Transcript: Laboratory Regulations

Lecturer: Okay, so today we will be talking about regulations. We've noticed that when students graduate and then they come into the lab, it's not something that we're really discussing during school. So everyone's very confused about regulations.

I wanted the discussion board up so we could kind of talk about what we know, which I was surprised how much some people knew, but I wasn't expecting anyone to really know that much about regulations. So, what we will be talking about are:

• Lab regulations versus personnel regulations
• Accreditation versus certification
• Regulatory bodies and standards
• Regulations and laws

I was going to talk about quality principles in this lecture, but it ended up being pretty long, so I left quality off. Maybe that'll be another lecture at another time.

So, I left these abbreviations... all these regulatory organizations usually have pretty long names, so we usually say the abbreviations. We don't say Food and Drug Administration. So, here are the abbreviations that we'll be using during this lecture. I also have some definitions here that you might want to refer to or come back to.

Lab Regulations

So, who regulates the lab? And to be specific, who regulates the clinical lab? A clinical lab is defined as any lab performing patient testing, other than research labs. Research labs do not have to obey the same rules that clinical labs do.

They are under the oversight of CLIA. CLIA is the Clinical Laboratory Improvement Amendments of 1988. It was written into federal law in the CFR Title 42, Part 493, Laboratory Requirements, and this is administered by the Centers for Medicare & Medicaid Services (CMS).

So this is why "regulatory" is so confusing to everyone—because there are laws, there are so many different organizations, some people have power, some people don't have power. It's very complicated, so that's why I wanted to kind of address this and break it down for you guys.

So, what is CLIA? It's basically the ultimate rulebook for clinical labs. They have requirements for all of these areas, and we're going to go through each one to talk about the specific requirements.

Competency Requirements

So first, competency requirements. This is really important. One thing I didn't address here is what competency is. Basically, it is confidence that you know what you're doing before you're performing a test on a real patient.

So, how frequently do you need to do this? Employees need to show that they are competent for each test that they perform before actually performing that test on a patient by themselves. You're not going to just get thrown into a lab, and they're going to say, "Okay, go ahead and do the crossmatch for this patient." You're going to have a trainer, and they're going to watch you do it, make sure you're following the SOP, that you know how to do it, and then they're going to sign you off.

Then, during the first year—most people have this set up to be six months after you get signed off—you have to be observed again to make sure you're doing it correctly, because some things do stray. You might think you're doing something right, and then it turns out you started doing something different.

(Addressing a question from the audience) I have a question. I will address it in one second. And it's actually a very good question.

Anyway, at six months or so, you'll get a competency check. And then you are required to have a competency check annually. So, every year. Why is this important? Because people sometimes just start doing whatever they want, or they start making shortcuts. So, it's important to make sure that everyone is doing things the same way and the correct way.

And what does it mean to have your competency checked? CLIA breaks it down into six different categories. This is a big thing because some people were only doing one of these things, or two of these things, or whatever is easiest, and you will get write-ups if you are not doing every single one of these.

1. Direct observation of the test.
2. Monitoring the records and reporting of test results. So you want to make sure they know how to perform the test and they know how to record the results correctly.
3. Review of intermediate test results or worksheets, quality control records, proficiency testing results, and preventative maintenance records.
4. Direct observations of performance of instrument maintenance and function checks.
5. Assessment of test performance through testing previously analyzed specimens, internal blind testing samples, or external proficiency testing samples.
6. Assessment of problem-solving skills. This is a very important one to me because techs need to know what can go wrong with a test, how to know if something went wrong with the test, and how to address problems when they happen.

CLIA is very vague in how you have to perform these things, but you need to have your own SOP at your facility for how to address them. And in Florida, you must be assessed by a licensed supervisor. To be a supervisor in Florida, you have to have five years of experience in that specialty area.

Lecturer: And the question was, "During internships, is it a similar process, or do we just generally shadow the trainer?" And that's going to depend on your rotation and where you're at. Some places, depending on the type of testing, you might just shadow someone... or they might actually let you do stuff but watch you the whole time. Or you might be given fake patient samples or old patient samples to test, so that you're not actually reporting out any results. And that is important because, under Florida law, with your trainee license, you cannot report any results. And we will talk about that later on too.

CLIA Validation Requirements

So, there is validation and there is verification. This is when you get a new instrument or you bring on a new test.

Lecturer: Okay, back to the question. So, signing off on competency. As a student, competency is making sure you're competent and, yeah, doing the test. So that would be... you'll have a checklist of all the things you need to be competent in. So that is, you know how to perform that test, but you won't necessarily be doing it on patient samples.

Student: Gotcha, thank you.

Lecturer: Yeah. So, what is the difference between validation and verification?

If an assay is FDA-approved IVD, which is in vitro diagnostics, that company has gone through such rigorous testing that the FDA has approved it. You don't have to redo all that testing; you just need to verify that it works for your population.

If it has not gone through FDA approval, you have to do a full validation. This is also required if it is a Research Use Only (RUO) assay, a Lab-Developed Test (LDT), or if you modify an IVD in any way.

