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Page 37:

Document Review

Required quality monitors with data from the past 4 months (initial surveys) and/or 12
months for triennial surveys
A sample action plan for a root cause analysis for a sentinel event or a near miss
A sample FMEA action plan
An example of a measure from the JCI Library of Measures on which a validation was
performed (see page 102)
A list of the five clinical practice guidelines, clinical pathways, and/or clinical protocols the
hospital selected to guide clinical care

Page 38:
DOCUMENTS AVAILABLE IN ENGLISH
Required Hospital Programs

All equipment used for laboratory testing is regularly inspected, maintained, and calibrated, and
appropriate records are maintained for these activities. (AOP.5.4)
Quality control procedures are in place, followed, and documented. (AOP.5.9)
A radiation safety program is in place that addresses potential safety risks and hazards encountered
within or outside of the department. (AOP.6.2, ME 1)
All equipment used to conduct radiology and diagnostic imaging studies are regularly inspected,
maintained, and calibrated, and appropriate records are maintained for these activities. (AOP.6.5)
Quality control procedures are in place, followed, and documented. (AOP.6.8)

Required Policies and Procedures, Written Documents, or Bylaws

Policies and procedures support consistent practice in all situations and locations. (IPSG.1, ME 5)
Policies and procedures support consistent practice in verifying the accuracy of verbal and telephone
communications. (IPSG.2, ME 4)
Policies and/or procedures are developed to address the identification, location, labeling, and storage
of high-alert medications. (IPSG.3, ME 1)
Policies and procedures are developed that will support uniform processes to ensure the correct site,
correct procedure, and correct patient, including medical and dental procedures done in settings
other than the operating theatre. (IPSG.4, ME 4)
Policies and/or procedures are developed that support continued reduction of health careassociated
infections. (IPSG.5, ME 3)
Policies and/or procedures support continued reduction of risk of patient harm resulting from falls
in the organization. (IPSG.6, ME 4)
The organization uses an instantly recognizable mark for surgical-site identification and involves the
patient in the marking process. (IPSG.4, ME 1)
Policies identify which screening and diagnostic tests are standard before admission. (ACC.1, ME 5)
The organization has established entry and/or transfer criteria for its intensive and specialized
services or units, including research and other programs to meet special patient needs. (ACC.1.4, ME
1)
Established criteria or policies determine the appropriateness of transfers within the organization.
(ACC.2, ME 2)

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Policy and procedure define when the discharge summary must be completed and in the record.
(ACC.3.2, ME 6)
The records of transferred patients contain documentation of any change in patient condition or
status during transfer. (ACC.4.4, ME 5)
The organization has a clearly defined informed consent process described in policies and
procedures. (PFR.6, ME 1)
The organization has listed those procedures and treatments that require separate consent.
(PFR.6.4.1, ME 1)
Organization policy and procedure define the assessment information to be obtained for inpatients.
(AOP.1, ME 1)
Organization policy and procedure define the assessment information to be obtained for outpatients.
(AOP.1, ME 2)
Organization policy identifies the information to be documented for the assessments. (AOP.1, ME 3)
The minimum content of assessments performed in inpatient settings is defined in policies.
(AOP.1.1, ME 3)
The minimum content of assessments performed in outpatient settings is defined in policies.
(AOP.1.1, ME 4)
Written policies and procedures address the handling and disposal of infectious and hazardous
materials. (AOP.5.1, ME 3)
The organizations leaders have identified the high-risk patients and services. (COP.3, ME 1)
The leaders develop applicable policies and procedures. (COP.3, ME 2)
The uniform use of resuscitation services throughout the organization is guided by appropriate
policies and procedures. (COP.3.2, ME 1)
The handling, use, and administration of blood and blood products are guided by appropriate
policies and procedures. (COP.3.3, ME 1)
Appropriate policies and procedures, addressing at least elements (a) through (f) found in the intent
statement, guide the care of patients undergoing moderate and deep sedation. (ASC.3, ME 1)
There is a presedation assessment performed that is consistent with organization policy to evaluate
risk and appropriateness of the sedation for the patient. (ASC.3, ME 3)
Established criteria are developed and documented for the recovery and discharge from sedation.
(ASC.3, ME 6)
There is a plan or policy or other document that identifies how medication use is organized and
managed throughout the organization. (MMU.1, ME 1)
Policies guide all phases of medication management and medication use in the organization.
(MMU.1, ME 3)
Policies and procedures guide the safe prescribing, ordering, and transcribing of medications in the
organization. (MMU.4, ME 1)
Policies and procedures address actions related to illegible prescriptions and orders. (MMU.4, ME 2)
A medication error and near miss are defined through a collaborative process. (MMU.7.1, ME 1)
The organizations leadership participates in developing the plan for the quality improvement and
patient safety program. (QPS.1, ME 1)
The hospital leaders have established a definition of a sentinel event that at least includes (a) through
(d) found in the intent statement. (QPS.6, ME 1)
The organization establishes a definition of a near miss. (QPS.8, ME 1)

