Clinical Transplant Standards

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Clinical Transplant Standards

• JACIE Standards
• Section B

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Standards of the Clinical Transplant Programme

• Definition and size of the programme
• Data Management
• Quality Control
• Staff Requirements
• Clinical Unit Requirements
• Most common deficiencies

3
Standards of the Clinical Transplant Programme

• Definition and size of the programme
• Data Management
• Quality Control
• Staff Requirements
• Clinical Unit Requirements
• Most common deficiencies

4
B1.000 Definition of a Clinical Transplant
Programme

• Integrated medical team
• Single programme director
• Common protocols
• Common staff training
• Common quality assessment
• Geographically contiguous or proximate space
• Cell collection processing facilities that meet
  JACIE standards

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B1.000 Clinical Transplant Programme

• Guidance
• Non-contiguous sites must be sites within the
  same metropolitan statistical area (MSA)
• Single programme director
• Demonstrate that clinicians work together

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B1.000 Clinical Transplant Programme

• Guidance
• Common staff meetings
• Common clinical protocols (research or practice
  guidelines)
• Regular interaction
• Common database

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Metropolitan Statistical Area Definition

• ...a core area containing a large population
  nucleus, together with adjacent communities
  having a high degree of economic social
  integration with that core

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B1.000 Non-contiguous programmes

• An MSA may have more than one clinical programme
• Non-contiguous sites outside a single MSA are not
  considered a single programme
• No requirement for clinical, collection
  processing facilities to be under one roof
• Cell processing lab may process and store cells
  for several programmes

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SIZE OF THE PROGRAM

• B1.310 Minimum 10 new patients during a
  twelve-month period (allo-auto).
• B1.320 If accreditation for allo and auto 20 new
  patients, including at least 10 new allo and at
  least 5 new auto.

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• CENTERS PERFORMING PEDIATRIC Tx
• B3.110 Shall have a transplant team trained in
  the management of pediatric patients.
• B3.120 There shall be at least one attending
  physician who is board certified/eligible in
  Pediatric Hematology/Oncology.

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CLINICAL TRANSPLANT UNIT

• B1.340 For adult and pediatric programs, a
  minimum of 4 new adult and 4 new pediatric
• B1.350 For programs utilizing more than one
  clinical site for transplantation, a minimum of 4
  new patients per site

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Standards of the Clinical Transplant Programme

• Definition and size of the programme
• Data Management
• Quality Control
• Staff Requirements
• Clinical Unit Requirements
• Most common deficiencies

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B4.000 Data management

• B4.100 Each programme shall keep complete
  accurate records
• B4.200 Include data of the type required
  published by the IBMTR or EBMT (Med A)

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B4.000 Data management

• Review data from 10 consecutive autologous
  patients (pink)
• Review data from 10 consecutive allogeneic
  patients (blue)
• The programme may choose format
• shadow chart
• Flow charts
• Electronic Primary record

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B4.000 Data management

• Records are assessed for accuracy by comparing
  the provided patient record with a primary
  record.
• Data will be verified against a primary pathology
  report, a laboratory record, or similar data from
  another source.

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B4.000 Data management

• Guidance
• Each form has 10 items allogeneic autologous.
  10 consecutive allo and 10 consecutive auto are
  reviewed
• Records will be assessed for completeness on the
  basis of 10 key pieces of transplant-related data

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B4.000 Data management

• 10 records are checked to see if
• 10 transplants have been performed in the
  previous year
• Data is available
• Data is accurate
• Audit is not to assess outcome
• Data are confidential and privileged

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B4.000 Data management

• If there are errors, it is probable that
  additional problems with records exist
• If there are no errors in the partially inspected
  data, it is probable that the records are
  basically complete and accurate

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Standards of the Clinical Transplant Programme

• Definition and size of the programme
• Data Management
• Quality Control
• Staff Requirements
• Clinical Unit Requirements
• Most common deficiencies

24
B3.000 Quality Management Plan

• Each programme shall have a Quality Management
  Plan

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Quality Management Definitions

• Quality conformance of a product or process
  with pre-established specifications or standards
• Quality assurance the actions, planned
  performed, to provide confidence that all systems
  elements that influence quality are working as
  expected

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Quality management plan Scope

• Covers all aspects of transplant programme
• Standard operating procedures (SOPs)
• Training and continuing education
• Proficiency testing/competency education
• Errors, accidents adverse reactions
• Records management
• Quality assurance audits (written reports)

