Personnel Training and Evaluation USP 800
Personnel Training and Evaluation
Sterile Hazardous Compounding <800>
Purpose/ Applicability: To provide guidelines for training and evaluating personnel to show competency in safely and properly handling sterile hazardous compounds.
Scope: Applies to all personnel who handle sterile compounded hazardous preparations.
Definition(s):
HD: Hazardous Drugs
PPE: Personal Protective Equipment
SOP: Standard Operating Procedure
Equipment: N/A
Procedure:
Background
- Personnel who are compounding sterile hazardous preparations must be trained in properly donning PPE and in aseptic and negative pressure techniques that are necessary for working with sterile HDs
- Additional training is required when new equipment, new HD, or new procedures are put in place
- Personnel competency must be reassessed every 12 months and documented appropriately (in the form below)
Training Categories
Personnel must be trained and show competency in:
- Spill management and the necessary documentation
- Receipt, transport, and storage of HDs
- Dispensing and administering HDs
- Proper use of equipment and devices (i.e. engineering controls)
- Response to known or suspected HD exposure
- Overview of formulary and risks of HDs carried
- Aseptic techniques
- Proper labeling
- Cleaning, sanitizing, deactivation, and decontamination of HDs
- Proper disposal of HDs and trace contaminated materials
- Proper donning and doffing of PPE
- Daily cleaning and disinfection of cleanroom
Training for Handling of Hazardous Drugs:
Name of personnel: |
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Activity |
Date assessed |
Initials of assessor |
Spill management and the necessary documentation |
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Receipt, transport and storage of HD’s |
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Dispensing and administering of HD’s |
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Proper use of equipment and devices (i.e., engineering controls) |
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Response to known or suspected HD exposure |
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Overview of entity’s list of HDs and their risks |
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Aseptic techniques |
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Proper labeling |
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Cleaning, sanitizing, deactivation and decontamination of HD’s |
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Proper disposal of HDs and trace-contaminated materials |
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Proper hand hygiene techniques |
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Proper donning and doffing PPE |
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Daily cleaning & disinfecting of Cleanroom |
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- Personnel should review all appropriate SOPs, complete cleanroom certification (donning/doffing of PPE), and review cleanroom cleaning and disinfection procedures
- Following reviews, personnel should be able to communicate procedures effectively and appropriately