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SpR Competency Assessment: training in haemostasis & thrombosis
Local Hospital Address here
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1.0
Background & methods of assessment
1.1
Aim
This document describes the skills and competences required by an SpR in order to meet a
satisfactory level of competence in haemostasis and thrombosis in the UK. Competency
assessment as described in this document does not constitute part of the formal training
programme for SpRs in haematology in the UK as governed by Statutory bodies, for example
PMETB, the Specialty Advisory Committee of the RCP or the RCPath's examination for
FRCPath. However, it is suggested that the proposal could be used at the discretion of local
trainers to objectively inform and contribute to:

the RITA/ARCP process & career development;

educational supervisor sponsorship for entry to FRCPath examinations;

the portfolio of evidence for specialist training for purposes of certfication and
validation.
The purpose of the proposed competency assessments is to facilitate the ability of trainee
haematologists to achieve the competency to deliver high quality patient care. It is anticipated
that the assessment programme will promote development of professional competence
through to 'safe to undertake unsupervised clinical and laboratory practice' (level 3 and
above). It is intended to promote harmonisation of training and competency, both clinical and
laboratory, in order to ensure that a trainee has reached a level of competence that is
satisfactory for practice as a Consultant Haematologist in the UK. The programme can also
be used as a framework for continuous professional development and maintenance of
competence.
1.2
Assessment
Methods of assessment will be determined by local arrangement. The frequency and
opportunity for assessment at different levels of competence will depend on local training
programmes and schedules. The competency assessments are intended to bring clarity to the
training needs of trainees and identify training opportunities. It is anticipated that trainees will
use the curriculum to direct learning and obtain experience and as an indication of when they
are ready to present themselves for a competency assessment. It is suggested that
competency assessments could be used to objectively inform the RITA/ARCP process
through the educational supervisors reports and as part of the trainees e-portfolio and identify
when candidates are suitable to proceed to FRCPath examinations.
The appendices are suggested competencies at 4 levels. The required competencies will be
defined by local trainers and should reflect what can be delivered by a local training
programme in combination with what standard is expected for satisfactory performance in the
haemostasis and thrombosis sections of the FRCPath examinations. It is anticipated that
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input on the content of the programme from trainee representatives would promote the
usefulness of the assessments.
It is suggested that the levels of competency assessment reflect the following levels of
expertise:
Level 1 - able to perform daily duties as an SpR with responsibility for haemostasis and
thrombosis, including on-call competency
Level 2 - level of competence reflecting standard expected for attainment of part 1 FRCPath
Level 3 - level of competence reflecting standard expected for attainment of part 2 FRCPath
Level 4 - higher level of competence reflecting special interest in haemostasis and thrombosis
Interactive problem solving will be developed locally to reflect clinical and laboratory problems
encountered in practice so as to ensure comprehensive training in all aspects of haemostasis
and thrombosis.
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2.0
The Training Programme
The Programme is informed by and is complimentary to the European Curriculum for
Thrombosis & Haemostasis developed by the European Association for Haemophilia
and Allied Disorders (EHA) (Astermark et al Haemophilia 2009;15:337 - 344)
The SpR must develop competence in haemostasis and thrombosis and possess expertise in
the diagnosis, assessment and treatment of patients with congenital and acquired bleeding
and thrombotic disorders. As well as understanding the management of adult patients, it is
important that there is appreciation of the specific requirements of infants and children as well
as their families:

direct responsibility for the immediate care of patients with thrombotic disorders,
particularly those with venous thromboembolism (VTE), and especially those who
present diagnostic or therapeutic difficulties;

provide leadership and management of a community anticoagulant service to ensure
that patients receive an appropriate level of antithrombotic therapy;

provide a consultative service in the area of haemostasis and thrombosis to all
hospital specialties and to general practitioners;

oversee and advise on the general arrangements for service provision of haemostatic
and thrombotic services to a wide range of hospital specialties and to the community;

direct responsibility for the provision and management of a comprehensive care
haemophilia service. This will require oversight of both the direct clinical care of
patients with haemophilia and allied bleeding disorders and the diagnostic
coagulation laboratory service. Knowledge of changes in haemostatic systems with
age from birth onwards is especially important particularly to ensure that children are
treated appropriately;

