Course Description & Rationale

This course provides a pediatric preparation –focused instruction and training for the successful production of sterile pediatric preparations, a major responsibility of pharmacy personnel in hospitals, long-term care facilities, and home healthcare. A study of sterile products, hand washing techniques, pharmaceutical calculations, references, safety techniques, aseptic techniques in compounding, proper use of equipment, and pediatric preparations. This important work requires the proficiency in aseptic technique: the procedures that avoid introducing pathogens into sterile products,including pediatric preparations, ensure patient safety, and maintain product consistency.

Prerequisite Requirement

Credit Prerequisite: HPRS 1106 or HPRS 1206; HPRS 1171, EDUC 1100 or EDUC 1300; and PHRA 1301 (or PHRA 1201),

PHRA 1309, PHRA 1313, PHRA 1345, PHRA 1349, and PHRA 2271.

CE Preferred Course (not required): PHRA 1091 - Sterile Compounding and Aseptic Technique.

Financial Disclosure Attestation Statement

I, Shannon Bui disclose no personal stake in or affiliation with any healthcare organization or corporation offering financial support or grant monies for this continuing education activity, or an affiliation with an organization whose philosophy could potentially bias my presentation.

Main Educational Objectives for Pharmacists

• Identify the components and compatibility of sterile compounding and aseptic technique as defined in USP <797> and hazardous drugs in USP <800>.
• Perform and verify pharmaceutical calculations required in sterile compounding of pediatric preparations.
• Demonstrate various aspects of aseptic technique including garbing, hand washing, hood cleaning, equipment cleaning, and proper use of automated compounder.
• Prepare and perform verification checks on various compounded pediatric preparations, including Pediatric dilutions, standard concentrations, narcotics, Neonatal IV fluids and Pediatric TPN.

Main Educational Objectives for Pharmacy Technicians

• Identify the components of sterile compounding, including pediatric preparations and aseptic technique as defined in USP <797> and hazardous drugs in USP <800>.
• Perform pharmaceutical calculations required in sterile compounding of pediatric preparations
• Demonstrate various aspects of aseptic technique including garbing, hand washing, hood cleaning, equipment cleaning, dilutions, narcotics, proper use of automated compounder.
• Prepare and perform verification checks on various compounded pediatric preparations, including Pediatric dilutions, standard concentrations, narcotics, Neonatal IV fluid and Pediatric TPN.

COURSE RESOURCES

Course BlackBoard Website: https://acconline.austincc.edu/  

You will use this website to access course materials, submit assignments, take assessment quizzes, and take your exams.       Make sure you check Blackboard regularly.  You are responsible for course information posted

Course Materials:

Textbook:  Sterile Compounding and Aseptic Technique: Concepts, training, and Assessment for Pharmacy Technicians, 1st edition,         by Lisa McCartney - Text with online resources via Cirrus

Purchase the textbook.

ACC campus bookstore: click LINK:
Textbooks

Additional materials will be posted on Blackboard. It is your responsibility to access these materials and bring copies of whatever will be needed in class when instructed to do so.

Respondus Lockdown Monitor for ONLINE Final Exam. Installation Link:

https://download.respondus.com/lockdown/download.php?id=999134577

Technology Requirements:

You will be required to access course materials and complete/submit assignments & exams online for this course.  If you do    not have access to a computer/laptop/webcam, please use the Learning labs available on ACC campus.  See Learning Lab campus locations: http://www.austincc.edu/support-and-services/tutoring-and-academic-help/learning-lab-services

You will also be required to upload documents in PDF format using such programs or apps such as Evernote Scannable (you may download this app for free at: https://evernote.com/products/scannable).

DISTANCE EDUCATION

This course is a distance course which will require students to use the Blackboard learning management system for assignment instructions, submitting assignments, and collaboration. To be a successful online student you must be self-motivated, have good study skills and good time management skills. If you are new to distance education, I encourage you    to review the ACC Distance Education General Information available at https://www.austincc.edu/academic-and-career-programs/acconline/frequently-asked-questions/

COURSE EXPECTATIONS

Class Participation

This course can help you become a more strategic learner if you take responsibility for your own learning and engage the process. The instructor will determine this part of the grade based on your preparedness and participation in class.

There are four components of success:

Advanced reading and preparation of assigned materials – Review pediatric dilution calculation examples under the course document section of Blackboard. Review the Hazardous Drug/Chemotherapy calculations in Blackboard prior to the hands-on lab portion of the course. This will help hardwire your math skills required for pediatric dilutions and hazardous drug dosing using body surface area (BSA) use during lab.

Well-formed comments during lab discussions. Informed and well-formulated comments during lab discussions is an expectation. USP Chapters on sterile compounding (USP <797>) & hazardous drugs (USP

<800>) are minimum requirements. We will discuss best practices during lab. I will not be able to address specific facility issues during lab. The time we have in lab is limited and extended discussions regarding interpretation of specific USP Chapter <797> & USP Chapter <800> requirements may continue our course blog.

