Newsletter #10 - May 30, 1999

This memo summarizes the essential details of the Point of Care European Connectivity Industry Consortium (CIC) Initiative Meeting in Prague, held May 29, 2001 during the EuroMedLab Congress. Twenty-eight attendees from throughout Europe joined this important meeting on POC Connectivity.

In this issue:

• Meeting objectives
• Differences between Europe and the US
• Organization of standardization efforts throughout europe
• Creation of a strategy for the organization of the european cic initiative
• Events, timelines and activities
• Action items

The objectives of this meeting were to catalyze the formation of a "network" of principal individuals from health care providers, regulatory bodies and industry who are committed to advancing POC Connectivity Standardization in Europe.

The two proposed objectives for this network are:

1. Advocate for POC Connectivity Standardization throughout Europe
2. Provide European Perspective and Requirements to the CIC's POC Standardization Effort.

The outcome of the discussion was:

1. Standardized patient and operator identification is becoming very important in Europe (positive, relative to the US)
   • Starting in 2002, Germany will implement a requirement to link test results to the patient and operator
   • One significant 'enabling' issue is standardization of Patient identification ("CliniCard")
   • A "health professional" card is expected to be ready and available by end of 2001
2. In Europe, there is a lack of a standard certification process or regulatory bodies (like CLIA, CAP in the US)
3. There is a wide diversity of skill set, organization level, expertise and experience in the European POC world regarding how to implement POCT successfully
• In general, however, centralized POCT committees are lacking, and there are conflicts of interest and control between clinicians and laboratorians
• The decision power still rests in the hand of a few individuals, rather than a committee
4. There is a lack of awareness regarding how connectivity can improve the usefulness and effectiveness of POCT

1. T.Norgall presented how the European standard organizations are organized.
2. E.Völkert pointed out that we need to make sure that the NCCLS standard proposal is accredited by ANSI
3. Moving a standard forward in ISO and CEN requires man-power and money
   • Effort required involves transfer of expertise to ISO / CEN: e.g. user input, technical input
   • A team was nominated to detail our strategy and move it forward: T.Norgall, S.Field, A.St.John, J.Perry, P.Schmitz, (R.Jones - absent)

1. The IFCC seems to be an appropriate resource for international redistribution and advertisement of the publication of the CIC standard
   • H.Ziervogel raised the issue that in the past IFCC did seem open to strong vendor involvement.
   • A.StJohn commented that this has changed over the past three years.
   • H.Merkle agreed to contact Mathias Mueller (President, IFCC) - complete
2. E.Völkert suggested that we contact the IHE (Integrating the Health Care Enterprise) to find out differences and communalities between the CIC approach and theirs
3. It was agreed to have the current standard document reviewed by the following individuals:
   • Prof. G.Hoffmann for Germany - done by Dr.Fratermann
   • Prof. P.Mocarelly for Italy
   • R.Riuz for Spain
   • Dr. D.Hirst for the U.K.
   Fee-back will be forwarded to Jeff Perry who will consolidate it.
4. The following individuals agreed to form a team to define the strategic direction of the European Round Table:
   • T.Norgall
   • S.Field
   • R.Riuz
   • J.Perry
   • Prof. P.Schmitz, (Dr. R.Jones in absence)

The following events have been identified:

• July 20th deadline for review input - postponed, we should review the NCCLS AUTO6 Standard doc available since end July.
• July 29th 2001, AACC, Chicago IFCC meets with NCCLS in Chicago. - white paper - discussion started H.Merkle to contact M.Mueller, IFCC - complete Review of LIS vendors: S.Field international
• End August, 2001 ISO Meeting, London - 2 reps: Technical and user, Task: open work item
• October 19th 2001 European HL7 Meeting, Göttingen; Workshop for users and vendors
• November 21st - 24th 2001 Medica, Duesseldorf, WASP
• October 2002, IFCC Kyoto, Japan

The following action items have been defined:

1. Creation of a white paper that outlines the benefits and European requirements of standardized POCT connectivity, published under the umbrella of IFCC. Andrew St.John coordinates with Dr.Schmitz, J.Dudeck, H.Ziervogel, G.Hoffmann, D.Hirst. Due date: July 29th. Chicago, Meeting between IFCC and NCCLS to discuss the white paper
2. Sean Field to contact European LIS vendors Due date: End of July 2001
3. Participation of ERT/CIC reps (one technical, one user) in the ISO Meeting in London End of August (precise date needed). Task open work item
4. CIC/ERT representatives' participation at the European HL7 Meeting in Göttingen, Germany Oct. 19th. 2001, providing a workshop for users and vendors.
5. Review of CIC standard proposal by Prof.G.Hoffmann, Prof.P.Mocarelli, Dr.Schmitz, R.Ruiz, Dr.D.Hirst feed-back to J.Perry.
6. Contacting IHE (Integrating the Healthcare Enterprise) (J. Perry, H.Merkle)
7. Ensure that the NCCLS POCT standard (current NCCLS name "AUTO6") is ANSI certified
8. Introduce "work item" for ISO-certification of "AUTO6" to ISO TC215WG2
9. Ensure that ISO TC215 POCT standard is reflected in national mirror norm organizations
10. Ensure that ISO TC215 POCT standard is reflected in CEN TC251