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The program is guided by appropriate policies and procedures [to reduce risks of health care
associated infections]. (PCI.5, ME 5)
When single-use devices and materials are reused, the policy includes items (a) through (e) in the
intent statement. (PCI.7.1.1, ME 2)
The organization develops an infection prevention and control program that includes all staff and
other professionals and patients and families. (PCI.11, ME 1)
The organizations governance structure is described in written documents, and those responsible for
governance and managing are identified by title or name. (GLD.1, ME 1)
Organization plans describe the care and services to be provided. (GLD.3.2, ME 1)
The organization has a written description of the nature and scope of services provided through
contractual agreements. (GLD.3.3, ME 2)
There are written plans that address the risk areas (a) though (f) in the intent statement. (FMS.2, ME
1)
There is an inventory of all medical equipment. (FMS.8, ME 2)
There is a preventive maintenance program. (FMS.8, ME 5)
There is a product/equipment recall system in place. (FMS.8.2, ME 1)
The organization plans a program to ensure that all occupants of the organizations facilities are safe
from fire, smoke, or other nonfire emergencies. (FMS.7, ME 1)
Medical equipment is managed throughout the organization according to a plan. (FMS.8, ME 1)
Policy or procedure addresses any use of any product or equipment under recall. (FMS.8.2, ME 2)
There is a process described in policy for the review of each medical staff members credential file at
uniform intervals at least once every three years. (SQE.9.1, ME 1)
The organization uses a standardized process that is documented in official organization policy for
granting privileges to each medical staff member to provide services on initial appointment and on
reappointment. (SQE.10, ME 1)
The ongoing professional practice evaluation and annual review of each medical staff member are
accomplished by a uniform process that is defined by organization policy. (SQE.11, ME 2)
There is a written policy for addressing the privacy and confidentiality of information that is based
on and consistent with laws and regulations. (MCI.10, ME 1)
The policy defines the extent to which patients have access to their health information and the
process to gain access when permitted. (MCI.10, ME 2)
There is a written policy or protocol that defines the requirements for developing and maintaining
policies and procedures including at least items (a) through (h) in the intent, and it is implemented.
(MCI.18, ME 1)
There is a written protocol that outlines how policies and procedures that originated outside the
organization will be controlled, and it is implemented. (MCI.18, ME 2)
There is a written policy or protocol that defines retention of obsolete policies and procedures for at
least the time required by laws and regulations, while ensuring that they will not be mistakenly used,
and it is implemented. (MCI.18, ME 3)
There is a written policy or protocol that outlines how all policies and procedures in circulation will
be identified and tracked, and it is implemented. (MCI.18, ME 4)

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Page 53:

System Tracer: Infection Control

Process for handling an influx of infectious patients

Process used to perform an infection prevention and control risk assessment, including the
reasons for conducting the assessment and the results of the analysis
Prevention and control activities (for example, staff training, education of
patient/resident/client population, and housekeeping procedures)

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System Tracer: Improvement in Quality and Patient Safety

DOCUMENTS/MATERIALS NEEDED
Hospitals should have all of the following documents available for review during this session or for the document
review session on day one (see pages 37 to 40).

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 hospital should
will show at least one example of a process that was analyzed and redesigned to prevent possible
problems.
Clinical practice guidelines and clinical pathways for the five areas selected as priority focus
areas in order to explain the guidelines and pathways that are in use, the guidelines developed in
the past 12 months, how the guidelines and pathways use was monitored, how the data on the
use and usefulness/effectiveness of specific guidelines and pathways are collected, and which
changes in practice were affected

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System Tracer: Improvement in Quality and Patient Safety,

continued
Determine the effectiveness in implementing the hospitals 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.
Review and discuss the measures validation process. Surveyors will review one of the measures the
hospital used in order to see how it was validated, how the analysis was conducted, and how a process
changed as a result.
Evaluate the root cause analysis action plan to validate the findings

