Female doctor looking at clipboard with test results
Syndromic Testing

Convincing your administration to invest in PCR panel tests

By QIAGEN Syndromic Testing

Infectious diseases are notoriously difficult to diagnose. Many pathogens may be at play, and symptoms can overlap. To manage patients effectively, you need to identify the underlying pathogen quickly. Unlike standard-of-care methods, multiplex PCR panel tests can provide results for a comprehensive range of pathogens at once. 

Read on to learn how to convince your institution that this technology is worth the investment.

Multiplex PCR panel tests, also known as syndromic tests, are molecular diagnostic assays that can dramatically reduce the time and effort required to perform a comprehensive microbiological assessment.

The QIAstat-Dx system is an exceptionally efficient and reliable example, backed by nearly 40 years of QIAGEN expertise in sample prep. It uses a one-step preparation process that requires no extra reagents, reducing the risk of contamination. It also provides insights in the form of easy-to-view Ct values and amplification curves (1).

These tests can help practitioners significantly improve care for patients with infectious diseases (2). By providing comprehensive results quickly, syndromic tests can optimize the diagnostic process. This can reduce unnecessary additional testing and support diagnostic stewardship (3).

And by enabling evidence-based pathogen identification and rational antimicrobial use, they are also a crucial component of antimicrobial stewardship programs (3). As a result, syndromic testing can shorten hospital length of stay, reduce overall testing, improve infection control decisions and optimize antimicrobial use (2).

Despite these benefits, there are barriers to implementing syndromic tests, with the primary obstacle being cost. Syndromic tests typically incur greater upfront and running expenses than standard-of-care microbiology methods.

The patient management benefits provided by syndromic testing may reduce overall healthcare costs.
But many studies have shown that these tests can reduce overall healthcare costs. For example, compared to standard of care, respiratory syndromic testing has demonstrated cost savings in multiple scenarios:
Study* Demonstrated cost savings of syndromic testing
versus standard of care
Shengchen D, Gu X, Fan G, et al. Clin Microbiol Infect.
2019;25(11):1415-1421.		 $237.8 per patient

Rogers BB, Shankar P, Jerris RC, et al. Arch Pathol Lab Med.
2015;139(5):636-641.

 $231 in hospital costs and $17 in antibiotic use per patient

Martinez, RM, et al. Poster #C-368 presented at:
Clinical Virology Symposium. 2016.

Positive test: >$9,000

Negative test: >$8,000
Shadowen RD, Doshi A, Ndzi R, Kazimuddin F. 1991.
Open Forum Infect Dis. 2019;6(Suppl 2):S668.		 Total antibiotic cost: $202.73
Antibiotic charges: $240.23

Syndromic testing can significantly benefit both patients and an institution's bottom line. How can you convince your administration to invest if you want to bring this technology to your lab?

To pitch a new molecular diagnostic instrument to your hospital administration, you must prepare and submit a business plan to justify the cost and explain the benefits to the hospital.

We've put together some tips and best practices you can use the next time you need to develop a business plan.

Business people negotiating at boardroom behind closed doors

Getting into the administration mindset

While you may think implementing syndromic testing is in your hospital's and its patients' best interests, you must convince your hospital administration. Take a moment to put yourself in your administration's shoes. How can you make the most compelling case for syndromic testing?

Clinicians, laboratory professionals and administrative personnel all play important – but distinct – roles in healthcare.

Clinicians work with patients daily and prioritize providing the best possible care.

In contrast, administrative personnel manage the financial side of healthcare and ensure that the organization remains financially stable. If they don't adhere to a strict budget, they can be penalized with negative performance evaluations or put the medical center in financial jeopardy (4).

While for-profit and non-profit private hospitals may have some financial wiggle room, safety net hospitals do not. In a recent article, Dr. Brad Spellberg, Chief Medical Officer for a safety net hospital in Los Angeles, emphasized the tradeoff he must make whenever a new proposal hits his desk: "To fund a new initiative means defunding an existing initiative" (4).

To fund a new initiative means defunding an existing initiative.

