The Accreditation Process

(ACC)

Notices
The Joint Commission Connect® extranet site is the primary means of communication by
The Joint Commission. Any required notices to be given to an organization shall be sent
to the organization via the organization’s secure Joint Commission Connect extranet site.

ACC Chapter Contents

This chapter introduces the Joint Commission’s accreditation process, beginning with
general information about eligibility for accreditation and the application process,
accreditation policies, and types of surveys. Details are then provided on what
organizations can expect before, during, after, and between accreditation surveys.
Finally, the chapter ends by listing the accreditation decision rules and outlining review
and appeal procedures. This outline provides a way to easily navigate the chapter and
find information quickly.

Notices......................................................................................................................... ACC–1
ACC Chapter Contents............................................................................................. ACC–1
Overview...................................................................................................................... ACC–3
General Eligibility Requirements...................................................................... ACC–3
Scope of Accreditation Surveys......................................................................... ACC–4
Accreditation Policies ................................................................................................. ACC–4
Tailored Survey Policy....................................................................................... ACC–4
Organizational and Functional Integration...................................................... ACC–6
Multiorganization Option................................................................................. ACC–9
Concurrent Survey Option ............................................................................... ACC–9
Contracted Services.......................................................................................... ACC–10
Proficiency Testing Monitoring ..................................................................... ACC–10
Initial Surveys................................................................................................... ACC–11
Information Accuracy and Truthfulness Policy............................................ ACC–12
Good Faith Participation in Accreditation/Certification............................. ACC–14

Shading indicates a change effective July 1, 2024, unless otherwise noted in the What's New.
CAMLAB Update 1, July 2024 ACC – 1
E-dition July 1, 2024, Release
◤Comprehensive Accreditation Manual for Laboratory and Point-of-Care Testing

Public Information Policy............................................................................... ACC–15

Process for Responding to a Complaint ........................................................ ACC–16
Before the Survey ...................................................................................................... ACC–16
An Organization’s Secure Joint Commission Connect Extranet Site ............. ACC–16
Role of the Account Executive....................................................................... ACC–17
Electronic Application for Accreditation
(E-App)....................................................................................................... ACC–18
Accreditation/Certification Contract and Business Associate Agreement.. ACC–19
Annual and Survey Fees .................................................................................. ACC–20
During the Survey..................................................................................................... ACC–21
Survey Notification.......................................................................................... ACC–22
Initial and Full Survey Team Composition ................................................... ACC–24
Survey Agenda.................................................................................................. ACC–25
Tracer Methodology........................................................................................ ACC–27
Immediate Threat to Health or Safety ........................................................... ACC–30
Summary of the Accreditation Reports ......................................................... ACC–33
After the Survey ........................................................................................................ ACC–34
The Scoring Process......................................................................................... ACC–34
Evidence of Standards Compliance (ESC) Process ...................................... ACC–39
Accreditation Award Display and Use........................................................... ACC–43
Between Accreditation Surveys................................................................................ ACC–44
Duration of Accreditation Award .................................................................. ACC–45
Continuous Compliance................................................................................. ACC–45
Intracycle Monitoring (ICM) ......................................................................... ACC–45
Focused Standards Assessment (FSA) ............................................................ ACC–46
Sentinel Event Follow-up ................................................................................ ACC–48
Notifying The Joint Commission About Organization Changes................ ACC–49
Accreditation Status of Organizations That
Cease Services After a Disaster.................................................................. ACC–51
Accreditation Status of Organizations That Cease Services or Do Not Have
Patients for a Period of Time.................................................................... ACC–53
Reentering the Accreditation Process ............................................................ ACC–53
Additional Surveys........................................................................................... ACC–53

Shading indicates a change effective July 1, 2024, unless otherwise noted in the What's New.
ACC – 2 CAMLAB Update 1, July 2024
E-dition July 1, 2024, Release
 The Accreditation Process◥

Decision Rules for Organizations Seeking Initial Accreditation........................... ACC–55

Decision Rules for Organizations Seeking Reaccreditation .................................. ACC–58
Process for Organizations That Meet Decision Rule PDA02 for Patients Placed at Risk
for Serious Adverse Outcomes Due to Significant and Pervasive Patterns, Trends,
and/or Repeat Findings................................................................................... ACC–63
Process for Organizations That Meet Decision Rule PDA04............................... ACC–65
Review and Appeal Procedures ............................................................................... ACC–65

Overview
The policies, procedures, and explanations of process described in this chapter apply to
any health care organization interested in Joint Commission accreditation, whether it is
applying for the first time or seeking continued accreditation. All laboratories must
follow the policies and procedures listed in this chapter to participate in the
accreditation process. Failure to follow the policies and procedures described in this
chapter can result in denial of accreditation. Because this information is reviewed and
revised as necessary on a continuous basis, all accredited laboratories are responsible for
keeping track of changes to these policies and procedures.
Changes made to accreditation requirements between manual updates will be
announced in the monthly Joint Commission Perspectives® newsletter.
The “Accreditation Participation Requirements” (APR) chapter also includes specific
requirements for accreditation participation. The APRs are existing policies and are
currently effective for accreditation purposes. Cross-references to the APRs are noted in
the applicable sections of this chapter.

General Eligibility Requirements

Any laboratory may apply for Joint Commission accreditation if all the following
requirements are met:
■ The laboratory is in the United States or its territories or, if outside the United
States, is owned or operated by the US government or under a charter of the US
Congress.
■ If required by law, the laboratory has a facility license, CLIA license, or registration
to conduct its scope of services.

Shading indicates a change effective July 1, 2024, unless otherwise noted in the What's New.
CAMLAB Update 1, July 2024 ACC – 3
E-dition July 1, 2024, Release
◤Comprehensive Accreditation Manual for Laboratory and Point-of-Care Testing

■ The laboratory can demonstrate that it continually assesses and improves the quality
of its care, treatment, and/or services. This process includes a review by clinicians or
qualified designee as defined by CLIA, including those knowledgeable in the type of
care, treatment, and/or services provided at the laboratory.
■ The laboratory identifies the health care services it provides, indicating which care,
treatment, and/or services it provides directly, under contract, or through some
other arrangement.
■ The laboratory provides services that can be evaluated by Joint Commission
standards.

Scope of Accreditation Surveys

The Joint Commission evaluates all health care services provided by the organization for
which The Joint Commission has standards and makes an accreditation decision for
each accreditation program surveyed. The survey results are documented by the
surveyor(s) and provided (with the exception of for-cause surveys) in the Preliminary
Accreditation Report. During a survey, an organization must be prepared to provide
evidence of its compliance with each applicable standard. To attain accreditation, an
organization must demonstrate compliance with the applicable standards and their
elements of performance (EPs).
In addition to using standards and EPs, The Joint Commission also surveys
organizations by using APRs and the Joint Commission National Patient Safety Goals®
(see the APR and “National Patient Safety Goals” [NPSG] chapters, respectively). Used
in conjunction with the standards, these requirements help assess an organization’s
performance.

Accreditation Policies
This section provides information on the policies that govern the accreditation process
for laboratories and describes how The Joint Commission shares information about an
individual organization.

Tailored Survey Policy

The public expects all of the programs or services delivered under the auspices of an
accredited organization to have been evaluated. As such, The Joint Commission applies
its Tailored Survey Policy to components (for which there are applicable Joint

Shading indicates a change effective July 1, 2024, unless otherwise noted in the What's New.
ACC – 4 CAMLAB Update 1, July 2024
E-dition July 1, 2024, Release
 The Accreditation Process◥

Commission standards) that are organizationally and functionally integrated with the
health care organization applying for accreditation (see the “Organizational and
Functional Integration” section).
The Joint Commission will include another service, program, or related entity (that is,
component), whether providing programs or services directly or through a contractual
arrangement, * in the survey of the applicant organization under the following
circumstances:
■ There are Joint Commission accreditation requirements applicable to the compo-
nent.
■ There is organizational and functional integration between the component and the
applicant organization.
The Joint Commission survey, assuming satisfactory compliance, provides one accredita-
tion award for each accreditation program surveyed (for example, ambulatory health
care, behavioral health care, home care, nursing care centers, and so forth).
Any service, program, or related entity that is a component of an accreditation-eligible
organization may independently seek accreditation if it can meet Joint Commission
survey eligibility requirements. The results of such a separate accreditation survey will
not affect the overall organization’s decision. If the service, program, or related entity
seeks separate accreditation, the Tailored Survey Policy does not require the larger
complex organization to be separately accredited.†
The Joint Commission conducts a survey based on the services or programs provided by
the organization, as reported in its electronic application for accreditation (E-App).
After completing its E-App, the organization is able to view which manuals are
applicable to the accreditation survey on the “Applicable Manuals” tab. The Joint
Commission surveys and, assuming satisfactory compliance, provides one accreditation
award for each program surveyed.

*
Contractual arrangements are evaluated for tailoring applicability on a case-by-case basis.
†
The laboratory must meet the requirements of decision rule FOC01 for the organization to be
accredited. See the “One-Month Survey” section in the “Accreditation Decision Rules” for the full
requirement.

Shading indicates a change effective July 1, 2024, unless otherwise noted in the What's New.
CAMLAB Update 1, July 2024 ACC – 5
E-dition July 1, 2024, Release
◤Comprehensive Accreditation Manual for Laboratory and Point-of-Care Testing

Organizational and Functional Integration

Organizational and functional integration refers to the degree to which a component is
overseen and managed by the applicant organization that is either seeking accreditation
or currently accredited. A component is a service, program, or related entity that delivers
care, treatment, or services and is eligible for survey under one of The Joint
Commission’s accreditation programs listed in the “Introduction” (INTRO) chapter.
Organizational integration exists when an applicant organization’s governing body
either directly or ultimately controls budgetary and resource allocation decisions for the
component or, where individual corporate entities are involved, there is greater than 50%
common governing board membership for the applicant organization and on the board
of the component.
Functional integration exists when the entity meets at least three of the following eight
criteria:
1. The applicant organization and the component do the following:
■ Use the same process for determining membership of physicians and licensed
practitioners in practitioner panels or medical or professional staff and/or
■ Use the same process for credentialing and assigning of privileges or clinical
responsibilities to physicians and licensed practitioners and/or
■ Share a common organized medical or professional staff between the applicant
organization and the component
2. The applicant organization’s human resources function hires and assigns staff at the
component and has the authority to do the following:
■ Terminate staff at the component
■ Transfer or rotate staff between the applicant organization and the component
■ Conduct performance appraisals of the staff who work in the component
3. The applicant organization’s policies and procedures are applicable to the compo-
nent, with few or no exceptions.
4. The applicant organization manages significant operations of the component (that is,
the component has little or no management authority or autonomy independent of
the applicant organization).
5. The component’s clinical records are integrated into the applicant organization’s
clinical record system.
6. The applicant organization applies its performance improvement program to the
component and has authority to implement actions intended to improve perform-
ance at the component.

Shading indicates a change effective July 1, 2024, unless otherwise noted in the What's New.
ACC – 6 CAMLAB Update 1, July 2024
E-dition July 1, 2024, Release
 The Accreditation Process◥

7. The applicant organization bills for services provided by the component under the
name of the applicant organization.
8. The applicant organization and/or the component portrays to the public that the
component is part of the organization through the use of common names or logos;
references on letterheads, brochures, telephone book listings, or websites; or
representations in other published materials.
A checklist to help determine whether organizational and functional integration exists is
provided in Figure 1.

Shading indicates a change effective July 1, 2024, unless otherwise noted in the What's New.
CAMLAB Update 1, July 2024 ACC – 7
E-dition July 1, 2024, Release
◤Comprehensive Accreditation Manual for Laboratory and Point-of-Care Testing

Figure 1. Checklist to determine organizational and functional integration.

Shading indicates a change effective July 1, 2024, unless otherwise noted in the What's New.
ACC – 8 CAMLAB Update 1, July 2024
E-dition July 1, 2024, Release
 The Accreditation Process◥

Multiorganization Option
The Joint Commission offers an optional survey process for multiorganization systems
that own or lease a minimum of two organizations. This option has the following three
components:
1. A corporate orientation held at the beginning of the survey year
2. Surveys of participating organizations with an identified survey team leader(s)
3. A corporate summation after the last organization in the system is surveyed

The orientation session provides an opportunity for corporate staff to orient the surveyor
or survey team to the structure and practices of the system. The identified survey team
leader(s) also surveys centralized corporate services, documentation, and policies and
procedures applicable to Joint Commission requirements. The corporate summation
provides an overall analysis of the system’s strengths and weaknesses. It also provides
education related to accreditation survey findings across the system.
Through the multiorganization option, The Joint Commission accredits the individual
health care organizations that are part of a multiorganization system, not the system itself.
Therefore, each organization within a system receives its own survey, accreditation
decision, and Final Accreditation Report. The findings and decision for one organization
within a system have no bearing on those of another organization within the system.

Concurrent Survey Option

The Joint Commission offers a concurrent survey option for laboratories or systems with
multiple Joint Commission–accredited laboratories. This option provides a structure
across the entire system and has the following components:
■ Unannounced surveys of participating laboratories occur at the same time.
■ Each participating laboratory must demonstrate compliance with all Joint Com-
mission requirements independent of any other laboratories within the system.
■ Each participating laboratory under a separate health care organization identification
number will receive a separate survey report and accreditation decision.
The concurrent survey process works best when conducted in systems where 12 or fewer
entities wish to be surveyed at the same time.

Shading indicates a change effective July 1, 2024, unless otherwise noted in the What's New.
CAMLAB Update 1, July 2024 ACC – 9
E-dition July 1, 2024, Release
◤Comprehensive Accreditation Manual for Laboratory and Point-of-Care Testing

Contracted Services
The Joint Commission evaluates an organization’s management and oversight of the
quality of care, treatment, and services (for which there are Joint Commission standards)
provided under contractual arrangements. The Joint Commission reserves the right to
evaluate, as part of its survey, the care, treatment, and services provided by another
organization or provider on behalf of the applicant organization. It may survey
performance issues between the contracted organization and the applicant organization,
regardless of the accreditation decision of the contracted organization. The Joint
Commission also surveys care, treatment, and services provided on site under contract to
the applicant organization.

Proficiency Testing Monitoring

The Joint Commission and the Clinical Laboratory Improvement Amendments of 1988
(CLIA ’88) require you to maintain successful performance on proficiency testing (PT)
(see “Quality System Assessment for Nonwaived Testing” [QSA] Standard QSA.01.01.
01, EP 5, Note 1). The Joint Commission receives unsuccessful PT performance data
from the US Centers for Medicare & Medicaid Services (CMS) and the PT providers for
all regulated analytes through an electronic communication link. Unsuccessful PT
performance is defined as a failure to achieve satisfactory performance for two
consecutive or two out of three consecutive testing events.
When an unsuccessful PT event occurs, a letter will be posted to the organization’s secure
Joint Commission Connect extranet site to request a Plan of Action (POA). Laboratories
will be asked to submit information including, but not limited to, the following:
■ Current and historical PT reports
■ Analysis and corrective action of the unacceptable PT results
■ Steps taken to assure the accuracy and reliability of patient results
■ Review and approval of the corrective action by the laboratory director named on
the CLIA ’88 certificate (see “Leadership” [LD] Standard LD.04.01.01, EP 1,
Note 2)
If the problem cannot be resolved, an evaluation may be conducted which may
ultimately affect your accreditation status. An evaluation may also be conducted for
extreme problems or those that jeopardize patient safety. At any time during the process,
the laboratory may voluntarily discontinue testing. If the laboratory decides to
voluntarily discontinue testing, the laboratory must notify the project manager at The
Joint Commission in writing. The laboratory may not resume testing until reinstatement

Shading indicates a change effective July 1, 2024, unless otherwise noted in the What's New.
ACC – 10 CAMLAB Update 1, July 2024
E-dition July 1, 2024, Release
 The Accreditation Process◥

criteria are met and the laboratory receives written confirmation from The Joint
Commission that it may resume testing. Reinstatement criteria include, but are not
limited to, evidence of satisfactory performance on two PT events.
If the POA is acceptable, a letter will be posted to the organization’s secure Joint
Commission Connect extranet site. PT monitoring will continue. The laboratory will be
required to submit copies of the next two consecutive PT events.
If the laboratory fails to achieve satisfactory performance on one of the next two events,
the laboratory must cease testing for a minimum of six months after the notice is issued
for the testing specified. The laboratory may not resume testing until reinstatement
criteria are met and the laboratory receives written confirmation from The Joint
Commission that it may resume testing.
A full description of the requirements for accreditation may be found in the
“Accreditation Participation Requirements” (APR) chapter at APR.10.03.01. For
questions or notifications regarding unsuccessful PT and submission of a corrective
POA, please contact the Laboratory Project Manager by phone at 630-792-5248, via
e-mail at [email protected], or in writing at The Joint Commission,
One Renaissance Boulevard, Oakbrook Terrace, IL 60181, ATTN: Laboratory Project
Manager.

