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LD.1 The cancer service facility has the required licenses by the national authority.
LD.1.1 The facility is accredited by (CBAHI) for Hospitals or ambulatory care.
LD.1.2 The cancer service facility is currently licensed by KSA Ministry of health/ or other governmental authorities to provide cancer services. LD.1.3 The cancer service facility is currently licensed by KSA Ministry of health/ or other governmental authorities to provide chemotherapy. LD.1.4 The cancer service facility is currently licensed by KSA Ministry of health/ or other governmental authorities to provide blood transfusion services. LD.1.5 The cancer service facility is currently licensed by NRRC to provide cancer radiology diagnostic services.
LD.1.6 The cancer service facility is currently licensed by NRRC to provide cancer radiology therapeutic services.
Explanation:
Standard mandates that any cancer care facility operating in the Kingdom of Saudi Arabia must maintain full legal, clinical, and radiological authorization across three primary regulatory bodies before providing patient care.The facility holds active accreditation from the Saudi Central Board for Accreditation of Healthcare Institutions (CBAHI) under either the Hospital or Ambulatory Care standards.
The facility holds a valid operational license from the Ministry of Health (MOH) or relevant governmental authority authorizing the delivery of comprehensive cancer services.
The facility holds specific authorization from the MOH or relevant authority to safely compound and administer chemotherapy and systemic therapies.
The facility maintains a certified license from the MOH or relevant authority to operate blood bank and transfusion services for supportive patient care.
The facility holds valid operational permits from the Nuclear and Radiological Regulatory Commission & Control (NRCC) for diagnostic imaging modalities used in cancer staging and diagnosis, such as CT, PET/CT, and SPECT. The facility holds active NRRC licenses for therapeutic radiation delivery systems, including Linear Accelerators, CyberKnife, and Brachytherapy units.
LD.2. The (ONC) service is effectively managed by a qualified leader.
LD.2.1. The leader of (ONC) service is an oncologist with a minimum of 3 years of experience in the care of cancer patients at the level of consultant.
LD.2.2. There is a written job description describing the (ONC) leader's roles and responsibilities.
LD.2.3. An approved and updated organizational chart identifies the lines of authority between hospital leaders and (ONC) service leaders.
LD.2.4. The leader, together with the other leaders, develops the (ONC) scope of services based on community needs.
LD.2.5 The leader evaluating, assessing, and enhancing quality and safety program throughout the cancer service facility
LD.2.6. The leader ensures the (ONC) service's compliance with all relevant laws, regulations, and policies.
LD.2.7. The leader supports and protects patients' and families' rights and responsibilities.
Explanation
The (ONC) service must be managed by a leader qualified in education, skills, training, and experience. The leader must be a certified oncologist by the Saudi commission of health specialties, with a minimum of 3 years of experience in the care of cancer patients as a consultant by SCFHS. The leader manages the interrelationships among access, quality, safety, cost, resource allocation, accountability, (ONC) care setting, community need, and professional roles. The leader defines, requests, organizes, and monitors all required resources to meet the patient's needs. The leader uses data to assess performance, set targets, monitor indicators and trends, and determine if deliverables are met. The leader is responsible for the (ONC) service's compliance with all applicable governmental laws and regulations, including, but not limited to, patient care regulations, medication management, opening licensure regulations, staffing licensure and certification, civil defense requirements, municipality requirements, and other regulatory requirements. Efficient and effective healthcare organization management requires effective staff communication and clear reporting lines. Hence, the organizational chart should be developed to present the relationship between hospital leaders, (ONC) service leaders, and the front-line staff. The leader ensures patient and family rights and responsibilities are established and implemented.
LD.3. There is an adequate number of qualified and competent staff to run the (ONC) service. LD.3.1. (ONC) service appoints and assigns qualified staff to meet the needs of safe patient care based on staffing plan, recruitment policy, and the scope of service.
LD.3.2. The leader defines the number, type, and credentials of the required staff.
LD.3.3. There are at least two full-time oncologists available in each oncology subspeciality to ensure the (ONC) services coverage 24 hours a day, 7 days a week.
LD.3.4. The (ONC) staffing plan is updated annually, monitored to identify deficiencies, and actions for improvement are implemented as required.
LD.3.5. The leader designs specific job descriptions that outline the knowledge, skills, and attitude necessary to perform the job responsibilities for each position.
LD.3.6. The leader develops an effective process to evaluate staff performance at least annually.
The (ONC) service leader recommends the appointment of qualified leaders to manage the service and identify the required number, type, and credentials of staff to meet the needs of safe patient care. The (ONC) service leader designs job descriptions for each position to outline the roles, responsibilities, knowledge, skills, and attitude of each staff member. The (ONC) service exerts all efforts to delineate the privileges of the clinicians based on their credentials and competency. The service ensures that the clinicians are performing an adequate number of procedures to maintain their skills. Neither the clinicians nor the program can introduce a new procedure without first ensuring the competency of the clinicians performing the procedure and updating the clinicians' privileges to reflect this competency. To ensure satisfactory staff performance according to the job descriptions and privileges, a standardized objective process for gathering and assessing the staff's performance, scope of practice, professional development, and attitude is developed for each staff category. The performance evaluation's objective criteria are shared with the staff.
LD.4. Medical staff providing (ONC) services have currently delineated clinical privileges.
LD.4.1. The (ONC) service has a policy and procedure that defines the process of granting clinical privileges to its medical staff based on the staff's current competence and available services.
LD.4.2. The clinical privileges are recommended by the (ONC) service unit leader and approved of by the delegated relevant committee.
LD.4.3. The (ONC) service leader ensures that all clinicians practice within the approved clinical privileges that are assigned to them.
LD.4.4. The clinical privileges are reviewed and updated every two years or earlier if needed.
The privilege of medical staff is one of the most beneficial proactive risk management approaches concerning patients' safety. It allows medical staff to perform procedures for which they are qualified through education, training, and certification. This prevents patients' exposure to the risk of morbidities. Each medical staff should have a list of the invasive procedures that he/she is allowed or privileged to perform. The (ONC) service must have a policy and procedure for granting individual privileges. These clinical privileges should be accessible in the areas where the (ONC) medical staff are practicing, and should be reviewed and updated every two years, or earlier if needed. The clinical privileges are recommended by the (ONC) service leader and approved by the hospital-wide privileging committee.
LD.5. The (ONC) service supports continuing education and training for all categories of staff.
LD.5.1. The (ONC) service has a schedule for education and training programs based on staff needs.
LD.5.2. The (ONC) service leaders encourage staff to attend educational and training activities relevant to the (ONC) scope of service.
LD.5.3. All (ONC) staff members who provide direct patient care maintain a valid certificate on basic life support (BLS).
LD.5.4. All (ONC) staff members who provide direct patient care in Chemotherapy Day unit maintain a valid certificate on advanced cardiac life support (ACLS).
LD.5.5. The (ONC) service identifies other staff members to be trained in advanced life support as appropriate to the scope of service.
LD.5.6. Staff personnel records show documented evidence of training and education.
Staff professional development is essential for improving (ONC) services. The service should drive continuous education in different disciplines. All (ONC) staff members providing direct patient care must have valid basic life support certification and some members must be trained in advanced life support as appropriate to the scope of service. The (ONC) service uses both direct physical and virtual means to disseminate knowledge. Training and education may include on-site or remote training, workshops, lectures, case studies, morbidity & mortality rounds, and journal clubs. The service assesses the effectiveness of the training through direct and indirect feedback and takes action accordingly.
LD.6. The (ONC) service steering committee ensures the provision of reliable, timely, and safe service.
LD.6.1. The (ONC) service leader establishes and leads a steering committee for the (ONC) service.
LD.6.2. The steering committee meets regularly to integrate all organizational services involved in the management of cancer patients.
LD.6.3. The steering committee ensures that protocols, clinical practice guidelines, and standards are followed.
LD.6.4. The steering committee receives and resolves, patient-related and administrative ethical dilemmas regarding (ONC) service, within an identified timeframe.
LD.6.5. The steering committee summarizes and reports ethical issues regarding (ONC) service to the hospital leadership.
The steering committee is led by the service leader and includes the appropriate leaders of the (ONC) units and other senior staff members as required. The leaders must integrate program services with all organizational relevant services such as social services, patient relations, laboratory…etc. The leaders of the (ONC) service need to ensure that operations in each service follow (ONC) protocols, guidelines, and standards. The service leaders are responsible for developing the framework that governs how patient care is conducted ethically across the program's activities. The committee ensures receiving and resolving ethical issues concerning patients, visitors, and staff in (ONC) service.
LD.7. The (ONC) service enhances community participation and education to improve public awareness.
LD.7.1. The (ONC) service provides the community with appropriate information on its scope of services and how to access care.
LD.7.2. The service coordinates with the community's key stakeholders to improve public awareness of the cancer risk factors and early symptoms of cancer.
LD.7.3. Appropriate and understandable educational resources on cancer are made available and accessible to the community through various communication channels.
LD.7.4. Continuous community education is regularly conducted and evaluated for its effectiveness and impact on community health and wellbeing.
Health education focuses on prevention, early detection, and risk reduction. The (ONC) service conducts training for a wide range of organizations that encounter cancer patients. The (ONC) service conducts onsite/offsite educational activities/workshops targeting its public awareness objectives. Health education is available through a variety of sources including the hospital website and social media and displayed in the facility. The (ONC) service considers the perspective of the community as partners in healthcare decision-making processes. The service identifies the relevant community stakeholders, including transport authorities and local governments, to undertake accessibility planning and how they meet current and future healthcare needs. The educational activities provided to the community must be regularly evaluated for their effectiveness and improvements are planned accordingly.
LD.8. The (ONC) service seeks feedback from patients and service users regarding the services provided.
LD.8.1. Patients' complaints are resolved within the time frame described in the policy.
LD.8.2. The (ONC) service assigns a staff member to be responsible for managing complaints. LD.8.3. Patient satisfaction surveys are conducted regularly.
LD.8.4. Data collected from surveys, complaints, and suggestions are analyzed and trended, and the results are used for improvement and integrated into the quality and safety program.
The (ONC) service develops and implements a policy and procedure to ensure and facilitate the patients' right to voice their complaints, concerns, and suggestions and assigns a staff member to be responsible for managing complaints. In addition, patient satisfaction surveys must be conducted biannually to assess the level of patient satisfaction with the services provided. The service can conduct direct patient/service user interviews at the provision point and/or through focus groups, telephone calls, and social media. The findings from patient complaints data and patient satisfaction surveys must be used for performance improvement.
LD.9. The (ONC) service develops and monitors the implementation of the quality improvement and patient safety plan.
LD.9.1. The (ONC) service develops a quality and patient safety plan that is aligned with the facility -wide quality and patient safety program.
LD.9.2. The quality and patient safety plan of (ONC) service utilizes various evidence-based quality tools and methodologies to measure performance and improve clinical and managerial areas.
LD.9.3. The (ONC) service implements at least one improvement project per year utilizing an evidence-based quality improvement methodology.
LD.9.4. The (ONC) service develops and prioritizes a set of indicators that cover the essential structures, processes, and outcomes of the services provided, based on standardized criteria.
LD.9.5. The indicators' results are benchmarked and accessible on a timely basis to those involved in the delivery of services and hospital leadership.
LD.9.6. The service continuously evaluates the gap in its reported outcomes and utilizes the results of benchmark evaluations to improve (ONC) services.
LD.9.7. The quality team supports the quality and patient safety plan of (ONC) service through integrating data collection, aggregation, validation, analysis, and interpretation.
LD.9.8 The cancer center should have documented regular M&M committee meeting
The (ONC) service should ensure the quality of its services and its continuous improvement by developing a quality management and patient safety program, according to national initiatives on quality and patient safety. The quality and patient safety program of (ONC) service utilizes key performance indicators, surveys, audits, peer reviews, feedback, risk assessment, safety incidence, complaints, and suggestions for prioritizing quality improvement projects and improving the program's operational planning as well as clinical and managerial operations. Staff are notified of the performance findings, and the information provided is utilized to further improve clinical and managerial areas (structure, process, and outcome). The quality staff support and facilitate the implementation of different quality management, patient safety, and risk management plans and coordinate activities with the hospital's quality improvement and patient safety program. The quality staff support integrated data collection, aggregation, validation, analysis, and interpretation of relevant data from multiple sources including quality indicators. The (ONC) service implements at least one improvement project per year, based on prioritization, using an evidence-based approach such as FOCUS-PDCA or DMAIC models.
Performance indicators are measurable values expected to measure a specific aspect of performance. These indicators reflect the quality of care provided and are used as a guide to monitor, evaluate, and improve the quality of services. The collection of key performance indicator (KPI) measurements should follow an evidence-based approach, and the selection criteria are based on essential priorities. The indicators should cover a variety of issues based on structure, process, and outcome.
These indicators may include adherence to the (ONC) pathway, (ONC) discharges with post treatment prophylaxis therapy, evaluation prior to discharge, secondary prevention plan, the proportion of patients diagnosed with (ONC) readmitted within 30 days after discharge, and crude/risk-adjusted mortality. The results of the indicators must be discussed with staff and reported regularly to hospital leadership along with action plans taken for improvement. Internal and external benchmarking with peer services must be conducted to check performance compared to other similar services.
LD.10. The (ONC) service develops and implements a risk management plan that is aligned with the hospital-wide risk management program.
LD.10.1 The (ONC) service risk management plan addresses clinical, managerial, and financial risks related to (ONC) service.
LD.10.2 The plan highlights utilizing the incident reporting process to report and identify performance concerns and identify areas of improvement.
LD.10.3 The (ONC) service reports and discusses the identified risks, reported incidents, and action plans with frontline staff and hospital leaders regularly.
LD.10.4 (ONC) participates in a multidisciplinary committee that is responsible for developing and evaluating the quality and risk management program and any corrective actions are taken as needed to address any deficiencies.
The (ONC) service risk management plan describes its roles and responsibilities, time frames, risk grading criteria, and details on how risks are assessed identified, analyzed, recorded, reported, managed, and monitored. The (ONC) service participates actively in a multidisciplinary committee that is responsible for developing and evaluating the quality and risk management program and any corrective actions are taken as needed to address any deficiencies. The (ONC) risk management plan highlights the use of an incident reporting policy with a unified reporting mechanism for all occurrences, variances, or accidents. Reporting includes near misses (accidents that were prevented or discovered before reaching the patient). (ONC) staff are encouraged to report incidents without fear of retribution.
LD.11. The (ONC) service maintains an effective information management system to serve its users and stakeholders.
LD.11.1. The (ONC) service maintains an internal register containing at least demographic data, disease-specific code, and procedure code for each registered patient.
LD.11.2. The (ONC) service uses diagnosis codes and procedure codes including international classification of diseases (ICD), or an equivalent coding system, consistent with the applicable laws and regulations.
LD.11.3. Patient medical records contain sufficient updated medical information to safely manage the patient and promote continuity of care including history, physical examination, plan of care, investigations, consultations, consents, procedure reports, medications, and allergies.
LD.11.4. All entries in the patient's medical record are legible, dated, timed, signed, and made by staff who are allowed to write in the medical record as per medical records policy.
LD.11.5. Only standardized/approved abbreviations and symbols are used in medical records.
LD.11.6. The (ONC) service conducts regular checks on returned medical records to ensure the completion of medical information and authentication. The results of the regular check are used to improve compliance with record completion.
LD.11.7. The (ONC) service implements a policy and procedure for the clinical documentation improvement (CDI) program.
To ensure continuity of care, each patient cared for in the (ONC) service has an individual medical record that has a unique medical record number. The (ONC) service needs to develop a policy to ensure uniformity and legibility of writing in medical records and avoid misinterpretation of written information. Also, the policy should specify the category of staff allowed to write in the medical record. In the patient medical record, only standardized and approved abbreviations and symbols must be used because abbreviations can be problematic, confusing, interpreted differently, and may result in inadvertent medical errors. Standardized diagnoses, procedures, and services codes help programs track pathology and standard procedures and comply with the requirements of regulatory entities and insurance companies. Hence, a clinical documentation improvement (CDI) program is fundamental in any healthcare facility or service to ensure timely completion of the medical records, proper utilization of data, and accurate data reporting to the health authorities as per local regulations. If an electronic healthcare information system is used, an adequate data-capturing process during downtimes is critical to maintaining the completeness and comprehensiveness of data. At the end of a patient's visit, the medical record is returned to a safe medical records store or electronically stored.
LD.12. The (ONC) service provides secure telehealth (ONC) services to ensure integrated (ONC) care, whenever the need arises.
LD.12.1. The (ONC) service develops criteria for telehealth service.
LD.12.2. The (ONC) service leaders ensure the credentialing and privilege of all healthcare providers involved in the process of providing telehealth (ONC) services before starting the service.
LD.12.3. Telehealth services used for cancer patients are registered and comply with national health laws and regulations.
LD.12.4. The (ONC) service leaders ensure the security and confidentiality of cancer patient information exposed in telecommunication process.
The (ONC) service should have defined criteria for telemedicine services and types of patient that could be served through telehealth platforms. The (ONC) service ensures the competency of the physicians providing the services. The confidentiality and security of patient information are secured by allowing access only to the relevant (ONC) staff members and only to required information from the patient's file.
LD.13. The (ONC) service participates in research activities.
LD.13.1. The (ONC) service that conducts or participates in research projects has internal policies and procedures for research conduction.
LD.13.2. The hospital research committee or similar structure oversees all research activities in oncology.
LD.13.3. The service implements the research outcomes to improve its services.
LD.13.4 Special consent forms used for patients involved in research.
Medical research has great value in modern medicine in terms of the improvement of healthcare services. Research activities should be implemented with regulatory guidelines, professional requirements, selection criteria, code of conduct, appropriateness, and safety. Findings from research should be used in daily operations to improve services. Special consent forms used for patients involved in research.
LD.14. There is a process to manage the supply chain, related to the (ONC) service, cost-effectively.
LD.14.1. The (ONC) service leader works collaboratively with hospital leadership to manage (ONC) service-related supply chain.
LD.14.2 The (ONC) service has an appropriate and organized area for medical supplies with labels showing the name of the item and the expiry date.
The (ONC) service leader works collaboratively with hospital leadership to adhere supply to procurement regulations in terms of contract management and tendering guidelines and to manage the interface between the links and logistics of supply chain services within the organization and the program as well as to work to achieve timelines and efficiency in supply delivery, warehousing, and distribution.
LD.15. The (ONC) service maintains a safe environment for patients, visitors, and staff, through an effective facility management and safety program.
LD.15.1. The (ONC) leaders ensure that the building used to provide (ONC) service complies with national standards, environmental protection standards, laws and regulations, and the recommendations of professional entities.
LD.15.2. Fire systems covering (ONC) service, including the fire alarm, fire extinguishers, and fire equipment, are in place and functioning.
LD.15.3. Hazardous materials used in (ONC) service are stored, handled, transported, used, and disposed of effectively as per the “Safety Data Sheets".
LD.15.4. (ONC) staff, including new hires, volunteers, and trainees, receive education on fire drills, evacuation plans, dealing with hazardous materials, and dealing with waste disposal, with a training record kept in personal staff files.
LD.15.5. (ONC) staff working in radiation areas including new hires, volunteers, and trainees, receive education on radiation safety.
The (ONC) service leaders must ensure that the service is provided in a safe building (includes the building and its surroundings) that comply with national standards, environmental protection standards, laws and regulations, and the recommendations of professional entities. Also, the (ONC) service must protect its occupants from the effects of hazardous materials and waste through proper handling, segregation, and disposal of waste. In addition, the fire safety of the facility, where (ONC) service is provided, must be ensured through several facility control measures. In addition, staff training must be conducted through fire drills including the use of RACE/PASS and evacuation techniques, staff working in radiation areas including new hires, volunteers, and trainees, receive education on radiation safety.
LD.16. The ONC facility leader supervises the cancer healthcare professional's stress
LD.16.1 The ONC facility leader determines, assess healthcare professional stress and burnout throughout cancer service facility at least annually
LD.16.2 The ONC facility leader establish a formal, data-driven process to understand the well-being of the staff.
LD.16.3 The ONC facility leader supervises and follows cancer healthcare professional's regular screening for burnout, stress and depression.
LD.16.4 The ONC facility leader supports and deals with professional healthcare stress and burnout throughout the cancer service facility
LD.16.5 The ONC facility leader allocates resources and changing systems to help staff cope with the inherent demands of oncology work and to reduce factors contributing to burnout.
LD.16.6 The supportive mechanisms must be accessible and available to all staff,
ONC facility leader to be proactive and systematic in managing the occupational stress and burnout of the cancer healthcare professionals they supervise. It is a critical component of maintaining a healthy work environment, ensuring staff retention, and ultimately, safeguarding the quality and safety of patient care , mandates that the leader must establish a formal, data-driven process to understand the well-being of the staff , Determine and Assess the staff mental health using validated tools (e.g., surveys, questionnaires like the Maslach Burnout Inventory) to quantify and identify the levels of stress and burnout. The assessment must be comprehensive, covering all professional staff involved in cancer care (nurses, physicians, social workers, radiation therapists, etc.) to capture the full picture and at Least Annually to track trends, measure the effectiveness of interventions, and respond to changing environmental factors (like staffing shortages or new treatment protocols).Supports resources (e.g., peer support programs, wellness initiatives, time-off policies, resilience training, adjusting workloads, improving scheduling, addressing interpersonal conflicts, or providing confidential counseling services recognizes that staff well-being is a core responsibility of leadership.
LD.17 The cancer organization implements structured communication programs related to staff, patients and their families.
LD.17.1 Staff have appropriate and adequate training in communication skills.
LD.17.2 There is evidence of staff training in communication skills and it's available in staff personal files.
LD.17.3 There is a process for communication among staff, patients and their families for the following, but are not limited to:
LD.17.3.1 Among healthcare professionals within the cancer organization.
LD.17.3.2 Among healthcare professionals in different national or international cancer organizations.
LD.17.3.3 Methods or tools to report critical lab and image findings.
LD.17.3.4 Patient and their family with health care professional during hospitalization, and after discharge.
LD.17.4 All methods and/or tool utilized for communication must be documented in patient medical records.
Standard requires cancer organizations to build clear, structured communication systems across all clinical and administrative operations to ensure safe patient care, teamwork, and strong patient-family support.
All clinical and support personnel must receive specialized communication training (e.g., breaking bad news, managing treatment goals), with official certificates or logs filed in their personal HR records.
Standardized pathways must exist for daily care handovers, tumor board discussions, and sharing clinical data with national or international cancer centers for second opinions or transfers.
Clear protocols with closed-loop "read-back" verification must be used to immediately report urgent diagnostic lab, pathology, or imaging results to treating physicians.
Structured channels must support clear dialogue with patients and families during hospitalization and after discharge (e.g., care conferences, discharge plans, telephone advice lines).
Every critical update, family discussion, and referral must be documented directly in the patient's medical record.
Provision of Care (PC)
PC .1 The cancer service facility has a defined scope of service
PC .1.1 The cancer service facility has written defined scope of service that describes the services provided and Available Therapeutic services approved by the higher management.
PC .1.2 The cancer service facility has written defined targeted age of served population.
PC .1.3 The cancer service facility has written defined working hours
The single most common cause of harm in an under-resourced cancer service is not error but overreach: a facility accepting a patient whose complexity exceeds its capability. The declared scope of service is therefore the foundation of this chapter. It is a binding statement, not a marketing document. A facility that declares paediatric oncology must possess paediatric-competent staff, paediatric formulations, paediatric critical care access and paediatric-specific protocols; if it does not, paediatric oncology is removed from its scope and its certificate.
PC .2 The cancer service facility has adequate qualified full-time SHSC-certified consultants specialized in diagnosing and treating cancer patients according to Saudi National Cancer center staffing requirement:
PC.2.1 The medical oncology service facility has full-time SHSC-certified Consultant medical oncologist for every 150 annual new medical oncology patients.
PC.2.2 The haematology cancer service facility has full-time SHSC-certified consultants Hematologist for every 50 annual new malignant hematology patients.
PC.2.3 The paediatric haematology oncology service facility has full-time SHSC- Certified consultant pediatric oncologist for every 30 annual pediatric Oncology patients.
PC.2.4 The cancer radiation oncology facility has full-time SHSC-certified consultants radiation oncologist for every 150 new annual radiation oncology patients.
PC.2.5 All surgeons involved in planning and performing cancer surgery should be SHSC-certified consultant surgeons with appropriate surgical oncology training and certification, or at least 5 years post-board experience in surgery at a consultant level.
PC.2.6 The cancer service facility with in-house chemotherapy preparation should have at least one SHSC certified senior clinical pharmacist with acceptable cytotoxic pharmacy knowledge and experience.
PC.2.7 The cancer service facility with in-house chemotherapy preparation should have at least 2 certified cytotoxic pharmacy technologists with acceptable cytotoxic pharmacy knowledge and experience.
Standard mandates that a cancer service facility maintains qualified, full-time consultants certified by the Saudi Commission for Health Specialties (SCFHS/SHSC) alongside specialized oncology pharmacy personnel, aligned with Saudi National Cancer Center (SNCC) patient-to-staff ratios.
Medical Oncology : Minimum 1 full-time certified Consultant Medical Oncologist for every 150 new medical oncology patients per year.
Adult Hematology : Minimum 1 full-time certified Consultant Hematologist for every 50 new malignant hematology patients per year.
Pediatric Hematology/Oncology : Minimum 1 full-time certified Consultant Pediatric Oncologist for every 30 new pediatric oncology patients per year.
Radiation Oncology : Minimum 1 full-time certified Consultant Radiation Oncologist for every 150 new radiation oncology patients per year.
Surgical Oncology : All attending surgeons operating on cancer patients must be certified consultants with formal surgical oncology training/certification, or a minimum of 5 years post-board surgical consultant experience.
Oncology Pharmacy Leadership : Facilities preparing in-house chemotherapy must employ at least 1 certified Senior Clinical Pharmacist trained in cytotoxic drug preparation and handling.
Cytotoxic Pharmacy Technologists : Facilities preparing in-house chemotherapy must employ at least 2 certified Cytotoxic Pharmacy Technologists experienced in safe compounding and cytotoxic safety protocols.
PC.3. Oncology and malignant hematology clinical services (OMHCS) has a process for accepting cancer patients with defined time frame:
PC.3.1 The cancer service facility establishes and implements a process for accepting cancer patients within defined time frame
PC.3.2 All referred cancer patients have Pathology report confirming the diagnosis of Cancer upon referral to the cancer service facility
PC.3.3 The new accepted cancer patient to be seen in clinic within 14 days from acceptance.
PC.3.4 Length of time between the date of referral for histopathological confirmed cancer to the date of delivery of first cancer treatment (Surgery, Radiation, Chemotherapy & anti-cancer Medication) is less than 28 days.
