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JOURNAL OF HEALTHCARE RISK MANAGEMENT • VOLUME 27, NUMBER 2 27

Enterprise Risk Management

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Including patients in root cause
and system failure analysis:
Legal and psychological implications

The act of open disclosure of an adverse event alone may not be
enough for patients or their families. Patients and patient advocates
are asking for increased transparency and a greater role in the
process of change. When properly handled, involving patients in
post-event analysis allows risk management professionals to further
improve their organization’s systems analysis process while
empowering patients to be part of the solution. This article examines
the legal and psychological considerations surrounding the involvement
of patients in system failure analysis and provides tools for selecting
patients who are able to benefit from this process and for adequately
preparing patients and caregivers for what lies ahead.

INTRODUCTION

Incorporating patient perspectives into the problem solving process is not a new
concept. Healthcare organizations have included patients on special committees
for some time.(1)

Organizations have also begun to accept patients and families (hereafter referred
to as patients) opening the doors to the failure mode and effects analysis (FMEA)
and root cause analysis (RCA) processes to patients.(2)

Participation in system failure analysis (SFA) permits patients to understand
the high level of importance that organizations place on patient safety and the
seriousness of the event that adversely affected them.

However, including every patient involved in an adverse event or near miss analysis
is not appropriate. In some instances, it can cause further distress or harm.(3)

Legal considerations

While offering an exciting opportunity to healthcare providers and patients
alike, patient participation in root cause analysis can be legally risky.

A proactive assessment of all potential consequences must be performed. Issues
surrounding sharing of confidential communications, information and the
existence of potential evidence must be explored. State and/or federal privilege
may exist to protect quality assurance and performance improvement activities.

By Theresa M. Zimmerman,
RN, BSN, JD, ARM, CPHRM,
FASHRM, and Geraldine Amori,
Ph.D., ARM, CPHRM, DFASHRM

continued next page

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28 JOURNAL OF HEALTHCARE RISK MANAGEMENT • VOLUME 27, NUMBER 2

Federal statutes, state statutes and case law may strongly
influence any organization’s decision whether to open the
QA/PI process to patients.

It is also important to ensure that actions taken do not waive
any available privilege by including people not typically
considered protected under the quality privilege, or by
conducting these meetings hastily without careful thought
and preparation. In instances where privilege should not
be waived, it remains imperative that the proceeding be
handled with confidentiality and under stringent guidelines
to protect the integrity of the QA/PI process. Instituting
a policy that addresses ways to include patients as part of
the quality process for purposes of fact-finding would be
beneficial for preserving the integrity of the analysis.

Alternative methods of encouraging
patient involvement without
compromising the confidential nature
of the QA/PI process may also be
available. These include placing
limitations on the involved patient’s
participation in the system failure
analysis process, or involving a patient
who received similar treatments but
was not directly involved in the adverse
event currently under review.(4)

Another way of including the
patient while preserving the quality
privilege granted by law is to ask the
patient to deliver an opening statement
at the RCA or FMEA and limiting
their participation to that level. This practice both allows
the committee members to meet the patient and the
patient to see that a process change is underway.

Psychological considerations

An adverse medical event is traumatic for both the provider
and the patient. The risk management professional has
an ethical duty to ensure that no additional or unnecessary
trauma is experienced by any of the parties in the process
of fact-finding and development of corrective actions.(5)
Consequently, care must be taken to screen all individuals
carefully prior to the SFA meeting.

Care should be taken to consider the psychological concerns
of any patient who is invited to participate in an SFA.
One major issue centers on the vulnerable trust that the
patient has in the healthcare system following an adverse
event. Prior beliefs about the system and caregivers’ ability
to heal have been compromised. Fear of retribution for
speaking out about the error and the failure of the system are
strongest when the error results in a need for further care.

The healthcare system is a comfortable environment for
those who work in it. This is not necessarily the case for
patients. Some patients believe they can make a contribution

based on their knowledge base to improve healthcare
processes. More often, however, they are intimidated and
feel they have nothing to offer because they do not under-
stand the medical field. In either situation, the disparity
of experience and knowledge between the patient coming
into the SFA and the other members of the team can
negatively affect the team’s cohesiveness if not properly
managed by a skilled facilitator. The facilitator must be
prepared to use conflict resolution skills to avert non-verbal
divisiveness, verbal defensiveness, and other behavior
destructive to patient and caregiver participants and the
overall

process.

