Download Regional Models of Care for Systemic Treatment

Evidence-Based Series 12-10
A Quality Initiative of the
Program in Evidence-Based Care (PEBC), Cancer Care Ontario (CCO)
Regional Models of Care for Systemic Treatment
T. Vandenberg, M. Trudeau, N. Coakley, J. Nayler, C. DeGrasse,
E. Green, J.A. Mackay, C. McLennan, A. Smith, L. Wilcock,
and the Regional Models of Care Systemic Treatment Project Team
Report Date: May 22, 2007
An assessment conducted in November 2015 deferred the review of
Evidence-based Series (EBS) 12-10, which means that the document remains
current until it is assessed again next year. The PEBC has a formal and standardized
process to ensure the currency of each document (PEBC Assessment & Review Protocol)
This EBS is comprised of 3 sections and is available on the CCO Website
on the PEBC Systemic Treatment page.
Section 1: Standards for the Organization and Delivery of Systemic Treatment
Section 2: Evidentiary Review
Section 3: Development and External Review—Methods and Results
For information about the PEBC and the most current version of all reports,
please visit the CCO website at http://www.cancercare.on.ca/
or contact the PEBC office at:
Phone: 905-527-4322 ext. 42822
Fax: 905-526-6775
E-mail: [email protected]
Guideline Citation (Vancouver Style): T. Vandenberg, M. Trudeau, N. Coakley, J. Nayler, C. DeGrasse,
E. Green, et al. Regional models of care for systemic treatment. Toronto (ON): Cancer Care Ontario; 2007 May
22 [2011]. Program in Evidence-based Care Practice Guideline Report No.:12-10.
EBS 12-10
Evidence-Based Series #12-10: Section 1
Regional Models of Care for Systemic Treatment:
Standards for the Organization and Delivery of Systemic Treatment
T. Vandenberg, M. Trudeau, N. Coakley, J. Nayler, C. DeGrasse,
E. Green, J.A. Mackay, C. McLennan, A. Smith, L. Wilcock,
and the Regional Models of Care Systemic Treatment Project Team
A Special Project of the Systemic Treatment Program, Cancer Care Ontario, and
The Program in Evidence-based Care, Cancer Care Ontario
Report Date: May 22, 2007
Question
What is the best way to organize the delivery of ambulatory systemic treatment in
Ontario?
Rationale for a Standards Document
Rapidly expanding indications for systemic treatment, combined with human resource
and facility constraints, require an innovative approach to organizing and delivering cancer care
in Ontario. The purpose of this document is to provide a practical framework that will guide the
standardized delivery of evidence-based systemic treatment province-wide, in hospitals beyond
the confines of regional cancer centres. The primary goal of the framework is to provide safe,
evidence-based systemic cancer treatment, maximizing the efficient use of resources and
employing the principle of patient-centred care with an emphasis on providing care as close to
home as possible. Service provision, complexity of care, safety, accessibility, and quality care
across all levels defined from the patient, organization, and system perspective, as well as
appropriateness, transparency, and accountability, were all taken into consideration. Because
education ties in with many of the safety elements, while research ties in with complexity,
quality, and education, both are an integral part in the regional delivery of systemic treatment.
Scope of Report
The following report, developed by the Regional Models of Care Systemic Treatment
Project Team, applies to the organization and structure of systemic treatment programs in
Ontario. The standards apply to all institutions and programs delivering ambulatory systemic
treatment within the province of Ontario and address the following elements: types of providers
and their roles, education of providers, service type/complexity, service volumes, quality
assurance and safety, facility requirements, and administrative and organizational
responsibilities. Geographically dispersed and rural areas may require innovative strategies
such as advanced practice roles and remote support to achieve the standards.
STANDARDS – page 1
EBS 12-10
Development of the Standards Document
Evidence on the current organization and delivery of systemic treatment across Ontario,
Canada, the United Kingdom, Australia, and New Zealand was gathered through a systematic
search of the literature and a scan of documents from organizations concerned with systemic
treatment quality practice. The Regional Models of Care Systemic Treatment Working Group,
which included medical oncologists, a Cancer Care Ontario Regional Vice President, a regional
cancer program administrator, a systemic treatment satellite nursing administrator, oncology
nurses, administrators, pharmacists, and other professionals, reviewed the evidence and
developed the standards for Ontario, using a combination of evidence-based analysis, existing
recommendations from other jurisdictions, and expert opinion based on experience and
consensus. Due to the low quality of available research evidence, these standards are largely
based on expert opinion informed by existing standards and recommendations from other
jurisdictions. The standards were developed to accommodate long-range needs and take into
account the projected increase in systemic treatment needs over the next decade due to a
growing and aging population. More importantly, these standards were developed with the
expectation of increasing accessibility to safe, quality care.
Regional Models of Care for Systemic Treatment
The planning and performance monitoring of cancer services is the responsibility of the
Regional Cancer Programs (RCPs) that have been established by Cancer Care Ontario (CCO)
in each provincial Local Health Integrated Network (LHIN). Through the Regional Vice
President, Cancer Services, the RCP advises CCO as to the appropriate distribution of services
and is the primary mechanism through which existing and new CCO quality and access
standards for cancer services are implemented and monitored. The RCP includes the Integrated
Cancer Program (ICP) for the LHIN, which is located at one host hospital, other hospitals and
healthcare agencies, and health care providers involved in the delivery of cancer services. The
RCP comprises clinical and prevention programs associated with the various phases of care,
each linked to a CCO provincial program.
One component of each RCP is a Regional Systemic Treatment Program (RSTP), lead
by the Regional Head, Systemic Treatment and linked to the CCO provincial program for
systemic treatment. The Regional Systemic Treatment Program responsibility is to plan for and
facilitate the implementation of the CCO standard outlined in this document. The RSTP will
bring together the partners responsible for systemic treatment care delivery to develop a
regional plan for implementation of this standard. The RSTP will then work with its regional
partners to support the implementation, with additional support from the CCO provincial
program in systemic treatment.
The Regional Model for Quality Systemic Treatment (Figure 1) consists of a key set of
fundamental elements and regional programs designed to implement, monitor, and evaluate
quality indicators related to the delivery of safe, evidence-based, and patient-centred care. The
Model is an organizational framework for the delivery of systemic treatment within a RSTP. The
main goal of the Model is to facilitate the provision of the appropriate care in the appropriate
setting within the appropriate timeframe for all patients, regardless of where a patient receives
systemic treatment. The Model is comprised of three integrated structures: Integrated Cancer
Programs (ICPs), affiliate institutions, and satellite institutions, each with a defined scope of
practice. The ICPs are multidisciplinary organizations that provide complex cancer care. Affiliate
institutions have their own systemic treatment programs, although they are linked through
formal agreements with the RSTP. Satellite institutions have fewer oncology-related resources
and have a formal linkage to the RSTP for support in delivering systemic treatment.
All regional partner institutions will participate in the development of their RSTPs and will
collaboratively determine the appropriate configuration of their model, including the formal
STANDARDS – page 2
EBS 12-10
linkages that will be required among institutions. The complexity of care delivered in each type
of institution may vary; standards encompassing four levels of care (1-4) are recommended for
the delivery of systemic treatment in Ontario. It is the level of complexity and the availability of
services that differentiate one level from another. The Regional Systemic Treatment Program
determines the appropriate level of care for each institution. Levels are hierarchical, with the
satellite responsibilities encompassed within the affiliate and ICP levels. The designation of a
level requires an institution to meet all the standards for that level. As individual institutions
expand or focus their services, the configuration of the model and designation of institutional
levels may change over time, following consultation between the RSTP and the institution.
Adapted from: Champlain Regional Cancer Surgery Model, 2006.
The successful implementation of the standards is intended to create sustainable, accessible,
quality care and improve measurable patient outcomes. These four levels include:
Level 4 (Satellite):
 Provides ambulatory facilities, nursing, pharmacy, and physician support for the
administration of low-risk to high-risk, intravenous systemic treatment under the direction of
an oncologist from an ICP or affiliate level 3 institution.
 Systemic treatments given under the supervision of a physician with appropriate training in
oncology.
 Requires access to specialized services and providers with a formalized linkage to the
RSTP.
STANDARDS – page 3
EBS 12-10
Level 3 (Affiliate):
 Systemic treatments given under direct supervision of an on-site staff medical oncologist,
hematologist, or gynecologic oncologist.
 Limited teaching and research responsibilities.
Level 2 (ICP):
 Systemic treatments given at an ICP with radiation treatment services and capable of
providing most complex systemic treatments, including concurrent head and neck
chemoradiation and/or radiolabelled conjugates.
 Limited teaching and research responsibilities.
Level 1 (ICP):
 Academic institutions with teaching and research responsibilities.
 Experimental Investigational New Drug (IND) Program (IND phase 1 and or 2 trials with
highly developed clinical trials infrastructure, e.g., participate in the National Cancer Institute
of Canada Clinical Trials Group [NCIC-CTG] IND program and Princess Margaret
Hospital/National Institute of Health [PMH/NIH] new drug consortium)
 Responsible for training future health care professionals, including oncologists (subspecialty
residents and fellows).
Standards for Systemic Treatment
The goal of the RSTP is to ensure safe, standardized, evidence-based care across the
regions. To ensure equitable access to systemic treatment, the following tables delineate the
required standards by level in the following areas. Definitions for key terms are provided at end
of this section.
The following table provides an example of some key differentiating features. However,
an institution is required to meet all the standards at a level to be designated at that level. (See
Tables 1-7)
Complexity
Experimental
Investigational New
Drug Program
Concurrent Head and
Neck Chemorads
and/or Radiolabelled
Conjugates
Oncologist on Site
Determines
Treatment Plan
All other Systemic
Treatment
Level 1
(ICP)
Level 2
(ICP)
Level 3
(Affiliate)
Level 4
(Satellite)

X
X
X


X
X



X




 = yes, X = no
Chemorads = chemotherapy + radiation therapy
STANDARDS – page 4
EBS 12-10
Table 1. Standards for health care providers and their roles.
All levels of care:

Where the Standard identifies that services are to be provided in a multidisciplinary environment, all providers required for the service at a particular level are available or
readily accessible.

All patients being considered for systemic treatment must be assessed by an oncologist.

All treatment plans are recommended and parenteral systemic treatment prescribed by the consulting oncologist.

Individual treatments as part of an approved course may be ordered by a family physician or internist with oncology training.

Ongoing care must be coordinated with the consulting oncologist.

Only Registered Nurses with appropriate chemotherapy certification may administer parenteral drugs.

Only pharmacists or pharmacy technicians will prepare systemic treatment.
Level 4 (Satellite)
Level 3 (Affiliate)
Level 2 (ICP)
Level 1 (ICP)
Oncologists
- Access to oncologist from a level 1, 2 or 3 hospital required to
- Oncologist(s) on staff and
Level 3 plus:
Level 2 plus:
determine and recommend the treatment plan, to manage disease
on site.
- Developed specific sub- Academic responsibilities
status, and to discuss patient management issues with the health
- Mentoring family
specialized practices.
including teaching and
care team.
physicians / internists.
research.
- Limited teaching and
research.
Family
- Supervise IV systemic treatment administration with one on site
Same as level 4.
Same as level 3.
Same as level 2.
physicians /
or readily available (within 15 minutes) during the drug
Internists
administration time.
- Consult oncologist regarding patient management issues (e.g.
dose alteration).
- Assess and manage toxicity.
- Participate in education programs related to the management of
patients receiving systemic treatment.
Nurses
- Administer systemic treatment including monitoring and
Level 4 plus:
Level 3 plus:
Same as level 2.
intervening for side effects and reactions, and provide supportive
-Plans to implement
-Specialized oncology
care to the patient.
Advanced Oncology Nurse.
nurses working towards the
- Provide patient education related to planned systemic treatment,
national certification
in collaboration with pharmacist and physicians.
CON(C)* within five years of
- Communicate with ICP or affiliate team members and
employment.
collaborating with supervising physicians as necessary.
- Advanced Oncology Nurse
- Manage symptoms.
to manage selected patient
populations independently or
inter-dependently with
oncologists.
Pharmacists
- Review and verify systemic treatment orders and supervise the
Same as level 4
Level 3 plus:
Same as level 2.
preparation and dispensing of systemic treatment.
- ICP pharmacists provide
- Consult with ICP or affiliate pharmacist as required.
support and consultation to
- Pharmacist or pharmacy technician manages the new drug
regional systemic treatment
funding program reimbursement process.
program.
- Provide patient education related to medications in collaboration
- Dedicated oncology
with nurses and physicians.
pharmacists provide clinical
- Supervise/manage dispensing and documentation of clinical
services.
trials.
Pharmacy
- Prepare systemic treatment under supervision of a pharmacist.
Same as level 4.
Same as level 3.
Same as level 2.
technicians
Abbreviations: Advanced Practice Nurse prepared at the Master’s level ICP – integrated cancer program; IV – intravenous; CON(C) Certified Oncology Nurse (Canada).
STANDARDS – page 5
EBS 12-10
Table 2. Standards for the education of health care providers.
All levels of care:

Minimum standards are met for orientation and annual continuing education/mentoring in systemic treatment for all staff working in oncology services.

Providers are competent to provide the designated level of service and have ongoing education to maintain that competence.