quality control of laboratory and community based testing;

the role of audit in the development of provision of care to individual patients.
Training in haemostasis and thrombosis should involve supervised periods of responsibility
for distinct aspects of both laboratory and clinical service.
2.1
General Competence
Includes:

the use and interpretation of guidelines;

total quality management in the laboratory;

understand and demonstrate the importance of comprehensive care and the cooperation with other healthcare professionals, including those who are experienced in
looking after children, such that the roles of these professionals are delineated and
consistent messages are delivered to the patient and their families;

use of molecular biological techniques in diagnosis and in prenatal and family testing
(molecular and phenotyping);
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
background knowledge of genetic counselling and how to give information to the
patient and family in a way that is understandable, encourages discussion and
promotes the patient s participation in decision-making;

2.2
participate in interdisciplinary team meetings.
Diagnostic procedures
Includes:

performance and interpretation of laboratory testing including issues relating to
instruments/methods and their pitfalls;

basic principles of laboratory management (e.g. setting of ranges, quality assurance,
laboratory, computing, health and safety, accreditation);

genetic features in haemostatic disorders (e.g. structural chromosomal changes,
gene mutations, polymorphisms) and the implication of these for inheritance and
genetic counseling.
2.3
Patient Safety
Includes:

Definition and classification of adverse events, risk management, root cause analysis
and Patient Safety.
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3.0
Specific Competence
3.1
Use of antithrombotic agents
Mechanisms of actions, pharmacology, therapeutic indications, dosing, monitoring,
precautions and the side effects of:

parenteral anticoagulants, including heparins, synthetic heparin analogues, direct
thrombin inhibitors and anti-Xa inhibitors;

oral anticoagulants, including warfarin, direct thrombin inhibitors, anti-Xa inhibitors.
appropriate tests for anticoagulant control (e.g. INR), including self-testing, and
different models of anticoagulant management, including computerised systems and
implementation of multi-professional delivery of anticoagulant control;

follow-up of patients receiving anticoagulants, including advice on duration and
intensity of therapy and management of surgery/invasive procedures;

withdrawal in association with invasive procedures and bridging with heparin;

fibrinolytic drugs, including Streptokinase, Urokinase, t-PA;

antiplatelet agents, including aspirin, dipyridamole, thienopyridrine derivatives and
glycoprotein IIb/IIIa inhibitors;

optimal management before invasive procedures including discontinuation in high risk
situations (e.g. coronary stent and dual antiplatelet therapy).
3.2
Management of thrombotic disorders

pathophysiology of and mechanisms involved in venous and arterial thrombosis;

gene-environmental interactions in thrombosis;

clinical and laboratory evaluation of hypercoagulable states, including age-specific
normal ranges;

epidemiology, molecular basis, appropriate use of clinical and laboratory methods to
reach a diagnosis, including family history, and management of heritable
thrombophilia including deficiencies in Protein C, S, antithrombin, factor V Leiden,
prothrombin gene variant, dysfibrinogenaemias, abnormalities of fibrinolysis;

cost/benefits and clinical effectiveness of screening for inheritable thrombophilias in
specific populations;

management of acquired hypercoagulable and thrombotic states, including those
arising with the use of in-dwelling catheters, in association with malignancies,
myeloproliferative disorders and other underlying disorders;

Clinical significance of JAK-2 mutation and other cytogenetic abnormalities
associated with a hypercoagulable state;

diagnostic aspects and clinical management of acquired thrombotic disorders in
association with pregnancy and postpartum, the use of oestrogen containing
therapies (e.g. combined oral contraceptive and HRT), in the postoperative states
and during immobility as well as other disorders;
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
diagnostic aspects and clinical management of lupus anticoagulant and
antiphospholipid syndrome;

pathogenesis, risk factors, diagnosis and management of heparin-induced
thrombocytopenia (HIT), including interpretation of bio-and immunoassays and use of
alternative anticoagulants;

microangiopathic conditions/TTP-HUS;

natural history, clinical manifestations and complications of venous thrombosis;

diagnostic aspects of VTE (DVT, PE) including the use of pretest probability scoring

and D-Dimer;

imaging techniques to diagnose VTE and PE;

management of thrombosis in all locations including catheter-related episodes;

clinical management of thromboembolism during pregnancy;

assessment of risk factors and risk of recurrence from clinical assessment;

prophylaxis of venous thrombosis and risk assessment;

treatment of DVT and PE including the use of IVC filter;

management of post-thrombotic syndrome;

use and efficacy of mechanical methods employed for the prevention of VTE.

