Deep Dive: Common Lab Deficiencies and What They Really Mean

Deep Dive: Common Lab Deficiencies and What They Really Mean

In this solo episode of LabReflex, Dr. Chris Zahner continues building the Lab Inspection Playbook with a practical look at common laboratory deficiencies. The point is not just to memorize a list of citations. The more useful question is why the same categories keep showing up across CAP, CLIA, COLA, Joint Commission, and other inspection frameworks. The central idea: common deficiencies are where the lab’s documented system separates from its real operating system. They are predictable drift points. Competency becomes paperwork. Procedures fall behind practice. Proficiency testing becomes a score instead of a learning system. Maintenance logs get completed but not reviewed. Method comparisons are missed because the operation changed faster than the quality system. Director oversight becomes formal instead of functional. 1. Competency assessment Competency assessment is one of the most consistent deficiency themes across inspection programs. The key issue is not simply whether a form was completed. It is whether the lab can show credible evidence that a person can actually perform the test system correctly, recognize when something is wrong, and respond appropriately. Training is not competency. A quiz alone is not competency. A signature is not competency. Competency matters because it is one of the lab’s core safety systems. If a lab treats it as an annual paperwork ritual, it misses the point. A meaningful competency process should connect to real work, including routine testing, QC, maintenance, result reporting, and problem-solving. Links: CAP 2022 Top 10 Deficiencies: https://documents.cap.org/documents/Accreditation_2022_Top_10_Deficiencies.pdf [https://documents.cap.org/documents/Accreditation_2022_Top_10_Deficiencies.pdf] ASCLS Common Laboratory Deficiencies: https://ascls.org/common-laboratory-deficiencies-and-ways-to-avoid-them/ [https://ascls.org/common-laboratory-deficiencies-and-ways-to-avoid-them/] 2. Procedure manuals and procedure reality Procedure manuals are one of the clearest ways inspectors can see whether the lab’s written system matches actual bench practice. A procedure is not supposed to be a static document sitting in a folder. It should describe how the lab actually works. When the SOP says one thing, staff explain another thing, and the bench process works a third way, the lab no longer has a controlled process. It has institutional memory. This is why inspection readiness is not binder readiness. It is reality alignment. The question is not just, “Does the procedure exist?” The question is, “Does the procedure match current practice, and can staff use it when something goes wrong?” Links: CMS 2024 CLIA Top Ten Deficiencies: https://www.cms.gov/regulations-and-guidance/legislation/clia/downloads/cliatopten.pdf [https://www.cms.gov/regulations-and-guidance/legislation/clia/downloads/cliatopten.pdf] CAP Laboratory Quality Improvement Ideas From CAP Inspections: https://documents.cap.org/documents/CAP_Laboratory-Quality-Improvement-Ideas-From-CAP-Inspections_Apr-25-23.pdf [https://documents.cap.org/documents/CAP_Laboratory-Quality-Improvement-Ideas-From-CAP-Inspections_Apr-25-23.pdf] 3. Proficiency testing Proficiency testing is not just about passing. It is one of the lab’s external reality checks. PT asks whether the lab is getting the same answer others would get, whether the testing system is performing as expected, and whether failures or trends are being recognized and addressed. The problem is that PT can become clerical: receive, test, submit, file, move on. But inspectors are often looking at the review process. Who reviewed it? Was anything unacceptable? Was there a trend? Was corrective action meaningful? PT is not just a grading event. It is a learning system. Links: CMS CLIA Proficiency Testing Brochure: https://www.cms.gov/files/document/clia-brochure-proficiency-testing-and-pt-referral-october-2024.pdf [https://www.cms.gov/files/document/clia-brochure-proficiency-testing-and-pt-referral-october-2024.pdf] CMS 2024 CLIA Top Ten Deficiencies: https://www.cms.gov/regulations-and-guidance/legislation/clia/downloads/cliatopten.pdf [https://www.cms.gov/regulations-and-guidance/legislation/clia/downloads/cliatopten.pdf] 4. Maintenance, function checks, temperatures, storage, and reagents This is the boring operational category that reveals a lot about laboratory culture. Maintenance records, function checks, temperature logs, expired reagents, storage conditions, and equipment review are rarely conceptually difficult. They are difficult because they require reliable rhythm. The lab has to do the work, document the work, review the work, and respond when something is out of range. A log without a response pathway is not a quality system. It is just a diary. The inspection question is not only, “Did you record the number?” It is, “What happens when the number is wrong?” Links: CAP Laboratory Quality Improvement Ideas From CAP Inspections: https://documents.cap.org/documents/CAP_Laboratory-Quality-Improvement-Ideas-From-CAP-Inspections_Apr-25-23.pdf [https://documents.cap.org/documents/CAP_Laboratory-Quality-Improvement-Ideas-From-CAP-Inspections_Apr-25-23.pdf] CMS 2024 CLIA Top Ten Deficiencies: https://www.cms.gov/regulations-and-guidance/legislation/clia/downloads/cliatopten.pdf [https://www.cms.gov/regulations-and-guidance/legislation/clia/downloads/cliatopten.pdf] 5. Method verification, AMR, and comparability Method verification, analytical measurement range, and comparability are more technical, but they are common because labs change constantly. New instruments come in. Backup analyzers are added. Tests move between platforms. Point-of-care testing expands. Reagent lots change. Send-out tests come in-house. Each change may create a new obligation to verify, compare, document, or review. The deeper problem is that labs often change faster than their quality systems. Every new method, instrument, backup process, or alternate pathway creates a new obligation to prove that results remain reliable. Links: ADLM Top Laboratory Deficiencies Across Accreditation Agencies: https://myadlm.org/cln/articles/2018/july/top-laboratory-deficiencies-across-accreditation-agencies [https://myadlm.org/cln/articles/2018/july/top-laboratory-deficiencies-across-accreditation-agencies] CAP Laboratory Quality Improvement Ideas From CAP Inspections: https://documents.cap.org/documents/CAP_Laboratory-Quality-Improvement-Ideas-From-CAP-Inspections_Apr-25-23.pdf [https://documents.cap.org/documents/CAP_Laboratory-Quality-Improvement-Ideas-From-CAP-Inspections_Apr-25-23.pdf] 6. Personnel qualifications and director oversight Personnel qualifications and director oversight connect common deficiencies to the larger issue of laboratory leadership. The lab director, technical supervisor, general supervisor, technical consultant, and other required roles are not just names on paper. They are part of the lab’s control structure. They help ensure people are qualified, PT is reviewed, procedures are appropriate, test systems are verified, and quality issues are addressed. Many deficiencies look like documentation problems on the surface, but underneath they are ownership problems. Who owns competency? Who owns PT review? Who owns method comparability? Who owns corrective action follow-up? If nobody clearly owns the process, the proce...

