Guide-To-Accreditation Textes
Guide-To-Accreditation Textes
Guide-To-Accreditation Textes
org
Table of Contents
Application Process 8
Director Responsibilities 9
Our annually updated accreditation checklists provide a road map for running a
high-quality laboratory while simplifying the accreditation process. The checklists
are used by the laboratory to prepare for inspections and by the inspection team
as a guide to assess the overall quality of the laboratory and compliance with
CAP checklist requirements. CAP inspections are educational, not punitive. Our
unique, reciprocal, peer inspection model benefits both the laboratories being
inspected and the laboratories providing the inspection teams.
Only the CAP offers an engaging, dynamic, collaborative process that fosters an
environment of continuous improvement to ensure the highest quality patient
care.
What to expect by A laboratory inspection with a CAP-provided team occurs every two years. To
participating in the meet each laboratory’s unique needs, inspection methods may include in-person
CAP Laboratory
or virtual inspections, document review prior to or during the inspection, or some
Accreditation
Program? combination of these methods. In the years when an external inspection does
not occur, the laboratory performs a self-inspection using materials provided by
the CAP.
1 Request ▪ Fill out and submit the Request for Application* form at cap.org.
Application
*Note for International laboratories: you must be enrolled in CAP Proficiency
Testing (PT)/External Quality Assurance (EQA) for a minimum of six months
before requesting an application.
2 Review ▪ Check your email to access the link to the online application (look for “CAP
Welcome Kit Accreditation Application Available” in the email subject line).
▪ Review additional information enclosed with the application link on how to
get started with the accreditation process.
▪ Schedule an optional onboarding call with CAP staff who will guide you
through the next steps in the accreditation process and answer questions.
3 Complete ▪ Complete the accreditation application within 3 months from the day it
Application becomes available online**.
▪ Review the due date on the homepage after you log in.
▪ Monitor email reminders that the CAP will send out as the application due
date approaches.
▪ Work with the CAP staff on any follow-up questions during application
review.
**NEW – Laboratories now have the option to upload a preselected set of
documents for review by the inspectors ahead of the inspection date during their
application submission process.
5 Schedule ▪ Look for a letter in the mail (sent to the accreditation contact from your
Inspection Date laboratory) announcing the inspection team leader’s name and organization.
▪ Schedule*** the inspection date with the inspection team leader (the team
leader will contact the laboratory director to set the inspection date).
▪ Prepare for the initial inspection that will take place within 6 months after the
submission of the online application.
***Note: After the first inspection, all subsequent routine inspections for the
Laboratory Accreditation Program are unannounced.
For international laboratories and specialty accreditation programs, subsequent
routine inspections are announced.
All inspections are performed within the 90-day period preceding the
anniversary date.
6 Host Inspection ▪ If the inspection is in-person, expect the arrival of the inspection team who
Day will conduct the inspection with the same customized checklists that you
received earlier.
8 Support CAP ▪ Collaborate with the CAP technical specialist on any follow-up questions
Review of regarding submitted responses.
Responses
▪ Promptly respond to requests from the technical specialist to provide
additional documentation when needed to complete the review of deficiency
responses.
▪ Anticipate an accreditation decision within 75 days of the inspection date.
9 Receive ▪ Look for the laboratory’s Certificate of Accreditation by mail, to the attention
Certificate of of the laboratory director.
Accreditation
▪ Mark your calendar with anniversary date displayed on the certificate.
10 Perform Self- ▪ Receive materials from the CAP and conduct a self-inspection around the
Inspection and laboratory’s one-year anniversary date. Correct deficiencies identified
Maintain during the self-inspection and retain records of these activities.
Continuous
▪ Make changes in laboratory directorship, location, name/ownership, test
Compliance
menu, roles, and personnel by logging into e-LAB Solutions Suite at any
time.
▪ Enroll in or discontinue PT/EQA products when the test menu changes, if
needed, by contacting the CAP Customer Contact Center or visiting our
online store.
▪ Note that the accreditation cycle repeats every two years, starting with
completing the reapplication in Step 3, seven months prior to the two-year
anniversary date.
