Quality Management Oral Session O167 Continuous Quality Control (CQC) as a method to improve Cost Effectiveness without Compromising Clinical Care J. Schriber1,*, A. Szetela1, E. Simpson1, S. Kendrick1, J. Abbas1, A. Briggs1 1 CANCER TRANSPLANT INSTITUTE, Scottsdale, United States Introduction: Continuous quality control (CQC) conjures up images of costly oversight, however it can also be utilized to modify protocols and procedures to maximize productivity and cost effectiveness. We describe several simple changes instituted over the past 2 years based on CQC procedures and the cost savings realized. Materials (or patients) and methods: The process starts with identification of an area to consider, review of the literature, and then implementation with an observation period prior to final adaptation. Cost savings are estimated using US dollars and unless otherwise noted are normalized to reflect a per patient cost. Results: The first change was enforcement of Platelet (Plt) transfusion parameters. Despite a Standard Operating Procedure (SOP) that patients without fever should not be transfused until Plto10, an audit determined that this was not occurring. Reinforcement of the lower threshold resulted in an 11% decrease (781 to 690) in transfusions despite a slight increase in the number of transplants (101 to 107) and no change in the case mix. There were no changes in bleeding episodes, engraftment or LOS. Cost savings per patient was $671. As part of an annual review, a simple shift to performing a CMP 3x/week rather than daily and discontinued daily differentials was made with no consequences and cost savings of $1500 and $180 per patient respectively. Our most common indication for autologous transplant (ABMT) is Multiple Myeloma (MM). A review of the literature, showed no clear advantages to 2 day infusions, so we launched a pilot trial using a single day infusion of Melphalan. Cost savings of $2000 per Myeloma patient were observed through combining vials, decreased fluid requirements, nursing and ancillary medicine

Process Change

Observed Results

Cost Savings/Pt


Enforce Plt Transfusion Change to 3x/ wk CMP Change from daily Diff Melphalan 1 day Infusion Time change for GSCF post

11% drop transfusions NA











10% decrease in G 6% able to skip





Skip Plerixafor

*MM patients only. **ABMT only.


costs. A simple change to our SOP in the timing of G CSF support post ABMT resulted in 10% of patients not receiving a dose they would have previously received. This resulted in an average cost saving of $160 per autologous patient. We recognized, that in the 30% of our ABMT patients who required Plerixafor (P) to mobilize stem cells that 20% (6% of the entire patient population) were close to their preset target collection goals after the first dose of P. We collected the second day without P and all patients collected sufficient numbers of cells for transplantation at a cost savings per autologous transplant of $420 based on an average cost of $7000 per dose of P. Conclusion: Although each change by itself does little to shift costs in an individual patient, when taken in aggregate substantial savings can be realized without compromising care. Savings will vary by transplant center based on their individual costs. CQC is an effective way to improve productivity and cost effectiveness for transplant programs. Disclosure of Interest: None declared. O168 Title: Implementation of the JACIE Quality management system, by focussing on transformation of JACIE standards into higher quality of daily day nursing L. B. Kristensen1,*, T. B. Sorensen1 1 Hematology, Aarhus University Hospital, Aarhus C, Denmark Introduction: The Transplantation Unit at Aarhus University Hospital in Denmark was established in 2009. Being a new Transplantation Unit major focus has been given to the general clinical nursing quality and to complying with the prescribed Danish Quality Management System as well as to other general demands given to a Danish hospital ward. Besides this, we are working towards the JACIE accreditation. The Transplantation Unit has employed a nurse as Quality Manager (QM), who together with The Clinical Program Director (CPD), are working dedicated towards the JACIE accreditation. But since Danish nurses for many years have worked independently and reflectively with high professional standards, the QM were faced with difficulties in trying to motivate these nursing professionals to work according to JACIE standards. In 2013 it was necessary to develop a new strategy for the implementation of the JACIE standards. Materials (or patients) and methods: To motivate the nursing staff to contribute constructively to the implementation of the JACIE standards, it was considered important to create a meaningful relation between the JACIE Quality Management System and the daily clinical work of the nurses. To achieve this, the Nurse Manager and the QM in a confident corporation first revised the existing Standard Operating Procedures (SOP’s) most important to the nurses and focused on the improvement in quality JACIE standards could give. Thus, for instance, motivation to work with deviations and adverse events were enhanced by focusing on patient safety and on the development potentials in this area. Because of the many new SOP’s and changes in existing SOP’s, it was considered important to implement JACIE’s systematic approach to the education and qualifying of the staff as soon as possible. An earlier introduction- and education-program was, therefore, adjusted to comply with the JACIE standards and rapidly implemented in the ward. One important factor, was the use in an existing computer systems for Electronic Document Management (EDM) and for documentation of education and qualifications of the nursing staff. Finally the Nurse Manager and a transplantation specialist nurse had a

