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 FY2016

    For FY2016, 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 of the final rule, “Requirements for Blood and Blood Components Intended for Transfusion or for Further Manufacturing Use” (5/22/2015).  We combined deviation codes associated with sexual and non-sexual risk by using the term “intimate contact with risk for a relevant transfusion-transmitted disease”, defined in 21 CFR 630.3(f) as having engaged in an activity that could result in the transfer of potentially infectious body fluids from one person to another. For the deviation codes involving “sex partner/cohabitant”, we changed “sexpartner/cohabitant” to “ Intimate contact with risk for a relevant transfusion-transmitted infection ”.  We deleted “sex partner or cohabitant received clotting factor” as an example because we recommend deferral of an individual with hemophilia or related clotting factor deficiencies requiring treatment with clotting factor concentrates for reasons of donor safety only.  For the deviation codes involving receiving a transfusion or clotting factor, we deleted “clotting factors” because we recommend deferral of an individual with hemophilia or related clotting factor deficiencies requiring treatment with clotting factor concentrates for reasons of donor safety and not product quality.  In addition, we modified several codes for clarification and consistency.

  2. Summary of FY2016 Revisions

    An overview of the changes that were made to the BPD codes for FY2016 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-12-08 Sex partner tested reactive for HIV
          • PD-12-09 Sex partner tested reactive for HTLV
          • PD-12-10 Sex partner tested reactive for HBV
          • PD-12-11 Sex partner tested reactive for HCV
          • PD-12-12 Sex partner tested reactive for hepatitis, not specified
          • PD-12-32 Non-sexual exposure to HIV
          • PD-12-33 Non-sexual exposure to hepatitis, not specified
          • PD-12-34 Non-sexual exposure to Hepatitis B
          • PD-12-35 Non-sexual exposure to Hepatitis C
      • Under Donor Screening section:
        • DS-28-** Deferral screening not done or incorrectly performed, including incorrect ID used during search, prior deferral due to history:
          • DS-28-08 Sex partner tested reactive for HIV
          • DS-28-09 Sex partner tested reactive for HTLV
          • DS-28-10 Sex partner tested reactive for HBV
          • DS-28-11 Sex partner tested reactive for HCV
          • DS-28-12 Sex partner tested reactive for hepatitis, not specified
          • DS-28-32 Non-sexual exposure to HIV
          • DS-28-33 Non-sexual exposure to hepatitis, not specified
          • DS-28-34 Non-sexual exposure to Hepatitis B
          • DS-28-35 Non-sexual exposure to Hepatitis C
        • DS-29-** Donor gave history which warranted deferral or follow up and was not deferred or follow up questions were not asked:
          • DS-29-08 Sex partner tested reactive for HIV
          • DS-29-09 Sex partner tested reactive for HTLV
          • DS-29-10 Sex partner tested reactive for HBV
          • DS-29-11 Sex partner tested reactive for HCV
          • DS-29-12 Sex partner tested reactive for hepatitis, not specified
          • DS-29-32 Non-sexual exposure to HIV
          • DS-29-33 Non-sexual exposure to hepatitis, not specified
          • DS-29-34 Non-sexual exposure to Hepatitis B
          • DS-29-35 Non-sexual exposure to Hepatitis C
      • 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-32-08 Sex partner tested reactive for HIV
          • DD-32-09 Sex partner tested reactive for HTLV
          • DD-32-10 Sex partner tested reactive for HBV
          • DD-32-11 Sex partner tested reactive for HCV
          • DD-32-12 Sex partner tested reactive for hepatitis, not specified
          • DD-32-32 Non-sexual exposure to HIV
          • DD-32-33 Non-sexual exposure to hepatitis, not specified
          • DD-32-34 Non-sexual exposure to Hepatitis B
          • DD-32-35 Non-sexual exposure to Hepatitis C
        • DD-35-** Donor incorrectly deleted from deferral list or donor not reentered properly, prior deferral due to testing for:
          • DD-35-08 Sex partner tested reactive for HIV
          • DD-35-09 Sex partner tested reactive for HTLV
          • DD-35-10 Sex partner tested reactive for HBV
          • DD-35-11 Sex partner tested reactive for HCV
          • DD-35-12 Sex partner tested reactive for hepatitis, not specified
          • DD-35-32 Non-sexual exposure to HIV
          • DD-35-33 Non-sexual exposure to hepatitis, not specified
          • DD-35-34 Non-sexual exposure to Hepatitis B
          • DD-35-35 Non-sexual exposure to Hepatitis C