epidemiology of arterial thrombosis;

pathophysiology and prevention of the atherosclerotic process including cardio-and
cerebrovascular risk factors;

stroke and associated thrombophilic disorders including antiphospholipid antibodies,
and hereditary thrombophilia;

antithrombotic management of stroke including anticoagulation, antiplatelet agents
and thrombolysis;

diagnosis and clinical management of cerebral venous thrombosis;

epidemiology, thromboembolism prevention and anticoagulant management of atrial
fibrillation;

anticoagulants, antiplatelet drugs and thrombolytics in acute events and interventions
of acute coronary syndromes, acute myocardial infarction and percutaneous coronary
interventions;

haemostatic changes secondary to cardiac bypass and management of associated
bleeding;

thrombotic risk associated with broad categories of prosthetic heart valves, as well as
long-term anticoagulation, management of invasive procedures and options in
pregnancy.
3.3
Consultative haemostasis & thrombosis
3.3.1
Gynaecology/obstetrics
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
effects of gender, pregnancy, oral contraceptive and hormone replacement therapy
on haemostatic parameters;

evaluation, characterization and treatment of menorrhagia;

potential bleeding states arising in carriers of heritable bleeding disorders;

management of carriers of bleeding disorders;

risk estimation for VTE in pregnancy and in association with the use of OC and HRT
in women with inherited thrombophilia;

management of postpartum haemorrhage;

anticoagulant treatment during pregnancy, postpartum and in the lactation period;

diagnosis and management of thrombocytopenia in pregnancy, including gestational
thrombocytopenia, ITP, HELLP, familial thrombocytopenia, foeto-maternal alloimmunisation.

haemostatic aspects of foetal loss;

clinical implications of lupus anticoagulants and antiphospholipid syndrome;

diagnosis and management of haemostatic changes associated with pre-eclampsia.
3.3.2

Intensive care
haemostatic aspects of the pathophysiology and clinical management of
SIRS/Sepsis;

pathophysiology and diagnosis of disseminated intravascular coagulation and
consumptive coagulopathy, including the use of basic assays, activation markers,
inflammatory markers and sepsis-related organ failure assessment;

therapeutic options and clinical management of DIC and consumptive coagulopathy,
including the use of heparin and physiological anticoagulants such as antithrombin
and (activated) Protein C. anticoagulation for venoarterial extracorporeal membrane
oxygenation.
3.3.3

Oncology
awareness of the haemostatic and thrombotic complications association with
malignant diseases due to the pathophysiological process itself or to the use of
chemotherapy;

awareness of recommendations regarding the prevention and management of
haemorrhagic and thromboembolic complications in association with various benign
haematological disorders, including ITP, myeloproliferative disorders such as
polycythaemia and high platelet levels and malignancies as well as haemostatic
aspects of chemotherapeutic and immune modulatory/regulatory agents.
3.3.4
Nephrology

haemostatic and thrombotic defects associated with chronic renal failure;

anticoagulation in association with dialysis;
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
use of antithrombotic and haemostatic agents in patients with renal failure;

haemostatic aspects of renal transplantation.
3.3.5
Surgery

prevention and treatment of venous thromboembolism;

management of surgery in patients with congenital defects of haemostasis;

management of invasive procedures for patients with abnormal coagulation tests and
patients on anticoagulants;

management of patients with intra or postoperative bleeding;

pathophysiology and diagnosis of haemostatic alterations in trauma patients including
patients with hypothermia, acidosis, dilution, massive transfusion and hypocalcaemia;

treatment of bleeding in trauma patients and the use of red blood cell concentrates,
platelets, fresh frozen plasma, activated rfVII, fibrinogen, antithrombin, PCCs and
antifibrinolytics;

