No regulatory body for medical labs on federal level

ISLAMABAD: A draft of regulatory body for medical laboratories has been finalised by the Law Ministry, said State Minister for National Health Services, Regulations and Coordination Mrs Saira Afzal Tarar while talking to The News on Tuesday. The said draft will soon be approved by the federal cabinet, she said.

“I am aware of the importance of regulating the medical labs. The medical laboratories in Punjab province are being regulated by the Punjab Health Care Commission. However, soon a regulatory body on the federal level will be formed once the bill is approved,” said the minister.

Lab tests play a crucial role in detection, diagnosis and treatment of disease. An estimated 60 percent to 70 percent of all decisions regarding a patient’s diagnosis and treatment, hospital admission and discharge are based on laboratory test results.

At a time when these tests guide more than 70 percent of medical decisions and personalised medicine, the majority of labs are not being accounted by any regulatory body.One such case of faulty result diagnosed by one of renowned medical labs in Lahore reveals how they are playing havoc with patients by issuing wrong and faulty result.

Muhammad Abdullah Abrar Syed consulted the lab for blood test. He gave sample of serum test of testosterone test however the lab gave him a wrong result. As per the lab result, the testosterone level of Mr Syed was 197 ng/gl while the normal level of the said hormone in the human body is 246.5 ng/gl to 1606 ng/gl.

After finding the hormone level abnormally low in the patient, the doctor advised him to undergo further tests to find out the actual cause of the abnormal low level of testosterone hormones. However, later the results of other renowned laboratories proved that the report of the lab was wrong.

Mr Syed has sued the laboratory for over Rs2 million over the wrong results and causing mental stress to him. This is not the first time the said laboratory has produced wrong results as such kind of incidents had already happened in 2012.

Mrs Fatima Sameer sued the lab for Rs11 million for a false negative pregnancy test which caused complications in her pregnancy. She was diagnosed with a severe urinary tract infection. Her doctor told her to get a Beta HCG (pregnancy hormone) test before starting the treatment. Sameer says her doctor wrote two prescriptions for her: one with antibiotics that are safe to take during pregnancy and the other which can have adverse side-effects during pregnancy.

She had a blood test done at the said lab. After the lab declared her “not pregnant”, she started a week-long course of antibiotic injections. About 16 days later, she had another pregnancy test done but this time from other branch of this lab — which was positive. Sameer consulted a doctor the same day and following some tests was told that she had an ectopic pregnancy, which could cause problems. That night she had to be operated upon to terminate the pregnancy.

When contacted, the director operations of the lab said they had resolved the matter with Mrs Fatima Sameer out of the court. He said there was a minor fault in the machine which has been removed immediately after the complaint was received. He said they were being regulated by Punjab Health Care Commission.“We have received a legal notice from Mr. Muhammad Abdullah Abrar Syed and our lawyer will respond to it,” he said.