John Ledek, Worldwide President – BD LifeSciences – Preanalytical Systems, highlights the importance of a fortified laboratory system for prevention and treatment of infectious diseases and better patient care
In 2011, India achieved the status of full adherence to Good Laboratory Practices (GLP) certified by the Organisation of Economic Co-operation and Development (OECD). GLP is a quality system, which has been evolved by the member countries of OECD, concerned with the organisational process and conditions under which non-clinical health and environmental safety studies on the above-said chemicals are planned, performed, monitored, recorded, reported and archived. This system helps to ensure the quality and integrity of safety data (on chemicals) produced by test facilities.
The need for developing a strong laboratory system is crucial to supporting prevention and treatment of infectious diseases. There are over 50,000 clinical laboratories in India and the number is increasing every year. Various studies have indicated that nearly 68 per cent of all errors in laboratory testing are associated with the pre-analytical phase – phlebotomy (blood collection) being a major component of this phase. There is immense potential to enhance the skills of laboratory technicians in line with the growing healthcare needs of the Indian population.
Clinical laboratories, like other parts of the healthcare system, are striving to provide high-quality servi ces in the face of ever-shrinking resources and increasing regulatory demands. Lab directors and managers see pre-analytical phase of laboratory testing as a critical area for improvement that can drive not only better patient care and satisfaction, but also productivity gains and cost savings.
Quality in laboratories is very important today in this era of evidence based medicine. Quality encompasses the entire process from the time of sample collection that is pre-examination or pre-analytical phase, the testing phase also known as the examination phase and the post analytical phase. The pre-examination phase is the most important in the entire testing process and this must be addressed well. The sample collection, labelling, transport, all need to be understood well.
While quality, effectiveness and impact on outcomes continue to emerge as value-added services for the laboratories, a comprehensive quality control programme, along with pre-analytical awareness and training can prove to be valuable tools to improve specimen quality and subsequently patient care.
Pre-analytical errors can contribute to costs by impacting quality of patient care (erroneous medical diagnosis, and delayed results), safety (needle-stick injuries to patients or staff), time (increased turnaround times and repeat sample collections), resources and budget (staff and equipment) and reputation (with patients and fellow colleagues).
Becton, Dickinson & Co (BD) has committed to drive high-quality practices that improve patient safety in India through several initiatives. For example, BD in support with national and international labs has started the Centre of Excellence in Phlebotomy (blood collection, sampling). This landmark initiative will provide certified phlebotomy courses to healthcare professionals, laboratory technicians, assistants and nurses, and support them in driving best practices in pre-analytical processes for accurate and reliable diagnosis. BD also conducts workshops on phlebotomy based on good laboratory practices that are endorsed by the Association of Clinical Biochemists of India (ACBI), an organisation that is at the forefront of constantly improving practices in laboratory medicine.
With the bilateral support of the US Centers for Disease Control and Prevention (CDC) and Ministry of Health and Family Welfare, BD implements the Labs for Life which is a partnership project for improving quality of laboratory services, building sustainable laboratory systems, and strengthening country owned institutions within the public health sector. Technical partnerships with international agencies have enormous potential to improve health systems. It also presents an opportunity for collaborations on common goals, with an opportunity for tapping the strengths, methodology, and resources of various expertises in the field to foster sustainability.
The Objectives of the Project are to enhance capacity for diagnosis of communicable and non-communicable diseases in India, help in improving the quality services of identified labs from the baseline assessment by at least two additional stars/grades/levels as measured by the checklist, strengthen specimen referral mechanisms and linkages between various levels of facilities and ensure sustainability of interventions through local, state-level and country ownership.
The geographic focus for the collaborative activities will include seven states (Rajasthan, Gujarat, Maharashtra, Andhra Pradesh, Telangana, Assam and West Bengal) covering the five regions-North, West, East, North East and South. The programme will seek to identify innovative practices to support integrated laboratory services that can be leveraged across co-morbidities of persons living with HIV/ AIDS. BD is conducting baseline assessment that will present as a gap analysis for lab quality system strengthening efforts, identify facility-specific challenges and systemic areas of need that must be prioritised and addressed.
Patient safety in today’s scenario is a shared responsibility. Stakeholders in safe lab practices must ensure laboratories are safe because neglecting safety can be costly. This can not only risk lives and health of patients but also jeopardise the reputation of the entire nation.
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