Mandatory attendance and punctuality for hands on lab component of the course - The hands-on lab process validations are designed to maximize the value of our time together and leverage the educational benefits of having a cohort of peers to learn alongside, so do yourself and your course participants a favor by coming prepared and contributing to the learning experience during lab. Plan for Austin traffic.

Professionalism. Our lab sessions are a time and place for learning, where all students are expected to engage the learning process and not disrupt this opportunity for themselves or others. Behaving respectfully toward everyone in the course means engaging in the learning activities at hand and refraining from doing anything not related to them (e.g., using cell phones/tablets/computers, carrying on side conversations, etc.). See “Technical Standards and Essential Functions” below.

Stay up to date

Unless otherwise stated, all assignments, class materials, supplemental resources, grades, email, and announcements will be posted on the course Blackboard site. You are responsible for keeping up with information and communication via Blackboard. I recommend 1) bookmarking the course site in your default browser for easy access, and 2) updating your notification preferences in your settings for this Blackboard course so you can receive essential information regarding this course in the most timely, reliable, and convenient way possible. However, you decide to set it up, check for announcements and messages frequently.

Professional Code of Conduct

Treat others with respect. Students will be held accountable for professional behavior during the course. It is the student’s responsibility to communicate with the instructor throughout the duration of the course. You may contact me through email, and I will respond within 24- 48 hours.

Communicate with me:

The best way to reach me is via email at shannon.bui@austincc.edu. If you have questions or concerns about the course, need some help with a difficult concept or assignment, or anything else, I am always willing to listen and do what I can to help you.  Part of taking responsibility for your own learning in this course is staying in touch with me about any issues you may encounter that could affect your academic performance.  Don’t wait until it is too late to seek help! 

Some things to keep in mind:

• If you have a question that the whole class would benefit from, please ask during lab.
• If you have a personal question (e.g. regarding grades) that lends itself to an extended discussion, please see me   during the lab lunch break or after lab concludes for the day. Also, you can make an appointment with me and I          will send a link to a private virtual meeting room.

• Instructor E-mail Response Time: It is ACC policy for instructors to respond to a student's e-mail within 24 to 48 hours Monday through Friday during business hours. If a student e-mails an instructor in the off-hours or weekends, e-mails will be responded to the next business day.
• Email Etiquette: All emails between professor and student must be written in a professional manner.  In the subject line please include the course number PHRA 2374 and reason for email (e.g., PHRA 2374 Assignment #3 Question). Please send all email from your ACC email account & include your name so I know who I’m responding to.

Instructions for activating an ACC email account can be found at http://www.austincc.edu/accmail/index.php.

GRADING

DIDACTIC HOME STUDY COMPONENT (60% of Final Grade)

Final Exam (50%) – 50 questions, multiple choice exam. A passing grade of 75% (or higher) is required to receive a passing grade.

Five (5) Blackboard (Bb) Quizzes ( 5 %) - A passing grade of 85% (or higher) is required to receive a passing grade. For ACPE Pediatric Preparation Certification see requirements see page 5.

Students will have two (2) opportunities to score an 85% or higher on blackboard quizzes.

Blackboard (Bb) PEDI Calculation Packet (3%) - A passing grade of 85% (or higher) is required to receive a passing grade.

Discussion Board (1%) – Students must complete a minimum of five entries: maximum score of 10 points per post.

Class Participation & Professionalism (1%) – Attendance and punctuality; advanced reading and preparation; professional conduct during the hands-on lab.

LIVE HAND-ON LAB COMPONENT (40% of Final Grade)

Process Validations 1 – 8 (35%) – A passing grade of 75% (or higher) is required to receive a passing grade. For ACPEPediatric Preparation Certification see requirements see below.

Students will have an opportunity to repeat failed process validations and score 75% or higher

LIVE PEDI Calculation for PV 1 -8 (5%) – A passing grade of 85% (or higher) is required to receive a passing grade.

For ACPE Pediatric Preparation Certification see requirements below

• • Students must pass the didactic home study blackboard assignments, hands on lab process validations, and      final exam with a grade 75% (or higher) to receive a passing grade for the course.
  • Final grades are NOT rounded. Rounding will be considered only in a pass/fail situation and will be determined on a case-by-case basis.

ACPE CONTINUING EDUCATION STUDENTS:

Requirements for Statement of ACPE PEDI PREPARATIONS CERTIFICATON Credit 6.4 CEUs (64.0 hours)

Final Exam - A passing grade of 75% (or higher) is required to receive a passing grade.

Process Validations (8) – A passing grade 90% (or higher) adherence to aseptic technique is required.

Homework Assignments (5) in Blackboard – A passing grade of 85% (or higher) is required.

Homework Calculation packet in Blackboard - A passing grade of 85% (or higher) is required.

