Writing clear, assay succinct procedures (SOPs) can be one important aspect of a Manager's job.Sometimes, technical personal are tasked with procedure writing, but it is the manager's responsibility to ensure they follow the proper format and meet all requirements.After a new procedure is prepared, the Laboratory Director will approve and sign off on it.After the institution of a procedure, it must be reviewed and approved biennially (every 2 years),When a procedure is removed from use, it must be marked with the date of discontinuation and saved with the laboratory documents.

Questions:

1. List the headings and sections that must appear in all procedures. Don't forget approvals and sign-offs. To answer this question, use the CLSI document.

2.Why do you think it is so important to have a standardized format for procedures?

3. Name an agency which does on-site inspections and can write citations for non-compliance with regulations?

4.Who may approve a new procedure?

5.Who may review and sign-off on a SOP forthe biennial review? Hint: it is not limited to the lab director.

6.What should be done with discontinued procedures? NOTE: If you are in the SBB Program,your answer must include the length of time that blood bank procedures must be retained.