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

Recent Developments in Patient Safety Recent Developments in Patient Safety and and

Scope of Patient Safety Special Interest GroupScope of Patient Safety Special Interest Group

Ali Rashidee, MD. MS.Ali Rashidee, MD. MS.

Co-Chair, Patient Safety SIGCo-Chair, Patient Safety SIG

PATIENT SAFETY: Estimates of medical errorsPATIENT 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.

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.

Burden of medical errors

IOM ReportsIOM 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)

IOM RecommendationsIOM 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.

DefinitionsDefinitions

Original IOM Errors report: “An adverse event is Original IOM Errors report: “An adverse event is defined as an injury caused by medical management defined as an injury caused by medical management [[commissioncommission]] rather than by the underlying disease rather than by the underlying disease or condition of the patient.”or condition of the patient.”

Patient Safety definition: “An adverse event results in Patient Safety definition: “An adverse event results in unintended harm to the patient by an act ofunintended harm to the patient by an act of commission or omissioncommission or omission rather than by the rather than by the underlying disease or condition of the patient.”underlying disease or condition of the patient.”

Some Current Patient Safety IndicatorsSome Current Patient Safety Indicators

Domain Abbreviated Definitions(and alternative language when NQF,JCAHO, and State definitions differ)

NQF JCAHONQF JCAHO USDHHS Medical-Event-Related Data Systems

StateSystems

Surgery Wrong site surgery X X FL, MA,, ME, OH,PA, TN, UT, WA

Surgery on wrong patient X FL, MA, ME, OH,PA, RI, TN, UT, WA

Wrong surgical procedure performed on patient X FL, MA, RI, TN

Foreign object left in a patient after surgeryor other procedure

X HCUP, NNIS FL, MA,TN

Intraoperative or immediately post-operativeDeath in an ASA Class I patient (NQF)

Anesthesia-related event (JCAHO)

X X HCUP, BPD, MERS,MEDMARX, NNISASA Class I patient designation unlikely to be available

CO, NJ

Death or near death for anesthesia andcardiac procedures (NJ)

NJ

[Intraoperative or Post-operative complication X HCUP 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

Domain Abbreviated Definitions(and alternative language when NQF,JCAHO, and State definitions differ)

NQF JCAHO USDHHS Medical-Event-Related Data Systems

StateSystems

Product orDeviceEvents

Death or serious disability from use ofcontaminated drugs, devices, or biologics by facility

X AERS, 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 orfunction of a device in patient care, when other than intended (NQF)

Medical equipment-related event (JCAHO)

Intravascular catheter related events (TN)

X X AERS, ARS, DSN, MAUDE, CMS, MEDSUN, MEDWATCH, MERS, MEDMARX, NNIS

CO, MA,ME, NY,OH, TN

Death or serious disability fromintravascular air embolism during care at a facility

X AERS, ARS, DSN, MAUDE, MEDSUN, MEDWATCH, MERS,MEDMARX, MPSMS

CO

Ventilator death or injury X CO

CareCareManage-Manage-mentmentEventsEvents

Death or serious disability from medication error (e.g. wrong drug, dose, patient, time, rate, preparation, or route (NQF)Medication error (JCAHO)

X X HCUP, 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)

X X HCUP, 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)

X X HCUP, 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 ina healthcare facility

X HCUP, DSN, MAUDE,MEDSUN, MEDWATCH, MERS, MEDMARX

Death or serious disability (kernicterus) associated with failure to identify and treat hyperbilirubinimia in neonates

X HCUP, MAUDE, MEDSUN,MEDWATCH, MERS,MEDMARX, NNIS, VAERS

Perinatal death or loss of function X HCUP, MAUDE, MEDSUN,MEDWATCH, MERS,MEDMARX, NNIS, VAERS

Stage 3 or 4 pressure ulcers acquired afteradmission to a healthcare facility

X HCUP, CMS, MEDSUN,MEDWATCH

Patient death or serious disability due to spinal manipulative therapy X MAUDE, MEDSUN,MEDWATCH

Delay in treatment X

Infestation by parasites or vectors (CA) CA

Death due to malnutrition, dehydration, or sepsis (PA) PA

More…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.

