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Changes to BDP Codes

Changes to BDP Codes. Effective October 1, 2011. Deleted Codes . ROUTINE TESTING RT-61-** Testing performed, interpreted, or documented incorrectly for: RT-61-02 ABO RT-61-03 Rh

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Changes to BDP Codes

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  1. Changes to BDP Codes Effective October 1, 2011

  2. Deleted Codes ROUTINE TESTING • RT-61-** Testing performed, interpreted, or documented incorrectly for: • RT-61-02 ABO • RT-61-03 Rh • RT-63-** Testing performed using reagents in which QC was unacceptable, not performed, not documented or expired reagents were used • RT-63-02 ABO • RT-63-03 Rh

  3. Deleted Codes, continued QUALITY CONTROL and DISTRIBUTION • QC-93-** Testing not performed, incompletely performed or not documented for: • QC-93-08 ABO (donor/unit or recipient) • QC-93-09 Rh (donor/unit or recipient)

  4. Modified Description ROUTINE TESTING • RT-61-** Testing performed, interpreted, or documented incorrectly for: • RT-61-04 ABO and/or Rh • RT-63-** Testing performed using reagents in which QC was unacceptable, not performed, not documented or expired reagents were used • RT-63-04 ABO and/or Rh

  5. Modified Description, continued QUALITY CONTROL and DISTRIBUTION • QC-93-** Testing not performed, incompletely performed or not documented for: • QC-93-16 ABO and/or Rh (donor/unit or recipient)

  6. New Codes Added MISCELLANEOUS MI-01-** Donor implicated in transfusion associated disease • MI-01-07 Malaria

  7. Questions?? Contact: CBER @(301) 827-6220 or bp_deviations@fda.hhs.gov MVRBC QA Dept @ 800-747-5401: • Elaine Mundt, Compliance Manager (ext 220) emundt@mvrbc.org • Tina Chanez, Director Regulatory (ext 222) tchanez@mvrbc.org

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