Guide To CAP Accreditation

Table of Contents
Laboratory Accreditation
Guide to CAP Accreditation
for International Participants
cap.org
Last updated May 2013.

© 2013
© 2013 College of College
Americanof Pathologists.
American Pathologists. All rights reserved.
All rights reserved. cap.org | 2
Table of Contents
Click on the topic of your >> Laboratory Accreditation and the College of American Pathologists
choice to be taken directly
to that section.
>> Things to Know Before Applying for CAP Laboratory Accreditation
>> Request for Application
>> Director Responsibilities
>> Document Control System
>> Chemical Hygiene Plan
>> Laboratory Information Systems
>> Test Method Validation
>> Competency Assessment Program
>> Quality Management Program
>> Proficiency Testing/External Quality Assurance and the CAP
>> International PT/EQA Process Overview
>> Preparing an International PT/EQA Order
>> Placing an International PT/EQA Order with the CAP
>> International PT/EQA Sample Order Form
>> Next Steps After Placing Your Order
>> Successful Shipping of International PT/EQA Orderss
>> Inspect Your International PT/EQA Shipment
>> Sample Kit Instructions
>> CAP International PT/EQA Order Renewal
>> Questions and Answers

© 2013 College of American Pathologists. All rights reserved. cap.org | 1
Table of Contents
Laboratory Accreditation and the

College of American Pathologists
About the CAP Laboratory The CAP Laboratory Accreditation Program is an internationally
Accreditation Program recognized laboratory inspection program, the only one of its kind
utilizing multidisciplinary teams of practicing laboratory professionals
as inspectors. Because they deal with laboratory issues on a daily basis,
these inspectors are uniquely qualified to provide you with a thorough
inspection that is specific for each section of the laboratory.
A laboratory inspection occurs every two years. In the years when an
on-site inspection does not occur, the laboratory must perform a self-
inspection using materials provided by the CAP. The accreditation
program is voluntary and helps laboratories achieve the highest
standards of excellence in patient care.
The program is based on accreditation requirements. These

requirements are included in documents called checklists,
which are used both by the laboratory to prepare for inspections
and by the inspection team as a guide to assess the overall quality
of the laboratory.

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Laboratory Accreditation and the

What Is CAP Laboratory Accreditation is a continuous process by which the CAP reviews and
Accreditation? monitors the laboratory’s performance.
All testing performed at a single location under the leadership of one

laboratory director must be reported during the application process.
The CAP does not accredit portions of laboratories.
CAP Accreditation Process
• Enroll in CAP PT/EQA for all patient reportable tests,

when PT is required
1 Enroll in CAP PT/EQA • Perform CAP PT for a minimum of six months prior to
application request
• Request CAP application material

2 Application for
Accreditation • Complete and submit application
• Prepare for on-site inspection using CAP materials
• Inspection team leader schedules inspection date

3 On-Site Inspection • Participate in an on-site inspection
• Inspection team leader will submit report to CAP and

4 Inspection Results
provide a copy to the laboratory at the conclusion
of the inspection
• Review your copy of the inspection report
• Respond to findings (deficiencies) from on-site inspection

5 Inspection Follow Up • Submit responses to CAP within 30 calendar days of
the inspection
• CAP Commissioner reviews results, provides

6 Evaluation accreditation expertise, and ensures continuous
compliance
• CAP awards accreditation and issues a Certificate

7 Certificate of
Accreditation
of Accreditation
• Maintain compliance to accreditation standards
within a two-year program
• Receive and review self-inspection materials

8 Self-Inspection • Perform self-inspection at the time of the one-year
anniversary
Outcome of Completing The laboratory is awarded a “CAP Laboratory Accreditation” certificate

a Successful Inspection upon successful completion of the inspection process and becomes part
of an exclusive group of more than 7,300 laboratories worldwide that
have met the highest standards of excellence.

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Things to Know Before Applying for

CAP Laboratory Accreditation
Eligibility To be eligible for CAP Laboratory Accreditation, the laboratory must

have a qualified laboratory director, participate in proficiency
testing/external quality assurance, and perform patient testing.
Director Qualifications The CAP requires specific qualifications for the laboratory director, the
person responsible for operation of the laboratory. Qualifications may
differ based on the type of testing performed; more complex testing
may require a more experienced individual. A laboratory director must
have an MD, DO, PhD, or must have commensurate education and
experience necessary to meet personnel requirements as determined
by the CAP.
A director of a laboratory subject to US regulations (CLIA), educated

outside of the United States must provide documentation of a third-party
education equivalency assessment from a NACES (National Association
of Credential Evaluation Services) accredited organization or the AICE
(Association of International Credential Evaluators). If the laboratory
director is boarded by an HHS-approved (Health and Human Services)
board, the third-party equivalency assessment is not required.
Laboratory Personnel CAP requires that all testing personnel have earned an associate degree
Qualifications in a laboratory science or medical technology from an accredited
institution, or equivalent laboratory training OR have earned a high
school diploma or equivalent and documented training.
The laboratory must provide documentation that all testing personnel

have satisfactorily completed initial training on all instruments/methods
applicable to their designated job.
External Quality Assurance External quality assurance (EQA) also known as proficiency testing (PT) is
an interlaboratory peer program that compares a laboratory’s test results
using unknown specimens to results from other laboratories using the
same or similar methods.
The laboratory must enroll in CAP PT/EQA and must do so a minimum of

six months prior to the CAP application process.

