Transcript JACIE Inspector Training and Update Course

Clinical Programme –
Standards and Inspection
The Standards Section B
• B 1. General - programme size and organisation
• B 2. Clinical Unit Facilities
• B 3. Personnel
• B 4. Quality management
• B 5. Policies and Procedures
• B 6. Donor selection, evaluation and management
• B.7. Therapy administration
• B 8. Clinical research
• B 9. Data management
• B10. Records
Assessment of compliance
• Documentation
– Submitted
– Available on site
• Observation
• Interview
Plan
Go through checklist
and note what you
need to see and who
and what you need
to ask
Documentation – Clinical programme
• Submitted before inspection
– Organigramme of programme
– CVs, registration, evidence of
training, educational activity for all
senior medical staff
– Nursing summary (staffing,
training etc)
• Documentation to see on site
– Patient notes
– Sample donor notes
– Selected SOPs (e.g. donor
evaluation)
– Proformas for HDT
– Training records
– Quality manual and SOP for SOP
– Audit reports
– List of SOPs
– Adverse Event (AE) reports
– Patient and donor consent forms
–
Minutes of meetings
– List of patients (Activity data)
• Quality review meetings
– MED-A data for 10 consecutive
• Patient management
meetings
patients
– etc
B 1. General - programme size and
organisation

Definition of a programme

Programme size
B1.1 Definition of a Clinical
Transplantation Programme
• i.e. what is considered as a “single programme”
• particularly relevant to:
– A combined adult and paediatric programme (on same
site or different sites)
– Programmes with a second clinical site or “satellite”
units, e.g. local hospital doing a small number of
autologous transplants.
• Rationale
– two smaller programmes that are really working
separately should not join up just to meet activity
targets for accreditation
B1.1 Definition of a Clinical
Transplantation Programme
•
•
•
•
an integrated medical team
housed in geographically contiguous or proximate space
single Programme Director
common
– protocols
– quality management
– training
– data management
Programmes that include non-contiguous institutions in the
same metropolitan area* must also demonstrate
• joint review of clinical results
• evidence of regular interaction
* Defined for JACIE as “Geographically near enough to allow close and regular
interaction”
B1. Evidence
• ?single Programme Director
– documents (organigramme, minutes of meetings)
– interviews with staff (nurses, junior doctors)
• ? Common clinical protocols / training / QMP
– documents
•
•
•
•
SOPs
evidence of joint nursing training and competency assessment
Common patient database /data management
evidence of joint quality meetings
– Interview (nurses, junior doctors, quality manager)
• ? Regular interaction (non-contiguous units)
– Documents (minutes of meetings etc)
– Interview (especially staff at second site)
• B1.3 The Clinical Program shall abide
by all applicable laws and
regulations.
B 1.5 & 1.6 Programme size
• Minimum number of new allo or auto
transplant patients in the preceding year (plus
additional requirements for specific situations)
• Allo includes ID-sib, haplo, VUD, RIC-allo etc.
• The transplant unit can define the 12 month
period but it must end within 12 months before
the application
• The transplant unit must supply a complete list
of patients for this 12 month period
B1.5 & 1.6 Programme Size
Programme
Type
Total
minimum
required
Allo OR Auto
10 or 5
10
Allo AND Auto
10
10
Combined
Paed & Adult
programme
10
More than 1
clinical site
As above
Auto
minimum
required
Change re: 3rd edition
OR
5
Auto minimum reduced
from 10
AND
No
minimum
reqd
No total minimum and
accredited allo unit
considered to have met
numeric req for autos
Allo
minimum
required
5 Adult and 5Paed
for allo and same for auto
5 per site
increased from 4
increased from 4
B 2. Clinical Unit

what facility must have

safety requirements
B2. Clinical Unit Ward /OP
B2.1 There shall be a designated inpatient unit of adequate space,
design, and location that minimizes airborne microbial
contamination.
Guidance: “Inspectors will recognize that the unit facilities may
vary between centres”
to
- recognition of an increasing use of ambulatory approaches
transplantation,
-the standard is not meant to imply that every unit must
have
laminar airflow available
-HEPA filtration with positive pressure is recommended for
high-risk
patients, but is not required for every unit.
B2. Clinical Unit Ward /OP

A designated area for outpatient care that reasonably protects
the patient from transmission of infectious agents and can
provide appropriate patient isolation, administration of
intravenous fluids etc

Provisions for prompt evaluation and treatment by a transplant
consultant/senior physician available on a 24-hour basis.


