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

 

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

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  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, 2011 are identified with a dagger (†).

The changes to the deviation codes for FY2012 are listed below.

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

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)

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

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)

New Codes Added:

MISCELLANEOUS
MI-01-** Donor implicated in transfusion associated disease
MI-01-07 Malaria

If you are a transfusion service only, the deviation codes you should select from 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 MI codes for confirmed positives if testing performed at your facility}

PD-11-01 Other
PD-11-02 Tested reactive for Hepatitis B post donation
PD-11-03 Tested reactive for Hepatitis B prior to donation
PD-11-04 Tested reactive for Hepatitis C post donation
PD-11-05 Tested reactive for Hepatitis C prior to donation
PD-11-06 Tested reactive for HIV post donation
PD-11-07 Tested reactive for HIV prior to donation
PD-11-08 Tested reactive for HTLV post donation
PD-11-09 Tested reactive for HTLV prior to donation
PD-11-10 Tested reactive for sexually transmitted disease post donation
PD-11-11 Tested reactive for sexually transmitted disease prior to donation
PD-11-12 Tested reactive for hepatitis not specified, post donation
PD-11-13 Tested reactive for hepatitis not specified, prior to donation
PD-11-14 Tested reactive at another center, specific testing unknown
PD-11-15 Tested reactive for Hepatitis A post donation
PD-11-16 Tested reactive for Hepatitis A prior to donation
PD-11-17 Elevated ALT post donation
PD-11-18 Elevated ALT 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 or surgery {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}
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, or Avodart
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
PD-13-03 Post donation diagnosis or symptoms of Hepatitis C
PD-13-04 Post donation diagnosis or symptoms of HIV
PD-13-05 Post donation diagnosis or symptoms of HTLV
PD-13-06 Post donation diagnosis or symptoms of sexually transmitted disease
PD-13-07 Post donation diagnosis or symptoms of hepatitis, not specified
PD-13-08 Post donation diagnosis or symptoms of 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-23-** Deferral screening not done or incorrectly performed

DS-23-01 Donor not previously deferred {use DS2301 when the deferral file is not checked during donor screening process or the deferral file check was incorrectly performed (e.g., all search criteria not used) and the donor was not previously deferred}

DS-24-** Deferral screening not done or incorrectly performed, donor previously deferred due to testing: {use DS24** when the deferral file is not checked during donor screening process or the deferral file check was incorrectly performed (e.g., all search criteria not used) and the donor was previously deferred due to testing}

DS-24-01 Other
DS-24-02 HIV reactive
DS-24-03 HBsAg reactive
DS-24-04 Anti-HBc reactive
DS-24-05 Anti-HCV reactive
DS-24-06 Anti-HTLV reactive
DS-24-07 ALT elevated
DS-24-08 Syphilis reactive

DS-25-** Deferral screening not done or incorrectly performed, donor previously deferred due to history {use DS25** when the deferral file is not checked during donor screening process or the deferral file check was incorrectly performed (e.g., all search criteria not used) and the donor was previously deferred due to history}

DS-25-01 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-25-02 History of hepatitis, not specified
DS-25-03 History of jaundice
DS-25-04 History of Hepatitis B
DS-25-05 History of Hepatitis C
DS-25-06 Sexually transmitted disease
DS-25-07 Sex partner has or had a sexually transmitted disease
DS-25-08 Sex partner tested reactive for HIV
DS-25-09 Sex partner tested reactive for HTLV
DS-25-10 Sex partner tested reactive for HBV
DS-25-11 Sex partner tested reactive for HCV
DS-25-12 Sex partner tested reactive for hepatitis, not specified
DS-25-13 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-25-14 Male donor had sex with another man
DS-25-15 Female had sex with a man who had sex with another man
DS-25-16 IV drug use {includes taking illegal drugs by needle, e.g., IM}
DS-25-17 Sex with IV drug user
DS-25-18 Non-IV-drug use {includes taking illegal drugs by route other than needle}
DS-25-19 Sex partner used non-IV drugs
DS-25-20 Donor lived in or immigrated from an HIV Group O risk area
DS-25-21 Sex partner lived in or immigrated from an HIV Group O risk area
DS-25-22 Exchanged sex for drugs or money
DS-25-23 Sex partner exchanged sex for drugs or money
DS-25-28 Donor received transfusion or clotting factors
DS-25-29 Donor received tissue allograft or transplanted organ
DS-25-32 Non-sexual exposure to HIV
DS-25-33 Non-sexual exposure to hepatitis, type not specified
DS-25-34 Non-sexual exposure to Hepatitis B
DS-25-35 Non-sexual exposure to Hepatitis C
DS-25-36 Travel to malaria endemic area/history of malaria
DS-25-37 History of disease or surgery {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}
DS-25-40 Risk factors associated with Creutzfeldt-Jakob Disease - brain surgery
DS-25-41 Risk factors associated with Creutzfeldt-Jakob Disease - family history
DS-25-42 Risk factors associated with Creutzfeldt-Jakob Disease (vCJD) - travel
DS-25-43 Risk factors associated with Creutzfeldt-Jakob Disease - received insulin or other bovine derived product
DS-25-44 Received growth hormone
DS-25-45 Received finasteride (Proscar or Propecia), Tegison, Accutane, or Avodart
DS-25-46 Received medication or antibiotics
DS-25-47 Received vaccine or immune globulin
DS-25-48 Exposure to a disease
DS-25-49 Incarcerated
DS-25-50 Resided in a rehabilitation center or psychiatric hospital
DS-25-51 History of Hepatitis A
DS-25-52 Exposure to Hepatitis A
DS-25-53 Multiple high risk behaviors/contacts
DS-25-54 Positive drug screen
DS-25-55 Deferred by another center - reason unknown
DS-25-56 Travel to leishmania risk area {e.g., Baghdad, Tikrit, Ramadi}
DS-25-57 Travel to leishmania and malarial endemic area {e.g., Afghanistan, Iraq (except Baghdad, Tikrit, Ramadi)}
DS-25-58 Risk factor associated with Chagas
DS-25-59 Donor received tattoo and/or piercing {includes tattoo, any type of piercing or a combination of tattoo and/or piercing}
DS-25-60 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-26-** Incorrect ID used during deferral search

