Lab results review

Just 41% of laboratories today use IT to reduce manual intervention according to a survey conducted by MLO in 2019 (Silva, 2019).  This means that over 50% of laboratories are still manually reviewing results as their primary process.

Manual Result Review

The clinical laboratory industry is highly regulated in how they manage the patient specimen from its point of origin to the final results release to the medical professional. Labs develop written policies and procedures to qualify patient results based upon regulatory agencies that specify the steps and conditions to approve results. Our laboratory industry regularly provides  best practices to logically review and make decisions (pre-determined review criteria) regarding the steps to take to finally provide a fully vetted result by type of test and process.

Labs enforce these pre-determined review criteria with their staff through written procedures, checklists, staff training, flow charts and diagrams to ensure that carefully  prescribed actions and activities are followed.

Many non-lab people ask me – what does it take to really approve results for release to the doctor? What are the characteristics and attributes of a result from an instrument or manual analytical process that a medical technologist must consider for a final qualification result?  How does a technologist mentally go through the process of checking the validity of a laboratory result before the technologist feels that a result is ready to report?

Result qualification - It is complicated!

The process of result qualification begins at the collection point through the point of generation of the result from the instrumentation. The result review process is multi-dimensional and There are many layers of analytical decision making that has to be performed for a fully qualified result. The data is be filtered through different analytical and clinical levels before releasing to system of record. The process of manually filtering, sifting, and correlating data using manual cues and written procedures is like following a flow chart in your head to arrive at a final result to report.

It many take many steps to resolve a simple analytical or instrument sample issue. Let’s review a common linearity example and the minimum steps needed to get to a final result.

Use Case: A glucose result is > 700 mg/dl and exceeds the instrument high measurement range of 600 mg/dl.

What steps would a technologist need to follow to get to a final result?

1.       Was the result numerical or non-linear or an invalid results format? Check the operational or instrument manual to determine next steps based on the instrument result or flag.

2.       Was there any visible sample integrity issues such as hemolysis or lipemia that may invalidate the test? Check the operational or instrument manual for a list of interfering substances and protocols. The sample may need to be recollected.

3.       If a flag was generated for a result issue – what type of flag? What does the instrument manual indicate is the next action?

4.       If a dilution is recommended for the result type - determine the diluent (saline) and dilution volume for the sample per the procedure or instrument manual. Make the dilution in a separate tube for analysis.

·        Example 1:2 dilution is ‘1 part in total of 2 parts’- The dilution factor is 2.

5.       Rerun the specimen in dilution on the instrument again.

6.       Multiply the new result by the dilution factor (2) to get the new corrected result.

7.       Verify that the new result is within the instrument analytical range of measurement and no other flags remain.

8.       Enter the new result in the reporting system as the corrected result per the procedural manual noting the dilution factor or other laboratory specific comments.

Mapping the manual review process is usually provided in laboratory policy and procedure manuals and documented using flow charts. Examples of review algorithms flow charts can be found in the CLSI AUTO-15 Autoverification Guidance document (CLSI, 2019). These flow chart diagrams represent what a technologist does to refine the result to a single reportable value to the clinician. A technologist in a manual review environment repeats this process over 100’s of times a day categorizing data into different decision points.

These decision points can be different for every laboratory, but in general there are four (4) layers of data review and qualification as displayed in Figure 1.

Manual Review is no longer sustainable

Technologists are trained to make judgements based on a plethora of data streams and observations – they are often called ‘diagnostic detectives’ of the clinical environment. They correlate and confirm data using a multitude of methodologies, best practices and their own expertise learned over time. There is great dedication and nobleness to finding the true result for every single specimen.

However – The process of reaching a result conclusion one sample at a time, manually, is not viable in today’s modern laboratory because:

• It takes too much time. Given that 70% of lab results are typically negative, that’s alot of time spent manully confirming routine results. What’s more, manual results review can never get faster and can’t help you improve your turnaround time.

