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It has been 13 years since World Health Organization (WHO) has come out with guidelines on the safe transport of infectious substances and diagnostic specimens, but the government of India is yet to adopt it. The lack of guidelines has serious bearing on safe transport of patients' samples from one laboratory to another thus affecting their quality.
Poor quality samples often result in inaccurate laboratory diagnosis thus impacting treatment outcome. It defies the purpose of the government to expand access to quality health for a sizable population through Ayushman Bharat health protection scheme.
In 2005 WHO had come out with guidelines for the safe transport of infectious substances and diagnostic specimens which provide practical guidance to facilitate compliance with current international regulations for the transport of infectious substances and patient specimens by all modes of transport, both nationally and internationally as improper sample transport has a direct bearing on patient test result which ultimately affects a medical decision by a doctor in treatment of a patient, said Dr Rohit Jain, founder member of Forum of Practising Pathologists.
The guidelines say the diagnostic specimen such as excreta, blood and its components, tissue and tissue fluids, obtained from patients with suspected infectious diseases, must be packaged, labeled and transported as an infectious substance as it has an infectious agent. In case of transport mishap, this could expose a carrier to an infection. Thus, the packaging of infectious materials for transport should be designed to minimize the potential for damage during transport. In addition, the packaging will serve to ensure the integrity of the materials and timely processing of specimens.
It recommends a triple packaging system: a sealed bag containing the specimen vial should be wrapped in absorbent material, placed in a watertight and leakproof second container, and then placed in a rigid, outer shipping package. Each sample and each level of packaging must be well-labeled.
The international regulations for the transport of infectious materials by any mode of transport are based upon the recommendations of the United Nations Committee of Experts on the Transport of Dangerous Goods. The Universal Postal Union (UPU) reflects these recommendations in its regulations, particularly for packaging. The International Civil Aviation Organization (ICAO) and the International Air Transport Association (IATA) have also incorporated the UN recommendations in their respective regulations, as have other international transport organizations. WHO serves in an advisory capacity to these bodies.
Dr Jain had filed a RTI with Union health and family welfare ministry seeking guidelines on sample transportation from a medical diagnostic laboratory in a village/town/city to a medium/advanced medical diagnostic laboratory in another city/same city/higher centre.
The health ministry in response to his RTI on August 2, 2018 stated that there is no such information available about the guidelines on sample transportation from one lab to another.
Dr Jain said the result of any laboratory examination is only as good as the sample received in the laboratory. Managing sample transport in accordance with global best practices is essential to accurate laboratory diagnosis. It influences laboratory efficiency, therapeutic decisions and directly affects patient care and outcome. In absence of the government guidelines, its responsibility of a laboratory to train its staff in sample collection and transport procedures to ensure that sample is protected against temperature variation and is adhered to transport time and packaging and preservation norms as per WHO guidelines, he opined.
Talking about best practices adopted by SRL Diagnostics to ensure safe transport of diagnostic specimen, its senior consultant pathologist in South Delhi, Dr Anu Kundra said “We follow WHO guidelines for transportation of patients' specimen from their doorstep or collection centres to our lab which ensures quality and integrity of samples. We have lab specific SoPs defining parameters for sample specific temperature control during transportation. We refrigerators with re-calibrated thermometer to maintain temperature log-sheet. To ensure integrity, samples are transported in leak proof containers under frozen condition.”
We have a separate logistic department which adheres to international guidelines on sample transportation, said Dr Kundra.
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