The Process of Infusing Cryopreserved Stem Cells by Registered Nurses Presenters: Kristen Brazel, RN BScN Kate Duke, RN BScN 5 West Haematology Unit, The Ottawa General Hospital, Ottawa, Ontario, Canada
Abstract The purpose of this presentation is to describe the procedures used for the safe infusion of autologous peripheral blood stem cells (AuPBSC) by clinical haematology nurses. This procedure allows Registered Nurses to work to their full scope of practice, combining theoretical and clinical skills throughout the transplant process. A specialized education program was developed to train experienced haematology nurses to infuse AuPBSC. The program consists of an indepth review of current AuPBSC theories, policies and procedures. Prior to certification, each nurse must complete a modified clinical practicum. Initially, the nurse was responsible for all aspects of the AuPBSC infusion; however, cases of delayed engraftment were noted amongst patients. As a result, changes to the policy were required. A comparison of these policies and procedures along with the clinical outcomes will be presented. The critical factors for a successful program include: an interdisciplinary team approach, implementation of specialized knowledge and skills, and adherence to accreditation standards.
Presentation Overview Background Timeline Review of certification program for RN s Policy and Procedures of AuPBSC infusions (2006 & 2009) Statistics related to engraftment time Indications for policy changes Evaluation
Background The Bone Marrow Transplant Unit began at the Ottawa General Hospital in 1981. Ten years later, in 1991 the unit started performing AuPBSC transplants with the use of cryopreservation. With an increase in the number of patients requiring transplants, stem cell administration techniques needed to be addressed. This presentation will look at the changes made to our program over the last 10 years.
Timeline 1981-1999 : Physicians gave stem cells by IVP. With the introduction of PICC lines, the IV push method became contraindicated 1999 : APN started infusing auto stem cells along with physician Current research supports changes in infusion practices due to liability and viability studies APN began AuPBSC infusion at a rate of 10-12 patients per month An increasing amount of patients undergoing AuPBSC transplants and an increase demand on the APN for infusion required a change to policy. 2006 :RN Certification of AuPBSC infusion rolled out by the BMT APN 2008 :Review of the Program to Date 2009: Roll out revised AuPBSC infusion certification program for RN
RN Certification Program (2006) BMT APN/Manager selected expert RNs to attend a four hour certification class taught by the BMT APN and Canadian Blood Services (CBS) The class focused on autologous stem cell collections, processing of stem cells, infusion procedure and possible complications Hands on experience for RNs opening the cryopreserved cassettes Review of emergency procedure for stem cell retrieval from broken bag/damaged cassettes Post session test A return demonstration with BMT APN or Physician prior to certification
Infusion Policy in 2006 Ensure protocol is proceeding as scheduled Review all policies and procedures prior to infusion Verify physician order for date and time of infusion Verify and document when last chemotherapy agent or last radiation dose given Ensure physician availability during infusion Obtain baseline vital signs, administer pre-medications and start water bath (heat to 37.5 C) Verification of components requested with paper work and patient
Infusion Policy Thaw cassettes one at a time, starting with the cassette with the highest CD34 count Infuse AuSC through a central venous access device using normal saline and blood administration tubing with a maximum rate of 300ml/hr on an IV pump Monitor vital signs every five minutes during the infusion, assessing patient for DMSO reactions Each AuSC bag must be infused within 30 minutes of thawing Complete marrow infusion report, documenting product infused, total cell count and any adverse reactions Continue close monitoring of patient post infusion
Auto Stem Cell Infusion Record
Evaluation of 2006 Program POSITIVES 1. RNs report a high satisfaction with the theory and advanced education opportunity 2. RNs report an increase in patient trust with the infusion of stem cells and monitoring patients 3. Less time strain on BMT APN role (more time to spend with patients, families and the BMT program) NEGATIVES 1. RNs expressed a need for increased training in regards to opening and handling cassettes 2. RNs expressed concerns over increased workload during infusions related to 1:1 monitoring 3. RNs felt unsupported by physicians and wanted an increase in MD involvement and participation during infusions
Where do we go next?
Changes a foot! In late 2008, the Physicians and the BMT APN met to review the engraftment data and evaluate the effectiveness of the infusion process during 2007 and 2008. It was noticed delayed engraftment times occurred between 2007 and 2008.
Engraftment Times
Important to Note No major errors by RN identified No explanations were revealed for the delayed engraftment time; it was hypothesized that the length of infusion from thaw to completion played a role in engraftment Delayed infusion time increases the risk of the cells being exposed to the DMSO The hypothesis related to RN involvement, focused on the need for additional support related to work load, and number of RNs trained to infuse AuPBSC
Changes/Updates Development of BMT Checklist The checklist covers the entire infusion It starts with a review of the policy and procedure and guides RN through the verification processes and all the steps involved in safely infusing AuPBSC.