When there has been a death from an adverse event, those
families involved should be considered for participation

in a systems analysis carefully and on
a case-by-case basis. By its nature,
the analysis should take place soon
after the event when facts and details
are fresh in everyone’s minds. During
this critical time, however, the family
is managing post-mortem details as
well as dealing with acute grief.
Examining the care that may have
contributed to the death is likely to
exacerbate normal grieving processes
and affect objectivity which is necessary
to improve the system.

In cases where the adverse event has
not resulted in death but in the need
for significant ongoing care, the
family’s mental and emotional energy

will be focused on the care of the patient. Discussion of
the details of the adverse event can heighten the family’s
awareness of the patient’s vulnerability and raise concern
over the potential for another medical error. The emotional
impact on the family of reviewing the details of what
occurred to determine the causes of the adverse outcome
may outweigh the benefit of participation in the SFA.

Screening for appropriateness

The appropriateness of patient participation in the analysis
should be a consideration during all discussions held with
the patient following an adverse event. However, a formal
screening should be avoided to limit the possibility of
creating an expectation with the patient which may then
change because the patient is not suitable.

Once the determination has been made that the patient is
psychologically, emotionally, intellectually and attitudinally
ready and able, the direct question of participation can be
broached during a follow-up conversation.

The risk manager or whoever is responsible for inviting
participants to the SFA should be sensitive to the existing
emotional state of all potential participants. If the patient’s
primary focus is expressing anger or a desire to litigate,

The disparity of
experience and

knowledge between the
patient and the other
members of the team

can negatively affect the
team’s cohesiveness if not

properly managed.

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JOURNAL OF HEALTHCARE RISK MANAGEMENT • VOLUME 27, NUMBER 2 29

he or she may not a good candidate. The art of assessing
emotional suitability requires an understanding of human
nature. Awareness of culturally defined responses to emotional
trauma and cultural beliefs about healthcare is essential.

Furthermore, the skill required to engage people who are
in distress and move them along emotionally is necessary
for assessing patient and staff readiness to participate in
process improvement activities.

In addition to ensuring emotional and psychological
readiness to participate, a determination should be made
as to whether patients understand what is being asked of
them and whether they are able to participate without
becoming confused. They should be able to handle what
may be an emotionally charged situation for all involved.
Most importantly, it is essential that
patients understand the valuable role
they play and how critical their per-
spective is to the process.

The skilled risk management profes-
sional should be able to ascertain
whether a patient is interested solely
in punishing the providers or truly
has a desire to ensure that the injury
he or she experienced does not happen
to someone else. The potential
participant should also be able to
exhibit the emotional and intellectual
readiness necessary to deal with the
root cause process, the other attendees
and the limitations that will be part
of the process.

Preparing patients

The patient’s well-being must be a primary concern if he
or she is to be involved in the analysis. The patient must
be prepared for the experience and supported during and
after the formal process is concluded. Additionally, efforts
should be made to keep the lines of communication open
and make patients aware of the positive changes that have
resulted from their input.

At a minimum, the patient preparation must include the
following elements (See Patient Preparation Guide for
expanded information):

• Information about the root cause analysis process;

• Information about the patient’s role in the process;

• Information about the organization’s expectations for
the patient during and after the process.

Preparing the healthcare organization

The committee must be carefully coached in preparation
for the patient’s participation. They must understand that
their role is not to challenge the patient but to be supportive
and seek additional information that will support the
process. Any staff participant who is unable to appreciate the
value of the patient’s contribution may not be a welcome
attendee and should be asked to send a more amenable
representative. Prior to the first meeting, the facilitator
should be aware of conflicts and issues that may arise.

It is essential that caregivers, just like patient participants,
be screened for psychological readiness. Strong beliefs that
cannot be overcome – e.g., that patients add no value to
the process or should not be involved because of legal

implications – can have a chilling
effect on the interactions. Provider
guilt about the cause of the event
or conclusions regarding fault arrived
at without thorough investigation
can lead to inappropriate admissions
of liability before the root cause can
be determined.

