Government bodies and regulators are constantly called upon to make decisions related to protecting the health and welfare of consumers and the public, protecting the environment, developing new regulations and requirements, measuring compliance with regulatory and legal requirements, and allocating resources, both technical and financial. Regulators tap laboratories in carrying out testing, inspection, measurement or calibration. Obtaining data and test results from accredited laboratories gives them the confidence in making informed decisions about these public policies.
Have you ever experienced having a wrong laboratory test result given to you? If it happens, the consequences can be daunting like incorrect medical diagnosis and management; missed job
opportunities or even the anxiety and stress of worrying over a dreadful disease. The possibility of such a costly mistake is ever present with the proliferation of laboratories which are not competent to carry out and deliver accurate test results.
Medical laboratory services are essential in the diagnosis and assessment of the patient’s health. Their services encompass arrangements for requisition, patient preparation, and patient identification, collection of samples, transportation, storage, processing and examination of clinical samples, together with subsequent result validation, interpretation, reporting and advice. It is vital that medical laboratories are able to effectively meet the needs of patients as well as the clinical personnel. But how can one be assured that the medical testing laboratory is competent and can deliver reliable test results; that it can provide safe health and social care for patients and its staff; and that it has in place measures to prevent misdiagnosis and handle patients’ confidential information?
The Philippine Accreditation Bureau of the Department of Trade and Industry (DTI-PAB) provides accreditation services to ISO 15189, an internationally recognised standard that contains the
requirements necessary for diagnostic laboratories to demonstrate the quality and reliability of medical testing services and medical testing laboratories.
ISO 15189 covers the essential elements for medical laboratories to demonstrate the quality and competence of their services, as well as to consistently deliver technically valid test or uexamination” results as they are known in the standard. The standard, which has been developed with strong involvement from the medical, scientific and clinical community, is used as a guide by medical laboratories in developing their management systems and maintaining their competence; and by accreditation bodies globally to confirm the competence of these laboratories through accreditation.
Accreditation is the process in which an authoritative body formally recognizes the competence, impartiality, and capability of an organization to carry out specific activities, such as certification, testing, calibration and inspection. Accreditation against the global standard ISO 15189, allows medical laboratories to demonstrate, through a rigorous process, the technical competence of that laboratory to all stakeholders including health care providers.
In the Philippines, the DTI-PAB is the national accreditation body that handles the accreditation of inspection bodies, certification bodies, calibration and testing laboratories including medical testing laboratories, and other bodies offering conformity assessment services.
As of July 31 , 2016, the DTI-PAB has accredited six medical testing laboratories to ISO 15189. For more information, please contact DTI-PAB at +632 751.4707 or e-mail at pab@dti.gov.ph
Source: www.ilac.org