EDUCATON :: COST OF ERRORS
“US deaths annually due to medical error at 250,000 minimum, and as high at 400,000. This range equates to 500–1000 deaths every day. 1 —Andy Quintenz.
”
employ indicated tests, use of outmoded tests, or failure to act on results. In its 2015 report, Improving Diagnosis in Healthcare, the Institute of Medicine estimated that diagnostic error is the cause of 10% of patient deaths, 17% of hospital adverse events, and the leading driver of malpractice claims. Perhaps even more surprising was the report’s estimate that, in the US, an individual will be incorrectly diagnosed at least once in their lifetime. This is not just receiving an incorrect diagnosis but that the doctor will also have acted upon it.
It should be noted that not all diagnostic errors originate in the clinical laboratory. The reported statistics include other types of diagnostics such as imaging, diagnostic errors stemming from misinterpretation of results, and diagnosis and treatment with inadequate information. Unfortu- nately, very few medical institutions have processes in place, or the resources to track diagnostic errors or determine their causes. Therefore, it’s unknown how many are attributable to laboratory errors. Laboratories, hospitals, and clinicians
alike are naturally reluctant to share in- formation about diagnostic errors due to the litigious nature of society. While almost every laboratory has experienced a laboratory error being acted upon, it is rare that these are shared outside of the institution, even for the sake of educa- tional enlightenment. US laboratories routinely run upwards of 500 tests, larger laboratories may have another 500 that are run less frequently. This requires each lab to be able to main- tain equipment and competency for up to 1000 tests, and the larger reference labs even twice that, with tests running the gamut of highly automated instrumenta- tion to very manual methods. All of these tests require reliance on equipment and staff performing at the highest level. But instruments fail and human nature being what it is, people make errors as well.
Categories of errors It’s important that laboratorians, and others who are involved in the testing process, understand potential sources of error so they remain alert and bring
20 MAY 2022
MLO-ONLINE.COM
attention to a situation that needs to be evaluated before reporting out results. Not all errors are created equally. There are errors that are limited in impact, affecting a single or small number of test results, while other errors have the potential to affect a large number, even across days or weeks of testing. Below are examples of these types of errors Errors that typically affect multiple patients: • Lab equipment isn’t working prop- erly. Equipment failures can be small enough to impact sample results without causing an obvious failure. Certain components can begin to react to wear, and will still allow operation but may use an inadequate amount of reagents or cause the calibration to shift.
• Improper storage or handling of reagents. Reagents that are left out or stored at improper temperatures may degrade before their expiration dates and lead to incorrect test results until replaced with reagents that have been handled properly.
• Procedures aren’t followed. A hastily trained employee may not understand a procedure well and apply a short- cut that inadvertently affects all the samples they are running.
• Samples are not properly handled. Samples that are collected offsite may be stored properly until pickup or left for courier pickup and then exceed storage temperatures after leaving the facility.
Errors that typically affect a single patient: • A sample isn’t collected or labeled properly. The sample may be collected in the wrong tube, it may be poorly drawn and hemolyzed, or not labeled at the time of draw with an incorrect label applied later. In these instances, the impact is to the tests designated to be run on that particular sample tube.
• Samples aren’t properly handled. This can be caused by not rocking the tube to cause mixing with the anti-coagulant. Excessive vibration from transport can cause hemolysis.
• Lab testing with time constraints are delayed in running or reading. Certain tests require samples to be centrifuged or run within a certain amount of time from collection and when not, may lead to incorrect results. Similarly, when a test cartridge that must be read within a specified time period after inoculation is read later than required, may lead to an incorrect result.
• A test result is entered incorrectly into the patient record, or the wrong record. Many but not all instruments automatically
communicate with an LIS and many test methods require manual entry of results. These can lead to transcription or transposition errors.
Moving forward
Sometimes a single lab test can diagnose a disease but more frequently, several lab tests are used by the clinician to gain insights as to what is happening in the body and aid in the diagnosis. These test results impact the treatment plan a patient receives, such as surgery, medica- tion, or type of therapy. Clinicians use test results as one piece of the puzzle when diagnosing patients but it’s a critical piece that provides insights that clinical observation cannot uncover. As the reports point out, errors will
always occur but steps can be taken to reduce their number and their impact. Errors can be prevented by designing
systems that make it hard for people to do the wrong thing and easy for people to do the right thing. [It is] a serious concern in health- care that, if discussed at all, is discussed only behind closed doors. As healthcare and the system that delivers it become more complex, the opportunities for errors abound. Communication is key. One of the rec- ommendations of the Institute of Medicine is for health systems and laboratories to create an environment where errors and near misses can be discussed and triaged for improvements. These learnings need to be shared, in a blinded way, outside the individual institutions to benefit not only the greater laboratory community but more importantly, for patients’ well- being. Staff coming forward and sharing errors and near misses during monthly or quarterly quality reviews should also become standard practice. It’s how we all learn.
REFERENCES:
1. Institute of Medicine. Committee on Quality Health Care in America. Kohn KT, Corrigan JM, Donaldson MS, eds. To Err is Human: Building a Safer Health System. Washington, DC: National Academy Press. 2000.
2. National Academies of Sciences, Engineering, and Medicine. Balogh, E., Miller, B., Ball, J., eds. Improving diagnosis in health care. Washington, DC: The National Academies Press. 2015.
3. Gabler, E. Hidden Errors. Milwaukee Journal Sen- tinel. May 17-Nov 15, 2015 (series). https://archive.
jsonline.com/watchdog/watchdogreports/hidden-
errors-360092411.html. Accessed March 21, 2022.
4. Makary M A, Daniel M. Medical error—the third leading cause of death in the US. BMJ 2016; 353 : i2139 doi:10.1136/bmj.i2139.
Andy Quintenz serves as Global Scientific and Professional Affairs Manager for Bio-Rad Laboratories’ Quality Systems Division. He works to promote an understanding of laboratory regulations and best
practices as they pertain to QC and EQA/PT programs.
Page 1 |
Page 2 |
Page 3 |
Page 4 |
Page 5 |
Page 6 |
Page 7 |
Page 8 |
Page 9 |
Page 10 |
Page 11 |
Page 12 |
Page 13 |
Page 14 |
Page 15 |
Page 16 |
Page 17 |
Page 18 |
Page 19 |
Page 20 |
Page 21 |
Page 22 |
Page 23 |
Page 24 |
Page 25 |
Page 26 |
Page 27 |
Page 28 |
Page 29 |
Page 30 |
Page 31 |
Page 32 |
Page 33 |
Page 34 |
Page 35 |
Page 36 |
Page 37 |
Page 38 |
Page 39 |
Page 40 |
Page 41 |
Page 42 |
Page 43 |
Page 44 |
Page 45 |
Page 46 |
Page 47 |
Page 48 |
Page 49 |
Page 50 |
Page 51 |
Page 52