PC.3.5 The cancer service facility has clear process to manage life threatening cases regardless of nationalities or ID.
Standard establishes the regulatory framework governing patient intake, diagnostic verification, care access timelines, and emergency protocols within Oncology and Malignant Hematology Clinical Services (OMHCS). Compliance ensures structured governance, clinical safety, and alignment with healthcare accreditation standards.
The facility must document and execute a standardized operational protocol for accepting oncology referrals within defined administrative timeframes.
Histopathological verification is a mandatory intake prerequisite; non-confirmed or speculative cases cannot be admitted into the oncology service without a signed pathology report validating malignancy.
Upon referral acceptance, the patient must be evaluated in an outpatient clinic within 14 calendar days.
The elapsed duration between the date of referral (with confirmed histopathology) and the delivery of the first therapeutic intervention—whether surgery, radiation therapy, chemotherapy, or systemic biological agents—must be less than 28 calendar days.
Immediate management protocols must be executed for all oncological emergencies (e.g., spinal cord compression, superior vena cava obstruction, neutropenic fever). Triage and emergency treatment must proceed without administrative delay, regardless of nationality, identification status, or financial guarantee.
PC.4 The hospital's layout, structure, and function facilitate the delivery of reliable, timely, streamlined, and safe care to patients.
PC.4.1. The hospital's layout optimizes the flow of patients between the oncology / malignant hematology unit and intensive care unit, emergency room, radiology department, endoscopy unit, and operating rooms.
PC.4.2. The facility assigns Chemotherapy Day Unit (CDU) area, or contract for outsource infusion centers.
PC.4.3. Diagnostic services are accessible within an identifiable timeframe as per hospital policy and procedure.
PC.4.4. The facility layout provides dedicated and protected areas for vulnerable cancer patients undergoing radiology and endoscopy procedure, ensuring privacy, safety and timely access to care.
PC.4.5. The facility layout ensures appropriately designed isolation rooms in Intensive Care Unit (ICU) to accommodate oncology/hematology patients.
Oncology and malignant hematology clinical services developed collaboratively with the services leadership to provide easy flow for patients during their treatment journey. (important services)
Optimizing patient flow means moving patients smoothly through inpatient and outpatient settings. This forms part of proper resource utilization and includes optimizing the flow of patients between different hospital departments and between the hospital and other acute care settings. The process includes reducing patient and staff waiting time, minimizing backlogs, avoiding unnecessary admissions, improving response time, and supporting transfer and discharge planning. The oncology and hematology services director collaborates with hospital leadership and relevant clinical representatives to facilitate the patient's journey and overcome obstacles.
PC .5 The response time for cancer referred cases is implemented and accordance to national rules and regulations
PC .5.1 Response time for cancer referred cases as Life-threatening within two hours
PC .5.2 Response time for cancer referred cases as Urgent or Emergency within twelve (12) hours.
PC .5.3 Response time for cancer referred cases as Elective within seventy-two (72) hours.
PC .5.4 Periodic report about the accepted & delayed referral cases per specialty presented to cancer quality committee for improvement purpose.
PC .5.5 The referring hospital receive notification if the referred case is rejected containing enough information about the reason of rejection.
PC .5.6 The referred patient receive notification if his/her case is rejected containing enough information about the reason of rejection .
Standard PC.2 governs the timeliness of clinical responses for oncology referrals, establishing a legally compliant, acuity-based triage system to prevent care delays and improve clinical outcomes. Any case labelled by the referring hospital/physician as (Life-Threatening) for acute oncological emergencies presenting severe, immediate risk to life or organ function mandates immediate specialist evaluation and response within two hours.
Any case labelled by the referring hospital/physician as (Urgent or Emergency) Requires clinical review and response within 12 hours to manage acute symptoms or prevent rapid clinical deterioration. 72-hour threshold for stable, routine consultations, diagnostic evaluations, or non-urgent specialist referrals.
Providing specific clinical reasons must be communicated with the Referring hospitals and the patient when a referral is rejected with clear, accessible explanations for the rejection to ensure they can seek alternative care without delay.
PC.6. There is a referral pathway to guide the patient referral process based on the patient's health needs.
PC.6.1. The patient referral pathway defines referral acceptance criteria and communication channels to facilitate immediate transfer.
PC.6.2. The patient referral pathway defines the essential information to be communicated and the care required during transfer.
PC.6.3. The patient referral pathway addresses the infection prevention and control measures to be considered and followed before and during referral.
PC.6.4. Patients and their families are involved in the transfer decision and referral plan.
PC.6.5. Capable ambulance services and staff are available to transfer critical cases promptly and safely.
PC.6.6. The patient is monitored during the transfer process and the monitoring record is kept in the patient's medical record.
PC.6.7. Handover process of patient's condition to be clear and concise between referring and receiving organizations.
Patient referral is based on the patient's health needs for continuing care that is available in the receiving organization. The pathway highlights eligibility and physiologic acceptance criteria. The summary of the patient's condition accompanies the patient and includes reason for admission, diagnosis, hospital course, investigations, services provided, medication list with time of last dose, and infection prevention and control measures. The referral pathway defines staff accountability on both ends of the process. The patient's condition determines the qualifications of the staff member monitoring the patient and the type of medical technology required during transfer. The hospital evaluates the quality and safety of the transfer process to support safe transfer with qualified staff and appropriate medical technology.
PC.7. The hospital's emergency room is efficiently designed, appropriately equipped, and staffed by qualified and competent personnel to manage oncology patients.
PC.7.1. The emergency room is appropriately equipped to meet the oncology patients' needs.
PC.7.2 The emergency room provides isolation rooms for immunocompromised patients.
PC.7.3. The emergency room is covered by a certified emergency medicine consultant physician and nurse with knowledge and experience in managing oncology patients.
PC.7.4. The emergency room maintains an on-call schedule for oncology and hematology services.
The emergency room is equipped with the medical devices, medications, and consumable materials required to meet the needs of oncology patients. Qualified staff are available to meet patient demand, including an emergency physician certified by the Saudi Commission for Health Specialties as an emergency medicine consultant and an experienced nurse. The emergency room maintains an on-call schedule for medical oncology, hematology oncology, radiation oncology, paediatric hematology oncology, and oncology palliative care consultation.
PC.8 The cancer service facility provides emergency room services on-site or referred to another cancer service facility by service agreement regulations
PC.8.1. Emergency medicine services are available onsite or referral to another hospital near to the cancer service facility, and approachable within 15 minutes
PC.8.2. The cancer service facility has ambulance care within the cancer service facility entity
PC.8.3. Continues monitoring for the ambulance readiness in place
PC.8.4. Transporting emergency bag, essential equipment, and emergency medication is available during the transfer
PC.8.5. Cancer patient within 2 weeks of receiving chemotherapy should be seen in fast track within 15 minutes of arrival to ER
PC.8.6. neutropenic patient should be isolated in ER upon diagnosis of neutropenia
PC.8.7. Antibiotic treatment for neutropenic patient should be started in ER within 30 minutes of diagnosis
Explanation :
The requirement establishes emergency care accessibility, rapid triage, and time-critical infection control protocols for oncology patients.
Key Time-Sensitive Benchmarks (KPIs)
15 Minutes (Referral Distance): Maximum approach time to a referral facility if emergency services are not provided on-site.
15 Minutes (Chemotherapy Fast-Track): Maximum time from arrival at ER to clinical evaluation for patients who received chemotherapy within the last 14 days.
30 Minutes (Antibiotic Door-to-Needle): Maximum time allowed from neutropenia diagnosis to the administration of initial broad-spectrum antibiotics in the ER.
Evidence of compliance. On-call rosters; triage records with arrival and assessment times for oncology presentations; fast-track policy; isolation practice observation; response-time audit for on-call attendance; ambulance readiness log; training records.
PC.9. Oncology and malignant hematology clinical services (OMHCS) uses clinical pathways and protocols to guide the process of providing effective emergency care.
PC.9.1. Oncology and malignant hematology clinical services (OMHCS) implements a standardized protocol following national or international oncology guidelines for the immediate triaging and management of a suspected oncology emergency.
PC.9.2. Oncology and malignant hematology clinical services (OMHCS) utilizes an evidence-based neutropenic sepsis management pathway, including early warning scores and risk stratification tools.
PC.9.3. Oncology and malignant hematology clinical services (OMHCS) uses a protocol to rapidly assess oncology patients presenting with acute symptoms, with the goal of initiating the diagnostic workup within acceptable time according to emergency department standards.
PC.9.4. Oncology and malignant hematology clinical services (OMHCS) uses a protocol for a spinal cord compression alert process to ensure prompt activation upon identifying clinical or radiological signs suggestive of malignant spinal cord compression.
PC.9.5. The oncology on-call team arrives on-site within 30 minutes of consultation for patients requiring urgent care.
PC.9.6. The initiation of empiric antibiotic therapy for suspected neutropenic sepsis is aligned with the defined national benchmark and documented in the emergency care pathway.
PC.9.7. Oncology and malignant hematology clinical services (OMHCS) uses a standardized referral protocol to transfer patients to an external emergency department with the appropriate oncology capabilities when required.
Oncology and malignant hematology clinical services (OMHCS) provides timely and effective emergency care through standardized protocols aligned with national and international oncology guidelines for triaging and managing acute conditions such as neutropenic sepsis and spinal cord compression. Evidence-based pathways incorporate early warning scores and risk stratification tools to guide clinical decisions. Rapid assessment protocols support the timely initiation of diagnostic workups, such as blood cultures, complete blood count, and imaging. A dedicated alert process supports prompt team activation for malignant spinal cord compression. The service also uses a standardized referral protocol for transferring patients to external emergency departments with appropriate oncology capabilities. The protocol includes criteria for referral, communication procedures, documentation standards, and confirmation of acceptance by the receiving facility prior to transfer.
PC.10. Patient care is clearly defined and documented in each encounter in cancer care facility
PC.10.1 Reason for admission is documented in the medical note in each admission.
PC.10.2 Expected length of stay is documented in the medical note in each admission.
PC.10.3 Treatment goals are documented in the medical note in each encounter.
PC.10.4 Diagnosis and Cancer stage and performance status are documented in the medical note in each encounter.
PC.10.5 Previous oncology therapies, medications history, allergies and previous treatment side effects are documented in the medical note in each encounter.
PC.10.6 Code status is clear in each admitted patient medical note.
Clear Documentation of patient status is entered in the patient EMR for all Inpatient Admissions that include : Primary clinical reason/indication for acute admission (e.g., planned chemotherapy, severe febrile neutropenia, pain management), Target/Expected Length of Stay (ELOS in days) recorded in the admission physician note, treatment intent and goals (e.g., curative, neoadjuvant, adjuvant, disease control, palliative), Primary cancer diagnosis, clinical/pathological staging (e.g., TNM, Stage I–IV), Performance status score (e.g., ECOG scale 0–4 or Karnofsky score), Prior oncology treatments (chemotherapy, radiation, surgery, immunotherapy), Current medication list & verified drug allergies, Previous treatment toxicities/side effects (e.g., neuropathy grade, nausea, cardiotoxicity), Code Status directive (e.g., Full Code, DNR / Allow Natural Death) clearly documented in the inpatient medical note.
PC.11. Continuity of care is communicated with the care givers in each encounter in cancer care facility post chemotherapy or radiotherapy and anti-cancer treatment
PC.11.1 Discharge criteria are identified and implement in each admitted patient medical note.
PC.11.2 Post treatment potential complications are clear in patients discharge summary.
PC.11.3 Post treatment instructions are provided to the discharged patient in Arabic unless the Arabic is not the mother tongue.
PC.11.4 Detailed discharge note is provided to the patient upon discharge from the hospital or chemotherapy / radiotherapy course completion that include expected post treatment complications
PC.11.5 The discharge summary provided to the patient include mode of emergency communication with cancer center.
this standard enforces safe patient discharge, multi-lingual patient communication, and clear emergency access following oncological therapies. Discharge criteria (e.g., vital stability, pain control, oral intake) documented and signed off in the EMR prior to discharge.Clinical discharge summary explicitly itemizing potential short- and long-term treatment complications (e.g., febrile neutropenia, severe nausea, organ toxicities), Language Accessibility Patient-facing discharge instructions printed in Arabic (or translated into the patient's primary language), Treatment Completion Comprehensive clinical note issued to the patient at hospital discharge or at the end of a chemotherapy/radiotherapy regimen outlining cumulative treatment and expected outcomes.
Discharge summary clearly displaying 24/7 emergency contact info (e.g., direct hotlines, oncology triage lines, ER pathways).
PC.12 The cancer service facility has a process of patient assessment and screening
PC.12.1. There are written policy and procedure for cancer patient assessment /screening criteria upon patient admission
PC.12.2. There are written policy and procedure for cancer patient assessment /screening criteria or triage upon arrival in emergency department ER
PC.12.3. There are written policy and procedure for cancer patient assessment /screening criteria upon arrival for outpatients' clinics, oncology day units and radiotherapy day units.
PC.12.4. There are written policy and procedure for cancer patient assessment upon referral or and transfer.
PC.12.5. All cancer patients have assessment for pain
PC.12.6. All cancer patients have assessment Nutritional need.
PC.12.7. All cancer patients have assessment for psychosocial, Emotional and physical needs
The facility to have formal, written policies and procedures for how cancer patients are evaluated at every possible point of entry. The goal is to eliminate guesswork, reduce waiting times for critical treatments, and ensure patient safety.
When a cancer patient is admitted to the hospital, there must be a clear process to determine their immediate medical needs, baseline status, and safety risks (e.g., risk of infection)
Cancer patients often present to the ED with life-threatening complications like Febrile Neutropenia or spinal cord compression. This standard requires a specialized "triage" system so oncology patients are identified immediately and fast-tracked ahead of non-urgent cases. Before a patient receives chemotherapy, immunotherapy, or radiation on an outpatient basis, a structured pre-treatment assessment must occur. This ensures it is clinically safe to administer the treatment that specific day (e.g., checking blood counts, kidney function, and vital signs). When a patient is moved from another hospital, or transferred between departments (like ICU to the Oncology Ward), there must be a formal handover policy. This ensures that critical data, treatment histories, and current toxicities are safely communicated without gaps in care.
Mandatory Holistic Assessments mandate that cancer care goes beyond just treating the tumor. The facility must assess the whole person using scientifically validated clinical tools for Pain. Hospitals must screen all cancer patients for pain regularly using standard scales (like rating pain from 0 to 10) and evidence that the hospital re-evaluates the patient after giving pain medication. The hospital must use a formal tool (like the Malnutrition Screening Tool) to identify at-risk patients early and refer them to a dietitian. A cancer diagnosis brings immense emotional distress, financial anxiety, and physical limitations, checking for depression, anxiety, and coping mechanisms (often using a "Distress Thermometer").
Physical: Measuring how well the patient can handle daily activities (often using functional scales like the ECOG Performance Status).
PC.13. The hospital develops and implements a cancer pain assessment and management program
PC.13.1 Appropriate pain assessment tool is used based on the age and cognitive ability of the cancer patient.
PC.13.2 All cancer patients assessed and reassessed for the presence of pain or discomfort daily for admitted patients
PC.13.3 All cancer patients assessed and reassessed for the presence of pain or discomfort on arrival to the emergency Room.
PC.13.4 All cancer patients assessed and reassessed for the presence of pain or discomfort on arrival to oncology day units.
PC.13.5 Pain assessment and assessment documented into the patient's medical records.
PC.13.6 Ineffective pain control must be reported to palliative physician or pain specialist.
PC.13.7 Cancer pain reassessments occur at a regular interval:
Cancer pain is highly complex that mandates the cancer care facility to manage pain using a structured, institutional Program. This program ensures pain is systematically identified, accurately measured, aggressively treated, and escalated to specialists when treatments fail
Pain is subjective. A patient who cannot speak or think clearly cannot use a standard 0–10 scale. This standard prevents clinical gaps by forcing the hospital to match the assessment tool to the patient's specific demographic and neurological state.
Validated Tools Expected by Auditors:
Adults (Cognitively Intact): Numeric Rating Scale (NRS) 0–10 or Visual Analog Scale (VAS).
Children (Ages 3+): Wong-Baker FACES Pain Rating Scale (matching faces to pain levels).
Infants/Toddlers: FLACC Scale (Face, Legs, Activity, Cry, Consolability).
Critically Ill / Non-Verbal Adults: Critical-Care Pain Observation Tool (CPOT) or Behavioral Pain Scale (BPS).
Dementia / Elderly: Pain Assessment in Advanced Dementia (PAINAD) scale.
Auditors want to see that screening occurs at key transition points and milestones daily for Admitted Patients as routine checking of vital signs (Blood Pressure, Pulse, Temperature, and Pain as the "5th Vital Sign") every shift.
Cancer patients visiting the ER are often experiencing an acute oncological crisis (e.g., bone metastasis fracture, bowel obstruction). Pain must be documented at the triage desk immediately upon arrival to dictate how quickly they see a physician.
Pain assessment is mandatory for patient arriving to Oncology and radiotherapy .
Medical Record Documentation for pain status is critical including :Intensity, Quality,Location & Radiation, Triggers & Relievers.
The Escalation Pathway for Ineffective pain Control for more than 24 hours despite optimized opioid regimens that mandate formal consultation to either a Palliative Medicine Physician or a specialized Interventional Pain Team.
If a patient is given a drug for pain, the nurse must go back and check if it worked. it must be based on the medication's pharmacological route: Intravenous (IV) / Subcutaneous injection: within 30 minutes , Oral (PO) within 60 minutes, Transdermal Patch (e.g., Fentanyl): daily .
PC.14 An initial Psychosocial, Spiritual, functional, and nutritional assessment performed and documented by specialized paramedical staff in each admission and for all new patients in outpatient departments:
PC.14.1 Social Worker assess all cancer patient within 48 hours of admission
PC.14.2 Clinical Nutritionist assess all cancer patient within 24 hours of admission
PC.14.3 Physical/occupational therapist assess cancer patient within 72 hours of admission
PC.14.4 Health educator assesses cancer patient within 72 hours of admission
PC.14.5 The cancer patient to be referred to Religious and Spiritual Counsellor when needed.
PC14.6 Oncologist (Medical, surgical, Radiation ) refer new cancer patient to Social Worker, Dietitian, Physical therapist and health educators at 1st outpatient encounter in cancer center.
PC14.7 Social Worker, Dietitian, Physical therapist and health educators assess all cancer new patients within 2 weeks of 1st encounter in cancer center.
a standardized, multidisciplinary intake process for all admitted cancer patients to ensure complete care across physical, emotional, functional, and social needs. Addresses vital non-medical factors such as mental wellbeing, mobility, and dietary needs—alongside primary oncology treatment.
Clinical Nutritionist assesses dietary needs and malnutrition risk Within 24 Hours of admission.
Social Worker evaluates psychosocial support, coping mechanisms, and home/discharge needs. Within 48 Hours of admission.
Physical/Occupational Therapist evaluates mobility and daily living capabilities within 72 Hours of admission.
Health Educator identifies learning needs and health literacy gaps regarding the diagnosis within 72 Hours of admission.
Spiritual/Religious Counsellor provides support through referral based on patient request or initial screening.
For new cancer patient seen in outpatient clinics , Oncologist (Medical, surgical, Radiation ) must refer the new cancer patient to Social Worker, Dietitian, Physical therapist and health educators at 1st outpatient encounter in cancer center and they must be seen within 2 weeks by Social Worker, Dietitian, Physical therapist and health educators.
PC.15. The oncology team develops a comprehensive multidisciplinary plan of care based on assessment findings and directed by clinical practice guidelines.
PC.15.1. The most responsible physician (MRP) ensures that the plan of care is patient-centered and developed collaboratively by members of the healthcare team.
PC.15.2. The plan of care is based on the assessment findings.
PC.15.3. The plan of care sets measurable desired outcomes and is documented for each patient.
PC.15.4. The plan of care is based on the oncology management pathway or protocol that guides the management of oncology patients in all oncology care settings.
PC.15.5. Patients' needs are reassessed when indicated and the care plan is revised and modified accordingly.
PC.15.6. Patient educational needs are identified and documented in parallel with the provision of oncology and hematology services.
A documented plan of care is essential for managing a patient's condition. The plan of care is developed according to the assessment information obtained by the healthcare team and is tailored to the patient's medical condition as well as spiritual and cultural needs. A collaborative plan of care includes nurses, dietitians, physiotherapists, social workers, occupational therapists, speech therapists, and clinical pharmacists as needed. The plan includes measurable goals and is reviewed by the most responsible physician during each visit and updated according to the patient's response.
PC.16 The cancer service facility has a structured multidisciplinary care meeting approach as a standard practice in cancer care
PC.16.1 A multidisciplinary meeting conducted at least weekly attended (physical or virtual ) by medical sub-disciplines that have a major contribution to patient care.
PC.16.2 There is written policy for hospital tumor board
PC.16.3 A standardize process for booking patients for discussion at tumor board meetings in place
PC.16.4 The tumor board meeting/s conducted in suitable environment with suitable displaying screens.
PC.16.5 There is a multi-disciplinary team who are consultants from different specialties to review and discuss the medical condition and treatment options of a patient that include at least 2 Oncologists (medical, Haematolgy, Radiation, Paediatric, Surgical) , 1 Radiologists and 1 pathologist.
PC.16.6 The primary treating consultant or his representative consultant present during his/her cases discussion
PC.16.7 The primary consultant who present the case in tumor board document the tumor board decisions in patient medical records within 24 hours.
These standard mandates are structured, weekly Multidisciplinary Care Meetings (Tumor Boards) to ensure every cancer patient receives a peer-reviewed, collaborative treatment plan driven by a formal policy and a standardized booking system to schedule patient case reviews.
Multidisciplinary Consensus eliminates single-physician decision by combining insights from oncology sub-specialties, imaging, and tissue analysis that enables immediate alignment between clinical presentation, radiological imaging, and pathological findings and maintains clear attendance logs and timestamped clinical entries for quality assurance and accreditation audits.
The MDT/Tumor board Held at least weekly in a facility equipped with specialized displays for viewing high-resolution radiology scans and pathology slides
Minimum Quorum requires at least 4 consultant-level specialists present: 2+ Oncologists (Medical, Surgical, Radiation, Pediatric, or Hematology), 1 Radiologist, and 1 Pathologist.
The patient's primary treating consultant or a designated consultant representative must be present at the time of his /her case discussion.
The presenting consultant must document the board's treatment decisions in the EHR within 24 hours.
PC.17. General oncology, hematology, surgical oncology, and oncology palliative ward for adult and pediatric patients is designed, structured, and organized to facilitate the delivery of reliable, timely, and safe care to oncology patients.
PC.17.1. The ward has an appropriate design, functional areas, and safe facilities following applicable national guidelines.
PC.17.2. The ward provides isolation rooms for immunocompromised patients.
PC.17.3. The ward has both a nominal and surge capacity management plan to meet changes in demand.
PC.17.4. The ward has the necessary equipment to continuously and concurrently monitor and record the patient's vital signs.
PC.17.5. Patients are admitted to and discharged from the ward according to standardized criteria supported by national guidelines.
PC.17.6. Staff stations are strategically located to support continuous patient monitoring.
PC.17.7. Pharmacy, blood bank, and laboratory services are integrated with, or easily accessible from, the ward.
The general oncology-related wards are appropriately and safely designed and equipped with beds, medical devices, medications, and consumable materials required to meet patient needs. The ward layout complies with national facility guidelines and includes separate functional areas for adult and paediatric patients where applicable. Isolation rooms are available for immunocompromised patients. Safety features such as fire exits, ventilation, and infection prevention stations are installed and maintained. Admission and discharge processes are coordinated between physicians, nurses, and other healthcare practitioners involved in the patient's care.
PC.18. The intensive care unit's design, structure, and function facilitate the delivery of reliable, timely, and safe care to oncology patients.
PC.18.1. The intensive care unit where oncology and hematology services. are provided has an appropriate design, functional areas, and safe facilities following applicable national guidelines.
PC.18.2. The intensive care unit has both a nominal and surge capacity management plan to meet changes in demand.
PC.18.3. Patients are admitted to and discharged from the intensive care unit according to standardized criteria supported by national guidelines.
PC.18.4. The management plan decisions are shared between the ICU team and oncology team.
PC.18.5 If ICU services is not available within the cancer care facility , There is contract with other institution for access to ICU when needed near to the cancer service facility, and approachable within 15 minutes.
The intensive care unit is equipped with the medical devices, medications, and consumable materials required to meet the needs of oncology patients. Admission and discharge processes are coordinated between physicians, nurses, and other healthcare practitioners involved in the patient's care. The most responsible physician is assigned to each patient based on hospital policy and procedure.
PC.19. The radiology and laboratory services are fully equipped and have adequate resources to meet the (OMHCS) patients' needs.
PC.19.1. The radiology service is fully equipped for a wide spectrum of diagnostic procedures to match oncology patients' needs.
PC.19.2. Qualified and competent staff perform, evaluate, and report all radiological procedures conducted for oncology patients.
PC.19.3. The clinical laboratory service is fully equipped to conduct a wide spectrum of investigative procedures to meet oncology patients' needs.
PC.19.4. Qualified and competent staff perform and report the tests in the clinical laboratory and oncology-specific diagnostics.
Radiology services are provided to oncology patients around the clock by qualified and experienced staff who are competent in their field and hold valid SCFHS registration. The radiology service is equipped for a wide spectrum of diagnostic procedures and has access to specialized oncology imaging and digital archiving systems. Laboratory services also provide oncology-specific diagnostics, such as immunostaining, molecular testing, and flow cytometry, through qualified and experienced staff. When required services are not available internally, they are provided through external outsource arrangement.
PC.20. Oncology and malignant clinical services (OMHCS) is active in preventing disease recurrence and supports patients to pursue an independent healthy lifestyle.
PC.20.1. The service has a well-established multidisciplinary recurrence prevention and survivorship protocol for adult and pediatric patients.
PC.20.2. Oncology patients have an individualized secondary prevention and survivorship plan based on documented risks, diagnosis, treatment exposures, and long-term complications.
PC.20.3. Oncology patients receive structured counselling and education on lifestyle modification, medication adherence, monitoring for recurrence, management of late effects, and avoidance of risk factors.
PC.20.4. Patients and their caregiver actively participate in the development, understanding, and implementation of the secondary prevention and survivorship plan.
Secondary prevention and survivorship care form an integral part of the oncology service. A comprehensive multidisciplinary protocol guides follow-up after initial treatment to prevent recurrence, detect complications early, and support long-term recovery. Each patient receives an individualized survivorship plan tailored to diagnosis, treatment exposures, and personal risk factors. Patients and families receive ongoing counselling on recurrence warning signs, medication adherence, lifestyle modification, nutrition, physical activity, psychosocial well-being, and avoidance of modifiable risk factors.
