CLIA and CAP: What You Need to Know

When it comes to your children’s health, you want them to receive the best care and attention from medical professionals. When evaluating any medical decisions that require a laboratory for testing, you expect the lab to be up-to-date with the latest standards of care.

For example, does the lab have CLIA certification or CAP accreditation?

Fore Genomics has partnered with the highest level of certified laboratories in the U.S. to increase clinical quality genetic tests for your child. Let's take a look at these certifications and how they affect the quality and usability of your child's clinical results.

What Is CLIA Certification?

CLIA stands for Clinical Laboratory Improvement Amendments. It is a federal law established in 1988 that requires medical labs to meet certain standards when performing tests on human samples. This includes ensuring accuracy and reliability, employing qualified personnel, and providing quality control procedures.

To obtain CLIA certification, labs must demonstrate that they are meeting these standards by submitting applications and undergoing inspections from the Centers for Medicare & Medicaid Services (CMS). Laboratories that successfully meet all requirements will receive a certificate of accreditation from CMS that is valid for two years.

Accredited laboratories that are CLIA-certified are able to perform complex medical tests such as genetic testing and molecular diagnostics that can be used by a physician in a clinical setting. Genetic tests run in labs that do not meet CLIA requirements can not be used clinically.

Why Use CLIA-Certified Labs?

Understanding the value of laboratories having CLIA certification is crucial. CLIA-certified labs are held to very strict standards that ensure reliable test results with high clinical quality every time.

Using a genetics company that partners with CLIA-certified labs such as Fore Genomics  guarantees quality. By having the most rigorous standards of quality, clinical accuracy, and patient safety enforced in clinical laboratory testing by the accreditation, CLIA-certified labs are regularly monitored to ensure they are meeting these necessary criteria.

Furthermore, taking advantage of these services will increase confidence in the diagnosis process and enable more effective decision-making when determining potential courses of treatment or care plans with your healthcare provider.

FDA vs CLIA

Wondering what the difference is between the U.S. Food and Drug Administration (FDA) approval and the CLIA certification?

CLIA and FDA are two federally recognized governing bodies.

However, CLIA-certified labs are accredited by the federal government to ensure quality standards, while labs approved by the FDA must adhere to its regulations for marketing test kits or other devices.

While CLIA certification is considered more reliable for genetics testing, many popular consumer brands that offer exciting results for ancestral research or health and wellness curiosity do not use CLIA-certified labs.

These companies tend to rely on FDA-approved laboratories that are less precise and medically sound than those with CLIA accreditation.

Knowing the difference between CLIA-certified labs and FDA-approved helps consumers make informed decisions when choosing genetics testing options.

What Is CAP Certification? 

In addition to CLIA certification, some labs also seek accreditation from the College of American Pathologists (CAP). This voluntary program is designed to ensure the highest level of quality in patient care through laboratory accreditation.

The CAP accreditation services are similar to CLIA certification but with more detail-oriented criteria related specifically to pathology testing.

CAP-accredited laboratories are required to adhere to stringent regulations related to laboratory safety and personnel qualifications, equipment maintenance, specimen collection, testing accuracy, patient data reporting accuracy, proficiency testing results evaluation, quality control procedures, and more.

To obtain CAP certification, labs must submit detailed documentation outlining their testing processes and undergo rigorous onsite inspections from certified inspectors. Once those steps are complete, labs may receive full accreditation from CAP if their practices are deemed satisfactory by the inspectors.

The CAP inspects laboratories every two years to ensure they meet all requirements for accreditation.

Why Use a CAP-Certified Lab?

Although very few genetics companies utilize laboratories with CAP accreditation, the impact of having accurate results is critical for genetic testing. We are committed to holding the highest standards for our collaborating labs, and this is why we only partner with labs that have both CLIA and CAP certifications.

By using the leading laboratories with the most rigorous standards in the U.S., parents know they are getting the most expert and comprehensive laboratory services available when starting their child on an individualized health strategy with genetic health screening.

Benefits of CLIA/CAP Certification

For laboratories:

1. Provides a structured approach for quality management and process improvement.
2. Promotes a culture of ongoing advancement by identifying areas for development through the certification process.
3. Demonstrates a commitment to high-quality standards and patient care, boosting the laboratory's reputation in the healthcare industry.

