1. SCOPE

1. This European Prestandard specifies general messages for electronic information exchange between clinical laboratories' computer systems and computer systems used by healthcare parties requesting the services of, or receiving results from, clinical laboratories (abbreviated as laboratories in this Prestandard).

2. This European Prestandard is applicable to messages requesting or reporting on the results of the services of the following specialties:

   • Clinical Chemistry;

   • Clinical Biochemistry;

   • Toxicology,

   • Clinical Immunology;

   • Immunohaematology;

   • Haematology.

   • Clinical Microbiology (including Bacteriology. Mycology, Parasitology and Virology).

3. This European Prestandard is not applicable to messages requesting or reporting on the results of the services of the following specialties (see 1.11):

   • Anatomic Pathology;

   • Histopathology, - Cytology, and * Autopsies.

4. This European Prestandard does not specify the manner in which clinical laboratory services are divided between specialties as this vanes in accordance with different national and local practices.

5. The scope of the messages specified by this European Prestandard comprises requests and results related to investigations carried out by clinical laboratories on subjects of investigation. This European Prestandard is applicable whether the healthcare party communicating with the clinical laboratory is a person (such as a doctor or other healthcare professional) or an organisation (such as a hospital, clinic or department). A clinical laboratory may itself act as the healthcare party submitting requests to, or receiving results from other clinical laboratories. However, this European Prestandard has not been developed to meet the needs of messages that are specific to communications between one clinical laboratory and another.

6. This European Prestandard is applicable to requests for investigation and modifications and cancellations of previously issued requests. It is applicable both to samples that are obtained from subjects of investigation at the point of care or at any other location and submitted to the clinical laboratory, and to requests for investigation for which the laboratory is requested to obtain samples. The messages it specifies support standing orders for laboratory services.

7. This European Prestandard is applicable to reports of the results of investigation and modifications and cancellations of previously issued reports. The messages it specifies support the communication of partial, supplementary, final supplementary, complete and cumulative reports. Reporting modes which can be implemented using this European Prestandard include: sending a laboratory service report only when all laboratory investigation results are available; sending individual results as they become available; sending new results as part of a cumulative report; and sending partial results.

8. This European Prestandard is not applicable to the communication of graphical or image information that forms part of a request for or result of a laboratory investigation.

9. This European Prestandard has not been developed to meet the needs of messages supporting administration, financing, management, interpersonal mail or external quality control nor of messages communicating sample collection lists, work lists or queries.

10. This European Prestandard does not support negative acknowledgment or error indication at the application level, nor positive acknowledgment at the application level.

11. The provisions of this European Prestandard have been validated in the domains and for the purposes described above (see 1.2 and 1.3). However messages conforming to this European Prestandard may be considered by some user communities to meet their needs for purposes outside this scope. Use of the messages in such circumstances is not precluded by the scope.

12. While the messages specified in this European Prestandard may convey clinical and administrative information concerning patients, the way in which this information is treated in this European Prestandard does not constrain the development of future standards for the electronic healthcare record or for other clinical and administrative messages.

13. The method for the specification of the messages in this European Prestandard only applies to this European Prestandard. This Prestandard does not constrain the development of other methods for the specification of standardised edi messages. The symbols used in this Prestandard have the meaning as defined in normative annex A for the purposes of this Prestandard only.