Patient safety organization

A patient safety organization is a group, institution or association that improves medical care by reducing medical errors. In the 1990s, reports in several countries revealed a staggering number of patient injuries and deaths each year due to avoidable adverse health care events. In the United States, the Institute of Medicine report (1999) called for a broad national effort to include the establishment of patient safety centers, expanded reporting of adverse events and development of safety programs in health care organizations. The organizations that developed ranged from governmental to private, and some founded by industry, professional or consumer groups. Common functions of patient safety organizations are data collection and analysis, reporting, education, funding and advocacy. On July 29, 2005, the United States Congress established guidelines for Patient Safety Organizations under the Patient Safety Quality Act of 2005. Under this act, a network of databases to collect and analyse outcomes was authorized.

Functions
Patient safety organizations may use several approaches to reducing adverse events:
 * 1) Collect data on the prevalence and individual details of errors.
 * 2) Analyze sources of error by root cause analysis.
 * 3) Propose and disseminate methods for error prevention.
 * 4) Design and conduct pilot projects to study safety initiatives, including monitoring of results.
 * 5) Raise awareness and inform the public, health professionals, providers, purchasers and employers.
 * 6) Conduct fundraising and provide funding for research and safety projects
 * 7) Advocate for regulatory and legislative changes.

Composition
President Clinton's Advisory Commission on Consumer Protection and Quality in the Health Care Industry completed its work on March 12, 1998. Its final report. entitled "Quality First: Better Health Care for All Americans," recommends the following characteristics of a patient safety organization:
 * Be located in an entity that is credible and respected.
 * Be located in an entity that does not have public or private regulatory responsibilities (i.e., it should not be a licensing, accrediting, or compliance entity).
 * Have the ability to collect and analyze data.
 * Have mechanisms for communicating with a variety of health care entities, facilities, providers, and plans.
 * Be linked with initiatives for conducting interdisciplinary research and demonstrations addressing health care quality improvement.

Organizations advocating patient safety
Several authors of the 1999 Institute of Medicine report revisited the status of their recommendations and the state of patient safety, five years after "To Err is Human". Discovering that patient safety had become a frequent topic for journalists, health care experts, and the public, it was harder to see overall improvements on a national level. What was noteworthy was the impact on attitudes and organizations. Few health care professionals now doubted that preventable medical injuries were a serious problem. The concept that bad systems, and not bad people, lead to most errors became central in patient safety efforts. A broad array of organizations had developed to advance the cause of patient safety.

World Health Organization
In response to a 2002 World Health Assembly Resolution, the World Health Organization (WHO) launched the World Alliance for Patient Safety. The goal was to develop standards for patient safety and assist UN member states to improve the safety of health care. At the Fifty-Ninth World Health Assembly in May 2006, the Secretariat reported that the Alliance held patient safety meetings in five of the six WHO regions and 40 technical workshops in 18 countries. Since the launch of the Alliance in October 2004, significant progress was achieved in six areas:
 * 1) The First Global Patient Safety Challenge, which for 2005-2006 (addressing health care-associated infection) developed the WHO Guidelines on Hand Hygiene in Health Care.
 * 2) A patient involvement group, Patients for Patient Safety, built networks of patients’ organizations from around the world, through regional workshops.
 * 3) A Patient Safety Taxonomy was developed to classify data on patient safety problems.
 * 4) Prevalence studies conducted on patient harm in ten developing countries.
 * 5) A WHO Collaborating Centre was established to develop and disseminate safety solutions.
 * 6) The WHO Draft Guidelines on Adverse Event Reporting and Learning Systems.

TGA and ANZTPA
The Therapeutic Goods Administration (TGA) is a unit of the Australian Government Department of Health and Ageing. The TGA approves and monitors prescription and non-prescription drugs (including herbal products), medical supplies and devices, and blood and biological products. Risks to users are assessed prior to product introduction, and manufacturers are regularly audited for efficacy, quality and safety. Manufacturers are required to report adverse drug effects to the Adverse Drug Reactions Advisory Committee (ADRAC) of the TGA; reporting by medical professionals and consumers is voluntary. ADRAC notifies medical professionals and the public by recalls and alerts on its website and publications.

