LEADING LABORATORY QUALITY
LEADING LABORATORY QUALITY
LEADING LABORATORY QUALITY
Focused on its mission, the CAP, in lockstep with its members and customers, confronted the unexpected using the extensive array of laboratory quality solutions in its arsenal.
Focused on its mission, the CAP, in lockstep with its members and customers, confronted the unexpected using the extensive array of laboratory quality solutions in its arsenal.
Focused on its mission, the CAP, in lockstep with its members and customers, confronted the unexpected using the extensive array of laboratory quality solutions in its arsenal.
CAP Upholds the Highest Standards of Excellence
If unwavering commitment to quality and excellence in laboratory medicine were not enough, the global COVID-19 pandemic challenged the CAP to go above and beyond in its service to deliver accurate test results and provide rigorous laboratory quality management for clinicians, patients, and the broader health care community. The CAP, in lockstep with its members and customers, remained focused on its mission and, with the extensive array of laboratory quality solutions in its arsenal, confronted the unexpected.
In facing the pandemic, members remained mission focused and agile to provide unmatched laboratory quality solutions, with accreditation programs and proficiency testing (PT) at the core. Laboratories in more than 100 countries look to the CAP for its leadership, knowledge, and expertise, even more so with the global pandemic upending their daily operations.
Members on committees within the CAP Council on Scientific Affairs (CSA) and Council on Accreditation quickly pivoted to provide programs, education, and guidance, offering clarification and simplification of regulations in an evolving regulatory landscape due to the global pandemic—all the while remaining focused on the management and delivery of laboratory quality solutions.
More than 23,000 laboratories worldwide rely on the CAP’s PT program to ensure the highest quality results for patient testing. Members design and lead these programs, ranging from the routine to esoteric, as medicine and technology continually evolve and, as was the case for 2020, face unforeseen demands.
In 2020, the CAP introduced 22 new PT programs, with four of these developed mid-year to meet urgent laboratory quality needs related to SARS-CoV-2 (COVID-19) testing. Though pandemic challenges were numerous, the CAP worked diligently for customers to deliver PT around the United States and the world as borders shut down and shipments were delayed. Further, we overhauled internal systems, deploying new technologies to more efficiently track inquiries and provide service data to CAP teams serving all our members and customers.
With nearly 8,000 laboratories accredited worldwide, the Laboratory Accreditation Program is based on rigorous standards translated into detailed checklist requirements, organized into 21 discipline-specific checklists. CAP inspection teams use them as a guide to assess the laboratory’s overall management and operation. The program, internationally recognized and the largest of its kind, is unlike any other. It utilizes teams of trained, practicing board-certified pathologists and laboratory professionals as team leaders and inspectors, allowing for sharing of best practices, learning, and professional development.
CAP Upholds the Highest Standards of Excellence
If unwavering commitment to quality and excellence in laboratory medicine were not enough, the global COVID-19 pandemic challenged the CAP to go above and beyond in its service to deliver accurate test results and provide rigorous laboratory quality management for clinicians, patients, and the broader health care community. The CAP, in lockstep with its members and customers, remained focused on its mission and, with the extensive array of laboratory quality solutions in its arsenal, confronted the unexpected.
In facing the pandemic, members remained mission focused and agile to provide unmatched laboratory quality solutions, with accreditation programs and proficiency testing (PT) at the core. Laboratories in more than 100 countries look to the CAP for its leadership, knowledge, and expertise, even more so with the global pandemic upending their daily operations.
Members on committees within the CAP Council on Scientific Affairs (CSA) and Council on Accreditation quickly pivoted to provide programs, education, and guidance, offering clarification and simplification of regulations in an evolving regulatory landscape due to the global pandemic—all the while remaining focused on the management and delivery of laboratory quality solutions.
More than 23,000 laboratories worldwide rely on the CAP’s PT program to ensure the highest quality results for patient testing. Members design and lead these programs, ranging from the routine to esoteric, as medicine and technology continually evolve and, as was the case for 2020, face unforeseen demands.
In 2020, the CAP introduced 22 new PT programs, with four of these developed mid-year to meet urgent laboratory quality needs related to SARS-CoV-2 (COVID-19) testing. Though pandemic challenges were numerous, the CAP worked diligently for customers to deliver PT around the United States and the world as borders shut down and shipments were delayed. Further, we overhauled internal systems, deploying new technologies to more efficiently track inquiries and provide service data to CAP teams serving all our members and customers.
