College of American Pathologists

Last updated
College of American Pathologists
AbbreviationCAP
Type NGO
Legal status501(c)(6) Nonprofit
PurposePhysician Membership, Advocacy, Laboratory Improvement, and Laboratory Accreditation
HeadquartersNorthfield, Illinois
Membership
Approximately 19,000
President
Donald Karcher, MD, FCAP
CEO
Michael Fraser
Staff
Approximately 650
Website http://www.cap.org/

The College of American Pathologists (CAP) is a member-based physician organization founded in 1946 comprising approximately 18,000 board-certified pathologists. It serves patients, pathologists, and the public [1] by fostering and advocating best practices in pathology and laboratory medicine. [2]

Contents

It is the world's largest association composed exclusively of pathologists certified by the American Board of Pathology, [3] and is widely considered the leader in laboratory quality assurance. The CAP is an advocate for high-quality and cost-effective medical care. [4] The CAP currently inspects and accredits medical laboratories under authority from the Centers for Medicare & Medicaid Services. Their standards have been called "the toughest and most exacting in the medical business." [5] The CAP provides resources and guidance to laboratories seeking accreditation in programs for biorepositories, genomics, ISO 15189, and more. [6] In November 2008, Piedmont Medical Laboratory of Winchester, Virginia became the first laboratory in the United States [7] to be officially accredited under ISO 15189.

The CAP provides accreditation and proficiency testing to medical laboratories through its laboratory quality solutions programs. Early versions of proficiency testing—known as surveys—which laboratories use to help test and ensure accuracy, were first initiated in 1949. Laboratories first began receiving CAP accreditation in 1964, [8] and the organization was later given authority to accredit medical laboratories as a result of the Clinical Laboratory Improvement Amendments of 1988. [9]

The CAP publishes checklists containing requirements pertaining to the performance of laboratory tests. The All Common Checklist (COM) contains a core set of requirements that apply to all areas performing laboratory tests and procedures. [10] Some requirements exist in both the COM checklist and in a discipline-specific checklist, but with a different checklist note that has a more specific requirement. In these situations, the discipline-specific requirement takes precedence over the COM requirement. [10] The COM checklist also describes the requirements for analytical validation/verification of the method performance specifications (i.e. accuracy, precision, reportable range) that laboratories must perform for each test, method, or instrument system before use in patient testing. [10] CAP has also created programs that look at the frequency of errors throughout laboratory testing, including Q-Probes and Q-Tracks. [11] CAP's Q-Probes studies aim to describe errors at different stages of testing; pre-analytic, analytic, and post-analytic. [11] In order to reduce the frequency of errors occurring at the different stages of testing, performance measures have been put in place in order to improve patient safety. [11] CAP has created a database to record the error rates seen from more than 130 inter-laboratory studies. [12]

The CAP opened a Washington, DC, office in 1970 [8] and advocating for pathology in a legal and policy-oriented capacity remains a core mission of the organization, both through direct action and programs that connect pathologists to legislators. [13]

The CAP Foundation is the philanthropic arm of the organization and is classified as a 501(c)(3) charitable entity. Its flagship program, See, Test & Treat, partners with hospitals and clinicians to provide free cancer and HPV screening, as well as educational events, to underserved communities. The program served over 900 women in 2017. [14]

Minimum periods of retention

CAP [15] and Clinical Laboratory Improvement Amendments. [16] have written policies for the minimum period of that laboratories should keep laboratory records and materials, with some examples as follows:

Microscopy slidesHistology and non-forensic autopsy10 years [16]
Forensic autopsyIndefinite [16]
Cytology, fine needle aspiration10 years [15]
Cytology, apart from fine needle aspiration5 years [16]
Paraffin-embedded blocksNon-forensic2 [16] or 10 years [15]
ForensicIndefinite [16]
Requisition form and test reportPathology reports10 years [16]
Other2 years [16]
Blood bank recordsQuality control records5 years [15]
Donor and recipient records10 years [15]
Records of indefinitely deferred donorsIndefinite [15]
Wet tissuesUntil report is completed [16] or 2 weeks thereafter [15]
Proficiency testing records and quality management/quality control records2 years [16]
Discontinued procedures2 years [16]
Blood smears and other body fluid smears, microbiology slides (including Gram stains)7 days [15]
Flow cytometry plots10 years [15]

