Quality: An essential characteristic, property, or attribute;
character with respect to grade of excellence. Quality is
exceeding your customer's expectations.

A continuous quality improvement program makes sense for any organization, especially one that is in healthcare delivery and concerned with infection prevention. It lowers costs, improves the quality of service, and reduces nosocomial and post-op infections. Furthermore, if you are seeking accreditation, having a CQI program is mandatory. In this article I will give you ideas on how to start and maintain a CQI program in your facility.

What is CQI?
Quality improvement is a business strategy that requires the complete endorsement and support of all levels of management and staff. It is a systematic method that uses a statistical approach to:

• analyze systems and work processes;
• evaluate outcomes;
• look at process interrelationships;
• define bottlenecks;
• match people to processes; and,
• streamline and improve processes, priorities, programs, practices, and people

Important skills at making CQI a reality in your organization are:

• people skills;
• customer relations;
• system analysis; and,
• the ability to graphically represent outcomes.

To put together a successful CQI program, you must challenge idiosyncratic traditions that abound in healthcare delivery for their clinical and economic validity, and you must foster creativity and innovation. CQI does not accept the attitude of "We have always done it that way." To paraphrase a saying from a recent popular movie, CQI says, "Show me the results."

CQI Teams
Teamwork is essential if your CQI process is to succeed. CQI teams bring together employees from different departments, with different perspectives, and enable them to work together toward a shared goal of improvement.

Required elements for an effective CQI team are:

A coach: A good coach understands all the elements of a successful CQI program. The ideal coach is a consultant who is steeped in CQI theory and practice but knows nothing about the particular problems that motivated the CQI effort. This enables the coach to bring a fresh perspective to the discussion and ask questions such as "Why do you call the room outside the OR a sub-sterile room?" "Is the sterile field really sterile?" "Wouldn't the debris on your instruments be easier to clean off if you rinsed them right after they were used?" Once the CQI effort is underway, the initial coach passes the torch to a permanent member that the team has elected.

Team members: The structure of the team depends a great deal on the size and complexity of the organization. Ideally a team will consist of five to seven members representing all the departments that impact the quality of patient care. This may include the billing department, finance, and maintenance, as well as the clinical departments. CQI teams are appropriately called "cross-functional."

Ground rules: Without ground rules that are accepted and understood by all members, issues will inevitably trigger emotional debates that could sink the team before it ever gets a chance to do its work. A potential set of ground rules may include:

a) The welfare and care of patients is the number one priority.
b) Summaries of all meetings will be prepared and circulated before the next meeting.
c) If a member can't make a meeting, he or she must send a replacement.
d) Members will be respectful of each other and criticism will be constructive.
e) "Why" will be asked often.
f) All members will take joint ownership of final decisions.
g) Input from peers and outsiders will be sought between meetings.
h) Everyone will abide by the rules.

Outcomes: CQI teams must have the ability to focus on the outcomes, not the solutions, and be able to thoughtfully address their purpose for existence. The first question to ask is "what do we want the end result to be?" and then "how can we do it?" A potential problem, for example, might be patients complaining about how cold the OR is. The end result would be a reduction in (or elimination of) complaints about the cold. There are many possible solutions to the problem but probably only one that will satisfy all members of a properly staffed team.

CQI teams in action
The job of the CQI team is not just to find solutions, but also to develop a process to ensure that the solution is working. This is called "quality control" and it is defined as a system for verifying and maintaining a desired level of quality in a product or process by planning, continued inspection, and taking corrective action as required. It must be standards based, performance oriented, and managed with data, not emotion or opinion. Quality control involves writing down the approved elements of the process, statistically sampling that each element is performed satisfactorily, and then assigning responsibility to an individual for performance (who gets fired if it is not done). The probability that the process will achieve its goal is the sum of the probabilities of each element of the process.

Let's take a simple example:

The problem: You are using flash sterilization routinely for all your instruments between cases. Surgeons have been complaining that many instruments are not cleaned properly between cases. Debris is baked on to instruments, and they dull quickly and look dirty. Often, instruments will be missing from the set. Surgeons are threatening to quit using your facility unless something is done. The final straw is when a fleck of dried blood falls into a patient's eye during surgery.

The solution: A multi-disciplinary CQI team tackles the problem with the goal of always having clean, sharp, sterile instruments available for every procedure. Their solution is to buy more instruments, upgrade their CS or sub-sterile room, and hire a trained sterilization supervisor (you can see why finance is a critical team member).

Process validation: Process validation involves writing each step of the process into a procedure manual; describing how and when each step is to be sampled; and identifying a person or persons responsible for compliance. Let's say that step A describes what happened to the instruments immediately after they are used; step B is how they are transported to be decontaminated; step C is how they are cleaned and decontaminated; step D is how they are assembled into a tray; step E is how they are wrapped; step F is how and where they are stored, step G is how they are transported back to the OR; and step H is how they are presented into the sterile field.

In order to establish a probability of success that this procedure would accomplish the desired outcome, each step has to be sampled and charted on a quality control chart. Let's say that step A requires that immediately after use the instruments are to be placed into an enzymatic solution in a basin that are then covered for transport. The CQI team determines (probably through negotiation, although there are statistical charts that will determine the number that need to be sampled from a known universe in order to attain a desired probability of success) that all the instruments from the 100 cases per week will be sampled for compliance (easy to do). A maximum of six cases per week out of compliance is acceptable (upper limit). Two cases a week out of compliance would signal a point at which the team would want to examine if they were spending too much time on compliance (lower limit). It is not within the scope of this article to fully explain the rationale behind the establishment of upper and lower limits and it is not important, as you will see.

Each week, a mark is made on the QC chart showing the number of "failures." A failure is simply not doing what the procedure manual says needs to be done, for example, not covering the dirty instruments with the enzymatic solution, or not disassembling them properly, etc. As long as the failures stay within the upper and lower limits, the process is under control. The chart is posted in a readily accessible area so that everyone involved in the process can see what is happening. If the chart starts to creep upward, everyone can tell that it needs attention and corrective action can be taken.

In a typical healthcare setting the universe being sampled is rather small (compared to a manufacturing facility). Establishing the upper and lower limits, therefore, is somewhat less than an exact science. The point is to start somewhere and then adjust the limits as you gain experience.

Costs of Quality vs. Cost of Poor Quality
This may sound like a lot of work and difficult and expensive to do. However, it is easy to quantify just how expensive it is by keeping track of the costs of compliance. This is the cost of quality. What is the cost of poor quality?

The cost of poor quality in the manufacturing sector is easy to identify-it can be as high as 25 to 35 percent of profits. Unfortunately, no reliable estimates of the costs of poor quality in health care are available. But to better understand that costs of poor quality are useful CQI tools, let's examine the example I gave above regarding instruments in the OR. A patient is awaiting surgery in a prep area while the nurses and technicians are preparing the OR. As the instruments are unwrapped and set up in the sterile field it is discovered that some instruments important to the surgery are missing. Now track the costs of rescheduling the procedure, or the time and all the costs required to identify the problem and get it corrected. Are there costs to interview the negligent party and perhaps fire and replace him or her?

Consideration of this or any other single event does not constitute a cost of poor quality study. Closer examination of the event and acknowledgement that this type of problem is not isolated provides important insight into the potential costs of quality problems throughout the organization. Knowledge of these costs, coupled with a strong commitment to CQI, will, over time, result in spending less time correcting problems and more restful sleep at night.

Why is it that there is never enough time or money to do something right but always enough time and money to do it over?