BMT Checklist
Changes/Updates Development of physician order form Contents of the pre-printed physician order form include: the specific date of transplant the pre-medication required the infusion instructions the type of product to be infused.
Physician Order Sheet
The Change Continues Involvement of Transfusion Medicine Technologists (TMT) TMT became involved in the verification and thawing processes of the cryopreserved AuPBSC. This leaves the RN time to focus solely on the patient assessment and the infusion process.
Transfusion Medicine Technologists Role Preparing the water bath Verifying stem cells with RN Visually inspecting and thawing stem cells. Thawing of cells does not occur until the infusion record documentation is complete
Transfusion Medicine Technologists Role Document Cell Infusion Record Time the procedure from thaw to end of infusion. Ensure total Time of infusion is less than 30 minutes to prevent cells being exposed to DMSO (Dimethyl sulfoxide) NOTE: Prolonged exposure to DMSO can lead to cell death.
Continued Steps in Change Changes to the Infusion Process To decrease exposure to DSMO, the policy required changes to infusion rates As of 2009, infusion rate starts at 100ml/hr for 5 minutes. If the patient tolerates this rate with no adverse events, the rate is increased to 400ml/hr for the remainder of the infusion An ideal infusion time is <30 minutes; preferred time is 20 minutes.
Final Steps in Change Changes to the Certification Program RNs trained in 2006 were re-certified with the new P&P by BMT APN and CBS 8 new RNs were certified to infuse AuPBSC Post-session tests and return demonstration were required prior to certification Recertification is required every 2 years
Infusion Policy in 2009 Ensure protocol is proceeding as scheduled Review all policies and procedures prior to infusion Verify physician order for date and time of infusion Verify and document when last chemotherapy agent or last radiation was completed Ensure physician availability during infusion: All AuPBSC products will be infused between 0800 and 1700.
Infusion Policy Obtain baseline vital signs and administer pre-medications Check serum creatinine Prepare Y type blood infusion tubing Verify the 3 documents that accompany the AuPBSC to the unit 1. Shipping document: identifies patients name, chart number, AuPBSC product number and the number of cassettes 2. Cell counts contained in each individual cassette 3. AuPBSC product infusion record
Infusion Policy Transfusion Medicine Technologist will prepare the water bath, verify paperwork with RN, and on completion of documentation they begin to thaw the 1 st bag of cells with the highest CD 34+ count The technologist will start the timer as soon as the cells are immersed in the water bath. THE TOTAL TIME FROM BEGINNING OF THAW TO COMPLETION OF INFUSION IS THIRTY MINUTES TO PREVENT CELL DEATH
Infusion Policy Begin infusion at a rate of 100ml/hr x 5 minutes and increase to a maximum of 400ml/hr Transfusion medicine technologist will begin timer to verify length of infusion Once infusion is started, vital signs will be done at 5 minutes and end of infusion Remain with patient at all times until infusion is completed
Final Steps In infusion policy Repeat previous steps for each bag present DO NOT THAW NEXT COMPONENT UNTIL THE PREVIOUS ONE IS INFUSED COMPLEETLY Complete marrow infusion report, document in the integrated progress notes the products infused, component identification numbers, volume, and any adverse events associated with infusion Monitor patient post infusion
Engraftment Times
Evaluation Evaluation of program from the APN standpoint: Devised an effective and successful training program for RN s They have increased support as more nurses are trained to infuse AuPBSC Increased satisfaction with overall BMT program BMT team is satisfied with the apparent decrease to engraftment times
Evaluation Evaluation of program from the TMT standpoint: Initial increase in workload as TMT staff needed to be trained in the use of the water bath and thawing the AuPBSC. Can be time consuming, as it pulls TMT staff from the lab for extended periods of time The staff are committed to high levels of patient outcomes and care High level of investment in BMT program
Evaluation Evaluation of program from the RN standpoint: High satisfaction with theoretical aspect/training program Feel supported by Physicians, APN and Unit Manager With increased awareness of program, there is an increase in support from fellow RNs to cover the workload during infusions RNs feel the process is more cohesive from start to finish due to TMT involvement.
Conclusion With TMT involved in the verification and thawing, the process of AuPBSC infusions runs smoother overall. RNs report feeling more supported with the increase in number of people trained and the new certification program. Engraftment times to date have lowered, therefore increasing patient outcomes.
Conclusion In conclusion, there has been positive feedback from the clinical team involved in the process of infusing AuPBSC. Our goal is to continue to monitor and evaluate the many aspects involved in the BMT program.
Questions