For patients:

1. Ensures that test results are accurate, reliable, and delivered in a timely manner.
2. Increases patient confidence in the laboratory's capabilities to provide high-quality testing and accurate diagnoses.
3. Guarantees that laboratories adhere to strict guidelines for protecting patient privacy and managing confidential information securely.

Providing a Usable Clinical Report

Both CLIA and CAP certifications ensure that a laboratory is capable of producing information that can be used to diagnose diseases or other medical conditions with high quality and reliability.

Because medical decisions will likely be based on these results, it is extremely important that only certified laboratories are used for testing purposes so users receive actionable clinical reports through thorough results every time.

This information will help parents and healthcare providers make informed decisions about their child’s healthcare needs going forward.

How Do CLIA/CAP Certifications Comply with HIPAA Regulations?

Labs must comply with HIPAA regulations, which govern the privacy and security of patient health information. HIPAA sets national standards to protect individually identifiable health information, regulating how this data can be used and disclosed. Thus, all protected health information (PHI) sent to and from CLIA/CAP certified labs must be managed through HIPAA-compliant channels to ensure data security and patient privacy.

Fore Genomics Uses CLIA and CAP Certified Labs

At Fore Genomics, we demand accuracy in our genetics testing. To ensure clinically verified results, we employ labs that are both CAP and CLIA-certified which meet the highest standards of scientific analysis. Rest assured that you are receiving reliable genetic testing for your child. Our services use only the best medical standards and provide thorough analyses to get you the most precise genetic information possible.

These licensed labs are held to rigorous standards and ensure that results are medically accurate and reliable. By partnering with the most trusted clinical laboratories in the medical genetics field, we guarantee accurate genetics data for our clients.

With this knowledge in hand, you can feel confident in collaborating with us for your child’s genetic testing. When it comes to making sure your child receives the highest quality medical care — including accurate lab testing — it is essential that the partnering laboratories are CLIA and CAP-certified to ensure your child receives only top-notch care based on reliable laboratory testing results every time.

*The results are not intended to be used as the sole means for clinical diagnosis or patient management decisions. The chance of a false-negative or a false-positive result due to laboratory error cannot be completely excluded. These results should not be regarded as investigational or for research.

FAQs

What does CLIA certification mean for medical labs?

CLIA certification ensures that medical laboratories meet federal standards for quality in testing. Established under the Clinical Laboratory Improvement Amendments of 1988, CLIA certification requires labs to demonstrate accuracy, reliability, and competency in handling human samples. This certification is essential for labs performing high-complexity tests like genetic testing, overseen by the Centers for Medicare & Medicaid Services (CMS).

Why choose CLIA-certified labs for your child's genetic testing?

Choosing a CLIA-certified lab for genetic testing guarantees that the facility adheres to rigorous standards for accuracy and quality. For parents seeking reliable results in their child's genetic tests, partnering with a company like Fore Genomics, which uses CLIA-certified labs, ensures that each test meets stringent quality controls, increasing diagnostic confidence and treatment effectiveness.

What are the benefits of CAP certification in laboratories?

CAP certification, granted by the College of American Pathologists, is a mark of excellence for laboratories, especially in the field of pathology. This voluntary accreditation goes beyond basic requirements, focusing on comprehensive standards including specimen handling, test accuracy, and laboratory personnel qualifications. CAP certification represents a lab’s commitment to maintaining the highest standards of operational excellence.

How important is dual CLIA and CAP certification for genetic testing labs?

Dual certification in both CLIA and CAP for a laboratory signifies the highest level of adherence to medical and pathology testing standards. Labs that meet both sets of criteria, like those partnered with us, provide the most dependable and precise results in genetic testing. This dual certification ensures the accuracy and reliability of test results – vital for proper medical diagnosis and patient care.

Can I rely on genetic test results from CLIA and CAP certified labs for medical decisions?

Absolutely. Genetic testing performed by labs that are both CLIA and CAP certified produces highly reliable and accurate results. These certifications ensure that the lab operations meet the stringent requirements necessary for precise diagnostics. While these results are critical for informed medical decision-making, it is also advised to use them alongside other medical information and consultations with healthcare providers to ensure the best patient care.