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External Quality Assurance Requiring enrollment and participation for six months helps the laboratory
(continued) build the discipline necessary to monitor laboratory testing quality and to
better ensure that processes and procedures exist for corrective action.
This time frame also enables the laboratory to become familiar with the
requirements to obtain permits and any other documents necessary
to receive PT/EQA shipments. It also ensures the inspection team has
sufficient data to verify testing quality when conducting the first on-site
laboratory inspection.
Key Components In order to meet CAP Laboratory Accreditation requirements, the

laboratory must have the following key documents/processes:
• Quality Management Program
• Chemical Hygiene Plan
• Document Control Process
• Competency Assessment Program
• Test Method Validation Documentation
• Laboratory Director Oversight Documentation
• Laboratory Information System (LIS) – if applicable
Additional Resources • The following products and documents are available for purchase
from the CAP to assist laboratories contemplating accreditation or in
the process of preparing for accreditation:
• CAP Accreditation Readiness Assessment (CARA)
• Audioconferences/Webinars
• Online Inspector Training
• CAP Accreditation Checklists *
• Laboratory Accreditation Manual *
• Online Competency Assessment Program
• Standards for Laboratory Accreditation*
* These items are included as part of the accreditation application.

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Cost of Accreditation Accreditation fees are paid annually and are based on the institution’s
laboratory sections, list of performed testing (activity menu), organization
structure and complexity.
To receive an estimate of annual accreditation fees, complete and

return the International Fee Estimate Worksheet.
International laboratories are required to pay for roundtrip, business-

class airfare for intercontinental travel by inspector(s). The number of
inspectors sent will be based on the volume and/or testing type in the
laboratory. The CAP will pay for all hotel accommodations, meals,
ground transportation and in-country air travel. Inspections typically
occur once every two years.
Please note that accreditation fees do not include the cost of

proficiency testing (external quality assurance).

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Request for Application
Overview Review the “Things to Know Before Applying for CAP Accreditation”
section of this document. Laboratories ready to become accredited
must request an application.
How to Request Download the CAP Accreditation Request for Application form at
an Application cap.org.
• Complete the form
• Print
• Submit via email, mail or fax (information provided on form)
• Include the nonrefundable fee
-- Credit card
-- Wire transfer
-- Check
For additional information on payment refer to the “Placing an

International PT/EQA Order” section for specific payment requirements
What Next? After the Request for Application is processed by the CAP, the laboratory
will receive a paper copy of the application and an email notification,
including instructions for accessing the application online through the
CAP’s online resource (e-LAB Solutions).
Application The application may be completed online through e-LAB Solutions™.

Information about e-LAB Solutions may be found at:
• cap.org/accreditation – select the e-LAB Solutions tab.
• For online assistance, contact Customer Contact Center at
001-847-832-7000 or email accreditationonline@caporg.
OR
A paper application may be completed and returned to the CAP

via email, fax, or mail.
Applications must be submitted within six months of receipt

by the laboratory.

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Director Responsibilities
What Is the Director’s The director of a CAP-accredited laboratory is responsible for ensuring
Responsibility? ongoing compliance with the Standards for Laboratory Accreditation
and implementing the requirements of the accreditation checklists.
The director must have the qualifications and authority to fulfill these
responsibilities effectively.
Key Components An effective director ensures:

• The following components are defined, implemented, and
monitored:
-- An effective quality management program.
-- Adequate number of appropriately trained
and qualified personnel.
-- A safe laboratory environment.
• Availability of consultations for ordering appropriate tests and the
interpretation of laboratory findings’ medical significance.
• Anatomic pathology services are provided by a qualified
anatomic pathologist.
• The ability to function effectively with applicable accrediting
and regulatory agencies, the medical community, patients, and
administrative officials.
• Educational programs, strategic planning and research, and
development appropriate for the laboratory and institution. If
delegating activities to others, documentation specifying which
individuals are authorized to act on his/her behalf.
• If not present full-time, a written agreement defining the frequency
of, and responsibilities for, on-site visits. Activities performed during
visits must be documented.

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Director Responsibilities
Who Is Responsible? The director of a CAP-accredited laboratory is responsible for ensuring

ongoing compliance with the Standards for Laboratory Accreditation
and implementing the requirements of the accreditation checklists.
Outcome of an Laboratory benefits include:

Effective Director • A culture committed to continuous improvement.
• A testing environment always prepared for an inspection.
• Having an involved director who serves as a mentor and
promotes a culture of quality.
• A safe environment.
• Ongoing compliance with CAP requirements.

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Document Control System
What Is Document Control? Document control is the management of all paper or electronic
documents, including policies, procedures, and forms. A written
document control system outlines how all documents are initiated or
revised, approved, utilized, reviewed, retained, and discontinued.
Every document within the laboratory must be:

• Current – have up-to-date review and reflect current practices.
• Accurate – only authorized revisions are made to documents,
substantial revisions are reviewed and approved before
implementation, and revisions are reflected on all copies
of documents.
• Available – readily accessible to all staff utilizing them.
Key Components A laboratory’s document control system must ensure:

• All copies of policies, procedures, and forms are current.
• Personnel have read the policies and procedures relevant
to their job activities.
• Personnel are knowledgeable about the contents of procedure
manuals (including changes) and demonstrate proficiency
relevant to the scope of their testing activities.
• All policies and procedures have been authorized by the
laboratory director before implementation.
• Policies and procedures are reviewed at least annually by
the laboratory directors or designee.
• Discontinued policies and procedures are quarantined in a
separate file for a minimum of two years from the date of
discontinuation (five years for transfusion medicine).
Who is Responsible? • The laboratory director who meets CAP director qualifications is
responsible for implementing and maintaining an effective
document control program.

