Technician Annual Sterile Preparation Compounding Process Validation and Media-Fill Testing

• Employee

• Conducted on

  Date

• Prepared by

Hand Hygiene and Garbing Practices

• Removes all jewelry from hands, wrist, and above neck?

  Yes

  No

  N/A

• Scrub nails, hands, arms (to elbows) with water and disinfecting agent for at least 30 seconds?

  Yes

  No

  N/A

• Rinses hands and arms holding hands upright to allow water to drip down to elbows?

  Yes

  No

  N/A

• Uses disposable non-shedding towels to dry hands?

  Yes

  No

  N/A

• Proper Garbing sequence: shoe covers, head cover, mask, hand hygiene, gown, and gloves?

  Yes

  No

  N/A

• After entering IV Room, disinfects hands with alcohol-based hand scrub, allows hands to dry before donning sterile gloves?

  Yes

  No

  N/A

• Can explain proper method to routinely disinfect gloves with sterile 70% isopropyl alcohol prior to entering hood?

  Yes

  No

  N/A

Ante Room-IV Room Product Transfer

• Understands concept of "dirtiest to cleanest" when transferring product to IV Room?

  Yes

  No

  N/A

• Understands all products are misted with sterile 70% isopropyl alcohol on Ante Room cart prior to transfer to IV Room?

  Yes

  No

  N/A

• Individual preparation baskets are disinfected with sterile 70% isopropyl alcohol?

  Yes

  No

  N/A

• Understands products must be disinfected with sterile 70% isopropyl alcohol prior to restocking the Ante Room

  Yes

  No

  N/A

Horizontal Laminar FlowHood

• If hood turned off: minimum time (30 minutes) required to run prior to any IV preparations?

  Yes

  No

  N/A

• Cleans hood in proper order: IV pole, sides, and bottom working top to bottom and back to front?

  Yes

  No

  N/A

• Does not utilize outer 6 inches of hood work surface or within 6 inches of back/sides of hood?

  Yes

  No

  N/A

• Uses sterile70% isopropyl alcohol wipes to clean hood? Does not use spray bottle?

  Yes

  No

  N/A

• Understands horizontal airflow and avoids blocking first air to critical sites during sterile compounding?

  Yes

  No

  N/A

Ampule Preparation

• Ampule neck clear of fluid, cleaned with alcohol and wrapped with alcohol swab or plastic amp breaker prior to breaking open?

  Yes

  No

  N/A

• Breaks ampule correctly and away from the HEPA filter?

  Yes

  No

  N/A

• Utilizes filter needle or straw to remove contents of ampule?

  Yes

  No

  N/A

• Removes filter needle and replaces with needle prior to injecting final container?

  Yes

  No

  N/A

• Uses proper technique to avoid contamination of needle, plunger, or syringe?

  Yes

  No

  N/A

• Cleans additive port on IV diluent bag with alcohol pad prior to injecting medication?

  Yes

  No

  N/A

• Recaps needle using one-handed "scoop method"?

  Yes

  No

  N/A

Vial Preparation

• Removes vial dust cover and properly disinfects vial stopper with sterile70% isopropyl alcohol swab?

  Yes

  No

  N/A

• Inserts needle correctly with bevel side up to reduce coring?

  Yes

  No

  N/A

• Inserts appropriate amount of air into vial to aid in removal of product?

  Yes

  No

  N/A

Compounded Sterile Preparation Label

• Aware of resources to determine appropriate beyond-use dating for prepared products?

  Yes

  No

  N/A

USP Chapter 797 Daily Documentation

• Understands required documentation of daily tasks for each shift?

  Yes

  No

  N/A

Compounding of Sterile Neonatal and Pediatric Preparations

• Understands how to utilize neonatal and pediatric dilution tables for IV preparations?

  Yes

  No

  N/A

• Selects correct Julian date for lot number to identify pool bag compounded for neonatal/pediatric batch bags?

  Yes

  No

  N/A

• Correctly determines beyond-use dating of compounded neonatal/pediatric preparations?

  Yes

  No

  N/A

• Understands how to complete Neo/Ped batch bag compound log and. Specific Ped patient IV compound dose log?

  Yes

  No

  N/A

TPN

• Understands process to spike and attach administration set to TPN bag?

  Yes

  No

  N/A

• Use of inline filter: 0.2 micron?

  Yes

  No

  N/A

Daily/Monthly Cleaning and Disinfecting Procedures

• Horizontal hood cleaning and disinfecting schedule: first of shift, prior to batch, and as needed during compounding?

  Yes

  No

  N/A

• Mop handles designated for floors, walls, and ceiling?

  Yes

  No

  N/A

• Cleaning product (obtained by EVS) used only for mopping IV Room and Ante Room?

  Yes

  No

  N/A

• Use of spray bottles of sterile 70% isopropyl alcohol and sterile low-lint wipes for daily cleaning of work surfaces and IV Room carts?

  Yes

  No

  N/A

• Trash removal procedure for IV Room and Ante Room?

  Yes

  No

  N/A

• Locates reference indicating monthly cleaning procedures/cleaners/areas?

  Yes

  No

  N/A

QI Medical PATT 2 Media Fill Testing

• Media Lot:

• Expiration:

• Incubation period 14 days:
  7 days room temperature and 7 days incubator

• Results:

  No Growth

  Growth

TSA Agar Plate Gloved Fingertip Sample Post Garbing-Cfu (colony forming unit)

• Initial validation (3 samples) or Revalidation (1 sample)

• Target=zero colony forming units

• Incubation period: 2 days (30-35 degrees) C

• Right Glove Cfu

• Left Glove Cfu

• Lot:

• Expiration:

• Select date

  Date

• Right Glove Cfu

• Left Glove Cfu

• Lot:

• Expiration:

• Select date

  Date

• Right Glove Cfu

• Left Glove Cfu

• Lot:

• Expiration:

• Select date

  Date

• Right Glove Cfu

• Left Glove Cfu

• Lot:

• Expiration:

• Select date

  Date

TSA Agar Plate Gloved Fingertip Sample Post Media Fill Testing

• Target=three or less colony forming units

• Incubation period: 2 days (30-35 degrees) C

• Right Glove Cfu

• Left Glove Cfu

• Lot:

• Expiration:

• Select date

  Date

• Right Glove Cfu

• Left Glove Cfu

• Lot:

• Expiration:

• Select date

  Date

• Add signature

  Sign