clear focus on the need for education and for developing new SOP’s, required by the JACIE standards. Results: JACIE standards have contributed substantially to prioritize and structure the development of nursing SOP’s. The demands concerning documentation of education and qualifications have improved and goal-directed the learning for newly employed nurses and have made it easier for experienced nurses to instruct the new ones. Working with the JACIE standards for EDM have increased the awareness of existing SOP’s, and has enhanced the use of these. Finally the nurses report more deviations and adverse events, and they are motivated to learn from these. Conclusion: By deliberately removing focus from the JACIE Quality Management System itself to the quality of the general clinical work of the nurses, we have reduced the resistance against working against the very structured standards following a JACIE accreditation. It has become evident to us, that the involvement of the management and a close corporation between QM, CPD, the transplantation specialist nurse and the Nurse Manager is very important in the development and the execution of the implementation strategy. Disclosure of Interest: None declared. O169 Retrospective analysis of reported patient incidents in a pediatric hematopoietic stem cell transplantation ward A. Maes1,*, S. Van Lancker1, T. Bauters2, C. Dhooge1, V. Bordon1, G. Laureys1 1 Paediatric Haemato-Oncology, 2Pharmacy Department, UZ Ghent, Gent, Belgium Introduction: Paediatric hematopoietic stem cell transplantation (HSCT) involves complex procedures and polymedication schedules. In 2011, the HSCT program implemented a Quality Assurance system according to the JACIE standards. Procedures were written and implemented in order to standardize processes and minimise errors. The quality assurance system uses a reporting system to register incidents which have occurred or have nearly occurred. Every incident is analysed by an expert team and corrective and preventive actions are defined and elaborated. Materials (or patients) and methods: Retrospective analysis of prevalence of different types of patient incidents (January 2012-October 2014) in the paediatric HSCT ward using the hospital based reporting system. Incidents are classified according to type of incident: process and procedural errors, drug errors, errors in standard of care, documentation (patient identification, test results, orders), medical devices/ instruments, blood and blood products (including cellular products), resources/ organisation/ management, accident of the patient, alimentation, incidents regarding oxygen/gas/steam and behaviour of the patient/personnel/third party. The types of incidents are further subclassified into processes and problems. Results: During the period of almost 2 years, 40 transplantations were performed (27 allogeneic and 13 autologous). Fiftyfour patient (nearly) incidents were reported during this period. Of them, 91% (48/54) were detected and reported by nursing staff. Drug errors accounting for 48% (26/54) are the most important type of incident followed by 19% (10/54) process/procedural errors, 9% (5/54) incidents with blood or blood products, 9% (5/54) documentation and 15% (8/54) others. This review focuses on drug related and process/ procedural errors as these have the highest incidence. Drug errors are further classified: 85% (22/26) of drug errors took place during administration to the patient, 8%(2/26) were prescription errors and 8% (2/26) occurred during the distribution process within and outside the pharmacy. Subanalysis of ‘‘administration to the patient’’ showed that 32% (7/22) incidents were related to wrong dose/ concentration or wrong frequency of administration and 32% (7/22) to omitted dose and 18% (4/22) to wrong drug administration. Process/procedural incidents mostly occurred during therapy/ intervention (4/10) and test/examination (2/10). For both