As a result, the decision to spend significant up-front capital on new medical devices or services requires evidence-based cost justification (4, 5). The rationale must explain how the intervention will provide a financial return through profit, loss reduction or cost avoidance (4, 5).

Therefore, laboratory professionals and clinicians looking to implement new molecular diagnostic tools like syndromic testing must bring the same rigor to the board room as they do to the clinic.

Developing a solid business case for syndromic testing

n asian chinese female writing on white board with her marker pen during conference meeting in office conference room

To pitch syndromic testing to your hospital administration, you must prepare and submit a business plan to justify the cost and explain the benefits to the hospital (4–6).

You can draw from examples in the literature to develop your business case. For example, justification for infection control and antimicrobial stewardship programs provide excellent examples (6).

Eli Perencevich et al. broke down the process of developing a business case, which we review here (5).

Step 1: Summarize the problem and how you can solve it with syndromic testing

Infectious diseases can be challenging to diagnose, as many pathogens can cause similar symptoms. Syndromic testing can help by providing quick and accurate detection of a wide range of pathogens in a single test. This can help improve patient care, reduce costs and optimize infection control.

For example, syndromic testing for suspected respiratory infections has the potential to (2):

  • Support your antimicrobial stewardship program's goal of reducing antimicrobial misuse by helping clinicians identify the most likely pathogen and target their antimicrobial therapy accordingly.
  • Improve patient management and flow through the hospital by enabling clinicians to make more informed decisions about patient isolation, admission and discharge.
  • Reduce the number of follow-up tests required to achieve a diagnosis, saving time and money for patients and the healthcare system.
  • Improve infection control by helping to identify and isolate patients with infectious diseases sooner, reducing the risk of transmission to other patients and healthcare workers.
Step 2: Meet with key stakeholders

Meeting with key stakeholders and building cross-disciplinary institutional support will be necessary to implement syndromic testing successfully. These stakeholders may include the chief medical officer, chief operating officer, laboratory director, antimicrobial stewardship program lead and infectious disease specialist.

When meeting with stakeholders, be prepared to discuss the following:

  • The benefits of syndromic testing, such as improved patient care, reduced costs and better infection control.
  • The specific resources needed to implement syndromic testing, such as the cost of the instrument and reagents, new staff requirements and changes required to the lab setup.
  • How syndromic testing will be integrated into the current clinical workflow.
  • How the success of syndromic testing will be measured.
Meet with stakeholders early to address concerns and gain support.
Step 3: Determine the annual cost of syndromic testing

Calculate the long-term operating costs for the new instrument, including consumable costs.

The annual cost of syndromic testing will vary depending on several factors, including the type of instrument, the number of tests performed and the cost of consumables. Here are a few essential costs that you should factor in when making your calculations:

  • Upfront cost of the instrument: The initial investment in a new laboratory instrument can be significant.
  • Cost of consumables: Consumables such as reagents and test kits can also be significant if you perform many tests. Use statistics from your institution to estimate how many patients you see every year for a given infectious illness to calculate the expected number of syndromic tests you'll need to perform.
  • Staff training and support: While syndromic testing instruments, such as the QIAstat-Dx, are easy to operate, you should consider what staff requirements may be needed. Will you need new staff in the lab, on the antimicrobial stewardship team or elsewhere? In addition, can your current lab setup accommodate a new benchtop instrument?
  • Waste disposal: Syndromic testing generates biological waste, so you must factor in the cost of proper disposal.
Step 4: Identify and calculate the costs that can be avoided – or optimized – by implementing syndromic testing
Understanding the differences between variable costs, attributable costs and fixed costs

Variable costs

Variable costs are hospital costs that can be directly impacted by implementing syndromic testing. These include:

  • Pharmacy (such as days of antibiotic therapy)
  • Supplies (catheters, intravenous tubing, implants, etc.)
  • Laboratory testing (complete blood counts, blood culture bottles, laboratory reagents, etc.)
Attributable costs

Attributable costs are the hospital costs that would have been avoided if a complication – such as antibiotic misuse, unnecessary additional testing or a hospital-acquired infection – had not occurred. For example, a study in Canada estimated that the cost of nosocomial RSV transmission in a pediatric population was $993 per admission (7).

