At Lompoc Valley Medical Center Pharmacy Services, the quality of the product we deliver to our patients is a top priority. We are committed to ensuring that all intravenous (IV) medications meet or exceed federal and state standards as well as national safety recommendations.
The scientific non-profit organization is known as United States Pharmacopeia and National Formulary (USP-NF) developed a chapter called USP 797 that establishes a standard of practice for pharmacies to mix intravenous compounds. USP 797 applies to everyone involved in what is known as “sterile compounding,” including pharmacists, physicians, nurses, and pharmacy technicians. This standard of practice is what LVMC Pharmacy Services strictly adheres to with specialized training of its staff by experts in the field, including a member of the committee that helped develop the USP 797 guidelines.
Extensive training for staff members begins during the initial employee orientation and continues throughout their employment with LVMC. Employees involved in this type of work must first complete a written module and test. They’ll also be assessed on the correct use of sterile gloves, in a process known as the “gloved fingertip test.”
After washing their hands, putting on medical gowns and putting on sterile gloves, the staff member touches their gloved fingertips to a sterile petri-dish. This dish is tested for microbial growth. If there is any growth on the dish – a sign of improper sterile technique – the trainee is retrained and the test redone. The trainee cannot continue to the next level until they master sterile technique.
Once approved by their supervisor, the staff member will learn proper manipulation of IV products before starting the compounding process. After this training is complete, they must pass a second hands-on technique test. This time, the trainee will simulate making multiple IV products. Monitoring the products of their hands-on test continues for 14 days to test for bacterial or fungal contamination.
The Pharmacy Technician trainee cannot move onto training for intravenous compounding until passing those tests. The next level continues under the direct supervision of an experienced pharmacy technician.
The experienced technician will sign off on the trainee’s ability to safely compound IV pharmaceutical products. Every member of the IV compounding team must complete and pass these competency tests annually. Thorough training and annual assessment of our pharmacy staff assure a high level of safety of our pharmaceuticals at Lompoc Valley Medical Center.
Ensuring safety in the pharmacy is not just centered on the person processing the compounding – it is also about the setting for the work. The specialized rooms where we make IV products must go through a thorough preparation and cleaning process each day before any medications are prepared. Twice daily, pharmacy technicians use antibacterial and antiviral products to clean the compounding “hood,” the area that sends sterile HEPA-filtered air over the preparation area. Specially trained Environmental Services staff also perform a “terminal clean” of the entire room on a daily basis. This intense and thorough process disinfects and sterilizes all surfaces.
Specific air standards are met as well. The air is HEPA-filtered, but the air filters must turn over the air in the room a minimum of 30 times per hour. In addition, the room is under positive pressure – meaning air is “pushed out” from the sterile compounding room into the anteroom (the buffer room between the compounding room and the main pharmacy) and then out from anteroom into the main pharmacy. This ensures that only the filtered air stays in the compounding room. When the compounding door is open, clean air always flows out; “dirty” air never flows into the room.
Specialized gauges outside each room monitor air pressure continuously. Every six months, an outside testing company further verifies the pressure. Third party testing for bacterial and fungal growth on the room air and surfaces also occurs every six months. Actions based on specific guidelines from USP 797 are taken if growth is discovered.
Once that the room is prepared for use, the highly trained pharmacy technician can begin preparing medications. In the anteroom, the technician dons booties, hair cover, gown, mask and washes and dries their hands, all before putting on sterile gloves and entering the sterile room. A tracking system logs each IV they make, including the name, amount, lot number, manufacturer and expiration date of the products.
During each step of the preparation process, the technician will take electronic pictures of what they have done. These pictures, which are saved and used for tracking, audits and survey inspections, are transmitted to the pharmacist who is monitoring the entire compounding process from the main pharmacy room. The pharmacist verifies that each step of the IV medication preparation is correct. Medications that pass the pharmacist’s inspection are sent to the floor for administration to a patient. Medications that do not pass that inspection are destroyed and the process is started again.
Once the IV is on the hospital unit, the nurse does a final check before administering the medication to the patient, including bar code scanning of both the patient and the product. This is the final safety measure to make sure the IV is the right product at the right time for the right patient.
The quality assurance does not end when the product leaves the pharmacy. In addition to all this training, preparation, monitoring and verification work, medications are sampled randomly to ensure that they are sterile and are of the correct concentration. This adds just one more level of certainty that Lompoc Valley Medical Center Pharmacy Services staff is producing a safe, quality product.