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Procedures To Follow For Practice And Final Evaluation

Procedures To Follow For Practice And Final Evaluation


Watch the relevant videos in the online course for the procedures described below.

A demonstration of the entire process will be uploaded soon to provide a general overview BUT the instructions below are more precise.

Class 7/8 ante-area

Garbing - Dirty to clean

1. Put on shoe covers one at a time. Put on the first shoe cover and then step over the line of demarcation. Both shoe covers must be on after having stepped over the line of demarcation.

2. Put on the mask and make sure to pinch the mask at the bridge of the nose AND pull the mask under your chin. For males with facial hair use a beard cover and make sure all facial hair is concealed.

3. Put on the bouffant cap making sure hair is not visible from under the cap. Hair must be concealed and tucked in the cap.

Aseptic Hand-washing

1. Turn on the faucet and rinse both hands. Under warm running water use a nail pick to scrape dirt from under the finger nails. Do this for each finger and for both hands. Watch video on how to use the nail pick. (Nail pick is not included in the supplies)

2. Then lather hands with the approved antibacterial soap ensuring you thoroughly clean the palms of the hand the back of the hand between the fingers and each finger individually for both hands for at least 30 seconds.

3. Then, scrub the soap wrist down in a circular motion down to your elbows on both sides of the hand and for both hands ensuring hands are kept vertical AND then rinse under warm running water in a criss-cross manner STILL keeping your hands vertical so the dirty water drips from the fingers down to the elbows and into the sink.

4. If the sink does not have an automatic shut off then use a lint free paper towel to turn off the faucet. Do not touch the faucet with bare hands.

5. Then, using another lint free paper towel pat dry both your hands and elbows.

6. Next, put on the sterile gown ensuring it does not have any holes or tears and ensure that it fits snugly and is buttoned up completely.

***See garbing and handwashing video here https://youtu.be/8_LRJ8vLMxI

***Keep in mind, the nail pick must be used under running water and hands must be pat dried with the lint free napkins.

Class 5 compounding room

Sterile Gloving

1. Make sure the gloves are the correct size for your hand.

2. Open the outer package of the sterile gloves.

3. Then, open the inner wrapping of the sterile gloves by pulling at the tabs on either side of the package if tabs are present.

4. Keep in mind these gloves are sterile and therefore do not touch the outside of the glove.

5. Gently lift the sleeve of one of the gloves with your dominant hand and slide in your fingers first and once the fingers are in bend your thumb towards the inside of the palm and slip your thumb in. Do the same for the other hand. For the other hand, you may slip 2 fingers under the cuff and then slip your fingers and thumb as described above.

6. Inspect the gloves for holes or tears and if none found proceed with the next step. If holes or tears are found discard and use another pair of sterile gloves.

7. Pick up the wrapper from the sterile part of the package which would be the inside middle and pick up other trash with the wrapper and discard. 

8. At this point spray your gloves with 70% isopropyl alcohol and scrub your hands.

9. Wait until gloves are dry before cleaning the ISO class 5 PEC (primary engineering control) device which in most cases is a vertical or horizontal laminar flow hood.

Most sterile compounding facilities have either horizontal or vertical hoods and the process below describes the cleaning procedure for both.

**See sterile gloving video here https://youtu.be/gpKlgGvD4ZE

Vertical Hood Cleaning

1. For vertical hoods the HEPA filter is in the ceiling of the hood AND this filter must not be cleaned OR come into contact with any cleaning solution as this may affect the integrity of the filter which in turn will affect the airflow within the hood which may lead to contamination of the sterile product(s).

2. Each ISO class 5 PEC must be cleaned twice. Once with sterile water to clean and then with 70% isopropyl alcohol or other approved cleaner to disinfect.

3. Each surface including the horizontal bar and hooks inside the hood must be wiped with a separate lint free towel. Place 5 lint free towels and stack in the center of the hood and saturate with sterile water. 