PC.21. A skilled multidisciplinary team guides the provision of comprehensive oncology rehabilitation services.
PC.21.1. Oncology and malignant hematology clinical services (OMHCS) defines, in a written policy, the admission and discharge criteria for inpatient and outpatient rehabilitation services.
PC.21.2. The policy defines the components of individualized patient assessment.
PC.21.3. Rehabilitation services are provided promptly based on individualized patient assessment findings.
PC.21.4. Rehabilitation services encompass dietetics, pain management, nutritional needs, pharmacy, smoking cessation, psychiatry, and other services as required.
PC.21.5. Rehabilitation services provide individualized education and counselling to each patient.
Oncology rehabilitation programs support patients in managing their disease, modifying risk factors, and improving function, capacity, and physical fitness safely after treatment or an acute oncology event. This contributes to improving overall function, supporting quality of life, and enhancing self-confidence through gradual conditioning. The oncology rehabilitation policy defines inpatient and outpatient criteria and supports comprehensive individualized assessment, including pain management, nutrition, physical activity, psychosocial support, and counselling.
PC.22. Oncology and malignant hematology clinical services (OMHCS) conducts mortality and morbidity meetings regularly.
PC.22.1. The oncology and hematology services reviews mortality and significant morbidity cases at least monthly to highlight avoidable and potentially avoidable cases.
PC.22.2. Oncology and malignant hematology clinical services (OMHCS) focuses on scientific discussion, improvement, and prevention with a non-punitive intent during mortality and morbidity meetings.
PC.22.3. Oncology and malignant hematology clinical services (OMHCS) recommend actions for improvement and evaluate their effectiveness.
PC.22.4. Oncology and malignant hematology clinical services (OMHCS) refers mortality and morbidity cases involving other departments to the medical director for decision and discussion in the hospital mortality and morbidity committee.
Mortality and morbidity meetings take place regularly. Highlighted cases are distributed among peers before the meeting to identify areas for improvement. The meetings focus on scientific discussion, improvement, and prevention with a non-punitive intent. Shared cases between departments are referred to the medical director for a decision on discussion in the hospital mortality and morbidity committee.
PC.23. The oncology and hematology services ensure the timely management of oncology patients when their medical needs exceed the available services.
PC.23.1. Oncology and malignant hematology clinical services (OMHCS) has a written agreement and clear communication channels with other hospitals or centers for the timely transfer of oncology patients when medical needs exceed the available services.
PC.23.2. Oncology and malignant hematology clinical services (OMHCS) has access to oncology surgery either onsite or through a written agreement with an oncology surgery-capable hospital or center within an acceptable timeframe.
PC.23.3. Oncology and malignant hematology clinical services (OMHCS) has a pathway to refer emergency oncology conditions when patient needs exceed the available service.
Hospital readiness is comprehensive and integrated with uniform initial management. When indicated care exceeds what the current healthcare facility can provide, transfer to a higher level of care is initiated to support timely management of oncology patients. A written agreement is secured between the transferring and receiving facility, with evidence of effective use of the agreement through measures that support timely and safe transfer. The pathway includes oncology emergency conditions such as spinal cord compression when the required service is not available in-house.
PC.24. The cancer service facility has allocated single room/ waiting areas for neutropenic and immunocompromised patients.
PC.24.1 The single room is equipped with washing and toilet sitting
PC.24.2 High risk cancer Patients who are at risk of infection in the Emergency or radiology have a separate waiting area.
PC.24.3 High risk cancer Patients who are at risk of infection in radiation therapy department have a separate waiting area.
PC.24.4 High risk cancer Patients who are at risk st have clear instructions and cards with full information to be used when he/she goes to another facility in case of emergency
PC.24.5 The cancer service facility has Central line policy and procedures or guidelines.
PC.24.6 The cancer service facility staff have clear information about central line management
Explanation;
These Standard mandates allocation of single room / waiting areas for any neutropenic or immunocompromised cancer patients to meet rigorous infection control protocols, isolated physical infrastructure, and central line safety standards to protect neutropenic and immunocompromised cancer patients from opportunistic infections and to minimizes air-borne and contact pathogen exposure during transit, diagnostic testing, and radiation treatments and to guarantees immediately recognition of medical emergencies (like neutropenic fever) upon presentation and to prevent CLABSI (Central Line-Associated Bloodstream Infections)
Dedicated Isolation single room must be equipped with private, en-suite handwashing and toilet facilities.
High-risk patients must be provided separate, designated waiting areas in high-traffic outpatient departments, specifically Emergency, Radiology, and Radiation Therapy suites Patients at high risk of infection must receive clear written instructions and emergency alert cards (e.g., Febrile Neutropenia cards) to ensure rapid triage if visiting external medical facilities.
The facility must enforce a formalized Central Venous Access Device (CVAD) policy and ensure all care staff are thoroughly trained in central line management protocols.
PC.25. Oncology and malignant hematology clinical services (OMHCS) discharges patients through an efficient, safe, and timely process.
PC.25.1. The most responsible physician specifies the estimated date of discharge for each patient upon admission and updates it throughout the duration of stay.
PC.25.2. The most responsible physician identifies the clinical criteria for discharge and confirms the patient's suitability for discharge.
PC.25.3. Medications and support services necessary for a safe discharge are organized and documented in the discharge summary.
PC.25.4. The discharge summary and follow-up plan are discussed with and provided to the patient prior to discharge.
PC.25.5. Post-discharge care is coordinated based on the assessment of the patient and identified needs.
PC.25.6. The patient and family are educated about how to access care when needed.
Patients and families have the opportunity to identify and discuss post-discharge needs, such as physical, emotional, social, and community support needs, with members of the multidisciplinary team involved in discharge decisions. A documented post-discharge care plan is developed early in the care process in partnership with the patient and family, and a copy is provided to them. This may include community services, self-management strategies, medication information and compliance advice, goals and therapy to continue at home, oncology support services, rehabilitation or outpatient appointments, and an appropriate contact number for any queries. The patient and family receive information on how and when to re-access health and supportive services when required.
NURSING (NR)
NR.1 The Cancer Services facility Ensures oncology nursing services are led by qualified nursing leadership with appropriate training, licensure, and maintained competencies.
NR.1.1 The Nursing Director/Manager is a registered nurse qualified by education, training, and experience in oncology care.
NR.1.2 The Nursing Director/Manager has a current, signed job description specific to oncology services.
NR.1.3 The Nursing Director/Manager holds a valid and active SCFHS license.
NR.1.4 The Nursing Director/Manager maintains updated clinical competencies and professional credentials related to cancer care.
NR.1.5 Nursing leadership monitors competency completion and maintains a compliance database/Record for all nurses working in Oncology /haematology /Radiation and palliative care areas.
Ensures that the person responsible for oncology nursing has the professional background necessary to safely manage a specialized cancer service. Oncology is a high-risk area involving chemotherapy, immunotherapy, stem cell transplantation, complex symptom management, and potentially life-threatening complications. Therefore, the Nursing Director or Manager cannot rely only on general nursing management experience; the leader should have relevant oncology education , clinical experience and specialized oncology training.
The leader has a current job description clearly defining responsibilities, authority, accountability, reporting relationships, and the specific scope of the oncology service. A valid and active SCFHS license confirms that the individual is legally authorized to practice. Maintaining updated competencies and professional credentials ensures the leader remains clinically current and capable of providing oversight of rapidly evolving oncology practices.
In practice, the facility should be able to demonstrate the leader's CV, oncology experience, training certificates, SCFHS registration, signed job description, competency records, continuing education, and relevant professional development activities. Strong oncology nursing leadership promotes staff competency, policy compliance, patient safety, and evidence-based care.
Nursing leadership monitors competency completion and maintains a compliance database for all nurses working in Oncology /haematology /Radiation and palliative care areas.
NR.2 The cancer service facility Ensures effective oncology nursing leadership and workforce planning to provide safe, competent, and evidence-based cancer nursing care.
NR.2.1 The cancer service facility has an approved organizational structure defining oncology nursing leadership roles and reporting lines.
NR.2.2 The cancer service facility implements an approved oncology nursing staffing plan based on patient volume, acuity, and regulatory requirements.
NR.2.3 Nursing staff are allocated according to competency, qualifications, patient volume, and acuity in alignment with regulatory requirements.
NR.2.4 Nursing schedules ensure adequate oncology staffing on all shifts.
NR.2.5 Oncology nursing leadership participates in relevant multidisciplinary hospital committees.
NR.2.6 Oncology nursing leadership ensures oncology nursing policies and procedures are developed, approved, and reviewed according to facility policy.
focuses on how the oncology nursing service is organized and staffed. The organization have a clear and approved nursing structure showing who is responsible for the oncology service and the reporting relationship between nursing leaders and staff.
Staff assignments should also consider individual competency. Nurses should only be assigned responsibilities for which they are trained and competent. For example, high-risk chemotherapy should not be assigned to a nurse who has not completed the required competency and certification.
Schedules maintain safe staffing across all shifts, including nights, weekends, and holidays. Nursing leaders should also participate in multidisciplinary committees so nursing concerns are represented in decisions related to quality, patient safety, infection control, medication management, education, and clinical practice.
Another important responsibility is ensuring that oncology nursing policies and procedures remain current, approved, evidence-based, and reviewed according to organizational requirements.
NR.3 Nurses work allocation in oncology /Haematology services is adequate to serve cancer patients
NR.3.1 Nurses: Patients ration in General Adult and Paediatric oncology /Hematology is 1:3
NR.3.3 Nurses: Patients ration in Adult and Paediatric Bone Marrow Transplant units is 1:2
NR.3.1 Nurses: Patients ration in palliative care units is 1:4
A formal staffing plan should determine how many nurses are required based on factors such as patient volume, patient acuity, type of treatment, nursing workload, and regulatory requirements. Staffing should not be based only on the number of occupied beds. A patient receiving complex chemotherapy, stem cell transplantation, or experiencing severe complications may require significantly more nursing attention than a stable patient. The nurse-to-patient ratio adult and pediatric oncology/hematology 1 nurse:3 patients or fewer, adult and pediatric transplant/bone marrow transplant unit 1 nurse :2 patients or fewer, and palliative care unit 1 nurse :4 patients or fewer.
NR.4 The cancer service facility ensures oncology nursing staff are qualified, and clinically competent to provide safe cancer care.
NR.4.1 The cancer service facility maintains a sufficient qualified and competent oncology nursing staff according to an approved staffing plan.
NR.4.2 The cancer service facility has defined oncology nursing competency requirements and ensures staff undergo regular competency evaluations.
NR.4.3 Each oncology nurse has a current, signed job description specific to oncology services.
NR.4.4 Oncology nurses complete a structured orientation program upon hiring.
NR.4.5 Orientation program includes competency file with validated oncology clinical skills before assuming independent duties.
NR.4.6 The cancer service facility nursing staff have documented competency assessment for Cytotoxic agent & target therapy Administration and Cytotoxic Agents, hazardous material.
NR.4.7 The cancer service facility nursing staff have documented competency assessment for Central lines venous access devices care: Implanted Venous Port Cath, Peripherally Inserted Central Catheter Line (PICC), Central line, Femoral line, Porta A Cath, Hickman line, Permcath.
The facility maintains an adequate number of competent oncology nurses according to its approved staffing plan.
The organization clearly define the competencies required for oncology nursing practice. These may include cancer assessment, central line management, chemotherapy safety, management of treatment-related toxicities, infection prevention, oncologic emergency recognition, pain management, and other competencies appropriate to the service.
Each nurse should have a current and signed oncology-specific job description so that responsibilities and expectations are clearly defined.
Newly hired nurses complete a structured orientation before functioning independently. Orientation should contain both theoretical and clinical elements and result in validated competency documentation.
The cancer service facility nursing staff working in cancer center / department should have documented competency assessment for Cytotoxic agent & target therapy Administration and Cytotoxic Agents, hazardous material.
The cancer service facility nursing staff working in cancer center should have documented competency assessment for Central lines venous access devices such as Implanted Venous Port Cath, Peripherally Inserted Central Catheter Line (PICC), Central line, Femoral line, Porta A Cath, Hickman line, Permcath.
NR 5. The oncology nurses working in highly specialized areas has validated oncology clinical skills and competency assessment related to the specialized area before assuming clinical duties.
NR.5.1 The radiotherapy / unsealed radiation isotopes therapy nursing staff have documented competency assessment for radiation safety and radiation spill / contamination management.
NR.5.2 The BMT nursing staff have documented competency assessment for Blood and Blood product transfusion and reactions and Stem Cell Infusion
NR.5.3 The palliative care nursing staff have documented competency assessment for Pain Management, End of life care, Administration and monitoring of Controlled Analgesia and its toxicity.
NR.5.4 The oncology nursing staff have documented competency assessment for stoma care.
The cancer service facility nursing staff working in highly specialized areas such as radiotherapy or bone marrow transplant units or palliative care units should have the skills and competency to deal with potential clinical incidents related to the area for example:
radiation safety and radiation spill / contamination management, Stem Cell Infusion, Pain Management, End of life care, Administration and monitoring of Controlled Analgesia and its toxicity.
NR.6 The cancer service facility ensures oncology nurses maintain ongoing competency through structured education, regular assessment, and verification of qualifications.
NR.6.1 Oncology nurses' complete competency-based practice assessments at intervals defined by the facility's policy.
NR.6.2 The facility uses validated and varied methods to assess oncology nursing competency.
NR.6.3 Competency assessment records are maintained in individual staff files.
NR.6.4 Nursing leadership monitors competency completion and maintains a compliance database/Record.
NR.6.5 Nurses administering chemotherapy or other high-risk therapies hold formal certification as per facility policy.
NR.6.6 Oncology nurses are trained to recognize oncologic emergencies and complete required education.
Oncology practice changes continuously as new medications, treatment protocols, technologies, and safety recommendations are introduced. Therefore, competency cannot be considered permanent after initial orientation.
Nurses should undergo competency-based assessments at intervals defined by hospital policy. The organization should use different validated assessment methods rather than relying only on written exams. Examples may include direct observation, return demonstration, simulation, case discussion, knowledge testing, competency checklists, and clinical performance evaluation.
Evidence of competency should be maintained in each employee's file, while nursing leadership should maintain a tracking system showing completion and expiration dates.
High-risk activities require additional controls. Nurses administering chemotherapy or other high-risk oncology therapies must have the certification or formal authorization required by facility policy.
The aim is to ensure that staff continue to demonstrate the knowledge and skills necessary for safe oncology practice rather than assuming continued competence simply because they have worked in the department for many years.
Cancer patients can deteriorate rapidly. Nursing staff should therefore be trained to identify oncologic emergencies and initiate appropriate responses without unnecessary delay.
The facility should have standardized escalation pathways such as RRT, Code Blue, or oncology emergency algorithms.
Emergency medications and equipment should be readily accessible, functional, and regularly checked.
Examples of situations nurses may need to recognize include severe infusion reactions, sepsis, febrile neutropenia, tumor lysis syndrome, spinal cord compression, superior vena cava syndrome, severe electrolyte abnormalities, bleeding, or respiratory deterioration, depending on the clinical service.
Nursing assessment, escalation, communication, interventions, and patient responses should all be documented.
NR.7 the cancer service facility Ensures oncology nursing practice supports patients and families through culturally sensitive assessment, education, communication, and continuity of care.
NR.7.1 Oncology nurses conduct timely and culturally sensitive assessments of patients' clinical and supportive care needs.
NR.7.2 Oncology nurses assess and address the supportive care needs of patients' families using culturally appropriate approaches.
NR.7.3 Oncology nurses provide patient and family education and psychosocial–spiritual support throughout the cancer care journey.
NR 7.4 Oncology nurses ensure continuity of care by communicating patient needs, updates, and treatment plans across care settings.
Cancer affects much more than a patient's physical health. It may affect emotional wellbeing, social relationships, financial circumstances, spiritual beliefs, family roles, and quality of life.
Nurses should therefore perform timely assessments that consider both clinical and supportive care needs. They should identify concerns such as symptoms, anxiety, coping difficulties, educational needs, cultural preferences, and family support needs.
Family members may also experience distress and require information, support, and guidance. Interventions should respect cultural and religious values and individual preferences.
Patient and family education should continue throughout the cancer journey rather than occurring only at admission or discharge. Nurses should explain treatment, possible complications, symptom management, medications, precautions, and appropriate actions if problems develop.
Continuity of care is particularly important because oncology patients frequently move between inpatient wards, outpatient clinics, chemotherapy units, radiation oncology, emergency services, palliative care, and home. Relevant information must therefore be communicated accurately between care settings.
NR.8 The cancer service facility ensures that chemotherapy and other high-risk oncology therapies are safely and consistently administered by competent oncology nurses using standardized verification, handling, administration, monitoring, and post-treatment care processes.
NR.9 The cancer service facility ensures oncology nurses implement infection prevention practices and neutropenic precautions to reduce the risk of health-associated infections and complications in immunocompromised patients.
Many oncology patients are at increased infection risk because of chemotherapy, neutropenia, immunosuppression, central venous devices, transplantation, and prolonged hospitalization.
Nurses should assess patients for infection risks and early signs of infection or neutropenia.
When indicated, neutropenic precautions should be implemented according to facility policy. The document identifies elements including positive-pressure rooms, visitor restrictions, food safety, environmental controls, and staff education.
Central lines require standardized assessment each shift. Nurses should examine for redness, tenderness, drainage, dressing integrity, securement, and other possible signs of infection.
Patient and family education is also important. They should understand hand hygiene, central-line protection during bathing, and symptoms that must be reported.
Suspected infection, febrile neutropenia, possible CLABSI, or sepsis indicators should be escalated promptly and managed using the appropriate clinical pathway.
Education should be reinforced throughout hospitalization, and the nurse should validate understanding rather than simply documenting that information was provided.
Any infection-control breach should also be documented and escalated according to policy.
The overall objective is prevention, early recognition, rapid escalation, and reduction of healthcare-associated infections.
NR.10 The cancer service facility ensures oncology nurses provide safe transition and discharge planning with oncology- specific instructions, symptom alerts, medication safety, follow up coordination and emergency contact information.
Discharge is a high-risk period because oncology patients may continue experiencing treatment-related complications after leaving the hospital.
Nurses should provide clear instructions covering medications, important symptoms, and when urgent medical review is required.
Home education may include: oral chemotherapy handling, infection prevention, hydration, nutrition, activity restrictions, and other treatment-specific precautions.
Patient and family understanding should be confirmed rather than assumed.
Follow-up appointments and required referrals should be organized.
When patients move to outpatient services, home healthcare, specialty clinics, or other facilities, relevant clinical information must be clearly handed over.
The aim is to prevent treatment interruption, medication errors, avoidable emergency visits, complications, and loss of continuity between services.
NR.11 the cancer services facility establishes a system for the assessment, reassessment, and management of pain for all patient.
Every cancer patient should initially be screened for pain.
When pain is present, nurses should perform a comprehensive assessment using a standardized and validated tool.
Assessment should include characteristics such as: location, intensity, quality, and frequency.
Pain should then be reassessed according to the patient's condition and care plan.
Importantly, pain should also be reassessed after interventions. The facility should define how soon reassessment must occur following pharmacological and non-pharmacological interventions.
Reassessment determines whether the treatment was effective or whether additional intervention is required.
All assessment and reassessment findings should be documented so clinicians can evaluate the effectiveness of the pain-management plan.
Effective pain management can improve comfort, mobility, sleep, function, quality of life, and the overall treatment experience.
NR.12 The cancer service facility ensures that radiation oncology nursing care is delivered safely and effectively through comprehensive assessment, individualized care planning, ongoing monitoring, patient and family education, staff competency, accurate documentation, and compliance with radiation safety requirements.
Bone Marrow Transplant (BMT) and Cellular Therapy Services
BMT.1. The BMT program is governed by a formally constituted leadership structure with defined accountability for clinical quality, safety, and compliance with national and international standards.
BMT.1.1. The BMT program designates a qualified BMT Program Director who holds subspecialty training in hematology or hematology-oncology with documented experience in stem cell transplantation, as recognized by the SCFHS.
BMT.1.2. The BMT program designates a BMT Nursing Director or Lead Transplant Nurse responsible for nursing practice, staffing, and clinical competency within the transplant unit.
BMT.1.3. The BMT program has a designated Quality Manager or Quality Officer who oversees the program's quality management system, documentation, and accreditation compliance.
BMT.1.4. The BMT program maintains a formal multidisciplinary BMT team that meets at least monthly and includes transplant physicians, transplant coordinators, clinical pharmacists, dietitians, psychosocial specialists, and data managers.
BMT.1.5. The BMT program meets minimum annual transplant volume thresholds: a minimum of ten (10) transplants per year for autologous programs and\or a minimum of ten (10) transplants per year for allogeneic programs, to maintain clinical competency and data integrity.
BMT.1.6. The BMT program operates a written quality management plan that includes defined key performance indicators (KPIs), audit cycles, adverse event reporting, and an annual program review.
BMT.1.7. The BMT program maintains active membership in, or data submission to, a recognized national or international BMT registry.
Effective governance is foundational to the safe and consistent delivery of BMT services. The Program Director provides overall clinical leadership and is accountable for the program's compliance with CBAHI, Foundation for the Accreditation of Cellular Therapy (FACT)- Joint Accreditation Committee of ISCT and European Society for Blood and Marrow Transplantation EBMT standards They are developed jointly by the (US) and the (JACIE) (Europe). In Europe and surrounding regions, these standards operate under the oversight of the. The multidisciplinary team model ensures that the complex needs of transplant patients are addressed collaboratively. Minimum volume thresholds are established to ensure that clinical teams maintain the procedural experience and institutional knowledge required to achieve outcomes consistent with international benchmarks. The quality management plan forms the backbone of continuous improvement and regulatory compliance.
BMT.2. The BMT unit is designed, equipped, and maintained to provide a safe physical environment that minimizes infection risk and supports the specialized care requirements of immunocompromised transplant patients.
BMT.2.1. The BMT inpatient unit consists of single-occupancy rooms with en-suite bathroom facilities, maintained under positive air pressure relative to the corridor, with HEPA filtration providing a minimum of twelve (12) air changes per hour.
BMT.2.2. Room design and construction comply with applicable national facility planning guidelines and international standards for transplant units, including requirements for surface materials, ventilation, and infection prevention.
BMT.2.3. The BMT unit has dedicated nursing stations, medication preparation areas, and patient support spaces physically separated from general oncology ward areas, as well as a dedicated ambulatory area for pre- and post-transplant management, including infusion bays and clinical assessment rooms.
BMT.2.4. The BMT unit is equipped with continuous monitoring systems capable of recording vital signs — including temperature, blood pressure, heart rate, oxygen saturation, and fluid balance — at the bedside and at nursing stations.
BMT.2.5. Emergency resuscitation equipment, including crash carts and defibrillators, is immediately accessible within the BMT unit and checked on a defined schedule.
BMT.2.6. Pharmacy services, blood bank, and clinical laboratory services are integrated with or rapidly accessible from the BMT unit within defined response timeframes.
BMT.2.7. The BMT cell processing laboratory meets the requirement of minimum cell manipulation standards and is physically separate from clinical care areas, with restricted access and continuous environmental monitoring.
The physical environment of a BMT unit directly impacts patient safety, particularly infection risk in severely immunocompromised patients. Positive pressure HEPA-filtered rooms reduce the incidence of invasive fungal infections and other airborne pathogens. Single-occupancy rooms with en-suite facilities are mandatory to prevent cross-infection. The cell processing laboratory requires Good Manufacturing Practice (GMP)-equivalent conditions to ensure the safety, identity, potency, and sterility of cellular therapy products. Proximity to pharmacy, blood bank, and laboratory services reduces critical response times during life-threatening complications such as engraftment failure or severe graft-versus-host disease (GVHD).
BMT.3. The BMT program applies rigorous, evidence-based criteria for patient selection and conducts a comprehensive pre-transplant evaluation to ensure transplant eligibility and optimize patient outcomes.
BMT.3.2. All transplant candidates undergo a standardized pre-transplant evaluation that includes cardiac, pulmonary, renal, hepatic, and performance status assessment, using validated tools such as the HCT-CI (Haematopoietic Cell Transplantation Comorbidity Index).
BMT.3.3. Infectious disease screening, including CMV, EBV, HIV, hepatitis B and C, HTLV, syphilis, and tuberculosis, is performed for all transplant candidates as part of the pre-transplant evaluation.
BMT.3.4. A psychosocial assessment and nutritional assessment are conducted for all transplant candidates prior to transplant, with individualized support plans developed and documented for each domain.
BMT.3.5. Fertility preservation counselling is offered to all patients of reproductive age prior to conditioning, in accordance with national guidelines and the patient's clinical condition.
BMT.3.6. All transplant candidates and their families receive structured education about the transplant process, anticipated complications, recovery timeline, and long-term follow-up requirements; informed consent is obtained using a disease- and procedure-specific consent document and recorded in the medical record.
BMT.3.7. All transplant cases are reviewed and approved by the BMT multidisciplinary tumor board prior to proceeding, with the decision and rationale documented in the medical record.
Comprehensive pre-transplant evaluation identifies comorbidities that may increase transplant-related mortality and informs the choice of conditioning intensity, donor source, and supportive care strategy. The HCT-CI is a validated tool that predicts non-relapse mortality and guides risk-adapted decision-making. Psychosocial assessment ensures that patients have the emotional and social resources required to navigate the transplant process and adhere to complex post-transplant care. Fertility counselling acknowledges the potential impact of high-dose conditioning on reproductive capacity and upholds patient autonomy. MDT tumor board review ensures that transplant decisions are evidence-based, consensus-driven, and appropriately documented.
BMTCTS.4. The BMT program conducts thorough, standardized evaluation and selection of donors for allogeneic transplantation to ensure donor safety, product quality, and recipient compatibility.
BMT.4.1. HLA typing of patients and potential donors is performed by a laboratory accredited or recognized by the relevant national or international authority, using high-resolution molecular typing for all allogeneic transplant pairs.
BMT.4.2. The BMT program has access to national and international unrelated donor registries, and the unrelated donor search process complies with WMDA (World Marrow Donor Association) standards.
BMT.4.3. All allogeneic donors undergo a comprehensive medical evaluation that includes complete history, physical examination, full blood count, metabolic panel, coagulation screen, organ function assessment, and infectious disease serology covering CMV, EBV, HIV 1/2, hepatitis B and C, HTLV I/II, syphilis, and other tests as indicated by national guidelines or donor history.
BMT.4.4. All donors receive independent medical assessment and education by a physician not directly involved in the care of the recipient, to protect donor interests and ensure voluntary, informed participation and detailed HLA typing education
BMT.4.5. Donor informed consent is obtained through a structured process that clearly explains the donation procedure, associated risks, alternatives, and the voluntary nature of participation, and is documented in the donor's dedicated medical record.
