jcia clinical laboratory survey process guide 2nd edition-final

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Contact Directory ...........................................................................................................................1

Introduction ....................................................................................................................................2

The Value of Joint Commission International Accreditation .................................................2

Joint Commission International—Who Are We?.....................................................................3

Who Is Eligible for an International Clinical Laboratory Accreditation Survey? ................5

How to Request an International Clinical Laboratory Accreditation Survey .......................5

Survey Scheduling, Postponements, and Cancellations ...........................................................6

The Standards Manual ...................................................................................................................7

International Patient Safety Goals for Clinical Laboratories ..........................................................9

Scoring Guidelines for Survey Consistency ............................................................................ 11

Accreditation Decision Rules – Effective 1 April 2010 ........................................................ 14

Accreditation Preparation .......................................................................................................... 17

Preparation Timeline .................................................................................................................... 18

Accreditation Process Timeline ..................................................................................................... 22

The On-Site Survey ................................................................................................................... 23

Sample Survey Agenda ............................................................................................................... 24

Tracer Methodology ................................................................................................................... 27

The Accreditation Decision ....................................................................................................... 30

Survey Agenda: Detailed Descriptions

Joint Commission International Accreditation Clinical Laboratory Survey Process Guide, 2nd Edition

Opening Conference ................................................................................................................. 32

Orientation to the Clinical Laboratory’s

Services and the Quality Improvement Process .................................................................... 34

Surveyor Planning Session ......................................................................................................... 36

Document Review ....................................................................................................................... 38

Documents Available in English .................................................................................................. 39

Evaluation of the Policies and Procedures by the Survey Team ...................................................... 41

Daily Briefing ............................................................................................................................... 43

Clinical Laboratory Environment Tour................................................................................... 45

Individual Patient Tracer Activity............................................................................................. 47

System Tracer: Infection Control ............................................................................................. 50

System Tracer: Quality Management and Improvement Process ....................................... 53

Visits to Laboratory Sections and/or

Off-Site Laboratories and Collection Stations ....................................................................... 56

Inpatient Unit/Setting Visits ..................................................................................................... 58

Undetermined Survey Activities ............................................................................................... 60

Education Session: Clinical Laboratory Decision Rules,

Scoring Guidelines, and Strategic Improvement Plan .......................................................... 61

Joint Commission International Accreditation Strategic Improvement Plan (SIP) Form ............... 62

Staff Qualifications and Education Session ............................................................................ 69

Competency Assessment Process Review Form .............................................................................. 71

Leadership Conference ............................................................................................................. 72


Surveyor Team Meeting ............................................................................................................. 74

Surveyor Report Preparation ..................................................................................................... 75

Leadership Exit Conference ...................................................................................................... 76

Survey Planning: Reference Lists

Required Quality Monitors ........................................................................................................ 79

Required Clinical Laboratory Plans .......................................................................................... 80

Required Policies and Procedures, Written Documents,

Clinical Laboratory Plans, and Bylaws ..................................................................................... 81

Standards that Reference Laws and Regulations and Standards of Practice ................... 106

Law and Regulation Worksheet ............................................................................................... .107

External Auditing Body Recommendation Worksheet ............................................................. .110


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Contact Directory

Joint Commission International Accreditation Central Office

1515 West 22nd Street, Suite 1300W

Oak Brook, IL 60523 U.S.A

Phone: +1.630.268.4800

Fax: +1.630.268.2996

E-mail: [email protected]

Joint Commission International Joint Commission International Joint Commission International

European Office Middle East Office Asia Pacific Office

Dr. Carlo Ramponi, Managing Director Dr. Ashraf Ismail, Managing Director Dr. Paul Chang, Managing Director

13, Chemin du Levant P.O. Box 505018 37th Floor

Immeuble JB Say Dubai Healthcare City Singapore Land Tower

F-01210 Ferney-Voltaire Dubai, United Arab Emirates 50 Raffles Place

France Phone: +971. 4369.4930 Singapore 048623

Phone: +33.4.50.42.60.82 Fax: +971.4362.4951 Phone: +6. 6829.7208

Fax: +33.4.50.2.48.82 E-mail: [email protected] Fax: +65.6829.7070

E-mail: [email protected] E-mail: [email protected]

Contact Joint Commission International for any of the following:

To inquire about a completed application for survey, survey date, or schedule or for

assistance with specific problems or information related to accreditation

To register for or receive information about education programs and to purchase or to

inquire about publications

Joint Commission International Web Site: http://www.jointcommissioninternational.org

Visit the Web site to obtain any of the following:

General information about accreditation

Joint Commission International news

Information about accreditation status for specific clinical laboratories

Application for survey

Frequently asked questions (FAQs)

JCInsight, JCI’s newsletter


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Revisions to standards

Standards

To submit a complaint about an accredited clinical laboratory

Joint Commission Resources Web Site: http://www.jcrinc.com

Visit the Web site to obtain any of the following:

Information about upcoming education programs

Catalog of publications

Access to official JCI publications and e-books

Video streaming presentations


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Introduction

The Joint Commission International Accreditation Clinical Laboratory Survey Process Guide is designed to help

clinical laboratories learn about Joint Commission International (JCI) standards and the survey

process. This guide will provide clinical laboratories with important information about JCI, the

clinical laboratory standards manual, eligibility for accreditation, how to request accreditation, survey

preparation, the on-site survey, and the accreditation decision.

Clinical laboratories should not hesitate to contact any of the JCI Accreditation Offices by telephone

or e-mail using the contact directory above for any other information they may need.

The Value of Joint Commission International Accreditation

Accreditation may benefit clinical laboratories by accomplishing the following:

Giving clinical laboratories a competitive advantage

Accreditation provides evidence of high-quality patient care that helps level the playing field for

clinical laboratories performing the same types of procedures.

Strengthening community confidence

Achieving accreditation is a visible demonstration to patients and the community that a

clinical laboratory is committed to providing the highest-quality services.

Obtaining recognition from insurers, associations, employers, and other stakeholders

Increasingly, accreditation is becoming eligibility prerequisite for reimbursement, association

membership, community awareness, and contracts or grants.

Validating high-quality care to patients

JCI standards are focused on achieving one goal: raising the safety and quality of care to the

highest possible level. Achieving accreditation is a strong validation that a clinical laboratory has

taken the extra steps to meet a high level of safety and quality.

Helping clinical laboratories organize and strengthen their improvement efforts

Accreditation encompasses state-of-the-art performance improvement concepts that help clinical

laboratories continuously improve quality.

Enhancing staff education


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The survey process is designed to be educational, not punitive. JCI surveyors are trained to help

clinical laboratories improve their internal procedures and day-to-day operations.

Improving risk management

By enhancing risk management efforts, accreditation may improve access to or reduce the cost

of liability coverage. It can also assist in lowering adverse events or outcomes for the clinical

laboratory, and, more importantly, for the patient.

Facilitating staff recruitment

As staff recruitment becomes more difficult, achieving accreditation as a demonstration of a

clinical laboratory’s commitment to quality and patient safety will enhance recruitment efforts

and retention of staff.


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Promoting team-building skills for staff

The process of obtaining and maintaining accreditation demands a team approach to good

patient care. Establishing processes and systems that support good patient care is achieved

through strong team activities.

Joint Commission International—Who Are We?

JCI is a division of Joint Commission Resources (JCR), the subsidiary of The Joint Commission. For

more than 75 years, The Joint Commission (U.S.A.) and its predecessor organization have been

dedicated to improving the quality and safety of health care services. Today, The Joint Commission

is the largest accreditor of health care organizations in the United States—it surveys nearly 18,000

health care programs through a voluntary accreditation process. The Joint Commission and JCI are

both nongovernmental, not-for-profit U.S. corporations.

The mission of The Joint Commission is to continuously improve health care for the public, in

collaboration with other stakeholders, by evaluating health care organizations and inspiring them to

excel in providing safe and effective care of the highest quality and value.

The Joint Commission was founded in 1951 under the auspices of the American Hospital

Association, the American Medical Association, the American College of Physicians, and the

American College of Surgeons, with the later addition of the American Dental Association, to act as

an independent accrediting body for organizations nationwide. As such, The Joint Commission

currently accredits nearly 80% of U.S. health care organizations. Because of the changing nature of

health care in America, beginning in 1975, The Joint Commission broadened its scope to include

accreditation of many non-hospital settings.

JCI extends The Joint Commission’s mission worldwide. Through international consultation,

accreditation, publications, and education, JCI helps to improve the quality of patient care in many

nations. JCI has extensive international experience working with public and private health care

organizations and local governments in more than 90 countries.

JCI established the Clinical Laboratory Accreditation Program to encourage quality testing in all

types of clinical laboratory facilities. Today’s health care environment is changing rapidly, and clinical


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laboratory providers are experiencing new competitive pressures in the health care marketplace.

Providing safe, high-quality testing and continually improving clinical laboratory performance are

benchmarks of success. JCI clinical laboratory accreditation is a widely recognized standard for high-

quality services.

Why Choose Joint Commission International over Other Options?

JCI is the leader in international accreditation, with more than 10 years of experience across the full

spectrum of health care organizations. JCI accreditation represents the ―Gold Seal of Approval™‖ in

health care and provides the most comprehensive evaluation process.


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The Joint Commission International Patient-Centered Accreditation Process

Significant changes were made to the JCI accreditation process in 2006 to make the process

more focused on the patient’s care experience. To help clarify the changes to this process,

tracer methodology was introduced as a new term. The new patient-centered process also shifts

accreditation away from survey preparation to continuous standards compliance. The survey

becomes merely the on-site evaluation piece of a continuous quality improvement process. See page

27 for more information on tracer methodology.

Joint Commission International Standards Represent an International Consensus

In October 2009, a revised set of standards was published for implementation on 1 April 2010. The

standards in the second edition of the Joint Commission International Accreditation Standards for Clinical

Laboratories were created through the following processes:

JCI Standards Committee, Accreditation Committee, and Board of Directors

The standards undergo extensive field review prior to being published. An International Standards

Committee, composed of experts in the health care quality and patient safety fields, was established.

This committee provides advice and assistance in developing new and revised standards and

recommends improvements to the accreditation process. These changes are reviewed by the

Accreditation Committee and are approved by the Board of Directors. This committee also oversees

the revision of the standards and their introduction to the health care community.

Regional International Advisory Groups

Regional International Advisory Groups, representing ministries of health, professional health care

associations, and national accrediting organizations, meet on a regular basis to discuss ongoing issues

and potential future improvements to the JCI accreditation process.

Field Review Process

When periodic revisions or changes to the standards are made, health care organizations, whether

accredited or not, are given an opportunity to comment on those changes. Field review

announcements are posted on the JCI Web site and are sent to the JCI list serve to elicit

individual/organization comments. To join the JCI list serve, please contact the JCI Accreditation

Central Office or sign up on the JCI Web site. (See the Contact Directory on page 1).


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Standards Interpretation

JCI will answer specific questions about JCI standards and how they are interpreted. This is a no-

cost service that can be accessed by telephone, by e-mail, or through the JCI Web site. Please direct

standards-related inquiries to Standards Interpretation at

http://www.jointcommissioninternational.org/interpretation-question/.


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Who Is Eligible for an International Clinical Laboratory

Accreditation Survey?

Any clinical laboratory may apply for JCI clinical laboratory accreditation if it meets the following

requirements:

The clinical laboratory is currently in operation as a health care provider in the country and

is licensed (if required).

The clinical laboratory assumes, or is willing to assume, responsibility for improving the

quality of its care and services.

The clinical laboratory provides services addressed by JCI standards.

How to Request an International Clinical Laboratory

Accreditation Survey

Clinical laboratories that wish to be accredited by JCI can obtain an application for survey by downloading the

application from the JCI Web site at http://www.jointcommissioninternational.org/Clinical-

laboratory/.

The application for survey should be submitted to JCI at least six months prior to the clinical

laboratory’s preferred on-site accreditation survey dates. Applications should be submitted, in

electronic format, by e-mail attachment to [email protected] or by fax to +1.630.268.2996.

The application for survey is valid for six months from the date it is submitted; this means a clinical

laboratory can submit its application and still have time to finish preparations before the on-site

survey takes place. It is best to submit the application when the clinical laboratory is confident it will

be able to demonstrate a four-month track record of compliance with the standards at the time of

the on-site survey (see ―Preparation Timeline‖ on page 18).

On the application for survey, clinical laboratories must indicate three months when they would like

the survey to take place and five additional weeks during the year when they would not like the


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survey to take place. JCI will make every effort to accommodate these time requests. The earlier the

request is submitted, the more likely the specific requests can be accommodated.

After the application for survey is received, the manager for JCI Accreditation Services will contact

the clinical laboratory. The manager will do the following:

Answer the clinical laboratory’s questions about survey preparation and help guide

individuals through each step of the accreditation process

Analyze the application for survey and contact the clinical laboratory if there are any

questions or items requiring clarification

Update changes to the clinical laboratory’s demographic information, including the address,

contact name(s), and so forth

Assist in locating other resources or JCI contacts to answer questions

Schedule the on-site survey and assign the survey team and survey team leader

Forward the contract agreement for the on-site survey for a signature

JCI schedules on-site surveys based on information provided in the application for survey. Based on

this information, JCI determines the number of days required for a survey, the composition of the

survey team, and the services to be reviewed.

Four to six months before the survey, the accreditation survey contract agreement will be sent to the

clinical laboratory. Until the signed contract agreement and the down payment of at least 50% of the

survey fees are received, the scheduled survey cannot be confirmed. The clinical laboratory will also

receive notification of the surveyor’s(s’) name(s) before its survey. The survey team leader will

contact the person responsible for the clinical laboratory’s survey approximately four to eight weeks

before the survey to finalize the agenda and to coordinate the availability of certain staff for key

survey activities, as well as to provide information regarding the surveyor’s(s’) travel arrangements

and logistics.

Handling Changes During the Application Process

If a clinical laboratory undergoes a change that modifies the information reported in the application

for survey after it submits its application, the clinical laboratory must notify JCI immediately of the

change. Changes that must be reported to JCI include the following:

A change in clinical laboratory name, ownership, and/or leadership


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A significant increase or decrease in the volume of services

The addition of a new type of health service

The deletion of an existing health service

A significantly altered building/physical plant

A required closure of a department or service by a regulatory or other legal authority

It may be necessary for JCI to schedule an additional survey for a later date if its survey team arrives

at the clinical laboratory and discovers that a change was not reported. JCI may also review any

unreported services addressed by its standards. In either case, additional fees may be assessed. JCI

will make the final accreditation decision for the clinical laboratory only after reviewing all services

provided by the clinical laboratory for which JCI has standards.

Survey Scheduling, Postponements, and Cancellations

Initial Schedules for Surveys

JCI schedules surveys systematically and efficiently to keep accreditation fees to a minimum.

Therefore, clinical laboratories are encouraged to accept scheduled survey dates. Initial surveys (a

clinical laboratory’s first full accreditation survey) should be scheduled within six months from the

time JCI receives the clinical laboratory’s application for survey.

JCI tries to honor specific requests for times during which a clinical laboratory prefers not to be

surveyed. The clinical laboratory should include these specific dates in the completed application for

survey, when possible. There may, however, be circumstances that prevent JCI from accommodating

these dates.

Definition of Postponement

JCI also allows the postponement of initial surveys or re-surveys. A postponement is a clinical

laboratory’s request to alter an already scheduled survey date or to push back the survey date before

it is actually scheduled. A clinical laboratory should direct a request for a postponement to the

manager for JCI Accreditation Services. A new survey application may be required when a new date

is established if the original application is older than six months.


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Acceptable Reasons for Postponement

A clinical laboratory may postpone scheduled surveys when one or more of the following events

occur:

A natural disaster or another major unforeseen event that totally or substantially

disrupts operations

A major strike that causes a clinical laboratory to cease performing tests

Patients and/or the clinical laboratory are being moved to another building during

the scheduled survey

JCI reserves the right to conduct an on-site survey if the clinical laboratory continues to perform

testing under such circumstances. Prior to postponing a scheduled survey, it is recommended that

clinical laboratories contact the manager for JCI Accreditation Services.

JCI understands that clinical laboratory operations may need to be modified to accommodate

construction and temporary disruptions in service. These situations are expected as part of managing

clinical laboratories and do not require postponement of a scheduled survey.

Cancellation

The survey may be canceled by JCI or the clinical laboratory without penalty or damages in the event

that acts of God, wars, terrorism, government regulations, disasters, strikes, civil disorders, or other

emergencies of a similar nature make it impossible, illegal, or unreasonable to go forward, provided

notice of the event requiring cancellation is communicated in writing as soon as practically possible.

Further, JCI may follow the advice of relevant ministries concerned with evaluating political and

military circumstances with regard to scheduling surveys.

If the clinical laboratory cancels the survey 60 days or less prior to the first day of the survey for any

reason(s) other than those previously stated, JCI Accreditation Services may require payment of one

half of the survey fees to recover costs JCI Accreditation Services has incurred.

The Standards Manual

The Joint Commission International Accreditation Standards for Clinical Laboratories, Second Edition is the

place to begin preparing for accreditation. The introduction to the manual contains the applicable


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JCI accreditation policies and procedures (see pages 1–5). Clinical laboratories considering

accreditation can review these policies and procedures to better understand the expectations before

beginning the accreditation journey. Even if clinical laboratories do not pursue accreditation

immediately, the manual is an excellent tool to help them evaluate current practices and structures.

The manual is designed to be used in self-assessment activities and forms the basis for an

accreditation survey. The manual contains functional standards that are organized around

management and leadership, resource management, management of the environment, and quality

control processes. The standards address clinical laboratory functions and processes, including

organization, management, and development and control of policies and procedures.

The JCI publication Joint Commission International Accreditation: Getting Started, Second Edition, provides

detailed information to assist clinical laboratories plan the approach, structure, and process for

beginning the accreditation journey.

Standards Chapters Several changes were made to the clinical laboratory standards chapters from the first to the second editions. The original five chapters were reduced to four, and the International Patient Safety Goals were added. Although the requirements of the standards have not changed significantly, the new revision has reduced repetition of requirements in more than one chapter and makes it easier to find the requirements. The chapters are as follows: International Patient Safety Goals (IPSG)

The purpose of the International Patient Safety Goals (IPSG) is to promote specific improvements

in patient safety. The goals highlight problematic areas in health care and describe evidence- and

expert-based consensus solutions to problems related to patient safety. Recognizing that sound

system design is intrinsic to the delivery of safe, high-quality health care, the goals generally focus on

systemwide solutions whenever possible. A summary of the IPSGs for clinical laboratories is

provided on page 9.

