Sterile Chapter Topics Sterile supplies for IV preparation
Sterile Chapter Topics Sterile supplies for IV preparation and administration IV solutions Specialized sterile compounding procedures Premade parenteral products Hospital pharmacy calculations Hazardous agents Quality assurance Learning Objectives Identify the role and function of equipment used in intravenous preparation and administration. Identify the components of an intravenous administration set.
Describe common characteristics of intravenous solutions. Identify types of intravenous solutions. Summarize the steps necessary for aseptic technique in a hospital pharmacy. Describe the correct procedure used in preparing compounded sterile preparations. Learning Objectives (continued) Discuss the preparation of total parenteral nutrition. Differentiate between expiration dating and beyonduse dating. Understand the types of premade parenteral products. Calculate intravenous flow rates. Discuss the importance of and techniques for preparing, handling, and disposing of hazardous agents. Define the purpose and list examples of quality assurance programs in the hospital.
Sterile IV Supplies Syringes Parts of a syringe Syringe selection and measurement Sterile compounding personnel must not touch the sterile parts of a syringe or needle. Inadvertent touching of these critical sites results in contamination and, consequently, disposal of the needle-and-syringe unit into a sharps container. Select a syringe that can be filled at least full.
Consider the measurement accurate to half of the smallest calibration mark. Read the measurement at the point of contact between the rubber-tipped piston plunger and the inside of the barrel. Sterile IV Supplies (continued) Needles 3 Gauge refers to the diameter of the opening or lumen of the needle. 3 Needles are individually wrapped to maintain sterility.
Sterile IV Supplies (continued) Handling of the needle-andsyringe unit Remove the outer wrapper without touching the syringe tip. Open the sterile packaging of the needle. Hold the needle by the cap. Twist the needle hub to the syringe cap. Do not touch the sterile parts or critical sites of the syringe or needle. Sterile IV Supplies (continued) IV administration sets
Also called IV tubing or an IV set Commonly attached to an IV infusion pump that adjusts the volume and administration rate Sterile IV Supplies (continued) IV administration sets Components of an IV set Universal spike adaptor A sharp, plastic spike is used to pierce the IVs tubing port. An air vent (on some IV sets) just below the spike allows filtered air to enter the bottle as fluid flows out of it.
Drip chamber Air bubbles rise to the top of the IV fluid, preventing them from entering the tubing and patient. Nurses set the infusion rate by counting the drops. The drop set is the number of drops of a given solution that it takes to make 1 mL. Sterile IV Supplies (continued) IV administration sets Components of an IV set Roll clamp
Hard plastic clip containing a small roller Loosely attached to the tubing Freely moving along the length of the tubing Rolled down to constrict tubing Rolled up to open tubing Allows healthcare personnel to regulate the IV flow rate Flexible tubing (IV tubing) Molded from pliable PVC and other plasticizers Not for use with Nitroglycerin and amiodarone Sterile IV Supplies (continued) IV administration sets Components of an IV set Needle adaptor
Located close to the patient Tapered to fit all needles and protected by a sterile cover Y-site injection port Allows medications to be added to the IV solution In-line filter Protects the patient against bacteria and emboli Preparation of an IV set Priming Flushing the tubings interior lumen with solution Eliminiates small particles Happens prior to medication administration Sterile IV Supplies (continued) IV administration sets
Medication delivery with an IV set Responsibility of nurses Attaching IV tubing to fluid container Establishing and maintaining a flow rate Managing overall regulation during administration of the solution Tubing changed every 24 to 96 hours to minimize infection Pharmacy personnel and IV sets Increasing need for pharmacy personnel to understand IV sets Sterile IV Supplies (continued) Filters Built-in or in-line filters
