Manual para la evaluación de estándares de calidad y seguridad en la atención en unidades de oncología y hematología pediátrica

Objectives

Provide a national framework for comprehensive, safe and high-quality paediatric cancer care, combining external quality assessment with a stratified network of Paediatric Haematology and/or Oncology Units (UHOP) that delivers diagnosis, treatment, referral, shared care, follow-up and palliative support according to service complexity.[1][2][3][4]The framework seeks to improve patient safety, quality of care, resource use, infrastructure, professional capability and standardisation of diagnostic techniques.[2]

• Strengthen a federal shared-care network for children and adolescents with cancer, with clear referral and counter-referral pathways and four service categories: Diagnostic, Referral and Follow-up Units; Standard UHOP; High-Complexity UHOP; and Maximum-Complexity UHOP.[3][4]
• Assess each centre’s capacity across human resources, infrastructure and equipment, imaging and radiotherapy, and comprehensive tumour-specific care, including for haematological malignancies, central nervous system tumours, retinoblastoma, bone and liver tumours, and other solid tumours.[3][4]
• Ensure that maximum-complexity units can manage very high-risk, metastatic, rare and otherwise highly complex cancers, supported by expert paediatric oncology staff, transplantation capacity, teaching and research functions, and a type 1 paediatric intensive care unit.[5]
• Promote rights-based, patient-centred care through reliable identification, safe transfers, management of high-risk medicines, pain and symptom relief throughout illness, end-of-life care, support for spiritual or religious needs, bereavement support, and respect for decisions concerning treatment refusal, resuscitation and life-sustaining treatment.[6][7][8]
• Strengthen safe diagnostic imaging and radiotherapy by ensuring timely reporting, specialised expertise, coordinated access to complex radiotherapy, radiation protection, optimised protocols and suitable protective devices for patients and workers.[8][9]
• Establish hospital-wide quality and patient-safety systems addressing medication safety, risk management, clinical-practice guidance, infection prevention and control, cleaning, disinfection, sterilisation, isolation and safe management of medical and surgical supplies.[10][11][12][13]

Implementation

Implement the framework through collaborative external assessment, structured self-assessment and network stratification, supported by multidisciplinary care teams, formal procedures, staff training, patient-pathway tracing, records review and continuous quality improvement.[2][9][4]External assessment is adapted from national and international quality and safety standards and is designed as a peer-based, patient-centred process.[2]

• Prepare institutions for external review by sharing service information, agreeing an agenda with local personnel, tracing patient pathways, and examining practice through observation, inspection, interviews with staff and patients, environmental review, photography, and review of protocols and clinical records.[2]Provide immediate feedback on strengths and improvement opportunities, followed by a risk-estimation spreadsheet, executive summary and tracer-patient assessments.[2]
• Classify oncology units through a self-administered questionnaire that identifies required, desirable, essential and prioritised characteristics.[4][5]Apply pre-established weighted response combinations and cut-off points to determine the level at which a unit can manage particular pathologies.[5]
• Organise care by complexity: diagnostic, referral and follow-up services assess suspected cancer, support post-treatment and palliative care, and contribute to shared follow-up; Standard Units manage lower-complexity cases; and High-Complexity Units manage more complex cases while sharing maximum-complexity care with reference centres or cooperative groups.[4]
• Maintain radiological-safety programmes integrated with hospital safety, facilities-management and infection-control arrangements, covering radiology, diagnostic imaging, cardiac catheterisation, nuclear medicine, fluoroscopy, radiotherapy and radiation oncology as applicable.[8][9]Provide safety equipment, orientation, workplace education and continuing training, including training on new procedures, equipment and hazardous materials.[9]
• Operate transplant services under qualified leadership with trained personnel, complementary examinations, information-management systems, sufficient resources, formal donor and recipient eligibility criteria, programme records and a multidisciplinary team coordinated across all stages of donor and recipient care.[9][14]
• Manage medicines through authorised prescribing, validation, transcription, dispensing or preparation, administration and post-administration monitoring.[6][14]Restrict controlled substances, chemotherapy, radioactive medicines and investigational medicines to authorised personnel with appropriate experience, and use documented administration procedures that confirm medicine, timing, frequency, dose, route and patient identity with at least two identifiers.[14][15]
• Maintain complete medication records, label medicines not administered immediately with key preparation and patient-identification information, monitor therapeutic and adverse effects of high-risk medicines, and report and respond to medication errors and no-harm incidents through the quality and patient-safety programme.[14][15]
• Apply continuous risk management and infection prevention based on epidemiological risk, focusing on priority infections, affected sites, devices, procedures and practices.[11][12]Support this through antibiotic-use optimisation, reduction of unnecessary invasive devices, hand-hygiene and personal-protective-equipment training, documented sterilisation cycles, and isolation policies tailored to clinical condition and transmission mechanism.[12][13][3]
• Monitor adherence to clinical-practice guidance, quality and safety data, medication effects, infection trends, radiology reporting times, radiation doses and transplant activities.[8][14][10][11][12]Analyse adverse trends, document improvement actions, and conduct root-cause analysis for defined sentinel events within 45 days.[11]The Instituto Nacional del Cáncer produces assessment reports and recommendations, and reassessment may occur every five years where necessary.[2]
• Use available resources efficiently, while recognising that the material identifies needs for equipment, safety devices, specialist staff, examinations, information systems and multidisciplinary services but does not specify budgets, funding sources, costs or financing gaps.[2][9][14]