Effective in 2010, the IPSGs were introduced into the laboratory standards and accreditation process. Surveyors will evaluate compliance with these goals during 2010 surveys, but the findings will not affect the accreditation decision. Effective 1 January 2011, laboratories are required to demonstrate compliance with the IPSGs to achieve and maintain accreditation.


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International Patient Safety Goals

for Clinical Laboratories

IPSGs Accountability/Applicability

Goal #1 Identify Patients Correctly

Requirement The organization develops an approach to improve accuracy of patient

identification.

(See the intent and measurable elements on page 30 of the second

edition of the standards manual.)

Goal #2 Improve Effective Communication

Requirement The organization develops an approach to improve the effectiveness of

communication among caregivers. (See the intent and measurable

elements on pages 30–31 of the second edition of the standards

manual.)

Goal #3 Improve the Safety of High-Alert Medications

Requirement

Note: Not applicable to

clinical laboratories.

The organization develops an approach to improve the safety of high-

alert medications.

Goal #4 Ensure Correct-Site, Correct-Procedure, Correct-Patient Surgery

Requirement The organization develops an approach to ensuring correct-size,

correct-procedure, and correct-patient surgery.

(See the intent and measurable elements on pages 31–32 of the second


Goal #5 Reduce the Risk of Health Care–Associated Infections

Requirement The organization develops an approach to reduce the risk of health

care–associated infections.

(See the intent and measurable elements on page 32 of the second


Goal #6 Reduce the Risk of Patient Harm Resulting from Falls

Requirement

Note: Not applicable to

The organization develops an approach to reduce the risk of patient

harm resulting from falls.


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clinical laboratories


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Management and Leadership (MGT)

These standards address the requirements for leadership planning and oversight of the functions of

the clinical laboratory. Effective leadership depends on successfully performing the following

processes:

Planning and designing services—defining a clear mission, including a vision of the future

and the values which underlie day-to-day activities

Directing services—developing and maintaining policies, providing an adequate number of

staff, and determining their qualifications and competence

Integrating and coordinating services to meet the needs of the laboratory’s clients.

Improving performance—including leaders’ critical roles in initiating performance and

maintaining a clinical laboratory’s performance improvement activities

Development and Control of Policies and Procedures (DCP) This chapter delineates the requirements for policies and procedures, including the following:

General requirements

Procedures to order laboratory tests

Step-by step instructions for collecting and handling specimens

Step-by-step instructions for performing tests and other procedures

Reporting of results

Record and specimen retention Resource Management and Laboratory Environment (RSM)

These standards address the requirements for providing and managing the resources necessary for proper functioning of the clinical laboratory. The standards specifically address the following:

Human resources, including providing leaders and personnel with the necessary qualifications for the testing provided by the clinical laboratory

Infrastructure, including provision of necessary space, utilities, and equipment

Providing processes and equipment to assure a safe and secure environment Quality Control Processes (QCP) This chapter has the most standards and addresses the following:

General quality control requirements for all areas of the clinical laboratory

Specific quality control requirements for each laboratory specialty


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SCORING GUIDELINES FOR SURVEY CONSISTENCY

PURPOSE OF THIS DOCUMENT

Each measurable element (ME) of a standard is scored either ―fully met,‖ ―partially met,‖ ―not met,‖

or ―not applicable.‖ The purpose of this document is to bring consistency to the assignment of these

scores, recognizing that many types of evidence will be examined prior to the survey team arriving at

a final score for each ME.

DETERMING THE APPROPRIATE SCORE

1. “Fully Met” Score

A. An ME is scored ―fully met‖ if the answer is ―yes‖ or ―always‖ to the specific

requirements of the ME. Also considered are the following:

i. A single negative observation may not prevent a score of ―fully met.‖ (Also

see ―Consideration of Impact and Criticality‖ on page 13.)

ii. If 90% or more of observations or records (for example, 9 out of 10) are

met

B. The track record related to a score of ―fully met‖ is as follows:

i. A 12-month look-back period of compliance for triennial surveys

ii. A 4-month look-back period of compliance for initial surveys

2. “Partially Met” Score

A. An ME is scored ―partially met‖ if the answer is ―usually‖ or ―sometimes‖ to the

specific requirements of the ME. Also considered are the following:

i. If 50% to 89% (for example, 5 through 8 out of 10) records or

observations demonstrate compliance

ii. Evidence of compliance cannot be found in all areas/departments in which

the requirement is applicable When there are multiple requirements in one

ME, at least half (50%) are present.

iii. A policy/process is developed, implemented, and sustainable but does not

have the track record required for ―fully met.‖


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iv. A policy/process is developed and implemented but does not seem to be

sustainable.

B. The track record related to a score of ―partially met‖ is as follows:

The requirements of the ME are ―fully met‖; however, there is only

i. a 5- to 11-month look-back period of compliance for triennial surveys; or

ii. a 1- to 3-month look-back period of compliance for initial surveys.

3. “Not Met” Score

A. An ME is scored ―not met‖ if the answer is ―rarely‖ or ―never‖ to the specific

requirements of the ME. Also considered are the following:

i. If 49% or fewer (for example, 4 or less out of 10) records or observations

demonstrate compliance

ii. There was a finding of ―not met‖ for the ME during the last full survey and

now the finding is 67% or fewer observations of compliance.

iii. When there are multiple requirements in one ME, 49% or fewer are

present.

iv. A policy/process is developed but is not implemented.

B. The track record related to a score of ―not met‖ is as follows:

The requirements of the ME are ―fully met‖; however, there is only

i. a less than 5-month look-back period of compliance for triennial surveys;

or

ii. a less than 1-month look-back period of compliance for initial surveys.

C. If an ME of a standard was scored ―not met‖ and some or all of the other MEs are

dependent on the one scored ―not met,‖ then the remaining MEs that are tied to

the prior ME are scored as ―not met.‖ See the figure below for RSM.5 as an

example:

RSM.5 There is a plan to ensure that laboratory services and


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facilities are secure.

❒ 1. A written plan that describes security measures for laboratory

services and facilities is implemented.

Not

Met

❒ 2. The plan addresses security issues for people, property, and

equipment, as required in elements c) and d) in the intent.

Not

Met

❒ 3. The plan provides safeguards for specimens, resources, and

laboratory spaces against unauthorized access.

Not

Met

4. “Not Applicable” Score

An ME is scored ―not applicable‖ if the requirements of the ME do not apply based on the

clinical laboratory’s services, patient population, and so forth (for example, the clinical laboratory

does not have blood donor services).


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OTHER CONSIDERATIONS

1. The Look-Back Period for New Standards

The effective date of new standards is published with the standards. Clinical laboratories are

expected to be in compliance with the standards on the published effective date. The look-back

period for new standards can go back only to the effective date of the standard. Thus, for a new

standard effective 1 January, the look-back period on a 1 April triennial survey is 3 months back to

the 1 January effective date, not the 12 months for existing standards. Similarly, for a 1 April initial

survey, the look-back period is 3 months rather than 4 months.

If a clinical laboratory does not meet the shorter look-back period for a new standard, the score on

the ME will be influenced in the same manner in which a full 12-month (triennial) or 4-month

(initial) look-back period would be influenced. For example, if on a triennial survey, the possible

look-back period for a new standard is 6 months, and the clinical laboratory is in full compliance

(―fully met‖) with the ME, but the clinical laboratory can demonstrate compliance going back only

4 months, the ME will be scored ―partially met,‖ as 67% of the required look-back period was met.

The ME would be scored ―not met‖ if compliance could be demonstrated for only 2 months, or

33% of the possible look-back period.

2. The Look-Back Period on Follow-Up Focused Surveys

If, following a full survey—initial or triennial—a follow-up focused survey is required within 90

days per the accreditation decision rules, the look-back period at the time of the follow-up focused

survey is from the date of the follow-up focused survey, not from the date of the full survey. This

will permit clinical laboratories with good compliance for an ME on full survey, but inadequate

look-back periods, to obtain 3 months of additional look-back and thus possibly obtain full credit

for compliance with the ME.

3. Consideration of Impact and Criticality

Scores may be influenced by other factors, such as the impact or criticality of noncompliance for a

standard or an ME. Impact refers to the effect or outcome of the finding. Criticality refers to the

level or measure of importance of the finding. It is important to note that impact and criticality

determinations are not rule based, nor are they individual based; rather, they are determinations


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made by the entire survey team, usually at the time each surveyor’s findings are integrated to

determine the final score of an ME.

Impact and criticality influence scoring in the following two ways:

1. The impact of a particular compliance percentage or the actual number of noncompliant

observations is an important consideration. For example, 1 sharps container that is full and

unavailable for use out of 6 sharps containers has a more limited impact than when all 6

sharps containers are full and unavailable for use. The criticality of the finding, rather than the

actual number of noncompliant observations, is also important. For example, failing to

provide, inspect, and identify the use of 1fire extinguisher out of 12 is a critical finding if this

fire extinguisher is the incorrect type or the only one available for a particular area of the

laboratory.


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Accreditation Decision Rules (Effective 1 April 2010)

I. ACCREDITATION DECISIONS

INTRODUCTION

The Accreditation Committee considers all information from the initial or triennial full survey and

any required follow-up focused survey in making its decision regarding accreditation. The outcome

is that the clinical laboratory meets the criteria for accreditation or does not meet the criteria and is

denied accreditation. The criteria for these two potential outcomes are as follows:

A. ACCREDITED

This decision results when a clinical laboratory meets all the following conditions.

1. The clinical laboratory demonstrates acceptable compliance at the measurable element

level.

Acceptable compliance is:

No more than one measurable element is scored a ―0‖ for any standard.

No more than one measurable element is scored a ―0‖ for any International Patient

Safety Goal.

2. The clinical laboratory demonstrates acceptable compliance with each standard.


A score of at least ―5‖ on each standard.

3. The clinical laboratory demonstrates acceptable compliance with each International

Patient Safety Goal.


A score of at least ―5‖ on each International Patient Safety Goal.

4. The clinical laboratory demonstrates overall acceptable compliance.


An aggregate score of at least ―9‖ on all standards.


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B. ACCREDITATION DENIED

This decision results when a clinical laboratory meets one or more of the following conditions

at the end of any required focus survey subsequent to an initial or triennial full survey, or during

the period of accreditation as a result of a focus survey for the evaluation of one or more policy

related conditions that may place the clinical laboratory At Risk for Denial of Accreditation.*

1. Two or more measurable elements in a standard or International Patient Safety Goal are

scored a ―0‖.

2. One or more standard is scored less than a ―5‖.

3. One or more International Patient Safety Goal is scored less than a ―5‖.

4. The aggregate score for all standards is less than ―9‖.

5. A required Focused Survey subsequent to an initial or triennial full survey has not resulted

in acceptable compliance with applicable standards. .

6. One or more of the conditions that place the clinical laboratory At Risk for Denial of

Accreditation* have not been resolved at the time of the focused survey to evaluate the

condition.

7. The clinical laboratory voluntarily withdraws from the accreditation process.

8. The clinical laboratory does not permit the performance of any survey by Joint Commission

International

* Conditions that place a clinical laboratory At Risk for Denial of Accreditation

1. An immediate threat to patient/public health or staff safety exists within the clinical laboratory.

2. An individual who does not possess a license, registration, or certification is providing or has provided health care

services in the organization that would, under applicable law or regulation, require such a license, registration, or

certification and which placed the organization’s patients at risk for a serious adverse outcome.

3. Joint Commission International is reasonably persuaded that the clinical laboratory submitted falsified documents

or misrepresented information in seeking to achieve or retain accreditation, as required by the Information

Accuracy and Truthfulness Policy.

4. The clinical 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 clinical laboratory is seeking accreditation.

5. The clinical laboratory has not met the accreditation policy for ―Reporting Requirements between Surveys‖.

6. The clinical laboratory fails to submit an acceptable Strategic Improvement Plan (SIP) within 120 days of the

clinical laboratory’s survey.


24

II. ASSIGNMENT OF FOLLOW-UP REQUIREMENTS AS A RESULT OF A FULL

SURVEY

INTRODUCTION

Full surveys are conducted at the time of initial accreditation and at the time of

reaccreditation, every three years. At the conclusion of the survey, the findings are evaluated

against the required conditions for accreditation. When the survey results meet all the

conditions for accreditation, the clinical laboratory receives an Accredited status. The clinical

laboratory will then be requested to develop a Strategic Improvement Plan (SIP) that defines

the improvement strategy(ies) and/or approach to bring any noncompliant standards

and/or International Patient Safety Goals into acceptable compliance. However, when the

results of a full survey do not meet one or more of the conditions for accreditation, the

clinical laboratory will have a period of time to come into acceptable compliance. Acceptable

compliance can then be demonstrated by a visit from one or more surveyors to the clinical

laboratory. The visit is named a follow-up focused survey, as only the standards and/or

International Patient Safety Goals in noncompliance are the ―focus‖ of the survey.

A. PROCESS

An Official Survey Findings Report is sent to the clinical laboratory by the Accreditation

Office within 10 to 15 days following the survey. An SIP will be requested for any ―not

met‖ standard(s)/measurable element(s) and/or International Patient Safety Goal(s) cited

in the survey report when the clinical laboratory meets the conditions for accreditation.

The SIP explains the clinical laboratory’s process in defining the improvement strategy(s)

and/or approach, including specific actions to bring the cited findings into acceptable

compliance. The plan also identifies the methodology to prevent reoccurrence and

sustain improvements over time. The SIP is due to the Accreditation Office for review

and acceptance within 45 days after receiving the final report.

B. A Preliminary Survey Findings Report is sent to the clinical laboratory by the

Accreditation Office when the documented findings of the accreditation survey team do

not meet one or more of the conditions for accreditation. The preliminary report is sent

to the clinical laboratory within 10 to 15 days after the survey; the report includes all

standard(s)/measurable element(s) and/or International Patient Safety Goal(s) that were


25

found to be not compliant at the time of the survey. Each of the noncompliant (―partially

met‖ and/or ―not met‖) findings will be reviewed for compliance by the surveyors

during the follow-up focused survey.

C. FOLLOW-UP FOCUSED SURVEY

A follow-up focused survey is required within 90 days from the date when the clinical

laboratory received the Preliminary Survey Findings Report. During the on-site visit, the

surveyor(s) will determine the clinical laboratory’s compliance with the standards and

International Patient Safety Goals through various survey activities and methods, such as

direct observation, staff or patient interviews, review of documents, review of medical

records and/or personnel files, or the inspection of the physical facility.

When the results of the follow-up focused survey meet all the conditions for

accreditation, the clinical laboratory receives an Accredited status. The clinical laboratory

will then be requested to develop an SIP.

When the results of the follow-up focused survey do not meet one or more of the

conditions for accreditation, the clinical laboratory will receive a Denied Accreditation

status by the Accreditation Committee.


26

Accreditation Preparation

After JCI accepts the clinical laboratory’s application for survey, both parties make preparations for

the on-site survey. To help clinical laboratories prepare for accreditation, JCI offers seminars,

custom education, numerous publications (such as Joint Commission International Accreditation: Getting

Started, Second Edition), online education and training (such as webinars or live video streaming), a

new electronic self-assessment tool, and this Clinical Laboratory Survey Process Guide. These resources

provide specific information on JCI standards and teach concepts related to performing tests in

clinical laboratories. Go to the JCI Web site at

http://www.jointcommissioninternational.org/Products-and-Services/ for up-to-date information

on available educational resources.

JCI organizes a team of surveyors to match the clinical laboratory’s needs and unique characteristics.

JCI will make every effort to provide a surveyor(s) who is fluent in the language(s) used at the clinical

laboratory. If a JCI surveyor(s) with the appropriate language capabilities is not available, it is the

clinical laboratory’s responsibility to provide interpreter services throughout the survey. The

interpreter(s) must be fluent in English and the language(s) used at the clinical laboratory, be

experienced in verbal and written translation, be able to follow recognized Medical Interpreting

Standards of Practice, and abide by the confidentiality policies and regulations set up by the clinical

laboratory.

On-site clinical laboratory accreditation surveys are typically conducted one or two surveyors,

depending on the size and complexity of the clinical laboratory. The survey follows laboratory testing

throughout the facility and includes interviews with key personnel, observation of the clinical

laboratory’s administrative and testing activities, assessment of the physical facilities and laboratory

equipment, and review of documentation. A sample survey agenda appears on pages 24–26. The

actual agenda will be customized by the survey team to fit the needs and services of the clinical

laboratory. The survey activities may vary depending on whether the clinical laboratory is an

inpatient or outpatient laboratory.

The survey team leader will contact the clinical laboratory approximately four to eight weeks prior to

the survey to discuss and coordinate a workable and mutually agreeable agenda. The survey team


27

leader identifies those services/areas that need to be included in the review and suggests staff who

should be involved in each survey activity.

Suggested “Ready to Go” List

The survey process can be facilitated if the following items are readily available to the

surveyor(s) at the time of the survey:

• High-level organization chart

• Accurate list of tests being performed in the clinical laboratory

• Required quality, monitors, and data

• Clinical pathways and clinical practice guidelines, as applicable to the laboratory

• Proactive risk assessments, such as a failure mode and effects analysis (FMEA),

hazard vulnerability analysis (HVA), and infection control risk assessment (ICRA)

• Required clinical laboratory plans (for example, fire response plan and emergency

storage plan)

• Required policies and procedures, written documents, or bylaws

• Current map of clinical laboratory sites

• Sample of all laboratory record forms

The list of required policies and procedures and plans appears on pages 82–105.

Preparation Timeline

Clinical Laboratories Requesting an Initial Survey

JCI Activity Clinical Laboratory’s

Activity

6 months before

preferred month

Review the first section of

the standards manual to


28

of survey better understand the

expectations related to JCI

accreditation policies and

procedures.

Submit the application for

survey to the JCI

Accreditation Central

Office (electronically or by

fax).

Upon receipt of

the application

for survey

JCI manager for Accreditation

Services will review the

application.

The clinical laboratory will be e-

mailed a complimentary copy of

this Clinical Laboratory Survey

Process Guide.

Clinical Laboratories Requesting Reaccreditation


Activity

6 to 9 months

before the due

date of the next

triennial survey

An application for survey is e-

mailed to prepare for the next

on-site survey.

Complete

application at

least 4 to 6

months before

the accreditation

expires

Staff member(s) with

knowledge of the clinical

laboratory’s services, sites,

and testing volume will

need to complete and

submit the application for


29

survey (electronically or by

fax). The application

should be received by JCI

no later than 4 to 6 months

before the preferred survey

dates.

All Clinical Laboratories Requesting Accreditation


Activity

4 to 5 months

before survey

A contract agreement is e-mailed to

the clinical laboratory.

