Written by
Leah Westover
Vice President, Client Success
When laboratory organizations talk about standardization, the conversation usually centers on policies, procedures, competencies, and workflows. Those things matter. But there is a deeper issue that is often overlooked in many organizations: it is possible to standardize every process on paper and still end up with fragmented quality management that is difficult to govern consistently. The reason? Standardizing processes without standardizing the platform they live on.
With 68% of U.S. hospitals now operating within health systems (AHA, 2025) and M&A activity reaching its highest levels since 2020 (Kaufman Hall, 2026), multi-site complexity is not a future problem. It is the current one. And the organizations that have figured this out are not just writing better SOPs. They have made a fundamentally different decision about infrastructure.
Why Does Process Standardization Alone Break Down?
It is possible to align policies across sites. It is possible to standardize competency requirements and train teams to follow identical workflows. But if those processes live in different systems, different tools, and different structures, over time, they can drift, fragment, and become harder to enforce consistently. And eventually, what was standardized on paper becomes variable again in practice.
This is not a failure of intent. It is often a limitation of infrastructure. CMS data shows that competency assessment has been among the most commonly cited deficiencies across CAP, Joint Commission, and COLA for decades (CMS Division of Clinical Laboratory Improvement and Quality, 2024). In 2024, proficiency testing and personnel requirements topped the list, cited in 738 and 709 laboratories respectively. If process standardization alone were sufficient, we would expect these numbers to show more consistent improvement over time. They have not — because the processes are not connected to a system that enforces them.
To illustrate: an organization can write the strongest competency assessment policy in the country. But if Site A tracks it in a spreadsheet, Site B uses a shared drive, and Site C still relies on paper binders; true standardization becomes difficult to maintain. There are three versions of the same intention, each drifting in its own direction.
What Have Leading Organizations Figured Out?
The organizations that are ahead of this curve have made a critical shift: they have standardized the platform, not just the process. This shift has a significant impact — not because the platform itself is the answer, but because it creates the connective tissue that makes process standardization actually enforceable.
Instead of asking "How do we standardize this workflow?" they ask a different question: "Where does this workflow live — and is it shared across our system?" Because they have recognized an important distinction: processes can be documented anywhere. But they can only be governed consistently when they are connected.
The laboratory software market reflects this recognition. It is projected to grow from $6.3 billion in 2025 to $10.1 billion by 2030 (MarketsandMarkets, 2025), driven by demand for automation, real-time data visibility, and compliance infrastructure that works across distributed networks. Organizations are not just purchasing better tools — they are investing in the ability to see and govern their entire operation from a single vantage point.
What Does Platform Standardization Look Like in Practice?
Leading organizations ensure three things are true across every testing location — from the high-complexity core laboratory to the smallest clinic running waived tests.
Every Site on the Same Set of Applications
Not a mix of full systems here, partial systems there, and separate tools elsewhere. A shared foundation. Because it is extremely difficult to build a consistently governed system on different infrastructures. When the AHA reports that some health systems now operate more than 100 hospitals (AHA, 2025), each with its own satellite sites, clinics, and POCT locations, the math on "different tools for different sites" simply does not work. The same is true for independent laboratories managing quality across dozens of client or regional locations.
Every Workflow Connects
Documents connect to competencies. Competencies connect to staff records. Staff records span across sites. Quality events connect back to processes and corrective actions. This creates continuity. Without it, everything becomes isolated — and isolated data makes it much harder to identify system-level patterns.
Consider that pre-analytical errors account for 60–70% of all laboratory errors (National Library of Medicine 2024). These errors happen at the intersection of people, processes, and documentation — exactly where disconnected systems create the most gaps. When workflows are not connected, the highest-risk error category is the one an organization is least equipped to track.
Every Data Point Contributes to System-Level Visibility
When all sites operate within the same platform, leadership can see trends across locations. Risk becomes identifiable early. Variation becomes measurable. Decisions become informed by data rather than assumptions. This is what supports effective governance — the ability to see, measure, and act on what is happening across the entire network.
Without it, organizations are left with what the research reveals: incident reporting systems that capture just 3.9% of adverse events (Oxford Academic, 2023). Platform standardization does not eliminate all reporting gaps, but it creates the infrastructure that makes comprehensive reporting possible.
Addressing the "Not Every Site Needs Everything" Concern
This is where many organizations hesitate. They assume clinics are too small, POCT sites are too simple, and satellite locations do not need a full quality management system. And there is some truth to that — not every site has the same level of complexity.
But that is not the same as needing a different system.
Here is why that distinction matters. Of the 317,545 CLIA-certified laboratories in the U.S., approximately 80% — approximately 254,000 — hold Certificates of Waiver (CMS, 2024). That number has been growing rapidly. The number of pharmacies alone holding CLIA Certificates of Waiver grew 140% between 2019 and 2023 (PubMed, 2024). These are the sites that most organizations treat as "too simple" for a quality platform.
