Quality Assurance

At Healix®, we are committed to quality, patient safety, clinical performance, order accuracy, and precise compounding. Our dedicated Quality Control (QC) Unit ensures that rigorous standards are adhered to for the environment, personnel and the products.  A stringent Continuous Quality Improvement (CQI) program establishes the framework to consistently provide the highest level of products and services.

Environment

In order to ensure a clean environment and high quality, sterile preparations, we regularly conduct environmental monitoring of all compounded areas.  Dedicated QC staff performs all the environmental testing and analysis.  The environmental testing involves surface sampling and air sampling of the facility for both bacteria and fungi on an ongoing basis.  Data is carefully recorded, trended, and analyzed with an accredited microbiology laboratory utilized if needed. 

Personnel

All compounding personnel are assessed frequently by QC staff with fingertip glove testing in addition to skills evaluations.  Healix fingertip gloving standards exceed industry standards and any personnel not meeting requirements at any time are re-trained and re-assessed prior to resuming compounding.  All pharmacist clinical evaluations and documentation are audited on a monthly basis, which is then reported and assessed quarterly through the formal CQI process.  All areas must meet required compliance levels or undergo further evaluation. If required, corrective action with root cause analysis and quality improvement measures are conducted until compliance is achieved.  

Products

Strict clinical and compounding oversight, extensive industry experience, and stringent compliance measures ensure reliable and accurate preparations that are potent, sterile, and stable.  With every order, a Healix clinical pharmacist evaluates patient- and drug-specific details, including drug dose and frequency, drug interactions, and laboratory data.  The order goes through a multiple check system with a minimum of four individuals including at least two pharmacists to verify the order. This check system verifies the order contains the correct drug, dose, frequency, and use for the right patient and location.

All products are prepared with rigorous standards with the use of compounding formulas and worksheets to ensure compounding consistency.  Products are compounded using sterile-to-sterile components with end-product sterility testing performed during every shift.  Additionally, preparations are frequently selected by the QC staff and assayed by an external laboratory for potency and sterility.  All medications are shipped with packaging that incorporates insulation, temperature monitoring devices, and may also include protection from light to ensure product stability.