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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Biological Product Deviation Reporting and HCT/P Deviation Reporting - Deviation Codes

 

Blood BPD Codes   |   Non-Blood BPD Codes   |   HCT / P Codes


  Blood BPD Codes:

Use the following list of Biological Product Deviation (BPD) Codes to assign a specific code to a reportable event when you submit the report to FDA. Use the guidance document, "Biological Product Deviation Reporting for Blood and Plasma Establishments," to determine if you must report an event. The list includes deviations from regulations, standards, and standard operating procedures (SOPs) that may affect the safety, purity, or potency of a product. These codes may not apply to all establishments because they include deviations and unexpected events related to SOPs implemented at individual establishments and may not be an industry standard or a procedure at your facility. The use of BPD Codes will assist the FDA in analyzing the data submitted and streamline the trend analysis.

Changes made on October 1, 2013 are identified with a dagger (†).

Reporting HCV Lookback (this paragraph updated November 30, 2012).
The Guidance for Industry: Biological Product Deviation Reporting for Blood and Plasma Establishments states that a BPD report is required if a donor tested negative, products were distributed, and the donor subsequently returned and tested confirmed positive at your establishment for HCV.  As stated at http://www.fda.gov/BiologicsBloodVaccines/SafetyAvailability/ucm322704.htm, the CHIRON® RIBA®; HCV 3.0 SIA (RIBA) assay for detection of antibodies to individual proteins encoded by the hepatitis C virus (anti-HCV) and intended for use as an additional, more specific test on human serum or plasma specimens found to be repeatedly reactive using a licensed anti-HCV screening test is currently unavailable. Given this situation, you should submit a Biological Product Deviation report for any blood and blood components previously donated that were distributed 12 months and less from the donor’s positive HCV NAT, regardless of any additional testing. 

The changes to the deviation codes for FY2014 are listed below.
  
We modified the description of three codes for clarification. We added “or fibrin” to code BC-43-05, “or transfusion record” to code LA-82-02 and “calibration” to code QC-94-06. 

Use one of the following BPD Codes to report an event that was recognized by a staff member who determined, prior to distribution, that the event has the potential to affect the safety, purity, or potency of the distributed product and the product was either not quarantined or inappropriately released from quarantine.

QC-94-** Distribution of product that did not meet specifications
QC-94-12 Product identified as unsuitable due to a collection deviation or unexpected event {event discovered prior to distribution, but failed to quarantine product}
QC-94-13 Product identified as unsuitable due to a component preparation deviation or unexpected event {event discovered prior to distribution, but failed to quarantine product}
QC-94-14 Product identified as unsuitable due to a labeling deviation or unexpected event {event discovered prior to distribution, but failed to quarantine product}
QC-94-15 Product identified as unsuitable due to a donor screening deviation or unexpected event {event discovered prior to distribution, but failed to quarantine product}
QC-94-16 Product identified as unsuitable due to a donor deferral deviation or unexpected event {event discovered prior to distribution, but failed to quarantine product}  
QC-94-17 Product identified as unsuitable due to a shipping or storage deviation or unexpected event {event discovered prior to distribution, but failed to quarantine product}
QC-94-18 Product identified as unsuitable due to a viral testing deviation or unexpected event {event discovered prior to distribution, but failed to quarantine product}

Modified description:

BLOOD COLLECTION
BC-43-** Collection process
BC-43-05 Product contained clots or fibrin, not discovered prior to distribution

LABELING
LA-82-** Crossmatch tag, tie tag or transfusion record incorrect or missing information
LA-82-20 Crossmatch tat, tie tag, or transfusion record missing or attached to incorrect unit (e.g., intended for different patient) 

QUALITY CONTROL and DISTRIBUTION
QC-94-** Distribution of product that did not meet specifications
QC-94-06 Product in which instrument QC, calibration, or validation was unacceptable, incomplete, not performed or not documented
If you are a transfusion service only, the deviation codes you should use are Component Preparation (CP), Routine Testing (RT), Labeling (LA), Quality Control and Distribution (QC).
Donor Suitability
PD - Post Donation Information
DS - Donor Screening
DD - Donor Deferral

BC - Blood Collection

CP - Component Preparation

Laboratory Testing
VT - Viral Testing
RT - Routine Testing

LA - Labeling

QC - Quality Control and Distribution

MI - Miscellaneous
  PD/DS/DD DONOR SUITABILITY (Back to top)
  PD-**-** POST DONATION INFORMATION (Back to top)
PD-10-** Miscellaneous
PD-10-01 Other
PD-11-** Testing {information provided by donor or third party, includes true positive and false positive test results; use PD-13 for a reactive test obtained post donation; use MI codes for confirmed positives if testing performed at your facility}
PD-11-01 Other
PD-11-03 Tested reactive for Hepatitis B prior to donation
PD-11-05 Tested reactive for Hepatitis C prior to donation
PD-11-07 Tested reactive for HIV prior to donation
PD-11-09 Tested reactive for HTLV prior to donation
PD-11-11 Tested reactive for sexually transmitted disease prior to donation
PD-11-13 Tested reactive for hepatitis not specified or elevated liver enzymes, prior to donation
PD-11-14 Tested reactive at another center, specific testing unknown
PD-11-16 Tested reactive for Hepatitis A prior to donation
 
