Feedback from Inspections of Hospital Blood Banks

1
Feedback from Inspections of Hospital Blood
Banks
Hospital Liaison Workshop Programme, 7th
November 2007
Dr. Patrick Costello Blood and Tissues Manager
2
Overview of Presentation

• A reminder of the regulatory framework
• Review of the Hospital Blood Bank Annual Report
  (HBBAR) 2006
• HBBAR for 2007
• Main Deficiencies identified at Hospital Blood
  Bank Inspections

3
Regulatory Framework

• EU (Directives)
• 2002/98 (Mother Directive)
• 2004/33 (Technical Requirements for Blood and
  Blood Components)
• 2005/61 (Traceability Haemovigilance)
• 2005/62 (Quality System)
• National (Statutory Instruments)
• S.I. 360 of 2005
• S.I. 547 of 2006
• S.I. 562 of 2006

4
Regulatory Framework Hospital Blood Banks

• 2002/98/EC
• Article 7 Provisions for existing
  establishments
• Article 10 Personnel
• Article 11(1) Quality System
• Article 12(1) Documentation
• Article 14 Traceability
• Article 15 Notification of SAE and SAR
• Article 22 Storage, transport and distribution
• Article 24 Data protection and confidentiality

5
Regulatory Framework Hospital Blood Banks

• S.I. 360 of 2005
• Regulations 11, 12 13
• Regulation 11
• Hospital Blood Bank Requirements
• Specifies person responsible for management of a
  hospital blood bank
• (DoHC confirmed that this person is the CEO /
  General Manager of a Hospital)
• Covers the requirements of the Articles
  applicable to Hospital Blood Banks in 2002/98/EC

6
Regulatory Framework Hospital Blood Banks

• Regulation 12
• Requirement for hospital blood banks to provide
  information to IMB
• 12 (1) As soon as practicable after the end of
  the reporting year, the person responsible for
  management of a hospital blood bank shall submit
  an annual report to the IMB, which shall
• a) include a declaration that the hospital blood
  bank has in place appropriate systems to ensure
  compliance with the requirements of these
  Regulations, and
• b) provide details of the systems which it has in
  place to ensure such compliance

7
Regulatory Framework Hospital Blood Banks

• Regulation 13
• Serving of notice in relation to hospital blood
  banks
• 13(1) If the IMB is of the opinion that-
• a) the person responsible for management of a
  hospital blood bank has failed in any material
  respect to comply with the requirements of these
  Regulations
• b) the testing, storage or distribution of blood
  or blood components cannot be safely
  administered for transfusion, or
• c) the information given by the person
  responsible for management of the hospital blood
  bank pursuant to Regulation 12 was false or
  incomplete in any material aspect
• Serve notice on the person responsible for
  management of the hospital blood bank requiring
  that the hospital ceases to
• conduct any of the activities specified in the
  notice,
• or refrains from administering to patients any
  blood or
• blood components specified in the notice

8
Regulatory Framework Hospital Blood Banks

• S.I. 360 of 2005
• 16(5) The IMB may inspect hospital blood banks
  with a view to ensuring that
• a) hospital blood banks and persons responsible
  for the management of hospital blood banks comply
  with the requirements of these Regulations
• b) problems relating to compliance with those
  requirements are identified and
• c) not later than 8 November 2008, the hospital
  blood banks operate to International Standard ISO
  15189 of the International Organisation for
  Standardisation

9
Hospital Blood Bank Annual Report - 2006

• Overview of HBBARs received in 2006
• 86 Hospital Blood Banks and Facilities identified
• 55 Hospital Blood Banks, 31 facilities
• 73 Reports in total reviewed (53 HBB 20
  Facilities)
• - 2 HBBAR contained info on 2 HBB
• - 2 N/A No transfusion took place on site
• - 9 No response Small Hospices / Community
  Hospitals
• Majority were received on time
• Review performed by Blood and Tissues Inspectors
• Validation (Second Review) of a number of HBBARs
  performed by Blood and Tissues Manager

10
Hospital Blood Bank Annual Report - 2006

• Results of Review
• Review was undertaken in relation to a template
  of expected responses
• Further information was requested from a number
  of Hospital Blood Banks in order to determine
  level of compliance
• Risk assessment performed
• Based on results of Risk Assessment Hospital
  Blood Banks were categorised as follows
• Compliant
• Non compliant and follow up at next HBBAR
• Non compliant and requiring inspection

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Hospital Blood Bank Annual Report - 2006

• Results of Review
• Hospital Blood Banks
• - 1 Hospital Blood Bank Compliant
• - 51 Hospital Blood Banks Non Compliant
• - 1 Hospital Blood Bank had just opened and is
  to be followed up in 2007
• 30 non-compliant hospital blood banks were
  identified for inspection
• Of these 13 were notified to the Department of
  Health Liaison as being of particular concern
• The remainder (21) were notified that they were
  non compliant and would be followed up at next
  HBBAR
• The Majority of Facilities were deemed to be
  compliant

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Hospital Blood Bank Annual Report - 2006

• 30 Hospital Blood Banks inspected
• April July 2007
• Usually 1 day inspections
• Major Deficiencies identified at all hospital
  blood banks

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Hospital Blood Bank Annual Report - 2006

• Classification of Deficiencies
• A critical deficiency may be defined as a failure
  which indicates a significant risk that
  blood/blood components could or would be harmful
  to the patient, or a failure which has produced
  harmful blood/blood components.
• A major deficiency may be defined as a
  non-critical failure which could or would result
  in blood/blood components that do not comply with
  the requirements of relevant legislation.
• An other deficiency may be defined as a failure
  which cannot be classified as either critical or
  major, but which indicates a departure from GP.
  These deficiencies are considered as minor.