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A4.000 Quality Management Plan Requirements

• Each programme shall establish QM plan under the
  supervision of a designated person who performs
• Policies procedures review/approval
• Compliance documentation
• Quality audits

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A4.000 Quality Management

• A4.300 Errors, accidents adverse reactions
• A4.310 System for detecting, evaluating,
  documenting reporting. Corrective actions shall
  be documented reviewed by Medical Director
• A4.320 Shall be evaluated promptly (according to
  the SOP) reviewed by the Medical Director

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B3.000 Institutional Review Board

• Formal review of investigational treatment
  protocols patient consent forms
• Mechanism for review approved by both Ethic
  Committees and agencies of the corresponding
  Ministry of Health

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A4.000 Quality Management

• A4.200 Documentation of all research
• protocols
• Procedures
• IRB protocols
• Investigational new drug/device exemption
• Adverse outcome

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Quality Management Documentation

• Formal organisational structure
• Written document that outlines quality assurance
  plan activities
• Standard Operating Procedure (SOP)
• Evidence of audits/reviews, communication,
  interventions and re-audit

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Standards of the Clinical Transplant Programme

• Definition and size of the programme
• Data Management
• Quality Control
• Staff Requirements
• Clinical Unit Requirements
• Most common deficiencies

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B6.100 Transplant team

• A dedicated transplant team, including Programme
  Director at least one other experience
  physician shall have been in place for at least
  one year
• Individuals may do things besides clinical
  transplantation (e.g. Research, non-transplant
  clinical care, administration)
• Changes in key personnel may require
  reaccreditation

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B6.200 Programme Director

• Shall be licensed to practice medicine in Europe
• Board-certified Haematology, Oncology,
  Immunology, Paediatric Haematology / Oncology
• Non-board-certified trained prior to 1985 with
  documented experience publications over a 10
  year period

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B6.220 Programme Director

• 1 year of specific clinical training in HPC
  transplantation, or
• 2 years experience as attending physician
  responsible for the clinical management of HPC
  transplant patients in inpatient or outpatient
  settings
• Written confirmation of training

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B6.230 Programme Director

• Responsible for administrative clinical
  operations including compliance with these
  Standards
• Review medical care of the other Transplant
  Programme attending physicians
• Guidance
• Not responsible for the clinical activities of
  other doctors

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B6.300 Other Attending Physicians

• B6.310 Shall be appropriately licensed should
  be board-certified
• Copy of licence
• Copy of fellowship certificate/requisite board
• B6.320 Should have specific clinical training in
  haematopoietic progenitor cell transplant (B6.400)

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B6.400 Physician training

• B6.411 1 year in transplant patients management
  (inpatient and outpatient)
• B6.412 Clinical training competency shall
  include the management of patients undergoing
  autologous, allogeneic or both types of
  transplants as appropriate

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B6.420 Cognitive Skills I

• Indications for transplant
• Pre-transplant evaluation
• Patient selection
• Administration of high-dose therapy
• Administration of growth factor
• Management of neutropenic fever

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B6.420 Cognitive Skills II

• Diagnosis management of
• Interstitial pneumonia
• Fungal disease
• VOD
• Graft failure

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B6.430 Cognitive Skill III

• Management of
• Thrombocytopenia bleeding
• Hemorrhagic cystitis
• Nausea vomiting
• Pain
• Terminal care

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B6.422 Allogeneic competencies

• Selection of progenitor cell source
• Methodology/implications of HLA typing
• Management of ABO incompatibilities
• Diagnosis management of
• Viral infections (including CMV)
• Acute chronic GVHD
• Post-transplant immunodeficiencies

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B6.430 Transplant procedural skills

• B6.341 The physician shall be proficient in
• Bone marrow harvest
• HPC infusion
• B6.342 The physician shall be knowledgeable in
• HPC processing
• HPC cryopreservation
• Aphaeresis

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B6.500 Consulting physicians

• Board eligible/certified physicians in key areas
  to assist in medical paediatric care
• Surgery - Psychiatry
• Cardiology - Radiation
• Pulmonary medicine - Pathology
• Gastroenterology - Nephrology
• Infectious diseases - Intensive care

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B6.600 Nurses

• B6.610 Nurses supervisors formally trained
  experienced in transplants
• B6.620 Training should include
• Haematology/oncology patient care
• High-dose therapy growth factors
• Infectious diseases
• Blood component administration

