Human Tissue Intended for Transplantation Skin, corneas, sclera, bone, heart valves, blood vessels, pericardium, tendons, cartilage, fascia

Transcription

1 TITLE / DESCRIPTION: DEPARTMENT: Human Tissue Intended for Transplantation Skin, corneas, sclera, bone, heart valves, blood vessels, pericardium, tendons, cartilage, fascia Surgical Services PERSONNEL: RNs, Scrub Technicians, Inventory data personnel EFFECTIVE DATE: August 2005 REVISED: August 2009, March 2012 I. Definition: Accrediting Agencies: Voluntary agencies which certify a minimum level of quality in the process followed by tissue banks/distributors to obtain, process, and store human tissue for transplantation purposes. The requirements of these agencies include assuring that banks meet all pertinent requirements of the Food and Drug Administration regulation. The major agencies utilized by tissue banks are The Eye Bank Association of America (EBAA) and the American Association of Tissue Banks (AATB) Donor screening: Documented evidence that the human tissue donor is free from risk factors for and clinical evidence of hepatitis B, hepatitis C, or HIV infection, etc. Human tissue: Human tissue includes bone, eye, and portions of eye, skin, tendon, fascia, cartilage, dura, heart valves and other tissues intended for transplantation into a patient. This policy specifically does not address tissue implants related to fertility, human milk or bone marrow or vascularized human organs obtained for transplantation. Infectious Disease Testing: Required infectious diseases testing includes, but is not limited to (FDA licensed screening tests): Human immunodeficiency virus, Type 1 (anti-hiv-1); Human immunodeficiency virus, Type 2 (anti-hiv-2); Hepatitis B (HbsAg); Hepatitis C (anti-hcv). II. Policy: The hospital uses standardized procedures to acquire, receive, store, and issue tissues. The responsibility for oversight of the Tissue storage and issuance will be the responsibility of the Director of Surgery. Receipt Of tissue:

2 All tissue both freeze dried and frozen will be logged into the appropriate log book with the following information entered: 1. 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). Validation records of licensed and registration with the FDA shall be provided by each facility that Springhill Memorial Hospital purchases Tissue from. These records will be provided to the Inventory Data personnel who will keep them on file in the Surgical Services inventory office for ten years after the last receipt date. 2. Coordinate Tissue ordering, receipt, storage, and issuance throughout the hospital. Tissue orders will be ordered by the purchasing department of the Hospital. Physician offices that order Tissue. when the Tissue arrives at the hospital it will be checked in with the inventory data personnel and all the Receipt procedure above shall be followed: Storage of tissue will only occurred in the Surgery Department..Ordering: Tissue orders will be placed by the inventory department of the surgery department through the SIS ordering system. When necessary the orders may be placed by phone from the surgery department to the source facility. Orders placed by the physicians office to the vendor. The Vendor must be FDA approved and that license on file with Springhill Memorial Hospital surgery department. Receipt: The tissue will be received into the department by the purchasing department in the proper storage container. The container will be brought promptly to the inventory department of surgery, where the date time and temperature (if necessary) will be logged. The tissue will be taken to the storage site (behind OR10). The integrity of the package is inspected for any outside damage and that the dry ice is still contained in

3 the box. The tissue is then logged into the appropriate logbook with the date, time and unique identifier number. A tissue log shall be maintained with the frozen bone in the orthopedic storage room(behind OR 10) the log will require: Transport, handle, store, and use tissue according to the source facilities or manufacturers (for example, for synthetic tissue) written directions. Log in all incoming tissue. Verify at receipt that package integrity is met and transport temperature range was controlled and acceptable 3. Maintain continuous temperature monitoring for storage refrigerators and freezers. The bone freezer (-40) is plugged into emergency power at all times and has functional alarms and emergency back-up. The temperature monitor is checked daily by one of the surgical personnel The temperature log is changed weekly by the week-end nurse. The temperature log is maintained for 10 years. Ambient freeze dried bone is monitored daily by a wall thermometer and recorded by the inventory data clerk The hospital s record keeping permit the traceability of all tissues from the donor or source facility to all recipients or other final dispositions. 1. The hospital s records permit tracing of any tissue from the donor or source facility to all recipients or other final dispositions, including discarding of tissue 2. The hospital s records track and identify materials used to prepare or process tissues and instructions used for preparation. 3. The hospital s records identify the following: Identity of staff involved in preparing or issuing tissue Identity of staff who accepts the tissues

4 Dates and times of the preceding activities 4. The hospital s records include documentation in the recipient s clinical record of tissue use, including documentation of the unique identifier of the tissue. 5. The hospital 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. 6. The hospital 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 distributaries, transplantation, disposition, or expiration of tissue (whichever is latest), or longer if required by state and/or federal laws. 7. The hospital that receives tissue provides a system that fully complies with the completion and return of tissue usage information cards requested by source facilities. The hospital has a defined process to investigate adverse events to tissue or donor infections Instance of tissue-born 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 thought 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. A hospital 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). III. Procedure: Human tissue for transplantation may only be obtained from tissue banks/distributors with a current contract/agreement. All contracts or agreements between Springhill Medical Center and tissue banks/distributors must include an acknowledgement on the part of tissue bank distributor that it meets all FDA regulatory requirements. 1. Donor screening and infectious disease testing 2. Determination of donor suitability for human tissue intended for transplantation 3. Record keeping and procedures 4. The inspection of tissue establishment Tissue banks/distributors must meet the standard of one of the accrediting agencies associated with the specified human tissue required for transplantation purposes, such as the American Association of Tissue Banks (AATB) or Eye Banks Association of America (EBAA).

5 Required procedures for processing human tissue for transplantation must be in place at each site to meet the standards from the Joint Commission on Accreditation of Healthcare Organization (TJC). 1. Director of Surgical Services responsibility for oversight if the tissue program, including ordering, receipt, storage and issuance of tissue; 2. Use only approved source facilities. Source facilities who supply the tissue must be licensed by State agencies and/or registered as a tissue establishment with the FDA. 3. Transport, handle, store, and use tissue according to the hospital and manufacturers written directions. a. Ensure tracking and documentation of all incoming tissues, continuous temperature monitoring for storage refrigerators/freezers, functionality or storage alarms/backup; discarded grafts (date and reason discarded [i.e.: contaminated, expired, etc.]) b. Identify materials or agents used to prepare graft for implantation; c. Maintain written instructions used for preparation of the tissue d. Identify staff preparing/issuing tissue e. All records related to tissue, must be kept a minimum of 10 years past the date of expiration or implantation. f. Records related to storage and ambient temperatures must be kept a minimum of 10 years. 4. Verify at receipt that package integrity and transport temperature range was controlled and acceptable. 5. Documentation in the Patient s medical records must include the a. Lot number b. Staff accepting tissue c. Dates/times of procedure 6. To investigate any adverse effects of tissue transplantation. 7. The Director of Infection Prevention and Control will be notified immediately to investigate any adverse effects of tissue transplantation. Administration, the patient s physician, and the patient will be notified by the physician of any exposure of diseases transmission or other complications that are suspected of being directly related to the use of tissue. Any tissue related to the recall will be sequestered and reported to the tissue supplier, Director of Surgical Services, and Director of Purchasing.