BMT.4.6. Pediatric donors receive age-appropriate information and assent, with legal guardian consent.
BMT.4.7. Donor follow-up is conducted at defined intervals post-donation to assess recovery and identify any donation-related adverse events.
BMT.4.8. The BMT program maintains written donor selection criteria for each transplant indication, aligned with current The European Society for Blood and Marrow Transplantation (EBMT) and the American Society for Transplantation and Cellular Therapy (ASTCT) or equivalent international guidelines, and approved by the BMT multidisciplinary team.
Donor safety and product quality are paramount in allogeneic transplantation. Independent medical assessment of related donors protects against coercion and ensures that donation decisions are truly voluntary. High-resolution HLA typing minimizes the risk of graft failure and severe GVHD. Compliance with WMDA standards ensures ethical and safe management of unrelated donor searches. Comprehensive infectious disease screening protects both donor and recipient. Donor follow-up is an ethical obligation and provides important data on long-term donor outcomes.
BMT.5. Stem cell products are collected, processed, cryopreserved, and stored in accordance with Good Manufacturing Practice GMP-equivalent standards that ensure product safety, identity, potency, purity, and sterility.
BMT.5.1. The apheresis unit performing stem cell collection meets applicable national and international standards for apheresis practice and is staffed by trained and competent personnel.
BMT.5.2. Peripheral blood stem cell mobilization protocols are standardized and evidence-based, including criteria for mobilization failure and alternative strategies; bone marrow harvest procedures are performed in a licensed operating theatre by trained personnel following written standard operating procedures.
BMT.5.3. All cellular therapy products are assigned a unique identifier and labelled in accordance with International Society of Blood Transfusion ISBT 128 standards throughout collection, processing, and administration, ensuring full traceability and chain of identity.
BMT.5.4. The cell processing laboratory performs product characterization, including CD34+ cell count and viability assessment, for all products prior to release for clinical use.
BMT.5.5. Sterility testing is performed on all cellular therapy products in accordance with written standard operating procedures, with defined action thresholds, hold policies, and documented product release criteria that verify identity, sterility, viability, and minimum cell dose.
BMT.5.6. Cryopreservation procedures follow validated, written protocols performed using programmable controlled-rate freezers, with cryoprotectant composition, cooling rates, and storage temperatures documented for each product.
BMT.5.7. Cryopreserved products are stored in dedicated liquid nitrogen storage vessels with continuous temperature monitoring, automated alarm systems, and defined backup contingency plans.
The integrity of the stem cell product is a prerequisite for successful engraftment and transplant outcome. International Society of Blood Transfusion ISBT 128 labelling provides a globally recognized system for unambiguous product identification and traceability from collection to administration. CD34+ cell count and viability assessment at the time of product release ensures the minimum therapeutic dose is met. Validated cryopreservation protocols prevent product degradation during storage, which may otherwise compromise engraftment. Continuous temperature monitoring with automated alarms protects against inadvertent product loss due to equipment failure. Chain of identity at every step is mandatory to prevent misidentification errors that could have fatal consequences.
BMT.6. The BMT program implements conditioning regimens and transplant procedures in accordance with evidence-based protocols, with robust safety checks to prevent medication errors and ensure patient safety throughout the transplant process.
BMT.6.1. All conditioning regimens are prescribed using standardized, disease-specific and patient-specific protocols approved by the BMT multidisciplinary team and reviewed at defined intervals.
BMT.6.2. Conditioning chemotherapy and radiotherapy agents are prepared, verified, and administered using a minimum double-check process by qualified pharmacy and nursing staff, with independent verification of dose, schedule, and route.
BMT.6.3. Patient weight, height, body surface area, and organ function are verified immediately prior to conditioning to confirm dose accuracy, and any dose modification is documented with clinical rationale.
BMT.6.4. Total body irradiation (TBI), where used, is delivered by a radiation oncology team experienced in transplant-related TBI, following a written protocol that defines fractionation schedule, shielding, and dosimetry verification.
BMT.6.5. Stem cell infusion is performed by a trained nurse or physician according to a written protocol specifying infusion rate, monitoring parameters, premedication, and management of acute infusion reactions; patients are monitored continuously throughout infusion with resuscitation equipment immediately available at the bedside.
BMT.6.6. GVHD prophylaxis regimens are standardized by transplant type and indication, prescribed according to written protocols, and administered with the same double-check verification standards applied to conditioning chemotherapy.
BMT.6.7. Medication reconciliation is performed at each transition of care during the transplant admission, and a current, accurate medication list is maintained in the medical record.
High-dose conditioning regimens carry a narrow therapeutic window and significant potential for life-threatening toxicity. Standardized protocols reduce variability and the risk of error. The independent double-check process for chemotherapy preparation and administration is a recognized patient safety requirement for high-risk medications. Dose verification based on current weight and organ function is critical, as conditioning regimens are typically body-surface-area or weight-based. TBI protocols require radiation oncology expertise to ensure accurate dosimetry and minimize organ toxicity. During stem cell infusion, reactions including anaphylaxis, cardiovascular compromise, and haemolysis may occur and require immediate bedside intervention.
BMT.7. The BMT program implements comprehensive, evidence-based protocols for the monitoring and management of post-transplant complications to minimize transplant-related morbidity and mortality.
BMT.7.1. Engraftment is monitored using standardized criteria; neutrophil and platelet engraftment dates are recorded for every patient, and chimerism testing is performed at defined time points for all allogeneic recipients using validated methods to guide clinical decision-making.
BMT.7.2. Standardized grading systems are used for both acute GVHD and chronic GVHD (NIH consensus criteria), with evidence-based, protocol-driven treatment pathways for each grade and a defined multidisciplinary follow-up schedule.
BMT.7.3. Infection prophylaxis protocols are implemented for bacterial, fungal, and viral pathogens, including mandatory antifungal and PCP prophylaxis, and quantitative PCR monitoring for CMV and EBV at defined intervals to guide pre-emptive therapy.
BMT.7.4. A Veno-Occlusive Disease (VOD/SOS) prevention and management protocol is implemented using validated diagnostic criteria (EBMT revised criteria or equivalent), with defined risk stratification tools and treatment algorithms.
BMT.7.5. Minimal residual disease (MRD) monitoring is performed at defined post-transplant intervals for applicable diagnoses using validated methods, and a written protocol guides the management of graft failure, including salvage options and escalation pathways.
BMT.7.6. Immune reconstitution is monitored at defined time points and a post-transplant vaccination schedule is implemented according to current national and international guidelines.
BMT.7.7. Nutritional support, physiotherapy, and psychosocial support services are integrated into the post-transplant care plan from the time of admission and are re-assessed at defined intervals throughout the transplant course.
Post-transplant complications are the primary driver of transplant-related morbidity and mortality. GVHD, infections, VOD/SOS, and graft failure require early recognition and protocol-driven management to achieve outcomes consistent with international standards. Standardized grading systems ensure consistent communication between clinicians and enable meaningful benchmarking of outcome data. CMV and EBV monitoring allows pre-emptive antiviral therapy before clinical disease develops, significantly reducing transplant-related mortality. MRD monitoring enables early detection of disease recurrence, allowing timely therapeutic intervention. Integrated nutritional and psychosocial support from day zero reduces post-transplant complications and improves quality of life during the critical recovery period.
BMT.8. The BMT program that offers advanced cellular therapies, including chimeric antigen receptor T-cell (CAR-T) therapy, meets the additional structural, clinical, and safety requirements specific to these treatments.
BMT.8.1. The CAR-T program designates a qualified clinical lead with documented training and experience in CAR-T administration and management of associated toxicities.
BMT.8.2. Patient selection for CAR-T therapy is performed by specialize multidisciplinary team in accordance with approved indications, current clinical evidence, and the specific product label.
BMT.8.3. A standardized leukapheresis protocol is maintained for T-cell collection, including patient eligibility criteria and minimum collection targets; chain of identity is verified and documented at every step from collection through manufacturing, shipping, and re-infusion.
BMT.8.4. All patients receiving CAR-T therapy are managed in a clinical setting capable of recognizing and treating Cytokine Release Syndrome (CRS) and Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS) using ASTCT consensus grading, with written protocols covering ICU escalation criteria, tocilizumab administration, and corticosteroid use.
BMT.8.5. Patients receiving CAR-T therapy are monitored in a setting with immediate access to intensive care services for a minimum observation period as defined by the product manufacturer and clinical protocol.
BMT.8.6. Pharmacovigilance obligations are met through timely reporting of all serious adverse events and unexpected serious adverse reactions to the product manufacturer, the national health authority, and the program quality management system.
BMT.8.7. All CAR-T outcomes, including response rates, toxicity data, and long-term follow-up, are reported to the relevant registry and the national health authority in accordance with regulatory requirements.
CAR-T cell therapy represents a paradigm shift in cellular immunotherapy and requires specialized infrastructure and clinical expertise beyond that needed for conventional stem cell transplantation. CRS and ICANS are potentially life-threatening toxicities unique to CAR-T therapy that can develop rapidly and require immediate, protocol-driven intervention. ASTCT consensus grading provides a standardized framework for toxicity assessment that enables consistent clinical management and outcome reporting. Chain of identity for CAR-T products is critical, as product misidentification can result in fatal outcomes. National regulatory approval is required prior to program initiation to ensure patient protection and pharmacovigilance.
BMT.9. The BMT program provides structured long-term follow-up for all transplant survivors, with individualized care plans that address the surveillance and management of late effects of transplantation.
BMT.9.1. A dedicated long-term follow-up (LTFU) program is established and staffed by clinicians with expertise in post-transplant late effects for both adult and paediatric populations.
BMT.9.2. Each transplant survivor receives an individualized Survivorship Care Plan (SCP) that documents the transplant history, conditioning regimen, and a personalized late effects surveillance schedule.
BMT.9.3. The LTFU program monitors and manages late effects including secondary malignancies, endocrine dysfunction (including growth failure in paediatric patients), cardiac and pulmonary toxicity, renal dysfunction, bone density loss, cataracts, and chronic GVHD.
BMT.9.4. Post-transplant vaccination is administered according to a written schedule aligned with current EBMT and national immunization guidelines, with documentation in the medical record.
BMT.9.5. Psychosocial follow-up and support services are available to all transplant survivors, with access to oncology psychology, social work, and peer support resources.
BMT.9.6. Patients are educated about late effects, signs of relapse, and when and how to access care, and this education is documented.
BMT.9.7. The BMT program maintains long-term outcome data for a minimum of five (5) years post-transplant.
Transplant survivors face a substantial burden of late effects resulting from high-dose conditioning, immunosuppression, chronic GVHD, and prolonged immune deficiency. A structured LTFU program ensures that these complications are identified and managed proactively. Secondary malignancies are among the most serious late complications and require long-term cancer screening. Endocrine late effects, including hypothyroidism, adrenal insufficiency, and gonadal failure, are common and significantly impact quality of life. Paediatric transplant survivors require specialist surveillance for growth and neurodevelopmental outcomes. The individualized SCP empowers patients to understand their health risks and engage actively in their own long-term care.
BMT.10. The BMT program maintains a robust data management system that supports real-time clinical decision-making, quality improvement, regulatory compliance, and benchmarking against national and international outcomes standards.
BMT.10.1. The BMT program designates a trained data manager responsible for the accurate and timely collection, entry, and submission of transplant data to the national and/or international registry.
BMT.10.2. The BMT program submits outcome data to a recognized registry — such as the EBMT Registry, the CIBMTR, or a nationally designated equivalent — in accordance with the registry's data submission requirements.
BMT.10.3. The following minimum outcomes are tracked and reported for all transplants: 100-day non-relapse mortality (NRM), one-year overall survival (OS), engraftment rate, acute GVHD incidence (grades II–IV and III–IV), relapse incidence, and primary graft failure rate.
BMT.10.4. The BMT program reviews its own outcomes data at least annually, benchmarks performance against national and international reference data, and uses findings to drive quality improvement initiatives.
BMT.10.5. Adverse events related to the transplant process, including serious adverse events (SAEs) and unexpected serious adverse reactions (USARs), are reported through the program's quality management system and to the relevant national authority.
BMT.10.6. The BMT program participates in national or international peer review or external audit processes as required for accreditation maintenance.
BMT.10.7. Patient data is managed in compliance with applicable Saudi data protection legislation, and access is restricted to authorized personnel.
Robust data management is the foundation of evidence-based quality improvement in BMT. Outcomes benchmarking against reference populations allows programs to identify underperformance and implement targeted interventions. Registry participation provides programs with access to aggregated international data that is not available from single-center experience alone, and enables identification of risk factors and best practices. Transparent reporting of adverse events supports a culture of patient safety and continuous learning. Annual outcomes review by the BMT multidisciplinary team with documented improvement actions closes the quality loop and is a core requirement of FACT-JACIE accreditation. Compliance with national data protection law protects patient privacy and institutional integrity.
Palliative and supportive care PSC
PSC.1 Cancer care service provides palliative and end-of-life care.
PSC.1.1 There is an identified structure for palliative care services in the organization chart.
PSC.1.2 There is a process to palliate cancer symptoms.
PSC.1.3 There is a process to provide end-of-life care services.
PSC.1.4 Palliative care services led by a palliative care consultant.
PSC.1.5 Palliative care services cover medical, nursing, psychosocial, and physical services.
PSC.1.6 Palliative care services have internal palliative care polices and procedures.
PSC.1.7 Palliative care services apply national palliative care clinical guidelines
To ensure the organization delivers comprehensive, structured, and high-quality palliative and end-of-life care for cancer patients. This is achieved through a clearly defined service model, evidence-based clinical processes, multidisciplinary leadership, and adherence to both internal protocols and national standards, thereby addressing the holistic needs of patients and their families.
To guarantee the systematic provision of palliative and end-of-life care. The requirements (PSC.1.1 through PSC.1.7) are designed to ensure:
Governance & Structure: Care is delivered by an identified, consultant-led service within the organizational framework (PSC.1.1, PSC.1.4).
Clinical Process: Standardized processes exist for symptom management and end-of-life care (PSC.1.2, PSC.1.3).
Comprehensive Scope: Care addresses the full spectrum of medical, nursing, psychosocial, and physical needs (PSC.1.5).
Quality & Compliance: Services operate under internal policies and national clinical guidelines to ensure safety, consistency, and best practices (PSC.1.6, PSC.1.7).
PSC.2 Palliative care units have the resources to provide palliative and end-of-life care for admitted patients
PSC.2.1 The facility allocates identified space to the Palliative care unit.
PSC 2.2 The facility allocate 10% of Oncology beds to the palliative care unit
PSC.2.3 The facility has appropriate space to conduct family meetings and counselling services for palliative care patients and their families.
PSC.2.4 The palliative care unit has an open visiting hour policy.
PSC.2.5 Palliative care services provide educational materials that are available and accessible throughout the cancer service facility
To ensure the Palliative Care Unit is appropriately resourced with dedicated space, staffing, and a supportive environment to deliver high-quality, compassionate palliative and end-of-life care to admitted patients. This standard guarantees the physical and operational infrastructure necessary for effective clinical management, family support, privacy, and unrestricted patient-family contact, in alignment with the principles of holistic palliative care.
To establish that palliative care is resourced as a core clinical service, not an afterthought. The requirements ensure:
Dedicated Capacity: A physically identified unit with a defined minimum bed allocation (10% of oncology beds) ensures available and appropriate care (PSC.2.1, PSC.2.2).
Supportive Environment: Private spaces for family meetings and counseling protect confidentiality and facilitate crucial communication (PSC.2.3).
Patient-Centered Access: An open visiting policy recognizes the vital role of family and loved ones in care and comfort (PSC.2.4).
Integrated Education: Readily available educational materials throughout the facility promote awareness and access to palliative care services (PSC.2.5).
PSC.3 Palliative care services monitor and measure service outcomes
PSC.3.1 Incidence of pressure injury in palliative care unit.
PSC.3.2 Evidence of proper comfort measures tools (ESASr) for all admitted patients.
PSC.3.3 Percentage of death incidence in privacy.
To establish a systematic framework for monitoring, measuring, and evaluating the quality and effectiveness of palliative care services through defined outcome indicators. This standard ensures that care delivery is data-driven, focused on patient comfort and dignity, and subject to continuous review and improvement based on key clinical and experiential metrics.
To implement a focused outcomes measurement system that evaluates the service on fundamental aspects of palliative care quality:
Clinical Safety & Prevention: Monitoring the incidence of pressure injuries serves as a key indicator of nursing care quality and proactive patient safety measures (PSC.3.1).
Symptom Management & Comfort: Requiring documented use of validated tools (ESAS-r) ensures standardized assessment and proactive management of distressing symptoms for every patient (PSC.3.2).
Respect for Dignity & Privacy: Measuring the percentage of deaths occurring in privacy ensures the service is organized to honor a fundamental aspect of dignified, person-centered end-of-life care (PSC.3.3).
PSC.4 The cancer care service provides nutritional services to oncology patients
PSC.4.1 Availability of a qualified dietitian to provide disease-related oral, enteral, and parenteral nutritional assessment and management.
PSC.4.2 Dietary and nutritional services are provided on-site.
PSC.4.3 There is a process for nutritional screening and assessment by a qualified dietitian for oncology patients.
PSC.4.4 There is a process for referral to a dietary services dietitian to address the nutritional needs of palliative & EOL care patients.
PSC.4.5 Infection control measures are implemented during food preparation and delivery to the cancer patients and watchers
PSC4.6 There is a process for enteral and parenteral nutrition preparation and handling.
to ensure that nutritional care is recognized as an essential, non-negotiable component of comprehensive cancer treatment. It requires the cancer service to proactively address the specific dietary needs of all oncology patients to optimize treatment tolerance, manage side effects, preserve physical function, and improve overall quality of life.
PSC.5 The cancer care service has a process for Breaking Bad News to Patients and their families
PSC.5.1 There is a process to guide healthcare professionals involved in breaking bad news to patients and their families.
PSC.5.2 The process contains procedures for delivering bad news if family members are unable to attend the hospital.
PSC5.3 Breaking bad news should be performed by the patient most responsible consultant and representative of social worker or spiritual advisor or psychology specialist.
PSC.5.4 All delivery of news to patients and/or their families is documented in the patient's medical records.
PSC.5.5 Medical interpretation is available when needed.
to ensure that the communication of life-altering, distressing information—such as a cancer diagnosis, disease progression, or transition to palliative care—is conducted with maximum empathy, clarity, and support, minimizing trauma and fostering a trusting therapeutic relationship.
PSC.6 The Cancer care service ensures that palliative care services are led and managed and operated by a qualified professional.
PSC.6.1 Palliative care are managed by a qualified palliative care consultant by SCFHS to plan, guide & manage the administrative and clinical activities for delivering Palliative Care services throughout the cancer service facility.
PSC.6.2 Palliative care unit is staffed with at qualified physicians with ration of 1 physician to serve up to 12 patients.
PSC.6.3 Palliative care run by a qualified palliative care nurse by SCFHS.
PSC.6.4 Palliative care unit is staffed with a nurse with ratio of 1 nurse to serve 4 patients.
PSC.6.5 Palliative care unit is covered by the services of physical /occupational therapy.
PSC.6.6 Palliative care unit is covered by the services of social workers services. .
The standard is to ensure that leadership, coordination, and clinical oversight palliative care are entrusted to an individual with the qualifications, expertise, and authority to deliver safe, high-quality care. The service must be led by a qualified professional with clinical expertise in palliative medicine and the administrative capability to plan, manage, and govern the service across the cancer facility.
Palliative care unit is staffed with at qualified physicians with ration of 1 physician to serve up to 12 patients.
The palliative care services operated by qualified nurse in palliative care and staffed by nurses with ratio of 1:4.
The palliative care services are covered by the services of physical or occupational therapy and social worker services.
PSC.7 The Cancer care service collaborate with that hospice and palliative home care services and long-term facilities if needed
PSC.7.1 The cancer care service has a process for transfer patients to and from hospice, palliative home care and long-term facilities.
PSC.7.2 The hospice care center and long-term facilities receiving cancer patient have qualified palliative care consultant to supervise the services and nurses to deliver palliative care services 24 hours.
PSC.7.3 The hospice care center and long-term facilities receiving cancer patient have license to care for cancer palliative care services.
PSC.7.4 The palliative care unit , hospice care center , palliative home care and long-term facilities have daily, weekly and monthly on-call Rota and schedule available and accessible for all cancer care practitioners.
PSC.7.5 The palliative care unit , hospice care center , palliative home care and long-term facilities have a process for end of life patients and their families .
These standards outline the critical transition of care for oncology patients moving from acute cancer treatment to specialized supportive environments. The goal is to ensure continuity of care, safety, and clinical competency during a vulnerable phase of the patient's journey.
It must establish formal relationships (MOUs or service agreements) with outside entities. This ensures that when a patient's needs shift from curative to comfort-based, the "hand-off" is seamless. A documented, standardized process must exist to move patients safely. The hospital is responsible for verifying that the facilities they refer patients to are actually capable of providing high-level care. they must have: Qualified Physicians with certification in Palliative Medicine and Specialized Nurses qualified in palliative medications. a long-term care or hospice center, they must verify the facility's legal authority to operate. The facility guarantees that patients and families receiving hospice or palliative care have uninterrupted access to expert guidance and coordinated support, 24 hours a day, 7 days a week. This is achieved by establishing formal, reliable mechanisms for consultation, referral, and on-call coverage, including a hotline that ensures seamless continuity of care across all shifts, weekends, and holidays. The facility have clear policy and guidelines to care for dying patients and their families.
PSC.8 Availability of Hospice and palliative care eligibility criteria for accepting hospice and palliative care patients
PSC.8.1 Palliative care unit and hospice have eligibility criteria for accepting and referring patients.
PSC 8.2 There is a defined process rejecting referrals directly from (ICU, ER, non-oncology hematology departments) for new patients to palliative care
PSC 8.3 The criteria require minimum of 14 days following the last active anti-cancer medicine or radical radiotherapy
PSC 8.4 The palliative care services establishes a formal protocol for the management and documentation of virtual referrals and remote consultations.
PSC.8.5 There is an identified structure & process for decision on DNR status and exceptions for revoking the decision for terminally ill patients
This standard suite ensures that palliative and hospice services are reserved for patients who meet specific clinical criteria, maintaining the distinction between acute curative care and supportive end-of-life care.
Core Pillars of the Standard
Standardized Entry: Every admission or referral must be backed by documented clinical eligibility. This prevents "gray areas" in patient placement and ensures the right care for the right patient.
Referral Gatekeeping: Direct transfers from high-intensity zones (ICU, ER) or non-oncological departments are restricted. Patients must typically be stabilized or assessed by a primary oncology or haematology before transitioning to palliative care to ensure they are medically appropriate for the unit.
The "14-Day Rule": A mandatory two-week gap is required between the last aggressive treatment (chemotherapy or radical radiation) and palliative admission. This ensures the patient is no longer in the "active treatment toxicity" phase and is ready for comfort-oriented management.
Digital Governance: Virtual and remote consultations are officially recognized but must follow a strict protocol for documentation and management to ensure the quality of care matches in-person standards.
PSC.9 Hospice and palliative care has a structured multidisciplinary team /approach meeting to coordinate all hospice and palliative care patients' plan of care activities based on the size of the hospice and palliative care services.
PSC.9.1 Multidisciplinary team (MDT) meeting conducted at least once a week to discuss the patients' care plans.
PSC.9.2 Multidisciplinary team includes essentially physicians, nurses, physiotherapists, social workers, and case managers.
PSC.9.3 Multidisciplinary team cover the need for psychiatry, occupational therapy, spiritual care need , dietary need, psychotherapy and clinical pharmacy.
PSC.9.4 All hospice & palliative care patients are presented and discussed in the multidisciplinary team (MDT)
PSC.9.5 The hospice and palliative care MDT plan of care is documented in a standardized format as part of the medical record
The standard mandates a holistic, team-based approach to patient care. It moves away from isolated medical decisions and requires a "circle of care" where various specialists coordinate to treat the patient's physical, emotional, and spiritual needs.
Key Pillars of the Standard: Routine Coordination, The MDT must meet at least once a week, Every single patient under the palliative/hospice service must be reviewed; discussions are not limited to "difficult" cases.
The "Core" Team: The team and the meeting are not valid without essential representation from Physicians, Nurses, Physiotherapists, Social Workers, and Case Managers.
The team must have a structured way to involve "secondary" specialties as needed, including Psychiatry/Psychotherapy, Spiritual Care, Clinical Pharmacy, Dietitians, and Occupational Therapy.
Decisions cannot be verbal-only. All MDT plans must be recorded in the patient's medical file using a standardized template to ensure the entire clinical staff is on the same page.
PSC.10 The patients accepted in Hospice and Palliative care service have initial assessment to guide the care plan.
PSC.10.1 The initial assessment completed by palliative care physician and palliative care nurses upon arrival and approved by palliative care consultant within 24 hours of arrival in the unit / Hospice.
PSC.10.2 The initial assessments are documented in patient medical records promptly using standardized Symptom Assessment Tool and the functional level tool.
PSC.10.3 The initial assessment includes the patient's reason for referral/consultation, medical history, physical exam, investigations, diagnostic tests, and advanced care planning.
PSC.10.4 The initial assessment includes baseline pain and ESASr assessments.
PSC.10.5 The initial assessment includes code status and the name and contacts no of patient's proxy.
PSC.10.6 The initial assessment followed by assessment by a Physiotherapist / occupational therapist, Dietitian, Social Worker within one week of 1st presentation to palliative care.
PSC.10.7 The initial assessment include assessment of the patient need for Psychiatry, psychotherapy and Spiritual care services.
PSC.10.8 All members of the Hospice & Palliative care team shall complete a daily round on patients
The standards ensure that every palliative patient receives a comprehensive, multidisciplinary evaluation immediately upon admission. This process is designed to establish a baseline for symptoms, clarify goals of care, and integrate various medical and supportive specialties. Timelines and Accountability : The initial assessment is a dual responsibility of the Palliative Care Physician and the Palliative Care Nurse and to ensure high-quality clinical governance, a Palliative Care Consultant must review and approve the assessment within 24 hours of the patient's arrival.
All findings must be documented in the Electronic Medical Record (EMR) or physical file promptly to maintain continuity of care using the standardized Symptom Assessment Tool, such as the Edmonton or Memorial Sloan Kettering Scale and the functional level tool
The assessment must go beyond simple vitals to include:
Contextual History: Reason for referral, comprehensive medical history, physical examination, and review of diagnostic tests.
Symptom Mapping: Mandatory use of the ESAS-r (Edmonton Symptom Assessment System) and baseline pain scales to quantify patient distress.
