The Impact of Blood Processing Deviations to the Organization’s Stakeholders

Capstone 3 – Analyze the Situation

Abstract

Blood establishments are responsible for actively ensuring that blood products meet regulatory specifications for safety and quality. The Supreme TACOs quality improvement team has implemented a plan to analyze root causes in the non-conformance of quality control testing and processing of blood products which occurred at Puget Sound Blood Center (PSBC) of Seattle, WA. The objective is to define input/output variables of the process, identify potential root causes and assess the impact of blood processing deviations to the organization’s stakeholders. The implementation of three Six Sigma quality tools (SIPOC, Ishikawa Fishbone, 5 WHYS) provided an opportunity to analyze the probable root causes. These are critical to visualize potential failure modes in the process and prioritize them to determine a strategy for correction and prevention. Previous research suggests that failure to establish, maintain, and perform standard operating procedures at blood establishments is frequently the root cause of inadequate test processes and results. These findings support the root cause analysis in determining that negligence in maintaining robust quality system documents and controls directly leads to adverse events involving transfusions. Financial ramifications, loss of reputation and market share value are considerable outcomes the organization must face. Furthermore, various customers and patients of PSBC are subject to avoidable harm without a mitigation plan. The next steps of this improvement project will explore solutions to address the root causes.

Keywords: Quality Improvement, Six Sigma, Root Cause Analysis, Blood Testing

Introduction

Puget Sound Blood Center (PSBC) received an FDA 483 warning letter in 2013 that identified numerous deviations from current Good Manufacturing Practice (cGMP) regulations for blood and blood products. Specifically, for the failure to perform standard operating procedures (SOPs) for assurance of quality control testing of blood products. Any failure to meet quality specifications in blood testing could lead to adulterated products issued to the general public. Similar to other medical laboratories, the quality of blood processed at PSBC has a significant impact on the organization, its customers and stakeholders. Therefore, a quality improvement project must be initiated to address failures in blood testing and processing.

The Supreme TACOs team focused on three areas to establish a plan to evaluate failures in blood testing and processing. Failures to investigate complaints, take corrective action on non-conforming test results and maintenance of SOPs for collection and distribution of blood are the most relevant deviations for this analysis. Using the DMAIC model to improve products and processes, a plan to understand the root causes for failed blood tests and processes will be implemented. Root cause analysis consists of problem solving practices that provide input data for effective solutions. The problem identified at PSBC requires different sources to measure the impact of the actual root cause.

Previous studies have resulted in successful implementation of six sigma quality tools to assure the quality of laboratory test results. According to Jairaman (2017), “the six sigma quality management system enabled us not only to look into the performance of our analyzers, but also take into account the pre-examination steps on specimen collection, transportation, and sorting and the post-examination steps on test interpretation and transmission.” In order to identify the root cause of testing failures at PSBC, hazard identification and failure mode analysis will be evaluated through the SIPOC diagram, Ishikawa Fishbone Diagram, and 5 Whys Root Cause Analysis quality system tools. This analysis will provide our team opportunities to measure the severity of the situation and later implement solutions.

Approach to Determine Root Cause

 According to Digging for the Root Cause, finding the root cause of a problem is much larger than many experts claim or understand it to be (Jing, G. G. 2008). The article claims that many resources provide tools without a clear explanation of the meaning behind root cause. Additionally, there are many sources that show cause and effect to its eventual ceaseless chain of causation (Jing, G. G. 2008). According to that theory there will never be a single root cause to a problem, but instead many potential causes. Supreme Tacos’ approach to finding the root cause involves three quality tools that would help outline the most frequent quality issues. The SIPOC, Ishikawa Fishbone, and 5 Whys quality tools will be conducted to identify and assess the potential root causes.

 Taking advice from Digging for the Root Cause,Supreme Tacos’ strategy was to focus on the causes with the highest frequency (Jing, G. G. 2008). By using the three aforementioned quality tools, the team could brainstorm what issues were most common to identify the root cause of the problem. The three quality tools would compliment each other to outline the causes that were within human control. Although this analysis has proven efficacy, there are limitations. It is imperative to focus on potential failures that were within the “span of control” (Jing, G. G. 2008). Any causes found to be outside of control should be not considered. For example, the presence of environmental factors like weather emergencies causing the problem.