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Document Control System
Outcome of an The laboratory will benefit by:

Effective System • Ensuring on any given day that practice matches policies
and procedures.
• Promoting the use of only approved policies, procedures, and forms.
• Organizing procedures for ease of accessibility by testing personnel.
• Tracking the status of approvals and reviews to ensure they occur
in a timely manner in accordance with CAP requirements.
• Maintaining ongoing compliance with CAP requirements.

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Chemical Hygiene Plan
What Is a Chemical A Chemical Hygiene Plan (CHP) includes procedures to protect

Hygiene Plan? employees from the health hazards of chemicals and keep exposures
below specified limits. All personnel involved in the laboratory must
receive training on the CHP and understand how it applies to their role.
Key Components An effective CHP includes:

• Laboratory director responsibilities and the assignment of
a chemical hygiene officer.
• Material safety data sheets (MSDS) for all hazardous chemicals
used in the facility. The MSDS must be accessible for review by all
laboratory employees during every work shift.
• A training program on interpreting chemical labels and MSDS, and
the use of proper protection for chemical handling and disposal.
• Proper labeling on all chemical containers.
• Informing all laboratory employees of the right to know the hazards
associated with their job.
• Evaluation of every chemical used in the laboratory for carcinogenic
potential, reproductive toxicity, and acute toxicity.
• Review of all incidents and occurrences of the past year.
Who Is Responsible? • The laboratory director is responsible for the CHP and must assign
a chemical hygiene officer.
Outcome of an • Laboratory benefits include:

Effective System • Increased employee safety and awareness.
• Reduction in laboratory accidents and improved spill responses.
• Safe and efficient organization for chemical storage.

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Laboratory Information Systems
What Are Laboratory Laboratory information systems (LIS)provide a database serving the
Information Systems? information needs of the laboratory by linking patient test results to
the ordering clinician/client, in addition to the patient’s medical record.
Overview Multiple LIS are available, including:

• Systems with a local host database (computer hardware and
software on site) where the laboratory is the only user.
• Systems with a host physically removed from the laboratory,
where multiple user laboratories may share the same database.
The Laboratory Accreditation Program does not consider the following

types of devices a LIS:
• Small programmable technical computers or dedicated
microprocessors that are an integral part of an analytic instrument.
• Purchased software services used for quality assurance and
data analysis.
• Microcomputers used for non-patient test result word processing,
spreadsheets, or other single-user functions.
Key Components • The laboratory must ensure the LIS is able to accurately and reliably
send test results and other patient-specific information from the point
of data entry (whether interfaced or entered manually) to the final
report destination in a timely manner.
The laboratory must provide the following:

• Computer facility and equipment with appropriate environmental
controls and safety elements.
• Written LIS policies and procedures with instructions for daily
operations appropriate to the level of use.
• Software validation for new installation and software updates,
including staff training.
• System security policies and practices for confidentiality of patient
data and protection against unauthorized alterations.
• Error detection and timely communication of patient data to the
ordering clinician/client.

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Laboratory Information Systems
Key Components • Auto-verification, if used, with system logic and rules to prevent
(continued) release of test results not meeting defined criteria.
• Data retrieval and preservation for the required regulatory
retention period available, within a time frame consistent with
patient care needs.
• Accurate transmission of data across instrument interfaces and
interfaces with other computer systems (e.g., middleware, hospital
information systems, and other output devices).
Who Is Responsible? The laboratory director who meets CAP director qualifications is
responsible for ensuring communication of laboratory data.
The director may delegate some LIS-related functions to others and is

responsible for determining the qualifications of these individuals. It is
the director’s overall responsibility to ensure these functions are properly
carried out.

Effective System • Accurate and timely transmission of patient data.
• Effective presentation of patient data.
• Retention and retrieval of patient data consistent
with regulatory requirements.
• Improved efficiency and productivity in the laboratory.

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Test Method Validation
What Is Test Method Test method validation verifies or establishes test method performance
Validation? specifications; these include analytic accuracy, precision, sensitivity,
interferences (specificity), reportable range, and reference intervals
(normal values), as applicable.
Overview The test method validation process must include:

• Written procedures describing the validation process for new
instruments and methods.
• Documentation of data collected in the testing environment where
the method will be implemented.
• Data obtained from studies performed by the manufacturer and
from published literature, as applicable.
• Summary statement documenting approval of the validation studies
by the laboratory director or qualified designee prior to initiation of
patient testing.
Key Components • The type of method validation required depends on the type of
testing as defined by the CAP.
• Unmodified Commercial Assays – verify manufacturer claims for each
aspect listed below, as applicable:
-- Analytic accuracy – closeness of agreement between a test
result and an accepted reference value.
-- Analytic precision – reproducibility of a test result.
-- Analytic sensitivity – smallest quantity reliably detected of
a given analyte.
-- Analytic interferences (specificity) – ability of an analytic
method to detect only the analyte it was designed to measure.
-- Reportable range – interval of test results over which the
laboratory can establish or verify accuracy.
-- Reference intervals – range of test values expected for a
designated population.
-- All other characteristics required for test performance.
• Laboratory-developed tests and modified commercial assays –
requires the laboratory to establish all aspects listed above,
as applicable.