4. Pick up the first saturated towel and fold it in half. For vertical hoods, the cleaning commences with cleaning the back wall of the hood starting at the top and moving horizontally left to right with overlapping strokes and moving top to bottom. Fold the towel midway and continue cleaning until the entire back wall is clean.

5. Next, take another saturated towel and clean the bar. The bar must be cleaned in one swift motion and NOT back-and-forth.

6. Then, clean all the hooks with either the same towel or use a new one.

7. Next, take another saturated towel and clean the side walls of the hood. Start with either the left or the right side and clean in a horizontal motion with overlapping strokes starting at the back wall of the hood moving towards you. Fold the towel midway and continue cleaning until the entire side wall is clean.

8. Repeat the process for the other wall.

9. Lastly, clean the DCA (direct compounding area) or the work surface. Clean from back of the hood moving towards the front in a horizontal left to right motion with overlapping strokes. Fold the towel midway and continue cleaning until the entire work surface is clean.

10. Wait for the hood surfaces to dry then repeat the procedure to disinfect with 70% isopropyl alcohol or other approved cleaner.

Horizontal Hood Cleaning

1. For horizontal hoods the HEPA filter is in the back wall of the hood AND this filter must not be cleaned OR come into contact with any cleaning solution as this may affect the integrity of the filter which in turn will affect the airflow within the hood which may lead to contamination of the sterile product(s).

2. Each ISO class 5 PEC must be cleaned twice. Once with sterile water to clean and then with 70% isopropyl alcohol or other approved cleaner to disinfect.

3. Each surface including the horizontal bar and hooks inside the hood must be wiped with a separate lint free towel.

4. For horizontal hoods, the cleaning commences with cleaning the ceiling of the hood starting at the top and moving horizontally left to right with overlapping strokes and moving towards the front of the hood. Fold the towel midway and continue cleaning until the entire ceiling is clean.

5. Next, clean the bar. The bar must be cleaned in one swift motion and NOT back-and-forth.

6. Then clean all the hooks with either the same towel or use a new one.

7. Next, clean the side walls of the hood. Start with either the left or the right side and clean in a top down motion with overlapping strokes starting at the back wall of the hood moving towards you. Fold the towel midway and continue cleaning until the entire side wall is clean.

8. Repeat the process for the other wall.

9. Lastly, clean the DCA (direct compounding area) or the work surface. Clean from the back of the hood moving to the front of the hood. Clean in a horizontal left to right motion with overlapping strokes. Fold the towel midway and continue cleaning until the entire work surface is clean.

10. Wait for the hood surfaces to dry then repeat the procedure to disinfect with 70% isopropyl alcohol or other approved cleaner.

**See video on horizontal hood cleaning here https://youtu.be/h5kiLKOBlpg

**Keep in mind, it’s best practice to take 5 lint free towels (one for each surface) and place them in the center of the hood and saturate them by pouring the 70% Isopropyl alcohol or sterile water or whichever agent your facility uses INSTEAD of spraying it onto a towel inside the hood.

Before Commencing Compounding Of Sterile Products

1. Ensure you have already performed the necessary calculations for compounding.

2. Ensure you know exactly which supplies and medications and IV bags to bring into the hood.

3. Before placing any supplies into the hood make sure all the surfaces in the hood are dry before beginning to compound.

4. Keep in mind, any item that is going to be placed in the hood must FIRST be wiped with a lint free towel that is saturated with 70% isopropyl alcohol before placing in the hood.

5. Vials, ampules or IV-bags/container must be placed in the center of the hood, 6 inches from the back of the hood and 6 inches from the front of the hood.

6. Items must be spaced at least 2 inches apart. IV bag ports must face the HEPA filter in a horizontal hood.

7. Items wrapped in paper products must be placed within the first 6 inches of the hood and opened within the first 6 inches of the hood to avoid fibers from the paper products from recirculating within the hood.

Aseptic technique procedure for powder vials and subsequent injection of the reconstituted solution into a IV or TPN bag/container.

