Common Deficiencies Encountered During Inspections and Possible Solutions

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Common Deficiencies Encountered During
Inspections and Possible Solutions

• Derwood Pamphilon
• Chair JACIE Accreditation Committee

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The FACT-JACIE Standards 3rd ed 2006







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Documentation

• Submitted before inspection
• Organigramme of programme
• CVs, registration, evidence of training,
  educational activity for all senior medical staff
• Nursing summary (staffing, training etc)
• Quality manual and SOP for SOP
• List of SOPs
• Patient and donor consent forms
• List of patients (Activity data)
• MED-A data for 10 consecutive patients
• INSPECTION CHECKLIST

• Documentation to see on site
• Patient notes
• Sample donor notes
• Selected SOPs (e.g. donor evaluation)
• Proformas for HDT
• Training records
• Audit reports
• Adverse Event (AE) reports
• Minutes of meetings
• Quality review meetings
• Patient management meetings

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The Inspection Checklist
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Areas of deficiencies Expressed as of total
deficiencies. Based on analysis of 632
deficiencies encountered in inspections



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Section D Deficiencies
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Trends in Deficiencies
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Procedure for Collection Facility Inspection
Procedure
File
Kits/solutions
Crash calls
Labels
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General Points

• Talk to junior staff members
• Talk through an ongoing procedure and review
  associated documentation
• Look at records of collections for procedures
  listed by clinical facility
• Ask to see training logs and records
• Look at the room(s) for donor evaluation
• Look at the stores

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Quality ManagementPlan (QMP)

• Programme Director responsible for QMP
• Organisational chart of key personnel and
  functions
• Include - policies, procedures and 3rd party
  agreements
• Defined process improvement plan
• Personnel requirements

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Quality ManagementPlan (QMP)

• Documentation and review of products and outcomes
  e.g. engraftment
• Conduct of audits
• System for - errors, accidents, adverse events
  and complaints
• Mechanism for document control

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Quality ManagementPlan (QMP)

• Process for product tracking
• Validation of equipment, reagents and processes
• Inventory control
• Ensure products meet predefined release
  specifications e.g. good safety, viability and
  integrity
• Microbiology testing in approved labs

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QMP - Joint Clinical Programmes
SOLUTIONS

• DEFICIENCIES
• Lack of overall Quality Manager
• for joint programme
• 2 sets of SOPs and policies
• Lack of integrated audits and adverse event
  reporting/review

X
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B4.000 Clinical Programme
DEFICIENCY There is no review of clinical
outcome
SOLUTION
Actions to be taken if deviation
Define parameters What is acceptable?

• Review of TRM, line
• infections
• Audits
• Adverse events

PD must review
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Problems with Clinical Units
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Assessment of Training and Ongoing Competency
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C4.000 Quality ManagementPeripheral Blood
SOLUTIONS

• DEFICIENCIES
• Collection outcomes e.g. yields and AEs not
  regularly reviewed by CF Director
• The QMP does not describe the validation of
  significant apheresis procedures
• The SOP does not give the range of expected
  outcomes/results

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B5.000 Clinical - SOPs
SOLUTIONS

• DEFICIENCIES
• Lack of SOPs e.g. for chemo, neutropenic fever
• No review dates
• No logical system of numbering
• Document control poor
• Not present in appropriate locations

Centre must submit proposal for development of a
comprehensive QMP
RESOURCE!!
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C5.000 CollectionPolicies and Procedures

• DEFICIENCIES
• No SOP for donor screening, consent, training, BM
  collection, storage or transport
• Range of expected results, ranges and end points
  not defined in SOP for stem cell collection
• No examples or worksheets and labels
• No arrangements for annual review
• Tolerance limits and corrective actions for
  collection not defined

SOLUTION
Revised Documentation
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C5.000 Collection Policies and Procedures

• Lack of proper communication from clinical to
  collection team
• SOP present but inadequate e.g. no acceptable
  results and tolerance limits / no instruction for
  action if these are not met
• No procedure for recording deviation from the
  SOPs relating to stem cell collection, or whether
  and how such deviations are approved

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SOP IllustrationBM Harvest
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B6.000 C6.000 Donors

