Title of the Change Project Student ID. MSc in Healthcare Management, Institute of Leadership, Royal College of Surgeons in Ireland Header line 1 Header line 2 Header line 3 Implementation of a Lean, Cost Saving Process Improvement for the Detection of Clostridium difficile 13119028 MSc Healthcare Management Abstract Introduction: C. difficile infection (CDI) is the leading cause of hospital acquired diarrhoea worldwide. The early and accurate identification of CDI cases, along with the appropriate treatment and infection control measures, are essential for reducing severe patient outcomes and preventing transmission. In a laboratory undergoing Lean reorganisation, it was proposed to improve the process of detecting C. difficile by moving from a costly 2-step algorithm to a cost effective, Lean 1-step method, using Polymerase Chain Reaction (PCR). However, there are concerns in the literature that PCR may be overly sensitive and detect the presence of the organism in patients who are asymptomatic carriers, thus creating a false increase in positive cases. The Irish Guidelines for the Diagnosis and Management of C. difficile stress that if PCR is used as a stand alone test, positive results must be interpreted along with the clinical indications of the patient. Aims and Objectives: The aim of this change project was to implement a Lean, cost saving, process improvement for the detection of C. difficile in a large Microbiology laboratory. The objectives were to validate the new method against the old one, train staff, develop standard operating procedures (SOPs) and to establish if there were cost savings. The rates of C. difficile detected in the laboratory using PCR would also be examined against the old methods. Methods: The HSE Change Model was used to guide the process. A cost analysis and process map pre-change, created urgency and engaged stakeholders. Validation, training and development of new SOPs were used to plan and implement the change. Mainstreaming involved the evaluation of the objectives post-change. Evaluation: The validation showed enhanced sensitivity and specificity compared to the old method. There was a cost saving of €2000 over a 3 month period despite having tested an additional 200 samples. Since the implementation of the new method there has been no increase in the rates of C. difficile in the hospital. Conclusion: With the streamlined work-flow and the cost saving benefits, this change has been successfully implemented. Whether the positive effects seen at evaluation are sustained in the long term is unknown. Change is a continuous process and the on-going auditing of long term outcomes is essential to maintain improvements.

Implementation of a Lean, Cost Saving, Process Improvement for the Detection of Clostridium difficile Abigail Salmon, MSc Healthcare Management Introduction & Background Methodology Evaluation C. difficile infection (CDI) is the most common cause of hospital-associated diarrhoea and can cause potentially fatal infection especially when it occurs in elderly and other vulnerable patient groups1. Early and accurate laboratory diagnosis is essential to limit the spread of infection. In a large microbiology laboratory undergoing Lean reorganisation, it was proposed the testing for C. difficile be streamlined from a costly 2-step algorithm to a cost saving, Lean, 1-step method by Polymerase Chain Reaction (PCR). The cost of testing potential positive samples using the 2-step method was €55 per test, while testing using PCR is €6.35. However, there are concerns in the literature that PCR is overly sensitive and may pick up asymptomatic carriers, thus causing an increase in positive cases. The current Irish Guidelines for the Diagnosis and Management of C. difficile state that PCR can be used as a stand alone test, provided that positive results are interpreted with clinical indications of the patient1. Using the HSE Change model, the initiative was implemented under the 4 main headings. Objective 1: Sensitivity/Specificity, NPV and PPV for new method were very satisfactory Figure 2: Figures for Sensitivity, Specificity, NPV and PPV Figure 1: HSE Change Model 2 Objective 2: There is a cost saving of €2000 post change despite an increase in specimens tested. Figure 3: Cost analysis pre and post change Initiation Creating the sense of urgency was enhanced by using Cost analysis and Process Map pre-change. These showed wastage in the system. TOWS Matrix and Force Field Analysis helped identify additional risks to the change. Key stakeholders identified through Stakeholder Analysis. Objective 3: There has been no increase in C. diff positive specimens post change. Figure 4: % of C. diff positive specimens over 3 month period in 2014 and 2015. Organisational Impact The new method is both sensitive and specific when compared to the old method, maintaining a quality result for the patient. There has been no increase in the rates of C. difficile in the hospital and there has been cost savings due to the streamlined process for the department. Planning Validation results were shown to key stakeholders to create “buy in”. Ongoing training of staff and and writing SOPs were essential. Other stakeholders eg. Infection Control team kept aware and involved at all times. Aims & Objectives Aim: To implement a process improvement for the detection of C. difficile as part of a Lean reorganisation within a large Microbiology laboratory. Objectives To validate the new method to determine sensitivity/specificity. To determine the cost savings once implemented. To examine the rates of C. difficile in the hospital since the new method was introduced. Implementation New test commenced January. Monthly meetings with stakeholders. Ongoing support, education and communication with all staff from change agent Conclusion With the Lean process and the cost saving benefits, this change been successfully implemented. As change is an on-going process, auditing of long term outcomes is essential. Mainstreaming Evaluate Objectives to establish if the change resulted in improvements. Presentation of results to all staff. References 1. NCEC. (2014). Surveillance, Diagnosis and Management of Clostridium difficile Infection in Ireland: National Clinical Guideline No. 3. 2.HSE. (2008). Improving Our Services: A User’s Guide to Managing change in the Health Service Executive.