An invoice for down payment of at

least 50% of the survey fees is e-

mailed by the Finance Department

when the signed contract is

received. The clinical laboratory

can elect to pay 100% based on the

preference of the clinical laboratory

E-mail or fax the signed

contract to JCI no later

than 90 days prior to the

survey date. Notify

accounts payable staff to

expect an invoice and to

remit payment with a wire-

transfer form (found in the

application) no later than

60 days prior to survey

date.

8 weeks

before survey

Verification of survey date(s) and

name of surveyor(s) are e-mailed to

the clinical laboratory.

4 to 8 weeks

before survey

The survey team leader contacts

the clinical laboratory’s contact

person to finalize the survey

agenda and to request presurvey

information.

Appropriate staff

member(s) will need to

discuss the proposed

survey agenda and

determine whether times

are feasible for the clinical

laboratory given patient


30


Activity

needs and availability of

staff.

Clinical laboratories must

follow the guidelines in

requesting observers

during a survey (refer to

the survey agreement and

policies in the manual).

Survey Surveyor(s) arrives for the on-site

survey. At the conclusion of the

survey, the clinical laboratory

receives a copy of the Exit Report,

which details partial or

noncompliant areas that need to be

addressed. This report is not final

until the JCI Accreditation Central

Office has reviewed the report.

As outlined on the survey

agenda, staff should be

available during the survey.

An approved observer may

not answer questions or

contribute to discussions

unless requested by the

surveyor(s).

Within 15

days after

survey

JCI reviews, approves, and sends

the Official Survey Findings

Report. A follow-up focused

survey may be required prior to an

accreditation decision

determination. If the accreditation

is granted, the award letter, report,

and accreditation certificate are

mailed after all the survey fees have

been paid. The Gold Seal

guidelines and publicity kit will also

be posted to the Accredited

Clinical Laboratory Resource

Center on the JCI Web site at

http://www.jointcommissionintern

After the JCI Accreditation

Central Office sends the

Official Survey Findings

Report, the clinical

laboratory should begin

either of the two follow-up

processes as requested:

Develop the SIP if

accredited.

Prepare for the follow-

up focused survey if the

conditions for

accreditation were not


31


Activity

ational.org/accredited.

The chief executive officer (CEO)

of the surveyed clinical laboratory

will be sent a JCI Accreditation

Satisfaction Survey to assist JCI in

performance improvement

activities.

met.

The CEO of the surveyed

clinical laboratory should

encourage members of the

leadership team to provide

input for the JCI

Accreditation Satisfaction

Survey.

Within 3 days

after the

certificate is

mailed

The clinical laboratory’s name,

location, and date of accreditation

are added or updated for public

viewing on the JCI Web site at

http://www.jointcommissionintern

ational.org.

The clinical laboratory may

request JCI Accreditation

Services to place a link on

the JCI Web site to the

accredited clinical

laboratory’s Web site.

Ongoing Each accredited clinical laboratory

will have access to the Accredited

Clinical Laboratory Resource

Center via the JCI Web site, which

contains the JCI newsletter

(JCInsight), as well as many other

resources, publications, and

services that will assist in achieving

continuous compliance with the

standards.

Staff should review all

changes featured in the

newsletter to keep abreast

of official changes and

developments in the

standards and survey

process. Compliance is

required with new

standards and survey

processes for accredited

clinical laboratories.

Periodic submission of

evidence of compliance is

required as part of the

accreditation process; for

example, IPSG monitoring

data, SIP compliance data,


32


Activity

and self-assessments of

standards compliance.

6 months after

publication of

a new JCI

Clinical

Laboratory

standards

edition

JCI publishes a new edition of the

clinical laboratory standards

approximately every 3 years. The

manual becomes effective for all

accredited clinical laboratories and

all surveys 6 months after

publication.

Staff should review the

new accreditation manual

or supplement to

implement and act on any

new and modified

standards, scoring

guidelines, policies, and

procedures. If JCI needs to

visit the clinical laboratory,

the current, effective

standards will be used.

Within 30 days of

any significant

organizational

changes

The clinical laboratory

must notify JCI (via letter,

fax, or e-mail) of any

significant change in the

clinical laboratory (as

defined in the ―Joint

Commission International

Accreditation Policies and

Procedures‖ chapter of the

standards manual).

6 to 9 months

before the due

date of the

next triennial

survey

An application for survey is mailed

to the clinical laboratory to prepare

for the next on-site survey.

Joint Commission International Accreditation Clinical Laboratory Survey Process Guide, Second Edition

33

Accreditation Process Timeline

12 to 24

Months Prior

to Survey

6 to 9

Months

Prior to

Survey

4 to 6

Months

Prior to

Survey

4 to 8 Weeks

Prior to

Survey

Survey

Dates

Within 15

Days After

Survey

6 to 9 Months

Prior to Triennial

Due Date

Obtain JCI standards

manual and begin

preparing for JCI

accreditation.

Submit

application for

survey to JCI, and

schedule survey

dates with JCI.

JCI survey team

leader contacts the

clinical laboratory

to determine

survey agenda and

logistics.

Receive accreditation

decision and Official

Survey Findings Report

from JCI.

Receive and complete

JCI survey contract and

invoices for survey fees.

JCI

accreditation

survey occurs.

Submit revised

application and

schedule triennial

JCI accreditation re-

survey.

Continuous

Quality

Improvement

Journey


34


35

The On-Site Survey

The purpose of a JCI accreditation survey is to assess the extent of a clinical laboratory’s compliance

with applicable JCI standards. Clinical laboratories undergoing their first survey need to demonstrate a

track record of 4 months of compliance with the standards. Clinical laboratories being re-surveyed

need to demonstrate 12 months of compliance with the standards. Understanding the clinical

laboratory and assessing compliance is accomplished through a number of methods, including the

following:

Receipt of verbal information concerning implementation of standards or examples of their

implementation

On-site observation by a JCI surveyor(s)

Review of documents that demonstrate compliance and assistance in orienting the

surveyor(s) to the clinical laboratory’s operations

The on-site survey uses tracer methodology to follow a sample of clinical tests and potentially active

patients, if appropriate, through the laboratory processes, and if appropriate, patients, through their

experiences of care in the clinical laboratory to evaluate individual components and systems of care.

An important characteristic of the JCI survey process is on-site education conducted by the

surveyor(s). This support occurs throughout the survey as the surveyor(s) offers suggestions and

strategies that may help the clinical laboratory better meet the intent of the standards and, more

importantly, improve performance.

The on-site review consists of the following steps:

1. Opening conference and orientation to the organization

2. Survey planning meeting

3. Document review

4. Individual patient tracer activities

5. Quality control process review

6. Visits to clinical laboratory areas

7. Visits to collection stations

8. Visits to off-site laboratory services

9. Competence assessment and credentials evaluation


36

10. Resource management, including tours of the building, facility space, and equipment

11. Leadership conference

12. Leadership exit conference

Frontline Staff Ownership of the Process

Involving staff in the initial accreditation process and continuing to involve them in ongoing

assessments and process and system reviews enhance ownership, which results in continued safe,

high-quality care for patients and their families. During the tracer activities, the surveyor(s) will focus

his or her discussions on the clinical and support staff and will request manager and leadership staff

only to provide clarification, if needed.


37

JOINT COMMISSION INTERNATIONAL

CLINICAL LABORATORY

SAMPLE SURVEY AGENDA

3 DAY – 1 SURVEYOR

DAY ONE

Time Survey Activity

07:30 – 08:00 Opening Conference

08:00 – 10:00 Document Review

10:00 – 11:00 Leadership Conference

11:00 – 12:00 Walk-through Orientation to the Laboratory(ies)

12:00 – 12:45 Lunch

12:45 – 13:45 Visit to Blood Collection and Processing Areas

13:45 – 15:15 Quality Management and Improvement Process Systems

Tracer


38

15:15 – 16:30 Visit to Patient Care Units


39


CLINICAL LABORATORY



DAY TWO

08:00 – 08:30 Debriefing

08:30 – 10:15 Visit to Hematology and Coagulation Testing Laboratories

10:15 – 12:00 Visit to Chemistry Laboratories

12:00 – 13:00 Visit to Immunology/Serology Laboratory

13:00 – 13:30 Lunch

13:30 – 15:00 Visit to Blood Bank and Transfusion Services

15:00 – 16:30 Undetermined Survey Activity*


40

* See page 60 for more information on ―Undetermined Survey Activities.‖


41


CLINICAL LABORATORY



DAY THREE

08:00 – 08:30 Debriefing

08:30 – 10:30 Visit to Microbiology Laboratories

10:30 – 12:00 Visit to Surgical Pathology and Autopsy Laboratories

12:00 – 12:30 Lunch

12:30 – 14:00 Visit to Histopathology and Cytology Laboratory

14:00 – 16:00 Surveyor time to organize findings

16:00 – 16:30 Leadership Exit Interview and Closing Conference


42

Tracer Methodology

Tracer methodology is the foundation of the JCI on-site survey and accomplishes the following:

Incorporates the use of information provided in the accreditation survey application and

previous survey and monitoring reports

Follows the experience of testing for a number of patients through the organization’s entire

health care process

Allows the surveyor(s) to identify issues in one or more steps of the patient testing process

or the interfaces between processes

Individual Patient Tracer Activity

The individual patient tracer activity is an evaluation method that is conducted during the on-site

survey and is designed to ―trace‖ the testing experiences that a patient had during his or her stay in

or visit to the organization. Tracer methodology is used to analyze a clinical laboratory’s system of

providing services using actual patients as the framework for assessing international standards

compliance. During an individual tracer, the surveyor(s) will perform the following:

Follow the course of testing services provided to the patient by and within the organization

and the clinical laboratory using current records whenever possible

Assess the interrelationships between and among disciplines and departments, programs,

services, or units, and the important functions in the services being provided

Evaluate the performance of relevant processes, with particular focus on the integration and

coordination of distinct but related processes

Identify potential concerns in the relevant processes

Using the information from the application, the surveyor(s) will select patients from an active patient

list to ―trace‖ their experiences throughout the organization. Patients typically selected are those who

have received multiple or complex services and therefore have experienced more contact with

various parts of the organization. This interaction will provide the opportunity to assess continuity of

care issues (also see the Glossary in the Joint Commission International Accreditation Standards for Clinical

Laboratories, Second Edition). To the extent possible, the surveyor(s) will make every effort to avoid

selecting tracers that occur at the same time and may overlap in terms of sites within the

organization.


43

Individual Patient Tracer Selection Criteria

Patient tracer selection may be based on, but not limited to, the following criteria:

Patients in the top five diagnoses groups for that organization, as applicable to the

laboratory setting

Patients who have testing done in more than one laboratory area, such as hematology, blood

bank, and microbiology

Patients who cross programs (such as patients who require laboratory results before dosing

and administration of certain medications)

Patients receiving specific tests on a specified date

The surveyor(s) will follow the patient’s experiences, looking at services provided by various

individuals and departments within the organization as well as ―handoffs‖ between them.

This type of review is designed to uncover systems issues, to look at the individual components of an

organization, and to examine how the components interact to provide safe, high-quality patient care.

The number of patients followed under tracer methodology will depend on the size and complexity

of the organization that the clinical laboratory serves and the number and types of the tests

performed. As appropriate to the provision of care being reviewed, the tracer will include the

following elements:

Review of the patient record with the staff person responsible for the patient’s care,

treatment, or services provided. If the responsible staff person is not available, the

surveyor(s) may speak with other staff members. Supervisor participation in this part of the

tracer should be limited. Additional staff involved in the patient’s care will meet with the

surveyor(s) as the tracer proceeds.

Observation of infection prevention and control issues

Discussion of data use in the clinical laboratory. This includes quality improvement

measures being used, information that has been learned, improvements made using data,

and data dissemination (also see the Glossary in the Joint Commission International Accreditation

Standards for Clinical Laboratories, Second Edition).

Observation of the impact of the environment on safety and staff roles in minimizing

environmental risk

Observation of maintenance of equipment (also see the Glossary in the Joint Commission


44

International Accreditation Standards for Clinical Laboratories, Second Edition) and review of

qualified personnel responsible for the maintenance of the equipment

Linkages to Other Survey Activities

Issues identified from the individual patient tracer activities may lead to further exploration in the

system tracers or other survey activities, such as the facilities tour and the leadership conference.

Findings from tracer visits provide focus for other tracers and may influence the selection of other

tracers. They may also identify issues related to the coordination and communication of information

relevant to the safety and quality of care services.

Individual-Based System Tracer Activity

Individual-based system tracers look at a specific system or process across the organization. When

possible, this activity will focus on the experiences of specific patients or on activities relevant to

specific patients. This differs from the individual tracers in that during individual tracers, the

surveyor(s) follows a patient or test through his or her course of care or through the test process,

evaluating all aspects of care rather than a system of care. During an individual-based system tracer,

the surveyor(s) will perform the following:

Evaluate the performance of relevant processes, with particular focus on the integration and

coordination of distinct but related processes

Evaluate communication among disciplines and departments

Identify potential concerns in relevant processes

An individual-based system tracer includes unit/department visits to evaluate the implementation of

the system process and to review the impact on patient care services, treatments, and tests. The

tracer also includes an interactive session that involves a surveyor(s) and relevant staff members and

that will utilize information from unit/department visits and individual tracers. Points of discussion

in the interactive session include the following:

Strengths in the process, weaknesses in the process, and possible actions to take in areas

needing improvement

Issues requiring further exploration in other survey activities

A baseline assessment of international standards and IPSG compliance

Education by the surveyor(s), as appropriate


45

Prevention and Control of Infections System Tracer

The infection prevention and control individual-based system tracer explores a clinical laboratory’s

infection prevention and control processes. The goals of this session are to assess a clinical

laboratory’s compliance with IPSG.5 and RSM.6.1 to identify infection prevention and control issues

that require further exploration, to determine actions that may be necessary to address any identified

risks, and to improve patient and staff safety.

Quality Management and Improvement Process Systems Tracer

The focus of this system tracer is the processes a clinical laboratory uses to collect, analyze, interpret,

and use data to improve patient safety, care, and processes. The surveyor(s) will also evaluate the

effectiveness of the clinical laboratory’s implementation of quality and safety action plans, processes,

and programs.

The Role of Staff in Tracer Methodology

Staff will be asked to provide the surveyor(s) with a list of patients presently in the organization,

including the patients’ names, current locations in the organization, and diagnoses, as appropriate.

The surveyor(s) may request assistance from organization staff for selection of appropriate tracer

patients. As the surveyor(s) moves around the organization, he or she will converse with a wide

variety of staff involved in the traced patient’s care, treatment, services, and tests. This staff could

include nurses, physicians, therapists, case managers, aides, pharmacy staff, lab personnel (as

appropriate), and support staff. 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

cared for or is caring for the tracer patient.


46

The Accreditation Decision

The final accreditation decision is based on the clinical laboratory’s compliance with JCI standards.

Clinical laboratories do not receive a numeric score as part of the final accreditation decision. When

a clinical laboratory successfully meets JCI accreditation requirements, it will receive an award of

Accredited. This decision indicates that a clinical laboratory is in compliance with all applicable

standards at the time of the on-site survey. The JCI Accreditation Central Office may request an SIP,

which must be accepted by the JCI Accreditation Central Office, or the status of Accredited could be

removed.

Promoting Accreditation

After a clinical laboratory receives official notification of the accreditation decision, it can publicize

its international accreditation achievement by notifying patients, the public, the local media, third-

party payers, and resident referral sources. JCI provides a free publicity kit to accredited clinical

laboratories that includes the following:

Suggestions for celebrating accreditation

Guidelines for publicizing JCI accreditation

Frequently asked questions

Sample news release

Fact sheet

Information about a clinical laboratory’s accreditation status will be posted on the JCI Web site at

http://www.jointcommissioninternational.org. The Web site allows anyone to locate JCI–accredited

clinical laboratories within a country and region of the world.

The Continuing Accreditation Cycle

The accreditation process does not end when the on-site survey is completed. In the three

years between on-site surveys, JCI requests ongoing evidence of compliance and corrective

actions, such as a self-assessment, periodic submission of compliance data, root cause

analyses, and/or response to complaints. For this reason, it is very important for the clinical

laboratory to maintain compliance with standards between on-site surveys as well as new

standards published in new editions of the manual.


47

Continuous survey compliance means clinical laboratories can focus less on ―ramping up‖ for

survey every three years and, instead, can (and should) focus on continually improving their systems

and operations, thereby eliminating the need for intense survey preparation. Continuous compliance

with JCI standards directly contributes to the maintenance of safe, high-quality care and improved

clinical laboratory performance.


48


49


50

Opening Conference

PURPOSE

During the opening conference, the surveyor(s) describes the structure and content of the

survey to the clinical laboratory.

LOCATION

At the discretion of the clinical laboratory

CLINICAL LABORATORY PARTICIPANTS

Laboratory director and/or chief executive officer

Individual responsible for coordinating the clinical laboratory’s survey agenda, such as a

survey coordinator

Representatives of the organization’s leadership if the clinical laboratory is part of a health

care organization, such as a hospital or ambulatory care center

Others, at the discretion of the clinical laboratory

SURVEYOR(S)

All surveyors

STANDARDS/ISSUES TO BE ADDRESSED

Introduction and coordination of the survey

DOCUMENTS/MATERIALS NEEDED

Final survey agenda

WHAT WILL OCCUR

Surveyor(s) will be introduced.

Leadership will be introduced.

Agenda will be reviewed and modified.

Surveyor(s) will answer questions about the survey agenda.

Surveyor(s) will explain the use of tracer methodology during the survey process activities.


51

Surveyor(s) will explain the concept of ―drilling down‖ as an interviewing

technique/approach that aims to gather specific information about a process or outcome.

Staff members involved in drilling down inquiries should not perceive this approach as

personal or necessarily an indication of noncompliance. It is an indication that the

surveyor(s) is evaluating the establishment of systems to support a process.

Surveyor(s) will explain staff involvement in the documentation review process.

Surveyor(s) will explain staff involvement in the staff qualifications and education interview.

Surveyor(s) will explain the purpose of and the leaders’ involvement in the daily briefing

sessions.

Clinical laboratory staff will be encouraged to ask questions and seek clarification from the

surveyor(s) throughout the survey process.

Clinical laboratory staff will notify the surveyor(s) where lunch will be served or where he or

she can purchase lunch.

Clinical laboratory staff will identify country-specific information to ensure that the survey

team observes significant customs and values of the clinical laboratory during the survey

process, particularly if observance of customs impacts the survey agenda. For example, how

would the clinical laboratory prefer that the surveyor(s) conduct survey sessions during

times that staff members participate in prayer activities? In addition, clinical laboratory staff

should indicate how staff members would prefer to be addressed and should discuss the use

of interpreters, when needed.

Clinical laboratory staff will show the surveyors where the surveyors can meet as a group.

This location should be the same room where documents are gathered for surveyor review.