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Test Method Validation
Who Is Responsible? The laboratory director who meets CAP director qualifications is
responsible for ensuring each method performed is of sufficient scope
and scientifically valid. The director documents final approval of the
validation prior to the initiation of patient testing.
Outcome of an The laboratory benefits include:

Effective System • Organized and clear evidence of method validation.
• Accurate patient test results when the new method is implemented.

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Competency Assessment Program
What Is Competency A competency assessment program appraises an individual’s knowledge

Assessment? and mastery of skills needed to properly perform a specific job.
Key Components A laboratory must have:

• A defined set of skills and knowledge specific to job descriptions.
• Tools to document and organize assessments.
• Criteria for acceptable levels of competency.
• A process for reevaluation, if personnel fail to meet
competency criteria.
Six Elements of • Direct observations of test performance.

Competency Assessment • Monitoring of test result reporting.
• Review of quality control records, proficiency testing results, and
preventive maintenance records.
• Direct observation of instrument maintenance and function checks.
• Assessment of test performance by external proficiency testing or
internal blind testing samples.
• Evaluation of problem-solving skills.
System Components • A laboratory must have a system ensuring:

• Employees’ competency assessments are completed semiannually
for the first year of patient testing, and annually thereafter.
• Competencies are appropriately customized.
• All six methods of competency assessment for each test
system are addressed.
• Employees are documented as competent to perform the list of tests,
procedures, or duties for which they are responsible.
Who Is Responsible? • The laboratory director who meets CAP director qualifications is
responsible for implementing and maintaining an effective
competency assessment program.

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Competency Assessment Program
Outcome of an The laboratory will benefit by:

Effective System • Organizing and scheduling staff competencies in a manner that
assures annual completion. For employees’ in their first year of
patient testing, competency must be assessed semiannually.
• Incorporating the six required elements into routine supervisory
surveillance conducted throughout the year, efficiently avoiding
duplication of effort.
• Determining employees perform and document laboratory tests and
functions according to established laboratory procedures.
• Retraining and reassessing should employee performance problems
be identified.
• Assessing all testing personnel.

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Quality Management Program
What Is Quality A dynamic quality management program (QMP) enhances any and all
Management? activities that impact patient care, promoting quality and patient safety
through risk reductions and continuous improvement.
Overview A laboratory must have a written and implemented QMP plan specific to
the laboratory that includes:
• All disciplines of the laboratory.
• All inherent processes, including quality control, assurance, and
improvement, operating on a continuous basis to provide quality
patient care.
Key Components • A QMP system requires:

• A set of processes for preanalytic, analytic, and postanalytic phases
of laboratory work.
• A system for monitoring these processes which must include:
-- A set of metrics or monitored key indicators for preanalytic,
analytic, postanalytic phases of testing and patient safety.
For each key indicator, the laboratory must specify:
◊ Criteria of acceptance
◊ Data collection, analysis, and evaluation
◊ Frequency of review
-- Annual evaluation of effectiveness
-- Measurement of patient and/or physician satisfaction.
-- A documented quality control system and evidence quality
control has been reviewed.
-- Internal and external communication of quality
management outcomes.
• A process improvement system, which must include:
-- Review of errors, complaints, and incidents.
-- Identification and implementation of corrective action.
• An infrastructure for the quality management system, including
aspects such as a document control system.

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Quality Management Program
Who Is Responsible? The laboratory director is responsible for the implementation

of the QMP plan with assistance and involvement from the:
• Manager
• Supervisor
• Laboratory staff
• Non-laboratory staff (e.g., hospital quality assurance coordinator
or safety and regulatory personnel)
Outcome of an • Laboratory benefits include:

Effective System • Continually ensuring that practice matches policies and procedures.
• Providing opportunities for quality improvement.
• Improving patient and/or clinician satisfaction.

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Proficiency Testing/External Quality Assurance

and the CAP
Overview External quality assurance (EQA), also known as proficiency testing (PT),
is a key indicator of laboratory quality monitored on an ongoing basis.
What Is PT/EQA? Each CAP-Accredited laboratory must be enrolled in CAP PT/EQA under
its own assigned CAP number.
• PT/EQA is an external quality assurance program that uses unknown
samples and allows laboratories to compare their own testing
results with other laboratories using the same or similar
instruments or methods.
• The PT/EQA program regularly sends specimens for testing.
• The laboratory sends the results back to the PT/EQA program for
evaluation, and then receives a performance report and summary.
• To determine which testing requires enrollment in PT/EQA, the
laboratory can refer to the Quote Request Form. Additional
information is available in the CAP Surveys or Excel catalogs.
When Must the The laboratory must be enrolled (using CAP PT/EQA) and performing
Laboratory Enroll? PT/EQA for all required analytes for a minimum of six months.
This time frame helps the laboratory build the discipline necessary to
monitor laboratory testing quality and to better ensure that processes
and procedures exist for corrective action. Prior enrollment also ensures
that the laboratory is familiar with the requirements to secure permits and
any other documents necessary to receive PT/EQA shipments and also
provides sufficient data for review during on-site inspections.
Country Requirements The laboratory should be familiar with its country’s requirements
(including customs/importation) and documents required to import
PT/EQA shipments.
• Import permits are obtained by the laboratory and forwarded to
the CAP to be included with the PT/EQA shipment. The laboratory
may also need to provide these documents to brokers or the local
shipping office.

