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

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Presentation on theme: "Recent Developments in Patient Safety and Scope of Patient Safety Special Interest Group Recent Developments in Patient Safety and Scope of Patient Safety."— Presentation transcript:

1 Recent Developments in Patient Safety and Scope of Patient Safety Special Interest Group 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): , and respectively, –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 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 CDC-National Vital Statistics Reports. 47(19):27, 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 CDC, National Vital Statistics Reports. 47(25):6, 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 The Lancet, 351:643-44, 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: , 1999 and Johnson WJ et al. The economic consequences of medical injuries, JAMA. 267: , 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. Burden of medical errors

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. 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 of commission or omission 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 of commission or omission rather than by the underlying disease or condition of the patient.

7 Some Current Patient Safety Indicators DomainAbbreviated Definitions (and alternative language when NQF, JCAHO, and State definitions differ) NQF JCAHO USDHHS Medical- Event-Related Data Systems State Systems SurgeryWrong site surgeryXXFL, MA,, ME, OH, PA, TN, UT, WA Surgery on wrong patientXFL, MA, ME, OH, PA, RI, TN, UT, WA Wrong surgical procedure performed on patientXFL, MA, RI, TN Foreign object left in a patient after surgery or other procedure XHCUP, NNISFL, MA, TN Intraoperative or immediately post-operative Death in an ASA Class I patient (NQF) Anesthesia-related event (JCAHO) XXHCUP, BPD, MERS,MEDMARX, NNIS ASA Class I patient designation unlikely to be available CO, NJ Death or near death for anesthesia and cardiac procedures (NJ) NJ [Intraoperative or Post-operative complicationXHCUP Often not specific RI, TN Surgical repair or damage resulted from planned surgical procedure where damage was not disclosed or documented to the patient FL

8 DomainAbbreviated Definitions (and alternative language when NQF, JCAHO, and State definitions differ) NQF JCAHOUSDHHS Medical-Event- Related Data Systems State Systems Product or Device Events Death or serious disability from use of contaminated drugs, devices, or biologics by facility XAERS, ARS, BPD, DSN, MAUDE, MEDSUN, MEDWATCH, MERS, MEDMARX, NNIS, VAERS, VSD Aspiration in non-intubated patient related to conscious/moderate sedation TN Death or serious disability from use or function of a device in patient care, when other than intended (NQF) Medical equipment-related event (JCAHO) Intravascular catheter related events (TN) XXAERS, ARS, DSN, MAUDE, CMS, MEDSUN, MEDWATCH, MERS, MEDMARX, NNIS CO, MA, ME, NY, OH, TN Death or serious disability from intravascular air embolism during care at a facility XAERS, ARS, DSN, MAUDE, MEDSUN, MEDWATCH, MERS, MEDMARX, MPSMS CO Ventilator death or injuryXCO

9 CareManage-mentEvents Death or serious disability from medication error (e.g. wrong drug, dose, patient, time, rate, preparation, or route (NQF) Medication error (JCAHO) XXHCUP, MEDSUN, MEDWATCH, MERS, MEDMARX, NNIS, VAERS MA, ME, PA, TN Patient death or serious disability associated with a hemolytic reaction due to the administration of ABO-incompatible blood or blood products (NQF) Transfusion error (JCAHO) XXHCUP, BPD, DSN, MEDWATCH, MERS, MEDMARX CO, MA, ME, PA, TN, WA Maternal death or serious disability associated with labor or delivery in a low- risk pregnancy while being cared for in a healthcare facility (NQF) Maternal death (JCAHO) XXHCUP, MAUDE, MEDSUN, MEDWATCH, MERS, MEDMARX, NNIS MA Hysterectomy in a pregnant woman, ruptured uterus (TN)TN Birth injury (RI)RI Patient death or serious disability associated with hypoglycemia, the onset of which occurs while the patient is being cared for in a healthcare facility XHCUP, DSN, MAUDE, MEDSUN, MEDWATCH, MERS, MEDMARX Death or serious disability (kernicterus) associated with failure to identify and treat hyperbilirubinimia in neonates XHCUP, MAUDE, MEDSUN, MEDWATCH, MERS, MEDMARX, NNIS, VAERS Perinatal death or loss of functionXHCUP, MAUDE, MEDSUN, MEDWATCH, MERS, MEDMARX, NNIS, VAERS Stage 3 or 4 pressure ulcers acquired after admission to a healthcare facility XHCUP, CMS, MEDSUN, MEDWATCH Patient death or serious disability due to spinal manipulative therapyXMAUDE, MEDSUN, MEDWATCH Delay in treatmentX Infestation by parasites or vectors (CA)CA Death due to malnutrition, dehydration, or sepsis (PA)PA