Monitoring & Evaluation

The framework combines external assessment, institutional quality management and service-stratification processes to monitor safety, clinical quality and the capability of paediatric haematology and oncology services. It relies on direct observation, record review, patient-pathway tracing, interviews, environmental inspection, data analysis and documented follow-up actions.[2][10][4]

• Conduct collaborative external assessments using an agreed agenda, review of protocols and clinical records, staff and patient interviews, observation, inspection, photography and tracer-patient methods. Assess equipment, medicines, emergency trolleys, signage, ambulances and consultation spaces as relevant to service quality and safety.[2]
• Issue an assessment report through the National Cancer Institute, detailing findings and recommendations for improvement. Provide immediate feedback on site, including preliminary strengths and improvement opportunities, then produce deferred outputs such as a risk-estimation spreadsheet, executive summary and tracer-patient assessments.[2]
• Repeat quality and patient-safety assessments every five years where necessary.[2]
• Set and document reporting times for radiology and diagnostic-imaging results, including urgent, emergency, out-of-hours and weekend examinations. Require contracted diagnostic providers to meet their contractual reporting obligations.[8]
• Operate radiation-safety arrangements across radiology, diagnostic imaging, cardiac catheterisation, nuclear medicine, fluoroscopic radiology and radiotherapy. Incorporate dose levels, reference levels and maximum doses within radiological-protection guidance.[8]
• Maintain a hospital radiological-safety programme coordinated with safety, facilities-management and infection-control programmes, supported by staff orientation, workplace education and continuing training on procedures, equipment and hazardous materials.[9]
• Record transplant programme activities and apply formal donor and recipient eligibility criteria. Maintain programme records, a multidisciplinary care model and a designated coordination mechanism for all stages of donor and recipient care.[9][14]
• Document medicines comprehensively in patient records, including pre-admission and outpatient medicines, medicines brought by patients or relatives, self-administration, and the identity of the administering professional with the date and time.[14][15]
• Label prepared medicines not administered immediately with the medicine name, dose or concentration, preparation and expiry dates, and two patient identifiers.[15]
• Monitor therapeutic and adverse effects among patients receiving high-risk medicines, including relevant blood-count, renal-function and liver-function measures. Record medication effects in clinical records and define the circumstances and timeframe for reporting adverse effects.[15][10]
• Maintain procedures to report and respond to medication errors and no-harm safety incidents, educate staff, and integrate learning into the hospital quality and patient-safety programme.[15]
• Measure adherence to clinical-practice guidance; aggregate and analyse quality and safety data; and define the frequency and method for dissemination of findings. Share aggregated data with external institutions where permitted by applicable law, while protecting confidentiality and information security.[10][11]
• Analyse unfavourable trends, document proposed improvements and actions, and ensure that the programme has personnel with suitable data-aggregation and analysis expertise.[11]
• Define and protocolise sentinel events, undertake root-cause analysis within 45 days, and develop improvement proposals.[11]
• Monitor rates and trends of healthcare-associated infections to inform improvement strategies.[12]
• Maintain documented sterilisation procedures and records for every sterilisation cycle. Monitor positive-pressure rooms for correct operation and verify that temporary negative-pressure rooms meet authorisation and fire-safety requirements.[13][3]
• Validate service stratification through a self-administered assessment tool that examines required, desirable and essential characteristics across human resources, infrastructure and equipment, imaging and radiotherapy, and comprehensive tumour-specific care. Use weighted questionnaire responses, predefined combinations and cut-off points to assign each unit to the appropriate complexity category.[4][5]

Quantitative performance targets, comprehensive surveillance indicators, routine external reporting frequencies and broader accountability arrangements are not consistently specified beyond the mechanisms described, including the five-year reassessment provision, radiology reporting-time records, sentinel-event review, infection monitoring, environmental checks and service-classification validation.[2][8][11][12][3][5]

Costing & Financing

The material identifies resource inputs required for safe paediatric oncology and haematology care, but does not provide budgets, expenditure figures, unit costs, financing sources, funding gaps, resource-mobilisation targets or economic assumptions.[2][10][11][12][13][3][4][5]

• Provide and assess infrastructure, equipment and supplies to support quality, patient safety and effective use of resources.[2]
• Resource radiological protection through suitable safety equipment, staff training and, where analogue X-ray technology is used, periodic assessment of developing reagents in accordance with manufacturers’ recommendations.[9]
• Support transplant services with qualified leadership, trained personnel, complementary examinations, information-management systems, multidisciplinary expertise and programme coordination.[9][14]
• Ensure capacity for safe medicines preparation and dispensing, including clean and legally compliant environments and authorised personnel for controlled substances, chemotherapy, radioactive medicines and investigational medicines.[14]
• Equip service levels according to their assessed capability in human resources, infrastructure, equipment, diagnostic imaging, radiotherapy and comprehensive tumour-specific care.[4]
• Maintain maximum-complexity capacity where applicable, including expert paediatric oncology specialists, transplantation capacity, specialist training and research functions, and a type 1 paediatric intensive care unit.[5]

No explicit monetary cost items are available in the supplied material.[2][5]