Volume 2024 | No. 2
SURVEYOR
PCAB COMPOUNDING
TCRX6-E Overview of the requirement:
Policies and procedures describe the use, calibration, cleaning, and disinfection or sterilization of equipment used throughout the compounding and delivery process. Compliance is assessed through review of policies and procedures, review of manufacturer’s instructions, response to interviews, and direct observation. Deficiencies were focused on calibration, environmental controls, and cleaning/ disinfection procedures. Surveyors noted several issues specific to the use of balances for compounding.
Comment on deficiencies:
Frequency of citation:
48%
Examples of surveyor findings:
n Calibration: ٝ .Magnehelic pressure gauges, pH meter(s), and the filter integrity gauge are not being checked for accuracy and calibrated as specified by the manufacturer. .The ACD (Repeater Pump) is calibrated each day prior to use but is not being documented. .A hot plate was required to be set at 70 degrees, but there was no calibration mark for that temperature. ٝ .Issues specific to balances: о The balance is missing one of the leveling feet. о The calibration weights being used by the pharmacy are not certified or assessed for accuracy.
Tips for compliance:
n Storage: ٝ . Make sure policies and procedures reflect pharmacy practices and vice versa. .Materials, supplies, chemicals, or components used in compounding must not be stored on the floor. .Remove all corrugated cardboard boxes from the compounding area(s). .Label storage containers with the name, strength, lot number, expiration date, transfer date, manufacturer, and appropriate warning labels. .Regularly audit the entire inventory to remove expired and outdated chemicals, preparations, and components. о Do not rely on just the pharmacy software, do this manually. о Any product left in inventory must have sufficient time left before expiration so that the product does not limit the BUD of the finished compound. ٝ . Store hazardous medications separately from other non-hazardous items. n Cleaning and disinfection: .Document the cleaning and disinfecting agent(s) used on the cleaning logs. .Use cleaning agents per the manufacturer’s directions. .Mop heads for the HD rooms should be disposable and discarded after each cleaning. Mops handles must be made of cleanable material (e.g., handles should not be made of wood or any other porous material) and must be cleaned and disinfected before and after each use. .Appropriately clean and sanitize/disinfect reusable containers.
о The minimum weighable accurate quantity (MWAQ) for the balances is not posted, and compounding personnel were not able to verbalize the correct MWAQ for the balance. о A balance was repeatedly moved while cleaning the hood and was not releveled and recalibrated after being moved. о A balance had not been moved for an extended period of time, as evidenced by an extensive amounts of powder under the balance.
n Temperature, humidity, and pressure differential:
The temperature/humidity devices are not appropriate for pharmacy use. The pharmacy does not verify the accuracy of its temperature and humidity sensing devices in a manner that complies with NIST standards and within the last 12 months. An ISO 8 pre-sterilization area was not being monitored for pressure differentials. n Issues specific to the powder containment hood: Operating the hood with the sash in the utmost position.
n Temperature and humidity:
ٝ . Document correct actions when temperature excursions occur. .Monitor temperatures and humidity for all applicable areas of the pharmacy at least once per day on days the facility is open or via a continuous recording device.
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