Individualized Quality Control Plans (IQCPs) represent a documented strategy that uses risk management techniques to prevent failures and detect non-conformities before reporting incorrect results. Building on testing device quality, current policies and procedures, and risk reduction features, an IQCP allows for the development of lab-specific, customized QC taking into consideration the environment, laboratory operators, and patient population. These plans often serve to save money for the overall organization through a reduction in waste. If your laboratory is researching the option of QC that differs from the Clinical Laboratory Improvement Amendments (CLIA) minimum of two levels each day of testing, consider the implementation of an IQCP when manufacturer instructions recommend a QC frequency less than that of CLIA.
Put an IQCP to Use
Implementing an IQCP requires a plan for all three phases of testing (pre- through post-analytical) and must include three basic steps:
- Risk Assessment
- Quality Control Plan
- Quality Assessment
Keep in mind that all CLIA, College of American Pathology (CAP), COLA, Joint Commission (if applicable), and Department of Health (DOH) regulations remain applicable and must be followed. If an IQCP template is selected for the organization, that template should be used for each evaluated test system (see FIGURE 1). For further assistance, CMS provides a free IQCP workbook that offers step-by-step instructions and sample worksheets that can be downloaded and modified. This workbook is available online at: https://www.cms.gov/Regulations-and-Guidance/Legislation/CLIA/Downloads/IQCP-Workbook.pdf.
Step 1: Risk Assessment
Similar to a failure mode effects analysis (FMEA), the purpose of a risk assessment is to identify sources of potential failures and evaluate their frequency and impact. To this end, form a team comprising the testing operator(s); related laboratory staff involved in test ordering and specimen collecting, receiving, and processing; as well as the laboratory supervisor/director. Begin with a planning meeting and then communicate project progress through a common intranet site, emails and/or paper handouts, or a large common-area poster board, and have staff provide input and analyze risks as they work. As always, successful process improvement projects require input from staff performing the testing. The risk assessment stage must encompass the entire testing process and evaluate the following five components:
Specimen: Collection, transport, integrity, receiving, processing
Environment: Temperature, humidity, power failure potential
Reagent/QC: Shipping, storage, preparation, expiration date
Test System: Sample or reagent failure, software failure, hardware failure, transmission of results
Testing Personnel: Education, training, competency
Subsequent to forming a team and establishing assessment parameters, collect facts regarding the test in question including but not limited to regulatory requirements, test method requirements, test site information, the instrument or device’s risk reduction features, and historical use data. Pay particular attention to the package insert and intended use (off-label use requires extensive validation). At this point, an IQCP provided by the manufacturer or another established laboratory may be used as a starting point, but in-house data must be utilized to demonstrate the stability of the test system in its own environment being run by its own testing personnel (see FIGURE 2). That said, sample IQCPs can be utilized to help in identifying unexpected risks.
The third step of the risk assessment stage is to investigate the testing process by having testing personnel break down each phase into steps (flow charts can be helpful). Look at each step to identify potential failures or sources of error and then reverse the view to see whether there are actions the lab can take to reduce these risks. Review historical data to determine the incidence of any QC or proficiency testing (PT) failures. Is there a record of complaints or corrected reports? Do current practices and processes help detect sources of error? Review the testing process in its entirety (ie, order placed through reporting) and consider whether the probability and severity of harm are acceptable. Scoring is not required, but it helps to identify high (critical) risks.
Finally, review current procedures, staff training, and specific device features in the development of reduction strategies for identified potential risks. High (critical) risks must have QC actions in place first (see FIGURE 3). Of note, if you have multiple identical test systems, a single risk assessment may be performed only if you take into consideration all differences in testing personnel and environment. These differences must be demonstrated in the evaluation and the ICQP must be customized as needed.
Step 2: Quality Control Plan (QCP)
The QCP describes practices, resources, and procedures to control the quality of test processes. This includes measures to ensure the accuracy and reliability of results. This step is initiated through the creation of a plan that comprises activities intended to reduce the likelihood of errors identified through the risk assessments. A key metric for review is the amount of overall QC necessary based on the frequency and volume of patient testing. Remember, QC procedures and requirements specified by the manufacturer must be followed and met.
The QCP must include the number and type of QC, frequency of testing, and criteria for acceptable results. It may include electronic/internal controls, procedural controls, training and competency assessments, calibration results, maintenance records, and other specified QC activities.
When reviewing external QC frequency, be sure to consider process steps in the event of a QC failure. For example, a laboratory decides on weekly QC for HIV testing instead of monthly with the rationale being that they saved specimens for 7 days, so in the event of a QC failure, they would still have specimens for retesting once the issue was resolved. No one wants to call a patient to explain a wrong HIV test result. The laboratory director must ultimately review and approve the QCP (signed and dated). Further, staff must be trained to the QCP initially, at 6 months, and then annually.
Step 3: Quality Assessment
The sustained success of an ICQP is dependent on monitoring and assessment. The IQCP must include a review of the effectiveness of corrective actions taken to resolve problems, and if a test process failure is detected, the cause must be identified along with any patient impact. As part of this process, the laboratory can run additional risk assessments and further modify the QCP as necessary based on information obtained in review. Keep in mind, the lab director must review and approve modifications (sign and date), and staff must be trained to the new QCP (See FIGURE 4).
In summary, risk management is something we already do. IQCP is voluntary; you can elect to perform a minimum of two levels external QC on every test. Each IQCP is unique as it considers your testing environment and testing staff. As such, plans may vary among laboratories. Once implemented, the IQCP must be monitored for effectiveness and modified as needed.
Katheryn Inglis, MS, MT(ASCP), is a supervisor for UPMC Susquehanna at Divine Providence Hospital in Williamsport, Pennsylvania. She has a master of science degree from Upstate Medical Center and more than 30 years of laboratory experience. Kathy is on the CLMA board of directors and has presented at KnowledgeLab.
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