Volume 2025 | No. 2
SURVEYOR
PHARMACY
Compliance tips for:
■ Staff were observed making an elastomeric differently than directed by the compound record. In this instance, the preparation was made correctly, but the directions on the record were incorrect. No documentation was made to note that the product was made differently from the record. ■ The requirement that only those medications, supplies, and equipment necessary for the current preparation are introduced into the controlled air environments was not adhered to. Two portable speakers were noted in the clean room, and a technician’s cell phone was visible in his pocket. ■ Multiple compounds were being prepared under the hood at the same time. ■ Matching lot numbers and expiration dates on the compounding records prior to sending it in to be compounded is not being performed. ■ Procedures for cleaning and sanitizing the compounding areas and equipment prior to compounding were not being followed. Compliance tips for:
■ Conditions for storage of pharmacy materials must be defined, monitored, and immediately corrected when a variance is out of range. ■ Regular inspections are used to identify, quarantine, and dispose of expired or recalled pharmaceuticals or components. ■ Methods for cleaning and disinfecting reusable containers are defined and documented. ■ At least quarterly, perform facility audits to ensure all pharmaceutical storage areas are monitored appropriately with thermometers that have been NIST calibrated, have appropriate min/max alarms, and that temperature excursions are addressed and documented. ■ Conduct physical monthly audits of pharmacy inventory to ensure all expired products are removed. Do not rely only on products identified from a computer generated inventory report. ■ Educate personnel on the proper storage temperatures according to USP <659> and appropriate responses and documenting of temperature excursions. ■ Educate personnel involved in the compounding process on proper cleaning and disinfecting procedures and the documentation of these activities. ■ Develop a system for identifying pharmaceuticals that will expire within 1 month, 2 months, and 3 months.
Nerd Newbies (understand the requirement)
Nerd Apprentices (audit for excellence) continued
■ Proper procedure for compounding includes but is not limited to: ٝ Personal hygiene, gowning, and gloving. ٝ Use of asceptic techniques to avoid cross contamination. ٝ Checks and rechecks at each stage of the process,
Nerd Newbies (understand the requirement)
Nerd Trailblazers (prepare the path for others)
ٝ Documentation of any deviation in procedure from that described in written compounding records.
■ Thorough cleaning and disinfecting of the compounding area and equipment, prior to and after use.
■ Audit the compounding process for compliance with: ٝ Hand hygiene, garbing, and gloving.
Nerd Apprentices (audit for excellence)
DRX7-8N Frequency of the citation: 23%
ٝ Bringing only the items necessary for the compounding process into the clean room. ٝ Aseptic technique, only compounding one preparation in the PEC at a time, not blocking first-air.
Overview of the requirement: Processes and techniques for compounding sterile preparations are documented in written policies and procedures. Personnel know and follow the policies and procedures. Comment on deficiencies: Surveyors review policy and procedure documents and observe compounding to assess compliance. In a few cases, policies had not been updated to reflect current USP <797> requirements however, most deficiencies were observed lapses in technique. Hand hygiene, gloving, and placement of materials and the technician’s body that blocked first air were the predominant observations. Examples of ACHC Surveyor findings: ■ The compounding technician was observed using improper technique for hand hygiene, garbing, and gloving. The individual was also observed blocking first air, both in how vials were placed and in hand placement when drawing reconstituted antibiotics from a large vial.
ٝ Cleaning and disinfecting procedures. ٝ Compounding record documentation.
■ Develop an audit tool to be used for observing compounding activities. ■ Use the compounding audit tool to educate compounding personnel on deficient findings and appropriate corrective actions.
Nerd Trailblazers (prepare the path for others)
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