IVQA provides three different kits to be used as part of quality assurance practices in the preparation of low-risk, medium-risk, and high-risk level compounded sterile preparations. Our test media contains Tryptic Soy Broth, which helps detect evidence of a wide variety of microorganisms, especially common aerobic and facultative anaerobic bacteria.
Revised USP Chapter 797 regulations mandate that training programs include a hands-on demonstration and practice with actual items such as CSP containers, devices and equipment. Regulations also require the caregiver practice aseptic and injection technique under the direct observation of a health professional. The caregiver is expected to demonstrate mastery of assigned activities before being allowed to administer CSP’s unsupervised by a health professional.
There are three levels of risk defined in USP Chapter 797 and three testing procedures to document each employee’s compliance.
Low Risk – All employees compounding low risk preparations must have successfully passed the low risk media-fill test procedure at least annually.
Medium Risk - All employees compounding medium risk preparations must have successfully passed the medium risk media-fill test procedure at least annually or more frequently.
High Risk – All employees compounding high risk preparations must pass the low risk media-fill test procedures annually and in addition, pass a media-fill test that represents a high-risk level every six months by each authorized person.
IVQA Media Test Kits are packaged to minimize space needs and limit foreign materials introduced into your IV preparation areas.
USP Chapter 797 is a recognized standard of care by the FDA. Although the FDA does not currently inspect for compliance, it expects compliance. If there was an incident or investigation, a pharmacy could be penalized for non-compliance. In any negligence, wrongful death or injury lawsuits, a lack of documentation of on employees, environments and procedures meeting USP 797 regulations or non-compliance would be presented as areas failing to meet accepted standards of care.
IVQA provides the media-fill test procedures that meet the USP Chapter 797 regulations. Log Sheets are included as a download to document that all appropriate personnel are trained and have successfully passed the needed media-fill test procedures is an important step in an effective quality assurance program.