The question of quality.

The question of quality

Have you noticed lately that you are being questioned more and more about the validity of your laboratory results? Thanks to recent mass-media reports about both the reliability of lab procedures and the qualifications of those doing the testing, lab quality is now a hot topic. Congress is getting into the act by forming committees to investigate how well we perform our jobs (if only we could turn the tables).

When all is said and done, we will probably find ourselves in a catch-22 situation, with additional costly guidelines to follow yet no corresponding increase in reimbursement.

The best way to show one and all that results are accurate and reliable is through a quality assurance program. Quality assurance should not be perceived as a nuisance or mindless point-plotting to satisfy lab inspectors, but as a critical step in rendering effective medical care.

No one should question the need to assure the patient, physician, and ourselves that the work we are per forming is accurate. In our industry, we have to strive for zero per cent error. A defective line item can be returned or scrapped. A defective lab result, however, can do a great deal of damage before it is detected.

But is an error-free rate really feasible in a large automated laboratory? Probably not. My laboratory, for example, annually performs about two million tests. If our accuracy rate is 99.9 per cent, we would still send out 2,000 erroneous test results per year.

It is evident that there must be a final link in the quality assurance chain-the physician. Too often the physician accepts our results with blind faith. Questioning or repeating a test that doesn't jibe with the patient's clinical condition is also part of quality assurance.

In a medium-size to large lab, assigning a full-time quality control technologist to oversee the QA pro gram might be beneficial. This person should eat, breathe, and sleep quality. He or she would coordinate all QA data, insure compliance with regulatory guidelines, and work with lab supervisors to document the quasity of their operations. As a key member of the lab staff, the QA technologist would report to the director and keep that individual informed of all quality assurance activities.

Good quality assurance needn't be expensive. While you have to absorb the cost of external proficiency testing, you can enhance your QA program through such low-cost activities as blind specimen analysis. By splitting a specimen for a single assay and assigning a fictitious name to one half, you can check the accuracy and reproducibility of your lab system.

One of the most pressing quality assurance areas may be the satellite or physician's office labs that many of us support. All too often these limited-scope labs have userfriendly instruments that basically run themselves. Because personnel who perform lab tests at these sites usually have training and duties in other areas, they often neglect to document proficiency of testing. As "experts" in quality, we must impress upon them the need for quality assurance.

We should also be expected to provide QA support outside laboratory boundaries. The lab should take an active role in providing expert opinions for hospitalwide quality assurance activities undertaken by the tissue committee, the utilization review committee, and others.

One of the main sources of contention in many hospitals today is bedside testing. While the laboratory may lose the war to be responsible for this testing, we should at least win the battle to demonstrate a need for QA activities, including regular instrument calibration checks and parallel testing.

How well we deliver services should also be monitored. We should quantify the proficiency o our support personnel, as we do with technologists. How fast do clerical personnel respond to a phone call and obtain a test result? How fast do they transmit lab results to patient floors? Do phlebotomists have time to verify pa tient 1D? You get the idea.

We have not had to justify the quality of services till now, so perhaps some of us grew complacent The current media and government focus on lab quality may be a blessing in disguise if it keeps us on out toes and forces us to quantify the quality of our services.