IMPROVING CORD BLOOD BANK OPERATIONAL EFFICIENCY

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1 IMPROVING CORD BLOOD BANK OPERATIONAL EFFICIENCY Francesc de Haro Partner, Blood Bank Solutions, Barcelona (Spain) INTRODUCTION Cord Blood Banks (CBBs) activities started to be popular in the late 90 s. Both public and private banks have spread their operations until today being one of the fastest growth markets which accounted in the last years an average per annum growth rate about 20% per year. All CBBs are looking for being more efficient in their operations and are challenging the way they can run all their processes in the best cost- effective manner. OPERATIONAL EFFICIENCY What is called Operational Efficiency (OE) is the capability of an organisation for delivering products or services to its customers in the most cost- effective possible manner, while still ensuring the highest level of quality and reliability of its products and services. OE results from the ratio between: a) The out- puts gained from the business: Quality (product/patient safety, product reliability). Money (revenue, cash, margin). Growth (customer market share). Customer Satisfaction (service, innovation). b) And the in- puts need to run it: Money (opex, capex). People (headcount). Effort (time). The three main pillars sustaining OE in an organisation are: - Utilize the best Workforce, Technology and Business Process. - Minimize Redundancy and Waste. - Leverage Critical resources to success. Lean Management is an operational methodology that leads OE increase when it is applied. This is a systematic approach focused on what is Value for the customer,

2 ensuring it flows continuously through the operations and eliminating all kind of Waste (activities that are not adding value). Typically, Non- Value- Added activities account up to 95% of the total activity, including Regulations Compliance, and this is Waste. From that, Required Waste (paper, computer, handling, walk, calls, inspection) should be minimized to reduce cost, and those activities representing Pure Waste must be eliminated. Being wasteful makes organizations unsustainable. LEAN MANAGEMENT AT CORD BLOOD BANKING The main mission of CBBs, either public or private, is to process and store the highest quality stem cell samples from a Cord Blood Unit (CBU) for future therapeutic use. Good stem cell transplants are correlated with the viable Total Nucleated Cells (TNC) dose. In CBBs only activities that transform the CBU retrieved during the birth into a cryopreserved stem cells sample with the highest viable TNC dose can be considered Value- Added activities. Other ones that take time, resources or space but they do not transform anything of the CBU can be considered as Non Value- Added activities, which means that, although required during the process, those ones are Waste. Typical activities that represent Waste in CBBs operations are: 1. COLLECTION Poor collection procedures Documentation not included 5. CRYO PREPARATION Handling and moving samples Manual cryopreservant addition 2. TRANSPORTATION Unplanned routes CBU out of temperature CBU out of time 6. CRYO PRESERVATION Handling and moving samples Wrong freezing procedures Manual processing data entry 3. CBU RECEPTION Paperwork and labeling Handling and moving CBU Manual CBU data entry several times 7. STORAGE Long walking distances Lost of labeling 4. CORD BLOOD PROCESSING Handling and moving CBU Manual processing data entry Many movements of personnel 8. RETRIEVAL Time lost looking for a sample Misplaced samples

3 Any of the above Wastes is adding cost, quality risk or delay in processing and cryopreserving cord blood stem cells. Other Wasteful management activities found in CBBs operations are: Qualified staff building collection kits. Unplanned breakdowns of equipment. Non- productive inventory. Bad housekeeping and visual noise. Waiting for work. Most of the Wastes generated in current CBBs were stated in the early phases of the business creation: the design and definition of the bank lay- out and work- flow. In some cases, processing and cryopreserving areas are placed in the basement level of hospitals or technological centres, where the surface available to run the operation is too small and that leads to over- charged space, poor work place organization and discontinuous flow. By far the biggest Wastes typically found in CBBs are associated with poorly designed processes and lay- out. Flow is the Goal: all the activities that create value have to run without interruptions, waiting, or barriers or detours. Through achieving and maintaining efficient continuous workflow, the implementation of a Lean approach delivers shorter cycle times, higher productivity & efficiency, increased flexibility, improved space utilisation, improved quality, and reduced costs. Let me show a recent case of a CBB: how the bank has improved its processes and how much they have saved by implementing some Lean management techniques. a) Co- locate operations throughout the value stream To minimise the work travel and to simplify the workflow the best is to structure the CBU processing activities as a production line: small work cells or areas and the majority of the workflow will be in one direction. All other activity, like cryopreservation area, has been located to the periphery, as much closely as possible of the processing area. b) Organization of the working areas To less travelling distance to the equipment as each appliance can be placed closer to the work cell in which it is used most frequently. Disposables can also be kept in the immediate workspace of the areas in which they are used. The 5S technique has helped a lot in that point. c) Appropriate process automation Some manual operations were still usual, like CBU volume reduction, DMSO addition, or freezing procedures. By automating some of those activities quality and productivity have increased significantly by reducing process variation. A key