      • Under Quality Control and Distribution section:
        • QC-91-** Failure to quarantine unit due to medical history:
          • QC-91-08 Sex partner tested reactive for HIV
          • QC-91-09 Sex partner tested reactive for HTLV
          • QC-91-10 Sex partner tested reactive for HBV
          • QC-91-11 Sex partner tested reactive for HCV
          • QC-91-12 Sex partner tested reactive for hepatitis, not specified
          • QC-91-32 Non-sexual exposure to HIV
          • QC-91-33 Non-sexual exposure to hepatitis, not specified
          • QC-91-34 Non-sexual exposure to Hepatitis B
          • QC-91-35 Non-sexual exposure to Hepatitis C
    2. The following is a summary of Blood BPD codes that have been added for FY2016:
      • Under Post Donation Information section:
        • PD-12-** - Behavior/History:
          • 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
      • Under Donor Screening section:
        • DS-28-** Deferral screening not done or incorrectly performed, including incorrect ID used during search, prior deferral due to history:
          • 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-29-** Donor gave history which warranted deferral or follow up and was not deferred or follow up questions were not asked:
          • 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
      • 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-32-61 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-35-** Donor incorrectly deleted from deferral list or donor not reentered properly, prior deferral due to testing for:
          • 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
      • Under Quality Control and Distribution section:
        • QC-91-** Failure to quarantine unit due to medical history:
          • 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
    3. The following is a summary of Blood BPD codes that have been modified for FY2016:
    • Under Post Donation Information section:
      • PD-12-** - Behavior/History:
        • 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-12-16 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-12-28 Donor received transfusion
        • PD-12-44 Received growth hormone (derived from human pituitary glands)
    • Under Donor Screening section:
      • DS-28-** Deferral screening not done or incorrectly performed, including incorrect ID used during search, prior deferral due to history:
        • 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-28-16 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-28-28 Donor received transfusion
        • DS-28-44 Received growth hormone (derived from human pituitary glands)
      • DS-29-** Donor gave history which warranted deferral or follow up and was not deferred or follow up questions were not asked:
        • 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-29-16 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-29-28 Donor received transfusion
        • DS-29-44 Received growth hormone (derived from human pituitary glands)
      • 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-32-07 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-32-16 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-32-28 Donor received transfusion
        • DD-32-44 Received growth hormone (derived from human pituitary glands)
      • DD-35-** Donor incorrectly deleted from deferral list or donor not reentered properly, prior deferral due to testing for:
        • 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-35-16 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-35-28 Donor received transfusion
        • DD-35-44 Received growth hormone (derived from human pituitary glands)
    • Under Labeling section:
      • LA-81** -** Labels applied to blood unit or product incorrect or missing information
        • LA-81-06 Expiration date or time extended or missing
    • Under Quality Control and Distribution section:
      • QC-91-** Failure to quarantine unit due to medical history:
        • 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 an unknown viral marker}
        • 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-91-28 Donor received transfusion
        • QC-91-44 Received growth hormone (derived from human pituitary glands)
        • 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 an unknown viral marker}
        • QC-91-28 Donor received transfusion
  3. 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, 2015 (the beginning of FY2016) are identified with a dagger (†).
The changes to the deviation codes for FY2016 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 - Viral 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-11-16 Tested reactive for Hepatitis A prior to donation