Attributable costs are important to consider when developing your business case, as they negatively impact existing hospital revenue.

Fixed costs

Fixed costs are costs that do not change or change very little, regardless of how much output is produced. Up to 84% of hospital costs are fixed. In the context of hospitals, fixed costs typically include:

  • Hospital infrastructure: This includes the cost of building and maintaining the hospital and the cost of utilities such as electricity, water and heating.
  • Equipment: This includes the cost of medical equipment, such as MRI machines and surgical equipment.
  • Salaried employee labor: This includes the cost of salaries and benefits for hospital employees.

Fixed costs are a major challenge for hospitals because they are hard to cut. For example, reducing patient length of stay or doing fewer tests will not reduce fixed costs. Instead, hospitals can focus on optimizing their fixed costs.

One way to do this is to reduce excess length of stay. Excess length of stay is the amount of extra time a patient spends in the hospital that is medically unnecessary or avoidable. Reducing excess length of stay can free up beds for new patients, which can lead to more revenue.

However, it can be difficult to predict how much money a hospital will make by reducing excess length of stay, as this depends on the types of insurance plans that the hospital's patients have and how much each plan pays.

To estimate the additional revenue that can be generated by reducing excess length of stay, you'll need to know:

  • How many bed-days may be freed up per year
  • What your payer mix is at the hospital (% Medicare, % Fee-for-service Medicaid, % Private)
  • The hospital's Medicare Case Mix Index
  • Medicare base pay rate
  • How your hospital's Medicaid patients are reimbursed
Collaborating with your institution's financial team to make these calculations is essential.
Financial benefits of syndromic testing

Syndromic testing has the potential to help healthcare institutions save money in several ways, including:

  • Reducing length of stay: Syndromic testing can help clinicians diagnose and treat patients more quickly, leading to shorter hospital stays. A meta-analysis found that syndromic testing reduced length of stay for patients with respiratory infections by 0.82 days compared to standard of care (2).
  • Reducing hospital admissions: Syndromic testing can also help reduce hospital admissions by enabling clinicians to identify high-risk patients sooner. In adults presenting to the emergency room (ER) with respiratory symptoms, using syndromic testing reduced hospital admissions by 8.4% (8).
  • Optimizing antibiotic use: Syndromic testing can help clinicians target antibiotic therapy more effectively, reducing the use of unnecessary antibiotics. A U.S. study found that, compared to standard of care, syndromic testing resulted in a savings of $202.73 per patient in total antibiotic costs through a reduction in antibiotic use (9).
  • Reducing unnecessary additional testing: Syndromic testing can also help reduce the need for further testing, such as chest X-rays. In children presenting to the ER with respiratory symptoms, syndromic testing reduced chest radiographs from 78% to 59% compared to standard of care (10).
  • Reducing nosocomial transmission and hospital-acquired infections: Syndromic testing can reduce these adverse outcomes by enabling clinicians to identify and isolate patients with infectious diseases sooner. Enhanced isolation precautions can reduce the rate of nosocomial respiratory virus infections by 39% (11).
Step 5: Calculate the total financial impact

Complete your business case analysis by determining the net financial impact of introducing syndromic testing.

To do this, subtract the upfront and long-term costs of implementing the syndromic testing instrument from the gross savings and additional revenue that can be generated.

Here is a simple formula:
Net financial impact = Gross savings + Additional revenue - Upfront costs - Long-term costs

Several financial impact studies have demonstrated that syndromic testing can save on overall healthcare costs. Compare the results of these studies to your business case analysis to get a more accurate estimate of the potential financial impact for your institution.