But external quality assessment data tells a different story: POCT participants fail at a rate of 9–10%, compared to just 1–2% for central laboratory participants (AACC Guidance Document, 2020). For patient identification errors, the gap is even more pronounced — 45.3% in POCT versus 0.02% in the central laboratory. These sites are often treated as lower complexity, but the data shows they can carry meaningful risk when oversight is limited.
And as of January 2025, CMS has expanded enforcement for the first time to Certificate of Waiver laboratories. They now face civil monetary penalties of up to $10,000 per day for immediate jeopardy findings (CMS, 42 CFR 493.1834). The regulatory environment has caught up to the reality: every site that performs testing contributes to patient outcomes, quality performance, and system-level risk. Every site must be part of the same quality system — not necessarily doing everything, but connected to everything.
Why Piecemeal Models Do Not Hold Up Over Time
When organizations allow sites to operate on different applications, three common challenges emerge.
- Data fragments — it becomes much more difficult to compare quality metrics across sites that report differently
- Visibility breaks — leadership loses the ability to see the system as a whole
- Governance becomes inconsistent — what is enforced at one site may be aspirational at another
Growth accelerates every one of these problems. With 72 M&A transactions in 2024 and 43.5% of 2025 deals involving financially distressed organizations (Kaufman Hall, 2026), many health systems are absorbing sites that were already struggling with quality management. Independent laboratories expanding into new regions face a parallel version of the same challenge. Each new location adds variation. Without a standardized platform, complexity can compound faster than teams can easily manage it.
At that point, standardization is not enforceable. It becomes difficult to sustain in practice. And aspirations do not hold up during a CAP survey — or, more importantly, in the daily quality work that happens between surveys.
Managing vs. Governing: What Is the Real Difference?
This is the real shift that platform standardization enables.
Without a standardized platform, organizations manage sites individually. They rely on local compliance. They react to issues after they surface. They often rely on their most experienced staff to bridge gaps between systems — and research shows that approach is unsustainable. A survey of 2,363 laboratory professionals found that 58.4% reported burnout, with compliance work rated the most burdensome and least valued responsibility (PubMed, 2023).
With a standardized platform, an organization sees across the network. It identifies risk early. It enforces consistency. It frees its best people to lead quality improvement instead of chasing documentation. This represents a more proactive operating model and a different approach to managing quality — one where oversight is continuous, not reactive.
The Quiet Advantage Leading Organizations Already Have
Organizations that have made this shift do not just operate more efficiently. They operate with greater confidence in their quality programs, because evidence is connected and current. They onboard new sites faster, because the infrastructure is already in place. They maintain stronger consistency across locations, because the platform enforces it. And they have clear visibility into their risk, because every data point feeds the same system.
They are not stitching together processes across disconnected tools. They are operating a connected system — and the difference becomes visible across many areas, from daily quality operations to staff retention to the speed at which they can integrate a new facility.
For organizations beginning this transition, the path is often more incremental than it may seem. Most start by:
- Identifying where key laboratory and testing-related quality workflows currently live across sites
- Bringing high-risk activities such as competency, inspection readiness, and event tracking into a shared lab quality ecosystem
- Expanding visibility step by step, rather than attempting to standardize everything at once
The goal is not to replace everything immediately — it is to create a connected foundation that can scale with the organization over time.
Frequently Asked Questions
Why is process standardization not enough for multi-site laboratory organizations?
Because processes that live in different tools drift over time. CMS data shows competency assessment has remained among the top deficiencies across accrediting agencies for decades (CMS, 2024), despite widespread policy standardization efforts. Without a shared platform, enforcement becomes inconsistent, and visibility breaks down.
What is the risk of leaving POCT and waived-testing sites on separate systems?
Significant. POCT participants fail external quality assessments at 9–10% compared to 1–2% for core laboratories (Clinical Chemistry and Laboratory Medicine). The 2024 CLIA Final Rule now exposes Certificate of Waiver laboratories to civil monetary penalties for the first time — up to $10,000 per day. These sites benefit from being part of a governed quality system.
How does organizational growth affect laboratory quality management?
Each new location — whether acquired through M&A or organic expansion — adds sites with different tools and workflows. Kaufman Hall reported 72 M&A transactions in 2024, with 43.5% involving distressed organizations by 2025. Without platform standardization, every new site can increase variation and risk faster than quality teams can easily compensate for.
What percentage of adverse events actually get reported through standard systems?
A 2023 systematic review found that incident reporting systems capture a median of just 3.9% of adverse events, with 12 of 14 studies showing less than 10% detection (Oxford Academic, 2023). Connected platforms will not catch everything, but they substantially improve event visibility compared to site-by-site tracking.
The Bottom Line
Standardizing processes is necessary. But it is not sufficient.
In a distributed laboratory environment, consistency requires connection. And the connection requires a shared platform. The organizations that recognize this early will move faster, scale more effectively, and operate with far greater control over their quality and risk.
Others may continue working toward standardization, but find it difficult to fully sustain without a shared platform.
The Top 20 U.S. Hospitals and Top 10 Clinical Laboratories already operate on a connected platform. Schedule a demo to see how MediaLab by Vastian could support standardization across your network.