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Infection Prevention and Control Data Issues (also see System Tracer: Infection Control
on pages 52---53)
Applicable in smaller surveys in which only one system tracer (Improvement in Quality and Patient Safety) is
scheduled.
Discussion explores the following topics:
Risk assessment process and findings
Surveillance methods for health careassociated and nonhealth careassociated infections
Types of monitoring measures and data collected:
o Whether infection-related data are collected
o Whether the hospital 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 hospitals plans to collect data relevant to the JCI Prevention and Control of Infections
standards
Page 82:

Required Quality Monitors

The hospital chooses the clinical and managerial structures, processes, and outcomes that are most
important to monitor based on its mission, patient needs, and services provided. The hospitals
leaders identify key measures (indicators) to monitor the hospitals clinical and managerial structures,
processes, and outcomes.
Hospitals are required to choose five measures from the JCI Library of Measures to help them
monitor their clinical and managerial structures, processes, and outcomes. The JCI Library of
Measures includes the following measure sets:
Acute myocardial infarction
Heart failure
Stroke
Childrens asthma care
Hospital-based inpatient psychiatric service
Nursing-sensitive care
Perinatal care
Pneumonia
Surgical care improvement project
Venous thromboembolism

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Pages 8384:

Required Hospital Plans

PREVENTION AND CONTROL OF INFECTIONS
The organization designs and implements a comprehensive program to reduce the risks of health care---associated
infections in patients and health care workers. (PCI.5)
ASSESSMENT OF PATIENTS
All equipment used for laboratory testing is regularly inspected, maintained, and calibrated, and
appropriate records are maintained for these activities. (AOP.5.4)
Quality control procedures are in place, followed, and documented. (AOP.5.9)
A radiation safety program is in place that addresses potential safety risks and hazards encountered
within or outside of the department. (AOP.6.2, ME 1)
All equipment used to conduct radiology and diagnostic imaging studies are regularly inspected,
maintained, and calibrated, and appropriate records are maintained for these activities. (AOP.6.5)
Quality control procedures are in place, followed, and documented. (AOP.6.8)
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Required Policies and Procedures, Written Documents, or Bylaws

The standards in the tables on pages 8699 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 patient assessment requirements are interconnected and can be
contained in one policy; for example, AOP.1 and AOP.1.1 can be combined, as can MCI.18, MEs 1 through
4.

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International Patient Safety Goals

STANDARD

MEASURABLE ELEMENT(S)

PAGE NUMBER(S)

ENGLISH

TYPE OF
DOCUMENTATION

IPSG.1

1. Patients are identified using

two patient identifiers, not
including the use of the
patients room number or
location.

36

Policy and Procedure

36-37

Policy and Procedure

2. Patients are identified before

administering medications,
blood, or blood products.
3. Patients are identified before
taking blood and other
specimens for clinical testing.
4. Patients are identified before
providing treatments and
procedures.
5. Policies and procedures
support consistent practice in
all situations and locations.
(See ME 1 through ME 4 for
policy inclusions.)
IPSG.2

1. The complete verbal and

telephone order or test result
is written down by the
receiver of the order or test
result.
2. The complete verbal and
telephone order or test result
is read back by the receiver of
the order or test result.
3. The order or test result is
confirmed by the individual
who gave the order or test
result.
4. Policies and procedures
support consistent practice in
verifying the accuracy of
verbal and telephone
communications. (See ME 1

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through ME 3 for policy

inclusions.)
IPSG.3

1. Policies and/or procedures are

developed to address the
identification, location,
labeling, and storage of highalert medications.

37-38

Policy and Procedure

38-39

Checklist (or checklist

used as a script to
perform)
Policy and Procedure

2. The policies and/or

procedures are implemented.
3. Concentrated electrolytes are
not present in patient care
units unless clinically necessary
and actions are taken to
prevent inadvertent
administration in those areas
where permitted by policy.
4. Concentrated electrolytes that
are stored in patient care units
are clearly labeled and stored in
a manner that restricts access.
IPSG.4

1. The organization uses an

instantly recognizable mark
for surgical-site identification
and involves the patient in the
marking process.
2. The organization uses a
checklist or other process to
verify preoperatively the
correct site, correct
procedure, and correct patient
and that all documents and
equipment needed are on
hand, correct, and functional.
3. The full surgical team
conducts and documents a
time-out procedure just
before starting a surgical
procedure.
4. Policies and procedures are

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developed that will support

uniform processes to ensure
the correct site, correct
procedure, and correct
patient, including medical and
dental procedures done in
settings other than the
operating theatre.
IPSG.5

1. The organization has adopted

or adapted currently published
and generally accepted hand
hygiene guidelines.

