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Patient Safety Research Introductory Course
Session 1
What Is Patient Safety? David W. Bates, MD, MSc External Program Lead for Research, WHO Professor of Medicine, Harvard Medical School Professor of Health Policy and Management, Harvard School of Public Health
Your picture is also welcome
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AimTo describe the fundamental concepts of the science of patient safety, in their specific social, cultural and economic context
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Overview1) Introduction 2) Theory 3) Examples 4) Interactive 5) Conclusions
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Questions for Lecture 11. Descriptive research is always better than inferential research. a. True b. False 2. When is doing qualitative research especially helpful? a. When you want to understand the reasons behind a safety issue b. When you do not have enough resources to do a large, prospective, quantitative study c. both a and b d. neither a nor b 3. When does it make most sense to do an observational research study? a. When the human subjects committee requires it b. When the magnitude of a problem isn’t known c. When you want to find out whether or not a solution worked d. When you have tested a solution and found that it didn’t work well 4. What is the strongest research design type? a. Cross-sectional b. Survey c. Retrospective d. Prospective
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Common Types of Error A nurse gives a patient a 4 X overdose of methotrexate; the patient dies A physician removes the wrong kidney A patient receives a 10 X overdose of insulin, goes into shock, is resuscitated, but has persistent brain damage.
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Case 64 year old woman is admitted to hospital with fevers. Presumed diagnosis of pneumonia, treated for that with penicillin. On day 2, she develops a severe rash, felt to be caused by her infection. Involves entire body. Service is very busy. No senior doctor available. Penicillin continued. Rash progresses. On day 4 she is confused, gets out of bed at night, floor is wet, and she slips and falls, fracturing hip. Dies on day 7. What happened?
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Causation Individuals made errors Junior doctor didn’t know what was causing rash Senior doctor wasn’t available Nurse wasn’t there when patient got out of bed
However, the system also allowed errors to slip through No good approach for dealing with very busy period Insufficient nurse staffing at night Operating room was too full and no surgeon available
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The Burden of Unsafe Care Adverse events due to medical devices & medications: Good data from developed nations Very little data from developing / transitional nations
Surgical errors, health-care associated infections Common sources of harm in all nations Preliminary data from developing / transitional nations
Unsafe blood products Likely major cause of harm in some developing nations Reasonably good data from select nations (WHO)
Patients safety among pregnant women and newborns Better data needed from developing / transitional nationsJha, Q
SHC, 2010
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The Burden of Unsafe Care: Developing CountriesMothers and newbornsMaternal mortality rates: North America: Asia (some countries): Africa (some countries): 1 in 3700 1 in 65 1 in 16
% deliveries in developing countries attended by health professional: 53%
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The Burden of Unsafe Care: Unsafe Injections 16 billion injections a year in developing countries 39.6% with syringes and needles reused non sterilized (70% in some countries)
Unsafe disposal can lead to re-sale of used equipment on the black market.
The extent of harm caused by unsafe injections is unknown
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Unsafe Blood, Counterfeit Drugs 5–15% of HIV infections in developing countries are due to unsafe blood Unsafe blood risks transmission of: hepatitis B & C syphilis, malaria, Chagas disease and West Nile fever Counterfeit drugs account for up to 30% of medicines consumed in developing countries
The extent of harm caused by unsafe blood and medications are unknown
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Deficit of Qualified Health-care Providers The deficit in 57 countries is estimated to be 2.4 million doctors, nurses and midwives Fatigue, production pressures cause high risk of mistakes
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Theory--Definitions Error The failure of a planned action to be completed as intended or use of a wrong inappropriate, or incorrect plan to achieve an aim.
Adverse event An injury that was caused by medical management or complication instead of the underlying disease and that resulted in prolonged hospitalization or disability at the time of discharge from medical care, or both
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Theory—Definitions (II) Near miss An event that almost happened or an event that did happen but no one knows about. If the person involved in the near miss does not come forward, no one may ever know it occurred.
Patient safety The avoidance, prevention, and amelioration of adverse outcomes or injuries stemming from the processes of health care. These events include “errors,” “deviations,” and “accidents.” Safety emerges from the interaction of the components of the system; it does not reside in a person, device, or department. Improving safety depends on learning how safety emerges from the interactions of the components. Patient safety is a subset of health care quality.
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Theory—Definitions (III) Safety cultureA culture that exhibits the following five high-level attributes that health care professionals strive to operationalize through the implementation of strong safety management systems.(1) A culture where all workers (including front-line staff, physicians, and administrators) accept responsibility or the safety of themselves, their coworkers, patients, and visitors. (2) [A culture that] prioritizes safety above financial and operational goals. (3) [A culture that] encourages and rewards the identification, communication, and resolution of safety issues. (4) [A culture that] provides for organizational learning from accidents. (5) [A culture that] provide
s appropriate resources, structure, and accountability to maintain effective safety systems.
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A Systemic Problem that Harms PatientsDEFENCESCulture Procedures
Physical barriersTraining
THE GAPSDisease manage protocols missing or not actioned
Patient harmed
Poor compliance, poor suppliesInadequate knowledge, lack of training opportunities
No clear leadership, no cohesive team structure