Manage sterile compounding rooms build-out or renovation projects.

Validate primary engineering control (PEC), compounding equipment, facilities, and utilities.

Design and process assessments to streamline and optimize compounding workflow tailored to site specifics.

Conduct a certification inspection readiness audit.

Create a complete set of customized policies and SOPs for the compounding process and other support activities.

Review, update, and maintain existing policies to meet the changing regulatory requirements.

Create and maintain master formulation records.

Review and provide guidance with labeling requirements.

Establish beyond-use dates in consideration of site-specific parameters.

Review and create policies for handling hazardous drugs (HDs) according to required quality standards pertaining to receipt, storage, compounding, dispensing, administration, and disposal.

Create and maintain a facility-specific list of formulary drugs classified as hazardous by NIOSH.

Conduct a risk assessment for hazardous drug handling and compounding tailored to site specifics.

Handle complaints and reported errors by investigating potential quality problems and implementing corrective actions if necessary.

Track scheduled certifications. 

Evaluate certification reports.

Plan and implement corrective action plans in response to out-of-range certification results.

Collect data in response to corrective actions.

Evaluate certification reports collected over a period of time to identify trends.

Maintain certification and corrective action reports.

Track and maintain environmental temperature and pressure monitoring records.

Track and maintain Equipment records (e.g., calibration, verification, and maintenance reports)

Generate reports on testing result trends.

Review and update ongoing training programs for personnel who perform cleaning and disinfecting duties outside of the primary engineering control (PEC).

Evaluate and update cleaning and disinfecting procedures, agents and supplies.

Create and maintain cleaning and disinfecting records.

Report cleaning and disinfecting documentation deficiencies.

Conduct gap analyses to assess compliance with the applicable regulations and accreditation requirements. 

Conduct an accreditation inspection readiness mock survey and provide a review of the findings report.

On-line access to compliance reports organized for easy access when needed. 

Generate compliance reports when requested during accreditation inspections.

Develop corrective action plans based on identified deficiencies. 

Create personnel training programs.

Review and update existing personnel training programs.

Track personnel knowledge and competency of core skills documentation.

Report personnel knowledge and competency of core skills deficiencies.

Maintain personnel knowledge and competency of core skills reports.

Develop and document corrective actions in the event of personnel knowledge and competency of core skills failure.

Track personnel garbing and hand hygiene competency documentation.

Report personnel garbing and hand hygiene competency deficiencies.

Maintain personnel garbing and hand hygiene competency reports.

Develop and document corrective actions in the event of personnel garbing and hand hygiene competency failure.

Track personnel testing in aseptic manipulation competency documentation.

Report personnel testing in aseptic manipulation competency deficiencies.

Maintain personnel testing in aseptic manipulation competency reports.

Develop and document corrective actions in the event of aseptic manipulation competency failure.

Send notifications of over-due competencies and failed measurements.

Document and track personnel Hazardous Drug Risk Acknowledgement.

Develop immediate-use compounded sterile preparations competency training modules.

Generate reports of compliance trends.