Unmanaged laboratories, unhealthy practices

Loopholes in policy encourages black marketers to play foul with public health


A resident of Kalanki, Krishna Devi-63 (name changed) recently lost her life due to the wrong prognosis of her blood report. She was suffering from heart ailment. Doctors from Ganga Lal Hospital sent her home after two months of treatment. The doctors had strictly instructed her family members to conduct regular blood tests. Residing in Kalanki itself, her blood was regularly sent to a nearby polyclinic for diagnosis and the blood reports clearly showed that the level of sugar and haemoglobin both were normal. But suddenly her health deteriorated and she was rushed to the hospital only to find that her haemoglobin level was far too less than normal. She was shifted to the ICU but it was too late.

Likewise, Manju Dangol (name changed) a patient from Patan, diagnosed with chest infection, was asked to have culture of sputum. She did the culture from Mediquest Laboratory at Pulchowk. In the report, she was diagnosed with Pseudomonas virus, a rare virus found in human body. Her doctor asked her to get admitted in the hospital soon after studying the report as the virus was resistant to oral antibiotics. Being skeptical about the report, she then consulted with doctors from Patan Hospital, Norvic Hospital and Grande Hospital. There she was told that she had already recovered from the chest infection. The virus showed in the report was due to the negligence of the laboratory; the sputum was infected in the laboratoryitself.

These are just a few examples. Due to wrong reports provided bypathology laboratories, many people receive wrong diagnosis and medicines, leading to untimely death.

Heights of Carelessness

Unskilled manpower, use of low quality equipment and reagent and not maintaining the temperature are major reasons that lead to wrong reports. Furthermore, haphazardly opened pathology laboratory, not following minimum standards, loopholes in policy, weak monitoring and enforcement and unhealthy competition among laboratory further encourage such foul play with public health.

“Laboratory reports play a vital role in terms of determining the cause of a patient’s ailment and severity of the disease. Wrong reports can be dangerous as doctors prescribe medicines according to the report,” said Dr Anjani Kumar Jha, President of National Medical Association. He also said, “Not only does the patient suffer from substandard laboratory reports but the laboratories not following the basic standard can be dangerous for operators as well.”

Agreeing that various issues of wrong reports from laboratories have come up in recent times, Jha said, “Unskilled manpower is one of the main reasons for incorrect report.” He elaborated, “The government has not defined specifications for who should conduct which tests. In polyclinics and labs, a lab assistant who may be unqualified handles all the tests.” He further said that the government should come up with proper guidelines clearly stating the qualifications required to conduct a particular test. “In Nepal, MBBS doctors and lab assistants trained for 15 months or so work on the same tests without restriction,” he added.

Agreeing with him, Chintamani Sharma, Laboratory Chief at National Reference Laboratory (NRL) said, “Ambiance, equipment selection, quality of reagent, temperature, lighting and human resource play equally important roles in maintaining the quality of any laboratory report.”

Citing that the quality of reagent determines the quality of the tests, Sharma said, “Quality reagent is important for a reliable test. It has to be stored in between the temperature of two to eight degree Celsius constantly. But many laboratories neglect the handling of reagent and use low quality product leading to incorrect results.” Pointing that the government’s monitoring mechanism is not functional and therefore, ineffective, he said, “There should be strict quality control but the government doesn’t bother to even go and monitor the laboratories that directly affect people’s health.”

Loopholes in policy

According to National Public Health Laboratory (NPHL), there are altogether 1,500 registered laboratories across the country. However, NPHL, the authorised body to inspect quality of pathology laboratories are unaware about the number of unregistered illegal laboratories across the country.

“The chaotic situation of laboratories is the outcome of the government’s negligence,” said Kishor Kumar Khanal, Managing Director at NRL. “The government has set a minimum standard to follow but due to lack of proper monitoring the rule is violated easily and frequently,” he added. He is of the opinion that the government should conduct proper and periodic monitoring, have proper database, categorise the laboratory as per their services and should seal the laboratory if found in violation of the minimum standard.

According to him, there is no specific licensing and grading system to service providers provided by the Public Health Office. While asked about illegal laboratories, Dr Geeta Shakya, Director of NPHL, said, “NPHL is responsible to recommend and monitor the quality check of polyclinic, diagnostic centres and pathology laboratories. However, we don’t have the right to punish such illegal entities.”

