Patient safety

Patient safety is a new healthcare discipline that emphasizes the reporting, analysis, and prevention of medical error that often lead to adverse healthcare events. The frequency and magnitude of avoidable adverse patient events was not well known until the 1990s, when multiple countries reported staggering numbers of patients harmed and killed by medical errors. Recognizing that healthcare errors impact 1 in every 10 patients around the world, the World Health Organization calls patient safety an endemic concern. [cite web |url= http://www.who.int/patientsafety/en/index.html | title= World Alliance for Patient Safety |accessdate=2008-09-27 |work= Organization Web Site | publisher= World Health Organization|date] Indeed, patient safety has emerged as a distinct healthcare discipline supported by an immature yet developing scientific framework. There is a significant transdisciplinary body of theoretical and research literature that informs the science of patient safety. [cite journal | author = Patrick A. Palmieri, et al | year = 2008 | title = The anatomy and physiology of error in averse healthcare events | journal =Advances in Health Care Management | volume = 7 | pages 33–68 | doi = 10.1016/S1474-8231(08)07003-1 | accessdate 2008-08-29] The resulting patient safety knowledge continually informs improvement efforts such as: applying lessons learned from business and industry, adopting innovative technologies, educating providers and consumers, enhancing error reporting systems, and developing new economic incentives. This patient safety page provides an evidence-based and peer-reviewed forum to learn about contemporary error and adverse event knowledge.

Prevalence of adverse events

:"See also Preventable medical error and Medical error"Millennia ago, Hippocrates recognized the potential for injuries that arise from the well intentioned actions of healers. Greek healers in the 4th Century B.C., drafted the Hippocratic Oath and pledged to "prescribe regimens for the good of my patients according to my ability and my judgment and never do harm to anyone." [National Institute of Health, History of Medicine: [http://www.nlm.nih.gov/hmd/greek/greek_oath.html Greek Medicine] ] Since then, the directive primum non nocere (“first do no harm) has become a central tenet for contemporary medicine. However, despite an increasing emphasis on the scientific basis of medical practice in Europe and the United States in the late 19th Century, data on adverse outcomes were hard to come by and the various studies commissioned collected mostly anecdotal events. [The Anesthesia Patient Safety Foundation, [http://www.apsf.org/about/brief_history.mspx A Brief History] ]

In the United States, the public and the medical specialty of anesthesia were shocked in April 1982 by the ABC television program 20/20 entitled "The Deep Sleep". Presenting accounts of anesthetic accidents, the producers stated that, every year, 6,000 Americans die or suffer brain damage related to these mishaps. [Janice Tomlin (producer): "The Deep Sleep: 6,000 will die or suffer brain damage", WLS-TV Chicago, 20/20. April 22, 1982] In 1983, the British Royal Society of Medicine and the Harvard Medical School jointly sponsored a symposium on anesthesia deaths and injuries, resulting in an agreement to share statistics and to conduct studies. [Anesthesia Patient Safety Foundation: [http://www.apsf.org/about/rovenstine/part4.mspx The establishment of the APSF] by Ellison C. Pierce, Jr., M.D.] By 1984 the American Society of Anesthesiologists had established the Anesthesia Patient Safety Foundation. The APSF marked the first use of the term "patient safety" in the name of professional reviewing organization. [Anesthesia Patient Safety Foundation: [http://www.apsf.org/about/pioneering_safety/page3.mspx Comments From the Anesthesia Patient Safety Foundation] ] Although anesthesiologists comprise only about 5% of physicians in the United States, anesthesiology became the leading medical specialty addressing issues of patient safety. [cite journal | author = David M Gaba | year = 2000 | title = Anesthesiology as a model for patient safety in health care | journal = Medical Care | volume = 320 | pages = 785–788 | url = http://bmj.bmjjournals.com/cgi/content/full/320/7237/785 | accessdate = 2006-06-24 | pmid = 10720368 | doi = 10.1136/bmj.320.7237.785 ] Likewise in Australia, the Australian Patient Safety Foundation was founded in 1989 for anesthesia error monitoring. Both organizations were soon expanded as the magnitude of the medical error crisis became known.

"To Err is Human"

In the United States, the full magnitude and impact of errors in health care was not appreciated until the 1990s, when several reports brought attention to this issue. [cite journal | author = Thomas, Eric J. MD, MPH, et al | year = 2000 | title = Incidence and Types of Adverse Events and Negligent Care in Utah and Colorado (Abstract) | journal = Medical Care | volume = 280 | issue = 38 | pages = 261–271 | url = http://www.lww-medicalcare.com/pt/re/medcare/abstract.00005650-200003000-00003.htm;jsessionid=GcgGTLTnGGQWDtLjQpxzYKyyQCBnvq6r2lH3fTn5FVX0LGp0J696!-1734750035!-949856144!8091!-1 | accessdate = 2006-06-23 | doi = 10.1097/00005650-200003000-00003 ] cite journal |author=Brennan TA, Leape LL, Laird NM, "et al" |title=Incidence of adverse events and negligence in hospitalized patients. Results of the Harvard Medical Practice Study I |journal=N. Engl. J. Med. |volume=324 |issue=6 |pages=370–6 |year=1991 |pmid=1987460 |doi=] In 1999, the Institute of Medicine (IOM) of the National Academy of Sciences released a report, "To Err is Human: Building a Safer Health System".cite web | last=Institute of Medicine | first= | year=1999 | url=http://fermat.nap.edu/catalog/9728.html#toc | title=To Err Is Human: Building a Safer Health System (1999) | publisher=The National Academies Press | accessdate=2006-06-20] The IOM called for a broad national effort to include establishment of a Center for Patient Safety, expanded reporting of adverse events, development of safety programs in health care organizations, and attention by regulators, health care purchasers, and professional societies. The majority of media attention, however, focused on the staggering statistics: from 44,000 to 98,000 preventable deaths annually due to medical error, 7,000 preventable deaths related to medication errors alone. Within 2 weeks of the report's release, Congress began hearings and President Clinton ordered a government-wide study of the feasibility of implementing the report's recommendations. [cite web | last=Charatan | first=Fred | year=2000 | url=http://bmj.bmjjournals.com/cgi/content/full/320/7235/597?ijkey=190e9b6dd6e8fec4ca3c2e353f290efb8237b334&keytype2=tf_ipsecsha | title=Clinton acts to reduce medical mistakes | publisher=BMJ Publishing Group | accessdate=2006-06-23] Initial criticisms of the methodology in the IOM estimates [cite journal | author = Harold C. Sox, Jr, Steven Woloshin | year = 2000 | title = How Many Deaths Are Due to Medical Error? Getting the Number Right | journal = Effective Clinical Practice | url = http://www.acponline.org/journals/ecp/novdec00/sox.htm | accessdate = 2006-06-22] focused on the statistical methods of amplifying low numbers of incidents in the pilot studies to the general population. However, subsequent reports emphasized the striking prevalence and consequences of medical error. In July 2004, Healthgrades, a leading health care ratings organization, published a study, "Patient Safety in American Hospitals", concluding that there were over one million adverse events associated with Medicare hospitalizations during 2000-2002, resulting in up to 195,000 accidental deaths per year in American hospitals.HealthGrades Quality Study: PDF| [http://www.healthgrades.com/media/english/pdf/HG_Patient_Safety_Study_Final.pdf Patient Safety in American Hospitals, July 2004] |223 KiB ]

