1
© American College of Surgeons 2014—Content cannot be reproduced or repurposed without written permission of the American College of Surgeons.
Chapter 1:
Program
Management
Standards,
Cont.
Thomas Eisenhauer, MD, FACS| Surveyor
Hendersonville, NC
Standard 1.7 Monitoring Conference Activity
Evaluate seven
areas of cancer
conference activity
Frequency
Multidisciplin
ary Att.
Evidence‐Based
Guidelines, Stage
Conf. Policy
Clinical Trials
Prospective case %
# case
presentation
Std 1.7: “The cancer conference
coordinator monitors and
evaluates the cancer conference
activities and reports findings to
the cancer committee at least
annually.”
3
© American College of Surgeons 2014—Content cannot be reproduced or repurposed without written permission of the American College of Surgeons.
Monitoring Conference Activity
Minimum of 15% of the annual analytic case load and 80% (or a
max of 450) of the annual analytic case presentations for
prospective presentation rate is required each year.
Conference activity can be reported in any type of format as long
as all required elements are included; grid is not a requirement.
If the conference grid or activity document does not include
cancer clinical trial information or other required elements, it
needs to be reported and documented somewhere else for
compliance.
A patient can be counted more than once if the program
discusses the patient's treatment plans at different conferences.
Intent of Standard
• Assures that cancer conferences are good teaching
sessions
• Helps reinforce that a patient's treatment plan is not
driven by the specialty of the first physician consulted
• Prospective discussion can help refer for clinical trials
when the patient needs to be untreated as an
eligibility criteria, that adequate biopsy samples are
taken for all specialists’ needs, and that neoadjuvant
treatment can be considered before surgery
5
© American College of Surgeons 2014—Content cannot be reproduced or repurposed without written permission of the American College of Surgeons.
Standard 1.8: Monitoring Community Outreach
Community Outreach Coordinator Responsibilities
Contributes to development of community outreach activities
–
Work with outreach organizations
–
Ensure activities meet community needs
–
Ensure activities follow accepted guidelines
–
Ensure positive findings are followed
–
Evaluate the effectiveness of referral
–
Create summary
Std1.8: “The community outreach coordinator monitors the effectiveness of community
outreach activities on an annual basis. The activities and findings are documented in a
community outreach activity summary that is presented to the cancer committee
annually.”
Community Outreach Coordinator
Coordinator responsibilities:
–
Contribute to development of community outreach activities.
–
Work with community outreach organizations.
–
Ensure that programs (prevention and early detection) reflect
cancer experience and meet community needs.
•
Use NCDB data and tools to study care and identify gaps
–
Ensure that prevention and early detection programs follow
nationally accepted evidence‐based guidelines and
interventions.
–
Ensure a mechanism is in place to follow‐up on all positive
findings.
7
© American College of Surgeons 2014—Content cannot be reproduced or repurposed without written permission of the American College of Surgeons.
Community Outreach Summary
Create community outreach activity summary report
outlining activities, results, and follow‐up.
Evaluate effectiveness of access and referral process.
The Community Outreach summary is NOT the same as
an annual report.
The summary cannot be just a list of activities, there
needs to be a summary with each activity.
The required elements of the summary are listed in the
CoC manual.
Measuring ‘Effectiveness’
Effectiveness for a screening activity might be the
rate of diagnosis made in the group screened or
perhaps this is an increase in screening participation
because of a new tool or new communication
strategy.
Effectiveness in a prevention activity could include
the number of participants who stopped smoking or
who began to change their lifestyle at the
completion of the program.
9
© American College of Surgeons 2014—Content cannot be reproduced or repurposed without written permission of the American College of Surgeons.
Standard 1.9: Clinical Trial Accrual
All CoC‐accredited programs should be able to provide
enrollment data and assistance to the cancer programs that
refer patients for enrollment in a cancer‐related clinical
trial.
NOTE: A cancer registrar who is abstracting cannot be
selected to fulfill this coordinator role.
Std1.9: “As appropriate to the cancer program category, the required percentage of
patients is accrued to cancer‐related clinical trials each year. The clinical trial
coordinator or representative reports clinical trial participation to the cancer
committee each year.”
Clinical Trial Accrual
Programs participating in cancer‐related clinical research
demonstrate that an independent peer review mechanism
consistent with national standards is in place and used.
All research projects must be approved by an internal or
external institutional review board (IRB).
Patients participating in clinical trials must give their
informed written consent, unless verbal consent has been
specified by the IRB.
11
© American College of Surgeons 2014—Content cannot be reproduced or repurposed without written permission of the American College of Surgeons.
Clinical Trial Accrual
Applicable clinical research studies includes:
–
Primary prevention of cancer
–
Treatment‐related clinical trials (NCI, Pharma)
–
Early detection of cancer
–
Quality of life related to cancer (supportive care trials)
–
Economics of care related to cancer
–
Locally developed biobank or repository
–
Patient registries with a cancer specific research focus
*Patients accrued to the American Cancer Society CPS‐3 study
cannot be counted toward this standard.
Patients Eligible for Accrual %
Diagnosed
and/or Treated
at your facility
Enrolled at
office of staff
physician
Enrolled at
your cancer
program
Referred and
enrolled at
another
facility
Enrolled on
cancer
prevention/
control study
13
© American College of Surgeons 2014—Content cannot be reproduced or repurposed without written permission of the American College of Surgeons.
