Standardizing Your Point-of-Care Testing (POCT) Program

Point-of-care testing (POCT) is gaining traction, as its benefits align with value-based healthcare goals. However, POCT management brings a unique set of challenges because of the diversity of locations, workflows, devices, and operators. The expected growth and ongoing benefits of POCT, alongside the complexity of its oversight, make standardizing your POCT beneficial, specifically by improving efficiency and controlling costs.

Benefits of POCT Standardization

Healthcare consolidation continues as organizations combine to achieve the economies of scale necessary to compete in value-based care, resulting in larger, more geographically dispersed healthcare networks.

As health systems continue to grow, standardizing laboratory practices—specifically POCT—can improve efficiency and positively impact patient satisfaction, quality of care, and overall clinical operations.

Lack of Standardization Causes Confusion

Differences across locations (e.g., testing requirements; processes for registration, billing, patient preparation, collection; etc.) create confusion for patients as well as providers who need to tell patients what to expect. Providers benefit from standardized POCT because it streamlines test result interpretation and subsequent treatment plan development. For example, when tests are not standardized, the reference intervals vary if staff across the healthcare facility use  different methodologies, making it more cumbersome for providers to use test results to create a treatment plan. Figure 1 highlights how lack of standardization can decrease efficiency.

Standardization Reduces Redundancy & Errors

When all sites employ the same methodologies and instrumentation to perform testing, they can share testing policies, procedures, and best practices. In addition, the EHR-LIS interface build for each test (test code, test name, reference range, critical values, etc.) is set up the same way, regardless of performing location.

Along that line, processes for QC tracking, decision-support rules, autoverification, result flag handling, etc., can be applied across the organization to streamline operational efficiency and promote quality and safety.¹ These efficiencies are profound in a POCT program because the diversity of locations, devices, device capabilities, and operators compounds the complexity level and offers more opportunities for non-conformance.

Improvements in staff efficiency result from uniformity in practice across departments and testing locations. Uniformity reduces learning curves and is particularly beneficial for staff who float between departments and use different devices.²

In addition, providers who are tracking patients with chronic diseases, such as diabetes or chronic kidney disease, benefit from the consistency that POCT standardization offers. For example, if a provider is tracking Healthcare Effectiveness Data and Information Set (HEDIS) components for comprehensive diabetes care (e.g., Hgb A1c, retinal exam, nephropathy, blood pressure), and different devices are used between exams, the overall evaluation lacks consistency and accuracy. POCT standardization can improve the overall quality of testing by increasing consistency in chronic disease tracking, reducing pre analytic errors, improving the ability to meet regulatory requirements, improving patient safety, and making positive changes in test utilization. See Figure 2 for some additional positive effects of POCT standardization.

Less Variability Means Cost Savings

Even though there is a cost associated with acquiring new instrumentation, it is possible to achieve overall cost savings through more efficient workflows, decreased supply expenses, and decreased maintenance and data management costs attributable to fewer vendor fees.³ In addition, there may be cost benefits related to interfacing fewer POCT devices.

Combined Knowledge: The Whole is Greater than the Sum of Parts

The path to standardization also provides opportunities along the way to reengineer processes and make improvements. By combining knowledge from different practices and experiences at all testing locations, facilities can develop an improved process that is designed with improved patient outcomes and service in mind.¹

Hurdles: Making Your Case

Every worthwhile endeavor takes eff ort to set up and sustain, particularly in a convoluted healthcare system. And, as in any other laboratory-driven endeavor, leaders must align the laboratory goals with the overall organizational goals. Today, the Triple Aim healthcare goals involve providing quality patient care with an eye on cost efficiency and patient satisfaction. Providing a case for standardization to the administrative level with these mutual, organization-wide beneficial goals gives a POCT standardization project a greater chance of success. The laboratory is addressing C-suite concerns, focusing on the broader picture of impacting patients and achieving cost savings.

Required Collaboration

POCT’s wide range of stakeholders and logistical diversity makes its standardization a challenging process requiring cooperation and consensus among many departments. Furthermore, differences in testing volumes, location sizes, services offered, site-specific clinical needs, and provider mix may require site specific workflow adjustments.¹ Undertaking a POCT standardization project requires a collaborative eff ort across the entire POCT team, from the laboratory director to the end operators. In a LabLeaders.com interview, Barbara Goldsmith, PhD, FACB, Chair of Medical Laboratory Sciences and Biotechnology at Thomas Jefferson University Hospital, remarks that “buy-in across the board” and a “clear directive from the top” are necessary components to standardize laboratory testing across a large organization.³

Inevitable Challenges

One of the challenges is to identify all the stakeholders that need to be involved and be sure they are included in the decision-making process. Another challenge is choosing POCT devices that successfully meet the needs of the various clinical areas. Additionally, it is necessary to achieve a full understanding of all associated costs for instrumentation (including reagents and EMR interfaces).

It takes effective change management to help different laboratories or locations agree and work together, including creating policies and procedures that address future decisions, combining purchasing power, and defining standardized instrumentation. Workflows need to be analyzed and streamlined for best efficiency and use of staff . All these challenges require collaboration with C-suite executives and clear and ongoing communication with providers and employees.

Necessary Trade-offs

Undertaking a standardization initiative requires trade-off s to avoid pitfalls that prevent success. The key to navigating those trade-off s is strong leadership within the lab. Regulatory requirements, patient needs, organizational goals, and workflow design are all potential factors that require ongoing discussion, compromise, and trade-offs.⁴

Overcoming Challenges: Successful Steps toward Standardization

Careful planning is step one in overcoming challenges and beginning a successful standardization effort. After due diligence and data collection, it is possible to present a well-thought-out recommendation and develop a final plan for standardization. Figure 3 lists some of the steps necessary to begin a standardization project.