Provide final filtration of fluid Protect patients against particulate matter, bacteria, air emboli, phlebitis Do not remove virus particles or toxins Common filter sizes: 0.5 micron: for removing large particles 0.45 micron: for filtering IV suspensions 0.22 micron: for removing bacteria IV Solutions Chemical properties of IV solutions Property Description pH value
The degree of acidity or alkalinity of a solution; blood plasma pH: 7.4; IV solution pH: 7.0 (neutral) A measure of the number of milliosmoles of solute per liter of solution (mOsm/L) The pressure required to maintain equilibrium, with no net movement of solution across body membranes A measure of the number of milliosmoles of solute per kilogram of solvent The ability to combine two or more additives in solution without any changes in physical or chemical properties Stability under various storage conditions Osmolarity Osmotic pressure Osmolality
Compatibility Stability IV Solutions (continued) Chemical properties of IV solutions Property Description Tonicity The manner in which cells or tissues respond to surrounding fluid Hypotonic Have fewer dissolved particles than blood (less than solutions 280 mOsm/L). When cells are exposed to this, water is drawn in, causing them to swell. An example is 0.45% sodium chloride ( NS). Hypertonic Have more dissolved particles than blood (greater
solutions than 310 mOsm/L). When cells are exposed to this, water is drawn out, causing them to shrivel. An example is 3% normal saline (NS). Isotonic Have a similar number of dissolved particles as blood solutions (280-310 mOsm/L). An example is 0.9% sodium chloride (normal saline). IV Solutions (continued) Types of IV solutions Largevolume parenteral s (LVPs) Used to replenish fluids; provide
drugs, electrolytes, and nutrients Available in 250, 500, 1000 mL Administered over 1 to 24 hours Smallvolume parenteral s (SVPs) Used to deliver medications Available from 25 to 250 mL Administered over 10 minutes to an hour Majority are IV piggybacks (IVPBs) IV Solutions (continued)
Preparation of labels for LVPs and SVPs Required information Patients name and identification number Room number Medication name and dose Base solution and amount Infusion period
Flow rate Beyond-use date and time Signature or initials of technician and pharmacist Any additional information required by the institution or state or federal guidelines IV Solutions (continued) Aseptic preparation of IV products Remove outer garments and jewelry. Put on shoe covers, a hair cover, and a face mask. Perform aseptic hand washing for 2 to 4 minutes. Put on a sterile gown. Apply sterile, foamed alcohol to hands and allow them to dry. Put on sterile gloves. IV Solutions (continued) Aseptic preparation of IV products (continued)
Clean the hood with sterile water and then 70% IPA. Remove syringe from packaging, attach a needle, and discard the waste. Swab needle-penetration closure on vials and injection ports with 70% IPA. Withdraw medication from vial or ampule and inject it into IV base solution. Check the solution for cloudiness, particulates, and appropriate color. Present the product, containers, devices, and label to the pharmacist for verification. In the Know: True or False The critical areas of a needle and syringe include the tip of the syringe and needle hub. true A 0.45 micron filter is capable of removing bacteria from an IV
solution. false A solution with an osmolarity of 300 mOsm/L is considered isotonic. true Large volume parenterals (LVPs) are typically used to deliver antibiotics. false Special Sterile Compounding Procedures Vials Types of vials Single-dose vials (SDVs) Do not contain a preservative Must be used within an hour, per USP Chapter
<797> Multiple-dose vials (MDVs) Contain a preservative Stable for 28 days unless otherwise specified by the manufacturer Special Sterile Compounding Procedures (continued) Withdrawing fluid from a vial 1. Choose the smallest-gauge sterile needle size appropriate. 2. Attach the needle to the syringe. 3. Draw air into the syringe equal to the amount of drug to be withdrawn. 4. Swab the vial, puncture the rubber top with the bevel up, bring the syringe and needle straight up and penetrate the rubber top.
