| Literature DB >> 19229367 |
T Vandenberg1, N Coakley, J Nayler, C Degrasse, E Green, J A Mackay, C McLennan, A Smith, L Wilcock, M E Trudeau.
Abstract
BACKGROUND: Increasing systemic treatment and shortages of oncology professionals in Canada require innovative approaches to the safe and effective delivery of intravenous (IV) cancer treatment. We conducted a systematic review of the clinical and scientific literature, and an environmental scan of models in Canada, the United Kingdom, Australia, and New Zealand. We then developed a framework for the organization and delivery of IV systemic treatment.Entities:
Keywords: Chemotherapy; health care facilities; health care policy; organizational policy; systemic treatment
Year: 2009 PMID: 19229367 PMCID: PMC2644625 DOI: 10.3747/co.v16i1.297
Source DB: PubMed Journal: Curr Oncol ISSN: 1198-0052 Impact factor: 3.677
FIGURE 1Regional model for quality systemic treatment. (Adapted from the Champlain Regional Cancer Surgery Model, 200614)
Type of systemic treatment care
| Complexity | Level 1 (ICP) | Level 2 (ICP) | Level 3 (Affiliate) | Level 4 (Satellite) |
|---|---|---|---|---|
| Experimental investigational new drug program | Yes | No | No | No |
| Concurrent head-and-neck chemorads, or radiolabelled conjugates, or both | Yes | Yes | No | No |
| Oncologist on site determines treatment plan | Yes | Yes | Yes | No |
| All other systemic treatment | Yes | Yes | Yes | Yes |
icp = integrated cancer program; chemorads = chemotherapy plus radiation therapy.
Administrative and organizational responsibilities
| All levels of care | Should measure common provincial indicators. | ||
| May also measure regional indicators as defined by the regional cancer program. | |||
| Data reporting requirements | Level 4 | (Satellite) | Outcome indicators that are specific; measurable; attainable, achievable, action-oriented; relevant; time-framed (SMART |
| Decision-support resources to collate and analyze quality indicators. | |||
| Level 3 | (Affiliate) | Same as level 4. | |
| Level 2 | ( | Same as level 3, plus: | |
| Compliant with Cancer Care Ontario data book. | |||
| Level 1 | ( | Same as level 2. | |
| Leadership | Level 4 | (Satellite) | 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. | |||
| Level 3 | (Affiliate) | Level 4, plus: | |
| May have formalized linkages with a satellite. | |||
| Level 2 | ( | Level 3, plus: | |
| Regional vice president and regional systemic treatment leads. | |||
| Level 1 | ( | Same as level 2. | |
| Logistics support | Level 4 | (Satellite) | Clerical staff and clinic facilities to support patient scheduling, health records management, and clinic management including clinic and administrative supplies for systemic treatment suites and ambulatory clinic visits. |
| Level 3 | (Affiliate) | Same as level 4. | |
| Level 2 | ( | Same as level 3. | |
| Level 1 | ( | Same as level 2. | |
| Information systems | Level 4 | (Satellite) | Information system hardware and support to maintain a secure electronic systemic treatment order entry program and other electronic systems as indicated (for example, electronic patient record). |
| Level 3 | (Affiliate) | Same as level 4. | |
| Level 2 | ( | Same as level 3. | |
| Level 1 | ( | Same as level 2. | |
icp = integrated cancer program.