Percentage Requirements Based on
Annual Analytic Cases – % Effective in 2015
NEW Category
Minimum (each year)
Commendation (each year)
INCP
6% (no change)
8% (no change)
NCIP
20%
30%
ACAD
6%
8%
VACP
2% (no change)
4% (no change)
CCCP
4%
6%
CCP
2%
4%
HACP
Exempt
2% (no change)
PCP
30%
40%
FCP
2%
4%
Intent of Standard
• Brings clinical research closer to home, avoiding unnecessary
travel and loss of patients to competitors.
• Vital teaching component.
• Elevates cancer program’s profile in community as a clinical
research facility.
Key to Successful Compliance
•
Research coordinator, data manager, or other clinical research
professional assists with
•
Recruitment, consent/enrollment, monitoring patient accrual,
and identifying and providing information and education
about new cancer related clinical trials
•
Frequent reminders to providers about trials that are open for
enrollment.
15
© American College of Surgeons 2014—Content cannot be reproduced or repurposed without written permission of the American College of Surgeons.
Clinical Trial Accrual, Cont.
•
A retrospective chart review of data is not a clinical trial.
•
Cancer tissue taken can be counted only once; you count the
person NOT the tissue sample.
•
If a patient enrolls in more than 1 trial, he/she can be
counted for both trials.
•
If the patient withdrawals from a study or is taken off by
physician, you can still count them as an accrual.
•
Programs can count patients enrolled in both bio specimen
repositories and registry trials.
•
To be counted, the bio repository or registry must have IRB approval
and participating patients must give their informed consent.
Clinical Trial Accrual Documentation
Patient accrual must be monitored and reported to
the cancer committee each year.
•
The report includes number of patients accrued to
cancer‐related clinical trials each year.
•
The report is documented in the cancer committee
minutes.
17
© American College of Surgeons 2014—Content cannot be reproduced or repurposed without written permission of the American College of Surgeons.
Standard 1.10: Clinical Educational Activity
One activity required annually; additional activities encouraged
Focus on stage and prognostic indicators and evidence‐based
guidelines.
The CC must monitor the success of and attendance at educational
activities each year.
A webinar is to be a minimum of one cumulative hour annually.
The webinar is to be viewed as a group with a physician leader from
the CC designated to facilitate discussion.
Std1.10: “Each year, the cancer committee offers at least 1 cancer‐related educational
activity, other than cancer conferences to physicians, nurses, and other allied health
professionals. The activity is focused on the use of AJCC or other appropriate staging in
clinical practice, which includes the use of appropriate prognostic indicators and evidence‐
based national guidelines used in treatment planning.”
Clinical Educational Activity
• Attendance geared for physicians, nurses,
and other allied health professionals
• Can be a review of a single cancer site
• Can be a general presentation on staging and
site specific prognostic indicators and evidence‐
based guidelines in treatment planning
• Must not be held during cancer conference
• Encouraged to apply for CME
19
© American College of Surgeons 2014—Content cannot be reproduced or repurposed without written permission of the American College of Surgeons.
Accepted Educational Formats
Including, but are not limited to:
–
An educational symposium
–
A lecture or panel discussion
–
A video conference
–
A webinar (must be a minimum of one cumulative hour
annually. The webinar is to be viewed as a group with a
physician leader from the cancer committee designated
to facilitate discussion.)
Standard 1.11: Cancer Registrar Education
Applies to:
• CTR staff
• Contract CTR staff who are contracted for 3 or more
consecutive months, regardless of the number of hours
worked
• All non‐credentialed staff, including:
– Staff abstracting under the supervision of a CTR
– Staff performing follow‐up activities
– Management or supervisory personnel
Std1.11: “Each year, all members of the cancer registry staff participate in 1 cancer‐
related educational activity, other than cancer conferences.”
21
© American College of Surgeons 2014—Content cannot be reproduced or repurposed without written permission of the American College of Surgeons.
Educational Activity Definitions
A cancer‐related lecture offered by the program (local activity)
A face‐to‐face meeting or workshop
•
Local
– involves one program or facilities located in one city.
State
– involves one state.
•
Regional
– involves multiple states working collaboratively to
develop one educational activity for all to participate in.
•
National
– sponsored by a national organization (non‐profit
org.) and targeted to a national audience.
Other ‘Local’ activities
• Video conference, webinar, or DVD
• Web‐based training modules
• Journal‐based articles that offer CE creditss
Standard 1.12: Public Reporting of
Outcomes
The report must be published in electronic or printed format
and distributed to an audience external to the facility and
medical staff.
There is no ‘due’ date for the outcome report, but it is
to be completed by December 31
st
of the calendar year.
Std1.12: “Each year, the cancer committee develops and disseminates a report of
patient or program outcomes to the public.”
23
© American College of Surgeons 2014—Content cannot be reproduced or repurposed without written permission of the American College of Surgeons.
Public Reporting of Outcomes
The content of the report includes outcome information on
1 or more of the following standards (not just survival
outcomes):
−
4.1 Prevention programs
−
4.2 Screening programs
−
4.4 Accountability measures
−
4.5 Quality improvement measures
−
4.6 Monitoring compliance with evidence‐based
guidelines
−
4.7 Studies of quality
−
4.8 Quality improvements
Public Reporting of Outcomes, Cont.
A survival analysis nor national data comparison is not
required to be part of this report.
A physician does not have to solely author the report. The
cancer committee develops this report, however, it is more
meaningful if a physician member is the author.
Commendation in this standard is part of the criteria for
the Outstanding Achievement Award (OAA).
Public reporting of outcomes needs to take place by
December 31 of each year.
25
© American College of Surgeons 2014—Content cannot be reproduced or repurposed without written permission of the American College of Surgeons.