Improving patient safety in transfusion medicine: contemporary challenges and the roles for bedside and laboratory biovigilance in addressing them

Figures & data

Table 1 Hemotherapy (HT) through the years: an historical overview

Time period	The foundational years –1600–1920s	The ascent of components 1930–1960s	The era of infections 1970–1990s	The age of biovigilance 2000-present
Key events associated with period	Establishment of fundamental knowledge regarding the nature of blood, circulation, and the clinical basis for HT; discovery of blood- group antigens; recognition of risks/ benefits of HT; medicolegal aspects; introduction of governmental regulatory oversight; military/ wartime lessons	Anticoagulant/preservative solution developments; fractionation of whole blood; plasticware introductions; expansion of HT into routine clinical practice; establishment of hospital blood banks and solid-organ transplantation programs; ongoing identification of blood-group and histocompatibility antigens; military/ wartime lessons	Discovery of hepatitis viruses and HIV/ AIDS, and recognition of infection via HT; expansions of donor-transmissible agent testing; development of bone marrow- and peripheral blood-derived stem cell- transplantation programs; realization of the potential for new Agent X transmission by HT; advances in pathogen inactivation; blood bank computerization; military/wartime lessons	Development of national hemovigilance networks; greater emphasis on patient blood management (PBM); HT adverse-outcome mitigation strategies (eg, TRALI mitigation and bacterial testing of platelets); adoption of and expansion of hemovigilance strategies into cellular therapies and tissue transplantation care areas; introduction of new preservative solutions and derivatives; continuing research into “blood substitutes”, including exploration of stem cell culturing; adoption and expansion of electronic health records (EHRS); health care reform initiatives and global economic realities impacting HT and blood collectors
Main compatibility concerns	Biologic/serologic	Serologic	Serologic; electronic	Serologic; electronic; electronic health networks
Major loci of activity	In situ; in vivo (animals >> humans); in vitro	In vivo (humans >> animals); in vitro	In vitro; in vivo (humans and animals)	In vitro; in vivo; in silico

Abbreviations: HIV, human immunodeficiency virus; AIDS, acquired immunodeficiency syndrome; TRALI, transfusion-related acute lung injury.

Table 2 Perceived chief concerns and hazards of hemotherapy (HT) through the years

Time period → Chief areas of concern ↓	The foundational years –1600–1920s	The ascent of components 1930–1960s	The era of infections 1970–1990s	The age of biovigilance 2000–present
Infectious	Bacterial sepsis; syphilis	Bacterial sepsis and pyrogens; syphilis; hepatitis; malaria; miscellaneous agents’ transmission	Bacterial sepsis; syphilis; hepatitis viruses (A, B, C); human immunodeficiency virus (HIV); human T-lymphotropic virus I/II (HTLV I/II); cytomegalovirus (CMV); EBV; malaria; babesia	Transfusion-associated sepsis; syphilis; hepatitis viruses; HIV; West Nile virus; protozoans; tick- borne pathogens; prion agents; Agent X
Noninfectious	Serologic incompatibilities, eg, hemolysis, agglutination; anaphylaxis; serum sickness; air embolism; acute heart dilation; circulatory overload; metabolic/ chemical, due to additives, eg, citrate	Hemolytic; major and minor ABO-mismatch incompatibilities; circulatory overloading; allergic/ anaphylactoid; febrile; citrate intoxication; potassium intoxication; acquired allergic sensitivities by transfer; air embolism	Circulatory hypervolemia; immunologic; immune alloimmunization; hypothermia; foreign/particulate material transfer; iron overload; transfusion-associated graft-versus-host disease (TA-GVHD); posttransfusion purpura (PTP); transfusion-related acute lung injury (TRALI); biochemical defects associated with massive transfusion; air embolism	Hemolytic; febrile; allergic; transfusion- associated circulatory overload (TACO); TRALI; transfusion-related immunomodulation (TRIM); transfusion-associated adverse pulmonary sequelae (TAAPS); lead; TA-GVHD; PTP; iron overload; foreign/particulate material transfer; biochemical defects associated with massive transfusion; air embolism; hypothermia; immune alloimmunization
Logistical/administrative	Patient/specimen identification (ID); direct transfusions; blood availability	Stored blood lesions; blood substitutes; establishment of hospital blood banks; wartime and peacetime operations, overtransfusion	Patient/specimen ID; blood substitutes; blood shortages	Patient/specimen ID; pathogen-reduction technologies; RBC age issues; inventory management; time of day for transfusions; electronic health care network compatibilities; battlefield TM; PBM; experienced workforce staffing challenges; TM IS/data-management specialists; cost

Abbreviations: EBV, Epstein–Barr virus; TM, transfusion medicine; IS, information systems; RBC, red blood cells.

Figure 1 Care map for uncomplicated hemotherapy (UHT), showing major diagnostic, therapeutic, and biovigilance activities and considerations associated with the various phases of a blood-transfusion event. See text for further details and information related to UHT care maps.

Note: Modified with permission from Andrzejewski C Jr, McGirr J. Nursing hemotherapy bedside biovigilance in the recognition and management of suspected transfusion reactions. In: Popovsky M, ed. Transfusion reactions, 4th edition, Bethesda, MD: AABB Press, 2012;551–577.²⁵
Abbreviation: HT, hemotherapy.

Table 3 The twelve “rites” of hemotherapy

1. Right knowledge/reason

2. Right patient

3. Right testing

4. Right product

5. Right care locus

6. Right timing

7. Right volume

8. Right rate

9. Right monitoring, response, and follow-up

10. Right documentation

11. Right regulation

12. Right reimbursement

Table 4 Potential classification basis of suspected transfusion reactions (STRs)

Degree of RBC destruction

- Hemolytic

- Nonhemolytic Temporal onset

- Acute/intermediate

- Delayed/remote Severity of reaction

- Mild/moderate/severe/fatal Infectious/noninfectious aspects

Details for STR classification: process basis

• Identification problems

- Patient/specimen/unit

- Errors/nonconformities

- Missing/incomplete information

- Managerial deviations

- “WBIT” - wrong blood in tube

• Transportation/storage conditions

• Rate of infusion

• Concurrent fluid challenges

• Practice deviations

• Monitoring, trending, and responding to vital-sign value measurements

• Peritransfusion medication administration

Details for STR classification: product basis

• Component type

• ABO/Rh blood-group compatibility/identity with recipient

• Age of unit

• Storage temperature

• Special attributes of product

- Leukoreduction

- Gamma-irradiation

- Degree of pathogen inactivation

• Extent of manipulations

- Pooling

- Prestorage

- At issue

• Product nonconformities

Immune-system involvement

- Immune versus nonimmune

- Degree of participation

- Active versus passive immunity aspects

Patient basis Product basis Process basis

Abbreviation: RBC, red blood cell.

Andrzejewski C Jr, McGirr J. . Nursing hemotherapy bedside biovigilance in the recognition and management of suspected transfusion reactions. In: Popovsky MA, editor. Transfusion Reactions. 4th ed. Bethesda (MD): AABB; 2012:551–577.

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