Conversely, if a provider communicates
the belief that the event would have
happened regardless of the care given,
they can come across as uncaring or
callous to a patient who has experi-
enced a medical error.

At a minimum, the preparation
of caregivers must contain the following elements (See
Caregiver Preparation Guide for details):

• Information about the patient’s role in the process;
• Information about expectations for caregiver behavior.

For both patients and caregivers, concerns and questions must
be addressed promptly and with respect and sensitivity to
the vulnerabilities created when both sides begin to explore
unanticipated events jointly.

Alternatives to patient participation

Healthcare institutions that have substituted patients
undergoing similar treatments, but who were not directly
involved in the event being analyzed, have reported positive
experiences. The non-involved patients’ treatment ought
to be completed before including them in this process.(6)
This will prevent the participants from experiencing any
additional anxiety associated with knowledge of possible
serious adverse outcomes that could occur.

Other alternatives include having the patient meet with the
team at a date following completion of the formal SFA
process. A patient meeting with the team may bring addi-
tional insights and a valuable perspective to the evaluation
of the improvement plans implemented. Surrogate patient

It is essential that
patients understand the
valuable role they play
and how critical their
perspective is to the

process.
continued next page

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30 JOURNAL OF HEALTHCARE RISK MANAGEMENT • VOLUME 27, NUMBER 2

SFA participants who have had similar services without an
adverse event may also be able to contribute information
on how patients experience the process. Patient participants
on standing committees can offer constructive insight into
the patient experience. Finally, creating carefully supportive
and sensitively handled processes permitting patients and
those involved in their care to debrief together after an
adverse event can facilitate the healing essential for all
involved parties.

Keys for success

Keys for success include:

• careful screening;

• structuring the process to optimize
patient involvement without jeop-
ardizing the potential for success;

• adequate preparation of participants;

• follow-up with patients.

The process must be supervised to
ensure that patients and caregivers
have the greatest opportunity for
positive interactions. Furthermore,
the legal implications must be con-
sidered and accommodated in the
meeting structure. Issues such as the
extent of the patient’s role must be
addressed in advance.

When possible, consideration should be given to compen-
sating providers and caregivers for time spent outside of
their normal work hours to participate in a SFA. This
reflects the value you place on their willingness to
improve care.

If the patient is to provide an opening statement only at
the beginning of the process, the entire meeting should be
dismissed so that patient and caregivers leave the meeting
together. Experience has shown that having participants leave
at different times sets in motion a feeling of separateness
and concerns about “are they talking about me now?”

Preparation is essential for success, as well. Patients must
understand what they are being asked to do and what it
means. The meeting organizer (whether risk management
or quality management) must make efforts to establish a
trusting relationship with the patient prior to the meeting.

If necessary, patients need to be made aware that their
involvement will be limited. However, the information
that they deliver will be taken seriously and used as part
of the action plan and problem resolution process. Post-
meeting communication and follow-up is crucial to
maintaining the positive relationship. Patients need to
have a sense that changes have been made and that the
process was

not a sham.

Although careful selection of participants is essential,
that alone is insufficient to assure success. Equally important
is careful preparation of all participants in the process and
facilitation of meetings to permit the open and honest
exchange of ideas necessary for meaningful change.

RISK MANAGEMENT IMPLICATIONS

Confidentiality constraints

One risk concern that must be considered before permitting
patients to participate is their ability to understand and
comply with the confidentiality constraints that will be
imposed on all those attending. This includes recognition

that the patient might share confidential
information outside of the confines of
the meeting room. One possible scenario
might involve the patient discussing
the meeting with a reporter.

Covert patient conduct

Another important risk to be mindful
of is the possibility of covert conduct
by the patient. (There have been
instances during disclosure meetings
and other discussions following adverse
events in which patients and/or their
family members have hidden recorders
and cell phones to record discussions,
or have used digital technology to
capture some of the material presented

or discussed at meetings unbeknown to the other attendees.)
While this possibility alone should not prohibit patient
inclusion, it should be anticipated and dealt with if possible
(e.g., having all participants leave their cell phones at the door).