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Proficiency Testing/External Quality Assurance

and the CAP
Country Requirements • Laboratories should work with local authorities to determine if any
(continued) permits are required.
• Use of order descriptions in the CAP PT/EQA catalogs will
prevent discrepancies in permit preparation and customs
clearance documents.
• Orders will not ship without required documentation.
• The laboratory is responsible for monitoring permit expiration dates
and submitting new permits.
• Permits should be submitted at the time of ordering or at least six
weeks prior to the stated order ship date to ensure on-time delivery.
Who Is Responsible? The laboratory director is responsible for ensuring PT/EQA requirements
are met for the laboratory’s current testing menu. For assistance
or questions in enrolling, contact the Customer Contact Center at
[email protected] or 001-847-832-7000.

Effective System • Ensuring quality of laboratory testing.

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International PT/EQA Process Overview
Prepare information 1. Define laboratory test menu.

prior to CAP PT/EQA 2. Identify the needed CAP
purchase
PT/EQA programs.
3. Select CAP programs to order through
the Quote Request Form or contact
the CAP for selection assistance.
1. Begin applying for any permits needed

Place a CAP
PT/EQA order
to import your PT/EQA.
2. Complete order form.
3. Email the order to the CAP including
a form of payment.
4. Request a pro forma invoice/quote,
if needed.
1. CAP enters order and creates an invoice.

When the CAP
receives an order 2. CAP sends order confirmation to the
laboratory.
1. Unpack the kit.

Once kit arrives 2. Read the kit instructions and complete
testing.
3. Review result form.
4. Submit results.
Contact the CAP with questions: [email protected] or

001-847-832-7000

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Preparing an International PT/EQA Order
Identify PT/EQA Needed Make a list of all tests performed in the laboratory, including the following
information for each:
• Test name
• Instrument model or kit, and manufacturer
• Specimen type (e.g., whole blood, urine)
Complete the Quote Form • The PT/EQA Quote Request Form is available online at
cap.org/accreditation and will guide you through the required
information.
Include the following:
• Name, email address, and phone number of the laboratory director
• Name, email address, and phone number of the person organizing
the order (order contact)
• Mailing address for letters
• Shipping address for packages (post office box addresses will not be
accepted)
• Select one of the following categories:
-- Private laboratory
-- Private hospital
-- Public/Government laboratory
-- Public/Government hospital
-- Contract Research Organization (CRO)
• State whether the order is for one or more locations
• Requirements for making payment to a US company
• Indicate if the laboratory is CLIA-certified (or planning to become so)
• Include whether the laboratory is CAP-accredited (or planning to
become so)
Identify the CAP Programs • To receive an itemized list of the needed CAP programs, send the
Quote Request Form to [email protected].

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Placing an International PT/EQA Order with the CAP
Complete a CAP • Download the order form at cap.org/catalogs.

Order Form • Complete the form.
• Attach all needed permits for receiving international goods.
Payment • Orders must contain payment or payment information to be

accepted. Include a form of payment with your order:
• All payments should include:
-- Customer name
-- CAP number (if available)
-- CAP account number (if available)
-- Invoice and/or order number
• Acceptable payment forms include:
-- Check: Make payable to the College of American Pathologists
in US dollars.
-- Credit Card: Include number, expiration, cardholder’s name,
and authorized signature.
-- Purchase Order: A purchase order indicates a future
commitment to pay using a purchase order number.
-- Letter of Authorization: Include a signed letter of authorization
on your institution’s letterhead if your institution does not use a
purchase order system. Also include payment method (draft,
bank transfer, etc) information in your letter of authorization and
enter “Letter of Auth” in the purchase order field of the payment
information section on the order form.
-- Wire transfer: Include all bank fees with your payment. The CAP
is not responsible for bank fees incurred while remitting payment.
Once the transfer is complete notify the CAP at [email protected].
-- Remit wire transfer payment to:
BMO Harris Bank, 311 West Monroe Street, Chicago, IL 60606 USA
Phone: 312-461-2121
Account Number: 223-733-7
ABA Number: 071000288
SWIFT #: HATRUS44
• Quote Request: If your organization requires a quote (pro forma
invoice) prior to payment, please notify [email protected]
(quoted values will be reduced if orders are received after scheduled
ship dates).
Order Email completed order form and payment to [email protected].

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International PT/EQA Sample Order Form
Tip #1
List CAP number if 1
available.
Tip #2
CLIA Number is not required
for international customers.
2
However, if the laboratory
has a CLIA number please
provide it here. 3
Tip #3
Provide laboratory
director and order
contact information.
Tip #4
Provide laboratory
shipping information
for package delivery.
Post Office boxes are not
acceptable for sample 4
deliveries.