PD-12-** Behavior/History
PD-12-01 Other {includes: type of behavior or history unknown or not specified; unacceptable address; rape; donor unreliable, for example mental status questionable or donor unable to comprehend donor history questions}
PD-12-02 History of hepatitis not specified
PD-12-03 History of jaundice
PD-12-04 History of Hepatitis B
PD-12-05 History of Hepatitis C
PD-12-06 Sexually transmitted disease
PD-12-07 Sex partner has or had a sexually transmitted disease
PD-12-08 Sex partner tested reactive for HIV
PD-12-09 Sex partner tested reactive for HTLV
PD-12-10 Sex partner tested reactive for HBV
PD-12-11 Sex partner tested reactive for HCV
PD-12-12 Sex partner tested reactive for hepatitis, not specified
PD-12-13 Sex partner/cohabitant unsuitable or engaged in high risk behavior {includes: sex partner/cohabitant- received clotting factor; incarcerated; history of jaundice; deferred by another center or on national or state deferral list, tested reactive for a viral marker or history/behavior unknown or not specified}  
PD-12-14 Male donor had sex with another man
PD-12-15 Female had sex with a man who had sex with another man
PD-12-16 IV drug use {includes taking illegal drugs by needle, e.g., IM}
PD-12-17 Sex with IV drug user
PD-12-18 Non-IV-drug use {includes taking illegal drugs by route other than needle}
PD-12-19 Sex partner used non-IV drugs
PD-12-20 Donor lived in or immigrated from an HIV Group O risk area
PD-12-21 Sex partner lived in or immigrated from an HIV Group O risk area
PD-12-22 Exchanged sex for drugs or money
PD-12-23 Sex partner exchanged sex for drugs or money
PD-12-28 Donor received transfusion or clotting factors
PD-12-29 Donor received tissue allograft or transplanted organ
PD-12-32 Non-sexual exposure to HIV
PD-12-33 Non-sexual exposure to hepatitis, type not specified
PD-12-34 Non-sexual exposure to Hepatitis B
PD-12-35 Non-sexual exposure to Hepatitis C
PD-12-36 Travel to malaria endemic area/history of malaria
PD-12-37 History of disease {donor was aware of condition or disease prior to donation; does not include diseases that do not affect the safety, purity, or potency of the product, e.g., heart disease, hemochromatosis, autoimmune disorders, such as Rheumatoid Arthritis, Lupus; history of surgery is reported under PD-12-28 only if blood products were received during surgery or under PD-12-29 if donor received tissue allograft or transplanted organ}
PD-12-40 Risk factors associated with Creutzfeldt-Jakob Disease - brain surgery
PD-12-41 Risk factors associated with Creutzfeldt-Jakob Disease - family history
PD-12-42 Risk factors associated with Creutzfeldt-Jakob Disease (vCJD) - travel
PD-12-43 Risk factors associated with Creutzfeldt-Jakob Disease - received insulin or other bovine derived product
PD-12-44 Received growth hormone
†PD-12-45 Received finasteride (Proscar or Propecia), Tegison, Accutane, Avodart, Jalyn, or Absorica
PD-12-46 Received medication or antibiotics
PD-12-47 Received vaccine or immune globulin
PD-12-48 Exposure to a disease
PD-12-49 Incarcerated
PD-12-50 Resided in a rehabilitation center or psychiatric hospital
PD-12-51 History of Hepatitis A
PD-12-52 Exposure to Hepatitis A
PD-12-53 Multiple high risk behaviors/contacts
PD-12-54 Positive drug screen
PD-12-55 Deferred by another center - reason unknown {reason for deferral unknown or not provided by the other center - use more specific PD code if reason known}
PD-12-56 Travel to leishmania risk area {e.g., Baghdad, Tikrit, Ramadi}
PD-12-57 Travel to leishmania and malarial endemic area {e.g., Afghanistan, Iraq (except Baghdad, Tikrit, Ramadi)}
PD-12-58 Risk factor associated with Chagas
PD-12-59 Donor received tattoo and/or piercing {includes tattoo, any type of piercing or a combination of tattoo and/or piercing}
PD-12-60 Donor was exposed to blood or body fluids other than tattoo or piercing {includes: accidental needlestick; animal bite; human bite; occupational exposure; scarification; branding; exposure not specified; multiple exposures, not including tattoo or piercing}
PD-13-** Illness
PD-13-01 Post donation illness (not hepatitis, HIV, HTLV, STD, cancer or cold/flu related) {information not known by donor prior to donation, but diagnosed after donation; includes post donation reaction (e.g., infection) at phlebotomy site; Babesiosis; West Nile Virus, Chagas}
PD-13-02 Post donation diagnosis or symptoms of Hepatitis B, or reactive test for Hepatitis B
PD-13-03 Post donation diagnosis or symptoms of Hepatitis C, or reactive test for Hepatitis C
PD-13-04 Post donation diagnosis or symptoms of HIV, or reactive test for HIV
PD-13-05 Post donation diagnosis or symptoms of HTLV, or reactive test for HTLV
PD-13-06 Post donation diagnosis or symptoms of sexually transmitted disease, or reactive test for sexually transmitted disease
PD-13-07 Post donation diagnosis or symptoms of non-specific hepatitis, reactive test for non-specific hepatitis, or elevated liver enzymes
PD-13-08 Post donation diagnosis or symptoms of Hepatitis A, or reactive test for Hepatitis A
PD-13-10 Post donation diagnosis or possible diagnosis of Creutzfeldt-Jakob Disease {includes variant CJD}
PD-14-** Not specifically related to high risk behavior, unsuitable history, or post donation illness
PD-14-01 Other {does not include reports of post donation illness - use PD13** codes; includes anything not included in PD12**}
PD-14-02 Donor does not want their blood used
PD-14-03 Donated to be tested or called back for test results
  DS-**-** DONOR SCREENING (Back to top)
DS-20-** Miscellaneous
DS-20-01 Other
DS-21-** Donor did not meet acceptance criteria
DS-21-01 Other {includes inappropriate acceptance of donor with unacceptable address or no proof of an acceptable address}
DS-21-02 Hemoglobin or Hematocrit unacceptable, not documented, or testing performed incorrectly {includes use of expired reagents for hemoglobin or hematocrit}
DS-21-03 Temperature unacceptable or not documented
DS-21-04 Medical review or physical not performed or inadequate
DS-21-05 Platelet count, no documented platelet count for product
DS-21-06 Unexplained weight loss
DS-22-** Donor record incomplete or incorrect
DS-22-01 Other {includes missing donor records}
DS-22-02 Donor identification {includes donor using false identification, e.g., twins}
DS-22-03 Donor history questions {includes: abbreviated questionnaire used instead of full-length questionnaire; response to educational material/AIDS questions not documented ; incorrect gender specific question asked}
DS-22-04 Arm inspection
DS-22-05 Donor signature missing
DS-22-06 Confidential Unit Exclusion (CUE) procedure not performed in accordance with specifications
DS-22-07 Donor confidentiality compromised
DS-26-**Deferral screening not done or incorrectly performed including incorrect ID used during deferral search
DS-26-01 Donor not previously deferred  {use DS2601 when the deferral file is not searched or searched using incorrect donor identification information; or the deferral file was incorrectly searched and the donor was not previously deferred}
DS-27-** Deferral screening not done or incorrectly performed, including incorrect ID used during search, prior deferral due to testing {use DS27** when the deferral file is not searched or searched using incorrect donor identification information; or the deferral file was incorrectly searched and the donor was previously deferred due to testing}
DS-27-01 Other
DS-27-02 HIV reactive
DS-27-03 HBsAg reactive
DS-27-04 Anti-HBc reactive
DS-27-05 Anti-HCV reactive
DS-27-06 Anti-HTLV-I reactive
DS-27-07 ALT elevated
DS-27-08 Syphilis reactive
DS-28-** Deferral screening not done or incorrectly performed, including incorrect ID used during search, prior deferral due to history {use DS28** when the deferral file is not searched or searched using incorrect donor identification information, or the deferral file was incorrectly searched and the donor was previously deferred due to history}
DS-28-01 Other {includes: type of behavior or history unknown or not specified; unacceptable address; rape; donor unreliable, for example mental status questionable or donor unable to comprehend donor history questions}
DS-28-02 History of hepatitis, not specified
DS-28-03 History of jaundice
DS-28-04 History of Hepatitis B
DS-28-05 History of Hepatitis C
DS-28-06 Sexually transmitted disease
DS-28-07 Sex partner has or had a sexually transmitted disease
DS-28-08 Sex partner tested reactive for HIV
DS-28-09 Sex partner tested reactive for HTLV
DS-28-10 Sex partner tested reactive for HBV
DS-28-11 Sex partner tested reactive for HCV
DS-28-12 Sex partner tested reactive for hepatitis, not specified
DS-28-13 Sex partner/cohabitant unsuitable or engaged in high risk behavior {includes: sex partner/cohabitant- received clotting factor; incarcerated; history of jaundice; deferred by another center or on national or state deferral list, tested reactive for a viral marker or history/behavior unknown or not specified}
DS-28-14 Male donor had sex with another man
DS-28-15 Female had sex with a man who had sex with another man
DS-28-16 IV drug use {includes taking illegal drugs by needle, e.g., IM}
DS-28-17 Sex with IV drug user
DS-28-18 Non-IV-drug use {includes taking illegal drugs by route other than needle}
DS-28-19 Sex partner used non-IV drugs
DS-28-20 Donor lived in or immigrated from an HIV Group O risk area
DS-28-21 Sex partner lived in or immigrated from an HIV Group O risk area
DS-28-22 Exchanged sex for drugs or money
DS-28-23 Sex partner exchanged sex for drugs or money
DS-28-28 Donor received transfusion or clotting factors
DS-28-29 Donor received tissue allograft or transplanted organ
DS-28-32 Non-sexual exposure to HIV
DS-28-33 Non-sexual exposure to hepatitis, type not specified
DS-28-34 Non-sexual exposure to Hepatitis B
DS-28-35 Non-sexual exposure to Hepatitis C
DS-28-36 Travel to malaria endemic area/history of malaria
DS-28-37 History of disease{donor was aware of condition or disease existed prior to donation; does not include diseases that do not affect the safety, purity, or potency of the product, e.g., heart disease, hemochromatosis, autoimmune disorders, such as Rheumatoid Arthritis, Lupus; history of surgery is reported under DS-28-28 only if blood or blood products were received during surgery or under DS-28-29 if donor received tissue allograft or transplanted organ}
DS-28-40 Risk factors associated with Creutzfeldt-Jakob Disease - brain surgery
DS-28-41 Risk factors associated with Creutzfeldt-Jakob Disease - family history
DS-28-42 Risk factors associated with Creutzfeldt-Jakob Disease (vCJD) - travel
DS-28-43 Risk factors associated with Creutzfeldt-Jakob Disease - received insulin or other bovine derived product
DS-28-44 Received growth hormone
†DS-28-45 Received finasteride (Proscar or Propecia), Tegison, Accutane, Avodart, Jalyn, or Absorica
DS-28-46 Received medication or antibiotics
DS-28-47 Received vaccine or immune globulin
DS-28-48 Exposure to a disease
DS-28-49 Incarcerated
DS-28-50 Resided in a rehabilitation center or psychiatric hospital
DS-28-51 History of Hepatitis A
DS-28-52 Exposure to Hepatitis A
DS-28-53 Multiple high risk behaviors/contacts
DS-28-54 Positive drug screen
DS-28-55 Deferred by another center - reason unknown
DS-28-56 Travel to leishmania risk area {e.g., Baghdad, Tikrit, Ramadi}
DS-28-57 Travel to leishmania and malarial endemic area {e.g., Afghanistan, Iraq (except Baghdad, Tikrit, Ramadi)}
DS-28-58 Risk factor associated with Chagas
DS-28-59 Donor received tattoo and/or piercing {includes tattoo, any type of piercing or a combination of tattoo and/or piercing}
DS-28-60 Donor was exposed to blood or body fluids other than tattoo or piercing {includes: accidental needlestick; animal bite; human bite; occupational exposure; scarification; branding; exposure not specified; multiple exposures, not including tattoo or piercing}
DS-29-** Donor gave history which warranted deferral or follow up and was not deferred or follow up questions were not asked {use DS29** when a donor gives disqualifying information during the screening process and was not appropriately deferred or provides some information that requires further questioning to determine donor eligibility and follow up questioning was not done}
DS-29-01 Other {includes: type of behavior or history unknown or not specified; rape; donor unreliable, for example mental status questionable or donor unable to comprehend donor history questions; response to educational material/AIDS questions unacceptable}
DS-29-02 History of hepatitis, not specified
DS-29-03 History of jaundice
DS-29-04 History of Hepatitis B
DS-29-05 History of Hepatitis C
DS-29-06 Sexually transmitted disease
DS-29-07 Sex partner has or had a sexually transmitted disease
DS-29-08 Sex partner tested reactive for HIV
DS-29-09 Sex partner tested reactive for HTLV
DS-29-10 Sex partner tested reactive for HBV
DS-29-11 Sex partner tested reactive for HCV
DS-29-12 Sex partner tested reactive positive for hepatitis, not specified
DS-29-13 Sex partner/cohabitant unsuitable or engaged in high risk behavior {includes: sex partner/cohabitant- received clotting factor; incarcerated; history of jaundice; deferred by another center or on national or state deferral list, tested reactive for a viral marker or history/behavior unknown or not specified}
DS-29-14 Male donor had sex with another man
DS-29-15 Female had sex with a man who had sex with another man
DS-29-16 IV drug use {includes taking illegal drugs by needle, e.g., IM}
DS-29-17 Sex with IV drug user
DS-29-18 Non-IV-drug use {includes taking illegal drugs by route other than needle}