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Hospital Blood Bank Annual Report - 2006

• Of 30 Hospital Blood Banks inspected, the
  management of 7 were requested to attend the
  offices of the IMB
• Serious but open discussion on how the hospital
  intended to comply with Legislation.
• Likely re-inspect these sites and others
  depending on review of HBBAR for 2007

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Hospital Blood Bank Annual Report - 2006

• Number of rounds of correspondence with Hospital
  Blood Banks have taken place with regard to the
  deficiencies identified and the corrective
  actions proposed
• 21 Hospital Blood Bank Inspections have been
  closed out Follow up at next HBBAR or at next
  inspection if required
• 9 Blood Bank Inspections Open currently
  undergoing rounds of correspondence

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Hospital Blood Bank Annual Report - 2006

• Stakeholders
• In general welcomed the inspections
• In majority of cases agreed with findings
• Found Inspections helpful to identify gaps
• Useful for local hospital management to hear the
  outcomes
• Allowed Hospital Management to prioritise blood
  service
• One complaint received

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Hospital Blood Bank Annual Report 2007

• 2007 Hospital Blood Bank Annual Report
• The annual report will be on the IMB website by
  the end of November 2007 www.imb.ie
• Mostly same information requested but re-wording
  of a number of questions based on experience from
  2006
• Guidance document will also be available
• Queries to compliance_at_imb.ie
• Deadline for submission January 31st 2008

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Hospital Blood Bank Annual Report 2007

• Inspections
• Likely in 2008
• 7 hospital blood banks invited to IMB
• Others based on review of HBBAR
• Facilities that do not have laboratory service
  onsite but store large volumes of blood
• In the future
• On foot of a serious adverse event / reaction
• On the basis of third party information
• Following a failure to obtain or maintain
  ISO15189 accreditation

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Deficiencies at Hospital Blood Bank Inspections

• Organisation and Management
• No Holistic approach to blood service at
  hospital
• Responsibility not defined for Quality
• Clinical Responsibility for transfusion not
  defined
• Personnel
• Training Records / Matrix / Programme not
  adequate
• No induction / legislation / re - training
  defined
• Competency Assessment not recorded
• No documentation
• Inadequate staffing levels

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Deficiencies at Hospital Blood Bank Inspections

• Documentation
• No SOPs
• Poor Document Control Systems / Wrong versions
  in use
• No Review System
• No or inadequate training records associated
  with SOPs
• Critical Steps not included
• Equipment and Materials
• No VMP No systematic approach to validation
• Operating Instructions
• Batch Acceptance system
• Release of critical items
• System for keeping inventory records
• Ownership of records (Eng. Dept)

21
Deficiencies at Hospital Blood Bank Inspections

• Deviations / Non-conformances / Complaints
• Not auditable
• Investigation not to root cause!
• No Trending or Analysis
• Multiple systems across hospital
• Recall
• Authorised Person
• Recall initiated by IBTS and Locally
• Responsibilities defined
• Practice Run

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Deficiencies at Hospital Blood Bank Inspections

• Corrective and Preventive Actions
• Not readily auditable
• Corrective action does not often address real
  cause of deviation
• No Trending or Analysis
• Self-Inspection
• Not fully in place
• Systems Audit
• Number of individuals trained
• Close out period
• Ability to escalate findings higher

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Deficiencies at Hospital Blood Bank Inspections

• Haemovigilance (HV)
• No SOPs laboratory and clinical side
• No auditable log of SAE and SAR
• No tracking and trending
• No holistic approach to HV
• No cover in times of absence
• Supply to other hospitals responsibility not
  defined
• Traceability
• No mechanism for 100 traceability
• Autofating of units NB
• No procedure for untraceable units
• Supply to other hospitals responsibility not
  defined

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Deficiencies at Hospital Blood Bank Inspections

• Storage and Distribution
• Issue of units for transfusion
• Storage conditions - in Lab and at Satellite
  Locations
• Time out of fridge
• Delivery system Validation
• Transport / Distribution Conditions,
  Validation, Responsibilities
• Control of Returned Units
• Appropriate records of inventory and
  distribution
• Defined procedures
• Overall
• No Systematic approach to implementation of a
  quality system!!

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Summary

• Progress towards compliance
• Submission of HBBARs ongoing
• Hospitals to be ISO accredited in 2008
• Otherwise continuation of IMB Inspections
• In the future - Less frequent IMB inspections
  (Hopefully!)

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Questions