4 benefit of automation is a level of standardisation and consistency in the process that personnel cannot achieve. d) Tracking system and data integration The same identification data of a CBU was entered several times by several staff in the different IT management systems of the bank (customer service, processing, storing, etc.). The use of a single ERP has helped to reduce mistakes and wasting time. A manual handwritten system was the common practice for tracking the samples during processing: this was inefficient and had a higher potential for mistakes. Great success has been achieved using tablets and a barcode label system, which have the advantages of being faster, more efficient and reduce the likelihood of mistakes for tracking and integrating the processing data of a CBU sample. In the same way, the processing data were not integrated, which put more difficult to find the whole processing and storing data of a single CBU for traceability purposes. Integrating the files from different equipment in a single ERP has eliminated wasting time by entering data manually. e) Overall equipment readiness Equipment breakdowns and shortages of supplies (power, liquid nitrogen) were part of the routine of this bank unfortunately. The definition of a Facility Management System and an equipment Maintenance Plan is helping now to monitor and control key operation parameters like particle count, temperatures, humidity and nitrogen liquid level, and having a process under control by eliminating wasting time due to either process interruptions or manual activities. f) Materials management To avoid preparing disposables and materials at the classified areas, and in order to have the right quantity at the right place of use, those are now prepared in such a kind of kits outside the laboratory, eliminating the waste of preparation times. Disposables and reagents inventories were common to be found in different areas of the bank creating, in much of the cases, additional visual noise due to be in cramped idles, passing lanes or corners. An Inventory Control Management has been put in place, defining the proper space to stock all the materials, and implementing a Visual Control System (Kanban) that avoid any material shortage. Although the bank of this case is still in the early phases of the implementation of the techniques above mentioned on its Lean Management journey, they have already shown a 15% of productivity improvement and their operational costs have been cut by 22%, as well as they have gained 26% of space and the disposables and materials inventory have been reduced by 31%.

5 CONCLUSIONS Following our consulting experience a Lean Management approach provides significant improvement opportunities for the OE of CBBs. By focusing on how they are adding Value for their customers CBBs will relentlessly increase Competitiveness and Sustainability of their operations, by getting more business out- puts (quality, money, growth or customer satisfaction) or by reducing the in- puts need to run their activity (people, money or effort). REFERENCES Thomas Griffiths, Andrew Peto, Joseph Thorogood, Daniel Tiffany, Oliver Michalakis. Conceptual Design of a Cutting Edge Stem Cell Research Facility. School of Mechanical Engineering, Faculty of Engineering Lessons learned from Lean practices. Lab Focus. November 2007 Susan F. South and Jo Ann S. Hegarty. Using Lean to Identify Process Improvement Opportunities and Improve Effectiveness of Transfusion Professionals. September 2010 Mick Chomyn, Martin Fottles. TLA- The Lean Alternative. Path Links Pathology Service, U.K. Capitalizing on opportunities in cord blood industry growth. Bioinformant Worldwide, L.L.C. April 2012 Thomas Bart. Cost effectiveness of cord blood versus bone marrow and peripheral blood stem cells. October 2010 Susan F. South. Optimizing Transfusion and Blood Banking Services by Using Lean and Smart Automation Chih Wei Teng, Lucy Foley, Peter O Neill and Chris Hicks. Effective supply chain management in the regenerative health industry. October 2011 David A. Novis. Reducing Errors in the Clinical Laboratory: A Lean Production System Approach. September 2008, Volume 39, Number 9, Labmedicine

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