**Ensure you are spraying your gloves periodically when performing aseptic technique AND when removing hands from the hood. Do not spray the gloves inside the hood.**

**The 70% Isopropyl alcohol must not be sprayed on gloves or on any surface directly in the hood.**

1. To reconstitute a powdered vial first check the integrity of the vial to make sure it isn’t damaged in anyway.

2. Next, ensure that it is the correct drug or diluent.

3. Then check to make sure the drug or diluent hasn’t expired.

4. Ensure the vial is wiped with a lint free towel saturated with 70% alcohol before placing it in the center of the hood as described above.

5. Next, do the same for the vial with the diluent.

6. Keep both vials spaced at least 2 inches apart.

7. Place the appropriate syringes, needles and alcohol prep pads within the first 6 inches of the hood. Do not unwrap until you’re ready to perform the dilution.

8. Remove the IV or TPN bag from its wrapper if applicable and wipe the IV or TPN bag with a lint free towel saturated with 70% isopropyl alcohol and place the IV or TPN in the center of the hood with the port facing the HEPA filter in a horizontal hood.

9. Next, remove the cover(s) off of the vial top(s) for both the drug and diluent.

10. Then tear a corner of ONE alcohol pad and remove the swab and place it on top of the vial AND do the same for the other vial.

11. Next, place your thumb on the swab(s) of the first vial putting slight pressure on it and swipe the swab towards you in one motion. Repeat for the second vial.

12. Next, prep the syringes. Unwrap the syringe to be used with the first vial, facing it towards the HEPA filter and prime it by pulling and pushing the syringes’ plunger to remove any stickiness.

13. Place the syringe within the first 6 inches of the hood and place it upright in the center of the hood.

14. Next, unwrap the needle facing the HEPA filter within the first 6 inches of the hood and secure it onto the syringe.

15. Repeat for the second syringe and needle.

16. At this point you’re ready to perform the dilution.

17. First, pull the plunger of the syringe to be used with the diluent to within 1 mL of the actual amount required, to make it easier to withdraw the volume from the vial.

18. Then, uncap the needle and place the cap with it's opening facing the HEPA filter and place the needle BEVEL up ensuring the syringe is held horizontally, then raise the syringe at a 90 degree angle and puncture the vials’ rubber stopper and inject empty air into the vial. This is necessary for closed systems such as vials.

19. Next, hold the vial between your index and middle finger with palm facing up and raise the vial vertically with the syringe still attached and withdraw the appropriate amount of diluent using the milking technique. The milking technique is simply pushing the syringe plunger up and down to create negative pressure in order to withdraw liquid from a vial.

20. Once the appropriate amount of diluent is drawn into the syringe TILT the needle so it’s in an empty space in the vial to prevent splashing of the diluent when the syringe is withdrawn.

21. Draw the syringe out and recap using the one handed scoop method. The one handed scoop method involves recapping the needle by guiding the needle into the cap while the cap is on the hoods’ surface.

22. Once the cap is on then you may secure it with your hand onto the needle firmly.

23. At this point, raise the syringe vertically and remove any air bubbles by gently tapping on the syringe with your knuckles.

Now you’re ready to dilute the powder vial.

1. To dilute the powdered vial uncap the needle and place the cap with it's opening facing the HEPA filter and place the needle BEVEL up ensuring the syringe is held horizontally, then raise the syringe at a 90 degree angle and puncture the vials’ rubber stopper and inject the diluent from the syringe into the vial ensuring the diluent is injected against the wall of the vial instead of directly on the powder contained in the vial.

2. Once the entire volume of the diluent has been injected in the powdered vial withdraw the needle and recap using the one handed scoop method.

3. Pick up the powdered vial and gently swirl or rub between your palms to dissolve the powder completely.

4. When the powder is dissolved completely place the vial in the center of the hood and uncap the second needle and place the cap facing the HEPA filter and place the needle BEVEL up ensuring the syringe is held horizontally, then raise the syringe at a 90 degree angle and puncture the vials’ rubber stopper. To prevent coring (disintegration of the rubber stopper) ensure you are not puncturing the same puncture site.

