Steve Halasey, CLP.

Steve Halasey, CLP.

For clinical laboratorians, diagnostic quality is not a particularly elusive concept. As explained by Irwin Z. Rothenberg, MBA, MT(ASCP), of COLA Resources Inc, in this issue’s article on “Peer-Reporting Programs for Lab Quality” (page 16), it begins with the regular performance of quality control (QC) processes designed to measure the ability of a laboratory’s measurement systems to “reproduce the same result over time and under varying conditions.”

But as Rothenberg’s article makes clear, performing internal QC is not by itself sufficient for ensuring the reproducibility of an individual laboratory’s measurements over extended periods. To accomplish that goal, writes Rothenberg, “laboratories should participate in a program of ‘external QC’ assessment through the use of a peer-reporting system.”

“The unique capability of peer-reporting programs is to monitor the accuracy of a laboratory’s test methods and make sure that they remain stable and on-target with the true or correct values,” says Rothenberg. “The essential characteristic of peer-reporting programs that make use of interlaboratory QC is the availability of results derived from the use of comparable instruments and test methods in other laboratories.”

Making certain that a laboratory’s testing processes are unfailingly correct is an ongoing obligation of clinical laboratorians—and a significant contribution to nationwide efforts to eliminate or minimize the incidence of diagnostic error. A 2015 study by the Institute of Medicine (now the National Academies of Sciences, Engineering, and Medicine) found that most Americans will experience at least one diagnostic error in their lifetime, and that a major contributing factor is the lack of effective measurement related to the diagnostic process and diagnostic outcomes.1

In September, the National Quality Forum (NQF) issued its final report on developing a conceptual framework for measuring diagnostic quality and safety, and to identify priorities for future measurement development.2 The report offers a wide-ranging structure of domains and subdomains intended to help healthcare stakeholders identify gaps in the measurement of diagnostic quality and safety.

In the NQF scheme, clinical laboratorians play a small but vital role as members of the healthcare team working to develop, refine, and confirm a diagnosis, or to explain the patient’s health problem. Diagnostic efficiency and diagnostic accuracy—two areas newly added in the final version of the report—are especially important to comprehend the contributions of clinical laboratories to diagnostic quality.

But for laboratories, as Rothenberg notes, it all starts with proper performance of QC.


  1. Institute of Medicine. Improving Diagnosis in Health Care. Washington, DC: National Academies Press, 2015. Available at: Accessed September 21, 2017.
  1. Improving Diagnostic Quality and Safety. Washington, DC: National Quality Forum, 2017. Available at: Accessed September 21, 2017.


Steve Halasey
Chief Editor, CLP
[email protected]
(626) 219-0199