ARCHIVED - Summative Evaluation of the Blood Safety Contribution Program - Final Report

Appendix D: Glossary of Terms

Glossary from the Transfusion Transmitted Injuries Surveillance System User’s Manual Version 3.0 (2007):

Adverse Event: An undesirable and unintended occurrence during or after the administration of blood, blood components, or blood products (plasma derivatives) whether or not considered to be related to the administration of these products.

Note: The following are considered to be types of adverse events:

Incident: An accident or error that could lead to an adverse outcome affecting

1. the safety, efficacy or quality of blood, blood components, or blood products (plasma derivatives); or
2. the safety of recipients.

Accident: An unexpected or unplanned event, not attributable to a deviation from standard operating procedures or applicable laws or regulations, that could adversely affect

1. the safety, efficacy or quality of blood, blood components, or blood products (plasma derivatives); or
2. the safety of recipients.

Error: An unexpected, unplanned deviation from standard operating procedures or applicable laws and regulations, usually attributable to a human or system problem, that could adversely affectt

1. the safety, efficacy or quality of blood, blood components, or blood products (plasma derivatives); or
2. the safety of recipients.

Adverse Reaction: An undesirable and unintended response to the administration of blood, blood components, or blood products (plasma derivatives) that is considered to be definitely, probably or possibly related to these products.

Serious Adverse Event: An adverse event that

• requires in-patient hospitalization or prolongation of hospitalization
• directly attributable to the event,
• results in persistent or significant disability or incapacity,
• necessitates medical or surgical intervention to preclude permanent damage to or impairment of a body function,
• is life-threatening, or
• results in death.

Unexpected Adverse Event: An adverse event that is not identified in nature, severity, or frequency among the currently known adverse effects associated with the administration of blood, blood components, or blood products (plasma derivatives).

Blood Component: A therapeutic component of blood intended for transfusion (e.g., red cells, granulocytes, platelets, cryoprecipitate, plasma) that can be prepared using the equipment and techniques available in a blood supplier centre (e.g., by centrifugation, filtration, or freezing).

Blood Product (Plasma Derivative): A product derived from human or animal plasma by a fractionation process. Note: Examples of blood products (plasma derivatives) are human serum albumin, solvent detergent products, immunoglobulin preparations, factor IX, or factor VIII concentrate products. Examples of related products are porcine factor VIII and coagulation factors produced using recombinant DNA.

Provincial/Territorial Blood Office: An office/department established in each province or territory to manage the collection of data regarding adverse events related to transfusion.

Glossary from the TOSS Performance Measurement and Evaluation Framework (2008)

Acceptability: Willingness of persons and organizations to participate in the surveillance system. (CDC updated guidelines for evaluating public health surveillance systems. MMWR July 27, 2001; 50 NO RR-3).

Attribute: A characteristic typical of an individual or item.

Evaluation: Examines how consistent the services actually delivered are with the goals of the program, whether services are delivered to appropriate recipients, how well service delivery is organized, the effectiveness of the management, the use of program resources, and other such matters.” Rossi H, Lipsey MW, & Freeman HE. (2004). Evaluation: A systematic approach, 7th ed. Sage Publications: Thousand Oaks CA. p. 58).

Formative Evaluation: Conducted during the development or improvement of a program, often more than once, for in-house staff of the program with the intent to improve. (Scriven M, Evaluation Thesaurus, 4th ed. Publisher: City; 1991).

Summative Evaluation: Evaluation that is conducted after completion of the program for the benefit of some external audience or decision-maker, though it may be done by either internal or external evaluators or a mixture. (Scriven M, Evaluation Thesaurus, 4th ed. Publisher: City; 1991).