• Appropriate consent (risks/benefits, tests,
  rights to review tests/refuse donation,
  alternatives), available to CF staff prior to
  procedure
• Proper assessment procedures
• Use of donors not meeting the safety criteria
• Protect recipient from disease transmission
• - Tests for HIV, HTLV, HBV, HCV, syphilis
• - d-30 for HPC d-7 for TC

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B6.000 Donors - Problems

• DEFICIENCIES
• Lack of written donor information
• e.g. collection procedures and risks of
  G-CSF, central lines
• Missing/inconsistent donor info e.g. travel,
  transfusion, immunisation histories
• Lack of clear selection criteria
• No clear final authorisation
• Not relaying donor info to collection facility
• No record in patient record of donor suitability
  e.g. HLA, CMV, ABO

• SOLUTIONS
• Clear, comprehensive and unambiguous policies and
  procedures
• Checklists
• Final approval documents

Resources
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C6.000 Donor Selection Management

• No written orders for collection
• Absence of written consent
• No arrangements for assessment of (interim) donor
  suitability
• No formal policy / SOP for assessment of venous
  line placement
• Assessment of venous line placement not
  documented in patient/donor record

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Format of Documents
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Format of Documents
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C7.000 D7.000 - Labelling

• Labels - held upon receipt/printed on demand
  reviewed against a copy or template
• Obsolete labels destroyed
• Archive representative labels for 10 years
• Biohazard labels - risk factors or marker
  positive
• Label Table will defined whether information
  should be affixed (AF), attached (AT) or
  accompanying documents (AC)

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Labels Storage
C7.000 C8.000
SOLUTION

• DEFICIENCIES
• Responsibility for label production and
  control unclear - new SOP
• Lack of unique alphanumeric identifier
• Must give proper name e.g. Human HPC-A
• CF and PL need to agree HPC identifiers

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C7.000 C8.000 Labels Storage

• PROBLEMS
• Example labels not appended to SOP
• SOP to include Biohazard label
• Pre- or demand -printed labels
• Human HPC-A
• Name volume of AC / additives not stated

SOLUTION
Biohazard
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C7.000 - Biohazards

• Biohazard label if screening indicates
• - presence of a communicable disease
• - risk factor /clinical signs of one
• Creates 3 categories of product labelling
• - warning tests reactive for..
• - warning advise patient of
  communicable disease risk
• - not evaluated for infectious
  disease risk

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(No Transcript)
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C9.000 - Records

• Facility records relating to QC etc - 10 years
• Patient records - min 10 years after admin and
  as according to governmental laws
• Research records - min 10 years after admin
• Where divided must show extent of each facilitys
  responsibility

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C9.000 Records

• Facilities for patient record storage
• inadequate
• No records for ... personnel training
• No copy of collection record
• (safety, purity) sent to Clinical Unit

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Interactions Between Facilities

• Collection facility must use processing
  facilities that meet JACIE standards
• Bone marrow collection normally integral to
  clinical programme but must be inspected and
  accredited as a collection facility
• Apheresis collection and processing facilities
  may be integral to programme, or external, e.g.
  National Transfusion Service

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Interactions Between Facilities

• Links between facilities are important e.g.
• Written requests for collection, or component
  issue
• Provision of engraftment data to collection and
  processing facilities
• Reporting of AEs to other facilities, if
  appropriate
• Service agreements or contracts with external
  facilities

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A View of One Centre
The collection facility is run to a high
standard by the blood service. The interface
requires more formal organisation especially for
reporting of AE and variances in practice. The
was a lack of awareness that the facility was
functioning as part of the overall
transplant programme. Inspector
Communication between the facility and the
clinical programme needs more formal
organisation. AEs are reported within the Blood
Service but no SOP for reporting to the Clinical
Programme, quality manager or patients
physician. JACIE Medical Director
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The Solution

• Establish a new Quality Forum - regular meeting
  between all parts of the programme
  - regular review of AE, outcome
  of audits etc
• New SOPs address the relationship
• Collection and Processing Facilities at Blood
  Service meet monthly to review outcome data and
  report AE, incidents etc to Clinical Programme

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Thank You