1. Saskatchewan Update NAC Spring Meeting April 28-29, 2016
Donna L. Ledingham, MSc, MD, FRCPC
Hematopathologist
Regina Qu’Appelle Health Region

2. Saskatchewan Diagnostic Services
Crossmatch and reference services which are currently contracted through CBS Diagnostic Services will be repatriated to the province as part of National Facilities Redevelopment Program, Phase 2a. The future location of prenatal testing in Saskatchewan has yet to be determined by the Ministry of Health.
Ongoing efforts at standardization via the Advanced Testing Working Group

3. Crossmatch Process Design Event
The province will be hosting all stakeholders in a 3 day Process Design meeting using Lean methodology.
Taking place May 16-18, 2016 in Saskatoon
Goals include the development of:
New provincial process for referral of crossmatch samples
Implementation plan

4. Blood administration sets:
New caution labeling on blood administration sets manufactured by Hospira
CAUTION: Change at least every 4 hours

5. Previous Wording:
Replace per CDC guidelines or health care provider policy for blood and blood products. Discard after single patient use.
CAUTION: Observe AABB standards of practice or facility protocol for blood transfusions.

6. References supplied by Manufacturer:
Saskatchewan expressed concerns as this change has both environmental and financial costs.
We were uncertain if it was evidence-based so did a literature search and asked the manufacturer for their evidence base.
The references used (as per the supplied list) do not consistently support the new labeling on the package.

7. Meetings with Hospira’s Clinical Quality Representatives:
This change was not mandated by a third party such as a regulator. The change to create consistent wording on administration sets to improve patient safety.
Hospira changed the packaging to align with AABB guidelines regarding blood product infusion (i.e., the “four hour rule”). The 17th edition of the Technical Manual states the following…
“If there are no contraindications from the manufacturer, institutions frequently allow the tubing to be reused as long as subsequent units are transferred within 4 hours of the start of the initial transfusion”
Hospira did not provide references to scientific research or hemo/biovigilance databases to support their position.

8. Action steps:
Hospira has committed to an internal review of the caution label due to the differences in global procedures and protocols for blood administration sets.
The current “change at least every 4 hours” on the packaging will remain in place until Hospira has a suitable statement to replace it.
Using a Hospira product outside the manufacturer’s recommendation is an “off label” use. In these cases, the liability falls to the customer.

9. Action steps:
Saskatchewan’s 3sHealth has sent a letter to Hospira requesting formal communication of their remediation plan, including timeframes and implications for use of the product given the current caution label.
There is a commitment by Hospira to follow up to Saskatchewan’s expert group by the first week in May.

10. Action steps:
Our discussions with Hospira have highlighted the lack of national and international research related to microbial growth rates and blood administration sets.
Hospira would consider supporting project(s) to develop an evidence base for how often RBC administration sets should be changed.
Is there a Canadian group or organization interested in collaboration?
Is it time to establish an evidence base for the “four hour rule” as well?

11. Provincial Landscape
Saskatchewan Projected Use in 2015/16 – 193,399g at a cost of about $23M. In 2015/16 we are forecasting a 5.2% increase provincially, 5.9% in SHR and 2.6% in RQHR
RQHR and SHR account for about 72% of the usage, but it is felt that their physicians influence most of the usage in the province.
33 facilities within the province have received IVIG in the past 3 years

12. IVIG Usage in RQHR and SHR
** Based on 10 months actual data

13. IVIG – SK IG Optimization Program

14. Program implemented in RQHR in June 2015

16. Welcoming a new colleague…
Oksana Prokopchuk-Gauk, MD, FRCPC
Internal Medicine (Saskatoon)
Clinical Hematology (Calgary)
Transfusion Fellowship (Edmonton/Calgary)
Starting work in Saskatoon on May 2

17. Happy Medical Laboratory Professionals Week!

18. References supplied by Manufacturer to support change:
Guidelines for the Administration of Blood Products. 2nd Edition. Australian and New Zealand Society of Blood Transfusion LTD. Royal College of Nursing Australia    – The blood administration set must be changed when transfusion is completed or every 12 hours if the transfusion episode is not yet complete.  This is intended to reduce the risk of bacterial growth occurring.
Clinical Guide to Transfusion. 4th Edition. Canadian Blood Services – Various standards indicate that blood administration sets should be changed within four hours, eight hours, or up to 24 hours following initiation of the transfusion.  Four to eight hours is a reasonable time frame with up to four units being transfused in this interval prior to filter change.  When there is a delay between units of an hour or more, it is prudent to replace the administration set.

19. References supplied by Manufacturer to support change continued:
 3. Guideline on the Administration of Blood Components. British Committee for standards in hematology – The administration set should be changed at least every 12 hours (or in accordance with manufacturer’s instructions).
 4. Technical Manual, 18th Edition, American Association of Blood Banks. Chapter 21. Administration of Blood Components, page If additional units are transfused, the institution’s guidelines and/ or manufacturer’s recommendations should be consulted to determine whether the same blood administration tubing may be used for subsequent units.  If there are no contraindications from the manufacturer, institutions frequently allow the tubing to be reused as long as subsequent units are transfused within 4 hours of the start of the initial transfusion.  Therefore, if more than 1 unit can be infused in 4 hours, blood administration tubing sets may be used for more than one component.

20. References supplied by Manufacturer to support change continued:
 5. Gorski L, Hadaway L, Hagle M, et al. Infusion therapy: Standards of practice. J Infusion Nurs 2016; 39 (1S): S1-S159. –  42. Administration Set Change VI. Blood and Blood Components A. Change the transfusion administration set and filter after the completion of each unit or every 4 hours, the transfusion set can be used for a 4-hour period (refer to Standard 62, Transfusion Therapy).  62.  Transfusion Therapy I. Change the transfusion administration set and filter after the completion of each unit or every 4 hours.  If more than 1 unit can be infused in 4 hours, the transfusion set can be used for a 4-hour period (see Standard 42, Administration Set Change).8    Reference for this statement.  Maynard K. Administration of blood components.  IN:  Fung MK, Grossman BJ, Hillyer CD, Westhoff CM, eds.  AABB Technical Manual. 18th ed. Bethesda, MD:  AABB; 2014:

21. References supplied by Manufacturer to support change continued:
 6. O’Grady NP, Alexander M, Burns LA, et al. CDC. Guidelines for the prevention of intravascular catheter-related bloodstream infections, – Replace tubing used to administer blood, blood products, or fat emulsions (those combined with amino acids and glucose in a 3 in 1 admixture or infused separately) within 24 hours of initiating the infusion.  Category IB
Category IB.  Strongly recommended for implementation and supported by some experimental, clinical, or epidemiologic studies and a strong theoretical rationale; or an accepted practice (e.g., aseptic technique) supported by limited evidence.
7. Finnish Medical Society Duodecim. Blood Transfusion: Indications and Administration – 9. The same administration set may be used to transfuse several packs of red cells without interruption (according to the capacity of the administration set filter), but it is recommended that the administration set is changed after six hours in order to reduce the risk of bacterial contamination.