The experience has been similar in other countries. [Commonwealth Fund International Survey: [http://www.cmwf.org/Publications/Publications_show.htm?doc_id=313012 Taking the Pulse of Health Care Systems: Experiences of Patients with Health Problems in Six Countries] (2005)]
*Ten years after a groundbreaking Australian study revealed 18,000 annual deaths from medical errors, [cite journal | author = Wilson RMcL, Runciman WB, Gibberd RW, et al | year = 1995 | title = The Quality in Australian Health Care Study | journal = Medical Journal of Australia | volume = 163 | issue = 9 | pages = 458–71 | url = http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=7476634 | accessdate = 2006-07-01 ] Professor Bill Runciman, one of the study's authors and president of the Australian Patient Safety Foundation since its inception in 1989, reported himself a victim of a medical dosing error. [Australian Broadcasting Corporation, "The World Today": [http://www.abc.net.au/worldtoday/content/2005/s1363139.htm Concerns over medication errors in Australian hospitals] ]
*The Department of Health Expert Group in June 2000 estimated that over 850,000 incidents harm National Health Service hospital patients in the United Kingdom each year. On average forty incidents a year contribute to patient deaths in each NHS institution. [cite web | last=Department of Health Expert Group | year=2000 | url=http://www.dh.gov.uk/PublicationsAndStatistics/Publications/PublicationsPolicyAndGuidance/PublicationsPAmpGBrowsableDocument/fs/en?CONTENT_ID=4098184&MULTIPAGE_ID=4936222&chk=HmuDH3 | title=An organisation with a memory | publisher=Department of Health, United Kingdom | accessdate=2006-07-01]
*In 2004, the Canadian Adverse Events Study found that adverse events occurred in over 7% of hospital admissions, and estimated that 9,000 to 24,000 Canadians die annually after an avoidable medical error. [cite journal | author = G. Ross Baker, Peter G. Norton, et al | year = 2004 | title = The Canadian Adverse Events Study: the incidence of adverse events among hospital patients in Canada | journal = Canadian Medical Association Journal | volume = 170 | issue = 11 | pages = 1678–1685 | url = http://www.cmaj.ca/cgi/content/full/170/11/1678 | accessdate = 2006-07-04 | doi = 10.1503/cmaj.1040498 ]
*These and other reports from New Zealand, [cite web| url=http://www.moh.govt.nz/publications/adverseevents| title=Adverse Events in New Zealand Public Hospitals: Principal Findings from a National Survey| date December 2001| publisher=New Zealand Ministry of Health| accessdate=2006-07-15] Denmark [cite journal | authorlink = Schioler T, Lipczak H, Pedersen BL, Mogensen TS, Bech KB, Stockmarr A, Svenning AR, Frolich A | title = Incidence of adverse events in hospitals. A retrospective study of medical records | journal = Ugeskr Laeger | volume = 163 | issue = 39 | pages = 4377–9 | date = 2001 | url = http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=pubmed&cmd=Retrieve&dopt=Abstract&list_uids=11590953&itool=pubmed_Abstract | accessdate = 2006-07-15 ] and developing countries [ World Alliance for Patient Safety: PDFlink| [http://whqlibdoc.who.int/bulletin/2004/Vol82-No12/bulletin_2004_82(12)_892.pdf Patient safety_a global priority] |56.6 KiB Editorial, December 2004 (retrieved on July 15, 2006)] have led the World Health Organization to estimate that one in ten persons receiving health care will suffer preventable harm.World Health Organization: [http://www.who.int/features/factfiles/patient_safety/en/index.html 10 facts on patient safety] Accessed 2008-05-19]

Causes of health care errors

The simplest definition of a health care error is a preventable adverse effect of care, whether or not it is evident or harmful to the patient. A conservative average of both the Institute of Medicine and HealthGrades reports indicates that there have been between 400,000-1.2 million error-induced deaths during 1996 - 2006 in the United States. These casualties have been, in part, attributed to:Paul A, Gluck, MD: "Medical Errors: Incidence, Theories, Myths and Solutions" (Presentation at the [http://scmsociety.typepad.com/patient_safety/2006_summit/index.html Seminole County Patient Safety Summit] , April 22, 2006)] cite journal | author = Saul N Weingart, Ross McL Wilson, Robert W Gibberd, and Bernadette Harrison | year = 2000 | title = Epidemiology of medical error | journal = British Medical Journal | volume = 320 | pages = 774–777 | url = http://www.pubmedcentral.nih.gov/articlerender.fcgi?artid=1117772 | accessdate = 2006-06-23 | doi = 10.1136/bmj.320.7237.774 ] ;Human Factors
*Variations in healthcare provider training & experience, [cite journal | author = Wu AW, Folkman S, McPhee SJ, Lo B | year = 1998 | title = Do house officers learn from their mistakes? | journal = JAMA | volume=265 | pages=2089–2094 | url = http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&dopt=Abstract&list_uids=2013929 | accessdate = 2006-06-24 | doi = 10.1001/jama.265.16.2089] cite journal | authorlink = Graham Neale, FRCP, Maria Woloshynowych, PhD, and Charles Vincent, PhD | title = Exploring the causes of adverse events in NHS hospital practice | journal = Journal of the Royal Society of Medicine | volume = 94 | issue = 7 | pages = 322–330 | date = July 2001 | url = http://www.pubmedcentral.nih.gov/articlerender.fcgi?artid=1281594 | accessdate = 2006-07-15 | pmid = 11418700 ] fatigue, [cite journal | author = Antony Nocera, Diana Strange Khursandi | year = 1998 | title = Doctors' working hours: can the medical profession afford to let the courts decide what is reasonable? | journal = Medical Journal of Australia | volume=168 | pages=616–618 | url = http://www.mja.com.au/public/issues/jun15/nocera/nocera.html | accessdate = 2006-06-24] cite journal |author=Landrigan CP, Rothschild JM, Cronin JW, "et al" |title=Effect of reducing interns' work hours on serious medical errors in intensive care units |journal=N. Engl. J. Med. |volume=351 |issue=18 |pages=1838–48 |year=2004 |pmid=15509817 |doi=10.1056/NEJMoa041406] [cite journal | author = Laura K. Barger, Najib T. Ayas, Brian E. Cade, John W. Cronin, Bernard Rosner, Frank E. Speizer, Charles A. Czeisler | year = 2006 | title = Impact of Extended-Duration Shifts on Medical Errors, Adverse Events, and Attentional Failures | journal = PLoS Medicine | volume=3(12) | pages=e487 | url = http://medicine.plosjournals.org/perlserv/?request=get-document&doi=10.1371/journal.pmed.0030487 | accessdate = 2007-01-12 | doi = 10.1371/journal.pmed.0030487] depression and burnout. [{cite journal | last = Amy M Fahrenkopf, iTheodore C Sectish, Laura K Barger, Paul J Sharek, Daniel Lewin, Vincent W Chiang, Sarah Edwards, Bernhard L Wiedermann, Christopher P Landrigan | title = Rates of medication errors among depressed and burnt out residents: prospective cohort study | journal = British Medical Journal | volume = | issue = | pages = | date = 2008 | url = http://www.bmj.com/cgi/content/full/bmj.39469.763218.BEv1 | doi = 10.1136/bmj.39469.763218.BE | accessdate = 2008-03-23]
*Diverse patients, unfamiliar settings, time pressures.
*Failure to acknowledge the prevalence and seriousness of medical errors. [cite journal | author = Michael L. Millenson | year = 2003 | title = The Silence | journal = Health Affairs | volume=22 | pages=103–112 | url = http://content.healthaffairs.org/cgi/content/full/22/2/103?maxtoshow=&HITS=80&hits=80&RESULTFORMAT=&andorexactfulltext=and&searchid=1&FIRSTINDEX=120&volume=22&resourcetype=HWCIT | accessdate = 2008-03-23 | doi = 10.1377/hlthaff.22.2.103] [cite journal | author = Elizabeth A. Henneman, RN, PhD, CCNS | year = 2007 | title = Unreported Errors in the Intensive Care Unit, A Case Study of the Way We Work | journal = Critical Care Nurse | volume=27 | pages=27–34 | url = http://ccn.aacnjournals.org/cgi/content/full/27/5/27 | accessdate = 2008-03-23 | pmid = 17901458] ;Medical complexity
*Complicated technologies, powerful drugs.
*Intensive care, prolonged hospital stay.;System failures
*Poor communication, unclear lines of authority of physicians, nurses, and other care providers.
*Complications increase as patient to nurse staffing ratio increases. [cite journal | author = Linda H. Aiken, PhD,RN, et al | year = 2002 | title = Hospital Nurse Staffing and Patient Mortality... | journal = JAMA | volume=288 | pages=1987–1993 | url = http://jama.ama-assn.org/cgi/content/abstract/288/16/1987 | accessdate = 2006-06-24 | doi = 10.1001/jama.288.16.1987]
*Disconnected reporting systems within a hospital: fragmented systems in which numerous hand-offs of patients results in lack of coordination and errors.cite web | last=Gardner | first=Amanda | date=6 March 2007 | url=http://www.washingtonpost.com/wp-dyn/content/article/2007/03/06/AR2007030601334.html | title=Medication Errors During Surgeries Particularly Dangerous | publisher=The Washington Post | accessdate=2007-03-13]
*Drug names that look alike or sound alike. [cite web | last=8th Annual MEDMARX® Report | first= | year=2008-01-29 | url=http://www.usp.org/aboutUSP/media/newsCenter.html?article=105435 | title=Press Release | publisher=U.S. Pharmacopeia | accessdate=2008-03-23] )
*The impression that action is being taken by other groups within the institution.
*Reliance on automated systems to prevent error.cite journal | last = McDonald, MD | first = Clement J. | title = Computerization Can Create Safety Hazards: A Bar-Coding Near Miss | journal = Annals of Internal Medicine | volume = 144 | issue = 7 | pages = 510–516 | date = 2006 | url = http://www.annals.org/cgi/content/abstract/144/7/510 | accessdate = 2006-07-31 | pmid = 16585665]
*Inadequate systems to share information about errors hamper analysis of contributory causes and improvement strategies. [cite web | last=US Agency for Healthcare Research & Quality | first= | year=2008-01-09 | url=http://www.ahrq.gov/news/press/pr2008/errepsyspr.htm | title=Physicians Want To Learn from Medical Mistakes but Say Current Error-reporting Systems Are Inadequate | publisher= | accessdate=2008-03-23]
*Cost-cutting measures by hospitals in response to reimbursement cutbacks. [cite journal | last = Clement JP, Lindrooth RC, Chukmaitov AS, Chen HF | title = Does the patient's payer matter in hospital patient safety?: a study of urban hospitals | journal = Medical Care | volume = 45 | issue = 2 | pages = 131–8 | date = February 2007 | publisher = American Public Health Association | url = http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=pubmed&cmd=Retrieve&dopt=Abstract&list_uids=17224775&query_hl=40&itool=pubmed_docsum | accessdate = 2007-04-07 ]
*Environment and design factors. In emergencies, patient care may be rendered in areas poorly suited for safe monitoring. The American Institute of Architects has identified concerns for the safe design and construction of health care facilities. [cite journal|journal=The American Institute of Architects Academy Journal|publisher=The American Institute of Architects|title=Incorporating Patient-Safe Design into the Guidelines|date=2005-10-19 | url=http://www.aia.org/journal_aah.cfm?pagename=aah_jrnl_20051019_guidelines&dspl=1&article=article ]
*Infrastructure failure. According to the WHO, 50% of medical equipment in developing countries is only partly usable due to lack of skilled operators or parts. As a result, diagnostic procedures or treatments cannot be performed, leading to substandard treatment.

