Recent Developments in Patient Safety and Scope of Patient Safety Special Interest Group

1. Recent Developments in Patient Safety and Scope of Patient Safety Special Interest Group Ali Rashidee, MD. MS. Co-Chair, Patient Safety SIG

2. PATIENT SAFETY: Estimates of medical errors The Harvard Medical Practice Study (Brennan TA et al. and Leape LL et al. Results of the Harvard Medical Practice Study. New England Journal of Medicine 324(6):370-376, and 377-384 respectively, 1991. • adverse events in 3.7% of hospitalization, and about 28% of these attributable to negligence. Although about 71% of these caused disabling injuries that lasted less than six months, 2.6% caused permanent disability and 13.6 percent lead to death. The Colorado and Utah Hospital Discharge Study (Thomas EJ et al. Incidence and Types of Adverse Events and Negligent Care in Utah and Colorado. Medical Care, Spring 2000) • adverse events in 2.9% of hospitalizations, and 6.6 % of these lead to death, and over half assessed to be preventable. When extrapolated to 33.6 million admissions to US hospitals in 1997, the results of a study in Colorado and Utah conducted by Thomas E J et al. imply that at least 44,000 Americans die each year as a result of medical errors. Another study by Leape L L et al.. at Harvard Medical Practice Study, 1991 suggests 98,000 deaths due to medical errors- AHA Hospital Statistics.

3. Burden of medical errors • Even when using the lower estimate, deaths due to medical errors exceed the number attributable to the 8th leading cause of death. Death: Final data for 1997. CDC-National Vital Statistics Reports. 47(19):27, 1999. • More people die in a given year as a result of medical errors than from motor vehicle accidents (~44,000), breast cancer (~43,000) or AIDS(~16,500). Births and Deaths: Preliminary data for 1998. CDC, National Vital Statistics Reports. 47(25):6, 1999. • Medication error along, occurring either in or out of hospitals, are estimated to account for 7000 deaths annually. Phillips DP et al. Increase in US medication error deaths between 1983 and 1993. The Lancet, 351:643-44, 1998. • Total national cost of preventable adverse events are estimated between 17 billion of which health care costs represent one half. Thomas EJ et al. Cost of Medical Injuries in Utah and Colorado. Inquiry 36:225-264, 1999 and Johnson WJ et al. The economic consequences of medical injuries, JAMA. 267:2487-2492, 1992. • The Quality in Australian Health Care Study (Wilson RM et al. The Quality in Australian Health Care Study. The Medical Journal of Australia. 163(9):458-71,1995 • 16.6 percent of hospital admissions involved adverse events, half of those considered preventable. About 14 percent of adverse events were found to have resulted in permanent disability, with 4.9 percent resulting in death.

4. IOM Reports IOM reports have consistently emphasized the need for enhancing patient safety and healthcare quality: • Patient Safety: A New Standard for Care ( 2003) • Priority Areas for National Action: Transforming Healthcare quality (2003) • Crossing the Quality Chasm (2001) • To Err is Human (2000) • Computer-based Patient Record (1991, 1997)

5. IOM Recommendations The future healthcare models need to actively pursue many key elements: • Consider care to be a continuous process • Knowledge is shared & information flows freely • Decision making is evidence-based, with protocols & process support • Safety is a system property • Transparency is a necessity • Care delivery is Team-based • Cooperation among the clinicians is a priority Patient Safety will be of paramount importance as healthcare grows exponentially complex, and the discipline needs to encompass entire spectrum of healthcare.

6. Definitions • Original IOM Errors report: “An adverse event is defined as an injury caused by medical management [commission] rather than by the underlying disease or condition of the patient.” • Patient Safety definition: “An adverse event results in unintended harm to the patient by an act ofcommission or omission rather than by the underlying disease or condition of the patient.”

7. Some Current Patient Safety Indicators

10. More… • Environmental Events: Falls, Burns, Fire, Electric shock, Restraint malfunction, etc. • Criminal Events: Impersonation, Physical assault, Poisoning, Accident, Abuse, Negligence, etc. • Site-specific Outcomes: Brain injury, spinal cord injuries, Fracture/dislocation of bones, Incident involving sight or hearing impairment, etc. • General Outcomes: Death arising from unexplained cause/suspicious circumstances, death due to unnatural causes, treatment for adverse incident, transfer required due to adverse incidents, serious injury, impairment, death or further treatment due to adverse incidents, etc.

