Individualized Quality Control Plan

The Individualized Quality Control Plan (IQCP) is a quality management system consisting of a Risk Assessment (RA), Quality Control Plan (QCP), and Quality Assessment (QA), under the US Clinical Laboratory Improvement Amendments (CLIA) federal regulatory standards. ^[1] It is designed to enable regulated medical laboratories to manage the frequency of their quality control. ^{[2] [3] [4]}

Beginning Jan 1, 2016, US laboratories under CLIA performing non-waived testing were required to either perform two levels of controls daily or implement an IQCP. ^{[5] [6]} An IQCP may be less stringent than CLIA, but not less stringent than the manufacturers recommendation. ^{[7] [8]} IQCPs were introduced in 2013 enabling a transition period. ^{[9] [10]}

An IQCP is based on a laboratory's own data and includes a risk assessment of potential errors in the preanalytical, analytical, and postanalytical phases and the likelihood and impact of potential patient harm for each error. ^[11]

History

In 2012, the ISO 14971:2012 was published.± ^[12]

In 2013, the CLIA Interpretive Guidelines were updated to include risk assessment for all aspects of laboratory testing. ^[13]

In 2014, the Individualized Quality Control Plan (IQCP) was introduced and laboratories would have a 2-year transition period, from January 1, 2014, to December 31, 2015, to move away from Equivalent Quality Control (EQC) and either perform the default CLIA frequency for daily QC or implement an IQCP. ^[13] However, IQCP was initially presented as "optional" or "voluntary" limiting adoption. ^[13] It was not until mid-2015 and that it was clarified that EQC would be formally phased out that IQCP would not optional that laboratories began to implement IQCP. ^[13]

References

1. Turgeon, Mary Louise (14 September 2022). Clinical Laboratory Science - E-Book: Clinical Laboratory Science - E-Book. Elsevier Health Sciences. p. 72. ISBN   978-0-323-83221-2.
2. "When Cost-Cutting in the Clinical Pathology Laboratory Collides with Effective QA/QC: How Savvy Labs Sustain the Accuracy and Quality of their Lab Test Results". Dark Daily. Sep 4, 2013.
3. "Individualized Quality Control Plan (IQCP) | CMS". www.cms.gov.
4. Nichols, James H (1 July 2016). "Benefits of Developing an Individualized Quality Control Plan". The Journal of Applied Laboratory Medicine. 1 (1): 5–8. doi:10.1373/jalm.2016.020222.
5. Westgard, James O.; Armbruster, David; Westgard, Sten (6 February 2017). Risk, Error and Uncertainty: Laboratory Quality Management in the Age of Metrology, An Issue of the Clinics in Laboratory Medicine. Elsevier Health Sciences. p. 114. ISBN   978-0-323-47764-2.
6. Zhou, Rui (Dec 11, 2017). "Understanding and implementing of individualized quality control plan". Chinese Journal of Laboratory Medicine. doi:10.3760/cma.j.issn.1009-9158.2017.12.001.
7. Anderson, Nancy (November 2015). "The Individualized Quality Control Plan—Coming Soon to Clinical Microbiology Laboratories Everywhere!". Clinical Microbiology Newsletter. 37 (22): 177–185. doi:10.1016/j.clinmicnews.2015.11.001.
8. Martin, Rebekah M. (28 February 2025). 101 Topics for Clinical Microbiology Laboratory Leaders: Accreditation, Verification, Quality Systems, and More. John Wiley & Sons. p. 169. ISBN   978-1-68367-447-4.
9. Bruno, Linda C. (June 2019). "Individualized Quality Control Plan: 3 Years Later". Clinical Microbiology Newsletter. 41 (12): 103–109. doi:10.1016/j.clinmicnews.2019.05.003.
10. Westgard, James O. (March 2013). "Perspectives on Quality Control, Risk Management, and Analytical Quality Management". Clinics in Laboratory Medicine. 33 (1): 1–14. doi:10.1016/j.cll.2012.10.003.
11. "Individualized Quality Control Plan". May 9, 2023. doi:10.1002/9781683670438.cmph0169.{{cite journal}}: Cite journal requires |journal= (help)
12. Westgard, James O; Westgard, Sten A (January 2016). "Quality control review: implementing a scientifically based quality control system". Annals of Clinical Biochemistry: International Journal of Laboratory Medicine. 53 (1): 32–50. doi:10.1177/0004563215597248.
13. Bruno, Linda C. (November 2016). "IQCP: Guideline and Helpful Tools for Implementation". Laboratory Medicine. 47 (4): e42 –e46. doi:10.1093/labmed/lmw047.