The Joint Commission's Annual Report on Quality and Safety 2007 found that inadequate communication between healthcare providers, or between providers and the patient and family members, was the root cause of over half the serious adverse events in accredited hospitals. [The Joint Commission’s Annual Report on Quality and Safety 2007: [http://www.jointcommissionreport.org/ Improving America’s Hospitals] (Accessed 2008-04-09)] Other leading causes included inadequate assessment of the patient's condition, and poor leadership or training.

Common misconceptions about adverse events are:
*"Bad apples" or incompetent health care providers are a common cause. (Although human error is commonly an initiating event, the faulty process of delivering care invariably permits or compounds the harm, and is the focus of improvement.cite journal | author = Saul N Weingart, Ross McL Wilson, Robert W Gibberd, and Bernadette Harrison | year = 2000 | title = Epidemiology of medical error | journal = British Medical Journal | volume = 320 | pages = 774–777 | url = http://www.pubmedcentral.nih.gov/articlerender.fcgi?artid=1117772 | accessdate = 2006-06-23 | doi = 10.1136/bmj.320.7237.774 ] )
* High risk procedures or medical specialties are responsible for most "avoidable" adverse events. (Although some mistakes, such as in surgery, are harder to conceal, errors occur in all levels of care. Even though complex procedures entail more risk, adverse outcomes are not usually due to error, but to the severity of the condition being treated.).cite journal | author = René Amalberti, MD, PhD; Yves Auroy, MD; Don Berwick, MD, MPP; and Paul Barach, MD, MPH | year = 2005 | title = Five System Barriers to Achieving Ultrasafe Health Care | journal = Annals of Internal Medicine | volume = 142 | pages = 756–764 | url = http://www.annals.org/cgi/content/full/142/9/756 | accessdate = 2006-07-12 | pmid = 15867408 ] However, USP has reported that medication errors during the course of a surgical procedure are three times more likely to cause harm to a patient than those occurring in other types of hospital care.)
* If a patient experiences an adverse event during the process of care, an error has occurred. (Most medical care entails some level of risk, and there can be complications or side effects, even unforeseen ones, from the underlying condition or from the treatment itself. [cite web | last=Institute of Medicine | first= | year=1999 | url=http://darwin.nap.edu/books/0309068371/html/4.html | title=To Err Is Human: Building a Safer Health System, page 4 | publisher=The National Academies Press | accessdate=2006-07-01] )

Initiatives in patient safety

afety programs in industry

;Aviation safety:In the United States, two organizations contribute to one of the world's lowest aviation accident rates. [Federal Aviation Administration (FAA): [http://www.ntsb.gov/aviation/Table2.htm Accidents and Accident Rates, 1986 through 2005, U.S. Air Carriers] ] Mandatory accident investigation is carried out by the National Transportation Safety Board, while the Aviation Safety Reporting System receives voluntary reports to identify deficiencies and provide data for planning improvements. The latter system is confidential and provides reports back to stakeholders without regulatory action. Similarities and contrasts have been noted between the "cultures of safety" in medicine and aviation. [cite journal | author=Robert Helmreich | year=2000 | url=http://bmj.bmjjournals.com/cgi/ijlink?linkType=FULL&journalCode=bmj&resid=320/7237/781 | title=On error management: lessons from aviation | journal=British Medical Journal | volume=320 | pages=781–785 | accessdate=2006-06-24 | doi=10.1136/bmj.320.7237.781] Pilots and medical personnel operate in complex environments, interact with technology, and are subject to fatigue, stress, danger, and loss of life and prestige as a consequence of error. [cite journal | author = J Bryan Sexton, Eric J Thomas, Robert L Helmreich | year = 2000 | title = Error, stress, and teamwork in medicine and aviation | journal = British Medical Journal | volume = 320 | pages = 745–749 | url = http://bmj.bmjjournals.com/cgi/content/abstract/320/7237/745?ijkey=089b05c47228169635bbae42155fe7e647ab7e39&keytype2=tf_ipsecsha | accessdate = 2006-06-24 | doi = 10.1136/bmj.320.7237.745 ] Given the enviable record of aviation in accident preventioncite news | last = Wald | first = Matthew L. | title = Fatal Airplane Crashes Drop 65% | publisher = The New York Times | date = October 1, 2007 | url = http://www.nytimes.com/2007/10/01/business/01safety.html| accessdate = 2007-10-01] , a similar medical adverse event system would include both mandatory (for severe incidents) and voluntary non-punitive reporting, teamwork training, feedback on performance and an institutional commitment to data collection and analysis. The Patient Safety Reporting System (PSRS) is a program modeled upon the Aviation Safety Reporting System and developed by the Department of Veterans Affairs (VA) and the National Aeronautics and Space Administration (NASA) to monitor patient safety through voluntary, confidential reports. [cite journal | author = L. A. Lenert, MD, MS, H. Burstin, MD, MPH, L. Connell, MA, RN, J. Gosbee, MD, MS, and G. Phillips | year = 2002 | title = Federal Patient Safety Initiatives Panel Summary | journal = J Am Med Inform Assoc | volume = 9 | pages = s8-s10 | url = http://www.pubmedcentral.nih.gov/articlerender.fcgi?artid=419408 | accessdate = 2006-06-28 | pmid = 12386172 ]

;Near-miss reporting:A near miss is an unplanned event that did not result in injury, illness, or damage - but had the potential to do so. Reporting of near misses by observers is an established error reduction technique in aviation, and has been extended to private industry, traffic safety and fire-rescue services with reductions in accidents and injury. [cite news | last = Mandak | first = Joe | title = Database seeks to lower firefighter deaths | publisher = USA Today | date = September 18, 2005 | url = http://www.usatoday.com/tech/news/2005-09-18-firefigher-database_x.htm?POE=click-refer | accessdate = 2006-07-08] AORN, a US-based professional organization of perioperative registered nurses, has put in effect a voluntary near miss reporting system (SafetyNet [AORN: [http://www.patientsafetyfirst.org/safetynet/ SafetyNet] ] ), covering medication or transfusion reactions, communication or consent issues, wrong patient or procedures, communication breakdown or technology malfunctions. An analysis of incidents allows safety alerts to be issued to AORN members.

;Limits of the industrial safety model:Unintended consequences may occur as improvements in safety are undertaken. It may not be possible to attain maximum safety goals in healthcare without adversely affecting patient care in other ways. An example is blood transfusion; in recent years, to reduce the risk of transmissible infection in the blood supply, donors with only a small probability of infection have been excluded. The result has been a critical shortage of blood for other lifesaving purposes, with a broad impact on patient care. Application of high-reliability theory and normal accident theory can help predict the organizational consequences of implementing safety measures. [cite journal | author=Tamuz M, Harrison MI | year=2006 | url=http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?orig_db=PubMed&db=PubMed&cmd=Search&defaultField=Title+Word&term=Improving+Patient+Safety+in+Hospitals | title=Improving patient safety in hospitals: Contributions of high-reliability theory and normal accident theory.| journal=Health Serv Res. 2006 Aug;41 (4 Pt 2):1654-76. | volume=41 | pages=1654–76 | accessdate=2006-09-08]

