Infection Control in - Pharmacy - TPN &IV Preparation

Sterile products are prepared following specified procedures which assure that they are:

Therapeutically and pharmaceutically appropriate to the patient. Free from microbial and pyrogenic contaminants. Free from unacceptable levels of particulate and other toxic contaminants. Correctly prepared. Properly labeled, stored, and distributed.

Sterile products preparation requirements

(1) PHYSICAL REQUIREMENTS:

A.
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Space:
The facility shall have a designated area with entry restricted to designated personnel for preparing compounded sterile products. This area shall be designed to avoid unnecessary traffic and airflow disturbances from activity within the facility. This designated area shall be used only for the preparation of these specialty products. It shall be of sufficient size to accommodate a laminar airflow hood and to provide for the proper storage of drugs and supplies under appropriate conditions of temperature, light, moisture ,sanitation, ventilation, and security.

B. Equipment:
The facility shall have: (1) Appropriate environmental control devices capable of maintaining proper conditions in the work space where critical objects are exposed and critical activities are performed. (2) Sink with hot and cold running water which is convenient to the compounding area for the purpose of hand scrubs prior to compounding.

(3) Appropriate disposal containers for used needles, syringes,

etc., and if applicable for cytotoxic waste from the preparation of chemotherapy agents, and infectious wastes. (4) When cytotoxic drug products are prepared, appropriate environmental control also includes appropriate biohazard cabinetry. (5) Refrigerator/Freezer with a thermometer. (6) Appropriate delivery container including temperature controlled container when needed.

Horizontal Laminar Flow Hood

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Laminar flow hood,it will maintain an area free of microorganism contaminants and particulate matter when it is properly maintained, prepared, and used by operators with good aseptic technique. The use of good aseptic techniques is required at all times. If, for any reason the IV hoods are turned off, they must be reoperational at least 30 minutes before they are used to prepare sterile products. Ampoules are bagged upon removal from the hood to protect from traces of medication and sharp edges. Rapid movements are avoided while working in the hood to prevent disruption of the air flow.

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Before beginning work in the hood, the interior bottom work surface and two side surfaces are swabbed first with sterile water for irrigation (allowing it to dry) and then 70% alcohol using a side to side movement beginning at the rear edge of the surface and working forward. Allow the alcohol to dry in order for it to exert the maximum bactericidal effect. Personnel work at least 6 inches inside IV hood and no closer than 2 inches to the sides, back, and surface of the hood. Any materials that have been laid on the surface of the hood (for example, needle with protective cap removed) are not reused.

Preparation of Hazardous Sterile Products:

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All hazardous sterile products are prepared in the pharmacy in a vertical flow hood The use of the vertical flow hood is limited to the preparation of hazardous drugs. Additional attire is required for preparation of hazardous sterile products including specially provided gowns and latex gloves. Double gloving is required. Latex free gloves are recommended to be worn under the latex gloves. All protective clothing is changed immediately upon contamination by hazardous products.

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Protective clothing is not worn outside the hazardous sterile product room. Protective clothing is disposed of in supplied labeled trash receptacles. Disposable absorbent plastic backed paper liners are used in the vertical flow hood and are changed at least every shift or upon obvious contamination. Approved chemo vents are used to prevent aerosolizing of hazardous medications.

All contaminated preparation materials (i.e., gauze,used syringes, empty vials) are disposed of in the chemo trash can. All contaminated materials (i.e., partially filled hazardous medication vials and returned medications) are disposed of in the appropriately labeled supplied container. A covered sharps container is located in the vertical flow hood. These containers have a label attached that says * Caution - Chemotherapy - Handle With Gloves. Dispose of properly*.

All doses of hazardous sterile products are delivered to inpatient units in ziplock bags labeled "Caution: Chemotherapy". All personnel involved in the preparation of hazardous sterile products annually read and understand the latest editions of the following publications which are available in the Sterile Product Preparation Manual:

Work Practice Guidelines for Personnel Dealing With Cytotoxic (Antineoplastic) Drugs (Occupational Safety and Health Administration (OSHA)). ASHP Technical Assistance Bulletin on Handling Cytotoxic and Hazardous Drugs.

