Participant regulations of the Association for Quality Assessment in TDM and Clinical Toxico­logy. (in Dutch: 'Stichting Kwaliteitsbewaking Klinische Geneesmid­delanalyse en Toxicologie, KKGT').

Introduction

KKGT was officially founded in 1984 with the aim of organizing on a regular basis an educational external quality assessment scheme (EQAS) in TDM and Clinical Toxicology.

The Association has Articles, an Executive and an office. Participants to KKGT-EQAS will subscribe yearly to the programs and will then not influence the composition of the Executive or the financial affairs of the Association.

1        Participants.

1.1.      Participants to the external quality assessment scheme (EQAS) of the Association KKGT can be:

a.  Laboratories of institutions for health care, represented by the chief laboratory who has the final responsibility for laboratory results (incl. interpre­tations of lab data) in TDM and clinical toxicology.

b.  Other laboratories and industrial or commercial institutions. These laboratories need the prior approval of the KKGT-executive.

1.2.    Only one person per laboratory or institute will be admitted as representative.

1.3.    In the case of a change in the person having the final responsibility, KKGT should be informed.

2        Laboratory results.

2.1.    Both the participant and the KKGT are obliged to keep secret all individual results in EQAS, organised by KKGT; the laboratories will be coded to ensure anonimi­ty.

 2.2.    When KKGT-EQAS results will be used for scientific studies or publications, KKGT Executive's approval is needed
           beforehand. Anonimity of participants should be guaranteed.

2.3.    The participant will not use his/her individual KKGT test results to recommend his/her laboratory or institute, unless the KKGT Executive has given permission to do so.

3        KKGT EQAS

3.1.    The KKGT organizes each year an external quality assessment scheme. The participant is obliged to subscribe yearly to at least one program.

3.2.    KKGT will do its utmost in preparing specimens of good quality. However, any liability for possible financial or medico-legal consequences  resulting from the use of the KKGT speci­mens or from KKGT analyses of participant's laboratory results is excluded.

3.3.    The participant should report the EQAS results of at least 50% of the test specimens, distributed to him/her during the year.

4        Finances

4.1.    The participant will receive each year a subscription form for all KKGT programs and for ordering extra reference serum specimens.

4.2.    The participant will pay the bill within 30 days.

4.3.    Payment reimbursement, completely or partly, is not possible, unless KKGT is unable to fulfill its contractual obligations (see 5.1).

5        Miscellaneous

5.1.    KKGT may refrain from its contractual obligations if the circumstances are beyond its control, including when suppliers of materials used by the KKGT fail to satisfy established criteria.

5.2.    The participant's regulations cannot be incompatible with the articles of the Association KKGT. If there is any incompatibility, the Associations' articles will prevail.

5.3.     Participation in EQAS will start on the date, mentioned in the contract, to be signed by KKGT and the participant. It will be renewed annually, unless written notice is given, at least 3 months before the end of the contracted period.

This english version of the KKGT Participant Regulations made up on April 10, 1996, is, with some additional explanations, derived from the Dutch version of April 10, 1996 and the KKGT Foundations' Articles of 12th April 1984 amended on April 10, 1996, which shall in case of doubt or controversy, be used as the original version.