1. NPTA Licensed Trainer In-Service Sterile Products
Presented by: Mike Johnston, CPhT
Chairman & CEO - NPTA

2. Agenda Program Overview Program Requirements The Process Cycle
Program Resources
Q & A

3. Program Overview
NPTA’s Sterile Product Certification Course has been designed to train pharmacy technicians on the topic of sterile product preparation and aseptic technique. This course is designed to meet all applicable State Board of Pharmacy training requirements.
40.0 Contact Hours/4.0 CEU
ACPE No H04
This program was released November 1, 2005.
Official Logo

4. Program Requirements Nine (9) Chapter-based Modules
Twenty (20) Hours of Validated, Hands-On Training
Nine (9) Process Validations

5. Overview of Modules Modules Module No. = Chapter No. Hands-On Training
Process Validations
Module No. = Chapter No.
Each Module includes:
specific learning objectives
assigned reading
(Sterile Products: The Pharmacy Technician Series by M. Johnston)
vocabulary
an end-of-chapter/module review assignment
a ten-question module quiz

6. Overview of Modules Modules Module No. = Chapter No. Hands-On Training
Process Validations
Module No. = Chapter No.
Each Module includes:
specific learning objectives
assigned reading
(Sterile Products: The Pharmacy Technician Series by M. Johnston)
vocabulary
an end-of-chapter/module review assignment
a ten-question module quiz (GRADED)

7. Module Quiz Answer Form
Modules
Hands-On Training
Process Validations
Very Important!
The Answer Form must:
be completed in ink.
contain only 1 answer selected per question.
No scratch outs.
be graded by faculty – not other students.
scored in red ink.
contain all participant/student information requested.

8. Module Quiz Answer Form
Modules
Hands-On Training
Process Validations
Now, let’s review an actual form!
Remember! – The Answer Form must be completely filled out, signed and graded with a passing score of 70% or higher to be considered valid.
If they fail the quiz – do NOT submit it to NPTA.

9. Module Topics Modules Hands-On Training Process Validations
Module 1 – An Introduction to Sterile Products
Module 2 – Facilities, Garb & Equipment
Module 3 – Aseptic Calculations
Module 4 – Properties of Sterile Products
Module 5 – Aseptic Technique
Module 6 – Sterile Product Preparations
Module 7 – TPNs
Module 8 – Chemotherapy
Module 9 – Quality Control and Assurance

10. Module Schedule Modules Hands-On Training Process Validations
Module 1 – An Introduction to Sterile Products
Module 2 – Facilities, Garb & Equipment
Module 3 – Aseptic Calculations
Module 4 – Properties of Sterile Products
Module 5 – Aseptic Technique
Module 6 – Sterile Product Preparations
Module 7 – TPNs
Module 8 – Chemotherapy
Module 9 – Quality Control and Assurance
Remington Unit 4
Remington Unit 7

11. Overview of Hands-On Training
Modules
Hands-On Training
Process Validations
Must complete a total of 20 hrs. (or more) of documented and observed aseptic skills training.
A separate Training Log Form must be fully completed for each training session.
Group-based training can be utilized, but only in small groups which are interacting together at the hood.
i.e. all group members must be able to have a complete view of the benchtop…students must be rotating observing and practicing…probably no more than 3-5 students per hood simultaneously.

12. What is Valid for Hands-On Training?
Modules
Hands-On Training
Process Validations
aseptic hand washing
hood cleaning
label preparation
vial preparations
ampule preparations
bag preparations
syringe/needle manipulation
chemo preparation
TPNs
spill clean-ups
misc./non-parenteral sterile compounding
etc.

13. Aseptic Technique Training Log
Modules
Hands-On Training
Process Validations
Now, let’s review an actual form!
Remember! – The Training Log must be completely filled out, signed and dated to be considered valid.

14. Overview of Process Validations
Modules
Hands-On Training
Process Validations
Must complete all nine process validations.
The correct Process Validation Record must be fully completed for each validation.
Group-based validations are not permitted.
These are individual validations for individual skills.
Each process validations must have a 100% pass score.
This means they make no mistakes and you are able to check only “yes’s.”

15. Process Validations Modules Aseptic Hand Washing
Hands-On Training
Process Validations
Aseptic Hand Washing
Horizontal Laminar Flow Hood
Vertical Laminar Flow Hood
Vial Preparation
Ampule Preparation
Vial Preparation (Hazardous)
Ampule Preparation (Hazardous)
TPN
Sterile Product Label Preparation

16. Process Validation Questions
Modules
Hands-On Training
Process Validations
We don’t have a vertical [horizontal] hood…
Instruct the student to utilize the hood acting as if it were a vertical [horizontal] hood.
We don’t have hazardous vials…
Utilize standard vials and instruct the student when to consider it a “hazardous” product…or
NPTA/Meducation will be launching “hazardous” placebos in the 4th quarter of 2006.
We don’t have a TPN machine…
Teach them using the gravity method…

17. Process Validations Modules Hands-On Training
Now, let’s review an actual form!
Remember! – Each Validation Record must be completely filled out, signed and dated and be scored with all “yes’s” to be considered valid.

18. The Program Process Cycle
Campus places P.O. for SPC-20 (using E-questor)
NPTA receives P.O. and ships textbooks.
Course
Campus packages completed packets (per student) and ships to NPTA.
NPTA receives packets, checks for all required paperwork and “spot” grades quizzes.
If packets are incomplete – they get held up until corrected.
NPTA prepares (for each student) a Statement of Credit and Certificate…these are mailed back directly to the campus.
NPTA enters students as new members of NPTA (at no charge for 1 year) and send a new member kit within 3-4 weeks.

19. Estimated Time
Please allow (when possible) up to 2 weeks for shipments of the textbooks.
Please allow up to 3 weeks for certificate issuance of completed packets.
Longer (?) if not submitted correctly.

20. Slowing the Process Cycle
Missing Quizzes
Non-graded Quizzes
Incorrectly Graded Quizzes
Missing Training Logs
Training Totals < 20 Hours
Incomplete Training Forms
Missing Process Validation Records
Incorrect/Failed Process Validation Records
Incomplete Process Validation Records
Non-signed/Non-dated Forms/Records

21. There are six main reasons!
Why is it so strict?
There are six main reasons!

22. Resources http://pharmacytechnician.org/en/cms/?953
Sterile Product Certification Program Instructor CD
NPTA’s LTF (Licensed Training Facility) Support Page
Bookmark this page…it is not publicly available.
Sterile Products: The Pharmacy Technician Series by M. Johnston [Prentice Hall] Instructor Manual and CD-Rom
Phone Fax

23. New Forms & ID #s Licensed Trainer Profile
Licensed Training Facility Dossier
Change of Status Form
All Trainers will be issued a new NPTA Licensed Trainer ID Number, upon completing this In-Service and submitting their Licensed Trainer Profile.

24. Questions?