clia cap training

CLIA & CAP REGULATORY

TRAINING

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A few acronyms.. CLIA USC CFR CAP GLP GDP

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First, a few acronyms.. CLIA Clinical Laboratory Improvement

Amendments LAP Laboratory Accreditation Program

USC United States Code CFR Code of Federal Regulations CAP College of American Pathologists GLP Good Laboratory Practices GDP Good Documentation Practices

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CLIA 88

CLIA program

It started with CLIA

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A brief history (CLIA)CLIA began in the late 60's when problems arose in

the cytology laboratories that read PAP smears. The personnel in these laboratories were overworked and had a very high error rate. Many women suffered or died because the cytologists had missed the early stages of cancer on the PAP smears. In 1967, the Clinical Laboratory Improvement Amendment was passed (CLIA-67) and the first laboratory regulations were born. In 1988, a second amendment was passed (CLIA-88) but did not go into effect until 1992 when the new regulations were approved.

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UNITED STATES CODE TITLE 1 GENERAL PROVISIONS TITLE 2 THE CONGRESS TITLE 3 THE PRESIDENT… TITLE 21 FOOD AND DRUGS (Part 11 & Part

58 GLP)

… TITLE 42 THE PUBLIC HEALTH AND

WELFARE

(CLIA - Part 493)

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?CLIA 88

?

CLIA program

By whom do you think CLIA is administered?

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CMS administers CLIA

US Department of Health & Human Services

Et al...

Administration for Children and Families (ACF)

Agency forHealthcare Research and Quality (AHRQ)

Centers for Disease Control and Prevention (CDC)

Food and Drug Administration (FDA)

Centers for Medicare & Medicaid Services (CMS)

Administration on Aging (AoA)

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Centers for Medicare & Medicaid Services (CMS)

(It’s US gov’t – naturally there are more boxes..)

Center for Medicare Management

… and many moreCenter for Medicaid and State Operations

CMS regulates all laboratory testing (except research) performed on humans in the U.S. through the CLIA. In total, CLIA covers nearly 200,000 laboratory entities. The Division of Laboratory Services, within the Survey and Certification Group, under the Center for Medicaid and State Operations (CMSO) has the responsibility for implementing the CLIA Program.

HIPAACLIA

Survey and Certification Group

Division of Laboratory Services

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CMS approves other entities to inspect..

?

Centers for Medicare & Medicaid Services (CMS)

CLIA 88

US Dept of Health & Human Services (HHS)

CLIA program

approved

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APPROVED ACCREDITATION ORGANIZATIONS UNDER CLIA

AABB American Osteopathic Association American Society for Histocompatibility and

Immunogenetics COLA Joint Commission

College of American Pathologists (CAP)◦ 325 Waukegan Road◦ Northfield, Illinois 60093-2750◦ 1-800-323-4040

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What is CAP?◦ CAP Mission Statement: The College of American

Pathologists, the leading organization of board-certified pathologists, serves patients, pathologists, and the public by fostering and advocating excellence in the practice of pathology and laboratory medicine.

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More brief history (CAP)

◦ 1922: American Society of Clinical Pathologists (ASCP) established.

◦ 1936: American Board of Pathology (ABP) established.

◦ 1943: American Medical Association (AMA) recognizes pathology as the practice of medicine

◦ 1947: Organizational meeting of CAP Board of Governors

◦ 2003: Laboratory Accreditation Program (LAP) offers inspection checklists customized for individual labs

◦ 2005: Laboratory Accreditation Program (LAP) announces new initiatives including mandatory inspector training and unannounced inspections.

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18 CAP Checklists ANP Anatomic Pathology CHM Chemistry and

Toxicology CYG Cytogenetics CYP Cytopathology FLO Flow Cytometry FDT Forensic Urine Drug

Testing HEM Hematology &

Coagulation HSC Histocompatibility IMM Immunology

GEN Laboratory General

LSV Limited Service Laboratory

MIC Microbiology MOL Molecular Pathology POC Point-of-Care Testing RLM Reproductive

Laboratory TLC Team Leader

Assessment of Director & Quality

TRM Transfusion Medicine URN Urinalysis

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Sample: (1 of 265 audit questions from General Lab checklist)

GEN.43099 Phase II N/A YES NOIs downtime for maintenance scheduled to

minimize interruption of service? COMMENTARY:N/A REFERENCE: Valenstein P, et al. Laboratory

computer availability. A College of American Pathologists Q-Probes study of computer downtime in 422 institutions. Arch Pathol Lab Med. 1996;120:626-632.

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CAP LAP CAP’s LAP involves community inspections:

members inspect each other using the checklists maintained by CAP. Auditors are often from member companies rather than from CAP itself. Inspectors from CAP more often visit at non-US sites. Checklists are obtained from LAP by the inspecting team and reports returned to LAP.

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How does CAP affect AIT?

College of American Pathologists (CAP)

Centers for Medicare & Medicaid Services (CMS)

CLIA 88

US Dept of Health & Human Services (HHS)

CLIA program

approved

CAP Lab Accreditation Program

ParticipatingInspectors

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60 CAP questions categorized Access

Audit Trails Change Control - Hardware Change Control - Software Computer Facility Continuing Education Data Back-up Data Restoration Data Storage Data Restoration Data Transfer Disaster Recovery Document Practices Emergency Service Environment Facilities

HIPAA Lab Instruments Logical Security Networks Patient Data Patient Data; Change Control -

Software Power Procedures Reporting SDP Service Records System Maintenance System security Training; Change Control Validation; Change control -

hardware and software

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How does CAP affect AIT?

College of American Pathologists (CAP)

Your lab

Centers for Medicare & Medicaid Services (CMS)

CLIA 88

US Dept of Health & Human Services (HHS)

CLIA program

approved

CAP Lab Accreditation Program

ParticipatingInspectors

Certification!

checklists

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History of 21 CFR Part 11 The FDA has required pharmaceutical, biotech, and medical device companies

to validate their computerized systems since the mid-1980's under various current good manufacturing practice ("cGMP") regulations. The validation of computerized systems in FDA regulated industries has been evolving ever since. However, technology was outgrowing the existing regulations. These regulations could not accommodate paperless record systems. The old regulations kept industry from realizing the advances in efficiency, accuracy, and productivity that new technologies were allowing. In 1991, members of the pharmaceutical industry met with the agency to determine how they could accommodate paperless record systems. The ultimate result of this action was 21 CFR Part 11 ("Part 11"), which became effective on August 20, 1997.

To date 21 CFR Part 11 has been in effect for nearly four years. There was an official grace period of five months, and there are no grandfather provisions in the regulation. The current regulatory environment is one of ever broadening interpretation of federal law and harsher penalties by the FDA. On November 2, 1999, Abbott Laboratories announced it had reached an agreement with the FDA to enter into a consent decree. Under the terms of the consent decree, Abbott Laboratories agreed to a $100 million payment to the U.S. Government. This record FDA penalty seems to have signaled the start of increased regulatory pressure being applied by the FDA to the pharmaceutical industry. Since the record Abbott fine, Schering-Plough, Eli Lilly, and Pharmacia & Upjohn have all recently been issued harsh warnings by the FDA.

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