Analyzing root causes that are within the “span of control” provides our team the ability to plan recommendations and implement changes. According to Getting To The Bottom of Things,effective recommendations can be made for root causes. It is beneficial to directly address root causes and generate specific changes (Rooney, J. J., & Hopen, D. 2005). Combining three tools and comparing their outcomes is an effective strategy to determine the most probable root cause.

Application of the SIPOC Tool

One option for assisting with the visualization of relevant components in a system is utilizing a SIPOC tool. SIPOC is an acronym that summarizes information about suppliers, inputs, processes, outputs and customers. This allows users to break down their system into five categories that can further define important details that are present at each level within a given system or organization. It is especially important when considering how to make improvements to a supply chain. When utilizing the SIPOC tool, it is often useful to start in reverse order and identify the customers first (COPIS). This allows the user to understand how the rest of the model impacts the customers, and in turn allows the user to make suggestions based on what will benefit the customer base (Hook & Hong, 2017). For this assessment, processes were reviewed using information from both Bloodworks Northwest (2017) and the American Red Cross (2019).

According to recent figures from Bloodworks Northwest (formerly PSBC), the organization provides approximately 55,000 transfusions every year (Bloodworks Northwest, 2017). This helps to provide the scope of reach for the processes that were previously implemented by PSBC. The SIPOC diagram is often used along with the DMAIC process for quality improvement. This tool can assist with the DMAIC “define” phase by establishing where problems may be occurring in a given system (Mishra & Sharma, 2014). The SIPOC tool can help uncover problems within the blood draw and collection processes at PSBC. The SIPOC model utilized for the purpose of helping define the potential root causes in this analysis is shown in “Appendix A.”

Application of the Ishikawa Fishbone Tool

The second quality system tool used was the Ishikawa fishbone diagram. The fishbone diagram is a commonly used tool for determining potential causes for a problem. According to ASQ, many causes are sorted into several categories by this tool and it is great for brainstorming (Fishbone (Ishikawa) Diagram. n.d.). The fishbone visually looks like a fish head and its skeleton. The fish head contains the effect, otherwise known as the problem statement. The skeleton is broken up into as many categories as needed which include the causes within. The major categories typically include methods, machines, people, materials, measurement, and environment (Fishbone (Ishikawa) Diagram. n.d.). The causes are then brainstormed and written down for all categories that apply.

In Algora et al.’s (2018) study, this quality tool examined all the possible reasons why personnel deviated from SOPs established by management. This type of tool helps generate questions of why and many different ways the problem could have occured. Supreme Taco’s chose the fishbone diagram because of its adaptability and utility for most situations with a problem statement. Furthermore, this tool was effective as a brainstorming tool and allowed the team to generate several possible causes. The Ishikawa Fishbone Diagram used for the purpose of uncovering possible root causes for the problems found at PSBC can be found in “Appendix B.”

Application of the Five Whys Root Cause Analysis Tool

A problem that reoccurs on a regular basis during a process is often due to a larger issue. To stop the issue from recurring, it is crucial to identify the true cause. The 5 Whys Root Cause Analysis (5Y) was chosen by Supreme Tacos because of its simplicity. When used correctly, it can be a very effective process. 5Y can be used to resolve a variety of issues including quality improvement, troubleshooting and problem solving (Mind Tools Ltd., n.d.). It is most effective when used by the individuals responsible for the process under investigation.

Starting with a problem statement, a team of individuals can work towards the root cause by asking, “Why did the problem occur?”, until they agree that they have reached the root of the problem. It is known to the team that the root cause has been identified when they can no longer answer “why?” (Pojasik, 2000). For more complex issues, teams may have to ask themselves “Why?” more than the recommended number of 5 times to get to the root cause. It can also be used with other quality improvement tools to further evaluate whether the true root cause has been identified. The 5 Whys Root Cause Analysis tool utilized for the purpose of identifying the potential root cause for the issues documented at PSBC can be found in “Appendix C.”

Analysis of Tools and Determination of Root Cause

 A strong quality system framework is important when ensuring that donated blood and blood components are safe for transfusion. Safety of donated blood is a process that begins with screening of volunteer blood donors and ends with recipient transfusion and follow-up. Whole blood or blood components are collected and sent for further processing and evaluation for safety after donor qualification. These evaluations include blood type determination, infectious disease testing and further modifications. If the blood products meet established quality control standards, they can then be distributed to hospitals and/or clinics for transfusion into patients. Products processed by the blood collection service personnel at PSBC were distributed for transfusion despite quality control testing failures. To identify the failing processes at PSBC and pinpoint the root cause, Supreme Tacos analyzed the outcome of three quality system tools.

