When it comes to staying up-to-date with the latest regulations, standards, and accreditation changes, we need all the help we can get. After all, missing anything can cost you a lot of time, money and even your reputation. From The Joint Commission to OIG/OCR having information at your fingertips is crucial to staying abreast in healthcare.
The College of American Pathologists (CAP) is the world’s largest organization of board-certified pathologists, with a mission to ensure that there is excellence in how pathology and laboratory medicine is practiced around the world. Under deemed authority by the CMS, the CAP has spent over 70 years promoting excellence in laboratories and advancing the practice of pathology and laboratory science. With various laboratory improvement programs such as Proficiency Testing (PT) and accreditation programs including the Laboratory Accreditation Program (LAP), the Forensic Drug Testing (FDT) Accreditation Program, and CAP 15189 (a quality management program), being CAP ready can mean providing better quality of care while fostering and advocating best practices in pathology and laboratory medicine.
What is the CAP Laboratory Accreditation Program (LAP)?
CAP LAP is an internationally recognized program and a leader in the industry. According to the CAP, they accredit “the entire spectrum of laboratory test disciplines using the most scientifically rigorous customized checklist requirements.” These checklists are developed from rigorous accreditation standards that are more stringent than or equal to the requirements of the Clinical Laboratory Improvement Program (CLIA). They are designed to not only cover regulatory compliance requirements but to also assist laboratories in achieving the highest standards of excellence for positively impacting patient care.
As of 2017, the CAP has 21 checklists – an All Common Checklist (COM) that contains a core set of requirements applicable to all areas that perform laboratory tests and procedures, a Director Assessment Checklist, a Laboratory General Checklist, and discipline-specific checklists. These checklists contain approximately 3000 requirements against which laboratories are assessed on their overall management and operation. The checklists are reviewed yearly to ensure that they are up-to-date with advancements in medicine, technology and laboratory management while maintaining the rigor of the program and the high standards of patient care for which they are known.
All laboratory testing performed on human samples in the US except for research purposes are regulated by the Centers for Medicare and Medicaid Services (CMS) through CLIA. However, the CAP is approved by the CMS as an accreditation organization and thus has deeming authority to inspect laboratories under CLIA. This means that accreditation by CAP covers CLIA requirements and a laboratory accredited by the CAP does not need to be inspected by CMS. CAP accreditation is also recognized by The Joint Commission and can be used to meet many state certification requirements. The CAP currently accredits more than 8000 laboratories of which approximately 437 are international.
How does the CAP LAP work?
The CAP LAP utilizes a peer-based inspection model in which the inspectors are practicing laboratory professionals who have been trained through a CAP training program. These inspectors conduct on-site inspections every two years using the CAP accreditation checklists to assess the laboratory’s compliance with the program requirements. The steps in the accreditation process are:
- The laboratory applies for accreditation
- Custom checklists are sent to the laboratory and preparations for inspection begin
- An inspector and team are assigned by the CAP
- Inspection is conducted – within a 3-month timeframe
- The laboratory corrects any deficiencies identified and demonstrates compliance
- Upon meeting the requirements of the program, the laboratory is accredited for the next 2 years
- At year 2, the laboratory performs a self-inspection and prepares for the cycle to begin once more
Who can apply for CAP accreditation?
Any laboratory that performs testing on specimens from human beings or animals can apply for the CAP LAP. However, laboratories must be appropriately licensed to perform testing where it is required by law. The CAP LAP inspects a variety of laboratory settings, from complex university medical centers to physician office laboratories, and covers a complete array of disciplines and testing procedures.
The CAP LAP is available to laboratories in the US as well as internationally.
Advantages of CAP accreditation?
The CAP is an internationally recognized organization known for its advancement of quality in laboratory medicine. Accreditation by the CAP is therefore seen as an attestation to quality laboratory practices and comes with many advantages:
- Helps US laboratories to meet and exceed CLIA requirements
- Use of the most comprehensive scientifically endorsed laboratory standards ensures laboratories are compliant with regulations
- Detailed, customized checklists provide laboratories with a clear path as to what to do and how to do it
- Comprehensive evaluations ensure that test results are always accurate and thus patients diagnoses are also accurate
- Inspections are conducted by expert teams of multi-disciplinary laboratory professionals
- Laboratories are driven to provide the highest standard of services
- Numerous valuable educational and training resources are provided by the CAP
- Accreditation by the CAP is a symbol of quality that increases the value of the laboratory to organizations, patients, and customers
CAP-accredited laboratories around the world can demonstrate excellence in patient care and confidence in laboratory practices.
How are Policies and Procedures impacted by CAP requirements?
CAP accreditation checklists are detailed and stringent, indicating exactly what is required from laboratories to be compliant with the accreditation program. As such, the laboratory is required to have numerous policies and procedures such as those to ensure quality laboratory testing and patient safety. Policies will need to address areas such as:
- Validation of test systems
- Analytic quality control
- Quality management of pre and post-analytic processes
- Proficiency testing
- Communication to various stakeholders – clinicians, patients, administration
A laboratory also needs to document all the processes by which they operate, for example, how samples are treated, how tests are conducted, how results are communicated, etc. These, in addition to all the required policies, result in laboratories having thousands of documents which they need to keep updated and accessible to staff.
All this being said, it seems essential that hospitals find a way to stay on top of regulations, standards and accreditation rules, such as CAP requirements. More and more, especially in a world where news travels rampantly, it’s important to be seen as competitive and reputable, which is where maintaining quality of care for patients, as well as best practices for pathologists, come in to play. It’s up to you now to find a way to achieve this!