ISO 15189

Laboratory medicine is constantly evolving, not only with diagnostic innovations but also in adapting practices that reflect the constant need for quality in both the local and international environment.

The laboratory does not lag in these business developments and to be accredited with technical competence and quality management standards that are globally recognized is a noble step towards improving patient care.

Overview and Purpose
The International Standardization Organization (ISO) is the world’s largest developer and publisher of International Standards. The ISO provides the standards for business, government and society. It is a network of the national standards institutes of 163 countries, one member per country, with a Central Secretariat in Geneva, Switzerland, that coordinates the system.

ISO is a non-governmental organization that forms a bridge between the public and private sectors. Therefore, the ISO enables a consensus to be reached on solutions that meet both the requirements of business and the broader needs of society.1

ISO was born from the union of two organizations–the International Federation of the National Standardizing Associations (ISA), established in New York in 1926; and the United Nations Standards Coordinating Committee (UNSCC), established in 1944.1

The ISO was established in 1947 and has since then published more than 18,500 international standards. Most of the earlier standards have been in business, where many of its member institutes are part of the governmental structure of their countries, or are mandated by their government. Other members have their roots uniquely in the private sector, having been set up by national partnerships of industry associations. 1

The work of the ISO stems from international agreements and are published as international standards. Medical laboratories now have the opportunity to comply with these published international standards and obtain recognition for quality of their products and services.

Laboratory medicine has embraced this challenge with the clinical side being in the forefront of the program. Cytology will always be a close follower. With the increasing scope of molecular diagnostics and automation, this will definitely bring cytology to another level of service quality.

As laboratory practitioners, we have to remember ISO accreditation is in addition to and not a replacement for the Clinical Laboratory Improvement Amendments (CLIA) requirements.

Demonstration of Competence
ISO 15189 was first published in 2003 (and later withdrawn and revised in 2007) and is commonly referred to as ISO 151898:2007. It specifies requirements for quality and competence particular to medical laboratories.

It is to be used by medical laboratories in developing their quality management systems and assessing their own competence, and to be used by accreditation bodies in confirming or recognizing the competence of medical laboratories.

As the standard is about competence, accreditation is the formal recognition of a demonstration of that competence. Unique to CLIA’s approach to accreditation using peer review, ISO 15189 accreditation is to be carried out by a third party organization, and not by the peers (first party) nor by the patients (second party); thus being independent of those parties involved.

Not to be confused with and earlier laboratory-related standard published in 1999, ISO 17025 is the main standard used by testing and calibration laboratories. While it is an excellent standard for research and industrial laboratories, ISO 17025 does not fully address the needs of the medical laboratory. To provide an appropriate process to measure both technical competence and quality management, ISO 15189 was proposed and published. ISO 15189 is actually based upon ISO 17025 as well as ISO 9001.

Practical Applications
Standards ensure the characteristics of products and services we want and expect are met: these include laboratory results that reflect quality, environmental friendliness, safety, reliability, efficiency and interchangeability–all at an economical cost.

When products and services meet our expectations, we tend to take this for granted and be unaware of the role of standards. However, when standards are absent, we soon notice. We soon care when products turn out to be of poor quality, do not fit, are incompatible with equipment that we already have, are unreliable or dangerous.1

To meet the growing interest of recognition, the College of American Pathologists (CAP) initiated ISO 15189 accreditation in 2008.

ISO 15189 and Cytology
As more laboratories strive for accreditation, one may not help but wonder how this may influence the regulations and quality assurance practices already in place.

We already have the guidelines and oversight from CLIA ’88. These standards will not be replaced but rather supplemented by ISO 15189. With our current strict and thorough national standards, it is assuring to expect laboratories will meet these international requirements. However, we do have to understand that the third party will always have the discretion of implementing more stringent guidelines as it deems necessary.

Accreditation to ISO 15189 is voluntary, but the benefit for the profession and the services offered to patient care are paramount. Could international standards mean international business? Possibly, if construed in its literal definition. Can laboratory work be subjected to international testing practices? Again possibly, with considerations of digital imaging and remote access technology.

Aside from meeting international standards of quality and competence, business interaction among the countries that recognize the accreditation is a natural development that is made possible. It is speculative, but whenever the need arises and economic practicality is met, it is hard not to imagine such arrangements.

It is interesting to see the extent of laboratory participation of other countries that may want to establish reciprocal ties. Does a global economy mean an increase in distant (international) laboratory testing? Again, speculatively, yes to certain assays and procedures.

Oftentimes, when our laboratory products and services are reliable, accurate and timely, it is because they meet standards. This is what we generally strive for with all of our laboratory services. This time, with ISO 15189, we have the instrument to apply and practice this concept locally as well as internationally.

Where does this take cytology? Our role to patient care is foremost, and it is definitely a step that takes our services to another level of technical competence.

Nelson Barayuga is laboratory supervisor, NSLIJ Plainview and Syosset Hospitals, New York.

References

  1. International Organization for Standardization, Available at: www.iso.org. Last accessed Jan. 14, 2012.
  2. American National Standards Institute. Available at: www.ansi.org. Last accessed Jan. 14, 2012.
  3. College of American Pathologists. Available at: www.cap.org. Last accessed Jan. 14, 2012.

About The Author