PD-12-** Behavior/History

PD-12-01 Other {includes type of behavior or history unknown or not specified; unacceptable address; rape; donor unreliable, for example mental status questionable or donor unable to comprehend donor history questions}
PD-12-02 History of hepatitis not specified
PD-12-03 History of jaundice
PD-12-04 History of Hepatitis B
PD-12-05 History of Hepatitis C
PD-12-06 Sexually transmitted disease
†PD-12-07 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, hemochromotosis, 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-12-51 History of Hepatitis A
PD-12-52 Exposure to Hepatitis A
PD-12-53 Multiple high risk behaviors/contacts 
PD-12-54 Positive drug screen
PD-12-55 Deferred by another center - reason unknown {reason for deferral unknown or not provided by the other center – use more specific PD code if reason known}
PD-12-56 Travel to leishmania risk area {e.g., Baghdad, Tikrit, Ramadi}
PD-12-57 Travel to leishmania and malarial endemic area {e.g., Afghanistan, Iraq (except Baghdad, Tikrit, Ramadi}
PD-12-58 Risk factor associated with Chagas
PD-12-59 Donor received tattoo and/or piercing {includes tattoo, any type of piercing or a combination of tattoo and/or piercing 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-13-** Illness

PD-13-01 Post donation illness (not hepatitis, HIV, HTLV, STD, cancer or cold/flu related) {information not known by donor prior to donation, but diagnosed after donation; includes post donation reaction (e.g., infection) at phlebotomy site; Babesiosis; West Nile Virus, Chagas} 
PD-13-02 Post donation diagnosis or symptoms of Hepatitis B, or reactive test for Hepatitis B
PD-13-03 Post donation diagnosis or symptoms of Hepatitis C, or reactive test for Hepatitis C
PD-13-04 Post donation diagnosis or symptoms of HIV, or reactive test for HIV
PD-13-05 Post donation diagnosis or symptoms of HTLV, or reactive test for HTLV
PD-13-06 Post donation diagnosis or symptoms of sexually transmitted disease, or reactive test for sexually transmitted disease
PD-13-07 Post donation diagnosis or symptoms of non-specific hepatitis, reactive test for non-specific hepatitis, or elevated liver enzymes
PD-13-08 Post donation diagnosis or symptoms of Hepatitis A, or reactive test for Hepatitis A
PD-13-10 Post donation diagnosis or possible diagnosis of Creutzfeldt-Jakob Disease {includes variant CJD}

PD-14-** Not specifically related to high risk behavior, unsuitable history, or post donation illness

PD-14-01 Other {does not include reports of post donation illness – use PD13** codes; includes anything not included in PD12**}
PD-14-02 Donor does not want their blood used
PD-14-03 Donated to be tested or called back for test results

DS-**-** DONOR SCREENING (Back to top)

DS-20-** Miscellaneous

DS-20-01 Other

DS-21-** Donor did not meet acceptance criteria

DS-21-01 Other {includes inappropriate acceptance of donor with unacceptable address or no proof of an acceptable address} 
DS-21-02 Hemoglobin or Hematocrit unacceptable, not documented, or testing performed incorrectly {includes use of expired reagents for hemoglobin or hematocrit} 
DS-21-03 Temperature unacceptable or not documented
DS-21-04 Medical review or physical not performed or inadequate
DS-21-05 Platelet count, no documented platelet count for product
DS-21-06 Unexplained weight loss

DS-22-** Donor record incomplete or incorrect

DS-22-01 Other {includes missing donor records} 
DS-22-02 Donor identification {includes donor using false identification, e.g., twins}
DS-22-03 Donor history questions {includes abbreviated questionnaire used instead of full-length questionnaire; response to educational material/AIDS questions not documented; incorrect gender specific question asked} 
DS-22-04 Arm inspection
DS-22-05 Donor signature missing
DS-22-06 Confidential Unit Exclusion (CUE) procedure not performed in accordance with specifications
DS-22-07 Donor confidentiality compromised

