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Gambling With Lives - Let’s Do No Harm


Keeping Focused on Lab Quality -- the Ultimate Quality Goal of Accreditation

Every medical laboratory has a primary duty and responsibility to ‘DO NO HARM’. This is not an easy goal to achieve since laboratory testing is exceedingly complex, involving many steps, from taking a patient sample to using the result to effectively manage a patient. Laboratory errors are common. A recent United States study estimated that 2.9 million errors occurred annually,causing harm to more than 160,000 patients.1 A truly frightening statistic!

Millions of laboratory tests are conducted annually in the Caribbean. In the absence of laboratory regulations or standards, to ‘DO NO HARM’ becomes exponentially more difficult.

Laboratory Error Hurts

The avoidance of laboratory errors presents a multidimensional challenge. Even accreditation, if not appropriately managed, may not guarantee that incidents of laboratory are avoided.

The 2004 experience of Maryland General Hospital (MGH) in the USA is instructive in this regard.2 MGH was a highly regarded laboratory, repeatedly accredited in 2001 and 2003 by the College of American Pathologists (CAP). In spite of this, a terrible preventable laboratory incident resulted in HIV infection of one staff member, over 2000 clients having to be offered free retests, the temporary closure of the laboratory and the convening of a US Congressional hearing at which it was revealed that the MGH was given high marks in an accreditation assessment process even while severe operational problems existed. Stakeholders discovered that ‘Accreditation’ and ‘Quality’ are not always synonymous.

In a more recent 2012 occurrence, a crime lab chemist in Massachusetts (Mass) was arrested on suspicion of altering or faking thousands of drug-related tests.3 As new information emerges it seems that almost 200,000 cases may have to be re-opened. Hundreds of persons may have been incarcerated unfairly and even more alarming, hundreds of dangerous criminals may have to be released due to untrustworthy evidence. This lab , which was not accredited, has been closed as investigations continue.

What do both of these cases have in common? Their staff lost sight of their primary duty to “DO NO HARM” and failed to either comply with standard quality requirements (MGH) or to implement the required quality systems (Mass).

Standards, Quality Systems and Accreditation as Strategic Motivation

A laboratory seeking to ‘DO NO HARM’ needs to adhere to the tenets of any quality-focused business operation i.e. identify an appropriate quality standard, implement appropriate quality structures and systems, work towards full compliance and seek credentialing of quality achievements.

In 2004, Caribbean Governments agreed that the ISO 15189 Standard would be the benchmark for medical and related public health laboratory operations.4 Significant resources have been invested in laboratory improvements and the lure of accreditation is giving impetus to this effort.

How can accreditation work for your lab and for your clients?

diceimgThe accreditation process requires specialist assessors to conduct a thorough evaluation of systems, people, infrastructure, equipment and client satisfaction. In order to maintain the integrity, credibility and trustworthiness of the accreditation process, a critical aspect must be that Accreditation Bodies ensure that assessors are competent to conduct evaluations and provide sound feedback.

Becoming accredited means having appropriately skilled staff; maintained equipment; efficient sampling; relevant technology; valid methodologies; effective recording and reporting procedures; excellent customer service and of course competitive costing of services. Becoming accredited means consistently aiming to “DO NO HARM” and taking the ‘continuous quality improvement’ path.

Some laboratories prepare for accreditation without fully engaging, staff, management and key stakeholders in the quality improvement effort. These laboratories eventually experience significant quality systems gaps that inevitably lead to error incidents and possibly to a loss of accreditation.

No Accreditation Body can guarantee that a laboratory complies with standard requirements on a continuous basis or that every laboratory test will be accurate. Some Accreditation Bodies now include this disclaimer in their instructions.


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CMLF News Issue #7
27th January 2016