Here are two examples:

  • Case study example 1: Implementation of syndromic testing for adult patients presenting to the ER with respiratory symptoms (8)
    • Over the 2-month study, the authors observed an 8.4% reduction in hospital admissions for patients testing positive with syndromic testing, equivalent to 31 avoided admissions.
    • 1043 fast diagnostic tests were performed at a total cost of $156,450 ($150 per test).
    • The national average cost for inpatient stay for community-acquired pneumonia is $7282.
    • Preventing just 22 unnecessary admissions would have accounted for the cost of performing syndromic testing.
    • In addition, the authors recorded reduced antibiotic initiation in patients with normal chest imaging (54.7% versus 96.8%). Still, they did not factor this into their financial analysis, suggesting that additional savings were unaccounted for.
  • Case study example 2: Decision tree modeling was used to determine the costs associated with syndromic testing compared to standard of care testing for patients with suspected respiratory infections (12)
    • The cost of hospitalization was calculated by averaging the cost per patient and the number of patients in each arm of the decision tree.
    • The study considered pathogen prevalence data and the sensitivity and specificity of syndromic and standard-of-care tests.
    • The authors calculated that for laboratory positivity rates of 11% or higher, syndromic testing would achieve a cost savings of $291 per case, mainly attributed to shortened length of stay.
      • They propose these savings would apply across all 12 months of the year, including months with a lower prevalence of respiratory infections in the community.
      • Based on an annual investigation of 1820 pediatric inpatients with suspected viral infections, this would amount to a savings of $529,620 per year.
Step 6: Discuss additional regulatory, financial or health benefits

The implementation of syndromic testing may have benefits beyond those discussed so far. Consider the impact on factors like patient experience, the institution's reputation and patient safety. In addition, will implementing syndromic testing help meet any national regulatory or legal standards, such as antimicrobial stewardship requirements?

For example, all U.S. acute care hospitals accredited by the Joint Commission must implement an antimicrobial stewardship program and meet certain core criteria, known as the Core Elements (13).

Here are some examples of how syndromic testing can support implementation of the Core Elements:

Step 7: Make the case for your business plan

Once you have a draft of your business plan, meet with key stakeholders individually to discuss the next steps for successful implementation, including:

  • Developing action plans
  • Setting budgets
  • Measuring performance
Step 8: Collect cost and outcome data after the test is implemented

Collect data on the outcomes and costs of syndromic testing after implementation. This data can be used to show that the intervention is effective and to maintain support for it within the organization.

Some key outcomes to measure include:

  • Length of stay
  • Hospital admission rate
  • Antimicrobial use
  • Additional testing (X-rays, blood draws, etc.)
  • Nosocomial transmission and hospital-acquired infection rates

    • To assess the cost-effectiveness of syndromic testing, you can compare it to a reference case, such as standard of care. A common way to do this is to use the quality-adjusted life year (QALY) metric. A QALY is a measure of both the quantity and quality of life lived.

    By comparing the cost per QALY of syndromic testing to the cost per QALY of the reference case, you can determine whether syndromic testing is a cost-effective intervention.

    Measure the impact of the intervention to prove its effectiveness and secure ongoing support.

    For more information on developing your business plan, use the following reviews as a jumping-off point:

    • Spellberg B, Bartlett JG, Gilbert DN. How to Pitch an Antibiotic Stewardship Program to the Hospital C-Suite. Open Forum Infect Dis. 2016;3(4):ofw210. Published 2016 Oct 15. https://doi.org/10.1093/ofid/ofw210
    • Perencevich EN, Stone PW, Wright SB, et al. Raising standards while watching the bottom line: making a business case for infection control. Infect Control Hosp Epidemiol. 2007;28(10):1121-1133. https://doi.org/10.1086/521852
    • Wenzler E, Timbrook TT, Wong JR, Hurst JM, MacVane SH. Implementation and optimization of molecular rapid diagnostic tests for bloodstream infections. Am J Health Syst Pharm. 2018;75(16):1191-1202. https://doi.org/10.2146/ajhp170604

    Learn more on demand

    Learn how rapid diagnostic tools can support antimicrobial stewardship programs
    Ready for more? Watch our on-demand webinar with Dr. Eric Wenzler, Assistant Professor in the Department of Pharmacy at the University of Illinois at Chicago. He'll walk you through how syndromic testing can support antimicrobial stewardship programs and help optimize clinical and economic outcomes.
    Watch now