Nurses experienced in the care of transplant patients.
A nurse/patient ratio satisfactory to cover the severity of the
patients’ clinical status.
Note - Inspector must make a judgement on these issues.
B2.3 Other required services
• A transfusion service providing 24-hour
availability of CMV appropriate and irradiated
blood products
• A pharmacy providing 24-hour availability of
medications
• For allogeneic programmes, HLA testing
laboratories accredited by the European
Federation for Immunogenetics (EFI)
B2.Clinical Unit - Evidence
• Facilities - On site tour
 isolation facilities
 air handling (for high risk patients) - should be documentable
from a facilities management office.
 hand washing
 signage
 designated OP area - Can it be used for infusions?
• Nurse staffing
 Are there enough nurses available to cover the patients’
needs?
 Can nursing staff provide for >1nurse/patient if required?
 documentation / Interview senior nursing staff
• Safety issues
– Documentation (SOPs, training logs)
– Observation and Interview (safety training)
B 3. Personnel
B 3. Personnel

Team - including requirements for paediatric BMT
Programme director (PD) – qualifications, training,
responsibilities

Other senior / consultant physicians - qualifications,
training


Mid-level practitioners - training and competency

Nurses - training and competency, policies and SOPs

Consultants in other specialties – qualifications

Other staff (co-ordinator, dietitian etc)
Programme Director
 Responsible for all administrative and clinical operations,
including
 selection of patients and donors,
 collection of cells, and processing of cells whether
internal or contracted services,
 quality management (can be delegated)
 Review of all AEs
 oversight of the medical care provided by the
Programme including medical care provided by the
physicians on the transplant team.
 verifying the knowledge and skills of the physicians of
the transplant team.
PD - Evidence
•
check he / she
– is responsible for administrative and
medical operations of the Unit
(interviews, minutes of meetings)
– Reviews the care of the attending
physicians (interviews, minutes,
outcomes audits, appraisals)
Other Staff - Evidence
Senior Physicians
• CV
• Training documents ; letter from PD etc
• CPD documentation
• interview
Mid level practitioners
• competency record
• interview
Other Staff - Evidence
• Nurses
•qualifications in haematology
• in-service training log
• personal CPD record
• centrally kept competency record
• SOPs for nursing procedures
• interview
• Other staff – seek confirmation of
•transplant co-ordinator
•pharmacy staff
•Dietetics
•social support
•physiotherapy staff
•data management staff
B 5. Policies and Procedures
(SOPs)
B5. Policies and
Procedures
Evidence



Look at SOP for SOP


Ask staff about SOPs – where and how to access

Ask to see how deviations are documented
Look at selected SOPs – can request prior to visit
Look for evidence of document control - approval,
date implementation, data review
Observe if staff use the SOPs while carrying out a
procedure
B 6. Donor evaluation,
selection and care

Evaluation procedures

Consent
B6. Donor EvaluationProcedures 1




and
procedures must address risk of disease transmission
to recipient and risk to donor from collection
There must be written criteria for donor evaluation
and selection.
The use of a donor not meeting the criteria must
require documentation of the rationale for his/he
selection by the transplant physician and the
informed consent of the donor and the recipient.
For allogeneic donors, A transplant physician must
document in the recipient’s medical record the
prospective donor’s suitability before the recipient’s
high-dose therapy is initiated.
* unless otherwise specified applies to allogeneic
autologous donors
B6. Donor Evaluation Procedures 2

Procedures must be in place to ensure both
confidentiality of donor and patient health
information.

Any abnormal findings must be reported to the
prospective donor with documentation in the donor
record of recommendations made for follow- up
care.

Issues of donor health that pertain to the safety of
collection procedure must be communicated in
writing to the collection facility staff.
B6. Donor Evaluation Procedures 3

Prospective donors must be evaluated by medical history,
physical examination and laboratory testing.

The medical history must include at least the following
 Vaccination history
 Travel history.
 Blood transfusion history
 Questions to identify persons at high risk for
significant transmissible infections.
B6. Donor Evaluation Procedures – 4
IDM
B6.6.1 Within 30 days* prior to (each) collection, each donor must
be tested for evidence of infection by the following communicable
disease agents:
Human immunodeficiency virus, type 1
Human immunodeficiency virus, type 2
Hepatitis B virus
Hepatitis C virus
Human T-lymphotropic virus, type I**
Human T-lymphotropic virus, type II
Treponema pallidum (syphilis)
Cytomegalovirus) (unless previously
documented to be positive)
*HTLV will only be required if there are specific risk factors
B6. Donor Evaluation Procedures
Other tests

Allogeneic Donors



HLA-A, B, DR typing by an EFI-accredited
laboratory.
ABO group and Rh type and appropriate red cell
compatibility with the recipient.
Pregnancy assessment for all female donors of
childbearing potential *
* In 3rd edition assessment must be within 7 days of stanting
conditioning of allgeneic recipient or of stanting mobilisation if
autologous donor
B6. Donor Consents
 Informed consent from the donor must be obtained and
documented by a licensed physician or other health care
provider familiar with the collection procedure
(for allogeneic donors, before the high dose therapy of the
recipient is initiated.)
 The procedure must be explained in terms the donor can
understand, and must include information about the
significant risks and benefits of the procedure and tests
performed to protect the health of the donor and
recipient and the rights of the donor to review the results of
such tests.
(Does not specifically have to be written info but probably
should be)
B 7.Therapy administration

