Editors: Olga Pozdnyakova, MD, PhD, Geoffrey Wool, MD, PhD, David Bernard, MD, PhD & Raul S. Gonzalez, MD
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Q. We manage multispecialty laboratories in multiple hospital locations. Most of the laboratories function on the traditional model of compartmentalized specialty-based testing units that offer routine and specialized services with their own dedicated space, equipment, and personnel. There is a future plan to establish an offsite centralized referral lab, but to improve operational efficiency and cost savings sooner, management is considering consolidating testing services at each location. What factors should be considered while planning the consolidation, keeping in mind the plan to establish a centralized reference lab? Should the testing services that will eventually be performed in the reference lab be excluded from the current consolidation plan? And how should we manage operations during the transition phase, i.e. once consolidation is completed but prior to the reference lab implementation?
A. August 2025—This complex question essentially covers laboratory design, workflow, and performance over multiple institutions and aims to optimize those operations. Although members of the CAP Practice Management Committee believe your questions may be best handled by a consultant, we want to provide resources that might help drive the questions to be included in the scope of the project.
To this end, there is noteworthy guidance in chapter two of Henry’s Clinical Diagnosis and Management by Laboratory Methods, 2022, on optimizing laboratory workflow and performance (pages 13–21), written by Mark Lifshitz, MD.
Additional references include the following articles on the consolidation of clinical microbiology services across multiple institutions, which may serve as case studies: Sautter RL, et al. Consolidated clinical microbiology laboratories. J Clin Microbiol. 2015;53(5):1467–1472; Carter E, et al. A model for the consolidation of clinical microbiology laboratory services within a multihospital health-care system. Clin Leadersh Manag Rev. 2004;18(4):211–215.
Ultimately, these changes will require careful planning and should involve a project team made up of administration, pathology leadership, technical leadership, and end users, among others, who can help design the workflows during the different phases of the project.
Juanita Evans, MD
Chair, Department of Pathology
Henry Ford Providence Southfield Hospital
Southfield, Mich.
Henry Ford Providence Novi Hospital
Novi, Mich.
Chair, CAP Practice Management Committee
Q. We have been discussing supervisory review of test results that are manually entered into our laboratory information system (i.e. a test result not sent via interface from an analyzer or autoverified). Examples are a urine hCG performed on a kit cassette or a manual differential performed on a CBC, entered directly into the LIS by the performing technologist. Do manual test results require supervisory review, or is it only higher-complexity tests (like the differential) performed by a medical laboratory technologist that require such review? If review is required, who can review and what is the recommended time frame?
A. CAP accreditation checklist requirements address your questions. Manual test results do not necessarily require supervisory review. As described in the all common checklist requirement COM.04050, laboratories must have a process to detect and correct significant clerical and analytical errors and unusual laboratory results in a timely manner. While one method may be to have a qualified employee (e.g. technologist, supervisor, pathologist) review those results before they are released, the laboratory may define other processes (e.g. automatic “traps” for improbable results, delta checks).
COM.04050 says the process must provide for timely correction of errors, i.e. before results become available for clinical decision-making. The specific time frames would be at the discretion of the laboratory director. If erroneous results are reported, corrective actions must be taken promptly.
Supervisory review is required for high-complexity testing performed by trained high school graduates who qualify as high-complexity testing personnel and performed in the absence of an onsite supervisor. As stated in COM.04100, their work must be reviewed within 24 hours. This requirement does not apply to personnel with higher levels of education who qualify to perform high-complexity testing, such as those with an associate degree in medical laboratory technology.
Laboratory general checklist requirement GEN.43825 addresses the verification of results that are entered into the LIS manually or by automated methods. The intent is that an authorized individual verifies the accuracy of the result entered into the LIS before releasing the result. This verification can be done by testing personnel as they are running and entering the results or by another person. Laboratories should be able to demonstrate how results are entered and verified in the laboratory information system, as well as generate an audit trail for the verification step.
Clinical and Laboratory Standards Institute. AUTO08-A: Managing and Validating Laboratory Information Systems; Approved Guideline; 2006.
College of American Pathologists. COM.04050 Error detection and correction. In: All common checklist. Dec. 26, 2024.
College of American Pathologists. COM.04100 Supervisory review for high complexity testing. In: All common checklist. Dec. 26, 2024.
College of American Pathologists. GEN.43825 Result verification. In: Laboratory general checklist. Dec. 26, 2024.
Standard: Comparison of test results. 42 CFR §493.1281(b) (2003).
Trudy R. Darden, MA, MT(ASCP)
Manager, Accreditation Services
CAP Accreditation Programs
College of American Pathologists
Northfield, Ill.