Clinical laboratory staff will introduce the surveyor(s) to the staff member who will provide

assistance throughout the day. This staff person will help the surveyor(s) to move quickly

between clinical laboratory locations and to maintain the planned schedule. This staff person

is usually a leader of the clinical laboratory or the survey coordinator.

HOW TO PREPARE

Set up a meeting or conference room large enough for the surveyor(s) to meet with key

organization and clinical laboratory leaders and with survey coordinators.

Notify clinical laboratory receptionists, so they can direct the surveyor(s) to the room when

he or she arrives.

Have copies of the survey agenda available for all participants in the opening conference.


52

Prior to the survey, decide which clinical laboratory leader or staff member will accompany

each surveyor throughout the survey day.

Arrange for surveyor(s) to be served or to purchase lunch.

Notify clinical laboratory staff of the survey agenda.

The surveyor(s) will wear a name badge that will identify him or her as a JCI surveyor(s). If

the clinical laboratory requires additional clinical laboratory–specific identification, prepare

and make it available to the surveyor(s) in the opening conference.

Note: The survey team leader will conduct a brief meeting prior to the opening conference with the

CEO, survey coordinator, and translators to discuss the logistics and expectations for the on-site

survey and use of translators. If there will be any approved observers, clinical laboratories must

provide a list of their names, titles, and organization affiliations to the survey team leader.


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Orientation to the Clinical Laboratory’s Services and the Quality

Improvement Process

PURPOSE

The clinical laboratory orients the surveyor(s) to the services, programs, and strategic

activities the clinical laboratory provides and its quality improvement process. This

information provides the surveyor(s) with baseline information about the clinical laboratory

and the quality and patient safety program that can help focus subsequent survey activities.

LOCATION



Chief executive officer

Individual responsible for coordinating the clinical laboratory’s survey agenda, such as a

survey coordinator

Medical staff leadership

Nursing leadership

Staff responsible for the quality improvement and patient safety program, if applicable

Others, at the discretion of the clinical laboratory

SURVEYOR(S)

All surveyors


Overview of the clinical laboratory’s services

Overview of the quality improvement and patient safety program and process


Organization chart

Quality improvement example


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WHAT WILL OCCUR

The clinical laboratory will give an overview of its structure, services, and strategic activities.

The clinical laboratory may include a brief presentation about the structure and methods of

the quality improvement and patient safety program.

The presentation should show how quality and safety information flows through the clinical

laboratory committee structure.

The presentation should describe the following:

o How quality and safety measures were chosen

o How the measures were prioritized for data collection

o How data are collected, aggregated, and analyzed

o How findings from data analysis are communicated and used for planning

improvements

The clinical laboratory may choose to present a quality improvement example to

demonstrate the clinical laboratory’s methodology and sustained improvement.

The surveyor(s) will ask questions, as needed, to clarify information or to request additional

information for use at a later time.


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Surveyor Planning Session

PURPOSE

During this session, the surveyor(s) reviews data and information about the clinical laboratory and

the organization (if appropriate) and plans the survey agenda. The surveyor(s) also selects initial

tracer patients/tests.

LOCATION

The clinical laboratory should provide space for this activity, usually the room designated as the

―surveyor headquarters.‖ This space should have the following items:

Conference table

Power outlets

Telephone

High-speed Internet connection/access for each surveyor

Printer


Clinical laboratory survey coordinator (as needed by team)

Translators (as needed by team)

SURVEYOR(S)

All surveyors

WHAT WILL OCCUR

This time is set aside for the surveyor(s) to review and discuss pertinent data and plan the survey

agenda. The surveyor(s) reviews the following items (as applicable to the setting), and these materials

should remain available to the surveyor(s) for the entire duration of the survey:

Performance improvement data, including committee meeting minutes for 12 months

prior to the survey

Infection prevention and control surveillance data, including committee meeting minutes

for 12 months prior to the survey

An organization chart and map


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A current list of inpatients, including their names, diagnoses, ages, admission dates,

physicians, and units/services

Name of key contact person (such as a supervisor or scheduler) who can assist the

surveyor(s) in planning tracer selection

A list of contact telephone numbers in case the surveyor(s) needs to reach key staff

SELECTION OF INDIVIDUAL TRACERS

Surveyor(s) reviews the information from the survey application and the list of patients

currently receiving care in the organization to guide his or her selection of patients to

trace.

Surveyor(s) identifies a clinical/service group and some general information about the

patient population receiving care and services.

Surveyor(s) describes to the survey coordinator the type of patient that he or she is

seeking to trace and requests staff’s assistance in identifying an individual.

In surveys longer than one day, the surveyor(s) informs the clinical laboratory during the

morning daily briefing about the types of tracers he or she wants to perform that day to

facilitate activity planning. This does not mean that the surveyor(s) will identify a specific

patient from the list supplied by the clinical laboratory. For example, the surveyor(s) may

choose to trace the following types of patients:

o An ambulatory patient who visited the internal medicine clinic and had

laboratory services

o An intensive care patient who is receiving blood gas testing

o An inpatient receiving point-of-care testing

o A critical patient receiving multiple tests

o A patient whose medication dosage is dependent on results of a laboratory test

(for example, a patient on heparin)

In team surveys, tracer selection should be coordinated when possible to avoid overlap of

visits to various units.


57

In clinical laboratories with multiple sites, individual tracers will include patients who

move between locations and services addressed by the represented accreditation

programs.


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Document Review

PURPOSE

The objective of the document review session is to survey standards that require some written

evidence of compliance, such as the plan for the Quality Management and Improvement Process or

Proficiency Testing documentation. Additionally, this session orients the survey team to the structure

of the organization, clinical laboratory, and management.

LOCATION

A meeting room or office that will be used throughout the duration of the survey as a meeting place

and work area for the survey team


Participants should include clinical laboratory staff members who are familiar with the documents

that will be reviewed, can translate these, and are able to respond to questions the surveyor(s) may

have during the session. At the discretion of the team, the surveyor(s) may designate a limited

number of staff members to attend and participate in the document review session. The session may

be conducted as an interview of staff about the documents. This approach has been very effective

when language barriers exist and the survey activities necessitate the use of professional interpreters.

SURVEYOR(S)

All surveyors


Almost all standards chapters make reference to plans, policies, and procedures that are to be

written. The following section and the ―Survey Planning: Reference Lists‖ section on pages 79–110

will assist staff members in understanding the particular documents that are a part of the

accreditation survey.


The documents that should be available to the survey team for their review or reference during the

survey process are listed in the ―Survey Planning: Reference Lists‖ section on pages 79–110. The list

of documents includes the following:


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Required quality monitors with data from the past 4 months (initial surveys) and/or 12

months for triennial surveys

Required clinical laboratory plans

Required policies and procedures, written documents, or bylaws

Minutes of the key committees for the past year, such as Performance Improvement,

Infection Prevention and Control, Safety, Leadership/Management Team Meetings, and

Medication Systems

If the laboratory is part of a larger organization, the following documents are required:

o An accurate list of the patients currently receiving care in the organization

o A list of the operative and other invasive procedures scheduled for the day,

including surgeries in the operating theatre, day surgeries, cardiac catheterizations,

endoscopies/colonoscopies, and in vitro fertilizations

o A sample action plan for a root cause analysis for a sentinel event or a near miss

o A sample FMEA action plan

o A current map of the hospital campus

o A sample of all medical record forms

In addition, the clinical laboratory should complete and have available for the survey teams the

worksheet related to relevant national or local health care–related laws and regulations. (See the Law

and Regulation Worksheet on pages 107–109.)

DOCUMENTS AVAILABLE IN ENGLISH

Documents showing evidence of compliance with the following standards must be provided to the

surveyor(s) in English:

Required Clinical Laboratory Plans

The quality management and improvement program is defined in a written plan. (MGT.4,

ME2)

Definition of the laboratory’s mission, vales, and goals. (MGT.1, intent)

The leaders identify, in writing, the type and scope of services provided by the laboratory.

(MGT.1.1, ME 4)


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The organizational structure of the laboratory is defined in writing and/or by diagram, and

responsibilities and authorities of leadership positions are clearly communicated. (MGT.2,

ME 3, ME 4)

Required Policies and Procedures, Written Documents, or Bylaws

A collaborative process is used to develop policies and/or procedures that address the

accuracy of patient identification. (IPSG.1)

A collaborative process is used to develop policies and/or procedures that will establish

uniform processes to ensure the correct site, correct procedure, and correct patient,

including procedures done in settings other than the operating theatre. (IPSG.4, ME1)

The organization uses a checklist and time-out procedure just before starting a surgical

procedure. (IPSG.4, ME4)

The mission, values, and goals are delineated in a written document. (MGT.1, ME 2)

Laboratory leaders are involved in defining the program in writing. (MGT.4, ME 2)

The plan defines the structure, goals, and components of the program. (MGT.4.1, ME 2)

The plan describes the methodology used to measure and improve processes and services.

(MGT.4.1, ME 3)

The laboratory has a plan for inventory, handling, storage, and use of hazardous materials

and the control and disposal of hazardous waste. (RSM.6)

WHAT WILL OCCUR

The documents should be made available to the survey team in the meeting room that has

been designated for their use throughout the duration of the survey.

At the beginning of the session, one staff person should briefly orient the survey team to the

organization of the documents.

During the remainder of the session, a staff member who can respond to any questions the

surveyor(s) may have should be readily available (in person or by telephone).

The materials should remain available to the survey team throughout the survey for

reference purposes. However, if documents are required for use by clinical laboratory staff,

they may of course be removed. The surveyor(s) may schedule a second document review

session during the course of the survey. The survey team may also request additional

documents throughout the survey to clarify or become knowledgeable about the clinical


61

laboratory’s policies and procedures or performance. Clinical laboratory staff should be as

proactive as possible in complying with requests for documents.

Some of the documents may need to be translated into English, whereas other documents

may require an interpreter to be made available.

HOW TO PREPARE

It is highly probable that many of the required documents will be part of larger documents. Clinical

laboratories do not need to remove or photocopy pertinent sections of these documents. Instead,

clinical laboratories can identify these sections using bookmarks or tabs. Guidelines for cross-

referencing this information are provided in the next section.

Other documents, such as minutes and reports, may be freestanding or individual documents.

Clinical laboratories should decide whether to provide the original document or a photocopy. It is

always beneficial to have several examples of these documents, such as committee minutes from the

last few meetings.

If the clinical laboratory has a large quantity of examples or a large volume of materials on a given

topic, it should select the most representative or the most pertinent examples. There will not be time

for the surveyor(s) to review large amounts of material on any given topic.

ORGANIZATION OF THE MATERIALS

Because the issues identified in the document review list may be addressed in different documents

depending on the clinical laboratory, the following guidelines for organizing the documents to be

used by the surveyor(s) are provided.

Group the freestanding or individual documents according to the following lists provided in this

guide:

Required quality monitors (See page 79.)

Required clinical laboratory plans (See page 80.)

Required policies and procedures, written documents, clinical laboratory plans, or bylaws

(See page 81.)

Required personnel information, such as job descriptions, orientation documents, in-service

education documentation, and competence assessment information


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Quality control documents, including quality control procedures, quality control results for

each laboratory area, and proficiency testing results

Note: When possible, please indicate the standards that the document addresses. The documents

may be grouped in binders or folders or other means may be used to separate major topical areas.

Gather the documents in one place. Identify the location in the document where the specific

information that is required by the standard may be found. The clinical laboratory may use methods

such as the following to identify the information:

A guide

An index

Bookmarks

Tabs

Note: When information is provided using computer monitors rather than paper, the following

conditions should be met:

Each member of the survey team should be provided with a monitor.

A printer should be available in case a member of the survey team wishes to print a

paper copy of a given document.

Staff may be needed to assist the surveyor(s) in locating the documents in the

computer.

Printed copies of bylaws and longer documents that may require extensive reading or

scanning by the surveyor(s) should be available.

EVALUATION OF THE POLICIES AND PROCEDURES BY THE SURVEY TEAM

The documents reviewed by the survey team provide an overview of what they expect to see in

actual practice during the survey process. For example, they would expect to find the following when

a new procedure on the disposal of infectious waste is developed:

That appropriate staff have been educated about the new procedure

That any special skills or other needed training has taken place

That waste is actually being disposed of according to the new procedure


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That any documentation required by the procedure is available for review

The presence of a policy or procedure alone usually does not determine the score of the standard.

Rather, the score is determined by the daily practice (implementation) of the policy or procedure.

The survey team will look for evidence that the practice related to the policy or procedure is well

implemented, as appropriate, throughout the clinical laboratory and thus is sustainable. In the event

the implementation appears incomplete to the survey team or the implementation occurred in a

manner that is not sustainable, the survey team will make a recommendation that more time be

allowed for better evidence of sustainable implementation and for incorporating the

recommendation into the survey follow-up requirements.

In general, the length of time a policy has been implemented is referred to as a ―track record.‖ The

survey team will look for a 4-month track record for policy-related standards during an initial survey

and for a 12-month track record during a triennial survey. For policy-related standards to be scored

―fully met,‖ the track record requirement must be met. When the track record period has not been

met, but the survey team finds that the policy has been implemented in a sustainable manner, the

team has the prerogative to score the standard as ―fully met.‖

The track record for new standards will be from the ―effective date‖ to the date of survey. For

example, if a new standard/ME is effective on 1 April and the survey takes place on 1 September of

the same year, the required track record for the new standard/ME is 5 months for ―fully met.‖


64

Daily Briefing

PURPOSE

To facilitate understanding of the survey process and the findings that contribute to the

accreditation decision

LOCATION



Clinical laboratory survey coordinator (as needed by team)

Chief executive officer and/or clinical laboratory director

Designated leaders (as determined by the clinical laboratory)

SURVEYOR(S)

All surveyors

WHAT WILL OCCUR

The daily briefing occurs every morning of a multiday survey with the exception of the first

day. The session is intended to be brief; 30 to 60 minutes is suggested depending on the

number of surveyors on the team.

When multiple surveyors are on site, the briefing is conducted jointly, with the survey team

leader serving as the facilitator.

During the daily briefing with the clinical laboratory, the surveyor(s) will perform the

following actions:

Offer a concise summary of the survey process activities completed on the previous

day

Make general comments regarding significant issues resulting from the previous day’s

activities


65

Note any specific positive findings

Emphasize patterns or trends of significant concern that could lead to

noncompliance determinations. The surveyor(s) does not report minor, one-time, or

single observations that do not impact scoring.

Inform the clinical laboratory that final findings for any given standard will be

possible only when all activities are complete and results are aggregated

Allow the clinical laboratory to provide information that may have been missed

during the previous survey day

Address clinical laboratory requests for discussion on findings and indicate when

such discussions can take place

Schedule time for more extensive discussion or review of additional evidence of

compliance on issues that arise

Review the agenda for the survey day ahead (including the identification of

individual patient tracers) and make any necessary adjustments based on clinical

laboratory needs or the need for more intensive assessment of an issue during the

―undetermined survey activity‖ time

Conclude the briefing and transition to the next activity(s) according to the agenda

Do not expect the surveyor(s) to perform the following actions:

Repeat observations made at a previous daily briefing unless it is in the context of

identifying a systemic issue

Discuss, in detail, each survey activity, specific records, and conversations held with

individuals during tracers

Delay scheduled activities for the current day to have an in-depth discussion of

issues from the previous day

SPECIAL SITUATIONS

There may be instances when a surveyor(s) will be scheduled to survey an activity that is not

taking place at the same location where a daily briefing would normally occur; this may take

place particularly when surveying with a team. There may also be situations in which a


66

surveyor(s) is brought in for a day or two and departs earlier than the rest of the team. If a

surveyor(s) cannot be physically present for the daily briefing, the surveyor(s) will do the

following:

Try to make arrangements to join via conference call

Share details of the previous day’s activities and findings with another surveyor for

the daily briefing presentation, even if a conference call is anticipated


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Clinical Laboratory Environment Tour

PURPOSE

The purpose of the environment tour is to address issues related to the following:

The physical environment

Medical and other equipment

Patient, visitor, and staff safety and security

Infection prevention and control

Emergency preparedness

Hazardous materials and waste

Staff education

LOCATION

Depending on the size and location of the clinical laboratory services, selected areas of the clinical

laboratory will be visited. The surveyor(s) will be looking to see if the corridors and exit paths of

travel are free for the safe exit of the facility in an emergency. The tour is designed to cover high-risk

areas for safety and security.


Laboratory manager

Safety officer and/or facility manager (if applicable)

Laboratory director(s)

Infection control practitioner (if applicable)

Others, as identified by the clinical laboratory

SURVEYOR(S)

All surveyors


Laboratory environment safety (RSM.5, RSM.7)



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Documents, such as plans (for example the risk assessment plan identified in RSM.7, intent),

policies and procedures, test and maintenance reports (as identified in (a) through (g) of

RSM.4.1.1, intent), that describe the plans for the following:

(a) Safety and security (RSM.5, RSM.7.2)

(b) Hazardous materials (RSM.6, RSM.6.2, RSM.6.3)

(c) Biohazardous materials and waste (RSM.6.1)

(d) Fire safety (RSM.7.1)

(e) Laboratory equipment and other materials (RSM.4 through RSM.4.5)

(f) Utilities Management (RSM.3.2 through RMS.3.2.1)

(g) Infrastructure–Basic Facilities (RSM.3 through RSM.3.1.1)

WHAT WILL OCCUR

The surveyor(s) may request to review the risk management report identified in RSM.7, intent, and will then

visit different areas of the clinical laboratory to observe adequacy of space and other necessary resources,

such as equipment and supplies. The surveyor(s) will examine the design of the clinical laboratory and

whether areas that require mental concentration are separated from areas with constant disruptions and

whether high-risk areas, such as bacteriology, are away from main traffic areas. If specimens are collected

from outpatients in the laboratory, the surveyor(s) will observe the area to determine that it is protected and

provides adequate privacy.

The surveyor(s) will visit testing and patient care areas as well as non-testing and non–patient care

areas of the clinical laboratory. In all areas, the surveyor(s) will observe the facility and interview staff

to learn how the clinical laboratory manages the facility to accomplish the following:

Reduce and control hazards and risks

Prevent accidents and injuries

Maintain safe conditions

Maintain secure conditions

Implement emergency response plans

Note: In some survey agendas, two surveyors will visit separate sections of the clinical

laboratory at the same time. The clinical laboratory should be prepared to have staff

available to guide and assist each surveyor on the tour of the facility.


69

The non-patient care areas visited by the surveyor(s) include the following:

The emergency power generator

Storage areas such as:

o Hazardous materials storerooms

o Hazardous materials disposal area

o Equipment storage area

Decontamination areas

HOW TO PREPARE

Prior to survey, the clinical laboratory leaders and facility manager(s) should carefully

read the relevant standards.

