4.1.1-1 OMS Overview
Illuminating the Path to ISO 15189 (SLMTA 3) e-Learning Course Download Video
- Overview
- Resources
An effective Occurrence Management System (OMS) facilitates the continuous improvement effort by identifying process problems or potential problems that can affect patient safety, consume resources, and adversely impact the ability to provide quality services. Understanding the process interactions within an OMS can play a pivotal role in designing an OMS that is able to utilize a risk-based approach towards prioritizing, designing, and implementing improvement projects.
QMS 4.1 References
Ames, M. (n.d.). Quality Snapshot - Corrective Action. Retrieved March 1, 2015, from American Society for Quality Knowledge Center Webcast: http://asq.org/knowledge-center/webcasts.html
Ammerman, M. (1998). The Root Cause Analysis Handbook. Portland: Productivity, Inc.
Andersen, B., & Fagerhaug, T. (2006). Root Cause Analysis: Simplified Tools and Techniques. Milwaukee: American Socieity for Quality, Quality Press.
Andrew, W. (2007, December). A Role for Root Cause Analysis in Laboratory Medicine. Lab Medicine, 38(12), 709-712.
Astion, M. L., Shojania, K. G., Hamill, T. R., Kim , S., & Ng, V. L. (2003). Classifying Laboratory Incident Reports to Identify Problems that Jeopardize Patient Safety. American Journal of Clinical Pathology, 18-26.
Barker, T., & Noguez, J. (2015, January). The High Cost of Low Morale in the Clinical Laboratory: How Workplace Environment Impacts Patient Safety. Clinical Laboratory News, 24-25.
Berman, S. (2003, August). Using Aggregate Root Cause Analysis to Improve Patient Safety. Joint Commision Journal on Quality and Safety, 29(8), 434-439.
Boysen, P. G. (2013). Just Culture: A Foundation for Balance Accountability and Patient Safety. The Ochsner Journal, 13, 400-406.
Burnett, D. (2013). A Practical Guide to ISO 15189 in Laboratory Medicine. London: ACB Venture Publications.
CAPA Part 1: Improving CAPA Systems with a Closed-loop Methodology. (n.d.). Retrieved March 10, 2016, from Master Control: http://www.mastercontrol.com/downloadables/customervideos/standalone.html?c=115
CAPA Part 2: Taking Effective Action. (n.d.). Retrieved March 10, 2016, from Master Control: http://www.mastercontrol.com/downloadables/customervideos/standalone.html?c=116
CAPA Part 3: Effectiveness Checking and Management Review. (n.d.). Retrieved March 10, 2016, from Master Control: http://www.mastercontrol.com/downloadables/customervideos/standalone.html?c=120
Clinical and Laboratory Standards Institute (CLSI). (2004). Application of a Quality Management System Model for Laboratory Services: Approved Guideline (GP26-A3) (3 ed., Vol. 24). Wayne, PA: Clinical and Laboratory Standards Institute.
Clinical and Laboratory Standards Institute (CLSI). (2006). Laboratory Documents: Development and Control; Approved Guideline GP2-A5 (5 ed., Vol. 26). Wayne, PA: Clinical and Laboratory Standards Institute.
Clinical and Laboratory Standards Institute (CLSI). (2007). Management of Nonconforming Laboratory Events: Approved Guideline (Vol. 27). Wayne, PA: Clincial and Laboratory Standards Institute.
Clinical and Laboratory Standards Institute (CLSI). (2009). Risk Management Techniques to Identify and Control Laboratory Error Sources: Approved Guideline - Second Edition (EP18-A2). Wayne, PA: Clinical and Laboratory Standards Institute.
Clinical and Laboratory Standards Institute (CLSI). (2011). Quality Management System: Continual Improvement; Approved Guideline (QMS06-A3) (3 ed.). Wayne, PA: Clinical and Laboratory Standards Institute.
Clinical and Laboratory Standards Institute (CLSI). (2013). Laboratory QMS Certificate Program Module: QSE Continual Improvement.
Clinical and Laboratory Standards Institute (CLSI). (2013). Laboratory QMS Certificate Program Module: QSE Documents and Records.
Clinical and Laboratory Standards Institute (CLSI). (2013). Laboratory QMS Certificate Program Module: QSE Introduction.
Clinical and Laboratory Standards Institute (CLSI). (2013). Laboratory QMS Certificate Program Module: QSE Process Management.
