Preface What is the Competency Companion? Why assess ...

(EU) guide to GMP refers to continuing training. In the United States,
competency assessment is required by several agencies and regulations, including
the Clinical Laboratory Improvement Amendments of 1988 (CLIA ’88), the Food
and Drug Administration (FDA), and the Health Care Financing Administration
(HCFA).
Currently there is no regulatory requirement for competency assessment in
transfusion service laboratories in Canada. However, both CSA Standard Z902-
04 and CSTM Standards for Hospital Transfusion Services have personnel
requirements that include training, competency assessment, and records.
Facilities must identify training needs and develop training programs, including
initial and ongoing training; develop, maintain, and document formal
competency assessment programs; assess competency following training and at
regular intervals thereafter; assess effectiveness of training programs at least
annually; implement SOPs and important changes only after staff training is
complete; maintain documentation of qualifications, training, competency
assessments, continued competence; and implement remedial measures to
correct inadequate performance.
Although CSA Standards are norms of behaviour and best practice, not
regulations, Health Canada encourages health organizations to follow the
practices and procedures in the CSA Standards as they represent the current
industry standard for safety. Health Canada will use the CSA Standards as one of
several tools employed to develop new federal regulations for blood and blood
components.
The TraQ program recommends that assessment of competency be done upon the
completion of orientation, annually, and as required for performance
management of technologists who rotate or work in the transfusion medicine
area of the laboratory.
Competency programs should evaluate theoretical and practical knowledge of
procedures that include, but are not limited to:
• testing of proficiency samples;
• review of work records and/or Quality Control (QC)/Quality Assurance
(QA) records;
• written evaluation; and
• direct observation of test procedures.
How to implement the Competency Companion
Competency assessment is a process that takes large parcels of time to implement
and ongoing resources to maintain. Organizational and time management skills
are paramount in successful implementation.
Competency Companion to the Technical Resource Manual for Hospital
Transfusion Services
Introduction
Page ii of iv