Dear Colleagues! This is Asrar Qureshi’s Blog Post #985 for Pharma Veterans. Pharma Veterans Blogs are published by Asrar Qureshi on its dedicated site https://pharmaveterans.com. Please email to aq.pharmaveterans@gmail.com for publishing your contributions here.
Diagnostic labs have become an integral part of medical treatment. Unlike previous times, when few labs did manual testing and the only imaging available was x-ray, the diagnostic facilities have come a long way. Along with this development, the doctors’ dependence on lab tests has increased to the extent where almost 100 percent patients are prescribed multiple tests. While it has improved clinical outcomes, it has also added to the cost of medical treatment hugely.
In this blogpost, I shall explore the status of medical diagnostic labs in Pakistan.
National Laboratory Policy
While researching on this topic, I came across a National Laboratory Policy issued jointly by Ministry of National Health Services Regulations & Coordination along with its institutions National Institute of Health and National Institute of Public Health in December 2017. The policy was drafted in consultation with local stakeholders, and under the guidance of WHO and European Union representatives.
Vision 2025
Pakistan shall have well-organized, sustainable system of quality laboratory services under the One Health concept that are accessible and affordable to all.
- This system to be governed and monitored through implemented and regularly updated policies, plans, rules and regulations.
- Labs are organized in networks and use paperless information and communication systems.
- Up to date pre-service and in-service programs generate well-trained, qualified staff that is dedicated and well-paid. Trained lab managers are competent to manage and lead processes in the labs.
- All labs to be registered and licensed based on defined minimum standards and EQA programs are widely established. Labs are encouraged to pursue accreditation.
Without much research, we can understand that much of this is nowhere near achievement even though we are only four-months away from year 2025.
Pakistan Laboratories Network
German Federal Ministry for Economic Cooperation and Development had previously run the project for ‘Establishment of Pakistan Laboratories Network’ from 2011 to 2013. The objective was to have a sentinel laboratory network for maintaining a central database for the epidemiological surveillance of infectious diseases and providing a platform for a national disease early warning system. The PLN was formed by five major labs as founding members and probably have been collecting and sharing data.
GIZ – Deutsche Gesellschaft für Internationale Zusammenarbeit (GIZ) GmbH is the German organization working in areas of sustainable economic development, governance, climate change, and energy since 1961. They have offices in every province and have a staff of over 350 local and international employees.
Clinical and Diagnostic Laboratories – Present Status
Presence
Although a blog published by roberthook386 picks up five top labs of Pakistan as: NIH – National Institute of Health, Shaukat Khanum, Aga Khan, AFIP – Armed Forces Institute of Pathology, and Chughtai lab, but this selection is certainly unfair. There are many more labs that have been providing services for a long time and have established their reliability.
Previously, labs kept themselves restricted to one center mostly, or opened a few outlets on various locations within the same city, like Karachi. As technology grew and improved, it became possible to have as many collection centers as desired, collect samples and transport to the central lab, and get all tests done there. We, therefore, now see small collection centers of all major labs on every street. In addition, all major labs have a home-sampling facility where the lab person comes and takes the blood samples from the patient himself. Portable digital x-ray machines are available for taking basic x-rays at home. Ultrasound, Echocardiography, CT-scans, MRI, NMR, PET, all kinds of diagnostic imaging is available not far from the patients’ places.
Quality of testing cannot be termed equal in all labs. Most labs are using machines for analytical testing. These machines use specific reagent (chemicals) kits for testing. Two factors which may affect the result are the calibration of machine and the quality of test kit. The complaint that the same test results from various labs show variable readings is not necessarily a fault, it may rather be the difference in the system used and the reference followed.
Quality Management
PNAC – Pakistan National Accreditation Council issues accreditation to quality control labs in pharma industry which is ISO17025. They also accredit clinical labs which is ISO15189. PNAC states that “accreditation of medical labs in accordance with ISO15189 standards is the only means to assure credibility of such labs”.
A slightly older research article about standardization of pathology labs points out certain things which are still relevant.
- A Total Quality Management System with an internationally recognized accreditation process is the only guarantee of a reliable pathology service. However, in a developing country like Pakistan, where most labs are small and without adequate physical and manpower infrastructure, a modified, two-tier plan may have to be tailored for them.
- Accreditation based on ISO15189 should be introduced on voluntary basis. The labs which do not qualify for international standardization may be brought into quality net through a process of registration, and then initiated into a simplified quality management system. They should be provided education and training to become eligible for accreditation.
Laboratory Quality Management System – WHO
WHO published a 271-page handbook for LQMS, which gives detailed guidelines on the topics of:
- Introduction to Quality
- Facilities and safety
- Equipment
- Purchasing and inventory
- Process control – sample management
- Process control – introduction to quality control
- Process control – quality control of quantitative tests
- Process control – quality control for qualitative and semiquantitative procedures
- Assessments – audits
- Assessments – external quality assessment
- Assessments – norms and accreditation
- Personnel
- Customer service
- Occurrence management
- Process improvement
- Documents and records
- Information management
- Organization
The purpose of copying this list here is to show that running a medical lab is not like opening a shop and running business, it must be fully organized and controlled to provide reliable service.
Sum Up
Diagnostic labs and services have become a huge business raking in billions of rupees every month across Pakistan. While major labs which have presence in major cities only are providing reliable services generally, the same cannot be said for the bulk of small to medium labs present across the country in all large and small towns and cities.
Greed is a serious issue as the labs offer kickbacks to doctors who prescribe unnecessary tests to patients. Senior doctors’ reluctance to spend time on the patients to do clinical diagnosis is another issue as they put their entire reliance on tests.
The sum up is that the patients are being robbed and fleeced in every which way. The governments are too busy in political issues and do not pay attention to basic issues people are facing. At best, a policy is issued, committees are formed where bureaucrats along with “elected representatives’ sit and do nothing. It is time to raise awareness and get things improved.
Concluded.
Disclaimers: Pictures in these blogs are taken from free resources at Pexels, Pixabay, Unsplash, and Google. Credit is given where available. If a copyright claim is lodged, we shall remove the picture with appropriate regrets.
For most blogs, I research from several sources which are open to public. Their links are mentioned under references. There is no intention to infringe upon anyone’s copyrights. If, however, it happens unintentionally, I offer my sincere regrets.
References:
https://www.giz.de/en/worldwide/18003.html
https://pubmed.ncbi.nlm.nih.gov/19863917
https://www.pnac.gov.pk/Services/Medical-Laboratories
https://iris.who.int/bitstream/handle/10665/44665/9789241548274_eng.pdf?sequence=1