All hazardous sterile products are labeled with supplied warning labels. Spills are only cleaned using supplied chemo spill kits utilizing appropriate protective techniques. Syringes are no more than full when dispensing. All syringes are capped prior to removal from the vertical flow hood.

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Extremes of positive and negative pressure are avoided at all times to prevent spraying and aerosolizing of medications. Manipulation of liquids in syringes is done within a closed environment, for example, a needle cover or the needle actually in a bag to protect the preparer from inadvertent exposure to hazardous medications, through spilling or aerosolizing of medication. Nothing is placed over the front vent grill. This compromises the integrity of the hood's operational capacities and risks operator exposure to harmful medications.

C. Supplies:
The facility shall maintain: (1) Disposable needles, syringes, and other supplies needed for aseptic admixture. (2) Disinfectant cleaning solutions. (3) Hand washing agent with germicidal action. D. Security: The facility shall provide adequate security for all drugs.

(2) PERSONNEL

A. Pharmacist In Charge: Each facility shall be supervised by a pharmacist who is knowledgeable in the specialized functions of preparing and dispensing compounded, sterile pharmaceuticals, including the principles of aseptic technique and quality assurance.

B. Pharmacy Technicians: The pharmacist-in-charge may be assisted by pharmacy technicians. These personnel shall have specialized training in this field and shall work under the immediate supervision of a licensed pharmacist. C. Staffing: A pharmacist shall be accessible at all times at each facility to respond to patients and other health professionals questions and needs

Preparation Room Attire:

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Personnel preparing sterile products are not allowed to have or wear the following: 1. Fingernails in excess of inch
2. 3. 4. 5.

Artificial nails Facial makeup Hand jewelry Particle generating clothing (fuzzy sweaters)

Personnel don the required attire in the following order: hair cover, mask, gown, and gloves. Gloves are put on last. The cuffs of the gown are placed inside the gloves. (Note: double gloving is required for cytotoxic drug preparation.) Hands are washed with a bactericidal agent before donning and after removing gloves. Gloves are changed upon any obvious change in the integrity of the gloves.

Masks cover all facial hair, if present, as well as nose and mouth. Masks are not allowed to fall below the nose. The required attire for preparation of sterile products is supplied in the ante room. Food, drinking, chewing gum, facial makeup, and excessive talking is strictly prohibited in the sterile product preparation areas.

Pregnant or lactating women, male or female staff who are actively trying to conceive a child, or staff with a medical condition that may preclude them from handling cytotoxic drugs, have an option of whether or not they will handle or administer cytotoxic drugs. Pregnant or lactating women will not prepare undiluted cytotoxic drugs.

Preparation of IV admixtures

1- Admix all routine parenteral fluids in the pharmacy in a laminar-flow hood using aseptic technique Do not use any container of parenteral fluid that has visible turbidity, leaks, cracks, or particulate matter or if the manufacturers expiration date has Passed. 2- Use single-dose vials for parenteral additives or medications when possible. 3- Do not combine the leftover content of single-use vials for later use.

Ampoules - single dose containers:

With ampoule in upright position, tap neck gently to release solution trapped in the neck. Wipe neck with sterile alcohol pad. When the ampoule is broken, glass particles may fall into the ampoule.The neck must be clean. Withdraw being careful.The needle must be changed after contact with the ampoule.

If multidose vials are used:

1. Refrigerate multidose vials after they are opened if recommended by the manufacturer. 2. Cleanse the access diaphragm of multidose vials with 70% alcohol before inserting a device into the vial. 3. Use a sterile device to access a multidose vial and avoid touch contamination of the device before penetrating the access diaphragm. 4. Discard multidose vial if sterility is compromised. 5. Needle entry into vials with rubber stoppers is done cautiously to avoid the creation of rubber core particles.

Preparation of IV admixtures(cont.)
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To preserve the integrity of the clean room, pass-throughs are only opened from one side at a time. Both sides are not opened in order to communicate or pass materials directly to personnel in the sterile product preparation area. Materials are not brought in and out of the IV room without disinfecting before readmission. For instance, if the cart is rolled out of the IV room for restocking, it is disinfected with alcohol before readmission to the IV preparation room. Labels are completed, when possible, before admission to the IV preparation area. This includes dating and initialing. Labels are not placed in the hood or written on in the hood.

