Reporting and preventing medical mishaps: lessons from non-medical near miss reporting systems

Error

Failure to perform intended action that was correct given circumstancesw10

Failure to complete action as intended, or use of wrong plan to achieve aim.3

Near miss

Case where accident was narrowly averted5

Any situation in which ongoing sequence of events was prevented from developing further and hence preventing occurrence of potentially serious consequences"9

Error that almost happened but was prevented8

Non-events that can be called near histories—events that almost happened7

Regarded as incidents which under different circumstances could have far more serious consequencesw3

Dangerous occurrences: no personnel injury, but material damage—warnings of coming eventsw22

Mishap that causes, or close call that has potential to cause, major impact to space flight operations or prevents accomplishment of primary mission objectivew18

Non-consequential events

Occurrence that could have led to dangerous breakdownw21

Incidents

Event that under slightly different circumstances could have been an accident10

Near misses and accidents9

Any unusual event or occurrence in which potential liability may occurw35

Critical incident

Occurrence that is significant or pivotal in either desirable or undesirable way

Occurrence which if not discovered or corrected in time did or could lead to patient morbidity or mortalityw24

Accident

Random event that is unforeseen, unfortunate, and unexpected40

Caused by side effects of decisions made by different actors distributed in different organisations, at different levels, and during activities at different points in timew8

Unplanned, unexpected, and undesired event, usually with an adverse consequences6

Adverse drug events

Injury caused by medical management resulting in prolonged hospitalisation or disability at discharge39

Unintended injury caused by medical management resulting in measurable disability or prolonged hospitalisation40

Any noxious and unintended effect of drug that occurs at doses used in human for prophylaxis, diagnosis, or treatment41

Any illness resulting from diagnostic procedure or from any from of treatment42

 

Extra references

Non-medical near miss reporting systems

w1 Wiener E, Nagel D. Human factors in aviation. San Diego, CA: Academic Press, 1989.

w 2 Reynard WD, Billings CE, Cheney ES, Hardy R. The development of the NASA aviation safety reporting system. Washington, DC: Aeronautics and Space Administration, Scientific and Technical Information Branch, 1986. (NASA reference 1114.) www.afo.arc.nasa.gov/ASRS/callback.html; accessed 25 November 1999.

w3 Ives G. Near miss reporting pitfalls for nuclear plants. In: Van der Shaff, Lucas DA, Hale AR, eds. Near miss reporting as a safety tool. Oxford: Butterworth-Heineman, 1991.

w4 Carroll J. Incident reviews in high-hazard industries: sense making and learning under ambiguity and accountability. Ind Environ Crisis Q 1995;9:175-97.

w5 Van Vuuren W. Organizational failure: an exploratory study in the steel industry, and the medical domain [PhD thesis]. Eindhoven, Netherlands: Eindhoven University of Technology, 1998.

w6 Perrow C. Normal accidents: living with high risk technologies. New York: Basic Books, 1984.

w7 Sagan, SD. The limits of safety: organizations, accidents, and nuclear weapons. Princeton, NJ: Princeton University Press, 1994.

w8 Rasmussen J. The role of error in organizing behavior. Ergonomics 1990;33:1185-99.

w9 Turner BA, Pidgeon NF. Man-made disasters. London, Butterworth-Heinemann, 1997.

w10 Senders J, Moray N. Human error: cause, prediction, and reduction. Hillsdale, NJ: Lawrence Erlbaum, 1994.

w11 Moray N. Error reduction as a systems problem. In: Bogner MS, ed. Human error in medicine. Hillsdale, NJ: Lawrence Erlbaum; 1994:67-92.

w12 Aviation safety reporting system program overview. NASA aviation reporting system, Moffett Field, CA. http://asrs.arc.nasa.gov; accessed 25 November 1999.]

w13 Griffith S. Viewpoint. Aviation Week and Space Technology. 1998 July 13.

w14 www.alpa.org; accessed 25 November 1999.

w15 O'Leary M, Pidgeon N. Too bad we have to have confidential reporting programs. Flight Deck 1995;16:11-6.

w16 O’Leary M, Chappell SL. Confidential incident reporting systems create vital awareness of safety problems. ICAO J 1996;51:11-3.

w17 Shapell S, Weigmann D. A human error approach to accident investigation: the taxonomy of unsafe operations. Int J Aviat Psychol 1997;7:269-91.

w18  http://nasdac.faa.gov/asp/asy/fids.asp ; accessed 25 November 1999.

w19 Gliesson RM. Incident reporting systems in the medical field: an inventory using the NMMS framework [thesis proposal]. Eindhoven, Netherlands: Eindhoven University of Technology, 1997.

w20 Rees JV. Hostages to each other: the transformation of nuclear safety since Three Mile Island. Chicago: University of Chicago Press, 1994.

w21 Institute of Nuclear Power Operations. Human performance enhancement system. Atlanta: INPO, 1990. (Report No 90-005.)

w22 US Nuclear Regulatory Commission. Reporting safety concerns to the NRC. Washington, DC: US Nuclear Regulatory Commission, 1998. (NUERG/BR-0240.)

w23 Serig D. Translating a human factors process from nuclear power plants to health care. In: Proceedings of examining errors in health care: developing a prevention, education and research agenda. Rancho Mirage, CA: American Association for the Advancement of Science, American Medical Association, Oct 13-15, 1996.

