KATHMANDU, March 8: Responding to long-standing complaints from various sectors that most of the medical laboratories in the country are ill-equipped and lack required human resource and quality assurance, the Ministry of Health (MoH) has issued a directive to bring them under a regulatory framework soon.
MoH officials say there is no specific regulatory framework for establishing and operating clinical laboratories, though there are scores of laboratories operating across the country without maintaining even the minimum standard.
“There is no specific regulatory framework to define and set the quality and standards of clinical laboratories,” Anil Pratap Adhikari, a member of the policy making team at the secretariat of Health Minister Gagan Thapa, said, adding, “The cabinet has already approved the directive formulated by the ministry to regulate the medical laboratories.”
The directive has categorized medical laboratories into five levels - A, B, C, D and E. The national public health laboratory will be under category A and laboratories of big hospitals and medical colleges under category B while the labs of health posts will be of E category as per the directive.
The directive has classified the laboratories as public health laboratories, hospital-based laboratories, standalone laboratories, research laboratories, referral laboratories and reference laboratories. “Now onward, all clinical laboratories need to have qualified human resource, necessary equipment and reliable quality reports of the tests,” said Adhikari.
According to the directive, the medical laboratories need to be well ventilated, supplied with uninterrupted power, have sterilization facility and adequate water supply, efficient and quality operations, proper waste management facility, proper storage of samples, proper data management system, quality reagents and kits, logical work division and should be easily accessible. Similarly, they should have adequate number of experts, technicians and other staff.
“The National Public Health Laboratory will soon issue a notice to all labs to get registered and under regulation,” said Adhikari.
The National Public Health Laboratory (NPHL), which is believed to be a more reliable pathology lab in the country, is also the government's national reference laboratory under the Department of Health Services (DoHS) and the MoH. It is directly linked with different levels of 277 government laboratories across the country.
NPHL was established in 1968 as the Central Health Laboratory. Its name was changed to NPHL in 1991.