KARACHI, Jan 30: While medical diagnostic centres have mushroomed across the city, the absence of a central regulatory authority is leading to the issuance of misleading or outright wrong lab reports, Dawn has learnt.
The issuance of these reports, the accuracy of which is critical in order for medical practitioners to make diagnoses, is causing confusion amongst doctors and suffering amongst patients.
Experts say the increase in the number of clinical/pathological laboratories has also led to a corresponding increase in the number of incorrect test reports. They say there is now a dire need for the government to establish a regulatory authority, along the lines of the Sindh Blood Transfusion Authority which manages the province’s blood banks. Such an authority would not only register and monitor diagnostic laboratories, but would also ensure quality control.
At present, patients and their relatives pay large amounts of money to have tests done at these facilities, but there is no guarantee that the reports issued will be accurate.
Incorrect reports common
Take the case of a mother (name withheld on request) in her late 40s, waiting in line at a private hospital in North Nazimabad to get her son’s lab test results for a third time. Two different diagnostic laboratories had earlier issued contradictory reports about his suspected contraction of a dangerous disease.
The new report cleared her son of any dangerous viral diseases, but this mother remained shaken, and asked the staff member at the hospital’s lab if the ‘negative’ result was indeed correct. If it was, she said, she would then get the test redone in the actual name of her son, and not under a false name.
Such complaints are not uncommon in a city estimated to have about 1,300 small, medium and large laboratories run by individuals, the government or private hospitals and universities.
Observers say the efficiency of the labs has deteriorated as doctors find little time to carefully study lab reports. Many of them have also reportedly given up the habit of making complaints.
A 70-year-old citizen from the KDA Officers’ Housing Society reports that a pathology laboratory on Tariq Road is playing with the lives of people by issuing dubious and misleading lab reports for tests carried out there. On two consecutive days in January this year, the laboratory issued pathological reports pertaining to serum creatinine and serum cholesterol that were completely contradictory to each other.
In one of the reports, serum creatinine and serum cholesterol were stated to be 0.6mg/dl and 238mg/dl respectively. The second report stated the levels were 1.2mg/dl and 140mg/dl respectively.
The drastic change in numbers could mean that patients end up taking the wrong medication, a practice which can be fatal.
Secretary and program manager of the Sindh Blood Transfusion Authority Dr Zahid Hasan Ansari said that under the directives of the provincial health minister, he was conducting an enquiry into the case of a pathological laboratory in Hyderabad issuing incorrect results. The lab is accused of issuing a report that was contradicted by another test carried out at the laboratory of a teaching hospital in Karachi under the recommendation of the consulting physician. The Hyderabad report showed serum creatinine at 5mg/dl, while the Karachi lab showed results of 0.4mg/dl.
‘Helpless in absence of laws’
Being the secretary of the SBTA, Dr Ansari said that he received such complaints from time to time, but was helpless in the absence of laws regulating pathology laboratories. He said that the SBTA inspects the pathology laboratories attached to blood banks from time to time, but cannot take any legal action or issue any closure orders in the absence of legislation. Dr Ansari, himself a senior pathologist, said the establishment of a government certification system could lead to a gradual elimination of sub-standard and poorly run laboratories.
Dr Rafiq Khanani, director of the Dow Lab, Dow University of Health Science, said that the incorrect results can be attributed to many factors. He said a lab must be well-equipped with machines and trained personnel, and that samples must be collected properly. He added that all samples need to handled safely and placed in analysers in a timely fashion. Dr Khanani said the quality of the reagents and chemicals used in tests also had a significant effect on the accuracy of results.
He agreed with the contention that the majority of laboratories are failing to maintain quality control systems, and often issue incorrect results.
He said that a two or three per cent error rate is generally considered acceptable at these laboratories, but asserted that at a diagnostic set-up conducting up to 1,200 tests every day, this amounted to 120 erroneous results in 24 hours. He said the matter merits concern and indicates the carelessness of technicians and experts working at the laboratories.
Dr Khanani asserted that very few of the labs in the city had any system of internal or external quality control. He added that the majority of labs rely on part-time technicians, or worse, technicians working on a “trial and error basis”. He said that laboratories try and save face for the incorrect results by alleging that labels on samples were confused.
Dr Khanani urged the government to play its due role in the matter, and asserted that the authorities should make it mandatory for every lab to employ at least one trained technician and a qualified pathologist. He said that if this was not done, the problem of inaccurate reporting will continue to haunt specialists, who largely depend on lab investigations for diagnosis and prognosis.
Forgotten legislation
A source at the provincial health department said that grievances against private hospitals and laboratories in the city were on the rise, as there are currently no legal provisions for the regulation of such institutions. They said the laboratories find themselves answerable to no one for their alleged negligence and wrong-doing.
Sources indicate that the health department was quite close to passing the relevant laws through a government ordinance in mid-2007, but as no one in the present government is committed to the regulatory legislation, it now lies all but forgotten.
The draft legislation, which was developed after a number of meetings between stakeholders and was finally approved by the chief minister of Sindh, envisaged the establishment of an accreditation and licensing authority for regulating private hospitals, clinics, laboratories, physiotherapy centres, pathologists, nursing homes, maternity homes, diagnostic clinics and other health providers, including hakeems, operating in the province.
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