Medical reporting systems

w24 Cooper JB, Newbower RS, Long CD, McPeek B. Preventable anesthesia mishaps. Anesthesiology 1978;49:339-406.

w25 Campling EA. The report of the national confidential enquiry into perioperative deaths 1992/3. London: NCEPOD, 1995.

w26 Hart GK, Baldwin I, Gutteridge G, Ford J. Adverse event reporting in intensive care. Anesth Intens Care 1994;22:556-61.

w27 Wright D, MacKenzie S, Buchan I, Cairns C, Price L. Critical incidents in the intensive care therapy unit. Lancet 1991;338:676-8.

w28 Wagenar WA. Safety management in intensive care wards. In: Wilpert B, Qvale T, eds. Reliability and safety in hazardous work systems. Hillsdale, NJ: Lawrence Erlbaum, 1993.

w29 Donchin J, Gopher D, Badhi Y. A look into the nature and causes of human errors in the intensive care unit. Crit Care Med 1995;23:294-300.

w30 Derman H. Quality and liability issues with the Papanicolau smear: lessons from the science of error prevention. Arch Pathol Lab Med 1997;121:287-91.

w31 Richter ED, Deutsch P, Adler Y. Industrial disasters. Sentinel markers in industrial disasters. Pre-hosp Disaster Med 1992:7:389-95.

w32 Richter ED, Barach P. Occupation and environment in internal medicine: sentinel events and trigger questions. Mt Sinai J Med 1995;62:390-400.

w33 de Leval M. Human factors and outcomes of cardiac surgery. Pediatr Anesth 1996;6:349-51.

w34 Cohen MR, Proulix SM, Crawford SY. Survey of hospital systems and common serious medication errors. J Healthcare Risk Manage 1998;2:16-27.

w35 Fiesta J. Incident reports-confidential or not? Nurs Manage 1994;25:17-8.

w36 National Center for Patient Safety, National Patient Safety Registry (VA NCPS NPSR) and VHAPSC@med.va.gov.

w37 Thomas EJ, Studdert DM, Newhouse JP. Costs of medical injuries in Utah and Colorado. Inquiry. 1999;36:255-64.

w38 Brennan TA, Leape LL, Laird N, Hebert M, Localio AR, Lawthers A, et al. Incidence of adverse events and negligence in hospitalized patients: results of the Harvard medical practice study I. N Engl J Med 1991;324:370-6.

w39 Classen, DC, Pestotnik SL, Evans KS, Burke JP, et al. Computerized surveillance of adverse drug events in hospital patients. JAMA 1991;266:2847-51.

w40 Steel K, Gertman PM, Crescenzi C, Anderson J. Iatrogenic illness on a general medical service at a university hospital. N Engl J Med 1981;304:638-42.

 

Appendix 1

Questionnaire for directors of incident reporting systems

1. Background

a. What were the reasons or impetus behind creating a reporting system?

b. What or who were the driving forces? Stakeholders?

c. What were the roots of the process?

2. Objectives

a. What were the objectives in creating the reporting system?

b. How did this shape the kind of data that was sought after?

c. What was the rationale behind the methodology?

d. What were the definitions and inclusion criteria?

e. Is the incident reporting part of an accident reporting system or complementary?

3. Reporting format

a. Format—verbal, written, computer, chart or file review, fixed field, short narratives?

b. Who was the targeted reporter population?

c. What were the specifics of dealing with reporting—nuts and bolts of how it is done.

d. Was callback used to clarify or amplify narrative?

e. Automated or manual data systems?

4. Barrier incentive analysis

a. What were the barriers?

b. How were the barriers and incentives addressed?

c. Do some still remain?

d. What compromises were made?

e. How has this affected the achievement of the original objectives?

5. Immunity and confidentiality

a. Is there built in confidentiality and a means to maintain confidentiality?

b. Has it ever been challenged?

c. Is there an independent regulatory oversight body?

d. Is there a feedback mechanism to reporters and community?

6. Summary

a. How successful has the reporting system been in meeting its objectives?

b. What specific benefits have been produced as a result of the cost and effort? Tangible? Intangible? Process?

c. Who funded or sponsored the system? Costs?

d. In retrospect, what would you have done differently if given the choice?

7. Lessons to health care

a. What advice would you have for setting up a medical incident reporting system?

b. How can the accountability-information flow dynamic be best balanced in health care?
 

Appendix 2

The NASA aviation safety reporting system (ASRS)

In 1974, two flight crews nearly perished in the same Maryland location within a six week period due to identical air traffic control problems. In response, officials from the Federal Aviation Administration (FAA) established a Special Section Studies Advisory Group (SASAG). The group’s report prompted the Federal Aviation Administration to create an anonymous, non-punitive, and confidential reporting system.