DS-26-** Deferral screening not done or incorrectly performed, including incorrect ID used during 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-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, hemochromotosis, 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-28-51 History of Hepatitis A
DS-28-52 Exposure to Hepatitis A
DS-28-53 Multiple high risk behaviors/contacts
DS-28-54 Positive drug screen
DS-28-55 Deferred by another center - reason unknown {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-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, hemochromotosis, 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-29-51 History of Hepatitis A
DS-29-52 Exposure to Hepatitis A
DS-29-53 Multiple high risk behaviors/contacts
DS-29-54 Positive drug screen
DS-29-55 Deferred by another center - reason unknown {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

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-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, hemochromotosis, 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-32-51 History of Hepatitis A
DD-32-52 Exposure to Hepatitis A
DD-32-53 Multiple high risk behaviors/contacts
DD-32-54 Positive drug screen
DD-32-55 Deferred by another center - reason unknown {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-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, hemochromotosis, 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-35-51 History of Hepatitis A
DD-35-52 Exposure to Hepatitis A
DD-35-53 Multiple high risk behaviors/contacts
DD-35-54 Positive drug screen
DD-35-55 Deferred by another center - reason unknown {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

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-53-** Component prepared from Whole Blood unit that was
CP-53-01 Other
CP-53-02 Overweight
CP-53-03 Underweight
CP-53-04 Collected or stored at unacceptable or undocumented temperature
CP-53-05 A difficult collection or had an extended collection time

CP-54-** Component manufactured that was
CP-54-01 Other
CP-54-02 Overweight
CP-54-03 Underweight
CP-54-04 Lipemic
CP-54-05 Bloody

VT/RT LABORATORY TESTING(Back to top)

VT-**-** VIRAL TESTING (Back to top)

VT-70-** Miscellaneous

VT-70-01 Other

 VT-71-** Testing performed, interpreted or documented incorrectly (includes QC not performed or unacceptable) for {use VT71** only if testing was performed, interpreted or documented incorrectly; use QC92** if testing is positive or use QC93** if testing is not performed, incompletely performed, or not documented}

VT-71-01 HBsAg
VT-71-02 Anti-HIV-1
VT-71-03 Anti-HIV-2
VT-71-04 Anti-HIV-1/2
VT-71-05 HIV Antigen
VT-71-06 Syphilis
VT-71-07 Anti-HTLV
VT-71-08 Anti-HBc
VT-71-09 ALT
VT-71-10 Anti-HCV
VT-71-11 More than 1 test, e.g., all viral markers  
VT-71-12 Cytomegalovirus
VT-71-13 HIV Nucleic Acid Test (NAT)
VT-71-14 HCV Nucleic Acid Test (NAT)
VT-71-15 HIV/HCV/HBV Nucleic Acid Test (NAT)
VT-71-16 HBV Nucleic Acid Test (NAT)
VT-71-17 West Nile Virus
VT-71-18 T. Cruzi (Chagas)

VT-72-** Sample identification

VT-72-01 Other
VT-72-02 Incorrect sample tested
VT-72-03 Sample used for testing was incorrectly or incompletely labeled
VT-72-04 Unsuitable sample used for testing

RT-**-** ROUTINE TESTING (Back to top)

RT-60-** Miscellaneous

RT-60-01 Other

RT-61-** Testing performed, interpreted, or documented incorrectly for {use RT61** only if testing was performed, interpreted or documented incorrectly; use QC92** if testing positive or use QC93** if testing is not performed, incompletely performed or not documented}

RT-61-01 Other {includes DAT; Hemoglobin S testing}
RT-61-04 ABO and/or Rh
RT-61-05 Antibody screening or identification
RT-61-06 Antigen typing
RT-61-07 Platelet count
RT-61-08 Compatibility {includes electronic or immediate spin crossmatch performed instead of full crossmatch, when required}
RT-61-09 ABO, Rh, and antibody screen
RT-61-10 ABO, Rh, antibody screen, and compatibility
RT-61-11 Antibody screen and compatibility

