Editor: Frederick L. Kiechle, MD, PhD
Submit your pathology-related question for reply by appropriate medical consultants. CAP TODAY will make every effort to answer all relevant questions. However, those questions that are not of general interest may not receive a reply. For your question to be considered, you must include your name and address; this information will be omitted if your question is published in CAP TODAY.
Q. Can a person who has a bachelor of science degree in health care administration sign off on competency assessments?
A.January 2024—Having a bachelor of science degree in health care administration is not adequate by itself to qualify someone to assess competency for high- or moderate-complexity testing because it does not provide information on that person’s science-related education, training, or experience.
The laboratory must obtain records, such as a diploma or transcript, of the person’s highest level of education in a clinical laboratory-related science (for example, in a biological, chemical, physical, or clinical laboratory science or in medical technology) from an accredited institution and training and/or experience in the area of testing.
The laboratory must then ensure the person meets the minimum qualifications to assess competency based on the complexity of the testing performed, as required in the CAP’s laboratory general checklist requirement GEN.55510 and the related CLIA regulations. For high-complexity testing, the person would need to meet the qualifications of a technical supervisor, as outlined in CAP checklist requirement GEN.53400, or general supervisor, as per GEN.53600. For moderate-complexity testing, the person must meet the qualifications of a technical consultant, as per GEN.53625.
If more stringent state or local regulations are in place for supervisory qualifications, including requirements for state personnel licensure (for example, in California), those must also be followed.
Centers for Medicare and Medicaid Services. What Do I Need to Do to Assess Personnel Competency? November 2012. https://www.cms.gov/regulations-and-guidance/legislation/clia/downloads/clia_compbrochure_508.pdf
College of American Pathologists. GEN.53400 Section Director (Technical Supervisor) Qualifications/Responsibilities. In: Laboratory general checklist. Aug. 24, 2023.
College of American Pathologists. GEN.53600 General Supervisor Qualifications/Responsibilities. In: Laboratory general checklist. Aug. 24, 2023.
College of American Pathologists. GEN.53625 Technical Consultant Qualifications/Responsibilities. In: Laboratory general checklist. Aug. 24, 2023.
College of American Pathologists. GEN.55510 Competency Assessment—Assessor Qualifications. In: Laboratory general checklist. Aug. 24, 2023.
Erin Wilgus, MS, MLS(ASCP)CM
Technical Specialist
Laboratory Accreditation Services
College of American Pathologists
Northfield, Ill.
Q. Our laboratory uses a total protein assay from Beckman Coulter that has an analytical measurement range of 3–12 g/dL for serum determinations. The assay sensitivity states 1 g/dL of total protein. Can we loop sensitivity into our AMR and make our reporting range 1–12 g/dL? Will this make our assay a laboratory-developed test? Quite often our clinicians need assays reported to 1 g/dL, since they need to calculate the ratio of total protein serum to body fluid as per Light’s criteria. If we report to 1 g/dL, we have to loop sensitivity into our AMR.
A.The analytical measurement range on the manufacturer’s product insert is the AMR that has been approved by the Food and Drug Administration.
CLIA regulation 42 CFR §493.1253(b)(1) “Verification of Performance Specifications” states that when a laboratory introduces an unmodified, FDA-cleared or -approved test system, it must verify that the performance characteristics for which the test was approved are comparable to those established by the manufacturer. This standard is met by performing and documenting accuracy, precision, reportable range, and reference interval studies.
The instructions for use for the total protein assay from Beckman Coulter state that the AMR is 3–12 g/dL. This is the unmodified, FDA-cleared AMR.
Decreasing the lower limit of the total protein AMR to 1 g/dL modifies the lower limit. CLIA regulation 42 CFR §493.1253(b)(2) states that a laboratory “that modifies an FDA-cleared or approved test system . . . must, before reporting patient test results, establish for each test system the performance specifications” for seven performance characteristics, as applicable. Similarly, the “Test Method Validation and Verification—Nonwaived Tests” section of the CAP’s all common checklist states that “for modified FDA-cleared or approved tests and laboratory-developed tests (LDTs), the laboratory must establish accuracy, precision, analytical sensitivity, analytical specificity (interferences), reportable range, and reference intervals, as applicable; data on interferences may be obtained from manufacturers or published literature, as applicable.”
The reader indicates that they believe the assay sensitivity is 1 g/dL. This is incorrect and is a misinterpretation of the product insert’s wording. Beckman Coulter’s instructions for use for its total protein assay state, under “Sensitivity,” that the “[t]ypical change in absorbance per minute for 1 g/dL of total protein is . . . ” and then gives the amounts of change in absorbance for various models of its AU series analyzers. The reference to 1 g/dL under the sensitivity heading does not imply that the AMR’s lower limit can be decreased to 1 g/dL; rather, it is stating the typical change in absorbance per minute for 1 g/dL of total protein within the FDA-approved AMR of 3–12 g/dL.
Therefore, the answer to the reader’s question is that from 1.0 to 2.9 g/dL, the lab has a modified FDA-cleared/-approved test or laboratory-developed test that it must validate and document appropriately.
College of American Pathologists. All common checklist. Aug. 24, 2023.
Standard: Establishment and Verification of Performance Specifications. 42 CFR §493.1253(b)(1).
Standard: Establishment and Verification of Performance Specifications. 42 CFR §493.1253(b)(2).
Total protein. Instructions for use, BAOSR6X32 11. Beckman Coulter, Inc.; 2020.
Michelle K. Zimmerman, MD, MBA
Director, Clinical Chemistry, Point-of-Care Testing, Specimen Processing, and Send-out Testing
Indiana University Health
Pathology Laboratory
Associate Professor, Clinical Pathology and Laboratory Medicine
Indiana University School of Medicine
Indianapolis, Ind.