5. Invert the vial and depress the plunger, emptying air into the vial. 6. Withdraw the necessary volume of liquid. 7. Remove the needle-and-syringe unit from the vial. 8. Inject the liquid medication into an IV base solution. Special Sterile Compounding Procedures (continued) Vials Reconstituting powdered medication in a vial Check the medication package insert to verify which diluent and what volume should be added to the medication vial to make a correct concentration of sterile
solution. Reconstitute with a diluent such as sterile water or normal saline. Use a vented needle that allows the diluent to be injected while venting the positive pressure within the vial. Special Sterile Compounding Procedures (continued) Vials Preparing a CSP with a vials contents The vial, filled syringe, and base solution are arranged on the hood for the pharmacist to check.
The pharmacist completes the verification check. The technician repositions items so that critical components receive uninterrupted airflow from the HEPA filter. The technician swabs the injection port, removes the needle cap, and inserts needle into port. The technician depresses the flat knob of the plunger until all medication is injected into base solution. The technician removes the needle-and-syringe unit and disposes of it in a sharps container. The CSP is visually checked and labeled. In the Know: True or False Multi-dose vials are given a BUD of 60 days. false When withdrawing fluid from a vial, a volume of air is drawn into the syringe equal to the amount of drug to
be withdrawn. true When reconstituting powdered medication in the vial, consult the package insert to find out what diluent and volume to add. true Special Sterile Compounding Procedures (continued) Ampules Parts of an ampule Part Neck Break ring
Description Critical site, must be swabbed with 70% IPA before opening ampule. Scored area on the neck that marks the site where the ampule should be broken Special Sterile Compounding Procedures (continued) Ampules Opening an ampule 1. Tap the head of the ampule to clear medication from the head and neck. 2. Wrap a 70% IPA swab around the neck of
the ampule. 3. Using gentle but firm pressure, snap the neck of the ampule away from you. Special Sterile Compounding Procedures (continued) Ampules Withdrawing medication from an ampule Hold the ampule upright. Place the needle (bevel pointing down) of a filter needle or the tip of a filter straw in the corner near the opening. Tiny glass particles are screened out by the filter needle. Filter needles are unidirectional. Can either be used to withdraw fluid from an ampule or inject fluid into an IV or IVPB, not both. Withdraw the medication.
Change the filter needle to a regular needle to inject contents into an IV or IVPB. Special Sterile Compounding Procedures (continued) Ampules Preparing a CSP with an ampules contents The ampule, filled syringe, used filter needle, and base solution are arranged on the hood for the pharmacist to check. The pharmacist completes the verification check. The technician repositions items so that critical components receive uninterrupted airflow from the HEPA filter. The technician swabs the injection port, removes the needle cap, and inserts the needle into the port. The technician depresses the flat knob of the plunger until all medication is injected into the base solution.
The needle-and-syringe unit are removed and disposed of in a sharps container. The technician visually checks the CSP and then labels it. Special Sterile Compounding Procedures (continued) Total parenteral nutrition (TPN) solution TPN components Sterile water for hydration Dextrose for calories and energy
Amino acids for protein synthesis Fatty acids for chemical processes and energy Electrolytes, vitamins, and minerals for energy processes Medication (such as insulin) for treatment of a disease Special Sterile Compounding Procedures (continued) Total parenteral nutrition (TPN) solution Preparing TPN TPN is always prepared in volumes of at least 1,000 mL. In small hospitals, a technician prepares the base solution, draws up the additives, then injects them into the base. In larger hospitals, an automated compounding device (ACD) is used. If a fat emulsion is ordered as part of the TPN solution, this is called a 3-in-1 TPN solution.