RT-62-** Sample identification

RT-62-01 Other
RT-62-02 Incorrect sample tested
RT-62-03 Sample used for testing was incorrectly or incompletely labeled
RT-62-04 Unsuitable sample used for testing (e.g., too old)

RT-63-** Testing performed using reagents in which QC was unacceptable, not performed,  not documented, or expired reagents were used

RT-63-01 Other
RT-63-04 ABO and/or Rh
RT-63-05 Antibody screening or identification
RT-63-06 Antigen typing
RT-63-07 Multiple testing {includes all routine testing} 
RT-63-08 Coombs control cells

LA-**-** LABELING(Back to top)

LA-80-** Miscellaneous

LA-80-01 Other

LA-81-** Labels applied to blood unit or product incorrect or missing information

LA-81-01 Other {includes units collected from a paid donor labeled as collected from a volunteer donor} 
LA-81-02 ABO and/or Rh incorrect 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, hemochromotosis, 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-91-51 History of Hepatitis A
QC-91-52 Exposure to Hepatitis A
QC-91-53 Multiple high risk behaviors/contacts
QC-91-54 Positive drug screen
QC-91-55 Deferred by another center - 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-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 HIV/HCV/HBV Nucleic Acid Test (NAT)

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} 
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 HIV/HCV/HBV Nucleic Acid Test (NAT)
QC-93-16 ABO and/or Rh (donor/unit or recipient)
QC-93-17 ABO/Rh and antibody screen (donor/unit or recipient)

QC-94-** Distribution of product that did not meet specifications

QC-94-01 Other {includes inappropriate release of Rh Immune Globulin; product distributed prior to required record review} 
QC-94-02 Outdated product
QC-94-03 Autologous unit not meeting homologous criteria
QC-94-04 Product QC unacceptable (e.g., positive), not performed, not documented, or incomplete {includes platelet count; product hematocrit/hemoglobin; RBC recovery; absolute red cell volume or product volume; WBC count; pH (specify if used as a test for bacterial detection); bacterial detection testing; product QC not performed during validation of apheresis machine}  
QC-94-05 Product in which specification other than QC not met {includes incorrect dose (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}
QC-94-18 Product identified as unsuitable due to a viral testing deviation or unexpected event {event discovered prior to distribution, but failed to quarantine product; includes products released with positive or incomplete viral testing}

QC-96-** Shipping and storage

QC-96-01 Other
QC-96-02 Arrived at consignee at unacceptable temperature {use this code if shipment was packed appropriately, but the temperature upon arrival was unacceptable}
QC-96-03 Stored at incorrect temperature
QC-96-04 No documentation that product was shipped or stored at appropriate temperature
QC-96-05 Temperature not recorded or unacceptable upon return, unit redistributed
QC-96-06 Shipment exceeded time allowed for shipping
QC-96-07 Product not packed in accordance with specifications or no documentation that product was packed appropriately
QC-96-08 Product returned to blood center and reissued inappropriately {includes no record of inspection upon return; if specific to temperature, use QC-96-05}
QC-96-09 Visual inspection not performed or documented by blood center prior to distribution

QC-97-** Distribution procedure not performed in accordance with blood bank transfusion service’s specifications

QC-97-01 Other  
QC-97-02 Product not irradiated as required
QC-97-03 Product issued to wrong patient
†QC-97-04 Improper product selected for patient {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 transfusion associated disease

MI-01-01 Other
MI-01-02 HIV
MI-01-03 Hepatitis (specify type, if known) 
MI-01-04 West Nile Virus
MI-01-05 Babesia
MI-01-06 Chagas
MI-01-07 Malaria

MI-02-** Lookback; subsequent unit tested confirmed positive for {use MI02** when confirmatory or additional supplemental testing is positive; if confirmatory or additional supplemental testing is not positive, a report is not required}

MI-02-01 Other {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 FY2016, we implemented specific revisions to the deviation codes to improve our analysis of the submitted data. Specifically, we modified the deviation code under PC-24-** Process Controls, Bulk material does not meet specifications or otherwise found to be unsuitable, to include intermediate material.  We also modified the deviation code, PC-24-02 Contains precipitate and IM-14-02 Contains precipitate, to include particles. We did not delete or add any deviation codes for FY2016.

