Medical laboratories are at the hub of the information flow within the health care system. Evidence-based medical guidelines are being increasingly implemented in medical institutions and laboratory results are used to both classify patient risk and guide medical decisions. Internationally, Laboratory results are estimated to influence up to 75-80 % of all medical decisions. Clinicians depend on laboratories to manage patients and when they don’t trust laboratory results they often have to rely only on their clinical judgement. Direct and indirect costs of laboratory error can run into millions of dollars.
- A study by the National Institutes of Standards and Technology (NIST) in the United States, for example, examined the costs associated with just calibration error for the measurement of calcium. Calibration error in the testing of this one analyte costs the US health care system between 60 and 199 million USD per year. http://www.nist.gov/director/planning/upload/report04-1.pdf.
- In May 2004 the Baltimore Sun http://www.baltimoresun.com/news/maryland/bal-md.general11may11,0,6476739.story reported the unusual convening of a hearing by the US Congress into severe outcomes of laboratory error at the Maryland General Hospital, one of the largest hospitals in Maryland, USA. The hearing was intended to investigate the scandalous quality infractions that resulted in the distribution of over four hundred questionable HIV results and the nightmare of a laboratory staff member becoming infected with both HIV and Hepatitis C. The US Congress sought to determine, as a matter of urgent priority, the legislative changes needed to prevent a recurrence and to ensure that the nationwide inspection and accreditation programmes were more thorough and reliable.
- The Medical Laboratory Observer in December 2004, reviewed the situation with Maryland General Hospital Laboratory and another laboratory in Maryland, as well as the situation of the affected staff member and discussed implications for laboratories and policy makershttp://www.mlo-online.com/articles/200412/1204lab_management.pdf.
- An article by the New York Times (1995), highlighted error in laboratory histopathology services that resulted in five consecutive biopsies and pap smears being misread for a Wisconsin, USA patient who subsequently died. Law suits against the Wisconsin institution, laboratory director and pathologists in the first instance resulted in a $US 6.3 million payment to the family. http://www.nytimes.com/1995/04/13/us/medical-laboratory-faces-charges-in-cancer-deaths.html.
- In 2010, The New York Times told the story of breast cancer misdiagnosis and preventive actions required in “Prone to Error: Earliest Steps to Find Cancer”, http://www.nytimes.com/2010/07/20/health/20cancer.html?pagewanted=all&_r=0.
- The Montreal Gazette and the Canadian Press (2009) also highlighted a report by the Quebec Association of Pathologists of a possible 15-30% error in histopathology tests conducted by a Quebec laboratory that were used to guide treatment of cancer patients. Quebec pathologists estimated that laboratory errors could have resulted in a possible 5% rate of false negative results. Two thousand, seven hundred and thirty tests had to be repeated as a result http://www.bcam.qc.ca/fr/node/597. Claims for Can $35,000 for each woman receiving a false negative test were filed in Montreal.
- The Melbourne Herald Sun of May 2010 identified the case of Farah Jama, a 21 year old Australian male who was falsely incriminated by DNA evidence and jailed for 1.5 years before the laboratory error was acknowledged and the guilty verdict was struck down http://www.heraldsun.com.au/news/victoria/dna-error-slammed-as-farah-jama-went-to-jail-for-rape-he-didnt-commit/story-e6frf7kx-1225863338007. Mr Jama is seeking $1 million in damages.
- In 2011, in “A Review of Medical Errors in Laboratory Diagnostics and Where We Are Today”, Julie Hammerling looks at recent statistics concerning laboratory errors. http://www.iacld.ir/DL/elm/areviewofmedicalerrorsinaaboratorydiagnosticsandwherewearetoday.pdf
- In Clinical Chemistry 53:7, Carraro and Plebani tracked the occurrence of laboratory error within their stat laboratory in the pre-, intra- and post-analytic phases of testing, and showed that overall laboratory error rates declined over 10 years from 0.47% in 1977 to 0.33% in 2007 in their stat laboratory. They concluded that “the high frequency of errors attributable to processes external to the laboratory (approx. 80%), particularly in the pre-analytical phase, stresses the need for a closer control of all processes and procedures involving patients undergoing laboratory testing”. They also found that “a very high (73%) percentage of errors classified as preventable”, a key finding since “24.6% of the errors have resulted in unnecessary laboratory test repetition, further inappropriate investigations, and episodes of negative clinical outcomes”. Carraro and Plebani concluded that “in the last few decades, a significant decrease in error rates has been achieved in laboratory medicine, but there is much room for improvement, and the need for more effective procedures for quality assessment and control is greater.”
- In February 2013, The Dark Daily commented on the case of the Ohio State University Wexner Medical Center (OSUWMC), which was given severe sanctions by officials of the Centers for Medicare & Medicaid Services (CMS), based on the US federal law on the subject of enforcement of Clinical Laboratory Improvement Act (CLIA) proficiency testing errors. http://www.darkdaily.com/despite-passage-of-new-law-on-clia-enforcement-ohio-state-university-settles-with-cms-agrees-to-pay-268000-and-names-new-clinical-laboratory-medical-director-22013#axzz2QSpTCTuq
The settlement between OSUWMC and CMS called for OSUWMC to:
- Appoint a new medical director for the clinical laboratory,
- Pay $268,000, and
- Provide additional training to the medical laboratory staff in proficiency testing (PT).
All of these stories and articles point to the current crisis of laboratory error worldwide. It should be noted that the above cases all occurred in environments in which laboratories are regulated. While less data is collected and/or available in the Caribbean, snapshots of testing reliability indicate a high frequency of unreliable results. The performance of Caribbean laboratories participating in a bacteriology external quality assessment programme administered by a leading Canadian institution in 2008 resulted in unacceptable identification ranging from 30-96% for six important pathogens. Additionally, results for bilirubin, a commonly requested analyte, from a 2006 proficiency test programme, reflected a 70% failure rate among the ten Caribbean laboratories that participated (CMLF unpublished data).