Legal considerations, organizational policies

The risk management professional must be aware of
statutes, regulations and case law that can have an impact
on the decision to include patients in system analysis
processes or other meetings. A review of legal considerations
and organizational policies should be completed in advance
to assess if involvement of outside participants is something
that the organization can handle securely.

Before inviting a patient participant, work with legal
counsel to assure that all proper protections are in place.
Assure that each patient is evaluated for appropriateness
prior to inclusion in the system analysis process and that
expectations of conduct are expressed and understood by
all parties. Most importantly, assist with the preparation
of patients and healthcare providers alike to help create
a “safe” environment and a positive learning experience.

Patients need to have
a sense that changes
have been made and
that the process was

not a sham.

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JOURNAL OF HEALTHCARE RISK MANAGEMENT • VOLUME 27, NUMBER 2 31

Positive attitude toward change

If a healthcare organization is unable or unwilling to
include patients in the process of systems analysis, it is
important for risk management professionals to be agents
for positive change. Systems are typically resistant to
change and slow to respond once they recognize that it
is the right thing to do. Maintaining a positive attitude
toward the patient inclusion process and continuing to
advocate for and educate regarding this important topic
may lead to a success for the organization at a later time.

CONCLUSION

Despite the potential for emotional interactions requiring
well developed group facilitation skills, the psychological
benefits of including patients in SFA when appropriate,
can be profound.

In group situations where caregivers are willing and able
to listen, express vulnerability and concern, and patients
can express feelings openly, a bond of experience can
develop, permitting individuals to heal through shared
understanding and empathy. Patients, who have long
expressed the desire to ensure that adverse events they
experience are not experienced by others(7) are given the
opportunity to share in the process of improving the system.

Encouraging participation by patients is the essence of
true partnering in care. It empowers patients to truly be
members of the healthcare team benefiting the organization,
which learns what its patients actually experience in their care.

After an adverse event, many patients are able to understand
the vulnerability of healthcare processes and although upset
by their experience, wish to help improve the system. These
may be candidates for participation in the SFA process.

In order to take the next step to improve the integrity of
risk investigations and understanding system errors, the
inclusion of patients in the problem-solving process must
be considered. Essential to the successful implementation
of this initiative is recognition of the risk manager’s role
as leader and role model. Risk management professionals,
as advocates of open disclosure and patient safety, have a
particularly important role in influencing an organization’s
position on this issue.

Strong commitment to involving patients in process
improvement, combined with careful examination of the
legal, psychological and risk management implications,
can lead to significant organizational change. In order to
be an effective advocate in that regard, a risk management
professional must be cognizant of the laws and regulations
that afford certain quality privilege and protections and
assure that procedures are in place to foster those.

It is equally important for the risk management professional
to understand the psychological impact that involvement
can have on patients, families and the healthcare providers
and administrators, and be prepared to educate and support
the people that will be involved in the process.

If done well, patient inclusion in the system analysis process
will not only encourage more accurate investigative findings,
but can also help involved health care providers and patients
and their families to begin the healing process in a positive
and effective manner.

REFERENCES

1. Conner, M, Ponte, P., Conway, J. “Multidisciplinary
approaches to reducing error and risk in a patient
care setting.” Critical Care Nursing Journal.Clinics
of North America. 14: 359-367, December 2002.

2. Van Tilburg, C., Leistikow, I., Rademaker, C., Bierings,
M., Van Dijk, A. “Health care failure mode and effect
analysis: a useful proactive risk analysis in a pediatric
oncology ward.” Quality and Safety in Healthcare. 15:
58-64, Spring 2006.

3. Vincent, C. “Understanding and responding to adverse
events.” The New England Journal of Medicine
348(11):1051-1056, March 13, 2003.

4. Id.

5.http://www.ashrm.org/ashrm/aboutus/pdf/codeconduct.
pdf

6. Van Tilburg, C., Leistikow, I., Rademaker, C., Bierings,
M., Van Dijk, A. “Health care failure mode and effect
analysis: a useful proactive risk analysis in a pediatric
oncology ward.” Quality and Safety in Healthcare.
15: 58-64, Spring 2006.

