KPIC Aseptic Technique Training Course

KPIC Aseptic Technique Training Program

Registration closes: February 26, 2015

Program Title: Aseptic Technique Training Program

By registering for this program, you understand and agree that you must complete the home study portion in order to attend the live portion of the program. Upon registering for this live event, the SCCP will enroll you in the home study program and the textbook will be mailed to the address you provided during registration.

The home study pre-requisite portion of this program provides 7.5 hours of continuing pharmacy credit (0.75 CEUs) and the live portion of this program provides 16 hours of continuing pharmacy credit (1.6 CEUs). Participants who fully and successfully complete both portions may receive a maximum of 23.5 hours of continuing pharmacy credit (2.35 CEUs). Upon successful completion of the entire homestudy program, you will be allowed to attend the live portion. Cut-off for successful completion of self-study will be no later than 11:59pm on 03/09/2015.

Target Audience: This course is targeted for Pharmacists and Pharmacy Technicians responsible for preparing sterile compounded preparations. This course will provide core training for individuals new to sterile compounding or individuals seeking to review their knowledge and skills in sterile compounding and aseptic technique.

Program Description: The KPIC Aseptic Technique Training Program is an intensive practice-based educational activity designed to equip pharmacists and technicians with immersive, hands-on training in the compounding of aseptic products. Learners will be provided training in aseptic technique and objective evaluations following the preparation of Compounded Sterile Products (CSPs) according to USP <797> regulations through the use of didactic training, observation, coaching and practical skill assessments. The live session provides hands-on skills training focused on the current requirements and situations most likely to be encountered in a sterile compounding environment. Learners must successfully demonstrate competency via hands-on simulations in the state of the art compounding facility.

As a pre-requisite to the practice-based activity, the participant must first complete a home study component that will prepare the student for the intensive hands-on training. This self-study activity provides comprehensive instruction in current compounding techniques, and standards of practice for successful sterile compounding.

Participant Requirements: To receive continuing education credit for this program, participant must be a registered pharmacist or registered pharmacy technician. Participant must physically be able to stand for a minimum of 2 hour periods and must have manual dexterity to allow manipulation of needles, syringes and other products utilized to prepare sterile products. Participant must also have full range of motion to complete physical tasks required in the compounding processes.

Program Faculty:

Michaela Almgren, PharmD, MS

Clinical Assistant Professor

Department of Clinical Pharmacy and Outcomes Sciences

South Carolina College of Pharmacy

Columbia, S.C.

Nancy Roberts, PharmD, MS

Patient Care Pharmacist

West Georgia Medical Center

LaGrange, Georgia

and

Pharmacist

Southeastern Regional Medical Center
Newnan, Georgia

Carole Russell,RPh, BS, MHSA

Compounding Pharmacist

Medical University of South Carolina

Charleston, SC

Kathy Q. Moore, R.Ph, BS

Coordinator for the Applied Pharmaceutics Compounding Lab

Instructor, Community Lab

South Carolina College of Pharmacy

Columbia, S.C.

Carl Dunn

Pharmacist

Lexington Medical Center

West Columbia, SC

Program Date: March 12-13, 2015

Instructors for this session are: Dr. Almgren, Dr. Roberts, Carole Russell and Carl Dunn.

Program Schedule:

Location of event: The training program will be offered at the Aseptic Compounding Experience (ACE) Lab, located at 715 Sumter Street, South Carolina College of Pharmacy -University of South Carolina campus in Columbia, SC.

Registration fee: $1250

Registration is limited and will be taken on a first come first serve basis. Fee includes required self-study materials, on-site training, and continuing education credit. For the two-day live training program; breakfast, lunch, and morning and afternoon snacks are provided. Registrants are responsible for dinner, any travel expenses, and hotel accommodations.

Program Cancellation and Refund Policy:

Cancellation Policy: Cancellations received in writing at least 30 days prior to program date via letter or email to ce@sccp.sc.edu will receive a full refund minus a $200 cancellation fee.

SCCP reserves the right to cancel the entire program. In the event of a conference cancellation, each participant will be notified via phone and/or email at least 14 days prior to the program and a full tuition refund will be made.

In the event of inclement weather, the decision to cancel a course will be made no later than 9:00 am Eastern time the day before the program.

Registration transfers
Individuals attending the course in place of the registered individual will be honored as long as the request is made in advance of the registration deadline, which is 14 days prior to the start of the live component. Transfer participants must still complete the required pre-requisite self-study by the required cut-off date.

Refunds
Refund requests are subject to a $200.00 cancellation fee and must be received 30 days prior to the start of the live component. All registration cancellations must be submitted in writing or by e-mail to the Continuing Education Department at the following address.