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    References

    1. Cassidy H, Van Genne M, Lizarazo-Forero E, Gard L and Niesters HGM (2021) A discussion of syndromic molecular testing for clinical care. J Antimicrob Chemother 76(Supplement 3):iii58–iii66. https://doi.org/10.1093/jac/dkab243 
    2. Goldenberg SD, Bacelar M, Brazier P, Bisnauthsing K and Edgeworth JD (2015) A cost benefit analysis of the Luminex xTAG Gastrointestinal Pathogen Panel for detection of infectious gastroenteritis in hospitalised patients. J Infect 70:504–511. https://doi.org/10.1016/j.jinf.2014.11.009
    3. Soucek DK, Dumkow LE, VanLangen KM and Jameson AP (2019) Cost justification of the BioFire FilmArray Meningitis/Encephalitis panel versus standard of care for diagnosing meningitis in a community hospital. J Pharm Pract 32:36–40. https://doi.org/10.1177/0897190017737697
    4. Spellberg B, Bartlett JG, Gilbert DN. Open Forum Infect Dis. 2016;3(4):ofw210. Published October 15, 2016. https://doi.org/10.1093/ofid/ofw210
    5. Perencevich EN, Stone PW, Wright SB, et al. Infect Control Hosp Epidemiol. 2007;28(10):1121-1133. https://doi.org/10.1086/521852 
    6. Wenzler E, Timbrook TT, Wong JR, Hurst JM, MacVane SH. Am J Health Syst Pharm. 2018;75(16):1191-1202. https://doi.org/10.2146/ajhp170604 *
    7. Jacobs P, Lier D, Gooch K, Buesch K, Lorimer M, Mitchell I. A model of the costs of community and nosocomial pediatric respiratory syncytial virus infections in Canadian hospitals. Can J Infect Dis Med Microbiol. 2013;24(1):22-26. https://doi.org/10.1155/2013/916769 
    8. Weiss ZF, Cunha CB, Chambers AB, et al. Opportunities Revealed for Antimicrobial Stewardship and Clinical Practice with Implementation of a Rapid Respiratory Multiplex Assay. J Clin Microbiol. 2019;57(10):e00861-19. Published 2019 Sep 24. https://doi.org/10.1128/jcm.00861-19 *
    9. Shadowen RD, Doshi A, Ndzi R, Kazimuddin F. 1991. Implementation of Rapid Turnaround PCR Bacterial/Viral Panel Testing in Community-acquired Pneumonia Decreases LOS, Antibiotic Cost, Antibiotic Charges, and Antibiotic Use. Open Forum Infect Dis. 2019;6(Suppl 2):S668. Published 2019 Oct 23. https://doi.org/10.1093/ofid/ofz360.1671 *
    10. Subramony A, Zachariah P, Krones A, Whittier S, Saiman L. Impact of Multiplex Polymerase Chain Reaction Testing for Respiratory Pathogens on Healthcare Resource Utilization for Pediatric Inpatients. J Pediatr. 2016;173:196-201.e2. https://doi.org/10.1016/j.jpeds.2016.02.050 *
    11. Rubin LG, Kohn N, Nullet S, Hill M. Reduction in Rate of Nosocomial Respiratory Virus Infections in a Children's Hospital Associated With Enhanced Isolation Precautions. Infect Control Hosp Epidemiol. 2018;39(2):152-156. https://doi.org/10.1017/ice.2017.282
    12. Mahony JB, Blackhouse G, Babwah J, et al. Cost analysis of multiplex PCR testing for diagnosing respiratory virus infections. J Clin Microbiol. 2009;47(9):2812-2817. https://doi.org/10.1128/jcm.00556-09 *
    13. Core Elements of Hospital Antibiotic Stewardship Programs | Antibiotic Use | CDC. https://www.cdc.gov/antibiotic-use/core-elements/hospital.html

    * Data cited pertains to the use of a device from another manufacturer.

    For up-to-date licensing information and product-specific disclaimers, see the respective QIAGEN kit instructions for use or user operator manual. QIAGEN instructions for use and user manuals are available at www.qiagen.com or can be requested from QIAGEN Technical Services (or your local distributor).