See also

Further reading

Related Research Articles

<span class="mw-page-title-main">Pathology</span> Study of the causes and effects of disease or injury, and how they arise

Pathology is the study of disease and injury. The word pathology also refers to the study of disease in general, incorporating a wide range of biology research fields and medical practices. However, when used in the context of modern medical treatment, the term is often used in a narrower fashion to refer to processes and tests that fall within the contemporary medical field of "general pathology", an area that includes a number of distinct but inter-related medical specialties that diagnose disease, mostly through analysis of tissue and human cell samples. Idiomatically, "a pathology" may also refer to the predicted or actual progression of particular diseases, and the affix pathy is sometimes used to indicate a state of disease in cases of both physical ailment and psychological conditions. A physician practicing pathology is called a pathologist.

<span class="mw-page-title-main">Anatomical pathology</span> Medical specialty

Anatomical pathology (Commonwealth) or anatomic pathology (U.S.) is a medical specialty that is concerned with the diagnosis of disease based on the macroscopic, microscopic, biochemical, immunologic and molecular examination of organs and tissues. Over the 20th century, surgical pathology has evolved tremendously: from historical examination of whole bodies (autopsy) to a more modernized practice, centered on the diagnosis and prognosis of cancer to guide treatment decision-making in oncology. Its modern founder was the Italian scientist Giovanni Battista Morgagni from Forlì.

<span class="mw-page-title-main">Forensic pathology</span> Medical speciality

Forensic pathology is pathology that focuses on determining the cause of death by examining a corpse. A post mortem examination is performed by a medical examiner or forensic pathologist, usually during the investigation of criminal law cases and civil law cases in some jurisdictions. Coroners and medical examiners are also frequently asked to confirm the identity of remains.

Transfusion medicine is the branch of medicine that encompasses all aspects of the transfusion of blood and blood components including aspects related to hemovigilance. It includes issues of blood donation, immunohematology and other laboratory testing for transfusion-transmitted diseases, management and monitoring of clinical transfusion practices, patient blood management, therapeutic apheresis, stem cell collections, cellular therapy, and coagulation. Laboratory management and understanding of state and federal regulations related to blood products are also a large part of the field.

The Clinical Laboratory Improvement Amendments (CLIA) of 1988 are United States federal regulatory standards that apply to all clinical laboratory testing performed on humans in the United States, except clinical trials and basic research.

<span class="mw-page-title-main">Clinical pathology</span> Medical specialty

Clinical pathology is a medical specialty that is concerned with the diagnosis of disease based on the laboratory analysis of bodily fluids, such as blood, urine, and tissue homogenates or extracts using the tools of chemistry, microbiology, hematology, molecular pathology, and Immunohaematology. This specialty requires a medical residency.

<span class="mw-page-title-main">Medical laboratory scientist</span> Medical professional who works in the laboratory

A Medical Laboratory Scientist (MLS) or Clinical Laboratory Scientist (CLS) or Medical Technologist (MT) performs diagnostic testing of blood and body fluids in clinical laboratories. The scope of a medical laboratory scientist's work begins with the receipt of patient or client specimens and terminates with the delivery of test results to physicians and other healthcare providers. The utility of clinical diagnostic testing relies squarely on the validity of test methodology. To this end, much of the work done by medical laboratory scientists involves ensuring specimen quality, interpreting test results, data-logging, testing control products, performing calibration, maintenance, validation, and troubleshooting of instrumentation as well as performing statistical analyses to verify the accuracy and repeatability of testing. Medical laboratory scientists may also assist healthcare providers with test selection and specimen collection and are responsible for prompt verbal delivery of critical lab results. Medical Laboratory Scientists in healthcare settings also play an important role in clinical diagnosis. An estimated 70% of medical decisions are based on laboratory test results and MLS contributions affect 95% of a health system's costs.

