Personnel Training and Evaluation USP 800

Sterile Hazardous Compounding <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:

Activity

Date assessed

Initials of assessor

Spill management and the necessary documentation

 

 

Receipt, transport and storage of HD’s

 

 

Dispensing and administering of HD’s

 

 

Proper use of equipment and devices (i.e., engineering controls)

 

 

Response to known or suspected HD exposure

 

 

Overview of entity’s list of HDs and their risks

 

 

Aseptic techniques

 

 

Proper labeling

 

 

Cleaning, sanitizing, deactivation and decontamination of HD’s

 

 

Proper disposal of HDs and trace-contaminated materials

 

 

Proper hand hygiene techniques

 

 

Proper donning and doffing PPE

 

 

Daily cleaning & disinfecting of Cleanroom

 

 

 

  • 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


KeywordsTrain, evaluate, competency   Doc ID130915
OwnerJenny C.GroupUofI College of Veterinary Medicine Teaching Hospital
Created2023-09-06 14:44:02Updated2023-09-07 14:31:59
SitesUniversity of Illinois College of Veterinary Medicine Teaching Hospital
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