Cite this page: Tran MT, Hassell LA. Laboratory inspection and accreditation. PathologyOutlines.com website. https://www.pathologyoutlines.com/topic/labadmininspectionaccreditation.html. Accessed January 11th, 2025.
Definition / general
Laboratory accreditation refers to a stamp of approval granted to a laboratory by an external entity, intended to assure quality of processes and personnel; it generally indicates that the lab meets the standards established by the accrediting agency
Laboratory inspection refers to the processes by which an accrediting entity verifies that the laboratory has met their requirements
Essential features
Standards of performance and operation are specified by the accrediting agency
Transparency implies that the agency and the laboratory engage in good faith, without collusion or secondary motive, with the goal to improve the quality of patient care offered
Time frames for application, inspection and accreditation are defined and understood
Terminology
LAP: laboratory accreditation program
Driven by standards of established processes and personnel; provides an externally based affirmation of laboratory performance and quality
Verified by inspection and performance comparison with other labs
Accrediting entity may be local, regional, national or international
ISO: International Organization for Standardization, a federation of national standards bodies including more than 160 countries, providing standards and specifications that cover a wide array of fields, from healthcare to manufacturing, security and the environment
CAP: College of American Pathologists, a professional association of pathologists which also provides lab accreditation services, proficiency materials and other activities that aim to improve and assure quality laboratory services to patients
CLIA: Clinical Laboratory Improvement Amendments, a section of U.S. law governing laboratory activities in the U.S., the purpose of which is to ensure quality laboratory testing (Mil Med 2000;165:48)
A CLIA certificate is required to perform testing on patients covered under the U.S. Medicare or Medicaid programs
CLIA certificates are proof of registration and require regular inspection and accreditation to be recognized
JC: Joint Commission, an accrediting agency for hospitals and healthcare organizations with deemed status for inspection of laboratories within such entities
CDC: Centers for Disease Control and Prevention
FDA: Food and Drug Administration, the U.S. agency with regulatory oversight of food, drugs and medical devices sold in the U.S.; it thus has oversight of many laboratory devices or testing platforms or processes used in the U.S. and sets the provisions under which they can be marketed
CMS: Center for Medicare and Medicaid Services, the payer for a large portion of the U.S. populace's health expenses
COLA: Commission on Office Laboratory Accreditation
UKAS: United Kingdom Accreditation Service
Deemed status: in U.S. laboratory accreditation, an inspection and accreditation entity has deemed status when their inspections are deemed to be equivalent to those of a primary regulatory body (such as CLIA or FDA), and therefore the lab need not be dually inspected by the primary regulatory agency
Deficiencies: items identified during the inspection process that need the attention of the laboratory, as they do not meet the standards of the accrediting agency
Phase 1 deficiencies are items that need to be addressed but may require long term improvements and do not pose an imminent risk to patient care or quality
Phase 2 deficiencies are items that must be corrected prior to receiving accreditation
Diagrams / tables
Contributed by Mai Thy Tran, M.D.
How checklist items are developed at CAP
Images hosted on other servers:
CAP accreditation process and timeline
CAP virtual and onsite inspection
Options for lab accreditation
CLIA
CAP
ISO 15189
COLA
JC
Purpose
Assure accuracy, reliability of test results according to federal standards that are overseen by 3 federal agencies (FDA, CDC, CMS)
Work at state level (state department of health)
Confirm the laboratory is in compliance with CLIA standards
Intense proficiency testing monitoring
Focused on CAP checklists
Optional in U.S.
