Vaccines, Blood & Biologics

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 the appropriate BPD Code will assist the FDA in analyzing the data submitted and streamline the trend analysis.

Reporting HCV Lookback

(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 Information for Blood Establishments: DISCONTINUATION of CHIRON® RIBA® HCV 3.0 SIA (RIBA), 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.

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 relevant transfusion-transmitted infection testing deviation or unexpected event {event discovered prior to distribution, but failed to quarantine product}

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).

  1. Revisions to Blood BPD Reporting Codes for FY2017

For FY2017, we implemented specific revisions to the deviation codes to improve our analysis of the submitted data. Specifically, we modified some of the deviation codes following publication and implementation of the final rule, “Requirements for Blood and Blood Components Intended for Transfusion or for Further Manufacturing Use” (5/22/2015).  We modified the description of the category VT (Viral Testing) to Relevant Transfusion-Transmitted Infection. We added specific codes to capture events associated with Zika virus (ZIKV)  because we have determined ZIKV to be a relevant transfusion-transmitted infection (RTTI) under Title 21 of the Code of Federal Regulations (CFR) 630.3(h)(2). We added specific codes to capture events associated with the control of bacterial contamination (21 CFR 606.145). We deleted the codes related to Hepatitis A as described below because these reports are no longer required.In addition, we modified several codes for clarification and consistency.

  1. Summary of FY2017 Revisions

An overview of the changes that were made to the BPD codes for FY2017 is listed below. Refer to each section below for the complete list of BPD codes.

  1. The following codes were added to capture events associated with Zika virus:

Under Post Donation Information section:

  • PD-12-** Behavior/History
    • PD-12-66 Intimate contact with risk for a relevant transfusion-transmitted infection – Other
    • PD-12-67 Travel to Zika risk area

Under Donor Screening section:

  • DS-27-** Deferral screening not done or incorrectly performed, including incorrect ID used during search, prior deferral due to testing for:
    • DS-27-09 ZIKV
  • DS-28-** Deferral screening not done or incorrectly performed, including incorrect ID used during search, prior deferral due to history
    • DS-28-66 Intimate contact with risk for a relevant transfusion-transmitted infection – Other
    • DS-28-67 Travel to Zika risk area
  • DS-29-** Donor gave history which warranted deferral or follow up and was not deferred or follow up questions were not asked
    • DS-29-66 Intimate contact with risk for a relevant transfusion-transmitted infection – Other
    • DS-29-67 Travel to Zika risk area

Under Donor Deferral section:

  • DD-31-** Donor missing or incorrectly identified on deferral list, donor was or should have been previously deferred due to testing for
    • DD-31-09 ZIKV
  • DD-32-** Donor missing or incorrectly identified on deferral list, donor was or should have been previously deferred due to history
    • DD-32-66 Intimate contact with risk for a relevant transfusion-transmitted infection – Other
    • DD-32-67 Travel to Zika risk area
  • DD-35-** Donor incorrectly deleted from deferral list, prior deferral due to history
    • DD-35-66 Intimate contact with risk for a relevant transfusion-transmitted infection – Other
    • DD-35-67 Travel to Zika risk area

Under Quality Control and Distribution section:

  • QC-91-** Failure to quarantine unit due to medical history
    • QC-91-67 Intimate contact with risk for a relevant transfusion-transmitted infection – Other
    • QC-91-68 Travel to Zika risk area
  • QC-92-** Positive testing for
    • QC-92-17 ZIKV
  • QC-93-** Testing not performed, incompletely performed or not documented for
    • QC-93-19 ZIKV

Under Relevant Transfusion-Transmitted Infection Testing section:

  • VT-71-** Testing performed, interpreted or documented incorrectly (includes QC not performed or unacceptable) for
    • VT-71-20 ZIKV

Specific codes related to ZIKV were not added to the codes listed below. Please use the “**-**-Other” code and specify ZIKV.