DS-29-19 Sex partner used non-IV drugs
DS-29-20 Donor lived in or immigrated from an HIV Group O risk area
DS-29-21 Sex partner lived in or immigrated from an HIV Group O risk area
DS-29-22 Exchanged sex for drugs or money
DS-29-23 Sex partner exchanged sex for drugs or money
DS-29-28 Donor received transfusion or clotting factors
DS-29-29 Donor received tissue allograft or transplanted organ
DS-29-32 Non-sexual exposure to HIV
DS-29-33 Non-sexual exposure to hepatitis, type not specified
DS-29-34 Non-sexual exposure to Hepatitis B
DS-29-35 Non-sexual exposure to Hepatitis C
DS-29-36 Travel to malaria endemic area/history of malaria
DS-29-37 History of disease {donor was aware of condition or disease existed prior to donation; does not include diseases that do not affect the safety, purity, or potency of the product, e.g., heart disease, hemochromatosis, autoimmune disorders, such as Rheumatoid Arthritis, Lupus; history of surgery is reported under DS-29-28 only if blood or blood products were received surgery or under DS-29-29 if donor received tissue allograft or transplanted organ}
DS-29-40 Risk factors associated with Creutzfeldt-Jakob Disease - brain surgery
DS-29-41 Risk factors associated with Creutzfeldt-Jakob Disease - family history
DS-29-42 Risk factors associated with Creutzfeldt-Jakob Disease (vCJD) - travel
DS-29-43 Risk factors associated with Creutzfeldt-Jakob Disease - received insulin or other bovine derived product
DS-29-44 Received growth hormone
†DS-29-45 Received finasteride (Proscar or Propecia), Tegison, Accutane, Avodart, Jalyn, or Absorica
DS-29-46 Received medication or antibiotics
DS-29-47 Received vaccine or immune globulin
DS-29-48 Exposure to a disease
DS-29-49 Incarcerated
DS-29-50 Resided in a rehabilitation center or psychiatric hospital
DS-29-51 History of Hepatitis A
DS-29-52 Exposure to Hepatitis A
DS-29-53 Multiple high risk behaviors/contacts
DS-29-54 Positive drug screen
DS-29-55 Deferred by another center - reason unknown
DS-29-56 Travel to leishmania risk area {e.g., Baghdad, Tikrit, Ramadi}
DS-29-57 Travel to leishmania and malarial endemic area {e.g., Afghanistan, Iraq (except Baghdad, Tikrit, Ramadi)}
DS-29-58 Risk factor associated with Chagas
DS-29-59 Donor received tattoo and/or piercing {includes tattoo, any type of piercing or a combination of tattoo and/or piercing}
DS-29-60 Donor was exposed to blood or body fluids other than tattoo or piercing {includes: accidental needlestick; animal bite; human bite; occupational exposure; scarification; branding; exposure not specified; multiple exposures, not including tattoo or piercing}
  DD-**-** DONOR DEFERRAL (Back to top)
DD-30-** Miscellaneous
DD-30-01 Other
DD-31-** Donor missing or incorrectly identified on deferral list, donor was or should have been previously deferred due to testing{use DD31** if the donor should have been deferred due to testing at a previous donation and was either not on the deferral list or incorrectly identified on the deferral list, e.g. listed as temporary deferral instead of permanent deferral}
DD-31-01 Other
DD-31-02 HIV reactive
DD-31-03 HBsAg reactive
DD-31-04 Anti-HBc reactive
DD-31-05 Anti-HCV reactive
DD-31-06 Anti-HTLV reactive
DD-31-07 ALT elevated
DD-31-08 Syphilis reactive
DD-32-** Donor missing or incorrectly identified on deferral list, donor was or should have been previously deferred due to history{use DD32** if the donor should have been deferred due to history at a previous donation and was either not on the deferral list or incorrectly identified on the deferral list, e.g. listed as temporary deferral instead of permanent deferral}
DD-32-01 Other {includes: type of behavior or history unknown or not specified; unacceptable address; rape; donor unreliable, for example mental status questionable or donor unable to comprehend donor history questions}
DD-32-02 History of hepatitis, not specified
DD-32-03 History of jaundice
DD-32-04 History of Hepatitis B
DD-32-05 History of Hepatitis C
DD-32-06 Sexually transmitted disease
DD-32-07 Sex partner has or had sexually transmitted disease
DD-32-08 Sex partner tested reactive for HIV
DD-32-09 Sex partner tested reactive for HTLV
DD-32-10 Sex partner tested reactive for HBV
DD-32-11 Sex partner tested reactive for HCV
DD-32-12 Sex partner tested reactive for hepatitis, not specified
DD-32-13 Sex partner/cohabitant unsuitable or engaged in high risk behavior {includes: sex partner/cohabitant- received clotting factor; incarcerated; history of jaundice; deferred by another center or on national or state deferral list, tested reactive for a viral marker or history/behavior unknown or not specified}
DD-32-14 Male donor had sex with another man
DD-32-15 Female had sex with a man who had sex with another man
DD-32-16 IV drug use {includes taking illegal drugs by needle, e.g., IM}
DD-32-17 Sex with IV drug user
DD-32-18 Non-IV-drug use {includes taking illegal drugs by route other than needle}
DD-32-19 Sex partner used non-IV drugs
DD-32-20 Donor lived in or immigrated from an HIV Group O risk area
DD-32-21 Sex partner lived in or immigrated from an HIV Group O risk area
DD-32-22 Exchanged sex for drugs or money
DD-32-23 Sex partner exchanged sex for drugs or money
DD-32-28 Donor received transfusion or clotting factors
DD-32-29 Donor received tissue allograft or transplanted organ
DD-32-32 Non-sexual exposure to HIV
DD-32-33 Non-sexual exposure to hepatitis, type not specified
DD-32-34 Non-sexual exposure to Hepatitis B
DD-32-35 Non-sexual exposure to Hepatitis C
DD-32-36 Travel to malaria endemic area/history of malaria
DD-32-37 History of disease {donor was aware of condition or disease existed prior to donation; does not include diseases that do not affect the safety, purity, or potency of the product, e.g., heart disease, hemochromatosis, autoimmune disorders, such as Rheumatoid Arthritis, Lupus; history of surgery is reported under DD-32-28 only if blood or blood products were received during surgery or under DD-32-29 if the donor received tissue allograft or transplanted organ}
DD-32-40 Risk factors associated with Creutzfeldt-Jakob Disease - brain surgery
DD-32-41 Risk factors associated with Creutzfeldt-Jakob Disease - family history
DD-32-42 Risk factors associated with Creutzfeldt-Jakob Disease (vCJD) - travel
DD-32-43 Risk factors associated with Creutzfeldt-Jakob Disease - received insulin or other bovine derived product
DD-32-44 Received growth hormone
†DD-32-45 Received finasteride (Proscar or Propecia), Tegison, Accutane, Avodart, Jalyn, or Absorica
DD-32-46 Received medication or antibiotics
DD-32-47 Received vaccine or immune globulin
DD-32-48 Exposure to a disease
DD-32-49 Incarcerated
DD-32-50 Resided in a rehabilitation center or psychiatric hospital
DD-32-51 History of Hepatitis A
DD-32-52 Exposure to Hepatitis A
DD-32-53 Multiple high risk behaviors/contacts
DD-32-54 Positive drug screen
DD-32-55 Deferred by another center - reason unknown
DD-32-56 Travel to leishmania risk area {e.g., Baghdad, Tikrit, Ramadi}
DD-32-57 Travel to leishmania and malarial endemic area {e.g., Afghanistan, Iraq (except Baghdad, Tikrit, Ramadi)}
DD-32-58 Risk factor associated with Chagas
DD-32-59 Donor received tattoo and/or piercing {includes tattoo, any type of piercing or a combination of tattoo and/or piercing}
DD-32-60 Donor was exposed to blood or body fluids other than tattoo or piercing {includes: accidental needlestick; animal bite; human bite; occupational exposure; scarification; branding; exposure not specified; multiple exposures, not including tattoo or piercing}
DD-34-** Donor incorrectly deleted from deferral list or donor not reentered properly, prior deferral due to testing {use DD34** if the donor was deferred due to testing at a previous donation and was either inappropriately removed from the deferral list or not reentered properly}
DD-34-01 Other
DD-34-02 HIV reactive
DD-34-03 HBsAg reactive
DD-34-04 Anti-HBc reactive
DD-34-05 Anti-HCV reactive
DD-34-06 Anti-HTLV reactive
DD-34-07 ALT elevated
DD-34-08 Syphilis reactive
DD-35-** Donor incorrectly deleted from deferral list, prior deferral due to history {use DD35** if the donor was deferred due to history at a previous donation and was inappropriately removed from the deferral list}
DD-35-01 Other {includes: type of behavior or history unknown or not specified; unacceptable address; rape; donor unreliable, for example mental status questionable or donor unable to comprehend donor history questions}
DD-35-02 History of hepatitis, not specified
DD-35-03 History of jaundice
DD-35-04 History of Hepatitis B
DD-35-05 History of Hepatitis C
DD-35-06 Sexually transmitted disease
DD-35-07 Sex partner has or had a sexually transmitted disease
DD-35-08 Sex partner tested reactive for HIV
DD-35-09 Sex partner tested reactive for HTLV
DD-35-10 Sex partner tested reactive for HBV
DD-35-11 Sex partner tested reactive for HCV
DD-35-12 Sex partner tested reactive for hepatitis, not specified
DD-35-13 Sex partner/cohabitant unsuitable or engaged in high risk behavior {includes: sex partner/cohabitant- received clotting factor; incarcerated; history of jaundice; deferred by another center or on national or state deferral list, tested reactive for a viral marker or history/behavior unknown or not specified}
DD-35-14 Male donor had sex with another man
DD-35-15 Female had sex with a man who had sex with another man
DD-35-16 IV drug use {includes taking illegal drugs by needle, e.g., IM}
DD-35-17 Sex with IV drug user
DD-35-18 Non-IV-drug use {includes taking illegal drugs by route other than needle}
DD-35-19 Sex partner used non-IV drugs
DD-35-20 Donor lived in or immigrated from an HIV Group O risk area
DD-35-21 Sex partner lived in or immigrated from an HIV Group O risk area
DD-35-22 Exchanged sex for drugs or money
DD-35-23 Sex partner exchanged sex for drugs or money
DD-35-28 Donor received transfusion or clotting factors
DD-35-29 Donor received tissue allograft or transplanted organ
DD-35-32 Non-sexual exposure to HIV
DD-35-33 Non-sexual exposure to hepatitis, type not specified
DD-35-34 Non-sexual exposure to Hepatitis B
DD-35-35 Non-sexual exposure to Hepatitis C
DD-35-36 Travel to malaria endemic area/history of malaria
DD-35-37 History of disease {donor was aware of condition or disease existed prior to donation; does not include diseases that do not affect the safety, purity, or potency of the product, e.g., heart disease, hemochromatosis, autoimmune disorders, such as Rheumatoid Arthritis, Lupus; history of surgery is reported under DD-35-28 only if blood or blood products were received during surgery or under DD-35-29 if the donor received tissue allograft or transplanted organ}
DD-35-40 Risk factors associated with Creutzfeldt-Jakob Disease - brain surgery
DD-35-41 Risk factors associated with Creutzfeldt-Jakob Disease - family history
DD-35-42 Risk factors associated with Creutzfeldt-Jakob Disease (vCJD) - travel
DD-35-43 Risk factors associated with Creutzfeldt-Jakob Disease - received insulin or other bovine derived product
DD-35-44 Received growth hormone
†DD-35-45 Received finasteride (Proscar or Propecia), Tegison, Accutane, Avodart, Jalyn, or Absorica
DD-35-46 Received medication or antibiotics
DD-35-47 Received vaccine or immune globulin
DD-35-48 Exposure to a disease
DD-35-49 Incarcerated
DD-35-50 Resided in a rehabilitation center or psychiatric hospital
DD-35-51 History of Hepatitis A
DD-35-52 Exposure to Hepatitis A
DD-35-53 Multiple high risk behaviors/contacts
DD-35-54 Positive drug screen
DD-35-55 Deferred by another center - reason unknown
DD-35-56 Travel to leishmania risk area {e.g., Baghdad, Tikrit, Ramadi}
DD-35-57 Travel to leishmania and malarial endemic area {e.g., Afghanistan, Iraq (except Baghdad, Tikrit, Ramadi)}
DD-35-58 Risk factor associated with Chagas
DD-35-59 Donor received tattoo and/or piercing {includes tattoo, any type of piercing or a combination of tattoo and/or piercing}
DD-35-60 Donor was exposed to blood or body fluids other than tattoo or piercing {includes: accidental needlestick; animal bite; human bite; occupational exposure; scarification; branding; exposure not specified; multiple exposures, not including tattoo or piercing}
  BC- **-** BLOOD COLLECTION (Back to top)
BC-40-** Miscellaneous
BC-40-01 Other
BC-41-** Sterility compromised
BC-41-01 Other
BC-41-02 Bacterial contamination (identify organism if possible) {use BC4102 if contamination is discovered as a result of a patient transfusion reaction; if product was prepared in an open system (e.g. pooled Platelets), use CP5102; if contamination was found during Bacterial Detection Testing (product QC), use QC9404}
BC-41-03 Air contamination {system open during collection process, e.g., during sample collection}
BC-41-04 Arm prep not performed or performed inappropriately {includes: the use of incorrect arm preparation supplies; supplies not maintained appropriately, e.g. stored at unacceptable temperature}
BC-42-** Collection bag
BC-42-01 Other
BC-42-02 Blood drawn into outdated bag
BC-42-03 Incorrect anticoagulant
BC-42-04 Outdated anticoagulant
BC-42-05 Potential collection set (bag, tubing) defect (e.g., product leaking) {use BC4205 if event not related to component preparation}
BC-42-06 Incorrect collection bag used (e.g., 500 ml bag instead of 450ml bag)
BC-43-** Collection process
BC-43-01 Other {includes: use of incorrect collection supplies; use of supplies that were not maintained appropriately; product contained clots and was hemolyzed which was not discovered prior to distribution}
BC-43-02 Collection time extended, discrepant, or not documented; not discovered prior to component preparation