In December 2003, the Australian and New Zealand Governments signed an agreement to establish a joint regulatory organization for therapeutic products. The Australia New Zealand Therapeutic Products Authority (ANZTPA) will replace the Australian Therapeutic Goods Administration (TGA) and the New Zealand Medicines and Medical Devices Safety Authority (Medsafe), and be accountable to the Australian and New Zealand Governments. Implementing legislation is scheduled for introduction into both countries' parliaments in July 2006.

Australian Council for Safety and Quality in Health Care (ACSQHC)
The ACSQHC was established in January 2000 for a five-year term to provide leadership in improving patient safety and quality through advice to all federal, state and territory health ministers. Goals were to develop common standards for patient safety, improve data collection for safety monitoring and provide for public input at the governmental level. In 2005, the Australian Health Ministers agreed to release ACSQHC’s annual reports to the public. Report recommendations included a national trial of disclosure of adverse events, developing a national strategy for preventing health care associated infections, and national credentialling for medical practitioners in hospitals. The Council was replaced by the Australian Commission on Safety & Quality in Health Care in January 2006, with the same role.

National Patient Safety Agency (NPSA)
The NPSA is a NHS Special Health Authority created in July 2001 to improve patient safety within the National Health Service (NHS) by encouraging voluntary reporting of medical errors, conducting analysis and initiating preventative measures. Since 2005, the NPSA has also been responsible for: safety aspects of hospital design, cleanliness and food; safe research practices through the National Research Ethics Service (NRES); and performance of individual doctors and dentists, through the National Clinical Assessment Service (NCAS). The NPSA identifies patient safety deficiencies with the input of clinical experts and patients, develops solutions and monitors results of corrections within the NHS. Initiatives and alerts include hand hygiene, information for doctors and patients on steps to reduce risk of error, vaccine safety and disclosure of error to injured patients. In addition, the National Reporting and Learning System (NRLS) allows NHS employees to provide the NPSA with reports anonymously.

The Agency for Healthcare Research and Quality
In 2001, the US Congress responded to the IOM recommendation to create a National Center for Patient Safety by allocating $50 million annually for patient safety research to the Agency for Healthcare Research and Quality (AHRQ), the lead federal agency for health care safety. The AHRQ organizes patient safety activities, provides grants to other organizations, serves as a clearinghouse for safety information, and publishes guidelines for evidence-based or "best practices". By 2006, the National Guideline Clearinghouse (NGC) contained more than 1,700 disease-specific diagnosis, management and treatment recommendations, developed from current medical literature. The goal of the NGC is to provide health professionals and institutions, health plans and health care purchasers an accessible mechanism for obtaining objective clinical practice guidelines. Adoption of guidelines has been slowed by physician and hospital concern that practice guidelines threaten physician autonomy and authority, fuel malpractice liability, and allow managed care insurers to curtail patient care expenditures.

Under the Secretary of Health and Human Services, the Agency for Healthcare Research and Quality coordinates the Patient Safety Task Force composed of three other agencies with regulatory and data collection responsibilities: the Centers for Disease Control and Prevention (CDC) and its National Electronic Disease Surveillance System, the Centers for Medicare and Medicaid Services (CMS) and state Quality improvement organizations, and the Food and Drug Administration (FDA).

The AHRQ, in partnership with data organizations in 37 states, sponsors the Nationwide Inpatient Sample (NIS), a database of the Healthcare Cost and Utilization Project (HCUP). The HCUP is a Federal-State-Industry partnership providing all discharge data from 994 hospitals -- approximately 8 million hospital stays each year. The Nationwide Inpatient Sample is the largest all-payer inpatient care database in the United States from which national estimates of inpatient care can be derived. Using safety data from the NIS, the AHRQ has been able to provide complication rates and risk data, even for rare surgical procedures, such as bariatric surgery.

In 2005, AHRQ provided links to a compendium of 140 research articles, implementation programs and tools and products used to improve patient safety, sponsored jointly with the Department of Defense (DoD)-Health Affairs.