ISO 15189 Medical laboratories — Requirements for quality and competence is an international standard that specifies the quality management system requirements particular to medical laboratories. The standard was developed by the International Organisation for Standardization's Technical Committee 212. ISO/TC 212 assigned ISO 15189 to a working group to prepare the standard based on the details of ISO/IEC 17025:1999 General requirements for the competence of testing and calibration laboratories. This working group included provision of advice to medical laboratory users, including specifics on the collection of patient samples, the interpretation of test results, acceptable turnaround times, how testing is to be provided in a medical emergency, and the lab's role in the education and training of health care staff. While the standard is based on ISO/IEC 17025 and ISO 9001, it is a unique document that takes into consideration the specific requirements of the medical environment and the importance of the medical laboratory to patient care.

George D. Lundberg is an American board-certified pathologist and writer.

Public health laboratories (PHLs) or National Public Health Laboratories (NPHL) are governmental reference laboratories that protect the public against diseases and other health hazards. The 2005 International Health Regulations came into force in June 2007, with 196 binding countries that recognised that certain public health incidents, extending beyond disease, ought to be designated as a Public Health Emergency of International Concern (PHEIC), as they pose a significant global threat. The PHLs serve as national hazard detection centres, and forward these concerns to the World Health Organization.

<span class="mw-page-title-main">Veterinary pathology</span> Component of pathology that focuses on the application of veterinary science

Veterinary pathologists are veterinarians who specialize in the diagnosis of diseases through the examination of animal tissue and body fluids. Like medical pathology, veterinary pathology is divided into two branches, anatomical pathology and clinical pathology. Other than the diagnosis of disease in food-producing animals, companion animals, zoo animals and wildlife, veterinary pathologists also have an important role in drug discovery and safety as well as scientific research.

<span class="mw-page-title-main">Medical laboratory</span> Principles of management with special reference to medical science

A medical laboratory or clinical laboratory is a laboratory where tests are conducted out on clinical specimens to obtain information about the health of a patient to aid in diagnosis, treatment, and prevention of disease. Clinical medical laboratories are an example of applied science, as opposed to research laboratories that focus on basic science, such as found in some academic institutions.

<span class="mw-page-title-main">Cooperman Barnabas Medical Center</span> Hospital in New Jersey, United States

Cooperman Barnabas Medical Center (CBMC), formerly Saint Barnabas Medical Center (SBMC), is a 597-bed non-profit major teaching hospital located in Livingston, New Jersey. An affiliate of RWJBarnabas Health (formerly known as Barnabas Health and Saint Barnabas Health Care System), it is the oldest and largest nonprofit, nonsectarian hospital in New Jersey.

<span class="mw-page-title-main">National Accreditation Board for Testing and Calibration Laboratories</span> Indian accreditation organisation

National Accreditation Board for Testing and Calibration Laboratories (NABL) provides accreditation to Conformity Assessment Bodies (Laboratories) in India. NABL Schemes include Accreditation (Recognition) of Technical competence of testing, calibration, medical testing laboratories, Proficiency testing providers (PTP) & Reference Material Producers (RMP) for a specific scope following ISO/IEC 17025, ISO 15189, ISO/IEC 17043 & ISO 17034:2016 Standards. It has Mutual Recognition Arrangement (MRA) with Asia Pacific Accreditation Cooperation (APAC), International Laboratory Accreditation Cooperation (ILAC).

Barcode technology in healthcare is the use of optical machine-readable representation of data in a hospital or healthcare setting.

A pathologists’ assistant (PA) is a physician extender whose expertise lies in gross examination of surgical specimens as well as performing forensic, medicolegal, and hospital autopsies.

Specimen provenance complications (SPCs) result from instances of biopsy specimen transposition, extraneous/foreign cell contamination or misidentification of cells used in clinical or anatomical pathology. If left undetected, SPCs can lead to serious diagnostic mistakes and adverse patient outcomes.