BC-43-03 Overbleed; not discovered prior to component preparation
BC-43-04 Collection status not documented or discrepant
†BC-43-05 Product contained clots or fibrin, not discovered prior to distribution {includes clots discovered by consignee upon receipt of product or during transfusion}
BC-43-06 Product hemolyzed, not discovered prior to distribution {reporting not required if hemolyzed product discovered after consignee accepted it into their inventory}
BC-43-07 Source Plasma from two different donors pooled into one pooling bottle
BC-43-08 Donor sample tube mix-up or donor sample tube mislabeled
BC-43-09 Apheresis collection process
BC-44-** Apheresis collection device
BC-44-01 Other {includes collection kits not used within acceptable time period (or not documented) after loading or priming}
BC-44-02 Device defect
BC-44-03 Softgoods defect (bags, tubing, etc)
  CP-**-** COMPONENT PREPARATION (Back to top)
CP-50-** Miscellaneous
CP-50-01 Other
CP-51-** Sterility compromised
CP-51-01 Other
CP-51-02 Bacterial contamination (identify organism is possible) {use CP5102 if the contamination may be related to products prepared in an open system, e.g., pooled, washed, deglycerolized; if contamination is discovered during Bacterial Detection testing, use QC9404}
CP-51-03 Air contamination
CP-51-04 Product integrity compromised during component preparation (e.g., leaking at sterile connection site)
CP-52-** Component not prepared in accordance with specifications
CP-52-01 Other {includes insufficient or excessive plasma volume}
CP-52-02 Platelets made from Whole Blood collected from donor who took medication that may affect platelet function
CP-52-03 Resting time requirements not met for Platelets
CP-52-04 Platelets not agitated
CP-52-05 Platelet count or platelet yield not acceptable as a result of a component preparation deviation or unexpected event {includes platelet count too high to store in one bag or platelet count too low to store in multiple bags}
CP-52-06 Processed at incorrect centrifuge setting
CP-52-07 Product not frozen within the appropriate time frame or freezing time not documented
CP-52-08 Product prepared at incorrect temperature or held at incorrect temperature during component preparation
CP-52-09 Washing/deglycerolization not performed in accordance with specifications {includes expired saline or incorrect wash solution used}
CP-52-10 Leukoreduction not performed in accordance with specifications {includes: time component returned to controlled temperature not documented or discrepant; product not leukoreduced within allowable time frame; filtration process incomplete or performed incorrectly}
CP-52-11 Irradiation not performed in accordance with specifications {includes: time component returned to controlled temperature not documented or discrepant; documentation of irradiation process incomplete; product irradiated more than once; irradiation process incomplete or inadequate}
CP-52-12 Components not prepared within appropriate time frame after collection
CP-52-13 Additive solution not added, added incorrectly, or added to incorrect product or expired additive solution added
CP-52-14 Thawing frozen product not performed in accordance with specifications
CP-52-15 Pooling not performed in accordance with specifications {includes incorrect number of units pooled}
CP-52-16 Aliquot preparation not performed in accordance with specifications
CP-52-17 Sterile docking procedure not performed in accordance with specifications {includes incorrect, missing, or discrepant documentation of weld inspection}
CP-53-** Component prepared from Whole Blood unit that was
CP-53-01 Other
CP-53-02 Overweight
CP-53-03 Underweight
CP-53-04 Collected or stored at unacceptable or undocumented temperature
CP-53-05 A difficult collection or had an extended collection time
CP-54-** Component manufactured that was
CP-54-01 Other
CP-54-02 Overweight
CP-54-03 Underweight
CP-54-04 Lipemic
CP-54-05 Bloody
  VT/RT LABORATORY TESTING (Back to top)
  VT- **-** VIRAL TESTING (Back to top)
VT-70-** Miscellaneous
VT-70-01 Other
VT-71-** Testing performed, interpreted or documented incorrectly (includes QC not performed or unacceptable) for{use VT71** only if testing was performed, interpreted or documented incorrectly; use QC92** if testing is positive or use QC93** if testing is not performed, incompletely performed, or not documented}
VT-71-01 HBsAg
VT-71-02 Anti-HIV-1
VT-71-03 Anti-HIV-2
VT-71-04 Anti-HIV-1/2
VT-71-05 HIV Antigen
VT-71-06 Syphilis
VT-71-07 Anti-HTLV
VT-71-08 Anti-HBc
VT-71-09 ALT
VT-71-10 Anti-HCV
VT-71-11 More than 1 test, e.g., all viral markers
VT-71-12 Cytomegalovirus
VT-71-13 HIV Nucleic Acid Test (NAT)
VT-71-14 HCV Nucleic Acid Test (NAT)
VT-71-15 HIV/HCV Nucleic Acid Test (NAT)
VT-71-16 HBV Nucleic Acid Test (NAT)
VT-71-17 West Nile Virus
VT-71-18 T. Cruzi (Chagas)
VT-72-** Sample identification
VT-72-01 Other
VT-72-02 Incorrect sample tested
VT-72-03 Sample used for testing was incorrectly or incompletely labeled
VT-72-04 Unsuitable sample used for testing
  RT-**-** ROUTINE TESTING (Back to top)
RT-60-** Miscellaneous
RT-60-01 Other
RT-61-** Testing performed, interpreted, or documented incorrectly for {use RT61** only if testing was performed, interpreted or documented incorrectly; use QC92** if testing positive or use QC93** if testing is not performed incompletely performed or not documented}
RT-61-01 Other {includes: DAT; Hemoglobin S testing}
RT-61-04 ABO and/or Rh
RT-61-05 Antibody screening or identification
RT-61-06 Antigen typing
RT-61-07 Platelet count
RT-61-08 Compatibility {includes electronic or immediate spin crossmatch performed instead of full crossmatch, when required}
RT-61-09 ABO, Rh, and antibody screen
RT-61-10 ABO, Rh, antibody screen, and compatibility
RT-61-11 Antibody screen and compatibility
RT-62-** Sample identification
RT-62-01 Other
RT-62-02 Incorrect sample tested
RT-62-03 Sample used for testing was incorrectly or incompletely labeled
RT-62-04 Unsuitable sample used for testing (e.g., too old)
RT-63-** Testing performed using reagents in which QC was unacceptable, not performed, not documented or expired reagents were used
RT-63-01 Other
RT-63-04 ABO and/or Rh
RT-63-05 Antibody screening or identification
RT-63-06 Antigen typing
RT-63-07 Multiple testing {includes all routine testing}
RT-63-08 Coombs control cells
  LA- **-** LABELING (Back to top)
LA-80-** Miscellaneous
LA-80-01 Other
LA-81-** Labels applied to blood unit or product incorrect or missing information
LA-81-01 Other {includes units collected from a paid donor labeled as collected from a volunteer donor}
LA-81-02 ABO and/or Rh incorrect
LA-81-03 ABO and/or Rh missing
LA-81-04 Product type or code incorrect (e.g., RBC labeled as Whole Blood) {do not use LA8104 if there is a specific code available, e.g. use LA8113 if unit not labeled as leukoreduced}
LA-81-05 Product type or code missing
LA-81-06 Extended or missing expiration date or time
LA-81-08 Anticoagulant incorrect or missing
LA-81-09 Donor/unit number or lot number incorrect or missing
LA-81-10 Combination of incorrect or missing information {e.g., unit number and expiration date}
LA-81-11 Product or anticoagulant volume or weight incorrect or missing
LA-81-12 Irradiation status incorrect or missing
LA-81-13 Leukoreduction status incorrect or missing
LA-81-14 Irradiation and leukoreduction status incorrect or missing
LA-81-15 CMV status incorrect or missing
LA-81-16 Machine-readable bar code incorrect or missing {Lot number, product code, or ABO and Rh of the donor}
LA-82-** Crossmatch tag, tie tag, or transfusion record incorrect or missing information {Use LA-82 if tag physically attached to the unit is incorrect or missing information, the transfusion record, accompanied with unit, is incorrect or missing information, or both the tag and transfusion record are incorrect or missing information}
LA-82-01 Other {includes: Hemoglobin S; required information that’s not identified in any other deviation code}
LA-82-02 Unit ABO and/or Rh incorrect or missing
LA-82-03 Recipient ABO and/or Rh incorrect or missing
LA-82-04 Product type or code incorrect or missing
LA-82-05 Expiration date or time extended or missing
LA-82-06 Unit, lot or pool number incorrect or missing
LA-82-07 Recipient identification incorrect or missing (specify if autologous unit)
LA-82-08 Antigen incorrect or missing
LA-82-09 Antibody incorrect or missing
LA-82-10 Platelet count incorrect or missing
LA-82-11 HLA type incorrect or missing
LA-82-12 Product or anticoagulant volume or weight incorrect or missing
LA-82-13 CMV status incorrect or missing
LA-82-14 Irradiation status incorrect or missing
LA-82-15 Leukoreduced status incorrect or missing
LA-82-16 Crossmatch tags or transfusion records switched, both units intended for the same patient
LA-82-17 Compatibility information incorrect or missing
LA-82-18 Biohazard or test status incorrect or missing {includes autologous unit with a positive viral marker not labeled appropriately}
LA-82-19 Combination of incorrect or missing information {e.g., unit number and expiration date}
†LA-82-20 Crossmatch tag, tie tag, or transfusion record missing or attached to incorrect unit {e.g., intended for different patient}
  QC- **-** QUALITY CONTROL and DISTRIBUTION (Back to top)
QC-90-** Miscellaneous
QC-90-01 Other
QC-91-** Failure to quarantine unit due to medical history: {includes failure to quarantine after receiving post donation information, use the code specific to the post donation information}
QC-91-01 Other {includes: type of behavior or history unknown or not specified; unacceptable address; rape; donor unreliable, for example mental status questionable or donor unable to comprehend donor history questions}
QC-91-02 History of hepatitis, not specified
QC-91-03 History of jaundice
QC-91-04 History of Hepatitis B
QC-91-05 History of Hepatitis C
QC-91-06 Sexually transmitted disease
QC-91-07 Sex partner has or had a sexually transmitted disease
QC-91-08 Sex partner tested reactive for HIV
QC-91-09 Sex partner tested reactive for HTLV
QC-91-10 Sex partner tested reactive for HBV
QC-91-11 Sex partner tested reactive for HCV
QC-91-12 Sex partner tested reactive for hepatitis, not specified
QC-91-13 Sex partner/cohabitant unsuitable or engaged in high risk behavior {includes: sex partner/cohabitant- received clotting factor; incarcerated; history of jaundice; deferred by another center or on national or state deferral list, tested reactive for a viral marker or history/behavior unknown or not specified}
QC-91-14 Male donor had sex with another man
QC-91-15 Female had sex with a man who had sex with another man
QC-91-16 IV drug use {includes taking illegal drugs by needle, e.g., IM}
QC-91-17 Sex with IV drug user
QC-91-18 Non-IV-drug use {includes taking illegal drugs by route other than needle}
QC-91-19 Sex partner used non-IV drugs
QC-91-20 Donor lived in or immigrated from an HIV Group O risk area
QC-91-21 Sex partner lived in or immigrated from an HIV Group O risk area
QC-91-22 Exchanged sex for drugs or money
QC-91-23 Sex partner exchanged sex for drugs or money
QC-91-28 Donor received transfusion or clotting factors
QC-91-29 Donor received tissue allograft or transplanted organ
QC-91-32 Non-sexual exposure to HIV
QC-91-33 Non-sexual exposure to hepatitis, type not specified
QC-91-34 Non-sexual exposure to Hepatitis B
QC-91-35 Non-sexual exposure to Hepatitis C
QC-91-36 Travel to malaria endemic area/history of malaria
QC-91-37 History of disease {donor was aware of condition or disease existed prior to donation; does not include diseases that do not affect the safety, purity, or potency of the product, e.g., heart disease, hemochromatosis, autoimmune disorders, such as Rheumatoid Arthritis, Lupus; history of surgery is reported under QC-91-28 only if blood or blood products were received during surgery or under QC-91-29 if donor received tissue allograft or transplanted organ}
QC-91-39 History of Creutzfeldt-Jakob Disease
QC-91-40 Risk factors associated with Creutzfeldt-Jakob Disease - brain surgery
QC-91-41 Risk factors associated with Creutzfeldt-Jakob Disease - family history
QC-91-42 Risk factors associated with Creutzfeldt-Jakob Disease (vCJD) - travel
QC-91-43 Risk factors associated with Creutzfeldt-Jakob Disease - received insulin or other bovine derived product
QC-91-44 Received growth hormone
†QC-91-45 Received finasteride (Proscar or Propecia), Tegison, Accutane, Avodart, Jalyn, or Absorica
QC-91-46 Received medication or antibiotics
QC-91-47 Received vaccine or immune globulin
QC-91-48 Exposure to a disease
QC-91-49 Incarcerated
QC-91-50 Resided in a rehabilitation center or psychiatric hospital
QC-91-51 History of Hepatitis A
QC-91-52 Exposure to Hepatitis A
QC-91-53 Multiple high risk behaviors/contacts
QC-91-54 Positive drug screen
QC-91-55 Deferred by another center
QC-91-56 Post donation illness
QC-91-57 Travel to leishmania risk area {e.g., Baghdad, Tikrit, Ramadi}
QC-91-58 Travel to leishmania and malarial endemic area {e.g., Afghanistan, Iraq (except Baghdad, Tikrit, Ramadi)}
QC-91-59 Risk factor associated with Chagas
QC-91-60 Donor received tattoo and/or piercing {includes tattoo, any type of piercing or a combination of tattoo and/or piercing}
QC-91-61 Donor was exposed to blood or body fluids other than tattoo or piercing {includes: accidental needlestick; animal bite; human bite; occupational exposure; scarification; branding; exposure not specified; multiple exposures, not including tattoo or piercing}
QC-92-** Positive testing for {Use RT61** or VT71** if testing was performed incorrectly, use QC93** if testing was not performed, incompletely performed or not documented}