39

Checklist (or checklist

used as a script to
perform) Policy and
Procedure

40

Policy and Procedure

2. The organization implements

an effective hand hygiene
program.

IPSG.6

3. Policies and/or procedures are

developed that support continued
reduction of health care
associated infections.
1. The organization implements a
process for the initial assessment
of patients for fall risk and
reassessment of patients when
indicated by a change in
condition, medications, among
others.
2. Measures are implemented to
reduce fall risk for those assessed
to be at risk.
3. Measures are monitored for
results, both successful fall injury
reduction and any unintended
related consequences.
4. Policies and/or procedures
support continued reduction of
risk of patient harm resulting
from falls in the organization.

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Page 87:

Access to Care and Continuity of Care

STANDARD

MEASURABLE ELEMENT(S)

PAGE NUMBER(S)

ENGLISH

TYPE OF
DOCUMENTATION

ACC.1

5. Policies identify which

screening and diagnostic tests are
standard before admission.

43

Policy and Procedure

ACC.1.1.1

1. The organization uses an

evidence-based triage process to
prioritize patients with immediate
needs.

44

ACC.2

2. Established criteria or policies

determine the appropriateness
of transfers within the
organization.
2. The records of transferred
patients contain
documentation or other notes
as required by the policy of the
transferring organization.
5. The records of transferred
patients contain
documentation of any change
in patient condition or status
during transfer. (ACC.4.4, ME
5)

47

Criteria or Policies

54

Policy and Procedure

ENGLISH

TYPE OF
DOCUMENTATION

ACC.4.4

Process

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Assessment of Patients
STANDARD

MEASURABLE ELEMENT(S)

PAGE NUMBER(S)

AOP.5.3.1

1. A collaborative method is used

to develop processes for
reporting critical results of
diagnostic tests.

89

AOP.6.2

1. A radiation safety program is in

place that addresses potential

95

Process

Program

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safety risks and hazards

encountered within or outside
the department.
3. Written policies and procedures
address compliance with
applicable standards, laws, and
regulations.
4. Written policies and procedures
address handling and disposal
of infectious and hazardous
materials.

Policy and Procedure

Policy and Procedure

Page 91:

Care of Patients
STANDARD

MEASURABLE ELEMENT(S)

COP.3

1. The organizations leaders have

identified the high-risk patients
and services.
2. The leaders develop applicable
policies and procedures.

PAGE NUMBER(S)

106

ENGLISH

TYPE OF
DOCUMENTATION

Identification

Policy and Procedure

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Medication Management and Use

STANDARD

MEASURABLE ELEMENT(S)

PAGE NUMBER(S)

ENGLISH

TYPE OF
DOCUMENTATION

MMU.1

1. There is a plan or policy or

other document that identifies
how medication use is
organized and managed
throughout the organization.
3. Policies guide all phases of
medication management and
medication use in the
organization.

125

Plan or Policy

1. Organization policy defines

how appropriate nutrition
products are stored.
2. Organization policy defines
how radioactive,
investigational, and similar
medications are stored.
3. Organization policy defines

128129

MMU.3.1

Policy

Policy

Policy
Policy

Policy

Policy

Policy

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how sample medications are

stored and controlled.
4. All storage is according to
organization policy.

Policy

MMU.4.1

2. Medication orders or
prescriptions are complete per
organization policy.

130131

Policy

MMU.6.2

1. Policies and procedures are

implemented to govern patient
self-administration of
medications.
2. Policies and procedures are
implemented to govern the
documentation and
management of any
medications brought into the
organization for or by the
patient.
3. Policies and procedures are
implemented to govern the
availability and use of
medication samples.
1. A medication error and near
miss are defined through a
collaborative process.

135

Policy and Procedure

MMU.7.1

Policy and Procedure

Policy and Procedure

136

Written document

Quality Improvement and Patient Safety

STANDARD

MEASURABLE ELEMENT(S)

PAGE NUMBER(S)

QPS.10

6. Policy changes necessary to

plan, to carry out, and to
sustain the improvement are
made.

160

ENGLISH

TYPE OF
DOCUMENTATION

Policy

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Prevention and Control of Infections

STANDARD

MEASURABLE ELEMENT(S)

PAGE NUMBER(S)

PCI.7.1

4. There is a coordinated
oversight process that ensures
all cleaning, disinfection, and
sterilization methods are the
same throughout the
organization.