subclasses the incidents occurred because of incomplete or incorrect execution of the process or process step. Conclusion: Drug errors are the most reported type of incidents followed by deviations during processes/ procedures. Preventive actions include the implementation of an electronic medication module for the prescription and administration of drugs, clear identification of patient files, and provinding an online pharmaceutical calculation training module. Although a Quality Assurance system is implemented and documentation exists, personnel does not have the routine of consulting the available documentation/information. Training regarding the importance of the QA system remains advisable. Disclosure of Interest: None declared. O170 Management of cellular therapy products obtained from positive microbial cultures E. Maytalman1,*, S. Tepebası2, C. Gereklioglu3, C. Boga3, H. Ozdogu3, I. Kozanoglu4 1 Hematology, Cell processing, Baskent University, 2Quality Department, 3Hematology, 4Hematology, Cell processing, Baskent University Adult Bone Marrow Transplantation Center, Adana, Turkey Introduction: Microbial control and monitorization of cellular products is important for patient/product/personnel safety and knowing about the quality of the product that will be infused. Microbial control of all products is done in our center with the aim of protecting the patients from infection during transplantation process. The aim of this study is to make a retropsective analysis of the whole celluar products which were collected in our cell collecting center and cryopreserved in cell processing unit between March 2011 and December 2014 with regard to microbiologic contamination. Materials (or patients) and methods: Two mL of sample was obtained from the final product after collecting process and at cryopreservation stages and sent to microbiology laboratory in paediatric BACTEC PediPlus/F medium vial for microbial control of the cellular prducts collected through stem cell apheresis procedure. The samples were incubated at BACTEC automatized blood culture devices for 5 days. Species was detected by cultivating the positive signaling samples in petri dish. Results: Positivity was deteced in 12 (2,8%) collecting bags out of 428 stem cell apheresis procedures which were carried out in Cell Collecting Unit and sent to Microbiology Laboratory between March 2011 and December 2014. Pozitivity was detected in 23 (2,5%) out of 915 product bags which were cryopreserved and sent to Microbiology Laboratory after stem cell collecting procedure. Coagulase negative staphylocccus grew in 10 samples, staphylococcus aureus grew in 4 and diphteroid bacil in 1. Central authority was informed after council decision and patient information had been done and 2 bags of contaminated product was infused to one patient under proper antibiotic prophylaxis. Three patients did not accept infusion and the product was disposed and cell collecting was done again. Remaining patients either did not undergo transplantation or infusion was made using the bags in which contamination was not detected. Conclusion: In our center, quality control was started with the aim of adaptation to JACIE standards and is being continued in a gradually improving manner in order to maintain the accreditation obtained in January 2012. Making the microbiologic controls of the cellular products is understood to be important for patient and product safety. References: 1. Management of cellular therapy products obtained from positive microbial cultures (SOP Number: KITHIU-019) Baskent University Adult Bone Marrow Transplantation Center Quality Managment Department. 2. Akan H, Boga C. Infections in Hematopoietic Stem Cell Transplantion.


3. Sto¨rmer M, Wood EM, Schurig U, Karo O, Spreitzer I, McDonald CP, Montag T. Bacterial safety of cell-based therapeutic preparations, focusing on haematopoietic progenitor cells. Vox Sang. 2014;106(4):285-96. Disclosure of Interest: None declared. O171 Radar graphics: a model of physicians’ expertise level and training requirement assessment in hematopoietic stem cell transplant (HSCT) unit with JACIE accreditation A. Proia1,*, M. Vacca2, I. Majolino1 1 San Camillo Hospital, Rome, Italy, Hematology and HSC Transplant Unit, 2San Camillo Hospital, Rome, Italy, HSC collection and manipulation Unit, Rome, Italy Introduction: Minimum requirements to satisfy Italian National Authorities as GITMO, CNS and CNT, and European Boards as JACIE-FACT, standards impose for transplant specialists a continuous update. While design and supply of educational events has no critical elements, the periodic evaluation of acquired skills represents a complex task in the educational process. The competence evaluation procedure is not still defined, even though it is regulated by general principles. This verification should be regularly carried out by means of a method able to evaluate, in an objective way, the status of specific and technological knowledge of a HSCT team. Materials (or patients) and methods: To evaluate the acquired expertise of the transplant physicians, we submitted a questionnaire containing queries belonging to five different areas of competence, related to most critical points of HSCT activity. Each area included ten questions, six of them concerning fundamental principles, and four related to more complex issues, whose knowledge defines a more elevated skill level. To visualize the results we employed the radar graphic modality that provides the advantage to present an


immediate visualization of the competence level and formative requirements. Results: Th level of competence was rated basing on correct answer percentage: 60% and 80% are expression of an acceptable and good level of competence, respectively. 90% is expression of a high competence, defining the skill able to assume the role of Tutor. Questionnaire results in our HSCT Unit are showed in figure 1. Conclusion: Results provide the documentation of the physicians acquired competences according to criteria defined by the several certification boards (JACIE-FACT, GITMO, CNT and CNS). This model, when properly applied, is able to help the educational process identifying deficiencies in the clinicians’ expertise, allowing the continuous identification of the most appropriate scientific educational plan. Disclosure of Interest: None declared.

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The quality management group oral session.

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