Registered nurses meet organizational policy and standards to be certified in chemotherapy administration.
Level 4 (Satellite)
Level 3 (Affiliate)
Level 2 (ICP)
Level 1 (ICP)
Oncologists
- Ongoing CME as per Royal
Same as level 3.
Same as level 2.
College of Physicians and
--Surgeons of Canada.
- Participation in multidisciplinary
cancer conferences as required.
Family
- Initial orientation and annual Continuing
Same as level 4.
Same as level 3.
Same as level 2
physicians/
medical education.
Internists
- Mentoring should be available by an
oncologist.
- Relevant training for systemic treatment
being delivered.
- Knowledge of CCO regional systemic
treatment guidelines and standards and
regional policies and procedures.
- Participation in multidisciplinary cancer
conferences as required.
Nurses
- Registered nurse certified for the delivery
Level 4 plus:
Level 3 plus:
- Same as level 2
of systemic treatment.
- Registered Nurse specialized in
- Specialized Oncology Nurses
- Working towards CON(C) and/or reoncology, certified in systemic
working towards CON(C);
certification.
treatment administration, and
certification should be obtained
- Central venous access device
annually updated in guidelines and within 5 years of new employment.
management education and selection,
procedures.
- Advanced Oncology Nurse
certification. Annual update required.
- Plans to implement Advanced
(Clinical Nurse Specialist or Acute
- Oriented to and practicing according to:
Oncology Nursing roles.
Care Nurse Practitioner, Master’s
CCO Telephone Practice Guidelines
preparation) with additional
CCO Safe Handling of Cytotoxic Agents
knowledge and skills in managing
Standards
patients on systemic treatment.
CCO CVAD Guidelines.
- Additional education for nurses
- Participation in multidisciplinary cancer
managing transplant patients.
conferences encouraged.
- Additional ongoing education required to
match treatment type and complexity.
STANDARDS – page 6
EBS 12-10
Pharmacists
Pharmacy
technicians
- Specialized training in oncology.
- RSTP should provide a training or
certification program for staff involved in the
handing of cytotoxic agents and have a
policy on re-training. This may be done at or
in collaboration with an ICP or Affiliate
institution.
-Training may include institutional
training/orientation program for oncology
pharmacists, continuing education programs
or courses, oncology pharmacy review
courses (e.g. ASHP Oncology Review
course), preceptorship programs.
- Specialized training in the preparation
systemic treatment doses.
- RSTP should provide a training or
certification program for staff involved in the
handing of cytotoxic agents and have a
policy on re-training. This may be done at or
in collaboration with an ICP or Affiliate
institution.
Same as level 4.
Same as level 3.
Same as level 2.
Same as level 4.
Same as level 3.
Same as level 2.
Abbreviations: CCO – Cancer Care Ontario; CME – continuing medical education; CON(C) – Certified in Oncology Nursing (C)anada (www.cna-aiic.ca); CVAD –
central venous access devices; ICP – integrated cancer program. ASHP – American Society of Health-System Pharmacists
STANDARDS – page 7
EBS 12-10
Table 3. Standards for service type and complexity.
All levels of care:

Services are provided in the most appropriate setting where patients can be assured the best quality outcomes.

Each level has access to the other levels where necessary, for consultation or transfer for service delivery.
Level 4 (Satellite)
Level 3 (Affiliate)
Level 2 (ICP)
Level 1 (ICP)
Service type
Please see appendices 1.1-1.3 below for disease site specific CCO core and core restricted regimens
As per appendix.
Complexity
Patient
education
Supportive
care
Clinical trials
Low to high complexity
- Assessment for, management and coordination of central venous
access devices (such as PICC or port-a-cath).
- Drugs with a high risk of hypersensitivity reaction at first dose will only
be given at level 4 centres as agreed upon by the RSTP.
- Delivery of systemic treatment in presence of co-morbidity or
significant organ dysfunction that increases risk of toxicity and need for
dose adjustments, if agreed upon by RSTP.
- Monitoring and management of hypersensitivity reactions.
- If possible, on site patient education program that meets the CCO
standards.
Same as level 4 Plus:
- Delivery of first dose
high risk drugs
- Access to supportive care services to address specific patient needs.
Same as level 4.
Same as level 4 Plus:
- adhere to CCO patient
education standards
As per appendix plus:
- Concurrent
chemo/radiation.
- Radiopharmaceuticals.
High complexity
Level 3 plus:
- Provision of on site direct
coordination and
supervision of medical
and radiation treatment.
- Pathological consultation
on site.
Same as level 2.
Level 3 plus:
- Patient education
program related to
radiation treatment
- Comprehensive
supportive care expertise
as part of the ICP.
Same as level 3
Level 2 plus:
Same as Level 2
Same as level 2.
- Specific clinical trial
Same as level 2 plus:
education for patients
IND program with phase 1
and health care
and or 2 drugs
providers.
- Clinical Trials including
phase 2 and 3
Abbreviations: CCO – Cancer Care Ontario; ICP – integrated cancer program. PICC – peripherally inserted central catheter. RSTP – Regional Systemic Treatment
Program
- If Clinical trials are given at the institution, they must be under
direction of oncologist.
- Family physicians or internists with oncology training may be coinvestigators.
- Specific clinical trial education for patients and health care providers.
STANDARDS – page 8
EBS 12-10
Table 4. Standards for service volumes.
All levels of care:

There is sufficient patient volume at the location to maintain competency and skills of professional providers to address the acuity and complexity of the treatment
modalities and/or to provide cost-effective use of resources and drugs. (Refer to Discussion in Section 2 of this report).

The number of patients that can be treated will be affected by the complexity of treatment regimens.

Staffing must be sufficient to provide safe quality care at all times, including during vacation, illness, etc.
Table 5. Standards for quality assurance and safety.
All levels of care:

Cancer care includes management of complications of therapy.

All centres will follow CCO’s Safe Handling of Cytotoxic Agents Standards.

Up to date guidelines from the Regional Systemic Treatment Program are available for staff for relevant disease sites and relevant symptom management.

Training and guidelines include management of oncology emergencies.

Access to specialized centres (ICP level 1 or 2 or Affiliate 3) for support of quality and standards.

Provision of systemic treatment in the most effective manner.
Level 4 (Satellite)
Level 3 (Affiliate)
Level 2 (ICP)
Level 1 (ICP)
Safe handling - Policies and educational programs available
Same as level 4.
Same as level 3.
Same as level 2.
for all staff involved in systemic treatment
including storage, transport, spill management,
preparation, administration, and waste
disposal.
Patient
- Patient safety program that includes review
Same as level 4.
Same as level 3.
Same as level 2.
outcomes
of all medication adverse events and system
improvement.
Quality Indicators:
- Assessment of toxicities and documentation
of adverse reaction.
Organization
- Multidisciplinary cancer conference
Level 4 plus:
Same as level 3.
Same as level 2.
outcomes
participation encouraged (in line with CCO
- Multidisciplinary cancer
standards)
conference participation required.
Quality Indicators:
- Track volume of patients treated.
- Other indicators such as monitoring
adherence to guidelines.
System
Quality Indicators:
Level 4 plus:
Same as level 3.
Same as level 2.
outcomes
- Percentage of patients treated close to home. - Monitoring systemic treatment
wait times according to CCO
Standards.
Abbreviations: CCO – Cancer Care Ontario, ICP – integrated cancer program.
STANDARDS – page 9
EBS 12-10
Table 6. Standards for facility requirements.
All levels of care:

The necessary infrastructure is in place to provide the service level.
Level 4 (Satellite)
Level 3 (Affiliate)
Level 2 (ICP)
Clinic space
- Dedicated systemic treatment area adequate for volume of treatment
Same as Level 4.
Same as Level 3.
visits.
- Adequate space to provide clinical trials if applicable.
Clinic
- Computer, fax and phone accessibility.
Same as Level 4
Same as Level 3.
equipment
- Computer software available to provide computerized physician order
entry.
Systemic
- Oxygen.
Same as Level 4.
Same as Level 3.
treatment and - Biological Safety Cabinet (class 2) and externally vented.
facility safety
- Appropriate tubing, luer-lock syringes.
equipment
- IV equipment for parenteral therapy.
- IV equipment for ambulatory or inpatient infusional therapy (pumps).
- Personal protective equipment for staff who are handling systemic
treatment or waste.
- Spill kits and supplies for decontamination.
- Emergency resuscitation equipment (e.g. crash cart, other emergency
supplies, drugs, oxygen and suction) in case of cardiorespiratory arrest or
anaphylaxis.
- Supportive drugs for treatment of extravasation.
- Designated clinical trial storage if doing clinic trials.
Institutional
- Emergency department.
Same as Level 4 plus:
Level 3 plus:
facilities
- Pharmacy for secure storage and preparation of systemic treatment
- Intensive Care Unit and - Radiation therapy
drugs.
specialized Diagnostic
services on site.
- Access to inpatient beds for oncology patients.
imaging onsite
- Pathology services on
- Access to local specialized diagnostic imaging (CT, US, nuclear
site.
medicine) and laboratory tests / pathology for monitoring of systemic
- On site MRI.
treatment.
- Specialized diagnostic
- Access to Intensive Care Unit.
imaging on site.
- Access to facility for insertion of central venous catheters/port-a-caths.
- Potential for videoconferencing, remote web-based teaching, and patient
management as part of MCC.
Abbreviations: CT – computed tomography; ICP – integrated cancer program; IV – intravenous; MCC – multidisciplinary cancer conference; MRI
resonance imaging; US – ultrasound.
STANDARDS – page 10
Level 1 (ICP)
Level 2 plus:
- Dedicated clinical trials
infrastructure onsite
Same as Level 2.
Same as Level 2.
Same as level 2.
– magnetic
EBS 12-10
Table 7. Standards for administrative and organizational responsibilities.
All levels of care:

Should measure common provincial indicators

May also measure regional indicators as defined by the RCP.
Level 4 (Satellite)
Data reporting
requirements
- Outcome indicators that are specific, measurable,
attainable/achievable/action oriented, relevant, time-framed
(SMART) (3).
- Decision support resources to collate and analyze quality
indicators.
Leadership
- Physician and administrative leads identified with defined roles to
manage strategic and operational issues through regional forums.
- Formal linkage to a Regional Systemic Treatment Program.
- Nursing and pharmacy administrative leads identified with defined
roles to manage strategic and operational issues through the
Regional Systemic Treatment Program.
Logistical support
- Clerical staff and clinic facilities to support patient scheduling,
health record management, and clinic management including clinic
and administrative supplies for systemic treatment suites and
ambulatory clinic visits.
Information systems - Information system hardware and support to maintain a secure
electronic systemic treatment order/entry program and other
electronic systems as indicated (e.g., electronic patient record).
Abbreviations: ICP – integrated cancer program.
Level 3 (Affiliate)
Level 2 (ICP)
Level 1 (ICP)
Same as level 4.
Same as level 3 Plus:
- CCO data book
compliant
Same as level 2.
Level 4 plus.
- May have formalized
linkages with a satellite.
level 3 plus:
- Regional vice president
and regional systemic
treatment leads.
Same as level 2.
Same as level 4.
Same as level 3.
Same as level 2.
Same as level 4.
Same as level 3.
Same as level 2.
STANDARDS – page 11
EBS 12-10
DEFINITIONS
Advanced Oncology Nurse – The Advanced Oncology Nurse is prepared at the Master’s level
(MScN or equivalent). Ideally, the graduate program would be focused in oncology nursing,
likely with a particular emphasis on a subpopulation or area within cancer control such as
prevention, screening, and counselling or a theme within cancer care such as coping,
psychosocial care, and counselling. Theoretical knowledge in nursing and other sciences
grounds the nurse in the advanced provision of care to individuals, their families, and the
communities within which cancer care is given. Additional certification as an Acute Care Nurse
Practitioner, or other levels, may be acquired either within the Graduate Program or as a postgraduate course and certification. The domains of the Advanced Oncology Nurse include the
following:

