeff transitioned into the field of Hyperbaric Medicine and Wound Care, where he committed 21 years of his career to serving as the Program Director for a 24/7 Level 1 UHMS Accredited facility with Distinction. In this role, he continued to provide patient care while overseeing all administrative, clinical, and daily operations within the Wound Care and Hyperbaric Facility. Jeff is a Registered Respiratory Therapist and a Certified Hyperbaric Technologist (CHT). He has also undergone training as a UHMS Safety Director and a UHMS Facility Accreditation Surveyor. Jeff currently serves as a member of the UHMS Accreditation Council, the UHMS Accreditation Forum Expert Panel, and the UHMS Safety Committee. Additionally, he is an esteemed member of the NFPA 99 Hyperbaric and Hypobaric Facilities Technical Standards Committee. Jeff's dedication to the field has earned him numerous prestigious awards. In 2010, he received the Gurnee Award, which honored his outstanding contributions to undersea and hyperbaric medicine. Three years later, in 2013, he was awarded the Paul C. Baker Award for his commitment to Hyperbaric Oxygen Safety Excellence. Most recently, in 2020, Jeff was honored with "The Associates Distinguished Service Award (UHMSADS)," a recognition reserved for exceptional Associate members of the Society who have demonstrated exceptional professionalism and contributions deserving of the highest accolades.
An Advanced Certified Hyperbaric Registered Nurse and Certified Wound Specialist with expertise in billing, coding and reimbursement specific to hyperbaric medicine and wound care services. UHMS Accreditation Surveyor and Safety Director. Principal partner of Midwest Hyperbaric LLC, a hyperbaric and wound consultative service. Tiffany received her primary and advanced hyperbaric training through National Baromedical Services in Columbia South Carolina. In 2021, Tiffany received the UHMS Associate Distinguished Service Award. "This award is presented to individual Associate member of the Society whose professional activities and standing are deemed to be exceptional and deserving of the highest recognition we can bestow upon them . . . who have demonstrated devotion and significant time and effort to the administrative, clinical, mechanical, physiological, safety, technical practice, and/or advancement of the hyperbaric community while achieving the highest level of expertise in their respective field. . . demonstrating the professionalism and ethical standards embodied in this recognition and in the UHMS mission.”
Amy Smith, JD, RN, PHN
Amy Smith, RN, JD is a principal and founder of the Bay Area Lean Institute, an organization dedicated to helping health care companies improve operations. Her primary area of expertise is transforming front line clinical departments to highly efficient and reliable teams. Prior to forming the Bay Area Lean Institute, Amy spent 21 years with Kaiser Permanente. Most recently she managed the Surgery and Reconstructive Plastic Surgery clinics in Walnut Creek, California. The department serves over 351,000 members. Amy worked with surgeons and staff to run the day-to-day operations of the outpatient clinics. She transformed the department from one of the lowest performers in the Northern California Region to one of the best by implementing lean management principles over a three-year period. Amy also coached and mentored managers and physician leaders throughout Kaiser Permanente to implement performance improvement projects and manage using lean techniques. Amy had major clinical accomplishments including implementing video visits for wound care with community skilled nursing facilities and implementing care pathways for Colectomy, Gallbladder and Small Bowel Obstruction patients. Amy attended Kaiser’s Improvement Institute and is a certified Improvement Advisor. Amy served three years as the Healthcare Ombudsman-Mediator for Kaiser Permanente at the Oakland and Richmond Medical Centers. She has worked in Kaiser Foundation Hospitals and Medical Groups in both the Northern and Southern California Regions. Her nursing background includes pediatrics, home health, and general medical-surgical nursing. As an attorney Amy was Associate General Counsel/Compliance Advocate for Kaweah Delta Health Care District. She also served three years as the felony domestic violence prosecutor for Tulare County. Amy has a BSN from Mount Saint Mary’s College in Los Angeles (holding a public health certificate) and a JD from the University of La Verne College of Law in La Verne, CA. She is licensed with the California State Bar as an Attorney and the California Board of Registered Nursing.
Scott A. Robinson, MD
Dr. Scott Robinson is Board Certified in Emergency Medicine and has specialized in Wound Care and Hyperbaric Medicine. Dr Robinson has been in practice at the Lawrence Memorial Hospital Wound Healing Center since 2003 and currently serves as the Director of Hyperbaric Medicine at the Wound Healing Center which operates two monoplace Hyperbaric chambers. He received his medical degree from University of Kansas School of Medicine and did his Residency in Internal Medicine and Emergency Medicine at the UCLA Affiliate- Kern Medical Center in Bakersfield, California. He has been in practice for more than 33 years.
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