Quality Assessment: Evaluating the Process

An activity that can have a great impact on your laboratory is quality assessment (QA). Quality Management Systems (see our new feature Insight Into QMS) refers to this activity as internal assessment, and it is about reviewing and studying your laboratory system, paying particular attention to the interaction of all of its processes. Let’s look at quality assessment in this process-oriented way, focusing on ways to evaluate your laboratory system with its unique combination of environment, personnel, and processes. 

QA is a self-assessment activity, and is your opportunity to learn more about how you do things. You can confirm what works well, and identify where you can alleviate or even eliminate sources of frustration and rework that impact the day to day work environment.

Laboratory management should set up an internal quality assessment plan using a systematic approach to analyze operations in each phase of the laboratory path of workflow: general/administrative, pre-analytic, analytic, and post-analytic. Select processes or activities to monitor based on the likelihood for problems to exist and the level of impact should the process not be performed correctly or fail to deliver the intended outcome. Consider the impact on customer satisfaction, the quality of lab results, costs, and patient or employee safety.

You need to be willing to be honest when performing an assessment focusing on a particular activity. Sometimes we are too close to our own work, so we have difficulty recognizing failures in our own process. Sometimes our sense of ownership is too strong to allow us to admit an error or oversight. Your immediate customer can provide valuable feedback to help you. For instance, the phlebotomist may not realize the impact of a problem with collecting a single tube of blood for a panel of tests even though the specimen has to be shared by two different departments in the laboratory. This increases the amount of work and it may delay availability of the test results or even contribute to incorrect results if pour-off tubes aren’t properly labeled. By listening to feedback or shared insight, a better process can be designed so any and all phlebotomists will be able to easily tell if multiple tubes are required without having to rely on memory.

We also suggest that when possible, the individual reviewing the current process be someone who does not work in that area. Have the Chemistry supervisor conduct process assessments for Hematology. Have the Hematology supervisor conduct an assessment of Microbiology. Use the Microbiology supervisor to assess Phlebotomy. Each of these individuals brings an independent and unbiased view of how work is conducted in that area. They have no personal stake in the outcome that might obscure or influence their observations.

This is particularly useful when analyzing or investigating process problems. The individual does not need the expertise to solve the problem – that will be the responsibility of those with expertise in the area and authority to institute changes. The individual conducting the assessment is simply a neutral pair of eyes and ears. Give them the written policy, process map, or procedure and let them observe the work in progress. Let them interview various levels of staff to determine how well the process is understood, how effective communication is, and how unusual situations are handled.

Look for the activity or process which is draining your resources (people, money, time). Imagine the outcome if the process was improved and how efficiency is enhanced, expenses are decreased, cost savings are realized, or customer satisfaction is increased.

Table 1 lists a few examples of activities to review.

[Inset box]  Laboratory Path of Workflow / Activities to Review
Phase    Activity
General/Administrative Customer complaints
Pre-analytic   Specimen labeling / patient identification
Analytic Corrective action for maintenance, calibration, performance specifications, and quality control
Post-analytic   Critical value reporting

Effective quality assessment is more than just using a checklist to document that tasks were performed. What value do you realize by using a checklist to verify your personnel files are up to date each January? This should be part of the employment process.  Wouldn’t it be more useful to look at the future plans of the lab, results of internal and external assessments, as well as results of your personnel competency assessments to uncover opportunities to improve staff knowledge and performance, and to prepare for future staffing considerations such as retirement of a supervisor or expansion of laboratory services? You can then determine whether your efforts and resources should be directed towards designing a laboratory-wide training activity or setting up a remedial training in reading differentials for your part-time staff.

A great place to start would be to identify an activity that would actually benefit from process assessment. For instance, review customer and employee complaints. Look at the end of the process to determine if the outcome is influenced by a performance flaw. As we know, patients seldom “officially” report a bruise or painful venipuncture as a result of specimen collection. But you can be assured they have shared their “bruise” experience with everyone in their family or workplace. For every reported customer complaint about a venipuncture misadventure there are probably five that did not get dropped into your complaint box. By examining the complaints submitted into your complaint process, you can determine the frequency of complaints based on the type of activity, analyze those activities that if not corrected would have the greatest adverse impact on your business or patients, and investigate potential causes and brainstorm what can be done to prevent a reoccurrence.

A problem can have a minor to major impact on patient care or safety. Not every problem warrants a quality assessment review but even minor issues need investigation if they are repetitive. Even a small problem can cause a lot of repeat work that wastes resources.

Begin the correction phase of your assessment activity by classifying each problem or issue as to whether it is related to:
- process (failure in a policy, procedure, or system)
- knowledge (inadequate knowledge, ability, or training)
- behavior (willful disregard)
Knowing the type of problem is the first step to finding the root cause and is a key piece of information needed before attempting to design corrective actions. Your correction wouldn’t be successful if you try to fix a process issue, such as a computer software problem, by creating a training aid to improve personnel knowledge of computer data entry. The problem isn’t with the tech entering the data; the problem is with the parameters set up in the computer application.

Keep several things in mind as you design and implement your quality assessment plan:
- Establish your assessment schedule to focus on an activity in each phase of the laboratory path of workflow.
- Study an activity over a period of time rather than once to get a true picture of performance over time.
- Select those activities that when reviewed, studied, and improved would give you the most bang for your efforts.
- Determine an effective corrective action for the issue based on the nature of the problem: process, knowledge, or behavior.
- Communicate the assessment findings, corrective actions, and outcomes to all stakeholders, particularly laboratory staff.
- Implement corrective actions and monitor future performance
- Document everything

We all want to be better and provide quality in all we do. Think of quality assessment as an opportunity to make your laboratory practice a quality-focused organization. Target those activities that, once improved, will result in increased efficiency, revenue, and customer satisfaction.