  • DD-34-** DONOR DEFERRAL; Donor incorrectly deleted from deferral list or donor not reentered properly, prior deferral due to testing for
    • DD-34-01 Other - {ZIKV}
  • MI-01-** MISCELLANEOUS; Donor implicated in relevant transfusion-transmitted disease
    • MI-01-01 Other {ZIKV}
  • MI-02-** MISCELLANEOUS; Lookback; subsequent unit tested confirmed positive for
    • MI-02-01 Other {multiple markers, ZIKV}
  1. The following codes were added to capture events associated with controlling bacterial contamination:

Under Relevant Transfusion-Transmitted Infection Testing (VT) section:

  • VT-71-** Testing performed, interpreted or documented incorrectly (includes QC not performed or unacceptable) for
    • VT-71-19 Bacterial testing

Under Component Preparation section:

  • CP-52-** Component not prepared in accordance with specifications
    • CP-52-18 Pathogen reduction not performed in accordance with specifications

Under Quality Control and Distribution section:

  • QC-92-** Positive testing for
    • QC-92-16 Bacterial testing (specify organism)
  • QC-93-** Testing not performed, incompletely performed or not documented for
    • QC-93-18 Bacterial testing

**NOTE – QC-94-04, QC & Distribution; Distribution of product that did not meet specifications; Product QC unacceptable, not performed, not documented, or incomplete, should not be used for events related to bacterial testing.

  1. The following are changes to the relevant transfusion-transmitted infection testing codes (formerly Viral Testing) and QC & Distribution codes related to specific testing:

We added a code to capture other testing that is not listed; we combined the Hepatitis B testing, Hepatitis C testing and HIV testing.

  • Added:
    • VT-71-00 Other
  • Deleted:
    • VT-71-03 Anti-HIV-2
    • VT-71-04 Anti-HIV-1/2
    • VT-71-05 HIV Antigen
    • VT-71-08 Anti-HBc
    • VT-71-13 HIV Nucleic Acid Test (NAT)
    • VT-71-14 HCV Nucleic Acid Test (NAT)
    • VT-71-16 HBV Nucleic Acid Test (NAT)
  • Modified:
    • VT-71-01 HBV
    • VT-71-02 HIV
    • VT-71-07 HTLV
    • VT-71-10 HCV
    • VT-71-15 Multiplex Nucleic Acid Test (NAT)
    • QC-92-15 Multiplex Nucleic Acid Test (NAT) 
    • QC-93-15 Multiplex Nucleic Acid Test (NAT)
  1. The following codes related to Hepatitis A have been deleted.

These codes were deleted because neither the proposed nor final rule, “Requirements for Blood and Blood Components Intended for Transfusion or for Further Manufacturing Use” (5/22/2015), refers to a ‘‘history of viral hepatitis’’ as a factor in determining donor eligibility. Instead, under new § 630.3(h)(1)(ii) and (iii), HBV and HCV are relevant transfusion-transmitted infections. Under § 630.10(e)(1)(iii), an establishment must defer a donor exhibiting signs and/or symptoms of relevant transfusion-transmitted infections, including HBV and HCV.

Under Post Donation Information section:

  • PD-11-** Testing
    • PD-11-16 Tested reactive for Hepatitis A prior to donation
  • PD-12-** Behavior/History
    • PD-12-51 History of Hepatitis A
    • PD-12-52 Exposure to Hepatitis A
  • PD-13-** Illness
    • PD-13-08 Post donation diagnosis or symptoms of Hepatitis A, or reactive test for Hepatitis A

Under Donor Screening section:

  • DS28-** Deferral screening not done or incorrectly performed, including incorrect ID used during search, prior deferral due to history
    • DS-28-51 History of Hepatitis A
    • DS-28-52 Exposure to Hepatitis A
  • DS-29-** Donor gave history which warranted deferral or follow up and was not deferred or follow up questions were not asked
    • DS-29-51 History of Hepatitis A
    • DS-29-52 Exposure to Hepatitis A

Under Donor Deferral section:

  • DD-32-** Donor missing or incorrectly identified on deferral list, donor was or should have been previously deferred due to history
    • DD-32-51 History of Hepatitis A
    • DD-32-52 Exposure to Hepatitis A
  • DD-35-** Donor incorrectly deleted from deferral list, prior deferral due to history
    • DD-35-51 History of Hepatitis A
    • DD-35-52 Exposure to Hepatitis A

Under Quality Control & Distribution section:

  • QC-91-** Failure to quarantine unit due to medical history
    • QC-91-51 History of Hepatitis A
    • QC-91-52 Exposure to Hepatitis A
  1. Blood BPD Reporting Codes

Please use the appropriate code(s) from the listing below to report a deviation or unexpected event that occurred in a blood or plasma establishment.

Changes made on October 1, 2016 (the beginning of FY2017) are identified with a dagger (†).

The changes to the deviation codes for FY2017 are listed below.

The following list is a summary of abbreviations used to identify each category of Blood BPD codes:

Donor Eligibility
  PD - Post Donation Information
  DS - Donor Screening
  DD - Donor Deferral

  BC - Blood Collection
  CP - Component Preparation

Laboratory Testing
VT - Relevant Transfusion-Transmitted Infection Testing
  RT - Routine Testing

  LA - Labeling
  QC - Quality Control and Distribution
  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-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; donor did not meet specifications for TRALI risk mitigation (e.g., history of pregnancy)}
  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 Intimate contact with risk for a relevant transfusion-transmitted infection - sexually transmitted disease
  PD-12-13 Non-specific intimate contact with risk for a relevant transfusion-transmitted infection {includes contact with an individual who was deferred by another center, on a national deferral list, or tested reactive for an unknown viral marker}
  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 not prescribed by a doctor {includes taking illegal drugs by needle, e.g., IM}
  PD-12-17 Sex partner used IV drugs not prescribed by a doctor
  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
  PD-12-29 Donor received tissue allograft or transplanted organ
  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 or 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 (derived from human pituitary glands)
  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-12-53 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 and any other type of potential blood exposure}
  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-12-61 Intimate contact with risk for a relevant transfusion-transmitted infection - HIV
  PD-12-62 Intimate contact with risk for a relevant transfusion-transmitted infection - HTLV
  PD-12-63 Intimate contact with risk for a relevant transfusion-transmitted infection - HBV
  PD-12-64 Intimate contact with risk for a relevant transfusion-transmitted infection - HCV
  PD-12-65 Intimate contact with risk for a relevant transfusion-transmitted infection - hepatitis, not specified
†PD-12-66 Intimate contact with risk for a relevant transfusion-transmitted infection – Other
†PD-12-67 Travel to Zika risk area

  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-13-10 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 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 for: {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
  DS-27-03 HBV
  DS-27-04 Anti-HBc
  DS-27-05 HCV
  DS-27-06 Anti-HTLV
  DS-27-07 ALT
  DS-27-08 Syphilis
†DS-27-09 ZIKV

  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 Intimate contact with risk for a relevant transfusion-transmitted infection - sexually transmitted disease
  DS-28-13 Non-specific intimate contact with risk for a relevant transfusion-transmitted infection {includes contact with an individual who was deferred by another center, on a national deferral list, or tested reactive for an unknown viral marker}
  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 not prescribed by a doctor {includes taking illegal drugs by needle, e.g., IM}
  DS-28-17 Sex partner used IV drugs not prescribed by a doctor
  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
  DS-28-29 Donor received tissue allograft or transplanted organ
  DS-28-36 Travel to malaria endemic area/history of malaria
  DS-28-37 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 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 (derived from human pituitary glands)
  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-28-53 Multiple high risk behaviors/contacts
  DS-28-54 Positive drug screen
  DS-28-55 Deferred by another center - reason unknown {reason for deferral unknown or not provided by the other center – use more specific DS code if reason known}
  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 and any other type of potential blood exposure}
  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-28-61 Intimate contact with risk for a relevant transfusion-transmitted infection - HIV
  DS-28-62 Intimate contact with risk for a relevant transfusion-transmitted infection - HTLV
  DS-28-63 Intimate contact with risk for a relevant transfusion-transmitted infection - HBV
  DS-28-64 Intimate contact with risk for a relevant transfusion-transmitted infection - HCV
  DS-28-65 Intimate contact with risk for a relevant transfusion-transmitted infection - hepatitis, not specified
†DS-28-66 Intimate contact with risk for a relevant transfusion-transmitted infection – Other
†DS-28-67 Travel to Zika risk area