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Standards of the Clinical Transplant Programme

• Definition and size of the programme
• Data Management
• Quality Control
• Staff Requirements
• Clinical Unit Requirements
• Most common deficiencies

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B7.000 Clinical Unit

• Each programme shall have
• B7.400 Nurses experience in the care of
  transplant patients
• B7.500 Satisfactory nurse/patient ratio

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B6.700 Clinical Unit Staff

• B6.710 Coordinator(s)
• B6.720 Pharmacy
• B6.730 Dietary
• B6.740 Social services
• B6.750 Physical therapy
• B6.760 Data management (B4.000)

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B6.700 Clinical Unit Staff Guidance

• Staff committed to programme for the time
  required (may not be full-time)
• Documentation of staff function

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B7.000 Clinical Unit

• B7.100 A designated inpatient unit that minimises
  airborne microbial contamination
• Guidance
• Prepare for inspector tour
• Staff observation interaction
• Document air-handling system

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B7.000 Clinical Unit

• B7.200 Outpatient area that protects patients
  from infection can provide administration of
  fluids, blood etc.
• Guidance
• Addresses the minimum space requirements
• Does not imply need for specific design
• Space for visits infusions and transfusions
• Home health

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B7.000 Clinical Unit

• B7.300 Provisions for prompt evaluation by
  transplant attending on a 24-hour basis
• Guidance
• Physician need not be in the hospital
• Procedure for contacting attending
• Call schedule

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B7.000 Clinical Unit

• B7.600 Written policies on site for all
  procedures
• Infections prevention and control
• High dose therapy
• Immunosuppressive therapy
• Blood component administration

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B8.000 Other required services

• B8.100 All programmes shall have access to
• B8.120 Transfusion service providing 24-hour
  component support with irradiated products

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B8.000 Other required services

• Guidance (8.100)
• Can utilise a Collection Facility/Processing
  Laboratory not under the control programme
• Collection Facility/Processing Laboratory must
  meet JACIE standards
• Other clinical programmes supplied by the lab
  need not meet JACIE standards for the clinical
  programme to the accredited

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A5.000 Safety Requirements

• A5.100 Each facility/programme shall minimise
  risks to health safety of employees and
  patients. Suitable quarters, environment and
  equipment to maintain suitable operation

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B8.000 Other required services

• B8.200 All programmes shall have access to
• B8.210 24-hour CMV- blood component support
• Components suitable for CMV- patients defined in
  SOP (leukopoor vs. Screened)
• B8.220 EFI accredited DNA-based HLA-typing

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Standards of the Clinical Transplant Programme

• Definition and size of the programme
• Data Management
• Quality Control
• Staff Requirements
• Clinical Unit Requirements
• Most common deficiencies

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B1.000 Programme definition

• Clarification of Programme Director (identity
  job description)
• Attending physician identify
• Whether the programme meets standards as a
  programme

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B2.000 Programme size

• B2.000/B4.000 Patient log. Facility did not
  submit an adequate patient log

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B4.100 Data management

• Data management deficiencies errors noted
  during review of the transplant date sheets
  submitted by programmes

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B5.000 Quality management

• Inadequate, incomplete or no quality management
  plan submitted by the clinical facility

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B6.200/6.220 Programme director

• Inadequate documentation of programme director
  certification, training experience

B6.300 Attending physicians

• Inadequate doc of attending physician
  certification, training experience

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B6.42-6.43 Physician competencies/procedures

• Inadequate documentation of competencies and
  competency in procedural skills

B6.500 Consulting physicians

• Absent or inadequate documentation of consulting
  physician participation/availability to the
  programme

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B6.500 Consulting physicians

• Absent or inadequate documentation of consulting
  physician participation/availability to the
  programme

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B6.620 Nurse training

• Inadequate, incomplete or absent documentation of
  nurse training in the management of progenitor
  cell patients

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B7.600 Clinical facility SOPs

• Inadequate, incomplete or absent SOPs and/or SOP
  for SOPs

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Clinical Transplant Standards

• Summary I
• 1.- Integrated medical team.
• 2.- More than 10 Tx per year.
• 3.- Data complete and precise (original reports
  data manager).

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Clinical Transplant Standards

• Summary II
• 4.- SOPs, written plan for compliance with
  standards, detecting errors and adverse
  reactions, audits/reviews.
• 5.- Personnel (nº/qualification/training).
• 6.- Support pers, in/out area, labs,..