Strategic Planning: Early initiation of Advanced Care Planning (ACP) to align medical interventions with patient values.
The standard mandates the identification of two critical safety elements:
Code Status: Clear documentation of resuscitation preferences (e.g., DNR/AND).
Proxy Designation: Identification and contact information for the patient's legal decision-maker or next of kin.
Palliative care adopts a "Whole-Person" approach, requiring secondary assessments within one week of admission by:
Allied Health: Physiotherapists, Occupational Therapists, and Dietitians.
Psychosocial Support: Social Workers to manage family and logistical needs.
Existential Care: Screening for requirements in Psychiatry, Psychotherapy, and Spiritual Care to address non-physical suffering.
PSC.11 Palliative care and life-limiting conditions are multidisciplinary managed based on updated evidence-based practice guidelines
PSC.11.1 Pain multidisciplinary managed based on updated evidence-based practice guidelines for pain management.
PSC.11.2 Dyspnea and excessive Respiratory secretions multidisciplinary managed based on updated evidence-based practice guidelines.
PSC.11.3 Constipation multidisciplinary managed based on updated evidence-based practice guidelines for constipation management.
PSC.11.4 Ascites, anorexia, cachexia, and fatigue multidisciplinary managed based on updated evidence-based practice guidelines.
PSC.11.5 Delirium and depression multidisciplinary managed based on updated evidence-based practice guidelines for Delirium and depression management.
PSC.11.6 seizures multidisciplinary managed based on updated evidence-based practice guidelines for management of seizures.
PSC.11.7 Pruritus multidisciplinary managed based on updated evidence-based practice guidelines for management of pruritus
The management of patients with life-limiting conditions is predicated on a multidisciplinary approach that integrates medical, nursing, pharmacological, and psychosocial expertise. To ensure the highest quality of end-of-life care, all interventions are governed by Evidence-Based Practice (EBP) guidelines (e.g, ESASr, Edmonton Symptom Assessment System ), which are regularly updated to reflect current clinical research and pharmacological advancements. to maximize patient comfort, safety, and quality of life. To establish and implement a comprehensive suite of multidisciplinary, evidence-based, and best-practice clinical guidelines that standardize the assessment and management of the most common and distressing symptoms in palliative and end-of-life care. This ensures consistent, high-quality, and proactive symptom control, enhancing patient comfort, dignity, and quality of life across all care settings.
Approved update clinical guidelines must be available and implemented for :Pain Management , Respiratory Distress (Dyspnea and Secretions) Constipation) Ascites, Anorexia, Cachexia, and Fatigue Delirium and Depression ,Seizures and Pruritus (itching).
PSC.12 Oncology palliative care services practice engaging patients and their families in the plan of care and decision-making process
PSC.12.1 Patient and caregiver/proxy are engaged in the patient care plan
PSC.12.2 Patient, family and caregiver/proxy are educated about patient illness and the goals of care by the health educators.
PSC.12.3 Evidence of understanding the patient care plan and goals by the patient and family
PSC.12.4 Patient family and caregiver/proxy participating and directly involved in the management of symptoms and coping mechanisms.
Patient family and caregiver/proxy are engaged in direct care after proper education by the health educator to honor patient autonomy, improve care quality, and ensure that the care plan reflects the patient's personal values, goals, and preferences. To operationalize the principle of patient- and family-centered care by establishing a structured, intentional, and interdisciplinary process that actively integrates patients and their designated families or caregivers as essential partners in all phases of care planning and clinical decision-making within hospice and palliative services. This process is designed to respect patient autonomy, align medical interventions with deeply held personal values and goals, and empower families through education and collaborative engagement, thereby ensuring care is both dignified and concordant with patient wishes.
PSC.13 Management of pain in hospice and palliative care guided by updated medication protocol.
PSC.13.1 Use of opioids and other pain medications (morphine, hydromorphone, Methadone, ketamine, Intranasal fentanyl or sublingual, lidocaine transdermal patch, etc) is guided by updated evidence-based medication protocol.
PSC.13.2 The protocol contains at least the medication name, indication, and dosage.
PSC.13.3 The protocol is prepared by a multidisciplinary team and approved by the oncology services clinical pharmacy.
This protocol serves as a clinical guideline to standardize the use of key analgesic modalities, promote appropriate dosing, and support timely and dignified symptom relief. It's about creating a robust system to manage one of the most common and feared end-of-life symptoms. To ensure safe, effective, and consistent pharmacological management of moderate to severe pain for patients in hospice and palliative care through an evidence-based, multidisciplinary medication protocol.
PSC.14 Comfort Care, Dignity, & Last-Hours Protocol ( Imminent death protocol)
The cancer care service ensures dignified, comfort-focused care during the last days and hours of life through a structured Comfort Care or “Last Hours of Life" imminent death protocol.
PSC.14.1 The facility has updated, evidence based and approved Imminent death protocol for the dying patients.
PSC.14.2 The imminent death protocol is implemented for actively dying patients.
PSC.14.3 The facility provides single room and privacy for the dying patient.
PSC.14.4 Interventions focus on comfort, symptom relief, and emotional support.
PSC.14.5 Family is supported and informed throughout the dying process.
PSC.14.6 Privacy, cultural, and spiritual practices are respected and facilitated.
To affirm the service's unwavering commitment to providing humane, respectful, and expert care during life's final transition. This standard ensures that for every actively dying patient, a structured protocol is enacted, shifting the primary goal from curative intervention to the holistic management of comfort, dignity, and profound psychosocial support for both the patient and their family. To translate the ethical and clinical imperatives of end-of-life care into a concrete, actionable plan. The Comfort Care protocol exists to ensure that when death is imminent, our care is definitively reoriented toward:
Dignity & Respect: Through ensured privacy and the facilitation of cultural/spiritual practices.
Comfort & Alleviation of Suffering: Through a singular focus on symptom relief and emotional support.
Family-Centered Care: Through active inclusion, communication, and support for loved ones.
Consistency & Quality: Through a standardized approach that leaves no aspect of this vulnerable time to chance.
Standard standalone hospice including hospice structure, manpower, operation team ,nurse calling system, handicap toilets ,accepting ambulance, Rota operation
PSC.14.01: Hospice Facility Infrastructure and Accessibility
PSC.14.01.01: The hospice facility provides a homelike environment that complies with accessibility regulations, including handicap-accessible toilets with grab bars and emergency call activators within reach of a patient lying on the floor.
PSC.14.01.02: The facility has designated, accessible pathways with adequate lighting to facilitate ambulance drop-off and pick-up, ensuring safe patient transfer 24 hours a day.
PSC.14.01.03: All patient bedrooms are single-occupancy with a minimum clear floor area of 100 square feet per bed. Each patient room has direct access to natural light (window) and temperature control maintained between 68°F and 75°F (20°C to 24°C).
PSC.14.01.04: All patient care corridors and doorways have a minimum clear width of 36 inches (91 cm), with patient room doors providing 41 inches (104 cm) clear opening for bariatric bed access.
PSC.14.01: Patient Safety & Fall Prevention
PSC.14.01.06. Emergency call activators are provided at each patient bed, toilet, bathing area, and within reach of a patient lying on the floor.
PSC.14.01.07. Hot water at all patient-use fixtures is limited to a maximum of 110°F (43°C) to prevent scalding injuries.
PSC.14.01.08. Handrails or grab bars are installed throughout corridors and at all transition points (bed to toilet, bed to chair) to support patient mobility and fall prevention.
PSC.14.01.09. A portable or fixed patient lift/transfer system is available for safe transfer of immobile or bariatric patients.
PSC.14.01.10. Flooring in all patient care areas, toilets, bathrooms, and showers is slip-resistant, seamless, and non-absorbent.
PSC.14.01: Family Support Areas
PSC.14.01.11. A designated family zone or quiet room is available adjacent to patient care areas, equipped with comfortable seating and access to restroom facilities.
PSC.14.01.12. Overnight accommodation (fold-out couch or bed) is available within or immediately adjacent to each patient room for family members.
PSC.14.01.13. A private family consultation and grief support room is available away from patient care areas for delivering bad news, family meetings, and bereavement counseling.
PSC.14.01.14. A quiet room or meditation space (non-denominational) is available for patients, families, and staff use.
PSC.14.01: Infection Control
PSC.14.01.15. Hand hygiene stations (sink with soap/water or alcohol-based rub) are placed at all patient room entrances, inside each patient room, at medication areas, and at clean/soiled utility rooms.
PSC.14.01.16. A dedicated clean utility room is provided for storage of sterile and clean supplies.
PSC.14.01.17. A dedicated soiled utility room is provided with a clinical sink (hopper) and proper ventilation to contain odors and airborne pathogens.
PSC.14.01.18. Wall surfaces in patient rooms, toilets, bathrooms, and utility rooms are washable, non-porous, and finished in light colors to aid in visual cleanliness inspection.
PSC.14.01: Environmental Safety (Fire & Emergency)
PSC.14.01.19. Emergency backup power (generator) is capable of supporting life-sustaining equipment (oxygen concentrators, suction machines, infusion pumps), nurse call systems, emergency lighting, and medication refrigeration within 10 seconds of power failure.
PSC.14.01.20. Fire safety systems fully comply with civil defense requirements, including smoke detectors, fire alarms, fire extinguishers, automatic sprinklers, and clearly marked emergency exits with illuminated exit signs.
PSC.14.01.21. A clearly marked emergency evacuation plan is posted on each patient care unit, and fire drills are conducted at least quarterly for all shifts.
PSC.14.02: Communication and Emergency Response Systems
PSC.14.02.01: A nurse calling system is installed at every patient bed, toilet, and bathing area, capable of single-action activation.
PSC.14.02.02: The call system registers both visually (corridor light) and audibly at the nursing station, and remains active until physically reset by staff at the point of origin.
PSC.14.03: Manpower, Operational Structure, and Rota
PSC.14.03.01: The hospice maintains a defined operational team structure (including Administrator, RN, and direct care staff) sufficient to meet patient needs 24 hours a day.
PSC.14.03.02: Minimum staffing levels are maintained at all times: (1) Registered Nurse and (1) additional staff for 0-10 patients; adjusted ratios apply for higher census levels.
PSC.14.03.03: An approved staff rota is developed and updated weekly, documenting shift assignments, patient assignments, and 24-hour on-call telephone access.
To ensure the physical environment of the hospice supports the dignity, safety, and accessibility of patients and families. To ensure the hospice physical environment is designed, constructed, and maintained to provide a safe, accessible, homelike, and dignified setting for terminally ill patients, their families, and staff, while complying with all applicable safety, infection control, and accessibility regulations. To ensure a reliable system is available for patients to summon assistance immediately. To define the operational team, minimum staffing levels, and shift management to ensure continuous coverage.
Standard palliative home care including palliative home care structure, manpower, operation team ,nurse calling system ,accepting ambulance, rota operation .how far patient home from near facility standard, present of elevator in home if patient live in second floor.
PSC.15.01: Palliative Home Care Structure and Operational Team
PSC.15.01.01: The palliative home care service maintains a documented organizational structure that defines roles, responsibilities, reporting lines, and communication pathways among all team members.
PSC.15.01.02: The multidisciplinary team includes, at minimum, a palliative care physician, registered nurses, social worker, and access to spiritual care or counseling services.
PSC.15.01.03: The operational team composition follows evidence-based staffing ratios: patient-to-physician ratio of 5.5:1 to 6.5:1, patient-to-nurse ratio of 1.5:1 to 2.7:1, with registered nurses comprising at least 58% of nursing staff .
PSC.15.01.04: The same multidisciplinary team members are consistently assigned to each patient throughout the service duration to ensure continuity of care and relationship building .
PSC.15.01.05: The service maintains written job descriptions for all team positions, specifying qualifications, experience requirements, and scope of practice.
PSC.15.01.06: All clinical staff possess specialized training or certification in palliative and end-of-life care, with ongoing continuing education requirements .
PSC.15.01.07: The service has a designated clinical coordinator or team leader responsible for daily operations, staff assignments, and quality monitoring.
PSC.15.01.08: Administrative support staff are available during operating hours to manage scheduling, documentation, and coordination with external healthcare providers.
PSC.15.02: Nurse Calling System and Rota Operation
PSC.15.02.01: A dedicated nurse-calling system (telephone hotline) is available 24 hours per day, 7 days per week for patients, families, and caregivers to access clinical advice and support.
PSC.15.02.02: During office hours, a designated triage nurse team receives all incoming calls to prevent interruption of home visit nurses' schedules and reduce staff stress .
PSC.15.02.03: After-hours calls are received by an on-call team comprising at minimum a registered nurse and a physician available for telephone consultation
PSC.15.02.04: The calling system includes protocols for call prioritization, clinical assessment over the phone, escalation pathways, and documentation of all call encounters.
PSC.15.02.05: A formal staff rota is developed and published at least one week in advance, documenting daily assignments, patient visit schedules, and on-call responsibilities after hours.
PSC.15.02.06: The rota includes coverage for all clinical roles (physician, nurse, social worker) during operating hours and on-call nurse/physician coverage after hours.
PSC.15.02.07: The service maintains a minimum of two staff personnel available for field response during operating hours to ensure backup coverage for emergencies.
PSC.15.02.08: Staff rota records are retained for a minimum of one year and are available for review during inspections.
PSC.15.02.09: A rapid response team (nurse and physician) is available for urgent in-home assessments when telephone triage indicates clinical deterioration requiring immediate intervention .
PSC.15.03: Patient Eligibility, Home Environment, and Ambulance Protocol
PSC.15.03.01: The palliative home care service serves patients living within a defined geographic radius. The service area is defined as residences located within 50 kilometers (30–40 minutes driving time) from the base hospital or central facility .
PSC.15.03.02: For patients residing beyond 50 kilometers, a documented risk assessment is completed, and contingency plans for emergency coverage are established prior to acceptance.
PSC.15.03.03: The home environment is assessed prior to patient acceptance. For patients living on the second floor or higher, a functioning elevator must be present in the building to ensure safe access by staff and emergency transport .
PSC.15.03.04: If no elevator is available, the patient is only accepted if a ground-floor residence can be used or if documented safe transfer protocols (e.g., stair chair with two trained personnel) are in place.
PSC.15.03.05: A formal ambulance utilization protocol is established, including:
A letter or ambulance plan confirming palliative goals of care for each patient
Authorization for treatment of predictable crises (pain, bleeding, dyspnea) without automatic emergency department transfer
Documentation of patient and family wishes regarding hospital transfer
PSC.15.03.06: Families and caregivers are educated upon enrollment about the implications of calling emergency services and are provided with the palliative care ambulance plan .
PSC.15.03.07: The service maintains a pre-established agreement with a designated ambulance provider or emergency medical services for coordinated response to palliative care patients at home.
PSC.15.03.08: A backup inpatient palliative care bed is identified and reserved when possible for patients requiring admission, to avoid emergency department boarding .
PSC.15.03.09: The home environment assessment verifies:
Presence of a responsible adult caregiver available for at least 48 hours after enrollment
Access to a telephone or two functional mobile phones
No significant language barriers between patient/family and care team
Adequate space and utilities for safe care delivery
PSC.15.03.10: Family caregivers receive structured education on medication administration, use of medical equipment (oxygen concentrators, suction machines), and recognition of signs requiring urgent contact
To define the organizational framework, multidisciplinary team composition, and operational responsibilities required to deliver safe and effective palliative care in the patient's home. To ensure continuous patient and family access to palliative care support through a structured telephone triage system and defined staff scheduling protocols. To establish criteria for patient acceptance into home palliative care based on home environment suitability, geographic accessibility, and safe emergency transport planning.
Patient and Family Engagement and Education (PFE)
PFE.1 The cancer service facility has an effective process for patient & family meetings
PFE.1.1 The Cancer service facility implements a policy for conducting meetings that include patients and/or family members involved in care decisions.
PFE.1.2 Family meetings are conducted using defined structure and include the primary physician, nurse, social worker, and other stakeholders when required. There is a structured family meeting composed of primary physicians, Nurse, Social Worker, and other stakeholders when needed.
PFE.1.3 The information discussed & provided should include management plan options, management plan benefits, risks, and consequences of refusal of management plan.
PFE.1.4 Advance care planning, including end-of-life and DNR decisions for eligible patients, is discussed and documented.
PFE.1.5 Patient and Family Education meeting activities and decisions are documented in the medical record.
To guarantee that the patient and family are central partners in the cancer care process, not just passive recipients of treatment, by requiring a structured process for meetings involving family in care decisions. It is not left to individual staff preference but is a mandatory, documented organizational requirement in a policy through multidisciplinary team including the physician, nurse, social worker, and other stakeholders in addition to a family representative.
The facility guarantees that medical, nursing, psycho-social, and planning aspects are all addressed in one unified meeting, preventing fragmented communication to fulfill the ethical and legal requirement of treatment options, benefits, risks, and the risks of refusal that helping the patient/family to make a truly informed choice and to ensure that Advance Care Planning (ACP) and critical end-of-life decisions (like DNR) are discussed proactively and formally, rather than waiting for an emergency situation which respects the patient's autonomy and dignity.
Documentation confirms that the required discussion took place, who was present, what decisions were made, and provides a reliable record for all future care providers.
PFE.2 Ensures a structured patient and family education program that assesses needs, provides appropriate resources, and supports informed participant in cancer care
PFE.2.1 The cancer care facility has an approved policy and procedure (IPP) for family and patient education.
PFE.2.2 Standardized assessment tools/forms are used to identify patient and family educational needs and documented in the medical record.
PFE.2.3 All admitted patients receive an education needs assessment at least once per admission by a qualified health educator.
PFE.2.4 Educational needs of all new oncology patients are assessed before initiating any active treatment (surgery, systemic therapy, radiotherapy).
PFE.2.5 Educational materials and resources (brochures, videos, digital tools) are provided in Arabic or in the patient's preferred language to ensure understanding.
PFE.2.6 The cancer services facility should have at least one dedicated Qualified Health Educator Staff for every 250 new annual patients.
PFE.2.7 Patient and family education indicators are included as key performance indicators (KPIs) within the cancer service performance monitoring system.
To ensure the cancer service facility provides a structured, personalized, and robust education program that empowers patients and families throughout their care journey, this is achieved by ensuring key elements are in place: Formal Structure: Establishing a written policy and using assessment tools to make education standardized yet tailored to the patient's individual needs and learning style. Timely Intervention: Delivering essential education before any new active oncology treatment begins (for outpatients) and providing necessary information during every inpatient admission.
Accessibility: Ensuring all educational materials are available in Arabic and English to eliminate language barriers and guarantee equitable access to information. Resource Commitment: Dedicating adequate, qualified health educator staff based on patient volume (1:250 ratio) to handle the required workload.
Quality Oversight: Treating Patient & Family Education as a priority function by tracking its effectiveness through a Key Performance Indicator (KPI).
PFE.3 The cancer service facility implements a formal process for authorizing, educating, and supervising a patient watcher for oncology patients.
PFE.3.1 Policies and procedures define age criteria, eligibility, and responsibilities for authorizing a patient watcher.
PFE.3.2 The authorized attending watcher's name and contact details are documented and updated in the patient records.
PFE.3.3 The authorized watcher receives education on the patient's clinical care needs, and the education is documented.
PFE.3.4 The nursing team is notified of the authorized watcher using a defined communication process.
PFE.3.5 The authorized attending watcher daily activities are documented by nursing and care teams.
Authorization of a Watcher (Safe Support) to formalize the role of the patient's watcher/attendant to enhance safety, accountability, and clinical support and to Integrate the watcher as a safe, informed, and accountable partner in patient support.
Creating policies and age criteria for authorization, formally documenting the watcher's identity in the medical record, educating the watcher about the patient's specific clinical needs, and documenting the watcher's daily activities. The facility must move beyond informal practices to create formal, documented systems that guarantee effective communication, timely education, and safe, authorized support for all cancer patients and their families.
PFE.4 Ensures structured psychological and psychosocial support for cancer patients and their families through assessment, intervention, and post-treatment follow-up.
PFE.4.1 Psychological, social, financial, and behavioral screening must be performed at least once during each admission by Standardized, validated psychosocial and psychosocial screening tools.
PFE.4.2 All new oncology outpatients receive psychosocial screening using validated tools.
PFE.4.3 The facility provides psychological and social support services for all cancer patients based on screening outcomes.
PFE.4.4 The facility provides psychological and social support services for families of cancer patients.
PFE.4.5 The facility provides post-treatment support to facilitate patient reintegration into daily life and community.
To ensure that psychosocial care is an integral and mandatory part of cancer treatment program in holistic way addressing psychological, social, and financial burdens that cancer diagnosis and treatment impose on patients and their families using standardized, validated screening tools. The intention is to proactively identify distress, depression, financial hardship, and social barriers as early as possible. This prevents minor concerns from escalating into major crises that could interfere with treatment compliance or quality of life. The policy specifically aims to identify and manage distress and depression which can significantly impair a patient's ability to cope, make treatment decisions, and maintain quality of life. The mechanism for referral ensures specialized care is accessible.
Recognizing that cancer affects the entire family system, Addressing Socio-Economic Barriers and Facilitating Long-Term Reintegration to ensure that the patient is transitioning back to their normal life, work, and social environment, promoting long-term recovery and survivorship success.
PFE.5 The cancer care service facility ensures a transparent and timely process that support patients and families in obtaining a second medical opinion.
PFE.5.1 The Cancer service facility has written policy and procedures for second opinion .
PFE.5.2 The cancer service provides patients with easy access to medical reports, operative reports, discharge summaries, and other reports within 5 working days of the request.
PFE.5.3 Medical reports prepared for second opinion include the primary physician's contact information
To uphold the patient's right to informed decision-making by ensuring a transparent, structured, and timely process for obtaining a second medical opinion in cancer care through Empower Patients and Families exploring another opinion or alternative treatment pathways with rapid access to medical records , primary physician contact information to enables professional, direct communication between the primary and consulting physicians, thereby enhancing the overall quality and safety of the cancer service.
PFE.6 The cancer service facility ensures that cultural, psychosocial, religious, spiritual, and privacy needs of patients are respected and supported.
PFE.6.1 The Cancer service facility implements a policy that ensures the confidentiality of information related to the patient's health.
PFE.6.2 The Cancer service facility provides separate areas for women where appropriate in chemotherapy units treatment area.
PFE.6.3 The Cancer service facility provides access to spiritual care or advice that meets the needs of the different populations served.
PFE.6.4 Patient privacy is respected during all interviews, examinations, and treatments in all areas of cancer services units.
PFE.6.5 The Cancer service facility mandates written consent is obtained before photographing any patient.
To ensure that healthcare delivery in Cancer units is holistic, respectful, and dignified. The care provided must extend beyond the medical diagnosis and treatment to recognize and accommodate the whole person, including their personal beliefs, values, and psychosocial well-being. By requiring adherence to these standards, the organization commits to mitigating barriers to care, improving patient comfort and trust, and supporting emotional and spiritual health, ultimately leading to better patient engagement and adherence to the treatment plan. To ensure that care is truly patient centered by requiring staff to understand, respect, and integrate the patient's cultural, psychosocial, religious, and spiritual context into the planning and delivery of care. These fosters trust and reduce distress. To demonstrate respect for gender-specific cultural or religious requirements by ensuring the physical environment (specifically waiting/treatment areas in high-stress units like chemo/radiotherapy) is designed to provide appropriate privacy and segregation for women, thereby enhancing comfort and compliance. To acknowledge that severe illness often triggers spiritual distress or questioning. The intention is to provide readily accessible spiritual and religious support tailored to the diverse backgrounds of the patient population, promoting emotional resilience and coping. To establish a mandatory baseline for professional staff, conduct, ensuring that all clinical interactions prioritize the patient's dignity, personal boundaries, and privacy throughout all aspects of care, thereby preserving the patient's self-respect during vulnerable moments.
Radiation Oncology, Radiation Therapy and Radiation Therapy Physics
RO.1 The facility complies with all regulatory and licensing requirements issued by relevant national authorities.
RO.1.1 Facility has valid licenses by relevant authorities for all equipment, facilities and activities. RO.1.2 Facility has a named Radiation Safety Officer with a valid license by relevant authority.
RO.1.3 A radiation protection program is implemented to minimize staff and patient exposure (ALARA).
The RO.1 standard serves as the legal and safety foundation for any radiotherapy facility. It ensures that the center operates within the legal framework of national health and nuclear authorities, (Nuclear and Radiological Regulatory Commission (NRRC)), prioritizing the safety of the environment, the staff, and the patients.
The facility must ensure that every piece of specialized equipment (such as Linear Accelerators, Brachytherapy machines, or CT Simulators) has a current and valid license from NRRC.
The facility is required to appoint named certified individual as the Radiation Safety Officer (RSO) holding a valid personal license issued by the relevant authority, ensuring they possess the technical expertise to manage radiation risks.
A structured program must be in place to minimize radiation doses to both staff and patients without compromising the quality of the medical treatment. (As Low as Reasonably Achievable (ALARA).
RO.2 The facility has Radiation Safety Committee (RSC)
RO.2.1 Facility has an active Radiation Safety Committee (RSC).
RO.2.2 RSC has documented policies, procedures, and radiation safety manual.
RO.2.3 RSC meets regularly at least twice a year with appropriate documentation of meetings.
RO.2.4 RSC is chaired by an independent executive leader with no conflict of interest.
RO.2.5 The RSC has to report on its activities to the Chief Executive Officer or equivalent leader.
RO.2.6 RSO shall report staff exposure levels to the RSC. RO.2.7 RSO and department head shall discuss any non-intentional exposure incidents in the department during RSC meetings.
Standard RO.2 focuses on the administrative and clinical governance of radiation safety within the facility. While the Radiation Safety Officer (RSO) manages technical aspects, the Radiation Safety Committee (RSC) provides the high-level oversight necessary to ensure a safe environment for patients and staff.
The facility must maintain a functional and active committee specifically dedicated to radiation safety, The committee's operations must be guided by formal, documented policies, procedures, and a comprehensive Radiation Safety Manual. The ensuring, report its activities directly to the Chief Executive Officer (CEO) or an equivalent leader, The RSC must be chaired by an independent executive leader who has no conflict of interest, ensuring that safety decisions are not compromised .The committee is required to meet regularly, with a minimum of two meetings per year, all of which must be thoroughly documented, the RSO to report staff exposure levels to RSC ensuring they remain within safe limits, The RSO and the department head are required to discuss any non-intentional exposure incidents to RSC that allows the facility to analyze errors, implement corrective actions, and prevent future radiation-related incidents.
RO.3 The facility implements comprehensive quality assurance (QA) and quality control (QC) programs for all radiotherapy equipment.
RO.3.1 The facility has a written QA program that defines scope, frequency, tolerance levels, responsibilities, and documentation. RO.3.2 Facility treatment and simulation equipment have daily, weekly, monthly and annual QA tests by authorized staff.
