Healthcare providers depend on accurate and precise lab results in order to do their jobs well and give patients the best possible care. Often, laboratory results are the decision point in a patient’s treatment. With so much on the line, it’s no surprise that laboratories everywhere are committed to constant improvement.

This week (October 16-22) is Healthcare Quality Week, a week designated to celebrate and acknowledge the work of healthcare quality professionals perform all year round.  Quality professionals address many issues in the healthcare workplace including risk management, patient safety, and quality improvement.

In celebration of National Healthcare Quality Week, let’s have a closer look at some of the ways that laboratories contribute to patient safety and healthcare quality every day.

Quality control

Before running any patient specimens on a hematology analyzer, performing a pregnancy test, or assessing bacteria’s resistance to antibiotics, laboratory personnel run quality control (QC) on those tests. Samples with known values are tested: if the result isn’t right, everything stops until the lab can figure out why, and how to correct the problem.

Most QC is performed once daily, but some critical tests require that QC be run several times over the course of a day. If the results aren’t in the acceptable range, it’s an indication that something is wrong with the test, and patient results may be in question. Results are recorded and reviewed for outliers, shifts, and trends, in order to catch and correct instrument problems before they are severe enough to cause erroneous patient results. It’s also important that everyone in the lab takes a turn running QC samples for all tests they perform. Rotating QC is a way to assure that everyone can run the tests properly and get appropriate results.

Proficiency Testing

Laboratories must enroll in proficiency testing for all “regulated” analytes – all tests that are designated in the Clinical Laboratory Improvement Amendments  (CLIA). At least three times a year, labs receive “blind” specimens from proficiency testing providers. They must be tested exactly like normal patients, and the results are sent for evaluation. Failing scores follow a three-strikes rule. Once you’ve missed the mark three times for an analyte, you’re out; your lab can no longer run that test on patients until you’ve proven that you’ve implemented corrective action that has resolved the underlying problem and you can subsequently pass two new blind tests in a row.

Even when they’re only testing unregulated analytes, labs still need to be sure that everyone in their lab is doing the test correctly and can come up with an accurate result. They do this by “splitting” samples and sending them to another lab to see if the results match. The CLIA regulations require that they do this at least twice a year so that systemic problems can be identified before they might cause a risk to patients.

Labs Hire Specially-Trained Personnel

Not just anyone can work in a lab – the requirements for education and experience can be stringent, depending on the complexity of the testing, and only individuals who meet those criteria can hold core positions in a laboratory.

Laboratory directors and technical consultants tasked with oversight of the lab’s day-to-day operation typically must have advanced degrees and years of experience in clinical laboratory testing. Many testing personnel have degrees in clinical laboratory science and have passed exams to obtain national certifications as clinical laboratory scientists or medical laboratory technicians. Many lab personnel also attend seminars and complete continuing education courses every year to stay up-to-date on changes in the field.

Beyond initial qualification for the job, testing personnel must have their competency assessed at least annually, to show that they can interpret QC results, perform testing, and troubleshoot complex issues. New employees work under supervision until they are signed off on detailed checklists, and additional training is documented for the entire testing staff every time a new test or instrument is brought into the lab.

Labs Document Everything

The saying in the lab is that “if it’s not documented, it didn’t happen.” Lab staff document everything they do in order to maintain accurate records of testing, maintenance, training, and troubleshooting. Those records are kept long after the tests are reported, in case there’s ever a question about how the test was done or who did it. If results are corrected, the original is always retained as well – no covering up of errors! Those documents are checked every time a lab is inspected by a state regulatory agency or accrediting organization, and they’re also reviewed regularly as part of a lab’s internal quality assurance program.

Labs Assess Their Own Quality

It’s not enough to wait and respond to problems as they arise in a laboratory. A true commitment to quality means taking a proactive stance and watching for patterns that lend themselves to consistent quality improvement. A laboratory quality assurance program calls for regular assessments of the total testing process, from patient identification and specimen collection, all the way to calling critical lab results to physicians.

Regular collection of data and a periodic review of paperwork allow a laboratory to see areas that might need attention. Are maintenance worksheets clear and easy to fill out, or are the same mistakes being made on them over and over? Maybe they need to be changed to make them more user-friendly. Is the rate of mislabeled specimens going up over time? Maybe staff need to be re-trained on collection procedures and the lab’s specimen rejection guidelines.

Laboratories have an absolutely essential role in overall healthcare quality. Making sure that results are accurate and timely ensures that patients are able to get the best care as quickly as possible. A huge percentage of medical decisions depend entirely on laboratory test results, so it’s only natural that quality is always a laboratory’s highest priority.

About The Author

Jen is a Technical Advisor with COLA, where she helps laboratories to navigate the accreditation process and apply best laboratory practices to their work. She previously held a research and manufacturing position within the American Red Cross, and she is a licensed Medical Laboratory Scientist with over a decade of experience in high-volume hospital blood banks and core laboratories. She holds a Bachelor of Science degree in Human Physiology from McGill University and a Medical Technology degree from Dawson College. She is also a freelance science writer whose articles are featured on websites dedicated to consumer safety, renewable energy, STEM outreach, and science communication.

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