Context.—

Coronavirus disease 2019 (COVID-19) changed the dynamics of health care delivery, shifting patient priorities and deferring care perceived as less urgent. Delayed or eliminated care may place patients at risk for adverse outcomes.

Objective.—

To identify opportunities for laboratory test stewardship to close potential gaps in care created by the COVID-19 pandemic.

Design.—

The study was a retrospective time series design examining laboratory services received before and during the COVID-19 pandemic at a large metropolitan health system serving women and children.

Results.—

Laboratory test volumes displayed 3 distinct patterns: (1) a decrease during state lockdown, followed by near-complete or complete recovery; (2) no change; and (3) a persistent decrease. Tests that diagnose or monitor chronic illness recovered only partially. For example, hemoglobin A1c initially declined 80% (from 2232 for April 2019 to 452 for April 2020), and there was a sustained 16% drop (28-day daily average 117 at August 30, 2019, to 98 at August 30, 2020) 4 months later. Blood lead dropped 39% (from 2158 for April 2019 to 1314 for April 2020) and remained 23% lower after 4 months.

Conclusions.—

The pandemic has taken a toll on patients, practitioners, and health systems. Laboratory professionals have access to data that can provide insight into clinical practice and identify pandemic-related gaps in care. During the pandemic, the biggest patient threat is underuse, particularly among tests to manage chronic diseases and for traditionally underserved communities and people of color. A laboratory stewardship program, focused on peri-pandemic care, positions pathologists and other laboratory professionals as health care leaders with a commitment to appropriate, equitable, and efficient care.

The coronavirus disease 2019 (COVID-19) pandemic changed how patients access and use health care.14  In March 2020, state governments in the United States imposed lockdowns to mitigate viral transmission.5,6  Elective surgeries and nonurgent procedures were canceled or postponed.5,7  When restrictions eased, Texas Children's Health System (Houston) admissions and outpatient visits resumed, though not always to prepandemic levels. We examined the pandemic's impact on use of the health care system using representative laboratory tests and identified gaps in care that require a coordinated policy and health system response. Pathologists and laboratory professionals have a key role in identifying opportunities to close the gaps in care using laboratory data. We advocate a focus on conditions where laboratory information can provide guidance to reduce adverse consequences of missed interventions and benefit all of our patients during and following the pandemic.

We examined laboratory use during the pandemic within the Texas Children's Health System, one of the largest US pediatric health systems, serving the greater Houston area. It includes 3 children's hospitals (742 beds), a women's hospital (119 beds), and 85 ambulatory practices. Texas Children's Health System serves a diverse population (61% people of color, 50% Medicaid and Children's Health Insurance Program participants).7  Our study included tests reported during January through August 2020. Tests ordered but not performed were excluded from our analysis. Test volumes during the pandemic were compared with the corresponding time period in 2019. We heuristically identified laboratory tests that reflected different ordering trends in response to the pandemic and that also had sufficiently high volumes for analysis. We selected a limited sample of commonly ordered diagnostic tests (eg, complete blood count and surgical pathology), screening tests (eg, Papanicolaou smear), and tests to detect/monitor long-term health conditions (eg, hemoglobin A1c [HbA1c] and lead). We also looked at one test that is a low-volume and high-cost service (whole-exome sequencing). Using Microsoft SQL Server Management Studio 2008, we extracted clinical laboratory test volumes and hospital census and outpatient visit data from Epic Clarity, the reporting database of the Texas Children's Health System electronic medical record. We wrote custom code in Python with Plotly (Plotly Technical Computing, Montreal, Quebec, Canada) to visually compare the data. To minimize the noise from daily and weekly variations in test volumes, patient visits, and inpatient census, we applied a 28-day moving average, where mentioned. Each 28-day moving average data point is the mean of the counts of the current day plus the counts from prior 27 days. That is, the 28-day average at day i is:
\(\def\upalpha{\unicode[Times]{x3B1}}\)\(\def\upbeta{\unicode[Times]{x3B2}}\)\(\def\upgamma{\unicode[Times]{x3B3}}\)\(\def\updelta{\unicode[Times]{x3B4}}\)\(\def\upvarepsilon{\unicode[Times]{x3B5}}\)\(\def\upzeta{\unicode[Times]{x3B6}}\)\(\def\upeta{\unicode[Times]{x3B7}}\)\(\def\uptheta{\unicode[Times]{x3B8}}\)\(\def\upiota{\unicode[Times]{x3B9}}\)\(\def\upkappa{\unicode[Times]{x3BA}}\)\(\def\uplambda{\unicode[Times]{x3BB}}\)\(\def\upmu{\unicode[Times]{x3BC}}\)\(\def\upnu{\unicode[Times]{x3BD}}\)\(\def\upxi{\unicode[Times]{x3BE}}\)\(\def\upomicron{\unicode[Times]{x3BF}}\)\(\def\uppi{\unicode[Times]{x3C0}}\)\(\def\uprho{\unicode[Times]{x3C1}}\)\(\def\upsigma{\unicode[Times]{x3C3}}\)\(\def\uptau{\unicode[Times]{x3C4}}\)\(\def\upupsilon{\unicode[Times]{x3C5}}\)\(\def\upphi{\unicode[Times]{x3C6}}\)\(\def\upchi{\unicode[Times]{x3C7}}\)\(\def\uppsy{\unicode[Times]{x3C8}}\)\(\def\upomega{\unicode[Times]{x3C9}}\)\(\def\bialpha{\boldsymbol{\alpha}}\)\(\def\bibeta{\boldsymbol{\beta}}\)\(\def\bigamma{\boldsymbol{\gamma}}\)\(\def\bidelta{\boldsymbol{\delta}}\)\(\def\bivarepsilon{\boldsymbol{\varepsilon}}\)\(\def\bizeta{\boldsymbol{\zeta}}\)\(\def\bieta{\boldsymbol{\eta}}\)\(\def\bitheta{\boldsymbol{\theta}}\)\(\def\biiota{\boldsymbol{\iota}}\)\(\def\bikappa{\boldsymbol{\kappa}}\)\(\def\bilambda{\boldsymbol{\lambda}}\)\(\def\bimu{\boldsymbol{\mu}}\)\(\def\binu{\boldsymbol{\nu}}\)\(\def\bixi{\boldsymbol{\xi}}\)\(\def\biomicron{\boldsymbol{\micron}}\)\(\def\bipi{\boldsymbol{\pi}}\)\(\def\birho{\boldsymbol{\rho}}\)\(\def\bisigma{\boldsymbol{\sigma}}\)\(\def\bitau{\boldsymbol{\tau}}\)\(\def\biupsilon{\boldsymbol{\upsilon}}\)\(\def\biphi{\boldsymbol{\phi}}\)\(\def\bichi{\boldsymbol{\chi}}\)\(\def\bipsy{\boldsymbol{\psy}}\)\(\def\biomega{\boldsymbol{\omega}}\)\(\def\bupalpha{\bf{\alpha}}\)\(\def\bupbeta{\bf{\beta}}\)\(\def\bupgamma{\bf{\gamma}}\)\(\def\bupdelta{\bf{\delta}}\)\(\def\bupvarepsilon{\bf{\varepsilon}}\)\(\def\bupzeta{\bf{\zeta}}\)\(\def\bupeta{\bf{\eta}}\)\(\def\buptheta{\bf{\theta}}\)\(\def\bupiota{\bf{\iota}}\)\(\def\bupkappa{\bf{\kappa}}\)\(\def\buplambda{\bf{\lambda}}\)\(\def\bupmu{\bf{\mu}}\)\(\def\bupnu{\bf{\nu}}\)\(\def\bupxi{\bf{\xi}}\)\(\def\bupomicron{\bf{\micron}}\)\(\def\buppi{\bf{\pi}}\)\(\def\buprho{\bf{\rho}}\)\(\def\bupsigma{\bf{\sigma}}\)\(\def\buptau{\bf{\tau}}\)\(\def\bupupsilon{\bf{\upsilon}}\)\(\def\bupphi{\bf{\phi}}\)\(\def\bupchi{\bf{\chi}}\)\(\def\buppsy{\bf{\psy}}\)\(\def\bupomega{\bf{\omega}}\)\(\def\bGamma{\bf{\Gamma}}\)\(\def\bDelta{\bf{\Delta}}\)\(\def\bTheta{\bf{\Theta}}\)\(\def\bLambda{\bf{\Lambda}}\)\(\def\bXi{\bf{\Xi}}\)\(\def\bPi{\bf{\Pi}}\)\(\def\bSigma{\bf{\Sigma}}\)\(\def\bPhi{\bf{\Phi}}\)\(\def\bPsi{\bf{\Psi}}\)\(\def\bOmega{\bf{\Omega}}\)\begin{equation}{a_i} = {1 \over {28}}\mathop \sum \limits_{n = 0}^{27} \left( {{d_{i - n}}} \right)\end{equation}
where dj = daily count total for day j. Our research protocol, H-48396, was approved by the Institutional Review Board of the Baylor College of Medicine, Houston, Texas.

The first case of COVID-19 in Texas was reported on March 4, 2020.8  Texas Children's Health System began testing for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) RNA on March 10, and through the end of August 2020 performed 37 513 SARS-CoV-2 RNA tests. On March 19, Texas restricted activity, limited gatherings, and closed schools, gyms, restaurants, and bars.6,8  From March 22 through April 22, the governor of Texas issued an executive order to postpone all elective surgery. Phased reopenings began in May. During March to June 2020, the most restrictive stay-at-home period, hospital admissions and outpatient visits decreased by 17% (from 72 544 to 59 854) and 41% (from 506 879 to 298 065), respectively, compared with the corresponding period in 2019 (solid and dotted black lines in Figures 1 through 3). Telehealth visits increased nearly 275-fold, from 537 visits in January through August 2019 to 147 259 visits in January through August 2020, which helped mitigate the impact of reduced ambulatory visits. Despite this huge increase, telehealth visits (147 259) never exceeded more than 10% of the total outpatient visits (1 552 633).

Laboratory test volumes displayed 3 distinct patterns during the pandemic: (1) a decrease coinciding with state closing, followed by near-complete or complete recovery, (2) no change, and (3) a persistent decrease. The first category of tests was impacted by the pandemic but mostly recovered, their volumes closely mirroring the health system's inpatient census. With cancelled elective surgery, surgical pathology total case counts and inpatient complete blood count test counts decreased by 28% (from 9672 to 6941) and 34% (from 106 971 to 70 854), respectively, from 2019 to 2020 during the same March to August period. Both approached close to prepandemic volumes 4 months after the phase 1 reopening (Figure 1, A and B). Estradiol, commonly used when managing women seeking fertility treatment, displayed an initial precipitous fall followed by a dramatic return to prepandemic levels once restrictions eased (Figure 2, A). Peripartum testing, for example group B Streptococcus testing of pregnant women and neonatal bilirubin (in patients ≤30 days old), remained unaffected by the pandemic, reflecting the pandemic-invariant birth counts during this period (Figure 2, B and C). The last category of tests was those used for diagnosis or monitoring of chronic illness or for screening for disease at well-patient visits, for example HbA1c, blood lead, Papanicolaou smears, and whole-exome sequencing for childhood genetic conditions. This category recovered only partially. Hemoglobin A1c volumes declined 80% (2232 to 452) for April compared with the same period in 2019. The normally seen seasonal trend of HbA1c, with test volumes increasing prior to the start of school in the fall, was also disrupted. By August's end, despite the easing of mobility restrictions, there was a sustained drop in tests of approximately 16% by the end of August, from 117 in 2019 to 98 in 2020 (Figure 3, A, 28-day moving averages). Blood lead volumes dropped 39% (from 2158 to 1314) for April and ended August 2020 23% lower (from 43 to 33), compared with 2019 (Figure 3, B, 28-day moving averages). Papanicolaou smears dropped by 77% (from 719 to 167) in April and displayed a sustained decrease of more than 29% (from >21 to <15 in August) until the end of August (Figure 3, C, 28-day moving averages). Large decreases (45%) in whole-exome sequencing volumes (from 127 to 70) persisted into August 2020 (Figure 4).

Coronavirus disease 2019 has impacted health in many ways. The Blue Cross Blue Shield Association reported that routine childhood vaccinations decreased by 26% in 2020 compared with 2019.9  We examined COVID-19′s impact, from a laboratory diagnostics standpoint, on the health of children and women in Texas. Most laboratory tests initially declined as communities locked down and elective surgeries were canceled. Some tests, like estradiol, rebounded rapidly. The rapid fall and rise in demand of this test may reflect the discretionary nature of fertility treatments and the desire to resume them as soon as possible. The return of surgical pathology cases reflects the resumption of elective surgeries. Other tests recovered slowly, reflecting partial continuing deferral.

Tests that decreased in volume but did not completely recover are of special concern. Outpatient HbA1c declined but only partially recovered, suggesting suboptimal pediatric diabetes monitoring. The summer rebound reflects the expected annual increase in testing before school reopenings, but this increase still does not reach the volumes seen in 2019. Newborn lead screening for at-risk children identifies environmental exposure, facilitating interventions that reduce developmental delay. Texas recommends lead testing for Medicaid patients in targeted areas, with parental request or with clinical suspicion.10  Our data suggest many children have missed blood lead screening. Because of the importance of recognizing and mitigating lead exposure early, pediatricians must quickly identify patients and arrange for screening. Decreases in whole-exome sequencing testing suggest patients with complex genetic conditions may remain undiagnosed longer, possibly leaving only suboptimal and more expensive symptomatic treatment options.11 

We do not believe that downtrends in test volumes are attributable to correction of test overuse because there were no initiatives to reduce test misuse within the data collection period. Also, 2 studies12,13  showed that test volume variations are not associated with procedure appropriateness. Testing downtrends were also unlikely due to population loss. Allied Van Lines reported the percentage of moves into Houston (57.8%) exceeded moves out (42.2%) during 2020.14 

Routine Papanicolaou smears declined, consistent with women's limited access to routine primary care services during the second quarter of 2020. There was a partial recovery by summer, reflecting in part a slow return of patients for regularly scheduled ambulatory visits. Current US Preventive Services Task Force guidelines recommend Papanicolaou testing at 3-year intervals or high-risk human papillomavirus testing, with or without Papanicolaou testing, at 5-year intervals.15  In July 2020, the American Cancer Society issued updated recommendations favoring primary high-risk human papillomavirus screening.16  However, based on the timing of this study and ongoing professional dialogue about the relative clinical utility of high-risk human papillomavirus testing alone versus cotesting,17,18  new 2020 guidelines would not have influenced practice during this study period. Given the relatively long intervals specified for repeat testing, delays of several months are unlikely to significantly impact the population-based risk for cervical cancer. However, for an individual patient, a delay could be associated with adverse clinical outcomes. Furthermore, as the pandemic continues, it is important that health care providers ensure that those who have missed a scheduled cervical cancer screening obtain that service in a timely manner.

Laboratory medicine and the professionals engaged in this practice have access to data that can provide insight into clinical practice and can identify potential gaps in care. Laboratory stewardship programs are growing nationally19  and provide a framework to use data and analytic approaches to achieve effective test utilization.20  Effective test utilization strives to curtail overuse, underuse, and misuse of laboratory services.19  In the context of the pandemic, supported by the data presented above, the biggest patient threat that likely exists is underuse, particularly of those tests that are essential for screening and monitoring patients for chronic diseases. Data also suggest that underuse is prevalent in traditionally underserved communities and among people of color.21  An effective laboratory stewardship initiative, working within its health system, offers the opportunity to identify and close these gaps. When done effectively, a laboratory stewardship program, particularly focused around care during and after the pandemic, will position laboratory professionals as health care leaders with a commitment to assure appropriate, equitable, and efficient care.

The authors thank Erin Monteverdi, BA, for project coordination, and Bill Robinson, BS, and Ryan Kennedy, BA, MBA, of hc1 for their early input in conceptualizing the data analysis.

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Author notes

Hilborne is an employee of Quest Diagnostics and owns Quest Diagnostics stock. The other authors have no relevant financial interest in the products or companies described in this article.