  2. Summary of FY2016 Revisions

    An overview of the changes that were made to the BPD codes for FY2016 is listed below. Refer to each section below for the complete list of BPD codes.

    1. The following is a summary of Licensed Non-Blood BPD codes that have been modified for FY2016:
      • Under Incoming Material Specifications section:
        • IM-14-** Source or raw material does not meet specifications or otherwise found to be unsuitable
          • IM-14-02 Contains precipitate/particle
      • Under Process Controls section:
        • PC-24-** - Bulk or intermediate material does not meet specifications or otherwise found to be unsuitable:
          • PC-24-02 Contains precipitate/particle
  3. 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, 2015 (the beginning of FY2016) are identified with a dagger (†).

The changes to the deviation codes for FY2016 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 procedures not performed or performed incorrectly
PC-22-06 Media fill failure or media fill performed incorrectly

PC-23-** Process Water - specification not met

PC-23-01 Other
PC-23-02 Water for injection
PC-23-03 Purified water

†PC-24-** Bulk 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} 
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.

  1. Revisions to HCT/P Deviation Reporting Codes for FY2016

    For FY2016, we implemented specific revisions to the deviation codes to improve our analysis of the submitted data. Specifically, we deleted codes under “DS-01-** Donor screening not performed or documented” subsection and subsequently combined these codes under “DS-02-** Donor screening not performed [except as provided in §1271.60(d)] or performed incorrectly” so that both screening deviations (not performed or performed incorrectly) will now be categorized together. In past years, these two categories of deviations were reported separately under the DS-01 and DS-02 subsections. Likewise, we deleted virus subtyping for relevant communicable disease agents under “DT-**-** Donor Testing” section and subsequently combined the codes for each such relevant communicable disease agent into a single deviation reporting code, specifically DT-01-02, DT-01-07, DT-02-02, and DT-02-07 because we no longer need that level of detail for purpose of trending.  We also moved certain codes under the “Donor Eligibility, DE-02-** - Ineligible donor accepted [except as provided in 1271.65(b)]” subsection to the “DT-**-** Donor Testing” section so the deviations will be reported under the most appropriate core CGTP requirement.  In addition, we deleted “EQ-02-02 Quality control not performed or documented” under the “EQ-**-** Equipment” section because this is not a core CGTP.

    We also added the specific core CGTP regulation citation under 21 CFR 1271 to each section as referential information. In addition, for multiple deviation codes listed below, we modified descriptions related to specific deviations to better reflect the specific core CGTP.

  2. Summary of FY2016 Revisions

An overview of the changes that were made to the deviation codes for FY2016 is listed below. Refer to each section below for the complete list of deviation codes.