RO.3.3 Facility keeps all records and documentations of QA test results.
RO.3.4 Treatment planning systems and software undergo QA and validation after upgrades or configuration changes.
RO.3.5 The equipment used in QA programs has valid calibration certificate by authorized reference laboratory.
Standard RO.3 establishes the technical requirements for maintaining the precision, safety, and reliability of all radiotherapy equipment. The equipment performs within strict physical and mechanical limits to ensure patient safety and the clinical effectiveness of the treatment. The facility maintains a formal, written Quality Assurance program clearly define the scope, frequency of testing, tolerance levels (acceptable margins of error), and specific responsibilities for staff, All procedures documented to ensure consistency and accountability, treatment machines and Simulators undergo a rigorous schedule of QA tests categorized into daily, weekly, monthly, and annual intervals to capture both short-term fluctuations and long-term stability performed by Medical Physicists or trained specialists staff who are authorized to conduct such tests,
The facility is mandated to keep all records and documentation of QA test results as historical and legal proof of equipment performance.
Any upgrades or configuration changes to Software and Treatment Planning Systems (TPS) require mandatory QA and validation to ensure the software's calculations remain accurate. The instruments and tools used to measure radiation and perform QA tests have a valid calibration certificate issued by an authorized reference laboratory, ensuring that all measurements are traceable to national or international standards.
RO.4 The facility implements a patient-specific quality assurance (QA) program for complex radiotherapy treatments.
RO.4.1 Patient-specific QA is performed for radical complex radiotherapy IMRT/VMAT, SBRT, SRS plans. RO.4.2 All patient-specific QA results are reviewed by a qualified physicist / dosimetrist and approved by a consultant medical physicist.
Explanation: These standards mandate that for any complex radiotherapy plan; the facility performs a "dry run" of the treatment before it ever touches the patient. This is called Patient-Specific Quality Assurance (PSQA) for complex treatments like: VMAT/IMRT, SRS/SBRT because a small alignment error can cause significant damage. Common PSQA Methods are phantom based Measurement, EPID Dosimetry, second, different software programs.
This standard establishes a two-tier accountability system to ensure no error. The Review (Qualified Physicist or Dosimetrist) The first person to look at the data checks the Gamma Index. This is a statistical tool that compares the "Planned Dose" vs. the "Measured Dose". "Typical Tolerance: 95% of the points must agree within 3% dose difference and 3mm distance-to-agreement, If the result is 92%, the reviewer investigates why the plan failed.
Consultant Medical Physicist (or Chief) Physicist provides the final legal and clinical oversight. They ensure: The measurement setup was correct. Any deviations were clinically insignificant. The plan is officially "Cleared for Treatment."
RO.5 The facility shall ensure adequate and competent staffing for safe and effective radiotherapy services.
RO.5.1 The facility has minimum of 2 in house licensed radiation oncologist one of them board certified radiation oncologist registered as consultant by SCFHS.
RO.5.2 The facility has minimum of 1 licensed consultant radiation oncologist per 150 new patients annually.
RO.5.3 The facility has minimum of 2 in-house licensed medical physicists, one of them board certified physicist registered as consultant by SCFHS.
RO.5.4 The facility has minimum of 3 licensed radiation therapists by SCFHS per high energy machine.
RO.5.5 All professionals hold valid licenses from Saudi Commission for Health Specialties (SCFHS) with appropriate relevant classification (e.g. radiation oncologist, medical physicist, and radiation therapist). RO.5.6 Workload is monitored, and staffing levels are adjusted periodically as needed to maintain safety and quality.
RO.5.7 Continuing professional development (CPD) and annual performance reviews are mandatory and documented.
These standards outline the Staffing and Professional Qualification requirements for a Radiation Oncology service, specifically aligned with the Saudi Commission for Health Specialties (SCFHS) regulations. They are designed to ensure that the facility is legally compliant and adequately staffed to handle patient volume safely and to prevent burnout and clinical errors.
Every facility has at least two in-house Radiation Oncologists and two Medical Physicists. Crucially, at least one in each category must be a consultant registered with SCFHS. This ensures that a senior expert is always available in-house for high-level decision making.
As the facility grows, it hires one Consultant Radiation Oncologist for every 150 new patients seen per year as workload safety limit and for every linear accelerator (high-energy machine) at least three Radiation Therapists (RTTs)
The facility has minimum of 2 in-house licensed medical physicists during clinical treatment, one of them board certified physicist registered as consultant by SCFHS.
All medical staff hold a valid license and the correct classification from the SCFHS.
Management documents assessing staff performance, identifying weaknesses, ensuring clinical competency and proactively hiring more staff according to the patient's volume.
RO.6 The facility shall ensure a safe and standardized process for radiotherapy treatment planning.
RO.6.1 A proper documentation for each patient's radiotherapy planning process with details of simulation, contouring, planning, verification, and delivery.
RO.6.2 Each radical treatment prescription and plan are authorized and signed by a licensed Radiation Oncologist Consultant.
RO.6.3 Each radical treatment prescription and plan are authorized and signed by a licensed medical physics Consultant.
RO.6.4 Independent second plan check for plans by a second qualified medical physicist are mandatory before each curative, radical or specialized treatment (VMAT, IMRT, SBRT, SRS and brachytherapy).
RO.6.5 Coverage for radiation oncologist, medical physicist, and therapist is available during all treatment hours.
These standards focus on clinical workflow integrity to ensure patient safety ensuring that every treatment step is documented, double-checked, and supervised by senior experts, Documentation cover positioning/immobilization, simulation, contouring , planning dose calculation, verification and delivery to allow the facility to be able to reconstruct exactly where every centi-gray of radiation was delivered.
Dual SCFHS-registered consultants' authorization for radical treatments by the radiation oncology consultant and medical Physics consultant to Confirms the dose is sufficient the plan is technically achievable and that the machine can deliver it safely.
Independent Second Check by qualified physicist who was not involved in the original planning before the delivery of a complex treatment (like VMAT, SRS, or Brachytherapy) that include verification of the calculations, the machine parameters, and the data transfer to catch any mistake before the first dose is given.
On duty Radiation Oncologist, Physicist, and Therapist must be available physically during treatment hours to attend the patients or machines and to intervene immediately if needed.
RO.7 The facility shall ensure a safe and standardized process for radiotherapy treatment delivery.
RO.7.1 Patient identification and treatment site verification are performed and documented at each treatment session by two radiation therapists. RO.7.2 Image-guided verification (IGRT/portal imaging/Cone-Beam CT) is performed, documented, and approved before the 2nd treatment (fraction) and at least every 5 fractions for radical external beam radiotherapy (IMRT/VMAT/3-DCRT) by a consultant radiation oncologist.
RO.7.3 Image-guided verification (IGRT/portal imaging/Cone-Beam CT) is performed, documented, and approved before each brachytherapy fraction, SRS, and SBRT treatments by a consultant radiation oncologist.
RO.7.4 Image-guided verification (IGRT/portal imaging/Cone-Beam CT) is performed, documented, and approved before any palliative single fraction radiotherapy and before the second treatment (fraction) and at least every 5 fractions by Sub-consultant radiation oncologist (fellow, specialist or senior resident). RO.7.5 All deviations or interruptions are documented, reviewed and approved by the consultant radiation oncologist before corrective actions implemented for radical cases. RO.7.6 post-treatment summary reports completed and filed in patient medical file (health information system) within 5 days after treatment completion.
RO.7.7 post-treatment summary reports include dates of treatment, delivered dose and fractionation, site, technique/modality, any interruption, and follow-up plan.
These standards establish a "safety net" for radiotherapy. They ensure the right patient receives the right dose at the right location through a system of double-checks and rigorous documentation.
Core ComponentsThe Two-Person Rule: To prevent human error, two therapists must verify the patient's identity and treatment site at every single session.
Medication Management (MM)
MM.1. The oncology pharmacy has a clear organizational structure, is directed by a qualified pharmacist, and has an adequate number of qualified staff.
MM.1.1. The pharmacy has a clear organizational structure that shows its reporting lines within the center.
MM.1.2. The pharmacy is directed by a licensed pharmacist qualified by education, training, and experience, who holds valid professional registration with the Saudi Commission for Health Specialties (SCFHS) and any other licence required by law, and whose authorities and accountabilities are delineated in a job description that is reviewed at least every three years.
MM.1.3. The center has at least one clinical pharmacist qualified in hematology/oncology by residency training: a pharmacist registered and classified by the SCFHS in the clinical pharmacist category who has completed the SCFHS-accredited pharmacy specialty residency in hematology/oncology or an equivalent accredited postgraduate (PGY2) residency in oncology pharmacy. The responsibilities of the role are defined in a job description and include, at a minimum: clinical verification of systemic anticancer therapy orders; participation in the development of treatment protocols and supportive-care guidelines; participation in toxicity management and pharmacovigilance; and patient counselling on anticancer therapy, including oral anticancer agents.
MM.1.4. All pharmacy staff hold valid professional registration and licensure as required by law, and job descriptions define their roles and responsibilities.
MM.1.5. There is a current staffing plan, based on workload, that ensures sufficient qualified staff to deliver the approved scope of pharmacy services during all hours in which chemotherapy is prepared and administered.
MM.1.6. Staff responsible for chemotherapy and other hazardous drug compounding, sterile compounding, and clinical order review have documented training and competency assessment before working independently, and a designated pharmacist is responsible for the hazardous drug handling program (see MM.13).
MM.1.7. The pharmacy has an approved scope of service and defined hours of operation, reviewed when services change. For an oncology center the scope includes but not limited to: hazardous drug (antineoplastic) sterile compounding; review and verification of chemotherapy and supportive-care orders; dispensing, including oral anticancer agents; drug information; patient counselling; medication safety activities; controlled-substance management; and medication supply management.
The pharmacy is the department responsible for the medication management system. This standard requires that it be led by a licensed pharmacist with the qualifications appropriate to the services provided, that all staff are licensed and have defined responsibilities, and that staffing is planned according to workload. The scope of service and the hours of operation are defined so that leadership can confirm that pharmacy support matches the center's clinical activity; for an oncology center the minimum scope is listed in the sub-standard itself. A single designated pharmacist must be accountable for the hazardous drug handling program, as required by USP General Chapter <800>. An oncology center additionally requires at least one clinical pharmacist qualified in hematology/oncology through the SCFHS pharmacy specialty residency in hematology/oncology or an equivalent accredited oncology residency — board certification (BCOP) is encouraged in addition but does not substitute for residency training, since certification alone does not distinguish residency-trained pharmacists; this role carries the clinical functions of the chapter — order verification, protocol development, toxicity management, and counselling — and its presence is what distinguishes an oncology pharmacy service from a dispensing operation.
MM.2. Oncology center staff involved in medication management are oriented, trained, and assessed for competency.
MM.2.1. There is a structured orientation program in which new pharmacy and nursing staff are briefed on the center's medication management policies, including high-alert medications, LASA medications, hazardous drug handling, and error reporting.
MM.2.2. Competency is assessed and documented before staff work independently in hazardous drug compounding (pharmacy) or chemotherapy administration (nursing), and is reassessed at least every 12 months for hazardous drug handling and at least every two years for chemotherapy administration and other defined activities.
MM.2.3. Training in chemotherapy spill management and in the management of hypersensitivity reactions and extravasation is documented for the relevant staff, and a spill drill is conducted at least annually.
MM.2.4. There are continuing professional development activities for pharmacy staff, and records of training and competency are kept in personnel files.
The safety controls described in this chapter depend on staff who know the policies and are competent in the specific skills of oncology pharmacy and nursing practice, which is why this standard sits with the organization of the service rather than at the end of the chapter: qualification precedes practice. The standard consolidates the orientation, initial competency assessment, and periodic reassessment that the chapter then requires at each point of use — hazardous drug handling, sterile compounding, order verification, chemotherapy administration, and toxicity management. The center must be able to show, for each relevant staff member, that these have taken place.
MM.3. Medication management and use in the oncology center are guided by policies and procedures and comply with applicable laws and regulations, including those of the Saudi Food and Drug Authority (SFDA) and the Ministry of Health (MOH).
MM.3.1. There is a multidisciplinary policy or plan covering the medication management processes of procurement, storage, prescribing, preparation, dispensing, transport, administration, monitoring, and disposal.
MM.3.2. Policies and procedures are developed in collaboration with the relevant medical, nursing, pharmacy, and management staff, are approved, and are reviewed at least every three years or when laws and regulations change.
MM.3.3. An updated policies and procedures manual is readily accessible to all healthcare professionals involved in medication use.
MM.3.4. Appropriate sources of drug information are readily available to healthcare professionals involved in medication use, including current oncology regimen references and drug monographs, intravenous stability and compatibility references, and the current editions of USP General Chapters <797> and <800>, the NIOSH list of hazardous drugs, and the ASHP guidelines on handling hazardous drugs.
MM.3.5. Pharmacy services for order review, preparation, and dispensing are available during all hours in which chemotherapy is administered, and a pharmacist is reachable for urgent needs when the pharmacy is closed.
MM.3.6. Staff are oriented to the medication management policies and procedures at the time of hiring and when policies change.
The intent of this standard is that medication use in the center follows written, approved, and current policies that are known to staff, rather than individual practice. Policies must be consistent with national requirements, including SFDA regulations on medicines and pharmacovigilance and MOH regulations on narcotic and controlled substances. Because chemotherapy should not be prepared or administered without pharmacist review, the pharmacy must be operational, or a pharmacist reachable, whenever chemotherapy is given.
MM.4. The oncology center has a pharmacy and therapeutics committee, or an equivalent multidisciplinary body, that provides oversight of the formulary and medication use.
MM.4.1. There is a pharmacy and therapeutics committee, or an equivalent multidisciplinary body, chaired by a senior medical or pharmacy staff member, with terms of reference that define its functions, membership, quorum, frequency of meetings, and approval and distribution of minutes.
MM.4.2. The committee meets on a regular basis (at least quarterly), and its minutes record the members in attendance, items discussed, decisions reached, assigned actions, and follow-up.
MM.4.3. The functions of the committee include, at a minimum: developing criteria for medication selection (indication, effectiveness, safety, and cost); developing and maintaining the formulary, including a policy on biosimilar and therapeutic interchange; approving the protocols and regimens for all systemic anticancer therapy — cytotoxic chemotherapy, targeted therapy, and immunotherapy — and the center's supportive-care guidelines for antiemetic prophylaxis, growth factor use, hypersensitivity premedication, and extravasation management; reviewing medication safety data (adverse drug reactions, medication errors, drug recalls); and establishing therapeutic guidelines according to the scope of service.
MM.4.4. The center has a structured formulary that contains the essential medications for its scope of service, is limited to medications registered by the SFDA or obtained through an SFDA-approved process, is updated at least annually, is accessible to the healthcare team, and is indexed by generic and trade name and classified therapeutically.
MM.4.5. The formulary, or its appendices, includes the approved and prohibited prescribing abbreviations, guidance on dose adjustment in renal and hepatic impairment, drug safety in pregnancy and lactation, and the center's lists of high-alert, look-alike/sound-alike, and hazardous medications.
MM.4.6. The protocols and regimens for cytotoxic, targeted, and immunotherapy treatment used in the center are approved by the committee, referenced to recognized evidence-based sources, and available to prescribers, pharmacists, and nurses.
MM.4.7. Formulary changes and committee decisions are communicated to the staff involved in medication management.
A multidisciplinary committee is the mechanism by which the center controls which medications are used, how they are used, and how medication safety information is acted upon. In an oncology center this committee is also expected to approve the treatment protocols and regimens in use, since standardization of regimens is a basic safeguard against prescribing errors. A center that does not operate a separate pharmacy and therapeutics committee must assign every function listed in MM.4.3 to one named multidisciplinary committee and document them in that committee's terms of reference and minutes.
MM.5. The oncology center has a system for non-formulary medications, off-label use, and medication shortages.
MM.5.1. There is a policy and procedure for the selection, approval, and procurement of non-formulary medications within an acceptable time frame.
MM.5.2. There is a policy and procedure for prescribing formulary medications for off-label (unapproved) indications.
MM.5.3. Each individual case of non-formulary or off-label use is documented on a request form that includes the clinical justification, and is approved by the medical director, department head, or designee before the medication is dispensed; and the patient is informed when treatment involves a non-formulary or off-label medication.
MM.5.4. The pharmacy and therapeutics committee, or equivalent, periodically reviews the non-formulary and off-label requests.
MM.5.5. There is a policy and procedure for communicating medication shortages and outages to prescribers and other staff involved in medication management.
MM.5.6. Medication substitution protocols for use during shortages are approved by the pharmacy and therapeutics committee, or equivalent, and staff are aware of them.
MM.5.7. The center defines in policy the minimum stock levels of antineoplastic, supportive-care, and pain medications relative to its registered patients and scheduled treatments; before a new regimen is started, the availability of the medications required for the planned course is confirmed; and the prescriber is informed when a required medication is unavailable so that treatment can be planned accordingly.
Off-label use of medications is frequent in oncology and is acceptable when supported by evidence and approved through a defined process; the intent of this standard is that such use is deliberate, justified, documented, and reviewed rather than unmanaged. Shortages of oncology medications are common and can result in treatment delay or unsafe substitution; the center is expected to have a process for identifying shortages, communicating them to prescribers, and applying approved substitution protocols so that patients are treated with an appropriate alternative or informed of the delay.
MM.6. The oncology center develops and implements guidelines for the correct prescribing of antibiotics.
MM.6.1. A multidisciplinary team from the center adopts and updates evidence-based antibiotic guidelines, taking into account the center's antibiogram or local resistance data where available.
MM.6.2. The guidelines cover antibiotic prophylaxis before procedures, the empiric and therapeutic use of antibiotics, and the initial management of fever in neutropenic patients.
MM.6.3. The center defines the prescribing privileges or restrictions that apply to antibiotics.
MM.6.4. Implementation of the antibiotic guidelines is monitored and the results are reviewed by the pharmacy and therapeutics committee, or equivalent.
Misuse of antibiotics increases antimicrobial resistance and cost and exposes patients to avoidable harm. Oncology patients are frequently immunocompromised and receive antibiotics for prophylaxis and for the management of infection, including febrile neutropenia; the center is therefore expected to adopt and update its own evidence-based guidelines, to define who may prescribe restricted agents, and to monitor that the guidelines are followed. The depth of the program should match the center's scope of service.
MM.7. The oncology center has a system for the safety of high-alert medications. (ESR)
MM.7.1. There is a written multidisciplinary plan for managing high-alert medications that includes their identification, storage, labelling, prescribing, preparation, dispensing, administration, and monitoring.
MM.7.2. The center has an annually updated list of high-alert medications based on its own error data, the current list of the Institute for Safe Medication Practices, and SFDA requirements. The list includes: all antineoplastic and cytotoxic medications; controlled and narcotic medications; concentrated electrolytes; antithrombotic medications; insulins; investigational medications; anesthetic and neuromuscular blocking agents where these are used in the center; and any additional medications identified from the center's own data.
MM.7.3. The plan is implemented and includes: limiting access to high-alert medications, using auxiliary labels or computerized alerts, standardizing ordering, preparation, dispensing, and administration, and using standard concentrations for medications administered by intravenous infusion.
MM.7.4. An independent double check by two qualified staff members is performed and documented for chemotherapy and all other medications on the center's high-alert list at preparation, before dispensing, and before administration.
MM.7.5. Concentrated electrolytes are not stocked in patient care areas unless patient safety necessitates their immediate use; where stocked, they are kept in a separate locked location with proper signage.
MM.7.6. Staff involved in medication management are educated on the high-alert medication plan.
High-alert medications carry a higher risk of causing significant patient harm when used in error. All antineoplastic medications are high-alert medications by definition. The center must know which medications it considers high-alert, apply defined controls at every step of the medication process, and use independent double checks (two staff members separately verifying the same information without influencing each other) at the critical points of preparation, dispensing, and administration. This standard is aligned with the CBAHI Essential Safety Requirements.
MM.8. The oncology center has a system for the safety of look-alike/sound-alike (LASA) medications. (ESR)
MM.8.1. There is a multidisciplinary policy and procedure on handling look-alike/sound-alike medications.
MM.8.2. The center reviews and revises annually its list of confusing drug names, which includes the LASA medication pairs that the center stores, dispenses, and administers, including oncology medications.
MM.8.3. The center takes actions to prevent errors involving LASA medications, including: tall-man lettering on labels, shelf tags, and electronic listings; separated or non-alphabetical storage of the LASA medications on the list; inclusion of the indication on the prescription for LASA medications; reading the full label each time the medication is accessed; and minimizing verbal orders.
MM.8.4. LASA medications are identified with auxiliary labels or computerized alerts in the pharmacy and in storage areas.
MM.8.5. Healthcare professionals receive education on LASA medications at orientation and as part of continuing education.
Confusion between medications with similar names or packaging is a recognized cause of medication errors, and and several oncology medication pairs are affected. The center identifies the pairs on its own formulary and applies the measures in MM.8.3 to each of them. This standard is aligned with the CBAHI Essential Safety Requirements.
MM.9. The oncology center has a safe and secure system for the storage of medications in the pharmacy, stores, and patient care areas.
MM.9.1. There is a policy and procedure on the proper storage and control of medications, nutrition products, and medical samples from the point of receipt until the point of administration.
MM.9.2. Access to medication storage areas is limited to authorized individuals; storage areas are secured with proper locking and key control, including after hours and in emergencies.
MM.9.3. Medications are stored according to the manufacturer's recommendations. Room temperature storage areas are kept between 18 and 25 degrees Celsius and refrigerators between 2 and 8 degrees Celsius; medication refrigerators are connected to an alternate power source; temperatures are checked and documented at least once daily (or monitored continuously) and records are kept for at least three years; and there is a defined process for handling medications when temperature monitoring indicates an out-of-range value or a power outage. Temperature-sensitive medications, including biologics, are transported to and within the center in containers that maintain the required temperature.
MM.9.4. Medications are stored in a way that avoids mix-ups, with labels showing the drug name and expiry date; medications are not stored directly on the floor; antiseptics, disinfectants, and external-use products are stored separately from enteral and injectable medications; and the first-expiry/first-out principle is followed.
MM.9.5. All medication storage areas are inspected at least monthly by pharmacy staff for availability, stock level, expiry dates, and storage conditions, and the inspection is documented.
MM.9.6. There is a written and implemented process for detecting nearly-expired medications and returning them before the expiration date; expired and damaged medications are clearly labelled and stored separately from other medications until return or disposal, with documents of return to the supplier or evidence of proper destruction; no expired medications are present in patient care areas; and medication quality issues are reported to the SFDA as required.
MM.9.7. There are guidelines for ensuring the stability of multi-dose vials and other multi-dose medications; open multi-dose containers are labelled with the opening date and time, the beyond-use date, and staff initials; no expired or unlabelled open multi-dose containers are present in patient care areas; and food, drinks, and specimens are not stored in medication refrigerators.
Proper storage protects the integrity of medications and prevents unauthorized access, mix-ups, and the use of expired products. Many oncology medications are temperature sensitive and expensive, which makes documented temperature control and a defined response to temperature excursions particularly important. Monthly inspection of all areas where medications are kept, including treatment areas and emergency carts, is the basic mechanism for confirming that storage conditions are maintained.
MM.10. Narcotics, psychotropics, and other controlled medications in the oncology center are stored, prescribed, and accounted for in accordance with laws and regulations.
MM.10.1. There is a policy and procedure on the storage, prescribing, dispensing, administration, and accountability of controlled medications, in accordance with SFDA and MOH regulations.
MM.10.2. Controlled medications are kept behind double locks with restricted access and controlled key handling.
MM.10.3. There is proper documentation of receipt, count, endorsement between shifts, dispensing, wastage of unused portions with a witness, and disposal of empty containers; discrepancies are investigated and reported according to regulations.
MM.10.4. Only individuals permitted by the center and by law prescribe or order controlled medications; the list of permitted prescribers is known to pharmacy and nursing staff, and prescribing is on the forms required by regulations.
MM.10.5. Floor stock of controlled medications in patient care areas is limited to what is needed to meet patient needs.
Opioid analgesics and other controlled medications are used routinely in oncology care and are subject to specific national regulations. The center must demonstrate secure storage, full accountability from receipt to administration or disposal, and control over who may prescribe them.
MM.11. The oncology center ensures the availability, security, and monitoring of emergency medications and controls floor stock in patient care areas.
MM.11.1. The center has a standardized set of emergency medications for crash carts and emergency bags, in accordance with current Saudi Heart Association recommendations.
MM.11.2. Emergency medications, including those needed to manage hypersensitivity and infusion reactions, are available and readily accessible in all areas where chemotherapy is administered.
MM.11.3. Emergency medications in crash carts and emergency bags are protected from loss or theft using numbered plastic seals, and the seals are stored under the supervision of pharmacy or nursing.
MM.11.4. Emergency medications are checked at least every working day (or every shift) by nursing staff and at least monthly by pharmacy staff, and are replenished in a timely manner after use or when expired or damaged; the checks are documented.
MM.11.5. Supplies for the management of extravasation, including the antidotes and materials specified in the center's policy, are available where vesicant medications are administered, and their expiry dates are monitored.
MM.11.6. Medications assigned as floor stock in patient care areas are limited in quantity according to the needs of each area, are properly labelled and separated, and opioid and benzodiazepine antagonists are available wherever these medications are stocked.
Hypersensitivity reactions, anaphylaxis, and extravasation are recognized emergencies during chemotherapy administration. The center must ensure that the medications and supplies to manage them are immediately available where treatment is given, are protected from tampering, and are checked regularly so that they are complete and in date when needed.
MM.12. The oncology center has a system for handling recalled, discontinued, and damaged medications and for medications brought in by patients.
MM.12.1. There is a policy and procedure on the retrieval and handling of recalled, discontinued, and damaged medications within a specified time frame.
MM.12.2. The center maintains on file the drug recall notices received from the SFDA, manufacturers, or other legal bodies, and documents the action taken.
MM.12.3. Prescribers, staff involved in dispensing and administration, and affected patients are notified when a medication is recalled or discontinued for safety reasons.
MM.12.4. There is a policy and procedure on medications brought into the center by patients or their families; such medications are checked for integrity and labelled by a pharmacist if permitted for use, are documented in the medical record, and both patient and prescriber are informed when use is not permitted.
MM.12.5. Free medical samples are not administered or dispensed to patients.
MM.12.6. Unused or returned hazardous drugs are returned to the pharmacy in sealed chemotherapy bags and are re-used only when permitted by a written guideline on the safe recycling of returned sterile preparations; otherwise they are disposed of as cytotoxic waste.
