TIF Standards for Haemoglobinopathy Reference Centres
- Blood transfusions, which vary from very frequent to sustain life to occasional medical emergencies.
- Iron chelation, which aims to reduce iron that comes from increased absorption in the case of anaemia or the regular transfusions in the more severe forms.
- Constant monitoring of iron load and organ function, which is part of the routine of patient care
- Support from a multidisciplinary team of experts, especially in cardiology and endocrinology, which aims at proactive detection of organ damage and early, appropriate therapeutic response.
- Adherence to evidence-based guidelines and standards.
- Quality holistic care, which includes psychosocial support and quality of life promotion, allowing patients to approach “normality” in their daily lives.
- The first is a concern for patient safety;
- The addition of adherence to standards of care;
- Good patient communication;
- Keeping good medical records;
- Adequate and qualified professional staffing;
- Continuity of care;
- A holistic patient-centred approach, with the patient partnership.
3.1. Survey Response
3.2. Assessment of the Level of Services
- Accreditation: Centres were asked whether they had any kind of accreditation as reference centres. There were 116 responses, of which 20 have an international award (JCI, JCIE, ISO, and one is a WHO Collaborating Centre); 14/20 from high-income countries, 4/20 from upper-middle-income countries, and 2 from lower-middle-income countries. Another 37 claim a national recognition or accreditation, 59 have no recognition, and another 14 did not respond. Overall, 15.4% (20/130) of treatment centres were awarded an internationally accepted accreditation.
- Patient registers: Of 130 treatment centres, 88 (67.7%) have a local register (mostly paper or Excel), 26 (20%) are connected to a national registry, while 16 (12.3%) have no register.
- MRI to measure tissue iron: A total of 123/130 (94.6%) claim to perform annual cardiac T2* iron measurements, and 58/130 (44.6%) are also connected to FerriScan for R2 LIC measurements. Only 7 centres stated no MRI available.
- Specialist monitoring: A total of 125 centres stated annual cardiology examinations for their patient, and 126 centres stated regular endocrinology examinations.
- Availability of iron chelating agents: A total of 106/130 (81.5%) had all three iron chelators, and 21 (16.1%) did not have deferiprone. This includes some high-income countries, where it is presumed that regulatory authorities had not approved this medicament. In addition, isolated centres stated nonavailability in countries where other centres had all three drugs; one example was a centre in Greece that stated only deferoxamine was being offered in contrast to all other centres from that country.
- Transcutaneous O2 saturation: The vast majority of centres with a sizeable number of sickle cell patients have this service available within the centre, though 19 centres did not have this available, even though the SCD patients ranged from 10 to 550. This is a quality indicator, but the 19 centres were not related to the number of patients or the development of the country where they are located.
- Use of evidence-based clinical management guidelines: A total of 128 centres responded to this question. A total of 67 (52.3%) used guidelines for SCD and thalassaemia, 45 (35.2%) used guidelines for thalassaemia only, while 7 (5.5%) had guidelines only for the management of sickle cell syndromes (6 of these centres are in countries where SCD is a rare immigrant condition), and 9 (7%) centres did not follow any specific guidelines—6 of these were in countries where thalassaemia is a rare condition, mainly affecting the migrant population. It should also be noted that 12 of the 45 centres that use only thalassaemia guidelines (26.7%) follow a significant number of SCD patients (20-450) and should have both guidelines available. Of the seven centres that stated they follow only SCD guidelines, only one also had large numbers of thalassaemia patients (190).
- Free of charge services: From 129 responses, completely free (with no out-of-pocket expenses) was stated by 98 (76%) of centres, while in 27 centres (20.9%), there is partial coverage. In four centres (3.1%), services were exclusively out of pocket.
- Involvement in research: Only 23 (17.7%) from 130 treatment centres admitted not being involved in research. The rest presented subjects that have led to research and publications concerning various topics concerning haemoglobin disorders.
- Professional psychosocial support: A total of 93 of 129 (72%) centres stated that they offered a service from experienced staff within the centre. In contrast, the rest, 36 (28%), either did not provide support or refer patients to agencies outside the centre. Nevertheless, most centres are catering for monitoring and multidisciplinary care.
