Root Cause Analysis Why should you dig deeper? Joe Cabaleiro, R.Ph. Gates Healthcare Associates LP3 Network Inc. MEDISCA Network Inc.
Disclosures Joe Cabaleiro declare(s) no conflicts of interest, real or apparent, and no financial interests in any company, product, or service mentioned in this program, including grants, employment, gifts, stock holdings, and honoraria. The American College of Apothecaries is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education.
Disclosures Joe Cabaleiro is a Facilitator of LP3 Network Inc. s copyright program materials and a Consultant for MEDISCA Network Inc. 3
Copyright and Disclaimer The material in this presentation is Copyright 2017, LP3 Network Inc. DISCLAIMER: The information contained in this presentation, which may include treatment modalities, diagnostic and therapeutic information, and instructions related to regulatory guidelines and current standards of practice for pharmacy compounding, is FOR EDUCATIONAL PURPOSES ONLY and should not be taken as a treatment regimen, product indication, suggested treatment modality, or suggested standard of practice. NOTE TO MEDICAL OR ALLIED HEALTH PROFESSIONALS: Any treatments, therapies, or standards of practice must be fully investigated and prescribed by a duly licensed medical practitioner in accordance with accepted professional standards and compendia. Any regulatory or practice standard must be fully investigated by a licensed pharmacist in accordance with accepted professional practice standards and compendia. The opinions and views expressed in this presentation are those of the presenter only, and do not necessarily represent the views of LP3 Network Inc.
Learning Objectives At the conclusion of this program, the participating pharmacist or technician will be able to: Explain what a root cause is Discuss the key elements of a root cause analysis Use the root cause analysis to develop a plan of correction Apply root cause analysis to address compounding pharmacy scenarios
Proximate Cause A proximate cause is an event which is closest to, or immediately responsible for causing, some observed result.
Root Cause A root cause is an initiating cause of either a condition or a causal chain that leads to an outcome or effect of interest.
Root Cause Analysis Cracked Head Incident In addition to being the PIC at Otter Compounding, you are head groundskeeper for your property. For the last 6 months, every time you walk out the door you have been seeing a dry, dead branch overhead. Three months ago, your wife mentioned Did you see the dead branch over the door? The night before the event, the National Weather Service issued a high wind alert for your area with risk of flying debris.
What is a Root Cause? The most basic cause (or causes) that can reasonably be identified that management has control to fix and, when fixed, will prevent (or significantly reduce the likelihood of) the problem s recurrence. OR A Root Cause is the absence of a best practice or the failure to apply knowledge that would have prevented the problem.
Corrective And Preventative Action Plan for Cracked Heads Choice A: I will train myself and my family to always look up when I walk out the door to avoid falling branches. Choice B: I will pick up a tree saw on the way home from the ER and when I get home, I will trim any other risky looking branches to prevent future cracked heads. I created a reminder to trim trees quarterly
Root Cause Methodologies Storytelling The Five Whys The Six Ms Many, many others.
Storytelling Not a true root cause analysis method We know this as incident or adverse event reports. What happened A description of the event Who made the mistake What are you going to do to prevent it Sometimes a checklist of root causes or categories
The Five Whys Invite anyone affected by the issue Select a leader for the discussion Ask why at least 5 times Identify the root causes as the results of the questions Develop and implement corrective actions for the root causes identified Develop and implement ways to verify the corrective actions taken were effective
Ben Franklin s Five Whys For want of a nail a shoe was lost, for want of a shoe a horse was lost, for want of a horse a rider was lost, for want of a rider an army was lost, for want of an army a battle was lost, for want of a battle the war was lost, for want of the war the kingdom was lost, and all for the want of a little horseshoe nail.
Otter Compounding Five Whys Symptom: Our buffer room failed viable air sample test. Why did we fail air and surface sampling? Because excessive numbers of Micrococcus luteus (15 CFU) and Staphylococcus epidermidis (7 CFU) grew out in buffer air sampling. Symptom: Bacteria are growing in our buffer room. Why would these particular bacteria grow in our room? They are both Gram(+) organisms. Gram(+) organisms in cleanrooms almost invariably come from humans in the room. Symptom: Human skin flora are somehow getting into the room. Why would human skin flora be in our cleanroom? Some pharmacists are not gowning when they run in to check.
Otter Compounding Five Whys Symptom: Pharmacists are not gowning to perform checks. Why are pharmacists not gowning when they run in to check? They say it takes too long. They say they have always done it this way and it is not a problem. Symptom: It takes too long to perform checks. Why does it take so long? There are so many checks built into our system, they are constantly having to enter and leave the room. Management has never facilitated/invested in a better way to do it. Symptom: Pharmacists do not understand this is creating risk. Why do they think it is not a problem when it is obvious it is? We have never trained them on the importance of proper garb; to them, it is just an annoyance to getting things done.
Otter Compounding Root Causes Root causes: Pharmacists require more thorough training on cleanroom behaviors. Plan: Checking pharmacists will be re-educated regarding appropriate cleanroom behaviors. Pharmacy supervisor will be responsible for assuring no one enters the room without appropriate garb. The pharmacy lacks a system for remote pharmacist checks. Plan: A camera system will be evaluated. How will we verify effectiveness of corrective actions? Room will be retested immediately to verify the corrective action was effective. PIC will observe that no one goes into the room ungowned.
