130204P - PATIENT SAFETY: HISTORICAL AND ETHICO-LEGAL CONSIDERATIONS

Presentation at the 6^thInternational Nursing Symposium King Fahad Medical City Riyadh 4^th February 2013 by Professor Omar Hasan Kasule Sr. MB ChB (MUK), MPH (Harvard), DrPH (Harvard).

Key words: Patient’s safety, system theory, blame on culture, system failures, personal approach, violations and patient safety models.

1. WHAT IS PATIENT SAFETY?

·         In 1999 an Institute of Medicine report highlighted deficiencies in US health care system[1] that stimulated the emergence of a patient safety movement.

·         Patient safety is defined as a discipline in the health-care sector that applies safety science methods towards the goal of minimizing the incidence and impact of, and maximizes recovery from adverse events[2].

·         It is an infant science[3] with little research so far.

·         Health effects of safety violations: morbidity, disability, mortality, hospitalization, human suffering.

·         Economic impact of safety violations

2. PATIENT SAFETY GOALS

·         In 2003 the joint commission started publishing national safety goals updated annually and required hospitals to adhere to the goals to maintain accreditation[4].

·         Taiwan set up national safety goals against which hospitals could measure themselves

·         An audit in Holland showed low compliance with safety goals on low molecular weight warfarin[5].

·         Memphis area hospitals took actions to meet national safety goals for warfarin[6].

3. PATIENT SAFETY INDICATORS (PSIs)

·         PSI are used to study trends of adverse events.

·         The reliability, relevance, and validity of PSIs are in question.

·         Sentinel events are the most serious adverse effects and represent the tip of the iceberg.

·         PSIs are used to study patient safety trends

4. SOURCES OF DATA ON PATIENT SAFETY

·         Routinely collected administrative data and hospital data

·         Reporting of adverse effects: Underreporting of safety incidents[7]. Imperfect disclosure[8]

·         Other approaches: direct observation, videotaping, chart review, trigger tools, and automated methods

·         Methodological limitations: failure to detect and document such events, surveillance bias, lack of consistent definitions, different judgments

·         Mortality in low risk conditions is an indicator of safety[9]

·         Review of national safety reports[10]

5. PATIENT SAFETY CULTURE

·         Safety culture is a complex phenomenon not easy to operationalize. The following components have been suggested : (a) leadership, (b) teamwork, (c) evidence-based, (d) communication, (e) learning, (f) just, and (g) patient-centered. [11].

·         Assessment of the level of patient safety culture in hospitals using validated instruments

·         Patient safety culture should not be analyzed at the macro hospital level it should be analyzed as close to the patient as possible (department, unit, ward etc.)

·         A positive hospital safety culture is associated with fewer adverse events[12].

·         Predictors of patient safety: event reporting, communication, patient safety leadership and management, staffing, accreditation[13] , nurse empowerment[14], and Transparency about morbidity and mortality events[15].

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6. PATIENT SAFETY BY FEAR: THE BLAME CULTURE

·         There is change from the blame culture to treating errors as an opportunity to learn[16]. The traditional approach was to focus on identifying the individual responsible for the mistake for blaming, shaming, punishing, or retraining

·         The traditional approach to patient safety is similar to traditional child upbringing that relied on punishment to stop children from making mistakes.

·         We now know that adverse events occur not because bad people intentionally hurt patients but rather that the system of health care fails.

7. PATIENT DAFETY BY LITIGATION: MEDICAL NEGLIGENCE

·         Three ingredients must be proved in a case of negligence: (a) the physician owed a duty of care (b) the physician failed in that duty (c) the failure resulted in damage.

·         The burden of proof of breach of standard of care lies with the plaintiff.

·         The best protection against medical negligence is the conscience of all health care workers to make sure that mistakes do not occur

·         Boolam case: alternative standards accepted.

·         In the Bolitho case: standards relaxed in difficult circumstances.

8. LESSONS FROM THE AVIATION INDUSTRY

·         We can learn a lot from the aviation, nuclear, and military industries about system approaches to safety. Accidents due to multiple factors (b) chain of events helps understand the problem(c) complexity increases errors (d) latent human errors are more significant than technical errors (d) accidents are a result of a poor safety culture and violations of safety regulations.

·         checklists, simulation training, few moving parts, simple procedures, anticipation, treating near miss treated as real errors, communication to all, robotization, mechanical self-regulating systems.

·         The role of the human cannot be minimized in medicine by automation because of its greater complexity.

9. PATIENT SAFETY: A SYSTEMS APPROACH

·         Integrated (tauhidi) and comprehensive (shumuuli) view: look at what happened, why, and how and not who did it / not automatically blame the people involved

·         Factors beyond individual control and multiple causes of errors.

·         Human prone to err so has to be protected by a system

·         Easier to change the environment than to change people

·         Learn from errors and change the system

·         Safe mistakes are taken seriously

·         Errors of commission vs. errors of omission

10. PATIENT SAFETY MODEL 1

·         4 domains: (a) the HCW (b) the patients (c) the infrastructure (d) processes (e) feedback.

·         Organizations that place a premium on safety routinely examine all aspects of the system in the event of an accident,  including equipment design, procedures, training and other organizational features

11. PATIENT SAFETY MODEL 2: HEALTH CARE WORKER

·         Human dimension more important than technology (most air crushes due to pilot error).Personal skills recognized as important to patient safety[17].