Director The CAP requires specific qualifications for the laboratory director, the person
Qualifications responsible for operation of the laboratory. Qualifications of the director may
differ based on the type and complexity of the testing performed. A laboratory
director must have an MD, DO, DPM, PhD, and must have the experience
necessary to meet personnel requirements as determined by the CAP. Refer
to the Laboratory Director Qualifications chart below for more detail.
Laboratory CAP requires that all high complexity testing personnel have earned at least a
Personnel minimum of an associate degree in a laboratory science or medical technology
Qualifications
from an accredited institution. Personnel performing moderately complex
testing must have earned a least a high school diploma or equivalent.
The laboratory must retain records that all testing personnel have satisfactorily
completed initial training on all instruments/methods applicable to their
designated job.
For international laboratories, the laboratory must enroll in all available CAP
PT/EQA a minimum of six months prior to requesting CAP application.
This time frame enables the international laboratory to become familiar with
the requirements necessary to obtain permits and any other documents
needed to receive PT/EQA shipments.
Key Components To meet CAP Laboratory Accreditation requirements, the laboratory must have
the following key documents/processes:
Additional The following products and documents are available from the CAP to assist
Resources laboratories in the process of preparing for accreditation as part of the non-
refundable accreditation application fee:
Cost of Accreditation Annual accreditation fees are based on the institution’s laboratory sections, list
of testing performed (activity menu), organization structure, and complexity.
Please note that accreditation fees do not include the cost of proficiency
testing/external quality assurance.
APPLICATION PROCESS
Overview The application process involves two steps: 1) Request for application; and 2)
Completion of the online application in Organization Profile by logging into e-
LAB Solutions Suite on cap.org.
Request for Download the Accreditation Request for Application form at cap.org.
Application
• Complete the form
• Submit via email, mail or fax (information provided on form)
• Include the one-time, nonrefundable application fee
- Credit card
- Wire transfer
- Check
What’s Next? After the Request for Application is processed by the CAP, the laboratory will
receive an email notification with instructions for accessing the online
Organization Profile through the CAP’s online resource (e-LAB Solutions Suite).
Online Application Once all tasks are completed in the laboratory’s Organization Profile, click on
the “Application Complete” button.
DIRECTOR RESPONSIBILITIES
What are the The director of a CAP-accredited laboratory is responsible for ensuring ongoing
Director’s compliance with the Standards for Laboratory Accreditation and implementing
Responsibilities?
the requirements of the accreditation checklists. The director must have the
qualifications and authority to fulfill these responsibilities effectively.
Who Is Responsible? The director of a CAP-accredited laboratory is responsible for ensuring ongoing
compliance with the Standards for Laboratory Accreditation and implementing
the requirements of the accreditation checklists.
High Complexity Testing 1. MD, DO, or DPM licensed to practice in the jurisdiction where the
laboratory is located (if required), and have one of the following:
- Certification in anatomic or clinical pathology, or both, by the
American Board of Pathology or American Osteopathic Board of
Pathology, or possess qualifications equivalent to those required
for certification**; or
- Have at least one year of laboratory training during medical
residency/fellowship; or
- Have at least two years of experience supervising high
complexity testing;
OR
2. Doctoral degree in a chemical, physical, biological, or clinical
laboratory science from an accredited institution, and have current
certification by a board approved by HHS***
Moderate Complexity 1. Qualified as in (1) above
Testing OR
- MD, DO, or DPM, licensed to practice in the jurisdiction where the
laboratory is located (if required) and have one of the following:
- At least 20 hours of continuing medical education credit hours in
laboratory medicine; or
- Equivalent training during medical residency/fellowship; or
- At least one year of experience supervising non-waived
laboratory testing
OR
2. Doctoral degree in a chemical, physical, biological, or clinical
laboratory science from an accredited institution with one of the
following:
- At least one year of experience supervising non-waived
laboratory testing; or
- Current certification by a board approved by HHS***
Provider Performed 1. MD or DO, or DPM, licensed to practice in the jurisdiction in which the
Microscopy Testing laboratory is located (if required)
Waived Testing 1. MD or DO, or DPM, licensed to practice in the jurisdiction in which the
laboratory is located (if required) OR
2. Doctoral degree in a chemical, physical, biological, or clinical
laboratory science from an accredited institution
Laboratories not subject to US regulations
All Testing Complexities 1. MD, DO licensed to practice in the jurisdiction where the laboratory is
located (if required) and have one of the following:
− Certification in anatomic or clinical pathology; or
i. For laboratories subject to US regulations, additional qualifications for grandfathered individuals and
for the subspecialty of oral pathology may be found in the CLIA regulation 42CFR493.1443(b)(6).
ii. If more stringent state or local regulations are in place for laboratory director qualifications, including
requirements for licensure, they must be followed.
iii. A single individual may direct no more than five laboratories (not including laboratories that perform
only waived testing) and may not direct more laboratories than permitted by national, federal, state (or
provincial), or local law.