7. Vincent, C., Young, M., Phillips, A. “Why do people sue
doctors? A study of patients and relatives taking legal
action.” Lancet. 343(8913):1609-13, June 25, 1994.

ABOUT THE AUTHORS

Geraldine Amori, Ph.D., ARM, CPHRM, DFASHRM,
is senior director, Education and Professional Development,
The Risk Management and Patient Safety Institute,
Shelburne, VT. Theresa M. Zimmerman, RN, BSN, JD,
ARM, CPHRM, FASHRM, is division patient safety
officer, Catholic Healthcare Partners, Cincinnati, OH.

continued next page

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32 JOURNAL OF HEALTHCARE RISK MANAGEMENT • VOLUME 27, NUMBER 2

A S H R M P A T I E N T P R E P A R A T I O N G U I D E

Minimum Elements for Discussion:

Information about the root cause analysis process:

Description of the process

Goals of the meeting

Reason the organization uses RCA for process improvement

What the organization hopes to learn

What the organization will do with the information

How the organization will ensure that change occurs

A description of the types of people who will participate

Information about the patient’s role in the process:

The unique contributions of the patient to the process

• Perspective that naturally may be different from the those of the caregivers

• Value of their closeness to the event

• Their desire to ensure that whatever happened to them will not re-occur
if there is a way to prevent it

The nature of the patient’s participation

• Level of participation – whether for an opening statement or the entire process

• Who will be present

• The expectation for the patient’s contribution

• The expectation for the activity and behavior of the other participants
during the patient’s involvement

• What will be done with the patient’s information

• What the patient can expect after the meeting

• What the patient should do if they feel the meeting has not gone
as planned, they are uncomfortable, or they change their mind

The organization’s expectations of the patient during and after the process

Open and honest communication from both the patient and the organization

Honoring the process

• Promise on both sides not to tape or photograph secretly

• Promise on both sides not to use the meeting as a way to gather information
to be used “against” the other party

Recognition that the caregivers are sad and upset

• Not using the meeting as an opportunity to lash out at providers

• Not using the meeting as an opportunity to blame or argue about care.

Note: This guide may be freely reproduced for hospital use.

Information Prepared:

41377bdyfnl:41377 8/31/07 2:33 PM Page 32

JOURNAL OF HEALTHCARE RISK MANAGEMENT • VOLUME 27, NUMBER 2 33

A S H R M P R O V I D E R / C A R E G I V E R P R E PA R AT I O N G U I D E

Minimum Elements for Discussion:
Information about the patient’s role in the process:

The value brought by patient perspective

The psychology of patient commitment to improving the process

The nature and level of patient participation in the process

The legal considerations which have been addressed through planning
for the patient participation

How the patient has been prepared for participation

Information about the caregiver behavior expectations:

How the group will need to behave to preserve the faltering trust
and concerns of the patient

Non-verbal and verbal strategies to ensure that individuals do not
inadvertently create tension for the patient

How the meeting will be structured to ensure the patient feels
welcomed and comfortable

Note: This guide may be freely reproduced for hospital use.
Information Prepared:

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Do the applicable by-laws, policies, regulations
or statutes prohibit participation by patients
or others in Peer Review or Quality activities?

no

Does the organization’s culture recognize
that competent professionals can make
errors, and that often those errors
are related to system failures?

yes

Does the organization evaluate situations
for actual or potential system failures
before it addresses human error?

yes

Was the event so catastrophic that any/all
of the healthcare participants are extremely
psychologically fragile?

no

Are the individual, specific healthcare
participants emotionally and psychologically
able to provide a safe environment for the
patient/family participant (i.e., behaving in
an open and respectful manner; avoiding sarcasm
intimidating actions or words, or disruptive
and threatening behavior)?

yes

Was the injury so significant that the
patient/family may need to focus all their
attention on immediate patient/family needs?

no

Is the patient/family psychologically or
emotionally affected such that they are
unable or unwilling to participate?

no

Is the patient/family potentially violent,
or obviously adversarial?

no

Is the patient/family willing and able to
participate?

yes

Begin process of education;
make commitment to patient/family
to share results?