SIPOC Tool

The SIPOC tool was implemented to visualize the processing of blood and blood components for transfusion at PSBC. Beginning in reverse order (COPIS), the customers that receive the outputs of the process are the hospitals and patients. The products received by the customers should have completed quality control testing and certification as result of the process and are considered the outputs. Following was the process which is critical to this evaluation. The process steps include blood collection from volunteer blood donors, separation of collected blood into components, packaging of the individual components, inspection/testing of the components, component certification and labeling. Blood samples, vials, reagents, equipment, labels and accessories for transportation are the required inputs for process implementation. Finally, the input suppliers are the volunteer blood donors, equipment and materials suppliers for the entire process.

In the case of quality control testing failures at PSBC, Supreme Tacos concluded from the SIPOC analysis that the issue must be within the process element. In step four of the process defined by the SIPOC, blood collection service personnel are responsible for carrying out blood product testing and inspection. If step 4 is not implemented correctly, the products may be inaccurately labeled fit for use and inadvertently distributed to hospitals and clinics for transfusion.

Ishikawa Fishbone Tool 

The Ishikawa Fishbone tool was implemented by Supreme Tacos to more thoroughly explore all of the potential causes. The categories that were selected for evaluation were measurement, materials, machines, processes and manpower. A number of causes were identified within each category. Additionally, the potential causes were further broken down by asking “why?” where applicable. The results of the effective brainstorming highlighted that the issues were occurring across all of the selected categories. While many causes were identified for each category, the blood collection service personnel’s inability to follow written SOPs was the most common. The identification of this cause is within our “span of control” and could lead to a specific solution.

5 Whys Root Cause Analysis Tool 

Supreme Tacos implemented the 5 Whys Root Cause Analysis tool to further evaluate the reason behind PSBC’s inability to follow written SOPs and get closer to identifying a potential root cause. The outcome of the Ishikawa Fishbone Diagram tool was used as the problem statement to begin the 5 Whys Root Cause Analysis tool. After answering “why?” six times, Supreme Tacos agreed that no further “whys?” were required beyond this point because no further answers could be concluded from the available information. The lack of leadership involvement and oversight to ensure that a quality environment is created and maintained was identified as the potential root cause in this case.

Conclusion

Based on the analysis conducted using the SIPOC, Ishikawa Fishbone, and 5 Whys quality tools, the Supreme Tacos team has concluded that the most probable root cause at PSBC was the inability to follow written SOPs by blood collection service personnel. The root cause of the problem is the substandard quality of the written SOPs used by laboratory technicians when implementing quality control testing procedures. There are several steps in the process between blood being received by the center and certified blood being distributed to hospitals in the Pacific Northwest. PSBC failed to establish control over these processes.

The SIPOC highlighted where the issue could have potentially taken place. The Ishikawa Fishbone diagram identified which potential causes were within the scope of control for a lead into possible solutions. Finally, the 5 WHYs allowed the team to decisively determine the true root cause of the problem by asking more specific questions about why each potential root cause occured, eventually leading to a final answer that could not be reasoned further. According to data published by the FDA, the most commonly cited observation for 483s concerning biologics during fiscal year 2017 was the establishment, maintenance and following of manufacturing SOPs. Of the 115 biologic-related 483s, 49 were found to have this specific problem.

Per the FDA, informing the recipient of this particular issue the 483 describes that there is a need for all written standard operating procedures in the manufacture of blood or blood component products to be followed. There is also often a failure to make the SOPs readily available to relevant personnel (U.S. Food & Drug Administration, 2018). While a failure to follow SOPs is a major cause for concern, the Supreme Tacos determined that a lack of leadership and oversight led to a failure to establish a quality environment that is maintainable by blood collection service personnel.

Continued failures can increase the risk of causing harm to the approximately 55,000 patients PSBC serves each year by distributing products that were not inspected with proper quality control measures. The FDA 483 can lead to long-term negative impacts on PSBC by causing a diminishment of reputation in the market when compared to competitors. Furthermore, the financial impact to shareholders is significant with thousands if not millions of dollars in losses due to consulting costs, testing and other efforts to fix the problems found in the 483 (Chen, 2018). In another analysis, it was estimated that on average it will cost the medical device industry between $2.5 and $5 billion per year for these observations (Fuhr, George & Pai, 2013). In order to move forward with the ‘improvement’ phase of the DMAIC process, the Supreme Tacos will seek to determine which methods for process improvement will address the problems present at PSBC.