3.3. Quality of Care Analysis
3.4. TIF Suggestions for Thalassaemia Reference Centres
- A hierarchical structure should include a chief executive/managing director and a coordinated, professional team that includes multidisciplinary services, recognising the complex pathology of haemoglobin disorders.
- The administrative structure and staff organisation should clearly describe the rules and regulations of the centre’s services.
- A clear definition of the centre’s mission and the existence of policies and programmes to fulfil the mission.
- Ensuring staff qualifications, experience, and continual education. Staff qualifications, skills, knowledge, and experience are defined and described along with the job description.
- Staff includes the specialist practitioners who may serve the patient’s needs even if their regular position is outside the centre.
- The staff’s expertise in haemoglobin disorders assessment and management must be assured.
- The centre’s leadership should ensure good communication between the centre’s staff, the specialist contributors, and services such as the blood bank.
- The management monitors and evaluates the centre’s functions, including staff performance and patient safety. This includes a clinical audit aiming to assess if the facility is attaining the recognised standards .
- The advocacy for quality improvement and continued development according to scientific advances (including innovative therapies) to health authorities .
- Connection with patient support associations, with patient representation on advisory bodies.
- All stakeholders’ views regarding matters of priority and focus on any quality improvement activity are taken into account.
- All decisions are based on data, obtained through patient records and outcomes and any new developments noted through publications and trials.
- The governance of patient data is an administrative responsibility.
- A culture promoting ethical practices in all aspects of administration and clinical care should be ensured, considering internationally accepted patients’ rights.
- The administration is responsible for overseeing and ensuring that internationally accepted principles guide any research involving patients or patient-derived data and that expert ethical approval and patient consent have been obtained. Clinical research is an additional indicator of good clinical practice if regulated and aimed at benefitting patients.
- It is the responsibility of management and senior staff to seek accreditation according to international standards. This is not a frequent objective, but the long-term benefits to patients are well-supported .
- Safety concerns
- Staff education on safety is programmed. This includes both staff and patient safety.
- Patient identification is clear in individual records (electronic or paper-based), blood transfusions, and lab results
- There is effective patient communication and explanation of all interventions.
- Haemovigilance  and pharmacovigilance are practised, including drug safety alerts.
- There are evidence-based hand hygiene guidelines.
- Methods and procedures to minimise the risk of infection within the treatment centre are in place. A practical example in recent times is the prevention of COVID-19 transmission in patients arriving for preparation and to receive blood transfusions or visit their doctor .
- The danger of transmitting blood-born infections, especially hepatitis viruses, is a priority. There is constant communication with the blood bank, including knowledge of the safety practices in donor selection. Monitoring both by serological methods and molecular methods is implemented according to international recommendations for regularly transfused patients.
- There are measures to reduce accidents, such as falls in the centre. A secure environment is planned and regularly inspected. Hazardous material handling and disposal (such as needles) are part of the centre’s daily procedures.
- There are treatment rooms and resuscitation equipment.
- Fire safety and certification by the country’s fire services are available. This includes regular testing of any devices required for fire control.
- Cigarette and other smoking is forbidden on the premises.
- Emergency procedures are in place in the event of power and water cuts or contamination. Monitoring of water quality is performed regularly.
- Access to care
- The centre clearly serves benign haematology patients and does include malignancies as they constitute a dangerous and vulnerable cohabiter.
- Patient flow: there must be adequate numbers of patients in each diagnostic group—at least 50 thalassaemia patients and/or 50 SCD patients for the centre to be regarded as experienced.
- Continuity of care is safeguarded by low staff turnover and the presence of experienced and qualified caregivers.
- Clinical records with lifetime data are kept.
- Networking the reference centre with secondary and other centres of excellence nationally or internationally is an added value.
- A twinning programme with an academic centre is also an additional advantage.
- Any existing electronic health record must fulfil all the patient safety requirements, including patient consent, confidentiality, and anonymisation in data storage and sharing of data for research.
- Barriers to patient access, including distance, language, cultural or religious barriers, are considered and appropriately addressed.