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Tip #1
Provide payment
information in US dollars if
not using wire transfer.
Tip #2
List Purchase Order
Number if it must appear
on shipment. 1
2
Tip #3
Provide billing contact
information for
the organization. 3

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Tip #1
List names of programs
being ordered. Specify
by quantity needed and
catalog price.

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Next Steps After Placing Your Order
What Happens When the After an order is placed:

CAP Receives an Order? • Order and payment information is entered, and an invoice is created.
• If a valid shipping email address is provided on the PT/EQA order form,
an email is sent to confirm the order. To ensure receipt of the order
confirmation, please ensure that an accurate and functional email
address is provided to the CAP.
• Orders placed by December 1 of the year prior to the upcoming year
ship according to the CAP shipping calendar.
• A unique CAP laboratory identification number is assigned.
What Is the • To ensure appropriate quantities of materials, the CAP recommends

Shipping Procedure? that all orders for PT/EQA program materials are placed annually on
or before December 1. Orders received by December 1 will be
shipped according to the CAP shipping schedule located at
cap.org/accreditation (the shipping calendar published in the
CAP PT catalog.)
• Orders received after December1 will be shipped within six weeks of
the order date if material is available. If material becomes unavailable
due to late ordering, the CAP will adjust the invoice to reflect removal
of those shipments.
• The CAP ships PT/EQA via Federal Express delivery service and packs
materials to ensure material stability upon arrival. Post Office boxes
are not acceptable for these shipments; a street address is required.
Out-of-Stock Materials There is the possibility of of materials being out of stock. Out-of-stock
and Materials on Hold materials will be reflected on the order confirmation. If the CAP is able to
obtain additional materials, the invoice and the order will ship. The CAP
will issue a credit for orders that do not ship.
Materials requiring permits will not appear on the order confirmation if the
permits are not submitted with the order. A notification will be sent if the
CAP has not received a permit with the order. The CAP is unable to ship
the order until receipt of required permits.
Tip Assign a person to monitor the shipping schedule and to contact the
CAP with any questions. Each laboratory’s customized shipping schedule
can be found at cap.org under e-Lab Solutions.
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Successful Shipping of
International PT/EQA Orderss
Requirements International shipping requires laboratory involvement to ensure the

PT/EQA kits are delivered quickly and in good condition.
Key Components Effective involvement includes the following:

• Meeting with local shipping representatives and laboratory staff
responsible for receiving packages
-- Discuss the importance of quickly delivering PT/EQA kits
to the laboratory.
-- Ask for advice on importing PT/EQA materials.
• Contact the necessary government agencies for advice on importing
and required permits.
-- Contact the CAP for additional information to
complete permit applications.
-- The CAP ships orders from 14 different packaging sites.
Contact the CAP for specific shipper information.
-- Permits must be submitted to the CAP six weeks prior to
the ship date.
• Notify the CAP of any special shipping requirements six weeks prior to
the first shipment.
Direct questions to [email protected].
Additional CAP PT/EQA • The CAP must have a valid email address and phone number on file
Shipping Information for shipping purposes.
• PT/EQA kits are typically shipped via FedEx.
• FedEx brokerage is included in the CAP international shipping fee.
• The CAP is not responsible for international duties and taxes.
-- Participating laboratories should establish a FedEX account to
direct invoice duties and taxes.
• The CAP packages and ships according to US 49CFR, IATA, and ICAO.

Table of Contents
Successful Shipping of
International PT/EQA Orders
Additional CAP PT/EQA • Some CAP materials ship on dry ice as “UN 1845 dangerous
Shipping Information goods” shipments.
(continued) -- Not all locations accept dry-ice shipments.
-- Some locations require dry-ice shipments be picked up
at the airport.
-- Cool packs are sometimes used as an alternative to dry ice.
• Every shipment has a commercial invoice attached.
-- Commercial invoices are for customs purposes only and
do not require payment.
• A limited number of CAP materials cannot be delivered via FedEx.
-- The CAP will identify a freight forwarder or a premium
freight forwarder to deliver kits.
-- Brokerage fees are not included with freight
forwarding shipments.
-- A notification will be sent if there is an impact on the laboratory.
-- There are additional shipping charges for freight
forwarder shipping.
• Please respond to all contacts from FedEx or other package carriers
regarding PT/EQA kits.
• The laboratory “ship to” contact will receive a CAPTRAKersm email
when the kit is shipped via FedEx to assist in tracking the shipment.
• Contact the CAP if there are delivery problems.
• Contact the CAP for additional shipping information.
Direct questions to [email protected].

Table of Contents
Inspect Your International PT/EQA Shipment
What to Do? Upon receipt:

• Unpack the kit, removing all packaging materials and cool packs.
• Check for the following:
-- Kit instructions, which include specific kit contents
and storage directions
-- Result form(s)
-- PT/EQA samples
• Read the kit instructions.
-- Store the kit according to the instructions until testing
the samples.
• Review the result form.
Questions? For questions regarding the kit or if the materials are damaged, please
contact the CAP by email at [email protected]. Include your
laboratory specific CAP number, the program code, and specific
specimen numbers in all communications.

