Compliance

Compliance is the framework that holds our entire profession together. If Quality Control is the real-time check on our instruments, and Quality Assessment is the overall system for protecting a sample’s journey, then Compliance is the official “Rule book” for the entire game. It’s the set of non-negotiable laws, regulations, and standards that every single laboratory performing testing on human samples must follow. It’s not just a good idea; it’s the law

Think of it this way: you wouldn’t want to drive a car if there were no traffic laws, no driver’s licenses, and no vehicle safety inspections. It would be chaos, and it would be incredibly dangerous. Compliance provides that same structure for the laboratory. It ensures that a glucose result from a small clinic in a rural town is just as reliable as one from a massive university medical center. It is the great equalizer, and its ultimate purpose is to protect the public and ensure patient safety

Compliance isn’t about memorizing thousands of pages of regulations. It’s about understanding the “why” behind the rules and building a Culture of Quality where following these standards is just a natural part of our daily work

Regulatory Landscape: Who Writes the Rules?

There are several major players in the world of laboratory compliance, and it’s essential to know who they are and what they do

• CLIA (Clinical Laboratory Improvement Amendments of 1988): This is the big one. CLIA is the federal law, administered by the Centers for Medicare & Medicaid Services (CMS), that establishes quality standards for all laboratory testing. No lab can legally test patient samples without a CLIA certificate. CLIA categorizes tests into three levels of complexity—waived, moderate complexity, and high complexity—with the regulatory requirements increasing with each level. The majority of testing an MLS performs falls into the moderate and high complexity categories, which carry the most stringent rules for personnel qualifications, quality control, and proficiency testing
• Accrediting Organizations: The government (CMS) can’t inspect every single lab in the country. So, they grant certain private, non-profit organizations “deemed status.” This means that if a lab passes an inspection from one of these organizations, it is “deemed” to be in compliance with CLIA. These are the inspectors we most often see
  • CAP (College of American Pathologists): Considered the “gold standard” in laboratory accreditation. CAP inspections are famously rigorous and are conducted by a team of peer reviewers—meaning practicing laboratory professionals are inspecting your lab. They use incredibly detailed checklists that cover every facet of the lab’s operation, from the temperature of the water bath to the documentation of employee competency
  • TJC (The Joint Commission): TJC accredits entire healthcare organizations, not just the lab. During a hospital-wide inspection, TJC surveyors will certainly visit the lab, but their focus is often on the lab’s role in overall patient safety and care processes. They will look closely at things like patient identification procedures, critical value reporting, and how well the lab communicates with nurses and physicians
  • COLA (Commission on Office Laboratory Accreditation): COLA primarily focuses on accrediting physician office laboratories (POLs) and smaller clinics. Their goal is to help these smaller labs meet CLIA requirements and provide excellent patient care

Pillars of Compliance: What Are They Looking For?

When an inspector walks into your lab, they are there to find objective evidence that you are following the rules. This evidence is almost always in the form of documentation. The golden rule of compliance is: If you didn’t document it, it didn’t happen. Here are the key areas they will always scrutinize:

• Personnel Records: They will pull the files for every person working in the lab. Do you have a documented diploma, transcript, and license (if applicable) that proves you are qualified to do your job under CLIA? Do you have records of your initial training for every test you perform? Most importantly, is there a documented competency assessment for every single test, performed annually, that proves you are still proficient?
• Proficiency Testing (PT): This is arguably the most important part of compliance. PT is the lab’s “final exam.” Several times a year, an external agency sends us “blind” samples. We test them just like patient samples and submit our results back to the agency. They grade us on how well our results match those from other labs using the same method. Failure to perform successfully on PT can lead to a lab being shut down from performing that test. It is a direct, external check on our accuracy
• Quality Management System: Inspectors need to see your lab’s own rulebook. This includes your documented Quality Control procedures, your procedures for validating a new instrument before putting it into service, and your standard operating procedures (SOPs) for every single test
• Documentation, Documentation, Documentation: They will review everything. QC logs, Levey-Jennings charts, corrective action records for QC failures, instrument maintenance logs, reagent lot number verification, refrigerator and freezer temperature charts, critical value call logs… everything. A complete, organized, and accurate paper trail is the ultimate proof of a compliant laboratory

Troubleshooting Deficiencies: The Plan of Correction

No lab is perfect. It is common for an inspection to result in a few deficiencies, which are findings where the lab is not in compliance with a standard. This is not a time to panic; it’s a time to troubleshoot. The accrediting agency will give the lab a formal list of the deficiencies, and the lab must respond with a Plan of Correction (POC)

A POC is a formal document where the lab must address each deficiency by answering three questions:

1. What action did you take to fix the immediate problem?
2. What system or process change will you implement to ensure this problem never happens again?
3. How will you monitor this new system to make sure it’s working?

For example, if an inspector finds an expired reagent in the back of a refrigerator (a common deficiency), the POC can’t just be “We threw it away.” A robust POC would be: “We discarded the expired reagent. To prevent recurrence, we have implemented a monthly inventory check of all reagents by a designated technologist, and a log will be kept. The lab supervisor will review this log on the first of every month to ensure compliance.” This response fixes the problem and builds a better system for the future, which is the entire point of compliance

Key Terms

• CLIA (Clinical Laboratory Improvement Amendments): The foundational federal law that regulates all laboratory testing performed on humans in the United States to ensure quality, accuracy, and reliability
• Accreditation: The process by which a laboratory is assessed and certified by an external, non-governmental agency (like CAP or TJC) to meet or exceed a set of established quality standards
• Proficiency Testing (PT): An external quality assessment program in which a lab analyzes blind, unknown samples from a regulatory agency to evaluate the lab’s accuracy against its peers. It is a mandatory component of compliance
• Competency Assessment: A CLIA requirement to evaluate and document that each employee is proficient in performing their assigned testing duties. This must be done upon hire and at least annually thereafter
• Plan of Correction (POC): A formal, written response that a laboratory must submit after an inspection, detailing how it will fix identified deficiencies and prevent them from recurring
• Deemed Status: A status granted by CMS to an accrediting organization (e.g., CAP, TJC) that allows its standards to be substituted for CLIA regulations. A lab accredited by a “deemed” organization is considered CLIA-compliant
• Waived Test: A category of test under CLIA that is determined to be so simple and have such a low risk of an erroneous result that it is exempt from most routine regulatory oversight