Special Sterile Compounding Procedures (continued) Total parenteral nutrition (TPN) solution Administering TPN Requires insertion of a central venous catheter (CVC) or central line because TPN is hyperosmolar or hypertonic. Administered via an infusion pump IV tubing includes a 0.22 micron inline filter. Aseptic technique in preparation and catheter care are critical to avoid bacterial contamination. Tubing is replaced with each new bag. Premade Parenteral Products Vial-and-bag systems
Types of vial-and-bag systems ADD-Vantage (Hospira) and MINIBAG Plus (Baxter) are two examples. Only selected products are available. Vial-and-bag systems are assembled in an ISO Class 5 environment. Since vial-and-bag systems do not require sterile compounding, they are not considered CSPs. USP Chapter <797> beyond-use dating guidelines do not apply. Follow manufacturers recommendations for handling, storage, and beyond-use dating. Premade Parenteral Products (continued)
Vial-and-bag systems Benefits of Vial-and-Bag Systems Safety Decreased risk of admixture errors, contamination, and needle sticks Efficiency Doses premeasured for rapid reconstitution and assembly Cost-effectiveness No admixture or supply costs necessary Assembly and Activation of Vial-and-Bag Systems Activation Technician attaches vial to IVPB; labels the product Activation Nurse breaks internal chamber at the connecting site; drug mixes with fluid; Nurse administers solution Premade Parenteral Products
(continued) Frozen IV solutions Benefits Less wastage Later expiration dates Reduced risk of microbial contamination Less labor-intensive preparation Handling of frozen IV solutions
Thaw at room temperature or in refrigerator Warming bath or microwave not recommended for thawing Label product once thawed Expiration dates vary Once thawed, cannot be refrozen In the Know: True or False The critical site of an ampule is the neck. true When breaking an ampule, snap the neck of the ampule towards you. false The purpose of dextrose in a TPN solution is to
provide calories and energy. true Vial-and-bag systems are assembled on the nursing unit. false Hospital Pharmacy Calculations Determining IV administration flow rates What is the rate in mL/hr? How long will this bag last? x = TV/H What time will the next bag be needed? x = TV/IR
How many bags will be needed for the patient in a 24-hour period? Step 1: x = TV/IR Step 2: Add number of hrs (x) to the current standard time KEY: Step 1: x = TV/IR Step 2: Divide 24 by the number of hours calculated in Step 1 TV=total volume H=number of hours over which CSP will be administered (H) IR= infusion rate Hospital Pharmacy
Calculations (continued) Determining IV administration flow rates Problem A physician orders 4000 mL of D5NS to be administered over 24 hours. What is the infusion rate in milliliters per hour? x = TV/H TV = 4000 mL H = 24 hours 4000/24 = 166.67 rounded to nearest whole number x = 167 mL/hour Hospital Pharmacy Calculations (continued) Determining IV administration flow rates Problem The prescriber has ordered 500 mg of cefazolin in 50 mL of D5W to be administered at 100 mL per hour. How long will it
take to administer this medication? x = TV/IR TV = 50 mL IR = 100 mL/hr 50/100 = 0.5 (or hour) x = hour or 30 minutes Hospital Pharmacy Calculations (continued) Adding electrolytes to base solution Electrolyte solutions contain dissolved mineral salts. Solutions are measured in milligrams (mg) and in milliequivalents (mEq). Compounded LVP solutions typically require drawing up as an additive and injecting into the base solution. The ratio-proportion method is used to determine the volume of additive.
Hospital Pharmacy Calculations (continued) Adding electrolytes to base solution Problem You are requested to add 44 mEq of sodium chloride (NaCl) to an IV bag. Sodium chloride is available as a 4 mEq/mL solution. How many milliliters should you add to the bag? x mL = 1 mL 44 mEq 4 mEq x mL = 44 mL 4 x = 11 mL Hazardous Agents Risks of exposure to hazardous agents
Route of exposure Example Trauma or injury Accidental needle stick or cut from broken container Fine mist from broken bottle or poor manipulation technique Ingesting powder particles when crushing an oral tablet Accidental spills Inhalation Ingestion Direct skin contact
Hazardous Agents (continued) Risks of exposure to hazardous agents Acute health consequences Skin contact resulting in skin rash or allergic reaction Infertility, miscarriage, neonates with low birth weight or congenital malformations Long-term health consequences Higher risk for skin and bladder cancers and leukemia Hazardous Agents (continued) Protective clothing Disposable, lint-free, impervious, closed-front gown with cuffed sleeves Hair and shoe covers Eye protection, face mask, gloves
(Remove and discard all protective garb before leaving the hazardous drug preparation area.) Hazardous Agents (continued) Protective clothing Double gloving Tuck disposable gloves under the sleeve cuff of the gown. Place chemotherapy gloves over the top of the gown cuff. Turn gloves inside out when removing and discard them in a sharps container. Hazardous Agents (continued) Receipt and storage of hazardous agents Receipt of Hazardous Agents
Gloves must be worn. Hazardous drugs should be delivered directly to their storage area. Hazardous agents should be stored separately from other medications. Damaged packages should be inspected in an insulated area such as a vertical hood. Receipt of broken vials should be treated as a hazardous agent spill. Storage of Hazardous Agents Storage areas should carry warning labels. The storage area should maximize product recognition and minimize any potential for breakage.
