QUALITY MANAGEMENT PLAN

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QUALITY MANAGEMENT PLAN
JACIE Accreditation for the Collection, Process
and Transplant of Hematopoyetic Stem
CellsHEMATOPOYETIC STEM CELL TRANSPLANT PROGRAM
Ignasi BolíbarPrograma de Promoció i Avaluació
de la Qualitat Assistencial, Servei
dEpidemiologia Clínica i Salut Pública Mª
Salut BrunetServei dHematologia ClínicaClara
MartínezBanc de Sang
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QUALITY MANAGEMENT PLAN THE THEORY

• Quality the conformance of a product or process
  with pre-established specifications or standards.
• Quality management to significantly decrease
  errors, ensure the credibility of test results,
  implement effective continued product safety and
  quality. Includes
• quality assessment those measures to
  investigate, detect, and assess errors
• quality assurance the actions, planned and
  performed, to provide confidence that all systems
  and elements (processes, products or services)
  that influence quality are working as expected
  (outcomes)
• quality improvement measures to correct and
  prevent errors

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QUALITY MANAGEMENT PLAN THE THEORY

• Quality Management Plan the written document
  that outlines how a facility will implement its
  quality assurance activities.
• Its scope includes all aspects of the
  transplantation Program
• standard operating procedures
• training and continuing education of staff
• competency evaluation
• proficiency testing
• error and accident reports
• complaints
• adverse reactions
• records management
• and the conduct of quality assurance audits

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QUALITY MANAGEMENT PLAN THE THEORY

• Each transplant Program will have its own
  organisation for the Quality Program.
• The inspector should expect to find some
  structure, some written plan, and some
  documentation that audits or reviews have been
  performed, that results are documented and
  forwarded to appropriate personnel, that
  interventions have been made to correct problems
  or to improve the process, and that the system is
  re-audited.

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QUALITY MANAGEMENT PLAN THE PRACTICE
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THE HEMATOPOYETIC STEM CELL TRANSPLANT PROGRAM
AT THE SAINT POUL HOSPITAL
PROGRAM DIRECTOR
QUALITY MANAGEMENT
CLINICAL TRANSPLANTATION UNIT
CONTINUOUS TRAINING
PBSC EXTRACTION UNIT
BMSC EXTRACTION UNIT
HSC PROCESSEMENT UNIT (IRO)
RECEPTOR
DONNOR
DEPARTMENT OF CLINICAL HAEMATOLOGY DEPARTMENT OF
HAEMATOLOGY DEPARTMENT OF PAEDIATRICS BLOOD BANC
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Designed to achieve - the acreditation
standards of the JACIE-ISHAGE-Europe and EBMT -
the program for promoting and evaluating the
quality of care in the Hospital
Mission (WHO 1981) all phases of the transplant
performed correctly - according to the
current knowledge of medical science ?
efficacy - and in agreement with the
characteristics of the donor and receptor ?
effectiveness - with the minimum cost of
resources ? efficiency - the minimum exposure
to possible risks of an additional injury ?
security - and the maximum satisfaction of the
attended subjects ? patient oriented
HSP QUALITY MANAGEMENT PLAN
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HSP QUALITY MANAGEMENT PLAN THE ORGANIZATIONAL
STRUCTURE
QUALITY ASSURANCE
QUALITY ASSESSMENT
QUALITY IMPROVEMENT
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HSP QUALITY MANAGEMENT PLANTHE SCOPE PROGRAM
APPLIED TO 3 JACIE ACCREDITATION SECTIONS OF THE
HSCT AND DIVIDED BY 3 JACIE STANDARDS
JACIE ACCREDITATION SECTIONS OF HSCT
3 JACIE STANDARDS
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HSP QUALITY MANAGEMENT PLAN THE METHODS
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JACIE STANDARD - 1
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JACIE QUALITY ASSURANCE AUDIT

• Quality audit one mechanism of evaluating the
  effectiveness of the total quality assurance
  system consisting on a review of records with
  emphasis on the processes that occurred as well
  as the end product or service. They may be
• comprehensive - they involve a statistically
  significant number of records to evaluate the
  function of a system or process
• focused - to evaluate a specific problem that has
  been identified or to monitor more closely a
  specific critical area.
• There should be a written report documenting
  each audit procedure and results.

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HSP QUALITY ASSURANCE AUDIT

• GOALS
• To describe the problems about the registry of
  the fulfilment of the protocols and standards,
  and to suggest corrective measures.
• MATERIAL AND METHODS
• Retrospective revision of medical records
• Random and representative sample of all
  transplanted patients in the Departments of
  Clinical Haematology and Paediatrics performed in
  the last 6 months (20/8424)
• Repeated 2 times per year
• Revision by a trained external nurse

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HSP QUALITY ASSURANCE AUDIT

• INDEX OF CONTENT (88 items)
• 1.- FASE PRE-TRASPLANTE
• 1.A.- Paciente
• 1.B.- Donante alogénico
• 2.- FASE TRASPLANTE
  
• 2.A.- Catéter central
• 2.B.-Acondicionamiento
• 2.B.1.- Quimioterapia
• 2.B.2.- Radioterapia
• 2.B.3.- Medidas de soporte
• 2.C.- Infusión de PH
  
• 3.- SEGUIMIENTO POST -TPH
• 3.A.- Durante el ingreso hospitalario
• 3.B.- Seguimiento ambulatorio