Successful POCT Standardization Case Studies

Healthcare organizations that choose to standardize their POCT share the following goals:

• Improving workflow and patient safety
• Easing meeting of regulatory requirements
• Enhancing diagnostic capabilities with methodologies that match patient needs³

Following are three examples of successful POCT standardization projects.

Hvidovre Hospital in Denmark

The Hvidovre Hospital in Denmark, a large, 1,000-plus-bed facility, performed decentralized POCT for decades, with each department responsible for its training and testing, and the core lab supporting the various instruments and devices. Eventually, with more than 20 different vendors for blood gas and glucose testing, it made the case for POCT standardization.

The hospital’s POCT equipment diversity resulted in a tremendous amount of work for the laboratory, and the lack of standardization caused redundancy in test processes and procedures, as well as confusion about result interpretation. As the hospital embarked on its POCT standardization project, overcoming resistance to change was the biggest challenge it faced. The hospital resolved this issue by clearly communicating the overall value of the change (see Figure 4).

In the end, Hvidovre’s keys to successful standardization included:

• Standardizing all POCT instruments and procedures
• Total commitment to the project
• A POC Coordinator (POCC) dedicated to the project with enough time to focus on the project
• Overall project planning including an understanding of unit workflows
• Ongoing staff education
• Defined responsibilities for units and laboratory
• Open dialogue and collaboration between lab and end users⁵

Ann & Robert H. Lurie Children’s Hospital of Chicago

Laboratory staff at Ann & Robert H. Lurie Children’s Hospital, realizing POCT’s value in improving patient outcomes and also that they were victims of “device creep,” undertook a successful POCT standardization project. After extensive data collection, they started a five-month pilot implementation project and used that data to decide which POCT devices were best fit for their patients. They consolidated from four blood gas analyzers to one table-top analyzer and one handheld device, and from three ACT devices to one. Figure 5 depicts the gains realized by their POCT standardization project.^6,7

Atrium Health in North Carolina

As another example, Atrium Health in Charlotte, North Carolina, with more than 40 hospitals and 900 care locations, has spent the last several years working to standardize its test menu and methodologies, reference ranges, and analyzers and test platforms across 10 testing sites within the organization. By standardizing these systems, Atrium expects to see improvements in workflow efficiency, turnaround time (TAT), staff productivity, quality, and overall value contribution.⁸

Resources

The Clinical and Laboratory Standards Institute (CLSI) offers several resources and/or standards that are relevant to POCT:

• CLSI POCT04-Ed3: Essential Tools for Implementation and Management of a Point-of-Care Testing Program, 3rd Edition
• CLSI POCT07-A: Quality Management: Approaches to Reducing Errors at the Point of Care
• CLSI POCT09-A: Selection Criteria for Point-of-Care Testing Devices

In addition, the Centers for Disease Control and Prevention (CDC) offers customized QA and standardization programs (www.cdc.gov/labstandards) to help laboratories improve the quality and reliability of their measurement procedures. The specific CDC services offered include reference materials, proficiency testing, training, guidelines, and consultations. Each CDC laboratory QA and standardization program is voluntary and most are offered at no charge.

Summary

Laboratory standardization specific to POCT can reduce patient and provider confusion; improve efficiency, patient satisfaction, and quality of care; and offer cost savings. However, implementation of POCT standardization is a challenging undertaking that requires organization-wide cooperation and buy-in, alongside strong leadership. All three organizations highlighted in the case studies believe their POCT standardization eff orts were worth the hard work.

Reference List

1. Yu E. Lab standardization in the era of big healthcare networks. Clinical Laboratory News. https://www.aacc.org/publications/cln/articles/2017/september/lab-standardization-in-the-era-of-big-healthcarenetworks. Published September 1, 2017.
2. Suh-Lailam B. Is standardizing point-of-care testing (POCT) instrumentation worth the challenge? Scientific Shorts. https://www.aacc.org/community/aacc-academy/publications/scientifi c-shorts/2018/is-standardizing-poct-instrumentation-worth-the-challenge. Published May 22, 2018.
3. LabLeaders.com. Realizing standardization through collaboration. https://resourcecenter.lableaders.com/operational/realizing-standardization-through-collaboration. Published November 14, 2018. Accessed 2019.
4. LabLeaders.com. Proceed with caution: Heeding the required trade-off s of standardization. https://resourcecenter.lableaders.com/premium/proceed-with-caution-heeding-the-required-trade-off s-of-standardization. Published November 14, 2018. Accessed 2019.
5. Schwarz P, et al. Standardizing is the key to eff ective POCT. https://acutecaretesting.org/en/articles/standardizing-is-the-key-to-effective-poct. Published April 2003.
6. Suh-Lailam B. From many, one: A case study on standardizing point of care testing instrumentation. Clinical Laboratory News. https://www.aacc.org/publications/cln/articles/2017/november/from-many-onea-case-study-on-standardizing-point-of-care-testing-instrumentation. Published November 1, 2017.
7. Suh Lailam B. Standardizing point of care instrumentation: One institution’s experience [webinar]. https://www.whitehatcom.com/POC_Group_Webinars_2019.htm. Published November 7, 2019.
8. McBride M. Innovative clinical laboratories of hospitals and health systems now working to standardize and rationalize lab tests and lab services. Dark Daily. https://www.darkdaily.com/innovative-clinical-laboratories-of-hospitals-and-health-systems-now-working-to-standardize-and-rationalize-lab-tests-and- lab-services-92418/. Published September 24, 2018.