Recall notices for medicines are issued regularly by the SFDA and by manufacturers, and the center must be able to identify affected stock, remove it, and notify those who prescribed, dispensed, or received it. Patients often bring their own medications, including supportive and complementary products; the center must control whether and how these are used so that the medication record remains complete and interactions are identified.
MM.13. The oncology center has a hazardous drug handling program, consistent with USP General Chapter <800>, that protects staff, patients, and the environment from receipt to disposal.
MM.13.1. There is a written hazardous drug handling program, with policies and procedures covering hazard communication, receipt and unpacking, storage, transport, compounding, administration, deactivation, decontamination, cleaning and disinfection, spill control, waste disposal, and personnel training, and a designated pharmacist is responsible for the program.
MM.13.2. The center maintains a list of the hazardous drugs it handles, based on the current NIOSH list and its own formulary, that identifies the antineoplastic agents requiring full containment precautions and documents any assessment of risk applied to other hazardous drugs or final dosage forms; the list is reviewed at least annually and is available where hazardous drugs are stored or used.
MM.13.3. Hazardous drugs are received and unpacked in a designated area separate from the sterile compounding area, and damaged or leaking shipments are handled as spills according to policy.
MM.13.4. Antineoplastic hazardous drugs requiring manipulation are stored separately from other medications in a designated, clearly labelled storage area that is externally vented and maintained under negative pressure as specified in USP <800>; refrigerated antineoplastic drugs are stored in a dedicated refrigerator located in that area.
MM.13.5. Material safety data sheets are accessible, hazardous drug storage, preparation, and administration areas are identified with signage, and an eyewash station (and an emergency shower where required) is available where hazardous drugs are stored and prepared and is accessible to the areas where they are administered.
MM.13.6. There is a structured process for staff who handle hazardous drugs and who are attempting to conceive, pregnant, or breastfeeding to review potential exposure risks and be offered alternative work assignment.
Antineoplastic and other hazardous drugs pose an occupational risk at every step from delivery to waste disposal. USP General Chapter <800>, referenced by the SFDA and adopted as the benchmark in this chapter, sets the minimum elements of a hazardous drug program: a designated responsible person, a current list of hazardous drugs, designated receiving and storage areas with appropriate containment, hazard communication, accommodation of staff at higher risk, and annual training with competency assessment. Medical surveillance and environmental wipe sampling are best practices and are not required by this standard. Engineering controls for compounding are addressed in MM.21.
MM.14. The oncology center applies defined personal protective, containment, decontamination, and spill control measures whenever hazardous drugs are handled.
MM.14.1. The personal protective equipment required for each hazardous drug activity is defined in policy and is available and consistently used; two pairs of chemotherapy-tested gloves (ASTM D6978 or equivalent) and a disposable, impermeable gown are worn for compounding and administration of antineoplastic drugs, with eye, face, and respiratory protection as specified for the activity.
MM.14.2. Closed-system drug-transfer devices are used for the administration of antineoplastic hazardous drugs when the dosage form allows, and luer-lock connections and infusion sets primed according to policy are used for all chemotherapy infusions.
MM.14.3. A written procedure defines the agents, method, and frequency for deactivation, decontamination, cleaning, and disinfection of the biological safety cabinet, compounding areas, work surfaces, and administration areas, and performance is documented.
MM.14.4. Chemotherapy spill kits are available in all areas where hazardous drugs are received, stored, prepared, transported, or administered, spills are managed by trained staff according to a written procedure, and every spill is documented and reported as an incident.
MM.14.5. Hazardous drugs are transported in sealed, leak-proof chemotherapy bags within labelled rigid containers, are never transported by pneumatic tube, transport staff are trained in spill response, and the handover of prepared chemotherapy between the pharmacy and the receiving unit is documented.
MM.14.6. Hazardous drug precautions are applied to the handling of contaminated linen, body fluids, and excreta of treated patients for at least 48 hours after the last dose, or the longer period specified in the center's policy for specific agents, and housekeeping staff who clean hazardous drug areas are trained in the required precautions.
MM.14.7. Oral anticancer agents are handled as hazardous drugs in the pharmacy: they are not crushed or split outside containment, are counted using dedicated equipment, and are dispensed in the manufacturer's unit-dose packaging where available.
This standard sets out the handling controls that must be in place every time a hazardous drug is touched, whether in the pharmacy, the treatment area, or the waste stream. The glove, gown, closed-system device, and cleaning requirements are those stated in USP <800> and the ASHP guidelines as the minimum; the spill, transport, and excreta precautions are the corresponding minimum for areas outside the pharmacy. Oral anticancer agents are often overlooked and are included explicitly.
MM.15. The oncology center manages cytotoxic and pharmaceutical waste safely and applies infection prevention and control requirements in all medication areas.
MM.15.1. There is a policy and procedure on the segregation, collection, storage, and disposal of cytotoxic and pharmaceutical waste in accordance with MOH, SFDA, and environmental regulations; cytotoxic-contaminated sharps are placed in rigid, puncture-resistant, labelled containers and other cytotoxic waste in the designated colour-coded, labelled containers.
MM.15.2. Cytotoxic waste containers are available at the point of generation in preparation and administration areas, waste is removed by a licensed medical waste contractor, and disposal records are kept.
MM.15.3. All areas where medications are stored, prepared, dispensed, or administered are clean and tidy with clean preparation surfaces, are equipped with a wash sink, antiseptic soap or hand rub, and a sharps container of appropriate size, and do not permit food, drink, or smoking; separate housekeeping materials are dedicated to the clean room.
MM.15.4. Pharmacy and nursing staff observe standard precautions in accordance with the center's infection prevention and control program.
MM.15.5. A documented cleaning schedule for compounding areas and biological safety cabinet or laminar airflow hood surfaces is implemented.
MM.15.6. Unused, returned, and expired hazardous medications are disposed of as cytotoxic waste according to policy.
The waste generated by chemotherapy preparation and administration is hazardous to staff, waste handlers, and the environment and is regulated. The center must segregate it correctly at the point of generation and dispose of it through a licensed contractor. General infection prevention measures in medication areas protect both the sterility of prepared products and the safety of patients and staff.
MM.16. Patient-specific information is readily accessible to all healthcare professionals involved in the medication management process.
MM.16.1. There is a multidisciplinary policy and procedure defining the patient-specific information required for safe medication use. The information includes, but is not limited to: age and sex, current medications (including herbal and complementary products), diagnosis and co-morbidities, relevant laboratory values, allergies and previous adverse drug reactions, body weight and height, and pregnancy and lactation status.
MM.16.2. Except in emergency situations, patient-specific information is accessible when needed to all healthcare professionals involved in prescribing, preparing, dispensing, and administering medications.
MM.16.3. Allergies and previous serious adverse drug reactions are documented in a consistent location in the medical record and in the pharmacy medication profile, are visible to prescribing, pharmacy, and nursing staff, and newly identified allergies are added to the profile when reported.
MM.16.4. Current metric body weight and height are documented in the medical record and used for the calculation of body-weight and body-surface-area based doses.
MM.16.5. The patient's identity is verified using at least two patient identifiers before medications are prescribed, dispensed, and administered.
MM.16.6. Medication reconciliation is conducted at the first visit and whenever the patient's medications change, and the current medication list is documented in the medical record.
Safe prescribing, verification, and administration of oncology medications depend on the availability of a defined minimum set of patient information. Weight and height are essential because most cytotoxic doses are calculated on body surface area or body weight, and organ function results are needed to identify patients requiring dose adjustment. The center is expected to define this information in policy, keep it available in the medical record (paper or electronic) at the point of prescribing, dispensing, and administration, and to reconcile the patient's home medications so that duplications and interactions can be identified. The use of two patient identifiers is the basic safeguard against wrong-patient errors.
MM.17. Safe prescribing, ordering, and transcribing of medications in the oncology center are guided by a clear policy and procedure that defines prescribing privileges.
MM.17.1. There is a multidisciplinary policy and procedure that defines a complete medication order or prescription, including at least: patient name, age, and medical record number; allergy status; weight for pediatric and weight-based orders; date; medication generic name, dose, route, frequency, and duration where applicable; indication where required by policy; and the prescriber's name, signature, and identification.
MM.17.2. The center maintains an updated list of the signatures of medical staff authorized to prescribe medications, along with their prescribing privileges; chemotherapy and other antineoplastic medications are prescribed only by physicians granted chemotherapy prescribing privileges by the center; the first cycle of each new regimen is prescribed, or countersigned before verification, by a consultant holding those privileges; and the list is known to pharmacy and nursing staff.
MM.17.3. Medications are prescribed by generic name (except where brand names are acceptable or required); staff comply with the approved and prohibited prescribing abbreviations; and orders that are incomplete, illegible, or unclear are clarified with the prescriber before dispensing.
MM.17.4. There is a policy and procedure on specific types of medication orders, including as-needed (PRN), standing, weight-based and body-surface-area-based, range, tapering, hold-parameter, and discharge or home medication orders; blanket orders are prohibited.
MM.17.5. All current medication orders are written in a uniform location in the medical record, and transcription into the medication administration record is verified against the original order.
MM.17.6. There is a policy and procedure that limits verbal and telephone orders to urgent situations, defines the process for accepting, reading back, documenting, and authenticating them within a defined time frame, and does not permit verbal or telephone orders for chemotherapy except to hold or discontinue treatment.
Prescribing is the point at which the majority of serious oncology medication errors originate. The center is expected to define what a complete order contains, to restrict chemotherapy prescribing to physicians who have been credentialed for it, and to eliminate practices known to cause error, such as unsafe abbreviations, blanket orders, and verbal orders for chemotherapy. Because chemotherapy orders are complex, they are addressed further in MM.18.
MM.18. Chemotherapy and all other systemic anticancer therapy are ordered using standardized orders that contain the information required for safe verification, preparation, and administration.
MM.18.1. Chemotherapy is ordered on standardized pre-printed or electronic order forms or order sets that correspond to the protocols and regimens approved by the center; free-text handwritten chemotherapy orders are not accepted except in circumstances defined by policy.
MM.18.2. Each chemotherapy order includes, at a minimum: two patient identifiers; date of the order; diagnosis; protocol or regimen name, cycle number, and day; the full generic name of each medication (regimen acronyms are not used as the sole identifier); the dose per square metre, per kilogram, or fixed dose and the calculated dose; the route, rate or duration of administration, and date and sequence of administration; supportive and pre-medications; allergies; the number of cycles or the period for which the order set is valid; and the prescriber's name, signature, and identification.
MM.18.3. Doses are calculated using the patient's current metric weight and height (or body surface area) obtained at least at each cycle, and the values used are documented on the order.
MM.18.4. The center defines in policy the body surface area formula used, dose rounding rules, its approach to dose capping and dosing in obese patients consistent with recognized guidelines, and the cumulative lifetime dose limits that apply to anthracyclines, bleomycin, and every other agent for which the approved protocol references specify a limit, and these are applied to every order.
MM.18.5. Any dose modification or deviation from the approved protocol is documented on the order with the reason; a deviation other than a dose adjustment specified in the protocol itself requires a supporting reference or the authorization of a second privileged physician, recorded on the order.
MM.18.6. The pre-treatment parameters required by the protocol, including complete blood count, renal function, hepatic function, and toxicity assessment, together with any protocol-specific parameters, and the criteria for holding or modifying treatment are defined, checked, and documented by the prescriber before each cycle.
MM.18.7. Prescriptions for oral anticancer agents, whether dispensed by the center or by another facility, include: the patient's name and a second identifier; the full generic drug name; the date; the dose and the calculation methodology; the schedule of administration; the quantity to be dispensed; the duration of therapy; and the number of refills, with zero as the default. Oral anticancer agents are subject to the same verification and independent double-check requirements as parenteral chemotherapy.
Standardized, protocol-based orders are the single most effective control against chemotherapy prescribing errors. The center is required to use pre-printed or electronic order sets that correspond to its approved regimens and that capture the elements needed by the pharmacist and nurse to verify the order independently. Doses must be based on current measurements and any deviation from the standard protocol must be explained. This standard applies equally to oral chemotherapy, where the quantity dispensed and the duration must be explicit. Informed consent and pre-treatment documentation are addressed in the standard that follows.
MM.19. Written informed consent and complete pre-treatment documentation are in place before the first administration of each new systemic anticancer therapy regimen.
MM.19.1. Written informed consent is obtained by the privileged treating physician and documented in the medical record before the first cycle of each new regimen; it is signed by the patient or the legal representative and by the treating physician, and the center's policy defines the process to follow when the patient is unable to sign.
MM.19.2. The consent form includes: the diagnosis; the name of the regimen; the planned number of cycles or duration of treatment; the goal of therapy; the common and serious side effects, including infertility risk where relevant; the available alternatives; and the patient's right to withdraw consent.
MM.19.3. The consent is valid for the named regimen for a maximum of one year; a new consent is obtained for any new regimen and when treatment resumes after the validity has lapsed.
MM.19.4. Before the first administration of a new regimen, the medical record contains: pathologic confirmation of the diagnosis; the cancer stage or current cancer status; the medical history and physical examination; allergies and previous hypersensitivity or treatment-related reactions; the performance status; the initial psychosocial assessment; and the chemotherapy treatment plan, stating the drugs, doses, duration, goals of therapy, and planned monitoring.
MM.19.5. A pre-treatment patient assessment is documented before the first cycle that includes vital signs, weight, height, pain assessment, and the current medication list.
MM.19.6. Where the center treats pediatric patients, consent and assent are obtained and documented in accordance with the legal requirements that apply to minors.
Consent and pre-treatment documentation are the record that the right patient, with a confirmed diagnosis, is starting the right treatment for a stated purpose, with the patient's informed agreement. The documentation elements in this standard are those of the ASCO/ONS antineoplastic therapy safety standards and must be complete before the first dose; the nurse's confirmation of consent immediately before administration is covered under administration. This standard applies to parenteral and oral anticancer therapy alike.
MM.20. The oncology center has a system for reviewing the appropriateness of medication orders before medications are prepared and dispensed.
MM.20.1. The pharmacy maintains an updated medication profile (electronic or paper) for each patient treated in the center.
MM.20.2. A pharmacist reviews all medication orders before dispensing, except in emergency situations where the prescriber is physically present.
MM.20.3. The review of every medication order includes: allergies and sensitivities, indication, therapeutic duplication, drug-drug and drug-food interactions, appropriateness of dose, frequency, and route, and contraindications.
MM.20.4. In addition, for chemotherapy orders, a pharmacist independently verifies conformity with the approved protocol, recalculates the dose from the documented weight, height, or body surface area, checks cumulative dose limits and required dose adjustments for organ function, screens for clinically significant interactions (including those of oral anticancer agents with acid-reducing agents and enzyme inducers or inhibitors), and confirms that the required laboratory and clinical parameters have been met before preparation begins.
MM.20.5. All issues, concerns, or questions regarding an order are clarified with the prescriber and documented before the medication is dispensed.
MM.20.6. Chemotherapy is not compounded until the prescriber's confirmation to proceed with the cycle has been documented, except for the specific regimens and circumstances listed in the center's advance-preparation policy.
MM.20.7. Pharmacist interventions and clarifications are documented and their number and type are reported as part of the medication management indicators (MM.36).
Prospective pharmacist review is the second independent check on the prescribing process and is expected for every order, not only for chemotherapy. For chemotherapy the pharmacist recalculates the dose independently rather than accepting the prescriber's calculation, and confirms that the treatment conditions defined in the protocol are satisfied. Interventions and clarifications are documented so that the reasoning behind changes is available in the record.
MM.21. Where the oncology center compounds chemotherapy and other hazardous drugs on site, compounding is performed by the oncology pharmacy in facilities and engineering controls that meet USP General Chapters <797> and <800>.
MM.21.1. There is a policy and procedure on the preparation of sterile hazardous drug preparations; the compounding service is operated and managed by the pharmacy, and only qualified pharmacy staff work in the compounding area.
MM.21.2. Hazardous drug sterile compounding is performed in a containment primary engineering control: an ISO Class 5 Class II biological safety cabinet with 100 percent exhaust to the outside of the building (type B2) or a compounding aseptic containment isolator.
MM.21.3. The containment primary engineering control is located in a containment secondary engineering control (buffer room or containment segregated compounding area) that is physically separate from non-hazardous compounding, is externally vented, maintains negative pressure relative to adjacent areas, and provides at least 12 air changes per hour, as specified in USP <800>; the pressure differential is monitored and documented at least daily.
MM.21.4. An ante-area with hand-washing facilities and garbing space is provided, and pass-through or traffic arrangements prevent the movement of hazardous drug contamination into clean or public areas.
MM.21.5. The containment primary engineering control is certified at least every six months and after relocation or major repair, the secondary engineering control is certified to confirm airflow and pressure at the same interval, and certification records are kept.
MM.21.6. When the primary or secondary engineering control is out of certification or not operating within specification, hazardous drug compounding is suspended and the center applies its documented contingency plan for obtaining prepared chemotherapy from an alternative compliant source until the control is restored and re-certified.
The engineering controls in this standard are the minimum specified in USP <797> and <800> for compounding antineoplastic drugs: a Class II type B2 cabinet (or isolator) inside an externally vented negative-pressure room with adequate air exchange, certified every six months. The most common failure in practice is a cabinet or room that does not achieve the required airflow or pressure; this standard therefore requires that compounding stop, and an alternative be used, when the controls are not within specification. A compounding aseptic containment isolator located in a containment segregated compounding area that meets the ventilation and pressure requirements of USP <800> satisfies this standard in place of a clean-room suite. This standard and the one that follows apply to centers that compound on site; a center that obtains all of its compounded anticancer preparations from an outsourcing facility is assessed against the outsourcing standards of this chapter (MM.23 and MM.24) instead.
MM.22. Where the oncology center compounds on site, hazardous drug sterile compounding is performed by qualified personnel using a documented process that ensures the sterility, accuracy, and containment of every preparation.
MM.22.1. Personnel who compound hazardous drugs demonstrate competency in hand hygiene, garbing, and aseptic technique before independent compounding, including gloved fingertip sampling and a media-fill test, and are requalified at the intervals specified in USP <797>.
MM.22.2. Compounding is performed using aseptic technique and the garbing and personal protective equipment required for hazardous drugs (MM.14.1), and a documented schedule for deactivation, decontamination, cleaning, and disinfection of the engineering controls is followed.
MM.22.3. A compounding record is completed for every preparation that includes: patient identifiers; medication, strength, and manufacturer lot number and expiry; diluent and final volume; date and time of preparation; beyond-use date; and the identity of the person who compounded and the pharmacist who checked the preparation.
MM.22.4. Written and approved references on stability and compatibility are used, and beyond-use dates are assigned in accordance with USP <797> for the category of preparation and the available stability data.
MM.22.5. Every compounded hazardous drug preparation undergoes a pharmacist visual inspection for particulates, discoloration, and integrity and an independent double check of the drug, dose, diluent, and final volume against the verified order before release, and the check is documented.
MM.22.6. Environmental monitoring of the compounding areas is performed at the frequency required by USP <797> for the category of preparations compounded (including viable air sampling at certification and surface sampling), results are documented, and out-of-limit results are investigated and corrected.
MM.22.7. A compounding record and the certification, environmental monitoring, and personnel qualification records required by this standard are retained and are available for review, and any deviation from the compounding process is documented, investigated, and reported through the medication error process.
Engineering controls alone do not ensure a safe preparation; the personnel and process requirements in USP <797> — competency testing, a compounding record, stability-based beyond-use dating, independent verification, and environmental monitoring — are the corresponding core for the work itself. A compounding record for every dose is essential for traceability in the event of a recall, an error, or an adverse event.
MM.23. Where compounded anticancer preparations are obtained from an outsourcing facility, the facility is licensed, qualified, and governed by a written agreement, and the center retains accountability for every preparation administered.
MM.23.1. There is a policy that states whether the center compounds on site, obtains compounded anticancer preparations from an outsourcing facility, or both; defines the preparations within the scope of the outsourcing arrangement; and assigns accountability for the arrangement to the head of pharmacy.
MM.23.2. The outsourcing facility holds a valid SFDA licence for the compounding and distribution of the preparations supplied, and the licence is verified and kept on file.
MM.23.3. Before the first supply, the pharmacy qualifies the facility and documents evidence of its compliance with USP General Chapters <797> and <800>, including current certification of its primary and secondary engineering controls, environmental monitoring results, personnel qualification records, and its beyond-use dating policy; a site visit or an independent audit report forms part of the qualification.
MM.23.4. There is a written agreement with the outsourcing facility that defines, at a minimum: the preparations and volumes in scope; the required label content; the assignment and justification of beyond-use dates; order transmission, delivery windows, and turnaround times; temperature-controlled and hazardous-drug-compliant transport with chain of custody; notification of deviations, complaints, and errors; the recall procedure; and the conditions for termination.
MM.23.5. The pharmacy re-evaluates the outsourcing facility at least annually against the qualification evidence and the performance of the agreement, documents the evaluation, and reports it to the pharmacy and therapeutics committee, or equivalent.
MM.23.6. Preparation errors, deviations, contamination reports, and recalls originating from the outsourcing facility are reported through the center's medication error process and are included in its quality indicators.
MM.23.7. The center maintains records that allow every administered preparation to be traced to its order, the facility, and the delivery in which it was received.
Outsourcing transfers the compounding activity but not the accountability: the center remains responsible for every dose administered to its patients. This standard therefore requires the center to know and declare how its preparations are produced, to qualify the facility on evidence of compliance with the same USP chapters that would apply to its own pharmacy rather than on a contract alone, to govern the relationship through an agreement that specifies what quality means in practice, and to re-evaluate the facility annually. Traceability from the administered dose back to the delivery is what makes a recall or an investigation possible.
MM.24. Where compounded anticancer preparations are obtained from an outsourcing facility, the center verifies each order before transmission, inspects each preparation on receipt, and maintains a defined response for preparations and deliveries that fail.
MM.24.1. Every order is reviewed and verified by a pharmacist at the center in accordance with the pharmacist review standard of this chapter before it is transmitted to the outsourcing facility.
MM.24.2. The information transmitted to the facility is defined in policy, and the transmitted order is verified against the original order by a second qualified staff member before transmission; the transmission record is retained.
MM.24.3. On receipt, a pharmacist inspects each preparation against the original order and documents the check of: patient identifiers; drug, dose, diluent, and final volume; label content; beyond-use date; and physical integrity, together with the transport temperature record.
MM.24.4. Preparations that fail the receipt check, arrive outside their required temperature range, or arrive damaged or past their beyond-use date are quarantined, are not dispensed, and are reported to the facility under the agreement; the disposition of each rejected preparation is documented.
MM.24.5. There is a policy on advance ordering that defines when an order may be placed before the patient's pre-treatment assessment, the action to be taken when the pre-treatment parameters are not met or treatment is cancelled after a preparation has been made, whether the facility accepts returns, and how unused hazardous preparations are handled and wasted.
MM.24.6. There is a defined contingency arrangement for delivery failure or suspension of supply, naming an alternative qualified source or a documented arrangement with a compliant facility; chemotherapy and other sterile anticancer preparations are never compounded in treatment, procedure, or storage areas.
MM.24.7. Received preparations are stored, transported within the center, administered, and disposed of in accordance with the hazardous drug standards of this chapter.
When compounding takes place elsewhere, the center's controls shift to the two ends of the process: verification of the order before it leaves, and inspection of the preparation when it arrives. Transmission is a transcription step that does not exist in on-site compounding and is therefore independently checked. The receipt check is the center's only opportunity to detect a wrong drug, wrong dose, degraded, or expired preparation before it reaches a patient. Because outsourced doses are usually made before the patient is assessed on the day of treatment, the center must decide in advance how it will handle a preparation that can no longer be used, and must have a contingency that does not end in improvised preparation at the point of care.
MM.25. The oncology center has a system for supportive and other preparations that are not anticancer therapy, whether compounded on site or obtained ready to use, as applicable to its scope of service.
MM.25.1. Sterile preparations that are not anticancer therapy are compounded by pharmacy staff qualified in aseptic technique in an ISO Class 5 primary engineering control located in a positive-pressure clean room designed according to USP <797>, separate from the containment primary engineering control used for hazardous drugs; the control is certified at least every six months.
MM.25.2. Where the center cannot provide a separate primary engineering control, preparations compounded in the hazardous drug containment control are handled, labelled, and disposed of as hazardous.
MM.25.3. Sterile preparations are not compounded in treatment, procedure, or storage areas. A non-hazardous preparation may be prepared outside the pharmacy only under the immediate-use conditions defined in policy in accordance with USP <797> — prepared by trained staff, administered within the permitted period, and never stored; anticancer and other hazardous preparations are excluded from this provision.
MM.25.4. Where parenteral nutrition is provided, there is a policy and procedure on its preparation; it is compounded in the pharmacy clean room by qualified staff, a double check is performed at each stage with visual inspection of the final product, and appropriate filters and stability guidelines are used.
MM.25.5. Where non-sterile compounding is performed, there is a policy and procedure, suitable facilities and equipment, a referenced formulation manual, and a log of each preparation (name, strength, quantity, batch number, preparation and expiry dates, and prepared-by and checked-by signatures).
MM.25.6. Where the center does not compound on site, supportive and other non-hazardous sterile preparations are obtained as commercially prepared ready-to-use products or through the outsourcing arrangement of this chapter.
Oncology centers use supportive intravenous medications — hydration, antiemetics, and electrolyte replacement — alongside anticancer therapy, and some provide parenteral nutrition or extemporaneous oral preparations. This standard covers those preparations wherever they come from: compounded on site under the same basic conditions of qualified staff, appropriate environment, defined procedures, and documented checks, or obtained ready to use when the center has no compounding pharmacy. Preparation at the point of care is not an acceptable substitute for either route; the narrow immediate-use provision of USP <797> is the only exception and never applies to anticancer or other hazardous preparations.
MM.26. The oncology center has a system for labelling medications.
MM.26.1. All medications prepared but not intended for immediate administration are labelled, including injectable medications drawn into syringes or added to intravenous fluids in treatment and procedure areas.
MM.26.2. Patient-specific compounded preparations are labelled in a standardized format with: patient name and medical record number; medication name, dose, and total amount; diluent and final volume; route and rate or duration of administration; date and time of preparation and beyond-use date; storage requirements; and the identity of the staff who prepared and checked the preparation.
MM.26.3. Compounded chemotherapy is labelled with a clearly visible cytotoxic or hazardous-drug warning, and vesicant medications are identified as such.
MM.26.4. Medications dispensed for use outside the center, including oral chemotherapy, are labelled with the patient's name, medical record number, medication name, dosage form and strength, directions and duration of use, and relevant cautions, in a language and form the patient can understand.
MM.26.5. Where several medications are prepared for a single patient in a treatment or procedure area, each is labelled with the medication name and dose or concentration.
