Phlebotomy Technician

NSCC: medical laboratory technology

Dell Case Study: Brigham & Women's Hospital

The Surgical Planning Lab at Brigham and Women's Hospital uses a Dell cluster for high-speed digital imaging in real time to help improve the accuracy and quality of procedures

National Medical Laboratory Week

A message from Gil Grissom from CSI...

Medical and Clinical Laboratory Technologists

Good video for promoting the laboratory technologist profession.
But:
Mentions quality only once and that it's important. Doesn't actually say what quality is.
No mention of quality management systems or accreditation.

ISO 15189 or accreditation still isn't quite on the radar yet.

Infrastructure of the laboratory

The laboratory infrastructure is the work space and building(s) in which the laboratory conducts its business, together with the necessary testing and analytical equipment and supplies, and its administrative support such as clerical, financial, and purchasing activities.

In addition to the required control of environmental conditions for calibration activities it may often be necessary for the laboratory to control the atmospheric and other working conditions for all laboratory operations to the extent necessary to ensure the precision and accuracy of laboratory results. Where the test or method explicitly states specified ambient conditions for the conduct of the test or analysis, the measures taken to control environmental conditions should be described and the resulting data defining working conditions recorded. Such activities include not only elements such as those discussed below but also such things as restricted access provisions, clean room operations (including standard operating procedures), and special housekeeping and safety activities carried out on a routine basis.

Measuring and test equipment and calibration standards should always be calibrated in an area that provides for control of environmental conditions to the degree necessary to assure the required precision and accuracy of results.

Is ISO 15189 going to fly?

The ISO 15189 standard was issued back in 2003 and has not received as much recognition as the ISO 17025 standard. Which countries have accreditation schemes in place to support the implementation of the standard?

United States
The United States does not seem as concerned with utilizing an international standard for medical labs when there are so many FDA requirements as well as being home to the Clinical and Laboratory Standards Institute

Australia
The National Association of Testing Authorities has a web page that gives you the process to be accredited for medical testing at:
http://www.nata.asn.au/index.cfm?objectId=AD74874A-933B-BBCB-A904EAE6169EF49A
They don't actually mention ISO 15189 on the page, but you will find a number of laboratories accredited to ISO 15189 if you do the search on their site.


Canada
Ontario has implemented a program for medical laboratory accreditation that can be viewed at:
http://www.qmpls.org/ola/ola.html
It doesn't state that it subscribes to any international standard, but does mention such things as ISO 9000 and ISO 15189 as starting points, but they have set about their own set of requirements.

Japan
Click here for an interesting link that TUV Rheinland Japan Ltd has posted.

TUV is usually recognized as an ISO 9001 registrar so it is interesting to see a private company initiate a programme rather than a government body / non-profit organization.

A couple decades ago when ISO Guide 25 came out there were just about as many standards used as there were countries and states for "accrediting" laboratories. It has been a long process to get to where we are at today, but at least ISO 17025 has been firmly established as the standard of choice for accrediting laboratories worldwide. It should be interesting to see if the medical laboratory accreditation community will take the same long road or continue to use their own spin on quality management systems.

We'll see!