Initial Surveys
An organization that is seeking Joint Commission accreditation for the first time or that
has not been denied accreditation by The Joint Commission during the previous four
months is eligible for an initial survey if it serves the required minimum number of
patients regardless of how long the organization has been in operation. The full scope of
applicable standards is reviewed during the survey. The Joint Commission’s policy for
assessing and monitoring organizations new to the accreditation process is as follows:
■ Laboratories new to the accreditation process must be able to demonstrate a four-
month track record of compliance with the standards at the time of the initial survey.
■ If an organization new to the accreditation process demonstrates compliance with
applicable Joint Commission accreditation requirements, the organization will
receive accreditation.

Shading indicates a change effective July 1, 2024, unless otherwise noted in the What's New.
CAMLAB Update 1, July 2024 ACC – 11
E-dition July 1, 2024, Release
◤Comprehensive Accreditation Manual for Laboratory and Point-of-Care Testing

If the organization has a Requirement for Improvement (RFI), the accreditation effective
date for an organization that undergoes an initial survey is the date on which an
acceptable ESC was submitted. If there are no RFIs, the effective date is the day after the
last day of the survey.

Survey Postponement Policy

In rare circumstances, it may be appropriate to request a survey postponement. An
organization should direct a request for a postponement to its account executive. A
request to postpone a survey may be granted if a major unforeseen event has occurred
that has totally or substantially disrupted operations, such as the following:
■ A natural disaster or major disruption of service due to a facility failure
■ The organization’s involvement in an employment strike
■ The organization’s cessation of admitting or treating patients
■ The organization’s inability to treat and care for patients and its transfer of patients
to other facilities or organizations
The Joint Commission may, at its discretion, approve a request to postpone a survey for
an organization not meeting any of the criteria previously described. The organization
may be charged a fee to defray costs.
Effective January 1, 2024, the format for off-site surveys and the postponement policy is
inclusive of the off-site survey requirements. Organizations will be provided access to a
secure Joint Commission site to upload documents in advance of the scheduled survey.
Laboratories are required to upload documents identified in the “Off-Site Survey
Required Documents and Agendas” section located on its Joint Commission Connect ex-
tranet site not less than 72 hours after the organization’s primary contact has been
provided access to the secure site. An organization that does not comply with this
requirement will have its survey rescheduled as an on-site survey event and will be issued a
postponement fee.

Information Accuracy and Truthfulness Policy

The accuracy and veracity of relevant information, whether actually used in the
accreditation or certification processes, are essential to the integrity of the Joint
Commission’s accreditation and certification processes. Falsification, as the term is used
in the Joint Commission’s Information Accuracy and Truthfulness Policy, applies to
both commissions and omissions in sharing information with The Joint Commission.

Shading indicates a change effective July 1, 2024, unless otherwise noted in the What's New.
ACC – 12 CAMLAB Update 1, July 2024
E-dition July 1, 2024, Release
 The Accreditation Process◥

Information provided at any time by the organization must be accurate and truthful (see
APR.01.02.01 in the APR chapter). Such information may be furnished in any of the
following manners:
■ Provided verbally or in writing
■ Obtained through direct observation or interview by a Joint Commission surveyor(s)
or reviewer(s)
■ Derived from documents supplied by the organization to The Joint Commission,
including, but not limited to, an organization’s comprehensive systematic analysis
(for example, a root cause analysis) in response to a sentinel event or an
organization’s request for accreditation/certification
■ Electronically transmitted data or documents including, but not limited to, data or
documents provided as part of the E-App process
■ An attestation that the organization does not currently and knowingly use Joint
Commission full-time, part-time, or intermittent surveyors or reviewers to provide
any accreditation-/certification-related consulting services including, but not limited
to, the following:
❏ Helping an organization meet Joint Commission accreditation/certification
requirements
❏ Helping an organization with any Intracycle Monitoring (ICM) process
❏ Conducting mock surveys for an organization
❏ Helping an organization in the ESC process

Policy Requirements
The Joint Commission’s Information Accuracy and Truthfulness Policy includes the
following:
1. An organization shall not provide The Joint Commission with falsified information
relevant to the accreditation/certification process. (For the definition of falsification,
see the next item in this list.) The Joint Commission construes any effort to do so as a
violation of the organization’s obligation to engage in the accreditation/certification
process in good faith.
2. Falsification is defined for this policy as the fabrication, in whole or in part, and
through commission or omission, of any information provided by an applicant or
accredited organization/certified program to The Joint Commission. This includes,
but is not limited to, any redrafting, reformatting, or content deletion of documents.
3. The organization may submit additional material that summarizes or otherwise
explains original information submitted to The Joint Commission. These materials
must be properly identified, dated, and accompanied by the original documents.

Shading indicates a change effective July 1, 2024, unless otherwise noted in the What's New.
CAMLAB Update 1, July 2024 ACC – 13
E-dition July 1, 2024, Release
◤Comprehensive Accreditation Manual for Laboratory and Point-of-Care Testing

4. The Joint Commission conducts an evaluation when it has cause to believe that an
accredited organization/certified program may have provided falsified information to
The Joint Commission relevant to the accreditation/certification process. Except as
otherwise authorized by an officer of The Joint Commission with a clinical
background, the evaluation may include an unannounced survey. This survey uses
special protocols designed to address the information determined by The Joint
Commission to constitute possible falsification. It assesses the degree of actual
organization compliance with the standards and EPs that are the subject of the
allegation, if appropriate.
5. The Joint Commission takes action to deny accreditation/certification to an
organization/program whenever The Joint Commission is reasonably persuaded that
the organization/program has provided falsified information.
6. The Joint Commission may notify responsible federal and state government agencies
of any organization/program subject to such action.
7. If an organization/program is denied accreditation/certification because it provided
falsified information, The Joint Commission prohibits it from participating in the
accreditation or certification process for a period of one year. An officer of The Joint
Commission with a clinical background, for good cause, may waive all or a portion
of this waiting period.

Good Faith Participation in Accreditation/

Certification
The Joint Commission requires each organization seeking (re)accreditation or
(re)certification to engage in the process in good faith. The Joint Commission may deny
accreditation or certification to any organization that fails to participate in the process in
good faith. The following are examples of actions interfering with good faith
participation:
■ Deceiving The Joint Commission. Compliance with the Information Accuracy and
Truthfulness Policy requires a commitment on the part of the accredited
organization/certified program not to deceive The Joint Commission in any aspect
of the accreditation/certification process, such as during the completion of an
application for accreditation/certification, during the ICM process, or during a
survey/review.

Shading indicates a change effective July 1, 2024, unless otherwise noted in the What's New.
ACC – 14 CAMLAB Update 1, July 2024
E-dition July 1, 2024, Release
 The Accreditation Process◥

■ Deceiving the public. An accredited organization/certified program is not acting in

good faith if it misleads the public about the meaning and limitations of
accreditation/certification. Also, an accredited organization/certified program must
not inaccurately suggest to the public that its accreditation/certification award
applies to any unaccredited affiliated or otherwise related activities.
■ Retaliation. The Joint Commission invites open communication from any
accredited organization’s/certified program’s staff and recipients of care, treatment,
and services about any standards compliance or other issues related to the
accreditation/certification process. An organization’s/program’s good faith partici-
pation in the accreditation/certification process is questioned if the organization/
program does any of the following:
❏ Attempts to discourage such communication—for example, by taking disciplin-
ary steps against an employee solely because that employee provides information
to The Joint Commission
❏ Threatens those who communicate with The Joint Commission with a
defamation lawsuit based solely on what was said to The Joint Commission
❏ Allows the treatment or access to services of any individual or staff member to
be adversely affected by their or a family member’s communication with The
Joint Commission
■ Standards compliance. If an organization’s/program’s conduct reflects a lack of
commitment to standards compliance, issues of good faith may be raised. For
example, an intentional refusal to attempt to comply with a standard could suggest a
cavalier view of the accreditation/certification process.
The good faith participation requirement applies continuously throughout the accredita-
tion/certification process.

Public Information Policy‡

The Joint Commission is committed to making relevant and accurate information about
its accredited and certified health care organizations available to interested parties.
Information regarding a health care organization’s quality and safety of care can help
organizations improve their services. This information may also help educate consumers
and health care purchasers in making informed choices about health care. At the same
time, it is important that confidentiality of certain information be maintained to

‡
This policy meets the requirements of the Health Insurance Portability and Accountability Act of
1996.

Shading indicates a change effective July 1, 2024, unless otherwise noted in the What's New.
CAMLAB Update 1, July 2024 ACC – 15
E-dition July 1, 2024, Release
◤Comprehensive Accreditation Manual for Laboratory and Point-of-Care Testing

encourage candor in the accreditation and certification process. The Joint Commission’s
primary vehicles for providing public information are Quality Check® and Quality
Reports.

Process for Responding to a Complaint

The Joint Commission’s Office of Quality and Patient Safety (OQPS) triages and reviews
complaints, concerns, and inquiries related to accredited health care organizations, as
received from a variety of sources. These complaints may be submitted by patients,
families, and health care providers; by state and federal agencies in the form of reports; or
through information from the media. The term complaint therefore covers a broad
spectrum of information received by the OQPS.
Upon Joint Commission review of a complaint, a number of actions may result. These
include recording the information for trending purposes and possible action in the future
and/or conducting an immediate for-cause survey.

Before the Survey

This section provides information on the steps leading to a full accreditation survey.
These steps include the application process, the role of an account executive, and the
Focused Standards Assessment (FSA) process.

An Organization’s Secure Joint Commission

Connect Extranet Site
The Joint Commission provides each organization with a secure, password-protected
portal known as Joint Commission Connect. Joint Commission Connect is the platform
used for direct and confidential exchange of information such as accreditation/
certification reports, notifications, and other correspondence between The Joint
Commission and its accredited/certified health care organizations.

Ensuring Joint Commission Connect Security

Each health care organization is required to designate a primary accreditation and/or
certification contact. The primary accreditation/certification contact is the main point of
contact between The Joint Commission and the organization, so it is important that their
contact information is up to date on the Joint Commission Connect extranet site.

Shading indicates a change effective July 1, 2024, unless otherwise noted in the What's New.
ACC – 16 CAMLAB Update 1, July 2024
E-dition July 1, 2024, Release
 The Accreditation Process◥

A security administrator(s) also can be assigned on Joint Commission Connect. Security

administrators receive unlimited access to the extranet site and, along with the primary
accreditation/certification contact, are responsible for registering and deactivating other
users of the site.
Additional users from the health care organization can be registered on Joint Commission
Connect, and their level of access is controlled by security administrators and the primary
accreditation/certification contact. Each user must be provided with a unique user ID,
password, and permission levels. Joint Commission Connect users should never share the
same user name and password. Access to Joint Commission Connect should be limited to
designated staff to protect the integrity of the site’s information. Removing access for
individuals who no longer require it is the best way to ensure confidentiality and prevent
inadvertent disclosure of the site’s contents.
Guest access also is available for employees at the accredited/certified organization, which
provides access to Joint Commission Perspectives and the Surveyor Guidance Checklist. It
does not allow users to view any organization-specific data or reports.

Role of Consultants
The designated primary accreditation/certification contact must be an employee rather
than a contracted individual. Consultants should not be assigned as the primary
accreditation/certification contact. Consultants may be present during the survey;
however, their role is only as an observer. Consultants are not permitted to interact with
surveyors/reviewers, nor are they allowed to respond to questions on behalf of the
organization. This practice will ensure a quality assessment of an organization’s ability to
provide safe, quality care on an ongoing basis.

Role of the Account Executive

The Joint Commission assigns an account executive to an organization after receiving its
E-App and nonrefundable deposit. This person serves as the primary contact between the
organization and The Joint Commission. The account executive coordinates survey
planning and handles policies, procedures, accreditation issues or services, and inquiries
throughout the accreditation cycle. An applicant organization can find contact
information for its account executive on its Joint Commission Connect extranet site or by
calling 630-792-3007.

Shading indicates a change effective July 1, 2024, unless otherwise noted in the What's New.
CAMLAB Update 1, July 2024 ACC – 17
E-dition July 1, 2024, Release
◤Comprehensive Accreditation Manual for Laboratory and Point-of-Care Testing

Electronic Application for Accreditation

(E-App)
When an organization notifies The Joint Commission that it wants to become accredited,
The Joint Commission provides the organization with information explaining how to
access the E-App on the organization’s secure Joint Commission Connect extranet site. (An
applicant should contact Business Development at 630-792-5248 for initial access to Joint
Commission Connect.) Initial applications are valid for one year. An organization needs to
complete and submit its E-App upon initial application for survey and will be asked to
verify the information annually. An organization can provide updates to the
E-App at any time. (See the “Changes Affecting E-App Information” section for more
information on notifying The Joint Commission of significant changes within an
organization.)
The application provides essential information about the organization, including
ownership, demographics, and types and volume of services provided. The E-App does
the following:
■ Describes the organization seeking accreditation in terms of size and scope of services
■ Identifies an organization’s applicable standards based on programs/services pro-
vided
■ Drives the anticipated number of survey days, number and type of surveyors, and
survey agenda activities (see the “Survey Agenda” section)

Accuracy of the Application Information

The Joint Commission schedules surveys based on information provided in an
organization’s E-App. With the information provided, The Joint Commission deter-
mines the number of days required for a survey and the number and type of surveyors.
Inaccurate or incomplete information in the E-App may necessitate an additional survey,
which could delay the processing of survey findings and rendering of an accreditation
decision. It may also cause the organization to incur additional survey charges.

Shading indicates a change effective July 1, 2024, unless otherwise noted in the What's New.
ACC – 18 CAMLAB Update 1, July 2024
E-dition July 1, 2024, Release
 The Accreditation Process◥

Forfeiture of Survey Deposit

A nonrefundable, nontransferable deposit toward accreditation fees is required for initial
organizations.§ The Joint Commission applies the deposit to the organization’s open
invoices until the deposit is exhausted. An organization scheduled for an initial survey
forfeits its deposit if its survey is not conducted within one year of submitting its
application. The organization must then reapply and submit a new deposit to begin the
accreditation process again.
Note: A fee will be charged to defray costs if an organization requests the postponement of
an initial survey fewer than 20 days prior to the scheduled survey.

Accreditation/Certification Contract and

Business Associate Agreement
Organizations seeking Joint Commission accreditation for the first time or reaccredita-
tion with The Joint Commission must submit a signed Accreditation/Certification
Contract and a Business Associate Agreement. The contract outlines the responsibilities
of both the organization and The Joint Commission relative to the accreditation process.
The contract is accessible through the organization’s secure Joint Commission Connect
extranet site.
In accordance with the requirements of the Health Insurance Portability and
Accountability Act of 1996 (HIPAA) Privacy and Security Rules, and modified by the
HITECH (Health Information Technology for Economic and Clinical Health)
provisions of the American Recovery and Reinvestment Act of 2009, a health care
organization and The Joint Commission must have a signed Business Associate
Agreement before the organization’s survey/review can begin. This Business Associate
Agreement outlines the access, use, and disclosure of any patient-protected health
information between The Joint Commission and the health care organization.
An organization will not be scheduled for survey until it signs an accreditation contract
and Business Associate Agreement. When this happens, The Joint Commission will
proceed with the organization’s survey plans unless the organization notifies The Joint
Commission in writing of its intent to withdraw from accreditation and terminate the

§
The Joint Commission does not charge a deposit for accredited health care organizations that are
seeking a new tailored (or certification) program. Also, in instances where an “owner” of multiple health
care organizations has at least five accredited entities in good standing, that entity will be eligible for a
deposit waiver.