Access to storage and work areas for hazardous materials should be restricted. A list of hazardous agents should be compiled and posted throughout the workplace. Hazardous Agents (continued) Equipment for preparing hazardous agents Biological safety cabinet (BSC) This specialized hood is used to prepare chemotherapy and other hazardous materials. HEPA-filtered air flows downward and outward through the back and sides. Contaminated air is filtered either
to outside or back inside cabinet. A plexiglas shield at the front of the cabinet stops about eight inches from the work surface. Hazardous Agents (continued) Equipment for preparing hazardous agents Compounding aseptic containment isolator (CACI) Vertical airflow hood used to prepare hazardous materials Fully enclosed Hands placed into fixed gloves located at front of cabinet Supplies brought into hood through inner pass-through
window Hazardous Agents (continued) Supplies Used in Hazardous Drug Preparation Safely draws fluid from a vial into a syringe or injects it from a syringe into an IVPB or IV Closed-System Transfer Devices A thin mat used to soak up potential fluid spills and prevent fluid from seeping
through to the surface of the hood Chemotherapy Compounding Mat A device used to relieve the negative pressure within a medication vial Chemotherapy Dispensing Pin Hazardous Agents (continued) Hazardous agents in vials When working with
hazardous drugs, sterile compounding personnel should use negative pressure techniques whenever possible. Under no circumstances should a volume of air greater than 75% of the volume of the drug withdrawn be injected into the vial. Use a CSTD or chemotherapy dispensing pin, if available. If above not available: Slowly inject diluent into the vial. Allow excess pressure from vial to
vent into the syringe. Withdraw the reconstituted drug from vial using negative pressure techniques so that no drug is leaked or aspirated. Inject contents of syringe into an IV or IVPB. Hazardous Agents (continued) Hazardous agents in ampules Tap the head of the ampule to clear medication from the head and neck. Wrap a 70% IPA swab around the neck of the ampule.
Using gentle but firm pressure, snap the neck of the ampule away from you. Withdraw fluid using a filter needle. Oral hazardous drugs Wear gloves, a gown, and a respirator. Clean contaminated equipment after use. When crushing a drug in a unit-of-use package, place in a small, sealable plastic bag and crush with a spoon or pestle. Compounding with these drugs should be done in an
area free from drafts and traffic. Hazardous Agents (continued) Priming, Labeling, and Administering Hazardous Agents Priming an IV administration set Labeling hazardous agents Administering hazardous agents Priming should be done in a BSC or CACI. Insert the spike of the administration set into the CSPs tubing port. Fluid will run from the CSP through the tubing, thus priming it.
The label must contain the patients name and room number, solution name and volume, drug name, dosage, CSP administration information, storage requirements, and be clearly identifyed as a hazardous agent. Nurse must wear a mask, gloves, and special gown. Two nurses will check the dose and labeling before administration. Hazardous Agents (continued) Hazardous Agent Spill 1. Post warning sign outside of or near location of the spill. 2. Wear a gown, durable gloves, goggles, and a mask or respirator. 3. Place broken glass into puncture-proof containers. 4. Start cleaning the spill from the edge and work inward. 5. Use absorbent sheets, spill pads, or pillows for the liquids and damp cloths for the solids.
