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Draft 7th Edition NetCord-FACT Cord Blood Standards: Public Comment Period Extended

The draft Seventh Edition NetCord-FACT Cord Blood Standards and accompanying Accreditation Manual were published for public review and comment for a 90-day period on November 30, 2018.  To ensure that members of the cord blood community have reviewed the proposed significant changes in the draft Standards, and have had an opportunity to provide their input, the comment period is extended for an additional 30 days. Comments will now be accepted through April 1, 2019. Links are provided below to the draft Standards, Accreditation Manual, and comment form.

These Standards apply to all phases of cord blood collection, banking, and release for administration, including donor management, collection, processing, testing, cryopreservation, storage, listing, search, selection, reservation, release, and distribution to clinical programs.

Comments on any aspect of the draft are welcome. However, members of the cord blood community are strongly encouraged to specifically review and provide comment on three significant changes proposed in the draft Seventh Edition:

1.      ISBT 128 AND EUROCODE CODING AND LABELING

Appendix II, "Cord Blood Unit Labeling," has been updated to convey requirements specific to both ISBT 128 and Eurocode.

B6.1.2 If  Coding and labeling technologies have not yet been shall be implemented the CBB shall be actively implementing using ISBT 128 or Eurocode.

2.      SUPPLIES AND REAGENTS OF THE APPROPRIATE GRADE

A new standard was added that explicitly states the requirement for the use of supplies and reagents of the appropriate grade

B8.4.1 Where there are no suitable clinical or pharmaceutical grade reagents available, reagents shall undergo lot-to-lot functional verification and shall include acceptance criteria to confirm that new lots perform as expected compared to the previous lots.

3.      TESTING AND SPECIFICATION REQUIREMENTS

Appendix IV, Appendix V Viability of CD45 cells modified to:

Comments regarding the draft Seventh Edition NetCord-FACT Cord Blood Standards can be submitted by accessing the Comment Form.

Description and Instructions for Review and Comment
Draft NetCord-FACT Cord Blood Standards
Draft NetCord-FACT Accreditation Manual

Comments will be accepted through April 1, 2019.

For questions or assistance, please contact:



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