QC-92-01 Other {includes: Hemoglobin S; drug screen; West Nile Virus; Parvovirus, Babsia; Chagas; DAT}
QC-92-02 HIV  
QC-92-03 HBV (HBsAg, HBV NAT)  
QC-92-04 Anti-HBc  
QC-92-05 Anti-HCV  
QC-92-06 Anti-HTLV
QC-92-07 ALT elevated
QC-92-10 Antibody screen or identification (donor/unit or recipient)
QC-92-11 Antigen screen
QC-92-12 Syphilis
QC-92-13 All viral markers
QC-92-14 Compatibility
QC-92-15 HIV/HCV Nucleic Acid Test (NAT)
QC-93-** Testing not performed, incompletely performed or not documented for {use RT61** or VT71 if testing was performed incorrectly, use QC92** if testing was positive}
QC-93-01 Other {includes: Hemoglobin S; drug screen; West Nile Virus; Parvovirus}
QC-93-02 HIV
QC-93-03 HBV (HBsAg, HBV NAT)
QC-93-04 Anti-HBc
QC-93-05 Anti-HCV
QC-93-06 Anti-HTLV
QC-93-07 ALT
QC-93-10 Antibody screen or identification (donor/unit or recipient)
QC-93-11 Antigen screen {use QC9311 if patient has history of positive antibody screen and unit is not screened for corresponding antigen}
QC-93-12 Syphilis
QC-93-13 All viral markers
QC-93-14 Compatibility
QC-93-15 HIV/HCV Nucleic Acid Test (NAT)
QC-93-16 ABO and/or Rh (donor/unit or recipient)
QC-93-17 ABO/Rh and antibody screen (donor/unit or recipient)
QC-94-** Distribution of product that did not meet specifications
QC-94-01 Other {includes inappropriate release of Rh Immune Globulin; product distributed prior to required record review}
QC-94-02 Outdated product
QC-94-03 Autologous unit not meeting homologous criteria
QC-94-04 Product QC unacceptable (e.g., positive), not performed, not documented, or incomplete {includes: platelet count; product hematocrit/hemoglobin; RBC recovery; absolute red cell volume or product volume; WBC count; pH (specify if used as a test for bacterial detection); bacterial detection testing; product QC not performed during validation of apheresis machine}
QC-94-05 Product in which specification other than QC not met {includes incorrect dose; age of product; appearance; foreign objects or particulates}
†QC-94-06 Product in which instrument QC, calibration, or validation was unacceptable, incomplete, not performed or not documented {includes hemoglobin/hematocrit reagents; microhematocrit centrifuge; trip scale; collection device; incubator/heat block; waterbath; centrifuge; irradiator}
QC-94-08 Product distributed prior to resolution of discrepancy {conflicting information that requires investigation which is not resolved prior to distribution, e.g., discrepant test results; ABO discrepancy; Whole Blood Number discrepancy; do not use QC9408 if more specific code applies, such as QC9412 through QC9418}
QC-94-09 Product associated with product that contained clots or hemolysis {use QC9409 if in-house component is discovered to be clotted or hemolyzed and associated component has already been distributed; use QC9412 if in-house component is discover to be clotted or hemolyzes and associated product was not quarantined; if consignee discovers component is clotted or hemolyzed and associated components were also distributed, use BC4305(clotted) or BC4306(hemolyzed)}
QC-94-12 Product identified as unsuitable due to a collection deviation or unexpected event {event discovered prior to distribution, but failed to quarantine product; includes collection time extended, discrepant, or not documented; potential air contamination, unit or associated unit was clotted or hemolyzed}
QC-94-13 Product identified as unsuitable due to a component preparation deviation or unexpected event {event discovered prior to distribution, but failed to quarantine product; includes leukoreduction or irradiation not performed within specifications; transport (from collection center) conditions unacceptable, not documented, or discrepant}
QC-94-14 Product identified as unsuitable due to a labeling deviation or unexpected event {event discovered prior to distribution, but failed to quarantine product}
QC-94-15 Product identified as unsuitable due to a donor screening deviation or unexpected event {event discovered prior to distribution, but failed to quarantine product; includes donor history question not answered or incomplete; abbreviated donor history questionnaire used instead of full-length}
QC-94-16 Product identified as unsuitable due to a donor deferral deviation or unexpected event {event discovered prior to distribution, but failed to quarantine product}
QC-94-17 Product identified as unsuitable due to a shipping or storage deviation or unexpected event {event discovered prior to distribution, but failed to quarantine product; includes temperature excursions, shipping time out of specification}
QC-94-18 Product identified as unsuitable due to a viral testing deviation or unexpected event  {event discovered prior to distribution, but failed to quarantine product; includes products released with positive or incomplete viral testing}
QC-96-** Shipping and storage
QC-96-01 Other
QC-96-02 Arrived at consignee at unacceptable temperature {use this code if shipment was packed appropriately, but the temperature upon arrival was unacceptable}
QC-96-03 Stored at incorrect temperature
QC-96-04 No documentation that product was shipped or stored at appropriate temperature
QC-96-05 Temperature not recorded or unacceptable upon return, unit redistributed
QC-96-06 Shipment exceeded time allowed for shipping
QC-96-07 Product not packed in accordance with specifications or no documentation that product was packed appropriately
QC-96-08 Product returned to blood center and reissued inappropriately {includes no record of inspection upon return; if specific to temperature, use QC-96-05}
QC-96-09 Visual inspection not performed or documented by blood center prior to distribution
QC-97-** Distribution procedure not performed in accordance with blood bank transfusion service’s specifications
QC-97-01 Other
QC-97-02 Product not irradiated as required
QC-97-03 Product issued to wrong patient
QC-97-04 Improper product selected for patient
QC-97-05 Improper ABO or Rh type selected for patient
QC-97-06 Product not leukoreduced as required
QC-97-07 Product released prior to obtaining current sample for ABO, Rh, antibody screen and/or compatibility testing
QC-97-08 Product not CMV negative as required
QC-97-10 Filter not issued with product or incorrect filter issued
QC-97-11 Product not irradiated and leukoreduced as required
QC-97-12 Product not irradiated and CMV negative as required
QC-97-13 Procedure for issuing not performed or documented in accordance with specifications {includes: request slip labeled with incorrect or missing patient identification; emergency release procedure not followed}
QC-97-14 ABO and/or Rh retype of unit not performed or performed incorrectly
QC-97-15 Visual inspection not performed, not documented, or inadequate
QC-97-16 Product inspected and accepted upon receipt from blood center, subsequently discovered to be hemolyzed
QC-97-17 Product not washed as required
QC-97-18 Product returned and reissued inappropriately
QC-97-19 Product not documented or incorrectly documented as issued in the computer (computer documentation is final check of issue process)
QC-97-20 Product not volume reduced as required
QC-97-21 Product not hemoglobin S negative as required
  MI- **-** MISCELLANEOUS (Back to top)
MI-00-** Miscellaneous
MI-00-01 Other
MI-01-** Donor implicated in transfusion associated disease 
MI-01-01 Other
MI-01-02 HIV
MI-01-03 Hepatitis (specify type, if known)
MI-01-04 West Nile Virus
MI-01-05 Babesia
MI-01-06 Chagas
MI-01-07-Malaria
 