Clinical and Laboratory Standards Institute (CLSI). (2013). Quality Management System: Development and Management of Laboratory Documents; Approved Guideline (QMS02-A6) (6 ed.). Wayne, PA: Clinical and Laboratory Standards Institute (CLSI).
Clinical and Laboratory Standards Institute (CLSI). (2014). Undertanding the Cost of Quality in the Laboratory; A Report QMS20-R. Wayne, PA: Clinical and Laboratory Standards Institute (CLSI).
Clinical and Laboratory Standards Institute (CLSI). (2015). Nonconforming Event Management (QMS11) (2 ed.). Wayne, PA: Clinical and Laboratory Standards Institute.
Clinical and Laboratory Standards Institute (CLSI). (2015). Process Management (QMS18). Wayne, PA: Clinical and Laboratory Standards Institute (CLSI).
Clinical and Laboratory Standards Institute. (2013). Laboratory QMS Certificate Program Module: QSE Nonconforming Event Management.
Cochran, C. (2003). The Continual Improvement Process: From Strategy to the Bottom Line. Chico, CA: Paton Press LLC.
Cochran, C. (2010). Problem Solving in Plain English. Chico, CA: Paton Press LLC.
Cochran, C. (2015). ISO 9001:2015 In Plain English. Chico, CA: Paton Professional LLC.
Connor , M., Duncombe, D., Barclay, E., Bartel, S., Borden, C., Gross, E., . . . Reid Ponte, P. (2007, October). Creating a Fair and Just Culture: One Institution's Path Toward Organziational Change. The Journal of Quality anf Patient Safety, 33, 617-624.
Dawson, J. (2016). Cultivating a Culture of Quality. Retrieved May 1, 2016, from https://www.aacc.org/store/thought-leadership/10600/cultivating--a-culture-of-quality-in-the-laborat...
Dawson, J. (2017, February 9). Do No Harm: Diagnostic Errors and the Lab. Retrieved from http://www.labtestingmatters.org/do-no-harm-diagnostic-errors-and-the-lab/
Dawson, J. (2015, July-August). Navigating ISO 15189. Retrieved from MedicalLab Management: https://www.medlabmag.com/article/1201/?search=navigating%20ISO%2015189
Dawson, J. (n.d.). What's the Cost of Poor Quality? Measure the Value of Your Lab's Quality Program With the CoPQ Calculator. Retrieved from : LabLeaders
DiMaria, J. (n.d.). ISO 9001:2015 What are the changes? Retrieved May 6, 2016, from http://bsi.learncentral.com/aicc/9kChanges2016US/index_lms.html
German, R. (2014, April 24). “Use of a Nonconforming Events (NCE) Information System in the Laboratory to Select Key Indicators of Quality, and Meet AABB and CAP Requirements for Quality Management.”. Retrieved February 18, 2016, from Otis: http://www.youtube.com/watch?v=ONmUIvpxZz8&feature=youtu.be
Homer, M. (2019, February 26). After death of St. Luke’s patient, review uncovers 122 issues with blood labels over four-month period. Retrieved from KHOU 11: https://www.khou.com/article/news/health/after-death-of-st-lukes-patient-review-uncovers-122-issues-...
Institute for Quality Management in Healthcare (IQMH). (2014). Decoding ISO 15189 Interactive Online Education Series: Module 7 - Occurrence Management.
International Organization for Standardization (ISO). (2012). ISO 15189: 2012 Medical laboratories -- Requirements for quality and competence.
ISO 9001:2015 Part 1: Prepare for Impending Changes. (n.d.). Retrieved March 5, 2016, from Master Control: http://www.mastercontrol.com/downloadables/customervideos/standalone.html?c=128
ISO 9001:2015 Part 2: New QMS Structure Overview. (n.d.). Retrieved March 6, 2016, from Master Control: http://www.mastercontrol.com/downloadables/customervideos/standalone.html?c=137
ISO 9001:2015 Part 3: Risk-based Thinking Goes from Implicit to Explicit. (n.d.). Retrieved March 6, 2016, from Master Control: http://www.mastercontrol.com/downloadables/customervideos/standalone.html?c=145
Kopec, D., Levy, K., Kabir, M., Reinharth , D., & Shagas, G. (2005). Develpment of an Expert System for Classification of Medical Errors. Student Health Technology Information Journal, 114, 110-116.
Master Control White Paper. (n.d.). Simplifiying CAPA: Seven Steps to a Comprehensive CAPA Plan.
Master Control White Paper. (n.d.). How to Kick-Start Your CAPA Process.
