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Program Shipments Affected by European Commission Import Regulations

Program Shipments Affected by European Commission Import Regulations

Last updated: November 14, 2024

Due to the enforcement of import regulations set forth by the European Commission (EC), the College of American Pathologists (CAP) is holding current and upcoming shipments for all proficiency testing (PT)/external quality assessment (EQA) programs that contain animal by-product(s) (ABP) and fall under harmonized tariff schedule (HTS) code 3002.12. We are actively working on the necessary steps laboratories must take to receive shipments in Europe.

The CAP is investigating whether your laboratory may need to obtain import permit(s) for programs containing ABP classified as 3002.12 from your local authority. Additional information will be provided as it becomes available.

Programs impacted by the EC regulations

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Programs that contain ABP but do not fall under the HTS code 3002.12 may also experience delays in clearance due to veterinary inspection processes.

For PT/EQA kits on the impacted programs list:

If your laboratory received its PT/EQA shipment and already reported exception code 33

If program material is not expired (see 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 your laboratory received its PT/EQA shipment but has not reported exception code 33

If program material is not expired (see 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.

If your laboratory has not received its PT/EQA shipment and already reported exception code 33

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.

If your laboratory has not received its PT/EQA shipment and has not reported exception code 33

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 impacted programs list:

If your laboratory received its CVL or QCC shipment and already reported exception code 33

If program material is not expired (see 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 your laboratory received its CVL or QCC shipment but has not reported exception code 33

If program material is not expired (see 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.

If your laboratory has not received its CVL or QCC shipment and already reported exception code 33

CAP-accredited laboratories will need to use alternate methods to perform analytical measurement range verification and instrument comparisons.

If your laboratory has not received its CVL or QCC shipment and has not reported exception code 33

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.