South Carolina College of Pharmacy – USC Campus
Continuing Education

715 Sumter Street, Room 318

Columbia, SC 29208
Email: ce@SCCP.sc.edu

Registrants may receive 100% of the program registration fees, less the $200.00 cancellation fee up to 30 days prior to start date of the live component. No refunds are offered for cancellations fewer than 30 days prior to the start date of the live component or for no shows.

RSVP Information and cut-off date: Registration will be accepted until 14 days prior to the start of the live practice based component or until capacity has been reached.

There is no commercial support for this program.

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ACCREDITATION INFORMATION:

The South Carolina College of Pharmacy is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education. The KPIC Aseptic Technique Training Program has been accredited for 16 hours of live credit.

The pre-requisite home study activity must be completed prior to attending the live program. In order to receive continuing education credit for the self-study activities, the participant will be required to complete each reading and video assignment along with review questions and case studies, complete the pre and post-tests and on-line program evaluation. Post-test will be automatically graded, and you must receive a score of 70% or higher to be considered successful. This knowledge based activity has been approved for 7.5 hours of continuing education credit. ACPE#: 0062-0000-14-094-H04-P/T. Initial Release Date: 7/7/2014 Expiration Date: 7/7/2017

For successful completion for the live practice based activity, participants will be required to attend the accredited program in its entirety, successfully demonstrate practice based competencies using planned simulations, and complete speaker and program evaluations. This practice-based activity has been approved for 16 contact hours (1.6 CEUs) of live continuing education credit. ACPE# 0062-0000-15-051-L04-P/T. Initial Release Date: 03/12/2015. Expiration Date: 03/12/2018.

Credit claimed will be automatically uploaded to CPE Monitor. Each participant is required to provide their NABP ePID and month and day of birth; CPE credit will not be issued to individuals that do not provide this information. ACPE now requires that all completed pharmacy continuing education credits must be processed and claimed no later than 60 days from the date of the live activity or completion of an on-demand activity.

NOTE: For participants that complete the entire program, Certificates of Completion will be provided.

Contact Information: If you have questions about this CPE activity, please contact the CE office at 803-777-9979 or ce@sccp.sc.edu

Disclosure Statements:

Faculty Disclosures: Faculty reports no financial or personal relationship with any commercial interest producing, marketing, reselling, or distributing a product or service that appears in this presentation.

Activity Staff Disclosures: The planners, reviewers, staff and CME committee who control content have no relevant financial relationships to disclose.

REQUIRED COMPUTER HARDWARE/SOFTWARE:

Activity Requirement: Internet connectivity and Adobe Acrobat Reader are required for participation in this activity.

Please ensure the computer system you plan to use meets the following minimum requirements:

Operating System: Windows XP SP2 or later, Windows Vista, Windows 7, Mac OS X 10.5 or later
Internet Browser (Mac &/ Windows): Internet Explorer 7 or later, Firefox 3.5 or later, Safari 4
Broadband Internet connection: Cable, High-speed DSL & any other medium that is internet accessible
Peripherals: Computer speakers or headphones
Monitor Screen Resolution: 320 x 480 or higher
Media Viewing Requirements: For some components, the most up-to-date version of Adobe Flash may be required. To obtain the free Flash plug-in, go to http://get.adobe.com/flashplayer/.

Date: Mar 12, 2015 08:00 AM - Mar 13, 2015 05:15 PM

Fee

$1,250.00

CE Hours

23.50

CE Units

2.350

Registration closes on Mar 10, 2015 01:00 AM

Activity Type

Certificate-Based

Target Audience(s)

Pharmacists
Pharmacy Technicians

Accreditation(s)

The University of South Carolina College of Pharmacy is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education.

Support/Credits

KPIC ASEPTIC TECHNIQUE TRAINING COURSE GUIDE AND LEARNING OBJECTIVES - LIVE COMPONENT

The goal of this course is to provide training followed by objective evaluations of preparers of Compounded Sterile Products (CSPs) according to USP <797> regulations through the use of didactic training, written competence assessments, observations, coaching and practical skill assessments.