Data Quality: Completeness and validity of the data in the system (Owston R. Evaluation plan for i-PHS implementation. HC, Centre for Surveillance Coordination: Ottawa; August 23, 2002)

Evaluation Framework: A plan for conducting an evaluation focusing on issues to be addressed and, by implication, identify the data needed to support the evaluation. (HC Policy Manual –Evaluation Policy-Context for Evaluation)

Feedback: The process of routinely sending analyses and reports to the more peripheral levels of the surveillance system. Feedback may occur in the form of newsletters, bulletins, letters, memoranda, telephone calls, visits, or any combination of these. (Making surveillance work, Module 3: logistic management; WHO 2001)

Flexibility: Ability of the surveillance system to accommodate changes in operating conditions or information needs. (Declich S, Carter AO. Public health surveillance: Historical origins, methods, and evaluation. Bulletin of the world Health Organization 1994; 72(2):285-304)

Input: Resources used by organizations, policies, programs, and initiatives to produce outputs and accomplish outcomes

Logic Model: A depiction of the causal or logical relationships between activities, inputs, outputs, and the outcomes of a given policy, program, or initiative. (Treasury Board of Canada, Results-Based management Lexicon; 2005)

Objective: The precisely stated end to which efforts are directed, specifying the population outcome, variable(s) to be measured etc. (Last JM, editor. A dictionary of epidemiology. 4th ed. Oxford University Press: New York; 2001)

Outcomes: An external consequence attributed, in part, to an organization, policy, program, or initiative that are in the area of the organization's influence. Outcomes are classified as immediate, intermediate and long term. (Treasury Board of Canada, Results-Based management Lexicon; 2005)

Output: Direct products or services stemming from the activities of an organization, policy, program, or initiative, and usually written within the control of the organization itself. (Treasury Board of Canada, Results-Based management Lexicon; 2005)

Performance Measure: A quantitative or qualitative means of measuring an output or outcome, with the intention of gauging the performance of an organization, program, policy, or initiative. (Treasury Board of Canada, Results-Based management Lexicon; 2005)

Positive Predictive Value: Proportion of reported cases that actually have a health-related event under surveillance. (CDC updated guidelines for evaluating public health systems, MMWR July 27, 2001;50;NO RR-13)

Process: Business process that data providers, managers, researchers and policy makers use to create surveillance products throughout each phase of the surveillance system. (HC, Advisory Committee on Health Info structure, Tactical Plan for Health Surveillance, Ottawa, February 2001)

Sensitivity: 1) The proportion of cases of a health-related event detected by the surveillance system. 2) Ability to detect outbreaks, including the ability to monitor changes in the number of cases over time. (CDC updated guidelines for evaluating public health systems, MMWR July 27, 2001;50;NO RR-13)

Simplicity: Structure and ease of operation. (CDC updated guidelines for evaluating public health systems, MMWR July 27, 2001;50;NO RR-13)

Stability: Reliability (ability to collect, manage and provide data properly without failure and availability (ability to be operational when it is needed) of the public health surveillance system. (CDC updated guidelines for evaluating public health systems, MMWR July 27, 2001;50;NO RR-13)

Surveillance: HC defines surveillance as: “The collection, analysis, interpretation, use, publication, and distribution of information, in order to anticipate, assess, and address health needs or risks, evaluate developments in health, and guide public health action.”

Process of systematic collection, orderly consolidation and evaluation of pertinent data with prompt dissemination of the results to those who need to know, particularly those who are in a position to take action. (WHO, Protocol for the Assessment of National Communicable Disease Surveillance Response Systems, Annex 1.0 Surveillance Definitions, Document WHO/CHS/CSR/ISR/2001.2

Routine Surveillance: The regular systematic collection of specified data to monitor a disease or health event. (WHO, Protocol for the Assessment of National Communicable Disease Surveillance Response Systems, Annex 1.0 Surveillance Definitions, Document WHO/CHS/CSR/ISR/2001.2

Timeliness: Interval between the occurrence of the adverse health event and 1) the report of the event to the appropriate agency, 2) the identification by that agency of trends or outbreaks, 3) the implementation of control measures. (WHO Evaluation of epidemiological surveillance systems, February 1997)

Tracking: HC defines tracking as: “The ability to locate tissue or organ during any step of its donation, collection, processing, testing, storage, distribution, or disposition.” It implies the capacity to identify the medical facility receiving the tissue or organ and, at the medical facility, the ability to identify the recipient.

Usefulness: How helpful the system is to public health staff in taking action as a result of interpreting and analyzing the data. (Owston R. Evaluation plan for i-PHS implementation. HC, Centre for Surveillance Coordination: Ottawa; August 23, 2002)