IQCS: Individualized Quality Control Program
Does our lab have to do all this additional work?
Our compliance department has received numerous calls from physician offices that have in-house laboratories asking the question, “Does my laboratory have to do all this additional work?” The answer is, “No! But…you might decide that IQCP would improve the reliability of your laboratory test results. IQCP (Individualized Quality Control Program) will eventually replace EQC (Equivalent Quality Control). IQCP is not mandatory; it is voluntary. IQCP begins January 1, 2014, with a two-year phase-in time; the Educational and Transitional Period ends January 1, 2016. During the interim period, laboratories have three options:
- Follow the default requirements of a minimum of two levels of controls for each day of patient testing.
- Continue with EQC until January 1, 2016.
- Implement IQCP.
Beginning January 1, 2016, two options will remain:
- Follow the default requirements of a minimum of two levels of controls each day of patient testing; more if recommended by the manufacturer.
- Implement IQCP.
What is IQCP?
IQCP is an opportunity for laboratories to determine the best quality control frequency for their tests based on a risk assessment. Unlike EQC, the goal is not to reduce the frequency, but to improve patient safety by running controls at the frequency that will better ensure reliability of patient test results. The Clinical and Laboratory Standards Institute (CLSI) responded to concerns that EQC might not provide sufficient information for changing the frequency of QC by developing EP-23, “Laboratory Quality Control Based on Risk Management.” Centers for Medicare and Medicaid Services (CMS) adopted their version of this document as IQCP. COLA, a CMS-approved accrediting agency, will adopt IQCP and follow the CMS timing. IQCP is not a new regulation; just a new set of interpretive guidelines allowed by flexibility incorporated into the CLIA regulations. IQCP allows laboratories to customize Quality Control (QC) policies and procedures based on the test systems in use and the unique aspects of the individual laboratory setting. IQCP is based on Quality Systems established in the revised CLIA regulations in 2003 and on a risk assessment performed by the laboratory. The laboratory director is still ultimately responsible for determining the appropriate QC policies and procedures and to identify failures when they occur. Surveys will continue to be conducted using the Outcome Oriented Survey Process. The laboratory will only be cited as out of compliance with the CLIA quality requirements if:
- it does no QC, or
- or there are serious concerns about test quality, or
- or there is immediate jeopardy (i.e., real or potential harm to patients).
How should the laboratory proceed if it decides to develop an IQCP? Start by determining which tests might be eligible for IQCP. The IQCP Interpretive Guidelines specifically exclude pathology, histopathology, oral pathology and cytology; all other specialties are eligible. Any systems that have been operated under EQC would probably be appropriate to consider for IQCP. Factors to consider include stability of the test system itself, proficiency of your testing personnel, and environmental factors such as the effects of temperature fluctuations. If any of these factors have a lot of changes, IQCP may not be the best approach. Historical data may be used as part of your IQCP study, but there will be no “grandfathering.” At a minimum, all laboratories must run two levels of external controls every day of patient testing, and more if required by the manufacturer or your state or accreditation agency. IQCP may be used to determine if this minimum frequency is sufficient or to verify that a manufacturer’s minimum frequency, if less than the regulatory requirement, would ensure “equivalent” quality. The study may reveal a need for more frequent QC. An IQCP must include:
- Risk Assessment (RA) (Exception: microbiology. Guidance in other CLSI documents may be used in lieu of this step.)
- Quality Control Plan (QCP)
- Staff training
- Quality Assessment (QA)
Information to be used in the RA includes the user’s manual, package inserts and literature about the test system, your testing personnel, your testing environment (temperature, water, electricity, humidity), and how your providers use the test results. Identify risks—points at which errors may occur that would contribute to erroneous results. Common risks are listed below:
Requirement for Risk Factor
Must be properly collected, labeled, and processed
Temperature, humidity, electricity, and water must meet manufacturer’s specifications
Must be properly trained and competent
All specification verification studies must be passed, analyzer must be properly maintained and calibrated, quality control looks good across time, performance on proficiency testing is at or close to 100%
Evaluate the potential harm to the patient at each risk. Include pre-analytic and post-analytic risks as well as analytic ones. For each risk, develop a control program to minimize the risk. Take into consideration steps already implemented by the manufacturer to detect and/or minimize error. Risks may be put onto a fishbone diagram. Additional data gathered would be better viewed in a table format. After you have completed your study and developed your Individualized Quality Control Plan, train your staff and keep detailed records. Incorporate into your Quality Assessment Plan a periodic review of your new IQCP to verify that the IQCP is appropriate. This should be done at least once per year and anytime there is a QC or PT failure, or if patient results do not match the clinical picture. If problems occur, the laboratory may need to go back to the minimum of two levels of controls every day of patient testing. Remember, the laboratory director is always responsible for overseeing the quality control program and ensuring reliable patient test results.
If you have questions about this topic or any other issues around the business of medicine, contact us via email or call us at 800-635-4040.