FDA
The Food and Drug Administration is an agency of the United States government that regulates food, drugs, medical devices and biological products for human use. The FDA receives medication error reports on marketed human drugs from direct contacts and manufacturer's reports, and in 1992, began monitoring medication error reports that are forwarded from the United States Pharmacopeia (USP) and the Institute for Safe Medication Practices (ISMP). The FDA launched a new program in 2005 to provide drug risk information directly to the public through internet-accessible drug sheets and bulletins. The effectiveness of the FDA's drug safety monitoring procedures has been called into question after several approved drugs were shown to have serious side-effects. In September 2006, an Institute of Medicine report commissioned by the FDA found that its drug safety system is limited by inadequate funding, insufficient regulatory authority, and a lack of oversight by experts free of pharmaceutical industry ties.

Australian Patient Safety Foundation (APSF)
The APSF is a non-profit independent organisation founded in 1989 for anaesthesia error monitoring, and expanded to patient incident reporting and monitoring after results from the Quality in Australian Health Care Study (QAHCS) in 1995 prompted reaction from the public. Adverse medical events, both sentinel events (patient death and injury) and near misses (medical errors with potential harm), are reported and analyzed through its subsidiary, Patient Safety International (PSI), using a software tool, the Advanced Incident Management System (AIMS). AIMS is used in over half of Australia's hospitals, and was adopted in 2005 by the New Zealand Accident Compensation Corporation and the University of Miami Medical Group in Florida. Data remains confidential is protected from legal discovery under Australian Commonwealth Quality Assurance legislation. Patient safety information is provided by electronic newsletters.

Canadian Patient Safety Institute (CPSI)
The Canadian Patient Safety Institute (Institut canadien sur la sécurité des patients) was developed in 2003 after consultations among Canadian healthcare professional organizations, provincial and territorial ministries of health and Health Canada. An independent non-profit corporation, the CPSI promotes solutions and collaboration among governments and stakeholders to improve patient safety, and has a five year mandate. Areas of improvement are education, system innovation, communication, regulatory affairs and research. Together with the Institute For Safe Medication Practices Canada and Saskatchewan Health, a Canadian Root Cause Analysis Framework is offered to healthcare organizations to analyze the contributing factors that led to a critical incident or close call.

In April 2005, CPSI launched the Safer Healthcare Now! campaign, aimed at reducing error-related injuries by focusing on six evidence-based measures and through over 200 local organizations, based on the 100,000 lives campaign.

Institute for Safe Medication Practices Canada
The Institute for Safe Medication Practices Canada (ISMP) is an independent national non-profit agency that reviews and analyzes medication incident and near-miss reports. In collaboration with the Canadian Institute for Health Information (CIHI), and Health Canada, ISMP established the Canadian Medication Incident Prevention and Reporting System (CMIRPS) in 2003. ISMP takes the lead role of collecting reports from heath practitioners, analysing incidents, and disseminating preventative methods.

The National Institute for Health and Clinical Excellence (NICE)
The National Institute for Health and Clinical Excellence is an independent organisation that produces guidance on public health, health technologies and clinical practice in England and Wales. NICE has three centres of excellence. The Centre for Public Health Excellence develops public health guidance, with information for patients on diagnosis and treatment of specific illnesses and conditions. The Centre for Health Technology Evaluation recommends medicines and evaluates the safety and efficacy of procedures within the National Health Service. The Centre for Clinical Practice develops evidence-based clinical guidelines for clinicians on the appropriate treatment of people with specific diseases. NICE and the National Patient Safety Agency (NPSA) cooperate in risk assessment of new technology, monitoring safety incidents associated with procedures, and providing solutions if adverse outcomes are reported. In addition, NICE and NPSA share reporting in areas known as "Confidential Enquiries": maternal or infant deaths, childhood deaths to age 16, deaths in persons with mental illness, and perioperative and unexpected medical deaths.

The Health Foundation (Safer Patients)
Based in London, England, the Health Foundation is an independent charity that aims to improve the quality of health care for the people of the United Kingdom. The Safer Patients Initiative, one of the Foundation’s quality and performance improvement programmes, targets reducing medication-related adverse events and errors, reducing infections associated with intensive care units or surgery and improving organisational culture, leadership and expertise in measuring improvement. The goal of the initiative is a 50 percent reduction in adverse events per 1,000 patient days for each site. In 2004, The Health Foundation selected four hospitals from across the UK to work on a £4.3 million patient safety improvement programme. These four hospitals continue to show measurable improvements in their patient safety performance, and 16 more hospitals are being selected in 2006 to join the second phase.