Submission of Required Paperwork -Completed/NOT Completed

• ONLINE Student  Registration form
• Documentation of Training Hours form
• ACPE Course Evaluation form – online in Blackboard
• CPE Activity Evaluation – online course evaluation in Blackboard

NOTE: Students attending from outside the Austin area must contact instructor as soon as possible PRIOR to the lab meeting dates to determine procedures for final exam testing.

GRADING SCALE FOR COURSE

A: 90 – 100%       B: 80 – 89%       C: 75 – 79%                            D: 60 – 74%       F: 59% and below

NOTE: Students attending from outside the Austin area must contact instructor at shannon.bui@austincc.edu soon as possible

PRIOR to the lab meeting dates to determine procedures for testing and process validations.

Exam Requirements:

The final exam will be administered through Blackboard Respondus LockDown Browser & Monitor. LockDown Browser is a custom browser that "locks down" the testing environment in Blackboard. When students use LockDown Browser to take a Blackboard test, they are unable to print, copy, visit other websites, access other applications, or close the test until it is submitted for grading. Tests created for use with LockDown Browser cannot be accessed with standard browsers (Safari, Chrome, etc).

Using notes, books, other computer screens, a smartphone, smartwatch, etc. is also prohibited while taking both exams (they are NOT open-book tests). LockDown Monitor is a virtual proctor which uses your webcam to record you while you take the exam. The instructor can then review the video at a later date/time to check for academic dishonesty (using notes, books, a smartphone, smartwatch, etc).

During the first week of class, you are responsible for downloading the Respondus LockDown Browser application and taking  the LockDown practice exam on BlackBoard to verify that the browser works on your operating system. Any conflicts with your operating systems MUST be brought to the instructor's attention in the first week of class to properly troubleshoot or set up alternative testing.

If your computer does not have a webcam/camera, you can add an external webcam OR schedule a time to take the exam in one of ACC’s testing labs (this must be discussed with the instructor first since you will need a password to access the exam  from the testing labs).

To download the browser to desktop, go to: https://download.respondus.com/lockdown/download.php?id=999134577

Respondus LockDown Browser & Monitor Testing Requirements:

• Shutdown your cell phone.  NO phones allowed in the room you are testing.
• Make sure you have your student ID or driver’s license to show during the recorded exam.
• The exam uses facial recognition.  If you have long hair, pull back your hair so that your face is not obstructed.  No hats are to be worn during the exam.
• The Lockdown Browser will not allow you to open additional websites or notepads during the exam. You may not use any notes, books, other computer screens, a smartphone, smartwatch, etc. while taking the exam.
• Once you leave the exam, you will not be permitted to come back in.
• There will be a PRACTICE exam for you to test your home computer and webcam.

Exam Policy

Students must take a Final Exam and score a 75% or above on the exam to meet the ACPE requirement.

Final Exam

The Final Exam will be administered through Blackboard Respondus Lockdown Browser and Webcam on indicated day in the syllabus. The Final Exam will be given over Pediatric Dilution Calculations, lecture material including assigned chapters, virtual power point lectures, September 2021 USP <797> UPDATE, and material covered in lab. The Final Exam will comprehensively assess the student's knowledge of concepts, principles, techniques, and procedures related to the course material.

Homework/Assignment Submission Guidelines

All assignments are required for the progression of the course. Homework/Assignments must be submitted to the instructor through Blackboard unless otherwise instructed. Homework/Assignments are due according to the course schedule in the syllabus. The assignments must be submitted by 11:59 p.m. on due date. Passing grade of 85% or above is required per homework assignment for ACPE Pediatric Certification. You will have the opportunity to retake an assignment two times before or on the deadline.

Textbook:      TEXTBOOK Sterile Compounding and Aseptic Technique by Lisa McCartney and Brenda Jensen

                    Textbook + access to videos

                    LINK: https://www.paradigmeducation.com/austin-cc

Main Educational Objectives for Pharmacists

• Identify the components and compatibility of sterile compounding and aseptic technique as defined in USP <797> and hazardous drugs in USP <800>.
• Perform and verify pharmaceutical calculations required in sterile compounding of pediatric preparations.
• Demonstrate various aspects of aseptic technique including garbing, hand washing, hood cleaning, equipment cleaning, and proper use of automated compounder.
• Prepare and perform verification checks on various compounded pediatric preparations, including Pediatric dilutions, standard concentrations, narcotics, Neonatal IV fluids and Pediatric TPN.

Main Educational Objectives for Pharmacy Technicians

• Identify the components of sterile compounding, including pediatric preparations and aseptic technique as defined in USP <797> and hazardous drugs in USP <800>.
• Perform pharmaceutical calculations required in sterile compounding of pediatric preparations
• Demonstrate various aspects of aseptic technique including garbing, hand washing, hood cleaning, equipment cleaning, dilutions, narcotics, proper use of automated compounder.
• Prepare and perform verification checks on various compounded pediatric preparations, including Pediatric dilutions, standard concentrations, narcotics, Neonatal IV fluid and Pediatric TPN.