10 Trials of Lab Quality

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Tips for clinical laboratory professionals in implementing quality initiatives

1 Document Control
All too often, outdated documents with handwritten revisions can be found stuffed in drawers and posted throughout clinical laboratories. This can only mean a lack of proper document control. The use of current, validated procedures ensures consistency in the use of the highest quality standardized testing processes for patients. If your lab has issues with document control, it may benefit from training on what documents must be controlled and implementation of document control software.

2 Temperature and Humidity Monitoring
Have you ever encountered a temperature log that seemed forgotten, with the last readings entered months before? What about a recorded temperature that is outside of the acceptable range with no corrective action to be found?Temperature records are not kept just for CAP compliance, though this is a requirement. The intent of monitoring temperature is to ensure that reagents, supplies, equipment, kits and specimens are stored at appropriate, validated temperatures to ensure integrity of testing for the patient.

In order to ensure proper temperatures are maintained, all items to be stored in a refrigerator, freezer or room must first be evaluated for proper storage temperature. This fundamental step is often overlooked. Do not just assume that refrigerated means 2 to 8 degrees Celsius or frozen means -10 to -30 degrees Celsius. Manufacturers establish temperature specifications based on their own stability studies, and laboratories are obligated to follow these requirements.

Just as temperature monitoring is often ignored or done poorly, humidity monitoring is often overlooked. When humidity is found to be outside of acceptable ranges, often, no corrective action is implemented as potential solutions are seemingly too costly or complex. Has your laboratory performed a thorough evaluation of manufacturer and best practice stability specifications of temperature and humidity requirements for all reagents, kits, equipment and specimens? If not, your laboratory may have a serious compliance and patient safety risks lurking.

3 Non-Conforming Event Management
Errors and unexpected events occur in laboratories every day. Humans are fallible. Technology fails. Things just go wrong. Have you ever worked in a laboratory that rewarded you for pretending everything was perfect? Some labs proudly proclaim that they have not had a non-conforming event in months or even years! The only explanation for such a track record is that reporting of non-conformances is discouraged or even that non-reporting is positively reinforced. As laboratorians, we have an obligation to our patients to provide the highest quality services possible. The key to continuous improvement in the laboratory is to encourage reporting of non-conformances to facilitate elimination of root causes and continuous improvement.

4 QC Review
Daily performance of Quality Control is commonplace, but periodic trending of QC data, on the other hand, occurs less frequently. Evaluation of weekly, monthly and quarterly QC results allows for identification of QC issues that might otherwise go unnoticed. Furthermore, it allows for proactive course corrections before problems occur. Catching analytical issues before any impact to patients is certainly preferable to the alternative.

5 Validations
Imagine a laboratory that started clinical testing without completing the validation. There are also labs out there that get by with incomplete or subpar validations. Validations are what give the laboratory confidence in its test results. Without proper validations, we cannot be sure that we are supplying reliable results for our patients.

6 Instrument-to-Instrument Comparisons and Calibration Verification
Instrument-to-instrument comparisons and calibration verifications are often overlooked. Does your laboratory have multiple, identical instruments performing the same assay? If so, CLIA requires you to compare instruments performing the same test on a semi-annual basis. Calibration verification is the process of verifying agreement between materials of known analyte concentrations and measured values. This must also be done every 6 months. If these two requirements are not performed at the required intervals, your laboratory will not be in compliance and, more importantly, may not be aware of analytical issues with testing that may require corrective action.

7 Proficiency Testing
Many things can go wrong with management of proficiency testing. A lab could accidentally refer out a proficiency testing specimen, resulting in serious compliance issues and fines. A lab could neglect to sign up for commercially available proficiency testing (PT). If no commercial PT is available, a lab could overlook the necessity to design an alternative assessment program for that assay. If an unsatisfactory result is received, labs often fail to investigate thoroughly and eliminate root causes. If a satisfactory result is received, labs will frequently miss tell-tale trends that require proactive evaluation to prevent analytical problems from occurring.

8 Personnel Files
When was the last time a thorough audit of your lab’s personnel files was performed? Don’t assume that, if your Human Resources department keeps the files, your lab has no obligation to ensure they are complete. Personnel files are a commonly overlooked, but a critically important element of regulatory compliance. Elements such as training, education, qualifications, competency assessments and continuing education should be kept current. If CLIA comes to inspect your lab, they will want to look at all of your lab’s personnel files. If any are incomplete, those staff members will likely not be able to work until they ensure all required elements are in their files. The intent behind these files is to ensure that documentation is kept that only competent staff that are properly qualified and trained are able to perform patient testing.

9 Competency Records
Beyond ensuring that the proper documentation is in personnel files, a competency assessment program must ensure that all staff are competency assessed for all required elements for all assays that they perform within 6 months and 1 year during the first year of employment and annually thereafter. Tracking competency assessments and scheduling can become complex and confusing very quickly. Competency assessments continue to be a major area of focus for compliance with both CLIA and CAP. It pays to invest in software early on for management of competency assessments to ensure compliance and, more importantly, a competent workforce performing assays with a high level of patient safety.

10 Inventory Management
Has your lab ever run out of reagents, causing a delay in turnaround time? Have you ever run out of critical supplies? How frequently is your lab paying for overnight shipping due to a shortage in reagents or supplies? All of these situations indicate a lack of proper inventory management.

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About Author

Jennifer Dawson, MHA, DLM(ASCP)SLS, QLC, QIHC
Jennifer Dawson, MHA, DLM(ASCP)SLS, QLC, QIHC

Jennifer Dawson, MHA, LSSBB, CPHQ, DLM(ASCP)SLS, QLC, QIHC, is vice president of quality at Proove Biosciences in Irvine, CA.

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