Shading indicates a change effective July 1, 2024, unless otherwise noted in the What's New.
CAMLAB Update 1, July 2024 ACC – 19
E-dition July 1, 2024, Release
◤Comprehensive Accreditation Manual for Laboratory and Point-of-Care Testing

accreditation contract. Notification in writing is necessary to terminate the accreditation

contract, cease survey scheduling, and avoid a final decision of Denial of Accreditation. If
an organization fails to notify The Joint Commission in writing of its intent to withdraw
from accreditation and terminate its accreditation contract before a survey, The Joint
Commission’s decision rules provide for a final decision of Denial of Accreditation.

Annual and Survey Fees

The Joint Commission uses a subscription billing system for all accreditation programs.
Fees are determined annually and are based on the need to secure sufficient resources to
cover the costs of operation. The Joint Commission generally bases individual
organization annual fees on the volume and type of services provided and the sites to be
included in the organization’s accreditation survey. Questions about all fees can be
directed to the Pricing Unit ([email protected]) or by calling
630-792-5115.
The Joint Commission’s fee structure includes a nonrefundable, nontransferable annual
fee, which recognizes the provision of substantial accreditation-related services on a
continuous basis between surveys. The annual fee is billed each January and determined
by the organization’s size and complexity. The annual fee for organizations applying for
accreditation for the first time will be prorated, based on the quarter in which the
application is submitted.
In addition to the annual fee, organizations are billed a fee within two days after the
survey. The fee is designed to cover the direct costs of performing a survey.
Organizations requiring additional surveys, such as to evaluate a patient safety event, will
be assessed a separate survey fee.
Electronic invoices will be posted to the organization’s secure Joint Commission Connect
extranet site and are due upon receipt. The Joint Commission accepts payment for all
fees in any of the following ways:
■ Electronic payment using Visa, MasterCard (credit or debit), American Express,
Discover, or e-check by logging on the organization’s secure Joint Commission
Connect extranet site and clicking on the “What’s Due” tab or by calling Accounts
Receivable staff at 630-792-5115
❏ Effective January 1, 2023, invoices created on or after January 1, 2023, and paid
sixty-one (61) or more days after the invoice date will be assessed a 2% late fee.

Shading indicates a change effective July 1, 2024, unless otherwise noted in the What's New.
ACC – 20 CAMLAB Update 1, July 2024
E-dition July 1, 2024, Release
 The Accreditation Process◥

❏ Effective January 1, 2023, where allowed by law, payments made by credit or

debit card will be assessed a 2% electronic processing fee; E-checks will continue
to be accepted with no processing fee.
■ Check or money order by mail to The Joint Commission Receivables, PO Box
734505, Chicago, IL 60673-4505, or overnight checks to JPMorgan Chase,
Attention: The Joint Commission Receivables 734505, 131 S. Dearborn, 6th Floor,
Chicago, IL 60603
■ Wire transfer by calling Accounts Receivable staff at 630-792-5115
Failure to provide timely payment of any Joint Commission fees may result in the loss of
accreditation. Letters of nonpayment are posted to the health care organization’s Joint
Commission Connect extranet site. Failure to pay overdue amounts will result in a loss
of accreditation with no opportunity for appeal or reinstatement. For help in making a
payment, please contact Accounts Receivable staff at 630-792-5115.

During the Survey

During an accreditation survey, The Joint Commission evaluates an organization’s
performance of functions and processes aimed at continuously improving patient
outcomes. The survey process focuses on assessing performance of important patient-
centered and organization functions that support the safety and quality of care,
treatment, and services. This assessment is accomplished through evaluating an
organization’s compliance with the applicable requirements in this manual, based on the
following activities and information:
■ Tracing the care, treatment, and services delivered to patients
■ Verbal and written information provided to The Joint Commission
■ Observations and interviews by Joint Commission surveyors
■ Review of documents provided by the organization
Under this accreditation process, the full survey is the evaluation piece of a continuous
process. The accreditation process encourages organizations to embed the requirements
into routine operations to achieve and maintain excellent operational systems on an
ongoing basis.
A survey is designed to be individualized to each organization, to be consistent, and to
support the organization’s efforts to improve performance. The Joint Commission
determines the length of a survey based on information supplied in the E-App that
describes the organization’s size and scope of services. Although not a routine practice,

Shading indicates a change effective July 1, 2024, unless otherwise noted in the What's New.
CAMLAB Update 1, July 2024 ACC – 21
E-dition July 1, 2024, Release
◤Comprehensive Accreditation Manual for Laboratory and Point-of-Care Testing

Joint Commission surveyors may conduct some survey activities during early morning,
evening, night, and weekend hours, as necessary. These “off-shift” visits do not occur
before the opening conference at the start of the survey.

Survey Notification
The Joint Commission generally conducts unannounced surveys within the 90-day
period prior to the laboratory’s accreditation expiration date, except for situations in
which it would not be logical or feasible to conduct an unannounced survey. The
laboratory’s accreditation expiration date is 24 months plus 1 day from the previous full
survey end date. Table 1 outlines specific exceptions to unannounced surveys and the
length of advance notice.

Table 1. Exceptions to Unannounced Surveys|| #

Subject Exception Threshold

Initial surveys Announced
Organizations undergoing ICM Op- Announced (unless the organization re-
tion 2 and Option 3 surveys quests the survey to be unannounced)
Department of Defense facilities 7-day notice
“Small” organizations 7-day notice Fewer than 25,000 tests
per year
IVF laboratories (freestanding) 7-day notice

With an unannounced survey, an accredited organization will receive no notice of its

survey date prior to the start of the survey. In concert with the unannounced survey
process, the following procedures will be implemented:
■ Organizations will be able to identify, in their 15-month E-App, up to 10 days in
their survey eligibility range (within 90 days prior to the laboratory’s accreditation
expiration date) during which an unannounced survey should be avoided. After the
15-month E-App has been submitted, these dates cannot be modified. These 10 days
should not include federal holidays but may include regional events during which it
may be difficult to conduct a survey. The Joint Commission will continue to make
every effort to reasonably accommodate an organization’s avoid dates. However, The
Joint Commission reserves the right to conduct a survey during an “avoid period” if
the reason(s) given to avoid a survey at that time is such that a survey can be

||
In this table, 7 days refers to 7 business days.
#
These exceptions do not apply if tailored to another program not eligible for an announced survey.

Shading indicates a change effective July 1, 2024, unless otherwise noted in the What's New.
ACC – 22 CAMLAB Update 1, July 2024
E-dition July 1, 2024, Release
 The Accreditation Process◥

reasonably accomplished. Please note that The Joint Commission may not honor
single avoid dates clustered near the end of the accreditation cycle or other attempts
to choose dates that unreasonably narrow the period of time in which schedulers can
efficiently accommodate the unannounced survey process.
■ An organization is required to demonstrate how it communicates on an ongoing
basis to its public that if members of the public have any quality-of-care or safety
concerns, they should notify The Joint Commission (see APR.09.01.01 in the APR
chapter).
■ If an organization knows of a surveyor who works or has worked at the organization
or a competing organization or has had personal experience with the survey or that
represents a potential conflict, the organization is asked to identify the individual(s)
in its E-App or notify The Joint Commission via phone or e-mail as soon as possible
so that The Joint Commission may consider assigning another surveyor.
Organizations are notified of upcoming Joint Commission surveys according to which of
the following three types of survey they are going to receive:
1. Unannounced Events. After surveyors have arrived for an unannounced survey,
The Joint Commission will post on the organization’s secure Joint Commission Connect
extranet site the letter of introduction, the survey agenda and the biography and picture
of each surveyor assigned to conduct the event. In addition, an e-mail notification will be
sent to the individuals listed as chief executive officer, primary accreditation/certification
contact, and corporate contact (if applicable) on the organization’s extranet site; please
ensure that this contact information is correct. This e-mail notifies the organization that
an event has commenced that day and instructs the contact(s) to log in to the Joint
Commission Connect extranet site to view the event details.
2. Announced Events. Thirty calendar days prior to the scheduled announced event,
The Joint Commission will post on the organization’s secure Joint Commission Connect
extranet site the letter of introduction, the survey agenda, and the biography and picture
of each surveyor assigned to conduct the event. After this notification—which serves as
the official notice of the upcoming event—has been posted, an e-mail notification will be
sent to the individuals listed as chief executive officer and primary accreditation/
certification contact on the organization’s extranet; please ensure this contact infor-
mation is correct. This e-mail will advise that an event has been scheduled and instruct
the contact(s) to log in to the Joint Commission Connect extranet site to view the event

Shading indicates a change effective July 1, 2024, unless otherwise noted in the What's New.
CAMLAB Update 1, July 2024 ACC – 23
E-dition July 1, 2024, Release
◤Comprehensive Accreditation Manual for Laboratory and Point-of-Care Testing

details. The organization will also receive a separate e-mail by 7:30 A.M. in the
organization’s local time zone (for organizations within the United States and its
territories) on the morning of the event with the same information as previously listed.
3. Short-Notice Events. Seven business days prior to the scheduled event, The Joint
Commission will post on the organization’s secure Joint Commission Connect extranet site
the letter of introduction, the survey agenda, and the biography and picture of each
surveyor assigned to conduct the event. (This information is also posted on the extranet
the day of survey.) After the notification—which serves as the official notice of the
upcoming event—has been posted, an e-mail notification will be sent to the individuals
listed as chief executive officer and primary accreditation/certification contact on the
organization’s extranet. This e-mail will advise that an event has been scheduled and
instruct the contact(s) to log in to the Joint Commission Connect extranet site to view the
event details. This message is a courtesy notification and is not an opportunity to propose
a new event date.

Initial and Full Survey Team Composition

Based on the size and complexity of the organization being surveyed, an accreditation
survey may be conducted by one surveyor or a team of surveyors. The composition of an
organization’s survey team is based on the information provided in its E-App.
On surveys with more than one surveyor, one of the surveyors is designated as the team
leader. The team leader is responsible for integration, coordination, and communication
of survey activities. In addition to being one of the surveyors conducting the survey, the
team leader serves as the primary point of contact between the organization and The
Joint Commission. Among other responsibilities, the team leader leads the opening
conference and the daily and exit briefings.

Pathologist Specialist Survey

A pathologist may be included in the survey team that conducts the laboratory’s
accreditation survey. This is included as it provides enhanced expertise and consultation
during the survey of performance improvement activities, laboratory directorship
activities, and cytology and histology activities. Organizations will be selected, where
appropriate and at the discretion of The Joint Commission, to have a pathologist added
to their survey team. Please contact your Account Executive for more information on
assignment of pathologist surveyor.

Shading indicates a change effective July 1, 2024, unless otherwise noted in the What's New.
ACC – 24 CAMLAB Update 1, July 2024
E-dition July 1, 2024, Release
 The Accreditation Process◥

For organizations with limited specialties where a pathologist surveyor is not included but
would like to request a pathologist as a member of their organizations survey team. This
option is available in the E-App. The pathologist surveyor fee will apply. Please contact
Business Development at [email protected] regarding pricing for your
laboratory.

Survey Agenda
The Joint Commission reviews the data in a laboratory’s E-App and posts a sample
agenda on the organization’s secure Joint Commission Connect extranet site. Also available
on the secure Joint Commission Connect extranet site is the Survey Activity Guide, which
includes a list of initial materials the surveyor(s) will request to review at the onset of the
survey.
The organization’s Joint Commission account executive will contact the laboratory and
provide the anticipated number of days and number of surveyors that will be assigned for
the survey. On the first day of a survey, the surveyor(s) will work with the laboratory to
ensure the schedule considers the organization’s operations and needs. During the survey,
the surveyor(s) will work to minimize any disruption to patient care when conducting
survey activities.
The survey process focuses on continuous operational improvement in support of safe,
high-quality care, treatment, and services. The survey agenda will include the elements
described in the following paragraphs.**
Surveyor Arrival and Preliminary Planning Session. Upon arrival, surveyors will
check in with reception, present their identification, and indicate their purpose for
visiting. Staff should be prepared with a plan and instructions for how to proceed. The
surveyor(s) will want to get settled in and begin reviewing the documentation identified
on the Document List as soon as possible.
Opening Conference and Orientation to the Organization. During the opening
conference, the surveyor(s) describes the structure and content of the survey to
organization staff. Surveyors will take time to introduce your organization to the revised
clarification procedures and Survey Analysis for Evaluating Risk® (SAFER®) reporting
process. During the time designated for the orientation, staff provide the surveyor(s) with

**
Please see the Survey Activity Guide on the Joint Commission Connect extranet site or at https://www.
jointcommission.org/-/media/tjc/documents/accred-and-cert/lab-and-pbm/2024/2024-laboratory-
organization-sag.pdf for more detailed information on the survey process.

Shading indicates a change effective July 1, 2024, unless otherwise noted in the What's New.
CAMLAB Update 1, July 2024 ACC – 25
E-dition July 1, 2024, Release
◤Comprehensive Accreditation Manual for Laboratory and Point-of-Care Testing

information about the organization. At this time, the laboratory will briefly explain its
structures, mission, vision, and relationship with the community. This provides the
surveyor(s) with baseline information about the organization that can help focus
subsequent survey activities.
Regulatory Review. During this session, the surveyor(s) will review the CLIA
certificates for director and specialty/subspecialty information, applicable licenses, test
volumes, and Individualized Quality Control Plan (IQCP) documentation.
Proficiency Testing/Validation/Performance Improvement Data Review. Dur-
ing the proficiency testing validation review session, the surveyor(s) will review
proficiency testing enrollment, participation, and performance for regulated analytes;
proficiency testing performance for tests not requiring proficiency testing by law
(nonregulated analytes), if applicable; and performance improvement data.
Individual Tracer Activity. During the individual tracer activity, the surveyor(s) will
do the following:
■ Follow the course of care, treatment, or services provided to the patient by the
laboratory
■ Assess the interrelationships among disciplines and services/programs and the
important functions in the care, treatment, or services provided
■ Evaluate the performance of processes relevant to the care, treatment, or service
needs of the patient, with particular focus on the integration and coordination of
distinct but related processes
■ Identify vulnerabilities in the care processes
See the “Tracer Methodology” section for more information.
Issue Resolution. This session provides an additional opportunity, if needed, for the
surveyor(s) to follow up on potential findings that could not be resolved in other survey
activities.
Surveyor Planning/Team Meeting. This time is reserved for the surveyor(s) to review
and analyze the information gathered throughout the day and plan for upcoming survey
activities.
Daily Briefings. During the daily briefing session, the surveyor(s) will do the following:

Shading indicates a change effective July 1, 2024, unless otherwise noted in the What's New.
ACC – 26 CAMLAB Update 1, July 2024
E-dition July 1, 2024, Release
 The Accreditation Process◥

■ Report on findings from the previous day’s survey activities, including the placement
of findings up to that point on the SAFER Matrix (note that placement of findings
on the matrix is subject to change as the survey progresses and there may be
additional findings)
■ Emphasize patterns or trends of significant concern that could lead to noncompli-
ance determinations
■ Facilitate leaders’ understanding of the survey process and the findings
■ Highlight any positive findings or exemplary performance
■ Allow the organization to supply additional information that would demonstrate
compliance with a standard that a surveyor has indicated may be an RFI
■ Review the agenda for the survey day ahead and make any necessary adjustments
based on laboratory needs or the need for more intensive assessment of an issue
If the organization has additional information that would demonstrate compliance with a
standard that a surveyor has indicated may be an RFI, the organization should supply
that information to the surveyor(s) as soon as possible.
Accreditation Report Preparation. The surveyor(s) will use this time to compile,
analyze, and organize the data collected throughout the survey into a Preliminary
Accreditation Report reflecting the organization’s compliance with standards (see the
“Summary of the Accreditation Reports” section).
Exit Briefing and Organization Exit Conference. The surveyor(s) will offer to meet
with the most senior leader, usually the CEO or administrator, or the leadership team to
conduct a private Exit Briefing. During the Exit Briefing, the surveyor(s) will present the
survey findings and review the Preliminary Accreditation Report (including the SAFER
Matrix results), discuss any concerns senior leaders have with the preliminary report, and
determine the need for any special arrangements for the Organization Exit Conference.
During the Organization Exit Conference the surveyor(s) will review the survey findings
(if desired by senior leaders), review the issues of standards compliance that have been
identified during the survey, and review required follow-up actions, as applicable.