advanced clinical practice

education

research

scholarly/professional leadership

organizational leadership (4)
Certification in Systemic Treatment Administration (Certified in Chemotherapy) – No
registered nurse in Ontario should administer intravenous systemic treatment until and unless
they have received additional education and have demonstrated competency in the delivery of
these cytotoxic agents. This requirement is specific to the delivery of chemotherapy and is not to
be confused with the national examination process for Certification as an Oncology Nurse
through the Canadian Nurses Association.
Complexity – Determined by the preparation and administration requirements for systemic
treatment, risk of immediate grade 3/4 toxicities, medical condition of the patient, or use of
investigational agents or new agents just approved for which there is little long-term toxicity
data.
ICP: Integrated Cancer Program – A multidisciplinary in and out patient cancer program
including medical, radiation and surgical oncology. The ICP will also provide research,
education and organizational leadership for the RCP.
Institutional Facilities – Hospitals, clinics or offices as outlined in the facility requirements
element.
Local Health Integration Networks (LHINs) – The purpose of these regional districts is to
build a system that is focused on the needs of the local community and provides integrated,
safe, and high-quality services to meet those needs (1).
Oncologist – A physician with subspecialty training in the administration of systemic treatment,
recognized by the Royal College of Physicians and Surgeons of Canada, including medical
oncologists, hematologists and gynecologic oncologists.
Quality indicator – A specific, measurable, attainable, relevant, time-framed outcome from the
patient, organizational, or system perspective to assess performance (3).
Regional Cancer Program (RCP) – Links together cancer providers and organizations across
the spectrum of cancer care.
STANDARDS – page 12
EBS 12-10
Regional Systemic Treatment Program (RSTP) – An agreed-upon relationship between
satellites, affiliates, and ICPs.
Specialized Oncology Nurse – A nurse who has a combination of expanded education
focused on cancer care and experience such as two years in a setting where the primary focus
is cancer care delivery. The Specialized Oncology Nurse might acquire specialty education
through a variety of ways, for example, enrolment in an undergraduate nursing program,
completion of an Oncology Certificate Program, distance specialty education (such as offered in
Adult and Pediatric Oncology Nursing), or registration in and completion of the certification
exam offered by the Canadian Nurses Association and attainment of the distinction Certified in
Oncology Nursing (C)anada CON(C).
The Specialized Oncology Nurse works in a specialized inpatient setting
such as an oncology unit or bone marrow transplant unit; an ambulatory setting
focused on the delivery of cancer care; a screening program; or a supportive care
setting or community setting offering palliative care. There are many environments where the
enhanced specialty knowledge and skill can be utilized to manage symptoms and side effects of
treatment, counsel patients in coping strategies, teach self-care behaviours, and monitor the
responses to treatment and nursing interventions. (4)
Systemic Treatment – Any oral or parenteral hormonal, biological, chemotherapeutic, or
radiopharmaceutical anticancer agent.
STANDARDS – page 13
EBS 12-10
For further information about this report, please contact:
Dr. Ted Vandenberg
London Regional Cancer Program
London Health Sciences Centre
790 Commissioners Road
London, ON N6A 4L6
Email: [email protected]
TEL: 519-685-8640
Dr. Maureen Trudeau
Cancer Care Ontario
620 University Avenue
Toronto, ON M5G 2L7
Email:
Maureen.Trudeau@sunnybrook.
ca
TEL: 416-480-5145
Funding
The PEBC is supported by the Ontario Ministry of Health and Long-Term Care through Cancer Care
Ontario. All work produced by the PEBC is editorially independent from its funding source.
Copyright
This report is copyrighted by Cancer Care Ontario; the report and the illustrations herein may not be
reproduced without the express written permission of Cancer Care Ontario. Cancer Care Ontario reserves
the right at any time, and at its sole discretion, to change or revoke this authorization.
Disclaimer
Care has been taken in the preparation of the information contained in this report. Nonetheless, any
person seeking to apply or consult the report is expected to use independent medical judgment in the
context of individual clinical circumstances or seek out the supervision of a qualified clinician. Cancer
Care Ontario makes no representation or guarantees of any kind whatsoever regarding their content or
use or application and disclaims any responsibility for their application or use in any way.
Contact Information
For information about the PEBC and the most current version of all reports,
please visit the CCO website at http://www.cancercare.on.ca/
or contact the PEBC office at:
Phone: 905-527-4322 ext. 42822
Fax: 905-526-6775
E-mail: [email protected]
STANDARDS – page 14
EBS 12-10
REFERENCES
1. Government of Ontario. Local Health Integration Networks [homepage on the Internet]. 2006
[cited 2006 Apr 17]. Available from: http://www.lhins.on.ca/english/main/home.asp
2. Cancer Care Ontario. Ontario Cancer Plan 2005-2008 [monograph on the Internet]. 2004
[cited 2006 Apr 17]. Available from:
http://www.cancercare.on.ca/documents/OntarioCancerPlan.pdf
3. Project Smart. Smart Goals [monograph on the Internet]. 2006 [cited 2006 Nov 27].
Available from: http://www.projectsmart.co.uk/smart_goals.html
4. Canadian Association of Nurses in Oncology. Standards of care, roles in oncology nursing
and role competencies [monograph on the Internet]. 2001 [cited 2006 Nov 24]. Available at:
http://www.cos.ca/cano/web/en/docs/CANO_CONEP_Standards_AUG01.pdf
STANDARDS – page 15
EBS 12-10
Appendix 1.1. Core + core restricted CCO regimens organized by institutional level of
care for breast, gastrointestinal, and lung cancer and hematology, as of October 2006.
Clinical trial drugs will be given at level 1, 2, or 3 or at level 4 under the supervision of
oncologist. Concurrent chemotherapy and radiation may be given at level 3 facilities (for
head and neck or lung cancer) or level 3 or 4 facilities (for rectal cancer) with agreement
of the RSTP.
BREAST
GASTROINTESTINAL
LUNG
HEMATOLOGY
Level 4
Adjuvant
AC
AC-TAXOL
AC-TAXOL DD
CAF
CEF
CMF(IV or PO)
FEC100
FEC-T
TRASTUZ
TAMOX
ANASTROZOLE
LETROZOLE
EXEMESTANE
Neoadjuvant
CAF-T
AC-DOCETAXEL
LABC/INFLAM
AC-DOCETAXEL
AC-TAXOL
CEF
EC-GCSF
FEC100
FEC-T
Metastatic
TAMOXIFEN
LETROZOLE
ANASTROZOLE
EXEMESTANE
MEGE
FULVESTRANT
LHRH analogues
+(tamoxifen/AIs)
PAMIDRONATE
AC
FAC
FEC
CMF
DOXO
EPI
PACLI
DOCETAX
VINOR
CAPECIT-DOCE
TRASTUZ+ D/T/V*
*T=paclitaxel
*D=docetaxel
*V=vinorelbine
ANUS
Adjuvant
FU-CISP*LO
FU-CISP*HI
NSCLC
st
1 dose:
PACLI
ERLOTINIB
COLORECTAL Adjuvant
5FU (IV/CIV)
5FU-RT
FU-LEUC*LO
FU-LEUC*LO-RT
CAPEC
FOLFOX-4
Adjuvant
VINOCISP
Metastatic
CAPEC
BEVACIZUMAB-IFL
BEVACIZUMAB-FOLFIRI
BEVACIZUMAB-FOLFOX4
FU-LEUC*LO
FOLFIRI
FOLFOX4
IRINOTECAN
RALTITREX
ESOPHAGUS
FU-CISP*LO
FU-CISP*HI
GASTRIC
Adjuvant
ECF
ELF
FULV
Metastatic
CISPLATETOP
ETOPCARBO
DOCETAX
PACLITAXEL
VINOR
GEMCIT
DOCECISP
PACLICARB
PACLICISP
VINOCARBO
GEMCISP
GEMCARBO
SCLC
CAV
CAVEP
CISPETOP
ETOPCARBO
MESOTHELIOMA
RALTITREX-CISP
PEMETREXED-CISP
PANCREAS
FU
FU*CIV
GEMCIT
STANDARDS – page 16
CLL
CHLORAMBUCIL*PO
CHOP
CVP
FLUDARABINE*PO
CML
HYDROXYUREA
INTERFERON ALFA
IFN-CYTARABINE
IMATINIB
HAIRY CELL LEUKEMIA
CLADRIBINE
INTERFERON ALFA
HODGKIN’S Dx
ABVD
MINI-BEAM
DHAP
ESHAP
GDP
NHL
CHOMP
CHOP-RITUXIMAB
st
RITUXIMAB 1 dose
RITUXIMAB-MAIN
MYELOMA
BORTEZOMIB
CLODRONATE
PAMIDRONATE
DEXAMETHASONE*PO
MELPH-PRED
VAD
EBS 12-10
GASTRIC
Adjuvant
FULV-RT
Levels 1, 2, and 3
Locally Advanced
CISPETOP-RT
VINOCISP-RT
ACUTE LEUKEMIA
All
NHL
HYPER-CVAD
MAGRATH
IBRITUMOMAB
For updates and an explanation of the abbreviations, please see the CCO Web site at:
http://www.cancercare.on.ca/index_chemoRegimensbyDisease.htm.
STANDARDS – page 17
EBS 12-10
Appendix 1.2. Core + core restricted CCO regimens organized by institutional level of
care for gynecological, genitourinary, and head and neck cancer and sarcoma, as of
October 2006.
Clinical trial drugs will be given at level 1, 2, or 3 or at level 4 under the supervision of
oncologist
GYNECOLOGY
GENITOURINARY
CERVIX
CISP
CISPETOP
CISP-XRT
BLADDER
CMV
M-VAC
M-VAC (high dose)
GEM-CISP
Intravesical
ENDOMETRIUM
CARBO
CISPDOXO
PAC
PACLICARBO-UPSC
GESTATIONAL
TROPHOBLASTIC
EMA-CO
EP-EMA
GERM CELL OVARY
CISPETOP
PEB
PIE
HEAD & NECK
Level 4
HEAD&NECK
Advanced
FUCISP
METHO
SARCOMA
EWING’S
IE-VAC
IFOSDOXO
IFOSETOP
GIST
IMATINIB
PROSTATE
MITXPRED
DOCETAXPRED
ZOLEDRONIC ACID
KAPOSI’S
DOXLIPO
ABV
AB-VCR
IFN-ALFA
VINB
VINB-VIN
RENAL
IFN-ALFA
TESTIS
BEP
PIE
VIP
OSTEOGENIC
CISPDOXO
IFOS
IFOSETOP
GESTATIONAL
TROPHOBLASTIC
DACTIN
METHO
SOFT TISSUE
IFOS
IFOSDOXO
DOXO
DTIC
VINBMTX-DES
VINOMTX-DES
OVARY
CARBO
CISP
PACLICARBO
PACLICISP
DOXOLIP
TOPOTECAN
PACLITAXEL
UTERINE SARCOMA
DOXO
OVARY
Intraperitoneal chemo
RENAL
IL-2
SUNITINIB
Levels 1, 2, and 3
HEAD&NECK
Locally Advanced
CISPLO-RT
CISPHI-RT
NASOPHARYNX
CISPFU-RT
FUCIS-RT
For updates and an explanation of the abbreviations, please see the CCO Web site at:
http://www.cancercare.on.ca/index_chemoRegimensbyDisease.htm.
STANDARDS – page 18
EBS 12-10
Appendix 1.3. Core + core restricted CCO regimens organized by institutional level of
care for CNS and endocrine cancer, melanoma, and Unknown Primary, as of October
2006.
CNS/ENDOCRINE
MELANOMA
Unknown Primary
Level 4
BRAIN
PROCARB
LOMUST
CARMUST
PCV
TEMOZOLAMIDE
MELANOMA
Adjuvant
IFN ALFA IV
IFN ALFA sc maintenance
Metastatic
DACARB
BPD
CISETOP
PEB
PLF
PLF
CAP
ADRENAL
DOXO
CARCINOID
DOXO
IFN-ALFA
THYMOMA
EPI
VAC
Levels 1 and 2
CARCINOID
RADIOLABLED OCTREO
For updates and an explanation of the abbreviations, please see the CCO Web site at:
http://www.cancercare.on.ca/index_chemoRegimensbyDisease.htm.
STANDARDS – page 19
EBS 12-10
Evidence-Based Series #12-10: Section 2
Regional Models of Care for Systemic Treatment: Evidentiary Review
T. Vandenberg, M. Trudeau, N. Coakley, J. Nayler, C. DeGrasse,
E. Green, J.A. Mackay, C. McLennan, A. Smith, L. Wilcock,
and the Regional Models of Care Systemic Treatment Project Team
A Special Project of the Systemic Treatment Program, Cancer Care Ontario, and
The Program in Evidence-based Care, Cancer Care Ontario
Report Date: May 22, 2007
QUESTION
What is the best way to organize the delivery of ambulatory systemic treatment in Ontario?
INTRODUCTION
Cancer is a major cause of morbidity and mortality and the leading cause of potential years
of life lost in Canada. Increased demands for cancer services are related to annual incidence
increases of 3%, mainly due to population growth and aging (1). Medical oncology consultations are
increasing 10-20% annually. Systemic treatment has increased at an annual rate of 7-10%, a
growth related to the continuing introduction of new evidence-based therapies that improve survival
and quality of life (2), and newer treatments lie in the wings (3). These treatments, which are often
more complex than those replaced, are delivered for longer periods as the survival time with chronic
malignant disease lengthens. Furthermore, the complexity of care, increased patient expectations,
and the influence of information available on the Internet all require that more time be spent with the
average patient.
Continuing manpower shortages contribute to the difficulty of funding and filling new
oncology positions (2). The November 2005 Canadian Post-M.D. Education Registry (CAPER)
revealed that there are only 34 medical oncology residents and eight fellows in oncology training for
the entire country (4). Meanwhile, increasing numbers of physicians are reaching retirement age,
and retirements are expected to accelerate, particularly in rural areas (5). Existing facilities are no
longer able to support projected increases in demand for cancer care over the next decade (6). The
implementation of healthcare restructuring and an increased reliance on alternate healthcare
providers such as nurse practitioners and family physicians may pose recruitment problems in
some geographic regions. A national report from the Canadian Institute for Health Information (7)
suggested that Ontario had one of the oldest registered nurse (RN) workforces in Canada and
predicted that the province could lose 12% of that workforce by 2006. The impact of retirements will
affect the cancer system, where the majority of certified oncology nurses are in the ambulatory
setting. In the face of these changes, Ontario needs to devise innovative ways to deliver safe and
effective systemic treatment for people with cancer. The risks of not pursuing a revised and
EVIDENTIARY REVIEW – page 1
EBS 12-10
sustainable model of delivery of systemic treatment include the adoption of ad hoc and inconsistent
local solutions, the cessation of service in some jurisdictions, and inequalities in access to and
standards of care.
METHODS
A systematic literature search and environmental scan were conducted to find evidence for
the best way to organize the delivery of regional systemic treatment in Ontario. The searches
yielded the evidentiary base used by the Regional Models of Care Systemic Treatment Project
Team (the Panel) (Appendix 1) to facilitate their discussions and inform the recommendations.
Evidence Search Strategy
The scientific and clinical literature was systematically searched for published and
unpublished reports pertaining to the organization and delivery of systemic treatment. Published
sources included the medical databases MEDLINE (OVID; 1996 through June 2006), EMBASE
(OVID; 1996 through June 2006), CINAHL (OVID; 1996 through June 2006), and HealthStar (OVID;
1996 through June 2006). The following terms were used: “Antineoplastic Agents”,
“Chemotherapy”, “Infusions intravenous”, and “Neoplasms”, combined with “Health facilities”,
“Organizational policy”, “Continuity of Patient Care”, “Outpatient clinics”, “Ambulatory Care
facilities”, “Hospitals Rural”, “Hospitals Community”, “Hospitals General”, “Health Care facilities”,
and “Health Care policy”. Article bibliographies and personal files were also searched for evidence
relevant to this report
Environmental Scan
The environmental scan included reviewing published and unpublished sources relating to
systemic treatment delivery at hospitals outside a larger cancer centre. In addition to Canada,
health care organizations in the United Kingdom (UK), Australia, and New Zealand were chosen by
the Panel, because those countries have health care systems that most closely reflect those in
place in Canada. A starting point for the environmental scan was the Web sites of the Ministry or
Department of Health for each country. The next step involved the Web sites of provincial or district
cancer agencies for strategic cancer plans or similar documents pertaining to the organization of
systemic treatment in regional centres. The Web sites of cancer centres identified in the provinces
or districts were then searched for relevant documents. In addition, key people identified in the
documents or Web sites were contacted twice for possible additional information or reports, but
those contacts yielded no results.
The following Web sites were searched between June 25 and July 4, 2006 for documents
pertaining to the organization of systemic treatment:
 Other provincial cancer agencies in Canada
▪ Albert Cancer Board
▪ British Columbia (BC) Cancer Agency
▪ Cancer Care Manitoba
▪ Cancer Care Nova Scotia
▪ Newfoundland Cancer Treatment and Research Foundation
▪ Saskatchewan Cancer Agency
 National cancer agencies in the U.K., Australia, and New Zealand
▪ The Cancer Council Australia
▪ The Collaboration for Cancer Outcomes Research and Evaluation (Australia)
▪ National Cancer Control Initiative (Australia)
▪ New Zealand Cancer Control Strategy
▪ New Zealand Cancer Control Trust
▪ Regional Cancer Centre Waikato Hospital, Hamilton, New Zealand
▪ State Government of Victoria, Australia
EVIDENTIARY REVIEW – page 2
EBS 12-10
▪ Peter MacCallum Cancer Centre (Australia)
▪ Medical Oncology Group of Australia
▪ Cancer UK
▪ Cancer Services Collaborative, Avon Somerset and Wiltshire (UK)
▪ Cancer Services Collaborative National Health Service (NHS) Modernisation agency
▪ NHS -National Health Service (UK)
 Canadian Organizations:
▪ CAPCA (The Canadian Association of Provincial Cancer Agencies)
▪ CAMO (Canadian Association of Medical Oncologists)
▪ CINO (Canadian Intravenous Nurses Association)
▪ CANO (Canadian Association of Nurses in Oncology)
A free keyword search between June 25 and July 4, 2006 was done through the Internet search
engine Google (©2007 Google), using the following terms:
 Regional integrated cancer plan (and country was used for each search term)
 Cancer centre
 Cancer clinic
 Cancer services
 Cancer treatment
 Chemotherapy administration standards
 Chemotherapy facility standards
 Modes of cancer care
 Multidisciplinary cancer care chemotherapy
 Rural cancer clinic
 Satellite cancer clinics
 Systemic therapy
 Systemic therapy standards
 Systemic therapy cancer regional
 Systemic therapy guidelines
The final step in the environmental scan was a search for documents that were mentioned in the
text or references of the identified reports. Given the breadth of the information identified by this
approach, the selection of documents focused on reports from jurisdictions that were generalizable
to Ontario. These included jurisdictions having a government-funded universal health care system
with regional rather than hospital-based models of delivery of systemic treatment.
Inclusion Criteria
For the purposes of this project, the inclusion criteria were kept purposefully broad. For the
systematic review, studies published between 1996 and June 2006 were included if they provided
any evidence on ways to deliver systemic treatment with ambulatory institutions. Study design and
study outcomes were kept open. For the environmental scan, any report that provided information
on ways to deliver systemic treatment within ambulatory institutions was included.
Exclusion Criteria
Articles were excluded if they were published in a language other than English, because
translation services were not available.
RESULTS
An overview of the documents deemed eligible for inclusion is presented in Table 1. The
reports provide descriptive organization criteria for administering systemic treatment in an
ambulatory setting.
EVIDENTIARY REVIEW – page 3
EBS 12-10
Table 1: Documents eligible for inclusion.
Environmental Scan
Systematic Review
Types of
providers and
their roles
Education of
providers
Service
type/complexity
Service volumes
Quality
assurance and
safety
Facility
requirements
Administrative
and
organizational
responsibilities
Ontario
Canada, other than
Ontario
Number
Ref ID
Number
Ref ID
Number
Ref ID
8
(8-15)
6
(16-21)
3
3
(9,15,30)
5
(16,21,31
-33)
2
(8,13)
1
4
(10,12,15,
43)
5
United Kingdom
Australia
New Zealand
Number
Ref ID
Number
Ref ID
Number
(22-24)
3
(25-27)
2
(28,29)
0
5
(22,23,3436)
1
(25)
1
(28,37)
1
(38)
(39)
3
(24,40,41)
2
(26,27)
3
(28,29,42)
1
(38)
4
(21,3133)
2
(34,44)
2
(25,27)
0
(8,9,11,30,
45)
5
(16,21,32
,33,46)
3
(24,34,47)
1
(25)
1
(28)
0
2
(9,15)
4
(16,21,32
,33)
2
(24,34)
2
(25,48)
1
(28)
0
1
(9)
2
(32,33)
3
(23,24,34)
0
1
(28)
0
EVIDENTIARY REVIEW – page 4
0
Ref ID
EBS 12-10
Published Literature Characteristics (Table 2)
Overall, the quality of the evidence identified in the literature search was modest. As
expected, no randomized controlled trials were found. The six reports located dealt primarily
with the delivery of chemotherapy in rural settings (10,12-15,43). Three position papers were
also found, of which two were special statements from the American Society of Clinical
Oncology (ASCO). One ASCO paper referred to the use of private agencies outside the