170

ENGLISH

TYPE OF
DOCUMENTATION

Process

Governance, Leadership, and Direction

STANDARD

MEASURABLE ELEMENT(S)

PAGE NUMBER(S)

ENGLISH

TYPE OF
DOCUMENTATION

GLD.1

1. The organizations governance

180
structure is described in written
documents, and those
responsible for governance and
managing are identified by title
or name.
2. Governance responsibilities
and accountabilities are
described in the documents.
3. The documents describe how
the performance of the
governing entity and managers
will be evaluated and any
related criteria.

Written document

GLD.3.1

1. The organizations leaders meet

with recognized community
leaders to develop and to
revise strategic and operational
plans to address community
needs.

183

GLD.3.2

1. Organization plans describe the

care and services to be
provided.

184

Plans

GLD.3.3

2. The organization has a written

description of the nature and
scope of services provided
through contractual
agreements.

185

Written Description

Plan

Document

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Facility Management and Safety

STANDARD

MEASURABLE ELEMENT(S)

PAGE NUMBER(S)

ENGLISH

TYPE OF
DOCUMENTATION

FMS.2

1. There are written plans that

address the risk areas a) though
f) in the intent statement.
a) Safety and security (Also see
FMS.4 ME 1 through ME 4)
b) Hazardous materials (Also
see FMS.5 ME 2 through
ME 7)
c) Emergencies (Also see
FMS.6, ME 1)
d) Fire Safety (Also see
FMS.7.1 ME 1 through ME
5)
e) Medical equipment (Also see
FMS.8 MEs 1 through ME 3
and FMS.8.1 ME 1 and ME
2)
f) Utility systems (Also see
FMS.9.1, ME 3)
1. The organization has a program
to provide a safe and secure
physical facility, including
monitoring and securing areas
identified as security risks.
2. The program ensures that all
staff, visitors, and vendors are
identified, and all security risk
areas are monitored and kept
secure.
3. The program is effective in
preventing injury and
maintaining safe conditions for
patients, families, staff, and
visitors.
4. The program includes safety
and security during times of
construction and renovation.

196197

Written Plans

1. The organization identifies

hazardous materials and
waste and has a current list
of all such materials within

199200

FMS.4

FMS.5

198199

Program

Program

Program

Program

List

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the organization.
2. The plan for safe handling,
storage, and use of hazardous
waste is established and
implemented.
3. The plan for reporting and
investigation of spills,
exposures, and other incidents
is established and
implemented.
4. The plan for the proper
handling of waste within the
organization and disposal of
hazardous waste in a safe and
legal manner is established and
implemented.
5. The plan for the proper
protective equipment and
procedures during use, spill, or
exposure is established and
implemented.
6. The plan for documentation
requirements, including any
permits, licenses, or other
regulatory requirements, is
established and implemented.
7. The plan for labeling
hazardous materials
and waste is
established and
implemented.
FMS.6

2. The organization plans its

response to likely disasters
including items a) through g) in
the intent.

200201

FMS.7

1. The organization plans a

program to ensure that all
occupants of the organizations
facilities are safe from fire,
smoke, or other nonfire
emergencies.

201202

FMS.8

1. Medical equipment is managed

throughout the organization
according to a plan.
2. There is an inventory of all

203204

Plan

Program

Plan
Inventory
Program

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medical equipment.
5. There is a preventive
maintenance program.

FMS.8.2

1. There is a product/equipment
recall system in place.
2. Policy or procedure addresses
any use of any product or
equipment under recall.

204

Policy

FMS.9.1

3. The organization plans

alternative sources of power and
water in emergencies.

204205

Plan

Staff Qualifications and Education

STANDARD

MEASURABLE ELEMENT(S)

PAGE NUMBER(S)

SQE.6

1. There is a written plan for

staffing the organization.

215216

SQE.11

2. The ongoing professional

practice evaluation and annual
review of each medical staff
member are accomplished by a
uniform process that is defined
by organization policy.

STANDARD

MEASURABLE ELEMENT(S)

PAGE NUMBER(S)

ENGLISH

TYPE OF
DOCUMENTATION

MCI.10

1. There is a written policy for

addressing the privacy and
confidentiality of information
that is based on and consistent
with laws and regulations.
2. The policy defines the extent to
which patients have access to
their health information and
the process to gain access
when permitted.

236237

Policy

223224

ENGLISH

TYPE OF
DOCUMENTATION

Written Plans
X

Policy

Management of Communication and Information

Policy
X