CLIA & CAP REGULATORY

TRAINING
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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It started with CLIA

CLIA
88

CLIA program

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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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By whom do you think CLIA is administered?

CLIA ?
88

CLIA program

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CMS administers CLIA
US Department of
Health & Human Services

Administration for Centers for Disease

Administration on
Children and Agency for Control and Prevention
Aging (AoA)
Families (ACF) Healthcare Research (CDC)
and Quality (AHRQ)

Centers for Medicare & Food and Drug Et al...

Medicaid Services (CMS) Administration (FDA)

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 (It’s US gov’t – naturally there are more
boxes..)
Centers for Medicare & HIPAA
Medicaid Services (CMS) CLIA

Center for Center for Medicaid

Medicare Management and State Operations
… and many more

Survey and Certification Group
Division of Laboratory Services
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.

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CMS approves other entities to inspect..

US Dept of Health &

Human Services (HHS)
CLIA Centers for Medicare &
88 Medicaid Services (CMS)

CLIA program

ed
? approv

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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 NO

Is 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?
US Dept of Health &
Human Services (HHS)
CLIA Centers for Medicare &
88 Medicaid Services (CMS)

CLIA program

ed
College of American approv
CAP Lab Accreditation
Pathologists (CAP)
Program

Participating
Inspectors

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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?
US Dept of Health &
Human Services (HHS)
CLIA Centers for Medicare &
88 Medicaid Services (CMS)

CLIA program

ed
College of American approv
CAP Lab Accreditation
checkl
i s ts Pathologists (CAP)
Program

Participating Your lab Certification!

Inspectors

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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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