Health care providers and their roles
| All levels | 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 by and parenteral systemic treatment is 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. | |||
| Oncologists | Level 4 | (Satellite) | Access to oncologist from a level 1, 2, or 3 hospital is required to determine and recommend the treatment plan, to manage disease status, and to discuss patient management issues with the health care team. |
| Level 3 | (Affiliate) | One or more oncologists are on staff and on site. | |
| Mentor family physicians/internists. | |||
| Provide limited teaching and research. | |||
| Level 2 | ( | Level 3, plus: | |
| Developed specific subspecialized practices. | |||
| Level 1 | ( | Level 2, plus: | |
| Have academic responsibilities, including teaching and research. | |||
| Family physicians/internists | Level 4 | (Satellite) | Supervise intravenous systemic treatment administration with one physician on site or readily available (within 15 minutes) during the drug administration time. |
| Consult oncologists regarding patient management issues (for example, dose alteration). | |||
| Assess and manage toxicity. | |||
| Participate in education programs related to the management of patients receiving systemic treatment. | |||
| Level 3 | (Affiliate) | Same as level 4. | |
| Level 2 | ( | Same as level 3. | |
| Level 1 | ( | Same as level 2. | |
| Nurses | Level 4 | (Satellite) | Administer systemic treatment, including monitoring and intervening for side effects and reactions, and provide supportive care to the patient. |
| Provide patient education related to planned systemic treatment in collaboration with pharmacist and physicians. | |||
| Communicate with | |||
| Manage symptoms. | |||
| Level 3 | (Affiliate) | Level 4 plus: | |
| Plans to implement advanced oncology nurse. | |||
| Level 2 | ( | Level 3 plus: | |
| Specialized oncology nurses working towards the national certification—Certified in Oncology Nursing (Canada)—within 5 years of employment. | |||
| Advanced oncology nurse to manage selected patient populations independently or interdependently with oncologists. | |||
| Level 1 | ( | Same as level 2. | |
| Pharmacists | Level 4 | (Satellite) | Review and verify systemic treatment orders and supervise the preparation and dispensing of systemic treatment. |
| Consult with | |||
| Manage the reimbursement process for new drug funding program (pharmacist or pharmacy technician). | |||
| Provide patient education related to medications in collaboration with nurses and physicians. | |||
| Supervise and manage dispensing and documentation of clinical trials. | |||
| Level 3 | (Affiliate) | Same as level 4 | |
| Level 2 | ( | Level 3, plus: | |
| Provide support and consultation to regional systemic treatment program. | |||
| Provide clinical services (dedicated oncology pharmacists). | |||
| Level 1 | ( | Same as level 2. | |
| Pharmacy technicians | Level 4 | (Satellite) | Prepare systemic treatment under supervision of a pharmacist. |
| Level 3 | (Affiliate) | Same as level 4. | |
| Level 2 | ( | Same as level 3. | |
| Level 1 | ( | Same as level 2. | |
icp = integrated cancer program.
Education of health care providers
| All levels of care | Minimum standards are met for orientation and for annual continuing education and 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. | |||
| Oncologists | Level 4 | (Satellite) | — |
| Level 3 | (Affiliate) | Take ongoing continuing medical education per the Royal College of Physicians and Surgeons of Canada. | |
| Participate in multidisciplinary cancer conferences as required. | |||
| Level 2 | ( | Same as level 3. | |
| Level 1 | ( | Same as level 2. | |
| Family physicians/internists | Level 4 | (Satellite) | Take initial orientation and annual continuing medical education. |
| Mentoring by an oncologist should be available. | |||
| Relevant training for systemic treatment being delivered. | |||
| Know the systemic treatment guidelines and standards, and regional policies and procedures. | |||
| Participate in multidisciplinary cancer conferences as required. | |||
| Level 3 | (Affiliate) | Same as level 4. | |
| Level 2 | ( | Same as level 3. | |
| Level 1 | ( | Same as level 2 | |
| Nurses | Level 4 | (Satellite) | Registered nurse certified for the delivery of systemic treatment. |
| Working towards Certified in Oncology Nursing (Canada) or recertification, or both. | |||
| Educated in central venous access device management and selection, certification. Annual update required. | |||
| Oriented to and practicing according to the | |||
safe handling of cytotoxic agents standards, and | |||
central venous access devices guidelines. | |||
| Participation in multidisciplinary cancer conferences encouraged. | |||
| Additional ongoing education required to match treatment type and complexity. | |||
| Level 3 | (Affiliate) | Level 4, plus: | |
| Registered nurse specialized in oncology, certified in systemic treatment administration, and annually updated in guidelines and procedures. | |||
| Plans to implement advanced oncology nursing roles. | |||
| Level 2 | ( | Level 3, plus: | |
| Specialized oncology nurses working towards Certified in Oncology Nursing (Canada); certification should be obtained within 5 years of new employment. | |||
| Advanced oncology nurse (clinical nurse specialist or acute care nurse practitioner, Master’s preparation) with additional knowledge and skills in managing patients on systemic treatment. | |||
| Additional education for nurses managing transplant patients. | |||
| Level 1 | ( | Same as level 2. | |
| Pharmacists | Level 4 | (Satellite) | Specialized training in oncology. |
| Regional systemic treatment program should provide a training or certification program for staff involved in the handling of cytotoxic agents and should have a policy on retraining. Programs may be held at or in collaboration with an | |||
| Training may include institutional training or orientation program for oncology pharmacists, continuing education programs or courses, oncology pharmacy review courses (for example, American Society of Health-System Pharmacists oncology review course), preceptorship programs. | |||
| Level 3 | (Affiliate) | Same as level 4. | |
| Level 2 | ( | Same as level 3. | |
| Level 1 | ( | Same as level 2. | |
| Pharmacy technicians | Level 4 | (Satellite) | Specialized training in the preparation of systemic treatment doses. |
| Regional systemic treatment program should provide a training or certification program for staff involved in the handling of cytotoxic agents and have a policy on retraining. Programs may held at or in collaboration with an | |||
| be | |||
| Level 3 | (Affiliate) | Same as level 4. | |
| Level 2 | ( | Same as level 3. | |
| Level 1 | ( | Same as level 2. | |
icp = integrated cancer program.