- Partnership model
- Adequate information is always provided to patients/families about the disease and any treatment decisions, including possible side effects. Patient education is a prerequisite to partnership and shared decisions .
- Good communication is the basis of the doctor–patient relationship.
- Patients are given choices about their treatment.
- Self-management is encouraged, particularly in haemoglobin disorders, in which daily home treatment is the basis for preventing complications and survival. The patient must be aware of possible complications of the condition and its treatment and know when to inform the care team when warning signs and symptoms appear.
- Special attention to patient adherence is given, and the patients are supported appropriately.
- Workshops for patients/families are held regularly, at least once a year, in a language that laypersons can understand.
- Respect for patient rights and time is a must in all cases. This includes personal values and beliefs as well as privacy and confidentiality.
- Informed consent for all procedures is obtained. This includes the use of blood.
- Guidelines and standards for clinical care
- Evidence-based national guidelines put together by experts in the field or international guidelines (e.g., TIF) are used in the centre and adhered to.
- Guidelines and standards include diagnosis and monitoring as well as medical treatment.
- Pain screening is performed and a pain management system is in place. Pain, both chronic and acute episodes, is common in patients with haemoglobin disorders .
- Investigation of the underlying cause as well as management are basic requirements.
- Assessing the quality of laboratory and other technologies used to monitor patients is the responsibility of the clinical team, which must alert the providers of any divergent or inaccurate results. One example is the accuracy of MRI iron measurements for which instruments’ calibration and validation are required.
- Infection control procedures are part of the clinical standards of the centre.
- Availability of food during day care is necessary. The quality and nutritional value must be monitored.
- Blood transfusion procedures and standards according to international directives are kept .
- Any medical treatment, such as IV fluids and exchange transfusions, etc., are provided according to standards that ensure patient safety.
- Continual medical and other professional education are part of the centre’s long-term programme
- Staff/patient ratio is defined arbitrarily and approximately as one doctor per 100 patients and one nurse per 50 patients.
- Quality improvement
- Suggestions for quality improvement are the responsibility of medical staff, nursing staff, and the administration.
- Decisions should be based on information and performance data collected through monitoring and implementing policies .
- Quality improvement is a systematic approach to changes aiming to upgrade services and correct any deficiencies in the service’s governance, structure, and functions. Quality improvement aims to better the patient experience and outcomes by changing provider behaviour.
- How change is introduced and implemented is a matter of concern and may require expert advice.
- External influences, such as governmental policies or interests, budgetary support, and professional requirements, are considerations, and advocacy is a responsibility of all the team.
- Setting goals, monitoring progress, and choosing the tools to bring about change. These could be skills development, computerisation, and updating guidelines, etc.
- The patient’s voice must be involved in all stages of quality improvement. Patients/families can also effectively monitor the effects and benefits of change since they experience the whole “patient pathway”.
- Studying other centres’ experiences in change-making and understanding whether such changes have been successful elsewhere is necessary.
- Information management
- Patient records (paper or electronic) are kept with due consideration to confidentiality, security, and accuracy of data.
- The retention time of records in a haemoglobinopathy setting is lifelong, since the current clinical condition may be influenced by past events and disease control (such as iron levels).
- Standard diagnosis codes are kept (e.g., ICD10).
- E-health systems are assessed and tested for quality and patient safety before implementation.
- There is clear identification of those authorised to enter data and access patient records.
- Protection against loss, unauthorised access, or its use is ensured.
- Policies and procedures concerning record keeping are clearly directed to all the staff, through documents and training.
- The patient should be clearly identified on each record, with at least two identifiers.
Conflicts of Interest
- Description of Centre: Name and detailed address.
- Governance: Administrative authority (e.g., government, university etc), scientific advisory committee, and financial sustainability.
- Staffing: Staff names, ages, qualifications, and experience in haemoglobinopathies; administrative director, clinical director, and organisational chart of key personnel with qualifications and specialties (including medical specialists offering multidisciplinary support, nurses and social support). Staff/patient ratios.
