Chapter 1: Program Management Standards, Cont.

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1 Chapter 1: Program Management Standards, Cont. Thomas Eisenhauer, MD, FACS Surveyor Hendersonville, NC 1 Standard 1.7 Monitoring Conference Activity # case presentation Frequency Evaluate seven areas of cancer conference activity Prospective case % Multidisciplin ary Att. Clinical Trials Conf. Policy Evidence Based Guidelines, Stage Std 1.7: The cancer conference coordinator monitors and evaluates the cancer conference activities and reports findings to the cancer committee at least annually. 2

2 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. 3 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 4

3 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. 5 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. 6

4 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. 7 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. 8

5 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. 9 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. 10

6 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. 11 Patients Eligible for Accrual % Enrolled at office of staff physician Referred and enrolled at another facility Diagnosed and/or Treated at your facility Enrolled at your cancer program Enrolled on cancer prevention/ control study 12

7 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% 13 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. 14

8 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. 15 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. 16

9 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 evidencebased national guidelines used in treatment planning. 17 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 evidencebased guidelines in treatment planning Must not be held during cancer conference Encouraged to apply for CME 18

10 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.) 19 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 cancerrelated educational activity, other than cancer conferences. 20

11 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 21 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. 22

12 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 23 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. 24

13 Resources and Examples Best Practice Resource Library This repository contains tools, documentation and best practices designed to help cancer programs meet the Commission on Cancer Program Standards. Examples are submitted by our constituents, member organizations, and staff, for contributing to the repository and reviewed to confirm as BP Thank you! Any questions? 26

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