Technology in Healthcare

;OverviewAccording to a study by RAND Health, the U.S. healthcare system could save more than $81 billion annually, reduce adverse healthcare events, and improve the quality of care if health information technology (HIT) is widely adopted. [RAND Healthcare: [http://www.rand.org/pubs/research_briefs/RB9136/index1.html Health Information Technology: Can HIT Lower Costs and Improve Quality?] Retrieved on July 8, 2006] The most immediate barrier to widespread adoption of technology is cost despite the patient benefit from better health, and payer benefit from lower costs. However, hospitals pay in both higher costs for implementation and potentially lower revenues (depending on reimbursement scheme) due to reduced patient length of stay. The benefits provided by technolgical innovations also give rise to serious issues with the introduction of new and previously unseen error types. [cite journal | author = Ross Koppel, PhD, et al | year = 2005 | title = Role of Computerized Physician Order Entry Systems in Facilitating Medication Errors | journal = JAMA | volume = 293 | pages = 1197–1203 | url = http://jama.ama-assn.org/cgi/content/abstract/293/10/1197 | accessdate = 2006-06-28 | doi = 10.1001/jama.293.10.1197 ]

Types of Healthcare Technology

Handwritten reports or notes, manual order entry, non-standard abbreviations and poor legibility lead to substantial errors and injuries, according to the IOM (2000) report. The follow-up IOM report, "Crossing the Quality Chasm: A New Health System for the 21st Century", advised rapid adoption of electronic patient records, electronic medication ordering, with computer- and internet-based information systems to support clinical decisions. [cite web | last=Institute of Medicine | first= | year=2001 | url=http://www.nap.edu/books/0309072808/html | title=Crossing the Quality Chasm: A New Health System for the 21st Century | publisher=The National Academies Press | accessdate=2006-06-29] This section contains only the patient safety related aspects of HIT.

Electronic Health Record (EHR)

The Electronic health record (EHR), previously known as the Electronic medical record (EMR), reduces several types of errors, including those related to prescription drugs, to preventive care, and to tests and procedures. [American College of Physicians Observer: [http://www.acponline.org/journals/news/sep04/emr.htm How EMR software can help prevent medical mistakes] by Jerome H. Carter (September 2004)] Important features of modern EHR include automated drug-drug/drug-food interaction checks and allergy checks, standard drug dosages and patient education information. Also, these systems provide recurring alerts to remind clinicians of intervals for preventive care and to track referrals and test results. Clinical guidelines for disease management have a demonstrated benefit when accessible within the electronic record during the process of treating the patient. [cite journal | author = Kensaku Kawamoto, fellow1, Caitlin A Houlihan, E Andrew Balas, David F Lobach | year = 2005 | title = Improving clinical practice using clinical decision support systems: a systematic review of trials to identify features critical to success | journal = British Medical Journal | volume = 330 | pages = 765–768 | url = http://bmj.bmjjournals.com/cgi/content/full/330/7494/765 | accessdate = 2006-06-29 | doi = 10.1136/bmj.38398.500764.8F] Advances in health informatics and widespread adoption of interoperable electronic health records promise access to a patient's records at any health care site. Recent surveys in the United Kingdon have shown physicians' deficiencies in understanding the patient safety features of government approved software. [cite journal | author = C J Morris, B S P Savelyich, A J Avery, J A Cantrill and A Sheikh | year = 2005 | title = Patient safety features of clinical computer systems: questionnaire survey of GP views | journal = Quality and Safety in Health Care | volume = 14 | pages = 164–168 | url = http://qhc.bmjjournals.com/cgi/content/full/14/3/164 | accessdate = 2006-07-08 | doi = 10.1136/qshc.2004.011866 ]

Computerized Provider Order Entry (CPOE)

Prescribing errors are the largest identified source of preventable errors in hospitals (IOM, 2000; 2007). The IOM (2006) estimates that each hospitalized patient, on average, is exposed to one medication error each day.cite journal | year = 2006 | title = Preventing Medication Errors | last = The Institute of Medicine | journal = The National Academies Press | url = http://www.nap.edu/catalog/11623.html | accessdate = 2006-07-21 ] Computerized provider order entry (CPOE), formerly called computer physician order entry, can reduce medication errors by 80% overall but more importantly decrease harm to patients by 55%. [cite journal | author = David W. Bates, MD, et al | year = 1998 | title = Effect of Computerized Physician Order Entry and a Team Intervention on Prevention of Serious Medication Errors | journal = JAMA | volume = 280 | pages = 1311–1316 | url = http://jama.ama-assn.org/cgi/content/abstract/280/15/1311 | accessdate = 2006-06-20 | doi = 10.1001/jama.280.15.1311] A Leapfrog (2004) survey found that 16% of US clinics, hospitals, and medical practices are expected to utilize CPOE within 2 years. [cite web | title = Hospital Quality & Safety Survey | publisher = The Leapfrog Group | date = 2004 | url = http://www.leapfroggroup.org/media/file/Leapfrog-Survey_Release-11-16-04.pdf | format = PDF | accessdate = 2006-07-08 ] ;Complete Safety Medication SystemA standardized bar code system for dispensing drugs might prevent 25% of drug errors. Despite ample evidence to reduce medication errors, compete medication delviery systems (barcoding and electronic prescribing have slowed adoption of this technology by doctors and hospitals in the United States, due to concern with interoperability and compliance with future national standards. [cite news | last = Kaufman | first = Marc | title = Medication Errors Harming Millions, Report Says. Extensive National Study Finds Widespread, Costly Mistakes in Giving and Taking Medicine | pages = A08 | publisher = The Washington Post | date = 2005-07-21 | url = http://www.washingtonpost.com/wp-dyn/content/article/2006/07/20/AR2006072000754.html | accessdate = 2006-07-21 ] Such concerns are not inconsequential; standards for electronic prescribing for Medicare Part D conflict with regulations in many US states.

Technological Iatrogenesis

Technology induced errors are significant and increasingly more evident in care delivery systems. [cite news | last = Lohr | first = Steve | title = Doctors' Journal Says Computing Is No Panacea | publisher = The New York Times | date = 2005-03-09 | url = http://www.nytimes.com/2005/03/09/technology/09compute.html?ei=5089&en=402b792e748d99a2&ex=1268110800&adxnnl=1&partner=rssyahoo&adxnnlx=1150474153-xVix1BcYkvTKJpuLyHStrQ | accessdate = 2006-07-15 ] This idiosyncratic and potentially serious problems associated with HIT implementation has recently become a tangible concern for healthcare and information technology professionals. As such, the term technological iatrogenesis describes this new category of adverse events that are an emergent property resulting from technological innovation creating system and microsystem disturbances [cite journal | author = Patrick Palmieri, et al | year = 2007 | title = Technological iatrogenesis: New risks force heightened management awareness | journal = Journal of Healthcare Risk Management | volume = 27 | number = 4 | pages 19–24 | url = http://www.hom.ba.ttu.edu/FordPub/Palmieri_JHCRM_2008_Technological%20iatrogenesis.pdf | accessdate 2008-07-02] . Healthcare systems are complex and adaptive meaning there are many networks and connections working simultaneously to produce certain outcomes. When these systems are under the increased stresses caused by the diffusion of new technology, unfamiliar and new process errors often result. If not recognized, over time these new errors can collectively lead to catastrophic system failures. The term “e-iatrogenesis” [ cite journal | author = Weiner, et al | year = 2007 | title =e-Iatrogenesis: The most critical unintended consequence of CPOE and other HIT | journal = Journal of the American Medical Informatics Association | volume = 14 | number = 3 | pages 387-388 | url = http://www.jamia.org/cgi/reprint/14/3/387.pdf | accessdate 2008-08-24] can be used to describe the local error manifestation. The sources for these errors include:
*Prescriber and staff inexperience may lead to a false sense of security; that when technology suggests a course of action, errors are avoided.
*Shortcut or default selections can override non-standard medication regimens for elderly or underweight patients, resulting in toxic doses.
*CPOE and automated drug dispensing was identified as a cause of error by 84% of over 500 health care facilities participating in a surveillance system by the United States Pharmacopoeia. [cite web | last=Santell | first=John P | year=2004 | url=http://www.usp.org/pdf/EN/patientSafety/slideShows2004-12-09.pdf | title=Computer Related Errors: What Every Pharmacist Should Know | format = PDF | publisher=United States Pharmacopia | accessdate=2006-06-20]
*Irrelevant or frequent warnings can interrupt work flow. Solutions include ongoing changes in design to cope with unique medical settings, supervising overrides from automatic systems, and training (and re-training) all users.