MI-02-** Lookback; subsequent unit tested confirmed positive for {use MI02** when confirmatory or additional supplemental testing is positive; if confirmatory or additional supplemental testing is not positive, a report is not required}
MI-02-01 Other
MI-02-02 HIV
MI-02-03 HBV
MI-02-04 HCV
MI-02-05 West Nile Virus
MI-02-06 HTLV
MI-02-07 Babesia
MI-02-08 Chagas
??-??-?? DO NOT KNOW


 Licensed Non-Blood BPD Codes (Back to top)
Use the following list of Biological Product Deviation (BPD) Codes to assign a specific code to a reportable event when you submit the report to FDA. Use the guidance document, "Biological Product Deviation Reporting for Manufacturers of Biological Products Other than Blood and Blood Components," to determine if you must report an event. The list includes deviations from regulations, standards, and standard operating procedures (SOPs) that may affect the safety, purity, or potency of a product. These codes may not apply to all establishments because they include deviations and unexpected events related to SOPs implemented at individual establishments and may not be an industry standard or a procedure at your facility. The use of BPD Codes will assist the FDA in analyzing the data submitted and streamline the trend analysis.
No changes to the deviation codes were made for FY2014.
IM - Incoming Material Specifications
PC - Process Controls
TE - Testing
LA - Labeling
PS - Product Specifications
QC - Quality Control and Distribution
MI - Miscellaneous