The live practice based component will be held over 2 days and will provide 16 hours of live ACPE approved credit for pharmacists and pharmacy technicians:

KPIC Aseptic Technique Training Curriculum Schedule

Day 1 – March 12, 2015

Time	Session	Format
8:00-10:15am	Discussion of Low/Medium risk sterile compounding and aseptic technique	Lecture
	Vial pressures, Labels and Compatibility/Stability	Lecture/Demo/Lab
10:15-10:30am	Break
10:30-11:45am	Hands on training of Low/Medium risk sterile compounding and aseptic technique	Lab
11:45a-12:30p	Lunch
12:30-2:30pm	Assessments of Student Skills in Low/Medium Risk Sterile Compounding and Aseptic Technique	Lab
2:30-2:45pm	Break
2:45-4:45pm	Contamination, QA/QC for CSP	Lecture
	Special Topics	Lecture
4:45-5:15pm	Wrap up, Q&A, Remediation

Day 2 - March 13, 2014

Time	Session	Format
8:00-9:15am	Discussion of Low/Medium risk sterile compounding and aseptic technique Hands on simulation - Vial pressure	Lecture/demo
9:15– 11:15am	Smoke Testing (Demonstration of 1^st air) Hands on training of Low/Medium risk sterile compounding & aseptic technique (15 min break as participants finish exercises)	Lab
11:15-12:15pm	Compatibility/Stability, Beyond-Use-Dating exercises, Documentation, Quality Assessment/Control for CSP	Lecture/Demo
12:15p-1:00p	Lunch
1:00-2:00pm	Environmental Cleaning/Disinfection Documentation Requirements	Lecture
2:00-4:30pm	Review of Fingertip Sample preliminary results and remediation (if needed) Exercise 1: Assessment of Student Skills in Low/Medium Risk Sterile Compounding and Aseptic Technique (Media Fill) Exercise 2: Demo of Environmental cleaning processes/product review & documentation (15 min break as participants finish 1^st exercise)	Lab
4:30-5:00 pm	Special Topics – Hazardous Drugs	Lecture
5:00-5:15pm	Wrap up, Q&A

Live Practice Based Learning Objectives:

After completion of this activity, the pharmacist will be able to:

• Explain the need for sterile products and the importance of aseptic compounding

• Explain the items a pharmacist should verify for each CSP before it is released from the pharmacy

• Analyze the advantages and disadvantages of different parenteral routes

• Identify USP<797> requirements for the training and evaluation of preparers of CSPs as well as the responsibilities of personnel

• Analyze the difference between primary and secondary engineering controls

• Define ISO classifications 5, 7, and 8

• Describe the layout of a typical clean room, define ante area and buffer area

• Examine supplies used for CSPs and identify factors that influence selection

• Explain necessary manipulations for accommodating positive and negative pressure

• Apply understanding of critical sites and airflow in sterile compounding

• Perform the steps for proper transfers and handling of sterile preparations

• Demonstrate proper techniques to aseptically attach needle to syringe, withdraw contents from vial and ampule, reconstitute vial, and inject into IV bag following all USP <797> guidelines and utilizing appropriate aseptic technique

• Demonstrate proficiency in aseptic technique as it relates to the preparation of different CSPs

• Demonstrate proper garbing procedure, hand hygiene and proper cleaning/disinfecting processes

• Demonstrate accuracy in basic calculations related to the preparation of different CSPs

• Conduct a “media fill test” to assess ability to aseptically compound sterile preparations

• Discuss 3 types of contamination: microbial, chemical and physical

• Differentiate between QA and QC and analyze as it relates to personnel, facilities and monitoring

• Perform verification and final review of a finished sterile product to be dispensed for patient use

• Describe special considerations and requirements with preparation of chemotherapy and hazardous drugs including exposure risks and how to minimize them

Live Practice-Based Learning Objectives:

After completion of this activity, the pharmacy technician will be able to:

• Explain the need for sterile products and the importance of aseptic compounding

• Describe the advantages and disadvantages of different parenteral routes

• Identify USP<797> requirements for the training and evaluation of preparers of CSPs as well as the responsibilities of compounding personnel

• Discuss the difference between primary and secondary engineering controls

• Define ISO classifications 5, 7, and 8

• Describe the layout of a typical clean room, define ante area and buffer area

• Examine supplies used for CSPs and identify factors that influence selection

• Demonstrate proper garbing procedure and hand hygiene procedure

• Explain manipulations for accommodating positive and negative pressure

• Apply understanding of critical sites and airflow in sterile compounding

• Perform the steps for proper transfers and handling of sterile preparations

• Demonstrate proficiency in aseptic technique as it relates to the preparation of different CSPs

• Demonstrate accuracy in basic calculations related to the preparation of different CSPs

• Conduct a “media fill test” to assess ability to aseptically compound medium risk sterile preparations

• Discuss 3 types of contamination: microbial, chemical and physical

• Differentiate between QA and QC and analyze as it relates to personnel, facilities and monitoring

• Describe special considerations and requirements with preparation of chemotherapy and hazardous drugs including exposure risks and how to minimize them

KPIC ASEPTIC TECHNIQUE TRAINING COURSE GUIDE AND LEARNING OBJECTIVES - SELF STUDY COMPONENT

The Self-study component is a pre-requisite to the practice based live activity and provides 7.5 hours of knowledge based CE credit for pharmacists and pharmacy technicians using the provided textbook: Concepts in Sterile Preparations and Aseptic Technique, Burlington, MA: Jones and Bartlett Learning; 2015.