Tracer Methodology
The tracer methodology is the cornerstone of The Joint Commission survey. The tracer
methodology incorporates the use of information the organization supplies in the E-App
to follow the experience of care, treatment, or services for a number of individuals
through the organization’s entire health care delivery process. Tracers allow the

Shading indicates a change effective July 1, 2024, unless otherwise noted in the What's New.
CAMLAB Update 1, July 2024 ACC – 27
E-dition July 1, 2024, Release
◤Comprehensive Accreditation Manual for Laboratory and Point-of-Care Testing

surveyor(s) to identify performance issues in one or more steps of the process or in the
interfaces between processes. Laboratory surveys involve individual tracer activities, as
described in the following section.

Individual Tracer Activity

The individual tracer activity is conducted during a survey and is designed to “trace” the
care experiences that a patient had while at the laboratory. The tracer methodology is a
way to analyze a laboratory’s system of providing care, treatment, or services using actual
patients as the framework for assessing standards compliance. The surveyor(s) will use the
following general criteria to select initial individual tracers:
■ Patients whose tracers would allow for the evaluation of identified program-specific
risk areas/categories (EPs with the icon)
■ Patients who cross programs (for example, home care patients discharged from a
hospital or individuals served by behavioral health care organizations who present at
an ambulatory care facility in complex organizations)
■ Patients receiving complex services, such as surgery or treatment in an intensive care
unit††
Patients selected for initial individual tracer activity will likely be those whose diagnosis,
age, or type of services received may enable the best in-depth evaluation of the
laboratory’s processes and practices. In conducting a patient’s tracer, the surveyor(s) will
follow specific patients through the laboratory’s processes. A surveyor will not only
examine the individual components of a system but will also evaluate how the
components of a system interact with each other. In other words, a surveyor will look at
the care, treatment, or services provided by each department/unit/program and service, as
well as how departments/units/programs and services work together. The surveyor(s)
usually starts where the patient is currently located. Then they can move to where the
patient first entered the organization’s systems; an area of care provided to the patient
that may be a priority for that organization; or to any areas in which the patient received
care, treatment, or services. The location and order will vary. Along the way, the
surveyor(s) will speak with the health care staff member(s) who actually provided the care
to that individual tracer patient—or, if that staff member(s) is not available, will speak
with another staff member(s) who provides the same type of care, treatment, or services.

Please see the Survey Activity Guide on the Joint Commission Connect for more detailed information on
††

other program-specific criteria for tracer selection.

Shading indicates a change effective July 1, 2024, unless otherwise noted in the What's New.
ACC – 28 CAMLAB Update 1, July 2024
E-dition July 1, 2024, Release
 The Accreditation Process◥

Based on the findings, the surveyor(s) may select similar patients to trace. The tracer
methodology permits surveyors to further investigate if there is a reason to believe that an
issue needs further exploration.

Risk Areas
A surveyor conducting any type of tracer at a laboratory might notice something that
requires a more in-depth look. At that point, the surveyor will look at all processes at a
system level by asking more detailed questions or spending more time looking at a
particular risk area. The focused evaluation includes processes or procedures that, if not
planned or implemented correctly, have significant potential for affecting/impacting
patient safety. Examples of topics that surveyors might need to explore in more detail at
laboratories are nonwaived and Provider-Performed Microscopy Procedure (PPMP)
competencies.
Surveyors will assess and display the risk associated with findings by utilizing the SAFER
Matrix. Survey findings will be plotted on the SAFER Matrix according to the likelihood
the RFI could cause harm to patients, staff, and/or visitors and the scope at which the
RFI was observed.

The Role of Staff in Tracer Methodology

To help the surveyor(s) in the tracer methodology process, staff will be asked to provide
the surveyor(s) with a list of active patients, including the patients’ names, current
locations in the laboratory, and diagnoses/conditions, as appropriate. The surveyor(s)
may request assistance from laboratory staff for selection of appropriate tracer patients.
As the surveyor(s) moves around a laboratory, they will ask to speak with the staff
members who have been involved in the tracer patient’s care, treatment, or services if
available. If those staff members are not available, the surveyor(s) will ask to speak to
another staff member who would perform the same function(s) as the member who has
provided services for the tracer patient. Although it is preferable to speak with the testing
personnel, it is not mandatory because the questions that will be asked are questions that
any testing personnel should be able to answer in providing care, treatment, or services to
the patient being traced.

Shading indicates a change effective July 1, 2024, unless otherwise noted in the What's New.
CAMLAB Update 1, July 2024 ACC – 29
E-dition July 1, 2024, Release
◤Comprehensive Accreditation Manual for Laboratory and Point-of-Care Testing

Immediate Threat to Health or Safety

The Joint Commission defines Immediate Threat to Health or Safety as “a threat that
represents immediate risk and has or may potentially have serious adverse effects on the
health or safety of the patient, resident, or individual served.” Such a situation may occur
anywhere in an organization. (See APR.09.04.01 in the APR chapter.)
If a surveyor identifies any condition they believe poses a serious threat to public or
patient health or safety, the surveyor(s) will notify the health care organization’s CEO
and Joint Commission headquarters staff immediately. An officer of The Joint
Commission with a clinical background, or a designee, can then issue an expedited
Preliminary Denial of Accreditation decision based on the threat. An organization
notified of a Preliminary Denial of Accreditation decision‡‡ due to an Immediate Threat
to Health or Safety situation does not have a right to “clarify” the survey findings relative
to the situation. Since a Preliminary Denial of Accreditation is an official accreditation
decision category, the decision is posted on Quality Check.
The organization’s CEO (or a designee) and appropriate governmental authorities will be
informed of this decision and the findings that led to this action. After notification of the
Preliminary Denial of Accreditation decision, an organization has up to 72 hours to do
the following:
■ Eliminate the Immediate Threat to Health or Safety situation entirely
or
■ If the situation is such that it will take the organization more time to fully eliminate
it (such as situations involving building construction), then the organization must
implement emergency interventions§§ to abate the risk to patients (for example, cease
performing a certain procedure, implement additional safety measures) within 72
hours. If the situation is not fully eliminated within 72 hours, the organization will
have a maximum of 23 calendar days to do so.

‡‡
After the Preliminary Denial of Accreditation decision has been confirmed by the Joint Commission’s
Accreditation Council, the organization has five (5) days to notify The Joint Commission if it wishes to
appeal the decision. If this is the case, The Joint Commission’s Review and Appeal Procedures apply.
§§
Emergency intervention refers to any safety measure implemented to preserve life, whether related to
Life Safety Code® and/or Health Care Facilities Code deficiencies or another Immediate Threat to
Health or Safety situation. When referring to specific Life Safety Code and/or Health Care Facilities
Code issues, these interventions would be called interim life safety measures, which are defined as “a
series of 14 administrative actions intended to temporarily compensate for significant hazards posed by
existing National Fire Protection Association 101-2012 Life Safety Code and/or NFPA 99-2012 Health
Care Facilities Code deficiencies or construction activities.”

Shading indicates a change effective July 1, 2024, unless otherwise noted in the What's New.
ACC – 30 CAMLAB Update 1, July 2024
E-dition July 1, 2024, Release
 The Accreditation Process◥

The Accreditation Council can either confirm or reverse the Preliminary Denial of
Accreditation decision by an officer with a clinical background or a designee. The
Accreditation Council may take into consideration an organization’s corrective actions or
responses to a serious threat situation. The organization can provide information to
demonstrate that a serious threat to health or safety has been corrected prior to the
Accreditation Council’s consideration of the Preliminary Denial of Accreditation
decision.
In these situations, the corrective action is considered when a single issue leads to the
adverse finding and the organization demonstrates that it did the following:
■ Took immediate action to completely remedy the situation
■ Adopted necessary systems changes to prevent a future recurrence of the problem
If the organization indicates that it has taken corrective action following the survey, The
Joint Commission will conduct an abatement survey to validate the implementation of
the corrective action and that the immediate threat situation is no longer present. The
Joint Commission will remove the need for a 23-day abatement survey for any
organization that demonstrates that it completed the following prior to the conclusion of
the survey event during which the immediate threat situation was identified:
■ Took immediate action to completely remedy the situation
■ Adopted necessary systems changes to prevent a future recurrence of the problem
The results of the abatement survey will help The Joint Commission determine whether
to remove the Preliminary Denial of Accreditation decision (assuming there are no other
reasons for the Preliminary Denial of Accreditation). Therefore, the sooner an
organization eliminates the Immediate Threat to Health or Safety situation, the shorter
the period of time the organization may be in Preliminary Denial of Accreditation.
Upon resolution of an Immediate Threat to Health or Safety situation, if the
organization does not meet any other Preliminary Denial of Accreditation decision rules,
the organization’s accreditation status may change from Preliminary Denial of
Accreditation to another accreditation decision, such as an Accreditation with Follow-up
Survey, which shall remain as such until an accreditation follow-up survey is conducted
to assess the organization’s sustained implementation of appropriate corrective actions.
See Figure 2 for a visual representation of the process flow for Immediate Threat to
Health or Safety situations at organizations seeking reaccreditation.

Shading indicates a change effective July 1, 2024, unless otherwise noted in the What's New.
CAMLAB Update 1, July 2024 ACC – 31
E-dition July 1, 2024, Release
 ACC – 32
Process Flow for Immediate Threat to Health or Safety (ITHS) Situations

The Joint

seeking reaccreditation.
Central Office
Commission
Surveyor consults staff discusses
During survey, officer agrees with Organization receives
with The Joint the situation with NO
Survey is surveyors the ITHS and places alternative accreditation decision
Commission’s The Joint
conducted identify an the organization in
Central Office Commission’s based on survey findings
ITHS situation Preliminary Denial of
staff officer or
Accreditation
designee
(PDA)

NO PDA process
continues
YES

The organization is Organization notifies The Joint

PDA decision is The Joint Commission Commission ITHS situation
notified of PDA
presented to the that it has abated the conducts an no longer exists
decision and ITHS
Accreditation Council ITHS situation abatement survey
process is explained

YES
PDA decision is
posted on Quality
Check and govern- Unless another
mental/licensure
PDA decision rule AFS
agencies are notified
is met, the PDA process is
decision may be invoked
changed to
Organization is notified Accreditation
of the Accreditation with Follow-up
Accreditation Council’s decision and
YES Organization YES Appeal Survey (AFS)
Council its right to appeal appeals PDA process decision
confirms PDA

E-dition July 1, 2024, Release

provided The Joint decision
◤Comprehensive Accreditation Manual for Laboratory and Point-of-Care Testing

decision Commission is notified

within five days

NO NO

Organization receives Denial of Accreditation

alternative becomes final
accreditation decision after five days

Shading indicates a change effective July 1, 2024, unless otherwise noted in the What's New.
Figure 2. Process flow for Immediate Threat to Health or Safety (ITHS) situations at organizations

CAMLAB Update 1, July 2024

 The Accreditation Process◥

Immediate Threat to Health or Safety During Initial

Survey
There are only two possible outcomes—Accredited or Denial of Accreditation—for an
organization undergoing its first, or initial, Joint Commission survey; therefore, initial
organizations that have an Immediate Threat to Health or Safety situation will receive a
Denial of Accreditation decision with no opportunity for an appeal. After the Immediate
Threat to Health or Safety situation is identified, the organization will not be able to
withdraw from the accreditation process. In addition, The Joint Commission will notify
the licensing authority having jurisdiction that the organization was denied accreditation
due to the Immediate Threat to Health or Safety. If the organization decides to reapply
after the appropriate time interval (a minimum of four months), it will undergo a survey
to demonstrate that it has abated the Immediate Threat to Health or Safety. This survey
may be conducted before—or in conjunction with—the initial survey.

Summary of the Accreditation Reports

Following the evaluation of an organization’s performance of functions and processes,
the surveyor (or survey team) reviews the results of integrated individual findings. Then,
with the use of support software, the surveyor (or survey team) posts the organization’s
Preliminary Accreditation Report to the organization’s secure Joint Commission Connect
extranet site for a limited time. Included in this preliminary report is the SAFER Matrix,
which gives a visual representation of the risk level of each RFI. If requested, the surveyor
(or survey team leader) and the organization’s CEO meet prior to the closing conference
to determine how the Preliminary Accreditation Report will be shared (in terms of
detailed, summary, or general comments) at the closing conference. The surveyor (or
survey team) uses the preliminary report contents when making closing conference
presentations.
Shortly after a survey, an organization’s Final Accreditation Report is posted on the
organization’s secure Joint Commission Connect extranet site. The final report includes
RFIs, as appropriate. Each RFI will be plotted on the SAFER Matrix according to the
risk level of the finding—that is, the likelihood of the finding to cause harm to patients,
staff, and/or visitors and the scope at which the RFI was observed. If a laboratory does not
receive any RFIs, its accreditation decision is rendered at the same time that the
laboratory’s Preliminary Accreditation Report is available, and it is effective the day after
the last day of the survey. If a laboratory does receive RFIs, then its accreditation decision

Shading indicates a change effective July 1, 2024, unless otherwise noted in the What's New.
CAMLAB Update 1, July 2024 ACC – 33
E-dition July 1, 2024, Release
◤Comprehensive Accreditation Manual for Laboratory and Point-of-Care Testing

is rendered following the submission of an acceptable ESC report. (See the “Accreditation
Effective Dates” section and the “Evidence of Standards Compliance [ESC] Process”
section for more information.)

After the Survey

This section includes information relevant to an organization that has recently
participated in an accreditation survey. Material includes information on scoring, the
types of accreditation decisions, the ESC and clarification processes, how to request the
review of an accreditation decision, how to appeal an accreditation decision, and how to
use and display an accreditation award.

The Scoring Process

The performance expectations for determining if a standard is in compliance are included
in its EPs. If an EP is determined to be out of compliance, then it will be cited as an RFI.
Each RFI is placed in the SAFER Matrix according to how likely it is that the RFI will
harm a patient(s), staff, and/or visitor (low, moderate, high) and the scope, or prevalence,
at which the RFI was cited (limited, pattern, widespread). As the risk level of a finding or
an observation increases, the placement of the standard and EP moves from the bottom
left corner (lowest risk level) to the upper right corner (highest risk level). Figure 3 is a
representation of the SAFER Matrix.

Shading indicates a change effective July 1, 2024, unless otherwise noted in the What's New.
ACC – 34 CAMLAB Update 1, July 2024
E-dition July 1, 2024, Release
 The Accreditation Process◥

Immediate Threat to Health or Safety

HIGH
(Harm could
happen at any
time)
LIKELIHOOD TO HARM

MODERATE
(Harm could
happen
occasionally)

LOW
(Harm could
happen but
would be rare)
LIMITED PATTERN WIDESPREAD
(Unique occurrence that (Multiple occurrences of (Deficiency is pervasive
is not representative of the deficiency, or a single in the facility, or
routine/regular practice occurrence that has the represents systemic
and has the potential to potential to impact more failure, or has the
impact only one or a very than a limited number of potential to impact
limited number of patients/visitors/staff) most or all patients/
patients/visitors/staff) visitors/staff)

SCOPE

Figure 3. Survey Analysis for Evaluating Risk (SAFER) Matrix.

The SAFER Matrix is only a visual representation of risk associated with survey findings.
Placement of findings on the SAFER Matrix does not enter into the decision process.