American Society of Medication Safety Officers
The American Society of Medication Safety Officers (ASMSO) is a not-for-profit association established in 2006 with a mission to advance and encourage excellence in the profession of pharmacy by providing leadership, direction, education and communication among its members, to represent pharmacy in organized healthcare settings and promote the advancement of safe medication use.

The National Quality Forum
The National Quality Forum (NQF) is a not-for-profit membership organization created in 1999 to develop and implement a national strategy for health care quality measurement and reporting. Membership is open to national, state, regional, and local groups representing consumers, public and private purchasers, employers, health care professionals, provider organizations, health plans, accrediting bodies, labor unions, supporting industries, and organizations involved in health care research or quality improvement. The NQF has focused on several areas: error rates, unnecessary procedures and undertreatment, especially preventive care. Policies are formed through one of four Member Councils: the Consumer Council, Purchaser Council, Provider and Health Plan Council, and Research and Quality Improvement Council.

In 2002, the National Quality Forum defined 27 events that should never occur within a health care facility. There are six types of "never events" (officially called Serious Reportable Events): surgical events (e.g., surgery being performed on the wrong patient), product or device events (e.g., using contaminated drugs), patient protection events (e.g., an infant discharged to the wrong person), care management events (e.g., a medication error), environmental events (e.g., electric shock or burn), and criminal events (e.g., sexual assault of a patient). The NQF’s report recommends a national state-based event reporting system to improve the quality of patient care. As of 2006, a little more than half of U.S. states have some version of a reporting system for serious reportable events. More recently, the organization is developing a national consensus on symptom management and end-of-life care in cancer patients.

Leapfrog
Staggered by increasing health insurance costs, several large US companies met in 1998 to influence quality and affordability. The resulting Leapfrog Group agreed to base their purchase of health care on principles that "encourage provider quality improvement and consumer involvement". The group was officially launched in November 2000 with the initial focus provided by the 1999 Institute of Medicine report – reducing preventable medical mistakes (the report recommended that large employers leverage their purchasing power for the quality and safety of health care). The "leapfrog" concept involved large advances stimulated by rewarding hospitals that implement significant improvements (the Leapfrog Hospital Rewards Program ). The quality practices mandated are computer physician order entry CPOE, evidence-based hospital referral, intensive care unit (ICU) staffing by physicians experienced in critical care medicine, and a "Leapfrog Safe Practices Score", based on the National Quality Forum endorsed Safe Practices. Additional initiatives now include public reporting of health care quality and outcomes (hospital quality ratings) to influence consumers' choices. Leapfrog now includes more than 170 large private and public healthcare purchasers providing health benefits to more than 37 million employees and retirees, funded by the Business Roundtable, the Robert Wood Johnson Foundation and Leapfrog members.

JCAHO
Founded in 1951, the Joint Commission on Accreditation of Healthcare Organizations (JCAHO) is an independent, not-for-profit organization that evaluates and accredits nearly 15,000 health care organizations and programs in the United States. An organization must undergo an on-site survey by a Joint Commission survey team at least every three years. The scope of reviews by JCAHO is broad, including hospitals, home care agencies, medical equipment providers, nursing homes, rehabilitation facilities, surgical centers and medical laboratories. Passing a survey is crucial for most organizations, since accreditation by JCAHO is required for paticipation in Medicare and some state and private health care programs. Since the accreditation rate is over 90%, there have been questions raised regarding the effectiveness of these surveys.

In 1997, JCAHO began including outcomes and other performance data into the accreditation process (the "ORYX initiative"). Information gained allowed the Joint Commission to develop National Patient Safety Goals to promote specific improvements in patient safety. The Goals highlight problem areas in health care and describe evidence-based solutions. Examples include prevention of falls, patient identification, reducing hospital infections and pressure ulcers, and improving hospital staff communication. In addition, the Joint Commission created a "do not use" list of abbreviations in 2004 to avoid acronyms and symbols that lead to misinterpretation.

Identifying sentinel events and analyzing the root causes has been a focus of JCAHO since 1996; the first eight alerts were published in 1998. The Commission defines a sentinel event as "any unexpected occurrence involving death or serious physical or psychological injury, or the risk thereof." The heath care facility experiencing the sentinel event is expected to complete a thorough root cause analysis, make improvements to the underlying processes, and monitor the effectiveness of the changes. Although the cause of most sentinel events is human error, changes in organizational systems will reduce the likelihood of human error in the future and protect patients from harm when human error does occur. Specific causes of sentinel events and the solutions that hospitals then used successfully to reduce risks are publicized by JCAHO annually. Alerts have included issues as varied as wrong site surgery, restraint deaths, transfusion and medication errors and patient abductions.