Complete and standardized labelling allows the person administering a medication to confirm that it is the right medication, dose, and route for the right patient. Cytotoxic warnings alert staff to apply hazardous-drug precautions during transport, administration, and disposal. Labels for medications taken at home must be understandable to the patient or caregiver.
MM.27. The oncology center has a system for the safe dispensing and distribution of medications, including when the pharmacy is closed.
MM.27.1. The center has a uniform system for dispensing and distributing medications, and medications are dispensed in the most ready-to-administer form possible.
MM.27.2. Oral anticancer agents are dispensed in the quantity specified for the current cycle, in child-resistant packaging, with a hazardous drug warning label and written handling instructions for the patient and caregiver.
MM.27.3. Medications are dispensed in quantities consistent with patient need, and dispensing time frames for STAT and for routine orders are defined and implemented.
MM.27.4. Records are maintained for all dispensed medications.
MM.27.5. An independent double check is performed before dispensing all high-alert medications, including chemotherapy.
MM.27.6. There is a policy and procedure on obtaining medications when the pharmacy is closed that limits access to trained and authorized staff, defines a limited list of medications accessible to non-pharmacy staff, and ensures that a pharmacist is reachable to answer questions and provide other medications; after-hours access is documented.
The dispensing system should minimize handling and manipulation of medications at the point of care and should provide a record of what was supplied to whom. Because many oncology centers do not operate a 24-hour pharmacy, the center must define how medications are obtained safely and accountably outside pharmacy hours.
MM.28. The oncology center has a safe system for the administration of medications, including chemotherapy.
MM.28.1. The center defines the nurses and other clinical staff authorized to administer medications; nurses who administer chemotherapy have documented chemotherapy training and competency assessment before administering independently, reassessed at least every two years, and the records are kept in their personnel files.
MM.28.2. Before administration, the medication is verified against the medication administration record and original order for the right patient (two identifiers), right medication, right dose, right route, right time, and right frequency, and is checked for expiry date, visual integrity, and contraindications.
MM.28.3. For chemotherapy, an independent double check by two qualified staff members (at least one of whom is a chemotherapy-trained nurse) of the patient's identity, medication, dose, route, rate, and regimen, cycle, and day is performed and documented immediately before administration.
MM.28.4. Before chemotherapy is administered, the nurse confirms that the pre-treatment parameters required by the protocol have been met, that allergies have been reviewed, that written informed consent is documented in accordance with the consent standard of this chapter, that pre-medications have been given as ordered, and that vascular access is patent.
MM.28.5. The center has approved administration guidelines covering each route of systemic anticancer therapy in use — intravenous infusion and intravenous push, subcutaneous, intramuscular, and oral, and intravesical or intrathecal where provided — including the rate or duration and sequence of administration, standard administration times, and the use of infusion pumps for continuous or rate-critical infusions; the guidelines are accessible at the point of administration and implemented in all administration areas.
MM.28.6. Patients are observed for hypersensitivity and infusion reactions during and after administration according to policy, and staff are trained in the management of such reactions.
MM.28.7. The center maintains accurate records of medication administration, including the time, route, and site of administration and the identity of the administering staff, and does not permit administration of medications brought from outside the center unless prescribed by the treating physician.
Administration is the last point at which an error can be intercepted. In addition to the general safeguards required for all medications, chemotherapy requires that the person administering it be specifically trained, that a second qualified person independently verify the key elements immediately before administration, and that the conditions for treatment are confirmed. Observation for infusion reactions and readiness to manage them are essential in outpatient chemotherapy settings.
MM.29. The oncology center applies specific safeguards for wrong-route and high-risk cytotoxic administration, infusion devices, and the chemotherapy administration environment.
MM.29.1. Vinca alkaloids are labelled 'FOR INTRAVENOUS USE ONLY - FATAL IF GIVEN BY OTHER ROUTES' and are dispensed and administered as an infusion in a minibag, not in a syringe.
MM.29.2. Where intrathecal chemotherapy is administered, it is prepared and labelled 'FOR INTRATHECAL USE ONLY', is stored, transported, and delivered separately from intravenous chemotherapy and never together with vinca alkaloids, and is administered only by an authorized trained physician after an independent double check at the bedside.
MM.29.3. Vesicant medications are administered by trained staff through the type of vascular access specified in the center's policy for the medication and duration of infusion, continuous infusions of vesicant agents are administered through a central venous access device, the patient and access site are monitored during administration, and any extravasation is managed and documented according to policy.
MM.29.4. Infusion pumps used for chemotherapy are maintained under a preventive maintenance schedule, and rate-critical infusions are programmed and independently checked according to policy.
MM.29.5. Areas where chemotherapy is administered have available personal protective equipment, hazardous-drug waste containers, and a chemotherapy spill kit, and hazardous-drug precautions are applied when handling contaminated materials and body fluids according to policy.
MM.29.6. Where ambulatory infusion pumps are used for continuous chemotherapy infusion, the center has a procedure covering pump programming and double check, patient and caregiver instructions for disconnection and spills, and the return and disposal of used devices.
Inadvertent intrathecal administration of vinca alkaloids is fatal and has occurred in many countries; the labelling, minibag, and segregation requirements in this standard are the internationally accepted minimum controls to prevent it and apply to every center that uses these medications. Vesicant extravasation is a preventable cause of serious tissue injury and requires trained staff, appropriate access, and a management protocol. The remaining sub-standards address the hazardous-drug precautions that must be maintained in treatment areas.
MM.30. The oncology center provides education to patients and families about their medications and has a system for follow-up.
MM.30.1. Patients and families receive education from qualified staff before the first administration of each new regimen, delivered verbally and supported by written or electronic information in a language and form the patient can understand; the patient's or caregiver's comprehension is assessed; and both the education and the comprehension assessment are documented in the medical record.
MM.30.2. Education includes but not limited to: the names of the medications, the treatment schedule and duration, expected effects and common and serious side effects and what to do about them, when and whom to contact, what to do about missed doses, storage and safe handling of medications at home, including the handling of body fluids, linen, and waste for at least 48 hours after the last dose, precautions including contraception and fertility, the plan for follow-up visits and laboratory tests, and the use of supportive medications. Patients receiving immunotherapy are additionally educated on the symptoms of immune-related adverse events and are given written information or an alert card identifying the therapy and the symptoms that require urgent review.
MM.30.3. Patients receiving oral chemotherapy and other self-administered medications receive pharmacist counselling at the time of dispensing, adherence is assessed at follow-up visits, and both are documented.
MM.30.4. Patients are given a contact number and a defined 24-hour pathway to a practitioner — an on-call practitioner or a designated emergency department — for the management of treatment-related toxicities and emergencies, with instructions on when and whom to call.
MM.30.5. There is a process to identify and follow up patients who miss scheduled chemotherapy visits.
MM.30.6. Patient privacy is maintained during education and counselling.
MM.30.7. When the patient's care is transferred to another facility or practitioner, a written summary of the treatment plan, the chemotherapy administered, pending results, critical safety concerns, and the schedule of remaining treatment is communicated to the receiving party and documented.
Oncology patients manage much of their treatment at home, including oral chemotherapy, supportive medications, and the recognition of toxicities that require urgent attention. Structured education before treatment, counselling at the time oral chemotherapy is dispensed, and a clear route for advice when problems occur are therefore basic safety requirements for an outpatient oncology center. Any format of delivery is acceptable provided every content element in MM.30.2 is covered and the delivery is documented.
MM.31. The oncology center has a system to monitor the patient's response to medications.
MM.31.1. There is a multidisciplinary policy and procedure on monitoring the patient's response to medications.
MM.31.2. The laboratory and clinical monitoring parameters required for each protocol or regimen , including complete blood count, renal and hepatic function, cardiac function for cardiotoxic agents, assessment for immune-related adverse events for immune checkpoint inhibitors, and the agent-specific parameters specified in the approved protocol references, are defined, are checked before each cycle or at the interval specified in the protocol, and are documented in the medical record.
MM.31.3. Treatment-related toxicities are assessed at each visit, graded using the current version of the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE), and documented, together with any resulting dose modification, delay, or discontinuation.
MM.31.4. There is a collaborative process involving physicians, nurses, and pharmacists to monitor the effect of medications on the patient's clinical condition, the patient's perception of side effects to the first dose of a new medication, and unanticipated drug interactions.
MM.31.5. The center has an annually updated list of formulary medications that may affect the patient's equilibrium and increase the risk of falls, and appropriate precautions are applied.
MM.31.6. Allergic reactions are documented and flagged in the medical record.
Monitoring is the means of confirming that treatment is producing the intended effect without unacceptable toxicity, and of identifying patients who require dose adjustment or interruption. In oncology this monitoring is defined by the treatment protocol and must be performed before each cycle. Consistent grading of toxicity supports safe dose modification and communication among the treating team.
MM.32. The oncology center has approved guidelines and a defined capability for the management of treatment-related toxicities, including immune-related adverse events.
MM.32.1. The center has guidelines, approved by the pharmacy and therapeutics committee or equivalent, for the management of the principal toxicities of the therapies within its scope: hypersensitivity and infusion reactions; extravasation; chemotherapy-induced nausea and vomiting; febrile neutropenia; and, where immunotherapy is used, immune-related adverse events.
MM.32.2. The medications, antidotes, and equipment required by these guidelines are available in the areas where systemic anticancer therapy is administered, in accordance with the emergency medication requirements of this chapter.
MM.32.3. The febrile neutropenia guideline defines risk assessment and requires administration of the first dose of empiric antibiotics within one hour of presentation, before or during transfer where transfer is needed.
MM.32.4. The immune-related adverse event guideline defines management by CTCAE grade, including the criteria for initiating corticosteroids, for withholding or discontinuing immunotherapy, and for urgent referral.
MM.32.5. The center defines the toxicities it can manage on site and the criteria and pathway for escalation and transfer to a hospital for toxicity beyond its capability, supported by a documented transfer arrangement.
MM.32.6. Physicians, pharmacists, and nurses involved in systemic anticancer therapy are trained in the recognition and initial management of the toxicities in the center's guidelines, and the training is documented.
Treatment-related toxicity is the predictable emergency of systemic anticancer therapy, and an outpatient oncology center must be able to recognize it, begin the correct management immediately, and move the patient to a hospital when the toxicity exceeds what the center can manage. The guideline set in this standard covers the toxicities common to cytotoxic and targeted therapy together with immune-related adverse events, whose recognition and corticosteroid-based management differ from classical chemotherapy toxicity and are therefore required explicitly wherever immunotherapy is given. The one-hour antibiotic requirement for febrile neutropenia is the internationally accepted minimum. Monitoring and grading of toxicity are addressed in the preceding standard; this standard addresses its management.
MM.33. The oncology center has a process for detecting, managing, and reporting adverse drug reactions (ADRs).
MM.33.1. There is a multidisciplinary policy and procedure on handling adverse drug reactions that includes a clear definition of an ADR and its severity.
MM.33.2. The treating physician is notified at the appropriate time, and the patient affected by an ADR receives appropriate care.
MM.33.3. ADR report forms are readily available and in use, and all ADRs are documented in the patient's medical record.
MM.33.4. The center analyzes all significant and serious ADRs and refers the findings to the pharmacy and therapeutics committee, or equivalent, for recommendations to prevent recurrence.
MM.33.5. All serious or unexpected ADRs are reported to the SFDA National Pharmacovigilance Center in accordance with SFDA requirements and time frames.
MM.33.6. The center has a system for improving ADR reporting, including staff education.
Adverse reactions are frequent with antineoplastic and supportive medications, and distinguishing expected toxicity from a reportable adverse reaction requires a defined process. The center must manage the affected patient, document the reaction so that it informs future prescribing, review serious reactions internally, and fulfil the national reporting obligation to the SFDA.
MM.34. The oncology center has a process for monitoring, identifying, reporting, and learning from medication errors, near misses, and hazardous situations. (ESR)
MM.34.1. There is a multidisciplinary policy and procedure on handling medication errors, near misses, and hazardous situations, with clear definitions of each.
MM.34.2. There is a standard format and a defined time frame for reporting medication errors, and reporting takes place in a non-punitive environment that encourages staff to report.
MM.34.3. The treating physician is notified of the error at the appropriate time, the patient receives appropriate care, and the error is documented in the patient's medical record.
MM.34.4. The center conducts root cause analysis for all significant or potentially significant medication errors.
MM.34.5. Reported data are analyzed and used to improve the medication use process, and healthcare professionals receive feedback on reported errors, near misses, and hazardous situations.
MM.34.6. Sentinel events related to serious medication errors are reported to the relevant authorities as required.
MM.34.7. Staff are educated on the process and importance of medication error reporting.
A functioning medication error reporting system is the primary way in which a center learns about weaknesses in its medication processes before they cause serious harm. Reporting depends on a culture in which staff are not blamed for reporting, on a simple standard mechanism, and on visible action taken in response to reports. This standard is aligned with the CBAHI Essential Safety Requirements.
MM.35. Where the oncology center participates in clinical trials, investigational medications are controlled by the pharmacy in accordance with the approved protocol and applicable regulations.
MM.35.1. There is a policy and procedure on the receipt, storage, dispensing, accountability, and return or destruction of investigational medications, in accordance with the protocol, Good Clinical Practice, and SFDA and ethics committee requirements.
MM.35.2. Investigational medications are stored separately from other medications under the conditions specified by the sponsor, with temperature monitoring and restricted access.
MM.35.3. Accountability records are maintained for every unit received, dispensed, returned, and destroyed.
MM.35.4. Investigational medications are dispensed only against a protocol-specific order from an investigator authorized for that study, and are labelled in accordance with the protocol.
MM.35.5. Pharmacy and nursing staff involved in a study receive protocol-specific training before handling the investigational medication.
MM.35.6. Investigational antineoplastic agents are handled as hazardous drugs unless the sponsor's documentation supports otherwise.
Many oncology centers take part in clinical trials. This standard applies only where they do, and sets the minimum conditions for pharmacy control of investigational products: separate storage, full accountability, protocol-based dispensing, and trained staff. Unknown agents are treated as hazardous by default.
MM.36. The oncology center monitors the quality and safety of its medication management processes and takes action on the results.
MM.36.1. The center defines indicators for medication management that include, but not limited to: medication errors and near misses; adverse drug reactions; compliance with independent double checks for chemotherapy; pharmacist interventions on chemotherapy orders; hazardous drug spills and staff exposure incidents; engineering control certification and pressure monitoring status; and compliance with medication storage and temperature monitoring requirements.
MM.36.2. Indicator data are collected, analyzed, and reported to the pharmacy and therapeutics committee, or equivalent, and to the center's quality committee at least quarterly.
MM.36.3. Corrective actions arising from indicator results, error analyses, and audits are documented and followed up to closure.
MM.36.4. The pharmacy participates in the center's quality improvement and patient safety program.
Continuous monitoring of a small set of defined indicators allows the center to identify where its medication processes are not performing as intended and to demonstrate that problems lead to action. The indicators listed are the minimum.
MOI.1. The cancer organization defines in a policy the information that is shared among the staff and with other governmental and non-governmental entities and its format.
MOI.1.1. The policy highlights how patient demographic and medical information is shared with governmental entities according to personal data protection law.
MOI 1.2. The policy highlights how patient demographic and medical information is shared among medical and administrative staff.
MOI.1.3. The policy includes required information and the frequency of reporting to the Ministry of Health and National Cancer Registry.
MOI.1.4. The policy highlights the patient's personal and medical information required to refer the patient to a higher center.
MOI.1.5. The policy identifies the staff levels for accessing information.
MOI.1.6. The policy identifies how various information is secured and safely stored.
MOI.1.7. The policy highlights the different documents retention time consistent with rules and regulations of Saudi Arabia documents protection laws.
Communication failures contribute significantly to adverse events in healthcare. To reduce risks and ensure accurate, timely information exchange, the cancer center has to maintain a documented Information Management Plan.
This policy defines how clinical, administrative, and regulatory information is shared internally and externally, how access is controlled based on staff roles, and how information is stored and secured. It also specifies the format, frequency, and recipients of external reports, outlines referral documentation requirements, and sets retention periods for records in compliance with national regulations.
MOI.2 The cancer organization has a policy and procedure for controlling the development and maintenance of key documents and forms.
MOI.2.1 The cancer organization maintains a unique identifier for each key document, with title, number, date of issue, and date of revision.
MOI.2.2 Key documents are developed, approved, revised, and terminated or a archived by authorized individuals.
MOI.2.3 Key documents are communicated to relevant staff and are always accessible.
MOI.2.4 A process is in place to ensure that key documents are always implemented.
MOI.2.5 Records and information are protected against loss, destruction, tampering, and unauthorized access or use.
For the proper execution of key documents, policies, procedures, processes, and programs, there must be a standardized written structure and format. These documents should indicate the originating department, date of issue, date of revision, date of implementation, and date of expiry. Key documents such as plans, policies and procedures should be reviewed, approved, and updated accordingly by authorized individuals. Key function documents, policies, procedures, and processes must carry the name(s) of the author(s) and approving authority. A system must be in place to ensure that only approved and non-expired policies are circulating and available to staff. All staff should be familiar with the available key function documents, policies, procedures, and processes relevant to their practice.
MOI.3 Documentation of Medical Records:
MOI.3.1. A single medical record is generated for every patient using unique medical record number.
MOI.3.2. Each authorized discipline is responsible for providing complete, pertinent, current, and legible information in the medical record.
MOI.3.3. Documentation in the medical record must be adequate, timely, pertinent, complete, and legible.
MOI.3.4. Medical records contain the required patient demographics, including national identification, contact information, emergency contacts and insurance category.
MOI.3.4. All entries are written using the English language, except where Arabic language is required as applicable to facilitate patient's capacity to participate in making a decision regarding his/her healthcare process.
MOI.3.5. Documentation in the medical record identifies the patient, supports the diagnosis, justifies treatment, and explains investigation results, measurable goals, treatment and patient response, patient and family education and reflects continuity of care and communication across all disciplines.
MOI.3.6. All entries are dated using the Gregorian calendar with the format dd/mm/yy.
MOI.3.7. All entries are timed, using the 24-hour clock, to avoid confusion with AM and PM times.
To ensure continuity of care, every patient should have his/her own medical record that has a unique medical record number. All required information shall be completed by the authorized professional. The medical record shall be completed using English except if the Arabic is required. The Gregorian calendar is the approved system for all entries, utilizing the dd/mm/yy format.
MOI.4 The center has an implemented policy and procedure for the use of information technology in radiotherapy units
MOI.4.1 Radiotherapy planning Systems (RTP) are assessed and tested before implementation within the center and evaluated for quality and patient safety following implementation.
MOI.4.2 The policy and procedure describe the manual procedures required to execute the various activities in the event of radiotherapy system failure, maintenance or repair.
MOI.4.3 The center maintains and tests a program for response to planned and unplanned RTP system downtimes.
MOI.4.4 The center implements safeguards to protect the security and confidentiality of patient information when electronic communication is used in patient care.
MOI.4.5 The policy and procedure highlight how the generated information is stored and regularly backed up.
MOI.4.6 The center implements and regularly updates data-security measures, including defense against cyber-attacks, ensures regular backup of critical data and tested disaster-recovery arrangements, and provides staff with training on secure information management practices.
MOI.4.7 The center has a documented data-breach incident response procedure that describes how breaches of patient information are identified, contained, investigated, recovered from, and communicated to affected patients/service users, with post-incident review to prevent recurrence.
Information technology is critical to the safe and efficient delivery of healthcare services. To minimize risks during HIS downtime, the center must implement a policy that outlines fallback procedures, including manual workflows and responsibilities for clinical and administrative tasks. Downtime protocols must be regularly tested and evaluated after actual incidents to ensure readiness and effectiveness.
The policy also defines how electronic patient information is securely stored, backed up, and restored to prevent data loss. Backup systems must follow data protection protocols, with regular implementation and monitoring to ensure continuity. In addition, when electronic communication is used, such as telehealth, patient portals, or mobile messaging, the center must follow approved guidelines to ensure patient confidentiality, data security, and quality of care are maintained.
MOI.5 The cancer facility manages digital care and artificial intelligence systems and applications safely and responsibly.
MOI.5.1 The center uses a documented process to assess, approve, implement, and periodically review digital care and artificial intelligence (AI) tools.
MOI.5.2 The center consults healthcare providers before introducing new digital or AI tools to understand workflow implications and training needs.
MOI.5.3 The center ensures safe, timely non-digital alternatives and appropriate support for patients unable to use digital tools.
MOI.5.4 The center ensures compliance of digital care and AI systems with applicable laws, regulations, ethical standards, and data protection requirements.
MOI.5.5 The center provides technical support and maintains a tested downtime plan to ensure safe care when radiotherapy systems are unavailable.
MOI.5.6 The center monitors digital care and AI tools for performance and safety and implements improvements based on findings.
MOI.5.7 The center ensures documentation of all digital care and AI–supported consultations and patient information in the medical record.
Digital care includes technology-enabled health services such as remote monitoring, mobile apps, wearables, telephone or video consultations, remote test reporting, and other digital tools. AI systems use algorithms to support clinical tasks such as diagnosis, risk prediction, triage, and treatment decisions.
This standard requires the center to manage these technologies within a structured governance and risk-management framework. Before introducing any digital or AI tool, the center evaluates its clinical value, cost–benefit, interoperability, and potential unintended consequences, and involves frontline staff to understand workflow changes and training needs.
Patients who cannot use digital tools must receive safe, timely non-digital alternatives and appropriate support. All digital and AI solutions must comply with relevant laws, ethical requirements, and data protection rules, including regulations issued by SDAIA, digital government authorities, SFDA, and other relevant bodies.
Safe use is maintained through access to technical expertise, routine testing, quality checks, and a tested downtime plan to ensure continuity of essential services. Digital and AI tools are monitored for performance and safety, and the results are used to reduce risks and improve care.
Clinical accountability remains with qualified clinicians, even when AI contributes to decision-making. All digital and AI-supported consultations and information are documented in the medical record with full completeness and timeliness to ensure continuity and safe decision-making.
MOI.6 The cancer organization has a written policy and procedure for Cancer Registry management
MOI.6.1 The cancer organization has a written policy and procedure for data security guidelines for Cancer Registries.
MOI.6.2 The policy includes description for authorized access, release reports, the source of data, completeness of reporting and timeframe, data quality and analysis.
Explanation Clear written policies and procedures create a standardized framework for the entire cancer registry process. They define responsibilities, outline data security measures, ensure authorized access, and describe data collection methods. Policies on completeness, timeliness, and quality ensure consistent and accurate dataset submission. Such structured documentation supports staff performance, protects patient information, and improves reliability of cancer data for clinical and national reporting purposes.
MOI.7 The cancer organization has cancer registry unit with appropriate staffing as a part of the structure
MOI.7.1 Cancer care organization maintains and document cancer registry data on all patients diagnosed and/or treated for cancer at their facility.
MOI.7.2 The cancer organization has a Certified Tumor Registrar (CTR), Oncology Data Specialist (ODS) or equivalent national certification in cancer registry.
MOI.7.3 Certified registrar able to extract a complete summary of each cancer patient's history, diagnosis, treatment, and disease status into uniform data collection platforms or cancer registry.
MOI.7.4 Certified registrar manages and analyzes clinical cancer-related information for the purpose of processing, maintaining, compiling and reporting health information.
Explanation A functional cancer registry requires a dedicated unit with the appropriate structure, staffing, and expertise. Certified Tumor Registrars (CTR), Oncology Data Specialist (ODS) or National Certification possess specialized training in cancer diagnosis, staging, coding, and data abstraction. Their role is essential in ensuring uniform data collection, accurate extraction of clinical information, and proper data analysis. Maintaining comprehensive records of each patient's cancer history supports patient care continuity and contributes to research and prevention strategies. Evidence of timely data entry, completeness, and utilization demonstrates that the registry is fulfilling its intended operational and clinical functions.
MOI.8 The Cancer Registry complies with relevant laws and regulations
MOI.8.1 Cancer Registrar register oncology data to the hospital Cancer Registry within 1 month of cancer diagnosis.
MOI.8.2 Cancer Registrar submits oncology data to the National Cancer Registry within 6 months of cancer diagnosis.
MOI.8.3 Cancer Registrar Staff records cancer stages according to the International Classification of Diseases for Oncology (ICD-O), ICD-10 as well as the SEER Summary Staging System or other coding standards that are approved by National Cancer Registry.
Explanation Cancer registries must operate in accordance with national laws and regulatory standards. Timely submission of data to the National Cancer Registry ensures accurate cancer surveillance at the population level. Adhering to recognized staging systems and international disease classifications (ICD-O, ICD-10) ensures uniformity, comparability, and national alignment. Staff must be trained to interpret medical records, pathology reports, imaging, and treatment details to ensure accurate abstraction and coding. This standard ensures legal compliance, high-quality public health reporting, and standardized national datasets.
MOI.9 The cancer organization strictly monitors the coding standards (such as ICD-10AM, ACHI & ACS) for diagnosis and procedures.
MOI.9.1 There is a process for monitoring codes entered by physicians.
MOI.9.2 Physicians participated in entering diagnoses codes and definitions in HIS.MOI.9.3 There is a process of assigning the appropriate code to the primary diagnosis and secondary diagnoses that include complications and comorbidities.
MOI.9.4 Primary procedure and all possible secondary procedures that include diagnostic procedures is coded in the patient's medical records.
MOI.9.5 There is a process for Internal audit at least quarterly by using a random sample to validate the quality of coding information by at least 5% of all files in a year.
Explanation Accurate coding of diagnoses and procedures is essential for generating valid, high-quality, and statistically meaningful cancer data. Following standardized classification systems (ICD-10-AM, ACHI, ACS) ensures consistency and comparability across healthcare institutions. Monitoring physician coding practices, ensuring participation in accurate data entry, and assigning correct codes for primary and secondary diagnoses and procedures all support data integrity. Regular internal audits validate coding accuracy, identify errors, and sustain continuous quality improvement. This standard strengthens the reliability of the cancer registry and enhances the accuracy of clinical and administrative datasets
MOI.10 Virtual care, telehealth, and hotline services
MOI.10.1 Cancer care virtual care/ telehealth protocol is implemented for cancer patients.
MOI.10.2 Virtual and hotline interventions are designed and delivered to focus on comfort, symptom relief, and emotional and psychological support.
MOI.10.3 Availability of hotline services that support patients and their families.
MOI.10.4 Patient and family privacy, and their cultural and spiritual practices, are identified, respected, and actively facilitated throughout care.
To ensure that the cancer care service provides accessible, structured, and high-quality cancer care through virtual means (telehealth) and hotline services. This ensures continuity of comfort-focused care, symptom management, and psychosocial support for patients and families, regardless of location, while rigorously protecting patient privacy and respecting individual values.
Last update: 20 September 2026
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