Table 2.
Definition of error/incident categories (modified from SHOT categories)
| Error category | Subcategory | Error/incident definition |
|---|---|---|
| Avoidable, delayed or undertransfusion Near misses are not included |
Avoidable | Blood product unnecessary transfused according to guidelines with respect to clinical situation / laboratory values. Discarded blood products due to outdated or incorrect storage conditions, late return to the supply chain (reports of not indicated transfusions are not included- see Administration error, Indication below) |
| Delayed | Time delay by an error that happened earlier in the administration process | |
| Over transfusion/TACO | Transfusion associated circulatory overload, overdosing of blood product | |
| Undertransfusion | Ineffective dose of blood product administered | |
| Coagulation management and dosing error | Wrong dosing or error in coagulation management associated to the use of plasma and coagulation factors incl. concentrates, prothrombin complex, cryoprecipitate etc. | |
| Incorrect blood component transfused | General requirements not met | Wrong kind of blood product transfused (packed red cells, platelets, plasma, coagulation factors, outdated products, allogeneic instead of autologous etc.) |
| Unmatched | Unmatched or universal 0 negative red cells, not blood group matched platelets or AB fresh frozen plasma in elective cases, application of blood products unscreened for antibodies or compatibility | |
| Incompatible | Real administration (not near misses) of incompatible blood with respect of major blood group or allo-antibodies | |
| Compatible | Compatible blood but wrong recipient | |
| Specific requirements not met | Although necessary no irradiation, leukodepletion, washed, frozen, Jehovah witnesses transfused without consent etc. | |
| Errors related to cell salvage and preoperative donation | Production of autologous products | Use and production of autologous products including preoperative donation and operation of cell saver device Cell saver defect, technical malfunction Mismatch of products following disconnection or confusion of autologous products |
| Patient identification (ID) | Type and screen probe bedside test or laboratory | ID of patient not or wrong done, test withdrawn from wrong patient Laboratory test (hemoglobin levels, coagulation values or bedside test from wrong patient |
| Blood / coagulation product | Administration of blood /coagulation product to the wrong patient | |
| Handling and storage errors | ||
| Labeling | Labeling of blood samples / probes / tubes | Label not applied on tubes prior to withdrawal or wrong done (incorrect label form other subject) |
| Labeling of chart or other documents | Label not applied on chart or documents, incorrect label from other subject, wrong | |
| Labeling of blood products / coagulation products / drugs | Confused label on covers from other subjects, wrong content names or dosages | |
| Laboratory | Laboratory error | Wrong test results due to pre-analytic errors, diluted blood, test result issued for wrong subject, blood sample for antibody cross match expired, wrong blood sample sent, etc. |
| Testing error | analyzer defect or calibration missed, wrong POCT operation | |
| Storage | Storage error | Storage error of blood products (including ‘30-min rule’), extended storage in sub-depot location, extended non-agitated storage of platelets, unapproved storage in a food or drug refrigerator |
| Temperature deviation / cold chain error | Storage temperature deviations due to use of inappropriate storage i.e. warming or cooling devices | |
| Component expiry | Use of outdated products | |
| Product release /issue | Product / component issue / release | Mismatch or confusion at off-charge of product off the depot or blood bank, wrong or inappropriate component issued, wrong unit logged out, adjusting error, incomplete check out, documentation error |
| Transport | Transport error | Inadequate transport conditions, duration, products for multiple recipients in one box |
| Administration error | ||
| Indication | Indication | Erroneous indication for transfusion due to lab or pre-analytic error, missing guideline coverage due to misinterpretation of lab values, clinical context, circulatory symptoms, volume status or ignorance |
| Blood management | Uncorrected preoperative anemia | Uncorrected preoperative anemia in elective surgery |
| Transfusion trigger unrecognized | Restrictive transfusion strategy as suggested by guidelines | |
| Urgency of blood use | Not indicated emergency administration of not cross-matched, universal blood | |
| Volume status related to transfusion | Missing volume replacement for hyper-/hypovolemia, unsecure volume monitoring, blood products used for volume resuscitation | |