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 for transfer for service delivery. | |||
| Service type | See the disease-site-specific Cancer Care Ontario core and core restricted regimens as an example: | ||
| Clinical trial drugs will be given at level 1, 2, or 3, or at level 4 under the supervision of oncologist. | |||
| Levels 4 and 3 | (Satellite, Affiliate) | Per the example of Cancer Care Ontario core and core restricted regimens. | |
| Level 2 | ( | Per the example of core and core restricted regimens, plus: | |
| Concurrent chemotherapy and radiation. | |||
| Radiopharmaceuticals. | |||
| Level 1 | ( | Same as level 2. | |
| Complexity | Level 4 | (Satellite) | Low to high complexity. |
| Assessment for and management and coordination of central venous access devices (such as a peripherally inserted central catheter or Port-A-Cath). | |||
| Drugs with a high risk of hypersensitivity reaction at first dose will be given only at level 4 centres as agreed upon by the regional systemic treatment program. | |||
| Delivery of systemic treatment in presence of comorbidity or significant organ dysfunction that increases risk of toxicity and need for dose adjustments, if agreed upon by regional systemic treatment program. | |||
| Monitoring and management of hypersensitivity reactions. | |||
| Level 3 | (Affiliate) | Same as level 4, plus: | |
| Delivery of first-dose high-risk drugs. | |||
| High complexity. | |||
| Level 2 | ( | Level 3, plus: | |
| Provision of on-site direct coordination and supervision of medical and radiation treatment. | |||
| Pathology consultation on site. | |||
| Level 1 | ( | Same as level 2 | |
| Patient education | Level 4 | (Satellite) | If possible, on-site patient education program that meets the Cancer Care Ontario standards. |
| Level 3 | (Affiliate) | Same as level 4, plus: | |
| Adhere to Cancer Care Ontario patient education standards. | |||
| Level 2 | ( | Level 3, plus: | |
| Patient education program related to radiation treatment. | |||
| Level 1 | ( | Level 2, plus: | |
| Patient education related to investigational treatments | |||
| Supportive care | Level 4 | (Satellite) | Access to supportive care services to address specific patient needs. |
| Level 3 | (Affiliate) | Same as level 4. | |
| Level 2 | ( | Comprehensive supportive care expertise as part of | |
| Level 1 | ( | Same as level 2. | |
| Clinical trials | Level 4 | ( | If clinical trials are conducted at the institution, they must be under the direction of an oncologist. |
| Family physicians or internists with oncology training may be co-investigators. | |||
| Specific clinical trial education for patients and health care providers. | |||
| Level 3 | (Affiliate) | Specific clinical trial education for patients and health care providers. | |
| Clinical trials including phases | |||
| Level 2 | ( | Same as level 3 | |
| Level 1 | ( | Same as level 2, plus: | |
| Investigational new drug program with phase | |||
icp = integrated cancer program.