Iceberg Model of Accidents and ErrorsIceberg Model of Accidents and Errors

Serious EventsDeath/Severe Harm

Near MissUnwanted consequence

prevented because of recovery

No Harm Events

Priority Areas for National Action: Transforming Priority Areas for National Action: Transforming Healthcare Quality, IOM, 2003.Healthcare Quality, IOM, 2003.

Care Coordination- Cross cuttingCare Coordination- Cross cutting

Self management/Health literacy- Cross CuttingSelf management/Health literacy- Cross Cutting

AsthmaAsthma

Cancer Screening, esp. cervical and colorectal Cancer Screening, esp. cervical and colorectal

Children with special healthcare needs (Chronic physical, Children with special healthcare needs (Chronic physical, developmental, behavioral or emotional)developmental, behavioral or emotional)

End of life with advanced organ system failure: CHF and COPDEnd of life with advanced organ system failure: CHF and COPD

Priority Areas

Priority AreasPriority 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

Medication Management - preventing medication errors and Medication Management - preventing medication errors and overuse of antibioticsoveruse of antibiotics

Healthcare acquired Infection - prevention and surveillanceHealthcare acquired Infection - prevention and surveillance

Pain control in advanced cancerPain control in advanced cancer

Pregnancy and childbirth- appropriate prenatal and Pregnancy and childbirth- appropriate prenatal and intrapartum careintrapartum care

Severe and persistent mental illness- focus on treatment in Severe and persistent mental illness- focus on treatment in public sectorpublic sector

Stroke- early intervention and rehabilitationStroke- early intervention and rehabilitation

Tobacco dependence treatment in adultsTobacco dependence treatment in adults

Obesity (emerging priority)Obesity (emerging priority)

Priority AreasPriority Areas

Draft HL7 Patient Safety InventoryDraft 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.Suzanne Bakken, RN. DNSc.

Columbia UniversityColumbia University

HL7 TC/SIG Activities Relevance to Patient Safety

Arden Syntax Maintenance 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 Guide Arden Syntax Implementation Guide supports standard implementation of Arden Syntax and Medical Logic Modules

Attachments Initial 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.

CCOW Standard 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 Workbook Decision Support Workbook supports standard implementation.

Decision Support HDF Decision 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).


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.

Conformance This 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 functionality EHR 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.


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.

MedicalRecords/InformationManagement

Medical-legal agreements Medical-legal agreements such as consent forms are necessary to ensure that the patient is aware of the potential risks and benefits associated with treatment

Medication Representation 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 Methodology Reference Information Model essential for semantic interoperability and a necessary component of NHII (Committee on Data Standards for Patient Safety, 2003a).


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 interfaces Communication 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 Care Goals

Referrals

Goals are a significant aspect of evidence-based practice. Referrals are essential to coordination of care.


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, thespecial 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 labeling Accurate 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 representation Standard research protocol representation will support accuracy and timeliness of protocol sharing.


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 Framework Security 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).

Vocabulary Identification, 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).

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

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

Top level incident categoriesTop level incident categoriesTop level incident categoriesTop 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

Proposed relationship with WHO’s Patient Safety Proposed relationship with WHO’s Patient Safety AllianceAlliance

• 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

Australian ParticipationAustralian Participation

• Working with HL7 Australia

• Multiple needs in different settings

• Different groups have long-term experience, and have developed methodologies and tools

Japanese Participation…

Current thoughts on the Domain…Current thoughts on the Domain…

Specialties

Specialties

Infections

Infections

Patient Safety DomainPatient Safety Domain

Transfusions

Transfusions

Medication

Medication

Vaccines

Vaccines

Devices

Devices

Entry pointEntry point

OTHER

OTHER

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

Interactions with other TCs and SIGsInteractions 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…

What is neededWhat 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