The Federal Aviation Administration reporting system received few reports initially, as many reporters feared retribution by the Federal Aviation Administration if they filed reports, despite guarantees to the contrary. NASA was asked to design a new more acceptable format. The design was voluntary, confidential, and non-punitive. The system was contracted out to the Battelle corporation, an independent third party. Despite concern among Federal Aviation Administration officials that the aviation safety reporting system would undermine its enforcement responsibilities, the agency grudgingly accepted the concept of the independence of the aviation safety reporting system. The Federal Aviation Administration later improved the system by offering limited immunity from disciplinary action. NASA created an advisory committee with representation from all stakeholders of the aviation community, including the public. The system was widely described through advisory circulars to all aviation personnel in 1975. The Federal Aviation Administration funds the aviation safety reporting system; NASA administers the programme, with no regulatory enforcement powers over civil aviation.

Pilots, air traffic controllers, flight attendants, mechanics, ground staff, and other aviation professionals are asked to submit reports to the system if they are involved in, or observe, an incident in which aviation safety was compromised. The system is designed to collect near miss events, not accident data. Accidents fall under the jurisdiction of the National Transpiration Safety Board. Reporting forms are available on the website of the aviation safety reporting system. Submissions are voluntary.

Feedback to the community began immediately and includes Callback, a monthly, two page newsletter to over 80 000 personnel; quarterly reports to NASA; alert bulletins; DirectLine for technical issues; quick response studies to the National Transpiration Safety Board and the Federal Aviation Administration; testimony to Congress.

The reports must be filled within 10 days of an incident. The number of reports to the aviation safety reporting system is around 30 000 a year. Battelle, which was competitively selected to manage the system, currently receives 650 reports a week. Since the founding of the aviation safety reporting system, none of its more than 500 000 reporters have been disciplined for events they reported. Reports undergo an initial screen for accidents or criminal activity. No immunity is given if the accident was deemed intentional, where there is a question of qualifications, or if the reports are filed after 10 days. Reporters can get immunity only once in five years. The staff analysts include retired pilots, mechanics, and air traffic controllers. The reports are examined to identify hazards that require immediate actions, and to classify reports by cause. The system disseminates information about aviation safety hazards through alerting messages and through its newsletter, Callback. The annual cost of running the aviation safety reporting system is $2 million.

A complex balance of incentives and disincentives are associated with the system. Analysts contact reporters by phone to inform them of the results of the analysis and to determine whether appropriate measures are being taken to prevent future incidents. Reports are deidentified (made untraceable) within 48 hours and entered into the system’s database; the original reports are destroyed. The reporter’s identification is on the tear-off slip on the incident report to facilitate follow up for additional information. Over 3000 searches have been made of the database. The system has published over 56 research studies related to aviation safety problems noted in the reporting database.

Analysis of the data is conducted by the Ames Research Center, which conducts aviation’s operations and safety research.

The main themes of the aviation safety reporting system are that it is:

• Voluntary

• Confidential

• Non-punitive

• Objective

• Independent of regulatory system

• Gives feedback to all stakeholders

• Provides oversight

• Encourages full narrative, sometimes up to 20 pages

• All products are peer reviewed before publication.

Further reading

Reynard WD, Billings CE, Cheaney ES, Hardy R. The development of the NASA aviation safety reporting system. Washington, DC: Aeronautics and Space Administration, Scientific and Technical Information Branch, 1986. (NASA reference 1114.)

NASA Aviation Reporting System. Aviation safety reporting system program overview. Moffett Field, CA: NASA Aviation Reporting System, 1986.

Billings CE, Reynard WD. Human factors in aircraft incidents: results of a 7-year study. Aviat Space Environ Med 1984;55:960.

Tamuz M. Developing organizational safety information systems for monitoring potential dangers. In: Apostolakis GE, Wu JS, eds. Proceedings of physical sciences annual meeting III. Vol 2. Los Angeles: University of California, 1987;71:7-12.

Tamuz M. Monitoring dangers in the air: studies in information and ambiguity [PhD dissertation]. Stanford, CA: Stanford University, 1988.
 

Appendix 3

Excerpt from ASRS newsletter Callback, January 2000

The first officer of an air carrier float plane operating in the South Atlantic relates how missing the landing spot led to a rough ride for crew and passengers

I was the first officer [on the air carrier flight]. It was my flying leg and the captain and I both agreed to land in the protected waters on the leeward side of bay by approaching from the northwest (wind 060º 20 kts). The water in our landing area was [in] ideal conditions, with a light chop. During the approach I touched down slightly long of my aiming point in the protected area. As we slowed, the captain put the aircraft into beta to help stop us from getting into the unprotected water. As we approached the rough water, we were launched into the air by a wave that was larger than all the rest. Crosswind corrections were applied as we landed left wing low back into the water (during which, the left float became dislodged from the wing). Quickly afterwards the aircraft rolled to the right, breaking the right float as it went under the water. The right float remained attached to the wing by the fuel lines only.

We taxied towards the ramp area using extra power to keep the wings out of the water as much as possible. We completed a normal ramping and secured the aircraft using standard procedures.

This incident would have been prevented if we had performed a go-around when I realised that I had overshot my aiming spot. Also, we should have landed directly into the wind. Although the water was rougher, our ground speed would have been less.