Private pathology labs, a labyrinthian alley

Despite the negligence of the private lab, there has been no move from the state government to regulate such labs.

KOCHI: Never in her wildest dreams would Rajani, 38, have thought of the trauma she would undergo because of a misdiagnosis. Undergoing chemotherapy is a very draining process, both emotionally and physically, even for those who are diagnosed with cancer. So, one will be able to imagine the pain Rajani had gone through. 

A tru-cut biopsy test conducted at a private lab, which incorrectly reported a small area of malignancy on her breast, made her undergo chemotherapy at the Government Medical College Hospital, Kottayam. Despite the negligence of the private lab, there has been no move from the state government to regulate such labs. 

Why do private labs gain such momentum in our state?
The massive crowd of patients at laboratories in General Hospitals and Government Medical Colleges forces people to resort to private labs. The large inflow of patients to the Government Medical Colleges at Thiruvananthapuram, Alappuzha, Kottayam, Ernakulam and Kozhikode is a matter of serious concern.

According to Dr Sanil Kumar, MS General Surgery, people are, in reality, literally forced to rely on private labs as all of them will not be able to get timely lab reports from Government Hospitals. “The major attraction for people is the cheaper rates the government offers at the Medical Colleges and Hospitals. Those who can afford treatment at private hospitals will rely on clinical labs outside for results. Such results must be double-checked with the doctor treating the patient, before starting corrective medical procedures,” said Dr Sanil Kumar. 

Sometimes, patients have to wait for over four to five months to get an appointment for MRI and CT scans at Government Hospitals, and not many can afford such delays due to medical emergencies.

Rules and regulations 
As per the vice chairman of Clinical Laboratory Professionals Association (CLPA) Fathima Faswin, a series of norms and regulations is required to be fulfilled to get the final approval for a clinical lab. 
Area for the land must be obtained from the panchayat, certification of the health officer from primary health centres, pollution control certificate and Indian Medical Association Goes Eco-friendly (IMAGE) and biomedical waste management certificate, an initiative by the Indian Medical Association, must be obtained before starting a lab.  “Separate sample collection area for blood, urine and sputum must be demarcated for a lab before it is granted approval. 

Qualified lab technicians with Diploma in Medical Laboratory Technology (D-MLT), Bachelor of Science (Bsc) MLT and Master of Science (Msc) MLT are required in all approved labs. IMAGE has set certain guidelines to be followed in order to dispose of the hazardous waste generated from the labs. If any lab lacks technicians with proper qualification, the approval can be cancelled,” said Fathima.  Meanwhile, for pathology labs functioning in the state, there must be a clinical pathologist, who certifies the final report of the test results. According to sources, in most of the clinical labs in the state, trainees and postgraduate students are carrying out the tests and results are prepared accordingly.
Government just mute spectator?

Though the incidents of suspected medical negligence cases have been reported earlier, only a few cases have been proved as attributable to medical negligence. According to a forensic surgeon, it is very difficult to prove medical negligence as resulting in the death of a person. However, medical negligence resulting in wrong diagnosis must be acted against by the Ministry of Health.

“In the particular case of Rajani, the lapse from the doctor treating her is very evident and the government is trying to get away from the responsibility by blaming the private lab. In private labs, the test results vary from one to another and it is up to the expertise of the doctor to proceed with the further treatment,” said a senior surgeon of the Government Medical College Hospital, Kalamassery.

Meanwhile, Minister for Health K K Shailaja said the case reported at Government Medical College, Kottayam, is very unfortunate and a detailed report has been sought from the hospital authorities. “We are awaiting the reports, and if medical negligence is revealed, we will take serious action against the doctor. Meanwhile, a regulation on the private labs functioning in the state is a time-consuming task. We will take up the matter with the state government while implementing the Kerala Clinical Establishment Act,” said Shailaja.

Alarming facts 

  • 93 per cent or a total of 3,887 private medical laboratories in the state have no accreditation/certification from any of the agencies.
  • 26 per cent or 1,080 private medical laboratories in the state do not perform any internal/external quality checking of the working capacity of the equipment and the quality of the tests.
  • Only 9 per cent or 389 private medical laboratories use 
  • bio-safety cabinets.
  • Only 5 per cent or 203 private medical laboratories in  the state are equipped with 

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