Evidence-based medicine

Evidence-based medicine integrates an individual doctor's exam and diagnostic skills for a specific patient, with the best available evidence from medical research. The doctor's expertise includes both diagnostic skills and consideration of individual patient's rights and preferences in making decisions about his or her care. The clinician uses pertinent clinical research on the accuracy of diagnostic tests and the efficacy and safety of therapy, rehabilitation, and prevention to develop an individual plan of care. [cite journal | author = David L Sackett, William M C Rosenberg, J A Muir Gray, R Brian Haynes, W Scott Richardson | year = 1996 | title = Editorials: Evidence based medicine: what it is and what it isn't | journal = British Medical Journal | volume = 312 | pages = 71–72 | url = http://bmj.bmjjournals.com/cgi/content/full/312/7023/71 | accessdate = 2006-06-28 | pmid = 8555924 ] The development of evidence-based recommendations for specific medical conditions, termed clinical practice guidelines or "best practices", has accelerated in the past few years. In the United States, over 1,700 guidelines (see example image, right) have been developed as a resource for physicians to apply to specific patient presentations.Agency for Healthcare Research and Quality: [http://www.guideline.gov/about/about.aspx The National Guideline Clearinghouse] ] The National Institute for Health and Clinical Excellence (NICE) in the United Kingdom provides detailed "clinical guidance" for both health care professionals and the public about specific medical conditions.The National Institute for Health and Clinical Excellence (NICE) [http://www.nice.org.uk/page.aspx?o=home Providing national guidance on promoting good health] ]

Advantages: [cite journal | author = William Rosenberg, Anna Donald | year = 1995 | title = Evidence based medicine: an approach to clinical problem-solving | journal = British Medical Journal | volume = 310 | pages = 1122–1126 | url = http://bmj.bmjjournals.com/cgi/content/full/310/6987/1122?ijkey=66d01d04605a199df9496016e2da0399c7b081b1&keytype2=tf_ipsecsha | accessdate = 2006-06-28 | pmid = 7742682 ] Institute of Medicine: [http://darwin.nap.edu/books/0309045894/html/116.html Guidelines for Clinical Practice: From Development to Use] (1992)]
#Evidence-based medicine may reduce adverse events, especially those involving incorrect diagnosis, outdated or risky tests or procedures, or medication overuse.
#Clinical guidelines provide a common framework for improving communication among clinicians, patients and non-medical purchasers of health care.
#Errors related to changing shifts or multiple specialists are reduced by a consistent plan of care.
#Information on the clinical effectiveness of treatments and services can help providers, consumers and purchasers of health care make better use of limited resources.
#As medical advances become available, doctors and nurses can keep up with new tests and treatments as guidelines are improved.

Drawbacks: [cite web | url=http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=11728302&dopt=Abstract | title=The limits of evidence-based medicine | last=Tonelli | first=MR
publisher=NCBI PubMed | year=2001| accessdate=2006-06-27] American College of Surgeons Bulletin: [http://www.facs.org/ahp/proliab/pracgid.html Practice guidelines and liability implications] ]
#Managed care plans may attempt limit "unnecessary" services to cut the costs of health care, despite evidence that guidelines are not designed for general screening, rather as decision-making tools when an individual practitioner evaluates a specific patient.
#The medical literature is evolving and often controversial; development of guidelines requires consensus.
#Implementing guidelines and educating the entire health care team within a facility costs time and resources (which may be recovered by future efficiency and error reduction).
#Clinicians may resist evidence-based medicine as a threat to traditional relationships between patients, doctors and other health professionals, since any participant can influence decisions.
#Failing to follow guidelines might increase the risk of liability or disciplinary action by regulators.

Quality and safety initiatives in community pharmacy practice

Community pharmacy practice is making important advances in the quality and safety movement despite the limited number of federal and state regulations that exist and in the absence of national accreditation organizations such as the JCAHO - a driving force for quality in hospitals. Community pharmacies are using automated drug dispensing devices (robots), computerized drug utilization review tools, and most recently, the ability to receive electronic prescriptions from prescribers to decrease the risk for error and increase the likelihood of delivering high quality of care.

Quality Assurance (QA) in community practice is a relatively new concept. As of 2006, only 16 states have some form of legislation that regulates QA in community pharmacy practice. While most state QA legislation focuses on error reduction, North Carolina has recently approved legislation [ [http://www.ncga.state.nc.us/gascripts/BillLookUp/BillLookUp.pl?Session=2005&BillID=hb1493 North Carolina General Assembly - House Bill 1493 Information/History (2005-2006 Session) ] ] that requires the pharmacy QA program to include error reduction strategies and assessments of the quality of their pharmaceutical care outcomes and pharmacy services. [ Kessler, JM. Pharmacy Quality Assurance. Journal of the North Carolina Association of Pharmacists 2005: Winter]

Health literacy

Health literacy is a common and serious safety concern. A study of 2,600 patients at two hospitals determined that between 26-60% of patients could not understand medication directions, a standard informed consent, or basic health care materials. [cite journal | author = M. V. Williams, et al | year = 1995 | title = Inadequate functional health literacy among patients at two public hospitals | journal = JAMA | volume = 274 | issue = 21 | pages = 677–82 | url = http://jama.ama-assn.org/cgi/content/abstract/274/21/1677 | accessdate = 2006-06-30 | doi = 10.1001/jama.274.21.1677 ] This mismatch between a clinician's level of communication and a patient's ability to understand can lead to medication errors and adverse outcomes.

The Institute of Medicine (2004) report found low health literacy levels negatively affects healthcare outcomes. [The Institute of Medicine: [http://www.nap.edu/catalog/10883.html#toc Health Literacy: A Prescription to End Confusion] (2004)] In particular, these patients have a higher risk of hospitalization and longer hospital stays, are less likely to comply with treatment, are more likely to make errors with medication, [cite journal | author = Terry C. Davis, PhD; Michael S. Wolf, PhD, MPH; Pat F. Bass III, MD; Jason A. Thompson, BA; Hugh H. Tilson, MD, DrPH; Marolee Neuberger, MS; and Ruth M. Parker, MD | year = 2006 | title = Literacy and Misunderstanding Prescription Drug Labels | journal = Annals of Internal Medicine | volume = 145 | issue = 12 | url = http://www.annals.org/cgi/content/full/0000605-200612190-00144v1 | accessdate = 2006-11-30 | pmid = 17135578 ] and are more ill when they seek medical care. [U.S. Department of Health and Human Services: [http://www.health.gov/communication/literacy/quickguide/factsliteracy.htm Quick Guide to Health Literacy] ] cite journal | author = M. V. Williams, et al | year = 1995 | title = The test of functional health literacy in adults: a new instrument for measuring patients' literacy skills. | journal = J Gen Intern Med. | volume = 10 | issue = 10 | pages = 537–41]

Pay for performance (P4P)

Pay for performance systems link compensation to measures of work quality or goals. As of 2005, 75 percent of all U.S. companies connect at least part of an employee's pay to measures of performance, and in healthcare, over 100 private and federal pilot programs are underway. Current methods of healthcare payment may actually reward less-safe care, since some insurance companies will not pay for new practices to reduce errors, while physicians and hospitals can bill for additional services that are needed when patients are injured by mistakes.The Commonwealth Fund: [http://www.cmwf.org/publications/publications_show.htm?doc_id=278113 Five Years After "To Err Is Human": What Have We Learned?] ] However, early studies showed little gain in quality for the money spent, [cite journal | author = Meredith B. Rosenthal, PhD; Richard G. Frank, PhD; Zhonghe Li, MA; Arnold M. Epstein, MD, MA | year = 2005 | title = Early Experience With Pay-for-Performance: From Concept to Practice | journal = JAMA | volume = 294 | issue = 14 | pages = 1788–1793 | url = http://jama.ama-assn.org/cgi/content/abstract/294/14/1788 | accessdate = 2006-07-08 | doi = 10.1001/jama.294.14.1788 ] [cite journal | author = Laura A. Petersen, MD, MPH; LeChauncy D. Woodard, MD, MPH; Tracy Urech, BA; Christina Daw, MPH; and Supicha Sookanan, MPH | year = 2006 | title = Does Pay-for-Performance Improve the Quality of Health Care? | journal = Annals of Internal Medicine | volume = 145 | issue = 4 | pages = 265–272 | url = http://www.annals.org/cgi/content/abstract/145/4/265?etoc | accessdate = 2006-08-14 | pmid = 16908917 ] as well as evidence suggesting unintended consequences, like the avoidance of high-risk patients, when payment was linked to outcome improvements. [cite journal | author = M .B. Rosenthal and R. G. Frank | year = 2006 | title = What Is the Empirical Basis for Paying for Quality in Health Care? | journal = Medical Care Research and Review | volume = 63 | issue = 2 | pages = 135–57 | url = http://www.cmwf.org/topics/topics_show.htm?doc_id=371797 | accessdate = 2006-07-08 | doi = 10.1177/1077558705285291 ] [US Congress, House Committee on Employer-Employee Relations: Pay For Performance Measures and Other Trends in Employer Sponsored Healthcare, PDFlink| [http://www.cmwf.org/usr_doc/Rosenthal_testimony_05-17-2005.pdf Testimony of Meredith B. Rosenthal, PhD] |31.5 KiB May 17, 2005] The 2006 Institute of Medicine report "Preventing Medication Errors" recommended "incentives...so that profitability of hospitals, clinics, pharmacies, insurance companies, and manufacturers (are) aligned with patient safety goals;...(to) strengthen the business case for quality and safety."

