BCSCP flashcards
BCSCP · Build recall with a focused review session.
32 cards. Read the term and the definition here. The deck at the top of this page is optional.
- Immediate-use CSP limit
- Must be administered within 1 hour after preparation begins; it cannot be stored or assigned a longer beyond-use date.
- Category 1 BUD
- At controlled room temperature 12 hours and refrigerated 24 hours; frozen storage requires validated stability data.
- Category 2 BUD
- Four days at controlled room temperature, 10 days refrigerated, and 45 days frozen when prepared under Category 2 engineering controls.
- First-air rule
- No object may be placed between the ISO 5 HEPA filter and the critical site; airflow must reach the critical site first.
- Critical site
- Any opening or surface that can contact the sterile product, such as a needle, vial stopper, syringe tip, or injection port.
- Single-dose vial use
- Use for one patient only; do not save residual contents; discard after the labeled expiration or immediately after use per policy.
- Aseptic disinfection
- Swab stoppers and vial tops with sterile 70% isopropyl alcohol and allow to dry before needle entry.
- ISO 5 particle limit
- No more than 3,520 particles ≥0.5 µm per cubic meter; used for the direct compounding primary engineering control.
- ISO 7 particle limit
- No more than 352,000 particles ≥0.5 µm per cubic meter; typical buffer room classification for sterile compounding.
- Pressure cascade
- Buffer room positive to ante room and ante room positive to corridor; minimum 0.02 inches water column (5 Pa).
- PEC certification frequency
- Every 6 months and after relocation, repair, or HEPA filter change; airflow and filter integrity are tested.
- Viable sampling frequency
- Air and surface sampling in each ISO 5 PEC and buffer/ante room at least every 6 months.
- Unidirectional airflow velocity
- 0.45 m/s (90 fpm) ±20% at the work surface; verify with airflow visualization and certification.
- Media fill purpose
- Simulates compounding to detect contamination; incubate 14 days and investigate any positive result as a process failure.
- Gloved fingertip sampling
- Initial three consecutive zero-CFU sets before independent compounding; repeat at least every 6 months.
- Sterility test method
- USP <71> sterility testing; required for high-risk CSPs and when validation supports extended beyond-use dates.
- Endotoxin test
- USP <85> bacterial endotoxin test; limits depend on route and patient weight; required for high-risk CSPs.
- Visual inspection
- Inspect final container against black and white backgrounds for particles, discoloration, leakage, and container defects.
- Garbing sequence
- Shoe covers, head cover, mask, eye protection, hand hygiene, sterile gown, then sterile gloves in that order.
- Initial competency
- Documented training plus visual observation before independent compounding; reassess technique at least annually.
- HD PPE minimum
- Two pairs chemotherapy-tested gloves, closed-front gown, eye and face protection, and NIOSH respirator for aerosol risk.
- SDS access
- Safety data sheet for every hazardous drug must be readily accessible to staff before handling.
- Competency assessment
- Annual check of aseptic technique, calculations, garbing, and documentation; failure requires retraining before compounding.
- NIOSH Group 1
- Antineoplastic hazardous drugs; handle with full containment and USP <800> requirements, including engineered controls.
- NIOSH Group 2
- Non-antineoplastic hazardous drugs; require containment and safe handling practices based on a documented risk assessment.
- HD room pressure
- Negative pressure at 0.01 inches water column (2.5 Pa) relative to adjacent areas; at least 12 air changes per hour.
- C-PEC venting
- Containment primary engineering control for HDs must be externally vented; Class II or III BSC preferred.
- Deactivation order
- Deactivate, then decontaminate, then clean; use agents proven effective for the specific hazardous drug.
- FMEA RPN
- Risk priority number equals severity times occurrence times detection; higher scores prioritize which process improvements to implement first.
- Root cause analysis
- Retrospective team review of sentinel events to identify system causes and prevent recurrence rather than blame.
- Independent double check
- Two qualified staff separately verify high-alert drug, dose, calculation, and pump settings before administration.
- Just culture
- Nonpunitive reporting of errors and near misses while maintaining accountability for reckless behavior.