CLN - Focus on Laboratory Stewardship

HbA1c Access and Opportunity During the COVID 19 Pandemic

Special Section: JulyAug 2021

Derick Lim, MS, SC(ASCP)CM, MLS(ASCP)CM, Khushbu Patel, PhD, DABCC, and Tracey G. Polsky, MD, PhD

Getting the right test to the right patient at the right time is a common goal for medical and laboratory professionals working on laboratory stewardship. This mantra translates into ensuring that laboratory resources are optimized for patient-centered care.

To achieve this goal, laboratory professionals typically identify and address both underutilization and overutilization of laboratory resources. Overutilization of laboratory testing is a frequently targeted problem—and one that is easier to identify. However, underutilization is an equally important problem that often goes unnoticed, and therefore is tougher for stewardship programs to tackle. In fact, underuse is estimated to occur as frequently as overuse, if not more (1).

Test underuse can occur for many reasons. Providers may be unfamiliar with best practices, guidelines, or even available testing options. They may lack clinical decision support systems to help identify appropriate diagnostic testing. And patients may lack access to testing in a timely and convenient manner. To emphasize this latter point, the inability of patients to take time off work or school during normal business hours can be a major contributor to limiting physical access to testing.

COVID-19 Leads to New Underutilization Challenge

For most laboratories, analytic tools are not effectively designed to capture test underutilization. Identifying underuse often requires a close partnership between the laboratory and ordering providers to understand patterns of test ordering and assess the impact of these patterns on clinical management.

However, due to “medical distancing” resulting from the COVID-19 pandemic, laboratories were able to quickly identify areas of underutilization (2). One example is the measurement of hemoglobin A1c (HbA1c). Many diabetic patients at our institution have HbA1c measurements performed at the point-of-care during their clinic visit. However, early in the pandemic, many patients transitioned their routine care from in-person visits to telehealth visits. As a result, HbA1c testing was drastically affected for us, with point-of-care HbA1c testing volumes declining approximately 80% at the peak of the pandemic’s first wave.

International consensus guidelines recommend HbA1c measurements be performed every 3 months to assess and manage glycemic control in children, adolescents, and young adults with diabetes (3). With such a significant decline in volume for HbA1c testing performed at both the point-of-care setting and in the central laboratory, it became quite evident that many patients were not getting their HbA1c levels evaluated at the appropriate recommended interval.

Dealing with laboratory test underutilization and implementing an appropriate solution can be as challenging as identifying it. In our scenario of HbA1c underuse, our endocrinology colleagues promptly brought our attention to the problem. Test volume data from our laboratory’s operations dashboards also unmistakably pointed to the issue. It was clear that to address it, we needed a solution that improved patients’ access to testing. We needed a test that would allow patients to collect samples at home and send them to our laboratory for analysis.

To that end, we explored adding dried blood spots as an alternate specimen type to our existing central laboratory HbA1c assay. Fortunately, our colleagues at Seattle Children’s Hospital had validated a dried blood spot assay for this purpose. They had already been offering a dried blood spot option for immunosuppressive therapeutic drug monitoring for transplant patients long before the pandemic, and they graciously provided us with support (4,5).

Rising to the Opportunity

Rapidly deploying resources to implement a new test during the pandemic was challenging. Validating a test and training staff on a major change in procedure in a timely manner—in an understaffed and overworked laboratory—seemed insurmountable at the time. However, with the dedicated help of hardworking staff members, collaborators, and clinical colleagues, we were able to validate and implement our dried blood spot testing program for HbA1c in a matter of months of identifying the issue.

The most time-consuming aspect of the process turned out to be operationalizing the program, and not the actual validation of the dried blood spot HbA1c assay itself. We needed to quickly develop an intricate infrastructure to support a multistep process, which included identifying patients that would need the test in advance of a telemedicine visit, mailing the dried blood spot collection kit to the patient, the patient mailing the sample back to the lab, the lab tracking and receiving the dried blood spot sample, and creating a patient encounter in the electronic medical record so that results could be verified in time for the upcoming telemedicine visit.

Developing this workflow required close collaboration among the clinical and administrative staff at our diabetes clinic, information services, and sections of the clinical lab mailing the collection kits, performing the testing, and accessioning the mail-in samples. Much of the burden on creating this process fell on our central laboratory professionals, who had to operationalize a new process for mailing the collection kits and receiving the samples.

Identifying patients whose insurance would cover this service was another implementation challenge, one we continue to work on with our hospital’s financial services team, especially for patients who are covered by insurance with laboratory capitation.

Looking Ahead

The concept of telemedicine is not new to diabetes management. Several studies assessing the impact of telemedicine visits on diabetes management have shown better glycemic control through mean reduction in HbA1c levels. Telehealth use prior to the pandemic was mainly limited because of CMS restrictions, which were lifted in March 2020. 

Out of necessity, the COVID-19 pandemic has paved the way for a new and different future; it has accelerated the adoption of technologies that were long overdue. Regardless of whether the surge in telemedicine visits continues postpandemic, implementation of a remote blood sampling program has unveiled opportunities for our laboratory to address aspects of laboratory test underutilization when access is a key driver. Expansion of our remote sample-collection program to other tests beyond HbA1c will enable us to reach patient populations with chronic conditions that need more convenient and accessible laboratory testing.

In the era of value-based healthcare, it is of utmost importance that laboratories collaborate with care providers to identify and devise solutions that make the most of these opportunities.

References

  1. Zhi M, Ding EL, Theisen-Toupal J, et al. The landscape of inappropriate laboratory testing: A 15-year meta-analysis. PLoS One 2013;8:e78962. 
  2. Singh IR, Dowlin M, Chong TH, et al. Changes in test volumes during coronavirus disease 2019 (COVID-19): A laboratory stewardship opportunity. Arch Pathol Lab Med 2021; doi:10.5858/arpa.2021-0058-SA.
  3. DiMeglio LA, Acerini CL, Codner E, et al. ISPAD Clinical Practice Consensus Guidelines 2018: Glycemic control targets and glucose monitoring for children, adolescents, and young adults with diabetes. Pediatr Diabetes 2018;19 Suppl 27:105–14. 
  4. Roberts AJ, Malik F, Pihoker C, et al. Adapting to telemedicine in the COVID-19 era: Feasibility of dried blood spot testing for hemoglobin A1c. Diabetes Metab Syndr Clin Res Rev 2021;15:433-7. 
  5. Dickerson JA, Sinkey M, Jacot K, et al. Tacrolimus and sirolimus in capillary dried blood spots allows for remote monitoring. Pediatr Transplant 2015;19:101-6. 

Acknowledgements

We would like to acknowledge the clinical laboratory scientists Alya Nguyen (Seattle Children’s) and Ennis Xhepa (Children’s Hospital of Philadelphia), who helped make this innovation reality for our providers and patients.

Derick Lim, MS, SC(ASCP)CM, MLS(ASCP)CM, is a clinical laboratory section manager at The Children's Hospital of Philadelphia. +Email: [email protected]

Khushbu Patel, PhD, DABCC, is the director of clinical chemistry and point of care at The Children's Hospital of Philadelphia. +Email: [email protected]

Tracey G. Polsky, MD, PhD, is chief, division of community pathology at The Children's Hospital of Philadelphia. + Email: [email protected]

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