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HSP QUALITY ASSURANCE AUDIT Example
1.Yes 2. No 5. Non-assessable/lack
information 7. No medical record 9. NA

• 1.- FASE PRE-TRASPLANTE
• 1.A Paciente (donante autólogo). Se identifica en
  la historia clínica
• Serologías Hepatitis / CMV / HIV
• Firmas paciente y médico en hoja consentimiento
  informado del TPH
• Consta en actas de Sesión Clínica el plan
  terapéutico del paciente
• Movilización de PH en TPH-SP de paciente
  autogénico
• Tipo y dosis de movilización G-CSF?QT
• Fecha inicio movilización
• Analítica pre-aféresis, incluyendo número de
  CD34
• Fecha de inicio y final de la aféresis
• Nº total de aféresis
• Células CD34/kg receptor recogidas
• Tipo de manipulación exvivo de los PH extraídos
  (deplección linfocitos T, selección positiva
  cél.CD34,)

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HSP QUALITY ASSURANCE AUDIT Results

• Corrective measure The 100 of all IC must be
  found in the medical records. Their content will
  be improved, increased and updated. Paediatric
  IC must include the parents signature and
  testimonies. Special attention will be given to
  IC from clinical trials (MiniAlo).

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HSP QUALITY INDICATORS
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HSP QUALITY INDICATORS Example
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HSP QUALITY INDICATORS Results
Corrective measure The standard is fulfilled at
the 100, but 29 of BMT do not have records of
their HSC collected. Positive microbiology is
frequent.
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JACIE STANDARD - 2
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JACIE REGISTER OF ERRORS, ACCIDENTS AND ADVERSE
REACTIONS

• The emphasis is on preventing errors rather than
  detecting them retrospectively
• Each clinical Program should have a written
  procedure in its manual of Standard Operating
  Procedures (SOP) that describes the steps to be
  taken in the event of a suspected adverse
  reaction to progenitor cells, including infusion.
  
• Any suspected adverse reaction should be
  documented and investigated. The Medical Director
  should review the reports of reported adverse
  reactions, and the inspector should expect to see
  documentation of this review.
• Similarly, any accidents or errors should be
  reported, and the standard mechanism for such
  reporting should be described in the facility SOP
  manual. Appropriate corrective action should be
  initiated and documented and the incident as
  reported should be reviewed by the Medical
  Director.

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HSP REGISTER OF ERRORS, ACCIDENTS AND ADVERSE
REACTIONS

• What is an error, accident or adverse reaction in
  a HSCT ?
• Error accident erroneous, incorrect, mistaken
  and accidental events according to the protocols,
  presented in the everyday clinical practice
• Adverse reaction all those adverse patient
  responses different from that expected or looked
  for by the healthcare professional
• although sometimes inevitable, they are
  presented in an
• unusual, unexpected or extraordinary way
• Detection evaluation (causes and consequences)
  documentation communication to the program
  Director and patients physician registration
  of corrective actions
• Quick, prospective and systematic to all phases
  of extraction and clinical transplant ?
  availability of the register in all clinical
  settings.
• The protagonists are the medical and nurse
  personnel that attend the patient

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HSP REGISTER OF ERRORS, ACCIDENTS AND ADVERSE
REACTIONS
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HSP REGISTER OF ERRORS, ACCIDENTS AND ADVERSE
REACTIONS Example for the clinical
transplantation
Label
Date of the
error/accident/reaction ___ / ___ / 200_ NOMBRE
Y APELLIDOS
.... Date of
notification ___ / ___ / 200_ HISTORIA
CLÍNICA Time of the
notification ______
? Please, circle the code of the
error, accident or adverse reaction unusual,
unexpected or extraordinary ? 81specific codes
?Description of the problem ..
?Causes ?Consequ
ences ?Corrective
actions.. Signature of
the physician or nurse who notifies the
event Name and surname.
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JACIE STANDARD - 3
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JACIE VALIDATION AND QUALIFICATION STUDIES

• Validation establishes documented evidence that
  provides a high degree of assurance that a
  specific process will consistently produce a
  product meeting its predetermined specifications
  and quality attributes.
• Significant processes, SOPs and equipment used by
  the Transplant Program should be validated a
  consistent protocol for validation studies should
  be used.
• The results of the validation studies should be
  documented, reviewed and approved by the Program
  Director, and be available to the JACIE inspector
  for review.
• Validation can be prospective, retrospective, or
  a review of the results of that procedure
  performed in the same way under the various
  conditions that may exist for its performance, or
  by repeating an appropriate number of trials
  under identical operating conditions
  (reproducibility)

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JACIE VALIDATION AND QUALIFICATION STUDIES

• The Program Director is also responsible to
  determine what needs to be validated.
• To establish priorities for which processes to
  validate, it may be helpful to
• determine where problems have been noted in the
  past
• through review of product failures
• customer or user complaints
• quality assurance audit findings
• information obtained from the process users
• Also, new processes should be subject to thorough
  validation

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HSP VALIDATION AND QUALIFICATION STUDIES

• Technical reports
• Radiotheraphy. Apheresis
• Internal studies
• Usefulness of the basal leukocyte and CD34 cell
  count in peripheral blood to predict the yield of
  the apheresis (CD34gtde 5.000/ml in PB)
• Medical records audit
• Pre-transplant phase to compare the
  therapeutic plan of a given patient in the
  medical record with the one recorded in the
  clinical session
• Transplant phase agreement between the
  prescribed medication (medical records), the
  administered medication (nurse records) and the
  current standards medication (manual).