The need for clinical assay harmonization and standardization has received much attention from health guideline leaders in organizations such as the Clinical and Laboratory Standards Institute (CLSI) and the International Federation of Clinical Chemistry and Laboratory Medicine. While those processes are essential to the future of laboratory medicine and optimal patient care, I would also like to highlight the benefits of operational standardization within the clinical laboratory.
Operational procedures encompass a variety of tasks, including (but certainly not limited to) technical procedure specifications, equipment maintenance, new test evaluation, and emergency response plans. From a clinical laboratory director’s perspective, having clear and detailed instructions for these types of tasks enables effective delegation and consistency among team members. When expectations are clear and instructions are easy to follow, the process is more efficient and scalable to work for multiple sites. Standardizing these tasks may be especially helpful in large academic medical centers with several satellite laboratories in addition to the main medical center laboratory. I would like to highlight some of the most effective laboratory infrastructure tools employed by my institution. (The importance of a document control system is covered in a previous Scientific Shorts article (Hayden, January 2021) and will not be addressed in detail here.)
Our procedure entitled “Composition and Review of Standard Operating Procedures" offers great practical utility. This document includes detailed descriptions and example images of the standardized 14 sections required in each analytical and technical procedure in our chemistry and toxicology laboratories. Based on the College of American Pathologists checklists and CLSI document QMSO2 A6:2013, step-by-step instructions are provided to enable staff to compose a procedure that includes all necessary components. There is also an example section addressing document formatting (e.g., specifying font and font size), detailing methods for the storage of hard and electronic copies of the procedure and associated forms, and—importantly—outlining the steps of the procedure review process. This document enables supervisors and managers to write procedures with assurance that they are complete and in alignment with regulatory requirements. In addition, it ensures that when employees are cross-trained in several laboratories within a health system or just need to quickly review a particular parameter, that information will be easily accessible in a predictable location.
Another essential resource for staff and faculty is our comprehensive quality control (QC) document, which describes the policy for maintaining QC records and for QC decision making and problem solving. Based on a chapter in the 6th edition of Tietz Textbook of Clinical Chemistry and Molecular Diagnosticsi, this document includes general QC acceptance criteria, procedures for evaluating QC results in a variety of situations, and systematic instructions for entering the QC data into the laboratory information system. It also contains a section that laboratory leadership can consult to obtain instructions for review and interpretation of the stored data, including establishing new control limits and QC problem solving. Additionally, instructions for receipt, analysis, and strategies for exception investigation are outlined for proficiency testing materials.
Finally, one of the most helpful and time-saving documents in our infrastructure armamentarium is the method validation/verification procedure. Based on items in the College of American Pathologists checklist and CLSI documents EP05, EP06, EP07, EP09, EP15, EP37, and C28, this document describes the protocols for preparation, experimental design, and data input, with detailed analysis instructions (including screenshots) for essential parameters of clinical measuring system evaluation. A separate appendix document is currently under development that will describe the procedures necessary for validation of a laboratory-developed test (LDT). Each component of the method validation procedure has an associated data template in Microsoft Excel that matches the data analysis instructions in the procedure.
As both a director of a laboratory performing manual LDTs and an associate director of a highly automated clinical chemistry laboratory, I have observed how operational standards are an essential part of both types of operation. Process standardization often improves safety and regulatory compliance in addition to having positive impacts on product quality and employee satisfaction. Adopting these documents has improved staff morale, laboratory director efficiency, and consistency of practice within our facilities.
i Miller WG, Sandberg S. Quality control of the analytical measurement process. In: Tietz Textbook of Clinical Chemistry and Molecular Diagnostics, 6th Edition, ed. by Rifai N, Horvath AR, Wittwer C. Elsevier 2017, Chapter 6, p 121-156.