The facility manager(s) should tour the facility, conduct an inspection according to

the standards, and attempt to address any deficiencies prior to survey.

The clinical laboratory should be aware of relevant laws, regulations, and facility

inspections and should be able to share this information with the surveyor(s).

Complete the relevant sections of the Law and Regulation Worksheet on pages 107–

109.)

Representatives of the clinical laboratory should be prepared to show the surveyor(s)

how their facility management plans are implemented. For example, they should

demonstrate how hazardous materials are stored and disposed of.

Prior to survey, the clinical laboratory should ensure that all laboratory equipment

has been maintained, tested, and inspected and that these activities are documented

(RSM.4.1).


70

Individual Patient Tracer Activity

PURPOSE

A tracer follows the experiences of an individual patient’s testing process to evaluate the

laboratory’s and organization’s performance against international standards. One approach

to conducting a tracer is to sequentially follow the testing processes from ordering the test

through reporting the results. During an individual tracer, the surveyor(s) will do the

following:

Follow the course of the test using current records or patients who were tested in the

past

Assess the interrelationships between and among disciplines and departments,

programs, services, or units and the important functions in the care, treatment, and

services being provided

Evaluate the performance of relevant processes, with particular focus on the

integration and coordination of distinct, but related, processes

Identify potential concerns in the relevant processes

LABORATORY PARTICIPANTS

During a tracer, the surveyor(s) will converse with a wide variety of staff involved in the patient’s

care, treatment, and services. Staff could include nurses, physicians, therapists, case managers, aides,

pharmacy and lab personnel (as appropriate), and support staff. When an individual who actually

performed the function is available, the surveyor(s) prefers to interview that staff member. This

would include staff members who transcribe orders, collect specimens, transport specimens, receive

specimens in the laboratory, process specimens, perform patient testing, and review and report

results.

SURVEYOR(S)

All surveyor(s)


All standards chapters may be addressed during this visit.


71


All documentation of the clinical laboratory’s activities related to the quality control program may be

reviewed. This will include the documentation of the orders and test results in the clinical records of

patients.

WHAT WILL OCCUR

During the visits to the laboratory and patient care areas, the surveyor(s) may conduct a tracer. A laboratory

tracer follows the pre-analytic, analytic, and post-analytic testing practices through the entire process. A

complete tracer will include a review of the following:

Order for the test or blood component

Requesting process

Specimen collection procedures and processes

Specimen transport to the laboratory

Specimen accessioning and processing in the laboratory

Specimen testing

Review of test results and quality control reporting of results

The surveyor(s) selects patients for tracers using various methods, including the most treated diagnosis or

least treated diagnosis in a clinical laboratory, or he/she may select specific dates and ask the clinical

laboratory to give them a list of patients who had specific tests ordered on those dates. They will typically

select patients who have had testing performed in more than one laboratory area, for example, hematology,

blood bank, and microbiology. The surveyor(s) will then ―trace‖ the course of the patient and specimen

experience through the processes listed above.

The surveyor(s) will follow the patient’s experience, looking at services provided by various

individuals and departments within the organization as well as at ―handoffs‖ between them. This

type of review is designed to uncover systems issues, looking at both the individual components of

the clinical laboratory, and how the components interact to provide safe, high-quality patient care.

The tracer starts in the patient care setting or unit where the patient and the clinical record are

currently located. This is where the surveyor(s) begins to trace the entire care or service

process from preadmission through postdischarge. The surveyor(s) has approximately two

hours to conduct a tracer, although it may be shorter or longer depending on its complexity


72

and other circumstances. Multiple patient records may be reviewed during a single

designated tracer activity.

As appropriate to the provision of care being reviewed, the tracer will include the following

elements:

Review of records and documents in each step of the care process

Observation of specimen collection, processing, and testing, including the patient and specimen

identification processes

Observation of the movement of blood for transfusion out of the laboratory and to

the patient care unit where the identification process is observed and observation of

the initiation of the transfusion

Observation of infection prevention and control issues

Discussion of data use in the laboratory, including review and interpretation of

quality control data and other quality improvement measures

Observation of the impact of the environment on safety

Staff roles in minimizing environmental risk

If the surveyor(s) finds problems with the documents, such as quality control

documentation, he or she may select and review additional records to verify issues

that may have been identified. The surveyor(s) may ask staff to assist with the review

of the additional records.

Interview with staff

LINKAGES TO OTHER SURVEY ACTIVITIES

Issues identified from the tracer activities may lead to further exploration in the system tracers or

other survey activities, such as the facilities tour and leadership conference. The surveyor(s) will use

time scheduled as ―undetermined survey activity‖ on the agenda to conduct additional activities to

clarify issues, to gather additional information, and to evaluate standards compliance that is not

directly related to a patient tracer.


73

Findings from tracer visits provide focus for other tracers and may influence the selection of

other tracers. They may also identify issues related to the coordination and communication

of information relevant to the safety and quality of care services.


74

System Tracer: Infection Control

PURPOSE

During the discussion of the infection prevention and control program, the surveyor(s) and clinical

laboratory will be able to accomplish the following:

Identify strengths and potential areas of concern in the infection prevention and control

program

Begin determining actions necessary to address any identified risks in infection prevention

and control processes

Begin assessing or determining the degree of compliance with relevant standards

Identify infection prevention and control issues requiring further exploration

Note: When a separate Infection Control System Tracer is not noted on the agenda (for example, on

shorter surveys), the surveyor(s) will address infection prevention and control throughout individual

patient tracers and during the Quality Management and Improvement Process tracer.


Individuals from the clinical laboratory selected for participation should be able to address issues

related to the infection prevention and control program in all major areas within the clinical

laboratory. This group should include, but not be limited to, representatives from the following

departments, as applicable:

Clinical staff, including physicians, technicians, and laboratory personnel

Clinicians from the laboratory who are knowledgeable about microbiology

Staff responsible for the physical plant

Clinical laboratory leadership

Note: To facilitate a beneficial exchange between the surveyor(s) and the clinical laboratory, the

clinical laboratory should identify a relatively small group of active participants for discussions and

interviews. Other staff may attend as observers.

SURVEYOR(S)

All surveyors available to participate


75

WHAT WILL OCCUR

The session will open with introductions and a review of the goals for the Infection Control System

Tracer, which include the following:

Exploration, critical thinking, and potential problem solving about how the infection

prevention and control program incorporates laboratory services

Identification of potential areas of concern in the laboratory setting that relate to the

infection prevention and control program and areas for improvement and actions that could

be taken to address these

Process

The tracer may begin with a short group meeting with individuals responsible for the clinical

laboratory’s infection prevention and control program or in a patient care area identified by

the surveyor(s) for the focused-tracer activity.

During the group meeting, the surveyor(s) will gain a better understanding of the infection

prevention and control system and will identify potential areas that could be explored during

the patient care area visit and potential areas of concern that require further discussion with

staff knowledgeable about the clinical laboratory’s infection prevention and control

program. Examples of these areas include the following:

o How are infections, such as methicillin-resistant staphylococcus aureus (MRSA) and

Clostridium difficile (C diff), identified?

o Who is notified that these infections are present?

o How does the microbiology department communicate the various results to relevant

infection control personnel?

The surveyor(s) may move to other settings as appropriate and applicable to tracing

infection prevention and control processes across the clinical laboratory. Surveyors may ask

questions, such as the following:

o What are the infection control requirements for the different areas in the laboratory?

o Are there certain requirements related to eye protection, respiratory protection,

gloves, gowns and other protective equipment that should be worn in a laboratory?

The surveyor(s) will observe staff and engage them in discussions focused on infection

prevention and control practices in any setting that is visited during this system tracer

activity.


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Discussion

The surveyor(s) will draw from his or her tracer activity experience, clinical laboratory infection

prevention and control surveillance data, and other infection prevention and control–related data to

inspire scenarios for discussion with the clinical laboratory. Participants will be asked to discuss the

following aspects of the clinical laboratory’s infection prevention and control program as they relate

to the scenarios:

How patients with infections are identified by the clinical laboratory

Interactions with other departments, such as pharmacy, related to antibiotic selection

How patients with infections are considered within the context of the infection prevention

and control program

Current and past surveillance activities that took place in the previous 12 months or more

for re-surveys and 4 months or more for initial surveys

Type of analysis being conducted on the infection prevention and control data, including

comparisons

Reporting of infection prevention and control data, including frequency and audience

Prevention and control activities (for example, staff training, education of

patient/resident/client population, and housekeeping procedures)

Physical facility changes, either completed or in progress, that have an impact on infection

prevention and control

Actions taken as a result of surveillance and the outcomes of those actions

Effectiveness of implementation of IPSG.5 and the hand-hygiene guidelines

Clinical laboratories may use infection prevention and control data during this part of the activity if

the data are relevant to the discussion.

Conclusion

The surveyor(s) and clinical laboratory will summarize identified strengths and potential areas of

concern in the infection prevention and control program. The surveyor(s) will provide education as

applicable.


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System Tracer: Quality Management and Improvement Process

PURPOSE

This session focuses on the clinical laboratory’s activities to improve quality and patient safety

through the use of data to manage risk. The goals of this session include the following:

Review the laboratory’s quality management and improvement plans and current activities

Provide feedback on those quality management and improvement activities observed during the unit

visits and interviews

Provide education and technical assistance on the establishment of a coordinated program for

managing quality in the laboratory


Chief executive officer and/or chief operating officer (if applicable)

Medical director

Laboratory supervisors

Staff responsible for the quality management and improvement process activities (if applicable)

Others, at the discretion of the laboratory leaders.

Note: To facilitate a beneficial exchange between the surveyor(s) and the clinical laboratory, the

clinical laboratory should identify a relatively small group of active participants for discussions and

interviews. Other staff may attend as observers.

SURVEYOR(S)

All surveyors available to participate


Standards in the Management and Leadership (MGT) chapter


Clinical laboratories should have all of the following documents available for review during

this session or for the document review session on day one (see pages 38 to 39).


78

Leadership reports as identified in MGT.1.2.1 for contracted laboratory services and

reference laboratory services identified in MGT.1.2.2

Root cause analysis for any sentinel events and/or near misses, including definitions of

sentinel event and near miss and the methods and processes for performing a root cause

analysis. If possible, include a real-world example of a near miss event for which a root

cause analysis was performed.

Proactive risk assessments, such as failure mode and effects analysis (FMEA), hazard

vulnerability analysis (HVA), and infection control risk assessment (ICRA), including a

proactive risk analysis and redesign of at least one process per year. During this session,

the laboratory will show at least one example of a process that was analyzed and

redesigned to prevent possible problems.

Committee manuals, including committee minutes (for example, minutes from the

Quality Improvement and Patient Safety, Infection Prevention and Control, Risk

Management, and Complaint Management committees).

WHAT WILL OCCUR

The session is organized to better understand the processes related to quality monitoring and

improvement. Some of the activities for this session will be discussions and document

review for measures that are being used for improvement. Other activities can include the

surveyor(s) conducting focused tracers in the departments/services to evaluate the

effectiveness of the laboratory’s and organization’s implementation of the overall quality

plan; quality standards; and patient safety action plans, processes, and programs. The

surveyor(s) will perform the following activities and use the following methods:

The basics of data gathering and preparation, including the following:

o Selecting measures

o Data collection and aggregation

o Data analysis and interpretation

o Disseminating/transmitting findings

o Taking action

o Monitoring performance/improvement


79

Identify how the decision for the measures was made; how the data were collected; how

the findings were used; and how data, findings, and problems are communicated

throughout the clinical laboratory.

Determine the effectiveness in implementing the laboratory’s and organization’s action plans

developed as improvements following root cause analyses for sentinel events or near misses,

proactive risk assessments (such as FMEA and HVA), and managing quality and safety

complaints.

The surveyor(s) may incorporate examples from observations obtained from previous

individual patient tracers. During this session, the surveyor(s) will review only the monitoring

measures that have not been reviewed previously during the survey as part of the individual

or system tracers.

Infection Prevention and Control Data Issues (also see ―System Tracer: Infection

Control‖ on pages 50–52)

This system tracer is applicable in smaller surveys in which only one system tracer (Quality

Management and Improvement Process) is scheduled. Discussion explores the following

topics:

Types of monitoring measures and data collected:

o Whether infection-related data are collected

o Whether the laboratory and/or organization has developed and implemented a

system for measuring improvements

Using standardized definitions

Control methods (includes data dissemination to physicians, staff, leaders, and

external entities)

Prevention based on data findings

The laboratory’s and organization’s plans to collect data relevant to the JCI

Prevention and Control of Infections (PCI) standards

Conclusion


80

As a result of this session, the surveyor(s) and the laboratory leaders will be able to do the

following:

Identify strengths and weaknesses in the laboratory’s implementation of the quality plan,

including monitoring of performance measures, data use, areas identified for

improvement, and actions that could be taken

Identify specific data-use issues requiring further exploration as part of subsequent survey

activities

Provide appropriate education, as applicable


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Visits to Laboratory Sections and/or Off-Site Laboratories and

Collection Stations

PURPOSE

The purpose of the visits to the laboratory sections and/or off-site laboratories and collection stations is to

address the following topics:

Section-specific policies and technical procedures

Preventive-maintenance and quality control documentation

Infection prevention and control and safety practices

Specimen collection and processing practices

Staff competence and whether the number of staff is adequate

Proficiency testing

LOCATION

The surveyor(s) will visit each section of the clinical laboratory listed on the final survey agenda. If clinical

laboratories have locations other than the main site where laboratory testing is performed, the surveyor(s)

will also visit these areas. If clinical laboratories have remote specimen collection sites, the surveyor(s) will

visit a sampling of these sites as well.


The participants will be determined by the clinical laboratory but should include at least the supervisory staff

in each clinical laboratory area. The clinical laboratory director and/or manager may participate, as

appropriate.

SURVEYOR(S)

If there is more than one surveyor, this activity will be divided among them, and the locations each will visit

will be determined while preparing the survey agenda.

STANDARD/ISSUES TO BE ADDRESSED

Resource Management and Laboratory Environment (RSM)

Development and Control of Policies and Procedures (DCP)

Quality Control Processes (QCP)


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Written technical procedures for performing tests

Laboratory records and applicable logs and registers documenting the accession of specimens,

documenting patient results, and including examples of laboratory reports

Quality control records and evidence of quality control evaluations

Equipment maintenance, performance testing, calibration, and linearity testing records and

documentation of review of these records

Records of method validation for newly implemented test methods

Records of correlation of test methods performed according to different methodologies, at different

sites, or on different instruments

Records of remedial actions taken when quality control or equipment performance testing is not

acceptable

Evidence of implementing infection prevention and control and other safety policies and

procedures in the clinical laboratory

Adequacy of space and resources for services provided by the clinical laboratory

Discussion about and evidence of how STAT tests or critical values are reported

Documents that show this particular area of the clinical laboratory’s involvement in the quality

management and improvement process

WHAT WILL OCCUR

The surveyor(s) will review the documentation listed in the previous section and discuss the quality control

policies and documentation of remedial action with supervisory staff. The process used to label specimens

and access them into the clinical laboratory will be reviewed. The methods used to document test results will

be evaluated, along with the method of reporting these results. There will also be a discussion of the

knowledge each area of the clinical laboratory has concerning the laboratory’s quality management and

improvement process program as well as their involvement.

HOW TO PREPARE

Educate staff about applicable standards. Prepare staff by conducting mock interviews based on these

standards. Some sample questions include the following:


83

QCP.1.1 and QCP.1.1.1: Who performs the tests on proficiency samples? Do these personnel also test

patient samples? How many times do you analyze proficiency specimens, and is it consistent with how you

analyze patient samples?

QCP.1.1.2: Are there tests that are not included in a proficiency testing program? If so, what means do you

have of verifying their accuracy and reliability?

QCP.1.6: What is your process for reviewing quality control and patient results, and where is this review

process documented? Who performs the review?

QCP.1 (along with specific quality control standards found under each laboratory section): What are your

quality control processes for each test and how are results documented?

QCP.1.7: What are your policies regarding unacceptable quality control results, and how do you document

remedial action when this occurs?

Carefully observe the area to look for other standards compliance issues that the surveyor(s) is likely to

notice on the tour. These issues include infection prevention and control, fire safety, area cleanliness, and

equipment maintenance and performance testing.


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Inpatient Unit/Setting Visits (where applicable)

PURPOSE

The purpose of conducting visits to inpatient units/settings is to evaluate the interface between the

laboratory and the rest of the organization, to review any point-of-care testing performed on patient units,

and to review blood transfusion practices.

LOCATION

Patient unit or clinical department


Laboratory leader(s)

Clinic manager(s)

Others engaged in providing patient care in the unit/setting

SURVEYOR(S)

If there is more than one surveyor, each will visit separate patient units.


All standards chapters may be addressed during this visit.


A sample of clinical records of patients currently receiving care in the unit/setting

Laboratory specimen collection procedures

Procedures for blood transfusions and for identifying and reporting a suspected transfusion

reaction

WHAT WILL OCCUR

Visits to inpatient units/settings include the following elements:

A review of patient records to determine how laboratory results are reported

A review of laboratory specimen collection procedures provided to the unit

A review of blood transfusion procedures


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An observation of a clinician starting a blood transfusion (if possible)

A review of any point-of-care laboratory testing that is being performed on the unit/setting,

including laboratory testing performed outside formal laboratory areas

An interview with unit managers to determine how the laboratory works with units/settings and

how emergency test results and critical values are reported

The surveyor(s) begins the inpatient visit by explaining the purpose of the survey visit, then asks for a brief

general orientation to the unit/service from the manager or director. The surveyor(s) will then review a list

of the patients in the unit/setting and begin selecting patient clinical records to be reviewed with staff during

the visit.

The inpatient visit may include an observation of the start of a blood transfusion to verify adequate

procedures are being used to identify the patient and the unit(s) of blood and to ensure patient monitoring

for any signs of a transfusion reaction is initiated. (QCP)

The surveyor(s) may interview staff to better understand how the laboratory communicates with the

unit/setting. (MGT)

The standards require that anyone who prepares patients for specimen collection or who collects specimens

does so using written procedures for these activities. The surveyor(s) will verify that such procedures are

current, complete, and that staff are familiar with them. (DCP)

As in any unit/setting, the surveyor(s) will also observe the condition of the facility (RSM) and infection

prevention and control practices (RSM).

HOW TO PREPARE

Laboratory leaders should help managers and directors of each unit/setting become familiar with applicable

standards. Laboratory leaders should closely evaluate any point-of-care testing being performed on the unit

or in the setting to ensure applicable standards in the QCP chapter are being met. Necessary changes should

be made before the survey, and staff should be educated in care practices required by the standards.

