CQI and PDCA for Sterile Compounding Pharmacies

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Introduction to CQI for managers and operators of sterile compounding pharmacies.

Transcript of CQI and PDCA for Sterile Compounding Pharmacies

  • Willis C. Triplett, Pharm.D. Tuesday, July 22, 2014 Continuous Quality Improvement For Sterile Compounding Pharmacies
  • USP Chapter states: A provider of CSPs shall have in place a formal QA program intended to provide a mechanism for monitoring, evaluating, correcting, and improving the activities and processes described in this chapter. Emphasis in the QA program is placed on maintaining and improving the quality of systems and the provision of patient care. In addition, the QA program ensures that any plan aimed at correcting identified problems also includes appropriate follow-up to make certain that effective corrective actions were performed. USP Chapter
  • USP Chapter further states that characteristics of the QA Program shall include: 1. Formalization in writing; 2. Consideration of all aspects of the preparations and dispensing of products as described in this chapter, including environmental testing and verification results; 3. Description of specific monitoring and evaluation activities; 4. Specification of how results are to be reported and evaluated; 5. Identification of appropriate follow-up mechanisms when action limits or thresholds are exceeded; and 6. Delineation of the individuals responsible for each aspect of the QA program. USP Chapter
  • Often abbreviated as CQI; Refers to a PROCESS of IMPROVEMENT that reiterates continuously the moment it succeeds, it targets the next weakness and starts all over again from the beginning; The same steps are followed in the same order with each iteration of target problem-improvement; Those steps are PLAN-DO-CHECK-ACT. Continuous Quality Improvement
  • Continuous Quality Improvement Plan-Do-Check-Act, is commonly abbreviated as PDCA
  • CQI based on the belief that, no matter how good a business process is, it can be improved, and that no matter what the current state of our process is, we can and should strive toward a new, higher performance target. Continuous Quality Improvement
  • Management notes that HIPAA violations are occurring too often HIPAA violations found to center on pack and ship process Pack and ship team members retrained Outsourced pack and ship couriers retrained HIPAA violations still occurring too often HIPAA violations still occurring too often HIPAA violation incidence falls by 90% Pack and ship work flow redesigned Example of CQI in action:
  • In essence, CQI is like scientific research on the enterprises own results; It is based on statistical evaluation and requires faithful compilation of accurate performance records. In most organizations, the source of such information will be the enterprise software; Each iteration of PLAN-DO-CHECK-ACT is an experiment to see if the problem has been remedied to an acceptable level of risk. Continuous Quality Improvement
  • The PLAN revolves around picking the target that the team will improve; The target of the PLAN should be the systems MOST CRITICAL WEAKNESS; The target is determined by a frank and (brutally) honest examination of the systems failures; Continuous Quality Improvement
  • The choice of target is based on a weighing of the difficulty of the improvement versus the importance of the failure. Continuous Quality Improvement (Vital) 10 9 A 8 7 B 6 E C 5 4 F D 3 2 G (Trivial) 1 Z 1 2 3 4 5 6 7 8 9 10 Very Difficult (Very Easy) ImpactorImporatance Difficulty Among these choices, A would be the first target and B would be the second. Life is probably too short to ever get to Z
  • Picking the right target is a vital management decision, since CQI resources are always limited. The PLAN must be focused on only one activity at a time within a given team. There can only be one top priority at a time. Management must maintain a laser-like focus on the success of the PLAN. It must never be forgotten or lost in the shuffle; The PLAN must make sense to the teams workers and the goal must be desirable in their eyes. It will not succeed unless they see the need for it. Management should educate the team regarding what it means to them. Continuous Quality Improvement
  • Once the target deficiency is chosen, the team meets to identify and rank the most likely root cause(s) of the problem; After consensus is reached regarding the root cause(s), the remedy is designed. In a large organization, the remedy should be tested in one site, one department, or one unit; The chosen unit is retrained to operate according to the remedial process. Once trained, the unit begins to DO. Continuous Quality Improvement
  • The DO stage is the actual experiment on the remedy; The test department begins to operate in the new way, and the results are collected and compiled carefully for a prescribed period of time; (a week, a month, a quarter, etc.) Continuous Quality Improvement
  • Continuous Quality Improvement After sufficient data have been collected and compiled in the DO step, the results are analyzed in the CHECK step; The analysts contrast the actual results of the new process (the remedy) versus the historical results (thats the way weve always done it.) The analysts and management determine whether the target has been acceptably met, nearly met, or not met nearly well enough;
  • If the remedy has achieved the target goal, it is accepted as the new way things will be done. (Adoption) Policy and Procedures are altered to reflect the remedy (the new way we do this) Existing staff will be retrained in the new way company-wide. New hires will be taught according to the new way.; If the remedy caused improvement, but not enough to meet the goal, the PLAN team reconvenes to make further changes, and the DO step starts all over again; (Adaptation) If the remedy failed to cause any improvement in the target goal, the team starts all over again with a new PLAN step. (Abandonment) Continuous Quality Improvement
  • So, the remedy worked and weve improved our process, memorialized it in policy, and adjusted our staff training. Were done, right? Feet up on the desk? Time to kick back? Sadly, we only kick back if all of our other results are perfect. Otherwise, we identify our next-most-important problem and start another cycle of PDCA. Back to work! Continuous Quality Improvement
  • PLAN-DO-CHECK-ACT always works; PLAN-DO-CHECK-ACT does not always work the first time. In creating the tungsten filament light bulb, Edison failed hundreds of times before he succeeded. He was asked if he hated wasting his time, with the hundreds of failures. His answer was that none of the hundreds of failures were a waste of time because each one showed that a proposed solution DID NOT WORK. What would really be a waste of time is trying the same non- working solution more than once. Continuous Quality Improvement
  • PLAN-DO-CHECK-ACT is how we learn and grow. If you dont believe me, just watch an infant moving to toddlerhood. Every step: Rolling over; Hands and knees; Standing up by holding onto fixed objects; Standing up without support; Taking the first step; Taking multiple steps; Walking; Running. involves PDCA on the part of the infant. Every graduation involves goal-setting, experimentation, success/failure, evaluating results, contrasting against the old way, and changes in policy. Continuous Quality Improvement
  • Questions, Comments, Criticism, Counterpoints? To learn more about this topic contact Willis Triplett at: willis.triplett@comply797.com