  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; residency/travel outside U.S., unacceptable, discrepant or missing response to gender specific or attention question}
  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 Intimate contact with risk for a relevant transfusion-transmitted infection - sexually transmitted disease
  DS-29-13 Non-specific intimate contact with risk for a relevant transfusion-transmitted infection {includes contact with an individual who was deferred by another center, on a national deferral list, or tested reactive for an unknown viral marker}
  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 not prescribed by a doctor {includes taking illegal drugs by needle, e.g., IM}
  DS-29-17 Sex partner used IV drugs not prescribed by a doctor
  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
  DS-29-29 Donor received tissue allograft or transplanted organ
  DS-29-36 Travel to malaria endemic area/history of malaria
  DS-29-37 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 DS-29-28 only if blood or blood products were received during 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 (derived from human pituitary glands)
  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-29-53 Multiple high risk behaviors/contacts
  DS-29-54 Positive drug screen
  DS-29-55 Deferred by another center - reason unknown {reason for deferral unknown or not provided by the other center – use more specific DS code if reason known}
  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 and any other type of potential blood exposure}
  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}
  DS-29-61 Intimate contact with risk for a relevant transfusion-transmitted infection - HIV
  DS-29-62 Intimate contact with risk for a relevant transfusion-transmitted infection - HTLV
  DS-29-63 Intimate contact with risk for a relevant transfusion-transmitted infection - HBV
  DS-29-64 Intimate contact with risk for a relevant transfusion-transmitted infection - HCV
  DS-29-65 Intimate contact with risk for a relevant transfusion-transmitted infection - hepatitis, not specified
†DS-29-66 Intimate contact with risk for a relevant transfusion-transmitted infection – Other
†DS-29-67 Travel to Zika risk area

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 for {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
  DD-31-03 HBV
  DD-31-04 Anti-HBc
  DD-31-05 HCV
  DD-31-06 Anti-HTLV
  DD-31-07 ALT
  DD-31-08 Syphilis
†DD-31-09 ZIKV

  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 - Intimate contact with risk for a relevant transfusion-transmitted infection - sexually transmitted disease
  DD-32-13 Non-specific intimate contact with risk for a relevant transfusion-transmitted infection {includes contact with an individual who was deferred by another center, on a national deferral list, or tested reactive for an unknown viral marker}
  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 not prescribed by a doctor {includes taking illegal drugs by needle, e.g., IM}
  DD-32-17 Sex partner used IV drugs not prescribed by a doctor
  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
  DD-32-29 Donor received tissue allograft or transplanted organ
  DD-32-36 Travel to malaria endemic area/history of malaria
  DD-32-37 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 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 (derived from human pituitary glands)
  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-32-53 Multiple high risk behaviors/contacts
  DD-32-54 Positive drug screen
  DD-32-55 Deferred by another center - reason unknown {reason for deferral unknown or not provided by the other center – use more specific DD code if reason known}
  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 and any other type of potential blood exposure}
  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-32-61 Intimate contact with risk for a relevant transfusion-transmitted infection - HIV
  DD-32-62 Intimate contact with risk for a relevant transfusion-transmitted infection - HTLV
  DD-32-63 Intimate contact with risk for a relevant transfusion-transmitted infection - HBV
  DD-32-64 Intimate contact with risk for a relevant transfusion-transmitted infection - HCV
  DD-32-65 Intimate contact with risk for a relevant transfusion-transmitted infection - hepatitis, not specified
†DD-32-66 Intimate contact with risk for a relevant transfusion-transmitted infection – Other
†DD-32-67 Travel to Zika risk area