Staff should be told what to expect when the surveyor(s) visits the unit/setting. It may be helpful to conduct

mock interviews with staff, so they are comfortable with the types of questions the surveyor(s) may ask.


86

Staff should also be made aware of the location in the unit/setting of the laboratory’s specimen collection

procedures and quality control, maintenance, and competency records for the testing performed outside the

main laboratory. These records should be assembled and be readily available when the surveyor(s) visits the

area.


87

Undetermined Survey Activities

PURPOSE

Tracer methodology is used as the primary tool to assess standards compliance. However, other

tools or a focused approach can be used to gather additional information to evaluate standards

compliance that is not directly related to a specific patient tracer. Each of these focused activities is

listed on the survey agenda as an ―Undetermined Survey Activity.‖

Undetermined survey activities are broadly defined and encompass a variety of activities customized

to the particular needs of each clinical laboratory. Undetermined survey activities are selected by the

survey team to allow for a more intensified assessment of a targeted area when information from any

survey activity, such as tracers or discussions, identifies a need to focus on a specific concern or to

increase the sample size of a review item.


Participants will be identified by the surveyor(s) depending on the activity being evaluated.


Standards/issues that will be addressed are those that relate to the specific activity that is being

surveyed. For example, if the survey activity is focused on hazardous materials, one of the standards

that would be addressed is RSM.6.

WHAT WILL OCCUR

Examples of undetermined survey activities include, but are not limited to, the following:

Focused tracers that are not patient tracers:

o Access to medical information

o Disinfection processes

o Blood product infusion processes

Focused process tracer:

o Hazardous materials management

o Laboratory specimen handling

Specific patient safety and quality activities:


88

o Failure mode and effects analysis

o Root cause analysis review

o Sentinel event review

Focused document/policy review to close gaps in the usual document review exercise

Other items as appropriate to the needs of the team


89

Education Session: Clinical Laboratory Decision Rules, Scoring

Guidelines, and Strategic Improvement Plan

PURPOSE

The purpose of this session is to provide education to clinical laboratory leadership to help them

understand the decision rules, the surveyor scoring guidelines, and the SIP.

LOCATION

At the discretion of the clinical laboratory leaders



Chief operating officer

Chairman, governing body, or similar representative


Survey coordinator and core quality leadership group

Others, at the discretion of the clinical laboratory leaders


Clinical laboratory decision rules

Surveyor’s(s’) scoring guidelines

SIP tool


None

WHAT WILL OCCUR

The surveyor(s) will cover the following topics:

Explanation of each of the decision rules for clinical laboratories

Scoring criteria for ―fully met,‖ ―partially met,‖ ―not met,‖ and ―not applicable‖ logic based

on the surveyor’s(s’) scoring guidelines


90

The survey team leader or designee will select one or two of the surveyor’s(s’) observations

that were reported at the daily debriefing to use as examples to illustrate how the findings

would be scored based on the scoring guidelines.

The survey team leader or designee will provide education on developing a postsurvey SIP

to address compliance issues identified in the ―not met‖ findings in the survey report.


91


92


93


94


95


96


97


98

Staff Qualifications and Education Session

PURPOSE

The objective of this interview is to address the clinical laboratory’s processes to recruit,

orient, educate, and evaluate all clinical laboratory staff. In addition, the interview addresses

the clinical laboratory’s process to evaluate the credentials of the medical and other health

care professional staff and their ability to provide clinical services consistent with their

qualifications.

LOCATION

Small meeting rooms at the discretion of the clinical laboratory’s leaders

CLINICAL LABORATORY PARTICIPANTS FOR EACH INTERVIEW WHEN HELD

SEPARATELY

The survey team may elect to conduct separate interviews, depending on the number of health care

professional staff present in the laboratory and the number of surveyors. Staff who may be

interviewed are as follows:

Medical staff:

o Elected or appointed senior leader of the medical staff and/or the medical director (if

applicable)

o Representatives of the medical staff involved in credential collection and review

Other health professional staff

o Manager of the human resources/personnel department

o Representatives of the group(s) involved in the orientation, education, and training of

health professional staff

Other clinical laboratory and/or organization staff

o Manager of the human resources/personnel department

o Representatives of the group(s) involved in the orientation, education, and training of

clinical laboratory staff

SURVEYOR(S)

All surveyors


99


RSM.1: Provision of resources

RSM.1.1: Personnel policies and procedures

RSM.1.2 : Qualified professionals who direct pathology and clinical laboratory services

RSM.1.3: Training and qualifications of supervisory staff and other leaders

RSM.1.4: Number of qualified staff

RSM.1.5: Orientation to organization of the laboratory and specific job responsibilities

RSM.1.6: In-service or other education and training required to maintain and improve competence

RSM.1.7: Competence assessments

RSM.2: Documented personnel information


100


Policies and procedures related to human resources/personnel management, staff

credentials, and staff orientation and education

A sample of laboratory personnel files and health care practitioner staff credential files

A sample of medical staff files

The surveyor(s) will provide instructions on the first day of the survey, generally during the

document review session, regarding this interview and the preparation of the files for review. The

survey team will provide the director of human resources with a list that identifies the type and

number of personnel and medical staff files selected for review later in the survey during the staff

qualifications and education interview. Sample request and review forms are shown on the next few

pages. The survey team will provide copies of the current survey tool on the first day of the survey.

It is important to know that the tools used by the surveyor(s) throughout the survey may change at

any time to continually improve the survey team’s abilities to score the laboratory’s compliance with

standards fairly and accurately. The tool merely reflects current JCI standards.

HOW TO PREPARE

The laboratory should include a list of all current personnel and medical staff in the document

review session on the first day. The list should identify each staff member’s specific discipline, hire

date, and department or service assigned (for example: Medical Director; Hired 20 July 2001;

Pathology). These documents should be in English, when possible.

The laboratory should closely review all personnel and credential files using the Competency

Assessment Process Review Form on page 71. Laboratories should ensure that all required elements

are in the files.


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Health Care Professional Staff

Competency Assessment Process Review Form


102

Name or

Category of

Staff

Date

of

Hire

Job qualifications

applicable to

services provided

and in accordance

with law and

regulations

RSM.1.4

QCP.2.2

All new employees

are oriented to the

area where they are

assigned and to

specific job

responsibilities

RSM.1.5

In-service education

and training are

provided, specifically

for occasions identified

in a) through e) of the

intent statement

RSM.1.6

Verification

of

education,

training, and

experience

RSM.2

QCP.2.2

Record of

appropriate personnel

information required

by standard, including

license and

certification, when

applicable.

RSM.2

Ongoing

competence

assessment

RSM.1.7

QCP.2.3


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Leadership Conference

PURPOSE

The purpose of the leadership conference is to assess communication among senior leaders of the

laboratory and the organization and how they address organizational performance issues.

LOCATION

At the discretion of the clinical laboratory’s leaders



Chief operating officer, when applicable


Medical director, when applicable

Quality improvement coordinator

Other senior leaders, at the discretion of the clinical laboratory

To foster an interactive process, a large group is not recommended for this conference.

SURVEYOR(S)

All surveyor(s)


Collaborative involvement of the senior leaders of the clinical laboratory and the organization in

governing, managing, and directing the laboratory will be evaluated. The following standards will be

addressed:

Laboratory planning, laboratory services, and resource planning (MGT.1 through MGT.1.3)

Responsibility and authority (MGT.2 through MGT.2.2)

Communication and coordination (MGT.3 through MGT.3.2)

Quality management and improvement processes (MGT.4 through MGT.4.1.4)



104

No documents are required to be made available during the leadership conference. However, during

the document review session, the surveyor(s) may have reviewed the following documents in

preparation for the leadership conference:

Organizational chart

Mission statement

Budget and resource allocation

Strategic planning documents

Staffing plans

Information management plan

Quality management plan

Worksheet of applicable laws and regulations

WHAT WILL OCCUR

The surveyor(s) will ask questions related to leadership activities and the decisions that have been

made as well as clarify any leadership issues identified during the survey. Everyone present should

participate in answering the questions. This is designed to be an interactive session.

The surveyor(s) will assess compliance with certain standards identified in the Management and

Leadership (MGT) chapter and with the Standards/Issues To Be Addressed in this section on page

72. During the leadership conference, the surveyor(s) will also identify issues that he or she will

pursue in later survey activities.

HOW TO PREPARE

Clinical laboratories should identify the participants in the leadership conference. Although leaders

should be familiar with all the standards, the clinical laboratory’s leaders should read closely the

standards identified in the Management and Leadership (MGT) chapter and the Standards/Issues To

Be Addressed in this section on page 72 prior to survey. In preparation for this session, it would be

useful to turn the standards into questions. Mock discussions could then be conducted with

participants, so they feel more comfortable with possible questions.

The following are a few sample questions:


105

RSM.1: Please explain the process you, as leaders, use to determine the resources needed to

support the operation of the laboratory.

MGT.2: How do you evaluate the effectiveness of the laboratory leadership?

MGT.4: What is a recent example of how laboratory leaders have supported and promoted the

quality management and patient safety improvement program?

MGT.1.2.1: How do you monitor the services offered by an outside organization with which you

have a contract to provide services?


106

Surveyor Team Meeting

PURPOSE

For surveys being conducted by more than one surveyor, scheduled team meetings provide an

opportunity for surveyors to share information and observations, plan for upcoming survey

activities, and plan for communication and coordination with the laboratory and/or organization.

When only one surveyor is present, this time is an opportunity to plan upcoming survey activities,

including the selection of additional tracers.

LOCATION

Surveyor headquarters


None

SURVEYOR(S)

All surveyors

WHAT WILL OCCUR

For surveys lasting more than one day, a 30-minute session is scheduled at the end of each day to

allow the surveyor(s) an opportunity to debrief and to plan for subsequent survey days and activities.

Surveys lasting longer than two days will include an additional 30-minute session before or after

lunch to allow for midday activity planning and observation sharing. During these sessions the

surveyor(s) will do the following:

Identify areas that have been visited during tracer activity

Coordinate locations, services, and other areas that will be visited during continuing

tracer activities

Share observations on the laboratory’s performance

Identify key findings that have surfaced

Ask other surveyors to follow up on potential issues

Identify issues/areas that all surveyors should be exploring during individual patient

and system tracers


107

When surveyors are in different locations at the times scheduled for team meetings, they may request

assistance from the laboratory and/or organization to facilitate communication among the members

of the team (such as ensuring availability of a speaker phone or a phone with conference call

capability).


108

Surveyor Report Preparation

PURPOSE

The surveyor(s) will use this time to compile, analyze, and organize the data he or she has collected

throughout the survey into a report reflecting the clinical laboratory’s compliance with standards.

LOCATION

Designated surveyor conference room with a computer that has an Internet connection and a printer

provided for the use of the surveyor(s) on each day of the survey


None

SURVEYOR(S)

All surveyors

WHAT WILL OCCUR

This time is reserved on the agenda for the surveyor(s) to review his or her observations and to

determine if there are any findings that reflect issues of standards compliance. The surveyor(s) will

be using his or her laptop computer to prepare the report and to plan for the leadership exit

conference.

The surveyor(s) may ask laboratory and/or organization representatives for additional information

during this session to confirm or disprove a finding. In addition, the surveyor(s) may request that the

laboratory and/or organization photocopy the report, as needed.


109

Leadership Exit Conference

PURPOSE

The purpose of this conference is to report the findings of the survey to clinical laboratory

leadership and to resolve any issues of interpretation that may have been identified during the survey.

LOCATION

At the discretion of the laboratory’s and/or organization’s leaders



Chief operating officer



Others, at the discretion of the clinical laboratory’s leaders

SURVEYOR(S)

All surveyor(s)


Survey findings


None

WHAT WILL OCCUR

This session includes the following two components:

1. Discussion with key leaders of the laboratory and/or organization about the survey report and

follow-up process, including review of the SIP. The discussion will cover the following topics:

Purpose of the conference

Summary of compliance findings related to standards

Discussion of any compliance findings for which there are questions or differences of

perspective


110

The content of the formal report of findings

The expected follow-up to the survey findings, for example, an SIP or a follow-up focused

survey

2. Formal presentations of an overview of the report to clinical laboratory staff selected at the

discretion of the CEO

The surveyor(s) will provide education to assist the laboratory in developing an SIP based on the

―not met‖ findings from the survey report. The surveyor(s) will explain the survey follow-up process

regarding communication of the accreditation decision by the JCI Accreditation Central Office.

At the discretion of the CEO, a brief conference will be held with other selected staff in the clinical

laboratory to provide an overview of the report and to complete the survey activities.


111


112

Required Quality Monitors

The clinical laboratory chooses clinical and managerial structures, processes, and outcomes that are

most important to monitor based on its mission, patient needs, and services provided. The

laboratory’s leaders identify key measures (indicators) to monitor the clinical laboratory’s clinical and

managerial structures, processes, and outcomes.

Required monitoring includes structure, process, or outcomes data on the following:

MGT.4.2.1 Quality measurement processes selected by the leaders, including aspects of:

a) The laboratory’s safety and infection control programs

b) The laboratory’s quality control programs

c) Pre-analytic processes, including:

Patient preparation

Specimen quality processes (collection, labeling, preservation, transportation, and

rejection)

Completeness of requisitions

d) Post-analytic processes, including:

Efficient transfer of information

Timeliness of reporting test results

Adequacy of documentation

Accuracy of reports

MGT.4.2.2 Managerial measurement includes aspects of the following selected by leaders:

a) The needs, expectations, and satisfaction of individuals and organizations served by the

laboratory

b) The appropriateness of tests offered


113

c) Key aspects of the procurement of routinely required supplies and equipment essential to

providing laboratory services

d) Those aspects of laboratory employee expectations and satisfaction selected by the

leaders

e) Those aspects of financial management selected by the leaders

f) Those aspects of the prevention and control of events that jeopardize the safety of

patients, families, and staff selected by the leaders, including the International Patient

Safety Goals

MGT.4.6 Data are analyzed when undesirable trends and variation are evident from the data.

MGT.4.6, ME 2 All confirmed transfusion reactions, if applicable to the laboratory, are analyzed.

MGT.4.9 An ongoing program of identifying and reducing unanticipated adverse events and safety risks

to patients and staff is defined and implemented.


114

Required Clinical Laboratory Plans

The following standards identify requirements that relate to a written plan. A plan is usually more

comprehensive in content than a policy or procedure. A plan can also be more long-range or strategic in

content. Frequently, a plan also sets priorities for the entire clinical laboratory. For example, the quality

management and improvement plan may address the clinical laboratory’s commitment to quality and

methods for organizing quality improvement efforts. It will also identify short- and long-range priorities and

methods to achieve those priorities.

A select few of these documents need to be in English. Please refer to the list of the documents that

need to be in English on page 39 or the tables on pages 82–105 of this guide. Other documents do

not need to be translated. For non-English documents, the survey team will have one member able

to read the documents, or alternatively, the survey team may request that one or more individuals be

available to describe the contents of the document and answer questions concerning the document.

QUALITY MANAGEMENT AND IMPROVEMENT

Laboratory leaders are responsible for planning, documenting, implementing, and monitoring a

quality management and improvement program. (MGT.4)

Laboratory leaders are involved in defining the program in writing. (MGT.4, ME 2)

MANAGEMENT AND LEADERSHIP

The laboratory’s mission, values, and goals are defined by laboratory leaders. There is a written

document that delineates the mission, values, and goals. (MGT.1, ME 1 and ME 2)

The type and scope of laboratory services provided are defined in a written policy. (MGT.1.1, ME 4)

DEVELOPMENT AND CONTROL OF POLICIES AND PROCEDURES

The requirements for developing and maintaining the laboratory’s policies and procedures are defined in a

written protocol. (DCP.1)

RESOURCE MANAGEMENT

The leaders determine and provide adequate resources to support laboratory services and implement

maintain and improve the quality management and improvement system. (RSM)


115

Planning should include the following areas, when appropriate to the facility and the activities of the clinical

laboratory:

1. An adequate number of qualified staff (RSM.1.4)

2. Adequate space, utilities, and equipment (RSM.3)

3. Adequate and reliable utilities and environmental conditions (RSM.3.2)

4. Hazardous materials and waste (RSM.6)

5. Reagents, equipment, and other materials (RSM.4.4)

6. Security of property and occupants (RSM.5)

7. Safety and security (RSM.5.)


116

Required Policies and Procedures, Written Documents, Clinical

Laboratory Plans, and Bylaws

The standards in the tables on pages 82–105 identify a requirement for a written document. In some cases,

that document is in the form of a policy and procedure. In other cases, the document is less formal but

addresses the issue identified in the standard. The document that is required is specified in the ―Type of

Documentation‖ column in the tables. In many cases, a number of standards requirements or MEs can be

combined into one policy and procedure. Organizations may find it useful to group all related policies and

procedures. For example, many of the quality control requirements are interconnected and can be contained

in one policy.

The standards in the tables on pages 82–105 also identify a requirement for a written plan. A plan is usually

more comprehensive, has more of a long-range focus, and is more strategic in content than a policy or

procedure. Frequently, a written plan also sets priorities for the entire clinical laboratory. For example, the

quality management and improvement plan may address the clinical laboratory’s commitment to quality and

methods for organizing quality improvement efforts. It will also identify short- and long-range priorities and

methods to achieve those priorities.

The surveyor(s) may not need to review all these documents in detail. It is, however, best to gather all these

documents into one book, or, alternatively, to identify the document by standard number in the traditional

location of the document for easy location.

Note: The specific requirements are addressed in the MEs for each standard; however, additional

details of what should be included in the documents is often found in the intent statement.

Note: Clinical laboratories should refer to the guidelines for document review for detailed suggestions on

the presentation of documents for the surveyor(s).

A select few of these documents need to be in English, and these are indicated in the ―English‖ column in

the tables Please refer to the list of the documents that need to be in English on pages 82–105 of this guide.

Other documents do not need to be translated. For non-English documents, the survey team will have one

member able to read the documents, or alternatively, the survey team may request that one or more


117

individuals be available to describe the contents of the document and answer questions concerning the

document.

The ―Page Number‖ column in the tables refers users to the page in the Joint Commission International

Accreditation Standards for Clinical Laboratories, Second Edition, where the standard is discussed.


