PTCB CSPT EXAM 2023

Patient harmed by compounded sterile preparations - Answer- microbial contamination, excessive bacterial endotoxins, variability in strength of ingredients, chemical/physical contaminants, inappropriate quality of ingredients non sterile compounding examples - Answer- products used orally, topically on skin or to fill gaps when not commercially available aesptic - Answer- state of being free from microbial contamination sterile compounded items - Answer- injections(iv, etc) ophthalmic drops, aqueous bronchial or nasal inhalations, baths for live organs, tissue implants, irrigation for wounds or cavities Non hazardous hoods - Answer- Laminar airflow workbench (LAFW) compounding containment isolator (CAI) Hazardous hoods - Answer- biological safety cabinet (BSC) compounding aseptic containment isolator (CACI) Primary Engineering Control (PEC) - Answer- a device or room that provides an ISO Class 5 environment for the exposure of critical sites when compounding CSPs. Such devices include, but may not be limited to, laminar airflow workbenches (LAFWs), biological safety cabinets (BSCs), compounding aseptic isolators (CAIs), and compounding aseptic containment isolators (CACIs). secondary engineering controls - Answer- the ante area and buffer area Buffer or Clean Room - Answer- ISO 7 Ante Room ISO class - Answer- ISO 8, unless provides access to negative pressure room then ISO 7 vertical hood - Answer- hazardous compounding-air flows vertically Horizontal Hood - Answer- air flows horizontally across the work area from back to front Direct Compounding Area (DCA) - Answer- - a critical area within the hood (ISO Class 5) where areas are exposed to filtered air; also known as "first air" Negative Pressure room - Answer- Hazardous materials High-efficiency particulate air (HEPA) filters - Answer- remove microbes 0.3 micrometers Ante Room - Answer- washing, garbing, product decontamination Buffer area air change per hour (APCH) - Answer- 30 exchanges per hour ante room air change per hour (APCH) - Answer- ISO 8-20 per hour ISO 7- 30 per hour Cleaning of compounding area - Answer- germicidal detergent & water for visible solids, 70% isopropyl alcohol ISO Class 5 PEC cleaned - Answer- beginning of each shift, before each batch, every 30 minus when compounding, after spills, contamination Cleaning of Counters and floors of specific sites - Answer- daily Cleaning Walls, ceilings, storage shelving: - Answer- monthly Suface sampling frequency - Answer- every 6 months or significant changes in procedure Temperature of CSP areas - Answer- room temperature 20'C(68'F) or cooler Airborne Particle Testing - Answer- every 6 months or device relocated or serviced ISO class 5 Particle Limit for sterile compounding - Answer- 3,520 particles that are 0.5 micron or larger ISO Class 7 Particle Limit for sterile compounding - Answer- 352,000 particles that are 0.5 micron or larger ISO Class 8 Particle Limit for sterile compounding - Answer- 3,520,000 particles that are 0.5 micron or larger ISO Class 5 Colony Forming Unit Action Level - Answer- 1 (3) ISO Class 7 Colony Forming Unit Action Level - Answer- 10-(5) ISO Class 8 Colony Forming Unit Action Level - Answer- 100 (100) Risk Level Classification - Answer- Low Risk, Medium Risk, High Risk, Immediate Use Risk Low Risk Examples - Answer- -compounding piggybacks or hydration fluids in a ISO 5 laminar flow hood (LVP with KCl and or vitamins) -Dual Chamber parenteral nutrition container with no more than 2 additives Medium-risk examples - Answer- -TPN using manual or automated devices -filling device reservoirs with more than 3 sterile drug products and evacuation of air before dispensing -transfer of volumes from multiple ampules or vials into one or more final sterile containers High risk examples - Answer- bulk drug containers, sterilization requirements, non-sterile components - non-sterile to sterile Immediate Risk Examples - Answer- emergent use preparations -made at bedside or OR Low Risk Beyond Use