ambulatory setting to prepare and administer chemotherapy (8), and the other referred to the
criteria needed for facilities and personnel in the preparation and administration of systemic
antineoplastic therapy (9). The other position paper, from The Cancer Nurses of Australia,
outlined the education requirements for nurses administering systemic treatment (30). Two
additional papers reported on surveys (14,45), and the final article located was an account of
how one health facility instituted a standard for delivering chemotherapy (11).
Environmental Scan Characteristics (Table 3)
The environmental scan yielded 31 relevant and important documents from 17
institutions and regions, but unpublished documents might exist that have not been identified.
Overall, the evidence was still quite modest as no randomized controlled trials were found. Few
documents considered or reported on evidence and many provided little detail in their
recommendations. Many were expert panel or consensus based, although they did explicitly
state how consensus was reached (24-27,29,38,42). The documents primarily consisted of
reports providing recommendations on how to improve and effectively deliver cancer services in
the community (24-29,34,36-38,40,42,47,48). Two documents reported on survey results
(37,48). Four documents were affiliation agreements between central cancer centres and
community hospitals delivering systemic treatment (16,21,32,33).
Evidence Focus (Table 4)
The inclusion of a document for detailed review by the Regional Models of Care
Systemic Treatment Working Group (Appendix 1) was based on the merits of the methods
behind and relevance of its conclusions (whether it was a consensus or working party report
versus a survey, whether or not information was referenced, and whether the system in
question was similar to the systemic treatment delivery system in Ontario). The documents were
then evaluated based on whether they addressed key program elements (types of providers and
their roles, education of providers, service type or complexity, service volumes, quality
assurance and safety, facility requirements, or administrative and organizational
responsibilities). Based on these criteria, the most relevant documents were chosen to develop
a core document outlining the levels of delivery of systemic treatment and the essential or
desirable features of the program elements required for each level. The documents from
Australia were not chosen as they were mainly based on the availability of surgical and radiation
oncology services. The model for Ontario is primarily directed at the provision of systemic
treatment services. Table 4 details the key documents chosen from the published literature and
the environmental scan by the report Working Group.
EVIDENTIARY REVIEW – page 5
EBS 12-10
Table 2: Description of reports identified in published literature.
Purpose /Scope
Methods
Intended Audience
1
2
No
No
Australian cancer nurses.
No
No
Oncologists who refer patients to
outside services to prepare and
administer chemotherapy.
No
No
Yes
Yes
Facilities that are interested in
administering antineoplastic
therapy.
Intended for use in author’s
hospital setting.
No
No
Not stated.
Yes
Yes
Health facilities providing
chemotherapy in rural areas.
No
No
Not stated.
No
No
Health facilities interested in
proving chemotherapy.
No
No
Author’s rural 225 bed hospital.
Yes
Yes
Health facilities and personnel
interested in rural cancer
services.
Yes
Yes
Findings provide useful
framework for cancer services in
rural areas.
1
Consensus
Minimum requirements nurses
PS
Yes
must have to administer
chemotherapy and check list of
safety requirements.
ASCO
(8) To ensure oncologists are aware of PS
No
(2003)
standards for outside agencies that
prepare and administer
chemotherapy.
ASCO
(9) Requirements for facilities that
PS
Yes
(2004)
want to administer antineoplastic
therapy
Mahoney (11) The team met to review current
C
Yes
(1998)
practices and to identify
inconsistencies and make
improvements. A consensus was
reached and incorporated into the
hospitals policy.
MacBride (10) Reviews author’s clinic in terms of
NA
No
(1999)
what is currently being done when
chemotherapy is being
administered to patients.
McCarthy (45) Provides information on what
S
Yes
(2003)
needs be done to ensure patients
in rural and remote places have
access to proper care.
McCavana (12) Reports on how chemotherapy is
N/A
Yes
(2000)
being delivered in author’s rural
clinic.
McLinden (15) Requirements for health facilities
N/A
Yes
(2001)
and personnel delivering
chemotherapy in a rural setting.
Parrish
(13) Creation of drug safety check lists
N/A
Yes
(1983)
to administer chemotherapy at a
rural hospital.
Smith
(14) Investigates chemotherapy service
S
Yes
(2004)
in rural Scotland. Discusses current
situation and areas that need
improvement.
Stevenson (43) To measure consensus and
C
Yes
(2003)
priorities among rural health
professionals who treat cancer.
Abbreviations: C – Consensus; PS – Position Statement; S – Survey.
Method
Cancer nurses
of Australia (30)
(2003)
References
included
Type
2
Author
Method – report provided description of how evidence was found and used – yes or no.
Consensus – report provided description of how conclusions/recommendations were reached – yes or no.
EVIDENTIARY REVIEW – page 6
EBS 12-10
Table 3: Description of reports identified in environmental scan.
Methods
Intended Audience
method
Consensus
To develop a framework of cancer services in the
state of Victoria in Australia.
Provides information about the organization,
structure and programs of the BC Cancer Agency.
To create a network of care in England and Wales
that will allow a patient to receive treatment close
to home.
Provides information on service type, roles, quality,
facility requirements and administrative duties for
health facilities delivering systemic treatment in
Nova Scotia.
Provides instructions and requirements for facilities
delivering systemic treatment associated with the
Cancer Centre of Southeastern Ontario.
Aim of survey was to map existing cancer services
in rural and remote areas in Australia and to
compare these with two metropolitan centres in
Australia.
Provides requirements for facilities delivering
systemic treatment associated with Sudbury RCP
C
Yes
No
No
W
No
No
No
C
Yes
Yes
Yes
C
Yes
Yes
Yes
Systemic treatment
programs in Nova Scotia.
A
No
No
No
S
Yes
Yes
No
Hospitals delivery
systemic treatment in
Southeastern Ontario.
Regional hospitals
delivering chemotherapy
in Australia.
A
No
No
No
Provides instructions and requirements for facilities
delivering systemic treatment associated with the
London Regional Cancer Centre
A
No
No
No
Medical Oncology Group
of Australia Incorporated
(28) (2001)
Ministry of Health (New
Zealand) (38) (2006)
To provides resources for health care providers
involved in cancer in rural and remote areas of
Australia
To develop cancer treatment strategies for all New
Zealanders
WP
Yes
No
No
G
No
Yes
No
National Health Service
(UK) (25) (2004)
This manual lists what measures/processes need
to be in place in an institution delivering systemic
treatment
Provides instructions and requirements for facilities
delivering systemic treatment associated with The
Ottawa Hospital Regional Cancer Centre
C
No
No
No
A
No
No
No
To consider workforce implications for clinical and
medical oncologists of implementing the
recommendations from the Calman-Hine report.
Results of survey. Provides ideas on how to make
improvements to adult chemotherapy outpatient
units.
WP
Yes
Yes
Yes
S
No
Yes
Yes
Anyone wanting to make
their chemotherapy unit
more patient friendly.
Provides information on the structure of the
Saskatchewan Cancer Agency. Provided through
their Web site.
Business plan for delivering chemotherapy in
community hospitals in southwestern Ontario.
W
N/A
N/A
N/A
A
No
No
No
Health facilities and
personnel in
Saskatchewan.
Regional hospital in
Southwestern Ontario
Barton (Australia) (29,42)
(2003)
BC Cancer Agency
(22,36,41,44,49) (2006)
Calman & Hine (UK) (26)
(1995)
Cancer Care Nova Scotia
(24) (2005)
Cancer Centre of
Southeastern Ontario (32)
(2005)
Clinical Oncological
Society of Australia (37)
(2006)
Hôpital Régional de
Sudbury Regional
Hospital (21) (2005)
London Regional Cancer
Centre (16) (2006)
The Ottawa Hospital
Regional Cancer Center
(33) (1998)
Royal College of
Physicians (UK) (27)
(2001)
Royal College of
Radiologists – Clinical
Oncology Patients’ Liaison
Group (UK) (48) (2003)
Saskatchewan Cancer
Agency (23,34,35,40,47)
(2006)
Southwest Region Cancer
Plan (31) (2006)
EVIDENTIARY REVIEW – page 7
1
References
included
2
Purpose
Scope
type
Author
Cancer services in the
state of Victoria, Australia.
Hospitals and Cancer
Centres in BC.
Cancer Units and Centres
in the UK.
Hospitals delivery
systemic treatment in
Northeastern Ontario.
Huron Perth Hospital,
Wingham and District
hospital and Stratford
General Hospital.
Health facilities
administering systemic
treatment in Australia.
Health facilities caring for
cancer patients in New
Zealand.
Health facilities delivering
cancer care in the UK.
Hospitals delivering
chemotherapy as a
satellite of The Ottawa
Hospital Regional Cancer
Centre in Champlain
LHIN.
Cancer Units and Centres
in the UK.
EBS 12-10
Intended Audience
Consensus
No
No
No
1
A
Health care facilities in
Ontario associated with
the Northwestern Ontario
Regional Cancer Centre.
Abbreviations: A – agreements; BC – British Columbia; C – consensus; G – Government Report; LHIN – Local Health
Integration Network; PS – Position Statement; S – Survey; UK – United Kingdom, W – Web Site; WP – Working Party
Report.
1
2
Provides instructions and requirements for facilities
delivering systemic treatment in Northwestern
Ontario.
method
2
Methods
References
included
Thunder Bay Regional
Health Science Centre
(17-20,39,46) (2006)
Purpose
Scope
type
Author
Method – report provided description of how evidence was found and used – yes or no.
Consensus – report provided description of how conclusions/recommendations were reached – yes or no.
EVIDENTIARY REVIEW – page 8
EBS 12-10
Table 4: Coverage of program elements by reports.
Providers
and their
roles
Cancer Care Nova Scotia
Levels of Care for Cancer
Systemic Therapy in
Hospitals (24) (2005)
BC Cancer Agency
(22,36,41,44,49) (2006)
Saskatchewan Cancer
Agency (23,34,35,40,47)
(2006)
Thunder Bay Regional
Health Science Centre (1720,39,46) (2006)
Royal College of Physicians
(UK) (27) (2001)
London Regional Cancer
Centre (16) (2006)
Hôpital Régional de Sudbury
Regional Hospital (21) (2006)
Cancer Centre of
Southeastern Ontario (32)
(2005)
The Ottawa Hospital
Regional Cancer Centre (33)
(1998)
ASCO (9) (2004)
Calman-Hine
A policy framework for
Commissioning Cancer
Services (26) (1995)
National Health Service
Manual for Cancer Services
(UK) (25) (2004)
Education
of providers
X
Service
type /
complexity
Service
volumes
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
Facilities
Administrative and
organizational
responsibilities
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
QA/
Safety
X
X
X
Abbreviations: ASCO – American Society of Clinical Oncology; BC – British Columbia; QA – quality assurance; UK –
United Kingdom
PROGRAM ELEMENTS
Neither the published literature nor the environmental scan yielded any evidence
demonstrating superior patient outcome (e.g., survival, quality of life) as a function of the service
model (e.g., service, volume). This does not mean a relationship does not exist; rather, this
phenomenon has not been studied and reported. The affiliation agreements selected reflect
current Ontario practices, although few referenced the evidence for or described the methods
behind the development of agreement requirements.
Types of Providers and Their Roles
Published Literature
Eight reports (Table 5) provided information on the relevant provider roles (8-15). Four
reports provided a description of the role of the oncologist, but these were not very detailed. The
role of the oncologist was primarily to prescribe the systemic treatment and to be in the facility in
case of an adverse reaction. All the reports except one provided information on the roles of
nurses administering chemotherapy, roles that were clearly defined and consistent from report
to report. A common theme throughout all the documents was the need for appropriate training
for nurses and pharmacists. The role of the pharmacists was described in four reports, with the
EVIDENTIARY REVIEW – page 9
EBS 12-10
roles being clearly defined and similar in all four. Certification in preparing and handling
cytotoxic agents was a requirement for all pharmacists. Two reports provided fairly consistent
definitions for the role of the general practitioner, which was mainly to administer chemotherapy
in difficult cases and to care for patients. While the role of other support staff was only
mentioned in one article, their role is clearly defined in this present report.
Environmental Scan
Eight reports (Table 6) contained information on providers and their roles (22-29). All the
reports clearly defined the roles of nurses administering chemotherapy, and the role
descriptions were consistent between reports. Five reports provided a description of the role of
the oncologist, but this was not very detailed and varied between reports. The role of the
pharmacists was described in five documents, with their roles being clearly defined and similar
in all the reports. Certification in preparing and handling cytotoxic agents was a requirement for
all pharmacists. Only four reports defined the role of the general practitioner, but the role
description was fairly consistent between reports and was mainly to be available for
chemotherapy emergencies. The role of other support staff was only mentioned in two reports,
but was clearly defined in both.
Environmental Scan - Ontario
Reports were available from three Ontario regions (Table 6) (16-21). The roles of the
medical oncologist from the Regional Cancer Program (RCP) and the role of the community
physician were clearly defined. The oncologist in the RCP was to prescribe the treatment and
the community physicians were to monitor the patient during that treatment. The role of the
nurses was only discussed by one region, but because the documents had very defined
sections on nursing education and training, it could be understood that nurses were to deliver
the systemic treatment. Neither the role of the pharmacist nor of administrative or other support
staff was discussed.
EVIDENTIARY REVIEW – page 10
EBS 12-10
Table 5: Providers and their roles – published literature.
Report
(reference)
ASCO (8)
(2003)
ASCO (9)
(2004)
Oncologists
Nurses
Appropriately trained
physician should be present
when a potentially
anaphylactic drug is being
administered.
Only qualified physicians
should prescribe
antineoplastic therapy.
Physicians should also
supervise nurses
administering antineoplastic
therapy.
Should have specific
training to administer
chemotherapy.
MacBride
(10) (1999)
Mahoney
(11) (1998)
McCavana
(12) (1998)
Only oncologists shall
prescribe antineoplastic
therapy. Can administer
chemotherapy if have
training and through
intrathecal route.
Visiting oncologist, lead
cancer clinician provides
care to rural community
hospital.
Pharmacists
General
practitioners
Should be qualified to
administer antineoplastic
therapy.
Can practice expanded
roles e.g., cytotoxic
administration,
venipuncture, and access
skin-tunnelled catheters.
Can make decisions
based on approved
protocols.
Antineoplastic agents can
only be administered by
specially trained nurses
and only through
approved routes.
Clinic operated by
Macmillan clinical nurse
specialist and oncology
trained ward sister.
Parrish (13)
(1983)
Adequate support
staff required to
maintain supplies,
schedule patients,
and complete paper
work.
Prepares the
antineoplastic
agents onsite
and adheres to
safe handling
procedures.
Team includes
specially trained
pharmacist.
Prepares
medication, takes
patient
medication
history and
educates patient
on side effects.
Smith (14)
(2003)
Chemotherapy mainly
delivered by specialist
nurses. Some ward staff
and nurses trained in
administration were also
utilized in the clinics.
McLinden
(15) (2001)
Nursing staff trained in
chemotherapy
administration administer
the systemic treatment.
Other support staff
GP’s with training
in advanced
chemotherapy
procedures care
for patients at
outreach clinics
and administer
chemotherapy if
patients very ill.
Two family
physicians with
oncology training
from cancer
centre help care
for chemotherapy
patients at the
hospital.
Prepares
medication; if a
properly trained
pharmacist is not
available a
pharmacy
technician or
physician can be
trained to mix the
agents.
Abbreviations: ASCO – American Society of Clinical Oncology; GP – General Practitioner.
EVIDENTIARY REVIEW – page 11
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Table 6: Providers and their roles – environmental scan.
Report (reference)
Oncologists
Nursing
Pharmacists
Cancer Care Nova
Scotia
(24) (2005)
Clear roles defined in
five different levels of
cancer care.
Clear roles defined in
five different levels of
cancer care.
Clear roles defined in
five different levels of
cancer care.
Only nurses recognized
by the Saskatchewan
Cancer Agency as
being certified in
chemotherapy
administration may
administer treatments.
Must be licensed and
have completed
chemotherapy
certification course.
Responsible for
preparation and
disposal of cytotoxic
agents.
Certified chemotherapy
nurse must record 50
chemotherapy
administrations per year
and participate in 10
hours of continuing
nursing education
related to systemic
therapy per year.
Clinical nurse
specialists in oncology
should only delivery
systemic treatment.
Specialist trained
nurses in the rationale
and use of
chemotherapy can
administer systemic
treatment.
Must have training in
the safe handling and
preparation of
cytotoxic and
hazardous drugs.
Nurse’s roles not
defined, but only team
members who have
specialty training in
chemotherapy
administration can
administer systemic
treatment.
Nurse with
chemotherapy training
would deliver
chemotherapeutic
agents.
A designated
pharmacist shall be
appointed the lead
and manage the
pharmacy according
to the prescribed
guidelines.
Saskatchewan
Cancer Agency
(23) (2006)
BC Cancer Agency
(22) (2006)
Calman-Hine
(26) (1995)
Royal College of
Physicians (27)
(2001)
When transferring
patient care to the
community oncology
network, oncologist
must ensure the
physician has the
necessary knowledge
and skill to manage the
patient.
Oncologists in cancer
units should have ties
and also practice in the
larger cancer centres.
Clinical and medical
oncologists responsible
for delivering nonsurgical specialist
services.
Must have two ½ days
in a cancer centre to
ensure not working in
isolation.
Will supervise
chemotherapy
administration.
National Health
Service
(25) (2004)
Barton (29) (2003)
Medical Oncology
Group of Australia
Incorporated
(28) (2001)
Prescribe, manage and
supervise
chemotherapy
administration.
General
practitioners
Clear roles
defined in five
different levels of
cancer care.
To be readily
available to assist
centre during
treatments and
for medical
emergencies.
Provides followup care in
consultation with
patient’s
oncologist.
Pharmacy should
have proper facilities
to mix and
reconstitute cytotoxic
drugs. Pharmacists
should have specialty
training. All drugs
should be checked by
oncology
pharmacists.
Chemotherapy
administered by
specialty nurses.
EVIDENTIARY REVIEW – page 12
GP’s should
follow guidelines
in caring for
chemotherapy
patients, though
this point will be
difficult to
enforce.
Registered
medical
practitioner on
call but not
necessarily on
site.
Other support
staff
Clear roles
defined in five
different levels of
cancer care.
Adequate
support staff
should be
available to
ensure health
records are
current and
easily
accessible.
EBS 12-10
Report (reference)
Ontario
Hôpital Régional de
Sudbury Regional
Hospital (21)
(2005)
London Regional
Cancer Centre (16)