  1. The following is a summary of deviation codes that have been deleted for FY2016:
    • Under the Donor Screening section, subsection DS-01-** Donor screening not performed or documented in the:
      • DS-01-01 Donor medical history interview
      • DS-01-02 Physical assessment of a cadaveric donor or physical examination of a living donor 
      • DS-01-03 Medical record review
      • DS-01-04 Evaluation of communicable disease risks associated with xenotransplant
    • Under the Donor Testing section:
      • DT-01-** Testing not performed or documented when required, for:
        • DT-01-02 Human immunodeficiency virus, type 2
        • DT-01-07 Human T-lymphotropic virus, type II
      • DT-02-** Testing incorrectly performed when required, for:
        • DT-02-02 Human immunodeficiency virus, type 2
        • DT-02-07 Human T-lymphotropic virus, type II
    • Under the Equipment section, subsection EQ-02-** Maintenance:
      • EQ-02-02 Quality control not performed or documented
    • Under Labeling Control section, subsection LC-02-** Labels unacceptable (NOTE: The description of LC-02-** was modified to “Verification procedures not performed for”)
      • LC-02-02 Illegible
  2. The following is a summary of deviation codes that have been moved from one section to another for FY2016:
    • Under the Donor Eligibility section, subsection DE-02-** Ineligible donor accepted [except as provided in 1271.65(b)], the following codes have been moved. These codes now appear under the Donor Screening section:
      • DE-02-03 Abbreviated donor screening inappropriately used or not performed
      • DE-02-05 Donor of viable, leukocyte-rich HCT/Ps not properly evaluated for evidence of infection due to HTLV
    • Under the Donor Eligibility section, subsection DE-02-** Ineligible donor accepted [except as provided in 1271.65(b)], the following codes have been moved. These codes now appear under the Donor Testing section:
      • DE-02-06 Assessment to detect evidence of TSE not performed for dura mater donor
      • DE-02-07 Donor incorrectly evaluated for plasma dilution
      • DE-02-08 Donor not evaluated or evaluation not documented for plasma dilution
  3. The following is a summary of deviation codes that have been modified for FY2016
  • Under the Donor Eligibility section, subsection 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-02-04 Donor tested reactive for relevant communicable disease in accordance with §1271.80 and 1271.85 [except as provided in §1271.80(d)(1)]
  • Under the Donor Screening section:
    • DS-02-** Donor screening not performed [except as provided in §1271.60(d)] or performed incorrectly
  • Under the Donor Testing section:
  • DT-01-** Testing not performed or documented when required, for:
    • DT-01-01 Human immunodeficiency virus
    • DT-01-06 Human T-lymphotropic virus
  • DT-02-** Testing incorrectly performed when required, for:
    • DT-02-01 Human immunodeficiency virus
    • DT-02-06 Human T-lymphotropic virus
  • DT-03-** Unacceptable specimen tested
    • DT-03-01 Specimen collected more than 7 days before or after recovery (except for peripheral blood stem/progenitor cell) 
    • DT-03-03 Specimen collected from a peripheral blood stem/progenitor cell donor more than 30 days before or 7 days after recovery
  • Under the Facility section:
    • FA-01-** Design
      • 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
  • Under the Environmental Control section:
    • EC-01-** Environmental controls, when required, not performed or documented for
      • 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-02-03 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
  • Under the Equipment section, subsection EQ-02-** Maintenance:
    • EQ-02-01 Cleaning, sanitization, or maintenance of equipment not performed or documented in accordance with established schedules
       
  • Under the Processing and Process Controls section, subsection PC-01-** Processing:
    • PC-01-02 HCT/Ps from two or more donors were pooled during manufacturing
  • Under the Labeling Controls section, subsection LC-02-** Verification procedures not performed for:
    • LC-02-01 Accuracy, legibility, or integrity
       
  • Under the Storage section:
    • ST-01-** Storage area and stock room not controlled to prevent mix-ups pertaining to the following items:
    • ST-02-** Storage area and stock room not controlled to prevent contamination or cross-contamination pertaining to the following items:
  • Under the Receipt, Pre-Distribution, Shipment, and Distribution section:
    • SD-02-** Inappropriate distribution
      • SD-02-05 Release criteria related to expiration date of product not met
    • 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
  1. The following is a summary of deviation codes that have been added for FY-2016
  • Under the Donor Eligibility section:
    • DE-03-** Donor eligibility determination
      • DE-03-01 Not determined by a responsible person, as defined in §1271.3(t)
  • Under the Facility section, subsection FA-02-** Cleaning and sanitization:
    • FA-02-02 Sewage, trash, and other refuse not disposed of in a timely, safe, and sanitary manner
  • Under the Processing and Process Control section:
    • 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
  1. HCT/P Deviation Reporting Codes

Please use the appropriate code from the listing below to report an HCT/P deviation. Changes made on October 1, 2015 (the beginning of FY2016) are identified with a dagger (†).

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: 10/1/2015

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: 10/15/2015
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