3.4
strategies for replacement therapy in trauma patients.
Bleeding disorders
Includes:

platelet structure and function;

mechanisms involved in primary haemostasis including platelet-vessel wall
interactions;

factors, interactions and mechanisms involved in plasma coagulation;

components involved and the principles of fibrinolysis;

natural inhibitors and their function;

cellular interactions involved in the process of thrombosis and haemostasis;
3.4.1
Haemophilia A & B
Includes:

relevant and accurate personal and family bleeding history;

focused clinical examination to assess for abnormal bleeding;

formulate a comprehensive differential diagnosis and management plan.

performance, interpretation and limitations of diagnostic methods including screening
tests, specific factor and inhibitor assays;

genetic counselling of patients with inherited bleeding disorders;

structural and functional aspects of the biology of factor VIII (FVIII) and factor IX
(FIX);

history of haemophilia and the evolution of replacement therapy;

an understanding of how haemophilia care is provided in different parts of the world
and the difficulties of providing diagnostic and therapeutic services in some countries;
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
epidemiology, classification and molecular basis of haemophilia A and B;

genetic/molecular diagnosis, inheritance and genetic counselling;

understanding of preimplantation genetic diagnosis (PGD);

recognise clinical manifestations of haemophilia from early age to adulthood,
especially in children, with a special focus on haemarthroses and haemophilic
arthropathy, muscular haematomas, pseudotumours, Volkmann's syndrome and
intracranial bleeding;

performance and interpretation of laboratory testing including the use FVIII/FIX
clotting activity, the original Bethesda assay as well as Nijmegen modification,
concepts of 'global testing';

therapeutic options and delivery of replacement therapy in various clinical settings for
both children and adults, including the principles of primary and secondary
prophylaxis, on-demand therapy of bleeds and the use of replacement therapy in
association with surgical procedures;

drugs to use in the management of bleeds, surgical procedures and for prophylactic
therapy (mechanisms of action, pharmacology, indications, dosing, precautions and
management of overdosing) including DDAVP, plasma-derived FVIII/FIX
concentrates, cryoprecipitate, recombinant FVIII/ IX concentrates, antifibrinolytics,
sealant measures, fibrin glues;

epidemiology, immunology and molecular basis of inhibitors to FVIII, or FIX, genetic
and environmental risk factors in the development of inhibitors in patients with
haemophilia A and B;

diagnosis, classification and clinical management of inhibitors to FVIII and FIX,
including knowledge of pharmacokinetics (recovery, half-life measurement);

mechanisms of action, pharmacokinetics, indications, dosing, precautions and
management of side-effects of by-passing agents, i.e. recombinant factor VIIa
(rFVIIa), aPCC;

dosing regimens for immune tolerance induction in patients with inhibitors, as well as
in the use of immuno-suppressive drugs, apheresis, immunoadsorption;

immune tolerance induction therapy (ITIR) in haemophilic patients with inhibitors to
FVIII or FIX, including treatment of intercurrent bleeds, use of CVC, diagnosis and
treatment of side effects such as nephrotic syndrome in haemophilia B patients;

dental care and the follow-up of patients in collaboration with dentists;

physiotherapy and outcome assessment of arthropathy in haemophilia patients;

indications, limitations and potential complications of orthopaedic surgery including
synoviorthesis and joint replacement;

management of gynaecological and obstetric haemostatic complications in carriers of
haemophilia A and B.
3.4.2
VWD
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
structural and functional aspects of the biology of Von Willebrand Factor (VWF)
including interactions with platelets, endothelium and FVIII;

understanding of the incidence, inheritance, classification (including molecular and
genetic aspects), clinical manifestations, natural history and complications of VWD;

principles and interpretation of laboratory testing including the use of the PFA-100
and platelet aggregation, Ristocetin Cofactor Activity (VWF:RCo), VWF:Ag, FVIII:C,
Collagen binding assay and vWF multimers;

genetic and environmental factors influencing the VWF level;

genetic counselling of patients with VWD;

therapeutic options in the management of patients with VWD, including mechanism of
action, pharmacokinetics, indications, dosing, precautions and management of overdosing;

management of bleeding episodes and surgery of patients with VWD;

dental care and prevention of complications of patients with VWD in collaboration with
dentists;

planning and outcome assessment of prophylactic treatment of patients with VWD;

diagnosis, treatment and clinical management of patients with VWD and inhibitors,
including knowledge of emergency treatment of subjects with anaphylactic reactions;