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

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

15 Draft HL7 Patient Safety Inventory 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). Suzanne Bakken, RN. DNSc. Columbia University

16 HL7 TC/SIGActivitiesRelevance to Patient Safety Arden SyntaxMaintenance and further development of the Arden Syntax Arden Syntax provides a standard for representing and sharing of clinical knowledge (decision support rules) through Medical Logic Modules Arden Syntax Implementation GuideArden Syntax Implementation Guide supports standard implementation of Arden Syntax and Medical Logic Modules AttachmentsInitial focus on NPRM attachments. Future projects include, but are not limited to, Home Health, Skilled Nursing Facility, Durable Medical Equipment (DME), End Stage Renal Disease (ESRD), and Pre- Authorization and Referrals. Beyond their primary purpose related to insurance and e- commerce, attachments such as those proposed in future project are of relevance to coordination of care across organizations and sites. CCOWStandard Context Management Specification Provision of specified data (e.g., patient name, allergies) across applications has the potential to decrease errors. Clinical Decision Support Common Expression Language (GELLO) Common expression language for guideline representation will improve the computability and sharing of guideline knowledge Decision Support WorkbookDecision Support Workbook supports standard implementation. Decision Support HDFDecision Support HDF enables creation of decision support messages. vmR - DIM/RMIM specialized from the RIM for decision support in EHR Decision support DIM/RMIM enables creation of decision support messages. Decision support aspects of EHR specification Decision support is an essential capability of EHR (Committee on Data Standards for Patient Safety, 2003a, b).

17 HL7 TC/SIGActivitiesRelevance to Patient Safety Clinical Guidelines Creation of the standard for the communication of clinical practice guidelines to facilitate their integration into health care systems, electronic medical records, and a variety of applications. Common expression language for guideline representation will improve the computability and sharing of guideline knowledge Community Based Health Services Messaging needs of community based providers such as home health, hospice, long term care and mental health. Work items include messages related to home health, telehealth, and referrals Information exchange between community-based and acute care settings is essential for coordination of care and ensuring patient safety. ConformanceThis group supports the HL7 mission to create and promote its standards by providing a consistent mechanism to specify conformance for HL7 Version 2.X and HL7 Version 3 messages and provide a framework for facilitating interoperability using the HL7 standard. Mechanism for assessing conformance with data standards is needed to facilitate adoption of data standards that support patient safety (Committee on Data Standards for Patient Safety, 2003a). Electronic Health Records EHR architecture and functionalityEHR systems form an essential component of NHII that supports patient safety (Committee on Data Standards for Patient Safety, 2003a, b). Imaging Integration Collection, review, development and documentation of use cases, information structures and message content related to ordering and reporting of non-textual data and associated information, including images themselves. Non-textual data such as images are critical patient information. Data from imaging systems, PACS, and associated radiological oriented systems require integration with other clinical information.

18 HL7 TC/SIGActivitiesRelevance to Patient Safety Laboratory, Automated, and Point of Care Testing Automated laboratory messages and (a) extension of the messages, triggers, and segments to Point of Care Testing devices, Home Testing devices, and data collection and processing computers that support these activities, (b) development of the aspects of the Reference Information Model that relate to automated clinical laboratory and point of care/home testing, and (c) development of version 3 messages for automated clinical laboratory and point of care/home testing. Communication among automated clinical laboratory systems, instruments, devices including point of care and home testing devices, and clinical information systems will improve the timeliness and accuracy of the information exchange. Medical Records/Information Management Medical-legal agreementsMedical-legal agreements such as consent forms are necessary to ensure that the patient is aware of the potential risks and benefits associated with treatment MedicationRepresentation of medication related information and pharmacy D-MIM Medication-related events are most frequently occurring adverse events across care settings. Messages that support accurate and appropriate prescribing, dispensing, and administering of medications are critical to patient safety. Modeling and Methodology HL7 RIM and Modeling MethodologyReference Information Model essential for semantic interoperability and a necessary component of NHII (Committee on Data Standards for Patient Safety, 2003a).