Need to work towards changing by-laws
and policies to reflect organization willingness
to have patients participate; ensure compliance

Need to work on developing a just culture
prior to involving patients or families

Need to work on developing a just culture
prior to involving patients or families

Consider having a healthcare participant with
similar experience, education, and background
participate in lieu of upset individual; get support
for the individual

Are the healthcare participants able to
work emotionally/psychologically with
any patient/family participant?

Consider substitute patient/family who
has/have the same treatment; must meet patient
& family criteria for suitability

Consider a substitute patient/family who
has/have experienced similar treatment; must
meet all other patient/family criteria for suitability

Consider substitute patient/family who has/have
experienced similar treatment; must meet all
other patient/family criteria for suitability

Consider substitute patient/family who has/have
experienced similar treatment; offer patient/family
professional psychological support

Consider substitute patient/family who has/have
experienced similar treatment; must meet
all other patient/family criteria for suitability

yes
no
no
yes
no
yes
yes
yes
no

no
Do not include
patients/families
until the culture
is more
supportive

yes

A L G O R I T H M : I N V O L V I N G PAT I E N T S I N R O O T C A U S E A N A L Y S I S A N D S Y S T E M F A I L U R E A N A L Y S I S

34 JOURNAL OF HEALTHCARE RISK MANAGEMENT • VOLUME 27, NUMBER 2

41377bdyfnl:41377 8/31/07 2:33 PM Page 34

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Fatal error: Uncaught PDOException: SQLSTATE[HY000]: General error: 1021 Disk full (/tmp/#sql-temptable-2ee4a-666-199.MAI); waiting for someone to free some space... (errno: 28 "No space left on device") in /home/assignmentnsolut/assignmentresearchwriter.com/prox-classes/Database/DbPDOCore.php:147 Stack trace: #0 /home/assignmentnsolut/assignmentresearchwriter.com/prox-classes/Database/DbPDOCore.php(147): PDO->query('\n SE...') #1 /home/assignmentnsolut/assignmentresearchwriter.com/prox-classes/Database/DbCore.php(379): Proxim\Database\DbPDOCore->_query('\n SE...') #2 /home/assignmentnsolut/assignmentresearchwriter.com/prox-classes/Database/DbCore.php(616): Proxim\Database\DbCore->query('\n SE...') #3 /home/assignmentnsolut/assignmentresearchwriter.com/wp-content/plugins/samples/samples.php(71): Proxim\Database\DbCore->executeS('\n SE...') #4 /home/assignmentnsolut/assignmentresearchwriter.com/wp-includes/shortcodes.php(433): Proxim_Samples::displaySamples('', '', 'display_samples') #5 [internal function]: do_shortcode_tag(Array) #6 /home/assignmentnsolut/assignmentresearchwriter.com/wp-includes/shortcodes.php(273): preg_replace_callback('/\\[(\\[?)(displa...', 'do_shortcode_ta...', '[display_sample...') #7 /home/assignmentnsolut/assignmentresearchwriter.com/wp-content/themes/assignmentmavens/widgets/samples.php(8): do_shortcode('[display_sample...') #8 /home/assignmentnsolut/assignmentresearchwriter.com/wp-includes/template.php(792): require('/home/assignmen...') #9 /home/assignmentnsolut/assignmentresearchwriter.com/wp-includes/template.php(725): load_template('/home/assignmen...', false, Array) #10 /home/assignmentnsolut/assignmentresearchwriter.com/wp-includes/general-template.php(206): locate_template(Array, true, false, Array) #11 /home/assignmentnsolut/assignmentresearchwriter.com/wp-content/themes/assignmentmavens/single.php(46): get_template_part('widgets/samples') #12 /home/assignmentnsolut/assignmentresearchwriter.com/wp-includes/template-loader.php(106): include('/home/assignmen...') #13 /home/assignmentnsolut/assignmentresearchwriter.com/wp-blog-header.php(19): require_once('/home/assignmen...') #14 /home/assignmentnsolut/assignmentresearchwriter.com/index.php(17): require('/home/assignmen...') #15 {main} thrown in /home/assignmentnsolut/assignmentresearchwriter.com/prox-classes/Database/DbPDOCore.php on line 147