Preparation bins are not placed within the laminar flow hoods. All materials are kept to a minimum in the hood to maintain the integrity of the laminar flow. Materials needed for compounding sterile products are placed in supplied bins along with directions for preparation or patient medication label. All materials are taken out of outer protective barriers before admission to the sterile product preparation area. For example, bags are taken out of plastic outer wrap and vials are taken out of boxes.

All materials are kept at a minimum in the sterile product preparation room. Only materials that are absolutely necessary for the preparation of the prodcut are in this area. Only one drug or preparation is placed in each bin. If different doses are included in the same bin, they are separated upon completion of preparation in such a way that it is obvious to the checking pharmacist how the doses were prepared (i.e., by bin separators). Only one medication or one dose is placed in the hood to be prepared at any given time.

Labeling:
In addition to regular labeling requirements, the label shall include: A. Parenteral products shall have the rate of infusion when applicable. B. Expiration date. C. Storage requirements or special conditions. D. Name of ingredients and amounts contained in each dispensing unit. Storage and Delivery: The pharmacist-in-charge shall be responsible for the proper storage in the pharmacy of all sterile pharmaceuticals after they are compounded.

Disposal of Infectious Wastes:

-The pharmacist-in-charge is responsible for assuring that there are written policies and procedures for safe collection and disposal of any medical or infectious waste resulting from the dispensing of sterile products. -These policies and procedures shall extend to any location where sterile products are administered.

Cleaning Procedures:
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The anteroom of the sterile product preparation area is completely cleaned at least monthly and recorded on the appropriate log sheet. This includes wiping down of every shelf. All bins and carts used within the sterile product preparation area are cleaned at least monthly and documented. Cleaning materials are made of materials that generate a low level of particulate.

Environmental Services personnel sweep the floors daily and then mop them with clean bactericidal water.Cleaning personnel don gowns, masks, and hair covers before entering the preparation area. Environmental Services personnel clean the walls and cleaning tiles in the sterile product preparation areas at least weekly with clean bactericidal water. Trash cans are not emptied within the sterile product preparation area. The trash cans are equipped with rollers so that they can be removed from the room when the trash needs emptying by appropriately attired personnel within the area, or by appropriately attired Environmental Services personnel.

Cleaning of IV hoods:

Hoods are cleaned at the beginning and end of each batch and when obvious contamination is observed. Cleaning is done first with sterile water and then alcohol. Cleaning of prefilters and under grill is done monthly and recorded on the appropriate chart.This is done by trained IV room personnel. Cleaning of the vertical flow hood is done on a monthly basis by trained personnel only and is recorded on the appropriate log sheet.

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The exhaust fan / blower is cut off during cleaning. The operator wears a disposable gown, disposable latex gloves covered by disposable utility gloves, safety goggles, hair covering, and a disposable NIOSH - approved respirator. Gloves are changed immediately if torn. Close and remove sharps container from the chemo hood. Discard and replace with new container after cleaning.

Decontamination is done from top to bottom (areas of lesser contamination to greater) by applying the cleaner, scrubbing, and rinsing thoroughly with distilled or deionized water. Removable parts of the cabinet are cleaned within the containment area of the cabinet and are not removed from the cabinet. The work tray usually can be lifted and placed against the back wall for cleaning of the undersurface of the tray and exposure of the bottom of the cabinet.

The outside of the cabinet is wiped down with cleaner to remove any drip or touch contamination. All contaminated disposals are contained in sealable bags for transfer to larger waste containers. Final cleaning is done with 70% alcohol before any aseptic procedure is begun.

Quality Assurance (QA) / Quality Control (QC) Program:

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Process Validation End Product Testing Personnel Performance Validation Equipment Validation Environment Validation

End Product Testing:

Low and Medium Risk: End product testing is performed each month, two products from each sterile product dispensing area are tested for sterility. If growth is detected, the entire sterile preparation process is evaluated, corrective action taken, and a process simulation test performed. High Risk Medications: An appropriate sample of prepared sterile product is inoculated and incubated for 14 days at the correct temperature to document sterility of batch preparation. This is used for batch preparations, for example, talc, sodium benzoate.