Volume 2025 | No. 2
SURVEYOR
PHARMACY
DRX7-9 A Applicable services: Ambulatory Infusion, Infusion Nursing, Infusion Pharmacy without Sterile Compounding, Mail Order Pharmacy, Specialty Pharmacy with or without DME
Compliance tips for:
■ The goal of this standard is to use data to a) evaluate effectiveness, b) address gaps with action plans, and c) share information. Pay close attention to all components of the standard. Tracking data is a good start, but without trending and reporting, the information is not useful for education and prevention. ■ The organization identifies what infections will be reported using criteria appropriate to the populations served and in accordance with applicable law and regulations. ■ Review your organization’s methods for assessing effectiveness of its infection control program. Are you completing the entire process? Are logs being left blank? Is information being shared? ■ Identify gaps and simple solutions. Develop calendar reminders and checklists. Set up email distribution groups. Remember that “small” ideas can solve large problems. ■ Consider your team’s understanding of performance improvement. Explaining the value of gathering and analyzing data may assist with compliance. ■ Lead an in-service or training with examples of how infection data control data is tracked, trended, and reported. Show how identification of a problem and a subsequent action plan can reduce risk and waste. ■ Assign small tasks that add up to a whole; make PI a group project.
Nerd Newbies (understand the requirement)
Frequency of the citation: 22%
Overview of the requirement: Written policies and procedures address purchasing and onsite storage of pharmaceuticals. Comment on deficiencies: Surveyors assess compliance through direct observation, response to interviews, review of policies and procedures, and review of temperature and cleaning/disinfecting logs. Most deficiencies related to inadequate temperature and humidity monitoring in drug storage areas. Examples of ACHC Surveyor findings: Temperature and humidity: ■ The pharmacy did not have a contingency plan for situations when storage conditions fall outside of established ranges for refrigerated medications. ■ Observed drug storage room was accessible to patients in the waiting area. ■ Oral premeds are stored in a locked area within the suite, but the area is not monitored for temperature and humidity as described in USP <659>. ■ Emergency medication kits were stored in areas not monitored for temperature/humidity (e.g., cart, nursing skills lab room, IOD room, cabinet). ■ The organization is not currently monitoring freezer temperatures where they store ice packs used in transport of medications from the pharmacy to the patient. ■ When the facility is closed, it is impossible for staff to know if USP <659> requirements for drug storage have been exceeded. ٝ The ambient temperature and relative humidity (RH) monitoring system is not monitored or recorded 24/7. ٝ Facility has a NIST sensing device, but it is not electronically monitored and does not have min/ max levels for alerts when in excursion mode. ■ The organization's temperature sensing devices are not verified and calibrated in conformance to National Institute of Standards and Technology (NIST) standards. ■ Temperatures and humidity excursions are being cleared in the system without comment. Unable to discern whether excursions are reviewed by appropriate personnel, whether action was necessary, and what actions were taken.
Nerd Apprentices (audit for excellence)
Nerd Trailblazers (prepare the path for others)
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