  DD-34-** Donor incorrectly deleted from deferral list or donor not reentered properly, prior deferral due to testing for {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
  DD-34-03 HBV
  DD-34-04 Anti-HBc
  DD-34-05 HCV
  DD-34-06 Anti-HTLV
  DD-34-07 ALT
  DD-34-08 Syphilis

  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 Intimate contact with risk for a relevant transfusion-transmitted infection - sexually transmitted disease
  DD-35-13 Non-specific intimate contact with risk for a relevant transfusion-transmitted infection {includes contact with an individual who was deferred by another center. on a national deferral list, or tested reactive for an unknown viral marker}
  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 not prescribed by a doctor {includes taking illegal drugs by needle, e.g., IM}
  DD-35-17 Sex partner used IV drugs not prescribed by a doctor
  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
  DD-35-29 Donor received tissue allograft or transplanted organ
  DD-35-36 Travel to malaria endemic area/history of malaria
  DD-35-37 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 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 (derived from human pituitary glands)
  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-35-53 Multiple high risk behaviors/contacts
  DD-35-54 Positive drug screen
  DD-35-55 Deferred by another center - reason unknown {reason for deferral unknown or not provided by the other center – use more specific DD code if reason known}
  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 and any other type of potential blood exposure}
  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}
  DD-35-61 Intimate contact with risk for a relevant transfusion-transmitted infection - HIV
  DD-35-62 Intimate contact with risk for a relevant transfusion-transmitted infection - HTLV
  DD-35-63 Intimate contact with risk for a relevant transfusion-transmitted infection - HBV
  DD-35-64 Intimate contact with risk for a relevant transfusion-transmitted infection - HCV
  DD-35-65 Intimate contact with risk for a relevant transfusion-transmitted infection - hepatitis, not specified
†DD-35-66 Intimate contact with risk for a relevant transfusion-transmitted infection – Other
†DD-35-67 Travel to Zika risk area

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 if 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-52-18 Pathogen reduction not performed in accordance with specifications

†CP-53-** Component prepared from a 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-53-06 Collected from a donor with potential TRALI risk

  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-**-** RELEVANT TRANSFUSION-TRANSMITTED INFECTION 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-71-00 Other
†VT-71-01 HBV
†VT-71-02 HIV
  VT-71-06 Syphilis
†VT-71-07 HTLV
  VT-71-09 ALT
  VT-71-10 HCV
  VT-71-11 More than 1 test, e.g., all viral markers
  VT-71-12 Cytomegalovirus
†VT-71-15 Multiplex Nucleic Acid Test (NAT)
  VT-71-17 West Nile Virus
  VT-71-18 T. Cruzi (Chagas)
†VT-71-19 Bacterial testing
†VT-71-20 ZIKV

  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 or missing
  LA-81-04 Product type or code incorrect or missing (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-81-06 Expiration date or time extended or missing
  LA-81-08 Anticoagulant incorrect or missing (e.g., CPD vs ACD)
  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
  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 Intimate contact with risk for a relevant transfusion-transmitted infection - sexually transmitted disease
  QC-91-13 Non-specific intimate contact with risk for a relevant transfusion-transmitted infection {includes contact with an individual who was deferred by another center, on a national deferral list, or tested reactive for a viral marker}
  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 not prescribed by a doctor {includes taking illegal drugs by needle, e.g., IM}
  QC-91-17 Sex partner used IV drugs not prescribed by a doctor
  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
  QC-91-29 Donor received tissue allograft or transplanted organ
  QC-91-36 Travel to malaria endemic area/history of malaria
  QC-91-37 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 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 (derived from human pituitary glands)
  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-91-53 Multiple high risk behaviors/contacts
  QC-91-54 Positive drug screen
  QC-91-55 Deferred by another center - reason unknown {reason for deferral unknown or not provided by the other center – use more specific QC code if reason known}
  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 and any other type of potential blood exposure}
  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-91-62 Intimate contact with risk for a relevant transfusion-transmitted infection - HIV
  QC-91-63 Intimate contact with risk for a relevant transfusion-transmitted infection - HTLV
  QC-91-64 Intimate contact with risk for a relevant transfusion-transmitted infection - HBV
  QC-91-65 Intimate contact with risk for a relevant transfusion-transmitted infection - HCV
  QC-91-66 Intimate contact with risk for a relevant transfusion-transmitted infection - hepatitis, not specified
†QC-91-67 Intimate contact with risk for a relevant transfusion-transmitted infection – Other
†QC-91-68 Travel to Zika risk area