5. Next, hold the vial between your index and middle finger with palm facing up and raise the vial vertically with the syringe still attached and withdraw the appropriate amount of the drug, being careful not to touch the plastic plunger of the syringe.

6. Once the appropriate amount of drug has been drawn into the syringe TILT the needle so it’s in an empty space in the vial to prevent splashing of the drug when the syringe is withdrawn.

7. Draw the syringe out and recap using the one handed scoop method.

8. Wipe the injection port of the IV or TPN bag.

9. If the IV bags’ port is facing the HEPA filter in a horizontal hood then you may rotate the bag horizontally so the port is facing either the left or right side of either wall of the hood to make it easier to inject the medication in the port without causing a needlestick injury.

10. Uncap the needle and hold in one hand and with the other hold the bottom of the port and insert the needle in the middle of the port and inject the contents of the syringe into the bag.

11. Next, withdraw the syringe and recap using the one-handed scoop method.

12. Place the provided seal over the IV port on the bag if no other medications need to be injected into the IV bag.

13. Check the bag for precipitation and gently squeeze the bag to check for leaks and gently roll the bag in your hand to mix the medication with the base solution.

14. If no precipitation or leaks are discovered wipe the bag with a lint free towel saturated with 70% isopropyl alcohol.

**See video of powder vial reconstitution here https://youtu.be/28iMd_pzaGw

Ampule Manipulation

1. Before proceeding with the ampule manipulation ensure that the surface of the hood or the DCA direct Compounding area has been wiped and sanitized, first with sterile water and second with 70% isopropyl alcohol as described above under hood cleaning.

2. Put on a new pair of gloves and discard the previous pair.

3. Check integrity of the gloves before compounding.

4. Wipe all the required supplies which the include ampule(s), syringes, needles, 5 micron filter needle or filter straw and the IV or TPN bag necessary for the manipulation with a lint free towel saturated with 70% isopropyl alcohol.

5. As described above, keep all paper products within the first 6 inches of the hood.

6. Place the ampule(s) and the required IV or TPN bag in the center of the hood.

7. Spray your gloves with 70% isopropyl alcohol.

8. Prep the syringe by removing it from the wrapper and face it towards the HEPA filter placing it upright in the center section of the hood 6 inches from the back and 6 inches from the front of the hood.

9. Unwrap the needle facing the HEPA filter and attach it to the syringe.

10. Take one alcohol pad and tear a corner of the pad and take out the swab and clean the entire ampule with that swab by rotating the ampule within the swab and cleaning the head, neck and body of the ampule, especially the neck.

11. Remove any air bubbles from the head of the ampule by tapping or inverting the ampule.

12. Hold the ampule with one hand and with the other hold the the head of the ampule and break the head away from you and against the sidewall of the hood.

13. Place the ampule down in the center of the hood.

14. Pick up the syringe and place it on your palm horizontally and uncap the needle. Place the needle cap facing the HEPA filter.

15. Pick up and hold the ampule horizontally and insert the needle in the ampule and draw up the required volume by holding the syringe in your palm face up and pulling the rounded end of the syringe plunger called the plunger flange with your thumb.

16. Once the required volume has been drawn up, recap the needle using the one handed scoop method and place the syringe facing the hepa filter in a horizontal hood or keep the syringe upright in a vertical hood.

17. Tear open another alcohol pad as described above and swab the port of the IV or TPN bag to disinfect it.

18. Unwrap the 5 micron filter needle and hold it between the index and middle finger while removing the existing needle from the syringe and then secure the filter needle onto the syringe.

19. Uncap the filter needle.

20. If the IV bags’ port is facing the HEPA filter in a horizontal hood then you may rotate the bag horizontally so the port is facing either the left or right side of either wall of the hood to make it easier to inject the medication in the port without causing a needlestick injury.

21. Hold the syringe in one hand and with the other hold the bottom of the port and insert the needle in the middle of the port and inject the contents of the syringe into the bag.

