In today’s environment, point-of-care coordinators (POCCs) have more to do in less time and with fewer resources than ever before. Likewise, Laboratory and Respiratory Departments are juggling “lean” initiatives along with shrinking resources. At a recent point-of-care meeting I attended, many POCCs seemed to have slumped shoulders; they were feeling the weight of increased regulatory burdens and the transition to Individualized Quality Control Plans (IQCPs).
However, IQCPs may be easier than they seem. For those who manage blood gas testing in the laboratory, in RT departments, or at the POC, IQCPs can positively impact managers, staff, and patients. The time and effort to develop IQCPs allow continued use, or initiation of non-traditional quality control (QC) processes found in some blood gas systems to automate quality management programs.
What is IQCP?
The Clinical Laboratory Improvement Amendments (CLIA) IQCP program adopts principles from the Clinical Laboratory Standards Institute (CLSI) Evaluation Protocol 23 (EP23): Laboratory Quality Control Based on Risk Management.1 The implementation process begins with collecting information from the manufacturer, regulatory agencies, and scientific literature and information about the specific environment where testing occurs. This includes conducting a risk assessment that spans the entire pre-analytical, analytical, and post-analytical process for testing and reporting results. The ultimate goal is to help identify where there is potential for system failures and focus measures to detect and mitigate the associated risks.1
At the POC, it is critical that the process examine the personnel collecting and testing the specimens to obtain an accurate assessment of the risks involved in each step.1 EP23 documentation focuses on five areas of error potential to address: 1) Samples, 2) Operators, 3) Reagents, 4) Lab or POC Environment, and 5) Measuring System. An IQCP must consider all five areas in each location2 within the hospital where blood gas systems are located. The training and competency levels of operators should be considered as well. The quality assessment involves continuous monitoring of the system post-implementation. If issues are identified, the plan must be modified to correct the issues. The medical director must sign off on the process put in place.1
Each POC location has a unique patient, test, and procedure context. Therefore, the laboratory IQCP for blood gas testing may not look the same as the IQCP for the cardiovascular operating room (CVOR). For example, samples from patients during cardiopulmonary bypass present a different risk profile than patient samples from a medical-surgical nursing unit. A directly measured hemoglobin versus a calculated hemoglobin or hematocrit may be required to reduce potential errors based on the testing method employed in a particular CVOR patient population.3
IQCP offers laboratorians and POCCs the opportunity to partner closely with manufacturers to mitigate risks and avoid errors in the pre-analytical, analytical, and post-analytical phases of testing. More effective integration of advanced automation and information technology can significantly enhance patient safety, reduce risk, and boost efficiencies.
The Centers for Medicare and Medicaid Services (CMS) recognizes the changing healthcare landscape, the advances in technology, and the need for new QC options. “This is not your grandmother’s QC, and a regulatory one-size-fits-all is no longer suitable,”¹ stated Judy Yost, Director of Laboratory Services for CMS, during a recent Medicare Learning Network webinar.2
In fact, continuous quality assessment features integrated into novel blood gas testing systems have shifted the paradigm in the quality control processes. The continuous QC model runs internal control solutions as frequently as before and after every sample, versus the traditional QC model based on 2-3 levels of external liquid controls every 24 hours, or one level of QC every eight hours. Traditional external liquid QC may no longer be the best way to detect errors and mitigate risk. Integrated, active, continuous error detection and correction through pattern recognition standardizes quality management to the system regardless of POC location, rather than tailoring quality control to the operator or test.
For example, risks introduced in the pre-analytical phase of testing, such as improper sample heparinization, which can cause microclots, may go undetected in traditional systems until a QC run is completed on a discrete schedule (eight-hour model). With continuous QC, microclots can be automatically detected and corrected, without operator intervention, ensuring top analytical performance with every sample. Since no operator intervention is necessary, continuous QC automatically tests the performance of the entire analytical system as it measures each patient sample. Accomplishing this in real-time, free of operator intervention, supports a successful POCT program that minimizes risk.
Automatic error correction (within minutes),4,5 such as a clot-bust rinse, and automatic documentation of the corrective actions are other key features of the continuous QC model performed by the system rather than the operator.6 The risk mitigation offered by these automated system checks helps detect errors sooner to possibly prevent the reporting of erroneous results.
Further, analytical system-related risk mitigation steps should include measures that check for expiration dates of reagents and prevent use of expired reagents, even those onboard. Information management systems can help mitigate areas of risk associated with the post-analytical process, such as positive patient ID, and automatic order creation functions reduce time to test initiation and ensure that the right test and the right patient are pinpointed every time.
Just as manual tests, such as body fluid counts, are becoming more automated and less labor-intensive in the lab,7 blood gas quality control and troubleshooting have become more automated, freeing up operators to perform other tasks while ensuring patient safety.
The continuous assessment model
CLIA’s move to allow more flexibility based on the strengths and weaknesses of systems yields the best QC to ensure patient safety. Novel technologies that continuously perform quality checks more frequently than traditional external liquid QC or traditional auto QC mean that errors can be detected sooner, effectively reducing risk. The continuous assessment model ensures that quality test results are reported and regulatory compliance is maintained with every sample. Not all testing systems carry the same regulatory quality control requirements, and not all have the same data management capabilities. Each blood gas system must be thoroughly evaluated during the validation process for purchasing to determine specific risk-mitigation features and how this will impact its corresponding IQCPs.
Ultimately, IQCPs offer great value to managers in the lab and at the POC in optimizing processes and efficiencies and reducing risk. Most importantly, IQCPs will enable great improvements in ensuring patient safety and optimizing patient care. The IQCP Education and Transition Period began 1/1/2014 and will conclude on 1/1/2016 when the Equivalent Quality Control option is phased out. Although the IQCP process will take time to implement, the automatic mitigation of risks and errors means greater patient safety. And ultimately, that’s something we can all feel better about!
- Wayne PA.CLSI document EP23-A: Laboratory quality control based on risk management; approved guideline. Clinical and Laboratory Standards Institute; 2011.
- Medicare learning network webinar “Clinical laboratory improvement amendment CLIA individualized quality control plan (IQCP) information and questions” Division of Laboratory Services. http://www.cms.gov/Regulations-and-Guidance/Legislation/CLIA/index.html. Accessed July 3, 2014.
- Myers GJ, Browne J. Point of care hematocrit and hemoglobin in cardiac surgery: a review. Perfusion. 2007;(22):179-183.
- Westgard JO, James O, Fallon KD, Mansouri S.Validation of iQM active process control technology. Point-of-Care: The Journal of Near-Patient Testing & Technology. 2003;3(2)1:1-7.
- Toffaletti J, McDonnell EH, Ramanathan LV, Tolnai J, Templin R, Pompa L. Validation of a quality assessment system for blood gas and electrolyte testing. Clinica Chimica Acta. 2007;6(382) 65-70.
- Laessig RH, Ehrmeyer SS. Meeting U.S. Regulations with IL GEM Premier 4000 with iQM. Instrumentation Laboratory.2007;1-27.
- Scott, G. An automated approach to body fluid analysis. Medical Laboratory Observer. 2014;46(6):20-22.