Benefits, limitations, and controversies on patient-based real-time quality control (PBRTQC) and the evidence behind the practice

Huub H van Rossum; Andreas Bietenbeck; Mark A Cervinski; Alex Katayev; Tze Ping Loh; Tony C Badrick

doi:10.1515/cclm-2021-0072

Benefits, limitations, and controversies on patient-based real-time quality control (PBRTQC) and the evidence behind the practice

Clin Chem Lab Med. 2021 Mar 10. doi: 10.1515/cclm-2021-0072. Online ahead of print.

Authors

Huub H van Rossum^{1

2}, Andreas Bietenbeck³, Mark A Cervinski^{4

5}, Alex Katayev⁶, Tze Ping Loh⁷, Tony C Badrick⁸

Affiliations

¹ The Netherlands Cancer Institute, Amsterdam, The Netherlands.
² Huvaros, The Netherlands.
³ Institut für Klinische Chemie und Pathobiochemie Klinikum, Munich, Germany.
⁴ Dartmouth-Hitchcock Medical Center, Lebanon, New Hampshire.
⁵ The Geisel School of Medicine at Dartmouth, Hanover, NH, USA.
⁶ Laboratory Corporation of America Holdings, Elon, NC, USA.
⁷ National University Hospital, Singapore, Singapore.
⁸ RCPA Quality Assurance Programs, Sydney, Australia.

PMID: 33691350
DOI: 10.1515/cclm-2021-0072

Abstract

Background: In recent years, there has been renewed interest in the "old" average of normals concept, now generally referred to as moving average quality control (MA QC) or patient-based real-time quality control (PBRTQC). However, there are some controversies regarding PBRTQC which this review aims to address while also indicating the current status of PBRTQC.

Content: This review gives the background of certain newly described optimization and validation methods. It also indicates how QC plans incorporating PBRTQC can be designed for greater effectiveness and/or (cost) efficiency. Furthermore, it discusses controversies regarding the complexity of obtaining PBRTQC settings, the replacement of iQC, and software functionality requirements. Finally, it presents evidence of the added value and practicability of PBRTQC.

Outlook: Recent developments in, and availability of, simulation methods to optimize and validate laboratory-specific PBRTQC procedures have enabled medical laboratories to implement PBRTQC in their daily practice. Furthermore, these methods have made it possible to demonstrate the practicability and added value of PBRTQC by means of two prospective "clinical" studies and other investigations. Although internal QC will remain an essential part of any QC plan, applying PBRTQC can now significantly improve its performance and (cost) efficiency.

Keywords: average of normals; moving average; patient-based real-time quality control (PBRTQC); quality assurance; quality control.