Laboratory needs to sustain integrated quality management system (QMS) across all parts of organization
International expert consensus
Effectiveness of corrective action
Create systems that will prevent problems and reduce errors
Help your clinical laboratory meet CLIA and COLA requirements
Laboratories within JC health care organizations to be accredited by COLA to meet JC requirements
Is ISO 9001:2015
Confirm the laboratory is in compliance with CLIA regulation
Leading Laboratory designation, help laboratories achieve high quality outcomes, assure professional development, engage in trusted leadership and earn laboratory visibility
Inspector
CLIA inspectors (usually state department of health personnel)
Peer inspections by CAP inspectors and self inspections by staff
Certified inspectors
COLA surveyor (most often medical technologists)
JC surveyors
Accreditation cycle
2 years
2 years
3 years
2 years
2 years
Frequency of inspection
Every 2 years
Peer inspections every 2 years and annual self inspection
Annual internal audit
Every 2 years
Every 2 years
Cost
One time registration fee of $100; certification fee based on the annual testing volume and number of laboratory specialties performed ($180 - $9,500 / year)
Nonrefundable one time application fee of $1,200 (domestic) or $1,500 (international); CAP's annual accreditation fee is determined based on the laboratory's size and complexity
The fee schedule will include an annual base fee and fees for assessments; cost will vary depending on the size and scope of the lab
Enrollment fee and certification fee
Onsite survey fee; annual fee based on the number of specialties the lab provides and the number of locations
Example for lab accreditation check list
Lab accreditation - general check list
Yes
No
N/A
Specimen collection, handling and reporting
Proficiency testing
Quality management
Result reporting and referral of testing
Quality of water and glassware washing
Reagents (storage, handling, labeling)
Instrument and equipment maintenance / function check
Federal regulations for U.S. based clinical laboratories were enacted in 1988, in response to crisis, primarily in the Pap testing industry
Provide industry standards for testing of human samples for diagnostic purposes
FDA, CDC, CMS are responsible for ensuring compliance
Aim:
Assure accuracy and reliability of test results
Give certificate of accreditation (COA) to a laboratory that performs moderate or high complexity testing, and attains accreditation by an organization approved by CMS
Give certificate for provider performed microscopy procedures to the laboratory in which staff performs specific microscopy procedures during a patient's visit
Give certificate of waiver (COW) to a laboratory that performs only waived tests
Give certificate of compliance (COC) to a laboratory that performs moderate or high complexity testing; CMS designee performs inspection to determine that the laboratory is compliant with all applicable CLIA requirements
Inspections: conducted by state departments of health or less commonly, by CMS or FDA (unannounced inspections)
Fosters and advocates for excellence in pathology laboratories
Accredits approximately 8,000 laboratories in over 50 countries
Revolves around 4 standards: evaluation of the laboratory director, physical facility and safety, quality control and performance improvement, inspection requirements
Becoming CAP accredited means that the lab meets all requirements of CLIA (deemed status)
Aim:
Maintain accuracy of test results
Offer professional development and learning opportunities for laboratory staff
Quality process improvements through (required) PT / EQA programs
Support the laboratory management to improve laboratory services
Risk reduction
Lab becomes more marketable in the industry
Inspections:
Conducted (biannually) by volunteer teams of peers who also work in and operate laboratories and by self inspection using standard checklists adapted to the individual laboratory's activity menu
Other accrediting entities
American Association of Blood Banks (AABB) serves blood collection and transfusion services of all sizes; it provides peer inspectors and standards unique to the blood collection, processing and administration process
Blood bank services are also subject to FDA inspections since they deal with a product administered to patients (Arch Pathol Lab Med 1999;123:468)
American Society for Histocompatibility and Immunogenetics (ASHI) offers inspection and accreditation services to laboratories performing HLA serotyping, DNA typing, next generation sequencing, flow cytometry, engraftment monitoring and some crossmatch, antibody identification and ABO / Rh typing services in support of organ transplantation and related processes
International laboratory accreditation program
International Organization for Standardization 15189 (ISO 15189):
Background:
First published in 2003 and revised in 2012
Originated from the requirements of the International Organization for Standardization / International Electrotechnical Commission (ISO / IEC) 170254 and the quality management system requirements of ISO 9001 (Arch Pathol Lab Med 2018;142:1047)
Verifies that medical laboratories meet both the technical competencies and management system requirements
By 2015, approximately 60 countries have made ISO 15189 a part of their mandatory medical laboratory accreditation requirements