To control such illegal and haphazardly opened laboratories, she said, “We need proper guidelines, policies and act to regulate laboratories.” According to her, they have already submitted the draft of Guidelines of Laboratories to the Cabinet and are waiting for its approval.

About quality control, Dr Shakya said, “Accuracy detention is crucial for quality checking and maintenance but we don’t have any guidelines. We are planning to make accuracy detention with the ownership of the Department of Industry that includes quality testing of products, equipment and laboratory.”

Stating that the situation of mushrooming illegal pathology laboratories is just an outcome of impractical policy introduced in 2073, she said, “We are not given much authority and the existing policy is entangled and cumbersome for service providers. They operate services without obliging by the rules enjoying the loopholes in the policy.”

At present, laboratories get registered at the Office of the Company Registrar or the Small and Cottage Industries Development Centre under the Ministry of Industry. The Ministry of Health and Population (MoHP) has given the responsibility of registration and renewing of pathology laboratories and medical diagnostic centres to the Regional Health Directorate based on the recommendation from NPHL and District Public Health Office (DPHO). However, no one bothers to renew their laboratory as the policy has not made it mandatory.

The MoHP formulated Minimum Laboratory Standard (MLS) to be followed in 2061. The MLS states that the minimum area for any laboratory to be set up should be 300 sq ft. There should be refrigeration facility to store reagent and other necessary medication, power back up system, allocated standard of incubator and reagent with minimum staff qualification to operate laboratories among others. However, NPHL said that 50 per cent of registered laboratories are operating below the standard and non registered laboratories are beyond the government’s eyes.

Dr Shakya said, “In our monitoring report of 2071/72 fiscal year, we found that only 50 per cent laboratories are following the basic standards while 25 per cent needs to upgrade their standard whereas remaining 25 per cent has not been following any norm.”

The government has no demarcation of certification to know the difference between registered and non-registered pathology laboratories. She said, “Until the parliament approves the proposal of Public Health Act and Guideline of Laboratories, we can’t do anything to control the situation.”

Non-operating legal provisions

Advocate Ram Chandra Simkhada said that the government is indifferent to increasing cases of sufferers from substandard reports of the laboratories. He informed that there are plenty of acts that protect the right to health. “If anyone suffers due to a wrong report from any pathology laboratory, one can file the case against the laboratory and the person performing the test as per Consumers Protection Act.”

The provisions in the Muluki Ain 2064 related to ‘cheating’ states that with or without carrying out any test, if a pathology laboratory provides wrong prognoses, both the laboratory and the person performing the tests are made to compensate for the fees paid by the service seekers and are fined up to Rs 5,000 as well as sentenced to imprisonment for five years.

The Consumers Protection Act 2054, Section 18 (D) provisions fines up to Rs 500,000 and five years of imprisonment to violating individuals and institutions that provide false services or counselling by taking fees or charges. He informed that there are plenty of acts that protect the rights of consumers for quality service such as Law Against Black Marketing and Social Act 2032, Competition Management and Market Protection Act 2063 and Consumers Protection Act 2054. If a service provider is found guilty of false services s/he can be asked to compensate to sufferers along with Rs 50,000 penalty plus five years of jail sentence and also up to Rs 500,000 penalty with lifelong imprisonment.

“Unhealthy competition, weak monitoring system, turning service business into commercial business, use of low quality material and unskilled manpower are reasons behind the increase in black marketing,” said Simkhada, who was also the immediate past secretary of Forum for Protection of Consumer Rights. According to him, the government should take sole responsibility to crack down on such malpractices. The Department of Quality Control, DPHO and NPHL should conduct regular market surveillance.

On this, Dr Senendra Raj Upreti, Secretary for MoHP, said, “We don’t have enough policies to crack down on existing illegal laboratories. We cannot restrict such illegal laboratories and diagnostic centres. We can only instruct service providers to abide by the law and MLS.” Citing that pathology laboratories and medical diagnostic centres began mushrooming after 2057, he said, “Earlier while drafting the policy, policy makers failed to take into account the growth of private sector at such a rapid pace. Now we are working on the policy level to manage this situation better.”

“We need proper guidelines, policies and act to regulate laboratories”

 Dr Geeta Shakya, Director of NPHL