Patient Safety


Scope of the Problem

  1. Institute of Medicine Report
    • in 2000, the Institute of Medicine issued a major report that concluded that medical mistakes result in 44,000 – 98,000 deaths/year and over 1,000,000 injuries/year
    • report concluded that good people are working in bad systems that need to be made safer
    • this report defined the type of medical errors that occur, and ultimately led to improving the systems that allowed them to occur

    1. Types of Medical Errors
      1. Adverse Event
        • injury caused by medical management rather than the underlying condition of the patient
        • prolongs hospitalization, produces a disability at discharge, or both
        • classified as preventable or unpreventable

      2. Negligence
        • care that falls below a recognized standard of care
        • standard of care is considered to be care that a reasonable physician of similar knowledge, training, and experience would use in similar circumstances

      3. Near Miss
        • an error that does not result in patient harm
        • analysis of near misses provides the opportunity to identify and remedy system failures before the occurrence of harm

      4. Sentinel Event
        • an unexpected event causing death or serious physical or psychological injury
        • the injury involves loss of limb or function
        • requires immediate investigation and response
        • transfusion involving major blood group incompatibilities
        • wrong-site, wrong-procedure, or wrong-patient surgery
        • medication error or other treatment-related error resulting in death
        • retained foreign body in a surgery patient

  2. Human Errors Resulting in Medical Errors
    • science of safety is based on the premise that everyone makes mistakes
    • specific processes can be implemented that prevent mistakes or minimize their adverse impact

    1. Action-Based Errors
      • skill-based errors (e.g. sticking the carotid artery instead of the internal jugular vein)
      • very common, but are usually identified and easily corrected

      1. Prevention
        • implementing known safety precautions such as using ultrasound for central line placement
        • standardizing techniques so that deviation from the expected result is more easily recognized
        • building redundancy into systems, such as use of both ultrasound and waveform transduction for central line placement
        • practice through simulation training

    2. Decision-Based Errors
      • due to faulty knowledge or poor judgement
      • more insidious and difficult to identify than action-based errors
      • cognitive biases may lead to incorrect diagnoses and/or choice of treatment
      • prevention involves strategies to improve awareness and insight into cognitive biases and increase consideration of alternative possibilities

      1. Prevention
        • use of cognitive aids to decrease reliance on memory through mnemonics, algorithms, computerized decision support
        • simulation training to develop strategies for specific clinical scenarios
        • implementation of evidence-based clinical practice guidelines

    3. Communication-Based Errors
      • occur commonly in the OR
      • leading root cause of serious adverse events that result in patient harm

  3. Creating a Culture of Safety
    1. Communication
      • communication breakdown is one of the top three root causes of sentinel events
      • traditional surgical culture is hierarchical and intimidating, which can discourage OR personnel from expressing safety concerns

    2. Teamwork
      • there is a strong correlation between better teamwork and improved safety
      • surgeons need to encourage OR personnel to voice any concerns that they may have

Risk Reduction Strategies

  1. Preoperative Briefings
    • facilitate transfer of information between team members
    • allow unfamiliar personnel to introduce themselves and to make sure that they understand their role
    • allow personnel to discuss potential problems before the case starts
    • ensure that all necessary equipment is available and operational
    • verify blood product availability, if necessary
    • ensure that evidence-based measures such as appropriate preoperative antibiotics and DVT prophylaxis are used
    • confirm the correct patient/procedure (TIME OUT)

  2. Minimizing Distractions in the OR
    • distractions and flow disruptions cause technical errors and communication errors
    • common distractions include conversations, door openings, alarms, pages and cell phone rings
    • techniques to minimize distractions include limiting interruptions to the surgeon to only those that are critical, turning all phones to vibrate mode, silencing noncritical alarms, limiting conversations

  3. Postoperative Debriefings
    • improve safety by discussing any errors or critical incidents that occurred during the case
    • should be used as learning opportunities rather than cause for punishment
    • sponge and instrument counts should be verified
    • correct labeling of the pathology specimen should be confirmed

  4. Sign Outs
    • poor sign outs to covering surgeons can result in omission of important information
    • all physician to physician sign outs should begin with the statement, “In this patient, I am most concerned about…”.
    • effective sign outs should include written communication, as well as verbal communication

Specific Operating Room Hazards

  1. Positioning Injury
    • examples include peripheral nerve injuries from compression or overstretching, pressure ulcers, corneal abrasions
    • all pressure points must be padded: heel protectors, ulnar nerve protectors
    • axillary roll for patients in the lateral decubitus position
    • particular care must be taken for patients in stirrups for the lithotomy position – the peroneal nerve must be protected

  2. Fire and Electrical Injury
    • fires require an ignition source (electrocautery or lasers) and an oxidizer (oxygen concentration greater than room air, nitrous oxide)
    • avoid pooling of alcohol-based skin prep solutions and allow for adequate drying time
    • procedures involving the head, neck and upper chest are at the highest risk, and if >30% oxygen concentration is required, then the airway should be secured with an endotracheal tube
    • electrical injury can occur from defective equipment or a poorly applied grounding pad

