What’s the Relation Between CAP and CLIA?
CAP Accreditations and CLIA Certifications
When labs are in compliance with CLIA (Clinical Laboratory Improvement Amendments), it is validated with a CLIA certificate. After becoming CLIA-certified, a lab can then pursue a higher level of quality by applying for accreditation by an accreditation agency such as CAP.
The College of American Pathologists (CAP) is a leading healthcare accreditation organization; it has spent over 70 years improving and advancing the practice of pathology and laboratory medicine. CAP is approved by the CMS, or Centers for Medicare and Medicaid Services, and thus has the authority to inspect labs that are CLIA-certified (specific to labs subject to US regulations).
This federal agency issues a certificate of accreditation to labs performing complex, high proficiency testing—tests that require a higher level of expertise, education, and training.
CAP releases a detailed checklist for the applicants, including both general and specific guidelines. All the requirements must be fulfilled in order to meet the higher quality standard of laboratory practices than just CLIA compliance alone.
A general laboratory checklist is given when applying for CLIA, but during the accreditation process by CAP, a discipline-specific checklist is sent directly to the respective laboratory.
Unlike CLIA, the accreditation process by CAP involves a thorough inspection conducted by a CAP inspector, who is a peer from a CAP-accredited lab. The on-site inspection takes place every two years using CAP accreditation checklists and a self-inspection checklist every other year.
Accreditation by CAP has more stringent expectations for laboratory standards than CLIA due to the high-complexity test types involved. And because CAP accreditations tend to hold higher credibility than a certification, it can often be easier to attract funding or sponsors for projects.
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CAP Accreditation Program Benefits
The College of American Pathologists (CAP) is an organization known to accredit testing laboratories and is closely involved in advances in medical and clinical studies. Its goal is to improve public health and patient safety. CAP Accreditation helps labs in:
In-depth checklist requirements
The CAP program provides an unparalleled checklist of requirements for applicants. With over 500 pathologists’ input, CAP accreditation checklists are more comprehensive, customized, and scientifically rigorous than other accreditors’ requirements.
Managing evolving changes in medicine and technology
CAP-accredited labs are driven to provide the highest quality of laboratory services and medical centers. The comprehensive use of testing techniques by CAP-accredited laboratories ensures the accurate generation of results that can add value to medical research. With advances in technology, the use of high-quality instruments by certified labs will contribute towards improved disease treatment and patient care.
Exchanging ideas and best practices among peers
The practice of CAP site inspections allows communication among peers of different CAP-accredited labs. As the inspection is conducted by a team of people with multidisciplinary backgrounds, it builds room for ideation and innovation. Additionally, becoming CAP-accredited opens up opportunities to collaborate with other CAP-accredited labs and professionals.
Professional development and learning opportunities
CAP provides numerous learning opportunities for laboratory staff and medical professionals through education and training resources. Not only is CAP an accreditation organization, but it’s also a network of like-minded professionals with resources for different professional development and learning opportunities.
Maintaining accurate test results and patient diagnosis
Accreditation by CAP is a symbol of high quality and precision. This promises accurate test results and ensures meticulous patient diagnosis.
Meeting the standards from FDA, OSHA, CLIA
The CAP program meets the rigorous standards required by the FDA, OSHA, and CLIA. In fact, CAP requirements actually often exceed these standards, ensuring excellent patient care and safety.
In order to be eligible to apply for a CAP accreditation, your lab must:
- Be appropriately licensed to carry out and perform testing when required by law.
- Enroll in the EQA/PT (external quality assurance/proficiency testing) a minimum of 6 months prior to requesting an accreditation application if you’re an international applicant.
- The CAP Laboratory Accreditation Program (LAP) is a peer-based model in which laboratory professionals qualified for CAP inspection are involved. They carry out an on-site inspection every two years by using the checklists accredited by CAP to assess the laboratory’s compliance.
- Non-accredited labs can purchase the checklists prior to accreditation. Participating labs can simply access the checklists through CAP’s e-LAB Solutions Suite.
- The CAP program’s peer-based inspection model uses small teams of practicing medical and healthcare professionals that have become qualified through a CAP inspector training program.
To learn more, visit www.cap.org.
What is the Accreditation Cycle and Process?
The CAP LAP accreditation process comprises both the accreditation and the inspection cycle. A typical accreditation cycle spans over 2 years. The general process is as follows:
- Application is requested.
- Application is completed and submitted.
- Customized checklists and welcome kits are received.
- A CAP inspector team is assigned for the scheduled inspection day.
- The inspection is conducted within three months.
- Laboratories respond to any deficiencies identified; labs must demonstrate compliance.
- Certificate of accreditation is received, and the laboratory gets accredited for the next 2 years.
- After two years, self-inspection is carried out to maintain the laboratory quality standards.
- Reapply for accreditation.
The flowchart below further illustrates the various steps involved in the cycle of CAP accreditation.
The complete laboratory accreditation manual is available here.
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Starting Your Lab on the Right Foot
CAP is an accreditation agency with the power to accredit laboratory testing performed on human samples, and specializes in quality control standards for medical and clinical laboratories.
While getting an accreditation can be time-consuming and challenging, it is critical that you do so. Running a healthcare company requires that the business meets the regulations and standards of organizations like CAP, as they are an attestation to the quality of laboratory practices and offer many advantages.
Without the accreditation, you may very well limit your operating capabilities and hamstring your financial viability.
Excedr has a long track record of working with CAP-accredited organizations, as leasing is an excellent option for labs looking to acquire highly-sensitive, yet exorbitantly expensive, lab equipment.