For healthcare organizations to operate properly, they must align with the latest healthcare regulations, standards, and accreditation changes. Non-compliance can cost organizations a lot of time, money and even their reputation. From The Joint Commission to the Office of Inspector General (OIG) and the Office of Civil Rights (OCR), staying up to date with guidelines related to these organizations is crucial to remaining compliant 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)?
The CAP LAP is an internationally recognized program and a leader in the industry. This program is responsible for accrediting the entire spectrum of laboratory test disciplines. CAP LAP accomplishes this by using the most scientifically rigorous customized checklist requirements. These checklists are developed with input from more than 500 pathologists and provide a clear roadmap for organizations to achieve accreditation and run a high-quality laboratory. 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 2019, 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 annually 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.
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 include:
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The laboratory applies for accreditation
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Custom checklists are sent to the laboratory and preparations for inspection begin
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An inspector and team are assigned by the CAP
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Inspection is conducted – within a 3-month timeframe
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The laboratory corrects any deficiencies identified and demonstrates compliance
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Upon meeting the requirements of the program, the laboratory is accredited for the next 2 years
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At year 2, the laboratory performs a self-inspection and prepares for the cycle to begin again
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:
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Helps US laboratories to meet and exceed CLIA requirements
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Use of the most comprehensive scientifically endorsed laboratory standards ensures laboratories are compliant with regulations
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Detailed, customized checklists provide laboratories with a clear path outlining specific actions and how they should perform these actions
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Comprehensive evaluations ensure that test results are always accurate and thus patients’ diagnoses are also accurate
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Inspections are conducted by expert teams of multi-disciplinary laboratory professionals
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Laboratories are driven to provide the highest standard of services
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Numerous valuable educational and training resources are provided by the CAP
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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 related to ensuring quality laboratory testing and patient safety. Policies will need to address areas such as:
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Validation of test systems
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Analytic quality control
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Quality management of pre and post-analytic processes
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Proficiency testing
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Communication to various stakeholders – clinicians, patients, administration
A laboratory also needs to document all the processes by which they operate. This can include how samples are treated, how tests are conducted and how results are communicated. In addition to all required policies, these laboratory-specific policies result in healthcare organizations having thousands of documents which they need to keep updated and accessible to staff. To make the most of these policies, organizations should implement a robust policy management system, such as RLDatix PolicyStat to help improve compliance around their policies and procedures. Having an effective policy management system in place not only drives streamlined communication across an organization, it also supports healthcare providers in having easy access to information at the point of care.
As healthcare continues to evolve, it’s critical that organizations stay aligned with regulations, standards and accreditation rules, such as CAP requirements. Standards & Regulations Manager, an optional add-on PolicyStat module, allows organizations to link their policies to accrediting agencies such as The Joint Commission, CAP, HFAP, DNV, CMS CoPs and others. To support organizations’ compliance efforts, Standards & Regulations Manager sends out automated email alerts and notifications when standards or regulations that organizations subscribe to change or are updated. To help streamline organizational processes, the module also allows organizations to directly link to standards and regulations within a given policy. RLDatix PolicyStat equips healthcare organizations with the tools to operate as competitive and reputable organizations that maintain quality of care for patients and promote best practices for pathology efforts.