Pulse: Who’s Counting the Labs?

This episode looks at new pressure points in lab medicine: payment reporting, LDT oversight, liquid biopsy expansion, supplier stability, and compliance risk. PAMA reporting: CMS is collecting private-payer data for the Clinical Laboratory Fee Schedule, but Laboratory Economics reports CMS may not know exactly which labs qualify as “applicable laboratories.” That raises questions about data quality, enforcement, and future Medicare lab rates. Enhancing CLIA Act of 2026: A new bill from Rep. Neal Dunn would keep LDT oversight centered in CLIA/CMS rather than FDA device regulation. It proposes a public LDT database, more transparency around validation and performance, third-party validity confirmation, centralized error reporting, and stronger CMS authority when LDT validity is questioned. Guardant360 Liquid CDx: Guardant received FDA approval for an expanded liquid biopsy panel. The story highlights the growing role of blood-based genomic profiling in oncology, along with challenges around interpretation, limitations, and reimbursement. Bio-Rad and Elliott: Elliott reportedly built a stake in Bio-Rad. For labs, this is a reminder that vendor strategy and financial pressure can affect reagents, QC materials, instruments, service, and validated workflows. Key Takeaway Labs are being asked to support payment policy, regulatory oversight, precision medicine, supply chains, and compliance systems. The big question: are the people designing these systems accounting for how labs actually work?

Pulse: Who Controls the Diagnostic Front Door?

