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In This Issue:
- Exploring What Makes a Strong Quality Program
- Questions Remain as PAMA Reporting Begins
- How MCED Testing Could Transform Clinical Labs
- Last Change: 2026 Lab Wage and Morale Survey
- Our May List of Most Placeable Lab Candidates
- Upcoming MolDx Webinar
- Guide to Starting & Maintaining a CLIA Lab
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Upcoming Webinar: From SOPs to Citations - How Inspectors Evaluate Your Lab's Quality Program
Operating with quality at the forefront in clinical laboratories is not just a best practice; it is a regulatory expectation. Whether your lab is inspected under CLIA, CAP, or COLA, surveyors are not simply asking whether you have a quality assurance plan. They are evaluating whether your lab is actively tracking, documenting, and acting on the metrics that define it.
Join us at 12 p.m. EDT, Wednesday, May 27, as Dr. Melissa Bell, DCLS, walks through how inspectors assess lab quality programs in real-world settings. Drawing on regulatory frameworks and field experience, this session will highlight what surveyors prioritize, where labs commonly fall short, and how to align your quality systems with inspection expectations.
Learning objectives:
- Understand how CAP, CLIA, and COLA inspectors evaluate laboratory quality systems
- Identify the most common quality-related deficiencies and why they occur
- Learn what documentation and records inspectors expect to review during surveys
- Explore how to align QA plans with day-to-day lab operations and metrics tracking
- Apply practical strategies to improve inspection readiness and avoid citations
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PAMA Reporting Period Underway: Key Compliance Questions Remain
The 2026 PAMA reporting period is now underway and runs through July 31, 2026. Applicable laboratories that fail to report required private payer data could face civil monetary penalties of up to $10,000 per day.
To determine whether reporting applies, laboratories that received $12,500 or more ($25,000 annualized) in Medicare CLFS payments between January 1–June 30, 2025, should evaluate their status. During a recent CMS webinar, administrators acknowledged they do not maintain a list of applicable laboratories, instead expecting organizations to make a "good faith effort" to determine whether they qualify.
Estimates from industry publication Laboratory Economics suggest more than 14,000 laboratories, including hospital outreach labs, independent labs, and physician office laboratories (POLs), may be subject to reporting requirements, making this a compliance issue to monitor. However, the fact that no laboratories were penalized for failing to report during the previous data submission period in 2017 raises questions about the use of monetary penalties moving forward.
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Why Multi-Cancer Early Detection Could Transform Clinical Laboratories
The clinical laboratory industry may be on the verge of one of its largest growth opportunities in decades.
The catalyst is the emergence of Multi-Cancer Early Detection (MCED) testing, blood-based screening assays capable of detecting signals associated with multiple cancers simultaneously, often before symptoms appear. MCED testing has the potential to reshape preventive medicine, create entirely new diagnostic workflows, and inject billions of dollars of new reimbursement revenue into the laboratory ecosystem.
Read insights from LLS Founder Jon Harol HERE>
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Closing Soon: 2026 Wage and Morale Survey of Lab Professionals
If you haven't completed our latest lab wage and morale survey yet, there is still time to do so through the end of May. The past four years of annual data have shown significant improvements in both areas during the past half-decade, and we hope this year's results continue to support these positive trends.
We've collected more than 500 responses already and hope to expand our results to provide a comprehensive look at the current state of the lab.
The survey takes roughly five minutes to complete and primarily consists of questions on how current staffing and compensation levels at your lab are impacting morale.
Start the survey HERE>
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The Lighthouse "Candidate Corner" is a recurring monthly spotlight featuring some of the great lab professionals our recruiters work with each day. Check out a quick preview of one individual below, then click over to our blog to see all five candidates for May.
If you'd like to learn more about anyone listed in this section or inquire about their ability to relocate, email us directly here!
Candidate: Lab Director or VP of Operations
- Education:
- Ph.D in Biochemistry
- Certification:
- MB(ASCP)
- HLCD ABB
- Preferred Location:
- Texas or Raleigh, NC.
View all candidates HERE>
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New Webinar: Multiplex Molecular Test Reimbursement - Strategies to Reduce Denials
If molecular reimbursement and MolDx issues continue to give you headaches, be sure to catch Ann Lambrix, Executive Director of our RCM Consulting Team, at 1 p.m. Wednesday, May 27, for a discussion of the latest payer developments and how to reduce denials as policies continue to evolve.
Thank you to Applied BioCode, Inc. for hosting this event!
Register HERE>
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NGS Transitions to Wellpoint Federal: Billing Items to Monitor for Impacted Labs
National Government Services (NGS) officially transitioned to the name “Wellpoint Federal” as of April 1, 2026. While there should be no operational changes to claims submission, payer IDs, portals, or EDI workflows, laboratory RCM and billing teams should still pay close attention.
Historically, even “administrative-only” payer transitions can create downstream revenue cycle issues if organizations are not prepared. Changes to remittance branding, payer naming conventions, portal access, or internal routing logic can quietly disrupt payment posting workflows, denial tracking, and AR reconciliation.
For laboratory billing and IT teams, now is a good time to:
- Review payer master files and ERA routing logic
- Alert billing vendors and clearinghouses to the branding transition
- Verify automated remittance posting workflows
- Monitor communications for any future payer ID or technical identifier updates
- Ensure staff understand that “NGS” and “Wellpoint Federal” may temporarily appear interchangeably on documentation and remittances
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2024 MIPS Payment Adjustments Now Affecting Medicare Payments
Performance Year 2024 Medicare Merit-based Incentive Payment System (MIPS) payment adjustments are appearing in 2026 Medicare reimbursements, meaning now is the time to ensure your anticipated adjustment is being applied correctly.
According to feedback from CAP, certain practices with strong 2024 MIPS performance scores may be receiving neutral or negative payment adjustments instead of the positive adjustments they earned. If confirmed, these issues could lead to Medicare underpayments in 2026.
Groups and individuals who participated in MIPS should review their 2026 remittance advice and look for Claim Adjustment Reason Codes (CARCs):
CARC 144: Indicates a positive incentive adjustment
CARC 237: Indicates a negative adjustment or regulatory penalty
RARC N807: Indicates a MIPS adjustment applies, but does not specify whether it is positive or negative
Program participants can check their results at qpp.cms.gov to ensure adjustments are matching their corresponding score.
| | DEEP DIVE: Guide to Maintaining a CLIA-Compliant Lab | | | |
The Clinical Laboratory Improvement Amendments set the national baseline for test quality, and understanding how CLIA applies to your operation is essential, whether you are launching a new service line, expanding an existing test menu, or refining your quality system.
This new guide explains what CLIA covers, how to select the right pathway for CLIA certification, the day-to-day requirements that keep your lab inspection-ready, and pragmatic steps to sustain compliance while supporting efficient operations.
Full Guide HERE>
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American Society for Mass Spectrometry: 74th Annual Conference
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The Lab Insighter is a monthly publication for Lab Owners and Decision Makers.
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Contact us at:
(919) 443-6553
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