As machines take over in some labs, the rest operate without any checks

There is no law or author­ity to make sure labora­tories are follow­ing standa­rds.

KARACHI:

As the Aga Khan University Hospital moves towards advancing its system of clinical technology the lack of any law or authority to govern laboratories in the country casts a dark and dangerous shadow over the credibility of crucial diagnostic tests — a vital prerequisite for life-saving treatments.

According to the director for clinical laboratories at AKUH, Dr Farooq Ghani, at least 70 per cent of healthcare decisions are based on laboratory tests, specialised and routine. Thus, there is no question about lab tests being an integral part of the healthcare system. In order to reduce human error and significantly increase time efficiency, AKUH launched Pakistan’s first automated laboratory system on Thursday.

“Our biggest challenge was how to quickly turn around tests,” he said at the launch outside the Soparivala building at AKUH. Ghani says the new system will increase time efficiency by at least 60 per cent. The automated system cost around $5 million and is programmed to run 107 tests. The machine has a capacity for 800 tests per hour, making it possible to do between eight to 10 million clinical chemistry tests annually. AKUH says there will be no extra charges for tests run on the new system.

But without a government body to ensure quality control, basically all of the laboratories in the country solely rely on following proper procedures and protocols for credibility. It is estimated there are at least 4,000 laboratories, diagnostic and academic, in Karachi and over a half a million countrywide. “There are more laboratories than there are pathologists in the country,” wryly remarked consultant haematologist at the National Institute if Blood Diseases (NIBD), Dr Tahir Shamsi.

With the department of health now in the hands of the provincial governments, it is thus up to Sindh to pursue the issue. “Right now we do not have any [way or law] to regulate and monitor laboratories,” confirmed Special Secretary for Health in Sindh Dr Suresh Kumar. “But we are in the process of tabling a bill.” When asked when one could expect such a bill to be tabled, the special secretary said “soon”.

But until ‘soon’ arrives, many people are largely unaware of the dangerous hands they put their lives in. Take the case of Khalid Mahmood Khuhro, who was prescribed the urine microalbumin test by his doctor at one of the leading private hospitals in the city. When the results came in Khuhro was horrified to see the inflated levels on the chart. They showed a level of 473mg/L whereas the reference range was less than 19 mg/L.

On the advice of his doctor, he undertook another test from Sindhlab, and this time his results were totally different, 72.7mg/L, and were within the normal range. “I was shocked,” Khuhro told The Express Tribune. “I was not at some roadside laboratory. This is one of the premier medical institutions of the country we are talking about.” Experts estimate the margin for human error is 0.1 per cent.

With laboratories mushrooming across the country, ensuring accuracy of tests is becoming an uphill task says the head of pathology at the College of Physicians and Surgeons of Pakistan (CPSP) and recently elected president of the Pathologists Association of Pakistan (PAP), Dr Aley Hasan Zaidi.

More horrifying are reports of many instances in which reports of results are being delivered without tests actually being conducted. “There were, and still are, some [lab] technicians providing results using their ‘so-called experience’ instead of actually conducting the tests,” Zaidi said. One example is of technicians shaking blood-filled test tubes to estimate the haemoglobin level without actually running the test through proper clinical protocols and procedures. “This is criminal on the part of technicians and if a doctor is involved in any way they are one too,” Zaidi said.

The head of pathology at the Sindh Institute of Urology and Transplantation, Prof. Mirza Naqi Zafar, explains how the efficacy of a test is compromised. “In many of small labs you have no qualified doctor or pathologist. The whole operation runs on lab technicians, most with questionable credentials,” he said. “One technician in the morning shift may be responsible for drawing the blood for the test but the other technician who is able to conduct the test doesn’t come in till evening.”

This is especially dangerous even more so for certain tests which require samples to be analysed within a limited time frame. “Blood, for example, has specified properties and characteristics that may be lost if the test is not conducted within the set time,” Zaidi explains. At least a 20 per cent difference is possible in such cases, Zafar adds.

But if unsafe practices are common, how is the number of labs growing? “It is because we have some black sheep among us,” Zaidi says. “Corruption has not spared the medical fraternity. Some doctors get a cut when they refer patients to certain labs to run tests.”

With a lack of a local body many major laboratories have opted for foreign accreditation. The head of pathology for the Shaukat Khanum Memorial Cancer Hospital, Dr Asif Loya, says they follow guidelines and protocols set by the College of American Pathologists (CAP) for their laboratory tests. This helps the hospital follow standardised measurement tools and pre-defined values for different tests as well as benchmarks for temperature controls and durations, he explains.

ISO certification is also an option. Many labs have registered with them but NIBD’s Shamsi says while the certification is “good” to have, ISO is not a monitoring body and therefore it is not the same thing as following lab protocols. Like Shaukat Khanum, AKUH and Ziauddin Hospital are also registered with CAP while NIBD opted for accreditation from Randox in the US and Neqas in the UK.  CPSP’s Zaidi says if the government showed an interest, PAP was willing to restart its initiative to register all laboratories and monitor their practices.

Published in The Express Tribune, January 20^th, 2012.