(2006)
Thunder Bay
Regional Health
Science Centre
(17-20) (2006)
Oncologists
Nursing
Pharmacists
Oncologist at RCP will
prescribe therapy
Oncologist at London
Regional Cancer Centre
will prescribe therapy
Oncologist at RCP will
prescribe therapy
Nurses responsible for
patient assessment and
chemotherapy
administration
General
practitioners
Other support
staff
Will see that
patient is fit to
receive each
cycle of therapy
Will assume
responsibility for
administration
and management
of adverse effects
of systemic
treatment
Will manage
administration of
chemotherapy,
perform clinical
assessment,
ensure CCO
standards in the
administration of
chemotherapy
are being
adhered to,
involved in followup care
Abbreviations: CCO – Cancer Care Ontario; RCP – regional cancer program.
Education of Providers
Published Literature
While most articles mentioned that specialized health personnel were required to
prescribe, prepare, and administer antineoplastic agents, few articles specified what training
these health professionals needed. The Cancer Nurses Society of Australia has a
comprehensive document that lists the minimum requirements that a nurse must have to
administer cytotoxic drugs, including both a theoretical and a clinical education (30). ASC0
(2004) also lists that physicians should acquire training in a formal setting or through a
combination of training and experience (9). Nurses should be in compliance with the individual
US State practice acts (9). McLinden writes that all nurses who administer chemotherapy must
take a chemotherapy course, which can be obtained through distance education. In addition,
nurses, family physicians, and pharmacists must all be involved with educational activities
hosted through their regional cancer centre during the year (cancer centres host special
weekend and teleconference sessions for health professionals in the community) (15).
Environmental Scan
In their survey of remote and rural oncology services, the Clinical Oncological Society of
Australia found that a significant number of nurses in remote areas were administering
chemotherapy without the proper education (37). To address this issue of education, the
environmental scan produced several documents providing very detailed lists of competencies,
accompanied by checklists of what training a nurse needed before being permitted to administer
systemic treatment (22,25,35,36). Several documents also stated that nurses and oncologists
must be provided with access to continuing medical education classes (24,29,35,39).
Environmental Scan - Ontario
Five documents from Ontario addressed provider education (16,21,31-33). With respect
to nursing education, the Memorandum of Agreement between the London Regional Cancer
EVIDENTIARY REVIEW – page 13
EBS 12-10
Centre and Huron Perth Hospitals Partnership and Wingham and District Hospital and Stratford
General Hospital requires that nurses successfully complete a closed-book chemotherapy
certification course and receive at least 85% as their final mark (16). The Hôpital Régional de
Sudbury Regional Hospital requires that all nurses have a certification of competence from the
College of Nurses of Ontario and that they renew the chemotherapy certification yearly (21).
The Southwest Region Cancer Plan requires that nurses be enrolled in and certified by the
Canadian Intravenous Nurses Association (CINA) (31). The Ottawa Hospital Regional Cancer
Centre requires nurses to be certified in chemotherapy, with annual recertification. In addition,
nurses must continue their professional development, as demonstrated by an annual written
current learning plan and membership in an oncology professional organization, and are
encouraged to attend at least one oncology-related seminar every two years (33).
Pharmacists and technicians must also have proper training. The Memorandum of
Agreement between the London Regional Cancer Centre and Huron Perth Hospitals
Partnership and Wingham and District Hospital and Stratford General Hospital requires that
pharmacy technicians must complete, and receive 100%, on an open-book chemotherapy
certification course (16). The Hôpital Régional de Sudbury Regional Hospital requires that
pharmacists be licensed with the Ontario College of Pharmacy, have hospital pharmacy
experience, and spend one day at the cancer centre to receive basic training, and they are
encouraged to attend continuing education seminars (21). The Cancer Centre of Southeastern
Ontario outlines the education that pharmacists should have and requires that pharmacists be
licensed with the Ontario College of Pharmacy and have hospital pharmacy experience
(particularly intravenous [IV] admixture), comprehensive knowledge of pharmaceuticals, and
patient counselling experience. They must also be aware of safe-handling procedures and
attend continuing oncology education seminars (32). The Ottawa Hospital Regional Cancer
Centre requires that pharmacists must have hospital pharmacy experience, and receive basic
training by spending one day at the cancer centre; continuing education is encouraged (33).
Only the Memorandum of Agreement between the London Regional Cancer Centre and
Huron Perth Hospitals Partnership and Wingham and District Hospital and Stratford General
Hospital outlines the training and education requirements of physicians. Community physicians
who agree to supervise chemotherapy delivery must attend a workshop at the London Regional
Cancer Centre. Upon successful completion of this course, the director of the London Regional
Cancer Centre will provide written notice that the community physician is prepared to begin the
supervision of chemotherapy delivery. Ongoing education is also encouraged for all staff (16).
All centres encourage their medical staff to participate in continuing educational activities
(16,21,31-33).
Service Type/Complexity
Published Literature
Two reports described the level and complexity of services that can be offered at
different centres (8,13). Parrish (13) reported on the types of chemotherapy drugs that the rural
Scioto Memorial Hospital (US) is able to administer. The Scioto Memorial Hospital has work
forms that list what adverse events need to be checked for, what laboratory tests need to be
completed, and what the proper dose to administer is. If patients require other chemotherapy
regimens, they must travel to the cancer centre. The ASCO statement on the use of outside
services to prepare or administer chemotherapy drugs reports on the different service types that
can be used (8). This report also lists key points to document when drugs are prepared by
outside agencies, including who prepares the treatment, if the staff has proper safety training, if
the facility has emergency guidelines, and who is supervising the delivery of the agents.
EVIDENTIARY REVIEW – page 14
EBS 12-10
Environmental Scan
Table 7 shows reports found through the environmental scan that list levels of service.
Table 7: Documents reporting levels of service and complexity - environmental scan.
Report
(Reference)
Specifies different levels of service offered
Cancer Care
Nova Scotia (24)
(2005)
Yes - 5 levels of cancer services
Community/Home level - oral systemic treatment
Basic Level Hospital- Basic chemotherapy may be administered
intermediate Level Hospital – chemotherapy where specialized nursing skill may be
administered at this site
Advanced Level Hospital – systemic treatment given under direct supervision of
oncologist
Specialized Level Hospital – Regimens that require a specialized facility or resources
Saskatchewan
Cancer Agency
(40) (2006)
No
BC Cancer
Agency (41)
(2006)
Calman-Hine
(26) (1995)
Yes – 6 levels.
Satellite; Affiliate; Associate; Treatment specific; Cancer Service; Special Circumstance
Royal College of
Physicians (27)
(2001)
Barton (29,42)
(2003)
Medical
Oncology Group
of Australia
Incorporated (28)
(2001)
Ministry of Health
- New Zealand
(38) (2006)
Specifies what
types of systemic
treatment or
services are
available at each
type of centre
Provides a
description of the
services available
at each level and a
detailed list of the
kinds of systemic
treatment can be
delivered at each
level
Lists approved
drugs that COPS
centres can
administer
No
Yes – Provides differences between Cancer Units and Cancer Centres
A cancer unit would normally be a district hospital providing a range of cancer services.
Would provide care for common cancers.
A cancer centre would have a high degree of specialization and comprehensive
provision of cancer care. Cancer Centres serve a population of at least 1,000,000
Yes – Builds on Calman-Hine document and provides greater detail in differences
between Cancer Units in smaller cities and Cancer Centres in larger cities.
Type I cancer unit serves a population of 250,000 and has a long travel time to the
larger cancer centre. It has a designated ward for cancer patients
Type II cancer unit serves a population of 250,000 and is a short distance from a large
cancer centre. This unit provides no beds for inpatients
Type III cancer unit is for a small catchments area near the large cancer centre. This
centre often only provides chemotherapy
5 levels of services
Level 1 cancer service – provide chemotherapy using pre-ordered materials. No dose
adjustment.
Level 2 cancer service – Nurse with specific chemotherapy training would be on site.
Administration, and preparation of chemotherapy is possible
Level 3 cancer service –same as level 2, with addition of surgical oncology services
and CT scanning
Level 4 cancer service –same as level 3, with addition of radiotherapy services on site
Level 5 cancer service –same as level 4, with addition of radiation and surgical
specialist services. Has paediatric facilities
Lists two types of services for rural areas:
Requirements for a sustainable resident specialist service in medical oncology and
requirements for a sustainable outreach service in medical oncology
List differences in
service between
types of centres
Regional clinics outside of cancer centres responsible for administering chemotherapy
Includes list of
cancer drugs that
should be available
in cancer treatment
centres
EVIDENTIARY REVIEW – page 15
List differences in
service between
types of centres
Provides brief
description of
services offered at
each centre
Lists service
requirements for
both types of rural
cancer clinics
EBS 12-10
Report
(Reference)
Thunder Bay
Regional Cancer
Care (39) (2006)
Specifies different levels of service offered
No
Specifies what
types of systemic
treatment or
services are
available at each
type of centre
Yes – Provides lists
of drugs that can
be delivered at
different sites
Abbreviations: COPS – Community Oncology Program – Saskatchewan;
Service Volumes
Published Literature
Four articles provided details on service volumes (10,12,15,43). Stevenson et al
reported on a consensus study that was undertaken in northeastern Scotland. The consensus
agreement was that two nurses trained in chemotherapy administration were required in each
facility that delivers chemotherapy, although no mention was made of patient volumes at the
centre. The two chemotherapy-trained nurses were required to sufficiently cover the clinic and
to make sure that there was no disruption in service during vacation or sickness (43). MacBride
reported that, in a nurse-led chemotherapy unit in the Western General Hospital in Scotland,
thirteen full-time nurses care for 1,300 patients a month, performing 1,200 procedures (10).
McCavana stated that a Macmillan nurse (a special cancer nurse in the UK) and a ward sister
cared for 12 patients at any one time at the Lorn Islands District General hospital in Scotland
(12); there was no mention of whether these patients were outpatients. McLinden wrote that two
family physicians with extra training in oncology should be available at each community clinic. In
addition, he noted that the number of nurses at each clinic might differ and was dependant on
patient volumes, but this was not specified in any more detail in the article (15).
Environmental Scan
The environmental scan produced four documents that reported on volumes
(25,27,34,44). The Community Oncology Program in Saskatchewan has personnel
recommendations for their program. A minimum of two chemotherapy-certified RNs and one
licensed pharmacist, a physician available to respond to emergencies, psychosocial support,
and clerical support are required in each centre (34). The BC Cancer Agency has a funding
formula that a community cancer centre can use to determine the minimum amount of staff
required. This formula, which takes into account patient education and scheduling, treatment
and support, and rehabilitation, was derived from a provincial survey of the staff that care for
cancer patients (44). The Manual for Cancer Services (UK) specifies that there should be an
arrangement involving the Head of Service, the oncology pharmacy, and the lead chemotherapy
nurse to limit the number of chemotherapy patients when those three judge the workload to
have reached unsafe numbers (25). There should also be a policy that states when it is
acceptable to deliver chemotherapy outside of normal working hours (25). This document only
suggests policies or measures that should be in place and does not provide any details or
define any terms. The Royal College of Physicians’ Working Party report (UK) on cancer units
has a section on workload estimates. For a type I cancer unit that serves a population of
250,000 and is a far distance from the larger cancer centre, twelve oncologists would be
required. For a type II cancer unit that also serves a large population (250,000) but is a short
distance from a large cancer centre, 10 oncologists would be required. For a type III cancer unit
that serves a small population and is a short distance from the larger cancer centre four
oncologists are required (27).
EVIDENTIARY REVIEW – page 16
EBS 12-10
Environmental Scan - Ontario
Four reports in Ontario addressed service volumes. Both the Southwest Regional
Cancer Plan and the Memorandum of Agreement from the Hôpital Régional de Sudbury
Regional Hospital recommend that two nurses be trained to administer chemotherapy in a
community setting. (21,31) The Cancer Centre of Southeastern Ontario recommends that there
be one full-time nurse per 1,700 systemic-suite visits, one pharmacist for 6,000 systemic-suite
visits, and one pharmacy technician per 11,500 IV chemotherapy prescriptions (32). While the
Ottawa Regional Cancer Centre does not provide a minimum number of chemotherapy
administration volumes, it does state that the volumes will be determined by the Centre and the
referring institution and be dependant on the resources available to both parties (33).
Quality Assurance and Safety
Published Literature
Quality assurance and safety were addressed in five reports (8,9,11,30,45). Mahoney et
al reported that in their hospital setting all adverse drug reactions were to be reported and
reviewed in accordance with the hospital adverse drug reaction policy (11). In addition, a
hospital-wide quality assurance policy would be established to review compliance with the
institution’s “Cancer Chemotherapy Clinical Practice Standard” (11). Both the ASCO special
articles addressed quality and safety in their standards for antineoplastic therapy in facilities
providing cancer care. The standards include complying with federal Health and Safety Acts,
having extravasation and dosing policies, and having properly trained and licensed
professionals prescribe, prepare and, administer the drugs (8,9). McCarthy et al, in their survey
of rural and remote health agencies in Queensland, observed that, out of 62 nurses, 13% (n=8)
reconstituted or mixed the chemotherapy drugs that they were administering (45). To address
this health and safety issue, McCarthy et al stated that Australia would make the Cancer
Nursing Society of Australia guidelines for cytotoxic administration mandatory in every
healthcare facility. The Society guidance document deals with a minimum list of health and
safety guidelines for facilities that handle cytotoxic drugs (30).
Environmental Scan
Five documents reported on quality and safety issues (24,25,28,34,47). The Manual of
Cancer Services from the National Health Service (NHS) (UK) has the most comprehensive and
detailed list of quality and safety guidelines (25). While the NHS does not provide an exact
guideline to follow, it recommends that health facilities have protocols in place to ensure quality
and safety standards are being met. Three documents provide a brief checklist of quality and
safety standards that should be adhered to (24,34,47). The Medical Oncology Group of
Australia Incorporated provides a list of established guidelines for handling cytotoxic drugs that
are to be adhered to in Australia (28).
Environmental Scan - Ontario
Thunder Bay Regional Health Sciences Centre has comprehensive policies and
procedures relating to chemotherapy safety that encompass the safe handling, preparation, and
disposal of cytotoxic agents; the handling of acute exposures; the monitoring of staff dealing
with cytotoxic agents; and safe administration (46). The Memorandum of Agreement between
the London Regional Cancer Centre and Huron Perth Hospitals Partnership and Wingham and
District Hospital and Stratford General Hospital lists a set of safety polices from the London
Regional Cancer Centre that includes guidelines for the handling and disposal of hazardous
drugs (16). The Hôpital Régional de Sudbury Regional Hospital requires that all chemotherapy
be prepared by pharmacy services and that standardized biological safety hoods be used (21).
The affiliation agreement from The Cancer Centre of Southeastern Ontario requires that the
community hospital involved adhere to the Cancer Care Ontario safe drug handling standards
EVIDENTIARY REVIEW – page 17
EBS 12-10
and procedures (32). The Memorandum of Agreement between Hawkesbury General Hospital
and the Ottawa Regional Cancer Centre states that Hawkesbury General Hospital is
responsible for ensuring that all safety standards and procedures are adhered to but does not
describe the standards and procedures (33).
Facility Requirements
Published Literature
The ASCO 2004 report provided information about treatment facility organization (9).
The report outlines the physical requirements that each facility should comply with, including
sufficient waiting room chairs and enough examining rooms for each physician, appropriate
treatment chairs and beds to meet patient needs, privacy when needed for the patient,
adequate nurse or physician access, and the storage and preparation of chemotherapy drugs
according to accepted protocols. This document was a general overview and did not define any
of the terms used. McLinden stated that the following should be present when administering
chemotherapy in a community setting: a clean, comfortable area to administer the
chemotherapy; a Class IIB biological fume hood; IV pumps; and access to a phone, fax, and
computer (15).
Environmental Scan
Five documents addressed facility requirements (24,25,28,34,48). These reports
provided recommendations on the physical space and equipment needed to deliver systemic
treatment. The most comprehensive Canadian document listing facility requirements was The
Levels of Care for Cancer Systemic Therapy in Nova Scotia Hospitals (24). This document lists
exactly what equipment and physical space is needed by a facility for 80-100 administrations
annually, providing details and requirements on treatment, clinic, and waiting area space and
also the minimum medical equipment and devices required at the unit (24). The Community
Oncology Program Centre Annual Site Visit Checklist from the Saskatchewan Cancer Agency
(34) and The Medical Oncology Group of Australia Incorporated (28) provide a detailed list of
facility requirements such as laboratory and pharmacy facilities, equipment and supplies,
physical space requirements such as space to coordinate appointments, and patient
