Who says you re competent?

Transcription

1 Who says you re competent? Eric Kastango MBA, RPh, FASHP ClinicalIQ, LLC 1

2 Disclaimer Although I am a member of the USP Sterile Compounding Expert Committee, I am speaking today in my individual capacity and not as a member of the Committee or as a USP representative. The views and opinions presented are entirely my own. They do not necessarily reflect the views of USP, nor should they be construed as an official explanation or interpretation of <797>. 2

3 "For 42 years, I made small, regular deposits of education, training and experience... and the experience balance was sufficient that on January 15th I could make a sudden, large withdrawal Chesley Sullenberger 3

4 Why Training? It is a requirement State Board of Pharmacy The Joint Commission Hospital policy What do your employees need to know to do their job accurately and consistently? Who trains new employees? What does a pharmacist need to know? What does a technician need to know? Is there an opportunity to revisit how we educate and train employees? 4

5 Brutal Facts March 2011, Alabama Serratia marcescens associated infections and deaths associated with contaminated parenteral nutrition prepared by a compounding pharmacy Scenario At least nineteen case of infection, 9 deaths from Serratia infection associated with parenteral nutrition (PN). Pharmacy used nonsterile components to prepare the PN-amino acids. The environmental contamination (sink, mixing tank, stirrer) that was found (genotype/phenotype) was the same found in the infected patients. Root Cause (probable) Untrained compounding personnel Failure to achieve sterility Improper use of filter

6 Training Quality On your first day, you brought a high-level of experience and knowledge to the organization. In training, we capitalized on your existing skills and began an educational development process to standardize your compounding skills and ensure that you were adequately prepared to meet the daily challenges of aseptic processing. Your participation and preparation prior to any training program is critical to your success. We can only build on the knowledge base you bring to training. Each of us must maintain our own ongoing personal training. Adapted from Continental Airlines Pilot Training Manual,

7 How, What and Where? Listservs ASHP Connect, IJPC, APIC, PDA, PMF Pharmacy, Purchasing and Products Magazine ( Almost every topic re: USP Chapter <797> has been written about at least once American Society of Health-System Pharmacists Compounding Sterile Preparation Series CriticalPoint,LLC The Course in Sterile Compounding The Virtual Compounder Lab Safety Corporation VALITEQ series 7

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13 Conscious Competence Learning Matrix Awareness: Learning is occurring Knowledge Ability Competency Proficiency Ignorance Wisdom: Knowledge is intuitive

14 Does Training = Learning? We should probably stop using the word training, but just in case, let s review why it s inappropriate. Training is something you do to someone. Learning is something people do for themselves. You hope people learn from training, for that is the objective. Adapted from 8 Dirty Words, Jay Cross. 14

15 One only knows something if one can explain it Giambatista Vico, 1710, constructivist philosopher Adults take knowledge and connect it to other information they hold true, changing their understanding in the process, as in this mock hazardous drug cleanup exercise. 15

16 Training Quality Content unaccompanied by monitoring and coaching is not always successfully transferred to practice, and may diminished (wear off or fade) over time requiring periodic reminder sessions. Education must be repeated as staff turnover 16

17 Four-step process Job Instructional Breakdown Prepare the worker. The trainee is prepared by getting him or her interested in the job and then asking him or her about similar experience. For example, "We re going to learn how to do finger-tip sampling. What do you know about this job?" The trainee is put into the correct position to do the job. This reinforces readiness to learn how to do, rather than simply what to do. Present the operation. The trainer gives verbal instructions demonstrating the job and stating the important steps, repeats the process to add the key points and repeats it again to add the reasons for each key step. Try out performance. The trainee repeats the process, first doing the job without talking, then stating the important steps, then adding the key points and finally listing the reasons why. By now, the trainer will know whether the trainee has learned the process or whether some of the steps need to be repeated. Follow- up. After training, the trainer follows up and continues to coach, providing input and answering questions for the trainee until the trainer is confident the operator knows the job. 17

18 What is Glove Fingertip Sampling Glove Fingertip Sampling detects the presence of microorganisms on the fingertips of gloves. Squamous cells are normally shed from the surface of the human body at a rate of a million or more per hour and these skin particles are laden with microorganisms. A Pharmacy ES Plan is a program of activities to measure both the microorganisms and particles in the controlled compounding environment and on surfaces like gloves. Copyright CriticalPoint - All rights reserved

19 What is Glove Fingertip Sampling? Detects transient organisms on gloves from poor aseptic technique or improper disinfection of gloves. Is one part of an ES program that also includes Air Sampling and Surface Sampling. Uses agar plates to test for microorganisms. Copyright CriticalPoint - All rights reserved