Table of Contents
Sample Kit Instructions
Tip #1
Product Fulfillment Group
1
(PFG) and CAP program
KIT# 00000000 0 00 00
year displayed
CAP# 0000000
2
Tip #2 ---- MAIL/PRODUCT ----
CAP number 4 ------ PRODUCT 1 -----
------- ADDR 1 ------- 3
displayed here ------- ADDR 2 -------
Tip #3
Laboratory’s address
displayed here 5
Tip #4
Results due date
displayed here
Tip #5
Survey reporting information 6
displayed here
Tip #6
7
Analyte displayed here
Tip #7
Results recorded here
(Either report results online
or fax this form to the CAP)

Table of Contents
Sample Kit Instructions
Tip #1
2
Survey programs included
in the Product Fulfillment C-B 2012
Group (PFG) displayed here Kit Instructions
©
CAP 2012
Tip #2
General Chemistry and Therapeutic Drug Survey
Survey PFG and
C1 ● C3 ● C3X ● C7 ● CZ ● CZX ●
1 CZ2 ● CZ2X
program year displayed

Table of Contents Kit Contents
here
C1 CHM-06 — CHM-10
Kit Contents ................................................ 1
C3 CHM-06 — CHM-10
Important: Before You Begin....................... 1
C3X CHM-06 — CHM-10 (2 vials each)
3
Detailed Testing Instructions....................... 2 C7 C7-02
Tip #3 Reporting Your Results ............................... 2 CZ CHM-06 — CHM-10
Specimens included Biohazard Warning ..................................... 4 CZX CHM-06 — CHM-10 (2 vials each)
CZ2 CHM-06 — CHM-10 (2 vials each), double instrument reporting
in the PT kit displayed here For Assistance ............................................ 5
CZ2X CHM-06 — CHM-10 (3 vials each), double instrument reporting
Manufacturer Updates ................................ 6
Master Lists ................................................ 7 Important: Before You Begin
Tip #4 New for this Mailing
Storage and Please answer supplemental questions at the end of the result form.
stability information Storage and Stability Instructions
displayed here 1. Shipping details: Specimens are shipped frozen on a cold pack but may arrive
partially frozen or completely thawed. Store at 2 - 8ºC upon receipt.
2. Unopened/Opened Storage: Analytes are stable at 2 - 8ºC for 7 days.
Alert! Review the Manufacturer Exceptions:
Updates table before reporting your
Lactate, ammonia Analyze within 24 hours of receipt.
results.
4
Alkaline Phosphatase, Acid Phosphatase, Analyze within 3 days of receipt.
bilirubin, and Ionized Calcium*
Pseudocholinesterase Stable for 2 days after reconstitution.
*Do not correct ionized calcium for pH or preheat specimens with CO2.
3. Special Handling: Keep vials tightly sealed and protected from light.
4. Instrument systems and methods that are sensitive to ammonium ions (ie, i-STAT,
NOVA Nucleus, etc.): The ammonia concentrations of the Survey specimens may
increase with time, even when refrigerated at 2 - 8ºC. Therefore, all analyses should
be completed within 24 hours of receipt.
Critical Reporting Information
1. For all regulated analytes:

• If your laboratory is discontinuing or beginning any testing, you must check
your Analyte Reporting Selection (ARS) document to ensure no changes are
needed. If changes are needed, indicate the modifications and note that they are
effective immediately on the document and submit to the CAP.
Important: See the Biohazard Warning at the end of these instructions.

Customer Contact Center 800-323-4040 option 1 (domestic), or 847-832-7000 option 1 (international) 1

Table of Contents
CAP International PT/EQA Order Renewal
Review the New Catalog The CAP will send renewal information every September to renew your
PT/EQA order for the next program year. Review the catalog for:
• New programs
• Discontinued programs
• Program changes
Place an Order Make any necessary changes and submit your order, including payment
information, by December 1 of the current year. Orders received after
December 1 will be shipped within six weeks of the order date if material
is available. If material becomes unavailable due to late ordering, the
invoice will be adjusted to reflect removal of those shipments.
Permits Review individual permit needs for the upcoming program year,
and start governmental reapplication process as soon as possible.

Table of Contents
Questions and Answers
Tracking Shipments Q: What if the kit has not arrived on schedule?

A: Call the CAP at 001-847-832-7000,
or email at [email protected].
Q: What if the kit is delayed in customs?

A: Call CAP at 001-847-832-7000,
or email at [email protected].
Kit Contents Q: What should I do if I think a specimen is missing?

A: Check the content list on the kit instructions against the samples
received. Be sure to check under and inside all packaging materials
in the kit. Some specimens are placed under cool packs or can be
found inside other packing material.
If you still believe your kit is incomplete, contact the CAP at

001-847-832-7000 for a replacement. Be sure to include contact
information, your CAP number, PT/EQA program code, and
specimen number.
Q: What if the paperwork for the kit is missing?

A: Email [email protected] or you can access the information
in e-Lab solutions.
Q: What if the kit is damaged?

A: Email [email protected]. Store the undamaged material
according to the kit instructions while waiting for a reply.
Q: If the samples have been held in customs, are they suitable
for testing?
A: Email [email protected]. Provide any known details about
the condition of how the kit was held (stored) by Customs.
Q: If samples have been at room temperature for awhile, are they
still suitable for testing?
A: Some kits ship at ambient temperatures without cool packs. Follow
storage instructions upon receipt. If the storage instructions indicate
storage at cold temperatures please email [email protected].
Q: Are safety data sheets (SDS) available?