With nearly 8,000 laboratories accredited worldwide, the Laboratory Accreditation Program is based on rigorous standards translated into detailed checklist requirements, organized into 21 discipline-specific checklists. CAP inspection teams use them as a guide to assess the laboratory’s overall management and operation. The program, internationally recognized and the largest of its kind, is unlike any other. It utilizes teams of trained, practicing board-certified pathologists and laboratory professionals as team leaders and inspectors, allowing for sharing of best practices, learning, and professional development.
CAP Upholds the Highest Standards of Excellence
If unwavering commitment to quality and excellence in laboratory medicine were not enough, the global COVID-19 pandemic challenged the CAP to go above and beyond in its service to deliver accurate test results and provide rigorous laboratory quality management for clinicians, patients, and the broader health care community.
The CAP, in lockstep with its members and customers, remained focused on its mission and, with the extensive array of laboratory quality solutions in its arsenal, confronted the unexpected.
In facing the pandemic, members remained mission focused and agile to provide unmatched laboratory quality solutions, with accreditation programs and proficiency testing (PT) at the core. Laboratories in more than 100 countries look to the CAP for its leadership, knowledge, and expertise, even more so with the global pandemic upending their daily operations.
Members on committees within the CAP Council on Scientific Affairs (CSA) and Council on Accreditation quickly pivoted to provide programs, education, and guidance, offering clarification and simplification of regulations in an evolving regulatory landscape due to the global pandemic—all the while remaining focused on the management and delivery of laboratory quality solutions.
More than 23,000 laboratories worldwide rely on the CAP’s PT program to ensure the highest quality results for patient testing. Members design and lead these programs, ranging from the routine to esoteric, as medicine and technology continually evolve and, as was the case for 2020, face unforeseen demands.
In 2020, the CAP introduced 22 new PT programs, with four of these developed mid-year to meet urgent laboratory quality needs related to SARS-CoV-2 (COVID-19) testing. Though pandemic challenges were numerous, the CAP worked diligently for customers to deliver PT around the United States and the world as borders shut down and shipments were delayed. Further, we overhauled internal systems, deploying new technologies to more efficiently track inquiries and provide service data to CAP teams serving all our members and customers.
With nearly 8,000 laboratories accredited worldwide, the Laboratory Accreditation Program is based on rigorous standards translated into detailed checklist requirements, organized into 21 discipline-specific checklists. CAP inspection teams use them as a guide to assess the laboratory’s overall management and operation. The program, internationally recognized and the largest of its kind, is unlike any other. It utilizes teams of trained, practicing board-certified pathologists and laboratory professionals as team leaders and inspectors, allowing for sharing of best practices, learning, and professional development.
Stringency in Accreditation Checklists Provide Quality Roadmap
CAP members, serving on many accreditation and scientific committees, annually review all checklists to maintain program stringency and the highest standards of patient care while reflecting advancements in medicine, technology, and laboratory management. Inspection teams understand laboratory operations and challenges. Through the application of accreditation program checklists, they provide expert guidance to peers, helping them:
- Maintain compliance with Centers for Medicare & Medicaid Services (CMS) regulations
- Improve the quality of laboratory services and implement risk reduction strategies
- Remain current with changes in laboratory medicine best practices
In the 2020 accreditation checklist edition, the CAP added 27 new requirements and revised approximately 139, with the most significant changes in quality management, infection prevention and control, and transfusion medicine. As related to COVID-19, the CAP enhanced, for example, requirements in the Laboratory General Checklist, including safety requirements for viral exposure due to airborne transmission and, in the Microbiology Checklist, specimen collection and processing requirements.
The Laboratory Accreditation Program is just one of the CAP’s accreditation offerings; the other programs are: Biorepository, Reproductive, and Forensic Drug Testing. In addition, the CAP 15189 program, complementing the Laboratory Accreditation Program, covers the ISO 15189 international quality standard for medical laboratories. It includes the ISO 15189’s process orientation and management of systems, helping laboratories probe deeper into systemic issues, root cause(s), risk management, and ways to improve operational agility and efficiency. The CAP worked closely with laboratories in all its accreditation programs to maintain their status throughout the pandemic, providing close guidance and virtual inspection options.
