Most labs are between a ‘rock and a hard place’ when it comes to thoroughly testing their auto-verification rules. Labs are in a difficult position because they have to resource the testing activities at the expense of using these same resources for revenue-generating tasks. The dilemma is too often the case as labs evaluate their regulatory compliance for annual rules testing against their scarcity of qualified lab personnel. In-depth auto-verification rule testing, spot-checking or no rule testing is often sacrificed so that the lab general operational goals can be met daily. Limited quality activities focusing on only the failures according to Quintenz and Williams, increases costs and adds to the overall lab budget over the long-term (Quintenez & Williams, 2018).

Auto-Verification - Benefits vs. Cost

The benefits of implementing autoverification rules come with many rewards and many benefits can be achieved with auto-verification technology.

Streamline the first-pass review of results to > 90%
Decrease tech handling of individual specimen review to < 10%
Improve result review standardization to nearly eliminate non-conformances or errors
Decrease result turnaround time from order to physician review
Increase sample capacity to improve revenue generation

If laboratories utilize auto-verification rules to streamline result review, increase capacity and standardize result output, there is a cost of good quality.

Creation and maintenance of a rule quality assurance program
On-going training and competency assessment of personnel responsible for rule construction & maintenance
Periodic rule performance assessment and quality audits
Rule testing events based on the lifecycle of the rules/rules base
Rule non-conformance impact evaluation and mitigation

The Cost of Quality Explained

The cost of quality for any organization including a clinical laboratory organization should follow the standard definition according to the American Society for Quality (ASQ, 2019). The primary costs for quality in the context of the clinical laboratory can be divided into three categories: Appraisal costs, Internal Costs, and External Costs.

Appraisal Costs: These costs are associated with the cost of verification, auditing, and confirmation.
Internal Costs: These costs are the issues or problems identified before delivery to the patient.
External Costs: Costs that are incurred after delivery results to the patient.

Cost of Good vs. Poor Rule Quality

A good auto-verification rule program factors in the cost of testing and verifying rule veracity periodically. Good quality is the practice of reviewing rules operation on a periodic basis and ensuring that they are fully tested annually. Poor quality is hastily testing your rules when implemented and employing little or no oversight to rules testing over time.

A Good Auto-verification Rule Quality Assurance Program includes these key aspects to the overall rule maintenance program that identifies issues before the delivery of patient results.

Cost of Good Rule Quality

Poor Auto-verification Rule Quality Assurance Program has to react to the following when there is little or no rule quality assurance allocated to reviewing, verifying, and monitoring your rule performance. These are costs that are incurred when patient results have to be changed or altered after delivery to the patient.

Cost of Poor Rule Quality

The Cost of Rule Quality Example Illustrated

The cost of one rule issue can multiply across the organization and can cost the laboratory thousands of dollars to mitigate.

Cost of Quality Calculation – Auto-Verification Rule Issue

Background: Test X – two rule outcomes issues with formatting to the LIS based on the rule construction and testing error.

Cost of Quality Calculation based on hard and soft costs of the issue.

Cost of Quality Summary

The cost of one rule issue with two outcomes could have a devastating impact on the clinical laboratory. Once the rule failure and incorrect result formatted was identified with one patient result to the medical professional, all results based on the rule trigger had to be investigated. If the results were reported erroneously based on the rule format issue, then all invalid results would need to be investigated and corrected in the LIS. A chart review would need to be performed to determine if any patient harm was inflicted. This rule issue could negatively impact the reputation and have economic consequences for the laboratory.

The entire week’s results will be called into question. Those results need to be re-evaluated, and if any affected information was submitted from the laboratory, it will need to be retracted. If the results leave the laboratory and reach the patient, those invalid results could negatively affect patient treatment and negatively impact your auto-verification program. Failure to properly test the rule result options could easily incur over $100,000 in costs for correction, analysis, re-work, and evaluation of the cost to patient safety.

Good to Best Quality – How to Achieve

The cost of good quality for the support of the auto-verification program is the money spent to achieve a quality laboratory service offering before the results are delivered to the patient. The cost of poor quality for an auto-verification program is the money spent to fix the problem after results are delivered to the patient. Implementing a comprehensive auto-verification rule assurance program will not only improve the quality of your auto-verification rules but in the long term will maintain or increase your auto-verification rate to optimize your laboratory performance. Jennifer Dawson, an industry expert on lab quality, encourages laboratories to invest in quality programs over the long haul as short-term savings eventually impact the quality of laboratory result delivery (Dawson, 2017).

The continuous improvement in your auto-verification program could be a differentiator and competitive advantage for your clinical laboratory. But more importantly, a rule quality assurance program is your insurance against delivering incomplete or insufficient laboratory results to your patients that could also negatively impact your laboratory's reputation. The costs of trading resources for thorough rule verification should be evaluated against the risk of poor quality that will eventually erode the integrity of your auto-verification rules. A deficient or broken auto-verification rule program is costly to remedy later when the harm has already been done.

Reference

ASQ, (2019). Cost of Quality. American Society of Quality. Retrieved from https://asq.org/quality-resources/cost-of-quality.
Dawson, J. (2017). What’s your copq? quantifying the value of the laboratory quality. MedicalLab Management Vol 6, No 6, Page 12, July-August 2017. Retrieved from https://www.medlabmag.com/article/1393.
uintenz A. & Williams, P. (2018). Exploring cost of quality in the lab. Medical Lab Observer. Retrieved December 21, 2018, from
https://www.mlo-online.com/management/qa-qc/article/13017214/exploring-cost-of-quality-in-the-lab

Between a Rock and Hard Place – Quality Auto-verification Rule Testing