In fact, continuous quality assessment features integrated into novel blood gas testing systems have shifted the paradigm in the quality control processes. “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. The Centers for Medicare and Medicaid Services (CMS) recognizes the changing healthcare landscape, the advances in technology, and the need for new QC options. More effective integration of advanced automation and information technology can significantly enhance patient safety, reduce risk, and boost efficiencies. 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. 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. For example, samples from patients during cardiopulmonary bypass present a different risk profile than patient samples from a medical-surgical nursing unit. Therefore, the laboratory IQCP for blood gas testing may not look the same as the IQCP for the cardiovascular operating room (CVOR). 1Įach POC location has a unique patient, test, and procedure context. The medical director must sign off on the process put in place. If issues are identified, the plan must be modified to correct the issues. The quality assessment involves continuous monitoring of the system post-implementation. The training and competency levels of operators should be considered as well. An IQCP must consider all five areas in each location 2 within the hospital where blood gas systems are located. 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. 1Īt 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. The ultimate goal is to help identify where there is potential for system failures and focus measures to detect and mitigate the associated risks. This includes conducting a risk assessment that spans the entire pre-analytical, analytical, and post-analytical process for testing and reporting results. 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. 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. 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. 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. However, IQCPs may be easier than they seem. 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). Likewise, Laboratory and Respiratory Departments are juggling “lean” initiatives along with shrinking resources. In today’s environment, point-of-care coordinators (POCCs) have more to do in less time and with fewer resources than ever before.
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