High dose chemotherapy

Administration of HPC
B7.000 Therapy Administration
B7.1
There must be a written policy to ensure that the preparative
regimen is administered safely.*
B7.1.1.1
The treatment orders must include the patient
height and weight, specific dates, daily doses (if
appropriate) and route of each agent. Pre-printed
orders should be used for protocols and
standardised regimens.
B7.1.1.3 The pharmacist preparing the chemotherapy must
verify the doses against the protocol or standardised
regimen listed on the orders.
B7.1.1.4
Prior to administration of chemotherapy, two
persons qualified to administer chemotherapy must
verify the drug and dose in the bag or pill against
the orders and the protocol, and the identity of the
patient to receive the chemotherapy.
Similar principles for radiotherapy
B7.000 Therapy Administration
B7.2
There shall be a policy to ensure safe administration of
cellular therapy products.
B7.2.1
Two qualified persons must verify the
identity of the recipient and the product
prior to the infusion of the product.
B7.2.2
There must be documentation in the
patient’s medical record of the unit identifier
for all infused products.
Therapy Administration
Evidence
• Therapy administration
– Ask to see protocols in the Unit and Pharmacy
– Review patient charts to confirm treatment given
– Interview pharmacist and nurses about normal
practice
– Ask nursing staff about chemotherapy training
– May watch treatment being given to check practice
against SOP
B 8. Clinical Research
B8. Clinical Research
 requirements
 Formal review of investigational treatment protocols
 Documentation for all research protocols
 Informed consent
 arrangements for financial disclosure
 evidence
 Are investigational protocols undertaken?
 If yes
see
protocol
see ethics Committee and R&D approval
see patient info sheets
See evidence of patient consent
B 9. Data Management
B9. Data Management
• The Programme must
– keep complete and accurate patient records.
– collect all the data contained in the Minimum Essential
Data Forms of the EBMT.
– use its data to periodically audit patient outcomes.
• Evidence
– on site audit of notes/ MED A data
– audit reports, annual reports etc
• Note
– Outcomes are not a standard
– Reporting to the EBMT/IBMTR is not a standard
B
10. Clinical Unit Records
B10.
B10.5
Records
Records In Case Of Divided Responsibility
B10.5.1 If two or more facilities participate in
the collection, processing or transplantation of the
product, the records of each facility must show
plainly the extent of its responsibility.
B10..5.2
The Programme must furnish to
other facilities involved in the collection or
processing of the product, transplant outcome
data in so far as they concern the safety, purity
and potency of the product involved.
i.e. Engraftment data, AEs
Clinical Programmes – Most Common
and Important Deficiencies
•B6
- Donors
•B6.3.2
- IDMs not tested within 30 days of collection
•B9
- Data management
•B4.10.4 - Corrective actions
•B2.6
- Outpatient area
•
- Discharge
Common problems with
Clinical Programme
• Different units not functioning as a single programme (lack of common training, common SOPs, close and regular
interaction)
• Training of medical staff not documented
• Quality management problems
– Adverse event reporting not adequate (e.g. adverse events
not reviewed by Programme director
– No regular audits or infrequent audits
Common problems with
Clinical Programme
 SOPS
•
SOPs
– references not included
– examples of forms and labels not appended to
SOPs
– SOPs not reviewed annually
•
Inadequate document control
•
deviations from SOPs not documented
Common Problems
Patient / Donor issues
 No record of verification of patient’s diagnosis
 Not clear if donor is always informed of abnormal
results and if arrangements are made for follow-up
 No formally documented criteria for defining suitable
donor
 Not clear how the decision is made to use a donor
not meeting the programme’s selection criteria
 Pregnancy not always assessed in female donors of
childbearing age
B6.000 Donors - Problems
• Lack of written donor information
e.g. collection procedures and risks of GCSF, 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
Testing for IDMs
• B6.1 states that “there shall be donor evaluation
procedures to protect the recipient from the risk
of disease transmission from the donor”
• B6.6 “Within 30 d prior to collection all HPC
donors shall be tested for evidence of clinically
relevant infection – HIV 1/2, HBV, HCV, HTLV
1/2*, syphilis
• Deficiencies – medical history doesn’t include
the correct questions
- specific tests e.g. syphilis omitted
- not repeated if SCT delayed
Data Management
• B9.1 describes the requirement to collect
all TED/MED-A data
• At a minimum – patient outcomes, donor
screening and testing and recipient 100d
mortality
• Deficits – incomplete or incorrect forms,
lack of engraftment data
- clinical status at SCT not well recorded
- lack of chemo prescription, date of
administration not recorded