NKTI Medical Laboratory gets first ISO 15189:2007 accreditation in RP

MANILA, Philippines - On March 27, 2009, the National Kidney and Transplant Institute (NKTI) Medical Laboratory made a significant milestone in the history of diagnostic medicine in the country as it launched the first total laboratory automation with an integrated laboratory information system in the Philippines.

It was another landmark in Philippine health care history last Jan. 18 when the NKTI Medical Laboratory was formally awarded its ISO 15189 accreditation by the Philippine Accreditation Office (PAO) of the Department of Trade and Industry (DTI).

The certificates of accreditation were awarded by Undersecretary Zenaida Maglaya of the Department of Trade and Industry and Cirila Botor, PAO officer-in-charge, and were received by Dr. Januario Veloso, chairman of the NKTI Medical Laboratory; Dr. Arnold Fernandez, laboratory quality manager; Dr. Ivy Rosales, laboratory quality officer; and Romeo Dy, laboratory technical manager.

The NKTI Medical Laboratory is the first and only clinical laboratory in the Philippines to be accredited for ISO 15189:2007. Specifically, a total of 51 laboratory tests in 10 different sections have been accredited.

The NKTI Medical Laboratory’s ISO 15189 accreditation is an addition to the NKTI’s being the first Philippine tertiary government hospital to be ISO 9001 certified since 2002.

The NKTI has again proven its steadfast pursuit of providing high-quality and world-class medical health care to the Filipino people.

ISO 15189 is the international standard particular to medical laboratories that specifies the requirements for quality management system and technical competence.

The ISO 15189 accreditation not only ensures the capacity of the medical laboratory to deliver accurate and reliable test results to their patients and medical consumers but also takes into account the competence, continuing education and training of the laboratory personnel who administer and perform the tests. With the accreditation, both patient and health care provider reap benefits.

Medical laboratories are considered as key partners in patient care. Diagnosis, prognosis and treatment are often based on results and interpretation of laboratory results. Inaccurate results lead to wrong diagnoses, inappropriate treatment and prolonged illness or death. Therefore, it is evident that the quality of laboratory services is a major factor which directly affects the quality of health care. 

Quality in the context of the laboratory is having the right test result at the right time, on the right specimen, from the right patient, with result interpretation based on the correct reference data and at the right price. 

These are what ISO 15189 accreditation ultimately aims to deliver to the end user — the patient. Even without adequate technical knowledge to determine which laboratory offers quality services, the public is empowered by ISO 15189 accreditation to make the right choice because the ISO seal is a stamp of excellence that is well-recognized worldwide. Patients are given assurance of getting their money’s worth.

On a nationwide level, ISO 15189 accreditation can have a political impact, too.

Government bodies and regulators are constantly called upon to make decisions and laws related to protecting the health and welfare of the public. Such organizations must have confidence in the data generated by laboratories in order to make these decisions and regulations.

Using an accredited laboratory can help establish and assure this confidence because an ISO 15189 accredited laboratory is capable of producing data that are accurate, traceable and reproducible — critical components in governmental decision-making.

Because of internationally acceptable testing and measurement practices, the services and data generated by an ISO 15189 accredited laboratory such as the NKTI Medical Laboratory would be more readily acknowledged worldwide.

The laboratory can now function as a referral laboratory beyond its borders. This accreditation can also help enhance medical tourism in the country by bringing forth confidence in the laboratory’s services. Local medical research supported by its laboratory data will likewise gain respect and recognition globally, not to mention garner enticing grants for future studies.

In her message during the awarding of the ISO 15189 accreditation to NKTI, Maglaya emphasized two points why the government actively pursues medical laboratory accreditation in the country. First is to fulfil the “desire to improve the delivery of medical services and second, to promote the Philippines as a medical tourism destination.”

The second point was highlighted by Dr. Enrique Ona, NKTI executive director, as he mentioned that being ISO 15189 accredited can “open the doors to trade and economic growth for the country as services and data generated would be more readily accepted worldwide.”

The benefits of ISO 15189 are clearly numerous and far-reaching. With this, the DTI is optimistic that more medical laboratories will follow suit, and that together with NKTI as the first clinical laboratory to be accredited, they can promote the benefits of accreditation to stakeholders, encouraging other medical laboratories to apply for accreditation, Maglaya said.

The success of NKTI in achieving ISO 15189 accreditation for its laboratory is proof that the Philippines is capable of upgrading and meeting international standards of quality. The quest for quality health care in the country begins and continuous to flourish with NKTI.

ISO 15189:2007 is the universal seal of quality that has a profound influence on things that deserve to be taken seriously — safety, reliability and efficiency in the clinical laboratory. For the NKTI Medical Laboratory, being the first to obtain ISO 15189:2007 accreditation in the Philippines, affirms its commitment to the highest standards of quality and service, catapulting it into the pinnacle of laboratory practice in the country.