22. Next, withdraw the syringe and recap using the one-handed scoop method.

23. Place the provided seal over the IV port on the bag if no other medications need to be injected into the IV bag.

24. Check the bag for precipitation and gently squeeze the bag to check for leaks and gently roll the bag in your hand to mix the contents.

25. If no precipitation or leaks are discovered wipe the bag with a Lint free towel saturated with 70% isopropyl alcohol.

**See video of ampule manipulation here https://youtu.be/KM1IDi5k5IQ

**Keep in mind, the ampule neck must be broken away from you and away from the HEPA filter. Ampule neck must be broken towards the side wall of the hood. To be safe, if withdrawing from more than 1 ampule use another filter needle instead of re-using the same filter needle.

Final Evaluation Related

***If you’re new to sterile compounding always refer to the manufacturers package insert for important details regarding the drug you are compounding.

Details to keep in mind include

1. Making sure the diluent is compatible with the powder in the vial if reconstituting a powder vial.

2. Making sure the base solution such as sodium chloride or dextrose in which you will be injecting the reconstituted or non-reconstituted solution is compatible with the drug you are injecting.

3. Finding out what the maximum concentration of the drug in the base solution should be. For the Vancomycin lab shown below, the maximum concentration must be 5 mg/ml and therefore the 500 mg of Vancomycin must be diluted in 100 or more mLs of sodium chloride. This is to prevent thrombophlebitis.

4. Find out the storage requirements, whether it should be the only drug in a IV solution or can it be mixed with other drugs depending on what the physician has ordered. In other words, find out the IV compatibility of the compounded drug with the base solution and other drugs that may be injected into the same base solution (IV bag) if the physician order calls for it.

5. Make sure you’re not drawing multiple doses out of single-dose vials which are included in the supplies.

6. A multi-dose vial is much bigger and labeled as such and may be used to withdraw multiple doses.

7. Ensure you have the correct size syringe and correct size needle.

The TPN LAB/Final Evaluation Lab is the Final Lab that you will be performing in front of an instructor for the final evaluation. You should've already practiced with the supplies already sent to you including completing the practice labs before scheduling the final evaluation.

This lab consists of performing everything that you’ve learned above which includes.

1. Correct garbing procedure
2. Correct handwashing technique
3. Correct sterile gloving technique
4. Correct technique to clean a horizontal hood
5. Correct technique to clean a vertical hood.
6. Correct way to reconstitute a powder vial and withdraw and subsequently inject the appropriate amount of drug from the vial into a IV or TPN bag.
7. Correct ampule manipulation and withdrawal of solution from the ampule and injecting into a IV or TPN bag.
8. Identify what is required on a label for a CSP at a minimum.
9. Perform the TPN evaluation lab in front of an instructor as shown below.

After having watched the TPN videos in the online course you should have a basic understanding of how TPNs are made and the white TPN bag included in your supplies is the final product after all the base solutions have been infused into the TPN using the TPN compounder you saw in the videos.

Keep in mind there are various other makes and models of TPN compounders. As you saw in the videos, the other ingredients have to be drawn up by hand and injected into the TPN bag.

The physician wants to initiate a TPN for a patient and wants the following ingredients added to the TPN.

- 12mM of sodium phosphate
- 5% calcium gluconate
- 2 mL of trace elements from the ampule
- 2 mL of the reconstituted powder solution. If you received the small powder vial labeled 2 mL then add 2 mL of the diluent to the powder in the vial.

Based on the details provided above.

  1. How many mLs of sodium phosphate are required?

  2. How many mLs of calcium gluconate are required?

  3. How much diluent is required? 

  4. What is the final concentration of the solution in the reconstituted vial? (will not apply if you received the small 2 mL powder vial)

  5. List the supplies and quantity (how many syringes, needles etc.) required to perform this manipulation. 

  6. Document (see practice labs section) the entire compounding process including the steps required prior to compounding such as garbing process etc. steps required during and after compounding such as wiping the supplies before placing them in the hood, aseptic technique, cleaning the surface of the hood after completing compounding etc. Email me your answers and documentation.