Ensuring that transplantable tissues are safely managed is critical for patient safety. This includes maintaining acceptable storage conditions, that there is bi-directional tracing of both tissues and products used in the preparation (such as diluents) in case of recall, and complete documentation to support both processes. A review of organizations’ transplant safety practices has revealed several opportunities that should be used to evaluate your program. Specifically, organizations should:
- Evaluate that your thermometers and refrigerators/freezers are maintained per the manufacturer’s instructions for use. This would include any calibration requirements.
- Evaluate your current practice for monitoring temperatures of tissue storage. Are there gaps in measures? Are excursions of temperatures from acceptable ranges addressed and documented?
- Review your tissue logs to determine if documentation is complete with all required information, including identification of diluents (and lot numbers) in the event of a recall. Are all documentation elements present to support the bi-directional tracing of tissue/diluent to the patient?
- Are any required certifications and licenses current and on file for tissue suppliers?
Leaders should periodically review transplant safety audits to ensure that there is adequate oversight to identify any potential gaps in practice.
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Courtemanche & Associates specializes in Healthcare Accreditation and Regulatory Compliance Consulting Services. With over 30 years of being in business and 100+ years of healthcare experience amongst our consulting team, we are ready to assist with your accreditation and regulatory compliance needs.