 

  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, Babesia; Chagas; DAT}
  QC-92-02 HIV
  QC-92-03 HBV (HBsAg, HBV NAT)
  QC-92-04 Anti-HBc
  QC-92-05 HCV (Anti-HCV, HCV NAT)
  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 Multiplex Nucleic Acid Test (NAT)
†QC-92-16 Bacterial testing (identify organism if possible)
†QC-92-17 ZIKV

  QC-93-** Testing not performed, incompletely performed or not documented for {use RT61** or VT** if testing was performed incorrectly, use QC92** if testing was positive}
  QC-93-01 Other {includes; Sickle Cell protocol; drug screen; West Nile Virus; Parvovirus; DAT, HLA antibodies}
  QC-93-02 HIV
  QC-93-03 HBV (HBsAg, HBV NAT)
  QC-93-04 Anti-HBc
  QC-93-05 HCV (anti-HCV, HCV NAT)
  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 Multiplex 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-93-18 Bacterial testing
†QC-93-19 ZIKV

  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, not performed, not documented, or incomplete {includes platelet count; product hematocrit/hemoglobin; RBC recovery; absolute red cell volume or product volume; WBC count; pH; product QC not performed during validation of apheresis machine}
  QC-94-05 Product in which specification other than QC not met {includes incorrect dose (e.g., single unit vs. pooled unit); age of product; appearance, foreign object 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 discovered to be clotted or hemolyzed 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 lekoreduction or irradiation not performed in accordance with 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; Source Plasma released prior to 60 day hold}
†QC-94-18 Product identified as unsuitable due to a relevant transfusion-transmitted infection testing deviation or unexpected event {event discovered prior to distribution, but failed to quarantine product; includes products released with positive or incomplete testing, e.g., HBV, HCV, HIV, bacterial testing, ZIKV}

  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 {e.g., FFP issued instead of RBC; use more specific codes, such as QC-93-11 if specific typing is not performed; use   QC-04-05 if incorrect dose (e.g., single unit vs. pooled unit) or incorrect age of product (e.g., not fresh) is issued}
  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; use QC9719 if product not issued in computer {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 relevant transfusion-transmitted 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 {multiple markers}
  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 the appropriate BPD Code will assist the FDA in analyzing the data submitted and streamline the trend analysis.

  1. Revisions to Licensed Non-Blood BPD Reporting Codes for FY2017

For FY2017, we modified the description of the deviation code PC-22-05 to include cleaning or maintenance of equipment.  We also modified the additional information of the deviation code PS-51-09 to include color. We did not delete or add any deviation codes for FY2017.