118

Joint Commission International Standards for Clinical Laboratories

INTERNATIONAL PATIENT SAFETY GOALS

STANDAR

D MEASURABLE ELEMENT(S)

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IPSG.1 1 A collaborative process is used to develop policies and/or procedures that address the

accuracy of patient identification. 30 X Policy and Procedure

IPSG.2 1. A collaborative process is used to develop policies and/or procedures that address the

accuracy of verbal and telephone communications. 31 Policy and Procedure

IPSG.4

1. A collaborative process is used to develop policies and/or procedures that will

establish uniform processes to ensure the correct site, correct procedure, and correct

patient, including procedures done in settings other than the operating theatre. 32

X

Policy and Procedure

4. The organization uses a checklist and time-out procedure just before starting a surgical

procedure. 32 X

Checklist (or checklist

used as a script to

perform)

IPSG.5 1. A collaborative process is used to develop policies and/or procedures that address

reducing the risk of health care–associated infections. 32



119


120

MANAGEMENT AND LEADERSHIP

STANDAR


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MGT.1 2. The mission, values, and goals are delineated in a written document. 37 X Mission Statement

MGT.1.1 4. The type and scope of laboratory services provided are defined in a written policy. 38 Policy

MGT.1.2

The laboratory director and other leaders define the process for selecting and approving

contract and reference laboratory services, including services that provide blood and

blood products.

38

Document

1. The laboratory director defines in writing the criteria used to select and approve

contract laboratory services. 38

Policy

2. The laboratory director defines in writing the criteria used to select and approve

reference laboratory services. 38

Policy

MGT.1.2.1 1. The laboratory director defines in writing the means used to monitor the accuracy,

availability, appropriateness, and effectiveness of contracted laboratory services. 39

Procedure

MGT.1.2.2 1. The laboratory director defines in writing the means used to monitor the accuracy,

availability, appropriateness, and effectiveness of reference laboratory services. 40

Procedure

MGT.2

Responsibilities for administrative direction and clinical direction of the laboratory are

defined in writing. In addition, other leadership roles are also defined. 41

Document

1. Laboratory directors’ responsibilities are clearly defined in writing. 41 Policy


121

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2. Other leaders’ responsibilities are clearly defined in writing. 41 Policy

4. The organizational structure of the laboratory is defined in writing and/or by diagram. 41 Document

MGT.2.2

The laboratory director is responsible for requiring practices that respect the needs of

patients and other customers. This includes defining and implementing policies that

support patients’ rights to:

a) privacy;

b) security;

c) confidentiality;

d) ask questions or express complaints about their care or services; and

e) effective communication.

42


1. Patients’ privacy and security are provided and supported by policies and practice. 42 Policy

2. The patient’s right to voice complaints about care or services and to have these

complaints reviewed—and, when possible, resolved—is respected and supported by a

written policy, and the policy is implemented.

42

Policy

3. The patient’s right to effective communication is supported by a written policy, and

the policy is implemented. 42

Policy

4. Confidentiality regarding patients and their information is required of all employees in

a written policy, and the policy is implemented. 42

Policy


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MGT.3.1 1. Leaders require procedures to address complaints from clinicians who order tests, to

address complaints or questions from patients, and to respect patient rights. 43

Procedure

MGT.3.2

Necessary policies are developed for communicating with clinicians who order tests. The

laboratory has defined policies and implemented practices for these communication

practices, which include the following:

a) There is a protocol for critical test results that indicate an immediate threat to the

patient’s condition.

b) Providing guidelines to practitioners for requesting and receiving test results on an

emergency or STAT basis.

c) A process for notifying clinicians and others responsible for the patient’s care when

incorrect test results have been reported and for correcting the results.

43–44


Protocol

Guidelines

Process

1. There are policies addressing communications with clinicians that include the

following elements:

a) There is a protocol for critical test results that indicate an immediate threat to the

patient’s condition

b) Providing guidelines to practitioners for requesting and receiving test results on

an emergency or STAT basis

c) A process for notifying clinicians and others responsible for the patient’s care

when incorrect test results have been reported and for correcting the results

44


Protocol



123

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MGT.4 2. Laboratory leaders are involved in defining the program in writing. 46 X Policy

MGT.4.1

2. The plan defines the structure, goals, and components of the program. 46 X Policy and Plan

3. The plan describes the methodology used to measure and improve processes and

services. 46

Policy and Plan

MGT.4.1.4

The leaders define performance and quality control activities used to monitor the

laboratory’s processes and the systems used to ensure proper operation and control of

these processes.

47

Document

1. The laboratory director requires and approves written quality criteria for test method

and equipment performance. 48

Criteria

2. The laboratory director requires and approves written criteria for internal quality

control and external quality control (proficiency testing) performance. 48

Criteria

3. The laboratory director requires and approves written quality criteria for specimen

quality. 48

Criteria

4. The laboratory director requires and approves written quality criteria for reporting

results and documenting all verbal reporting of results. 48

Criteria

MGT.4.2 The laboratory’s leaders identify key measures (indicators) to monitor clinical and

managerial structures, processes, and outcomes. 49

Document


124

DEVELOPMENT AND CONTROL OF POLICIES AND PROCEDURES

STANDAR


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DCP.1

The requirements for developing and maintaining the laboratory’s policies and

procedures are defined in a written protocol. 58

Document

1. There is a defined protocol for policies and procedures that includes the requirements

of the following elements:

a) Initial review and approval of all policies and procedures is performed and

documented by the clinical director of the laboratory. Policies and procedures are

not distributed for use until the approval process is completed.

b) Periodic review of all policies and procedures is performed and documented at a

frequency defined in the protocol, but at least every two years. This review is

performed by the director, an appropriate supervisor, or another knowledgeable

individual.

c) The director or supervisor approves, in writing, all changes in policies and

procedures.

d) All policies and procedures are clearly and legibly written.

e) If manufacturers’ manuals or package inserts are used for technical procedures,

they are enhanced to include specific operational policies (for example, detailed

quality control protocols, calibration procedures, and other laboratory-specific

58

Detailed policy


125

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procedures).

DCP.2

Procedures for ordering tests are defined in writing. 59 Document

1. Policies and procedures describe processes that comply with the following elements:

a) the use of correct request forms

b) the process for identifying patients

c) information required on orders or request forms, to include at least the following:

• Patient’s name

• Patient’s gender

• Patient’s age or date of birth

• Authorized requesting individual, including, as applicable, a contact person to

enable the reporting of imminently life-threatening laboratory results

• The specimen source, when appropriate

• Test(s) or examination(s) requested

• Date and, when relevant, time of specimen collection

• Additional information required to select appropriate tests and to ensure accurate

test interpretation and reporting of results (for example, race/ethnicity, family

history, pedigree)

59


2. The process for confirming oral and telephone requests is defined in writing. 59 Process

3. There is a written description of the process for ordering tests on an emergency basis. 59 Description


126

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DCP.2.1

Policies and procedures are developed to provide step-by-step specimen collection

protocols for each type of specimen submitted to the laboratory. (Also included on

written document list)

59–60

Detailed procedures

and instructions/

Document

DCP.2.2

Policies and procedures are developed to guide how specimens are accessioned and

processed in the laboratory. 60–61

Document

1. Policies and procedures describe how specimens are received by the laboratory, logged

in to the laboratory’s systems, and processed. 61

Detailed procedures

2. The policies describe the specimen accessioning process and how records are

maintained, including the system for maintaining the identity of specimens, aliquots,

and records throughout the time they are in the laboratory.

61

Detailed procedures

DCP.3

The laboratory has current written descriptions and instructions for performing test

methods and procedures. 61–62

Document

1. The laboratory has a current written procedure for each analytic method performed. 62 Detailed procedures


127

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2. The procedure includes the requirements in the following elements:

a) A complete description of reagents and equipment used

b) Any equipment function verification required before testing is performed

c) Specific instructions for verifying method validity through controls or calibrators,

including a definition of acceptable control values and actions to take when control

results are not acceptable

d) The reportable range for patient test results

e) Limitations in methodologies, including interfering substances

f ) A step-by-step description of each phase of patient testing

g) Reference ranges, when applicable

h) Instructions for reporting results

i) Literature references

62

Detailed procedures

DCP.4

The laboratory develops policies, procedures, and controls for the postexamination

processes. 62

Document

2. The defined requirements for the laboratory’s reports, including those from reference

or contract laboratories, include the following elements and are implemented:

b) The report includes the following:

• The name and other identifiers of the patient and the specimen

• The name of the ordering clinician

62



128

STANDAR


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• The tests performed, test results, and units of measurement

• Date and, when relevant, time of specimen collection

• The condition of any unsatisfactory specimen

• Reference values for the tests performed

• Date and time the result is reported

• The identity of the laboratory that performed the test

c) The above elements are also included in reports from reference or contract

laboratories.

d) Reports from reference or contract laboratories are not modified in any way that

would change their meaning.

DCP.4.1

The laboratory has defined a process for immediate notification of the responsible

clinician when specific critical results indicate that the patient’s situation is life-

threatening.

63

Document

1. The laboratory has a written policy defining the laboratory’s critical values and the

process to follow when a test result is critical. 63

Policy

DCP.4.2

The laboratory has defined the process for measuring turnaround times. 63 Document

Intent. The laboratory follows a written process to measure turnaround times for tests.

The process includes a means of ensuring that turnaround times are acceptable. 63

Defined procedure

DCP.4.3 The laboratory has a defined process for correcting reported results. (Also in written 64 Procedure/ Document


129

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document list)

DCP.5 A written protocol defines the storage and maintenance requirements for records,

including retained specimens, slides, tissues, and blocks. 64

Detailed policy/

Document


130

RESOURCE MANAGEMENT AND LABORATORY ENVIRONMENT

STANDAR


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RSM.1.1

Personnel policies and procedures are described in writing and are followed. 70 Document

Intent.

a) The desired education, skills, knowledge and other requirements of all staff

members have been described.

b) Each staff member’s responsibilities are defined in a current job description.

c) A policy describes how all staff members are oriented to the organization and the

laboratory.

d) There is a description of the laboratory’s process for staff education and training.

e) The processes for ongoing competence assessment and performance evaluation

are described.

70

Document

1. The following elements are described in written policies and other documents:

a) The desired education, skills, knowledge, and other requirements of all staff

members have been described.

b) Each staff member’s responsibilities are defined in a current job description.

c) A policy describes how all staff members are oriented to the organization and the

laboratory.

d) There is a description of the laboratory’s process for staff education and training.

71


Description

Job descriptions

Policy

Description


131

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e) The processes for ongoing competence assessment and performance evaluation

are described. Process

RSM.1.2 2. The professional education, training, experience, and expertise of the director(s) are

documented. (Also included on written document list) 71

Personnel

record/Document

RSM.1.3 2. Supervisor and management staff qualifications are documented. (Also included on

written document list) 71

Personnel

record/Document

RSM.1.5

2. Participation and successful completion of the orientation is documented, including

approval by the laboratory director or appropriate supervisor that the individual is

competent to perform assigned tasks.

72

Personnel

record/Document

RSM.1.6 2. In-service education and on-the-job training are documented for each staff member.

(Also included on written document list) 73

Personnel

record/Document

RSM.1.7 1. The organization has a laboratory policy that defines the process and criteria for

assessing staff competence. 74

Personnel record


132

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2. Staff members’ performance and competence are assessed annually. 74 Document

RSM.2

Documented personnel information is maintained for each staff member. 74 Document

1. There is documented personnel information for each staff member. 74 Personnel record

2. Documented personnel information includes the following elements:

a) A summary of education and training relevant to duties when hired

b) History of related work experience, including references from previous employers,

if available

c) Primary source verification of certification or licensure, if required by applicable

law and regulation

d) Evidence of certification or licensure, if not required by law and regulation, but if

required by organization policy

e) Current job description

f ) Records of initial orientation and any retraining required

g) Records of any additional training for new job responsibilities

h) Records of continuing education and achievement

i) Records of performance evaluations and periodic assessments of competence

j) Records of health status (as related to work), such as immunization status and

health status after work-related accidents

k) Records of radiation exposure and any monitoring for radiation exposure, when

74

Personnel record


133

STANDAR


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DOCUMENTATION

relevant

l) Records of monitoring for exposure to hazardous chemicals, when indicated

m)Records of untoward incident or accident reports, such as accidental needlesticks

RSM.3.2 A plan for providing and maintaining necessary utilities is defined and implemented. 77 Document

RSM.3.2.1

There is a system to inspect, test, and maintain critical operating components for utility

systems and to investigate and correct utility system problems. 77

Document

1. There is a written plan defining the inspection, testing, and maintenance of critical

components for utility systems. 78

Plan

2. The plan includes at least the following elements:

a) periodically testing the emergency generator

b) at least annually checking for polarity and ground integrity on electrical outlet

circuits

c) periodically checking (at least annually) and maintaining for the biological safety

hood

d) periodically checking (at least annually) on the chemical fume hood

e) daily monitoring of temperature-controlled spaces

f ) monitoring of humidity, where indicated.

78

Plan

RSM.4 1. There are defined processes for selecting and using equipment, reagents, and other

supplies. 78

Policy


134

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3. The director has defined performance criteria for test methodologies, equipment, and

quality control. 78

Policy

RSM.4.1

1. There is a defined program for regular monitoring of equipment to demonstrate

proper calibration and function. 79

Procedures /Document

4. All performed verification checks and preventive maintenance are documented. 79 Document

RSM.4.1.1

An historical record is maintained for each analytical instrument and piece of equipment

used by the laboratory. 79

Document

1. There is an historical record for each analytic instrument and piece of equipment. 80 Equipment records

RSM.4.3

There are defined processes in place for validating and maintaining computer software

and information when they are used by the laboratory. 80

Document

1. There is validation of computer software for computers or electronic testing

equipment, prior to use. 81

Procedures

3. Written procedures meet the requirements of the following elements:

c) Procedures are developed for the use of computers and routine maintenance.

d) There are defined procedures to protect data and information against loss,

destruction, tampering, and unauthorized access or use.

e) There is a defined backup procedure to follow a computer is not functioning, so

that laboratory results continue to be reported in a timely manner and data during

81

Procedures


135

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this time are not lost.

RSM.4.4

The laboratory follows written guidelines for the periodic evaluation of all reagents,

including water, to provide for accuracy and precision of results. 81

Document

1. Written guidelines address the requirements that the laboratory has and follows written

guidelines for the periodic evaluation of all reagents, including water, to provide for

accuracy and precision of results.

81

Procedures

2. Reagents, including water, are evaluated according to the requirements of the written

guidelines and the following elements:

b) Reagent performance and adequacy are verified before use.

c) Kits that contain all essential reagents, standards, diluents, and any other reagent

water are evaluated according to an established protocol.

d) Water used in laboratory testing is appropriate for such use.

81

Procedures

RSM.4.5

Laboratory records include documentation of required information for reagents, and

reagents are completely and accurately labeled. 81

Document

1. Records for reagents, controls, kits, and solutions include the identity of the reagent,

the date of receipt or preparation, and the lot number, if available. 82

Records


136

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2. All reagents are labeled with the information required in the following elements:

a) identity;

b) strength;

c) storage requirements;

d) cautionary and accessory information;

e) date prepared or received; and

f ) expiration date

82

Records

RSM.5

There is a plan to ensure that laboratory services and facilities are secure. 82 Document

1. A written plan that describes security measures for laboratory services and facilities is

implemented. 82

Plan

2. The plan addresses security issues for people, property, and equipment, as required in

the following elements:

c) addresses security issues for patients, visitors and other customers, laboratory staff,

and property

d) provides safeguards for equipment (software and hardware), reference materials,

consumables, reagents, and analytic systems

82

Plan

3. The plan provides safeguards for specimens, resources, and laboratory spaces against

unauthorized access. 82

Plan


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RSM.6

Intent

a) The laboratory identifies and safely controls hazardous materials and waste

according to a plan.

b) The plan addresses all types of hazardous materials and waste.

c) The plan requires an inventory of hazardous materials and waste.

d) Procedures define processes for

• handling, storage, and use of hazardous materials;

• reporting and investigation of spills, exposures, and other incidents;

• proper disposal of hazardous waste;

• proper protective equipment and procedures during use, spill, or exposures;

• documentation, including any permits, licenses, or other regulatory requirements;

and

• proper labeling of hazardous materials and waste

e) Safety policies and procedures are defined for the following, if found in laboratory

areas:

• Biohazardous or infectious materials and waste, including sharps

• Hazardous chemicals and waste

• Chemotherapeutic materials and waste

• Radioactive materials and waste

82

Document

83

Document


138

STANDAR


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• Hazardous gases and vapors

1. The laboratory has written plans for handling hazardous materials and waste, as

described in the following elements:

a) The laboratory identifies and safely controls hazardous materials and waste

according to a plan.

b) The plan addresses all types of hazardous materials and waste.

83

Plan

2. The laboratory identifies hazardous materials and waste and has a current list of all

such materials. 83

List

3. Procedures define processes for the processes identified in the following element:

d) Procedures define processes for

• handling, storage, and use of hazardous materials;

• reporting and investigation of spills, exposures, and other incidents;

• proper disposal of hazardous waste;

• proper protective equipment and procedures during use, spill, or exposure;

• documentation, including any permits, licenses, or other regulatory requirements;

and

83

Procedures


139

STANDAR


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• proper labeling of hazardous materials and waste.

4. Safety policies and procedures are defined for the types of hazardous materials

identified in the following element:

e) Safety policies and procedures are defined for the following, if found in laboratory

areas:

• Biohazardous or infectious materials and waste, including sharps

• Hazardous chemicals and waste

• Chemotherapeutic materials and waste

• Radioactive materials and waste

• Hazardous gases and vapors

83


RSM.6.1

The laboratory uses a coordinated process to reduce the risks of infection as a result of

exposure to biohazardous materials and waste. 83

Document

1. The laboratory has a defined process for reducing the risks of infection. 84 Process

3. The laboratory follows biosafety rules for relevant practices addressed in the following

elements:

a) Exposures to aerosols and droplets are controlled (for example, when mixing,

sonicating, centrifuging, and flaming inoculating loops).

b) Exposure to needlestick and puncture by other sharps is controlled.

c) Laboratory coats, gowns, or uniforms are worn to protect street clothes and

84

Rules


140

STANDAR


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prevent contamination.

d) Gloves are worn by all personnel who handle potentially infectious specimens,

cultures, or tissues.

e) Personnel are given training on the proper use of personal protective equipment

(for example, gloves, gowns, masks, eye protectors).

f ) Biosafety cabinets are used, when required.

g) Rules govern how to handle laboratory exposure to infectious agents, accidental

cuts, needlestick injuries, accidental ingestion, and contact of potentially infectious

agents with mucus membranes. These rules include decontamination procedures,

whom to contact for emergency treatment, and the location and use of safety

equipment.

h) Rules govern handling, decontamination, and disposal of infectious waste.

i) Appropriate immunizations are defined, as required.

j) There are written procedures defining safe collection, transport, and handling of all

specimens.

k) As part of the plan, there is a safety procedure prohibiting anyone in laboratory

technical areas from eating, drinking, smoking, applying cosmetics, manipulating

contact lenses, and mouth pipetting.

l) When relevant to their jobs, personnel have received training about precautionary

measures, modes of transmission, and prevention of bloodborne pathogens.