Valerie A. Fitzhugh is an American pathologist and Associate Professor of Pathology, Immunology, and Laboratory Medicine at Rutgers New Jersey Medical School as well as an Associate Professor of Pathology and Laboratory Medicine at Rutgers Robert Wood Johnson Medical School. She is the Chair of the Department of Pathology, Immunology, and Laboratory Medicine at Rutgers and the Chair at Rutgers Robert Wood Johnson Medical School as well. Fitzhugh specializes in bone and soft tissue pathology and cytopathology and has made the Pathology Power List by The Pathologist Magazine in 2016, 2018, and 2019. She is involved in educating pathology residents and she actively uses social media as a platform for education and for improving diversity in pathology and she also studies how effective social media is at enhancing accurate communication of science and medicine.

The Association for Molecular Pathology is a professional association of individuals serving patients through molecular diagnostics testing. Founded in 1995, the Association has more than 2,800 members in over 50 countries.

Validation and verification are procedures that ensure that medical devices fulfil their intended purpose. Validation or verification is generally needed when a health facility acquires a new device to perform medical tests.

References

  1. "Annual Report - College of American Pathologists". Annual Report - College of American Pathologists. Retrieved 2020-10-05.
  2. "College Of American Pathologists (CAP) Releases 2016 Annual Report Detailing Progress With Improving Patient Care, Advocating For The Specialty, And Advancing Quality" . Retrieved 2018-03-20.
  3. "American Board of Pathology". www.abpath.org.
  4. "CAP - Advocacy - NEWS - Oklahoma Spine". Archived from the original on 2012-01-20. Retrieved 2012-08-10.
  5. "16 Jul 1989, 28 - The Signal at Newspapers.com". Newspapers.com. Retrieved 2018-11-08.
  6. "The Joint Commission and SGS Now Offer Hospitals Coordinated Program for Medicare Accreditation and ISO 9001 Certification | Dark Daily". www.darkdaily.com. 16 March 2012. Retrieved 2018-11-08.
  7. "First Two Laboratories in U.S. Earn ISO 15189 Accreditation". February 13, 2009.
  8. 1 2 "Historical Timeline | College of American Pathologists". College of American Pathologists. College of American Pathologists. 2018-11-08. Retrieved 2018-11-08.{{cite web}}: CS1 maint: others (link)
  9. "Announcement of the Re-Approval of the College of American Pathologists (CAP) as an Accreditation Organization Under the Clinical Laboratory Improvement Amendments of 1988". Federal Register. 2015-03-27. Retrieved 2018-11-08.
  10. 1 2 3 "All Common Checklist, CAP Accreditation Program" (PDF). www.cap.org. College of American Pathologists. 2015-07-28. Archived from the original (PDF) on 31 January 2018. Retrieved 30 January 2018.
  11. 1 2 3 Howanitz, Peter J. (2005-10-01). "Errors in Laboratory Medicine: Practical Lessons to Improve Patient Safety". Archives of Pathology & Laboratory Medicine. 129 (10): 1252–1261. doi:10.5858/2005-129-1252-EILMPL. ISSN   1543-2165. PMID   16196513.
  12. Wagar, Elizabeth A.; Tamashiro, Lorraine; Yasin, Bushra; Hilborne, Lee; Bruckner, David A. (2006-11-01). "Patient Safety in the Clinical Laboratory: A Longitudinal Analysis of Specimen Identification Errors". Archives of Pathology & Laboratory Medicine. 130 (11): 1662–1668. doi:10.5858/2006-130-1662-PSITCL. ISSN   1543-2165. PMID   17076528.
  13. "11 Dec 2005, Page 124 - The Los Angeles Times at Newspapers.com". Newspapers.com. Retrieved 2018-11-08.
  14. "Annual Report - College of American Pathologists". Annual Report - College of American Pathologists. Retrieved 2018-11-08.
  15. 1 2 3 4 5 6 7 8 9 "CAP Policy Manual - Policy PP. Minimum Period of Retention of Laboratory Records and Materials" (PDF). CAP.org. Adopted August 1995. Revised September 2020
  16. 1 2 3 4 5 6 7 8 9 10 11 "42 CFR § 493.1105 - Standard: Retention requirements". Cornell Law School. [68 FR 3703, Jan. 24, 2003; 68 FR 50723, Aug. 22, 2003]