There is widespread international interest in health care pay-for-performance programs in a range of countries, including the United KingdomNational Health Service: [http://www.ic.nhs.uk/services/qof/ Quality and Outcomes Framework data] Retrieved July 8, 2006] , United States [cite journal |author=Meredith B. Rosenthal, PhD; Richard G. Frank, PhD; Zhonghe Li, MA; Arnold M. Epstein, MD, MA|title=Early Experience With Pay-for-Performance, From Concept to Practice |journal=JAMA |volume=294 |issue=14 |pages=1788-93 |year=2005|url=http://jama.ama-assn.org/cgi/content/full/294/14/1788, Retrieved 2008-07-18] , Australia [Medicare Australia: [http://www.medicareaustralia.gov.au/provider/incentives/pip/ Practice Incentives Program (PIP)] , Retrieved 2008-07-18] , Canadacite journal |author=Pink GH, Brown AD, Studer ML, Reiter KL, Leatt P. |title=Pay-for-performance in publicly financed healthcare: some international experience and considerations for Canada |journal=Healthc Pap |volume=6|issue=4 |pages=8-26 |year=2006 |pmid=16825853 , Retrieved 2008-07-18] , Germany [cite journal|author=Stefan Greß, E-mail The Corresponding Author, Axel Focke, Franz Hessel and Jürgen Wasem |title=Financial incentives for disease management programmes and integrated care in German social health insurance |journal=Health Policy |volume=78 |issue=2-3 |pages=295-305 |year=2006 |doi=10.1016/j.healthpol.2005.11.011, Retrieved 2008-07-18] , the Netherlands [cite journal |author=Thomas Custers, Onyebuchi A. Arah1, and Niek S. Klazinga |title=Is there a business case for quality in The Netherlands? A critical analysis of the recent reforms of the health care system |journal= Health policy |volume=82|issue=|pages=226-39|year=2007|doi=10.1016/j.healthpol.2006.09.005 , Retrieved 2008-07-18] , and New Zealand [cite journal |author=Rod Perkins, Mary Seddon |title=Quality improvement in New Zealand healthcare. Part 5: measurement for monitoring and controlling performance—the quest for external accountability |journal=New Zealand Medical Journal |volume=119|issue=1241|pages= |year=2006|url=http://www.nzma.org.nz/journal/119-1241/2149/, Retrieved 2008-07-18] .

United Kingdom

In the United Kingdom, the National Health Service (NHS) began a ambitious pay for performance initiative in 2004, known as the Quality and Outcomes Framework (QOF). General practitioners agreed to increases in existing income according to performance with respect to 146 quality indicators covering clinical care for 10 chronic diseases, organization of care, and patient experience. Unlike proposed quality incentive programs in the United States, funding for primary care was increased 20% over previous levels. This allowed practices to invest in extra staff and technology; 90% of general practitioners use electronic prescribing, and up to 50% use electronic health records for the majority of clinical care. Early analysis showed that substantially increasing physicians’ pay based on their success in meeting quality performance measures is successful. The 8,000 family practitioners included in the study earned an average of $40,000 more by collecting nearly 97% of the points available.cite journal |author=Doran T, Fullwood C, Gravelle H, "et al" |title=Pay-for-performance programs in family practices in the United Kingdom |journal=N. Engl. J. Med. |volume=355 |issue=4 |pages=375–84 |year=2006 |pmid=16870916 |doi=10.1056/NEJMsa055505]

A component of this program, known as " exception reporting", allows physicians to use criteria to exclude individual patients from the quality calculations that determine physician reimbursement. There was initial concern that exception reporting would allow inappropriate exclusion of patients in whom targets were missed ("gaming" [Wiktionary: [http://en.wiktionary.org/wiki/game_the_system Game the system] ] ). However, a 2008 study has shown little evidence of widespread gaming. [cite journal |author= Tim Doran, M.D., Catherine Fullwood, Ph.D., David Reeves, Ph.D., Hugh Gravelle, Ph.D., and Martin Roland, D.M. |title=Exclusion of Patients from Pay-for-Performance Targets by English Physicians |journal=N. Engl. J. Med. |volume=359|issue=3 |pages=274-84 |year=2008 |url=http://content.nejm.org/cgi/content/short/359/3/274 Retrieved 2008-07-18]

United States

In the United States, Medicare has various pay-for-performance ("P4P") initiatives in offices, clinics and hospitals, seeking to improving quality and avoid unnecessary health care costs. [Medicare: [http://www.cms.hhs.gov/apps/media/press/release.asp?Counter=1343 "Pay For Performance (P4P) Initiatives"] ] The Centers for Medicare and Medicaid Services (CMS) has several demonstration projects underway offering compensation for improvements:

*Payments for better care coordination between home, hospital and offices for patients with chronic illnesses. In April 2005, CMS launched its first value-based purchasing pilot or "demonstration" project- the three-year Medicare Physician Group Practice (PGP) Demonstration. [Centers for Medicare and Medicaid Services: [http://www.cms.hhs.gov/apps/media/press/release.asp?Counter=1341 Medicare Begins Performance-Based Payments For Physician Groups] (Retrieved 2007-04-15)] The project involves ten large, multi-specialty physician practices caring for more than 200,000 Medicare fee-for-service beneficiaries. Participating practices will phase in quality standards for preventive care and the management of common chronic illnesses such as diabetes. Practices meeting these standards will be eligible for rewards from savings due to resulting improvements in patient management. The "First Evaluation Report to Congress" in 2006 showed that the model rewarded high quality, efficient provision of health care, but the lack of up-front payment for the investment in new systems of case management "have made for an uncertain future with respect for any payments under the demonstration." [Centers for Medicare and Medicaid Services, Medicare Physician Group Practice Demonstration: [http://www.cms.hhs.gov/DemoProjectsEvalRpts/downloads/PGP_Final_Congress.pdf First Evaluation Report to Congress] (Retrieved 2007-04-15)]

*A set of 10 hospital quality measures which, if reported to CMS, will increase the payments that hospitals receive for each discharge. By the third year of the demonstration, those hospitals that do not meet a threshold on quality will be subject to reductions in payment. Preliminary data from the second year of the study indicates that pay for performance was associated with a roughly 2.5% to 4.0% improvement in compliance with quality measures, compared with the control hospitals.cite journal |author=Lindenauer PK, Remus D, Roman S, "et al" |title=Public reporting and pay for performance in hospital quality improvement |journal=N. Engl. J. Med. |volume=356 |issue=5 |pages=486–96 |year=2007 |pmid=17259444 |doi=10.1056/NEJMsa064964] Dr. Arnold Epstein of the Harvard School of Public Health commented in an accompanying editorial that pay-for-performance "is fundamentally a social experiment likely to have only modest incremental value."cite journal |author=Epstein AM |title=Pay for performance at the tipping point |journal=N. Engl. J. Med. |volume=356 |issue=5 |pages=515–7 |year=2007 |pmid=17259445 |doi=10.1056/NEJMe078002] Unintended consequences of some publicly reported hospital quality measures have adversely affected patient care. The requirement to give the first antibiotic dose in the emergency department within 4 hours, if the patient has pneumonia, has caused an increase in pneumonia misdiagnosis. [Citation | pmid=18299488 | title=Antibiotic timing and errors in diagnosing pneumonia | last=Welker JA, Huston M, McCue JD | journal=Arch Intern Med. | date=2008-02-25 | volume=168 | issue=4) | pages=347-8 | accessdate=2008-05-14]

*Rewards to physicians for improving health outcomes by the use of health information technology in the care of chronically ill Medicare patients.