While accreditation and PT are core to the CAP’s quality solutions, the commitment to quality does not end there. Cancer protocols, biomarker templates, and evidence-based guidelines, along with vigilance over ever-changing technology, deepen the CAP’s dedication to excellence in pathology and laboratory medicine.
Stringency in Accreditation Checklists Provide Quality Roadmap
CAP members, serving on many accreditation and scientific committees, annually review all checklists to maintain program stringency and the highest standards of patient care while reflecting advancements in medicine, technology, and laboratory management. Inspection teams understand laboratory operations and challenges. Through the application of accreditation program checklists, they provide expert guidance to peers, helping them:
- Maintain compliance with Centers for Medicare & Medicaid Services (CMS) regulations
- Improve the quality of laboratory services and implement risk reduction strategies
- Remain current with changes in laboratory medicine best practices
In the 2020 accreditation checklist edition, the CAP added 27 new requirements and revised approximately 139, with the most significant changes in quality management, infection prevention and control, and transfusion medicine. As related to COVID-19, the CAP enhanced, for example, requirements in the Laboratory General Checklist, including safety requirements for viral exposure due to airborne transmission and, in the Microbiology Checklist, specimen collection and processing requirements.
The Laboratory Accreditation Program is just one of the CAP’s accreditation offerings; the other programs are: Biorepository, Reproductive, and Forensic Drug Testing. In addition, the CAP 15189 program, complementing the Laboratory Accreditation Program, covers the ISO 15189 international quality standard for medical laboratories. It includes the ISO 15189’s process orientation and management of systems, helping laboratories probe deeper into systemic issues, root cause(s), risk management, and ways to improve operational agility and efficiency. The CAP worked closely with laboratories in all its accreditation programs to maintain their status throughout the pandemic, providing close guidance and virtual inspection options.
While accreditation and PT are core to the CAP’s quality solutions, the commitment to quality does not end there. Cancer protocols, biomarker templates, and evidence-based guidelines, along with vigilance over ever-changing technology, deepen the CAP’s dedication to excellence in pathology and laboratory medicine.
Stringency in Accreditation Checklists Provide Quality Roadmap
CAP members, serving on many accreditation and scientific committees, annually review all checklists to maintain program stringency and the highest standards of patient care while reflecting advancements in medicine, technology, and laboratory management.
Inspection teams understand laboratory operations and challenges. Through the application of accreditation program checklists, they provide expert guidance to peers, helping them:
- Maintain compliance with Centers for Medicare & Medicaid Services (CMS) regulations
- Improve the quality of laboratory services and implement risk reduction strategies
- Remain current with changes in laboratory medicine best practices
In the 2020 accreditation checklist edition, the CAP added 27 new requirements and revised approximately 139, with the most significant changes in quality management, infection prevention and control, and transfusion medicine. As related to COVID-19, the CAP enhanced, for example, requirements in the Laboratory General Checklist, including safety requirements for viral exposure due to airborne transmission and, in the Microbiology Checklist, specimen collection and processing requirements.
The Laboratory Accreditation Program is just one of the CAP’s accreditation offerings; the other programs are: Biorepository, Reproductive, and Forensic Drug Testing. In addition, the CAP 15189 program, complementing the Laboratory Accreditation Program, covers the ISO 15189 international quality standard for medical laboratories. It includes the ISO 15189’s process orientation and management of systems, helping laboratories probe deeper into systemic issues, root cause(s), risk management, and ways to improve operational agility and efficiency. The CAP worked closely with laboratories in all its accreditation programs to maintain their status throughout the pandemic, providing close guidance and virtual inspection options.
While accreditation and PT are core to the CAP’s quality solutions, the commitment to quality does not end there. Cancer protocols, biomarker templates, and evidence-based guidelines, along with vigilance over ever-changing technology, deepen the CAP’s dedication to excellence in pathology and laboratory medicine.
Cancer Reporting Today Prepares for Evolution Tomorrow
In 2020, members of the Cancer and Pathology Electronic Reporting (PERT) Committees led the release of 98 revised cancer protocols and biomarker templates, as well as updated terminology maps for ICD-O-3 and SNOMED CT. Key revisions included the World Health Organization Blue Book updates, incorporation of the American Joint Committee on Cancer Cancer Staging System for Cervix Uteri, Version 9, and improvements to lymph node and margin sections.
The October 2020 release was the first to utilize the new Single Source Product tool, streamlining production of the cancer protocols and electronic versions from a single database. The CAP is also looking to expand the use of protocol-driven standardized reporting beyond cancer through collaboration with the PERT, Autopsy, and Cytopathology committees, as well as other committees and stakeholders.
The CAP continued to build upon its vendor engagement program through initiation of a new virtual program in 2020. This program shines a renewed focus on real-time laboratory information system (LIS) software testing, validation of cancer protocol implementation and functionality, expanded committee member collaboration, and ongoing vendor education. The CAP engages six major vendors in this program, helping to ensure that pathologists can efficiently report on their cancer cases no matter which LIS vendor they use in their workflow. As more than 6,400 pathologists are now licensed to use the vendor integrated cancer protocols for diagnostic cancer reporting, this vendor engagement program has become an essential part of CAP customer service.
The CAP continued work on grants from the Centers for Disease Control and Prevention and the California Department of Public Health to further address cancer reporting standardization, structure, and transmission using national health information technology standards. These initiatives support continued cancer protocol product development, including technical and functional improvements, pathologist and cancer registrar educational activities, and promotion of downstream data usage for quality reporting and surveillance activities. The PERT and Cancer Committees and staff penned four articles in 2020 providing a review of the value and benefits of standardized, structured cancer reporting, with publication anticipated in 2021.
Cancer Reporting Today Prepares for Evolution Tomorrow
In 2020, members of the Cancer and Pathology Electronic Reporting (PERT) Committees led the release of 98 revised cancer protocols and biomarker templates, as well as updated terminology maps for ICD-O-3 and SNOMED CT. Key revisions included the World Health Organization Blue Book updates, incorporation of the American Joint Committee on Cancer Cancer Staging System for Cervix Uteri, Version 9, and improvements to lymph node and margin sections.
The October 2020 release was the first to utilize the new Single Source Product tool, streamlining production of the cancer protocols and electronic versions from a single database. The CAP is also looking to expand the use of protocol-driven standardized reporting beyond cancer through collaboration with the PERT, Autopsy, and Cytopathology committees, as well as other committees and stakeholders.
The CAP continued to build upon its vendor engagement program through initiation of a new virtual program in 2020. This program shines a renewed focus on real-time laboratory information system (LIS) software testing, validation of cancer protocol implementation and functionality, expanded committee member collaboration, and ongoing vendor education. The CAP engages six major vendors in this program, helping to ensure that pathologists can efficiently report on their cancer cases no matter which LIS vendor they use in their workflow. As more than 6,400 pathologists are now licensed to use the vendor integrated cancer protocols for diagnostic cancer reporting, this vendor engagement program has become an essential part of CAP customer service.
The CAP continued work on grants from the Centers for Disease Control and Prevention and the California Department of Public Health to further address cancer reporting standardization, structure, and transmission using national health information technology standards. These initiatives support continued cancer protocol product development, including technical and functional improvements, pathologist and cancer registrar educational activities, and promotion of downstream data usage for quality reporting and surveillance activities. The PERT and Cancer Committees and staff penned four articles in 2020 providing a review of the value and benefits of standardized, structured cancer reporting, with publication anticipated in 2021.
Cancer Reporting Today Prepares for Evolution Tomorrow
In 2020, members of the Cancer and Pathology Electronic Reporting (PERT) Committees led the release of 98 revised cancer protocols and biomarker templates, as well as updated terminology maps for ICD-O-3 and SNOMED CT.
Key revisions included the World Health Organization Blue Book updates, incorporation of the American Joint Committee on Cancer Cancer Staging System for Cervix Uteri, Version 9, and improvements to lymph node and margin sections.
The October 2020 release was the first to utilize the new Single Source Product tool, streamlining production of the cancer protocols and electronic versions from a single database. The CAP is also looking to expand the use of protocol-driven standardized reporting beyond cancer through collaboration with the PERT, Autopsy, and Cytopathology committees, as well as other committees and stakeholders.
The CAP continued to build upon its vendor engagement program through initiation of a new virtual program in 2020. This program shines a renewed focus on real-time laboratory information system (LIS) software testing, validation of cancer protocol implementation and functionality, expanded committee member collaboration, and ongoing vendor education. The CAP engages six major vendors in this program, helping to ensure that pathologists can efficiently report on their cancer cases no matter which LIS vendor they use in their workflow. As more than 6,400 pathologists are now licensed to use the vendor integrated cancer protocols for diagnostic cancer reporting, this vendor engagement program has become an essential part of CAP customer service.
The CAP continued work on grants from the Centers for Disease Control and Prevention and the California Department of Public Health to further address cancer reporting standardization, structure, and transmission using national health information technology standards. These initiatives support continued cancer protocol product development, including technical and functional improvements, pathologist and cancer registrar educational activities, and promotion of downstream data usage for quality reporting and surveillance activities. The PERT and Cancer Committees and staff penned four articles in 2020 providing a review of the value and benefits of standardized, structured cancer reporting, with publication anticipated in 2021.
Evidence-Based Guidelines Strengthen Laboratory Quality
The CAP’s Pathology and Laboratory Quality Center for Evidence-Based Guidelines (the Center) and the members who lead it continued to drive excellence in laboratory quality with the release of three guidelines in 2020.
Collaborating with eight other professional societies, the Center’s “Collection and Handling of Thoracic Small Biopsy and Cytology Specimens for Ancillary Studies” provides recommendations covering both malignant and nonmalignant specimens. Using a multidisciplinary expert panel of pathologists, pulmonologists, and radiologists, the guideline models the collaboration needed to provide treating physicians with valuable diagnostic, predictive, and prognostic information.
To update the 2010 Guideline Recommendations for Immunohistochemical (IHC) Testing of Estrogen and Progesterone Receptors (ER/PgR) in Breast Cancer, the Center partnered again with the American Society of Clinical Oncology. The guideline advances the specialty by addressing cases with low ER expression.
And finally, working with the American Society for Clinical Pathology and the American Society of Hematology, the Center developed its newest guideline, “Laboratory Workup of Lymphoma in Adults.”
With at least three more guidelines slated for 2021, the Center is committed to advancing the specialty and raising the profile of pathologists by working collectively with other clinical and laboratory professional societies.
Evidence-Based Guidelines Strengthen Laboratory Quality
The CAP’s Pathology and Laboratory Quality Center for Evidence-Based Guidelines (the Center) and the members who lead it continued to drive excellence in laboratory quality with the release of three guidelines in 2020.
Collaborating with eight other professional societies, the Center’s “Collection and Handling of Thoracic Small Biopsy and Cytology Specimens for Ancillary Studies” provides recommendations covering both malignant and nonmalignant specimens. Using a multidisciplinary expert panel of pathologists, pulmonologists, and radiologists, the guideline models the collaboration needed to provide treating physicians with valuable diagnostic, predictive, and prognostic information.
To update the 2010 Guideline Recommendations for Immunohistochemical (IHC) Testing of Estrogen and Progesterone Receptors (ER/PgR) in Breast Cancer, the Center partnered again with the American Society of Clinical Oncology. The guideline advances the specialty by addressing cases with low ER expression.
And finally, working with the American Society for Clinical Pathology and the American Society of Hematology, the Center developed its newest guideline, “Laboratory Workup of Lymphoma in Adults.”
With at least three more guidelines slated for 2021, the Center is committed to advancing the specialty and raising the profile of pathologists by working collectively with other clinical and laboratory professional societies.
Evidence-Based Guidelines Strengthen Laboratory Quality
The CAP’s Pathology and Laboratory Quality Center for Evidence-Based Guidelines (the Center) and the members who lead it continued to drive excellence in laboratory quality with the release of three guidelines in 2020.
Collaborating with eight other professional societies, the Center’s “Collection and Handling of Thoracic Small Biopsy and Cytology Specimens for Ancillary Studies” provides recommendations covering both malignant and nonmalignant specimens. Using a multidisciplinary expert panel of pathologists, pulmonologists, and radiologists, the guideline models the collaboration needed to provide treating physicians with valuable diagnostic, predictive, and prognostic information.
To update the 2010 Guideline Recommendations for Immunohistochemical (IHC) Testing of Estrogen and Progesterone Receptors (ER/PgR) in Breast Cancer, the Center partnered again with the American Society of Clinical Oncology. The guideline advances the specialty by addressing cases with low ER expression.
And finally, working with the American Society for Clinical Pathology and the American Society of Hematology, the Center developed its newest guideline, “Laboratory Workup of Lymphoma in Adults.”
With at least three more guidelines slated for 2021, the Center is committed to advancing the specialty and raising the profile of pathologists by working collectively with other clinical and laboratory professional societies.
CAP Monitors Technology Advances and their Pandemic Uses
Changes in technology and their impact on pathology and laboratory medicine are constant. Committee members within the CSA structure are ever vigilant to track, prepare, and educate regarding these impacts. To do so, committee members must assess the best way to share information broadly and design resources to aid the pathology and laboratory medicine community.
In 2020, the CAP continued efforts in positioning itself as a resource for artificial intelligence (AI) in pathology. The CSA’s AI in Anatomic Pathology work group is providing guidance for CAP leadership on the status of AI in anatomic pathology and potential opportunities for the organization. In addition, the Informatics Committee launched the first CAP webpage dedicated to AI.
With the CMS-granted remote sign-out waiver necessitated by the COVID-19 pandemic, members of the Digital and Computational Pathology and Informatics committees developed a robust and highly utilized FAQ resource for pathologists and laboratories to follow as they implement remote sign-out capabilities. The Informatics Committee continued to work with CAP Advocacy on developing statements to regulatory agencies, with the goal of making laboratories’ reporting requirements less burdensome during the pandemic. The committee continues to stay engaged and develop resources as reporting requirements evolve.
CAP Monitors Technology Advances and their Pandemic Uses
Changes in technology and their impact on pathology and laboratory medicine are constant. Committee members within the CSA structure are ever vigilant to track, prepare, and educate regarding these impacts. To do so, committee members must assess the best way to share information broadly and design resources to aid the pathology and laboratory medicine community.
In 2020, the CAP continued efforts in positioning itself as a resource for artificial intelligence (AI) in pathology. The CSA’s AI in Anatomic Pathology work group is providing guidance for CAP leadership on the status of AI in anatomic pathology and potential opportunities for the organization. In addition, the Informatics Committee launched the first CAP webpage dedicated to AI.
With the CMS-granted remote sign-out waiver necessitated by the COVID-19 pandemic, members of the Digital and Computational Pathology and Informatics committees developed a robust and highly utilized FAQ resource for pathologists and laboratories to follow as they implement remote sign-out capabilities. The Informatics Committee continued to work with CAP Advocacy on developing statements to regulatory agencies, with the goal of making laboratories’ reporting requirements less burdensome during the pandemic. The committee continues to stay engaged and develop resources as reporting requirements evolve.
CAP Monitors Technology Advances and their Pandemic Uses
Changes in technology and their impact on pathology and laboratory medicine are constant. Committee members within the Council on Scientific Affairs structure are ever vigilant to track, prepare, and educate regarding these impacts.
In 2020, the CAP continued efforts in positioning itself as a resource for artificial intelligence (AI) in pathology. The CSA’s AI in Anatomic Pathology work group is providing guidance for CAP leadership on the status of AI in anatomic pathology and potential opportunities for the organization. In addition, the Informatics Committee launched the first CAP webpage dedicated to AI.
With the CMS-granted remote sign-out waiver necessitated by the COVID-19 pandemic, members of the Digital and Computational Pathology and Informatics committees developed a robust and highly utilized FAQ resource for pathologists and laboratories to follow as they implement remote sign-out capabilities. The Informatics Committee continued to work with CAP Advocacy on developing statements to regulatory agencies, with the goal of making laboratories’ reporting requirements less burdensome during the pandemic. The committee continues to stay engaged and develop resources as reporting requirements evolve.
LIVING OUR QUALITY MISSION
23,176
laboratories using CAP PT
834
pathologists participating in on-site inspections*
7,778
CAP-accredited laboratories
*On-site inspections limited in 2020 due to COVID-19
LIVING OUR QUALITY MISSION
LIVING OUR QUALITY MISSION
23,176
laboratories using CAP PT
834
pathologists participating in on-site inspections*
7,778
CAP-accredited laboratories
*On-site inspections limited in 2020 due to COVID-19
