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 viral 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.

  2. 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 is a summary of Blood BPD codes that have been deleted for FY2016:
      • 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-HB
          • 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
      MI - Miscellaneous

       
      PD/DS/DD DONOR ELIGIBILITY (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, hemochromatosishemochromatosis, 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-27-09 ZIKV
      DS-27-08 Syphilis

      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 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-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 Anti-HTLV
        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-71-15 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, Babsia; 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-92-15 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 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 (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 FY2016

      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: 09/30/2016
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