*Disincentives: The 2006 Tax Relief & Health Care Act of 2006 required the HHS Inspector General to study ways that Medicare payments to hospitals could be recouped for "never events" [cite book | last = National Quality Forum | url=http://www.psnet.ahrq.gov/resource.aspx?resourceID=5363 | title = Serious Reportable Events in Healthcare 2006 Update: A Consensus Report | year = 2007 | isbn = 1-9338-7508-9 Retrieved 2007-08-25] , as defined by the National Quality Forum, including hospital infections. [Centers for Medicare & Medicaid Services (CMS): Press Release (2006-05-18): [http://www.cms.hhs.gov/apps/media/press/release.asp?Counter=1863 ELIMINATING SERIOUS, PREVENTABLE, AND COSTLY MEDICAL ERRORS - NEVER EVENTS] Retrieved 2007-08-25] In August 2007, CMS announced that it will stop payments to hospitals for several negative consequences of care that result in injury, illness or death. This rule, effective October 2008, would reduce hospital payments for eight serious types of preventable incidents: objects left in a patient during surgery, blood transfusion reaction, air embolism, falls, mediastinitis, urinary tract infections from catheters, pressure ulcer, and sepsis from catheters. [Citation | last1 = The Associated Press | title = Medicare Won't Pay for Hospital Mistakes | newspaper = The Washington Post | date = 2007-08-18 | year = 2007 | url = http://www.washingtonpost.com/wp-dyn/content/article/2007/08/18/AR2007081800760.html Retrieved 2007-08-25] Reporting of "never events" and creation of performance benchmarks for hospitals are also mandated. Other private health payers are considering similar actions; in 2005, HealthPartners, a Minnesota health insurer, chose not to cover 27 types of "never events". [Citation | last1 = Yee | first1 = Chen May | title = Medicare tightening the screws on medical mistakes | newspaper = The Minneapolis Star Tribune | date = 2007-08-22 | year = 2007 | url = http://www.startribune.com/535/story/1378153.html Retrieved 2007-08-25] The Leapfrog Group has announced that will work with hospitals, health plans and consumer groups to advocate reducing payment for "never events", and will recognize hospitals that agree to certain steps when a serious avoidable adverse event occurs in the facility, including notifying the patient and patient safety organizations, and waiving costs. [The Leapfrog Group: Press Release (2006-11-15): [http://www.leapfroggroup.org/media/file/Never_Events_release_FINAL.pdf Call to Hospitals to Commit to New Policy on "Never Events"] Retrieved 2007-08-25] Physician groups involved in the management of complications, such as the Infectious Diseases Society of America, have voiced objections to these proposals, observing that "some patients develop infections despite application of all evidence-based practices known to avoid infection", and that a punitive response may discourage further study and slow the dramatic improvements that have already been made. [IDSA, SHEA and APIC: [http://www.idsociety.org/Template.cfm?Section=Home&Template=/ContentManagement/ContentDisplay.cfm&ContentID=16348 Comment on CMS Inpatient PPS Proposed Rule 1488P: Healthcare-associated infection] (June 13, 2006)]

Complex illness

Pay for performance programs often target patients with serious and complex illnesses; such patients commonly interact with multiple healthcare providers and facilities. However, pilot programs now underway focus on simple indicators such as improvement in lab values or use of emergency services, avoiding areas of complexity such as multiple complications or several treating specialists. [American Academy of Neurology, Federal Legislation Position Statements: [http://www.aan.com/advocacy/federal/pdfs/P4P_statement.pdf Pay-For-Performance] (Retrieved 2007-04-15)] A 2007 study analyzing Medicare beneficiaries’ healthcare visits showed that a median of two primary care physicians and five specialists provide care for a single patient.cite journal |author=Pham HH, Schrag D, O'Malley AS, Wu B, Bach PB |title=Care patterns in Medicare and their implications for pay for performance |journal=N. Engl. J. Med. |volume=356 |issue=11 |pages=1130–9 |year=2007 |pmid=17360991 |doi=10.1056/NEJMsa063979] The authors doubt that pay-for-performance systems can accurately attribute responsibility for the outcome of care for such patients. The American College of Physicians Ethics has stated concerns about using a limited set of clinical practice parameters to assess quality, "especially if payment for good performance is grafted onto the current payment system, which does not reward robust comprehensive care...The elderly patient with multiple chronic conditions is especially vulnerable to this unwanted effect of powerful incentives."cite journal | last = Lois Snyder, JD & Richard L. Neubauer, MD | title = Pay-for-Performance Principles That Promote Patient-Centered Care: An Ethics Manifesto | journal = Annals of Internal Medicine | volume = 147 | pages = 792–794 | date = 2007 | url = http://www.annals.org/cgi/content/abstract/147/11/792?maxtoshow=&HITS=10&hits=10&RESULTFORMAT=&fulltext=pay-for-performance&searchid=1&FIRSTINDEX=0&resourcetype=HWCIT#FN | accessdate =2008-03-31 | pmid = 18056664 ] Present pay-for-performance systems measure good performance based on specified clinical measurements, such as glycohemoglobin for diabetic patients. [cite journal | last = Steven B. Leichter,MD,FACP,FACE | title = Pay-for-Performance Contracts in Diabetes Care | journal = Clinical Diabetes | volume = 24 | issue = 2 | pages = 56–59 | url = http://clinical.diabetesjournals.org/cgi/reprint/24/2/56.pdf | accessdate = 2008-03-31 | doi = 10.2337/diaclin.24.2.56 | year = 2006|format=PDF] Healthcare providers who are monitored by such limited criteria have a powerful incentive to "deselect" (dismiss or refuse to accept) patients whose outcome measures fall below the quality standard and therefore worsen the provider's assessment. Patients with low health literacy, inadequate financial resources to afford expensive medications or treatments, and ethnic groups traditionally subject to healthcare inequities may also be deselected by providers seeking improved performance measures.Citation | last = Cannon | first = Michael F. | title = Pay for Performance: Is Medicare a Good Candidate? | publisher = The Cato Institute | year = 2006 | url = http://www.cato.org/pubs/papers/cannon_p4p.pdf | accessdate = 2008-04-02 .]

Public reporting

Mandatory reporting

;Denmark :The Danish Act on Patient Safety [Danish Act on Patient Safety [http://www.patientsikkerhed.dk/admin/media/pdf/133907d0940e4d5f751852ec8f6b1795.pdf] ] passed Parliament in June 2003, and on January 1, 2004 Denmark became the first country to introduce nation-wide mandatory reporting. The Act obligates frontline personnel to report adverse events to a national reporting system. Hospital owners are obligated to act on the reports and the National Board of Health is obligated to communicate the learning nationally. The reporting system is intended purely for learning and frontline personnel cannot experience sanctions for reporting. This is stated in Section 6 of the Danish Act on Patient Safety (as of January 1, 2007: Section 201 of the Danish Health Act): "A frontline person who reports an adverse event cannot as a result of that report be subjected to investigation or disciplinary action from the employer, the Board of Health or the Court of Justice." The reporting system and the Danish Patient Safety Database is described in further detail in a National Board of Health publication [Danish National Board of Health: Danish Patient Safety Database 2007 [http://www.patientsikkerhed.dk/admin/media/pdf/0a9d4fdf5645d9b29a159288ff2a2a69.pdf] ] .

;United Kingdom :The National Patient Safety Agency encourages voluntary reporting of health care errors, but has several specific instances, known as "Confidential Enquiries", for which investigation is routinely initiated: maternal or infant deaths, childhood deaths to age 16, deaths in persons with mental illness, and perioperative and unexpected medical deaths. Medical records and questionnaires are requested from the involved clinician, and participation has been high, since individual details are confidential. [National Confidential Enquiries PDF|1= [http://www.nice.org.uk/page.aspx?o=212731 Strategy] ]

;United States :The 1999 Institute of Medicine (IOM) report recommended "a nationwide mandatory reporting system … that provides for … collection of standardized information by state governments about adverse events that result in death or serious harm." [Institute of Medicine: To Err is Human (1999) [http://darwin.nap.edu/books/0309068371/html/9.html Recommendation 5.1: Mandatory Reporting] ] Professional organizations, such as the Anesthesia Patient Safety Foundation, responded negatively: "Mandatory reporting systems in general create incentives for individuals and institutions to play a numbers game. If such reporting becomes linked to punitive action or inappropriate public disclosure, there is a high risk of driving reporting "underground", and of reinforcing the cultures of silence and blame that many believe are at the heart of the problems of medical error…" [Anesthesia Patient Safety Foundation: [http://www.apsf.org/about/pioneering_safety/page5.mspx APSF Response to the IOM Report] (February 2000)]

:Although 23 states established mandatory reporting systems for serious patient injuries or death by 2005, the national database envisioned in the IOM report was delayed by the controversy over mandatory versus voluntary reporting. [Agency for Healthcare Research and Quality: [http://www.ahrq.gov/news/medscap1.htm Reporting Requirements Cloud Consensus on Curbing Medical Errors] (May 2000)] Finally in 2005, the US Congress passed the long-debated Patient Safety and Quality Improvement Act, establishing a federal reporting database. [109th US Congress: [http://www.theorator.com/bills109/s544.html Patient Safety and Quality Improvement Act of 2005] (7/29/2005)] Hospitals reports of serious patient harm are voluntary, collected by patient safety organizations under contract to analyze errors and recommend improvements. The federal government serves to coordinate data collection and maintain the national database. Reports remain confidential, and cannot be used in liability cases. Consumer groups have objected to the lack of transparency, claiming it denies the public information on the safety of specific hospitals. [The Washington Post: [http://www.washingtonpost.com/wp-dyn/content/article/2005/07/28/AR2005072801907.html Plan Would Compile, Analyze Medical Errors] by Gilbert M. Gaul (July 29, 2005) page A06]