| Consent | Informed consent not done | Information about risks and complication of blood transfusion for conscious subjects and elective transfusion wrong or not done or not documented |
| Blood order | Blood order error | Missing or incorrect blood order, blood order for wrong patient, missing data on order form, etc. |
| Bedside test | Bedside test | Not or wrong done, wrong interpretation |
| Preparation for blood product administration | Type and screen, crossmatch | Missed/undone or wrong done type and screen, blood product reservation for elective transfusion or scheduled surgery, no antibody differentiation ordered |
| Pretransfusion procedure | immediately prior to blood product administration: lab value check, matching control of blood product ID blood group and patient blood group, antibody screen test, outdate of blood product, visual blood product control, transfusion system, venous access etc.) | |
| Timing | Inadequate timing of administration including premature timing of anesthesia before blood availability (induction of anesthesia without blood availability check) | |
| Delegation of transfusion | Start of transfusion cannot be delegated by German transfusion law | |
| Screen result expiry | Antibody screening test expires after 4 days | |
| Multiple transfusion | More than one transfusion process, more than one patient synchronously or massive transfusion as contributing factor or error | |
| Double unit administration | Ordering and transfusion of two units without review | |
| Monitoring | Monitoring during administration | Vitals and clinical symptoms monitoring for transfusion reaction not done |
| Documentation | Documentation of administration | Undone or wrong done documentation of administration of blood products |
| Inadequate timing of administration | For example at night time without urgency | |
| Errors related to IT | Wrong record selected | IT user based error: selection of wrong record and/or mismatch of order, test result or written entry to the wrong file/record. Attribution of diagnoses or diagnostic findings to the wrong chart/record by computer, analyzers or the operator manually, due to i.e. similar name, ID number or small font |
| Failure to consult or identify historical record | IT based or user based error: failure to retrieve a historical record in the data base with the search tool. For example, earlier blood group and antibodies cannot be compared with actual results for safety reasons | |
| Warning flag not updated or removed in error | IT user based error: Alert signs such as transfusion relevant antibodies are ignored, not updated or accidently removed | |
| Computer or other IT systems failure | Errors related to computer system such as no access possibility due to crash, updates or overhaul; errors related to electronic blood management system, access failure | |
| Incorrect entry | Incorrect or incomplete result or data entered or accessed manually, undetected or uncorrected wrong operation (copy, paste, delete) | |
| Blood order | Blood issued against wrong patient ID (sample or request form), error originates from electronic blood ordering system | |
| Administrator related error | Erroneous combination of records in data base, deletion of data, etc. | |
| Errors related to analog documentation paper-based forms/charts/documentation | Paper documentation related errors | Unreadable, wrong chart, misplaced, not filed in chart, torn, lacking, incomplete content etc. |
| Other equipment failure | Technical failure of used equipment | i.e. blood warming device for massive transfusion, blood gas analyzer, pressure device for rapid infusion, clotting of leukocyte depletion filters, etc. |
| Wrong or no equipment | Wrong or no equipment used, although available; monitoring, diagnostics, application technology not used, although first choice in a clinical situations, such as blood filter systems, plasmatherm for thawing of frozen blood components, hemoglobin analyzer≤ | |
| Understaffing | Reports, in which the error mainly is attributed to a lack of personnel | |
| Communication | Subject to subject | No or erroneous transmission of information from, i.e., surgeon to anesthesiologist, transfusion specialist to blood bank, nurse to physician, transport service to medical staff, etc. |
| Subject and technique including IT | Missing or erroneous exchange of relevant information from operator, reader or user to (hospital information system KIS, laboratory and monitoring IT or vice versa | |
Errors in categorizes and definition for the incidents. Near misses are not distinguished from real errors except when noted.
ID- = Identity check; IT = information technology, KIS = hospital information system; POCT = point of care testing; TACO = transfusion associated circulatory overload.