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

1. Willis C. Triplett, Pharm.D.
Tuesday, July 22, 2014
Continuous Quality Improvement For
Sterile Compounding Pharmacies

2. USP Chapter <797> 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 <797>

3. USP Chapter <797> 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 <797>

4. › 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

5. Continuous Quality Improvement
Plan-Do-Check-Act, is
commonly abbreviated
as PDCA

6. › 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

7. 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:

8. › In essence, CQI is like scientific research on the enterprise’s
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

9. › The PLAN revolves around picking the target that the team will improve;
› The target of the PLAN should be the system’s MOST CRITICAL WEAKNESS;
› The target is determined by a frank and (brutally) honest examination of the
system’s failures;
Continuous Quality Improvement

10. › 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

11. › 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 team’s 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

12. › 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

13. › 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

14. 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 (“that’s the way
we’ve always done it.”)
› The analysts and management determine whether the target
has been acceptably met, nearly met, or not met nearly well
enough;

15. › 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

16. › So, the remedy worked and we’ve improved our process,
memorialized it in policy, and adjusted our staff training.
We’re 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

17. › 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

18. › PLAN-DO-CHECK-ACT is how we learn and grow. If you don’t
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

19. › Questions, Comments, Criticism, Counterpoints?
› To learn more about this topic contact Willis Triplett at:
– willis.triplett@comply797.com