Dating - Answer- Room Temp - 48 hours Refrigerated - 14 days Frozen - 45 days Segregated-less than 12 hours Medium Risk Beyond Use Dating - Answer- Room Temp- 30 hours Refrigerated - 9 days Frozen - 45 days High Risk Beyond Use Dating - Answer- Room Temp - 24 hours Refrigerated - 3 days Frozen - 45 days Immediate Use Beyond Use Dating - Answer- Room Temp - 1 hour CSP Sterilization - Answer- 0.22 micron filter Multi Use Vials BUD - Answer- 28 Days Ampule BUD - Answer- none Single Use Vial BUD - Answer- manuf recommenced (4 to 8 hours) or 12 hours after entering High Risk CSP Testing quantity - Answer- more than 25 identical CSP Hand Hygiene (Hand Washing) - Answer- wash hand, under fingernails, wrists, up to elbow for 30 seconds-dry hands and arms with non shedding disposable towel or electronic hand dryer-sanitize hands with alcohol based hand rub prior to donning gloves garbing order - Answer- shoes, head covers, face masks, gown, gloves, then sanitize gloves with 70% IPA Labels for Single Compounded Preparations - Answer- Name of ingredients Amounts of ingredients BUD and time Storage Requirements Identification of compounding personnel Labels for Batch Produced CSP - Answer- control or lot number auxiliary label device specific instructions Media Fill Testing - Answer- low and medium risk CSP personnel-12 months high risk CSP personnel- 6 months Finger Tip Testing - Answer- Three sets prior to being allowed to compound, then at least every 12 months, 6 months for hazardous HEPA Filter - Answer- Changed every 6 months Pre filter-monthly Laminar Flow Hood Cleaning Order - Answer- Hang bar and hooks Ceiling-starting with back corner-side to side Side wall- starting upper back corner- up and down Other side wall workbench-either back corner - side to side Degarbing Order - Answer- sterile gloves, gown, eye shield, face mask, beard cover, hair cover, shoe coverings Piercing Rubber Stopper of vial - Answer- 45 to 90 degree insertion, bevel up milking technique - Answer- maintaining an equalized pressure in a vial during adding or withdrawing a solution syringe tip - Answer- luer-lock or slip-tip(not used with hazardous material) Next size up Rule of thumb for syringe - Answer- use the smallest syringe possible that holds more than the dosage amount Filter Needle - Answer- Used when extracting from an ampule Vented Needle - Answer- a needle used to dilute powders that simultaneously vents air pressure out of the vial while injecting diluent into the vial IV piggyback (IVPB) - Answer- used to dilute medications, used for antibiotics, antifunguals, and mineral replacements 100ml orless Large Volume Parenteral (LVP) - Answer- an IV fluid of more than 250 mL that may contain drugs, nutrients, or electrolytes Y-site medications -dont mix well - Answer- Amicillin and Gentamicin-cancel each other Phenytoin and D5W-forms white precipitate Dispensing Pin - Answer- used to withdraw from same vial multiple times Intravenous Admixture Seal (IVA) - Answer- foil port cover Amber Bags - Answer- light protection for IV bag or syringe USP 797 - Answer- Mandatory standards for sterile compounding guidlines for sterile compounding --Not administration of the drug Chemotherapy Medications - Answer- used to treat cancer also treat rheumatoid arthritis, lupus, psoriasis Body Surface Area (BSA) - Answer- BSA(m2) = square root of ht(cm) x wt (kg) over square root of 3600 kg= 2.2 pounds 2.54 cm = 1 inch Chemotherapy Pre Medicaiton - Answer- steroid (Dexamethasone or prednisone) Antihistamines (diphenhydramine) Benzodiazepines (lorazepam) anti nausea (Ondansetron) Fever reducer (Acetaminophen) Hazardous Medication Characteristic - Answer- Carcinogenicity Teratogenicity Reproductive Toxicity Genotoxicity Carcinogenicity - Answer- the ability of a substance to cause cancer Anastrozole- Arimidex Leuprolide-lupron Teratogenicity - Answer- developmental toxicity(harm to unborn baby) Valproic Acid (Depakote) Fluconazole (Diflucan) Reproductive toxicity - Answer- interfere with reprodu