3.4.3
management of gynaecological and obstetric complications in females with VWD.
Inherited platelet disorders
Includes:

disorders of platelet adhesion, including Bernard-Soulier syndrome;

disorders of platelet aggregation, including Glanzmann thrombasthenia;

disorders of platelet secretion and dense granule deficiency;

disorders of platelet procoagulant activity;

intrinsic disorders of platelet function in association with haematological disorders and
other organ failure/malfunction;

extrinsic platelet disorders associated with various haemostatic drugs, including
aspirin, non-steroidal anti-inflammatory drugs (NSAID), ADP receptor antagonists,
platelet GPIIb-IIIa antagonists, fibrinolytic agents and various foods;

microangiopathic disorders/Thrombotic Thrombocytopenic purpura (TTP) and
antiplatelet antibodies (ITP, SLE, alloimmunization).
3.4.5

Rare factor deficiencies
pathophysiological mechanisms, incidence, inheritance, clinical manifestations and
treatment of deficiencies of factor II, V, VII, X, XI, XIII, combined deficiency of FV +
FVIII, combined deficiencies of vitamin K-dependent factors, a/dysfibrinogenaemia,
and contact factor deficiencies;.
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
principles of biological techniques for molecular diagnosis, and prenatal diagnosis in
families with rare factor deficiencies;

therapeutic options in the management of patients with rare factor deficiencies;

indications, pharmacokinetics and dosing of different plasma-derived products usable
in patients with rare factor deficiencies;

management of bleeding episodes and surgery as well as aspects on dental care and
prevention of complications in patients with rare factor deficiencies;

principles of prophylactic replacement therapy for patients with rare factor
deficiencies.
3.4.6
Acquired bleeding disorders

antithrombotic drugs;

vitamin K deficiency;

liver disease;

Disseminated Intravascular Coagulation (DIC);

systemic fibrinolysis;

massive blood transfusion;

renal failure;

malignancies;

pregnancy and obstetrics;

congenital heart disease and cardiac surgery;

diagnostic aspects and clinical management of bleeds in association with: acquired
coagulation factor inhibitors including acquired haemophilia, VWD and acquired
inhibitors to other factors.

special aspects on acquired haemophilia A including the characterization of FVIII
inhibitors, the use of by-passing agents (rFVIIa and aPCC) and therapeutic options
aiming to eradicate the inhibitor;

non-accidental injury, especially in children, and how this is distinguished from those
with a haemorrhagic disorder;

vascular disorders including vasculitis, vascular malformation and structural
disorders.
3.4.7
Plasma derived and recombinant therapeutic agents

elimination methods of infectious agents:

indications, limitations and potential complications of replacement with fresh-frozen

plasma and cryoprecipitate;

indications, limitations and potential complications of replacement with prothrombin

complex concentrates (PCCs);

indications, limitations and potential complications of replacement with highly purified
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
plasma-derived molecules;

indications, limitations and potential complications of replacement with highly purified

recombinant molecules;

immunologic complications associated with replacement of the missing clotting factor;

indications, limitations and potential complications of replacement with bypassing
agents (FEIBA and rVIIa).
4.0
Clinical trials
Includes:

Good Clinical Practice;

Study design types and purposes of clinical trials;

estimation of number of study subjects, obtaining ethical approval, recruitment of
patients, patient information sheets and consent forms;