19 HL7 TC/SIGActivitiesRelevance to Patient Safety Orders/ Observations Orders communication (e.g., medications, laboratory, nursing) and observation reporting (e.g., laboratory, symptom assessments, surgery reports) processing requirements Orders communication and observation reporting form the central core of communication and information exchange among members of the healthcare team. Medical Device interfacesCommunication between medical devices and other information systems will improve the timeliness and accuracy of the information exchange. Communication between implantable device manager and HIS Communication between implantable device manager and other information systems will improve the timeliness and accuracy of the information exchange. Patient Administration Standards related to descriptions of persons, places, organizations, and other demographic and administrative entities Accurate identification of individuals is a prerequisite for patient safety. Patient CareGoals Referrals Goals are a significant aspect of evidence- based practice. Referrals are essential to coordination of care.

20 HL7 TC/SIGActivitiesRelevance to Patient Safety Pediatric Data Standards Definition of pediatric data standards required for interchange of standardized and comparable national pediatric performance measurement including required terminology. Pediatric safety and quality of care have specialized requirements in some instances (e.g., drug dosages by weight). Personnel Management Professional's identity, his/her rights and obligations, the special domain and qualifications, and the relationships to patients. The information exchanged is needed for the professional's authentication, authorization, access control and accountability for data and processes. Regulated Clinical Research Information Management Messages, document structures, and terminology to support the systems and processes used in the collection, storage, distribution, integration and analysis of regulated clinical research information. Regulated clinical research information is represented differently by different agencies. Efforts such as Consolidated Health Informatics are aimed at commonalities across agencies. Product labelingAccurate product labeling is a prerequisite for safe product administration and timely sharing of information about product- related adverse events. Regulatory reports related to adverse events (see Individual Case Safety Report, Patient Safety Individual Case Safety Report provides a standard representation for adverse event reporting to various federal agencies. Research protocol representationStandard research protocol representation will support accuracy and timeliness of protocol sharing.

21 HL7 TC/SIGActivitiesRelevance to Patient Safety Scheduling and Logistics Messages for the purpose of communicating and supporting the various processes related to the scheduling of appointments for services and associated resources. Processes include the functions of requesting, booking, notification, and modification pertaining to appointments and resources., sterilization message Issues related to scheduling of services and associated resources have the potential to delay or prevent necessary treatment and impede coordination of care. Security and Accountability HL7 Security Service FrameworkSecurity service a required component of NHII that supports patient safety (Committee on Data Standards for Patient Safety, 2003a). Standard Guide for Implementing HL7 EDI Communication Security Standard Guide supports implementation of security service. Structured Documents Clinical Document Architecture (CDA)CDA will facilitate the extraction of context-specific patient safety-related data that are structured and of non-structured data (through natural language processing) (Committee on Data Standards for Patient Safety, 2003a). VocabularyIdentification, organization and maintenance of coded vocabulary terms used in HL7 messages. Computable representations of terms are essential to semantic interoperability and required component of of NHII that supports patient safety (Committee on Data Standards for Patient Safety, 2003a).

22 Topics being addressed… 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 Top level incident categories Access, admission, transfer, discharge Clinical assessment (incl. diagnosis, tests, assessments) Consent, communication, confidentiality Disruptive, aggressive behaviour Documentation (including records, identification) Infection control Access, admission, transfer, discharge Clinical assessment (incl. diagnosis, tests, assessments) Consent, communication, confidentiality Disruptive, aggressive behaviour Documentation (including records, identification) Infection control Implementation and ongoing monitoring/review Infrastructure (including staffing, facilities, environment) Medical device, equipment Medication Patient abuse Patient accident Self harming behaviour Treatment, procedure Other 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 WHOs 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 groups 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 Current thoughts on the Domain… SpecialtiesSpecialties SpecialtiesSpecialties InfectionsInfections InfectionsInfections Patient Safety Domain TransfusionsTransfusions TransfusionsTransfusions MedicationMedication MedicationMedication VaccinesVaccines VaccinesVaccines DevicesDevices DevicesDevices Entry point OTHEROTHER OTHEROTHER

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


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