Laboratory Administration & Management of Pathology Practices

Inspection and accreditation processes

Laboratory inspection and accreditation



Last author update: 15 July 2022
Last staff update: 15 July 2022

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PubMed Search: Laboratory inspection and accreditation

Mai Thy Tran, M.D.
Lewis A. Hassell, M.D.
Page views in 2022: 207
Page views in 2023 to date: 65
Cite this page: Tran MT, Hassell LA. Laboratory inspection and accreditation. PathologyOutlines.com website. https://www.pathologyoutlines.com/topic/labadmininspectionaccreditation.html. Accessed February 3rd, 2023.
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

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 listYes NoN/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
Personnel
Laboratory computer services
Physical facility
Laboratory safety
Decision to pursue accreditation
  • Benefits of laboratory accreditation (J Med Biochem 2017;36:231):
    • Benefits to the laboratory:
      • Demonstrates competence of the laboratory
      • Assists lab employees in learning, developing a sense of pride in their work and in maintaining high standards
      • A tool to recognize laboratories worldwide
      • Ensure accurate patient diagnostics and efficiency of treatment
      • Better documentation of processes and responsibilities
      • Required for participation in payments from Center for Medicare / Medicaid Services
    • Benefit for patient:
      • Delivers a high quality of lab service
    • Benefits to the public:
      • Provides assurance of quality of results and related treatment choices
      • Assures public payments are used for quality testing
  • Costs or drawbacks to accreditation:
    • Administrative costs and effort to achieve compliance
    • Proficiency testing expenses
    • Inspection expenses and disruption of operations during inspection
    • Remediation of deficiencies may require added expense and time
Primary CLIA inspection
  • Background (Mil Med 2000;165:48):
    • 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)
    • Cost (CMS: CLIA Certificate Fee Schedule [Accessed 6 June 2022])
CAP laboratory accreditation program
  • Background (Arch Pathol Lab Med 1997;121:745):
    • Founded by a group of pathologists in 1946
    • 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
  • 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
      • Identify opportunities for improvement
      • Train staff by involving them in the problem solving process (Ann Lab Med 2017;37:365)
  • Stepwise Laboratory Improvement Process Towards Accreditation (SLIPTA):
  • The Joint Commission (StatPearls: The Joint Commission [Accessed 23 June 2022]):
    • Background:
      • 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
Lab inspection
  • 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
        • Provides them the opportunity to take a more active role in laboratory management (Acad Pathol 2017;4:2374289517699230)
        • Increases knowledge in laboratory QA management, resulting in better performance on the resident in service examination (RISE)
        • Helps residents prepare for board exams and future career as a lab director
        • Helps the department identify ongoing problems (Pract Lab Med 2019;16:e00123)
    • Peer inspection:
      • 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
    • Virtual and onsite inspection (see Diagrams)
Videos

CAP15189

UKAS accreditation

CAP accreditation


What is CLIA?

What is the Joint Commission?

Who is FDA?


CDC

CMS

Board review style question #1
What is the relationship between CAP and CLIA?

  1. All laboratories in the U.S. are required to be accredited first by CAP, followed by CLIA
  2. CAP has deemed status, which means that CAP can inspect on behalf of CLIA
  3. CLIA standards are more stringent than those of CAP, so most laboratories choose to be CAP accredited
  4. They are 2 entirely independent accreditation organizations
Board review style answer #1
B. CAP has deemed status, which means that CAP can inspect on behalf of CLIA

Comment Here

Reference: Laboratory inspection and accreditation
Board review style question #2
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?

  1. A corrective action plan must be included, along with the interim inspection results submitted to the accrediting agency
  2. Employees responsible for PT evaluation in that lab section should be disciplined or terminated
  3. Reporting this will automatically trigger an unannounced CLIA inspection
  4. The lab's accreditation status will be revoked
  5. 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

Comment Here

Reference: Laboratory inspection and accreditation
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