Self-study Learning Objectives:

After completion of this activity, the pharmacist will be able to:

Define parenteral preparations and the role of safety, accuracy and attitude in risk prevention
Discuss United States Pharmacopeia chapters applicable to pharmaceutical compounding of sterile products
Define the role of the pharmacist and the responsibilities pertaining to sterile compounding
Describe supplies and equipment used in sterile compounding and the safety considerations
Summarize the microbiological considerations in sterile compounding and the responsibilities of personnel in preventing contamination
Classify sterile preparations as low-, medium- or high risks and determine appropriate BUDs
Differentiate between primary and secondary engineering controls and the role they play in maintenance of sterile environment for sterile compounding
Describe the critical steps in proper aseptic technique and compounding manipulations
Distinguish between quality control and quality assurance for sterile compounding
Identify the key areas for monitoring for environment, personnel and end-product testing for a sterile compounding program

After completion of this activity, the pharmacy technician will be able to:

Define parenteral preparations and the role of safety, accuracy and attitude in risk prevention
Discuss United States Pharmacopeia chapters applicable to pharmaceutical compounding of sterile products
Define the role of the pharmacy technician and the responsibilities pertaining to sterile compounding
Describe supplies and equipment used in sterile compounding and the safety considerations
Summarize the microbiological considerations in sterile compounding and the responsibilities of personnel in preventing contamination
Classify sterile preparations as low-, medium- or high risks preparation based on their ISO class
Differentiate between primary and secondary engineering controls and the role they play in sterile compounding
Describe the critical steps in proper aseptic technique and compounding manipulations
Distinguish between quality control and quality assurance for sterile compounding
Identify the key area for monitoring for environment, personnel and end-product testing for a sterile compounding program

Participants will review provided textbook and complete the following prior to attending the hands on portion of the course:

Chapter 1: Pages 1-15 and complete review questions on page 14-15
Chapter 2: Pages 17-62 and complete review questions and case studies on page 62
Chapter 4: Pages 107-135 and completer review questions and case study on pages 135-137.
Chapter 5: Pages 141-171 and complete review questions and case study on pages 171-172. View required video for Chapter 5:

on Page 148: Cleaning the HLFW (Video length 3:58)

Chapter 6: Pages 175-220 and complete review questions and case studies on pages 220-222. View required videos for Chapter 6:

Page 177: Hand Washing (Video length 6.09)
Page 181: Personal Protective Equipment -Garbing(Video length 0:44)
Page 181: Personal Protective Equipment-Sterile Gloves (Video Length 1:16)
Page 189: Attach Needle to Syringe and Remove Cap of Needle (Video Length 0:43)
Page 190: Enter Vial (Video length 1:02)
Page 192: Withdraw Contents-equal pressure Milking (Video length 0:53)
Page 192: Withdraw Contents Reverse Milking(Video length 0:36)
Page 197: Removal of Air Bubbles (Video length 0:54)
Page 199: Ampule Breaking (Video length 0:59)
Page 199: Using A filter needle (1:28)
Page 199: Using a filter straw (1:31)
Page 206: Reconstituting Medications for Parenteral Administration (Video length 2:15)
Page 208: Uncapping and Recapping Needles (Video length 0:38)
Page 209: Capping a Syringe (Video length 0:51)
Page 210: Priming an Infusion Set (Video length 2.41)
Page 211: Positive Pressure (Video length 1:12)
Page 212: Negative Pressure (Video length 0:50)
Page 218: Workflow Process (Video length 2:12)

6. Chapter 11: Pages 347-367 and complete review question and case study on pages 367-369. View required video for Chapter 11:

Page 361: Gloved Fingertip Test (Video length 1:06)

Registration closes: February 26, 2015.

Thu, Mar 12, 2015

Registration closes on Mar 10, 2015 at 01:00 AM

Prerequisite Home Study

Registration Closed

Speaker(s)/Author(s)

Carl Dunn, RPh Pharmacist, Dorn VA
Carole Small Russell, RPh, MHSA Compounding Pharmacist, MUSC
Michaela Almgren, PharmD, MS Clinical Assistant Professor, University of South Carolina College of Pharmacy
Nancy Roberts, PharmD, MS Sterile Compounding Training, Program Director, KPIC, University of South Carolina

Activity Number

0062-0000-14-094-H04-P/T

Release Date: Jul 7, 2014

Credit Expiration Date: Jul 7, 2017

CE Hours

7.50

Registration Closed