141

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m) The laboratory has a plan to control exposure to tuberculosis.

RSM.6.2

The laboratory follows defined guidelines for handling and disposing of hazardous

chemicals and waste (including chemotherapeutic materials and waste). 84

Document

1. The program for hazardous chemicals and waste includes the requirements of the

following elements:

a) Guidelines describe the processes for selecting, handling, storing, using, and

disposing of hazardous chemicals and waste from receipt or generation through

use or final disposal.

b) The program includes evaluating each chemical in the laboratory for carcinogenic

potential, reproductive toxicity, and acute toxicity.

84

Program

2. Procedures and containers for handling chemicals meet the requirements described in


c) Handling criteria are defined for each category of hazardous chemical.

d) Containers of hazardous chemicals are labeled with precautionary information

identifying the type and severity of hazard. Examples of types of hazards include

flammable liquids, asphyxiants, corrosives, irritants, and potential carcinogens.

85

Procedures


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RSM.6.3

1. When the laboratory stores, uses, or generates radioactive materials and waste, safety

measures and procedures for decontamination are defined and followed, according to


a) There are safety measures for handling radionuclides and radioactive waste.

b) There are procedures for decontamination.

85

Procedures

3. There are procedures for monitoring the amount of radiation in the area. 85 Procedures

RSM.7

1. Laboratory leaders implement a process to evaluate safety issues required in the

following element:

a) Laboratory leaders conduct a risk assessment that proactively evaluates the impact

of buildings, grounds, equipment, occupants, and internal physical systems on

patient and personnel safety.

86

Process/Document

3. Laboratory leaders implement a process for reporting and investigating incidents as

described in the following element:

c) Laboratory leaders report and investigate all incidents of property damage,

occupational illness, and patient, personnel, or visitor injury.

86

Process/Document

4. Laboratory leaders implement safety processes to ensure a safe physical environment. 86 Process/Document

RSM.7.1 Intent. The laboratory’s safety processes provide adequate fire detection and prevention

policies and equipment. 86

Processes


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a) protecting patients, personnel, visitors, and property from fire, smoke, and other

products of combustion;

b) inspecting, testing, and maintaining all required fire alarm systems;

c) inspecting, testing, and maintaining all required automatic fire-extinguishing systems;

d) managing portable fire extinguishers, including monthly inspection, regular

maintenance, and guidelines for their identification, placement, and use; and

e) establishing evacuation routes in case of a fire in the laboratory.

RSM.7.1.1

1. A written policy describes how fire drills are conducted, along with employee roles in

drills and how they will be monitored. 86

Policy/Document

3. Results of drills are reviewed, and actions are taken to improve the laboratory’s

performance, when appropriate. 86

Document

RSM.7.3

Intent. The laboratory’s policies and practices for electron microscopy address the

following elements:

a) precautions related to radiation and the electrical hazards of electron microscopes;

b) pathologist review of embedded tissue sections to effectively select areas for

examination; and

c) reporting of all electron microscopic studies performed for diagnostic purposes in

the clinical record.

87

Policy


144


145

QUALITY CONTROL PROCESSES

STANDARD MEASURABLE ELEMENT(S)

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N

QCP.1 Quality control processes are established for each test method, and data from these

processes are available and used to monitor and ensure the stability of test systems. 95

Document

QCP.1.1

The laboratory has a program of external graded interlaboratory comparison testing or

proficiency testing for analytes for each specialty and subspecialty for which such

testing is available.

95

Document

QCP.1.1.1 Proficiency sample testing is performed in the same manner as patient sample testing. 96 Document

QCP.1.1.2 The laboratory uses a system for verifying the accuracy and reliability of test results

obtained for those tests not included in the formal proficiency testing program. 97

Document

QCP.1.2

The laboratory uses a system to evaluate and correlate the relationship between results

for the same test performed with different methodologies or instruments or at

different sites.

97

Document

QCP.1.3 The laboratory performs initial validation for new instruments and analytic systems to

verify that the method(s) will produce accurate and reliable results. 98

Document

QCP.1.4 The laboratory validates electronic or internal monitoring systems prior to using them

for routine quality control. 99

Document

QCP.1.5 Calibration, linearity checks, and other function checks are performed on instruments 100 Document


146


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N

and analytic systems used for patient testing.

QCP.1.6 The quality control processes of the laboratory include a coordinated review of patient

results, quality control results, and instrument function checks. 101

Document

QCP.1.7 The laboratory takes remedial action for deficiencies identified through quality control

measures or authorized inspections and documents such actions. 101

Document

QCP.2 There are quality control processes in place for surgical pathology and autopsy services. 102 Document

QCP.2.1 The laboratory has implemented processes for ensuring the proper identification,

preservation, and documentation of receipt of surgical specimens sent for analysis. 103

Document

QCP.2.1.2 When immunohistochemistry is performed, the laboratory has appropriate quality

control processes. 103

Document

QCP.2.2

The laboratory implements quality control and assurance processes for evaluating the

ongoing qualifications of individuals who perform gross analysis of tissue and

microscopic analysis of tissue.

103

Document

QCP.2.3 There are defined processes to document the ongoing proficiency of individuals who

perform microscopic analysis of tissue. 104

Document

QCP.2.4

The laboratory has implemented processes to ensure access to required patient

information and to crossreference such information to assist in providing a complete

and proper diagnosis.

105

Document


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N

QCP.3 A pathologist or physician qualified in cytology maintains the quality of the

cytopathology service through direct supervision. 105

Document

QCP.3.1 The cytology laboratory has a process to measure, assess, and improve quality. 106 Document

QCP.4 The laboratory leaders have defined quality control processes for all clinical chemistry,

hematology, and coagulation tests. 107

Document

QCP.4.1

For tests that produce quantitative results (such as many clinical chemistry,

hematology, and coagulation analyses), laboratory quality meets certain requirements.

The laboratory defines and follows certain quality control guidelines.

107

Document

QCP.4.2 The laboratory has quality control processes in place for blood film evaluation and

differential counts. 108

Document

QCP.5 The laboratory has quality control processes when performing bacteriology,

mycobacteriology, and mycology. 109

Document

QCP.5.1 Antimicrobial, antimycobacterial, and antifungal susceptibility testing systems are

verified with approved reference organisms. 110

Document

QCP.5.2 All stains are tested with appropriate controls. 110 Document

QCP.5.3 There are adequate quality control procedures when molecular microbiology testing is

performed. 111

Document


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QCP.6 If the laboratory is performing parasitology, appropriate reference materials,

equipment, and methods are used. 111

Document

QCP.7 If the laboratory performs tests for identifying viruses, records detailing the systems

used and the reactions observed are maintained. 112

Document

QCP.7.1 The laboratory uses controls that will identify erroneous results in tests for identifying

viruses. 112

Document

QCP.8 The laboratory ensures the quality of tests performed in urinalysis and clinical

microscopy. 113

Document

QCP.9

The laboratory runs serologic tests on unknown specimens, including those for

syphilis, concurrently with a positive control serum of known titer and a negative

control, or controls of graded reactivity, to ensure specificity of antigen reactivity.

113

Document

QCP.9.1 Equipment, glassware, reagents, controls, and techniques for syphilis tests conform to

manufacturers’ specifications. 114

Document

QCP.10 The laboratory uses written quality control procedures that provide diagnostic

reliability and patient and staff safety when it uses in vitro radioisotopes. 114

Document

QCP.10.1 Any laboratory performing in vivo testing uses an appropriate quality control system

for such testing and equipment performance checks. 115

Document

QCP.11 The director of the blood bank or transfusion services is responsible for developing 115 Document


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policies and procedures and implementing practices that ensure the safety of patients

being transfused.

QCP.11.1 There are defined procedures and practices for blood donor selection and blood

collection. Staff are trained and assessed as competent to perform these procedures. 116

Document

QCP.11.1.1 A detailed history of a donor is performed prior to selection for blood donation. 116 Document

QCP.11.1.2 An adequate physical examination is performed prior to approving the individual as a

blood donor. 117

Document

QCP.11.1.3 Donor blood is collected safely and aseptically according to a defined protocol. 118 Document

QCP.11.1.4 Written guidelines are implemented when autologous blood is collected. 118 Document

QCP.11.2 Blood and related donor records are properly identified, and the identification is

maintained from collection through the time the unit is transfused. 119

Document

QCP.11.3

Donor blood undergoes routine testing before being used for transfusion. In addition,

process controls are used to ensure appropriate tracking and prevent blood from being

released prematurely.

119

Document

QCP.11.4

When components are prepared or modified by the organization, there are defined

procedures for their processing and storage, and appropriate quality control measures

are taken.

120

Document


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QCP.11.4.1 Tests and processes are used to maintain the quality of whole blood. This includes

whole blood from which components and products are to be processed. 121

Document

QCP.11.4.2 Defined processes are implemented to maintain the quality of red blood cells. 121 Document

QCP.11.4.3 Defined processes are used to ensure the quality of platelets. 122 Document

QCP.11.4.4 Defined processes are used to ensure the quality of plasma. 123 Document

QCP.11.4.5 Defined processes are used to ensure the quality of cryoprecipitated AHF. 125 Document

QCP.11.5 The blood bank director ensures that blood and components are stored in a secure and

appropriate fashion in order to prevent damage or deterioration. 126

Document

QCP.11.5.1 Storage areas used for blood and components are appropriate for the volume and

variety of components stored. 126

Document

QCP.11.5.2 Storage areas for blood and components are monitored to ensure that appropriate

temperatures are maintained. 127

Document

QCP.11.6 The laboratory maintains identification and traceability of specimens; reagents; test

results; and blood, blood components, and products. 127

Document

QCP.11.7

The laboratory tests donor blood and recipient blood with potent typing sera and

adequately reactive cells of a known type to determine the correct ABO blood group

and Rh type.

128

Document


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QCP.11.7.1 The potency and reliability of reagents used for ABO grouping, Rh typing, antibody

detection, and compatibility determinations are tested for reactivity. 129

Document

QCP.11.8

Before blood is administered, appropriate compatibility testing and antibody testing

(except in an emergency) are performed. In addition, other procedural controls are

implemented.

129

Document

QCP.11.9 Specific procedures are followed when selecting blood and components for

transfusion. 130

Document

QCP.11.10 The director of the blood transfusion services provides policies and procedures to

guide acceptable practices for blood and component transfusion. 131

Document

QCP.11.10.1 There are defined processes for checking blood out of the blood bank before

transfusion. 131

Document

QCP.11.10.2 Specific policies and practices are required before and during blood administration. 132 Document

QCP.11.10.3 The director has defined criteria for recognition of transfusion reactions, as well as

steps to take when symptoms occur. 133

Document

QCP.11.11

When the laboratory draws donor blood, prepares blood components, stores blood

and/or components, and/or issues blood for transfusion, there are specific records

that must be maintained.

134

Document

QCP.12 When performing histocompatibility testing, the laboratory uses appropriate screening 135 Document


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techniques for donors and recipients.

QCP.12.1 The laboratory performs mixed lymphocyte cultures or other recognized methods to

detect cellular-defined antigens according to defined methods. 135

Document

QCP.12.2 The laboratory performs HLA serologic typing of both donor and recipient as

appropriate to the study or individual procedure performed. 136

Document

QCP.12.3

Before transplantation is performed, the laboratory crossmatches potential recipients

and donors using the most reactive and recent sera, as appropriate to the study or

individual procedure performed.

137

Document

QCP.12.4 The laboratory uses reagents and antisera that are specific and verified with appropriate

controls when available. 137

Document

QCP.12.5

The laboratory participates in at least one national or regional cell-exchange program, if

available, or develops an exchange system with another laboratory to validate

interlaboratory reproducibility.

138

Document

QCP.12.6 Storage of records and specimens is addressed. 138 Document

QCP.13 Laboratory procedures and practices in cytogenetics provide for accurate results. 139 Document

QCP.13.1 Laboratory records identify the media used, the reactions observed, and the details of

each step of the identification procedure. 139

Document

QCP.13.2 The laboratory obtains and includes in the interpretative report all required clinical 140 Document


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information.

QCP.13.3 The laboratory maintains individual sample identification during all phases of testing

and reporting. 140

Document

QCP.14 The laboratory follows written policies and procedures for molecular testing. 141 Document

QCP.14.1 Validation studies include representatives from each specimen type expected to be

tested in the assay and specimens representing the scope of reportable results. 141

Document

QCP.14.2 The laboratory establishes quality control limits, reference ranges, and reportable

ranges. 142

Document

QCP.14.3 The laboratory verifies each test run of patient samples in molecular pathology, using

quality controls. 142

Document

QCP.14.4 Molecular testing reports include specific testing information. 142 Document

QCP.14.5 The laboratory follows written policies and procedures for molecular genetic testing. 143 Document

QCP.14.6 Molecular genetic testing reports include specific testing information. 143 Document


154

Standards that Reference Laws and Regulations and Standards of

Practice

The Joint Commission International Accreditation Standards for Clinical Laboratories were designed to be surveyed

in the context of relevant, country-specific local and national laws and regulations. The survey process

takes into account laws and regulations under which a clinical laboratory operates and provides patient

care in one of the following two ways:

1. If a relevant law and/or regulation sets a less stringent expectation than the accreditation standard,

then the expectation of the accreditation standard is surveyed and scored.

2. If, on the other hand, the law and/or regulation sets a more stringent expectation than the

accreditation standard, then the survey team will expect to find that the laboratory is in compliance

with the relevant law and/or regulation.

In addition, it is possible that current standards of practice in a country or region are not identical to those

required by JCI standards but provide equivalent assurance of the quality of the laboratory’s services. The

Law and Regulation Worksheet on pages 107–109 is designed to allow the clinical laboratory to document

when laws and regulations or standards of practice differ with the JCI laboratory standards and to estimate

whether equivalency with each standard has been achieved. Clinical laboratories can use this worksheet to

indicate when there are laws and/or regulations that are in conflict with each other and with a JCI standard.

Clinical laboratory staff should complete this worksheet and provide it to the survey team at the

document review session. The worksheet contains additional space to include other laws and regulations

that may be applicable to the accreditation survey process but that may not be referenced in the JCI

standards.

Clinical laboratories can use the External Auditing Body Recommendation Worksheet on page 110 to

provide information regarding the results of on-site evaluations conducted by a government-authorized

department, a regulatory agency, or an invited evaluator within the past 12 months. An executive

summary (in English) of the outcome of on-site evaluations should be provided to the survey team at the

document review session.


155


156

Law And Regulation Worksheet

STANDARD

NUMBER

APPLICABLE

LAW/REGULATIO

N

(YES/NO)

IF YES:

NAME OF

LAW/REGULATION

SUMMARY OF LAW/

REGULATION

HOW DOES IT APPLY TO

THE STANDARD?

IS

LAW/REGULATION

MORE STRINGENT

THAN

STANDARD?

(note conflicts)

(YES/NO)

Does any regulatory

agency conduct on-site

inspections to evaluate

compliance with the

applicable law and

regulation?

(YES/ NO)

Management and Leadership

MGT.1.2, ME 5

MGT.1.2, ME 6

MGT.4.1.5, intent

Development and Control of Policies and Procedures

DCP.1, intent (f)

DCP.5, intent

DCP.5, ME 4

Resource Management and Laboratory Environment


157

RSM.1.2, intent

RSM.1.2, ME 4

RSM.1.3, ME 3

RSM.1.4, intent

RSM.1.4, ME 2


158

STANDARD NUMBER

APPLICABLE

LAW-

REGULATIO

N

(YES – NO)

IF YES:

NAME OF LAW-

REGULATION

SUMMARY OF LAW –

REGULATION


THE

STANDARD?

IS LAW-

REGULATION

MORE STRINGENT

THAN

STANDARD?

(note conflicts)

YES – NO

Does any regulatory



compliance with the

applicable law and

regulation?

*(Yes – No)

Resource Management and Laboratory Environment (continued)

RSM.2, intent (c, d)

RSM.4.1, intent

RSM.4.1.1, intent (h)

RSM.6.1, ME 2

RSM.6.2, intent (e, g)

RSM.6.2, ME 5

RSM.6.3, intent (e)

RSM.6.3, ME 4

RSM.7

Quality Control Processes

QCP.3.1, intent (d)

QCP.11, intent (c)

QCP.11, ME 2

QCP.11.1.4, intent (d)

QCP.11.3, intent (c)

QCP.11.4, intent


159

STANDARD NUMBER

APPLICABLE

LAW-

REGULATIO

N

(YES – NO)

IF YES:

NAME OF LAW-

REGULATION

SUMMARY OF LAW –

REGULATION


THE

STANDARD?

IS LAW-

REGULATION

MORE STRINGENT

THAN

STANDARD?

(note conflicts)

YES – NO

Does any regulatory



compliance with the

applicable law and

regulation?

*(Yes – No)

Quality Control Processes (continued)

QCP.11.4, ME 5

QCP.11.4.1, intent (h)

QCP.11.6, intent (h)

QCP.11.6, ME 4

QCP.11.10.3, intent (j)

QCP.11.11, intent

QCP.11.11, ME 4


160

External Auditing Body Recommendation Worksheet

If an on-site evaluation was conducted by a government authorized department, regulatory agency, or any other invited evaluator within the past 12

months, please complete and provide this form with an executive summary (in English) of the outcome of each on-site evaluation to the survey team

at the document review session.

Name of the governmental

department, regulatory agency,

or invited evaluator that

conducted the on-site

audit/inspection

Date of the

on-site

audit

Were any

recommend

ations or

citations

noted?

(Yes/No)

If Yes, what

department(s) or

service(s) was identified

in the report (for

example, laboratory,

operating theater,

kitchen, and pharmacy.)

How much time

was allotted to

achieve

compliance (for

example, 90 days,

6 months)

On what

date was full

compliance

was

achieved by

the clinical

laboratory?

Has the

auditor

returned to

validate

compliance?

(Yes/No)


161

Name of the governmental

department, regulatory agency,

or invited evaluator that

conducted the on-site

audit/inspection

Date of the

on-site

audit

Were any

recommend

ations or

citations

noted?

(Yes/No)

If Yes, what

department(s) or

service(s) was identified

in the report (for

example, laboratory,

operating theater,

kitchen, and pharmacy.)

How much time

was allotted to

achieve

compliance (for

example, 90 days,

6 months)

On what

date was full

compliance

was

achieved by

the clinical

laboratory?

Has the

auditor

returned to

validate

compliance?

(Yes/No)

jcia clinical laboratory survey process guide 2nd edition-final

Documents

accreditation preparation

survey scheduling

survey consistency

accreditation process

sample survey agenda

clinical laboratories

clinical laboratorys

preparation timeline