U.S. laboratories must first be accredited in the CAP LAP before seeking accreditation to the ISO 15189 standard with CAP 15189
CAP 15189 is a quality management program the CAP designed for accreditation to ISO 15189
Purpose:
Create systems aimed at preventing problems and reducing errors
Nonprofit, global entity, with various accreditation / certification programs, that is recognized and relied upon by many states
JC collaborated with ASCP to develop the Leading Laboratories, a unique designation exclusively for Joint Commission accredited laboratories
Accrediting hospital laboratory services since 1979 and freestanding laboratories since 1995
22,000 accredited healthcare systems in the U.S. and 1,000 healthcare organizations in over 70 countries have achieved the gold seal of approval as JCI accredited organizations; over 1,500 laboratories are accredited by the JC
Satisfies requirements of systems participating in providing care for Medicare and Medicaid patients
Aim:
Process of accreditation starts with the onsite survey with JC standards
Provides advisory services, education and training programs which are focused on leadership, quality improvement, patient safety
2 year accreditation cycle with unannounced inspections by nonvolunteer JC surveyors (not peer inspectors)
Cost:
Onsite survey fee
Annual fee, based on the number of specialties that the lab provides and the number of locations
The United Kingdom Accreditation Service (UKAS):
Background:
Not for profit organization; sole national accreditation body for the United Kingdom
Recognized and appointed by the government to assess against agreed standards for organizations and provide services for certification, testing, inspection and calibration; UKAS accreditation confirms the competence and performance capacity of these organizations
UKAS is a signatory, along with other recognized accreditation bodies from around the world, to multilateral agreements for the purposes of mutual recognition through the European cooperation for Accreditation (EA), the International Accreditation Forum (IAF) and the International Laboratory Accreditation Cooperation (ILAC)
Aim:
UKAS accredits medical laboratories with the ISO 15189 standards
Quality standard for imaging (QSI), medical physics and clinical engineering (MPACE) are addressed to BS 70000, point of care testing to ISO 22870, proficiency testing against the requirement of ISO / IEC 17043
Provides reassurance of the quality of a diagnostic service to patients, commissioners and healthcare providers
Application and preparation for accreditation
Select accrediting agency
Review laboratory operations in light of accreditation standards and published checklists
Ensure that the laboratory quality management and procedures are effective (PT testing, quality systems, error detection systems, etc.) (J Med Biochem 2017;36:231)
Perform a mock inspection (self or otherwise)
Submit application and await inspection
After inspection, inspectors will review areas of weakness, identify problems and further evaluate lab's corrective action and resolution
A review or audit of procedures and records, observations of operations, interviews with workers and evaluation of work product that may be:
Announced inspections (depending on agency): initial and biennial recertifications
Unannounced inspections: routine process or as a result of complaints and follow up inspections (CLIA will generally conduct a number of validation inspections following inspection / accreditation by a deemed agency)
Types of lab inspection:
Self inspection:
Purpose: ongoing compliance with the checklist requirement
Lab improvement and better patient care
Prepare for the next unannounced onsite inspection
Provides benefits to employees and trainees, including pathology residents
Process exposes the residents to operational issues and corrective actions
Benefits both the inspected laboratories and the laboratories providing the inspection teams
Benefits for pathologist / director led inspection teams:
All CAP inspectors are required to successfully complete training on the CAP website
Training provides in depth instruction on how inspections should be conducted
Allows laboratorians to interact with their coworkers and industry colleagues in different labs
Allows laboratorians to observe and learn from a variety of laboratory environments, while exchanging best practices to ensure high quality patient safety and care
While conducting an interim self inspection of your laboratory, you discover a phase 2 deficiency in that proficiency testing (PT) was not conducted for 2 consecutive quarters for several analytes reported by your laboratory. Which of the following is true regarding this event?
A corrective action plan must be included, along with the interim inspection results submitted to the accrediting agency
Employees responsible for PT evaluation in that lab section should be disciplined or terminated
Reporting this will automatically trigger an unannounced CLIA inspection
The lab's accreditation status will be revoked
The lack of PT results for the period means all analyte results must be invalidated
Board review style answer #2
A. A corrective action plan must be included, along with the interim inspection results submitted to the accrediting agency