  3. Sharps Injury
    • needlestick and sharp object injuries are common in the OR
    • both patients and OR personnel are at risk

Quality Measures

  1. The Surgical Care Improvement Project (SCIP)
    • incidence of post-op complications ranges from 6% for noncardiac surgery to more than 30% for high-risk procedures
    • complications increase cost, length of stay, and mortality
    • many common adverse events can be prevented by adhering to evidence-based standards

    1. Surgical Site Infections (SSIs)
      • occur in 2% - 5% of patients after clean procedures, and in up to 20% of patients undergoing intraabdominal procedures
      • proven care performance measures include an appropriate antibiotic administered within 1 hour of incision, prophylactic antibiotics discontinued within 24 hours post procedure, good post-op glucose control in diabetics, normothermia in the OR, appropriate hair removal in the OR

    2. Venous Thromboembolism
      • DVT occurs in 25% of patients, without prophylaxis, after major surgical procedures; PE occurs in 7%
      • DVT prophylaxis, given within 24 hours before surgery to 24 hours after surgery, reduces the number of fatal PEs by 50%
      • low-dose unfractionated heparin and low molecular weight heparin have similar efficacy

    3. Cardiac Events
      • adverse cardiac events occur in 2% - 5% of patients undergoing noncardiac surgery, and in 34% of patients undergoing vascular surgery
      • post-op MI is associated with a 40% - 70% mortality rate
      • in at-risk patients, β-blockers reduce perioperative ischemia
      • surgery patients on β-blockers pre-op must receive them in the perioperative period

    4. Global Measures of Quality
      • death within 30 days of surgery
      • readmission within 30 days of surgery

  2. National Surgery Quality Improvement Program (NSQIP)
    • program that allows hospitals to compare their rates of postoperative events to similar hospitals using a risk-adjusted ratio
    • focuses primarily on 30-day morbidity and mortality
    • prevention of errors reduces complications and can be used as a reliable quality measure
    • in hospitals with higher complication rates, the problem is most likely from system errors than from provider incompetence

  3. The Leapfrog Group
    • an alliance of large public and private healthcare purchasers
    • goal is to improve nationwide standards of healthcare quality and to lower healthcare costs
    • data is collected in a voluntary, web-based hospital quality and safety survey
    • 8 high-risk procedures are being scrutinized: CABG, cardiac stenting, AAA repair, AVR, pancreatic resection, esophagectomy, bariatric surgery
    • there are recommended hospital and surgeon volume criteria for these procedures

  4. “Never Events”
    • developed by the National Quality Forum (NQF)
    • errors in medical care that are serious, preventable, and clearly identifiable
    • indicate a real problem in the safety and credibility of a healthcare facility

    1. Retained Surgical Items
      • ~ 1 case/year/large hospital
      • most common retained item is a surgical sponge
      • risk factors include emergency surgery, unplanned changes in procedure, multiple procedures and multiple surgeons in the same operation, long cases involving shift changes, patients with high BMI
      • for prevention, current recommendations include standard counting procedures, using only x-ray-detectable items in the wound, and a thorough wound inspection before closing
      • for long and involved cases, many hospitals require an x-ray before closing, even if the counts are correct

      Retained Lap Pad
      1. Surgical Counts
        • the value of surgical counting to prevent retained items is unproven
        • when the surgical count is incorrect, OR protocols are triggered that usually mandate x-rays of the surgical site
        • however, in most cases of retained items, the count is ‘falsely correct’
        • even when the count is correct, it is still the surgeon’s responsibility to inspect the site to ensure that nothing is left behind

    2. Wrong-Site Surgery
      • any surgical procedure performed on the wrong patient, wrong body part, wrong side of the patient, or wrong anatomic level
      • it is estimated that ~ 4000 wrong site surgeries are performed each year in the U.S.
      • risk of wrong site surgery increases when multiple procedures are performed on the same patient
      • communication errors are the root cause in > 70% of wrong-site surgeries
      • additional causes include inadequate procedures to verify the correct surgical site and incomplete pre-op assessment
      • most errors involve symmetric anatomic structures such as the lower extremities and head and neck

      1. Preoperative Time Out
        • mandatory in all U.S. ORs
        • the patient, procedure, and site to be operated on are verified before the incision
        • the effectiveness of the time out in reducing wrong-site surgeries is unproven

Risk Management

  1. Communicating with Patients
    • physicians have an ethical and professional responsibility to immediately disclose complications or errors to patients
    • failure to disclose adverse events can lead to legal liability for fraud
    • historically, physicians’ fear of malpractice suits has been a major barrier to complete transparency with patients
    • however, paradoxically, immediate disclosure of errors leads to improved patient rapport, improved satisfaction, and fewer suits
    • many states have passed legislation that precludes any information from a physician’s apology for a medical error from being used in malpractice court (even a full admission of fault)







References

  1. Schwartz, 10th ed., pgs 365 – 380
  2. Sabiston, 20th ed., pgs 187 - 199
  3. UpToDate. Safety in the Operating Room. Joyce A. Wahr, MD, FAHA. Apr 07, 2020. Pgs 1 – 43