  IM-**-** INCOMING MATERIAL SPECIFICATIONS (Back to Non-Blood)

IM-10-** Miscellaneous
IM-10-01 Other
IM-12-** Container
IM-12-01 Specifications not met
IM-12-02 Defective
IM-13-** Closures
IM-13-01 Specifications not met
IM-13-02 Defective
IM-14-** Source or raw material does not meet specifications or otherwise found to be unsuitable
IM-14-01 Other {includes: source material collected from donor who traveled to vCJD risk area}
IM-14-02 Contains precipitate
IM-14-03 Contaminated with microorganism
IM-14-04 Contaminated with mold
IM-14-05 Impurities exceed specification
IM-14-06 Testing deviation
IM-14-07 Stored or shipped at incorrect temperature or lack of controlled temperature
  PC-**-** PROCESS CONTROLS (Back to Non-Blood)
PC-20-** Miscellaneous
PC-20-01 Other
PC-21-** Manufacturing or processing performed using incorrect parameters
PC-21-01 Other
PC-21-02 Incorrect temperature
PC-21-03 Filling not performed according to specifications
PC-21-04 Aseptic processing not performed according to procedures
PC-22-** Process/Procedure
PC-22-01 Other
PC-22-02 Interruption of process
PC-22-03 Environmental monitoring excursions
PC-22-04 Equipment not performing properly
PC-22-05 Sanitization procedures not performed or performed incorrectly
PC-22-06 Media fill failure or media fill performed incorrectly
PC-23-** Process Water - specification not met
PC-23-01 Other
PC-23-02 Water for injection
PC-23-03 Purified water
PC-24-** Bulk material does not meet specifications or otherwise found to be unsuitable
PC-24-01 Other
PC-24-02 Contains precipitate
PC-24-03 Contaminated with microorganism
PC-24-04 Contaminated with mold
PC-24-05 Impurities exceed specification
PC-24-06 Stored at incorrect temperature
PC-24-07 Stored for an excessive hold time
  TE-**-** TESTING (Back to Non-Blood)
TE-30-** Miscellaneous
TE-30-01 Other
TE-31-** Safety
TE-31-01 Performed incorrectly
TE-31-02 Not performed or not documented
TE-32-** Purity
TE-32-01 Performed incorrectly
TE-32-02 Not performed or not documented
TE-33-** Potency
TE-33-01 Performed incorrectly
TE-33-02 Not performed or not documented
TE-34-** Sterility
TE-34-01 Performed incorrectly
TE-34-02 Not performed or not documented
TE-35-** Identity
TE-35-01 Performed incorrectly
TE-35-02 Not performed or not documented
TE-36-** Stability
TE-36-01 Performed incorrectly
TE-36-02 Not performed or not documented
  LA- **-** LABELING (Back to Non-Blood)
LA-40-** Miscellaneous
LA-40-01 Other
LA-41-** Package insert
LA-41-01 Incorrect/illegible
LA-41-02 Missing
LA-41-03 Not current or approved
LA-42-** Product label
LA-42-01 Incorrect/illegible
LA-42-02 Missing
LA-43-** Carton label
LA-43-01 Incorrect/illegible
LA-43-02 Missing
LA-44-** Expiration date
LA-44-01 Extended/illegible
LA-44-02 Missing
LA-45-** Lot number
LA-45-01 Incorrect/illegible
LA-45-02 Missing
LA-46-** Storage temperature
LA-46-01 Incorrect/illegible
LA-46-02 Missing
LA-47-** Administration route
LA-47-01 Incorrect/illegible
LA-47-02 Missing
LA-48-** Concentration or volume
LA-48-01 Incorrect/illegible
LA-48-02 Missing
LA-49-** Multiple information {e.g., lot number and expiration date}
LA-49-01 Incorrect/illegible
LA-49-02 Missing
  PS-**-** PRODUCT SPECIFICATIONS (Back to Non-Blood)
PS-50-** Miscellaneous
PS-50-01 Other
PS-51-** Product specification not met
PS-51-01 Other
PS-51-02 Contains precipitate
PS-51-03 Contaminated with microorganism
PS-51-04 Contaminated with mold
PS-51-05 Impurity levels
PS-51-06 Moisture
PS-51-07 Preservative content
PS-51-08 Potency
PS-51-09 Appearance {includes: cloudy; hemolyzed; foreign object/particle}
PS-51-10 Fill volume
PS-51-11 Container closure not secure or damaged {includes reports of complaints of leaking vials due to loose cap; missing stoppers; damaged or incomplete seals that may be associated with manufacturing}
PS-52-**Component packaged with final product did not meet specifications
PS-52-01 Other
PS-52-02 Contains precipitate/particle
PS-52-03 Contaminated with microorganism
PS-52-04 Contaminated with mold
PS-52-05 Fill volume
PS-52-06 Broken/cracked vial
PS-53-** Stability testing failed
PS-53-01 Other
PS-53-02 Potency
PS-53-03 Preservative
PS-53-04 Container closure integrity
PS-53-05 Chemical analysis/purity
PS-53-06 Moisture
PS-53-07 pH
PS-54-** Administration set (packaged with product) incorrect or incomplete
PS-54-01 Other
PS-54-02 Incorrect or missing label
PS-54-03 Defective
PS-54-04 Expired
  QC- **-** QUALITY CONTROL AND DISTRIBUTION (Back to Non-Blood)

QC-60-** Miscellaneous

QC-60-01 Other

QC-61-** Product distributed inappropriately

QC-61-01 Other
QC-61-02 Product distributed prior to completion of required testing
QC-61-03 Product distributed prior to CBER approval of a PAS
QC-61-04 Product distributed less than 30 days after submission of CBE-30 or prior to submission of CBE-30
QC-61-05 Product distributed prior to validation of process
QC-61-06 Outdated product distributed
QC-61-07 Product distributed prior to release by the quality control unit

QC-62-** Shipping and storage
QC-62-01 Other
QC-62-02 Product shipped at incorrect temperature
QC-62-03 Product stored at incorrect temperature
QC-62-04 No documentation product was shipped or stored at appropriate temperature
QC-63-** Product identified as unacceptable, and not quarantined
QC-63-01 Other
QC-64-** Packing
QC-64-01 Other
QC-64-02 Vial missing
QC-64-03 Packaged incorrectly
QC-64-04 Broken or cracked vial
QC-64-05 Improper orientation (e.g., sideways)

MI- **-** MISCELLANEOUS (Back to Non-Blood)
MI-70-** Miscellaneous
MI-70-01 Other
MI-70-02 Leaking vial/container; not confirmed or cause of leak cannot be determined {includes complaints that are not confirmed or cause of leak cannot be determined.  If the leak is known to be due to the cap or metal seal, then use PS-51-11}
??-??-?? DO NOT KNOW


  Deviation Codes for Human Cells, Tissues and Cellular and Tissue-based Products (HCT/P) (Back to top)
Use the following list of Deviation Codes for Human Cells, Tissues and Cellular and Tissue-based Products to assign a specific code to a reportable event when you submit the report to FDA. The list includes numerous HCT/P deviations [see 1271.3(dd)] that may occur. However, an event is only required to be reported [see 1271.350(b)(2)] if it relates to “core Current Good Tissue Practices” [see 1271.150(b)], involves a distributed HCT/P, and occurs in your facility or a facility that performs a manufacturing step for you under contract, agreement, or other arrangement. The use of the HCT/P deviation codes will assist the FDA in analyzing the data submitted and streamline the trend analysis.
No changes to the deviation codes were made for FY2014.
DE - Donor Eligibility
DS - Donor Screening
DT - Donor Testing
FA - Facilities
EC - Environmental Control
EQ - Equipment
SR - Supplies and Reagents
RE - Recovery
PC - Processing and Processing Controls
LC - Labeling Controls
ST - Storage
SD - Receipt, Pre-Distribution, Shipment, and Distribution