How Accreditation Decisions Are Made

Accreditation decisions are made based on the premise that the immediacy of risk to
quality of care and patient safety—as shown by noncompliance with Joint Commission
standards and EPs—varies. All noncompliant EPs will be cited as RFIs. In addition, all
RFIs must be addressed via the ESC submission process. The time frame for completing
the ESC submission is within 60 calendar days. However, organizations recommended
for Preliminary Denial of Accreditation decision PDA02 (as a result of patients being
placed at risk for a serious adverse outcome due to significant and pervasive patterns,
trends, and/or repeat findings) are required to submit a Plan of Correction (POC) within

Shading indicates a change effective July 1, 2024, unless otherwise noted in the What's New.
CAMLAB Update 1, July 2024 ACC – 35
E-dition July 1, 2024, Release
◤Comprehensive Accreditation Manual for Laboratory and Point-of-Care Testing

10 business days instead of an ESC. A validation survey will be required within 60

calendar days to confirm that the organization has implemented the POC and is in full
compliance.
The organization’s accreditation decision will be held in abeyance pending submission of
ESC within the established time frame. For situations that constitute more immediate
risks to quality of care and patient safety, a more severe accreditation status will be
applied. In these scenarios, the following two accreditation classifications will be utilized:
■ Immediate Threat to Health or Safety
■ Decision Rules
Immediate Threat to Health or Safety. Immediate Threat to Health or Safety
situations that are identified have or may potentially have serious adverse effects on the
health or safety of patients. Upon resolution of an Immediate Threat to Health or Safety
situation, the organization’s accreditation status may change from Preliminary Denial of
Accreditation to Accreditation with Follow-up Survey and remain as such until a follow-
up survey is conducted to assess the organization’s sustained implementation of
appropriate corrective actions.
Immediate Threat to Health or Safety situations are cited at Accreditation Participation
Requirement APR.09.04.01, EP 1.
Decision Rules. Decision rules determine an accreditation decision that appropriately
represents an organization’s overall performance as measured by noncompliance with the
applicable standards. Decision rules are applied when a heightened risk to patient care
and safety is determined as a result of survey findings coupled with an organization’s
previous survey history. There are times when situations will automatically trigger a
recommendation for Preliminary Denial of Accreditation or Accreditation with Follow-
up Survey based on such issues as loss of facility licensure, provision of care by unlicensed
individuals who require such a license, and failure to send proficiency testing samples to
another laboratory for analysis. In follow-up to these situations, organizations must
demonstrate resolution of the situation through the ESC process. A survey is conducted
to validate implementation of corrective action.
For more information regarding decision rules, see the “Decision Rules for Organizations
Seeking Reaccreditation” and “Decision Rules for Organizations Seeking Initial
Accreditation” sections later in this chapter.

Shading indicates a change effective July 1, 2024, unless otherwise noted in the What's New.
ACC – 36 CAMLAB Update 1, July 2024
E-dition July 1, 2024, Release
 The Accreditation Process◥

Accreditation Decisions for Organizations Seeking

Renewal
The Joint Commission’s decision categories are designed to help distinguish organiza-
tions with serious patterns and trends in the provision of care, treatment, or services—
which require follow-up more quickly—from those with less serious compliance issues.
There are four possible decision categories for organizations undergoing a Joint
Commission survey for reaccreditation.Figure 4 illustrates the continuum of accredita-
tion decisions possible following resurvey activity. The Joint Commission’s four
accreditation decision categories for organizations seeking renewal of accreditation are as
follows:
1. Accredited. The organization is in compliance with all applicable requirements at
the time of the survey or has addressed all RFIs in an acceptable ESC within 60
calendar days following the posting of the Final Accreditation Report and does not
meet any other rules for other accreditation decisions.
2. Accreditation with Follow-up Survey. The organization is in compliance with all
standards as determined by an acceptable ESC submission. A follow-up survey is
required to assess sustained compliance.
3. Preliminary Denial of Accreditation. There is justification to deny accreditation to
the organization, for example:
■ An Immediate Threat to Health or Safety to patients, staff, or visitors, and/or
■ Submission of falsified documents or misrepresented information, and/or
■ Lack of a required license or similar issue at the time of survey, and/or
■ Failure to resolve the requirements of Accreditation with Follow-up Survey,
and/or
■ Significant noncompliance with Joint Commission standards.
A decision of Preliminary Denial of Accreditation may be subject to review and
appeal prior to the determination to deny accreditation. (See the “Review and Appeal
Procedures” section.)
4. Denial of Accreditation. The organization has been denied accreditation. All
available review and appeal opportunities have been exhausted.

Shading indicates a change effective July 1, 2024, unless otherwise noted in the What's New.
CAMLAB Update 1, July 2024 ACC – 37
E-dition July 1, 2024, Release
◤Comprehensive Accreditation Manual for Laboratory and Point-of-Care Testing

Figure 4. Continuum of survey activity outcomes for organizations seeking renewal of accreditation.

Decision Outcomes for Organizations Seeking Initial

Accreditation
For organizations undergoing their first, or initial, Joint Commission survey, the decision
process may result in only two possible outcomes—Accredited or Denial of Accredita-
tion. Initial organizations receive an Accredited decision when they are in compliance
with all applicable requirements at the time of the survey or when they have addressed all
RFIs in an acceptable ESC within 60 calendar days; if they do not address all RFIs in an
acceptable ESC within 60 calendar days, they receive a Denial of Accreditation decision.
The decision process is as follows:
■ Organizations found out of compliance with Joint Commission requirements during
their initial survey may voluntarily withdraw from the accreditation process prior to
the conclusion of the survey with no decision rendered. If they do not withdraw,
initial organizations are given an opportunity to provide clarifying evidence that
refutes survey findings. If an organization’s clarification request is not accepted, a
decision of Denial of Accreditation—with no opportunity to appeal—will result.
■ If an Immediate Threat to Health or Safety situation is identified during an initial
survey, the organization will not be able to withdraw from the accreditation process.
The organization will receive a Denial of Accreditation decision with no opportunity
for clarification or appeal. (See the “Immediate Threat to Health or Safety” section
for additional information.)

Shading indicates a change effective July 1, 2024, unless otherwise noted in the What's New.
ACC – 38 CAMLAB Update 1, July 2024
E-dition July 1, 2024, Release
 The Accreditation Process◥

An organization that withdraws from the initial survey, is denied accreditation because of
an Immediate Threat to Health or Safety discovered during the survey process, or is
denied accreditation because of failure to meet standards must wait a minimum of four
months before reapplying for an accreditation survey.

Accreditation Effective Dates

For accredited organizations undergoing a resurvey, the effective date of the accreditation
decision varies. (See the “Evidence of Standards Compliance (ESC) Process” section for
more information.) For organizations that do not receive any RFIs, the accreditation
decision will be effective the day after the last day of survey. Otherwise, an accreditation
decision is rendered after all RFIs have been resolved following the submission of an
acceptable ESC report, which is retroactive to the day after the last day of the full survey.
If the organization has an RFI, the accreditation effective date for an organization that
undergoes an initial survey is the date on which the last acceptable ESC was submitted. If
there are no RFIs, the effective date is the day after the last day of the survey.
When an organization’s accreditation decision becomes official, it is publicly disclosable
and is posted on Quality Check. In addition, the RFIs will be posted for those
organizations that receive a Preliminary Denial of Accreditation.

Withdrawing or Closing After Undergoing a Resurvey

An accredited organization’s request to withdraw from the accreditation process after
undergoing a resurvey (or that closes after undergoing survey), but before a final decision
has been made, does not terminate the decision-making process. The Joint Commission
then issues a final accreditation decision. A Denial of Accreditation decision will be
rendered if all follow-up activities are not completed.

Evidence of Standards Compliance (ESC)

Process
An ESC is a report submitted by a surveyed laboratory that details the action(s) that it
took to bring itself into compliance with a standard. The ESC report is available for
completion on the laboratory’s secure Joint Commission Connect extranet site at the same
time that the laboratory’s Final Accreditation Report is posted.

Shading indicates a change effective July 1, 2024, unless otherwise noted in the What's New.
CAMLAB Update 1, July 2024 ACC – 39
E-dition July 1, 2024, Release
◤Comprehensive Accreditation Manual for Laboratory and Point-of-Care Testing

After the survey, the surveyor(s) transmits survey findings to the Joint Commission’s
Central Office where it may undergo further review. The organization’s Final
Accreditation Report will be posted on its secure Joint Commission Connect extranet site
within 10 business days of completing a survey.
Every standard found not in compliance at the time of survey will generate an RFI. When
a laboratory receives an RFI, it can choose to go directly to corrective action or to try and
clarify the accuracy of the RFI. Organizations have 10 days to clarify the accuracy of an
RFI following the close of survey with the exception of any RFIs that resulted in an
Immediate Threat to Health or Safety. (See the “Immediate Threat to Health or Safety”
section for additional information.) The organization must submit either an acceptable
clarification or a corrective ESC for every RFI cited in a laboratory’s Final Accreditation
Report (see the “Clarifying ESC” section). Challenging specific surveyor observations will
not result in the automatic removal of an RFI. The time frame for submitting a
corrective ESC is 60 calendar days. A corrective ESC must address compliance at the EP
level for all applicable corrections.
Submission of the ESC report is considered final, even if submitted in advance of the due
date. This will initiate review and processing by The Joint Commission. In addition,
failure to submit the ESC report by the due date will result in a change to a laboratory’s
accreditation decision to Denial of Accreditation.
For those findings of a higher risk level, additional fields will be required within the ESC
for the organization to provide a more detailed description of the leadership involvement
and preventive analysis that will assist in sustaining the compliance plan. In addition,
these higher risk findings will be provided to surveyors for possible review or validation
during any surveys up until the next full biennial survey occurs. The SAFER Matrix
information in Figure 5 provides a representation of possible ESC follow-up activities for
RFIs of varying risk levels.

Shading indicates a change effective July 1, 2024, unless otherwise noted in the What's New.
ACC – 40 CAMLAB Update 1, July 2024
E-dition July 1, 2024, Release
 The Accreditation Process◥

Figure 5. SAFER Matrix placement and required follow-up activities.

Clarifying ESC
After a survey event, organizations have the opportunity to submit an ESC that clarifies
the accuracy of a finding if they believe that their organization was in compliance with a
particular standard at the time of survey. (This process does not include EPs identified as
noncompliant but for which corrective actions were implemented prior to the survey’s
conclusion. Also not included in this process is the placement of a finding within the
SAFER Matrix; that is, an organization can clarify the finding as a whole but cannot
change where the finding is placed within the matrix.)
The “clarification” is part of the ESC process and must be submitted within 10 business
days following the posting of the organization’s Final Accreditation Report on the Joint
Commission Connect extranet site. The submission of a clarification does not negate the
requirement for submission of a corrective ESC within 60 calendar days if the
clarification does not remove the RFI, nor does it provide an organization with additional
time to submit its ESC. Therefore, if an organization submits clarification and still has to
submit an ESC, the organization will have up to 60 calendar days in total to submit both
the clarification and the corrective ESC.
When submitting clarifying ESCs after a survey event, it is important to follow the
directions in the submission tool. Address each prompt, detailing why the organization
was in compliance at the time of survey. Remember to address the EP as well as the actual
Shading indicates a change effective July 1, 2024, unless otherwise noted in the What's New.
CAMLAB Update 1, July 2024 ACC – 41
E-dition July 1, 2024, Release
◤Comprehensive Accreditation Manual for Laboratory and Point-of-Care Testing

surveyor observation. (If required documents are not available at the time of survey,
documentation cannot be provided during the clarification process to demonstrate
compliance.)

Corrective ESC
A corrective ESC must provide evidence of corrective action already taken. An acceptable
corrective ESC report must detail the following:
■ Compliance at the EP level
■ Action(s), along with the final date of such action(s), that the organization took to
bring itself into compliance with a requirement
■ Title of the staff member ultimately responsible for implementing the corrective
actions and sustaining compliance
■ The plan for sustaining compliance
■ Leadership involvement in the corrective action and sustained compliance plan (for
those RFIs within the high-risk boxes on the SAFER Matrix, see Figure 5)
■ Preventive analysis (for those RFIs within the high-risk boxes on the SAFER Matrix,
see Figure 5)
An acceptable ESC report is due within 60 calendar days following the posting of the
Final Accreditation Report (unless the laboratory is recommended for a PDA02 decision,
in which case it must submit a POC within 10 business days and undergo a validation
survey within 60 calendar days). The required time frame will be specified in the final
report. Following the submission of an acceptable ESC report, the organization receives
an accreditation decision. However, the organization’s accreditation decision is retro-
active to the day after the last day of the survey, unless the organization is undergoing its
first Joint Commission survey. The accreditation effective date for an organization that
undergoes an initial survey is the date on which an acceptable ESC was submitted, if the
organization has any RFIs. If there are no RFIs, the effective date is the day after the last
day of the survey.
If the organization implements acceptable actions to address its RFIs, the organization’s
accreditation decision is Accredited.
The organization’s ESC submission(s) will be evaluated by Central Office staff using the
same scoring guidelines used by the surveyor(s) at the time of survey and by health care
organizations when they conduct their FSA. The Joint Commission will consider the
ESC acceptable when the laboratory has demonstrated resolution of all RFIs. If the

Shading indicates a change effective July 1, 2024, unless otherwise noted in the What's New.
ACC – 42 CAMLAB Update 1, July 2024
E-dition July 1, 2024, Release
 The Accreditation Process◥

laboratory has not met a rule for Accreditation with Follow-up Survey or Preliminary
Denial of Accreditation, and the ESC submission(s) is determined to be acceptable, its
decision will be Accredited.
On-Site ESC. Usually the ESC will be an electronic submission to The Joint
Commission; however, on occasion, a review of the ESC may also be conducted on site
by a surveyor. If an on-site evaluation is required to assess compliance with the relevant
standards following electronic submission, a copy of the laboratory’s electronic ESC is
provided to the surveyor(s) conducting the on-site ESC. The on-site ESC process
provides the opportunity to evaluate the organization’s success in correcting the issues.
A final decision letter will be posted to the laboratory’s secure, password-protected Joint
Commission Connect extranet site when its ESC has been reviewed and an accreditation
decision has been rendered. A Quality Report will then be posted on Quality Check on
The Joint Commission’s website. For more information, see “The Joint Commission
Quality Report” (QR) chapter.

Accreditation Award Display and Use

The Joint Commission provides each accredited organization with one certificate of
accreditation per accreditation program. There is no charge for the initial certificate(s).
Additional certificates may be purchased. Such requests should be submitted through the
organization’s Joint Commission Connect extranet site.
The certificate and all copies remain The Joint Commission’s property. They must be
destroyed if either of the following situations occurs:
■ The organization is issued a new certificate, reflecting a name change
■ The organization’s accreditation decision is changed, withdrawn, or denied for any
reason
An organization accredited by The Joint Commission must be accurate in describing to
the public the nature and meaning of its accreditation and its award. When an
organization receives an accreditation award, The Joint Commission sends the
organization guidelines for characterizing the accreditation award.
An organization may not engage in any false or misleading advertising of an accreditation
award. Any such advertising may be grounds for The Joint Commission to deny
accreditation. For example, an organization may not represent its accreditation as being
awarded by any of The Joint Commission’s corporate members. These include the

Shading indicates a change effective July 1, 2024, unless otherwise noted in the What's New.
CAMLAB Update 1, July 2024 ACC – 43
E-dition July 1, 2024, Release
◤Comprehensive Accreditation Manual for Laboratory and Point-of-Care Testing

American College of Physicians, the American College of Surgeons, the American Dental
Association, the American Hospital Association, and the American Medical Association.
The Joint Commission has permission to reprint the seals of its corporate members on
certificates of accreditation. However, these seals must not be reproduced or displayed
separately from the certificate.
Any organization that materially misleads the public about any matter relating to its
accreditation must undertake corrective advertising to a degree acceptable to The Joint
Commission in the same medium in which the misrepresentation occurred. If an
organization fails to undertake the required corrective advertising following the
communication of false or misleading advertising about its accreditation decision, the
organization may be subject to loss of accreditation.
The Joint Commission’s logo is a registered trademark. An accredited organization may
use the logo if it follows these guidelines:
■ The logo must remain in the same proportional relationship as provided and should
not be displayed any larger than an organization’s own logo.
■ The logo’s format cannot be changed, the name may not be separated from the
symbol, and the logo must be printed in the original color.
■ Graphic devices such as seals, other words, or slogans cannot be added to the logo,
except for the words “Accredited by.”
■ These guidelines apply to logo use on all print materials, Internet webpages, and
promotional items, such as coffee mugs, T-shirts, and notepads.
Contact The Joint Commission Department of Corporate Marketing at 630-792-5179
for questions about using The Joint Commission logo, or access the Accreditation
Publicity Kit online at https://www.jointcommission.org/accreditation-and-
certification/accredited/publicity-kit/.

Between Accreditation Surveys

This section provides information that is relevant to organizations between Joint
Commission surveys. Material includes the duration of an accreditation award, the
process for continuing accreditation, the FSA process, how to notify The Joint
Commission in the event of organization changes, and information on other types of
surveys.