  1. Licensed Non-Blood BPD Reporting Codes

Please use the appropriate code(s) from the listing below to report a deviation or unexpected event that occurred in a licensed non-blood establishment.
Changes made on October 1, 2016 (the beginning of FY2017) are identified with a dagger (†).
The changes to the deviation codes for FY2017 are listed below.
The following list is a summary of abbreviations used to identify each category of Licensed Non-Blood BPD codes:

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 or was diagnosed with CJD}
  IM-14-02 Contains precipitate/particle
  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; environmental monitoring not performed or performed incorrectly
  PC-22-04 Equipment not performing properly
†PC-22-05 Sanitization, cleaning or maintenance of equipment 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 or intermediate material does not meet specifications or otherwise found to be unsuitable
  PC-24-01 Other
  PC-24-02 Contains precipitate/particle
  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, color}
  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-51-12 Unexpected positive, negative, or weak reactions in testing

  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-53-08 Appearance

  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/syringe
  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 (HCT/Ps) to assign a specific code to a reportable event when you submit the report to FDA.  The list includes numerous codes for HCT/P deviations [see §1271.3(dd)] that may occur. However, an event is only required to be reported if it relates to core Current Good Tissue Practice (CGTP) [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 [see §1271.350(b)(2)]. The use of appropriate HCT/P deviation codes will assist the FDA in analyzing the data submitted and streamline the trend analysis.

HCT/P Deviation Reporting Codes

Please use the appropriate code from the listing below to report an HCT/P deviation. No changes to the HCT/P deviation codes were made for FY2017.
The following list is a summary of abbreviations used to identify each category of deviation codes based on applicable core CGTP:

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 ELIGIBILITY (21 CFR 1271.50)  (Back to HCT / P)

  DE-02-** Ineligible donor accepted [except as provided in §1271.65(b)]
  DE-02-01 Risk factors for, or clinical evidence of infection due to relevant communicable disease agents and diseases according to §1271.75(a)(1)
  DE-02-02 Xenotransplant recipient accepted as donor
  DE-02-04 Donor tested reactive for relevant communicable disease in accordance with §1271.80 and 1271.85 [except as provided in §1271.80(d)(1)]

  DE-03-** Donor eligibility determination
  DE-03-01 Not determined by a responsible person, as defined in §1271.3(t)

  DE-99-** Miscellaneous
  DE-99-01 Other

DS-**-** DONOR SCREENING (21 CFR 1271.75)  (Back to HCT / P)

  DS-02-** Donor screening not performed [except as provided in §1271.60(d)] or performed incorrectly 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
  DS-02-05 Abbreviated donor screening inappropriately used or not performed
  DS-02-06 Donor of viable, leukocyte-rich HCT/Ps not properly evaluated for evidence of infection due to HTLV

  DS-99-** Miscellaneous
  DS-99-01 Other 

DT-**-** DONOR TESTING (21 CFR 1271.80 and 1271.85) (Back to HCT / P)

  DT-01-** Testing not performed or documented when required, for:
  DT-01-01 Human immunodeficiency virus
  DT-01-03 Hepatitis B virus
  DT-01-04 Hepatitis C virus
  DT-01-05 Treponema pallidum
  DT-01-06 Human T-lymphotropic virus
  DT-01-08 Cytomegalovirus
  DT-01-11 Multiple tests
  DT-01-12 Assessment to detect evidence of TSE not performed for dura mater donor

  DT-02-** Testing incorrectly performed when required, for:
  DT-02-01 Human immunodeficiency virus
  DT-02-03 Hepatitis B virus
  DT-02-04 Hepatitis C virus
  DT-02-05 Treponema pallidum
  DT-02-06 Human T-lymphotropic virus
  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 (except for peripheral blood stem/progenitor cells)
  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/progenitor cell donor more than 30 days before or 7 days after recovery
  DT-03-04 Specimen storage conditions not met
  DT-03-05 Specimen did not meet requirements in test kit package insert {includes filtered specimen, specimen collected in an expired tube, outdated specimen}
  DT-03-06 Donor incorrectly evaluated for plasma dilution
  DT-03-07 Donor not evaluated or evaluation not documented for plasma dilution

  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

  DT-99-** Miscellaneous
  DT-99-01 Other

FA -**-** FACILITIES (21 CFR 1271.190(a) and (b)) (Back to HCT / P)

  FA-01-** Design
  FA-01-01 Facility not suitable in size, construction, and/or location
  FA-01-02 Inadequate lighting, ventilation, plumbing, drainage and/or access to sinks and toilets