In 2005, JCAHO established an International Center for Patient Safety to collaborate with international patient safety organizations to identify, develop and share safety solutions, conduct joint research, and advocate public policy changes. Educational materials to help patients prevent medical errors, sentinel event alerts and other resources are provide on the internet.

The Pittsburgh Regional Health Initiative
The Pittsburgh Regional Health Initiative, or PRHI, is an independent catalyst for improving healthcare safety and quality in Southwestern Pennsylvania. It operates on the premise that dramatic quality improvement is the best cost-containment strategy for health care. PRHI was the first regional consortium of medical, business and civic leaders to address healthcare safety and quality improvement as a social and business imperative. Turning its own community into a demonstration lab, PRHI strives to accelerate improvement and set the pace for the nation. Its experiment reflects three principles: PRHI offers clinicians and other healthcare professionals necessary tools, expertise, education, models and networks to perfect patient care and safety in their organizations. Using the Toyota Production System and Alcoa Business System as models, PRHI developed a quality improvement method for clinical settings known as Perfecting Patient Care. PRHI teaches this method through a five-day curriculum called Perfecting Patient Care University, as well as in advanced and individualized courses and on-site coaching. PRHI reports that thousands across the nation have already learned how to use Perfecting Patient Care principles and are demonstrating the value of quality engineering in any healthcare setting—from neighborhood clinics, to hospitals and nursing homes. PRHI, cofounded by Paul O’Neill and Karen Wolk Feinstein, is a nonprofit operating arm of the Jewish Healthcare Foundation. It is funded by local corporations, foundations, health plans and government contracts and grants.
 * 1) Health care is local. Federal policy changes alone cannot achieve needed reform.
 * 2) Those who work at the point of care develop quality and safety improvements that work and last.
 * 3) Continuous improvement in quality and safety requires the highest possible standard, namely perfection. To settle for less limits achievement.

The Institute for Healthcare Improvement (100,000 lives)
The Institute for Healthcare Improvement, a not-for-profit organisation whose mission is to accelerate the improvement of health care in the US and internationally, launched the "100,000 Lives" campaign in December 2004. The Institute has enrolled over 3,000 US hospitals (over 80% of total US hospital discharges) in this initiative to avoid 100,000 unnecessary deaths in US hospitals over the 18 months from January 2005 to June 2006. Hospitals used six evidence-based interventions that are known to significantly reduce harm to patients: A life saved is a patient who survived a hospital stay who would have died had he or she received that hospital's pre-campaign (2004) level of care. The campaign estimated that, as of April 2006, participating hospitals had saved over 84,000 lives, and by the end of the campaign over 120,000 lives.
 * 1) Deploy rapid response teams to patients at risk of cardiac or respiratory arrest.
 * 2) Deliver reliable, evidence-based care for acute myocardial infarction.
 * 3) Prevent adverse drug events by reliable documentation of changes in drug orders.
 * 4) Prevent central venous catheter infections.
 * 5) Prevent surgical site infections.
 * 6) Prevent ventilator-associated pneumonia.

The National Patient Safety Foundation
The National Patient Safety Foundation is a not-for-profit organization founded in 1996 by the American Medical Association, CNA HealthPro, and 3M, with significant support from the Schering-Plough Corporation. Based on the model of the Anesthesia Patient Safety Foundation, the NPSF provides leadership training, research support, and education. Since 1998, an Annual Patient Safety Congress has been held to promote patient safety and medical error research in the United States. The Foundation publishes the Journal of Patient Safety, containing original papers and reviews, and provides a searchable database on its website of active research projects.