Murphy, J., Dropp, K., Allstetter, P., Taylor, L., & Heath, C. (2009, My/June). The Root Cause Analysis (RCA) Process, One Step at a time. Topics in Patient Safety (TIPS), 9(3), pp. 1-3.
New York State Department of Health, Wadsworth Center. (2010). Guidance for Implementing a Laboratory Quality Management System.
Newitt, V. N. (2019, March). Labs add safety net to critical values procedure. Retrieved from CAP TODAY: https://captodayonline.com/labs-add-safety-net-to-critical-values-procedure/
Njoroge, S. W., & Nichols, J. H. (2014). Risk Managment in the Clinical Laboratory. Annals of Laboratory Medicine, 34, 274-278.
Noble, M. (2019, February 4). GB/T32230: Quality Culture and the Medical Laboratory. Retrieved from : Making Medical Lab Quality Relevant
Okes, D. (2009). Root Cause Analysis: The Core of Problem Solving and Corrective Action. Milwaukee: American Society for Quality, Quality Press.
Okes, D. (n.d.). Getting the Defects Out of Root Cause Analysis Webcast. Retrieved March 10, 2016, from American Society for Quality Knowledge Center Webcast: http://asq.org/2013/12/quality-tools/getting-the-defects-out-of-root-cause-analysis.html?WT.ac=CAR-3...
Osegbe, I. D., Zemlin, A. E., Kimengech, K. K., & Erasmus, R. T. (2013, June). The Impact of Non-Conformances on Patient Care at a Pathology Tertiary Care Laboratory In South Africa. Medical Technology SA, 27(1), 29-32.
Pendergraph, G. E., & Gruber, E. J. (2012). Risk Management in the Clinical Laboratory. MediaLab, Inc.
Rivenburgh, D. (n.d.). How to Create a Virbrant, Thriving Culture. Retrieved March 2, 2016, from American Society for Quality Knowledge Center Webcast: http://asq.org/knowledge-center/webcasts.html
Robitaille, D. (2003). The Preventive Action Handbook. Chico, CA: Patton Press.
Robitaille, D. (2004). Root Cause Analysis: Basic Tools and Techniques. Chico, CA: Paton Press LLC.
Robitaille, D. (2009). The Corrective Action Handbook (2 ed.). Chico, CA: Paton Press LLC.
Rooney, J. (2011, April). RCA for Beginners: Part 2 - Practical Application. Retrieved March 3, 2016, from American Society for Quality Knowledge Center Webcast: http://asq.org/2011/04/root-cause-analysis-for-beginners-part-2-webcast.html
Rooney, J. (n.d.). RCA for Beginners: Part 1 - A Conceptual Overview. Retrieved March 2, 2016, from American Society for Quality Knowledge Center Webcast: http://asq.org/knowledge-center/webcasts.html
Rosenstein, A. H., & O'Daniel, M. (2008). A Survey of the Impact of Disruptive Behaviors and Communication Defects on Patient Safety. The Joint Commision Journal on Quality and Patient Safety.
Smith, C. A. (n.d.). Promoting High Reliability on the Frontline. Retrieved from :American Nurse Today
VA National Center for Patient Safety. (2015). Root Cause Analysis Tools: Root Cause Analysis (RCA) Step-By-Step Guide. U.S. Department of Veteran's Affairs.
Vinton, E., & George, C. (2014, May/June). Staff leadership Key to Enhancing the Root Cause Analysis Process. Topic in Patient Safety, 14(3), pp. 1,4.
Wachter, R. M., & Pronovost, P. J. (2009+, October 1). Balancing "No Blame" with Accountability in Patient Safety. The New England Journal of Medicine, 361(14), 1401-1406.
Westgard, J. O., & Westgard, S. A. (2014). Basic Qaulity Management Systems. Madison: Westgard QC, Inc.
World Health Organziation, Regional Office for Africa. (2015). Stepwise Labarotry Quality Improvement Process Towards Accreditation (SLIPTA) Cheklist (ver. 2:2015).
Instructor(s)
![](/uploads/facilitators/elde_4.png)
Elde Mel Paladar
Mr. Paladar led the redesign of the classroom-based SLMTA 3 curriculum for on-line delivery and will serve as an instructor and facilitator of the e-learning course. Based in Malawi, he is a Project Manager at Adventist Health International, as well as Assistant Professor at the Department of Clinical Laboratory Science, Loma Linda University. Mr. Paladar has a Master of Science in Biochemistry and Molecular Biology. He is a SLMTA master trainer and has trained numerous laboratorians in the past decade.