20 Poll questions Do you conduct glove fingertip sampling testing on your employees? YES NO 20

21 Initially Where and When? Prior to preparing CSPs for human use Must complete successfully at least 3x Successfully complete an initial hand hygiene and garbing competency evaluation and gloved fingertip/thumb sampling procedure Sample taken immediately after donning sterile gloves to verify that compounder can garb without contaminating hands Passing results: Colony Forming Units (CFU) both hands = 0. Copyright CriticalPoint - All rights reserved

22 Where and When? (continued) Ongoing basis 1. At the time Personnel Aseptic Media Fill is performed 1. Annually (low/medium risk) 2. Semiannually (high risk) 2. DO NOT disinfect gloves with sterile 70% IPA immediately prior to testing (false negative). 3. Obtain sample while employee is in ISO Class 5 environment during preparation of personnel media-fill units but not immediately after gloves have been disinfected with sterile 70% IPA. 4. Passing results if collected in ISO Class 5 air: 3 CFU Copyright CriticalPoint - All rights reserved

23 5 Stages of Glove Fingertip Sampling The following slides will provide a step-by-step process to help you to properly perform Glove Fingertip Sampling. It may help to remember the proper sequence by using the acronym PSOID: Prepare Set-up Obtain Incubate Document Copyright CriticalPoint - All rights reserved

24 Performing Glove Fingertip Sampling The following section leads you through the process of performing glove fingertip sampling. The entire process is broken down to individual steps that are easy to understand, and are generally considered basic steps to take at any pharmacy. However, it is important to read your own pharmacy s SOP (standard operating procedure) to be knowledgeable about specific requirements at your organization. Copyright CriticalPoint - All rights reserved

25 Gather Supplies 2 TSApl (tryptic soy agar with polysorbate and lecithin plates) needed for sampling, plus one extra of the same lot number to be used as a field control Tape Black Permanent (e.g. Sharpie) Marker ES Documentation Form Pen Sterile Gloves Sterile 70% isopropyl alcohol (IPA) Lint free wipes Bin to bring supplies into cleanroom Copyright CriticalPoint - All rights reserved

26 Set-Up Prep Area Lay supplies out on a clean counter which has been wiped down with sterile IPA. Allow plates to come to room temperature. Remove outer packaging of media. Transfer three plates to counter. Replace unused plates in refrigerator. Copyright CriticalPoint - All rights reserved

27 How to Inspect Media Inspect each plate for: Packaging integrity: do NOT use if package integrity is compromised. Growth: Do NOT use if growth is present. If growth is present, report this to the manufacturer and obtain a replacement lot. Expiration dates: do NOT use if plates are expired. Copyright CriticalPoint - All rights reserved

28 Poll question Do you inspect your media prior to using it? Packaging integrity Growth Shrinkage 28

29 Label Plates Label the back of each plate using the black Sharpie marker; include: Employee initials LH (left hand) plate RH (right hand) plate Date Time taken Sampler s initials Label control plate as control and tape the top to the bottom in 2 places. Place each plate back into the clean bin after it is labeled. Copyright CriticalPoint - All rights reserved

30 Document Media Document the following on the Glove Fingertip Form: Name of the person obtaining the plates Date samples obtained Manufacturer Lot # of medium Expiration date of medium For the initial Test CFU Action Level is Zero Copyright CriticalPoint - All rights reserved

31 Enter Buffer Area Bring clean bin containing supplies into the ante area. Perform hand cleansing and garbing following your pharmacy s established policy and procedure. Enter buffer area and observe the identified employee compounding. Copyright CriticalPoint - All rights reserved

32 Identify and Sample Employee Perform as part of the initial employee garbing and gowning assessment process Employee to perform garbing and gloving procedure with sterile gloves Employee must NOT disinfect their gloves PRIOR to taking the sample. All employees must be successfully complete an initial garbing and gloving exercise three times with ZERO (0) CFUs. Copyright CriticalPoint - All rights reserved

33 Poll Question Have all employees who compound sterile preparations successfully demonstrated proficiency in donning sterile gloves with ZERO cfus? YES NO 33

34 Identify and Sample Employee (continued) Sample both of employee s gloved hands upon completing the compounding procedure (media fill or other) Employee must NOT disinfect gloves PRIOR to taking the sample. Carefully remove the cover of the agar plate without touching the interior surface of the plate. Place the cover of the plate face up on a clean surface in either the primary or secondary engineering controls. Copyright CriticalPoint - All rights reserved