·         Simulation training[18]widely used in the aviation, nuclear, and defense industries[19].

·         Work schedules, sleep deprivation, emotional state contribute to errors[20]^,[21]

·         Inclusion of safety in medical undergraduate curricula[22][23].

·         Empowering nurses improves safety[24].

12. PATIENT SAFETY MODEL 2: HEALTH CARE WORKER

·         Patient is the only stakeholder with no vested interest in hiding info.

·         If well trained the patient has best recollection he deals with one

·         Patient involvement in blood transfusion safety[25].

·         Patient reporting of safety violations[26]^,[27]

13. PATIENT SAFETY MODEL 3: INFRASTRUCTURE

·         Electronic medical records are double edge sword: They help fulfill safety goals but may create problems if the system fails[28].

·         Decision support systems may improve safety[29]^,[30].

·         Computerized entry reduces medication errors[31]. E-prescribing improves patient safety[32]. Drug labeling reduces ADE[33].

·         Medication administration technologies may also increase errors[34].

·         Technologies that contribute to patient safety: bar coding identification, radiofrequency identification, computerized intraoperative monitoring, and automated data registers[35].

·         Problems with devices: manufacturer error, device use error (human engineering)[36]. Human error is random and limited. Machine error is systematic and comprehensive.

14. PATIENT SAFETY MODEL 4: PROCESSES

·         Management safety culture enhances patient safety[37]. Hospital organizational culture affects safety culture[38].

·         Procedures to avoid mistakes for example in the operation theater by operation site marking, communication, pressure ulcers[39].

·         Reducing complexity improves patient safety[40].

·         Safety procedures can be improved by using the quality cycle: plan-do-check.

·         Analyses: failure modes and effects analysis[41]^,[42]. Hand-off communication and safety[43]

·         Evidence exists between teamwork and safety[44]. Measuring team performance[45]. Team work and communication[46]. Effective physician nurse communication[47]^,[48]

·         Increasing the number of nurses and their skill mix improves safety[49]

15. PATIENT SAFETY MODEL 5: PROCESSES

·         Violation is a deviation from safe operating procedures, standards or rules.

·         Routine violation e.g.: doctors who fail to wash their hands in between patients because they feel they are too busy.

·         Necessary violation: Nurses and doctors who knowingly miss out important steps in medication dispensing because of time constraints and the number of patients to be seen.

·         Adverse events reporting and disclosure as tools for patient safety[50]^,[51].

16. ETHICO LEGAL PRINCIPLES RELARED TO PATIENT SAFETY

·         Is patient safety a legal or an ethical problem?  Legal elates to punishment if caught. Ethical is morality and self-policing. We should emphasize the ethical aspect because most errors are not detected and if detected liability and hence punishment cannot be proved easily

·         Patient safety is violated in the process of bringing about a benefit. The vuilation may be a pure error or may be inevitable. We need rules to guide us in this.

·         The 5 purposes: din, nafs, nasl, ‘aql, & maal

·         The paradigms of integration, holism, shumuliyat and balance tawazun

·         The principal of dharar is the main one dealing with patient safety. It has several sub principles

·         Principal of custom:

17. PRINCIPLE OF INJURY, qa’idat al dharar

·         Article 7: injury is recent and not older, al dhararu la yakuunqadiiman

·         Article 20: injury should be relieved,al dahararyuzaalu

·         Article 25:injury is not relieved by a similar injury, al dharar la yuzaalu bi mithlihi

·         Article 26: personal injury is sustained to prevent public injury, yutahammal al dharar al khaaslidafuidhararaam

·         Article 27: bigger injury is relieved by smaller injury,al dharar al ashaddyuzaalu bi al dharar al akhaff

·         Article 28: if 2 adversities meet we commit the lesser one, idhata’aradhamufsidataanruu’iyaa’adhamahumadharar bi irtikaabakhaffahuma

·         Article 29:we commit the lesser of two evils, yukhtaarahwana al sharrain

·         Article 30: preventing injury has precedence over accruing benefits,dariu al mafasidawla min jalbi al masaalih

·         Article 31: injury is mitigated as much as is possible, al dhararyudfau bi qadr al inkaan

·         Article 35: you can order another person to commit an illegal act,ma harumafi’iluhuharumatalabuhu

18. PERSONAL RESPONSIBILITY, mas’uliyyatshakhsiyyat

·         Article 89: the doer is responsible for actions even if ordered if the order was not obligatory, yudhaafu al fi’iluila al fa’il la al aamir ma lam yakunmujbiran

·         Article 90: if the direct and accessory are involved it is the direct who is responsible, idhaijatama al mubaashirwa al mutasabbibyudhaafu al hukmila al mubaashir

·         Article 92: the performer is liable even if the action was not intended,  al mubaashirdhaaminwainlamyata’ammad

·         Article 93: the accessory is liable only if the action was intended,almutasabbibuyayadhmanuilla bi al ta’amud                                                          

19. OTHER PRINCIPLES

·         Article 17: difficulty calls forth easing of the rules, al mashaqqattajlibuaktaysiir

·         Article 36: what is customary is binding,  al ‘aadatmuhakkamat

·         Article 55: continuation can be excused where initiation cannot be,yughtafar fi al baqaau ma la yughtafar fi al ibtida

·         Article 56: continuation is easier than initiation, al baqaauashal min al ibtidaau

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