New Standards PC.17.10, PC.17.20, and PC.17.30
Note: The following standards apply to organizations that store or issue tissue, which may include areas outside of the clinical laboratory, for example, surgery and outpatient centers and tissue banks. 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 non-human based), and other cellular- and tissue-based transplant or implant products.
The organization uses standardized procedures to acquire, receive, store, and issue tissues.
Elements of Performance for PC.17.10
The organization develops, maintains and follows procedures to do the following:
A 1. Assign responsibility for overseeing the tissue program throughout the organization including storage and issuance activity.
A 2. Validate that source facilities who supply tissues are licensed by state agencies, and/or registered as a tissue establishment with the Food and Drug Administration (FDA).
B 3. Coordinate tissue ordering, receipt, storage, and issuance throughout the organization.
C 4. Transport, handle, store, and use tissue according to the source facilities’ or manufacturers’ (for example, for synthetic tissue) written directions.
C 5. Log in all incoming tissue.
B 6. Maintain continuous temperature monitoring for storage refrigerators and freezers.
C 7. Maintain daily records to show that tissues were stored at the required temperatures.
Note: Main types of tissue storage used are: “ambient” room temperature (for example, freeze-dried bone), refrigerated, frozen (for example, deep freezing colder than –40°C), and liquid nitrogen.
B 8. Storage equipment has functional alarms and emergency back-up.
A 9. Comply with state and/or federal regulations when acting as a source facility that supplies tissues.
C 10. Verify at receipt that package integrity is met and transport temperature range was controlled and acceptable.
The organization’s record keeping permits the traceability of all tissues from the donor or source facility to all recipients or other final disposition.
Elements of Performance for PC.17.20
A 1. The organization’s records permit tracing of any tissue from the donor or source facility to all recipients or other final dispositions, including discarding of tissue.
C 2. The organization’s records track and identify materials used to prepare or process tissues and instructions used for preparation.
A 3. The organization’s records identify the following:
- Identity of staff involved in preparing or issuing tissue
- Identity of staff who accepts the tissue
- Dates and times of the preceding activities
A 4. The organization’s records include documentation in the recipient’s clinical record of tissue use, including documentation of the unique identifier of the tissue.
C 5. The organization’s records including storage temperatures, and all superseded procedures, manuals, and publications, are retained for a minimum of ten years, or longer if required by state and/or federal laws.
A 6. The organization’s records document the source facility, the original numeric or alphanumeric donor and lot identification, all recipients or other final dispositions of each tissue, and expiration dates, and are retained for a minimum of ten years beyond the date of distribution, transplantation, disposition or expiration of tissue (whichever is latest), or longer if required by state and/or federal laws.
B 7. The organization that receives tissue provides a system that fully complies with the completion and return of tissue usage information cards requested by source facilities.
Note: Regarding protected health information, the HIPAA Privacy Rule provides at 45 CFR §164.512: “Uses and disclosures for which consent, an authorization, or opportunity to agree or object is not required… (h) Standard: uses and disclosures for cadaveric organ, eye or tissue donation purposes.”
The organization has a defined process to investigate adverse events to tissue or donor infections.
Rationale for PC.17.30
Instances of tissue-borne infection in recipients of donor tissues are well-documented. Organisms that have been documented to be transmitted from infected donors subsequent to tissue transplant include HIV, Hepatitis B and C, and Creutzfeldt-Jakob disease (CJD). Recipients may also contract bacterial or fungal infections through contamination of tissue products during transportation, storage, or handling.
Effective communication of an adverse event directly related to tissue use is critical to patient safety. An organization may become aware of an adverse event directly related to tissue use through external notification or internal detection. Prompt investigation of each event provides response and treatment to recipients affected by the infected tissue and prevents further implantation of the infected tissue(s).
Elements of Performance for PC.17.30
B 1. Procedures are in place to investigate recipient adverse events, including disease transmission or other complication(s), suspected of being directly related to tissue use.
A 2. Cases of post-transplant infections or adverse events are promptly reported to the source facility.
A 3. Tissue reported by the source facility as the cause of possible infection or tissue involved in an event that may have contaminated the product are sequestered.
A 4. Recipients of tissue from donors who are subsequently found to have HIV, HTLV-I/II, viral hepatitis, or other infectious agents known to be transmissible by tissue, are identified and informed of infection risk.
B 5. Procedures have been followed when adverse or suspected events have occurred.