Shading indicates a change effective July 1, 2024, unless otherwise noted in the What's New.
ACC – 44 CAMLAB Update 1, July 2024
E-dition July 1, 2024, Release
 The Accreditation Process◥

Duration of Accreditation Award

An accreditation award is continuous until the organization has its next full survey,
which will be between 22 and 24 months after its previous full survey, unless
accreditation is revoked for cause or as otherwise outlined in this chapter. An
organization may request a full accreditation survey more frequently than when it is due
to have a survey. The Joint Commission, at its discretion and in accordance with its
mission, determines whether to honor the request. An organization should send such a
request to its Joint Commission account executive.
An organization’s accreditation cycle is continuous, as long as the organization:
■ Has a full, unannounced survey within approximately 24 months of its last survey;
and
■ Continues to meet all accreditation-related requirements as required, including, but
not limited to, payment of all fees.

Continuous Compliance
The Joint Commission expects an accredited organization to be in continuous
compliance with all applicable standards and EPs. It may ask an organization to supply,
in writing, information about compliance with applicable standards. The Joint
Commission may conduct a survey if an organization fails to respond to a request for
more information. It may also survey an organization at any time with or without notice
in response to complaints, media coverage, or other information that raises questions
about the adequacy of patient health and safety protections (see the “For-Cause Surveys”
section for more information).
The Joint Commission may view an organization’s failure to permit a survey as the
organization no longer wanting to participate in good faith in the accreditation process.
In such a case, The Joint Commission begins proceedings to deny accreditation to the
organization (see APR.02.01.01 in the APR chapter).

Intracycle Monitoring (ICM)

To assist accredited organizations with their continuous compliance efforts, The Joint
Commission makes the ICM Profile available on the Joint Commission Connect extranet
site. The ICM Profile identifies high-risk areas and related standards for laboratories.

Shading indicates a change effective July 1, 2024, unless otherwise noted in the What's New.
CAMLAB Update 1, July 2024 ACC – 45
E-dition July 1, 2024, Release
◤Comprehensive Accreditation Manual for Laboratory and Point-of-Care Testing

These standards are displayed within the FSA tool with a special risk icon . The FSA
tool enables laboratories to conduct their own self-assessment of standards compliance
throughout the biennial accreditation cycle. Completion of the ICM Profile is optional.
The Joint Commission identifies critical systems/processes that could lead to adverse
effects if they become weak or fail. Risk is assessed by a system’s proximity to the patient,
probability of harm, severity of harm, and number of patients at risk. Risk categories in
the FSA are related to the following three categories:
1. National Patient Safety Goals
2. Accreditation program–specific risk areas
3. RFIs identified during current accreditation cycle survey events

Focused Standards Assessment (FSA)

The FSA process is designed to help laboratories incorporate Joint Commission standards
as part of routine operations and ongoing quality improvement efforts, supporting a
continuous accreditation process. A laboratory has access to its FSA tool on a continuous
basis throughout its accreditation cycle. The FSA tool becomes available to a laboratory
seeking accreditation for the first time after submitting its E-App and deposit. The FSA
tool permits the laboratory to evaluate compliance with all applicable Joint Commission
standards and EPs. For every noncompliant standard, the laboratory must identify a Plan
of Action (POA) at the EP level, identifying how it plans to come into compliance with
the requirement(s). By participating in the FSA, a laboratory will be better able to
incorporate Joint Commission standards into routine operations, which in turn will help
to ensure the provision of safe, high-quality care on an ongoing basis.
The FSA is accessible through the ICM application, which is located on the laboratory’s
secure Joint Commission Connect extranet site. The Joint Commission allows for
submission at the 12th month for lab applications (and at the 12th and 24th month for
general applications). An FSA submission will not occur during the year the laboratory is
scheduled for a full survey. Because full surveys can occur at any time between the 12th
and 24th month of the biennial accreditation cycle, should a full survey occur before a
laboratory’s anticipated FSA due date, the FSA due date will be reset accordingly. These
submission intervals are valuable collaborative and educational touch points to help
organizations remain in continuous compliance with the standards and keep current with
accreditation information. The tool and resources available are designed to provide
educational support.

Shading indicates a change effective July 1, 2024, unless otherwise noted in the What's New.
ACC – 46 CAMLAB Update 1, July 2024
E-dition July 1, 2024, Release
 The Accreditation Process◥

Organizations can select from one of the four ICM submission options. To accomplish a
full submission, the minimum subset of standards coded with the icon must be scored
as well as standards that have been scored as not compliant by the organization.
Organizations submitting Option 1 conduct and score their standards self-assessment but
elect not to submit the data to The Joint Commission. Next are the on-site Option 2 and
3 surveys. These surveys are conducted by a Joint Commission surveyor for an additional
fee. The Option 2 survey results in a written report of findings that the organization
follows up with POAs as appropriate. An Option 3 survey provides the organization with
a verbal report of survey findings but does not result in any historical written
documentation.
Enhancements made to the FSA tool because of the SAFER process include two
additional fields: Likelihood to Harm and Scope. These fields will only be displayed if an
EP is scored as not compliant. Please note that if an organization scores an EP as not
compliant, designating the likelihood to harm and scope is optional.
Sidebar 1 outlines some of the activities in each of these FSA options.

Sidebar 1. Focused Standards Assessment (FSA)

Options

Full
■ Organization uses the FSA tool to assess and score compliance with elements of
performance (EPs) for each applicable standard.
■ Organization creates a Plan of Action (POA)|||| addressing each EP scored as
not compliant.
■ If standards have been scored compliant, after the FSA is submitted, the
Intracycle Monitoring (ICM) requirement for that particular year is completed and
no further action is required.

Option 1
■ Organization uses the FSA tool to assess and score compliance with EPs for
each applicable standard if it chooses to do so.
■ Organization affirms that it has completed an assessment of its compliance with
applicable EPs and developed POAs as necessary, but it does not submit data
to The Joint Commission.
continued on next page

A Plan of Action details the action(s) an organization will take to come into compliance with each
||||

standard identified as not compliant.

Shading indicates a change effective July 1, 2024, unless otherwise noted in the What's New.
CAMLAB Update 1, July 2024 ACC – 47
E-dition July 1, 2024, Release
◤Comprehensive Accreditation Manual for Laboratory and Point-of-Care Testing

Sidebar 1. (continued)

Option 2
■ Organizations that choose an Option 2 on-site survey will be charged a fee.
■ The organization requests either an announced or unannounced FSA survey.
■ Surveyor conducts the FSA survey using tracer methodology and identified
accreditation program–specific risk areas; all standards are subject to review.
■ Surveyor leaves a written report of findings with the organization.
■ Survey Analysis for Evaluating Risk (SAFER) Matrix is included during on-site
visit and embedded within report.
■ Within 30 calendar days of the survey, organization submits POAs for each
noncompliant standard through the historical FSA tool.

Option 3
■ Organizations that choose an Option 3 on-site survey will be charged a fee.
■ The organization requests either an announced or unannounced FSA survey.
■ Surveyor conducts the FSA survey using tracer methodology and identified
accreditation program–specific risk areas; all standards are subject to review.
■ SAFER Matrix is included during on-site visit.
■ Surveyor delivers an oral report of findings at the closing conference of the on-
site survey. No written report of findings will be left at the organization.

Plan of Action (POA)

A POA is a detailed description of how an organization plans to bring into compliance
any standard identified as “not compliant” in the FSA. The POA must include the
planned action to be taken and target implementation dates.

Sentinel Event Follow-up

Accredited laboratories are expected to identify and respond appropriately to all sentinel
events. The laboratory is required to conduct a thorough and credible comprehensive
systematic analysis and develop a corrective action plan in a manner and time frame
acceptable to The Joint Commission as specified in the Sentinel Event Policy and submit
them to The Joint Commission or otherwise provide evidence of an acceptable response
to the sentinel event. (See the “Sentinel Event Policy” [SE] chapter for more information.
)

Shading indicates a change effective July 1, 2024, unless otherwise noted in the What's New.
ACC – 48 CAMLAB Update 1, July 2024
E-dition July 1, 2024, Release
 The Accreditation Process◥

Notifying The Joint Commission About

Organization Changes
Accreditation is neither automatically transferred to a new owner nor continued if
significant changes occur within a laboratory. Laboratories must notify The Joint
Commission promptly, in writing, when an additional service is contemplated## so any
potential impact to accreditation can be determined. After the change has actually
occurred, the E-App must be updated to reflect the change as well.

Changes Affecting E-App Information

At any time during the accreditation process, a laboratory may undergo a change that
modifies the information reported in its E-App (see APR.01.03.01 in the APR chapter).
Laboratories must notify The Joint Commission promptly, in writing, when an
additional service or location is contemplated so any potential impact to accreditation can
be determined. A laboratory may also be required to notify its state CLIA office for
certain changes.
After the change has actually occurred, the laboratory must update its E-App within 30
calendar days. Information that must be reported includes any of the following:
■ A change in ownership
■ A change in location
■ A change in laboratory director
■ A change in CLIA certificate type
■ A significant increase or decrease in the volume of services or individuals served
■ The addition of a new type of specialty or sub-specialty, program, or site of care
■ The deletion of an existing specialty or sub-specialty, program, or site of care
■ The addition of any high-complexity testing to the test menu
■ The acquisition of a new component, for example, a new CLIA certificate
■ The deletion of an existing component, for example, the deletion of a CLIA
certificate
The Joint Commission may conduct an additional survey at a later date if its surveyor or
survey team arrives at the laboratory and discovers that a change was not reported. The
Joint Commission may also survey any unreported services and sites addressed by its
standards during the survey as appropriate. The Joint Commission makes the final
accreditation decision for the laboratory only after surveying all or an appropriate sample

An organization is considered to have “contemplated” a change when leadership within the

##

organization has approved moving forward with the proposed change and identified a time frame for
implementing that change.

Shading indicates a change effective July 1, 2024, unless otherwise noted in the What's New.
CAMLAB Update 1, July 2024 ACC – 49
E-dition July 1, 2024, Release
◤Comprehensive Accreditation Manual for Laboratory and Point-of-Care Testing

of all services, programs, and sites provided by the organization for which The Joint
Commission has standards. Information reported in the E-App is subject to The Joint
Commission’s Information Accuracy and Truthfulness Policy.

Changes to the Site of Care, Treatment, or Services

When a laboratory offers its services or programs at a new location or in a significantly
altered physical plant,*** the laboratory must evaluate for Life Safety Code®†† ‡‡‡ and
Health Care Facilities Code deficiencies, as applicable, and document the corrective
actions (to be completed within 60 days of notification to The Joint Commission) and
interim life safety measures (ILSM) implemented to protect the building occupants while
the deficiencies are being corrected. Failure to provide timely notification to The Joint
Commission of these conditions may result in the laboratory’s loss of accreditation. If the
corrective actions cannot be accomplished within 60 days of notification to The Joint
Commission, the laboratory will need to contact its account executive.

Mergers, Consolidations, and Acquisitions

In the case of a merger, consolidation, or acquisition, The Joint Commission may decide
that the organization responsible for services must undergo a survey. If, after an
organization receives an accreditation decision, the organization’s structure changes
whereby one or more of its services, programs, or related laboratories are no longer part of
the organization that was originally surveyed, the service, program, or related organization
is no longer included in the organization’s accreditation.
See the “Extension Surveys” section for more information on what The Joint
Commission expects to accomplish on these surveys.

***
Facilities or spaces are considered significantly altered when changes align with the classifications of
“Modification” and “Reconstruction” in accordance with NFPA 101-2012, 43.2.2.1.3/4.
††
Life Safety Code® is a registered trademark of the National Fire Protection Association (NFPA),
Quincy, MA.
‡‡‡
The Joint Commission evaluation of Life Safety Code and Health Care Facilities Code requirements is
based on the 2012 edition of the NFPA Life Safety Code (NFPA 101) and the 2012 edition of the NFPA
Health Care Facilities Code (NFPA 99).

Shading indicates a change effective July 1, 2024, unless otherwise noted in the What's New.
ACC – 50 CAMLAB Update 1, July 2024
E-dition July 1, 2024, Release
 The Accreditation Process◥

Accreditation Status of Organizations That

Cease Services After a Disaster§§§
Following a disaster that requires a Joint Commission–accredited laboratory to cease the
provision of services for a period of time, The Joint Commission will work with the
affected laboratory to address the impact that the cessation of services will have on the
laboratory’s accreditation status and to ensure that the laboratory is prepared to provide
safe, quality care upon resumption of services. If after six months the laboratory cannot
resume services, The Joint Commission will withdraw the accreditation of the laboratory.
The impact of the cessation of services for a period of time on the accreditation status of
organizations that experience a disaster is described in the following subsections.
Cease Services Up to 30 Days. For laboratories that resume services within the first
30 days after a disaster and/or the laboratory’s decision to cease operations, the
laboratory’s original Joint Commission accreditation status will stay in effect. The time
frame for complying with any outstanding Joint Commission requirements (such as the
FSA or ESC) will pause until the laboratory resumes operation. In most cases, The Joint
Commission will not need to survey the affected laboratory to reassess its level of
standards compliance. If The Joint Commission decides to conduct a survey, however,
the laboratory’s accreditation decision will be driven by the interim survey findings.
Cease Services Up to 90 Days. For laboratories that resume services from 31 to 90
days after a disaster, The Joint Commission will conduct an extension survey to
determine the laboratory’s accreditation status. The circumstances surrounding the
laboratory’s closure will determine the survey’s length and scope.
Cease Services Up to Six Months. For laboratories that resume services from 91
days up to six months after a disaster, The Joint Commission will require a survey. This
survey will preferably take place one to two weeks after services are resumed. These
laboratories must receive clearance to operate from the fire marshal, if appropriate, and
other local/state authorities before resuming services. In addition, The Joint Commission
will conduct a second survey approximately four months after services have been resumed
to evaluate sustained compliance with Joint Commission standards and requirements.
The track record requirement for demonstrating standards compliance will be four
months.

§§§
Can be natural or man-made; any situation that causes cessation of services.

Shading indicates a change effective July 1, 2024, unless otherwise noted in the What's New.
CAMLAB Update 1, July 2024 ACC – 51
E-dition July 1, 2024, Release
◤Comprehensive Accreditation Manual for Laboratory and Point-of-Care Testing

More Than Six Months. For laboratories that do not resume services within six months
after a disaster or decide to cease operations, The Joint Commission will discontinue its
accreditation. If the laboratory resumes services, it must reapply to become accredited. In
such cases, the accreditation process will involve at least two surveys. The first survey will
be conducted at the laboratory’s request and will assess the laboratory’s ability to provide
safe patient care. The laboratory may qualify for an accreditation award as a result of this
survey. The second survey will be conducted approximately four months later to assess
sustained compliance with Joint Commission requirements.
The Joint Commission will continue to post on Quality Check all affected laboratories as
Accredited up to six months after a disaster, unless interim survey findings dictate
otherwise.
While working with affected health care organizations in the aftermath of a catastrophic
event, The Joint Commission will be sensitive to these organizations’ needs and will work
with responsible state and federal agencies to help reestablish the organizations’
operations as well as their qualification for accreditation.
If, following a disaster, a laboratory provides services at an alternate site, The Joint
Commission will determine whether an extension survey or a full survey is required based
on the scope of services being provided at the alternate site and the expected period of
time that the services will be provided at the site.
When a laboratory is affected by a natural disaster, its account executive should be
notified as soon as possible at 630-792-3007. Once notified, The Joint Commission can
cancel any accreditation-related events and offer assistance, if needed.
This policy outlines a framework that The Joint Commission will generally follow when
an organization is required to cease services for a period of time following a disaster.
Depending on the unique circumstances of each situation, The Joint Commission may
choose to modify this approach accordingly. In addition, The Joint Commission may
coordinate its response with local, state, and/or federal officials having jurisdiction over
the organization, as appropriate.