References

• Algora, M., Grabski, G., Batac-Castro, A. L., Gibbs, J., Chada, N., Humieda, S., … & AbdelWareth, L. (2018). Challenges in Establishing a Transfusion Medicine Service: The Cleveland Clinic Abu Dhabi Experience. Archives of pathology & laboratory medicine, 142(10), 1233-1241.
• American Red Cross Blood Services. (2019). What Happens to Donated Blood. In American Red Cross. Retrieved from https://www.redcrossblood.org/donate-blood/blood-donation-process/what-happens-to-donated-blood.html
• Bloodworks Northwest. (2017). Lives Saved. In Bloodworks Northwest. Retrieved from https://www.bloodworksnw.org/about/lives-saved
• Bloodworks Northwest. (2017). What happens to my blood?. In Bloodworks Northwest. Retrieved from https://www.bloodworksnw.org/donate/what-happens-to-my-blood
• Chen, T. (2018, August 22). A Bad 483 Could Cost a Company Millions. In FDAZilla. Retrieved from https://blog.fdazilla.com/2018/08/what-does-getting-an-483-or-warning-letter-really-cost-you/
• Fishbone (Ishikawa) Diagram. (n.d.). ASQ. Retrieved from https://asq.org/quality-resources/fishbone
• Fuhr, T., George, K., & Pai, J. (2013, October). McKinsey Center for Government – The Business Case for Medical Device Quality. In McKinsey & Company. Retrieved from https://www.mckinsey.com/~/media/McKinsey/dotcom/client_service/Public%20Sector/Regulatory%20excellence/The_business_case_for_medical_device_quality.ashx
• Hook, C., & Hong, A. (2017). The supply chain BALANCING ACT. ISE ; Industrial and Systems Engineering at Work, 49(3), 44-49. Retrieved from http://turing.library.northwestern.edu/login?url=https://search-proquest-com.turing.library.northwestern.edu/docview/1879457435?accountid=12861
• Jairaman, J., Sakiman, Z., & Li, L. S. (2017). Sunway Medical Laboratory Quality Control Plans Based On Six Sigma, Risk Management and Uncertainty. Clinics in laboratory medicine, 37(1), 163-176.
• Jing, G. G. (2008). Digging for the root cause. ASQ Six Sigma Forum Magazine, 7(3), 19-24,12. Retrieved from http://turing.library.northwestern.edu/login?url=https://search-proquest-com.turing.library.northwestern.edu/docview/213858402?accountid=12861
• Mind Tools Ltd. (n.d.). 5 Whys Getting to the Root of a Problem Quickly. Retrieved from https://www.mindtools.com/pages/article/newTMC_5W.htm
• Mishra, P., & Sharma, R. K. (2014). A hybrid framework based on SIPOC and six sigma DMAIC for improving process dimensions in supply chain network. The International Journal of Quality & Reliability Management, 31(5), 522-546. Retrieved from http://turing.library.northwestern.edu/login?url=https://search-proquest-com.turing.library.northwestern.edu/docview/1512578160?accountid=12861
• Pojasik, Robert B. (2000). Asking “Why?” Five Times. Environmental Quality Management). Retrieved from https://search-proquest-com.turing.library.northwestern.edu/abiglobal/docview/233184327/AD98BBD935E5484FPQ/6?accountid=12861
• Rooney, J. J., & Hopen, D. (2005). Part 4: Getting to the bottom of things. The Journal for Quality and Participation, 28(2), 15-21. Retrieved from http://turing.library.northwestern.edu/login?url=https://search-proquest-com.turing.library.northwestern.edu/docview/219111204?accountid=12861
• Speer, J. (2015, August 31). HOW TO FLUSH $400,000 DOWN THE DRAIN FIGHTING THE FDA. In Greenlight Guru. Retrieved from https://www.greenlight.guru/blog/fda-483-observation-and-warning-letter-issues
• U.S. Food & Drug Administration. (2018). FY 2017 Inspectional Observation Summaries. In U.S. Food & Drug Administration. Retrieved from https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/inspection-references/fy-2017-inspectional-observation-summaries

Appendices

Appendix A – SIPOC Diagram

Appendix B – Ishikawa Fishbone Diagram

Appendix C – 5 Why Root Cause Analysis Tool