DE -**-** DONOR ELIGIBILTY (Back to HCT / P)
DE-99-** - Miscellaneous
DE-99-01 - Other
DE-01-**Not performed or documented [except as provided in 1271.90]
DE-01-01 - Donor screening not performed or documented
DE-01-02 - Donor testing not performed or documented
DE-01-03 - Donor screening and testing not performed or documented
DE-02-** - Ineligible donor accepted [except as provided in 1271.65(b)]
DE-02-01 - Risk factors, clinical evidence or physical evidence identified
DE-02-02 - Xenotransplant recipient accepted as donor
DE-02-03 - Abbreviated donor screening inappropriately used or not performed
DE-02-04 - Donor tested reactive for relevant communicable disease
DE-02-05 - Donor of viable, leukocyte-rich HCT/Ps not properly evaluated for evidence of infection due to cytomegalovirus
DE-02-06 - Assessment to detect evidence of TSE not performed for dura mater donor
DE-02-07 - Donor incorrectly evaluated for plasma dilution
DE-02-08 - Donor not evaluated or evaluation not documented for plasma dilution
DS -**-** DONOR SCREENING (Back to HCT / P)
DS-99-** - Miscellaneous
DS-99-01 - Other
DS-01-** - Donor screening not performed or documented in the:
DS-01-01 - Donor medical history interview
DS-01-02 - Physical assessment of a cadaveric donor or physical examination of a living donor
DS-01-03 - Medical record review
DS-01-04 - Evaluation of communicable disease risks associated with xenotransplant
DS-02-** - Donor screening performed incorrectly (incomplete or inaccurate) in the:
DS-02-01 - Donor medical history interview
DS-02-02 - Physical assessment of a cadaveric donor or physical examination of a living donor
DS-02-03 - Medical record review
DS-02-04 - Evaluation of communicable disease risks associated with xenotransplant
DT -**-** DONOR TESTING (Back to HCT / P)
DT-99-** - Miscellaneous
DT-99-01 - Other
DT-01-** - Testing not performed or documented when required, for:
DT-01-01 - Human immunodeficiency virus, type 1
DT-01-02 - Human immunodeficiency virus, type 2
DT-01-03 - Hepatitis B virus
DT-01-04 - Hepatitis C virus
DT-01-05 - Treponema pallidum
DT-01-06 - Human T-lymphotropic virus, type I
DT-01-07 - Human T-lymphotropic virus, type II
DT-01-08 - Cytomegalovirus
DT-01-11 - Multiple tests
DT-02-** - Testing incorrectly performed when required, for:
DT-02-01 - Human immunodeficiency virus, type 1
DT-02-02 - Human immunodeficiency virus, type 2
DT-02-03 - Hepatitis B virus
DT-02-04 - Hepatitis C virus
DT-02-05 - Treponema pallidum
DT-02-06 - Human T-lymphotropic virus, type I
DT-02-07 - Human T-lymphotropic virus, type II
DT-02-08 - Cytomegalovirus
DT-02-11 - Multiple tests
DT-03-** - Unacceptable specimen tested
DT-03-01 - Specimen collected more than 7 days before or after recovery
DT-03-02 - Specimen collected from donor 1 month of age or younger, instead of from birth mother
DT-03-03 - Specimen collected from a peripheral blood stem cell donor more than 30 days before recovery
DT-03-04 - Specimen storage conditions not met
DT-03-05 - Specimen did not meet requirements in test kit package insert
DT-04-** Inappropriate test or test laboratory used
DT-04-01 - Required test used was not licensed, approved, or cleared {includes HIV/HCV NAT performed on pooled samples instead of individual samples}
DT-04-02 - Required tests approved for cadaveric specimens not used when available
DT-04-03 - Laboratory performing tests not CLIA certified (or equivalent for CMS)
DT-04-04 - Laboratory performing tests not FDA approved
FA -**-** FACILITIES
FA-99-** Miscellaneous
FA-99-01 - Other
FA-01-** Design
FA-01-01 - Facility not suitable in size, construction, and/or location
FA-01-02 - Inadequate lighting, ventilation, plumbing and/or drainage
FA-02-** Cleaning and sanitization
FA-02-01 - Cleaning or sanitization not performed or documented in accordance with established schedules 
EC -**-** ENVIRONMENTAL CONTROL (Back to HCT / P)
EC-99-** - Miscellaneous
EC-99-01 - Other
EC-01-** Environmental controls, when required, not performed or documented for
EC-01-01 - Temperature controls
EC-01-02 - Humidity controls
EC-01-03 - Ventilation and air filtration controls
EC-01-04 - Cleaning and disinfecting of rooms
EC-01-05 - Maintenance of environmental monitoring and control equipment
EC-02-** Environmental controls, when required, incorrectly performed for
EC-02-01 - Temperature controls
EC-02-02 - Humidity controls
EC-02-03 - Ventilation and air filtration controls
EC-02-04 - Cleaning and disinfecting of rooms
EC-02-05 - Maintenance of environmental monitoring and control equipment
EQ - **-** EQUIPMENT
EQ-99-** Miscellaneous
EQ-99-01 - Other
EQ-01-** Design
EQ-01-01 - Equipment is not of an appropriate design for its use, and/or suitably located
EQ-01-02 - Equipment not capable of producing valid results
EQ-02-** Maintenance
EQ-02-01 - Cleaning or sanitization not performed or documented in accordance with established schedules
EQ-02-02 - Quality control not performed or documented
  SR -**-** SUPPLIES AND REAGENTS (Back to HCT / P)
SR-99-** - Miscellaneous
SR-99-01 - Other
SR-01-** Not verified to meet specifications for use
SR-01-01 - Supplies
SR-01-02 - Reagents
SR-02-** - Reagent unsuitable
SR-02-01 - Not sterile, where appropriate
RE -**-** RECOVERY (Back to HCT / P)
RE-99-** - Miscellaneous
RE-99-01 - Other
RE-01-** - Manner of recovery
RE-01-01 - HCT/P contaminated, potentially contaminated, or cross-contaminated during recovery
PC -**-** PROCESSING AND PROCESS CONTROLS (Back to HCT / P)
PC-99-** - Miscellaneous
PC-99-01 - Other
PC-01-**- Processing
PC-01-01 - HCT/P contaminated, potentially contaminated, or cross-contaminated during processing (identify organism, if possible)
PC-01-02 - HCT/Ps from more than one donor were pooled during manufacturing
PC-02-** - In-process controls
PC-02-01 - Not followed
PC-02-02 - Inadequate
PC-03-** - In-process testing
PC-03-01 - Sample not representative of the material to be evaluated
LC -**-** LABELING CONTROLS (Back to HCT / P)
LC-99-** - Miscellaneous
LC-99-01 - Other
LC-01-** - Controls for labeling
LC-01-01 - Not established or maintained
LC-01-02 - Did not prevent mix-ups
LC-01-03 - Did not allow proper identification
LC-02-** Label unacceptable
LC-02-01 - Inaccurate
LC-02-02 - Illegible
ST -**-** STORAGE (Back to HCT / P)
ST-99-** - Miscellaneous
ST-99-01 - Other
ST-01-** - Storage area not controlled to prevent mix-ups of:
ST-01-01 - HCT/Ps
ST-01-02 - Supplies
ST-01-03 - Reagents
ST-02-** - Storage area not controlled to prevent contamination or cross-contamination of:
ST-02-01 - HCT/Ps
ST-02-02 - Supplies
ST-02-03 - Reagents
ST-03-** - Storage temperature
ST-03-01 - Not appropriate
ST-04-** - Expiration date, where appropriate
ST-04-01 - Incorrect or missing
SD -**-** RECEIPT, PRE-DISTRIBUTION SHIPMENT, and DISTRIBUTION (Back to HCT / P)
SD-99-** - Miscellaneous
SD-99-01 - Other
SD-01-** - Quarantined HCT/Ps
SD-01-01 - Shipped without quarantine identification
SD-02-** - Inappropriate distribution
SD-02-01 - Distributed without review of required records
SD-02-02 - Distributed without sign-off by a responsible person
SD-02-03 - Quarantined HCT/P that was determined ineligible for release
SD-02-04 - Contaminated or potentially contaminated HCT/P (identify organism, if possible)
SD-02-05 - Outdated product
SD-03-** - Inappropriate shipping conditions
SD-03-01 - Temperature
SD-03-02 - Packaging
SD-03-03 - Container construction
SD-04-** - Incoming HCT/P
SD-04-01 - Not evaluated and inspected for damage and contamination
??-??-?? DO NOT KNOW

 

 

 

 

Contact FDA

(800) 835-4709
(240) 402-8010
Manufacturers Assistance and Technical Training Branch (CBER)

Division of Manufacturers Assistance and Training

Office of Communication, Outreach and Development

Food and Drug Administration

10903 New Hampshire Avenue

Building 71 Room 3103

Silver Spring, MD 20993-0002