How accurate are those lab results?

Kenya medical Laboratory Technicians and Technologist board (KMLLTB) Chairman Abel Onyango has raised alarm over increasing number of unqualified personnel hired to run health facilities. [Photo by WILLIS AWANDU/STANDARD ]

It has been four years of physical pain and psychological trauma for Lillian Nagisa Saidi after one of her breasts was wrongly removed in one case of horrible misdiagnosis.

The 27-year-old lady had surgery to remove her breast in April 2012 after lab results at the Moi Teaching and Referral Hospital in Eldoret found she had cancer and needed urgent surgery.

But after surgery, further analysis of her breast tissues in several other medical labs in Nairobi ruled out cancer completely. Unfortunately, it was too late. “I feel a lot of pain in my heart for losing my breast unnecessarily and the surgical wound is still painful. I am looking for funds to pay for reconstructive surgery which I believe will make my life more bearable. It has been hell!” she says.

Lillian’s tragic experience is one example of the growing incidences of medical laboratories in the country producing wrong results and causing patients to receive inappropriate treatments that often results in health complications or even loss of lives. The Kenya Medical Laboratory Technicians and Technologists Board, the State agency that regulates practise of medical laboratory profession, has reported a surge in the number of Kenyans complaining about getting contradictory or wrong results from medical labs leading to wrong treatments offered by clinicians. The Board’s Chairperson Abel Onyango said ongoing investigations reveal that these incorrect results are not restricted to unlicensed backstreet labs run by quacks, but also some registered ones that do not procure validated reagents (lab chemicals) and equipment.

“Such laboratories have also ignored or failed to run internal quality controls to uphold the standard operating procedures to ensure quality testing. This leads to more likelihood of wrong results. This is a serious and growing problem and we have renewed a crackdown on such labs,” he said.

Some accredited medical labs in the country are also reporting increasing cases of patients being referred to them from other labs whose results turn out to be different from what they initially received from non-accredited labs.

“We are seeing this with various tests including basic and specialised tests. This trend is quite worrying because doctors can easily make wrong decisions about treatments if they are furnished with wrong lab results,” said Dr Ahmed Kalebi, Consultant Pathologist and CEO of Lancet Group of laboratories.

“Unfortunately when the discrepancy is reviewed, often the original erroneous results boil down to either sample mix-up, or inadequate quality control systems – both internal and external quality control,” Dr Kalebi said. Experts indicate that majority of private and public labs in the country are vulnerable to errors since they rely only on their internal quality control systems which can be flawed.

Because proficiency testing and accreditation to international standards, while mandatory in some countries, is still voluntary in Kenya - many labs do not participate in external and independent mechanisms that continuously monitor accuracy of lab results.

According to Kenya Accreditation Service (Kenas), only 24 out of an estimated 2,000 licensed medical labs have been accredited.

Kenas, the sole State accreditation agency in Kenya, finds this trend rather worrying saying there can therefore be no guarantee that majority of lab results are accurate

“Accreditation to the international standard should be mandatory for medical labs in Kenya since it is human lives and health at stake,” said Kenas Assistant Director for Health and Safety Doris Mueni.