Service volumes
| All levels of care | The location has sufficient patient volume to maintain competency and skills of professional providers to address the acuity and complexity of the treatment modalities and to provide cost-effective use of resources and drugs. |
| The number of patients that can be treated will be affected by the complexity of the treatment regimens. | |
| Staffing must be sufficient to provide safe, quality care at all times, including during vacation, illness, and so on. |
Quality assurance and safety
| All levels of care | Cancer care includes management of complications of therapy. | ||
| All centres will follow the 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 ( | |||
| Provision of systemic treatment in the most effective manner. | |||
| Safe handling | Level 4 | (Satellite) | Policies and education programs available for all staff involved in systemic treatment, including storage, transport, spill management, preparation, administration, and waste disposal. |
| Level 3 | (Affiliate) | Same as level 4. | |
| Level 2 | ( | Same as level 3. | |
| Level 1 | ( | Same as level 2. | |
| Patient outcomes | Level 4 | (Satellite) | Patient safety program includes review of all medication adverse events and system improvement. |
| Quality indicators: | |||
Assessment of toxicities and documentation of adverse reaction. | |||
| Level 3 | (Affiliate) | Same as level 4. | |
| Level 2 | ( | Same as level 3. | |
| Level 1 | ( | Same as level 2. | |
| Organization outcomes | Level 4 | (Satellite) | Multidisciplinary cancer conference participation encouraged. |
| Quality indicators: | |||
Track volume of patients treated. | |||
Other indicators such as monitoring adherence to guidelines. | |||
| Level 3 | (Affiliate) | Level 4, plus: | |
| Multidisciplinary cancer conference participation required. | |||
| Level 2 | ( | Same as level 3. | |
| Level 1 | ( | Same as level 2. | |
| System outcomes | Level 4 | (Satellite) | Quality indicators: |
Percentage of patients treated close to home. | |||
| Level 3 | (Affiliate) | Level 4, plus: | |
| Monitoring systemic treatment wait times. | |||
| Level 2 | ( | Same as level 3. | |
| Level 1 | ( | Same as level 2. | |
icp = integrated cancer program.
Facility requirements
| All levels of care | The necessary infrastructure is in place to provide the service level. | ||
| Clinic space | Level 4 | (Satellite) | Dedicated systemic treatment area adequate for volume of treatment visits. |
| Adequate space to provide clinical trials if applicable. | |||
| Level 3 | (Affiliate) | Same as level 4. | |
| Level 2 | ( | Same as level 3. | |
| Level 1 | ( | Level 2, plus: | |
| Dedicated clinical trials infrastructure on site. | |||
| Clinic equipment | Level 4 | (Satellite) | Computer, facsimile, and telephone accessibility. |
| Computer software available to provide computerized physician order entry. | |||
| Level 3 | (Affiliate) | Same as level 4 | |
| Level 2 | ( | Same as level 3. | |
| Level 1 | ( | Same as level 2. | |
| Systemic treatment and facility safety equipment | Level 4 | (Satellite) | Oxygen. |
| Biological safety cabinet (class 2) and externally vented. | |||
| Appropriate tubing, Luer-lock syringes. | |||
| Intravenous equipment for parenteral therapy. | |||
| Intravenous 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 (for example, 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. | |||
| Level 3 | (Affiliate) | Same as level 4. | |
| Level 2 | ( | Same as level 3. | |
| Level 1 | ( | Same as level 2. | |
| Institutional facilities | Level 4 | (Satellite) | Emergency department. |
| Pharmacy for secure storage and preparation of systemic treatment drugs. | |||
| Access to inpatient beds for oncology patients. | |||
| Access to local specialized diagnostic imaging (computed tomography, ultrasound, nuclear medicine), laboratory tests, and pathology for the monitoring of systemic treatment. | |||
| Access to intensive care unit. | |||
| Access to facility for insertion of central venous catheters or Port-A-Cath access devices. | |||
| Potential for videoconferencing, remote Web-based teaching, and patient management as part of multidisciplinary cancer conference. | |||
| Level 3 | (Affiliate) | Same as level 4, plus: | |
| Intensive care unit and specialized diagnostic imaging on site. | |||
| Level 2 | ( | Level 3, plus: | |
| Radiation therapy services on site. | |||
| Pathology services on site. | |||
| Magnetic resonance imaging on site. | |||
| Specialized diagnostic imaging on site. | |||
| Level 1 | ( | Same as level 2. | |
icp = integrated cancer program.