Gain Administration Buy-In For USP <800> Compliance
Utilizing a closed system drug-transfer device (CSTD) when compounding and administering hazardous drugs (HDs) is critical to ensure safety and compliance with USP General Chapter <800> Hazardous Drugs—Handling in Healthcare Settings, which recommends CSTD use during HD preparation and requires it during HD administration. With the enforcement date of December 1, 2019 for USP <800> compliance less than a year away, implementing CSTDs now is essential.
At the University of New Mexico Hospital in Albuquerque (UNMH), we are fortunate that administration is keenly aware of the approaching USP <800> compliance date, and supports pharmacy initiatives to ensure safety and regulatory compliance, including CSTD use for both HD compounding and administration. In fact, hospital administration relies on pharmacy for guidance on how the organization can ensure compliance with the chapter. UNMH also holds monthly oncology task force meetings to keep all stakeholders up-to-date on compliance concerns and to disseminate necessary information. Members of this team include pharmacy and nursing representatives from these areas.
If an organization’s administration does not have a clear understanding of the importance of USP <800> compliance, pharmacy should assume responsibility for educating hospital administration and staff regarding the requirements and timeline to enforcement, as well as the possible repercussions for noncompliance.
Determine the Organization’s Essential Requirements for Choosing a CSTD
Our hospital’s primary consideration when choosing a CSTD was to identify a device that unequivocally prevents staff exposure to HDs by averting any leakage. Ease of use was another significant consideration—for example, we were cognizant of products that included audible clicking sounds to alert the user when the device was correctly attached. As with any other substantial investment, cost was also a factor in our evaluation.
An additional qualification was ensuring the vendor we chose would provide superb, on-site CSTD training for end users, as well as ongoing customer service. Involving those frontline pharmacy and nursing staff members who use CSTDs in the vendor evaluation process was crucial to ensuring staff buy-in and comfort with our choice of device.
Trial CSTDs In-House
Conducting in-house CSTD trials was critical to choosing the most appropriate device for our organization. After UNMH made the decision to reevaluate the CSTD we had been using, we developed a robust request for proposal (RFP), to which five manufacturers responded. The vendors visited the hospital and presented their devices to pharmacy and nursing staff, whereupon we graded the CSTDs based on safety, ease of use, and cost. Next, we performed a leak test on each device, based on a study performed at the University of North Carolina (“Application of Vapor Containment Protocol for Closed System Transfer Devices to Assess Efficacy During Pharmacy Compounding and Administration of Hazardous Drugs”1), which utilized the National Institute for Occupational Safety and Health (NIOSH) proposed protocol to compare the CSTDs’ ability to contain vapors.2
Based on the results of the leak test, two devices that met our criteria were identified to trial: our current CSTD and another vendor’s device. Each CSTD was trialed for 1 month, during which time pharmacy and nursing prepared and administered all HDs using that CSTD. Prior to each trial, the vendors spent 1 week at the hospital providing staff with thorough training on correct use. Once the trials were complete, we conducted a survey of pharmacy and nursing end-users to grade the two devices on safety, quality, price, and ease of use. Ultimately, we decided to switch from the CSTD we originally used to a new CSTD for both pharmacy compounding and nursing administration.
Conduct Wipe Testing to Validate the Efficacy of CSTDs
Wipe analysis is an excellent tool for identifying areas containing HD residue; this data can be trended over time to help determine how well a CSTD is preventing exposure to HDs. Because UNMH sought to verify the effectiveness of our new CSTD, our RFP included the requirement that the CSTD vendors conduct wipe studies at their own expense. A vendor that is willing to conduct such wipe sampling clearly stands behind the efficacy of their device. Our new CSTD vendor conducts wipe studies every 6 months.
Involve Nursing in the CSTD Evaluation
To successfully implement a CSTD or switch from one device to another, involve the frontline staff who will actually use the device. In conjunction with pharmacy staff, our nurses were involved throughout the CSTD evaluation and selection process, including writing the RFP, viewing each vendor’s CSTD presentation, trialing the devices, rating each CSTD via survey, and implementing the chosen device. It is important to note that end users are much more likely to consistently use a device when they have had a voice in the selection process.
Develop a Positive Relationship with the CSTD Vendor
The value of choosing a CSTD vendor that provides stellar customer service cannot be overstated. The vendor chosen by UNMH is engaged in ensuring our success with the device, and visits our hospital to work with pharmacy, nursing, and our leadership team on a quarterly basis. They focus on methods of improving practice to increase efficiency and ensure safe CSTD use. In addition, recognizing that pharmacy budgets are always under close scrutiny, the vendor has been helpful in creating ways to control costs. For example, they introduced a pre-capped line adaptor and made recommendations for reducing the number of syringe sizes we stock based on drug usage.
Moreover, the training that we received from the vendor throughout the month-long CSTD trial and thereafter was phenomenal. If we have an issue with a specific device, the vendor sends us a mailer to return the device so they can evaluate the problem. Overall, staff is extremely satisfied with our choice of CSTD, and we hope to enjoy a positive relationship with our vendor moving forward.
Christopher Gallegos, MBA, CPhT, is the manager of business operations for the University of New Mexico Hospital (UNMH) in Albuquerque. He is a 2019 Doctoral Candidate in Health Care Administration. Christopher began working at UNMH in 2012 as a project manager and was promoted to manager of business operations in 2016.
- Forshay CM, Streeter SO, Salch SA, et al. Application of Vapor Containment Protocol for Closed System Transfer Devices to Assess Efficacy During Pharmacy Compounding and Administration of Hazardous Drugs. Poster presented at the American Society of Health-System Pharmacists Midyear Meeting; Las Vegas, Nevada: December 4-8, 2016.
- Hirst D, Mead K. A Vapor Containment Protocol for Closed System Transfer Devices Used During Pharmacy Compounding and Administration of Hazardous Drugs (draft). National Institute for Occupational Safety and Health, August 2015. www.cdc.gov/niosh/docket/review/docket288/pdfs/a-vapor-containment-performance-protocol-for-closed-system-transfer-devices.pdf. Accessed November 8, 2018.
Part 1 of a 2-Part Series: Elements of a USP <800> Compliant Cleaning Program
Conduct a Drug Diversion Investigation
Special PP&P Buyer's Guide: Temperature Monitoring
Develop a Pneumococcal Vaccination Program
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