Impact to you – how much time is it taking?

Do you know how long it actually takes to fully qualify a test or profile in your discipline? Assign a review time per discipline and multiply by the sample volume per shift to determine your manual review burden You might be surprised how much time that it takes to review each sample using manual methods. Could this be improved with technology to reduce even your review time by 50%, 60% or greater?

Download our Results Review Calculator to compute your time and cost of manual review activities by discipline. You might be surprised with the amount of time spent on manual review – time better spent on revenue generating tasks.

• Not the best use of precious resources. Lab technologist resources should be conserved only for the most precious technically demanding work. It is a waste for laboratory professionals to perform repetitive, manually tedious work.

• Increased use of generalists. Experienced technologists are often as rare as hen’s teeth in many markets. The growing use of Lab Generalists means relying on less technically knowledgeable staff to follow heavily manual procedures and processes.

• Manual processes are tedious and time consuming to maintain. All of the manual procedures and processes that direct staff to perform result review manually must also be verified and amended on a regular basis.

• Consistency is virtually unattainable. As much as we would like to think that all staff can work identically, and precisely according to written instructions and training, the human element will always introduce variability and therefore errors.

If we are describing your lab, then it’s time to seek automated software solutions that can help you offload manual tasks and processes. We aren’t just speaking about automated instruments or interface enhancements. We want you to look at software that cuts through and replaces routine human-based decisions with software decision rules. Software automation relieves and supports your team – it does not replace them.

Manual results review is not scalable

Lab volume is growing exponentially as our population ages along with a growing set of co-morbidity conditions. The demand on our lab resources change ‘by the hour’ - lab medicine is at an inflection point, a turning point for which most labs are not prepared to handle. To manage the expectations of our healthcare system, labs need to be able to scale. They need to be more flexible when faced with changes in lab volume, lab mergers, lab outreach as well as changes in the ability to add staff. When your lab is faced with a need to take on more, do more, do it faster, suddenly manual processing, especially manual result review, becomes a boat anchor, suffocating your lab from realizing its full operational potential.

•  Lack of lab technologist available to meet current volume or new volume:

  • Leads to: Delay in patient reporting, quality issues, result omissions and errors

• The process of data confirmation is more complex with more variables and data streams to consider:

  • Leads to: Errors, missing decision points, rare events, cross-discipline data correlecation

• Technologist insert their personal biases in how they qualify results:

  • Leads to: Inconsistencies in result qualification across technologist staff (newly hired to experienced technologists.

• Volume exceeds physical review capabilities:

  • Leads to: Technologist fatigue, errors in judgement, increased result tunaround time and possible care issues

It is time to act!

The traditional method of handling result review manually is worn out and is no longer sustainable, scalable, and certainly no match for the demands of the laboratory to flex and adapt to big changes in testing types and volumes. No lab in a post-pandemic world has immunity from layoff, furloughs, and drastic changes in operational models as we settle into a new normal where even small inefficiencies will not be tolerated. Unprecedented lab leadership and action is required to survive the next wave of virus activity that will impact lab operations in ways we cannot even anticipate. Act now to eliminate manual result review in your laboratory so you can be prepared to pivot faster when the next tsunami comes.

Inspire you. Imagine a world where you can free up more of your technologists’ time. What could that look like? Tahttps://www.mlo-online.com/information-technology/article/21117759/it-solutions-in-the-clinical-labke our ‘Imagination Survey’ to determine what you could do to change your current result review position.

References:

1.       CLSI (2019). AUTO-15: Auto-verification of medical laboratory results for specific disciplines, Clinical and Laboratory Standards Institute (CLSI), 2019.

2. Silva, B (2019). It solutions in the clincial lab. MLO. December 2019. Retrieved from https://www.mlo-online.com/information-technology/article/21117759/it-solutions-in-the-clinical-lab.

Let’s keep talking. Tell us how you qualify lab results and what you think will improve the process?