*Additional qualifications for laboratory directors are defined in the checklists for the following types of
testing or services:
** Individuals qualifying as board-eligible must supply a letter or other equivalent record from the board
with their eligibility status.
*** A list of boards approved by the CMS for doctoral scientists may be found at:
https://www.cms.gov/Regulations-and-
Guidance/Legislation/CLIA/Certification_Boards_Laboratory_Directors
What is Document Document control is the management of all paper or electronic documents,
Control? including policies, procedures, and forms. A written document control system
outlines how all documents are initiated or revised, approved, utilized, reviewed,
retained, and discontinued.
Who is Responsible? The laboratory director who meets CAP director qualifications is responsible for
implementing and maintaining an effective document control program.
What is a Chemical A Chemical Hygiene Plan (CHP) includes procedures to protect employees
Hygiene Plan? from the health hazards of chemicals and keep exposures below specified
limits. All personnel involved in the laboratory must receive training on the CHP
and understand how it applies to their role.
What is a Laboratory Laboratory information systems (LIS) provide a database serving the
Information System? information needs of the laboratory by linking patient test results to the ordering
clinician/client, and to the patient’s medical record.
Who is Responsible? The laboratory director is responsible for ensuring communication of laboratory
data.
What is Test Method Prior to clinical use of each test, the laboratory is required to establish or verify
Validation and Test the test method performance specifications to ensure that the test is adequate
Method Verification?
to meets clients’ needs.
Analytical test method validation is the process used to confirm with objective
evidence that a laboratory-developed test (LDT) or modified FDA-cleared or
approved test delivers reliable results for the intended application. For
laboratories not subject to US regulations, this also includes modified tests
approved by an internationally recognized regulatory authority (eg, the
European Union's Conformité Européenne (CE) Marking).
Who is Responsible? The laboratory director or designee who meets CAP director qualifications is
responsible for ensuring each method performed is of sufficient scope and
scientifically valid. The director or designee documents final approval of the
validation or verification prior to the initiation of patient testing.
Key Components
Assessment of competency involves evaluation of the applicable elements of
competency by a qualified individual for each test system at the required
frequency.
Who Can Assess Individuals assigned to assess competency must have the appropriate
Competency? education and experience to evaluate the complexity of testing being assessed.
What is a Quality A QMS is a set of policies, processes, procedures, and resources designed to
Management ensure high quality in an organization’s services. A dynamic QMS enhances all
System?
activities that impact patient care, promoting quality and patient safety through
risk reductions and continuous improvement.
Overview Each laboratory must design and implement a QMS to include components that
accurately reflect the operations of the laboratory. The QMS must cover:
▪ A document that describes the overall framework of the QMS and the
patient care and client services offered by the laboratory.
▪ A process for identifying and recoding non-conforming events.
▪ A process for investigation of non-conforming events, including root
cause analysis for sentinel events.
▪ A system for monitoring key indicators of quality in the preanalytic,
analytic, and post analytic phases of testing and comparing
performance to laboratory-defined targets.
▪ A process for recording corrective and preventive actions taken for
non-conforming events, quality indicators that do not meet defined
targets, and evaluating the effectiveness of actions taken.
▪ A process for employees and patients to communicate quality and
safety concerns to management.
▪ A process to assess the implementation of the QMS at least annually
for effectiveness.
▪ An infrastructure for the quality management system, including
aspects such as a document control system.
Who is Responsible? The laboratory director is responsible for the implementation of the QMS with
assistance and involvement from the:
▪ Manager
▪ Supervisor
▪ Laboratory staff
▪ Non-laboratory staff (eg, hospital quality assurance coordinator or
safety and regulatory personnel)