Voluntary disclosure

In public surveys, a significant majority of those surveyed believe that health care providers should be required to report all serious medical errors publicly. [US Agency for Healthcare Research & Quality: [http://www.ahrq.gov/news/ulp/ptsafety/ptsafety7.htm Beyond State Reporting: Medical Errors and Patient Safety Issues] (Accessed 2008-03-23)] [cite journal | author = Melanie Hingorani, Tina Wong, Gilli Vafidis | year = 1999 | title = Patients' and doctors' attitudes to amount of information given after unintended injury during treatment: cross sectional, questionnaire survey | journal = British Medical Journal | volume = 318 | pages = 640–641 | url = http://www.bmj.com/cgi/content/full/318/7184/640 | accessdate = 2008-03-23 | pmid = 10066205 ] However, reviews of the medical literature show little effect of publicly-reported performance data on patient safety or the quality of care.cite journal | author = Constance H. Fung, MD, MSHS; Yee-Wei Lim, MD, PhD; Soeren Mattke, MD, DSc; Cheryl Damberg, PhD; and Paul G. Shekelle, MD, PhD | year = 2008 | title = Systematic Review: The Evidence That Publishing Patient Care Performance Data Improves Quality of Care | journal = Annals of Internal Medicine | volume = 148 | pages = 111–123 | url = http://www.annals.org/cgi/content/abstract/148/2/111?etoc | accessdate = 2008-03-23 | pmid = 18195336 ] Public reporting on the quality of individual providers or hospitals does not seem to affect selection of hospitals and individual providers. Some studies have shown that reporting performance data stimulates quality improvement activity in hospitals. [cite journal | author = Judith H. Hibbard, Jean Stockard and Martin Tusler | year = 2003 | title =Does Publicizing Hospital Performance Stimulate Quality Improvement Efforts? | journal = Health Affairs | volume = 22 | pages = 84–94 | url = http://content.healthaffairs.org/cgi/content/full/22/2/84?maxtoshow=&HITS=80&hits=80&RESULTFORMAT=&andorexactfulltext=and&searchid=1&FIRSTINDEX=120&volume=22&resourcetype=HWCIT | accessdate = 2008-03-23 | doi =10.1377/hlthaff.22.2.84 ]

United States

Medical error

Ethical standards of the Joint Commission on Accreditation of Healthcare Organizations (JCAHO), the American Medical Association (AMA) Council on Ethical and Judicial Affairs, and the American College of Physicians Ethics Manual require disclosure of the most serious adverse events. [Joint Commission on Accreditation of Healthcare Organizations: 2006 Comprehensive Accreditation Manual for Hospitals: The Official Handbook. Oakbrook Terrace, IL: Joint Commission Resources, 2005] [American Medical Association: [http://www.ama-assn.org/ama/pub/category/8497.html Code of Ethics] ] However, many doctors and hospitals do not report errors under the current system because of concerns about malpractice lawsuits; this prevents collection of information needed to find and correct the conditions that lead to mistakes. [Medical News Today: [http://www.medicalnewstoday.com/medicalnews.php?newsid=31378 Sens. Rodham Clinton, Obama Propose National Medical Error Disclosure Program, USA] (29 September 2005)] As of 2008, 35 US states have statutes allowing doctors and health care providers to apologize and offer expressions of regret without their words being used against them in court, [SorryWorks! Coalition: [http://www.sorryworks.net/lawdoc.phtml List of US states with apology laws] (accessed 2008-05-18)] and 7 states [Massachusetts (ALM GL ch.233, 23D), California (Cal. Evid. Code section 1160), Florida (Fla. Stat. section 90.4026), Texas (Tex. Civ. Practice & Remedies Code section 18.0612), Washington (RCWA section 5.66.010), Oregon (2003 Oregon Laws Ch. 384), and Colorado (Colorado Revised Statute 13-25-135)] have also passed laws mandating written disclosure of adverse events and bad outcomes to patients and families.Citation | last1 = Sack | first1 = Kevin | title = Doctors Start to Say ‘I’m Sorry’ Long Before ‘See You in Court’ | newspaper = The New York Times | date = 2008-05-18 | year = 2008 | url = http://www.nytimes.com/2008/05/18/us/18apology.html?ex=1368849600&en=899b75692f687125&ei=5124&partner=permalink&exprod=permalink ] In September 2005, US Senators Clinton and Obama introduced the National Medical Error Disclosure and Compensation (MEDiC) Bill, providing physicians protection from liability and a safe environment for disclosure, as part of a program to notify and compensate patients harmed by medical errors.cite journal |author=Clinton HR, Obama B |title=Making patient safety the centerpiece of medical liability reform |journal=N. Engl. J. Med. |volume=354 |issue=21 |pages=2205–8 |year=2006 |pmid=16723612 |doi=10.1056/NEJMp068100] [The National Medical Error Disclosure and Compensation (MEDiC) Bill did not receive subcommittee approval in 2005. Clinton included the proposal in her Presidential campaign platform but has not resubmitted the bill to Congress. [http://www.nytimes.com/2008/05/18/us/18apology.html?ex=1368849600&en=899b75692f687125&ei=5124&partner=permalink&exprod=permalink (see NY Times article)] ] It is now the policy of several academic medical centers, including Johns Hopkins, University of Illinois and Stanford, to promptly disclose medical errors, offering apologies and compensation. This national initiative, hoping to restore integrity to dealings with patients, make it easier to learn from mistakes and avoid angry lawsuits, was modeled after a University of Michigan Hospital System program that has reduced the number of lawsuits against the hospital by 75% and has decreased the average litigation cost. The Veterans Health Administration requires the disclosure of all adverse events to patients, even those that are not obvious. [Citation | last=Kraman S.S., et al. | title= John M. Eisenberg Patient Safety Awards: Advocacy: The Lexington Veterans Affairs Medical Center |journal= Jt Comm J Qual Improv |volume=28 |pages=646–650| year= Dec. 2002] However, as of 2008 these initiatives have only included hospitals that are self-insured and that employ their staffs, thus limiting the number of parties involved.

Performance

In April 2008, consumer, employer and labor organizations announced an agreement with major physician organizations and health insurers on principles to measure and report doctors' performance on quality and cost. [Consumer-Purchaser Disclosure Project: Consumers, Purchasers, Physicians, and Insurers Agree on Principles to Guide Physician Performance Reporting (2008-04-01): [http://healthcaredisclosure.org/docs/files/PatientCharterDisclosureRelease040108.pdf News Release] ]

United Kingdom

In the United Kingdom, whistleblowing is well recognised and is government sanctioned, as a way to protect patients by encouraging employees to call attention to deficient services. Health authorities are encouraged to put local policies in place to protect whistleblowers. [Whistleblowing.org [http://www.whistleblowing.org.uk/] Retrieved on 2008-03-17 ] [UK Department of Health: News Release(1999-09-01: [http://www.dh.gov.uk/en/Publicationsandstatistics/Pressreleases/DH_4025596 Government Moves To Halt Secrecy In NHS] Retrieved 2008-03-17] [cite journal | author = Naomi Craft | year = 1995 | title = Medicine and books: Whistleblowing in the Health Service: Accountability, Law and Professional Practice; Whistleblowing: Subversion or Corporate Citizenship? | journal = British Medical Journal | volume = 311 | pages = 1444 | url = http://www.bmj.com/cgi/content/full/311/7017/1444 | accessdate = 2008-03-17 ]

Studies of patient safety

Numerous organizations, government branches, and private companies conduct research studies to investigate the overall health of patient safety in America and across the globe. Despite the shocking and widely publicized statistics on preventable deaths due to medical errors in America’s hospitals, the 2006 National Healthcare Quality Report [ AHRQ: [http://www.ahrq.gov/qual/nhqr06/nhqr06.htm 2006 National Healthcare Quality Report] Retrieved 2007-01-12] assembled by the Agency for Healthcare Research and Quality (AHRQ) had the following sobering assessment:

*Most measures of Quality are improving, but the pace of change remains modest.
*Quality improvement varies by setting and phase of care.
*The rate of improvement accelerated for some measures while a few continued to show deterioration.
*Variation in heath care quality remains high.

The Health Grades study in April 2006 determined that over 3% of hospitalized Medicare patients experienced adverse events, and that the total number of patient safety incidents has been increasing since 2001. [HealthGrades: PDFlink| [http://www.healthgrades.com/media/DMS/pdf/PatientSafetyInAmericanHospitalsStudy2006.pdf Third Annual Patient Safety in American Hospitals Study] |302 KiB November 20, 2006]

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 central concept of the report—that bad systems and not bad people lead to most errors—became established in patient safety efforts. A broad array of organizations now advance the cause of patient safety.

References

External links

* [http://cimit.org CIMIT Center for Integration of Medicine and Innovative Technology - Nonprofit organizations together advocating for Patient safety]

ee also

*Adverse effect (medicine)
*Adverse event
*Blood transfusion
*EudraVigilance
*Evidence-based medicine
*Hospital accreditation
*Iatrogenesis
*Iatrogenic disorder
*International healthcare accreditation
*Medical ethics
*Medical error
*Nursing care
*Patient Care Technician
*Patient safety organization
*Patient Safety and Nursing
*Palliative care
*Peter Pronovost
*Pharmacovigilance
*Public health
*Serious adverse event
*Swiss Cheese model of accident causation in human systems
*Structured Clinical Interview for DSM-IV "(SCID)"