- Patients: Total number, numbers by diagnosis, age distribution. The existence of a patient registry (whether paper-based, electronic, local or part of a regional or national registry, legal/ethical regulations kept in data sharing, data protection (e.g., patient consent, data transferred using encryption, transferred only to centres which also comply with security standards).
- Health system: Universal coverage, voluntary blood donation.
- Infrastructure: Building/spaces/functional areas according to patient needs facilitating patient journey, patient registration, transfusion rooms according to patient age groups, playroom for children, recreation room for adults, resuscitation room and equipment, treatment room, storage facilities, doctors’ consultation rooms, and nursing station.
- Patient services: (a) Working hours of the centre with the aim to maximise patient benefit. (b) Patient information: Full explanation given to patients concerning their medical condition; dietary advice; a research project in which patient data are used; concerning volunteering for clinical trials, including risks and benefits; and informed written consent for involvement in any treatment or research. Patient involvement is necessary in advisory committees, clinical decision-making that concerns them, encouraged in self-management. (c) Patient wellbeing: Availability and psychological care impacts on adherence to long-term treatment and, thus, survival. Beneficial approaches as identified in the literature include group sessions, family therapy, and patient camps. To be beneficial for the patients, expert psychological support has to be tailored to children’s needs, adolescents, and adults, as a service offered with multifaceted care. Dental care, nutritional status, and neurological sensory assessment are not neglected.
- Centre’s involvement in teaching and research.
- Clinical care: (a) Evidence-based guidelines: The centre operates based on evidence-based guidelines, which means that international levels of care are adopted. (b) Basic equipment availability: Refrigerator for blood storage, filtration, infusion pumps, stadiometers, growth charts, electronic communication, transcranial Doppler, ECG, etc. (c) Blood bank providing uninterrupted supply of blood: This is evaluated by interruptions and/or delays in providing blood transfusions, allowing Hb levels to fall. (d) Investigation facility: Availability of sophisticated examinations for diagnosis and monitoring patient progress: Including phenotypic and molecular diagnosis of Hb disorders, MRI, MRI-T2*, Ferriscan, DEXA, Abdominal U/S. All monitoring is according to international guidelines (TIF) in terms of timing. (e) Multidisciplinary team: Specialised care, including at least cardiological, endocrinological, hepatological, gynaecological, and psychological specialists, within reach in the same hospital. Communication between specialists and clinic doctors with regular discussions of findings and common/agreed treatment options. (f) Blood transfusion: Extended antigen typing is important before the first transfusion in order to assist future detection of antibodies. ABO, Rh(D)-compatible blood is offered following careful crossmatch, matching for C, E, and Kell (strongly recommended). Collaboration of blood banks is essential. Leuko-depleted blood. Record of reactions and annual transfusion requirements. For TDT patients pretransfusion Hb 9–10.5 g/dL, with Hb 11–12 g/dL for patients with heart complications. (g) Iron chelation: Availability of all three iron-chelating agents along with peripherals (infusion pumps). Tailoring according to each patient’s needs is practiced by experienced physicians. Effectiveness and possible side effects are monitored as described in the latest international or national guidelines.
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Angastiniotis, M.; Eleftheriou, A.; Naveed, M.; Assaf, A.A.; Polynikis, A.; Soteriades, E.S.; Farmakis, D. TIF Standards for Haemoglobinopathy Reference Centres. Thalass. Rep. 2023, 13, 10-20. https://doi.org/10.3390/thalassrep13010002
Angastiniotis M, Eleftheriou A, Naveed M, Assaf AA, Polynikis A, Soteriades ES, Farmakis D. TIF Standards for Haemoglobinopathy Reference Centres. Thalassemia Reports. 2023; 13(1):10-20. https://doi.org/10.3390/thalassrep13010002Chicago/Turabian Style
Angastiniotis, Michael, Androulla Eleftheriou, Mohammed Naveed, Ali Al Assaf, Andreas Polynikis, Elpidoforos S. Soteriades, and Dimitrios Farmakis. 2023. "TIF Standards for Haemoglobinopathy Reference Centres" Thalassemia Reports 13, no. 1: 10-20. https://doi.org/10.3390/thalassrep13010002