Q&A column

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.

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Q. Can a heel stick for a basic metabolic panel with magnesium and phosphorus be performed on a two-month-old baby?

A. A heel stick is a common method to obtain capillary blood samples in pediatrics, in part because it is less invasive than venous blood sampling. Heel sticks are the most commonly performed sample method in neonatal intensive care units. Samples obtained in this manner are used for a variety of testing, including the basic metabolic panel, magnesium, and phosphorus. These tests can be performed on a capillary sample obtained by heel stick if there is sufficient sample. When performing a heel stick, follow the guidelines for capillary sample collection, and consider the limitations of capillary blood sampling when interpreting the results. Due to the special technical requirements of this procedure, it is ideal to have experienced staff who perform heel sticks frequently.

Clinical and Laboratory Standards Institute. GP42-A6: Procedures and Devices for the Collection of Diagnostic Capillary Blood Specimens; Approved Standard. 6th ed. CLSI; 2008.

Grey VL, Loh TP, Metz M, Lang T, Hersberger M. Paediatric laboratory medicine—some reflections on the sub-specialty. Clin Biochem. 2017;50(12):648–650.

Jones PM, Dietzen DJ, Haymond S, Bennett MJ, eds. Pediatric Laboratory Medicine. McGraw-Hill Education; 2017.

Brenda Suh-Lailam, PhD, DABCC
Director, Clinical Chemistry and Point-of-Care Testing
Ann and Robert H. Lurie Children’s Hospital
Assistant Professor of Pathology
Northwestern University Feinberg School of Medicine
Chicago, Ill.
Member, CAP Clinical Chemistry Committee

Sridevi Devaraj, PhD, DABCC
Director, Clinical Chemistry and Point-of-Care Testing
Texas Children’s Hospital
Professor, Pathology and Immunology
Baylor College of Medicine
Houston, Tex.
Member, CAP Clinical Chemistry Committee

Q. Due to nationwide supply shortages affecting COVID-19 and other testing in the laboratory, we are concerned about using up critical supplies when assessing competency. Do you have suggestions or strategies we can use?

A. Performing competency assessment is a challenge, especially during the COVID-19 health care emergency, but it is crucial for ensuring that testing personnel are performing tests correctly and accurately for reliable results and patient care. While no exceptions for assessing competency have been made by the Centers for Medicare and Medicaid Services at this time, it helps to remember that some elements of competency can be assessed throughout the year during routine supervisory activities, such as review of records for daily maintenance, quality control, and proficiency testing. Corrective action logs can be a good source for evaluating problem-solving skills. There may also be opportunities to observe test performance and daily maintenance activities. The CAP has complementary example templates that may be useful for this purpose; they can be downloaded from cap.org (log in to e-LAB Solutions Suite and go to Accreditation Resources and then Templates). The CAP also has its optional Competency Assessment Program that helps laboratories develop assessment checklists and provides other tools to tailor a program specific to a laboratory.

Consider also the following suggestions to help reduce the potential burden on the supply chain and simplify the competency assessment process:

• Use routine controls or proficiency testing samples for evaluating technologist performance during competency assessment. Routine QC and PT performed for regulatory compliance also provide an opportunity to complete the blind sample element of competency assessment. QC materials can be de-identified to qualify as a blind specimen.
• Use one testing event to fulfill multiple requirements. For example, testing performed to meet compliance with instrument comparison (COM.04250) can also be used to meet the blind sample testing requirements. The CAP offers Quality Cross Check programs (COVQ2 and COVSQ) that can be used for instrument comparison and to evaluate the performance of personnel simultaneously. Many elements of competency can be met through this process if it is observed from start to finish and includes questions regarding troubleshooting.
• Determine if COVID-19 testing can be combined with an existing test system for evaluating competency. The CAP defines a test system as being the process that includes preanalytic, analytic, and postanalytic steps used to produce a test result or set of results. In many situations, tests performed on the same analyzer or platform may be considered one test system and a separate competency assessment would not be required for each test performed on the instrument. For example, if a SARS-CoV-2 test is added to the same instrument platform used to perform influenza and RSV testing and there are no differences in how the testing is performed or interpreted, the tests can be included under one test system for competency assessment. A separate assessment would not be required for the additional test; however, the laboratory must assess training needs and take appropriate action. Tests with unique aspects or procedures, such as differences in pretreatment of specimens prior to analysis, different procedural steps, or differences in evaluation/interpretation, must be assessed separately for competency to ensure they are performed correctly.

Clinical and Laboratory Standards Institute. QMS03-A3: Training and Competence Assessment; Approved Guideline. 3rd ed. CLSI; 2009.

Standard: Personnel Assessment. 42 CFR §493.1713 (1992).

Standard: Technical Consultant Responsibilities. 42 CFR §493.1413. https://j.mp/345dR11

Standard: Technical Supervisor Responsibilities. 42 CFR §493.1451(b). https://j.mp/2SXvEQK

U.S. Department of Health and Human Services. Centers for Medicare and Medicaid Services. What Do I Need to Do to Assess Personnel Competency? November 2012. http://www.cms.gov/Regulations-and-Guidance/Legislation/CLIA/CLIA_Brochures.html