Insufficient Supervision - An Overlooked Root Cause Pharmacists are busy consulting, checking etc. as a result: Sterile/Non-sterile compounding personnel are not closely monitored Pharmacists rarely go into cleanroom to observe compounding technique and garb Pharmacists rarely go into cleanroom/compounding room to check cleaning/disinfection The checking pharmacists wear blinders Focus is on documentation and prep, not how it was made
Retest Results The pharmacy reaches out to Slick s Cleanroom & Septic Tank Service Co. for a retest. The buffer room results are now: Micrococcus luteus (10 CFU) Staphylococcus epidermidis (0 CFU)
Why? Symptom: There are still excessive CFUs in our room Why did Micrococcus grow again? We know it comes from humans in the room, so we must still have gaps in garbing or cleaning. Symptom: Upon interview, a technician noted: Slick s air sampler head was dirty Slick wore sloppy clothes and shoes Slick barely washed his hands Slick pulled down his mask to scratch his nose during sampling Why are we allowing Slick to use such poor technique in our cleanroom? Boss, you said go with the cheapest & that was Slick
Root Cause & Plan Root Causes The pharmacy lacks an SOP for qualifying and monitoring certification vendors. Management is not considering the impact of their purely financial decisions. Plan An SOP for qualifying certification vendors will be developed and implemented. The PIC will observe & videotape certifications We are firing Slick and will retest with a qualified vendor.
We Also Have to Consider Who? Who else might be affected by this event? Do we need to warn patients/physicians? Do we need to do a recall? Do we need to go through our orders/prescriptions to determine if other patients are affected? Who else do we need to include in this analysis? USP <797> guidance: Highly pathogenic microorganisms (e.g., Gram(-) rods, coagulase-positive Staphylococcus, molds and yeasts) can be potentially fatal to patients receiving CSPs and must be immediately remedied, regardless of CFU count, with the assistance of a competent microbiologist, infection control professional, or industrial hygienist.
Knowing Your Flora. Micrococcus luteus Soil, dust, water & air Normal human skin flora Human mouth, mucosae, oropharynx and upper respiratory tract 96% of people carry M. luteus Highest rates: skin of head, legs and arms* *Kocur, M., Kloos, W.E., Schleifer, K.H. (2006) The Genus Micrococcus. In M. Dworkin, S. Falkow, E. Rosenberg, K.H. New York: Springer, pp. 961-971
Knowing Your Flora Cleanroom microbiology, Sandle T and R. Vijayakumar. PDA, 2014
Gram(+) Flora The most common cleanroom flora Microccocus luteus Non-pathogenic head, legs and arms Staphylococcus aureus Pathogen common on hands and face Other human Staphylococcus opportunistic pathogens S. epidermidis & S. capitis skin and head S. hominis S. haemolyticus
Gram(+) Flora Bacillus some pathogens (B. cereus) Spore formers Soil dwellers tracked in on feet, equipment, cardboard
Gram(-) Flora Pseudomonas aeruginosa pathogen Likes waterfront property sinks and drains
We Will Talk About Mold & Fungi Later!
The Six Ms - Another Useful Tool Man physical or knowledge work Machines equipment and technology Method processes and procedures Materials raw materials, consumables, Measurements data Mother Nature environmental factors
Man How was staffing at the time of the event? Are staff qualified and competent? Properly garbed? Thoroughly cleaned and disinfected? Actions or inaction from staff Horseplay and talking? Overlooking spills or other sources of contamination? Other staff factors: Fatigue Substance abuse Lack of focus Failure to follow procedures
Machine Is equipment working as designed? Are we using the right equipment? Is equipment being used correctly?
Method Are we using the correct method? Do we have a procedure? Was the procedure followed?
Materials Did we have the correct materials? Were our materials stored/handled properly? Were our finished preparations properly QC ed?
Measurements What do our measurements tell us? Temperature Humidity Potency Weights
Mother Nature How does mother nature influence the issue? Geographical location Yuba city vs Yukon territories Weather conditions Local environment around the pharmacy
Cleanroom Equipment Example
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Mold and Fungi Cleanroom microbiology, Sandle T and R. Vijayakumar. PDA, 2014
Consider the Cleanroom Shoes Human feet 1,291 molds 598 yeasts Including: Penicillium Aspergillus Cleanroom shoes are a good idea, but do not leave them in the anteroom when not wearing them. Probably the second dirtiest thing in the room after the humans!
Plan of Correction Once you understand proximate and root causes develop a written plan Address all findings Timetable for correction Assign responsibility Establish how effectiveness of corrective actions will be assessed
The Swiss Cheese Model* Contaminants HEPA Filters Cleaning & disinfection Garbing and Gowning Aseptic Technique *Reason, James (1990-04-12). "The Contribution of Latent Human Failures to the Breakdown of Complex Systems".
The Swiss Cheese Model* Moldy HEPA Filter Contaminants Skipped Cleaning & disinfection Bad Garbing and Gowning Poor Aseptic Technique Contaminated CSPs *Reason, James (1990-04-12). "The Contribution of Latent Human Failures to the Breakdown of Complex Systems".
In Summary Plug the holes in your Swiss Cheese before an adverse event happens! Pro-Active is better than Retro-Active RCA will allow you to thoroughly address an adverse event and prevent recurrence RCA is becoming an accepted part of regulatory requirements and is legally required in some cases. Always ask How will we know our corrective measures were effective?
In Summary The 5 Whys is a simple root cause analysis technique In the practice of pharmacy, we cannot ignore the Who The 6 Ms can help assure that you consider all the important aspects of your investigation.
Questions?
Need More Information? Joe Cabaleiro, R.Ph. Gates Healthcare Associates LP3 Network Inc. MEDISCA NETWORK Inc. Web: www.lp3network.com Email: info@lp3network.com