6. Use spill pads and water to rinse the area. 7. Use detergent to remove residue. 8. Wipe down spill area with a detergent solution at least three times. Hazardous Agents (continued) Procedures in case of exposure If skin exposed, flush affected area immediately then cleanse with soap and water. If eyes exposed, flush eyes with large amounts of water or use eyeflush kit. Remove and dispose of contaminated garments and gloves. Wash hands thoroughly. Escort exposed worker to the emergency room. Report exposure to the supervisor.
Complete an incident report. Hazardous Agents (continued) Final exposure and delivery to the patient care unit Inspection of CSP Check for accuracy in the identifications and quantities of ingredients, technique for mixing, packaging, labeling, and physical appearance. Delivery and administration of CSP Must prevent damage, leakage, contamination, or degradation during delivery Nurse must document administration times on the MAR. CSP and Manufactured Product Returns Criteria for reuse
A CSP can be redispensed only when the pharmacist or pharmacy technician is certain that it remained sterile and chemically stable during its storage on the nursing unit. 3 Storage conditions must remain in compliance with USP Chapter <797>. 3 A new patient-specific label must be generated. 3 In the case of a proprietary vialand-bag system that has not been activated, the vial-and-bag system may be returned to the pharmacy for reuse and relabeling.
In the Know: True or False Two pairs of gloves must be worn when preparing hazardous agents. true Hazardous agents should be stored separately from other medications. true When preparing hazardous agents, a volume of air equal to the volume of drug to be withdrawn should be injected into the vial. false If a hazardous agent spills, start cleaning the spill from the center and work outward. false Quality Assurance Overview Purpose of a quality assurance (QA) program is to detect and correct
errors so as to prevent recurrence. Emphasis is to fix systems and not to affix blame. Quality assurance in handling hazardous agents Documentation of personnel training is required by USP Chapter <797>. Follow written procedures for the handling and disposal of hazardous agents. Follow directions for the treatment and documentation of any exposure. Requirements for environmental and air sampling are required per USP guidelines. Chapter Summary IV infusions are used to deliver parenteral fluids, electrolytes, medications, or nutrients such as lipids, amino acids, sugars, and vitamins. Medications for parenteral administration must be prepared in a horizontal or vertical laminar airflow hood using proper aseptic
technique and the under the supervision of a licensed pharmacist. A pharmacy technician must become familiar with various syringes and needles as well as the components of each IV administration set. Parenteral medications can be administered by bolus injection or by infusion. A Y-site injection port allows nursing personnel to add medication to an IV solution. Chapter Summary (continued) An in-line filter in the IV administration set helps to protect the patient against particulate matter, bacteria, air emboli, and phlebitis. CSPs have many chemical properties that must be understood by the pharmacy technician. Many types and volumes of IV solutions may be used as a means of administering parenteral medications.
Parenteral solutions with or without medications may be administered via IV push, large-volume infusions, or small-volume piggybacked infusions. Medications may need to be reconstituted from vials or withdrawn from ampules before adding to the IV solution. Chapter Summary (continued) Special IV solutions prepared or labeled in the pharmacy include TPNs, proprietary vial-and-bag systems, and frozen IV solutions. A technician must be able to perform various types of calculations when preparing CSPs. Hazardous drugs require special techniques, equipment, and procedures to protect the health of the employee, especially women who are pregnant, breast-feeding, or trying to conceive. Accidental spills or exposures require immediate treatment, cleanup, reporting to the supervisor, and the completion of an incident report.
The pharmacy technician must undergo specific specialized training before working in a sterile compounding environment. Chapter Summary (continued) All parenteral medications must be properly labeled, checked, and physically inspected by the pharmacist before being sent to the nursing unit. Unused and returned manufactured parenteral products and CSPs can be used if the beyond-use dating has not been exceeded and if proper storage conditions on the nursing unit can be verified. A QA program to detect and correct errors is important to ensure the quality of patient care and employee safety and is required for accreditation.
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