BCSCP cheat sheet

USP <797> classifies CSPs as immediate-use, Category 1, or Category 2; assignment depends on starting ingredients, processing steps, and engineering controls.

Immediate-use CSP administration must begin within 1 hour of preparation start; no storage and no longer beyond-use date are permitted.

Category 1 CSP beyond-use date: 12 hours at controlled room temperature and 24 hours refrigerated; frozen storage requires validated stability data.

Category 2 CSP beyond-use date: 4 days at controlled room temperature, 10 days refrigerated, and 45 days frozen.

Disinfect CSP contact surfaces with sterile 70% isopropyl alcohol and allow to dry; work at least 6 inches inside the ISO 5 primary engineering control.

First-air rule: no object may be placed between the HEPA filter and the critical site; airflow must reach the critical site before any other surface.

Swab vial stoppers with sterile 70% isopropyl alcohol and let dry before needle entry; use a new needle for each entry when possible.

Final CSP label includes patient name, drug, strength, dose, route, volume, beyond-use date/time, storage, preparation date/time, and preparer/verifier.

Category 2 facility design: ISO 5 primary engineering control inside an ISO 7 buffer room, with an ISO 8 ante room and a positive pressure cascade.

ISO 5 particle limit: no more than 3,520 particles ≥0.5 µm per cubic meter; ISO 7 limit is 352,000 particles/m³.

Pressure differential between adjacent compounding rooms must be at least 0.02 inches water column (5 Pa); monitor continuously with alarm.

Certify each ISO 5 primary engineering control every 6 months and after relocation, repair, or HEPA filter change.

Perform viable air and surface sampling in each ISO 5 PEC and buffer/ante room at least every 6 months.

Unidirectional airflow velocity at the work surface is 0.45 m/s (90 fpm) ±20%; verify by airflow visualization and certification.

Maintain buffer and ante room temperature at 20–25°C and relative humidity below 60%; monitor and document.

Media fill simulates compounding to detect contamination; incubate 14 days and investigate any positive result as a process failure.

Gloved fingertip and thumb sampling: initial three consecutive zero-CFU sets before independent compounding, then at least every 6 months.

Sterility testing uses USP <71>; it is required for high-risk CSPs and when validation supports extended beyond-use dates.

Bacterial endotoxin testing uses USP <85>; limits depend on route of administration and patient weight.

Visual inspection of the final container: check against black and white backgrounds for particles, discoloration, leakage, and container defects.

Master formulation record includes ingredients, quantities, order of mixing, equipment, sterilization method, beyond-use date, and quality control checks.

Pharmacist release verification includes calculations, ingredients, label, final container, and documentation before the CSP leaves the pharmacy.

Garbing order: shoe covers, head/hair cover, face mask, eye protection, hand hygiene, sterile gown, then sterile gloves.

Perform hand hygiene before garbing and again before gloving; use soap and water or an alcohol-based rub per policy.

Initial competency requires documented training and visual observation before independent compounding; reassess technique at least annually.

Gloved fingertip sampling is required initially and at least every 6 months; three consecutive zero-CFU sets are needed before independent compounding.

HD PPE minimum: two pairs of chemotherapy-tested gloves, closed-front gown, eye and face protection, and NIOSH-approved respirator when aerosol risk exists.

Safety data sheet for every hazardous drug must be readily accessible to staff before handling.

Spill kit contents: chemotherapy gloves, gown, eye protection, absorbent pads, detergent, deactivation agent, and hazardous waste bags.

USP <800> applies to all healthcare personnel who handle hazardous drugs; NIOSH lists groups 1, 2, and 3.

NIOSH Group 1: antineoplastic hazardous drugs; require full containment and engineered controls.

NIOSH Group 2: non-antineoplastic hazardous drugs; require containment and safe handling based on a documented risk assessment.

HD compounding room: negative pressure at 0.01 inches water column (2.5 Pa) relative to adjacent areas and at least 12 air changes per hour.

Containment primary engineering control for HDs must be externally vented; Class II or III biological safety cabinet is preferred.

Deactivation, decontamination, and cleaning must be performed in that order using agents proven effective for the specific hazardous drug.

Hazardous drug waste goes into chemotherapy waste containers labeled hazardous; do not compact.

FMEA is prospective: risk priority number = severity × occurrence × detection; higher scores prioritize process improvements.

Root cause analysis is retrospective for sentinel events; identify system causes rather than individual blame.

Independent double check: two qualified staff separately verify high-alert drug, dose, calculation, and pump settings before administration.

Just culture supports nonpunitive reporting of errors and near misses while maintaining accountability for reckless behavior.

High-alert medications require tall-man lettering, auxiliary labels, and separate storage to reduce look-alike/sound-alike errors.

Track compounding errors, contamination rates, and turnaround times; compare against benchmarks and set improvement targets.

PDCA (Plan-Do-Check-Act) is an iterative method for testing, measuring, and sustaining quality improvement changes.