35 Obtaining the Sample The compounder should gently touch the agar surface with all fingertips and thumbs of one hand. The fingertips and thumbs should create a slight impression on the agar surface. The plate should be covered with the lid and the sampling procedure should be repeated for the other hand. Copyright CriticalPoint - All rights reserved

36 Seal the Samples and Document Secure the top and bottom of each plate with tape in at least 2 locations. Place all sealed plates into the clean bin with the control plate and other supplies. Remove bin with all supplies and sealed plates from cleanroom. Copyright CriticalPoint - All rights reserved

37 Discard Gloves and Wash Hands At the conclusion of the sampling, the compounder should remove and discard the sampled gloves. The employee must wash hands and don a fresh pair of gloves before starting any new compounding. Copyright CriticalPoint - All rights reserved

38 Incubate Samples Invert the plates so that they are upside down and immediately place them into the incubator. Plates should be incubated for 48 hours at 35 C + 2 C. Document the time the plates were placed in the incubator. Copyright CriticalPoint - All rights reserved

39 Reading the Results When incubation is complete, remove the plates from the incubator. Without opening the plate, read the results by counting the number of individual colony forming units (CFUs) that appear on the plate. Read the control plate; it should have no CFUs. Document the results in the correct space on the Glove Fingertip form that corresponds to the left or right hand. After reading the plates, they need to be properly disposed of as hazardous waste. Copyright CriticalPoint - All rights reserved

40 How to Interpret and Documents Results Test results are said to fail if the number of CFUs per 5 fingers & thumb exceed Zero (0) for the 3 initial tests and 4 or more CFUs for subsequent tests. Copyright CriticalPoint - All rights reserved

41 Documentation Complete all required elements of the Glove Fingertip documentation form. File the form for Manager review per established policy. Discard plates that are within established limits. Copyright CriticalPoint - All rights reserved

42 How to Handle Out of Limit CFUs If any CFU counts exceed established levels, retain the plate(s) in question. Do not discard any plates bearing unacceptable results. Report out of limit results to the appropriate manager immediately. Depending upon your institution s procedures, additional action will probably be required; this will usually involve retraining the compounder regarding hand hygiene, garbing procedures, and glove disinfection and then retesting them. This plate has more than 10 CFUs Copyright CriticalPoint - All rights reserved

43 Training in the USP <797> Compliance Framework Understand Regulation Assess Risk Level Identify Compliance Gap Develop Action Plan Implement Compliance Plan Competency & Control Training can help: Assimilate new staff: get into control, educate on a facility s practices, build baseline knowledge to become compliant with the way we do things Make sure everybody does it the same way according to policy and procedure. Maintain competency: remain in a state of compliance by demonstrating continued competency This is reflected in the compliance framework: get into control, then stay in control. Training and education is a key component of the compliance process: not a one-time event, but a continuing cycle of training, assessment, and improvement. Chapter <797> Compliance State of Compliance (point in time) Compliance process imagery licensed under , 2010 Clinical IQ, LLC. Some rights reserved. 43

44 Ways to evaluate your training Consider evaluating your training activities in four key areas: Is it appealing? Is it dynamic? Is it practical and job related? Is it authoritative? Will staff want to engage in the training program, or view it as a check the box exercise? What can be done to improve appeal? Introducing new learning methods? Is it updated to include recent changes (like the new chapter requirements!) or to reflect literature that has been published with best practices? Is there a clear linkage between what people need to do in their job, and the training they receive? Do staff receive feedback based on observations before and after training takes place? Does the training reflect processes that take place at the facility, and do they accurately communicate the concepts and requirements of the chapter? 44

45 Considerations for Training Program Development Recognize that USP <797> Changes Ingrained Behavior Research shows that training plays a big role in changing ingrained behaviors, particularly if new practices are different from what people know from the their experience Some compounding processes have critical steps or precise order. Training does two things: explain why it needs to be done correctly (rationale), and how to do it (process) Incorporate JIBs or checklists Opportunity to emphasize professional skills development Enlightened facilities view training as an opportunity to improve skills, morale, and engagement vs. a simple requirement. Supported by the literature Studies show that using multiple training techniques increases retention and competency (therefore didactic and hands on requirements for critical compounding steps) Addition of other methods (such as simulation) can be expected to yield further improvements 45

46 Excellence is an art won by training and habituation. We do not act rightly because we have virtue or excellence, but we rather have those because we have acted rightly. We are what we repeatedly do. Excellence, then, is not an act but a habit. Aristotle 46

47 Thank you My contact information: Eric S. Kastango, MBA, RPh, FASHP Clinical IQ, LLC 184 Columbia Turnpike, Suite 4, #282 Florham Park, NJ