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- Program Shipments Affected by European Commission Import Regulations
Last updated: December 16, 2024
Due to the enforcement of import regulations set forth by the European Commission (EC), the College of American Pathologists (CAP) is holding upcoming shipments for all proficiency testing (PT)/external quality assessment (EQA) programs that contain animal by-product(s) (ABP).
The CAP continues to work on the necessary steps laboratories must take to receive shipments in Europe. The CAP met with German veterinary authorities to gain more clarity on import regulations. Laboratories must reach out to their local authorities to determine specific import permit requirements in their country as they relate to ABP. You will need to obtain an import permit(s) to receive future shipments. Note: Your program(s) may contain materials originating from bovine, porcine, horse, rabbit, etc. You will want to ensure your permit(s) cover all these materials. For more details on permitting, contact largyil@cap.org.
Programs impacted by the EC regulations that require you to obtain an import permit(s) are listed in the following tables:
All programs that contain ABP may experience delays in clearance due to veterinary inspection processes.
For PT/EQA kits on the 2024 impacted programs list:
If program material is not expired (see 2024 table), CAP-accredited laboratories may use it to perform and document alternative performance assessment to meet accreditation requirements.
If your program material is expired, please discard. More information about alternative performance assessment can be found here.
If program material is not expired (see 2024 table), test immediately and report your results.
If your program material is expired, please discard and report exception code 33 for analytes tested in your laboratory. Your due date has been extended.
CAP-accredited laboratories are required to perform and document alternative performance assessment to meet accreditation requirements.
More information about alternative performance assessment can be found here.
CAP-accredited laboratories are required to perform and document alternative performance assessment to meet accreditation requirements.
More information about alternative performance assessment can be found here.
Report exception code 33 for analytes tested in your laboratory. Your due date has been extended.
CAP-accredited laboratories are required to perform and document alternative performance assessment to meet accreditation requirements.
More information about alternative performance assessment can be found here.
For Calibration Verification/Linearity (CVL) and Quality Cross Check (QCC) kits on the 2024 impacted programs list:
If program material is not expired (see 2024 table), test immediately and report your results. Your due date has been extended.
If your program material is expired, please discard. CAP-accredited laboratories will need to use alternate methods to perform analytical measurement range verification and instrument comparisons.
If program material is not expired (see 2024 table), test immediately and report your results.
If your program material is expired, please discard and report exception code 33 for analytes tested in your laboratory. Your due date has been extended.
CAP-accredited laboratories will need to use alternate methods to perform analytical measurement range verification and instrument comparisons.
CAP-accredited laboratories will need to use alternate methods to perform analytical measurement range verification and instrument comparisons.
Report exception code 33 for analytes tested in your laboratory. Your due date has been extended.
CAP-accredited laboratories will need to use alternate methods to perform analytical measurement range verification and instrument comparisons.
If you have any questions, call a Customer Contact Center representative at 800-323-4040 (within the US) or 847-832-7000 (Country Code: 1, outside the US), Option 1, or email ContactCenter@cap.org.