educational materials. The Clinical Oncology Patients’ Liaison Group (UK) has published a
report on what can be done to make a chemotherapy unit more patient friendly. This report lists
many practical suggestions such as having proper signage, having patient education materials
available, and having washrooms nearby, as well as enhancing facilities by hanging pictures
(48). The Manual for Cancer Services (UK) has measures that specify what should be available
in terms of safety equipment and storage at each site administering systemic treatment (25).
Environmental Scan - Ontario
The Memorandum of Agreement between the London Regional Cancer Centre and
Huron Perth Hospitals Partnership and Wingham and District Hospital and Stratford General
Hospital has a small section on facility requirements. Dedicated treatment and
assessment/consultation space should be provided for cancer patients receiving chemotherapy
(16). The Hôpital Régional de Sudbury Regional Hospital and the Ottawa Regional Cancer
Centre provides a detailed description of space and furnishing estimates for community
oncology clinics. They list essential equipment needed for treatment and clinical spaces and
waiting areas, as well as support staff, medical, and other equipment. They also provide a
section on recommended equipment for the clinics (21,33). The Cancer Centre of Southeastern
Ontario provides a comprehensive list of facility requirements, including treatment and clinic
space, support staff, administration, and medical equipment, and other planning considerations
(32).
EVIDENTIARY REVIEW – page 18
EBS 12-10
Administrative and Organizational Responsibilities
Published Literature
The ASCO (2004) special article on the criteria for facilities and personnel for the
administration of parenteral systemic antineoplastic therapy states that there should be
adequate staff to adhere to policies and procedures within the organization and to complete and
distribute medical reports, schedule patients, manage the office, order supplies, and take
inventory of the drugs (9). There should also be sufficient staff to provide patient education and
the staff and equipment to receive emergency medical reports. This consensus document does
not define what is meant by ‘adequate’ or ‘sufficient’.
Environmental Scan
Four reports addressed the need to have clerical and administrative support
(23,24,28,34). These documents mention that adequate support staff should be available to
help with patient scheduling and for health records maintenance. However, these documents do
not define what an “adequate” level of administrative staff would be or how they arrived at this
conclusion.
Environmental Scan - Ontario
The Cancer Centre of Southeastern Ontario states that the data on oncology visits
needed to obtain accurate workload information would be submitted to the appropriate national
agencies (32). The Ottawa Regional Cancer Centre provides a detailed description of
administrative duties that need to be preformed between the regional cancer centre and the
clinic, including dictation, transcript and chart preparation, and data reporting requirements (33).
DISCUSSION AND CONSENSUS
The Regional Models of Care Systemic Treatment Project Team used the modest
evidence that was available from the published literature and environmental scan, and their own
expert opinion, to reach consensus for the standards on the organization and delivery of
systemic treatment in Ontario. The Project Team also conducted a survey of Ontario institutions
providing cancer services in 2006, which was considered in developing the standards.
Cancer Care Ontario Regional (CCOR) networks had been delivering systemic
treatment, particularly in rural areas under a hub-and-spoke model for several years but without
regional governance or management authority (50). More recently, RCPs are being developed
in Ontario, with accountability agreements and/or formalized regional programs between an
RCP and local hospital(s) to ensure and improve equitable access to appropriate evidencebased and co-ordinated cancer services, including systemic treatment, across an identified
region.
To meet the new regional approach to the delivery of health services, a new integrated
regional systemic treatment model is recommended (Figure 1). The goal of this model is to
ensure that, regardless of where in the province a patient receives systemic treatment, the
same standard of care is guaranteed and that the patient receives appropriate care in the
appropriate setting within the appropriate timeframe. A regional program model replaces a hub
and spoke model to better reflect the inter-relationships between all partners delivering systemic
treatment.
In this new model, the Regional Systemic Treatment Program (RSTP) will assume
regional leadership for the delivery of systemic treatment with support from CCO. Although most
Local Health Integration Networks (LHINs) have ICPs, it is important to acknowledge that, to
best meet the needs of patients, cross-LHIN collaboration must also be considered in the
planning of regional systemic treatment programs. In addition, there are also LHINs without
ICPs and, therefore, regional cancer services must be planned through a neighbouring LHIN
ICP. Under the RSTP, systemic treatment ICPs, affiliates and satellites will work collaboratively
EVIDENTIARY REVIEW – page 19
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to ensure safe evidence-based care that maximizes the capacity of care given across the region
while ensuring appropriate high-quality care.
Figure 1. Regional model for quality systemic treatment.
Adapted from: Champlain Regional Cancer Surgery Model, 2006
The model is based on a set of key fundamental elements that include:
i) standards, guidelines, and clinical pathways
ii) performance data linked to quality indicators
iii) access to regional multidisciplinary cancer conferences (MCCs)
iv) regional programs to implement monitor and evaluate quality indicators related to the
delivery of safe, evidenced-based, patient-centred care
Standards, Guidelines and Clinical Pathways. The CCO Program in Evidence-Based
Care (PEBC) has been instrumental in developing clinical practice guidelines and
evidence summaries that provide a synopsis of the evidence available for clinical
practice (51). Guideline recommendations are to assist health care providers and the
public with appropriate decision making. The implementation of provincial guidelines as
the basis for defining standards for regional systemic treatment may be used, in addition
to the application of regionally determined standards, policies, and procedures and
professional standards. In addition, clinical pathways will assist providers and patients in
navigating a complex network of multiple programs and improve the coordination of
regional services. The pathway(s) will outline a realistic coordinated plan or routine
EVIDENTIARY REVIEW – page 20
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intervention that is designed to improve the effectiveness of resource utilization and
achieve a high quality of care and patient outcomes (52).
Quality Indicators. This model reaches beyond traditional organization boundaries.
Therefore, to ensure a high-quality and safe program, it will be important to identity such
a program, as well as linked quality indicators that may be classified as patient
outcomes, including safety, organization outcomes, and overall system outcomes.
Multidisciplinary Cancer Conferences. As in the CCO Multidisciplinary Cancer
Conference (MCC) Standards (53), the primary function of MCCs is to ensure that there
is an option to discuss appropriate diagnostic tests, treatment options, and treatment
recommendations for cancer patients in a multidisciplinary forum. This model assumes
that MCCs will be accessible for health professionals across a region.
In addition to discussion around the model of care, the Working Group focused on
appropriate levels of care. The key initial decisions about the number of levels and the
corresponding complexity of the levels were discussed in relation to the Nova Scotia document
(24), since it was considered the most detailed document with the most relevance to the Ontario
cancer system. The complexity of the administration of the treatment and the adverse effects of
the drugs were crucial in determining the number of levels. Strict criteria that are not open to
interpretation about what each level can and cannot deliver have been determined. The criteria
for each level are based on the current organization of services in Ontario.
The information produced by a survey of Ontario institutions providing ambulatory
systemic treatment in 2006 was also considered in determining the levels. The Working Group
decided that the results of the survey would not be added to the document but would be
included as an appendix, when available. The survey results may be useful to regions and their
respective partners as the standards are implemented and evaluated.
In order to accommodate some unusual circumstances, in particular the remoteness of
some locations, a statement was included to indicate that innovative strategies might be
required to implement the standards.
The types of providers and their roles and the education of providers were chosen as the
elements that should be dealt with first in the document. The Working Group decided these
elements were the most important since they outlined the responsibilities and education of the
providers. There were numerous discussions by the Panel about the role of the family physician
and/or internist. The term General Practitioner Oncologist (GPO) was not used because it would
not acknowledge the diversity of non-oncology physicians currently working in the province.
The types of drugs that could be administered in each level were originally listed under
service types and complexity but were moved to an appendix that will be linked to the CCO
Drug Formulary on the CCO Web site. This will allow access to updated regimens by disease
site. Brief sections on patient education and supportive care were added, since they closely
impact on the care and the systemic treatment that patients are receiving.
The educational requirements and definitions for pharmacy departments were somewhat
challenging for the Working Group as each institution delivering systemic treatment sets its own
internal standards for the pharmacists and pharmacy technicians.
There has been much discussion by the Group on service volumes. Given the lack of
evidence resulting from the scientific literature search and the environmental scan and the
difference in geographical areas in Ontario, the Group had difficulty determining the best
volumes for each level. After numerous discussions, the Group determined that service volumes
should depend on local conditions. A centre should have a sufficient patient volume to maintain
competency and safety. This topic itself may be the focus for further research on quality
indicators.
EVIDENTIARY REVIEW – page 21
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CONCLUSIONS
The standards for systemic treatment delivery in ambulatory centres in Ontario provide a
comprehensive regional and provincial framework. These standards have been formed through
a combination of evidence and expert consensus. Consensus was achieved through a small
Working Group and the larger Regional Models of Care for Systemic Treatment Project Team.
The standards outline the four levels of care that are recommended for the delivery of systemic
treatment. The standards do not prevent a hospital from moving up to the next level as long as
all the requirements are met and this move is agreed to by the RSTP. The role of this document
is to provide a framework for all hospitals to meet the same standards and at the same time
achieve quality care and service when administering systemic treatment in Ontario.
JOURNAL REFERENCE
 Vandenberg T, Coakley N, Nayler J, DeGrasse C, Green E, Mackay JA, et al. A framework
for the organization and delivery of systemic treatment. Curr Oncol. 2009 Jan;16(1):4-15.
For further information about this report, please contact:
Dr. Ted Vandenberg
London Regional Cancer Program
London Health Sciences Centre
790 Commissioners Road
London, ON N6A 4L6
Email: [email protected]
TEL: 519-685-8640
Dr. Maureen Trudeau
Cancer Care Ontario
620 University Avenue
Toronto, ON M5G 2L7
Email:
[email protected]
TEL: 416-480-5145
Funding
The PEBC is supported by the Ontario Ministry of Health and Long-Term Care through Cancer Care
Ontario. All work produced by the PEBC is editorially independent from its funding source.
Copyright
This report is copyrighted by Cancer Care Ontario; the report and the illustrations herein may not be
reproduced without the express written permission of Cancer Care Ontario. Cancer Care Ontario reserves
the right at any time, and at its sole discretion, to change or revoke this authorization.
Disclaimer
Care has been taken in the preparation of the information contained in this report. Nonetheless, any
person seeking to apply or consult the report is expected to use independent medical judgment in the
context of individual clinical circumstances or seek out the supervision of a qualified clinician. Cancer
Care Ontario makes no representation or guarantees of any kind whatsoever regarding their content or
use or application and disclaims any responsibility for their application or use in any way.
Contact Information
For information about the PEBC and the most current version of all reports,
please visit the CCO website at http://www.cancercare.on.ca/
or contact the PEBC office at:
Phone: 905-527-4322 ext. 42822
Fax: 905-526-6775
E-mail: [email protected]
EVIDENTIARY REVIEW – page 22
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EVIDENTIARY REVIEW – page 26
Evidence-Based Series #12-10: Section 3
Regional Models of Care for Systemic Treatment: Standards:
Development and External Review—Methods and Results
T. Vandenberg, M. Trudeau, N. Coakley, J. Nayler, C. DeGrasse,
E. Green, J.A. Mackay, C. McLennan, A. Smith, L. Wilcock,
and the Regional Models of Care Systemic Treatment Project Team
A Special Project of the Systemic Treatment Program, Cancer Care Ontario, and
The Program in Evidence-based Care, Cancer Care Ontario
Report Date: May 22, 2007
THE SYSTEMIC TREATMENT PROGRAM AND THE PROGRAM IN EVIDENCE-BASED
CARE COLLABORATION
The Systemic Treatment Program and the Program in Evidence-based Care (PEBC) are
initiatives of Cancer Care Ontario (CCO). The mandate of the Systemic Treatment Program is to
improve the delivery of systemic treatment in Ontario through initiatives designed to increase
access to care, improve the quality of care, support knowledge transfer and evidence-based
practice and foster research and innovation. The mandate of the PEBC is to improve the lives of
Ontarians affected by cancer, through the development, dissemination, implementation, and
evaluation of evidence-based products designed to facilitate clinical, planning, and policy
decisions about cancer care.
The PEBC is best known for producing high-quality evidence-based practice guideline
reports, using the methods of the Practice Guidelines Development Cycle (1,2). A typical PEBC
report consists of the comprehensive systematic review of the clinical evidence on a specific
cancer-related topic, the interpretation of and consensus agreement on that evidence, the
resulting clinical recommendations, and the results of an external review by Ontario clinicians
for whom the topic is relevant. The PEBC has a formal standardized process to ensure the
timeliness of each clinical practice guideline report, conducting routine periodic reviews and
evaluations of the scientific literature and, where appropriate, integrating that literature with the
original practice guideline report information.
This standards report, developed through collaboration between the Systemic Treatment
Program and the PEBC, employed a similar process, incorporating an environmental scan of
documents from other organizations and jurisdictions within the systematic review process. The
report was developed by a specially convened panel, the Regional Models of Care Systemic
Treatment Project Team, which comprises medical oncologists, a CCO Regional Vice
President, regional cancer program administrators, a systemic treatment satellite nursing
administrator, nurses, administrators, pharmacists, research coordinators, and other
professionals.
DEVELOPMENT AND METHODS – page 1
EBS 12-10
The Evidence-based Series
This evidence-based series is comprised of the following three sections:
 Section 1: Standards
This section contains the standards derived by the Regional Models of Care Systemic
Treatment Project Team through systematic review, an environmental scan, interpretation
of the clinical and scientific literature and expert consensus process, as well as through a
formalized external review by Ontario practitioners and administrators.
 Section 2: Evidentiary Review
This section presents the comprehensive systematic review of the clinical and scientific
research, the environmental scan and team discussion on the topic and the conclusions
drawn by the Regional Models of Care Systemic Treatment Project Team.
 Section 3: Methodology of the Standards Development and External Review Process
This section summarizes the standards development process and the results of the formal
external review by Ontario practitioners and administrators of the draft version of the
systemic treatment standards and systematic review.
DEVELOPMENT OF THE EVIDENCED-BASED SERIES
Developing the Draft Systematic Review and Standards
This evidence-based series was developed by the Regional Models of Care Systemic
Treatment Project Team. The report is a convenient and up-to-date source of the best available
evidence developed through systematic review, expert consensus, evidence synthesis, and
input from practitioners and administrators in Ontario. Section 2 contains the systematic review
of the evidence related to the organization of ambulatory systemic treatment delivery. The draft
standards derived from the interpretation of that evidence and the expertise of the members of
the Project Team are detailed in Section 1. Sections 1 and 2, along with Section 3, have been
circulated to Ontario practitioners and administrators for their feedback. Section 3 now presents
the feedback process results and any resulting changes made to the draft document.
REPORT APPROVAL PANEL REVIEW
A draft of the evidence-based series was circulated to the two members of the Report
Approval Panel (RAP) and the Scientific Manager of the PEBC in December 2006. Feedback
was provided by the Panel and the Scientific Manager and is summarized below. The feedback
was reviewed by the Regional Models of Care Group, and modifications were made to the
series in response (see modifications below).
Summary of Written Comments with Modifications/Actions Taken by the Regional Models
of Care Group
 The introduction section on regional models of care in section one was unintuitive and
difficult to follow.
o The section was revised and reorganized to improve clarity.
 The nuances between the descriptions of the levels were difficult to understand.
o To improve clarity, the levels of care in section 1 were further defined.
 It was suggested to add the levels to figure 1.
o Levels were added to the figure 1.
 At a more specific level, the document appropriately emphasizes a need for institutions to
deal with acute reactions to the administration of chemotherapy. This parameter is used to
differentiate different institutional Levels. The steering committee may have given undue
weighting to this parameter. Dealing with acute reactions (e.g., hypersensitivity, infusional
reactions) requires more “general medical” expertise, with focused clinical knowledge about
the agent in question. It is a skill that is very transferable to institutions that do not have
DEVELOPMENT AND REVIEW – page 2
EBS 12-10