This week on LabReflex Pulse, Dr. Chris Zahner and Dr. Aakash Bhatia dive into a series of stories that all point toward a bigger shift happening inside laboratory medicine: diagnostics are becoming infrastructure. From Nebraska rapidly validating an Andes virus PCR assay during a hantavirus scare… to Epic and Labcorp deepening diagnostic workflow integration… to AI pathology consolidation and real-time infectious disease surveillance dashboards — the organizations controlling diagnostic workflows may increasingly shape the future of healthcare itself. This week’s topics: Nebraska’s rapid Andes virus PCR response Following a hantavirus outbreak aboard the MV Hondius cruise ship, the Nebraska Public Health Laboratory rapidly validated an Andes virus PCR assay before exposed passengers arrived in the United States. The story raises major questions about rare-pathogen preparedness and rapid assay deployment in the post-COVID era. WIRED coverage: https://www.wired.com/story/race-to-develop-andes-hantavirus-test/ [https://www.wired.com/story/race-to-develop-andes-hantavirus-test/] CDC Health Alert: https://www.cdc.gov/han/php/notices/han00528.html [https://www.cdc.gov/han/php/notices/han00528.html] WHO outbreak notice: https://www.who.int/emergencies/disease-outbreak-news/item/2026-DON600 [https://www.who.int/emergencies/disease-outbreak-news/item/2026-DON600] Epic + Labcorp integration: interoperability or market positioning? Labcorp announced expanded integration with Epic Aura, giving Epic users broader access to Labcorp’s testing menu and specialty diagnostics workflows. Chris and Aakash discuss whether EHR workflow design may increasingly influence diagnostic utilization — and whether hospital outreach laboratories should be paying closer attention. Labcorp announcement: https://ir.labcorp.com/news-releases/news-release-details/labcorp-and-epic-expand-collaboration-advance-diagnostic [https://ir.labcorp.com/news-releases/news-release-details/labcorp-and-epic-expand-collaboration-advance-diagnostic] ARUP launches infectious disease positivity dashboard ARUP introduced a national infectious disease positivity trends dashboard using deidentified laboratory data to help identify emerging patterns and seasonal shifts. The episode explores whether large reference laboratories are quietly becoming real-time public health surveillance networks. ARUP announcement: https://www.aruplab.com/news/05-13-2026/arup-launches-national-infectious-disease-test-positivity-trends [https://www.aruplab.com/news/05-13-2026/arup-launches-national-infectious-disease-test-positivity-trends] Roche acquires PathAI Roche announced plans to acquire digital pathology company PathAI in a major move signaling that AI pathology is transitioning from experimental technology to enterprise infrastructure. Roche announcement: https://www.roche.com/media/releases/med-cor-2026-05-07 [https://www.roche.com/media/releases/med-cor-2026-05-07] Reuters coverage: https://www.reuters.com/legal/litigation/switzerlands-roche-agrees-acquire-us-based-pathai-2026-05-07/ [https://www.reuters.com/legal/litigation/switzerlands-roche-agrees-acquire-us-based-pathai-2026-05-07/] Quick Hit: Cepheid Xpert GI Panel Cepheid received IVDR CE marking for its multiplex GI PCR panel, capable of detecting 11 gastrointestinal pathogens in approximately 75 minutes. The conversation touches on the continued expansion of rapid syndromic molecular testing and what it may mean for the future of microbiology workflows. FDA summary: https://www.accessdata.fda.gov/cdrh_docs/reviews/K251721.pdf [https://www.accessdata.fda.gov/cdrh_docs/reviews/K251721.pdf] Cepheid announcement: https://www.morningstar.com/news/pr-newswire/20260513la58308/cepheid-receives-ce-marking-under-ivdr-for-xpert-gi-panel [https://www.morningstar.com/news/pr-newswire/20260513la58308/cepheid-receives-ce-marking-under-ivdr-for-xpert-gi-panel] Subscribe to LabReflex! For more conversations at the intersection of laboratory medicine, diagnostics, pathology, and healthcare strategy, subscribe wherever you get your podcasts.

Deep Dive: Your Quality Plan Is Not Your Quality System

Your Quality Plan Is Not Your Quality System In this LabReflex deep dive, we break down a simple but important inspection-readiness idea: A quality plan is what the lab says it does. A quality system is what actually happens when something goes wrong. Many labs prepare for inspection by trying to show that failures never happen. But real quality is not about pretending the lab is perfect. It is about having a consistent, repeatable system for detecting problems, documenting them, reviewing them, correcting them, verifying the fix, and improving over time. Key framework Detect → Document → Review → Correct → Verify → Improve A strong quality system makes follow-up obvious. It helps the lab answer: *  How did we know there was a problem?  *  Where was it documented?  *  Who reviewed it?  *  What changed?  *  Did the fix work?  *  What improved because of it?  Main example We use critical value notification delays as an example. A weak response is: “Staff were reminded.” A stronger response asks: *  Why were the calls delayed?  *  Was there a shift-specific pattern?  *  Were contact numbers correct?  *  Was the escalation process clear?  *  Did the lab audit afterward to prove improvement?  Big takeaway The strongest labs are not the ones that claim they never have problems. They are the ones that can show their quality system in action. The goal is not perfection. The goal is control, learning, and consistent improvement.

Pulse: Rare Bugs and Real Pressure

In this week's LabReflex Pulse we talk about: Hantavirus on the M/V Hondius A recent hantavirus cluster linked to cruise ship travel highlights the lab’s role in rare-disease recognition, exposure history, reference lab coordination, and public health escalation. New World Screwworm New World screwworm activity in Central America and Mexico is a One Health reminder: human health, animal health, agriculture, travel, and public health surveillance are connected. The lab lesson is recognition, specimen handling, and knowing when to escalate. PAMA / CLFS Reporting Window The 2026 PAMA reporting window is open from May 1 through July 31, 2026. This matters because reimbursement policy shapes what testing labs can sustainably offer.