A CCRE DI TA TI ON STANDARD S
Patient Safety
BONE, BONE PRODUCTS,
CELLS AND TISSUES
Appropriate bone products, cells and tissues are provided
INDICATORS:
 Written policy and procedures for the selection, procurement, receipt, storage,
maintenance and recall of bone, bone products, cells and tissues are in place
 Procedures that would require the replacement of blood are not performed
 A patient specific order is written for the bone products, cells or tissues
Bone products, cells and tissues are appropriately procured and received
INDICATORS:
 Bone products, cells and tissues are procured from an establishment registered with Health
Canada
 Bone products, cells and tissues are received from the providing establishment in a
validated container or evidence that acceptable conditions were in compliance is
documented (e.g. appropriate temperature and environment monitoring devices)
 Receiving staff are appropriately trained in the transportation of dangerous goods, as
appropriate (e.g. products received packaged on dry ice)
 Transportation containers are inspected for abnormal appearance or evidence of tampering
(e.g. broken tamper seal)
 Bone products, cells and tissues are kept in the shipping container until use
 Documentation of receipt of products, cells and tissues includes but is not limited to a
shipping form and packing slip containing:
•
name and identification of the bone products, cells and tissues
•
name and address of the establishment of origin of the bone products, cells and
tissues
•
unique donor identification number
•
retrieval and/or expiration dates
BONE, BONE PRODUCTS, CELLS AND TISSUES
•
•
ACCREDITATION STANDARDS
Patient Safety
date of receipt
name and signature of the personnel placing the products into inventory
 Every bone product, cell or tissue is recorded in a log and when transplanted, has an
associated recipient file
Bone products, cells and tissues are safely and appropriately stored
INDICATORS:
 Bone products, cells and tissues are stored and handled as per the label and/or insert
storage and handling instructions
 Bone products, cells and tissues are kept in the shipping container until use
 Bone products, cells and tissues are stored in a restricted access area
 Storage temperature data is checked and recorded daily
Bone products, cells and tissues are safely and appropriately transplanted
INDICATORS:
 Patients are informed that the procedure involves bone products, cells or tissues
 Informed consent is obtained and verified
 The patient’s identity is unequivocally verified
 The bone products, cells or tissues for transplantation are unequivocally verified
 A copy of any distributor/tissue bank “Tissue Recipient Form” is filed in the facility health
care record
 The patient is provided with information regarding the transplanted product including but
not limited to the name and identification of the bone product, cells or tissues
The final disposition of all bone products, cells and tissues is accounted for
INDICATORS:
 Written policy and procedures to ensure indefinite tracing of all bone products, cells and
tissues are in place
 All bone products, cells and tissues are accounted for
 The final disposition of all bone products, cells and tissues is recorded and reported to the
distributor/tissue bank
 Written policy and procedures for the return of unused bone products, cells or tissues are in
place
NHMSFP – College of Physicians and Surgeons of British Columbia
January 2012
Page 2 of 4
BONE, BONE PRODUCTS, CELLS AND TISSUES
ACCREDITATION STANDARDS
Patient Safety
Bone product, cells and tissues adverse events are recognized, reported and
investigated
INDICATORS:
 Written policy and procedures for reporting and investigating adverse events are in place
 Emergency contact information for the distributor/tissue bank is readily available
 Adverse event records are maintained
There are appropriate recall, lookback and traceback policy and procedures
INDICATORS:
 Written policy and procedures for recall, lookback and traceback investigations are in place
 Written policy and procedures shall be capable of being put into operation at any time,
during or outside normal working hours and shall specify the title(s) or position(s) of the
individual(s) responsible for the coordination
 Agreements are in place with the providing establishment to ensure all information required
for traceability is accessible
 Recall, lookback and traceback notification records are maintained
 Patients are notified, as appropriate, by a regulated health professional
 Patient notification is documented in the health record
Bone product, cells and tissue records are appropriately maintained
INDICATORS:
 Every bone product, cell or tissue is recorded in a log and when transplanted has an
associated recipient file
 Final disposition of all allogeneic bone products, cells and tissues is recorded and reported
to the distributor/tissue bank
 Records are accurate and include for each product (CAN/CSA-Z900.2.2-03):
•
donor identification number
•
tissue type
•
identification number
•
staff involved in procedures
•
source of the tissue
•
storage
•
final disposition
•
identity of the recipient
NHMSFP – College of Physicians and Surgeons of British Columbia
January 2012
Page 3 of 4
BONE, BONE PRODUCTS, CELLS AND TISSUES
•
•
ACCREDITATION STANDARDS
Patient Safety
date of transplantation
tissue identification number
 Records are appropriately retained and include but are not limited to:
•
final disposition of bone products, cells and tissues (∞)
•
superseded written policy and procedures for bone products, cells and tissues (∞)
•
distributor/tissue bank packing slips(∞)
•
bone producs, cells and tissues log and associated recipient information (∞)
•
adverse event, recall, lookback and traceback documents (∞)
•
distributor/tissue bank correspondence related to bone products, cells and tissues
(∞)
•
temperature monitoring of storage devices (five years)
(∞) – Indefinitely
REFERENCES
Canadian Standards Association. CAN/CSA-Z900.1-03 (R2008): cells, tissues, and organs for
transplantation and assisted reproduction - general requirements. Mississauga: Canadian
Standards Association; 2003.
Canadian Standards Association. CAN/CSA-Z900.2.2-03 (R2008): tissues for transplantation.
Mississauga: Canadian Standards Association; 2003.
Canada. Department of Justice. Safety of human cells, tissues and organs for transplantation
regulations: SOR/2007-118 [Internet]. Ottawa: Department of Justice, 2008 [cited 2012 Feb 1].
Available from: http://laws-lois.justice.gc.ca/PDF/SOR-2007-118.pdf
Health Canada. Guidance document for cell, tissue and organ establishments: safety of human
cells, tissues and organs for transplantation [Internet]. Ottawa: Health Canada, 2009 [cited 2012
Feb1]. Available from: http://www.hc-sc.gc.ca/dhp-mps/alt_formats/hpfbdgpsa/pdf/brgtherap/cell/cto_gd_ld-eng.pdf
Health Canada. Cells, tissues and organs [Internet]. Ottawa: Health Canada, 2009 [cited 2012
Feb1]. Available from: http://hc-sc.gc.ca/dhp-mps/compli-conform/info-prod/cell/indexeng.php
Steele, Tracy; Fawcus, Pat. (College of Physicians and Surgeons of British Columbia).
Conversation with: Julie Frketich, Ivan Yan (Quality coordinator, Tissue bank. Centennial
Pavillion, Vancouver Coastal Health, Vancouver, BC). 2011 Aug 15.
NHMSFP – College of Physicians and Surgeons of British Columbia
January 2012
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