USP
The United States Pharmacopeia (USP) sets official standards for all prescription and over-the-counter medicines, dietary supplements, and other healthcare products manufactured and sold in the United States, but USP standards are also recognized and used in more than 130 other countries. USP operates two programs to promote patient safety. The Medication Errors Reporting Program enables healthcare professionals to report medication errors directly to USP. MEDMARX, an internet-based error and drug reaction reporting program, is designed for use in hospitals. The USP analyzes the data it receives through its reporting programs, develops professional education programs and disseminates alerts related to medication errors. The MEDMARX report released in 2007 analyzed 11,000 medication errors during surgery in 500 hospitals between 1998 and 2005. The analysis showed that medication errors that happen in the operating room or recovery areas are three times more likely to harm a patient than errors occurring in other types of hospital care. As of 2007, this was the largest known analysis of medical errors related to surgery.

Institute for Safe Medication Practices
The Institute for Safe Medication Practices (ISMP), based in suburban Philadelphia, is the only nonprofit organization in the US devoted entirely to medication error prevention and safe medication use. Its medication error prevention efforts began in 1975 with a column in Hospital Pharmacy to inform healthcare professionals and others about medication error prevention. ISMP operates a voluntary practitioner error-reporting program to tabulate errors nationally, understand their causes, and share “lessons learned” with the healthcare community, known as the Medication Errors Reporting Program (MERP), operated by the United States Pharmacopeia (USP) in cooperation with ISMP. In addition, ISMP’s corporate subsidiary, Med-E.R.R.S. (Medical Error Recognition and Revision Strategies), works directly and confidentially with the pharmaceutical industry to prevent errors that stem from confusing or misleading naming, labeling, packaging, and device design. The ISMP list of error-prone abbreviations is distributed nationally.

Safe Care Campaign
The Safe Care Campaign is a Georgia corporation created to help eradicate hospital acquired infections. Its goal is to instigate a national change in ideology and practices within the health care environment in regard to hand hygiene, by emphasizing well-established methods proven to result in safer patient care. The organization compiles, develops, distributes and promotes educational resource material as well as creates targeted media campaigns aimed at safe care so that patients may become better informed, proactive, true partners in their own medical treatment and recovery.

The Safe Care Campaign was formed by Victoria and Armando Nahum after three members of their family acquired nosocomial infections in hospitals in three different states in the timespan of a year. The campaign seeks to partner with like-minded organizations and individuals including hospitals, corporations, advocacies, insurance companies and caregivers dedicated to bringing safer procedures to the US health care system.

TMIT
The Texas Medical Institute of Technology (TMIT) is a medical research organization founded in 1984 that is dedicated to accelerating performance solutions that deliver direct patient impact. TMIT measures patient impact by the Institute of Medicine(IOM), quality aims of patient safety, clinical effectiveness, efficiency, timeliness, patient-centeredness, and equity. They provide a perfect scorecard for the impact of TMIT-focused philanthropy, which supports efforts that embody the IOM design principles of patient-centeredness, evidence-based medicine, and systems performance improvement. TMIT is a leading developer of practices that enable providers to succeed in national and local pay for performance programs. TMIT has had formal collaborative initiatives with numerous federal agencies and associated organizations, including NASA, the Institute of Medicine (IOM), Health Resources and Services Administration (HRSA), and the Agency for Healthcare Research and Quality (AHRQ). TMIT has developed a survey and program that ranks U.S. hospitals on an annual basis, providing the mechanism to drive quality improvement and Patient safety. The program focuses on 30 Safe Practices established by a public/private partnership, led by the National Quality Forum (NQF), charged by the U.S. Congress to establish standards and guidelines under the auspices of the Innovation Transfer Act of 1995. TMIT has funded and leads this multi-year program with yearly updates to a survey, scoring method, and national ranking system. TMIT operates an individual TMIT task force with each of Joint Commission on Accreditation of Healthcare Organizations (JCAHO), Centers for Medicare and Medicaid Services (CMS), Agency for Healthcare Research and Quality (AHRQ), Institute for Healthcare Improvement IHI, and the Leapfrog Group  to provide input to the committee in order to generate a synchronized set of practices that will provide a common roadmap to hospitals. The Safe Practices, deployed as of October 2006, provide a harmonized set of targets that the payers can build into their P4P rewards. The TMIT /NQF Safe Practice Advisory Board Consists of: Dr. Charles R. Denham (Chairman), Dr. Lucian Leape, Dr. Don Berwick, Prof. James T. Reason, Dr. David W. Bates, Dr. David Classen, Dr. Carol Haraden, Dr. Gregg Meyer, Dr. James P. Bagian, and Dr. Roger Resar.