  FA-02-** Cleaning and sanitization
  FA-02-01 Facility not maintained in a clean, sanitary, and orderly manner
  FA-02-02 Sewage, trash, and other refuse not disposed of in a timely, safe, and sanitary manner

  FA-99-** Miscellaneous
  FA-99-01 Other

EC-**-** ENVIRONMENTAL CONTROL (21 CFR 1271.195(a)) (Back to HCT / P)

  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
  EC-01-04 Cleaning and disinfecting of rooms and equipment to ensure aseptic processing operations
  EC-01-05 Maintenance of equipment used to control conditions necessary for aseptic processing operations

  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
  EC-02-04 Cleaning and disinfecting of rooms and equipment to ensure aseptic processing operations
  EC-02-05 Maintenance of equipment used to control conditions necessary for aseptic processing operations

  EC-99-** Miscellaneous
  EC-99-01 Other

EQ-**-** EQUIPMENT (21 CFR 1271.200(a)) (Back to HCT / P)

  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, sanitization, or maintenance of equipment not performed or documented in accordance with established schedules

  EQ-99-** Miscellaneous
  EQ-99-01 Other

SR-**-** SUPPLIES AND REAGENTS (21 CFR 1271.210(a) and (b)) (Back to HCT / P)

  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

  SR-99-** Miscellaneous
  SR-99-01 - Other

RE-**-** - RECOVERY (21 CFR 1271.215) (Back to HCT / P)

  RE-01-** Manner of recovery
  RE-01-01 HCT/P contaminated, potentially contaminated, or cross-contaminated during recovery

  RE-99-** Miscellaneous
  RE-99-01 Other

PC-**-** PROCESSING AND PROCESS CONTROLS (21 CFR 1271.220) (Back to HCT / P)

  PC-01-** Processing
  PC-01-01 HCT/P contaminated, potentially contaminated, or cross-contaminated during processing
  PC-01-02 HCT/Ps from two or more donors 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

  PC-04-** Processing of Dura mater
  PC-04-01 Available published validated process that reduces the risk of transmissible spongiform encephalopathy not used
  PC-04-02 Available published validated process that reduces the risk of transmissible spongiform encephalopathy used, but not verified

  PC-99-** Miscellaneous
  PC-99-01 Other

LC-**-** LABELING CONTROLS (21 CFR 1271.250(a) and (b)) (Back to HCT / P)

  LC-01-** Procedures to control labeling of HCT/Ps 
  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-** Verification procedures not performed for:
  LC-02-01 Accuracy, legibility, or integrity

  LC-99-** Miscellaneous
  LC-99-01 Other

ST-**-** STORAGE (21 CFR 1271.260(a) through (d)) (Back to HCT / P)

  ST-01-** Storage area and stock room not controlled to prevent mix-ups pertaining to the following items:
  ST-01-01 HCT/Ps
  ST-01-02 Supplies
  ST-01-03 Reagents

  ST-02-** Storage area and stock room not controlled to prevent contamination or cross-contamination pertaining to the following items:
  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

  ST-99-** Miscellaneous
  ST-99-01 Other

SD-**-** RECEIPT, PRE-DISTRIBUTION SHIPMENT, AND DISTRIBUTION (21 CFR 1271.265(a) through (d)) (Back to HCT / P)

  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 {use this code if a positive culture result was known prior to distribution}
  SD-02-05 Release criteria related to expiration date of product not met

  SD-03-** Inappropriate shipping conditions
  SD-03-01 Temperature
  SD-03-02 Packaging
  SD-03-03 Container construction

  SD-04-** Receipt of incoming HCT/P
  SD-04-01 Not evaluated for the presence and significance of microorganisms and inspected for damage and contamination

  SD-99-** Miscellaneous
  SD-99-01 Other

??-??-?? DO NOT KNOW

Last Updated: 10/1/2016

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

Page Last Updated: 10/06/2016
Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English