11. Iceberg Model of Accidents and Errors Serious Events Death/Severe Harm Near Miss Unwanted consequence prevented because of recovery No Harm Events

12. Care Coordination- Cross cutting Self management/Health literacy- Cross Cutting Asthma Cancer Screening, esp. cervical and colorectal Children with special healthcare needs (Chronic physical, developmental, behavioral or emotional) End of life with advanced organ system failure: CHF and COPD Priority Areas for National Action: Transforming Healthcare Quality, IOM, 2003. Priority Areas

13. Priority Areas • Frailty associated with old age - preventing falls, pressure ulcers, maximizing function and developing advanced care plans • Hypertension- appropriate management of early disease • Immunization children and adults • Ischemic Heart Disease - prevention, reduction of recurrence, optimization of functional capacity • Major Depression- screening and treatment

14. Priority Areas • Medication Management - preventing medication errors and overuse of antibiotics • Healthcare acquired Infection - prevention and surveillance • Pain control in advanced cancer • Pregnancy and childbirth- appropriate prenatal and intrapartum care • Severe and persistent mental illness- focus on treatment in public sector • Stroke- early intervention and rehabilitation • Tobacco dependence treatment in adults • Obesity (emerging priority)

15. Draft HL7 Patient Safety Inventory Suzanne Bakken, RN. DNSc. Columbia University In order to ascertain the extent of patient safety-related activities in HL7, the recent documents of Technical Committees and Special Interest Groups on the HL7 web page were reviewed. For the purposes of the inventory, patient safety was broadly defined to include freedom from errors of commission (e.g., administering a drug to which a patient is allergic) and errors of omission (e.g., providing care that is not consistent with the best evidence). The inventory was limited to Technical Committees and Special Interest Groups that identified patient safety activities in their mission, minutes, or other documentation or provided infrastructure standards as specified in the 2003 Institute of Medicine patient safety data standards report (Committee on Data Standards for Patient Safety, 2003a).

22. Topics being addressed… • Individual Case Safety Reporting (ICSR) • Drugs, Vaccines, Devices • Blood Product Deviations • subject matter and vocabulary needs • Healthcare-acquired Infection Reporting

23. National Patient Safety Agency-UK needs Patient Safety incident: Any unintended or unexpected incident(s) that could have or did lead to harm for one or more persons receiving healthcare services Patient Safety: The multidisciplinary approaches by which an organisation reduces the risk and occurrence of harm to patients as a result of their healthcare

24. Access, admission, transfer, discharge Clinical assessment (incl. diagnosis, tests, assessments) Consent, communication, confidentiality Disruptive, aggressive behaviour Documentation (including records, identification) Infection control Top level incident categories • Implementation and ongoing monitoring/review • Infrastructure (including staffing, facilities, environment) • Medical device, equipment • Medication • Patient abuse • Patient accident • Self harming behaviour • Treatment, procedure • Other

25. Proposed relationship with WHO’s Patient Safety Alliance • Recognise need for international representation • PSA recognises that • “…no single player has the expertise, funding or research and delivery capabilities to tackle the full range of patient safety issues on a worldwide scale. An international alliance would provide a mechanism to decrease duplication of investment and activities and benefit by economies of scale.” PSSIG should work with the PSA to: • Raise awareness of the group’s activities • Disseminate key deliverables • Seek guidance • Ensure that needs of the international community are catered for

26. Australian Participation • Working with HL7 Australia • Multiple needs in different settings • Different groups have long-term experience, and have developed methodologies and tools Japanese Participation…

27. Entry point Current thoughts on the Domain… Patient Safety Domain M e d i c a t i o n V a c c i n e s D e v i c e s S p e c i a l t i e s I n f e c t i o n s T r a n s f u s i o n s O T H E R

28. Vision, Mission, Principles, Charter, Decision Making Process, Prioritization, Interaction with other TCs and SIGs, etc.

29. Interactions with other TCs and SIGs Patient Care TC to define settings and processes in medical care that effect patient safety and the related clinical/other information needs Electronic Health Record TC to identify and develop patient safety related functionalities within electronic medical record environment Pharmacy SIG to ensure proper medication usage (drug-drug interaction, contraindications, drug concentration and dosing, dispensing, AE reporting etc.) Structured Document TC to accommodate the patient safety related information needs within structured technical documents Clinical Decision Support TC to address patient safety needs at the point-of-care from a evidence-based healthcare practice perspective, and Vocabulary TC to improve patient safety related vocabularies (coding for HL7 internal codes, diseases, drugs, vaccines, medical devices/procedures, blood products, clinical terminology, regulatory terminology, etc.) and promote the usage of appropriate controlled vocabularies. PHER… CBHS…

30. What is needed • Finding ‘Natural Home’ for different topics • Coordination of efforts where overlaps are identified • Friday Q1 meeting with PC • Harmonization of domains and work products • Ensuring that the HL7 standard as a whole reflects the patient safety perspectives