A: You can find SDS for materials purchased from the CAP on cap.org
(requires e-LAB log in).
Table of Contents
Problems in the Laboratory Q: What if our instrument is not working?

A: Enter code 11 on result form and submit. Document the reason why
testing was not performed and maintain the record.
Q: What if the kits or reagents will not arrive in time to perform the test?
A: Email the CAP at [email protected] for an extension.
Q: What if our laboratory cannot enter the results by the due date?
A: Email the CAP at [email protected] for an extension.
Q: What if our laboratory has questions about the evaluation report?

A: Email your questions to CAP at [email protected] for
assistance.
Q: What if a specimen is damaged while testing?

A: Follow your standard laboratory procedures and contact the CAP at
[email protected].
Q: What if there is an accident with the material and it involves

a person?
A: Contact the Laboratory Accident Hotline at 001-847-470-2812.
Provide specific details including the program, specimen number
and your contact information.
e-LAB Solutions Q: How do I get into e-LAB Solutions?

A: You can access e-LAB Solutions only by creating an account. Use the
“Getting Started with e-LAB Solutions” guide on cap.org. You will need
the PIN sent to your laboratory. The CAP sends a communication to
the laboratory director with the PIN and instructions upon confirmed
payment of the laboratory’s Proficiency Testing order.
Documents Submitted Q: Can we submit documentation in our native language?

to the CAP A: Not at this time. All submitted documentation must be in English.

Table of Contents
Accreditation PT Q: How much PT is required?

A: Each laboratory must cover its current testing menu to ensure
PT requirements are met for their entire testing menu. The amount of
PT required is dependent on the testing performed by the laboratory.
To receive an itemized list of the needed CAP programs, complete

and submit a Quote Request Form.
Cost of CAP Accreditation Q: What does it cost to become CAP accredited?

A: Please submit the Request for Application Form, including the
non-refundable fee as listed on the form.
Accreditation fees are paid annually. The cost is determined by the

complexity and size of the laboratory. To receive an estimate of
annual accreditation fees, complete and fax the International Fee
Estimate Worksheet to the number on the form.
International laboratories are required to pay for roundtrip, business

class airfare for intercontinental travel by inspector(s). The number
of inspectors sent will be based on the volume and/or testing type
in the laboratory. The CAP will pay for all hotel accommodations,
meals, ground transportation and in-country air travel.
Please note that accreditation fees do not include the cost of

proficiency testing (external quality assurance).
Am I Ready to Become Q: How can I tell if the laboratory is ready to become accredited?
Accredited? A: Using this guide and ensuring all requirements are met is the first
step. Once the laboratory has started the application process, you
can also evaluate your laboratory using the CAP Accreditation
Checklists.
For additional information on the accreditation process, please visit

cap.org/accreditation.

Table of Contents

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Northfield, IL 60093-2750
001-800-323-4040
001-847-832-7000


Guide To CAP Accreditation

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Table of Contents

Last updated May 2013.

>> Request for Application

>> Director Responsibilities

>> Document Control System

>> Chemical Hygiene Plan

>> Laboratory Information Systems

>> Test Method Validation

>> Competency Assessment Program

>> Quality Management Program

>> Proficiency Testing/External Quality Assurance and the CAP

>> International PT/EQA Process Overview

>> Preparing an International PT/EQA Order

>> Placing an International PT/EQA Order with the CAP

>> International PT/EQA Sample Order Form

>> Next Steps After Placing Your Order

>> Successful Shipping of International PT/EQA Orderss

>> Inspect Your International PT/EQA Shipment

>> Sample Kit Instructions

>> CAP International PT/EQA Order Renewal

>> Questions and Answers

Last updated May 2013.

Laboratory Accreditation and the

The program is based on accreditation requirements. These

Last updated May 2013.

Laboratory Accreditation and the

All testing performed at a single location under the leadership of one

CAP Accreditation Process

• Enroll in CAP PT/EQA for all patient reportable tests,

• Request CAP application material

• Inspection team leader schedules inspection date

• Inspection team leader will submit report to CAP and

• Respond to findings (deficiencies) from on-site inspection

• CAP Commissioner reviews results, provides

• CAP awards accreditation and issues a Certificate

• Receive and review self-inspection materials

Outcome of Completing The laboratory is awarded a “CAP Laboratory Accreditation” certificate

Last updated May 2013.

Things to Know Before Applying for

Eligibility To be eligible for CAP Laboratory Accreditation, the laboratory must

A director of a laboratory subject to US regulations (CLIA), educated

The laboratory must provide documentation that all testing personnel

The laboratory must enroll in CAP PT/EQA and must do so a minimum of

Last updated May 2013.

Things to Know Before Applying for

Key Components In order to meet CAP Laboratory Accreditation requirements, the

Last updated May 2013.

Things to Know Before Applying for

To receive an estimate of annual accreditation fees, complete and

International laboratories are required to pay for roundtrip, business-

Please note that accreditation fees do not include the cost of

Last updated May 2013.

Request for Application

For additional information on payment refer to the “Placing an

Application The application may be completed online through e-LAB Solutions™.

A paper application may be completed and returned to the CAP

Applications must be submitted within six months of receipt

Last updated May 2013.

Key Components An effective director ensures: