Medical Laboratory Observer’s (MLO) third “State of the Industry” survey topic in 2022 is Disease Management. The majority of clinical laboratory professionals responding (93%) work in hospital labs.
The survey findings reveal higher testing volumes at a time when most labs are struggling with staff shortages. For many labs, changes made in diagnostic processes in response to the COVID-19 pandemic, such as supplier diversification and increased space for molecular testing, have become a permanent way to cope with continued challenges.
In addition to the survey data, we present insights from U.S. clinical lab professionals on the disease management trends they are seeing in their testing facilities.
Fewer staff to process more tests
The survey results show an increase in testing volumes across the board, with 67% of respondents saying their labs are processing more tests for respiratory-related diseases, 43% drugs of abuse, 36% sexually transmitted infections (STI)/sexually transmitted diseases (STD) and other sexually transmitted infections, 22% autoimmune related diseases, 22% cancer, 17% healthcare-acquired infections (HAIs), and 13% genetic-related diseases.
“Overall laboratory testing remains above pre-pandemic levels with what seems to constitute delayed services during the pandemic and new growth occurring within our system. The volumes that are presently challenging us are not specific to one department but mostly constitute Chemistry, Hematology, Microbiology, and Surgical Pathology. Some of the volume challenges we are hoping to address via improved order utilization and future laboratory automation.”
“The testing volume has become very unpredictable,” said Nassreen Fontanilla, QA/LIS Lab Supervisor, Northern Nevada Health System, Sparks, Nev. “And the supply chain crisis as well as manpower shortage due to infected or quarantining staff makes managing the testing volume even more challenging.”
The vast majority of lab professionals surveyed said they are dealing with staff shortages (92%).
Radke said his lab had adequate staffing levels throughout the pandemic but that changed in May 2022 with increased competition for talent in his area:
“With two other health systems in the local area and several more within the region, pressures from wage competition have caused staff to consider other opportunities or dayshift openings at other institutions. We’re attempting to combat this with changes to staffing models, flexibility with hours and shift assignment, ‘Thank You’ bonuses, and now sign-on bonuses of up to $5,000. The market is crazy and we are trying to keep up.”
Pandemic established permanent diagnostic process changes
The COVID-19 pandemic prompted most labs to make changes in the way they run tests and record results. The survey results indicate that many of these process changes have remained in place.
The percentage of respondents using multiple vendors for consumable testing supplies rose 11% since last year, at 65% in 2022 compared with 54% in 2021. Nearly half of respondents (46%) said they have reallocated or increased physical space for molecular testing in 2022, compared with 43% in 2021. More labs are using multiple reference labs at 22% in 2022, compared with 18% in 2021.
Other process changes have held steady, such as less reliance on just-in-time (JIT) and more standing orders (12% in 2022 vs. 11% in 2021), more electronic data and less paper (24% in 2022 vs 25% in 2021), consistent use of digital pathology (3% in 2022 and 3% in 2021), but decreased use of high-throughput platforms (22% in 2022 and 27% in 2021).
Those surveyed also provided their insights into polymerase chain reaction (PCR) testing:
- 23% use one PCR platform/analyzer (down from 25% in 2021)
- 30% use two PCR platforms/analyzers (up from 18% in 2021)
- 11% use three PCR platforms/analyzers (down from 14% in 2021)
- 21% use more than three PCR platforms/analyzers (up from 19% in 2021)
- 14% use no PCR platform/analyzer (down from 24% in 2021)
On her lab’s diagnostic process changes, Fontanilla shared: “Prior to COVID, materials management usually contracted with one or two vendors for supplies. During COVID, our purchasing department tries to reach out to different manufacturers to ensure that if one item is back ordered from one manufacturer, the hope is to find a feasible substitute. Prior to joining NNHS, I was involved in consolidating multiple instruments into two integrated systems and started an automation project during COVID.”
COVID testing trends
When asked what tests their labs conducted for COVID-19, the percentage of respondents indicated the following:
- D-dimer value: 79% (up from 53% in 2021)
- C-reactive protein: 67% (up from 50% in 2021)
- Fibrinogen: 51% (up from 30% in 2021)
- FDP: 11% (up from 6% in 2021)
- IL-6: 7% (down from 10% in 2021)
- Ferritin: 6% (data N/A in 2021)
- Cystatin C (CysC): 3% (down from 4% in 2021)
“The most common laboratory tests for COVID-19 patients constitute C-reactive protein, D-dimer, CBC, CMP, magnesium, and creatine kinase,” said Radke. “Admission labs are more diverse and include BNP, Procalcitonin, Urine Legionella Antigen, LDH, Vitamin D, and more. With COVID trending towards becoming more of an endemic and less lethal virus, I see our health system reducing some of the daily and admission labs. We are in discussions to reduce D-dimer, CBC w/ differential, BNP, and a few other assays to an as needed basis.”
For COVID-19 specifically, Radke says testing methodology has changed with the availability of supplies. For most of the pandemic, his lab was running the 7500 Fast Dx instrument for high-volume PCR testing because they could obtain the required supplies and had the technical staff to perform it. They complimented this testing with faster PCR methods from Cepheid and BioFire for cases requiring rapid/urgent results.
“With the Omicron surge, we split testing between the 7500 Fast Dx and the Hologic Panther TMA assay as supply became more available,” Radke explained. “This allowed for expansion of our testing personnel to provide timely molecular results, balanced workloads, and decreased supply constraints.”
“As we have been dealing with bouts of Stealth Omicron infections, most routine testing is occurring on the Hologic Panther instrument as the platform is more conducive to runs below 100 samples,” he added. “I’d like to believe we will not be changing methodology for COVID testing this year, but supply constraints may drive that consideration.”
More use of multiplex
Among lab professionals surveyed, 69% said they are using syndromic testing (multiplex) to detect SARS-CoV-2 and other infectious diseases, such as Flu A & B, RSV (up from 55% in 2021), and a further 2% said they plan to begin this type of testing in the future (down from 9% in 2021).
“Adapting to the various variants and the episodic surges prompted us to update our testing methodologies for COVID,” said Fontanilla. “We have the ID NOW and the Cepheid for our in-house needs, and we sent our pre-ops to a reference lab. However, when we were not able to obtain kits due to supplies being back ordered, we had to limit in-house testing for urgent COVID tests and send the majority to the reference lab. We also had to switch from the single Cepheid reagent to the four-plex cartridge.”
When asked if reimbursement for PCR tests to detect SARS-CoV-2 and related COVID-19 conditions is covering their labs’ costs, 21% of survey respondents said “yes” and 17% “no,” while more than half (54%) said they were “not sure.”
Diabetes testing
Among survey respondents testing for diabetes, their labs are using the following methodologies:
- HbA1c: 88% (up from 79% in 2021)
- Fasting plasma glucose test: 85% (up from 76% in 2021)
- Random plasma glucose test: 76% (up from 68% in 2021)
- Oral glucose tolerance test: 67% (up from 56% in 2021)
Those surveyed were also asked what methods of testing they used for HbA1c, one of the most commonly used for diabetes management. Responses were as follows:
- Immunoassay: 46% (up from 40% in 2021)
- Enzymatic: 21% (up from 17% in 2021)
- Cation exchange HPLC: 11% (down from 14% in 2021)
- Boronate affinity chromatography: 5% (up from 4% in 2021)
- Capillary separation: 4% (down from 5% in 2021)
- Adoption of next generation sequencing (NGS)
Only 7% of survey respondents said they conduct in-house NGS testing for cancer (down from 9% in 2021), but recent research shows increased interest in this modality given its ability to analyze genomic abnormalities in a cost-effective manner.
The American College of Medical Genetics and Genomics (ACMG) reports that “Next-generation sequencing (NGS) technologies are now established in clinical laboratories as a primary testing modality in genomic medicine…with advancements like DNA sequencing and RNA sequencing allow uncovering of genomic, transcriptomic, and epigenomic scenes of individual malignant growths.” 1
The ACMG says NGS technologies have made it “cost-effective to analyze an individual with disease-targeted gene panels, exome sequencing, or genome sequencing to assist in the diagnosis of a wide array of clinical scenarios.”
Physicians ordering NGS tests for patients with breast cancer increased more than six-fold from 2014 to 2019, according to research published in the November 2021 edition of JCO Precision Oncology.2
Looking ahead
The results of the 2022 Disease Management State of the Industry survey show how U.S. clinical labs continue to innovate despite the challenges of rising test volumes, supply chain disruptions, and staffing shortages.
Many of the advancements being embraced, from process automation to the use of diagnostic platforms to test for multiple conditions, benefit not only the patient in terms of more rapid and accurate diagnosis, but also the lab itself through greater efficiency and faster throughput.
References
- Rehder, C., Bean, L.J.H., Bick, D. et al. Next-generation sequencing for constitutional variants in the clinical laboratory, 2021 revision: a technical standard of the American College of Medical Genetics and Genomics (ACMG). Genet Med. 2021;23(8):1399-1415. doi:10.1038/s41436-021-01139-4.
- Sturgill EG, Misch A, Lachs R, et al. Next-generation sequencing of patients with breast cancer in community oncology clinics. JCO Precis Oncol. 2021;5:1297-1311. doi: 10.1200/PO.20.00469.
Collaboration in ICU medical rounds become reality
The COVID-19 pandemic has driven numerous changes in the clinical lab space, including those related to people, processes, and technology. While some have caused greater complexity, such as the need to diversify suppliers in the face of shortages, others have resulted in both clinical and operational benefits.
Tyler Radke, MLS(ASCP), Team Leader, Laboratory, Bellin Memorial Hospital, Bellin Health Oconto Hospital, Oconto, Wis., describes how the pandemic prompted his lab to pursue what he calls a “wish-list” item, daily intensive care unit (ICU) medical rounds:
“Care teams and providers often reached out to the laboratory for guidance on test methodology, interpretation, and insights on COVID-19 testing. We also saw some test ordering patterns where we began to question the value being added. At one point, we even had a provider during Medical Care Branch call out the recommendation to consult with the laboratory regarding new assays being considered for COVID-19 patients. In that specific case, it was the use of Brain Natriuretic Peptide for monitoring ambulatory outpatients with COVID-19.”
In response to these inquiries, Radke reached out to his facility’s Infectious Disease Provider to discuss the potential for a laboratorian to become part of the rounding team.
“He was very supportive of the idea which then led me to connecting with the ICU Nurse Practice Specialist who coordinates daily rounds,” said Radke.
With their acceptance and support, Radke’s lab is in what he calls the “infancy stages” of his team participating in ICU medical rounds.
“Everyone on the team was very welcoming to including our laboratory,” he explains. “Within the first week, several team members had commented on the benefit of including the lab to review tests being ordered, send-out and culture results pending, and input on collection and testing protocols. I honestly didn’t expect there to be as much opportunity to contribute in the first week as there was, but the collaborative environment was welcoming to the opportunity for improvement.”
Radke said the biggest findings in the first week of the lab’s participation in the ICU medical rounds were around canceling pending send-out tests that they no longer needed and recommending changes from ordering daily CBC with Differential to CBC No Differential.
“In one case, the provider reduced the needs of lab testing from twice daily to ‘as needed,’ said Radke. “In conversation with the Nurse Practice Specialist, she has been very supportive as she felt the laboratory piece was mostly overlooked as the responsibility loosely belonged to anyone involved in the care management process. The collaboration and communication have been great. I am hopeful this will open the door to future opportunities for other areas to work with the laboratory.”