data collection, statistical analysis and presentation of results.
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Appendices
Example levels of competence in relation to local
training programme and service needs, e.g. on call
competency
Level 1
Able to perform daily duties as an SpR with responsibility for
haemostasis and thrombosis, including on-call competency
Competencies in BOLD required before being on call
Applies to all SpRs
Competency
Date achieved
Consultant
signature
Introduction to department by haemostasis consultant
Introduction to Thrombophilia & Anticoagulant Service
by Nurse Specialist
Introduction to Haemophilia Service by Nurse
Specialist
Knows how to use anticoagulant computerised
decision support system software to review results (1
hr training)
Uses protocols for reversal of INR > 5, > 8, or >20
Understands which blood samples are required for
coagulation studies including INR
Knows the methods used to monitor heparin and warfarin
therapy
Knows how to investigate a prolonged PT & APTT
Is aware of the factor concentrate products available
for use and where they are stored
Knows how to issue factor concentrate to patients
Has been trained in reconstitution and administration
of factor concentrates (1 hr training)
Has the ability to use the anticoagulant computerized
decision support system software to dose and amend
patient accounts.
Able to advised on heparin bridging therapy
Familiar with BCSH warfarin guideline
Attendance in Anticoagulant clinic (8 hrs)
Attendance in Thrombophilia clinic (8 hrs)
Attendance in Womens clinic (8 hrs)
Attendance in Haemophilia clinic (16 hrs)
Attendance in Anticoagulant service (10 half days)
Attendance in Haemophilia service (20 half days)
Holder of Coagulation SpR bleep (2 weeks)
Satisfactory performance in interactive problem solving
reflecting curriculum (level 1)
Level 1 COMPETENCY ASSESSMENT SATISFACTORY
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Level 2
Suggested required before enrollment for Part 1 FRCPath examination
Competency
Date achieved
Consultant
signature
Confirmation of level 1 competencies and further
development reflecting experience and reflective thinking
Practical knowledge of standardised bleeding scores
Understands methods required for investigation of bleeding
Understands methods required for investigation of
thrombosis & thrombophilia
Moderate theoretical knowledge of coagulation system,
including cascade model
Understands principles and format of SOPs, IQC, EQA
including working examples
Familiarity with EQA reports
Understands principles of pre-analytical variables in
collection and preparation of samples
Understands and can describe methods for PT, INR, APTT,
TT, fibrinogen, factor assays, Bethesda assay,
chromogenic assays, tests for LA, PFA-100, platelet
aggregation, ELISAs
Anticoagulant clinic (9 hrs)
Thrombophilia clinic (6 hrs)
Womens clinic (6 hrs)
Haemophilia clinic (2 hrs)
Anticoagulant service (28 half days)
Haemophilia service (28 half days)
Coagulation SpR bleep (8 weeks)
Knows how to interrogate anticoagulant computerised
decision support system for individual patient and cohort
statistics e.g. Time in Range
Able to perform manual PT, APTT, fibrinogen, factor VIII
assays
Understands and can describe specific methods for factor
assays, AT, PC, PS, basic molecular tests (e.g. FVL)
Familiar with general and specific competencies - sections
2 & 3 of programme as described
Familiar with BCSH & UKHCDO guidelines
Satisfactory performance in interactive problem solving
reflecting curriculum (level 2)
Level 2 COMPETENCY ASSESSMENT SATISFACTORY
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Level 3
Suggested required before enrollment for Part 2 FRCPath examination
Competency
Date achieved
Consultant
signature
Confirmation of level 2 competencies and further
development reflecting experience and reflective thinking
Good working knowledge of coagulation system, including
cascade model
More advanced theoretical knowledge of coagulation
system, including cell based model of haemostasis
Able to perform automated PT, APTT, fibrinogen, factor
assays and chromogenic assays
Able to perform ELISA
Able to perform PFA-100 analysis and platelet aggregation
Understands classification of platelet disorders
Aware of advanced methodology - ETP, TEG
Working knowledge of general and specific competencies sections 2 & 3 of programme as described
Experience of implementation of BCSH & UKHCDO
guidelines
Satisfactory performance in interactive problem solving
reflecting curriculum (level 3)
Level 3 COMPETENCY ASSESSMENT SATISFACTORY
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Level 4
Higher level of competence reflecting special interest in haemostasis
and thrombosis recommended for SpRs with special interest in
haemostasis & thrombosis, i.e. beyond FRCPath
Competency
Date achieved
Consultant
signature
Confirmation of level 3 competencies and further
development reflecting experience and reflective thinking
Able to perform advanced assays, e.g. thrombin
generation, thromboelastography
Attended specialty meeting, e.g. BSHT, ISTH
Understanding of research methodology and critical
manuscript review
Satisfactory performance in interactive problem solving
reflecting curriculum (level 4)
Level 4 COMPETENCY ASSESSMENT SATISFACTORY
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