The Joint Commission Update for Infection Control
Joint Commission Q&A on safe tissue handling
Clarification in light of recent incidents
The Joint Commission has created some Q&A clarification of its standards regarding tissue handling and transplantation in light of some highly publicized incidents of inappropriate practices.
Last year, the Food and Drug Administration cracked down on one tissue handling facility after finding that the firm "had inadequately screened donors for risk factors for, or clinical evidence of, relevant communicable disease agents and diseases. … FDA regulations require that, before tissues are released for distribution, blood samples from each donor be provided to the testing laboratory for donor testing. Each sample must be clearly linked to an individual donor, and each tissue clearly linked to that donor."
With such incidents as a backdrop, The Joint Commission recently posted the following questions and answers on its web site:
Q: What is The Joint Commission looking for in adverse tissue reaction policies?
A: Policies addressing the investigation of adverse tissue reactions should define two essential processes:
1. Reporting potential disease transmission from the donor source facility to the patient;
2. Reporting adverse patient reactions to the donor source facility.
Reporting: Donor Source Facility to Patient
The Joint Commission encourages facilities to develop reporting policies comparable to the "look-back" procedures required for investigation of potential disease transmission in blood products. For example, this would include receipt of notification from the donor facility, determination of disposition, quarantine of donations in inventory from the indicated source, disposal, and notification of the recipient(s). The policy should specifically address HIV, HTLV-I/II, HBV and HCV, as well as other transmissible diseases, such as bacteria or fungus. Policies should define the timeframe for notification, the number of attempts required, and the notification procedure when the patient is deceased. References for policy development include the Centers for Medicare & Medicaid Services' "Conditions of Participation for Hospitals" [42 CFR 482.27(c)(4-8)] and the FDA's "Guidance for Industry" for blood establishments with regards to patient notification for HIV and HCV, respectively.
Reporting: Patient to Donor Source Facility
Similar to The Joint Commission requirements for suspected transfusion reactions, organizations need to develop policies and procedures for suspected tissue reactions. The process should be detailed and address criteria for identifying a suspected adverse tissue reaction, initial reporting internally, documented investigation of the complication, and prompt reporting to the donor source facility. When developing their process, organizations should keep in mind that symptoms of an adverse reaction could present as an acute or chronic condition (i.e., fever vs. hepatitis). Other examples of adverse reactions or complications could include, but are not limited to, infection (viral, bacterial, fungal), graft failure, or immune response to the tissue. Organization's can work with their donor source facilities to establish their reporting policies.
Interested organizations may wish to review the FDA regulations for current good tissue practice or participate in MedWatch, the FDA's reporting system for adverse events, product use errors and product quality problems associated with medical products.
Q: We sometimes send tissue to another healthcare organization. Does this make us a source facility?
A: Yes. The FDA would consider a routine policy or practice of shipping tissue to another facility the activity of a manufacturer, even if it is infrequent. Such facilities are required to register with the FDA within five days of beginning operations and to update their registration every December. Registered facilities must comply with those federal regulations applicable to the operations that they perform. This is a free registration, available at the following web site: http://www.fda.gov/cber/tissue/tisreg.htm.
Note: Returning unused tissue back to the source facility is not considered distribution and does not require FDA registration. Also, FDA registration would not be required in the rare and well documented urgent situation. However, such urgent situations should be the exception to the rule. If there is a routine pattern of distribution, the FDA would require registration.
Q: What are we required to do when receiving tissue?
A: Upon receipt of tissue, the organization should verify and document that the recommended temperatures and the integrity of the individual tissue packaging have been maintained during transport. Many distributors use validated shipping containers that have been tested to maintain the recommended temperature for a specified period of time. Often, the distributor can provide documentation for the organization to have on file regarding the specifications. When the tissue arrives through the routine shipping process, the receiver may then check that the shipping container was received undamaged and within the validated timeframe. Other checks could include noting the presence of any remaining regular or dry ice, taking the temperature within the box (in the center of the products) upon opening, or use of a commercial shipping temperature indicator.
Q: What is The Joint Commission looking for in regards to verification of registration and licensing of tissue suppliers?
A: The source facility should be registered with the FDA and licensed by the state, if the state in which the implanting organization resides requires licensure.
Annual registration is required by the FDA each December for all tissue suppliers who recover, screen, test, process, label, package, or distribute tissues. Suppliers are expected to be compliant with the FDA regulations that apply to their operations. Health care organizations that only receive and store tissues for implantation
or transplantation within their facility are not required to be registered with the FDA.
Licensing is state-dependent. As of March 2007, five states require licensing, which include New York, Florida, California, Georgia, and Maryland.
The Joint Commission standards can be met by requesting from the source facility copies of their current state license (when applicable) and FDA registration and keeping them on file. For FDA registration, the supplier's registration status also may be checked annually by using the FDA's online database.
Q: How do we determine if our record keeping permits traceability of implanted tissue?
A: The organization will need to be able to trace the chain of events or "audit trail" related to implanted tissue for both reporting and investigational purposes. Records should permit bidirectional tracing of any tissue in order to:
1. report potential disease transmission to the recipient when notified by the donor source facility;
2. report adverse patient reactions to the donor source facility;
3. investigate the chain of events, e.g. who handled the tissue, how it was transported, stored and processed, dates and times of such activities.
An organization could become aware of the potential for an adverse event from either the donor facility or the recipient. For example, the donor facility may notify the organization of a suspected infectious disease associated with a particular tissue source. The organization would need to promptly identify and notify all recipients and quarantine any implicated tissue not yet implanted. Alternatively, the patient's physician might notify the infection control nurse of a post-op infection associated with the tissue implant. Procedures and records should allow the organization to determine the tissue's unique identifier and enable reporting of the event to the source facility. In addition, records should facilitate an investigation to determine if the post-op infection could be related to the organization's storage or handling processes, e.g., use of sterile reconstitution supplies, OR procedures, storage temperatures, expiration dates, etc.
Q: What is considered tissue under the Tissue Storage and Issuance standards?
A: The Tissue Storage and Issuance standards apply to human and nonhuman cellular-based implantable and transplantable products. Examples of tissue specimens that might be found in an organization include, bone, cornea, skin, heart valves/conduits, tendons, fascia, dura, bone marrow, veins, arteries, cartilage, sperm, embryos, eggs, stem cells, cord blood, synthetic tissue (artificially prepared, human and nonhuman cellular based products), and other cellular and tissue based transplant or implant products.
Collagen or certain synthetic tissues, such as those derived from plastics and polymers, are not considered cellular based products and are not evaluated under the Tissue Storage and Issuance standards.
For autologous tissue, the standards and accompanying elements of performance apply to the extent that they are relevant. Also, if your state classifies something as a tissue that is beyond what The Joint Commission defines as tissue, the standards and accompanying elements of performance would apply to the organizations of that particular state.