Accreditation Status of Organizations That

Cease Services or Do Not Have Patients for a
Period of Time

Shading indicates a change effective July 1, 2024, unless otherwise noted in the What's New.
ACC – 52 CAMLAB Update 1, July 2024
E-dition July 1, 2024, Release
 The Accreditation Process◥

Joint Commission–accredited laboratories may stop providing care, treatment, and

services to patients or may not have any patients for a period of time for reasons other
than natural or man-made disasters. When a laboratory ceases to provide patient care
services, it is required to notify The Joint Commission. The Joint Commission will work
with the affected laboratory to address the impact that the cessation of services or the lack
of patients will have on the laboratory’s accreditation status and to ensure that the
laboratory is prepared to provide safe, quality care upon resumption of services. If after
six months the laboratory cannot resume services, The Joint Commission will terminate
the accreditation of the laboratory.
Up to 60 Days. If a laboratory does not have any patients for up to 60 days but resumes
patient services, The Joint Commission will continue the laboratory’s current accredita-
tion status.
Up to Six Months. If a laboratory does not have any patients from 60 days to less than
six months, but then resumes patient services within six months, The Joint Commission
will continue the organization’s current accreditation status after an extension survey. An
extension survey takes place as soon as possible in accordance with the laboratory’s
request. The purpose of this survey is to evaluate the laboratory’s capability for resuming
services and whether it meets current accreditation standards. If the laboratory refuses an
extension survey, the accreditation may be terminated.
More Than Six Months. If a laboratory does not have any patients for six months or
longer, The Joint Commission will terminate the laboratory’s accreditation. If the
laboratory resumes services, it will have to reapply for accreditation and have a full survey
in order to evaluate its current compliance with Joint Commission standards.

Reentering the Accreditation Process

For a previously accredited organization to be designated as “new,” it must not have
participated in the accreditation process during the previous four months. If an
organization is reentering the accreditation process before four months have passed, it
must demonstrate a continuous 12-month track record of compliance with the standards.

Additional Surveys
This section describes additional surveys that may occur during the accreditation cycle,
including extension surveys, for-cause surveys, and other follow-up surveys.

Shading indicates a change effective July 1, 2024, unless otherwise noted in the What's New.
CAMLAB Update 1, July 2024 ACC – 53
E-dition July 1, 2024, Release
◤Comprehensive Accreditation Manual for Laboratory and Point-of-Care Testing

Extension Surveys
The Joint Commission conducts an extension survey when an accredited laboratory
acquires a new service, program, or site for which The Joint Commission has standards or
significantly alters how it delivers care, treatment, or services. Extension surveys are
performed to ensure that the accreditation decision previously awarded to the laboratory
is still appropriate under the changed conditions. The results of an extension survey may
affect the laboratory’s accreditation status.
An extension survey is conducted at an accredited laboratory or at a site that is owned
and operated by the laboratory if the accredited laboratory’s current accreditation is not
due to expire for at least nine months and when at least one of the following conditions is
met:
■ Changed ownership and has a significant number of changes in the management and
clinical staff or operating policies and procedures
■ Offered services at a new location
■ Offered services at a significantly altered physical plant as defined by the
classifications “Modification” and “Reconstruction” in accordance with NFPA 101-
2012, 43.2.2.1.3/4
■ Expanded capacity to provide services by 50% or more, as measured by patient
volume, pieces of equipment, or other relevant measures. This criterion will generate
an extension survey only if there are also other changes at the organization.
■ Provided a more intensive level of service
When an organization acquires a CLIA laboratory registration certificate, adds high-
complexity testing, or upgrades a CLIA certificate of waiver or Certificate for PPMP to a
Certificate of Accreditation, an extension survey will be conducted within four to six
months to allow the organization time to bring a new service or site up to accreditation
standards compliance.||||||||||||

For-Cause Surveys
The Joint Commission may perform a for-cause survey when it becomes aware of
potentially serious standards compliance or patient care, treatment, service, or safety
issues or when it has other valid reasons for surveying an accredited organization (see
APR.02.01.01 in the APR chapter).
Note: While The Joint Commission may conduct a for-cause survey within a full survey

Per federal guidelines, a laboratory must obtain accreditation within 11 months of the issuance of a
||||||||||||

CLIA Laboratory Registration Certification number.

Shading indicates a change effective July 1, 2024, unless otherwise noted in the What's New.
ACC – 54 CAMLAB Update 1, July 2024
E-dition July 1, 2024, Release
 The Accreditation Process◥

(as these surveys may be referred to the full survey team for investigation), for-cause
unannounced surveys should not be confused with the regular unannounced surveys
described in the “Survey Notification” section.
Such a survey can either include all the organization’s services or only those areas where a
serious concern may exist.
A for-cause survey, which is usually unannounced, can take place at any point in an
organization’s accreditation cycle. A Preliminary Accreditation Report is not generated
after a for-cause survey; however, a Final Accreditation Report will be posted to an
organization’s Joint Commission Connect extranet site.
Note: An organization is charged for a for-cause survey. An organization can determine
the cost of such a survey by calling The Joint Commission’s Pricing Unit at 630-792-5115.
The Joint Commission may deny an organization accreditation if the organization does
not allow The Joint Commission to conduct an unscheduled or unannounced survey (see
APR.02.01.01 in the APR chapter).

Decision Rules for Organizations Seeking

Initial Accreditation
The Joint Commission makes accreditation decisions by applying decision rules to the
scored standards. Decision rules determine an accreditation decision that appropriately
represents an organization’s overall performance as measured by evidence of compliance
with the applicable standards. The Accreditation Council may exercise reasonable
discretion in individual cases to determine whether to vary from applicable decision rules
in furtherance of The Joint Commission’s mission to help health care organizations to
continuously improve health care for the public.
The decision rules for laboratories follow.
Note: Accreditation decision rules are numbered sequentially. Some accreditation rules
apply specifically to initial surveys and others only to resurveys. Consequently, gaps may
appear in the sequence of the decision rules included in this section.

Accredited
Accreditation will be recommended when one or more of the following conditions are
met:

Shading indicates a change effective July 1, 2024, unless otherwise noted in the What's New.
CAMLAB Update 1, July 2024 ACC – 55
E-dition July 1, 2024, Release
◤Comprehensive Accreditation Manual for Laboratory and Point-of-Care Testing

A01 The laboratory is in compliance with all standards at the time of the survey or
has addressed all RFIs in its first acceptable ESC submission and does not
meet any rules for other accreditation decisions.
A02 The laboratory, as a result of a follow-up survey, is compliant with the
original survey RFIs.
Note: Should additional RFIs be identified, appropriate decision rules apply.

Evidence of Standards Compliance (ESC)

An ESC will be required when one or more of the following conditions are met:
ESC01 A laboratory has one or more noncompliant standards at the time of a survey
event.
ESC02 A laboratory that fails to address all RFIs in an acceptable ESC may be
required to submit a second ESC.
ESC03 The laboratory demonstrates systemic patterns and trends of noncompliance
with standards requiring an on-site evaluation to validate compliance with
the relevant standards in a written ESC.

One-Month Survey
A one-month survey will be performed when the following condition is met:
FOC01 A full laboratory survey will be conducted when a laboratory providing
laboratory services cannot demonstrate to The Joint Commission that its
laboratory accreditation decision is in good standing with a Joint Com-
mission–recognized accreditor or the accreditation is more than 24 months
old.

Retrospective Cytology Survey

A retrospective cytology survey will be scheduled within 45 days when the following
condition is met:

Shading indicates a change effective July 1, 2024, unless otherwise noted in the What's New.
ACC – 56 CAMLAB Update 1, July 2024
E-dition July 1, 2024, Release
 The Accreditation Process◥

FOC02 A retrospective cytology survey will be conducted if, during a full laboratory
survey, a laboratory providing cytology services is observed to have quality
issues in this specialty. This will require a special survey that includes, but is
not limited to, a review of slides for diagnostic discrepancies, evaluation of
policies and procedures, and verification of staff workload.

Proficiency Testing Monitoring Survey

A proficiency testing monitoring survey will be scheduled when the following condition
is met:
PTM01 The laboratory has either initial or subsequent unsuccessful proficiency test
performance and a determination is made that an evaluation is required to
assess either the plan of action or the plan for reinstatement when applicable,
following cessation of testing (voluntary or involuntary).

Denial of Accreditation
Denial of Accreditation will be recommended when one or more of the following
conditions are met:
DA01 The laboratory does not permit the performance of any survey by The Joint
Commission. (APR.02.01.01, EP 1)
DA03 The laboratory has failed to submit payment for survey fees or annual fees.
DA04 The laboratory has failed to submit a timely ESC after a survey.
DA05 A laboratory undergoing its first Joint Commission survey has placed
patients at risk for a serious adverse outcome(s) due to significant and
pervasive patterns and trends in survey findings.
DA06 An Immediate Threat to Health or Safety exists for patients, staff, or the
public within the laboratory undergoing its first Joint Commission survey.
(APR.09.04.01, EP 1)
DA07 The Joint Commission is reasonably persuaded that the laboratory submitted
falsified documents or misrepresented information in any way in seeking to
achieve accreditation. If accreditation is denied following implementation of
this rule, the laboratory shall be prohibited from participating in the

Shading indicates a change effective July 1, 2024, unless otherwise noted in the What's New.
CAMLAB Update 1, July 2024 ACC – 57
E-dition July 1, 2024, Release
◤Comprehensive Accreditation Manual for Laboratory and Point-of-Care Testing

accreditation process for a period of one year unless an officer of The Joint
Commission with a clinical background, for good cause, waives all or a
portion of this waiting period. (APR.01.02.01, EP 1)
DA08 The laboratory undergoing its first Joint Commission survey fails to address
all RFIs in an acceptable ESC after two opportunities.
DA10 The laboratory’s patients have been placed at risk for a serious adverse
outcome because either an individual who does not possess a license,
registration, or certification is providing or has provided health care services
in the laboratory that would, under applicable law or regulation, require such
a license, registration, or certification; or an individual is practicing outside
the scope of their license, registration, or certification. (HR.01.02.07, EPs 1
and 2)
DA11 The laboratory does not possess a license, certificate, and/or permit, as or
when required by applicable law and regulation, to provide the health care
services for which the laboratory is seeking accreditation. (LD.04.01.01, EP 1)

Decision Rules for Organizations Seeking

Reaccreditation
Accredited
Accreditation will be recommended when one or more of the following conditions are
met:
A01 The laboratory is in compliance with all standards at the time of the survey or
has addressed all RFIs in its first acceptable ESC submission and does not
meet any rules for other accreditation decisions.
A02 The laboratory, as a result of a follow-up survey, is compliant with the
original survey RFIs.
Note: Should additional RFIs be identified, appropriate decision rules apply.

Shading indicates a change effective July 1, 2024, unless otherwise noted in the What's New.
ACC – 58 CAMLAB Update 1, July 2024
E-dition July 1, 2024, Release
 The Accreditation Process◥

Evidence of Standards Compliance (ESC)

An ESC will be required when one or more of the following conditions are met:
ESC01 A laboratory has one or more noncompliant standards at the time of a survey
event.
ESC02 A laboratory that fails to address all RFIs in an acceptable ESC may be
required to submit a second ESC.

One-Month Survey
A one-month survey will be performed when the following condition is met:
FOC01 A full laboratory survey will be conducted when a laboratory providing
laboratory services cannot demonstrate to The Joint Commission that its
laboratory accreditation decision is in good standing with a Joint Com-
mission–recognized accreditor or the accreditation is more than 24 months
old.

Retrospective Cytology Survey

A retrospective cytology survey will be scheduled within 45 days when the following
condition is met:
FOC02 A retrospective cytology survey will be conducted if, during a full laboratory
survey, a laboratory providing cytology services is observed to have quality
issues in this specialty. This will require a special survey that includes, but is
not limited to, a review of slides for diagnostic discrepancies, evaluation of
policies and procedures, and verification of staff workload.

Proficiency Testing Monitoring Survey

A proficiency testing monitoring survey will be scheduled when the following condition
is met:
PTM01 The laboratory has either initial or subsequent unsuccessful proficiency test
performance and a determination is made that an evaluation is required to
assess either the plan of action or the plan for reinstatement when applicable,
following cessation of testing (voluntary or involuntary).

Shading indicates a change effective July 1, 2024, unless otherwise noted in the What's New.
CAMLAB Update 1, July 2024 ACC – 59
E-dition July 1, 2024, Release
◤Comprehensive Accreditation Manual for Laboratory and Point-of-Care Testing

Accreditation with Follow-up Survey

Note: The Accreditation with Follow-up Survey could occur within 30 days or up to six
months after the decision is rendered.
Accreditation with Follow-up Survey will be recommended when one or more of the
following conditions are met:
AFS01 The laboratory demonstrates systemic patterns, trends, and repeat findings
with standards.
AFS03 The laboratory fails to address all RFIs in an acceptable ESC after two
opportunities.
AFS05 The laboratory, which has failed to resolve one or more of its original RFIs,
may be scheduled for a second Accreditation with Follow-up Survey.
AFS06 The laboratory fails to participate in ICM requirements.
AFS07 The laboratory fails to submit a written plan of action for unsuccessful
proficiency testing after two requests from The Joint Commission.
AFS09 An individual who does not possess a license, registration, or certification is
providing or has provided health care services in the laboratory that would,
under applicable law or regulation, require such a license, registration, or
certification; or an individual is practicing outside the scope of their license,
registration, or certification. (HR.01.02.07, EPs 1 and 2)
Note: Except as provided under rule PDA03.
AFS11 If the Immediate Threat to Health or Safety abatement survey through direct
observation or other determining method has demonstrated that the
laboratory has implemented sufficient corrective action of the Immediate
Threat, the Accreditation Council may change the decision to Accreditation
with Follow-up Survey.
AFS12 There is some evidence that the laboratory may have engaged in possible
fraud or abuse.
AFS13 If a laboratory that has met the PDA02 decision rule has implemented
sufficient corrective action as evidenced through a validation survey, the
Accreditation Council may change the decision to Accreditation with
Follow-up Survey.

Shading indicates a change effective July 1, 2024, unless otherwise noted in the What's New.
ACC – 60 CAMLAB Update 1, July 2024
E-dition July 1, 2024, Release
 The Accreditation Process◥

Preliminary Denial of Accreditation

Preliminary Denial of Accreditation will be recommended when one or more of the
following conditions are met:
PDA01 An Immediate Threat to Health or Safety exists for patients, staff, or the
public within the laboratory. (APR.09.04.01, EP 1)
PDA02 The laboratory’s patients have been placed at risk for a serious adverse
outcome(s) due to significant and pervasive patterns, trends, and/or repeat
findings.
PDA03 The laboratory’s patients have been placed at risk for a serious adverse
outcome because either an individual who does not possess a license,
registration, or certification is providing or has provided health care services
in the laboratory that would, under applicable law or regulation, require such
a license, registration, or certification; or an individual is practicing outside
the scope of their license, registration, or certification. (HR.01.02.07, EPs 1
and 2)
PDA04 The laboratory does not possess a license, certificate, and/or permit, as or
when required by applicable law and regulation, to provide the health care
services for which the laboratory is seeking accreditation. (LD.04.01.01,
EP 1)
PDA05 The Joint Commission is reasonably persuaded that the laboratory submitted
falsified documents or misrepresented information in any way in seeking to
achieve or retain accreditation. If accreditation is denied following implemen-
tation of this rule, the laboratory shall be prohibited from participating in the
accreditation process for a period of one year unless an officer of The Joint
Commission with a clinical background, for good cause, waives all or a
portion of this waiting period. (APR.01.02.01, EP 1)
PDA06 The laboratory with a decision of Accreditation with Follow-up Survey has
failed to resolve all RFIs after two opportunities.
PDA07 The laboratory has failed to comply with a cease testing order issued by The
Joint Commission, one of its cooperative partners, or a regulatory agency.

Shading indicates a change effective July 1, 2024, unless otherwise noted in the What's New.
CAMLAB Update 1, July 2024 ACC – 61
E-dition July 1, 2024, Release
◤Comprehensive Accreditation Manual for Laboratory and Point-of-Care Testing

PDA08 The organization’s laboratory personnel have referred proficiency testing

samples to another laboratory for analysis or participated in inter-laboratory
communication regarding proficiency testing results before the results have
been reported to the program provider. (QSA.01.04.01, EPs 1 and 2)
PDA10 The laboratory’s patients have been placed at risk for a serious adverse
outcome because there is some evidence that the organization may have
engaged in possible fraud or abuse.
PDA11 If the Immediate Threat to Health or Safety abatement survey through direct
observation or other determining method has not demonstrated that the
laboratory has implemented sufficient corrective action of the Immediate
Threat, the Accreditation Council will continue the decision of Preliminary
Denial of Accreditation.

