| Monday, January 01, 0001
On January 1, 2014, the Centers for Medicare and Medicaid Services (CMS) implemented a new alternative Quality Control (QC) option for non-waived laboratory testing. CLIA laboratories can now begin to voluntarily transition away from Equivalent Quality Control (EQC) and begin using either the default CLIA Quality Control (QC) requirement, or the new option called the Individualized Quality Control Plan (IQCP). Physician Office Laboratories (POLs) will now have to determine if IQCP is the right choice for them.
Laboratory Directors will be tasked with determining whether to maintain the CLIA minimum of at least two levels of QC per day, or to transition to the IQCP approach. The cornerstone of IQCP is identifying, evaluating, and controlling potential sources of error relevant to the individual laboratory. Performing a Risk Assessment will facilitate the development of an IQCP, which is achieved by implementing targeted quality control measures.
According to CMS, “There will be an IQCP Education and Transition Period to allow laboratories an opportunity to learn about IQCP and implement their chosen QC policies and procedures. The IQCP Education and Transition Period will begin on 01/01/2014, and conclude on 01/01/2016.” With the transition period already underway, labs are advised to begin now to educate themselves about IQCP. CMS stand ready to assist laboratories in this process; the educational arms of laboratory accrediting organizations also offer a variety of resources.
What IQCP Means to Physician Office Labs
While IQCP may seem like yet another regulation to follow, as an article in the American College of Physicians’ ACP Internist states, “While office labs do pose some disadvantages in the form of regulations, the rules are probably not as formidable as you think. Federal regulations are neither particularly expensive nor difficult to follow.”
In fact, IQCP can present distinct advantages to POLs. Because IQCP is Quality Control based on Risk Management, it can help mitigate the level and frequency of risk to patients. While a small office lab may not have the luxury of a designated QC Officer, this does not mean that they are not concerned about providing accurate test results to their patients. Indeed, it is most likely the opposite: Most POLs opened a lab in their practice to reduce turnaround time, paperwork and logistical headaches for diagnostic testing. Their Laboratory Director has committed to ensure that the site is compliant with all regulations, that the staff is competent and well trained and that patient test results are reliable and reproducible.
The New Quality Control Choices
During the IQCP Education and Transition Period, laboratories will have three acceptable QC options:
1. Follow the CLIA QC regulatory requirements as written
2. Continue to follow the Equivalent Quality Control (EQC) procedures as described in the current Interpretive Guidelines
3. Implement IQCP
As of January 1, 2016, EQC will no longer be an acceptable option to meet CLIA QC requirements and will be removed from the regulatory guidelines. At that point, only two options will remain to meet CLIA QC compliance:
1. Follow the CLIA QC regulatory requirements as written (Two levels of QC for each day of testing), or
2. Implement IQCP
IQCP in Brief
CMS defines IQCP as the “Right QC” for the test as it is performed in your laboratory given your lab’s unique circumstances. As such, IQCP is:
Quality Control based on Risk Management. Risk is a measure of the severity of the impact of a potential error, multiplied by the probability of how likely it is that the error will occur, and your ability to detect the error if it should occur. Identifying, evaluating, and controlling these potential errors through quality control measures is the basis of IQCP.
- While only specific tests qualified for EQC (Equivalent Quality Control – the alternative QC program replaced by IQCP), all specialties (except Pathology, and its associated subspecialties of Histopathology, Oral Pathology, and Cytology) are eligible for IQCP.
Keep these important points in mind:
- IQCP includes, for each test, a risk assessment performed within your laboratory based on your unique circumstances.
- IQCP recognizes that all phases of testing impact quality; therefore, the scope of riskassessments must encompass the entire testing process: pre-analytic, analytic, and post-analytic phases.
- IQCP focuses on the “right” QC for each test, which is not necessarily less frequent QC.
- IQCP is formalized as a documented Quality Control Plan. It may be electronic or hard copy; it may be documented as part of the testing procedure or as a separate manual.
Completely voluntary. Like the other CLIA QC requirements, IQCP is intended for non-waived testing; however, you may perform a risk assessment and develop an individualized plan for ANY test in your POL, including waived tests. Whereas IQCP is voluntary labs may use it for all, some, or none of the test systems in their laboratory. Indeed, laboratories can continue to run the CLIA “default” QC – two levels of external control each day of patient testing – instead of implementing Individualized QC Plans.
The manufacturer’s QC recommendation will remain the minimum acceptable QC protocol, but it may be necessary to develop an IQCP if you chose to follow this protocol. If the manufacturer’s QC recommendations for the test are less than the default CLIA requirement of two levels per day (for instance, the manufacturer’s instructions say to run controls with each lot number change), your lab may:
- Perform the default requirement of two levels per day AND run controls with each lot number change (to satisfy the manufacturer’s requirement); OR
- Develop an IQCP for the test to show that all relevant errors will be detected if the manufacturer’s protocol is followed.
The bottom line is that labs may not simply follow the manufacturer’s less stringent QC requirements without first performing a risk assessment to determine if this amount of QC is the “right” QC.
Other important IQCP rules
An IQCP is not necessary if the manufacturer’s stated number, type, and frequency of control procedures meet or exceed the CLIA requirement of two levels of external controls each day. However, if the manufacturer’s instructions specify more than two levels per day, you may not use an IQCP to reduce the number of daily controls to less than the manufacturer’s recommendation. In other words, since the manufacturer’s QC recommendations will remain the minimum acceptable QC requirement, if the manufacturer recommends two or more levels per day, your lab may not develop an IQCP with less than the number specified by the manufacturer.
IQCP provides the physician office laboratory the opportunity to look at the entire landscape of testing and address the potential for error in the pre-analytical, analytical and post-analytical phases. By looking at each phase objectively, your POL can identify what steps can be refined; subsequently clearly define roles and responsibilities; and determine where potential breakdowns in the system can occur. Working together Collection Specialists, Phlebotomists, Medical Assistants, Nurses, Nurse Practitioners, Data Management Specialists, Technicians and Clinicians, can assemble a complete picture of the testing process and pinpoint opportunities for improvement.
Although the discussion surrounding QC may continue, IQCP has the potential to help laboratories meet their unique quality control requirements while achieving regulatory compliance, thus paving the way to the ultimate goal of providing continuous quality patient care.
About COLA Resources, Inc. (CRI®)
CRI is a leader in online continuing education for physicians, laboratory personnel and allied health professionals. CRI offers continuing education through online courses, informational products in both electronic and hard copy form, webinars on cutting-edge technology and regulatory issues, and CRI on-site Symposia for Clinical Laboratories, providing live educational sessions and interactive workshops with leading industry organizations. For more information, visit their website at www.criedu.orgor call 1-800-981-9883.
 IQCP announcement letter for CLIA CoC and PPM laboratories [PDF, 100KB] http://www.cms.gov/Regulations-and-Guidance/Legislation/CLIA/Downloads/IQCP-announcement-letter-for-CLIA-CoC-and-PPM-labs.pdf
 February 2000 ACP–ASIM Observer, copyright © 2000 by the American College of Physicians–American Society of Internal Medicine. http://www.acpinternist.org/archives/2000/02/officelab.htm
 Interpretive Guidelines for Laboratories - Appendix C. Survey Procedures and Interpretive Guidelines for Laboratories and Laboratory Services. www.cms.gov/Regulations-and-guidance/Legislation/CLIA/Interpretive_Guidelines_for_Laboratories.html
 COLA Resources Inc. IQCP Implementation Guide. 2013.