medical or hematologic oncologists. Of far greater importance is the process to define and
systematically implement best practices
o The levels were reorganized, with the lowest level 5 removed. The only differentiating
factor between level 4 and 5 was the ability to deal with acute reactions.
“Research” is listed only for Level 1. As clinical trials form a major part of the research
agenda, the committee should rephrase as this type of research is conducted across many
Level 2 and all Level 1-2 institutions. The committee later acknowledges the broader range
of setting for clinical trials, but underestimates the potential for selected IND trials in Level
4 institutions.
o The ability to do clinical trials has been moved to level 4. It will depend on the
investigators and staff in each institution if they wish to participate in clinical trials.
It is not clear why Advanced Practice Nurses would not develop important roles within Level
3.
o The document was changed to reflect that Advanced Practice Nurses can work in any
level, but they are required in levels 1 and 2.
How will the formulary be kept up to date?
o The appendix will be updated by the CCO formulary and eventually will be replaced with
a hyperlink.
REVIEW BY REGIONAL MODELS OF CARE PROJECT TEAM
The Project Team met to review the report prior to the external review in March 2007,
and had many of the same comments as did RAP. They have previously been addressed and
will only be listed here.






The introduction to the regional models of care should be rewritten to effectively capture
the goals and direction of the systemic treatment program.
It was recommended that Level 5 should be merged with Level 4 as they are basically
the same except for the ability to give the first dose and respond to acute reactions.
Since we received two comments on this, we took action, as previously discussed, and
merged the two Levels.
Research and academic teaching should also be a part of Levels 2 and 3 to some
extent, but it should be acknowledged that research and academic teaching has a
greater role in level 1 facilities.
The regional models of care diagram (Figure 1) should be revised to show the
relationship to the RCP as well.
Clinical trials should be done at lower levels as well.
Questions arose how the appendices relating the drug formulary in section one would be
updated.
In May 2007, following the external review, the Project Team discussed and approved
the revised report. The Team discussed the external review results and their responses to the
external review feedback are detailed below. In addition, the Team agreed that an explicit
statement should be added to the report to clarify that the standards do not apply to home or
inpatient infusions. The need for Computerized Physician Order Entry (CPOE) was discussed
extensively by the Team. It was acknowledged that the cost of implementing CPOE may be
prohibitive for smaller centres, particularly in the short-term; however, the potential advantages
with regard to patient safety were considered primary. It was noted that in some regions, smaller
centres are able to access centralized CPOE systems remotely, although they cannot enter new
orders. It was agreed that obtaining CPOE should be a priority during the standards
DEVELOPMENT AND REVIEW – page 3
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implementation phase and required at all levels of care; therefore, the Standards for Facility
Requirements were revised accordingly.
The implementation and funding support for the standards were also a focus of
discussion. It was considered important to allow some flexibility around the implementation
process and to provide a forum for institutions and regions to share feedback on implementation
issues and experiences. Similarly, provision of appropriate resources was considered central to
the achievement of the standards province-wide. Separate CCO panels have responsibility for
driving the implementation and funding processes.
EXTERNAL REVIEW
Feedback was obtained through a mailed survey of 191 practitioners and administrators
in Ontario (primarily medical oncologists, nurses, pharmacists, general practitioners of oncology,
hospital CEOs and administrators and Local Health Integration Network CEO’s). The survey
consisted of items evaluating the methods, results, and interpretive summary used to inform the
draft standards and whether the draft standards should be approved as a provincial guidance
document. Clinicians and administrators received separate surveys. Clinicians received a longer
survey with some questions pertaining to the applicability of the standards in their clinical
practice. Both versions of the survey provided opportunity for written comments.
The external review was mailed out during the week of March 5, 2007. Follow-up
reminders were sent at two weeks (post card) and four weeks (complete package mailed again).
The Systemic Treatment working group reviewed the results of the survey.
Sixty-six responses were received out of the 191 surveys sent (34% response rate). Of
the 66 respondents, 56 completed the questionnaires (29%), and 35 provided written
comments. Three respondents who did not complete the survey provided written comments
only. A total of 38 written comments were received.
Table 1. Participant responses (N=44) to clinician external feedback survey questions (n
= 19).
1.
2.
Are you responsible in some way for the care of
patients diagnosed with cancer? This may include
direct clinical care or the organization/management of
services to provide care to these patients.
6.
There is a need for a standards document on this
topic.
The evidence (literature search and environmental
scan) is relevant and complete (e.g., no key
information sources or studies missed nor any
included that should not have been).
I agree with the methodology used to summarize the
evidence.
The draft standards are in agreement with my
understanding of the evidence.
The draft standards in this report are clear.
7.
I agree with the draft standards as stated.
3.
4.
5.
8.
The draft standards are suitable for the Ontario
context.
9. The draft standards are too rigid to apply in the
Ontario context.
10. When applied, the draft standards will produce more
benefits for patients than harms.
Yes
Unsure
No
44
0
3
Strongly Agree/
Agree
Neither Agree
nor
Disagree
Strongly
Disagree or
Disagree
41
0
3
34
8
1
40
3
1
35
8
1
40
39
1
0
3
5
38
3
3
10
9
25
36
5
3
DEVELOPMENT AND REVIEW – page 4
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11. The draft standards report presents a series of
options that can be implemented.
12. To apply the draft standards will require
reorganization of services/care in my practice setting.
13. The standards will be associated with more
appropriate utilization of health care resources.
14. The draft standards in this report are achievable.
15. The draft report presents standards that are likely to
be supported by a majority of my colleagues.
16. The draft standards reflect a more desirable system
for improving the quality of patient care than current
practice.
17. I would feel comfortable if patients received the care
recommended in these draft standards.
18. These draft standards should be formally approved.
31
7
5
19
12
13
25
15
4
33
8
3
37
5
2
35
6
3
39
3
2
36
4
3
Unsure
Not at
All/Not Likely
5
6
Likely/Very
Likely
19. If these draft standards were to be approved and
endorsed, how likely would you be to apply the
recommendations to the clinical care or
33
organizational and/or administrative decisions for
which you are professionally responsible?
* Where percentages total <100%–practitioner response(s) missing.
Table 2. Participant responses (N=12) to administrator external feedback survey
questions (n = 7).
1. Are you responsible in some way for the care of patients
diagnosed with cancer? This may include direct clinical care
or the organization/management of services to provide care to
these patients.
2. There is a need for standards on this issue.
3. The standards are clear.
4. The standards will be challenging to implement in my
institution or region.
5. The standards will be supported by stakeholders in my
institution or region
6. The draft standards reflect an effective approach that will lead
to quality improvements in patient care
7. The standards reflect an effective approach that will lead to
quality improvements in the cancer system.
Yes
Unsure
No
12
0
5
Strongly
Agree/
Agree
Neither Agree
nor
Disagree
Strongly
Disagree or
Disagree
12
11
0
1
0
0
4
4
4
10
2
0
11
1
0
10
2
0
* Where percentages total <100%–practitioner response(s) missing.
Clinical Respondents
The items that 80% or more clinical respondents agreed to were the rationale and need
for systemic treatment standards in Ontario, the methodology used, the clarity of the standards
report, agreement with the standards as stated, the suitability and acceptability for the standards
in Ontario, a more effective approach for improving patient outcomes, the support of a majority
DEVELOPMENT AND REVIEW – page 5
EBS 12-10
of colleagues accepting the standards and their comfort if patients received care recommended
in these standards.
The items that 70% of the respondents agreed to were that the literature search and
environmental scan were complete, the standards were in agreement with their understanding
of the evidence, the standards represent a series of options that can be implemented and are
achievable and that standards reflect a more desirable system for improving patient care.
Half of the respondents agreed that the standards would not be too rigid to apply, but
would also require service re-organization when applied, and that the standards would reflect a
more effective use of resources.
In terms of formal approval as a CCO standards document, 81% of respondents agreed
that the document should be formally approved, 9% were unsure, and 6% disagreed with formal
approval. Approximately 75% of respondents agreed with the statements that they or their
centre would be likely to apply the standards if formally approved. The remaining respondents
were either unsure (11%) or disagreed with the statements (13% respectively).
Administrator Respondents
The items that 80% or more of administrators agreed with were the rationale and need
for systemic treatment standards in Ontario, the clarity of the standards report, that the
standards would be supported by stakeholders in their region, and that these standards will lead
to quality improvements in patient care and in the cancer system. One third of the respondents
stated that the standards would not be too challenging to apply in their health care setting.
Several of the respondents provided written comments. The major themes emerging
from the comments provided by the respondents included:









Support for the document or the process of standardizing systemic treatment in Ontario.
Questions arising about the implementation of this standard, including funding and
human resource issues.
o Issues surrounding implementation will be addressed by Cancer Care Ontario.
Comments about the low-quality evidence for this review.
o The group made it clear in the document that the evidence was modest and the
standards were based on expert opinion.
Comment about smaller centres not wanting to take on complex cases.
o The can be addressed through negotiation with the RSTP.
College of Nursing literature not cited in the document.
o The literature is cited in section one of the document.
Comment about clarification that the central venous access devices would be inserted
outside the affiliate institution.
o The site is responsible for coordination and the insertion can be done at an off site
institution.
Duplication of some syntax in recommendations.
o Corrected.
Request for additional clarity around academic and research responsibilities around
roles and responsibilities pertaining to clinical trials and leadership of MCCs.
o The group felt it was not its job to be prescriptive, and this was adequately covered in
the document.
Concern for smaller centers having the ability to meet the requirements in the standards
without adequate support or resources.
o This will be addressed in the implementation and funding documentation by Cancer
Care Ontario.
DEVELOPMENT AND REVIEW – page 6
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


The guidelines will limit the ability to provide one stop shopping and increase
fragmentation of care.
o This will be also addressed in the implementation and funding documentation by
Cancer Care Ontario.
Concern for the level assigned to each centre; some may feel downgraded.
o There are four levels of care, determined by resources. The group felt that this issue
was outside the scope of this report.
Comments about a few specific drugs in the formulary.
o Revised.
These points were brought back to the working group for discussion, and modifications
were made as necessary. Lengthy discussions from the working group arose about the
comments, but the group did not feel the need to change the document except to provide
greater clarity and corrections to the formulary. The scope of this document was not to be
specific or prescriptive.
This standards document will provide an important source of information for regional and
provincial planning of systemic treatment services. While an implementation plan is beyond the
scope of the current document, the use of guidelines and standards is fundamental to the
success of Cancer Care Ontario's quality improvement initiatives. An implementation strategy
surrounding these standards will be provided by Cancer Care Ontario. This will include, but will
not be limited to, knowledge transfer, assessment, planning, evaluating outcomes, funding, and
adherence to the standards and support during the transition phase.
Conclusion
This report reflects the integration of feedback obtained through the external review
process with, final approval given by the Systemic Treatment Group and the Report Approval
Panel of the PEBC. Updates of the report will be conducted as new evidence informing the
question of interest emerges.
DEVELOPMENT AND REVIEW – page 7
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For further information about this report, please contact:
Dr. Ted Vandenberg
London Regional Cancer Program
London Health Sciences Centre
790 Commissioners Road
London, ON N6A 4L6
Email: [email protected]
TEL: 519-685-8640
Dr. Maureen Trudeau
Cancer Care Ontario
620 University Avenue
Toronto, ON M5G 2L7
Email:
[email protected]
TEL: 416-480-5145
Funding
The PEBC is supported by the Ontario Ministry of Health and Long-Term Care through Cancer Care
Ontario. All work produced by the PEBC is editorially independent from its funding source.
Copyright
This report is copyrighted by Cancer Care Ontario; the report and the illustrations herein may not be
reproduced without the express written permission of Cancer Care Ontario. Cancer Care Ontario reserves
the right at any time, and at its sole discretion, to change or revoke this authorization.
Disclaimer
Care has been taken in the preparation of the information contained in this report. Nonetheless, any
person seeking to apply or consult the report is expected to use independent medical judgment in the
context of individual clinical circumstances or seek out the supervision of a qualified clinician. Cancer
Care Ontario makes no representation or guarantees of any kind whatsoever regarding their content or
use or application and disclaims any responsibility for their application or use in any way.
Contact Information
For information about the PEBC and the most current version of all reports,
please visit the CCO website at http://www.cancercare.on.ca/
or contact the PEBC office at:
Phone: 905-527-4322 ext. 42822
Fax: 905-526-6775
E-mail: [email protected]
DEVELOPMENT AND REVIEW – page 8
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REFERENCES
1. Browman GP, Levine MN, Mohide EA, Hayward RSA, Pritchard KI, Gafni A, et al. The
practice guidelines development cycle: a conceptual tool for practice guidelines
development and implementation. J Clin Oncol. 1995;13:502-12.
2. Browman GP, Newman TE, Mohide EA, Graham ID, Levine MN, Pritchard KI, et al.
Progress of clinical oncology guidelines development using the practice guidelines
development cycle: the role of practitioner feedback. J Clin Oncol. 1998;16(3):1226-31.
DEVELOPMENT AND REVIEW – page 9
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Appendix 1. Regional Models of Care Systemic Treatment Project Team members.
The following Project Team members were part of the Working Group *
Dr. Maureen Trudeau (chair) *
Dr. Ted Vandenberg *
Cancer Care Ontario
London Regional Cancer Program
620 University Avenue
London Health Sciences Centre
Toronto, ON M5G 2L7
790 Commissioners Road
London, ON N6A 4L6
Nadia Coakley *
Research Coordinator
Program in Evidence-based Care
McMaster University
1280 Main Street West, Hamilton, Ontario L8S 4L8
Jeff Nayler (Program Manager) *
Cancer Care Ontario
620 University Avenue
Toronto, Ontario M5G 2L7
Cathy DeGrasse *
Senior Advisor, Regional Cancer Operations
The Ottawa Hospital Regional Cancer Centre
501 Smyth Road Box 941
Ottawa, Ontario K1H 8L6
Esther Green*
Provincial Head, Nursing & Psychosocial Oncology
Cancer Care Ontario
620 University Avenue
Toronto, Ontario M5G 2L7
Jean Mackay *
Research Coordinator
Program in Evidence-based Care
McMaster University
1280 Main Street West, Hamilton, Ontario L8S 4L8
Cindy McLennan *
Nurse Manager Oncology
Renfrew Victoria Hospital
499 Raglan Street North
Renfrew, Ontario
K7V 1P6
Dr. Anne Smith *
Regional Vice-President
Cancer Services for Kingston General Hospital
Cancer Centre of Southeastern Ontario
25 King Street West
Kingston ON K7L 5P9
Laura Wilcock *
Oncology Pharmacist
Lakeridge Health - Durham Regional Cancer Centre
1 Hospital Court,
Oshawa, ON
L1G 2B9
Helen Angus
VP, Planning & Strategic Implementation
Cancer Care Ontario
620 University Avenue
Toronto, Ontario M5G 2L7
Dr. Colin Germond
Medical Oncologist
Leader, Systemic Treatment Program
Regional Cancer Program
Sudbury Regional Hospital
41 Ramsey Lake Road
Sudbury, Ontario P3E 5J1
Tracey Keighley-Clarke
Director, Cancer Care Program
Royal Victoria Hospital
201 Georgian Drive
Barrie, Ontario L4M-6M2
Dr. Jacinta Meharchand
Toronto East General Hospital
825 Coxwell Avenue
Toronto, Ontario M4C 3E7
Debbie Milliken
Director, New Drug Funding Program
Cancer Care Ontario
620 University Avenue
Toronto, Ontario M5G 2L7
Kamini Milnes
Director, Informatics
Cancer Care Ontario
620 University Avenue
Toronto, Ontario M5G 2L7
DEVELOPMENT AND REVIEW – page 10
EBS 12-10
Susan Pilatzke
Director, Oncology Clinical Systems
Regional Cancer Care Program
Thunder Bay Regional Health Sciences Centre
980 Oliver Road
Thunder Bay, ON P7B 6V4
Vincent Pileggi
RS McLaughlin Durham Regional Cancer Centre
1 Hospital Court
Oshawa, Ontario L1G 2B9
Colin Preyra
172 Palmerston Avenue
Toronto Ontario M6J 2J4
Sue Robertson
Corporate Director, Regional Cancer Planning
Grand River Hospital
835 King Street West,
Kitchener, Ontario N2G 1G3
Jillian Ross
Director, Clinical Programs
Cancer Care Ontario
620 University Avenue
Toronto, Ontario M5G 2L7
Dr. Michael Sherar
Vice President, Regional Programs
Cancer Care Ontario
620 University Avenue, 16th Floor
Toronto, ON
M5G 2L7
DEVELOPMENT AND REVIEW – page 11