Denial of Accreditation
Denial of Accreditation will be recommended when one or more of the following
conditions are met:
DA01 The laboratory does not permit the performance of any survey by The Joint
Commission. (APR.02.01.01, EP 1)
DA02 The laboratory has failed to resolve an Accreditation with Follow-up Survey
status prior to withdrawing from the accreditation process.
DA03 The laboratory has failed to submit payment for survey fees or annual fees.
DA04 The laboratory has failed to submit an ESC or a POC.
DA05 A laboratory in the Sustaining Improvement Program fails to participate in
Joint Commission intervention.
DA06 A laboratory has received a Preliminary Denial of Accreditation decision in
any two surveys between two sequential triennial accreditation cycles or in
two triennial surveys.

Shading indicates a change effective July 1, 2024, unless otherwise noted in the What's New.
ACC – 62 CAMLAB Update 1, July 2024
E-dition July 1, 2024, Release
 The Accreditation Process◥

Process for Organizations That Meet

Decision Rule PDA02 for Patients Placed at
Risk for Serious Adverse Outcomes Due to
Significant and Pervasive Patterns, Trends,
and/or Repeat Findings
The following process applies for organizations that receive a PDA02 decision:
■ If an organization meets decision rule PDA02, the organization will be notified
within 10 business days of the completion of its survey when its Final Accreditation
Report is posted on its extranet site.
■ An organization will have the option of clarifying any inaccurate survey findings
within 10 business days of the posting of the Final Accreditation Report. The
organization may waive this clarification option.
■ After the clarification is completed or waived, a POC will be required within 10
business days. The POC must address all RFIs cited in the organization’s Final
Accreditation Report.
■ A decision of PDA02 will be rendered and remain in place until a PDA02 validation
survey can be conducted. If the PDA02 validation survey demonstrates corrective
actions and no other reason exists to keep the organization in PDA02, The Joint
Commission may change the decision.
Note: Organizations that fail to submit any timely POC will receive an automatic Denial
of Accreditation with no opportunity to appeal.
■ Following submission of a POC, an unannounced Preliminary Denial of Accredita-
tion validation survey will occur within approximately two months (60 calendar
days) from the posting date of the Final Accreditation Report. The validation survey
will review implementation of the corrective actions identified in the POC.
❏ If the Preliminary Denial of Accreditation validation survey confirms implemen-
tation of corrective actions identified in the POC, the organization may receive a
time-limited Preliminary Denial of Accreditation and Accreditation with
Follow-up Survey thereafter with a follow-up survey to assess sustainability.
❏ If implementation of corrective actions identified in the POC are not evident
during the validation survey, the Preliminary Denial of Accreditation status
continues and the organization may appeal the Preliminary Denial of Accredita-
tion decision to a Review Hearing Panel. If an organization fails to appeal the

Shading indicates a change effective July 1, 2024, unless otherwise noted in the What's New.
CAMLAB Update 1, July 2024 ACC – 63
E-dition July 1, 2024, Release
◤Comprehensive Accreditation Manual for Laboratory and Point-of-Care Testing

continued Preliminary Denial of Accreditation, the Preliminary Denial of

Accreditation decision becomes a final Denial of Accreditation within five (5)
business days of being notified of the continued Preliminary Denial of
Accreditation.
■ Following a Preliminary Denial of Accreditation validation survey that results in a
time-limited Preliminary Denial of Accreditation with an Accreditation with Follow-
up Survey decision, The Joint Commission’s Chief Medical Officer or Chief
Operating Officer, or their designees, will contact the organization’s leadership to
discuss the organization’s accreditation and to offer assistance to the organization in
making sustainable improvements.
■ For organizations that had a time-limited Preliminary Denial of Accreditation, The
Joint Commission will schedule the organization’s next unannounced biennial
survey early within the 22- to 24-month period.
■ Should the organization’s next biennial survey result in a repeat Preliminary Denial
of Accreditation, the organization will receive a Denial of Accreditation with the
opportunity for an expedited appeal without a hearing.
See Figure 6 for a visual representation of the PDA02 decision process flow.

Preliminary Denial of Accreditation 02 (PDA02*+) Process

Effective for Surveys Beginning January 1, 2017

Within 10 business days from

Within 10 business days of Within approximately two
the end of the survey, the Within 10 business days of
the comple"on of the months of the posted final
final report is posted on the posted final report, the
Survey is conducted clarifica"on process, the report, the organiza"on will
health care organiza"on’s organiza"on will have the
organiza"on is required to have a valida"on survey (VS)
(HCO’s) extranet site with a op"on to clarity inaccurate
submit a Plan of confirm standards compliance
recommenda"on of PDA02 survey findings
Correc"on (POC)

If the VS confirms
The organiza"on will have the -
standards compliance, the The organiza"on may have If standards compliance is
follow-up survey within
organiza"on may receive a its next biennial survey within not evident from the VS, the
4 months of receiving its AFS
decision Accredita"on with 22-24 months organiza"on may receive a
decision to assess sustainability
Follow-u[ Survey (AFS) PDA decision.
therea#er

*Care recipients are placed at risk for a serious adverse outcome(s) due to significant and
pervasive pa"erns, trends, and/or repeat findings
+Organizations will have the right to appeal this decision

Figure 6. PDA02 decision process flow.

Shading indicates a change effective July 1, 2024, unless otherwise noted in the What's New.
ACC – 64 CAMLAB Update 1, July 2024
E-dition July 1, 2024, Release
 The Accreditation Process◥

Process for Organizations That Meet

Decision Rule PDA04
If a laboratory does not possess a license, certificate, and/or permit, when required by
applicable law and regulation, to provide the health care services for which it is seeking
accreditation, The Joint Commission may initiate the Preliminary Denial of Accredita-
tion process under decision rule PDA04.
The process for Preliminary Denial of Accreditation in such circumstances is as follows:
■ If at the time of survey the laboratory does not have a required license, certificate, or
permit, the laboratory will be notified that it meets a rule for Preliminary Denial of
Accreditation and The Joint Commission will initiate such action.
■ The laboratory will also be notified that if it obtains the required license, certificate,
or permit or is able to provide proof of application and payment during the
clarification process, the Preliminary Denial of Accreditation decision will be
removed but the RFI will remain in the Final Accreditation Report.
■ The laboratory will not be presented to the Accreditation Council unless it meets a
decision for Preliminary Denial of Accreditation based on another decision rule.

Review and Appeal Procedures

After any Preliminary Denial of Accreditation decision, the organization has the right to
ask, in writing, within five (5) business days of being notified, for a telephone hearing
with a Review Hearing Panel. There is a charge for a Review Hearing Panel. Failure to
appeal results in a Denial of Accreditation.
Organizations that choose to appeal may submit additional materials, limited to no more
than thirty (30) pages, for the Review Hearing Panel’s consideration. After the hearing,
The Joint Commission reviews the findings of the Review Hearing Panel and either
denies accreditation to the organization or selects an appropriate alternative accreditation
decision.
The outline in this section details the review and appeal procedures for Preliminary
Denial of Accreditation decision.

Shading indicates a change effective July 1, 2024, unless otherwise noted in the What's New.
CAMLAB Update 1, July 2024 ACC – 65
E-dition July 1, 2024, Release
◤Comprehensive Accreditation Manual for Laboratory and Point-of-Care Testing

I. Evaluation by Joint Commission Staff

A. Review and Determination by Joint Commission Staff. Following any survey
activity, Joint Commission staff review survey findings, survey documents, and any other
relevant materials or information received from any source. Joint Commission staff may
take one of the following actions:
■ Recommend that the organization be Accredited.
■ Recommend that the organization receive Accreditation with Follow-up Survey.
■ Recommend that the organization receive Preliminary Denial of Accreditation.
■ Defer consideration while additional information regarding the organization’s
compliance status is reviewed.
B. Determination to Recommend Preliminary Denial of Accreditation. If Joint
Commission staff, based on survey findings, survey documents, survey history, and any
other relevant materials or information received from any source, determine in
accordance with approved decision rules to recommend that the organization receive
Preliminary Denial of Accreditation, it will outline its findings and determination. The
organization may take either of the following actions:
■ Accept the findings and determination of the staff through submission of the ESC
(or POC, if decision rule PDA02 is applicable).
■ Submit to The Joint Commission, through the ESC (or POC, if decision rule
PDA02 is applicable), any clarification of its compliance with Joint Commission
standards at the time of the survey.
Joint Commission staff members review the organization’s submission of any additional
information and shall, in accordance with approved decision rules, take one of the
following actions:
■ Recommend that the organization receive Accreditation with Follow-up Survey.
■ Recommend that the organization receive Preliminary Denial of Accreditation.
■ Recommend that the organization be Accredited.
C. Immediate Threat to Health or Safety. If the findings of any survey identify a
condition that poses a threat to public or patient health or safety, an officer of The Joint
Commission with a clinical background, or a designee, may promptly decide that the
organization be immediately placed in Preliminary Denial of Accreditation. This action
and the findings that led to this action shall be reported by telephone and in writing to
the organization’s chief executive officer and in writing to the authorities having

Shading indicates a change effective July 1, 2024, unless otherwise noted in the What's New.
ACC – 66 CAMLAB Update 1, July 2024
E-dition July 1, 2024, Release
 The Accreditation Process◥

jurisdiction. If no other Preliminary Denial of Accreditation decision rule applies, the

Preliminary Denial of Accreditation may change to Accreditation with Follow-up Survey
after a completed abatement survey.

II. Accreditation with Follow-up Survey

A. Survey to Determine Implementation of ESC. The Joint Commission conducts
a survey of the organization to determine the degree to which deficiencies have been
corrected or improvements implemented following a survey any time up to 6 months
from the date the organization is notified of its Accreditation with Follow-up Survey
decision.
B. Charges to the Organization. The full costs of all surveys shall be borne by the
surveyed organization.

III. Review Hearings

A. Right to a Review Hearing. Upon request, an organization that has received a
Preliminary Denial of Accreditation is entitled to a review hearing. A Preliminary Denial
of Accreditation decision will become a Denial of Accreditation unless the organization
makes a timely request for a review hearing to demonstrate why it should not be denied
accreditation. If an appeal is requested, the organization remains in Preliminary Denial of
Accreditation status until The Joint Commission renders a final decision.
B. Purpose of the Review Hearing. The review hearing is an opportunity for an
organization to present facts and/or arguments to a Review Hearing Panel. Presentations
are limited to either of the following:
■ Facts that were in error during the survey or immediate post-survey processes
■ Claims that The Joint Commission did not follow its policies, procedures, or
decision rules to the detriment of the organization
C. Requesting a Review Hearing; Notice of Time and Place. An organization
must submit a written request for a review hearing within five (5) business days of The
Joint Commission’s notification of the Preliminary Denial of Accreditation decision. For
the purpose of this section, the date of a notification is the date a notice was posted to the
organization’s Joint Commission Connect extranet site. Within a reasonable period of time
before the review hearing, The Joint Commission provides notice of the time and date of
the review hearing. If the organization intends to submit a written response, or other

Shading indicates a change effective July 1, 2024, unless otherwise noted in the What's New.
CAMLAB Update 1, July 2024 ACC – 67
E-dition July 1, 2024, Release
◤Comprehensive Accreditation Manual for Laboratory and Point-of-Care Testing

documents limited to the parameters established, such response and documents must be
submitted at least five (5) business days prior to the review hearing. The Review Hearing
Panel is under no obligation to consider late submissions.
D. Charges to the Organization. The organization will be charged a nonrefundable
fee for the review hearing, as published in the accreditation and certification pricing
schedule found on the Joint Commission Connect extranet site. The fee, along with any
other outstanding invoices due to The Joint Commission, must be paid in full at the time
an organization requests a review hearing.
E. Procedure for the Conduct of a Review Hearing. Review hearings are limited to
two (2) hours. After introductions, Joint Commission staff will summarize the historical
facts that led to the Preliminary Denial of Accreditation decision. The organization will
then have an opportunity to make its presentation to the Review Hearing Panel. The
organization’s presentation should be limited to factual or procedural errors. The Review
Hearing Panel may ask questions of the organization and of Joint Commission staff.
Hearings are not video/audio recorded. The organization may choose to retain a
transcriptionist for the hearing at its own expense. The organization shall provide a copy
of any transcript to The Joint Commission, at the organization’s expense, at or around
the same time the transcript is made available to the organization. Transcripts of Joint
Commission proceedings are confidential and shall remain confidential. Any disclosures
to a third party require the express written permission of The Joint Commission.
F. Participants at the Review Hearing. A review hearing may proceed with only two
of the three panel members present. Legal staff from The Joint Commission will be
present to address procedural matters and will not ask questions of the organization’s
representatives. Organizations are encouraged to limit representatives at the review
hearing to individuals who are knowledgeable about the organization in the standards
areas found noncompliant. An organization may choose to bring legal counsel and/or
consultants; however, this type of representative is permitted to address procedural
matters only and is not to speak on matters regarding substantive issues of the
organization’s standards compliance or question Joint Commission staff.
G. Report of the Review Hearing. After a review hearing, the Review Hearing Panel
will prepare and submit a report that summarizes its findings on factual matters with a
recommendation to The Joint Commission. The panel report may include a recommen-
dation for one of the following four accreditation decisions:
1. Denial of Accreditation

Shading indicates a change effective July 1, 2024, unless otherwise noted in the What's New.
ACC – 68 CAMLAB Update 1, July 2024
E-dition July 1, 2024, Release
 The Accreditation Process◥

2. Time-Limited Preliminary Denial of Accreditation

3. Accreditation with Follow-up Survey
4. Full Accreditation

IV. Following a Review Hearing

A. Scope of Review. After the review hearing, The Joint Commission will consider the
Review Hearing Panel’s findings and recommendation, the responses of the organization,
submitted documents limited to factual and/or procedural errors, and comments of staff,
if any.
B. Action by The Joint Commission. After review of the hearing report, The Joint
Commission may accept, reject, or modify the Review Hearing Panel’s recommendation.

V. Final Review & Appeal Request

A. Final Review & Appeal Request. An organization that has received Denial of
Accreditation after having had an opportunity for an appeal before a Review Hearing
Panel may seek a Final Review & Appeal with three members of The Joint Commission’s
Board of Commissioners. The Joint Commission must receive the organization’s request
for final review within five (5) business days after the organization receives notice of The
Joint Commission’s decision following a hearing. If the organization requests an appeal
to the Final Review & Appeal Committee, the organization remains in Preliminary
Denial of Accreditation until such time as the Committee meets and makes a final
decision.
B. Composition and Participation. No member of the Final Review & Appeal
Committee will have participated in the decisions of The Joint Commission to this point
but may, when convened for a final review and appeal, ask questions of Joint
Commission staff and the Commissioner who served on the Review Hearing Panel, if
available. Although the organization does not participate in the final review and appeal
proceeding, it may submit a letter to the Board members.
C. Notice of Time and Procedure for Review. The Joint Commission shall provide
notice of the date of the Final Review & Appeal meeting prior to the meeting. The
organization may submit written comments, not to exceed thirty (30) pages, to the Board
members conducting the Final Review & Appeal along with any documents not
previously submitted limited to factual or procedural errors made by The Joint
Commission. Any documents must be submitted, but at least five (5) business days prior
Shading indicates a change effective July 1, 2024, unless otherwise noted in the What's New.
CAMLAB Update 1, July 2024 ACC – 69
E-dition July 1, 2024, Release
◤Comprehensive Accreditation Manual for Laboratory and Point-of-Care Testing

to the meeting and should specifically identify any relevant documents previously
submitted for the purpose of demonstrating its compliance with standards or The Joint
Commission’s failure to follow its policies, procedures, or decision rules.
D. Final Action. The Board members conducting the Final Review & Appeal shall
review the decision of The Joint Commission, the organization’s responses, any materials
specifically identified as relevant by the organization, and other information it deems
relevant, and shall take either of the following actions:
■ Place the organization in Denial of Accreditation after finding that there is
substantial evidence to support The Joint Commission’s decision.
■ Make an independent evaluation of The Joint Commission’s decision and then
decide to grant Accreditation with Follow-up Survey or full Accreditation to the
organization.
The action taken by the Board members conducting the Final Review & Appeal shall be
the final accreditation decision of The Joint Commission.

Shading indicates a change effective July 1, 2024, unless otherwise noted in the What's New.
ACC – 70 CAMLAB Update 1, July 2024
E-dition July 1, 2024, Release