DS-26-01 Donor not previously deferred {use DS2601 when the deferral file is checked using incorrect donor identification information and the donor was not previously deferred}

DS-27-** Incorrect ID used during deferral search, donor previously deferred due to testing {use DS27** when the deferral file is checked using incorrect donor identification information 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-** Incorrect ID used during deferral search, donor previously deferred due to history {use DS28** when the deferral file is checked using incorrect donor identification information 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 or surgery {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}
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, or Avodart
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 or surgery {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}
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, or Avodart
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 or surgery {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}
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, or Avodart
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, donor previously deferred 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, donor previously deferred 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 or surgery {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}
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, or Avodart
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, 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-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 expiration date or time
LA-81-07 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 or tie tag incorrect or missing information {Use LA-82 if tag physically attached to the unit is incorrect or missing information, or both the tag and transfusion record are incorrect or missing information; Use LA-83 if transfusion record, accompanied with unit, is 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 tag 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 or tie tag missing or attached to incorrect unit {e.g., intended for different patient}

LA-83-** Transfusion record incorrect or missing information {Use LA-83 if transfusion record, accompanied with unit, is incorrect or missing information; Use LA-82 if tag physically attached to the unit is incorrect or missing information or both the tag and transfusion record are incorrect or missing information}

LA-83-01 Other {includes incorrect dosage for Rh Immune Globulin or factor concentrates}
LA-83-02 Unit ABO and/or Rh incorrect or missing
LA-83-03 Recipient ABO and/or Rh incorrect or missing
LA-83-04 Product type or code incorrect or missing
LA-83-05 Expiration date or time extended or missing
LA-83-06 Unit, lot or pool number incorrect or missing
LA-83-07 Recipient identification incorrect or missing (specify if autologous unit)
LA-83-08 Antigen incorrect or missing
LA-83-09 Antibody incorrect or missing
LA-83-10 Platelet count incorrect or missing
LA-83-11 HLA type incorrect or missing
LA-83-12 Product or volume or weight incorrect or missing
LA-83-13 CMV status incorrect or missing
LA-83-14 Irradiation status incorrect or missing
LA-83-15 Leukoreduced status incorrect or missing
LA-83-16 Transfusion records switched, both units intended for the same patient
LA-83-17 Compatibility information incorrect or missing
LA-83-18 Biohazard or test status incorrect or missing
LA-83-19 Combination of incorrect or missing information {e.g., unit number and expiration date}
LA-83-20 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 or surgery {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}
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, or Avodart
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** 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 {includes failure to quarantine a non-reactive unit collected from a donor who previously or subsequently tested positive}
QC-92-03 HBsAg {includes failure to quarantine a non-reactive unit collected from a donor who previously or subsequently tested positive}
QC-92-04 Anti-HBc {includes failure to quarantine a non-reactive unit collected from a donor who previously or subsequently tested positive}
QC-92-05 Anti-HCV {includes failure to quarantine a non-reactive unit collected from a donor who previously or subsequently tested positive}
QC-92-06 Anti-HTLV {includes failure to quarantine a non-reactive unit collected from a donor who previously or subsequently tested positive}
QC-92-07 ALT elevated {includes failure to quarantine a unit with normal ALT collected from a donor who previously or subsequently had an elevated ALT}
QC-92-10 Antibody screen or identification (donor/unit or recipient)
QC-92-11 Antigen screen
QC-92-12 Syphilis {includes failure to quarantine a non-reactive unit collected from a donor who previously or subsequently tested positive}
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** 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 HBsAg
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 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 QC9417}
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; 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}
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-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.

Changes made on October 1, 2011 are identified with a dagger (†).

The changes to the deviation codes for FY2012 are listed below.

Modified description:

LABELING
LA-41-01 Package insert; Incorrect/illegible
LA-42-01 Product label; Incorrect/illegible
LA-43-01 Carton label; Incorrect/illegible
LA-44-01 Expiration date; Extended/illegible
LA-45-01 Lot number; Incorrect/illegible
LA-46-01 Storage temperature; Incorrect/illegible
LA-47-01 Administration route; Incorrect/illegible
LA-48-01 Concentration or volume; Incorrect/illegible
LA-49-01 Multiple information; Incorrect/illegible

PRODUCT SPECIFICATIONS

PS-52-**Component packaged with final product did not meet specifications

PS-52-02 Contains precipitate/particle

New Codes Added:

PRODUCT SPECIFICATIONS

PS-52-**Component packaged with final product did not meet specifications

PS-52-06 Broken/cracked vial

QUALITY CONTROL and DISTRIBUTION

QC-62-** Shipping and storage

QC-62-04 No documentation product was shipped or stored at appropriate temperature

QC-64-** Packing

QC-64-05 Improper orientation (e.g., sideways)
 

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

†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-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

??-??-?? DO NOT KNOW

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  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.

Changes made on October 1, 2011 are identified with a dagger (†).

The changes to the deviation codes for FY2012 are listed below.

New Codes Added:

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 

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

SD-02-** - Inappropriate distribution

SD-02-05 – Outdated product

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