So if you're performing a validation, you have to do:

• Accuracy
• Precision
• Reportable range
• Reference range
• Analytical sensitivity
• Analytical specificity

Key Validation Concepts

Accuracy and Precision: Precision is how close repeated values are to each other. Accuracy is how close a value is to the correct, true value. The top right of a bullseye target, with a tight and centered grouping, is what you want in a lab test: high accuracy and high precision.

Reportable Range: Also known as Analytical Measurement Range (AMR) or linearity, this is the range of values where your test result is accurate and can be reported.

Reference Range: This is the "normal" range for a healthy population. You typically verify the manufacturer's range with 20 samples, or establish your own with 100+ samples.

Installation, Operational, and Performance Qualification (IQ, OQ, PQ):

• IQ (Installation Qualification): Installing the equipment correctly according to space, temperature, and other requirements.
• OQ (Operational Qualification): Ensuring the instrument operates as expected, including startups, shutdowns, and error alarms.
• PQ (Performance Qualification): Performing all the validation tests, like method comparisons and reproducibility studies (inter-run, inter-operator).

Proficiency Testing (PT) Requirements

PT must be performed on each test. The samples must come from a CLIA-approved agency like CAP (College of American Pathologists). These samples must be processed like a normal patient sample, and you absolutely cannot discuss results with other labs. The samples must be rotated among all staff who perform the assay.

What happens if you fail PT? If you score under 80% or have two consecutive failures, it's a serious issue. CMS can revoke the lab's ability to perform testing. It takes six months of successful PT to be reinstated.

What if no PT kit exists? For niche or lab-developed tests, you can either split blinded samples within the lab or, preferably, exchange samples with another external lab to ensure impartial analysis.

QC and Personnel Requirements

QC and personnel rules are based on test complexity: waived, moderate, and high.

• Waived Tests: So simple anyone can do them (e.g., home pregnancy test). No personnel requirements.
• Moderate Complexity: Requires at least a high school diploma and documented training.
• High Complexity: The CLIA minimum is an associate degree with science hours and clinical training or 3 months of specialty lab training.

CLIA Laboratory Certificates

Every lab needs a CLIA certificate based on the testing it performs. The main types are:

• Certificate of Waiver: For labs doing only waived tests.
• Certificate of Provider-Performed Microscopy: For physicians/dentists doing simple microscopy.
• Certificate of Compliance / Accreditation: For labs doing moderate/high complexity testing, inspected either by CLIA directly (Compliance) or a "deemed" organization like CAP (Accreditation).
• Certificate of Registration: A temporary certificate for new labs, valid for two years until an inspection occurs.

How Labs Are Assessed

Labs are assessed to ensure they follow regulations. CMS can grant "deemed authority" to organizations like CAP, AABB, and The Joint Commission to perform inspections on their behalf. These organizations often have standards that are more detailed and stringent than CLIA's.

Remember, these are accreditation services, not regulatory bodies. They can't shut you down, but they can report serious issues to CMS, who can.

What Inspections Look Like

Inspections are typically every two years, and some are unannounced. You must be inspection-ready at all times. This means knowing your standards, knowing how you comply, and knowing where all your documentation is.

FDA Inspections

The FDA inspects blood banks and transfusion services, viewing blood as a drug. These inspections are unannounced and occur at least every two years. If they find issues, they issue a Form 483, which is a public document.

After the Inspection

If problems are found, you will receive a report with citations or deviations that require a corrective action plan. Serious issues (conditional citations) require a follow-up visit. Recommendations are suggestions for improvement but are not mandatory.

Federal vs. State Regulations

CLIA is federal law, but states can have their own, often stricter, regulations. In Florida, the Agency for Health Care Administration (AHCA) oversees clinical labs. You must follow both federal and state rules.

Licensure vs. Certification

These terms are often confused, but they are very different.

• Certification: Granted by a private entity (like ASCP) after you pass an exam. It gives you a professional title (e.g., MLS(ASCP)) and shows you've met a standard. It is not a license to practice.
• Licensure: Granted by a state government (like Florida). It is a legal requirement to work in that state. It ensures the public that you have met minimum competencies and is required for practice.

Certification does not equal licensure. To work in one of the 11+ states that require it, you must obtain a state license in addition to your certification.

Benefits of Licensure for Lab Personnel

I was really pleased with your discussion board comments. Licensure isn't just about paying a fee; it provides real benefits:

• It helps guard patient safety by ensuring all practitioners meet high standards.
• It promotes continuing education, keeping us up-to-date in a rapidly changing field.
• It makes the HR process easier for employers, as a license is a verifiable credential.
• It provides job and wage protection. The high bar for entry creates high demand, which helps drive wages up.

Student: How do you then go about specializing? Like, is that after one year, two years of experience? How does that work?

Lecturer: It depends on the specialty. The ASCP website has eligibility routes for each exam. Most have an education route and an experience route. If you want a higher-level position in a specialty lab, like a supervisor in an AABB-accredited lab, you might be required to have that specialty certification (e.g., SBB).