Creating a Tissue Management Process Designed and Automated for Efficient and Safe Patient Care

Tissue tracking management, although required for regulatory compliance, is more importantly about having “effective control” of the process. In today’s highly regulated, highly litigious and expensive healthcare environment, it is imperative that hospitals have effective control of their tissue tracking process. One way to assess your organization’s extent of effective control is to consider how quickly your hospital could respond to a product recall/adverse event. Establishing a streamlined and automated Tissue Management process promotes the efficient delivery of quality patient care as well as timely access to critical data elements. Keep in mind, “automating” the process does not occur simply by implementing perioperative tissue tracking software, rather it requires an understanding of your overall organization’s workflow –all the touch points and areas that the tissue passes through and/or is utilized in.

Where to begin the automation process. Start with a focused review of the current state. Based on the thorough review, you will be able to establish a plan for optimal automation and have a clear understanding of the benefits that can be achieved through automation.

1. Review Current State

Perform a current state assessment that includes a review of:

  • Workflow -chain of custody from arrival at facility to implantation
  • Bidirectional recall capabilities
  • Record keeping completeness, including policies and procedures
  • Electronic software systems capabilities

Assessment Recommendations:

Map the chain of custody process from arrival at facility to implantation. Pay close attention to the common trouble spots (roadblocks) identified in Figure 1.

Tissue Management Figure 1


Evaluate the “paper trail” from donor/tissue supplier to recipient and from recipient back to donor/tissue supplier (“bidirectional tracing”). Disparate processes and lack of automation can result in data gaps that affect timely identification during product recall and adverse events. Furthermore, The Joint Commission requires hospitals to retain records that demonstrate the completeness of bidirectional tracing.

Evaluate the:

  • Length of time to obtain this information.
  • Number of disparate processes/systems storing this information.
  • Accuracy of information: patient, implant and location of product still on the shelf.

Ensure appropriate documentation exists and is maintained for 10 years. Required documentation includes:

  • FDA registrations and certificates for all tissue suppliers
  • Policies and procedures for acquisition, receipt, storage and issuance of tissues
  • Manufacturer’s written instructions for transporting, handling, storing and using tissu
  • Daily records of storage temperatures
  • Process to return tissue usage information cards to supplier
  • Written procedure for investigation of tissue adverse events

Before considering an investment in a new electronic system, assess the hospital’s existing related software system capabilities:

  • Ask your perioperative software vendor how they ensure a regulatory compliant system.
  • Enlist the support of perioperative IT industry experts to assess your system and identify optimization opportunities.
  • Review current system functionality with IT system analyst for evaluation of full potential; look for integration or interface capability between software systems.
  • Evaluate customization capabilities to add compliance components to the documentation.
  • Investigate intranet capabilities to upload manufacturer instructions, policies and procedures to a common drive for easy access.
  • Evaluate the Blood Bank software for tissue tracking capabilities; this system may be an option for tracking the tissue stored in the operating room as well as provide the integration with the clinical documentation to complete the tracking process.
  • Research whether your current automated supply cabinet vendor has a tissue tracking module.
  • Consider add-on software tissue tracking systems that integrate with your existing surgery software system.
  • Review the process for logging purchase order receipts for the potential to capture documentation of the person receiving the tissue and the package integrity.

2. Revise/Refine Process for Optimal Safety and Compliance

Establish a task team, including key stakeholders and staff champions, to revise the process for optimal patient safety and regulatory compliance.

Develop strategies to close the gaps identified during the assessment:

  • Limit the entry points for tissue delivery for easier process standardization.
  • Establish a process for tissue delivery outside of regular business hours.
  • Limit the chain of custody transfer points from entry into facility to storage and verify documentation at each change of custody.
  • Establish storage locations in close proximity to the operating room for easy retrieval and return during operative procedures.
  • Refrain from storing the same tissue products in multiple locations which can result in lost revenue due to duplicate ordering, overstock-expired items.
  • Work with the IT team to implement automation processes identified during the Software System Evaluation.
  • Utilize an automated stock management system that allows both purchasing and operating room staff to see item availability-first to expire and storage location.
  • Standardize the process-Identify additional areas within the organization using tissue products (i.e. Wound Clinic, Fetal Medicine) and confirm that processes and procedures are standardized.

3. Realize Benefits

Benefits achieved through automation include:

  • Standardized processes across the system
  • Legible records with electronic backup processes
  • Quick search capabilities during recalls
  • Improved inventory management, cost savings
  • Integration with clinical documentation systems
  • Dynamic reporting capabilities

Performing the analysis and due diligence and removing “stumbling blocks” to establish a streamlined automated tissue tracking process enhances patient safety, provides timely access to critical data elements and improves regulatory compliance.

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